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308 CIGARETTE LABELING AND ADVERTISING-.1985 have dealt specifically with the reaction of the lung to various chemical injuries, including the comparison of the changes observed to the malignant changes seen in animal or human lung cancer. This re- search has been supported for a number of years by grants from the National Institutes of Health. Several other of my research projects have also been supported by the National Institutes of Health as welll as by other health agellcies. I have supervised for a number of years trainees of the National Cancer Institute and fellows of the Amerlcan Cancer Society. I have recently been invited to participate in an Internat.ional Conference on Lung Tumours in Animals in Perugia, Italy, in June 1965, at which time my experimental work in this field will be presented. My research work has dealt essentially with the reaction of the lung to various injected irritants; such as, food, milk, gastric juice, alcohol, and weak hydrochloric and nitric acid solutions. In many of these experiments, striking changes were observed in the bronchlall epithe- lium. Some of these changes were so severe that they looked like tumors and many areas closely resembled human cancer of the lung. They also resemhled the changes described by Auerbach and his co- workers in autopsies from lungs of heavy smokers. We then at- tempted to produce lung cancers by injecting nitric acid and studying the animals for long periods of time. We also modified the experi- ment by giving cortisone to the animals, in soine cases after the injec, tion of the chemical into the lung, in other cases by beginning cortisone treatment at different time intervals before the injection of the cheml- cal into the lun . In many animals a picture resembling human lung cancer was pro~ueed. Ilowever, in animals studied for long periods of time, both the lesions resembling cancer and those resembling the picture in human lungs of heavy smokers,gr adually disappeared. In connection with the question of a possil~le causal relationship he- twoon cigarette smoking and cancer of the lunt;, I shoidd like to snhmit. the following tlu~ee conclusions and a brief discussion of my reasons for arrivinl; at. the.5e c,oinslusions: (1) Statistical evidence accumulated thus far is strong enough to suggest, tho possibilit,y of a comiection between cigarette smokingand cancer of the lung. This possibility should be investigated furt.her bti= all available scientific methods including further clinical studies, statistical data, chemical analysis, and animal exlxiriments. (2) The evidence submitted thus far by proponents of the theory that lung cancer is caused by smoking (including the C'ommitteee ap- P ointed by the Surgeon General to analyze available data on the snl~-- ct) does not constitute scientific proof of this theor,y, Acceptance of this theory is not only unscientific but dangerons since accehtance of this theory will lead to complacency concermng the etiology of this disease and mlght•, well preyent fruitful investin ation along other lines. (3) Existing researcli programs should be continne.d and new ones developed in an attempt to determine the cause or causes of all cancers including those of the lun~,~. Among some of the possible causes of lung cancer needing further study are virnses, industrial or occupa- tional exposure, atmospheric pollution and chronic inflammation and scarring of the lung such as occurs alter influenza, bronchitis, bron- chiect.atiis, and many other benign lung conditions. . CIGARETTE LABELING AND ADVERTISING-1985 309 My reasons for conclusion No. 2, that it has not been scientifically proven that cigarette smoking causes cancer of the lung, can be sum- inn.rized as follows: Tbe evidence quoted by proponents of the "ei-arette-smoking lung- cancer theory" is generally of three types: (1) 9tatistical or epidemi- ological; (2) animal experiments; and (3) hulmin clinical and autopsy studies. It is my belief that the only strongl,y sngt;estive evidence taia;t smoking may be a factor in lun;g cancer lies in the field of epidemiol- ~Lry; in other words, the statistical evidence. There are a number of widely quoted studies siiggest.ing that people with a history of pro- longed and excessive cigarette smoking have a higher incidence of lnnl,• c.ancer than the general population. However, even among epi- demiolo;*ists and statisticians there are nnmerons diffPrencesof opinion and varions interpretation5 of these studies. In a recent. analysis of 1,229 lung cancers at the University of Bonn in WPst Germa.ny by Poche, Mittman, and Kneller, the authors found no connection at. all between smoking and cancer of the lung. They divided the patients with lung cancer into three groups-nonsmokers, light smokers, and heavy smokers-and found the same incidence of lung cancer in all three --roups and the averu.ge age of occurrence of the cancer in all tlur.e, groups was exactly the same. Of the different factors they st.ndied, occupation was the only important positive factor, sug~*e5t.ing to them that indnstrial exposure may be related to lnnr c.aaicer. This stuily dealt with all forms of lung cancer but espec.ially .vith the scluaanous cell or epidermoid type, which is the one most frequently cited in the reports by proponents of the smoking lmig-cancer link. Sinee I am not an epidemiologist or statistician I will not. attempt to analyze the statistical evidence critically or in detail. I will list, however, some of the more important general obje.ctions to the Gtatis- tica] conclusion that smoking is a cause of lung cancer. These objections have been recognized in many statistical studies. (1) Over 95 percent of smokers, including heavy smokers, do not develop lung cancer. (2) Lung cancer of all types including squamous cell (or epider- moicl t.ype) occurs in nonsmokers. (3) There is relatively little cancer of the mouth, nose, throat, or trachea, although these areas are more exposed to cigarette smoke than the lungs, and the incidence of cancer in these organs is not increasing. (4) Lung cancer occurs much more frequently among men than women, and the disparity is growing, although smoking among women hns been common now for about 40 years and smoking among -women has been increasing rapidly during that period. (5) The incidence of lung cancer varies widely between different localities, as, for example, between the States of New York and Idaho and the cities of New Orleans and Atlanta. There is also a 1ighe.r incidence of lung cancer in urban populations as compared to rural. (6) There is more lung cancer in England than in this country, •de:5pite the fact that heaty smoking is more common in this country. 'Many other criticisms, both of inethodology and interpretation of the statistica.l surveys, have been made by qualified statisticians and ,epidemiologist.s. E~'~'ss9zooT

310 CIGARETTE LABELING AND ADVERTISING-1965 The second type of evidence quoted by those who believe that cigarette smokin~ eauses lung cancer is animal experimentation. To mo the experinientail evidenco presented thus far has little or no ap- plicaLion to tlie probleiu of human lung cancer.. It is true that soine skin caneers have been produced by application of the so-called tobacco tar totlle skin of tumor susceptible animals. However, similar canceis can be produced in tlie sl:in of sensitive animals by painting the : l:in with a variet.y of substances including sonie conunon f«Nls. No oiie has produced lung cancers in experimental animals by ex- posing them to cigarette smoke, although this has been tried by many research workers and many animals have been kept in ali atmosphere filled with cigarette smoke for prolonged jieriuds. 1'liese animyls develop cerhiin chunges in the bronchial epithelium similar to those seen in tlie lungs of heavy smokers at autopsy. IIowever, none of the animals with these changes have developed lung cancer and when the animals are removed from the cigarette smoke the changes gr.ulu- ally disappear. Uu the other hanT cancers of the lung have been )roducetl in animals by inoculation of viruses (Rabson) and by in- ~iaiat.ion of viruses and aerosols of hydrocarbuns which are substances present in high concentration in ga,5oline fumes (1{otin). Changes similar to those seen in hiumn lungs of heavy smokers and changes even more suggestive histologically uf cancer can be produced in a variety of ways in experimental animals. For exainlile, in my own experiments which I have mentioned in which rabbit lungs were dai.niaged by a chemical agent such as gastric juice, hydrochloric acid, alcoliol, or nitric acid and especially in severall groups which were pre-. t.ieat.ed by administration of cortisone, there were striking changes in the bronchial lining similar to but more severe than those described in human sinokers' lungs. However, none of these animals developed lung cancer, and although the animals were studied for lonf; periods of (nne after exposure to the chemicals the changes gradually disup- peared. The importance of these observations is thiit it is not always possible to predict biologic behavior from histologic appearance, and in the case of the changes described in human smokers' lungs I do not believe it is proper to call these malignant or premalignant lesions. They occur in too many benign conditions. In brief, animal experi- rnents have contributed nothing directly applicable to the problem of cif;aret.t.o smoking and human lung cancer. 1'he third type of evidence quoted by proponents of the "cigarette smoking eiiuses lung cancer" theory is in a general group of clinical and autopsy studies. Here again the clinical evidence is statistical and the statistics are subject to the same defects and objections already described. The autopsy evidence quoted is confined largely to several studies carried out by Auerbach and others in which certain changes in the lining epithelium were described in the lungs of heavy smokers. `'he5e changes have been interpreted as premalignant or as leadin;; to lung cancer. There is no solid evidence to suphort this claim. The changes are not specific for stnokers; they ma l>d seen in a variety of beaiil;n conditions, and they may be produce~ex~~~erimentally bot~i in linigs of animals exposed to cigarette smoke and a variety of other materials without evor leading to lung cancer. In experimental ani- nnils, they can be shown to disappear after the irritant has been re- a CIGARETTE LABELING AND ADVERTISING--198b 311 moved. This, as far as I am concerned, elimi_nates the application of these observations to human lung cancer. I propose to show a few slides today which I hope will explain some of the things I have said. I have mentioned there are three 1wincipal types of evidence used by those who believe cancer of the lungs is caused by cigarette smoking-that is statistical, hurnan autopsy studies, especially the studies of Auerbach, and animal ex))ernuents. 1'lie observations and slides that I propose to show are concerned priinarily witli the second type, Auerbacti's report, but also involve sonic experimental observations. Auerb;icli's thesis briefly is in his studies of human autopsies certain changes were consistently demonstrated in the lungs of smokers, and that these changes showed a progressive development to cancer through the following stages: hyperplasia, metaplasia, carinoma in situ, and invasive cancer. Other pathologists have also found an in- creased incidence of squamous nietaplasia among smokers, but have not found the incidence of carcinoma in situ cited by Auerbach, and do not aurree with his conclusions. The slides will show several things. First, normal lung, and bron- cliial epithelium, second, squanious metaplasia of the type described by Auerbach, in people who have never smoked. And, then, the re- semblance of cancer of the lung in a nonsmoker to cancer of the lung in a smoker, and the resemblance of each of these to a cancer of the larynx in a nonsmoker. Fourth, metaplastic changes in animal lungs, resembling the changes described by Auerbach, except that they appear histologically even more malignant, in which long-term experinients have shown that these changes do not progress to cancer. I will try to show the slides. For purpose of orientation, I have here a normal lung from a 10- montli-old baby who died of meningitis. But the lung is not involved in the disease. This is just to try to give you an idea of the pattern of t,lie lung, so you can see the comparison with the slides I show later which show tumors. Slide i: This is the normal air space. This is a blood vessel here. This is the breathing space of the lung. In the next slide, I will show this under a little higher power. Slide 2: This is the actual air space. The air comes into this space, and this is where the oxygen passes through the lining of the alveolor wall and gets into the red blood cell. These orn.nge-stained bodies-here and here-are red blood cells. This is where tlie carbon dioxide passes out into this air space, and the oxygen passes into the bloodstream. Slide 3: This slide shows the air passage itself-in other words, the bronchial tube, or bronr.hus, and shows the structure with which we tLre concerned. Most of the clianges we talk about-squamous metn- p1:Lsia, lung caneer, and so forth, occur in this particular area. 1'his is the muscular wall of the brotu;hial tube, and this is the etii- tlieliuin. You can see the lining of tlie epitlieliuni here contains these structures whicli are called eilia. Ne hear a lot abo_ut the cilia, ]x.c.ause the cilia ltelp in the niechanism of clearing out tuiy foreign material that gets in t.he lung. r , C ., Ya I r i VC5969?'U0T

312 CIGARETTE LABELING AND ADVERTISING--1965 'I'his is the normal appearance, then, of the epithelium lining the bronchial wall. This is alll in the same 10-month-old baby and there is no change in this epithelium at all. Slide 4: This slide is from a woman 53 years old who had never smoked, but who had a condition called bronchiectasis. And this change, squamous metaplasia, in this woman corresponds to the change described by Dr. Auerbach. Over here we have the normal epithelium. Here is the cilia. And this is the normal lining up to here. And then we have this peculiar chan ge in appearance of the cells. You see that these cells in this are:% look different from this other area. And that is referred to as squamous metaplasia. But this occurred in a woman who had never smoked and who was 53 years old. The next slide, please. Slide 5: Now, this is a lung cancer, a squamous cell cancer, or epi- dermoid cancer, occurring in a 51-year-old man who was known to be a heavy smoker. I think you can see by comparison with the previous slides that there has been a complete loss of pattern or the architect,ure of the lung. T he normal lung is gone. And here we see these nests and sheets of cells. I think in the next slide we have a higher magnif cation. Slide 6: This again is from a lung cancer from a heavy smoker, showing a little higher power. You see these cells which are rather pink staming , and urauged without any definite pattern into sheets and nests. :1nd this is .vhat is called a squamous cell or epidermoid cancer. '1'he next slide, please. Slide 7: This comes from a 54-year-old man who had never suloked-had never smoked a cigarette in his life. This case came up several nlouths ago at one of our tumor clinic meetings in our hospital. Tlle man was still alive-the lung has been removed at surgery. We had several doctors go up and take independent histories. All doc- tors reported that this man stated very firmly lie had never smoked, and no one had ever seen him smoking. T his is asquamous cell carcinoma of the same kind as the previous one shown. It could not be distinguished by any pathologist from a squamous cell cancer occurring in a smoker. This sanle day that we were discussing this case at the tumor clinic, there was a young doctor present who said that that did not surprise him, because his father had just had asq-uamous cell cancer removed in a New 1 ork hospital and his father, because of religious reasons, had never smoked anything. The next slide, please. Slide 8: This is a higher power from this same man who had never smoked iit all, showing these same large pink-staining cells, and the nests and sheets of cells which have completely replaced t•he lung structure. So this is an example, then, of a squ:unous cell carcinoma in a man who haui necer smoked. The next, slide, please. Slide 9: Now, this is another squamous cell cancer. This cancer occurrml in the larynx. And this was from a 53-year-old man who had CIGARETTE LABELING AND ADVERTISING-I965 313 never smokeil at all-ci~nnr.ttes, pipes, or anything else. This sho~~s 1110 ries<,ml/lslnce again to the ap1>c,lrallce we saw til st in the cancer of I he Inan ~eho suloke~l aild, ~:colul, in the cancer of the lung of the man ai-ho:lid not. timoke. In these last sli~les we h;u•e sllown three examples of snuamous cell caucer-two of the lung nnd one of the larynx. One occurred in the lung of a smoker, one in the lung from a man who had never smoked, awd the cancer of the larynx was in a man who had never smoked. The next slide, please. Slide 10: Now, this is an example of what is called squamous meta- pl:lsia, rather severe squamous metaplasia, in a 63-year-old woman who had a disease called scleroderma. That is a disease avhicll involves the connective tissue of the body, and often involves the lullgs. And here are similar appearing cells, or similar cells-thev ~ :u•e not tlle same, but they are similar appearing cells all throuhh here. You see the loss of the pattern of the lung. It does not have Ille normal breathing space arrangement. And this is called stin.i- nlous metaplasia,. But this is in a benign condition and is not malig- naut at all. 'I'his change occurred in a nonsmoker. This woman had never smoked. Slide 11: This is another example of severe squamous metaplasia in n 45-yea..r-old woman. This woman had never smoked. She had severe rheluuatoid arthritis, and these changes here, all through here, are similar in appearance to t.he cells that we saw in the squamous cell cancer, and they are similar to what Dr. Auerbach has described in his studies as squamous metaplasia, or even carcinoma-in-situ, and yet this lesion is essentially benign-it does not progress to cancer. Next slide, please. Slide 12: 'tlll5 is a slide from a 14-year-old boy who died of a dis- ca~e c.tllc~cl Cutiliing'S disease. This boyhad never snloked. And here is an example of another area of inetaplnsia that might on casual in- sl,ex•tion look like a mnlitinlant gland or like a cancer. This is not Illal1g11:Lllt at 1Lll. - - Next slide, please. tilide 13: '1his is a nodule in a rabbit lung. We had givell these rabbits cortisone for aweek, and then injected a weak solution of nitric acid into the lung. Thisis a week later, showing this nodular tlhpeara.nce, the loss of a pattern of the normal lung, and an appear- suice resembling tumor. I think this could easily be mistaken for a cancer. Now, beginning at this point we will deal with experimental slides. I'llese are rabbits and all of this material, by the way, is from tuy oavll nuiterial, and I have done till this work, incltuiin; studyinl; the slides anll taking, the pictures. 't'he next slide. Slide 14: This is another area from the rabbit lung, showing a large no/hdo of tllese atypical cells. There are some features that look like a, Irnaligliant tumor In some of these. In fact, some of these slides were es:unmei by patholoh•ists who thoul;ht they w~ere malignant. But, o11 1011g-tel7n studies, and careful obserl-,itio_n, nll of the.5e chaulges di.ajll/ealyd over a periodo€ months. T le next slide. 48-824-65-21 SE~969ZOOt

314 CIGARETTE LABELING AND ADVERTISING-.1965 Slide 15: This is a higher magnification, from one of these rabbits in a similar area, 5howing the loss of pattern. This cell here shows what is called a rlutotlc figure. Ordinarily this is considered an indication of malignancy. An increase in the nmu- ber of lnitotic figiu'es is one of the characteristic features of cancer. This slide also shows large atypical cells. These red-staining bodies are called nucleoli. They are prominent here and they are also protui- nent in cancer. So )'ust looking at this pattern alone, you could easily calll this a can- cer when, in fact, it is not. The next slide, please. Slide 16: This is another area from the rabbit lung, showing the loss of norma..l pattern, and this is an area in which the npealYtuce could be mistaken for what is called an adenocancer, a glandular-t.ype caalcer, in contrttst to the others, which look more like a squamous cell cancer. This is the last of the slides. '1'he C1iA1RMAN. Doctor, the practical observation- Dr. MoRAN. Mr. Chairman, could I interrupt you just a minute? I have a few sentences more in my prepared statement. Tlte CIIAIR111AN. Very well. Dr. MORAN. The following conclusions may be drawn from the slides presented. (1) Cancers of similar type such as squamous cell cancer or adeno- cancer look and behave alike regardless of the site of origin in the hody (lung, larynx, esophagus, uterus, and so forth) and regardless of whether the patlentluid a history of smoking or not. (2) Changes of squamous metaplasia such as those described in lungs of smokers are also seen in many people who have never smoked. These changes are associated with a large variety of inflanunatory and reparative changes in the lung and are not to be considered as lnuli~-a- nant or premlignant or as part of a series of changes which eventunllu lead to lung eancer. Dr. Auerbach's thesis, then, of a progression ciP changes in smokers' lungs leading to invasive cancer is not substantiated. In summary, I wish to submit my opinion that there exists enough evidence of tt statistical association between cigarette sitlokiug and lung cancer to justify considerable additional research in this aI'ea, but that the cause or causes of lung cancer, as all human cancer, has not yet been scientilica.lly established and rep;earcl>, into its causation along atll pos- sible avenues of approach is urgently needed. (The attachments to Dr.lltoran's statement follow:) CUaR[CULUM VITAE-THOMAa J. MOBAN, M.D. Born : October 14,1912, Rennerdale, Pa. Residence: Creekside,l2anville, Va. Degrees: B.S. University of Pittsburgh, February 1936; M.D. University of Pittsbnrgh, School of Medicine, June 1936. ,ltotating internship: Mercy IIospital, Pittsburgh, Pa., 1936-37. Iter+ident in pathology, assistant pathologist, and director of laboratories at Pittsburgh City Home and Hospitals, Mayview, Pa., from September 1937 to April 1:142. U.S. Navy, April 1942 to January 1946. Patholol;lst, Welborn Memorial Hospital, Evansville, Ind., January 1946 to December 1946. Pathologist, the Memorial Hospital, Danville, Va., December 1946 to Sep- tember ep- tember 1960. f CIGARETTE LABELING AND ADVERTISING-.1985 315 Pathologist, St. Margaret Memorial Hospitnl, Pittsburgh, Pa., September 1950 to November 1954. Also, director, John C. Oliver Memorial Research Foun- datlon, Pittsburgh, I'a., uud assistant professor of pathology, University of I'ittKbarkh School of Medicine. .lyyociate professor of pathology, University of_ Pittsburgh, School of Medi- cine, +ind director of laboratories, Presbyterian, Woman's, and Eye and Bar Ilospitals of the University of Pittsburgh Medical Center, November 1954 to July 1958. !'rofe,sor of pathology, University of Pittsburgh School of Medicine and di- rw•tor of laboratories, Presbyterian, Woman'x, and Eye and Ear Hospitals, July 195S to Augast 19(i2. Director of laboratories, the Memorial Hospital, Danville, Va., August 1962 to present. :1leFnlmr: American Medical Association; American Association of Pathologists thologists & 13acteriologists; American Society for Experimental Pathology; American Soc iety of Clinical Pathologists • College of American Pathologists • Pennsyl- rnuia Association of Clinical Pathologista; International Academy of Pathology • Patholot;ical Society of Great Britain and Ireland; College of Pathologists (Great Britain). Diplomute: American Board of Pathology (pathologic anatomy and clinical pathology). I3IDLIOORAPHY-TIIOMAB J. MoaA:v, M.D. Chroinophobe Pituitary Adenoma with Simmonds' Disease: Case Report with Autopsy, J. Lab. and Clin. Med. 26:128t1, 19_ 46, with Dr. George H. ,Fetterman. Anomalies_ of the Circle of Willis in Relation to Cerebral Softening, Arch. Path. 3':251, 1941, with Dr. George xi. Fetterman. Food Aspiration 1'neumonia, Pennsylvania M. J. 45:810, 1942, with Dr. George If. Fetterman. Thi~ Cold Agglutination Test, U.q. Naval Medical Bulletin, 1944, with Dr. George II. Fett.erman and William li. tlews. Rapid 111ethrKl of Staining Tubercle Bacilli with Tergitol No. 7, Am. J. Clin. Paith. 17:75, 1947, with Merle L. Radcliffe and Isabelle 11. Tevault. Pulmonary Embolism in Nonsurgical Patients with Prostatic Thrombosis. Am. .I. Ciin. Path. 17:211; , 1947. Necropsy Incidence of Tuberculosis in a Hospital for the Mentally 111, Diseases of the Chest, 14 :132, 1948. RPiapcing Febrile Nodular Nonsnppurative Pannlcnlitis, Report of Case Treated %vith Penicillin, Ann. Int. Med. Y.9•958, 1948, with Dr. Alfred J. Niedermayer. Autoi.vy Incidence of Pulmonary Embolism in tloronary Heart Disease, Ann. Iut. Med. 32 :949,19si0. Autopsy Incidence of Pulmonary Embolism in Tuberculosis, Diseases of the eh est, 1 s :171,19:,0. Eslx'rimental Food Aspiration Pneumonia, AMA Arch. Path. 52:350. 1951. l;habdomyosurcoma with Fatal Ilemorrhage from Intestinal Metastases, Am. J. Clin. Path.22:401,1!1:;2, with Dr. Frederic C. Leshner. Congenital Goiter with Death from Milk Aspiration Pneumonia, AMA Arch. I'ith.54:213,1952. Milk Aspiration Pneumonia in Human and :lnhnal Subjects, AMA Arch Path. 55 :286, 19ri.4. Pulnuinary Edema Produced by Intratracheal Injection of Milk, Feeding Mix- hires, nnd Sugars, AMA Am. J. Dis. Qhild. 88:45.19ri3. T'ibro-ant.hracoHiq of the Lungs in Elderly erly Individuals in a Smoky City, Diseases of the Chest, 24 :C,58,19.ri3. Experiniental Aspiration Pneumonia lII. Pneumonia Produced by Intratracheal Injection of Carbohydrate Solutions, AMA Arch. of Path. 57:194, 1954. Granulomas of the Stomach 1. Granulomatous Reaction to Damaged Smooth itlusc•le and Fibrous Tiysue of the Human Gastric Wall. Am. J. Clin. 1'ath. 23:115, 13L4, with Dr. Frank E. Sherman. Granitlomas of the Stomach 2. Experimental Production by Intramural In- jection of Foreign Material Including the Animal's Gastric Juice, Am. J. Clin. Path,'14:922_,1954, with Dr. Frank E. Sherman. I:xperimental Aspiration Pnetunonia, Ain. J. Path. 31 :579, 1955, Abstract. Experitnental Aspirntion Pneumonia. IV. Inflammatory and Reparative Changes Produced by Intratracheal Injections of Autologous Gastric Juice and Ilydrochloric Acid, AMA Arrh. Path. 60:122,1955. 9~5969ZOOZ

316 CIGARETTE LABELING AND ADVERTISING-1985 l'lxlmrimental Aspiration Pneumonia. V. Acute Pulmonary I9dema, Pneumonia, nnd Bronehiolitis Obliterans Produced by Injection of Ethyl Alcohol, Am. J. Clin. I'ath. 27:3110, 1957, with Dr. Il:. Richard IIellstrnm. Studie~q on llrhronovi9, Aat. J. Path. 3.3:591,1967, Abstract. Studies on Ochronosis. 1. Report of Case with Death from Ochronotic Nephro- sis• AMA Arch. Path. (41:40, 1!)57, with Dr. Jeanne A. Cooper. rs. 18nthonlntons Biliary Cirrhosis, Tr. A. Am. Physicians 70:243_, 1957, with Drs. J. D. Myers, Jessica Lewis, and Robert Olson. PsE'udoxantlimua Elasticum. J. of Gerontology 12:429, 1957, Abstract, with Dr. A. I. Lansing. Studies on the Nature of the Abnormal Fibers In Pseudoxanthoma Elasticum. AMA Arch. Path. G5:e88, 1958, with Dr. A. I. Lansing. Asian Iulluenza and 111itral Stenosis. Report of a Case with Autopsy. JAMA 1G/i :1407, March 1958, with Drs. J. A. Rock, and A. i. Brande. The Ilistolo~;y of "Farmer's Lung." Arn. J. Path. 34:6t3.5, 1958, Abstract with Dr. R. S. Totten. Farmer's Lung: Report of Two Cases with Lung Blopsies. Am. J. Med. 25:803, 1958, with Drs. R. S. Totten, D. II. S. Reid, and Il. D. Davis. The 1'athoeenesik of Exlerimental lironehiolitis Obliterans. Am. J. Path. 34 :1100. 19;i8, Abstract, with Dr. H. R. Hellstrom. Bronchielitis ObliteranR. An Experimental Study of the Pathogenesis nnd Use of Cortisone In Modification of the Lesions, AMA Arch. of 1'ath. 66:091, 1958, with Dr. II. Ii. IIeilatrom. Studies on Enrlogenous Lipid Pneumonia and Blood Lipid Levels In Cortisone- treeted Rabbits. J. Clin. Path. 11 :6 51, 13).58, Abatract. Familial Muscular Subaortic Stenosis • An Unrecognized Form of "Idiopathic HCart Disease", with Clinical and Autopsy Observations, Circulation 21:11i7, 1!NiO, with Drs. L. B. Brent, A. Aburano, D. L. Fisher, J. D. Myers and W. J. Ta ylor. EtTects of Cortisone on Atypical Cellular Proliferation In Rabbit Lungs. Proc. Ain. As>9oc. Cancer Res. 3:157, 1900, Abstraet, with Dr. R. S. Tott.eu. Cortisone and Atypical Pulmonary "Epithelial" Hyperplasia. Effects of Pre- treatment with Cortisone on Repair of Chemically Damaged Rabbit Lungs, Ain. J. Path. 38:.ri75, 1961_, with Dr. R. S. Totten. Studies oa Ochronosis iI. Effects of Injection of Homogentisic Acid and Och- romMic Pigment In Experimental Animals. Am. J. Path. 40:359, 1lN12 with Eduardo J. Yunis, M.D. DiaM•tic and Cortisone-Induced Renal Lesions. A Morphologic and Immuno- hiqechemieal Study, Lab. Invest. 3:240, 1962, with Drs. Stanley M. Kurtz, and J. J. Vazquez. Cortio-one-InduccKi Alterations In Lipid Metabolism. Morphologic and Serologic Observations In Rabbits. Arch. of Path. 73 :300,1i1Fi2. Villous Tumors of the Rectoyigmoid Colon with Severe Electrolyte Imbalance. A t`,anRe of Unexplained Morbidity and Sudden Mortality, with Dr. C. L. Wens arid l)r. N: M: CooPer. The Am. J. of Cl: Path. 37'507, 1tN12. Weight Loss In Cortisone-Treated Rabbits-F.ffects of Streptomyvin and Penicil- liu. AitLi Arch. of Path. Sept. 1aR.4, vol. 78, pp. 330-332. I)r. DioeAx. Thank you.. '1'lre C'llMtcarnx. I)octor, thank you for this interesting presentation. I tiulrpose, we probahl•y could consider this a graduate study cotn'se. It hot5 Iteen ~'ety reveuling and interest ing to me. I qas alrout to ask earlier-as an ordinary layman-what,you have shown here clenlonstrntes the failnt•e of the lung to take sutPicient oxy- gen to surply the body because of the condition which you have stated to the committee; is that true$ Dr. MORAN. If the process involved enough of the lung. Usually in the ordinary lung cancer there is not enough of the lung involved at least at the lreginnln'-, to cut off oxygen to the entire lung, so the patient nlay live a long time with a lung cancer, unless it becomes so extensive thnt. almost all of tite lunfi tissue is lost. The CHAIRMAN. I had reference to cancer as well as the other con- ditions you showed. 4CS969?'00t CIGARETTE LABELING AND ADVERTISING-1985 317 Now, you showed a picture of a lun~r that was affected, these poclcets-the pockets where air was taken in were closed up with the cells that you showed. Dr. DIoIIAN. Yes, sir. The Ctrnlnrrnx. And the more of those-I buess with the under- standing I have, I call them cells-tite more of those cells thatt fill tip those pockets, the less room there is for oxygen to go into that lnnh; is that right? llr. MORAN. That is correct. However, in the animal slides which I showed, these nodules are not present everywltere. They occur irregularly in some parts of tllet llutt;. Tlte animals are still able to bretlthe. And the animals that do live- a few of them die. But the animals that do live, then lose these nod- ules, and the changes disappear. In other words, it is not a lulifornl pt oce.ss inv~olvinl; the cnt ire lungstrttcture. Tho CHAIRMAN. I realize that. iVe talk about the cituse and so forth. Would this indicate tltat. the man who has an enot'mous chest expansion has a very fine 1un~; that is capable of taking in at lot, of oxy;;en, and a mall who cloesu't have tunclt of a chest expansion better jpet his lnn~,~ analyzed? I)r. MORAN. I think this would be a dilficult, question to answer. I don't, think chest, expansion alone would be a complete index. I am afraicl my chest has heen expanding solne, iuld yet it doesli t mean thatt I_ cnn breat.he any better. '1'lte CtreeRltrnx. Well, it is a very interesting analysis. I personally w;tnt t.o thank ou for it. Mr. RogerY rir. l:rnir:es of Texas. Thank you, Mr. Chairman. 1)octor, I am sorry I was not here earlier, because I looked forward to your testimony. But there seems to be agreat deal of concern insofar as the legislative processes are concerned, that the words "tnay" "ma,y be detrimental to health," or hazardous to health, is not sufliclent. The people who have come in and undertaken to press this matter, including the Federal Tra.cie. Commission, take the position- and lhe scientists and some of the doctorr;---that they must have the word as a definitive straight statente.nt that cigarette smoking is haz;trclous to yonr health. Now, after listenin9 to the last part of your testimony, which was very interc6ting, it came to my attention some of the things that are in these summaries cost the taxpayers of this Nation apparently quite a bit of money to find out. Now, I notice in this booklet on smoking and health, by the nepart- ment of I[ealth, Education, and Welfare, on page 376-1 read a sti>.te- ment the other day whic•h we thought was a great find. It says: Although smokers are different from nonsmokers psychologically and4socially, there are mnny differeaces amoug Rmokers and atnons nonsinokers, so t1rat Rnwe smolcen, may be like sonre uonsmokerq. Would you at,ree thcn thatt finding was tlhte ? I)r. MORAN. I am afraid I ctllulotpas.g on that. particular statement. I,jnst don't know enout;Il about the psychology of either smokers or itonzmokerR. ;\Ir. R(Hn-:es of Texaq. I think it. is imporhlntt in that they lulve used the words "sotue smokers may be like solne nonsmokers,"'httt I don't.

318 CIGARETTE LABELING AND ADVERTISING-19t15 think it, required a lot of taxpayers' money to find this out. I could have told t.heni this before they went t.o all this trouble. Now, in No. 4 they say smeking a~pears to he not one behavior, but a range of psychoh>gtcally diverse liehaviors, ettcli of which mtiy be iuclncecl lty a dltl'ereut coiubination of factors and may serve ditferent needs. TLerefore, no single explanation can sullice. Then, otl N o. 6 they say : There is sugge.yted evidence that early stnoking may be linked with self-isteem and status tieedls, although the uature of this liukage is open to different itder- pretatious. Well, now, thatt was a profotmd finding if I ever heard one. But yett this s,uue group of hco1~le came in, after all of these stateutents-.uxl they are ,ill tln•ouhh the book. llere is another one: luerea,ixl mortality of smokery 1.'rom cirrho.,is of thee live.r has lwen rhown in the liruspectire studies. The data ute not sutti(•Ient to sulyi"rt at direct or causal association. Now, thosc• kind of statements are all through here. Yet those svue lx-ople ca..tne in here and stttted as a de,finite, tixed conelusioai, inany of them, that every person who sntohcs ci;;strette•s is u ITeet iu-, his health. 11'h,lt 117uukl he your orinion on it, sir? -ree with those who I)r. MottAN. Well, I can only say that I do not ag have re')orte~l that it is l~roven, that smokin+; causes cancer of the Ittn~. I dis i,ree with this viewi)oint. 1, too, have observed through the text, through the body of the report, that there are many qualifying statements in it, such ats "may be," "presunirtibly,° "presumptive" atnd that sort of thing, which do not appear in the conclusions which have been pretty widely hub- licized. While I think in general the report is a very fair one, I have no- ticed that it did not include those qualifying statements in the con- clusions. And Ithink this is one thnlg about the report that I would disa"ree.vith. Mr. Roea:RS of Texas. Now, Doctor, in some of the conclusions they say they have testified here that there is a definite connection between enihltysetua and smokin~,•. Now, the conclusion stated in this booklet, on page 302, says: A relationship existe between polmonary emphyAema and cigarette smoking, but It hns not been establiehedthatRhe relationshipis causal. 1\'ow.what. doesfihat mean ? I)r. AhMA:v. Well, I think it just means that a certain number of Peol>le ha.-e, emphysema, and a certain number of people smoke, and the stattstics do not show clearly .vhether this is just coincidence of nn occurrence of emphysema in people who smoke, who may have some- thing else n•hich is really causing the emrhysemaa or whether the cig- arette smoking presuniably causes it. In otlter words, they just don't know. 11fr. RO:FRS of Texas. Tsn't it a fact, Doctor, tltat if one man had emhhy~selna and also smoked, there would be a relntionshiP be.cmtse all of tlte activities are occurring in one body, although there mit;ht not he anyassoi-iat ion at all between the two? CIGARETTE LABELING AND ADVERTISING-1965 I)r. MORAN. I think that is correct; yes, sir. 319 Mr. iiooFns of Texas. So actuttilly the finding that they have said there is a relationship means nothing, insofar as the issue involved here is concerned. I)r. 11ioRA`. I would agree with that; yes, sir. Mr. Roaens of Texas. I think that is all the questions I have. Mr. l'ounger? ;1[r. Tou:.GSR. Tltankyou. I think, Da•tor, you, have made a very good contribution. But for a layu~an, it only adcs confusion and compounds it, because we have very goo(l doctors come in with reports that they are very rositi~•e ~that sn10king does cause lung cancer-and we have >ti nlunUer of other dnctors who testify ns ,you do, from the wealth of their experience. This puts us in a biul positioii of trying to reach a decision-when the e,xtwt^Is all clisarre_e.. That is one of the niost, confusing things that we have. And yet tlle Federal t'rade Cominission just took one side of the question. You clidn't testify before the Federal Trade Commission, did you? Dr. DIoR.uN\o_, sir. Mr. I oL*aca:r. T)o you know anything about the hearings they held ? I)r.11[oaA-,--. No, I do not, sir. Prr. Yorxclat. You don't know whether they were generally adcer- t iscd, or-the doctors wc•re not.ified so they coula testify $ I)r. AinttA`. I don't know a thing about it. 3 f r. YoUNCF.R. Tltank you very much. DFr. R4x:Fns oF Texas. Mr. Iiornegay ? D[r. IcoltNFOAY. Thank you very much. First I want to thank you, Doetor, for coming before the committee with your great, knowledge of the suh~'ect matter. It is very helpful to have this information and the benelit of your many and long years of experience. At the risk of showing the extent of my ignorance, I have two or three questions. Dr. Moran, you testified that there is a cancerous cell called the squamous cell, or squamous carcinoma, or whatever you term it, that is found in the lung-is that correct,sir? I)r. MORAN. Yes, sir. Mr. r. KORNEGAY. Is that the most common type of carcinoma found in the lung? Dr. MORAN. Yes, I think squamous cell cancer would be the most common type. :1fr. KcinNEOAY. Well, now teill the committee whether or not that same type of carcinomaa or cancer is found in other areas of the body. Dr. hfoltnN. Yes, es, it is very commonly found in many other areas. it is particnilarly-- Dfr. K(1RNF.(7AY. Are these areas such that they could have no possible irlationship between that area and cigarette smoking? Dr. MORAN. They are areas that certainly could have no possible exhcsure to cigarette smoking, the most common being cancer of the cervix of the uterus in women. 11fr. KnnxFOAY. This is the same_ type of cancer that is most cotn- nlon in the lungs, is that correct? sCsssszooi

320 CIGARETTE LABELING AND ADVERTISING-1985 Dr. blosAN. Yes, sir. Air. I10RNFAIAY. Now, you also state on page 4 of your statement that lung cancer occurs much more frequently among Inen than women, and the disparity is growing. By that I take it that you mean th;it, tlle clistance between the two, or the differential in the incidence of cancer between men and women is increasing each year. Dr. MoItAN. Yes, sir. Air. KoItNEG,tY. Is there any scientific reason for that, or do ,,ou have snty idea as to why men are more suscept ible to lung cancer t}ian women 4 1)r. MORAN. No, I do not have, and I don't think anybody knows. We know that nien are more susceptible to a nuutber of diseases, and this happens to be one of them. Tlle average life expec•tancy of nlen is a 1>prox nnatel,y 5 years less than for wommn. MI'. I1CORNF.(7AY. If you relate that to the percentage of men and the percentage of women who smoke, ]tow does it stand, or what is the cotnparison in that case? l)r. MORAN. I do not have the figures. I really don't know how many people in the country or how many people in any given area of the country smoke-men or women. I think this is one of the hard things to evaluate in any of the statistical studies. I believe that mauy more people smoh:e than do not snioke, and this makes it hard to evaluate the figure5. llr. hAItNF.(IAY. Now, the work that you have done and shown us llero in the area of lung cancer-did you, as a pathologist, perform tlte autopsies? Dr. MORAN. Yes, sir. Mr. I1ConNEaAY. Did you make the slides? Dr. MORAN. I dicl not cnt and stain the slides. That is done by technicians. But I have read a,ll the slides.-that is, I have looked at them personally under t.he microscope in all cases, selected'the areas for photographs, and took the photographs. 9Ir. iioxNEGAY. And who collected the histories? Dr. DioleAN. I collected the charts and reviewed the histories given by the doctors, and in some of the cases-in the one case in particular which I showed the slides of, the patient was still alive. Tllis was a surgical specimen. And we had several doctors go up and check on the history there. Mr. KoaNEtaAY. You have personally clone a considerable amount of .vork going into the process of the operation, the autopsy, the his- tory taking, and the reading of the slides? Dr. MottaN. Yes. All tlle pictures that I showed I went. over the sl ides personally and reviewed them myself, and took the pictures. Air. KORNEGAY. I don't know whether this is a fair question or not, Doctor. If it is not, yon just tell me so. The question Is-wouid it be extremely difficult for a medical man, assuming even that lie is an expert in this area, simply to take the slide, without having done any of the procedures before staining, and come to any accurate conclu- sions about what the slide showed, wllat were the results and what condition was depicted in t1le slicleF Dr. MORAN. Well, I am not sure that I can answer that question. I would say it. would depend on t.he circumstances, it would depend on who was handling the rest of the material, who selected the slides, anil -who did the autopsies. s~sssszoot CIGARETTE LABELING AND ADVERTISING-1965 321 11ir, KORNEGAY. Put another way-would you be in a much better position to come to some accurate conclusions if you were exposed to the case and had knowledge of the case from the standpoint of the liistory of tlle individual involved, the autopsy, and all the way down tlie line•I l)r. AIoRAN. Well, you would be in a better position, yes. But I wuiilil not want to say that it, is always possible to do it tllatway. I think in a l cr;e study you have to Iely-cert;linly for the histories-on soulehotl-v~ eltie. The patltologist has tot anyhow. Air. I1oRNEt.AY. Now, yon said that it is very easy to make a mistake in the appearance of solne of the conditions of the lung-that is, to call thein precancerous. I believe that was the term that Dr. Auer- l,aclt, who was here ,yesterdt y, used-precancerous lesions. Could one i»isl il:e a benign condition for a precancerous lesion? 1)I. MORAN. Yes; I think this is a very easy mistake to make: and it is one of the areas in which there is the greatest clitl'erellce of optnion .unonti pathologists. Mr. Kt,nNE(..tY. As I gather from your statement here today, based u>on your_ experimentation \~•ith animals palt__icularly, that inhalation of smolcemay change the appearance of the lung, but wllen that in- ha l,it ion is rentoved, tlteu the cluulge ;;oes away. Dr. 1folt.vN. That is correct; yes, sir. Al r. 11CuRNEC::cl. A nd it resumes its orlginal appearance. Dr. AIot::%,v. Yes sir. A ft. KoRNr.GAY. jliow, I)r. Aloran, are you familiar with anil have von studied the report of the Advisory Committee to the Surgeon (weneral on Smoking and 1-Iealth? Dr. MORAN. Yes, sir, I_ have. Air. KonNtx:AY. Now, based upon that report, Dr. Dioran, in your opinion is there sutlicient evidence to link cigarette smoking witll )ullg cancer and to justify and warrant the labeling of every package of cigr;irettes with a warning which has been proposed by the Federal Trade Commission to the effect that cigarette smoking is dant,rerous to health, and may cause death from cancer or other diseases? Dr. riolznN. Well, I think this is the problem that you e ntlemen have to decide. I have given my opinion to the best of my ability, which is that it is not proven that smoking causes cancer ofthe lun~, and other people have testified otherwise~ And I think this is the problem that ongress has to decide. I really cannot say on that. I can just give my opinion. Air. I1CoIINEGAY. Yes, sir; I understand. All I am asking for is your opinion-whether or not this report of the Advisory Committee of the Surgeon General on Smoking and Health is sutficient. proof that smoking-cirarette smoking causes cancer of the lung and that citarette packages should be labeled. Dr. MORAN. No, sir; I do not believe that. Air. KORNEGAY. Thank you very mucil. I aln very grateful to you, I)octor, for coming here. Thank yon, Mr. Chairman. The CHAIRMAN. Air. Satterfield? Air. :iATFERFIELD. No questions. 1'he CHAIRMAN. Mr. h'arnsley I Air. FARNSLEY. Thank you, Mr. Chairman.

322 CIGARETTE LABELING AND ADCERTISING-19t15 Doc•tc~r, the nearest I ean figure out, giving the bene..fit of the doubt to the report of the Surgeon-General-which is 18 uwnths ola has there been ntuch research in the field siuce then, public•ations available4 1)r. MORAN. I think there has been a~*reat deal of research in the area. I cloir't think there have been any significant c•nntributions to tlie tmclelstandin g of the problem, or any further adclitional experi- mental or clinic.al work which wonld help one way or the other. Mr. F.%RN6LEY. You feel that the facts were in at that timc and they have not chan;~ed, is that right-the best knowledge in the fiekl 1 Dr. MoR:%x. I feel that the information that, was available to them then is the same information that is available now to anyone who tries to evaluate the situation. AIr. FA1;NL8EY. I brought a clipping in the other dat~-it is in the record-psychologists saylng they thought-one t*roup' of 72 percent that had had cancer had had a history of depression when they were young. And they felt there was a correlation. Ilad you ever heard of thattheory$ I)r. MoRnx. Well, I have heard of such, yes. I cannot say I am very enthusiastic about them. But I cannot deny them, either. Sir. FARNSLEY. I)o you feel you are competent to have an opinion iu t hat field $ I)r. A[oRAx. No, sir, I do not. Mr. FARNSLEY. I found another one. Another one is that some of them think it may be virus that Inay be the cause. Is this a new theory $ Has this been going on a lond tilne $ IIow do you hold with that one ? Dr. MORAN. 'the virus theory of causation of cancer is not a new theory. It is an old theory. It was dropped for some years or par- tially dropped. But there has been a revival of it, and at the present time there is considerable evidence that at least solne cancers are caused by viruses. Experimentally cancers can be produced by viruses. There has been some recent research work in human cancers now that indi- cate that viruses are probably responsible for certain human cancers. So I personally feel that the virus study is a wide-open field. I think this is shown by the development of interest in this field by some very outstanding scientists. For instance, the men who developed the polio vaccines-Dr. Salk and Dr. Sabin-they are both working now on the relationship, or a possible relationship, between viruses and cancer, and both feel strongly enough that this may be the cause that they are doing experimental work in this field. Mr. 1•'AnNSLEY. You say this theory is old and it was dropped and then has been taken up again. When would you say it was taken up a~ain $ Dr. 31foRAx. Well, I probably shouldn't have said that it was dropped. All 1 can say is that probably for a period of about 15 years or so there was no additional evidence to help support it, and in the last I or 5 years, a number of things have developed which have revived interest in it, and now many people are working on the re- lationship of viruses to cancer. Mr. FARNSLEY. More now than any time in the last 20 or 30 years d Dr. MoRnN. Yes, sir. Mr. FARNSLLI.YY. All ll I can find is clippings. I don't have the learned journals you have. OVS969700Z CIGARETTE LABELING AND AD1'ERTISING-1965 323 I found another one. Somebody thought male hormones were mixed up in this thing. I-Iow do you feel about thnt $ I)r. MORAN. Well, this is one of the theories that has been ad- vanced, and I think there is no question that the hormones altect cet•- taut types of cancers. Sometimes_ favorably, sometimes unfavorably. As far as the relationship to cancer of the lung, I don't know whether there is any evidence to indicate a hormone relationship. It has been discussed. But I don't know what the answer is. Mr. FARNSLEY. Can one man keep up with the literature in this fieid $ Dr. MORAN. No, sir; I am sure of that. At least I cannot. Mr. FAI.NHLEY. That is what has been going through ncy mind, with the smattering of social science I have got.. We are tohl-I (10 not kuow-08 percent of the members of the AM.1 agree with the Surgeon's report. I do not know if they agree or disagree. Dr. 11[ounN. I would say first of all I doubt very much that. 98 per- c•ent, of Hre members of the AMA agree with the Surgeon General's report. I doubt this very strongly. I do not.. know what percentage agree. I;ut I think many of the Inen, for instance, who are not keeping np with the specific literature in cancer of the lung have to accel->t something like the Surgeon General's report. The fact that a certain number of men who are in practice of surgery or general practice, or internal medicine, may accept this cloes not necessarily prove that they know anything about t it, any more than at)elson who reads it in the newspaper. l~ir, FARnrsr.EY. You have an interest in this field, obviously. You have testified well, and you work in the field of cancer of the lung. And you say you are unable to keep up with the literature. Or is that all caneer liferature, or just cancer of the lung$ I)r. Afounx. 11'ell- Mr. FnRNSLr:Y. I am not trying to trap you. I am just trying to learn. 1)r. MORAN. I was thinking specifically of cancer in general, all aspe,-t,s of it-the experimental aspects of viral studies, the experi- mental a.spects of chemical studies. I try very hard to keel) up with all the literature on cancer of the lung. But even there I have diffi- culty. And I resort to not only agreat, number of patholop• jonrlials which I read all the time, but certain abstract journals which are published which deal with abstracts of the cancer literature. Even then I find it impossible to keep ttp with all of it. Mr. Fnexsl.EY. Iiow many scientists-that is scientists in tite health sc•.iences-would you say try as hard as you do to keep up with the literatnre on cancer of the lcmg$ Would you want to guess on that $ Dr. MORAN. I think it. would depend on the interest of the indi- vidnal. A man who is interested in lung cancer specifically would certainly make the same efCort that I do to keep up .rlth it. A man wh0 may be interested in diabetes or pneumonia or some other disease probably would only read occasional articles dealing with cancer of the lung. Afr. FAnxsLEY. I know we cannot get exact figures. Rnt ac a la,ymnn I do not know whether it would be 10,000 or 10 or 100 that niight keeli nh with the literature on cancer of the lung. ])r, MORAN. Iwonkl guess nott more than 1 percent of the doctors in t he c•ountly keep up with all the liternture on cancer of the lunh. .. (d. F E~ t ~, A . Y 4 p . t

324 CIGARETTE LABELING AND ADVERTiSING-1965 Mr. FARNSLEY. In tlie social sciences some men talk of aa cultairstil lag, and getting a vested iiiterest-they might feel sonle people get a vested interest in theories and reports and so forth. But you re- assln•ed me if there was a new committee to study this thing willl a completely ol)en mind that you do not feel a sihniticant change of philosophy since the Surgeon General's people stucliecl it? Ih•. Mors.XN. I said I did not think there was any additional infor- nialion that might Lelp any. Now, if you choose an entirely ne%v colunlittee, I think it would delencl upon the menibers you happened to uhoose wlu)t conrlu5icin they mifihtilrawt lint I do not: think that is the iuiportautt thint; that we need 1o c1o. I think ,.%•e have huc! enonl;h counnittees, and what we ought to do is develop the research progrquus and find out what the facts are. Mr. FAnxsl,r,r. I.Ij;ree Ai~itli that. I am not proposing another c•oln- Iuittee. I.uu just tryint; to tind out how valid tlle inforlnation before us is. .1re there any other theories as to what causes cancer or lung cancer that. we have not meiitioned? ])r. MorsAN. Well, I mentioned in the text the possibility of atmos- phericc pollatioll. Mr. FAIS'.,LSV. Ilow do you feel about t1latt one? ])r. MoIIAN. I just (10 not know the answer. I think it is agood ' pnssibilit~•. ;~onle of the experimental work, work by Dr. Icotin and I)I. 11'isel•y, where they have crombined viruses and oxidized -aso- 1ine, and have producer lung canceis in animals, I think may Le iL substantial Ste ) along this direction. I certainly 3o not, feel that smoke, industrial smoke, is any better for ns than cigarette smoke. 11f r. F.xei,st.r:v. I low ~Iboirt: automobile fumes? ility, I)r. MonaN. Well, I just do not know. I think that is a possibility, but I do not know the answer. Mr. FARNSLEY. Any other theories running around loose in your profession as to what causes cauc•er? I)r. MORAN. I think I have fouched on all the important ones. Mr. FAIeNSLEY. Thank you. Thunk •yotl, Mr. Chairluan. The CIiAIRMAN. I)(X`tor, I presume your grave concern about this problem is that if what has been proposed in the so-called Surgeon General's report is taken with full faith and credit-I do not.. indicate you nre taking any position but what there is scxne substantial that, c•redibility in the report-but as I gather from what you have said, this is only one of the probable causes of cancer. and if we proceeded, or if this is carried out, that it will no doubt relax efforts to try to overcome the other causes which you feel exist. Am I correct in that $ nr. MoaAN. I think,you have expressed itver•y well. My feeling is that• if everyone accepts the idea that cancer of the lung is caused by cigarette smoking, and that all we have to do is to putr on a big campaign to stop smoking, that we will not make any further progress on what really causes cancer of the lung. And I think that, research should be continued along all lines-fnrther in- vestigation of the possibility that cigarette smoking does cause cancer of the lung should be carried on. But also research into viral causes, chemical causes, or anything else that might be worth while. CIGARETTE LABELING AND ADVERTISING-1965 325 I do not think we should stop at this point because of a committee report which says that there is an assoclation. 'hhe CHAIIIDfA1T. l1'ell, now, would you disagree with this statement, 8 "As a matter of fact," as laymen we understand this a little bit better than we do these highly technical problems that you have men- tiuned here, "cigarette smoking is dangerous to health tuld may cause death from cancer~ and other diseases." ])I•. MonnN. 1Ve11, I cannot see any objection to a statenlent that ci;; Irette smoking Inay cause cancer of the hmg. I think this is one of the things that we are investigating as a possibility. I do not ob•jec•t to that statement. That ls, ttlat part of it. '1'IIe CIIAIRaiAN. Would it not'be more factually shLted-I am ask- ing if this would be correctly or not-that cigarette sulokinb, among other causes, is dangerous to health. What I have in inind, to see if I do understand it correctly-you are not sure that in a given case that the causation of that condition n is dno to cigarette smoking or something else. l)r. MORAN. That is corlect; yes sir. 1'lle CIIAIR1IAN. And do I Iulclerstand you correctly that there is no way now, with tLe research that you have, that you can tell whether it is caused from cigarette smoking or something else. I)r. MORAN. That is cc)rreot •, yes, sir. The CHAIRMAN. I believe it was the Chairman of_ the Federal Trade Commission who objected to using the language in aa so-called warning that it may be dangerous to your health, and lie stuck with the ti1711 conviction that cigarette smoking is dangerous to health. In otller words, there is no question about the-it is just a matter of fact, according to him. I lun not trying to argue one way or the other on the thing myself. I anI merely trying to make a record and get from you-you seem to have made such an outstanding contribution in this field, and I along with other people hopa you are able to continue yonr very fine Acork and your research and experimentation, because I feel it would be very valuable (town the road. And I hope whatever happens here, it does not in any way relax our efforts, through research, to get to tlle facts. 1 hope someday we may know. Irave you ever discussed this wit)h the committee of the American Medical Associat ion tha.t has given thought to this Proble.m ? l)r. MolraN. No, sir, I have not. '1'lIe CIInIRntAN. I think it would be an interesting tllin- if people sucll as yourself clid have a conference or a meeting for t7te purpose of discussing this whole matter. I must agree with you. I think we are trying " to arrive at a oint where we hope by passing a law or a rule down In the Federul 7~~ade Commission Ave c:ul do away with cancer of the iunl;-just by saying that, cigarettes are the cause of all of it. I agree with you. I think probably cigarette smoking does cause some difficulties. That is my own suspicion, shall I say. That is about all I can depend on. That is the w:Iy I feel about it. ])r. McinAx. I did not quite llear wha:t you said about what you agreed with me, sir. On wha.t? The CIIAIIeuaN, I agree witll you that I think some cigarette smolcing in some cases does cause some diHiculties. iVS969700Z

326 CIGARETTE LABELING AND ADVERTISING-1965 I)r. MoRAN. The most I am willing to say is that cigarette smok'tng - nt:cy cautie cancer of the lunn. I cannot say that it causes it in some cau•s, or It, does not cause it in some cases. I think it is a possibility i u ti~,me cases. But I cannot say for sure that it causes it. 11ir. Iiair:ns of Texas. Would the gentleman yield I I)octor, there are a great number of people who smoke cigarettes NO ho are healthy, are there not $ I)r. MORAN. Yes, sir. Mr. Ro(:ERs of Texas. And there are great numbers of people who are uuhealthy. who smoke cigarettes and would be just as unhealthy if they did not smoke cigarettesg I)r, NfoRaN. I think that is true, yes, sir. Mr. 114 x:rres of Texas. Thank you. Mr. `iA•iuTReIr:LD. Doctor,T would like to ask you one question. In listening to your statement and your answers, you indicated that the phrase "may cause lung cancer" would be acceptable. Would this be t he more acceptable way to phrase it, or would it be more acceptable to sny that it, maybe a cause of lung cancerY I)r. MORAN. Well, I have not actually said, as far as aa warning ]alxd-I have not even thought very much about that. I would cer- tainly say it would be more acceptable and more scientific to say it nuay be a cause of lung cancer than it is to say it is a cause of lung cancer. Mr. SATIFRFIra.D. Or that it may cause lung cancer? I)r. MORAN. I think that that is a statement I would be willing to make-that it may cause lung cancer. But I would not be willing to say it is a cause or the cause of lung cancer. Afl. S:%TTeRr•IFLO. Would you say it may be more accurate to say it may be a cause of lung cancer than that it may cause lung cancerf I)r. DIoRAN. I think either of those statements would be all right.. May be a cause of lung cancer would probably be the best statement. Mr. SA7I~:RFIr:r.n. Thank you. Thank you, Mr. Chairman. The CHAIRncAN. Doctor, thank you very much. We appreciate your presentat ion. I)r. \foRnN. Thank you, sir. The CIIAIR11fAN. Dr. Douglas Sprunt. STATEMENT OF DR. DOUGLAS H. SPRUNT, PROFESSOR OF PATH- OLO(3Y AND CHAIRMAN OF THE DEPARTMENT OF PATHOLOGY, UNIVERSITY OF TENNESSEE Dr. SPRIINT. My name is Douglas Ii. Sprunt. I am professor of pathology and chairman of the department of pathology at the Uni- versity of Tennessee. I received my undergraduate aegree at the Uniyersity of Virginia and my M.D. at Yale Unlverslty. I also re- ceivecl a master of science degree from Yale University, and stayed on at Yale on the faculty as an assistant, then instructor and then a Ster- ling research fellow. Thereafter, I was on the staff at Rockefeller Institute and, in 1932, I went to Duke University School of Medicine as an associats professor of pathology, before coming to t.lie University of Tennessee in Memphis in 1944. In addition to my positions at the University of '1'enne.%we., I have been chief of the laboratories of the city of Memphis hospitals. CIGARETTE LABELING AND ADVERTISING-1965 327 During World War II, I was consultant to the Secretary o€War on epidemic diseases and for several years I was consultant in niedicine to t.he Oak Ridge Institute for Nuclear Studies. I served for 4 years ou the Committee on Growtll of the National Research Council. I a,n a member of all five national pathology societies and have served as an oflicer for four of them, including the presidency of two of tliem, T IIe Association of Pathologists & I3acterlologlsts auid the Anier- ic,ul Society ociety for i.xperimental Pathology. I nnm a menlber of many other professional societies, all of which tire listed in tlie attached cur- ricululn vltae. I have published 93 articles oII the subject of pathology, ~u:uly of whicll dealt with cancer. A list of my publications is also attached. I have been interested in cancer of the lung for many years. Some of my early work involved studying the respiratory eplthelium and its reaction to various infectious agents and, in addition to my continuing work in this field I__ have followed the literature and 'the work of others in the field. ~ There is a considerable amount of statistical data which show an as.sociation between smoking and cancer of the lung. Statistical data is extremely valuable. I have used such data extensively in my own work and we have in our department at Tennessee a fuY-time statis- tician and several workers trained in the use of computer and other electronic equipment to aid us in analyzing clinical and experimelltal data. Statistical data, sllowing a high association between two factors, however, does not necessarily mean that there is a causal relationship between them. A statistical association may mean one of three thinb . It may be the result of chance, it may mean that the two related fact,ols uiay both be the result of some third factor or the relationship nlny I~e that one ne causes the other. To determine the meaning of a statistical association, it is necessary to go beyond the statistical evidence to the laboratory and clinical ex- 1wrience. In the labolatory, we do not accept statist.icti.l evidence alone, hut believe that if statistics show a close ussociation of two factors, we must show that one cau cause he other in the experimental animal before we can be certain a causal relationship exists between the two. To date, no one has prcKluced cancer of the lung in an experimental anitnal with tobacco snioke or with condensates extracted from tobacco smoke. Thus, laboratory confirmation of the statistical association 15 stilll lacking. It is true that cancers have been produced on the skins of aninlals by various condensates of tobacco smoke, but skin cancer in experimentul animals can also be produced by a number of innocuous substances, sucll as sugar, beef, et cetera. I c_lo not think one can attach any breat significance to this work. The clinical data likewise do not support the suggestion that ciga- rette smokin« causes lung cancer. There are maiiy observed incon- sistencies in t~te pat.tern of lung cancer incidence, which cannot be er- plained by any presently known facts relating to cigarette smoking or, for that matter, other suspected causal agents. The geograpllicatil dis- crepancies in lullg~ cancer incidence do not follow observed differences in cigarette constunption. For example, even though the annual con- sumption of cigarettes in England is less than in this country, the in- - -_ ZD5969700Z