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Philip Morris

Comprehensive Smoking Prevention Education Act of 810000 Hearing Before the Committee on Labor and Human Resources United States Senate Ninety-Seventh Congress Second Session on S. 1929 to Amend the Public Health Service Act and the Federal Cigarette Labeling and Advertising Act to Increase the Availability to the American Public of Information on the Health Consequences of Smoking and Thereby Improve Informed Choice, and for Other Purposes

Date: 16 Mar 1982
Length: 50 pages
2060465306-2060465355
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Acad Med
Academy of Psychosomatic Medicine
Advisory Comm
Am J Epidemiol
Am J Med Sci
Amed, American Medical Association
American Assn for the Advancement of Sci
American Board of Internal Medicine
American Cancer Society
American Chemical Society
American College of Cardiology
American College of Chest Physicians
American College of Clinical Pharmacolog
American College of Nutrition
American College of Physicians
American College of Toxicology
American Heart Assn
American Heart Assn Research Comm
American Heart Journal
American Lung Assn
American Lung Assn Occupational Health T
American Medical Women Assn
American Psychiatric Assn
American Public Health Assn
American Society of Clinical Hypnosis
American Society of Pharmacology + Exper
American Statistical Assn
Arteriosclerosis
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Boston Lying in Hospital
Boston Univ
British Medical Journal
Brown Univ
Burke Marketing Research
College of Physicians of Philadelphia
Columbia Univ
Comm on Drug Abuse + Alcoholism
Comm on Smoking + Health
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Cooperative Alcohol + Drug Abuse Comm
Cooperative Cancer Comm
Cooperative Mental Health Service
Council on Clinical Cardiology of the Am
Council on Epidemiology of the American
CTR, Council for Tobacco Research
Drug Abuse + Alcoholism Comm
Education + Research Foundation
Fda, Food and Drug Administration
Francis Delafield Hospital
Free Hospital for Women
FTC, Federal Trade Commission
Gallup
Gerontological Society of America
Group Health Medical Center
Harvard
Harvard Cancer Commission
Harvard Univ
Hebrew Union College
Henry Ford Hospital
Hew, Dept of Health Education and Welfare
Inst of Pyschosomatic + Psychiatric Rese
Intl Assn of Bioinorganic Scientists
Intl College of Angiology
J Chron Dis
J Epidemiol Comm Health
JAMA
Journal of Cardiovascular Pharmacology
Journal of Clinical Pharmacology
Journal of Gerontology
Journal of Marketing
Kaiser Permanente Foundation
King County Medical Society
La Dept of Health + Human Resources
La Ethnogenetic Disease Assn
La State Univ
Lancet
Lenox Hill Hospital
Ma Memorial Hospitals
Marketing Science
Medical College of Pa
Mi State Univ
Michael Reese Hospital + Medical Center
Nas, Natl Academy of Sciences
Natl Research Council
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Natl Security Agency
Nci, Natl Cancer Inst
NEJM
New England Deaconess Hospital
New England Pathological Society
New England Society of Pathologists
Nih, Natl Inst of Health
Niosh, Natl Inst for Occupational Safety & Health
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Ny State Mental Hygiene Medical Review B
Philadelphia Geriatric Center
Princeton Univ
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Roper, Roper Org
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Society for Experimental Biol + Medic
ST Francis Kavier Cabrini Psychiatry Ser
Stanford Univ
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Task Force on Occupational Health
Ti, Tobacco Inst
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Axelson
Belamaric
Bell
Bodeau
Buell
Burch
Butler
Carson, R.
Creagan
Framingham
Fraumeni
Friedman
Goffman
Hammond
Holme
Hutchison
Lillienfield
Mason
Murphy
Naeye
OOI
Pendergass, E.
Purdy, A.
Rantakallio
Reif
Roberts, J.
Rose
Rothschild, H.
Russek, H.I.
Schrauzer, G.N.
Selikoff
Seltzer, C.C.
Sommers, S.C.
Sterling, T.D.
Stror
Surgeon General
Thomas, L.
Tokuhata
Weiss, W.
Wind, Y.J.
Yerushalmy
Litigation
BCNJ/PRODUCED
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2060464895/5406

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Rothschild, H.
Russek, H.I.
Sachs, B.C.
Schrauzer, G.N.
Seltzer, C.C.
Sommers, S.C.
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Wind, Y.J.
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Lenox Hill Hospital
Simon Fraser Univ

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90E5qV000Z • • TABLE 7:3 Perinntal deaths r®on6 all infants and anang lan- birthneiaht infanta bY mothar's snokinp status in faur larno studlos . Per cent L.B.7. Infants Perinntal death.i/10C0 ,lll Infants T LBH Infants T Itnestirator Ro. of Ibn non Yoar BirTtl Smoker Non-smokar Smoker Snol:er Smoker Zmokrr Vtslernood & Associates (31) 1967 L8505 8.9 5.7 20.5 19.7 187.5 269.0 Bantekallao (50 1969 11931 6.1 3.5 23.4 23.2 287.5 S'.3.6 Butler & Co31ea6ues (zv) 1969 16994 9.3 5.4 1,4.8 32.4 268.5 2F..5 Yetwaalaym (,25) 1971 Rhite 9793 6.4 3.2 11.3 11.0 113.9 218.3 Black 3290 12.3 5.8 21.5 17.1 113.8 201.6 e Neorotal deaths only Tablm 31 Incidenaa of Ie.. birthweirht (LBr) mccaMCne to protein intake in sakere and non-emokera Number of pregnancies LBY in normal protein intake LB/ in low protein antaka Non-a+akera Light sekere Medtum sckers 470 189 - 224 16 out of 422 4 out of 173 S out of 175 3.78 % 2.3 % '•4 % 12 out of 47 9 out of 18 36 oat of 48 25.5 % 50 % 54 % LBY in all seakere: Normel protein: 14 out of 540 . 3.81 % Low protein: 53 out of 98 . 54 % All LBY infanta with low protein: 65 out of 95 = 68 % Heavy makers Total 127 1010 4 nut of 95 30 out of 865 4.2 % 3.4 % 18 out of 32 65 out ef 145 56.2 % 44.8 % Liqht makers (less than 10 cigarettes a day); Medinu makers (10-19 cigarettes a day) Nenvy vnokers (20 or more cigarettes a day) a m v 40 0 0 40 0 0 0 0
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10E09b090Z ~ 7 i ~ I.F G,1.K • _.___.,DrFFEREnCES IN aLRPNNC/GNT gEr4£CN L/FMf 140 HeeYY ]v.sERt F<.nr .vnirc• r+>r L/Lf• Z4 ~q µy..7 f .Car. )aea'.~..aYu/~.y 4fl •.---. L:7u r...e..+tt. cy....fw/a.y. '.~r M.un(~ ~n rCs P.4ds ef Il. .(t.+r Sv.M'ar+~ 4..e 1~/^r k e. d'qr.... iqr<. L [of4 tlL.lrrGti aF DlFFCRFU/QEf /N Wr./Ci/r (.Aln LMD BrtrMY/Ifj&/ /6ETVrSr D.sin A+'C srtrwe Itls..+..ves S.fr/ n. 1.6 ';.w rVk s 1 V.q.i FY•^ 17s - 90 20. 4^. ! m .. A A A 6 A I A A A 0
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• • ~ • 640 l • t 1 • P 6• l. v 4 ~7 . n u•y9 JY~2n.Xr..' ns~ 4 • E e' 1. 2. z 3• /. 5• a d 6. V 7. B, ~ 9. ~ >t 10. • -e 11. a W 12. 13. . 14. 15. 16. 17. 106 J 19. 20. 21. 22. 23. 24. W . W 641 a D.S. 5ur6.an-Crn.r.1'e Beport on S.okinB and Seelth 1979. B1*ch, N.C. & Coa.o., J.D. Sn D1s.d.urteBW Children: Beeltb. Butrltlon .nd School fnilure. Crom & Stratton. Ber York and Lendoo. 1970. Chuberlan, M., Chaabrrleln C., Borlet, D. R C1.Sr.ur, 1. on Brltlsh Blrth., 1970. Looden. B.ln.un, 1975. tho.oon, l.M. B111e.iea, v.1. & B72t.n, P.E. The 4..nwent of fetal Brnrth. Brlt. J. Obstst. C7naecol. U, 903 I11.1e7 A. & CSncald J.C„ 4. Perinstal Mortality 11.L.A.tnua, Bdinbur6h, P. 270. 1963. Drllllea, C.M. Brit. J. Ob.t.t. Olueeel. §1, 161. 1957 Binkq, M.T., Clell.nd, B.C. & Benr., B.J. (197B). i.. J. Obatet. Clnaacol. ]]1. D0'}$11, 1978 Orvenr.ld, P: B1o1. Beunot. 5, M. 1963 Miller, N.C. Bs..neis, M., & BanslelBT, P.l. ,b. J. OMt.t. Clneeeol. jj3, 55 1976 U.S. Svpon-CSner.1'. report on S.okio; and Be.lTh, 1973. Morri. J.M. l.ncet 1. 87. 1979 John.on, W.C. !r. J. Obet.t. Cln.acul. ]j$, 29. 1917 Cro.bl, B.M., Netenft, J, Co.ti1N, J.P. M.rnsh, M., Send.tead, B.M., Baeob, D.l. tlcLalr, P.B., J.ceb.on, C. M.Sd,B„ Durm, 0, 6.. J. OD.tet. Cln.esol. M, 22,,19/7 wi.rn B. D.n. MN. 0.11. jj. 146, 1916 Morrl., J.P. ! Pharo.b, P.O.D. L.ncet, i1, 252. 1979 M.e, L.C.S, L.ne.t 1. 976. 29/9 BwL, D. Br1t. J. Ob.tet. Clmecul. ¢,l, 746, 1974 Derie., D.P., Crq, O.P., Mlrood, P.C. ! lbernathl, M. Loeet 1, 'm5, 1976. N.a. 0. Laun.t 1. E.7 1 1976. Drl.r, N,D, A.. J. Obet.t. CPrseol. ]31, 6B8 197® Nq.r, M.D, Jont., D.J. a Ton.eoi., J.1. 1.. J. Bpideaol. jQ}, 464 1976 Mslo, B.L. Brit, J. Obat.t. Clerenol. M.$,, 732, 197B Tero.hal.7 J, L.J. Obet.t. Cltuenol. ]u, YrJ, 1971 l.n.lrlq 1. Y.J. Obstet. Clnneeol. j,U. 571, 19/1
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• • • 0 642 25. sil.ersen, D. Ia,J. Epide.iol. jll, 513, 17" • 26. Ce11u, d.P. Roaenfald, 0.R., & Baltqhta P,C, 27, 20, 29. 30. ea.J, oEstet. olnaenol. 1]$,, 1045, 1973 irie., 7, l.. J. OMtet, Oyeneeol, j~,j', 610. 1975 Butler, R.E. ! 1lberssn, &D. Edltors in Perlmtal Prebleos L1rlnEStooe, Edinbureh, 1969. Raeh, D. a Eass, E.E., L, J. Epideaiol. 36, 10), 1972 Rlsrosdsr, L,R. & Oerdaa, R. 1n Yeaan aod thatr Prsgoencles tol. 1 PbaldelPhia, 1972. 31, Certstoek, O,Y, Dbab, ' P,E. ! tlqsr, R,B, y, J, Obstet. Oyna.eel, jjj, 53, 1971 32. Und.rrood, P.B., Yesler, E,l. 0'Laas, J.R, e Ca1laBan, D.l, Ob.t.t. qrnaeeol. 11, 1, 1969 33. Rantekallie, P. Icta Padiat. eeaed, BopPl. 195 91. /abla, J. Canad. Rsd. Aean. J. 1Qg, 1104, 19T9 35. Raeer, B,J. Bo111nBwortb, D.R. R Carlsen J,Y. d Luotta, L. 1U'D.J. Obst.t. Oryseool. jjQ, 1080, 1974 36. SpellacJ, Y,1, Boh1, Y,C, a Birk. B,l. Ja, J, Obetet. Oypaaeol. ]T,j, 272, 1977 37. ll.ear J, & Brouke, 0,0, Lane.t 1. 1130, 1977 643 go 0 I am Dr. Jay 6oberta. Professor and Chairman of the Departrent of Pharmecology at the Medical Colleqe of Pennsylvania in Philadel- Paia l also have served as a consultant for the National nesearch touncll. NIM study section groups, end a number of private romPanies and laboratories. I have a,.., been a Research Associate on the consulting staff at the Philadelphia Geriatric Center. My current activities in the scientific research field include dir<ct laboratory experlmentation end editorial and reviewing F resooneibllitiae for scientific publlcations. I am on the Editorial Eoard for the Journal of Clinical Pharmacoloey, Journal of Cardio- vascular Pharmacology and Journal of Gerontology. The professional societies to which I belong lnclude the Lmerlcan Society of Pharmacology and Experimental Therapeutlos, the Society for Experimental Sioloey and Medicine and the American [ollege of ClSnical Pharmacology• I am a Fellow in the dnerican college of Cardiology., the College of Physicians of Philadelphia and the Gerontolegical Society of America. I have been asked to comment as a scientist on two bills pending before Congrese, YR 4957 and S 1929. My comments will be limited to the scientific points that are raised Sn the proposed legislation. My primary eoncern with both proposed bills is the conclusive nature of Section 2. A number of unanswered, scientific questions come to mind, 1. To what extent has the physiological and pathological channes associated with eoing been taken into account? 0
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• 644 Paqe Z 2. Where are the data that conclusively prove one-third of heart disease deaths are attributable to smoking? 3. How much and to what degree do occunational exoosures contri- bute to chronic disease statfetlcs? 1. What Is the relationship between smoking, aging and the physiological and psychological constitution of the lndividual] How do these relationships affect disease rates? While statistical correlations are lmportant and euqgestive.the eclentific conclusions reached need to be explored further. Smoking per ee is not the only factor or characteristic of smokers that needs to be examined in studies. For example, the effect of stress on the cardiovascular system In well known and exposure to high levels of etress for lonq perlads of time may have a major impact on the health of certain people. Another complicating unknown is the relationship between stress and smoking; why do people smoke and what does it say about their attempt to deal with stress? Our animal studies involving nicotine show that it produces acute cardiovascular effects. But we need to know more about the ehronic effects of nlcotine in animels. Similarly, we need to know more about how nicotine is handled In the human system and how this directly relates to changee in the cardiovascular system. My experimental work both in the cardiovascular system and in aging areas leads me to conclude that the factors involved in the idevelopment of chronic disease are complex. oespite extensive research in animals and observational work in humans, there are many unanswered questions why and how people develop diseases of the cardlovaecular system. Statements in the present bills, such as, '1/3 of the deaths attributable to heart disease are associated with • t 645 Paqe 3 rmokipg^ would seem to imply that the answers to the questions I reisa are already answered and no further scientific study of this patter is warranted. But one may ask whether the diseases of the prdiovasnular ayatsm in question are a natural result of the nging pracees or do other factors such as genetic background and lifestyle hablts initiate and promote the disease? Ae a acientist, I an interuted in research and its rols in Pcoviding reliable scientific informatlon. I believe throuqh further research the questions raised above could and should be answered. •
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• 646 Statement of Henry Rothschild, II.D., Ph.D. Introduction I am Henry Rothschild, a medical doctor and doctor of philosophy specializing in genetics, molecular biology and oncology, currently Professor of dledicine and Anatomy at the School of Medicine, Louisiana Slate University, New Orleans, Louisiana. Since 1962 1 have been engaged in research involving the genetic basis of disease and am director of the Louisiana Ethnogenetic Disease Association. I currently serve as consultant to the Louisiana Department of Ileaitti and Human Resources and am a member of the Research Committee of the American Heart Association of Louisiana. I have published over 90 scientific articles. \Iv Curriculum Vitae and list of publications are attached. Discussion Studies conducted in Louisiana have demonstrated an unusual dfslr,bvhon nl lung cancer mortality. The lung cancer mortality in white males in Lmiisiana is the highest in the nation, and in particular the 27 southern preponderantly rural parishes ranked in the top 3% nationally from 1950 through 1976 and has risen since then. Studies that I have been conducting since 1973 on this population indicate that genetic factors may play a significant role in this excess mortality from lung cancer. In our initial investigation we interviewed the next-of-kin of 234 of the 815 ~ persons who died of lung cancer during 1971 through 1977 in the 10 southern, nonurban parishes. We found that 109 (l3%) of the decedents had been employed for at least six months as sugarcane-farm workers at some time during their lives and that the relative risk estimate of lung cancer mortality lor sugarcane-farm workers was more than twice that of the eontrols. Neither employment in other industries rxx tobacco consumption could account for the elevated risk of lung 647 rancer mortality associated with sugarcane farming. we then began to explore the thesis expressed by many investigators nrluding a group from the National Cancer Institute (Got(man, et al.,, 1982) that there may be "an inherited predisposition to lung cancer,^ Studies have shown that there are genetidfactors associated with lung cnneer pathogenesis. It has been lound,for example, that first-degree relatives of individuals diagnosed as having P lung cancer have higher rates of lung cancer that cannot be accounted for by other factors such as age, sex, birth cohort, or cigarette smoking. It was also shown that a non-smoking first-degree relative of an individual with lung cancer has about a lour/old risk of dying of lung cancer when compared to control relatives. (Takuhata and Lillienfield, 1967, Tokuhata, 1964) A similar study reported an mrrrased r,tk of lung cancer mortality in siblings of mdivid•tals with lung cancer IpW_mem e~/9771 The argument ror the potential genetic regulation of tnmor incidence (Llodeau et aL, 1974) is supported by results ol studies indicating that many mouse strains differ In their incidences for specific tumor types (Murphy, 1966). In humans, a spectrum of different genetic predispositions for each tumor implies that a distribution curve of genetic susceptibilities exists for each tumor (Reif, 1981). Studles of distribution of cancer among different ethnic groups further support this proposition. Compared with whites, for example, blacks have a more rapidly accelerating incidence of lung cancer in the United States, Americans of Mexican and Chinese extraction (Buell et al., 1969; Fraumeni and Mason, 1974) also have a higher Incidence, and American Indians (Creagan and Fraumeni, 1972) a lower ittcidence. Chinese In Hong Kong have an unusually high prevalence of adenocarcinoma of the lung, a relatively Infrequent cell type in other areas (Belamarlc, 1969). In analyzying our data we obtained results that establish a strong genetic component for lung cancer in the Louisiana population. (Ooi et al., 1931). Of the •
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• 11 Yr 648 446 white residents of the target parishes who died of lung cancer during 197g 1979, we interviewed the next-al-kin of 323 cases. Of the )23 case families, 54 (16.5%) had first-degree relatives with lung cancer, compared with 16(5.3'ti) in 304 control lamilies. There were 61 (2.2%) lung cancers among the 2767 case first- degree relatives, compared with 18 (0.8%) in 2389 control relatives. This aggregation of lung cancer couldnot be attributed to differences in age at death, family size, or mortality. Six (1.8%) of the case families had two or more first_ degree relatives with lung cancer. First-degree relatives ol persons with lung cancer had, therefore, a lung cancer risk more than twice that of control relatives. Comparing case and control relatives by stepwise logistic regression indicated that a person's relationship to the person,with lung cancer, and the square ol a person's age, are the two strongest predictors of lung cancer outcome, even after controlling for the effects of age and sex. We are In the process of further investigating this population to attempt to ascertain whether any major genes can be isolated as being involved in the pathogenesis of lung cancer. II we can isolate such genes, it will be major step forward in unravelling the mystery of lung cancer causation. .` kg/LL4r[i?I/.Y.N • 0- Literature C:r-d nelamaric J: Cancer 4:560-573, 1969 nodeau P, de Saint-Maur P, Herreman G, et al: 5em Hop Paris 50:1161-1168. 1974, puell PE, Mendez WM, Dunn JE Jr: Cancer 22: 186-199, 1968. Creagan ET, Fraumeni JF Jr: J NaB Cancer Inst. 49:959-967, 1972. Fraumeni JF Jr, Mason T7: 3 Natl Cancer Inst 52:659-665, 1974. Fraumeni 7F, Wertelecki W, Blattner WA, et al: Am J.\Sed 59:145-151, 1975. Gnffman TE, Hassinger DD, Mulvihill JJ: JAMA 247: 1029-1023, 1942. Murphy ED: Characteristics ol tumors: Ingreen (ed), Bioloay ot the Laboratory Ooi WL, Rothschild H, Chen VW, et al: Clin Res 29:862A, 1931. Reif AF: Oneola 38:76-85, 1981. Tokuhata GK: Am J. Epidemioi. 89:139-153, 1964. Tokuhata GK, Lllienteld AM: J Natl Cancer Inst 30:289-312, 1963. • Henry Roth*hild, M.D., Ph.D.
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• 660 l am Dr. Henry 1. Rueeek, a practising specialist in the field of cardiovascular disease. I recelved my medical degree from the Royal College of Physicians 6 Surgeone In Edlnbnrgh, Scotland. Formerly. I was Director of Cardiovascular Research at the U.S. Public Hcailh Service Hospital, Staten Island. and Reeearch and Clinical Professor in Cardiovascular Disease at New York Medical College. In addition, I served as consultant In cardiology at several other New York area hoapitale. I am a Fellow of the American College of Phyelciane, the American College of Cardiology, the Council on Clinical Cardiology of the American Heart Aesoclation, the American College of Chest Physicians and the International College of Angiology. I am certified by the American Board of Internal Medicine and hold certification in the subspecialty of cardiovascular disease. I have published over one hundred and fifty ecientific articles and have edited erven booka cnncerned with diseases of the heart. Since 1968, 1 have bern Program Chairman for the Annual Cardiovascular Graduate Symposium for the Amcrlcan College ul Cardiology. I have been asked to comment on proposed legislation in the current Congress JH. R. 4957 and S. 1929) which contains several etatrmentn deecribing cigarette smoking ae a^cauee^ of heart disease. I would like tn direet my commente to thnse conclueions. For more than 30 years I have had a euetalned interest In idenlifling the (aclore responsible for the high ineidence of coronary heart disease among pereune living /n the United States. My early invesligationa conducled in young coronary patients and healthy controls 651 ileady indlcaled that emotional etreee of occupational origin was far more i,nportanl etatietically than high fat diet, obeeily, lack of exerclne or rigarette emoking In relatien 1. prevalence of the dieeaee. Those early observations led to our Investigation of the oceurrence of coranary heart disease in profeeeional groups In which there were significant differences 1. the demande and reeponelblHtiee of routipe employmenlL In a questionnaire survey which we conducted among 25,Otlo persons In 20 occupational categories, a striking correlation was found between the prejudged stressfulnese of occupation and the reported prevalence of coronary heart disease. Of further Intereet was the observation that the frequency and /ntensity of the smoking habit in different professional groups was directly correlated with the relative etresefulness of the occupallonal activity. Due to such confounding, we could not eay whelhersmoking is lndependently associated with heart disease or whether it ie elmply related to what may be the real culprit, emotional serese. My sludlee of emol/anat strese and c1in1<a1 experlence have led me to question the widely accepted view that high cholesterol, elevated blood pressure and cigarette smoking are the most Important factors in the etiology of coronary heart diseaee. The fact /e that these traditional risk factors sre often absent In new caees of heart disease encountered in clinical practice. Moreover, I believe one can queetion seriously whether preventive measures directed againettheee "etlologic" influences have been successful. In this regard, our analysis of data on American phyalclans over a twenty-year period showed thal there had been no eignificant change either in overall longevity or in average age at death 2. •
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• r 652 from cnronary heart disease. Thie observation made it evldent tn ue that ~.dher risk factors muet be involved because U.S. physicians are repnrted In smoke very little and no negment of nur eociety is more zware of the potential danRers of hypercholeelerolemia and hypertension. Further Insight Into the etiology of heart disease was obtained during our analysis of data from large population surveys. We observed that pereuns who had sto ed emokin of their own free will aclually had a ._ PC_.._-__ lower prevalence of coronary heart disease than persone who had never emoked. The original Framingham studies showed similar findings but no attempt waa made to interpret this anomaly. Our explanation is that pernons who discontinue emokinR for reasons unrelaled to medical necessity, fear or coercion, may poesees an unusual capacity for adaptation to etress and thus a diminished vuinerability to alheroRenic influencee. My clinical observations and research have led me to conclude Ihit while smoking of cigarettes ie harmful to the cardiac patient, many of the conclusions and findings about heart disease etiology need to be reexam- ined in a broader framework. Constslent and persuasive findings are being reported linking coronary heart disease to prolonged emotional stress, coronary-prone behavior patterns, sociocultural mobilily, and stressful life events. Obviously, If cigarette smoking is involved in the pathogenesls of coronary artery disease, the relationehlp Is far from clear and further research in needed in this complex area. Z-~ nrr/1. Russe 653 After graduating `ra-i ti:e U.1i:rrslt: of ni-:h: _ n-_ i }ledical School "with distinctior." in 1"72, T too,~ ship and post-graduate triiinin? at t1icF,=.el Reese Ilos~it.rl and Medical Center, and the Institute for Pyschosomatic and Psychiatric Research and Training, in Chicago, 1942-19M19. i Since that time, I have practiced psycitiatry and ps}•chosonat'ic medicine in a pre-paid Coop~rative Plan which delivers comprehensive medical care to S^attle, Washington, and its, environs. The Cooperative has 325 board-certified or hr_ard- eligible physicians who serve a population of 285,000, ana it owns and operates t:+o hos?itals comprising 450 beds. it is one of the first, and one of the largest, He+iltit Maintenance Organizations INaOi in the Gnited States. I am president of the Academy of Psychosomatic Medicine, Trustee of the King County tledicai Society a,i,e,d to the Drug Abuse and Alcoholism Committee, member of T!:^ Coope[ative's Cancer Committee, Baard Ilember of the Eduration and Research Foundation of the American Socie.'.y of Clini nl Hypnosis, and Chairman of its Research and Grants Con~ittee. I am past Chief of The Cooperative's Mental Ilealth Service (1970-72r 1976-78), past President of the American Medical Homen's Association, Ame:ican Society of Clinical Hypnosis, American PsychiatrlcAssociation's Seattle nranch, and past •
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654 Chairman of the Cooperative's Alcohol and Drug Abuse Committee. In my medical practice, I have seen thousands of patients and given talks to and met with thousands of'persons who shared my interests in community health and welfare. My curriculum vitae and bibliography are attached. The large body of psychiatric experience demonstrates that disease is a problem of the individual as a whole, and not an autonomous disturbance localized in a particular organ. The extraordinary complexity of the activities and reactions of man leads physicians trying to understand and classify them to talk about the mind and body as if they were distinct and separate entitites. The emphasis on specialization in medical practice of past decades increases this dichotomy of thinking. But, in every area, including smoking and health, we are dealing with a whole entity; an interrelated complex of underlying, constitutionally determined, physical and psychic patterns of behavior. Since causes of reaction are complex, so the causes of disease are multiple. The 1964 Surgeon General's Advisory Committee on smoking and health recognized this basic proposition: "A1l members," the Report notes, "shared a common conception of the multiple etiology of biological processes" and "all were thoroughly aware of the fact that there are series of events in occurrences and developments 2 655 Sn these fields, and that the end resnlt.s are thn nor r.'.f- of many actions and counteractions." What we cannot tell from simple statistical association--even if it is assumed that the association is real--is.whether both smoking and the various diseases statistically associated with it are correlated with other hidden factors such as psychological and physiological differences which themselves exert the true causal force. . Accumulated data suggest a number of reasons to believe this is so. In a presidential address to the American Cancer' society 20 years ago, Dr. Eugene Pendergass stated about cancer: "There is a distinct possibility that within one's mind is a power capable of exerting forces which can either enhance or inhibit the process of this disease." In a statement to the Congress in 1965, when the Congress was considering proposed warnings for cigarette packages and advertising, I warned that admonitory labeling of cigarettes could well fan the fire of youthful rebellious- ness, rather than deter smoking by teenagers. At that time, it.was long since well-known that public health officials had branded cigarettes smoking as deleterious to health. As I predicted, surveys following the adoption of warning statements showed a rise in smoking by children, particularly girls, fast catching up with boys. Yet, a high 3
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• 656 percenta(e oP youngsters believe that cigareltr sninl:i.ng cnn Relativ~ly r!nre cause lung cancer, emphysema, heart disease. smoking students in 1971 than 1964 believe that smaLinq impairs health. Still, it was reported that despite the anti-smoking campaigns and programs, approximately 1-1/4- 1-1/2 million adolescents were starting smoking each year. Education to the health hazards of smoking didn't deter them. .,r'.re techniques and preaching didn't deter them. They smoke anyway. Teenagers rebel against restriction. Teenagers feel that they should be able to do the things they want to do when adults tell them they can't do them. Teenagers want to control what happens to then. Consider teenage sex activity, which ad•iIc-,'•fully know can produce venereal disease, and pr"yt.v, 'y. with high rates of premature deliveries and congenital anomalies. Availability of contraceptive measures to teenagers, costly and extensive educational efforts abnut birth control, have not decreased the number of teenage pregnancies. These pregnancies have increased. RR 4957 purports to find the present Federal, state and private lnitiatives insufficient to warn the American public about the dangers of smoking. This is not the fact. The fact is that awareness does not alter behavior after a point. The people reached by warnings about smoking have been reached. The others are not going to change their 4 657 behavior, whatever the warning. Different people snok~ for di(frrnnt rea;(as, among them: 1) To cope with feelings of andety and stress; 2) For pleasurable relaxation; 3) To raise energy levels; 4) As a "suicidal a,.1.," not only consciously e in the hope that health will be impaired, but also unconsciously as an inner-directing of aggressive behavior; 5) To control hostility and anger. if we look at initiatives conveying heaL•h varnings that I havr had a lnt of rsprttono" •nith in [.t^ pa:t f,°:7 yonte--cnmpnlqns at+ent drvc:, ccp!;in•:, r.wna.t" pr.~nm~c1..--vn fiod .tF.t' la.. IPr•,tnbi'.t^nl di.'l unt ahort drlnking (30% or more ot hospitalized patients today have alcohol-related problems); availability of contracrptives and birth control education to children did not decrease teenage pregnancies; numbers of people continue to smoke; there is more drug-taking throughout the adult and adolescent populations than ever before. The King County Medical Society Committee on Drug Abuse & Alcoholism, of which I am past Chairman, has addressed itself to campaigns for the education of physicians, as well as the general population. There has 5 •
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• 658 been no discernible change in behavior, unless it i:: iu tlm direction of increasing tension-relieving behavior. The way to learn about people's attitudes and reactions is to work closely, as I have, with thousands of patients. I have not seen a patient since the mid-fifties who was not aware of the assertion that they should not smoke. This information had even filtered down to children, who learned ta tell their parents not to smake in the belief that parentall smoking is harmful to their parents and themselves. Dut of course I see every day patients with cancer, and lung and heart disease, who have never smoked. Medical "preventive" health is a personal problem. People are apprised of the dangers of smoking, but they have their own personal reasons for not giving up smoking. Dire medical advice coming from legislative bodies is not effective advice. Smoking ls a personal medical matter, not a legal issue. stringent warnings have a negative effect. ps The Smoking Digest, U.S. Dept. HEW, MCI, 1977 stated; "Fear-arousing messages actually increase smoking among the particularly vulnerable people and those with low self- esteem. Such messages tend to make the smoker defensive and harden his attitude and resistence. People who smoke to 6 659 , , 1u..c .~nsr..,y- wla.. ..1..... . strong health threat in nr•' fear." ff inedi•tne is to teach "preventive" medicine, it must address itself to finding and promoting adaytive ways to deal with stress. The 1964 Surgeon C"n~cal's report stated: "Stress seems to be related to smoking and there is evidence that the experience of stressful situations contributes to the beginning of the habit, to its continuation and to the numbers of cigarettes consumed." The Report further stated: "Existence of an association between stress and tensions on the one hand and smoking behavior on the other can probably be accepted with a reasonable degree of confidence." From the research material in the smoking field we could conclude that the same stress that stimulates heavy smoking may be the stress that precipitates the complex cancer process or produces the coronary-prone individual. It is up to the medical profession to reduce. stress in the population -- and not by fiats or mandates that engender guilt, anger and resistance, which in turn 7 t •
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i 660 crante mrrm st.ress and can pronote tlm very disra::r.s tllcy are. trying to prevent. It is costly and inappropriate for Congress to busy itself in this area. "GOOd health" and "good behavior" cannot be legislated. It is physicians who should and do address themselves to tlle [,erson -- to the person's constitutional diathesis and self-motivation, and to techniques for reducing the person's stress with its deleterious physiological reactinns and maladaptivc responses. -z- / 3IF z M IIFICIICE (p:ll : 5.u iH, ME,^.Tii. IIE.LLpI SI ": 1•-' GRONP NEALTII (qnPCV 11'C ':r P:'SC Sni •:p Seattle. Nashtngtm: 93102 rl'FPICGLIf•l VITAE and RIBLIOGR.tPNy I91B - Bnrn Septemher 16, Peasa/c, Nex Jersey lop - B,L. Cum Laude, Unlverslty of 9lchlgan ,-- a.H. •'alth dist/nctlon," L'nlversitF of Hl(blean aedlc.,i S.h,r•1 Internshfp and Vost-gradnate me,benl tntnlnp, In rb!caga at [!Ichael Reese Hospital and tledlaal Center ,nd eb.• Institute far Psychaeumatle and PsycM1iatrtc Pesearch .,m! TraOLLne rr Michnel Reese Hospital and Hedlral Lenter. 19:.9 - Practlce of Psychiatry and Psychusumulc >led!clne at LreuP Heal•.n Cooperative of Puget Sound; Chief of Y+ntv1 Ile:d•I: 5,•r-i•-~.u. Health nedlcal [nnter 1970-72, 19%5-:e HOSPITAL SiAFF: Grnup Ilealth Medical Center St. Francis Rasler Cabrlnl Psvchlatrv Servlce PPOfESSIUNAL SOCIETIES: Amerlcan Medical Aeaactatton Hashington State Medical Society Task Force on Hatlonal Health fnsurance King County Medical Society Alternnte Heleg.,te King [nunty Medical Soclety, Medla Relurlona Crmmlttne 19'7-14 Mental Health Coa.lttee 1910-KI Chaltvan, Alcohol end Drug Abuse 191c-gl Trustee 1982-84 and Delegate to the Ma.vhtngtnn State )!ad/:al Fellov of dcadeny of Paychmneat[c Medtclne, Credentl.,is Crnm.. 1"S^ . Exe<otive Cuoncll l91]-16, Secretary 19IA-1l, Evecntlve Cnunril Prealdent-Elect 1981 - President 19112 4aahlnkton Academy nf Clln4al HYVnosls. Prrsident lo>n-)s; 191i-%' I/unurary President 1918- Sncicty fur Cltnlul and Esperimentnl Ibpnoslv (Frlleu) •
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• 662 PROFLSSION.\I. SOCILTIE9: (cnnt,) Puget Sound Croup Psychutherapy Associnclon Fellow of Neerlcan Society of Cl Comm. 1910-11, National tre inlcel IIYPnncls, Component asurer, 191)-16, Unrkshop Section FacultY 191)-11, 7 8-79 Flrst Vice-Presldsnt 1916-11, President 1977. Seusletter Editor 19 Pcllou of ASCII - Research and Education Foundation Dnard af irustees. Chalrman of erants, 1981-4 Seattle Hedlcal Homen's Assaclaclnn, Prestdent 1959-1966 American Nealral unmen'a Aesnnfatinn. President 1965 Hash/ngcon State Delegate 1959-61 National Recording Secretary 1959-60 Ind Vice President 1960-61 Vice President 1961-61 Presldent-Elect 1964-65 President 1965 Coune/lor: Crouth 6 Development 1966-68 Nat. P & PR Chalrman 1973-75 Pan-Amerlean Ned/cal Nomen'e Alliance correspond(ng Secretary 1960-62 Vlce-Prestdene of USA 1962-64 Medical Naaen'e Interna[lonal Aesaclat/on Puget Sound Association of Phi 8ete Kapps A.11.H.A. Sponmr of the RERNICE C. SACHS JUNIOR BRANCH OF UNIVERSITY OF WASHINGTON SCHOOI- OF MEOICINE Nnmen'a Medical Cotlege of Pennaylvanla (Board Member, ea-nffle/o) Anerlcan Association fur the Advancement af Sclence Aernnpace Medlcal Association amer/can Psychlatrlc Association - Presldent-Elect, Seattle Chapter 1915-76 President, Seattle Chapter 191A-17 Councll of Medlcal Adalniatrators Internatlonal Platfnrn Assaelatfon Amerlcan Cerfntrlcs Society, Founding Pellov, Nest Division. 1971 Amerlcan Psychnsomatlc Society American Psychiatric Aseoelztlon - Observer - Consultant to Council of Internaaonal Affalrs 1918-19 ohserver - Cnnsultant 1918-19 CosmaLttee on Prafesslonal Liability 1980-86 " " Losa Contrul Revleu 1980-86 HONOR SCIIOIMSI/IP SOCIETIES: Alpha Lambda Delta (Freshwan Hanorary) lota Sigma Pl (Chemical Honoreq) National Forensic LeaRUe (Distinction in Debating) Phi eeta Kappa (Elected to Natlanal Nnnorary in Junior Year) Phi Kappa P61 (Senlor Nonnrary) Alpha Umega Alpha (Elected to National Medlcsl Honorary fn Jonlor Year) 663 cmDlcalTy nP.caslxArm,vS: gnard nf Directors: Nealth 5 Helfare Camcll 1?V-194n Pas[ Presldrntd Asacnblv 1941-1961 Sea[tle-ging o nn[;. Sn:ecr nnclt 1960-1^19 f.nvernor's Advisory Committec nn Ynn[b Oppnrtnnl[lec 196'!-19r,5 Group Health Credit Unlon - Board of Dtrecturs - iv-9-94 (Secrecarv) yATIONAL ORCANIZATIONS: Soraptomisr [tomen's Untvernfty Club of Seattle Amerlcan Aesaclatton of Unlversity Homen Yarinnal Resource Personnel Bozrd of tlte Incercollegla[e Association of Ilomen Students Women's Confevence Commlttee of satlonal Safetv Council Yortar Nnard IIOSORS: 1955 - Cold Key for "HOSt Outstanding Cltlzen" at tOtn Iligh Scbcul Reunion 1964 -"8ernlce C. Sachs Junfor granch of Amerlcen ;ledlcai 4omen's Assecta- tlan" argznited by ahe Unlverstty of Hashtngven 9edlcal ::omrn Stnde-cc 1965 - Theta Sigma Phi (National Honorary Journalism Snrien•) Special Honom Auard fnr "Nnman of Achlevemeni" 1946 -',Rdical Noman of the Year". A.;1.'J.A. presentatl.•n. ::ashingC.C. "In recognition ol outsuanding conteibution to her pr-iession, her care:anlty and to her fellov human beings" 1967 -"ayrtle Wreath Auard" - Narlnnal Hadassnh "In r cngnitlon of h onelnutng contrlbut/on to humanlty In tbe f1e1J of eeJlclni ?r 196% - Ilonorary Hemberol Mnrtar 6oard. )latlonal Senior Hunorar•: "because her career esemplifles tbe Mortar Board guils of leadershlp, scholarship and service," Tut,• Chapner, Unlversity of Washington 19/5 - "SALUTE AHAND" "For en outstanding contribntlon to the Conv.ntL,n and Plsltor Industry of Seattle and King County" 1919 - Ellznbeth llaeRuell Xedal 1. hnnur of cutscrnJln: r rrlbutl.+n to medicfne end advancing ebe cause o( vomen In ~eJtrine 19g0 - Presidential Merlt Aaerd "In sincere appreciation of her dynomlc and crr::~- s r r: t; the Ameplcan Society of Clinical Ii.pnosls" •
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665 I 664 KNOI/LLOGEU IV: 1v.npds - tJhn's Ifno In Haehlnpton - Centurv !1 Ldltlnn uho's Illm tu the Ilt•et Nho'a 4bo of anerlein Hnmen 14,es mm In .Smerica uhnb YM1O 1. [he World Rlctinnarv of International Dtnpraphv Intematlunal ScSolars Director Nutlonal Regln[er of Praminent Amer/rann .md [acernn[lonnl ::atablus l9%s-)i No[able Nnerlfnns of the Blcentennlal Era T,Y. Apprarnncev: flatlonal: Decrmber 1965, GLRL TALR Janoary 1966. Jobnny Carson: TO\Ir,HF 5110H LnraL: October 1966 - KIRB "Eye oI Seer[le" February I96J -Judlth Lane Shm. October 1961 - KINC - Cnmmunlty Servlces Prngram February 1971 -¢IyG, KOHO, KIRO -"PaychoW;lcal R/O[a and Peaponalblltttes of Unmen" September 1911 - KCTS - At Pnge - Intervlca "Nennpau=e - the Peuse that Refreshes" :brch 1912 - KOHO "V/enpo/nt" May 1972 - KING "teleseope" - Jean Eneraon, Hou.vd 11..11 "Blddleacent aanaa" rebrnarr, 19]5 - RUG[ FN - Unlvertstv of Hashlnpeon, •'Psyahoso.atlc MedlCfne" June 1976 - KISG "Seattle TnJaj" - PSychoeomatir Nedlcine" Fehruary 19// - KIHG "Seat[le Today" -"AginL Gc.cefull." MarcM1'19)/ - KI]G "It's •tbout Tlme" 14 rcb 19/9 - KING "Today Show" -"Ilnmen Over Porty" March 1900 - KING "Todal' Show" -"GOmen's Issues in !'eneal Ilealtli' Srcrcnrs: Iscrrnarinnal: Puerto Riru, Columbla, South dmerlca, Tukyn, Can..da, N.rtlnnnl: Austrla, Australia. Iarael, Rin dc Jancl, Chtcagn, Derrnit, RochesteL %eu York, .\uqusta. ClovelanA, Nea orleaas, Gulfpor[, Las ]o:eles, Ssncp Cruc, 5 m fr um Portland. Olympfn, Minneapolta, Phoenis. PhllaJrlnhl.r, Dalla Ilalln, Sea Inland, G.,,, S,,n w= , 5ac.rvnr,. .nstnn. Honolulu, Analrelm. Nea Jer.ey F.CtILI': 9nrrled In 1941 to SurFeon; two cblidren, [bree cosndrhlldren / LONSULT•1Ni: ClrluRo Roard of Public I/ealtb 1'/n,-1VashlnRtun. O.C. Junc 196n Invlted by Pres/dcnt Jnpnsnn UasM1ln6ton, II.C. Janoars L9M19 - confuwn•• ,,•xtin_':•Ji,al : Needs: Optlmum UtiJlrat/on or Gnen Oncrorrs. 1,1,1 b,.. O.p~.t. of Labor, •aonen's DPtlslon FdCULTY: HYpnasl. [rorkshopa of Amerlcan Sncletv .•f rll:•IC.iI It:2nrsl; t~. Education and Nesearch Fonnda[lan H)'pnasls in Clinical Practice. sponiared -( Oepartment of PsychLttry and Instituta nt Penns"1-:ola Hvc,'lt JGroup Health Preventlon Nnunds, 198n- PUbLICAElOBS: "PSychosanatlc Nedle/ne", Journal of yerlcan :Iedlcal 'l.nen s Asso-aatP /larch 1961 "PSycheaomatlc Arpecta of Accldenca", Industrlal IleJlcine and Surger., i. . 525-532, December 1962 - "Psychoaummatie Aspects of Accidents", grltlsh Culumbin Jnurnal rf ::e1Lir., 6(5), 188-192, May 196G "Knou Then Thyself", JAIR/d, Vol. ]H, \o, 1, Janu,•I'.S "Ilediclne aa a Career for Wuman", IntercolleGl.,[ss :+•.c(a;l:n .f '., .~ Students, Winter Issue 1965 "Clinical Problems o[ Adolescents". JCPfA, Vnl. 20, Ko. 6, June I9•:' "Nomen's Destiny, Chance or Chotce", JAMG\, VoL. 20, 9, August l~n "PSycholo8le or Emotional Faatnrs ln the CLIIJ ahu Fails t•• ihrivc". JACDIA,VOl. 21. No. t, 12l-Ill. PebruarY 1966 "Eautlonal Health 1. Induatry". Journal of OrcuparirnaL :1eJL:lnt, t, No. 9, SepterAer 1967 "Ilenllnes In Medlclne", Massachusetts Physlcian. Sent, 12uJ. rnl. ;... "Sex and the unwarrted Adutt". JA•ntA, l•nl. n. co. ). J•,l- wr,9 "Problem of PoPUlatlon Eeploslan nnd Its Control: PscA,,.laclral. Relldloos and Educational Jspects"..hl'[6\ Sxu[.m4,•r 1"~1 "Ods R,.ane Business - part I: Chao9lnR `npnasH i, .lspects of Iluman Seeuallty• [•ol. 111. ;,, , ,, rp,.o_ et\rrl; ;•r
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• I 666 runl.IrdilnYs: (cnnt.) "Tbls Boson nusloess - Part IL Cnsmetic .lid• and :l:dic.,l ,brerts nl Iluman SexualLLy, Vnl. [I1, 1,,. ~, rr. I5-]L, H,.. 1'u.n °Sex Fducatlon - Imy, uEere. Hoe, By Imnm'." Ylr~+. (F.mup Henlt] eoaPrra[/ve of Puget snund hlmonthlo pnblJcetinnl. Part I - Sept.-ort. 1968 Pnr, 11 - Rov.-nee. 1968 ^40lLwpouER Psychusnmatle Mpllcarlons -/mntal or oetrlnen[a1:" The Ilnnan Plrvsiclan Vul. 25, April 1910, Vn. 1 "RS [or the Cltmacterlc Collage" Pat/ent Cnre, AuRust L969 "Hov To Get :\Inng vlth Your reenaRer nltlmn[ ResortlnR to Violence" t'IE[. (Group Ilealth Cooperative of PaRet Sound hlnonthl, puAllcatlon) Part I - Sept.-Oct. 1970 Part IL - Mov.-Dec. 1970 "Tbe Adolescen[ 1. )ly Practice". THE WOMAN PXYSICIdN. VoL 25 Mo. 2 Feb. 1470 "The Tired /lousealfe Syndrome" - PATIENT CARE Januarv 1971 "An Experience fn Provld/ng Mental Health Care In a Cvmprehenntv+ Prepald r,rnnp Pr.xtlce Plan". J.VMA, Vul. 2%, vo. 4 pp 1.9e-In6 April In " "flennpuse Can Be The Panse That Refreshes" - l'I1::+. .lul•-.+ncus[, le'+ "The Ilenopause 6 Estrnsen Thurdpy'• Jri :'L\L or RrP?t"', "rrl•1" ''I tl Yo. 6 Oc<ember 1973 "Imrnct of Snclal Forces on Hental Henitl:' - J,tlW.t, 1'nl. Jn Sn. It ~.•~e+ I+ "PSY~M.t[[Lvv111(e-Mathen Some Aapects of Role Inte~~ra[lan", American Jnurnal of Psychiatry. Vul. 133 Ho. 7 July 19/6 "Farrs bv Snrbs", Ring Cuunty Medlcal Suclety TNE BL'LLETI`:, Feb. 19:4 vol. 51 rP. Iz S "Breaxrs: So. Symbula 6 Releasers". Breaa[p O1+casec af the Breavt l'el, l=. ..n. : Bec. 1976, pp• 26-10 "HVpnotherepy with Cancer Patlenti". CLINICAL eSP5U5I5 11 :IEBICI%E. pp. A9-g7. Puhllsbed aovember 1980 by Symposta Speclallatz, dlutrihuted bv 1'var eoot /ledlcal Pnblicatlona, ChlcaSO, Illlnols. I • • • 667 CONCERNING THE "tCODPRDiENS1VE SMOKING PREVENTION ACT OF 1982" G.N. Schrauter, Ph.D. La Jofla, California I am Professor of Chemistrr at the University of California, San Diego. I hold a Ph.D. degree in chemistry from the University of Munich and em the president and Eounder of the Internatlonal Afsociation of Blolnorganic Scientists. I am a menber of several scientific societies, Including the Merican Chemical Society, the Association oE Clinical Scien- tists, and the American Public Health Association. I am the author of approximately ZOO research publications and have edited Z books. My main research Interests are in cancer-prevention, cancer epldenlology, trace minerals in human and animal nutri- tion, and various fields of experimental chemistry. I have done ploneering work on the prevention of cancer by the essen- tiat trace ineral seleniln and in 1978 received a special award Erom the Santa Clara Section of the tmerican Cancer Soclety- As a chemist, cancer researcher and American Citiaen I wish to comment upon the [•Cnmprehensive Smoking Prevention Act •
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668 of 1982" recently introduced into U.S. Congress. In this Act, it is stated, among other things, that "smoking is the number one cause of lung cancer in the United States". In my opinion, what role, lf any, smoking plays In the causation of cancer, including lung cancer, has still to be determined. Those who claim smoking causes cancer rely upon the reported statistical association and ignore the inconsistencies of the smoking causation thm ry in the scientific literature.' For example, to date, no one has ever been able to produce lung cancer in laboratory aniaals through exposure to fresh, whole cigarette smoke. Moreover, the vast maJority of smokers never develop lung cancer and there are serious inconsistencies in the epidemiological evidence and dose-response relationships. For example, a Japanese male smoking SO cigarettes per day has a lower risk of dying from lung cancer than a British smoking doctor smoking only 1.14 cigarettes per day. In addition, no ingredient or combination of ingre- dients, as found In tobacco smoke, has been shown to cause human lung cancer. Tobacco smoke is a very complex mixture of thousands of ingredients. Some of these Ingredients, In isola- tion, have been reported to be carcinogenic In test animals. However, this does not mean that tobacco smoke is harmful to humans. Campounds that are carcinogenic in test animals, when applied in Isolatlon, hare ti... f",s1 r1 •. .n•'.,. -.r--: when applled In combination with each otSer. Since it is oro- bable that the many hundreds of compounds present in smoke (nteraet with each other, It is highly artificial to focus upon the effects of any one ingredient or combination of ingredients In isolatlon from the others. It has long been known thac cer- d tain smoke constituents act as anti-carcinogens in test ani- .als. For example, tobacco belongs to the selenium accumuLa- ting group of planh and selenium has been-shown to possess antl-careinogenie properties. Also, constituents of 2lgarette smoke previously thought to be lacking altogether In carcinoge- nic activity have recently been found to be ant i-carcinogenic when applied with true carcinogens In test animals. Cancer Is an extremely conpiex, multifactorial disease. Studies indlcate that many factors, other than smok- ing, are statistically associated with cancer. Some of these factors are familial predispositim ,..posure to tumor viruses and other biological causing agents, exposure to ionizing radlation and industrial carcinogens, diet, exogenats environ- mental factors and stress. Further, studies lndicate that a number of agents nor- eally present ln foods may have activating effects on tuimr .iruses and that there is an ssociation between lung cancer
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. mortalities and other variables of life-style and diet. For erample; the lung cancer mortalities are correlated with the per capita intakes of sugar and milk, and with the consumption of seafoods. It also has been repeatedly suggested and recent• ly reaffirmed that the consumption of diets rich in pro-vitamin A(carotene) may have lung cancer protecting effects. The "findings" in the "Comprehensive Smoking Preven- tion Act" have not been proven. Moreover, passage of the Act will divert attention from other etiologic leads to the disvan- tage of the American Public and the progress of the health seiences. GEH1/AflD N, SCHNAU1Eg is professor or chemistry at the University of California, San Dleg^• He received his Ph.D. Degree 't nm the University of Munich, Germany, in 1956. An lnorganic nist by training he has became a major exponent in the nev field of biolnorganic chemlatry. He Is internationally known for his work an the role of selenium and other trace elements in nutrition ~ and carclnogenesis. He 1s also a leading specialist in t'~r ir^r er catatysis, blocetalysis, organometallic and c-,- .. :.i chemistry. Dr.Schrauzer is the founder and pre;i9^^' Internatianal Association or Uioinorganic Editar-in-chief and rounder of the Journal Element Mesearch" and former editor and founder uf _ ^alolnorganic Chemistry". He is the author of mare t'~i~ 2^,D research papers and has edited tvo books. lie ras born in 1972 and recelved his academle training at the University of Munich. He /emigrated to the United States in 1964, is a Naturellzed U.S. Citizen and has been t the University of California, San Olego; alnee 1966. Schrauzer !s a member of the American Chemical Society, the Association of Clinical Scientists, the American Celisqa of Toxicology and an Affiliate Fellow or the American Colleqe of Nuteition. •
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• 672 I am pr. Carl C. SelGter, /lc.crar;• 5 s,-:.. ..s_-inte at 1... .+e_ _ Museun, Mnrvard University and Ptofessor of :lu•:...:n. Tufts t:.r;:-'.. I'+as formnrly Sentor Reaearch Associate at the Health. II••'+ork in the amoking and heattt A=P+ ts aver [h.a,-(ive IJi1 ertlcles sinen 1..4 vc :[s ;._ -u-: r. _:eL:n, L.t relatlonshlp bnt'.een smckln9 and cnrv:ar'iiea:[ __? sse . as ,._u,_a.._ b.r the sure•en eeie:aib 2dnisoq' Cc.-r•itraa r- =-_<tn> +r'- I!eelth Isce:ibvtnd n s2etlnn to the 1964 Pe-ortl and e, s:+tl- , ato'+ >f r..e O:cnciL on Ecicenl- olo9y o( the Ynerican neact dsabciatioc. Ny t^•'estl9ativs +ez la thx iazr] dleease field iacludes partlelpatlan ln studies In.nlY'in' t.i- 'n+ - n 4eart Study. The M1mericaa Medlcal Association, the '..-eraca ~E-:-.Iatrsc:cr a-d the Kateer-Permanente Faundatlon. /I.R. 4951 proFoses cha' the la_el stanene-- a__•a. _,. ciyarette packa9es: "aarnin9+ Ulyarette amok:rc is a ior :.~s. .'. 9eatt ntseasn." This pruposal ls apparently based on the claln. pet fo.-.h as a Congressional 'finding ln the first part of the bill, tSa: ore :ilrd o'- deaths frcm CMO are "attrihutaGle to smoking." Theee hald statements are not based an conara:...... ve1:0. Le--.s':atle aclent(flc euidence, ard ace vlthou[ eetabllabed ~-ccf. AF=arer::/. t. , are based on the vle.s of n succeaalon of Surgeon Ge-erals suhse^.oes: :~ the 1?5: Keport. on the atatemente of the American Heart daaoclat'_on. the Fun/c-.h,am 4eart steAy ard athera. • I 673 Page 2 The prlme % ba+/e for these vr-,s „- tes: L- _....rt...... -, statementa from the 1981 Surgeon General'z iepcr: and "e the +•.ar. study. The 1991 Re,.rc atated• "The ef(ect ef nr.'• ~- ~';tr9 0. r:£'. ._.._.. many epldea'lolog/cai criteria for a exnsal asscctxce:-; Fcv-r._l. e- q---_, duae related, end reveralble." Kacnel of s_.-__ r_,~ ... "[auaal inferences are supported b:~ cCe `ac: t-a: -' <analate^t. demonatreted Frospecelc•1-, lr'e~eY.'• - t. s.- , .n....s. asd can be eaplalned by the kecva e„_-.s ~_ cardlnvaacuLr apparatua. Flnally. it has beco sSo+-. .na. ~bes. . anoking have only half the risk of thene vho cca•i.irs data have ... tended to indicate an lndeperd-r•. _-.rsl.i.. . reversible, triggering effect of cigaretce ameking." la-tl 1lacotd(n9ly, the msin evidence ndva-re! .,. f:_--_._ betueen clgaCette aamkln9 and CMD la that the aseeelattun la Ill atron9. 111 consis'ert, .St '., lndependent of asaoeiated rlak fectors, and (5/ re•'ersiS:e p-:y(-o. 461 [n addltlen, the asaeeletlon le said to he esplatrei .-.l ., cigarette snokln9 en the cardlovaecular eystem. Let _s ..<-r-._ .hese turn. Claln l. 1s the rulatlonthlp strong? The I^6s Sucgr.•^ c.oe.t. s- p r. e.a.-, that In the U.S. the mertelity ratio of amoksrs t. .e.smca..s n.. . Aut, this is not a at[onq [elatioest:p, acoor]tlg .. Profeanor Hucchleon of che ner.ard School -. .uitc vea.-.. ~_i_, _. •
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676 674 11cad Med. 19661 this Independent cbserver !eele that a mor_a_/ty ratio of two or less is actually lndicetY:e of aweak relatlunehlc vhich may poseibly be explained by confounding lactors. Can the relationship be characterized as "_. ecng" .<...t the 1979 SorSacn. General'e Report, although dlscussicg scokin9 a:d health ec_diee throughout the world, limits its cet•.cY_slen L_ r.e.m and ucten Sa the United States.' and Rnnnel of the Frentactan Stud; talks abcut the excess CRO death rates of smokers "ln r.ast of Western eocletles"? 16Nd• 1901) If the relationship be^_veen smokers ar: CFC ls "stretg," why Is it not present Ln all xestern societies or Sa non=+escern societLeel Claim 2. la the relationship canekatent? Since -c _. i!L-a-.t n.atasrica3 essoclatlane between smoking and CFD ha':e been reFnrted S:. '_cter.d. the Netherlende, Italy• Greece. Yugcalavia, .. p n r-d P-e__o Rics, it Se clearlT Incorrect to claim that the relat!onahip is ccnsistent. The relationship Sa not evan comistent in the ?rsni.^.chem Studp. I, eppnnred to be consistent In lnitld analyaes. but when ntardard risk tactors and such paychnloglcsl Factore aa :ype A Fereonetlty ve_e controlled, lt was found that "clgarettes smoked car day" were rot predictive of CRD and myacardial Infarctlan incide^.ce tn men• or of CMD and englne pe:toria incidence in vamen. f&a j Coldemlol. 1?99. 675 Pa9e a C.n Ne relationship be che[ec:er!asd ae c_:.alstest when ehe 1g'9 Surgeon Ceneral'e ReFart concladed t:ut ° . e 4redletl.a raf's !e___r association of smoking uith the Snaiderce of an9=sa pectcris is no, elear"? The Fra.ingham Neert Study also eports that "the releaocsh'- to angine pacturis Ia rodest, If It esL:-s s. ail.' is the r,elatlonehlp consistent •+hea :kx re:aci•re cak pn:rxu!rxly declines with lncraatinq age? _el.=er de-rs-rated end ?acnel noce[ that the beneflta of quittinq tmoklr.q do not exiead beyccd the sc_ o. 65 as n9ards heart ettacks. (IUn d Ned Scl. 19-3: ' luall rurthernore, the 20 year follow-up data of the Frer.i-:-ao sr.d, s.n+ no excess Lncldence of CND in men or vomen 55 years a-d _.e.. (Franingham data nade available to Seltzer as consultan:.l ' Can.the relationshlp be cherecterized as cocslneect ...r the r.aminoher Neart Stud•/ reports an abaence of a reletlonsh_c o_ and C9u In votrnl tlaia l. Is Ne relationship dofe-related? CtD rater do noc c>a!s:er C- str+ a risinq gradient in relatlon to en increased ancnnt o! czqere^e aenkinq. p6MA, 1968) Ln eeme studiee• the gradient 1s ectonily raveread. h?RIUI, 19661 2 found that data from the FramLgham Study do not show a conslstent rise In CND risk with increastnq amcunts a. cigarette emoklnq because of the 'heteroqenous" character o! lts "aone" rsteqory, a deceptlve nroced>re. The -ane' cateqo{ _n )rantngham
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0 icPCiPa c141 'OBdi VaqaaaEa6 ul TvTanalPa ue ca puinof ]iva4 or>laavt' aGO ul pas¢a:~c . nansp oa an ary a.4w •asaasta ]aaep 1 vua:.p pav 6upsl>ws„ 'alafaaa c•zav]la9 u1 pavlsauoa si ]uwqeas q4a :aoiins o_ :accy.a a.: )0 4ana •PC4s7T4cass uaa9 aou an.4 Wu sacnca ^Ipa6alle 6u.;ous o., vnoo SaT4n wq swaiua4aau 044 as4a q Aallaao plo aV1 'suc?:~?Daaauao a.a caa4i 'aal ul 'pu. •oF.ta aTV] aoJ .iuapiwa .-c. ;aT:ac va r, .an4L Iie6i 'YYiI(C) ~'.na.a.id. a.lnas.nolpxca aGO uc 6c:r,auc a._.z !.ya Jn qoalJV unau4 aVi 64 PauTvidua a4 uo .. sa~.a:a:v/ ~¢cao.. ::vW anlvV 6pn]5 rny6:auaa3 a4a Ja iauuql '9.f.C. 'uuRd:vnauoa aAUa6P a:.npa: ~,-ollaJ ~AtiC 1- rcla ci aolt~ap ay: PaavvN.axam„ an.y Avu aip'=s -se3 :a4] a. :_.a; w uo4lnv a4a Pai c1V3 •auu p7P 6u[4ous -. ,ucv:r..pa: '_._ 1..:.,aap rvva/Ji•z61c AllviaNaRa]s a pun ad Do 4bno4alY 1I861 ']aauYll unpanpaa 1°aa=s-,u:- -r "_ ..uc 4-04 Jc caaalla a4] pauiu:a.a 4ai4w Aswaax Tvu: W1n auaiclaucn c 1 alncu q41 'pasvzauoaaP ]oo can a)TI c•aa4wsc ::¢ia :v. ..• ...:liq-sa:a:a p:baila a4] 'an41 '6u i4ouc deau oa - Jo a]vz e - : . u...ccca~ __• _c -~ uolouanaaaui aa ]aaCqna dnua6 aVa y caca:: :4t:a Ala•a:: a-:ptl IB[61 '4aivaM ~nc~ -?oT u-.pTff2 f/ ass:¢qG avlr.xa.:clp-s= y r,c:a 4674 av ryuanaaa ITnia uoPUOi ; ::~i~ L- Jolpasr_np:s J_ . .. - . ,, a4] )o SaTaa .uoAUanaaau/, 6t'J etvoc_a5ac1 :saT: a4: c[ 0113 lo ycTY a4Y sa>nVaa 6uTYC'as 6ulddoic ac4] w[ala aG :o AoalTC; a4: u. cauTOd yaT4a. aauapina yo aaznoc puooac a91 iTTa aa Pc4oua anaq oa aanvu uc4a ]lnb o] ua4a p~s 6uT4owc v16a5 ua saiaaq IT a: 1.44 uca. cl4a caoU 'IApna9 uc46clraa_ ey: u? Puno; av4a cv AlaWaua a.as a4a> uaqauc-aa a4] ua4a c,.c: nll] aa4-14 PanTqT4s. szayous aan.u Aqa pano4a aadvd aaivl aiV IT eavP A]ilv]am ay: h4n uiaidxa uvupaVA pip aoN 'aadad pucaec e 01 aauviaoiwl na4a A•.•:p Puv aadad .un IT /saoaaq 4sVl miasPeaaazv4a pa;eTaz ~'J.J : anlan a4: adeoa PTnoa a4 noy u1cidua aou Rip ue .?a?-_ 11p61 '1~ aK oa aa]]al vrwpatz3/ 'Aldaa q4 ul ualaTaTan .Gaea Civc:nin Papvwa uvspaTa) '11861 'W~3Y oa ua]]aT aaaala5 puv 4=aoE1 la5 pua 4a:n8 .14 paa/aATaa on aadud vT4a 46:p4]lY •caa4ous bc?r-i~ ~a zaqG sartoa:no QXD aanoi qno4c ITTas czayoec-aa CvV] al=aTl cpvu AlWnaa. upslaaaaua4a Paaelw-mlo aarwi a4a :aV; ?•uTaia ha4Z 'eaaams-aa a4] la ao?aclaaaaaav4a Paaelea-UUB ...ml cu,] nc cis.lleuv a:viavzPlnb 46noa4a canbfa4oaa uoT]aaaana ?eoTaaa=a4] b~1A13da .14 =civ? ]aGG lu ¢]Infav e4a aav6au oa Palaa caa4]c p'.e ~caPap3 'IL^3G a= IT pa4sll4nd a1a1Ye auanbaeqne v ul 'ual:aa;ac--; -c 4 m4~ 5=T•' v?a~q c: suoczad;lo spui4 OvaaalliP aaa ;:a4: accv~aa ]c4 6clVoac Paddop¢ ha4] a.naoaq aou •cnaNOwc 6uTnupuoa .:e5= ca_a_ne aava ONJ aa.ol anv4 sza4uias-.a aa4a aaei a4] aoJ quna_aa c: _saiie pinon c141 16'd1 'e~U uoa4D C) •ayowc oa PanalJVm a._saad aca4a uaW '6'-.,: c psddoaa Aoy] aaopa9 PqWPay Pvs) BL9 • • • • I •
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• • 680 Page 9 discusses those etatements of the i?-? <urcaon eaneral'a P r- _which illustrate the absence of fir-: evidence cf nechanlnxa by v'a'_e' srckrnq affects CHB, such aa: IlI little ts k..e.n about the recha-ism by which smoking enhancee atherc5ener!a. CI _urther r_searcn is -teE to ehov the mechanlama of sudden Eeach and :. pr:r+rmu va=_a, :CI tP.e data on the eHece of smoking no blood Gpids are cct :• __ 'il the association ber+een cholesterol acd amca!:o is micsmized, I51 the acuce and transient e._ec.s of smekir.= ce to 1-cr^ese h^ar- ra__ ecd blood pressure to a mlco[ degree, lil anok(ny is not a r1eY `ac4cr for hypertension. f71 the aseoctation of se:oking with vcr p, manlfeetatiom of atherosclerosle, aLo.n u[1ac:palC! b:' yr-P in New Orleans, now hes been contradicted by a stcd.: by Ho:oe, Strcr. and others who found that smmkln9 dcd not s..o+ a , ., association with cotonery artery lesions. [3rter!caeleroals, :231) More evldence comes from other scurces. An editoria! in the IWqus[ 1980 British Medical Journal states that the mec.h.a^SSm av whicYt emo3leq affects coronary heart dlseasa is unknown. the aasrtaan eeart hsaociatlon Heartbook states: "the mechanisms by which cigarette emnking is associated with higher ratea of c rcnary heart disease are not yet fully undentood." The 1981 Burgeon Oeeeral's Recort stateu "Enttnatlan of the inpact of varying cigarettes on coronary heart disease risk is difflcult, baceuse the exact etloioqic aqent[sl have not been ldentlfled.' yhus, the blll's oroeond to label c-gare-te packagee with levels of tar, nlcotlne, and carbon moroxide Is not 681 Page to Justified on scientific grounds. the S__en General ad-lts ~Tac it has not been clearly demonserated that theae factors er - r'a,e etlolaq/c agents I. the ceusetfon c; iccreased cHE in snoYecs. This is also shown by the conclur!.. -- -_._ _r.,re -.ae det . radical thanges I. the cnmpositlon o. clcsrettes es_r the Irst 1) ac If yeara (filter, tar, nicotinel, there was no c,e. y decc-,s--etet cr. ea[dlavueular dleense. This r,rrnL-- --s,lt is cloe-}v conslsttent with the proFositlon that anc_... ..a„ cerbnn monoxide in cigarette smoke ratea, and that there componenrs or `ste_-c s... _._ -, - etlolo9lc aqents. B/nea at eardloloq!ses telleve ,at stheresclerosi• ts the n•cst lmportant factor I. cnrnnary heart dlsease dc•elaonem, they clatn tnw: anaklnq enhancea atMroscleroals, despite t.`,e lack of definlttve avldenea, On the other hand, the Pramingha.e Iteart So-_dy has disavowed the atharaaelarotlc argument and claimed thet the effect of smokioq cn the heaet is acuta Inot ptoqreaaivel, and dleeo-ears o nnp;i:' vhen awoklnq ta atoppad. theae are contradlctory c.atna antl 11:^rtre:e the lack of definitive knowledge to this field. It I. clear from the abova that exeenslve raee__S data do ;cc ncoc,-t the Congreaslenal finding in H.N. 4951 that e , _raFarttnn c' the rr s . :P[ '_ .. In this country are attrlbutable to Bmoktny. On the hill's p -, •
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• 682 Page 11 warning, "Cigarette smoking is a mejor cause of Heart Olsease." ls .n.c- aclentlflcally velld. In e~ery lnstance.'en ewaminat_or. cf t. r_aivs mads e4a!'s: ct:arefte ancking and CNn shu.'s that they ere e1CVr .__.. +'=='s-s.ev. zslxave. unsubscentlated. or, 1. many respects, cvr.trar-; 't tt.a e_a ~nea o[ tns 0.,rgeun ceneral. the a,nerlcaa Heart assecintion e:d c.`.e srsnlrc`e, ieer_ ir+d!. Sa9ned Data 683 STATEMENT DP SHELDON C. SOMMENS, M.D. I am Sheldon C. Sommers, M.D., a physician specializing in patholegy, currently Clinical Profeseor of Pathology at Columbla.University College of Phyeicians a Surgeons, New York, H,Y., and University of Southern California School of Medicine, ! Lea Angelee, CalLfornle. Also I am consultant In pathology, Lenox Hill Hospital, New York; Chalrman, New York State Mental Hygisoe Hedical Bevlew Boardr and Presldent-Elect, Arthur Purdy Stout society of Surgical Pathologists. r am past president of the Nev Lnqlnnd Pathological Society and Nera York Pathological Society. Slnea 1916, except for World War II yeare, I have been engaged in medical research with particular reference to cancer, endocrine and gastrolnteetinal diseases, with over 300 publlcationa -- about !0 percent dealing with lung end lung cancer, and also some on pancreatic cancer. I em coeditor of Pathology Annual and Diagnostic Gynecology i Obstetrics and sarve on the editorial boards of five other medical journals. My curriculum vitae and publlcatlon list are attached. For the pa.t six months, I have served ae Scientific Director, Cotmcll for Tobacco Hesearch USA, Inc. This is a funding agency for biomedical research ln the area of smoking and health, funded by tobacco menufacturera. The budget for research grants an 1902 1e 7 m111ien dollars. Appllcatione are acted upon by a Scientific Advisory Board, and those approved with a favorable rating
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• 684 are funded for up to three years with an opportunity for continuation grant, thereafter. The council for Tobacco Research exerts no in- fluence upon the granteee, who may freely publish what they find as they choose. About eighty active grants now exist in the U.S. and abroad. _ My appearance at this hearing is voluntary, and the opinions expressed are personal, not representing those of any organization. They are the neeult of over 45 years of study, investigation and practice In the field of pathology and clinical- pathologic correlations of diseases, some of which have been at- brLbuted to cigarette mnoking. In the field of science, knowledge is gained through experiment and interpretetion, the scientific method. A theory is proposed. Thereafter, experiments confirm or refute Lt. If the latter, a new theory Ss developed. It is a c•ontinuoue evolutionery process, and needs a critical and open mind. One must be constantly alert for surprises, as Lewis Thomas wrote. Lung cancer is high in the list of statements in R111 HR 9857 attributing diseases to cigarette smoking. There are two general methods of lnveetigating the cause of cancers in humans or animale. One is the biomedical method. Cauee mlght be defined biologically as something both necessary and sufficient to cause a condition. Cigarette smoking is not a necessary factor in human Lung cancer, which existed for centuries In radium minern before cigarettes were invented.' Lung cancer accompanies scarring processes in the lung due to TB, connective tissue disease, and various other 685 ahnormalities in nonsmokera. Also, Cigarette emoking falls to meet the causal criterion of being sufflcient. The fact is that the vant major of amoksrs, more than 904 of even heavy smokers, eo not develop lung cancer. Bence cigarette smoking La neither necesnary nor sufficlent !n the development of human lung cancer, and by the biological definition 1s not the cause. y Like many Other diseaees of older age, lung cancer eppears to be multifactorlal, which means the disease ls associated with searcmanyhers things, now in eddition to amoking. Practically all active re- agree on this point. Theee include: (1) Heredity. famllles with lung cancer are known. Other families have decreased lung function. (=) Sex and Ltace. Hen have three to six times more lmig cancer than woman. Blacka and orientala differ from whitea In Incidence. (3) Urban. Certain urban areas have high lung cancer rates which eannot be accounted for by smoking. These arens are characterlsed by savere winter weather inversion patterns •.+ith high air pollution. (4) Occupation. As already noted, eome twenty occupationa tnvolve lncreasad rlsk. Some eorhers smoke while others do not. (51 tmnune competGnce. Individuals with demonstrably tbur" lmmunity have developed lung cancer. This may explain baa family eaaes, and the increase of cancer with age. •
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686 (6) Hormones. Adrenal and sex hocmones accelerate some metabolic processes leading to human lung cancer. (7) Aging. The maan age of lung cancer diagnosis has been reported as about 67 years, and eaid to be rising to older ages in some populations. Currently, researchers do not know which, if any, of these or other factors play a role !n the causation of lung cancer. The otner approach to cancer causation investigation is epidemiologic and statistical. Edpidemiqlogie statistics involves an experimental group and a control group. For a valid comparison, the groups must be alike ae nearly as possible in all respects except for the item being investigated. In studies of cigarette amokinq, matching smakere and nonsmokers by aex and age was achieved, and it haa been eeaumed that in all other respects the two groups were comparable. This is not true, since in body build, extroversion-introversien, marital hletary, alcohul use, use of nonprescription medications, police records, military tecorda and other aspects, cigarette smokers are devonstrably different from nonsmokers. The fallacy of a one-to-one comparison of smokers and nonsmokers with respect to mortality ras pointed out in a monograph by Rose and Bell in 1971. They studied predictors of longevity in war veterans from Boston, re-axamined at intervals. one-an-one comparisons placed cigarette smoking 01 aa a predictor of early death, like many other studies. Hultifactorial statistical analysis 687 dropped smoking to somewhere below 130 as a predictor, and "dis- satiafaetion with job" became 11. The lesson is that in the present relatively undeveloped etate of epidemiology to beware of facile and sweeping conclusions. , A Where do the data on deathe from lung cancer and other conditions come from? The diagnoses are largely from death . certificates. t0st are not supported by autopsy examinations. A death certificate ls an authorization for burial not requiring permission of the coroner or medical examiner. It is a legal but not a sclentific document. when death certificate diagnoses ars compered to eutopey dlaqnoses of lung cancer, errars in the death certlfirato have been foend to range from 30 to 60 percent. er atudiu in the U.S. and other countries in the past two years again show this large error. The basic data for lung cancer incidence thus are of poor quality and uncertain verification. The problem is getting worse since the ACS dropped their requirement for accreditation of hos- pitals to have 201 uinlmum autopeies. A11 pathologists have noted a decline by hall or two-thirds of U.S. autopsies. Soon we may have so few t~hat naw diseases like legionnaires' disease cannot be effectively lnvestigated. Recall that legionnalres' disease was blamed on cigarettes among other things, and that it was eomnunlty hospital routine autopsies which permitted identification of the responsible organism. Beside the lnadequate epidemlologic matching and the
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• 688 defective lung cancer data from death certificates, one other event has occurred which bears upon the annual quantification of lung cancer. The rules have been changed. In the revision of the International Causee of Death, Oth editlon, called ICD-0 to ICD-9, for reporting mortality the two rubrics: Primary Lunq Cancer and Lung Cancer Not Otherwiee Specified (NOS) were for the first time combined. Lung cancer NOS could begin in lung or have spread to lung from many different body sites. Lung metastaeee are among the three most common lo- cations for all major internal cancers. Nhat ln essence ICD-9 did was to guarantee a continued inerease 1. the reported lung cancer mortallty, convenlently disregarding that half or more of these cancers began elsewhere ln the body and spread to the lungs. Two last points about statistical epidemiology. Every textbook etatee them. Every active scientist knows them. Epi- demiologic studies by the nature of the mathematice so far developed deal mainly with random popoulatlons. But amokers are self selected, an are nonsmokers. Comparlsons of selected populationa using mathematics valid only for random populations cannot be expected to provide valid answers. Second, epidemiology cannot prove cause and effect. All it can demonetrate is a relationship. The nature of the re- lationahip, causal or otherwlee, has to be worked out by other methods, usually experimental. r" The CTR in 1970 undertook a large seale research program to lnvestlgate whether cigaretce smoking causes lung cancer in anlmals. Almost 14 million dollars went into the project in twelve years. To take account ef heredity, inbred mice were used, and`they were teated for and vacctnated against respiratory viruses. To show that these an/mals could develop the major types of human lung cancer, pure chemical carcinogens were introduced down their tracheaa. Riochemlcally, these particular mice were known to atabollse lhese earclnogene into the blologlcally active forme. About 20* developed "human type' lung cancers an a result of ex- posure to these pure chemical carclnogens. 1 Thereafter, thousands of mice were exposed daily to freeh whole cigarette smoke of either low nicotine and high tar or high nicotine and high tar content up to maxlmum tolerance during their whole livee, up to 40 months in some cases. At one point, there were 11,000 animal manipulatlons per day, including shae emoking nnd control mice. After all these years of cigarette seake exposure, practieally zero lung cancers developed, and not one case of equamoue pll cetcinoma, the humen cancer most often baamed on .moking• There was no question that the cigarette seroke had penetrated into their longs, since this was worked out guantitatlvely. . ` In other experiments, Mice were primed with (ntratracheal Pure carcinogenie chemlCala and then exposed to cigarette smoke during their whole lives. No increase in lung cancer occurred over the Aneidence found after using pure chemicals alone, and in one asPerlment the smokinq was associated with a reduced lung cancer •
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• • A 0 690 Yate. The nllmbers of animals and the computeriEed lnformatiou aYe 90 ebundant that statistical analysl9 by modern ezperimentel methods is still eontinuing. Some 40 publltatLons heva in part nlready appeared or are in prospnctn rn summary+ a massitae experimnnt to demonstrate that cigarette smoking can caune lurlg cancer inY.meutat modelrisein negative. One knovs hotP Lmportant an expe cancer reseaYeh [rom the excitement that ettended the elnlms years ago that cancens of ltmg or larynx had been produced by cigarette smoke tn animals• However, no model so ofrthevalleged withstands an objectlve analysie of the pnthology cancera• In summary, lmag <enceY. 11ke many other buman cancers, remains a major biologlcal mystery• Epidemioiogic studies report a stetlsticnl aseoclation betveen cigacette smoking and lung cancer. No.rever, ehe blomeAlcal expecimentation does not support the nmokLnq causation hypothesie. • 691 S,n.IdCn C. So-•eY., !L~. rrrn: lult t, {5:6, Ind4sn ;ol!a. snE4ana r[4ed: xaee ket 9, 043. Cdl:h EY.fi4s, no cFtldr<n Y.ar•ard ColleSe• 19]), cm LauCe P raatG I1aE!col Sclool, 19[:, cun leude Lfern: CAfcusn Unlveratrt' Clin/ca, locP41 Arstsranp Resident end Res![ent /n Pa[hcloEy, Ila• En61an[ Pea[onns Iloap/tel, 9os[~on, Ine6-0e arslstsn[ Retident in PorM1Ole6)'. ftee NcsPl[al for Ilecen, 6rmkllne. )lass., 19<B Asslsranc Resident Ln PatSol[EY+ Pns:on LSlnt-In Horo!ol, Rue[eh 19A6-6a resldent ln Pa[httlosY• xaoq rord Fesolt.f. Oevolt, 19c9-09 A-er/[an 6osra Certlflcare In FathuloRy (Cllnl[ai Pa[hulorr ~ P.tFnlu6lc Anetunl•), 195a Assocla/e P.[FOIo65st, Ne, EnElana peaccnens Nospl[al, poe[on, 1010-51 Asslsranr 9atholoadst. x.rvare 6nu: fe~rssa!:a, Loston, 1950-5] 'ratbeloalst. llaas•<ivsetce .^,er.utt.1 xcay4tals, Eos[en, 19s3-61 Ra= n,;land Soctet; at Pa[helo;,ists; Prestdeno 1959-fU ' rr.holeF=st, Scrt9ps Heuortal xospttal, la lclla, Call!enste, I?51-5] Assors•ae Otac[or of L.Loratortes, rtancls Oelatteld HnsPteal. Nea Yerk. 1961-61; mv[rur, 156i-68 praror of Labor.rorics, Lenm: Nil! Nosplul, Yeo Yor:, 1966•!L EssP[va: In Pat6olad5'. Hart•ard Aedlral School, 1958-:n; Instructor In Pa[holo6y. 195n-5:; Asseclace In Pa[6olopr, L°32-53; LeRarer In P.[neloE•, 19$.-61 xurcla:e Professor et Pathrlo6"• so.<,rn LNverslry' Sch[ui of acdlclne. Amton, 1951-61 tPnicrl Pmfensnr of Petholn5". Gnl.ursit° of Sn,at4em Californla Scheol aa nedicine. Ira en[eles, ]96? - . +ate Pte:essor of PnFCIoEI". Cn`u-b;a Unlsersit-•. Celle¢e r! rb+elciaoe 6 Surpeens, Y.1'., 1961-05; Psniessnr of ParSOlo:y, 1n65-68; Cl.'nicul Professor o? Pa[FOlrfy. IP69 - C..^:afn. "edi[al Co:>s, Uni:ed Statex Ar:.>, 1o.3-t6 :.I~a 5:et, tronre Stat, Crnt:~ de Gecrre and Preadent!al :,nlt C1[ation "-. In[f Counb( )ledlcel SoCle[y, 4ev nt'P. Kerlon fissoeia[lua of Pa[holoElss 1~ n erl[an ratunloEtsro c5orlrr• or Cllnleal Pa[1r1eF!srs .r~..ia.d nn r~Sa[l.•ty . .lodrm. o: Potbalo9~' Lirra,edr5ee!etlex for [.x.+ra'.ental :/cln„+ and `IeJlc!n. [aaer ol '+emc . raer•- sricn ,ula; oc!eo;: Srrrewr': 1`•'•9--1: Prrsldcnt ' Inh-" ,ftt--tLa' :tl, t^A4 - ^atl.rlofi': Cet nnta{a, lni1: [o-Cai[or. 'I:c • - cel^- aud e4otetrtc+, 19;c - '+. ..-vrlena : nal rf Snr^/c+l PAtl.nla[`. Hur.•n PatFoluce, t'r°loRlc c,•d4nlo.^,v Clcraatrl•ccur. I rnth.•lo^ :.u rr\ar[o rexear[n• Inf]-; rsearcu n1[rtror, S:iantl6c nlrector,' ]99]- '[.rl /lrtirnr "eJlcaa P,ev/e+• Anard, ':° nrP trnte, Clr.rlmap. LaIR_ r. ue Purl~ S[eu[ Snclatv of <urclralPa[hrlr¢/sre, Prrcldent•Clert, InAI
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692 FDl.tSHEM ARTLCLES Stal34n C. Saauers; M,D, 1. Jrcobs, J.L, and Semnert. S.C.: The specificity of fornolLeed proteins. J. Imunol., )6: SJI-54L. 1977. 2. Menhln, V„ Radish. M.A. ad Samere, S.C,i Leukacytorf.•prwattng factor tn lnflannntnry vrudotee of uan. Arch, teth., 33: 156-192, 1942. 5, Lecenpto, P,M., Sa.nrrt, S.C. ad s.nthrnp, F.D,t Tunor nf earotld body type erlsing 1. the middle eer. Arch. lethl., 44:76-g1, 1941. 4. Warren. S. and Suneere, S.C.: Cicattlrlry enterltts (reglonq Ileltls) es e pathologlc entity. Am. J,:Peeh., 24:475-501, 1968. 5. uerren, S. ad Soemere, S,C.r Glent-eell /nclusloor 1n elesttleing entertttv, Proc, Soc. E yer. Siol. & Med., g: 661-467, 1948. 6, Warren, S. and Senners, S.C.: PntAosanes/e of ulceretive colttlt. Am. J, Path., 25: 657-659. 1949. 7. Hert13, A.T, and Smeeerv, S.C.: ConeNe of andwetrlel caretnome. t, Study uf prlor blupslcs. Crnccr, 2: 946•956, 1949. 6. Soneoev, S,C.. Nert15, A,T, and Senglolf, g,t, Geneslt of endanetrlal \/1 orclnomn. 11. Cneev 19 tu 33 yeors old. Ceneer, 2: 937-963, 1949. ' 9. Nertl6. A•T•, Sunncre, S,C, end genglofl, g,: Genests of endaoetrlel cerrtnnma. Ill. Corclnomt In situ. Cancer, 2: 9E4-971, 1949. 10. Smneta, S,C„ Lruley, T,g, end Nert/g. A,T,: A study of the placente In pregnancy treated by stllbeetral. An. J. Obtb & Gyoec., 5g: 1010, 1941. Il. Warren, S, end Samere, S.C.: Proteolye/s In intestinal dbcase. Ceetrocnterolo6Y. 14: 527-526, 1950. 12. Wyatt, JLq and 5~~nnere, S,C,: Chronic narrw failure, ayelatc:zrasls end ectronedullerY heaatopolerte. Sload, 5: J19-347, 1950. 17. Neluner, Y,A, ad Suorert, S.C.: PoRpertu. vndametrlel hyperplesla in Einbetlo toeoted vtth ettlbtettal nnd pragut<mne. J. Citn. Endacr/nal., 10: 6U3-6g9, 1950. 14. Smmner.. S,C, and Johnson, J.M,: CanRenlbl tricueptd etrevta. An. Heart J„ 41: 170-14y, 1951, • 15. . . . 693 2_ Sxtaers, S.C.. Vllvon, J,C, end Hrrtvan, F,u,: Lyupha/d leslonc in pol/unyelltte, J, E.:par. Med., 93: 503-512, 1931. 16. Wrrren, S., Molt, M,W, and Saaeer.. S,C,t 5one early nuclear effects of tenlrtn5 radtetlon. Peoe, Snc. E Ver. gloi. & Hed., 77: 2gR-291e1951. 17. golt, M,N., Somners,.S,C, end Waeren, S,t Preparatlen of tbme .ecebn. for qunntitative hletocheofcet etudie.. Anet. gee., 112: 171-1g6, 1932. Ig. A~er'.tb C' 53:~1601oh, 166, 1932N,; Ovorlnn stronal hyperplasle tn 6rma onc{r. , 19. Nerren, S„ N>Iq M,Y, ad Sarreer., S,C,: Seue cyrologle and hbtoeheolcel aud/ar of radlatton reaCttan- An. J, Clin, Prth., 22: 411-617, 1952. 20. Wrtt<sl atravoldhg~u, g,C,; gteaet eane.r Pragnmtb ad werlen yperplaetn. Nev Eng. J, Med„ 246: 590-g92, 1972, Il- e°O1671-6g9, C 1932and. Yaunt. S,L,t O.;Yphtl perethyrofd nLenanae, An. J, loth., 22. Edoards, J,L, ond Smmert. S,C,: gadlatton reactlonr 1, parablotle rats. J. Lab- end Citn. Hed„ 40; 542-554, 1952. 17. pere6tosts.lm rle~ntt{on, glood, yen10ol05yttc dbease ad Palycythmfa -1016, 1n 1952, 24. gollnndet, A, end Sovmrs, S.C,: Lepranetou. 247: 634, 1932 .1<pro.y, Nev Eng. J, N.6„ . 25. Chrietensen, N~g„ Somers, S,C, nnd Spouldingp C,R.: Effect of mft roentgan rey- the rabbit s6in An J R !6. 26,1. • . , nn[genol-, 63: g01-gOg, 1952. S:r.nrcrs, S,C, Chute. g,N, nnd Warren, 5,: getorotrnnsplantetlan of hunnn can<er, I. Irradiated rats. Conaer Ret., 12: 909-911, 1932- Chute, R,N„ goatere, S,C, nnd Warren, S.: Nvtenrrnn.plentatton af 6unan cancaq IL N:nster eheeA pouch. Caneer gee., 12; 912-14, 1952. 5=men, S.C„ Sull(van, S,A, ad Nrrren, S.: Neterotrneeplnntatlan of hunen coarer. pl. Ch9rtoa{lento/c nenbrenet Res. ., 12: 9l5•917, 1957 vf enbryonated ege• C.-ncer .
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9 • 694 2'. Itrovn, N,J„ Nlnston, R- and Sarvrs, S-C,t Meabrenaua stephylococcol enterftls sRer antibiotic therapy. Report of tuo cases. Am. J, D18es0. Dle., 20: 73-75, 1953. pg. Swmers, S.C. eM McMenue, II-C,t Mutrlple araenlcal cancers of skin and internal oreena. Ceneer, 61 347-359, 1953. 29. Sandeera, S.C„ Anderaan, L,M. and Narren. S,: 1rse.ent venbrenes 10 chronic Intestinal dbeasea. Lob• lnveat., 2: 223-226, 1953. - 30. Wnkefield, R,O, and Soeererq S,C,: Patal aeubr.nous atsphylecoccal enteritls in sur6lcal patSents, Ann. Sure•• U6: 249-252, 1953. 31, IkManus, R.C. r,nd Smneett, S,C,7 Significance of patrlc palypa eccm.panYing aancer. M. J. Clln. Path., 23: /46-757, 1953. 32. Saenera, S.C,: Ovar/en Rete Cystt. M. J. Path., 29: 663-639, 1953. 33. Saonerr, S,C,i Endoar(ne changes aft.r hentadrsnateetmy nd total bedy Irradfat/nn (n perobtot/e rate. J. Leb. 6 Cito. Hed" 24: 396-407, 1953. 30. Nnlt, H,N„ Somnexa, S.C. ond Narren, S,t Intranualeat ehan6ea resulting fron c::posure to IonBing radiation at detected tn froeen•drfed preperatlone. Lcb. Inveat., Tt 406-416, 1953.• 35. Souecra, S,C., Geyet, R,S, atd Chute, R.M,: Autoradlo6raphle arsenic locnltratlan In adult and embryonic ep(theltun end cunnecetva tinue. Proc. Sac. E per. 6l01, & Med„ 04: 234-239, 1953. 36. Sor.nera, S-C., Tcloh, N,A, end Coldnen, C,: OvarSan Snfluence upon survival to brenet conccr. Arch. Suq„ 67: 916-919, 1973. 37. Snmcrs, S,C, and Lenberd, O.M,t Ccncar eua<lated vlth ovarian rttonal hypcrplatn. Arch. P:th., 56: 462-465, 1953. 38, Warren, S, and Senxras S.C.: Prtholop of re6/onal /1c.:u and ulceratlve <olltls, J, An. Med- Auoe., 154: 189-193, 1954. 39. AGaman, N,C„ Jr. end Synera, S.C., Endonetrtal aralflutlon. An. J. Obst. ond Cynee., 67: 167•190, 1934. 40. Chute, R,N„ Runton, R,R, and Sarnera, S.C,: A laboratory ep[denlc of hunan•tYpe tubereuloelr to hensters. An. J. Cltn. Path., 74: 223-226, 1954. 41. Norc/al•ROJea, R.A. :nd S nnsra, S,C,t Olftarentletad wraepldernold 1 tunors of rallvary glands. Arch. Otolaryne., 33: 135-140, 1934. 695 47. Hollan2er, d„ SItmcra, S.C. •uf Crlwodc, A,E,: gletechcn/cwl anJ ultraviolet nlcraecoplc studies If chronic dernurosee and the corlun nanbranc. J. Invest, Ucrnat-, 72: 535-34D, 1554- 43, Stranda, A„ Saners, S,C, end petrak, M,: Re6tanal anterocolleb /n cocker apnniel doga, Arch. Pceh., 37e 357-362, 1654. 44. Svtnert, S,C, and Ikhenar. N,A,e ecsennnt nenbrane chanees In chronlc thyrald/tla end other thyroid dleeaaee- An. J, Clin. Prth., 24: 4J4-440, 1:54. 65. NooA, J,S„ lr., Hotyake, E.It„ Clason, N,P,C„ Sanera, S,C, cnd N;rren, S,: Sn c::perlnentol study nf the rclotlonshlp betucen tulor a/ac ond ' nunber of lunS notestares, gnncer, 7: 437-447, 1954. 46. CedLnrd, J,N, and Sxncrr, S.C. H_thed foi thyroid cell nnpplnR• Lcb. Invcat., 3: 197•210, 1954. , 47. Celeock, 6,f. and Sa.crs, S,C,: pro6nostr (n P:pt's Clscaae a( the breast. Surg. Clln. N, An., 34: 773'n~, 1954. 40. Surt, L.S„ Lrndln6, E,N, and Samera, S,C,: Mphophtl tunort o( thc hypcphya0 1.4 ... 4 1. nice by 1131, C-ncur Bes., 14: 4c,7-502, 1954. 69. S;rners, S,Cs end Melweer, U,A,: Ca~suel vereinonas at thn pancreas, Rrch. P:th., Sg: 101-111, 1Y54. S0. Sovwra, S,C„ E!uardt, J,L, and Chutc, R,N.: Inerecse to hyper- senr[tivity loelane af pambloslr Intoalcatlan after n!rennleceany. J, Leb. and Clin. Mec„ 44; 531-543, 1954, 31. Sr.nera, S,C„ Crotler, R, and Nxren, S,: Ultravtolat nlcroscapy of gionerulnr d/aantas, in. J. 30: 914-939, 1954. 52. 25 1 : /44 tnrner, -D-0,165 and1934 Smseer., S.C.: Medteal (ntalil6enee. Meu. Eng. J, MeJ., SS. Ftteraon, N,6„ Chute, R.N, and Somers, S,C.: Trnnplontntlon n( huoen tunurr tnto eortlaane-trented hanscera. Cancer Rea., 14; 656-659, 1956. 54. Cod_ord; J,N, and Sceaera, S,C,: Thyrlld rtinulatlon in diabetes nellitus. Dtabotca, 3: 367q6g, 1954. SS. Secevrs, S,G„ Nurphy, S,A, etM Nnrren, S,: Pxneraac(e duct hyperptanta anc cancer. CnstroenteroloRy, 27: 629•640, 1934. 56. Rchnan, M. anJ Soutc r, S,C,: A rloubla prlnary corclnonn of the urinnry bladder, J. Urol., 72: 11)4-1177, 1954,
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• 696 S7' Ss~; SCl~ga yS4 pllentlnne of ultrwlole[ nlcros<apY I, patholaRY• e~ 58. Lemrc, H`H' 14071 0~r1954,C.0 CIInICOPatM1eloSlc cantererce. AH. ]. Cltr- Path.. 59. Socaere, S.C„ Crorler, R. a~b Yern•„ S.: A reudY of the ulttavlulet ost~PY of rn.ol veecul.r dbeun. Clreultelm, il: J8-43, 1955. ml cr 60. 4aud. ].p.. Jn , YulruYe, E.D., 6>•aere, S,C, and Yerrer, S.: I flneree ol pltultary 6rwth hor,ew•e m, {rwth and .etousle.for96ti97-IW. 1455e tru..splentable nuuse enrcomn- 6u11. John Nopkins Norp•, .nr.sYarcei~. 5.: Ulcetitfve eolFtie lolone ln trred/eted C' t. DSe•, 72: 111, 1935. 61. iu'+r. t, fn. 5' J, Dl6a 611 Sarnere, S.C,: Erdocrine ebnormalltbt in uwen vlth breut caneor. Lob. Invot., 4: 160.174, 1955• 63. Naley, B.L., Dev., C-N. ad Sn:.nre, S.C,: A hlsteehenlcel cwVarlron n/ prlmiry thYtolA hYporplarle and tdonaebus 6ott.r. Arch. peth.,. 59: 635-640, 1955. I64. C IInCrP nM1. 1S: IO~SrJ1057SI9SSCIlnlcapntholnRic Cinteroncr. Am. l. nadal, Lnte recar.enrr ^f Rren~l-re Cater, D0 oml 66: 65. 5^r-re, S,C., 593-)9R, 1933. cell [umeu. Dbrt. 6 GYnee., 66. 5=n'+en. S.C.: DrvelaPment nf r.eeerch ae Hnreerhueeter Hrn^rI•1 N~.petele. 67. 67p, 6: 115-115, 1'755• Nondler, A.N., Davle, 5, and Sanmen, S,C,: Neterotransplantnt/an e~.pcrlnenu vlrE huean canrers, Cencer Re.•, 16: 5)-56, 1956. 68. Pzr4er, i.G, and See'en, S-0.[ Adrenol cortirul hYperpleelo amsnPnnylnR cenror. Arch. SurR•, 71: 493-499, 1936, 611. Scn+en, S,C,: Tuettrulu sprr,wto3enlc rell hYprrenphY nccompnnYln6 .eenrer. . J, pnth., 32: IRS-t99, 1956. pratntlc hYpertraphY and An 7D. S_.mcrs, S.C, ad IL+leY. K•N:: 5lntlarttY ul Slworuler ultrovlolot aburp[lor.r ln d/abetes Io t767-765, f1956eoreteors therapy. Prnc- f~e. E per. 6tol. & Hed.. S • 697 _ /. /{. Sorver., S,C, and Chute, P,N,; Cerclno8ene.1. ont elter.d haa oorelanr Sn p.re6(oete reb, Arch, Peth., 6t-• 793-]04, 1956, ]7• 57mae^`.ASH A„ 7lr~uetlan ta pethnloBY of neoplestle dl..etea, J~ 5, APril, 1956. 77• CmeCeah8lr117-IIS, ., $ oevere, 5,C„ Chrnnlc I9S6I aWrua endwetrfun, Ob.[. { 14. ~5•. •ere S,C„ Reaenent nenbranee, Brnund subetenree and IFphacrtle 1 gRrc6o[ee ln qlnR ergnna. J, Ceruntnl., 75 Il: 751•16p, 1954 . 9S,C,: f, ull6hted'• eeeleee tueur. ireneplant, Sull„ 1956, ib. Sutmn, S.C, and Yrdeen, P,J,: PethoReneae of polYCYttlr orerl.e, M, J• Obet. 4 Cynec., 17;160-169, 1956. /7. Seu6htw, C,A, oeE S~,uere, S,C.: Rnnal rhanRee In aburk treated vlch levorterenol (LevoPhed), An, J, Clln. lnth„ 77:]9-J4, 1957,. f6. P:R. enG Sdraert, S,C,: Unsunl rnuaee en. Htart J- 53 of death after eard/ac c '- 1J]-71^., IS37, ad f.eyrr. 3,C-C l,u!rcrln. <orraellan. In m4v..q eden>- t " M rbmlr eY.Ur .altrlt. Ann. pur Ip. f .n 1• 145: ]76-tJJ, 195>. S,C,gntVrlne r6en3ee - a N5 pt, 19" „IIA pr.rlrttr r rclna.r. Cnn[rr, IV: 41. L-nbt., A,p, 6unrm,a, R,A, ad Srerear., S,C.: Cllnlropaholuglc C.nferenre. Refractary enenln, aS.mmeSlobullneole, ad medlnaelncl tnxor, Ln. ,t, Clln. Pcth„ 27: 444-457, 1977, 17, ecllultY, J,R, and Surmera, S,C,; Keratoacnnthxu nr e eur6icul pathulcSlc ntley, SurR-. Gynee, & Ob.e., 104;'661-66R, 1937, 11. Janea, R,C, and S.eeec. S.^,e 6lweruler altereebss in k/dney. ef nu treated l[h dnoeyeartlcostorvne, Arch. Poth„ 64; 58-67, 1957. µ• 94tt, N, S,wwrt, S.C, and SnlthuleR, R,H,: Cllnlcopathn1o81c :rrelntlellr af tenol b/speGt frw seenetnl hyperecnrive pne/enta. Clrrulnelen, 16: 707-712, 1?57, f1. Herriw, J,Cr, Jr, and Soencr., S,C.: Mncrvey perlducral hyntln In dla6eelc vorren. L-6. [nveat. 6: 617-420, 1937, i
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• 698 I 06. Nalcenur, U,A„ Smncre, S.C. snA Sherman, C.: En'-onetrlel hyperpLtte, endanetrlel carcinoma, aod endowetrtor3e produced experimentally by eeeroden. Cancer, Ig: 500-SUS, 1557. 01. Sx.rare, S,C, end Nclamm, Y,A.: Noat relatbnthlps tn experimental endcwetr/el earctns,e. Cancer, 1U:S10-573, 193?. 88- Sornerr, S,C, and Nelemer, tt.A.: Endoerlne abnormalities secwepanylnd hunen endametrfal cancer. Cancer, 10: 316-521, 1957. 89. Soutter, L„ Samcrt, S.C... Kelwn, Aad, end E.erenn, C,P,: Prnb/eaa in the eurglcnl management of thynie tunart, Ann. S ur0., 146:424- 43g, 1957. 9g- Sarr, R,N, and Smmtea, S.C.: Endeerlno abneroal/ttca aecanpanying hepatic clrrhorle em! hepotma, J. Cltn. Endpcrivl., U: IDt7-1029, 195/. 91. Ullrtck, N,C,. Lentlnl, E,A. and Samen, S.C,: E-.eltabtllty and contractility of pottoatem human heart wuecla. Lab. Invert., 6: 520-535. 1957. 92. Sumere, S.C.: Naer factov in fatal hunan Lung cancer, Arch. Peeh., 65: 1D4-Ill, 1".56, 93. Nerrlam, l.C., Sovxre. S,C, aM Snithu/ek, R,N,: CltnieopathobRl< cnrrelatlont of renal b7opMea In hypertenefon with pyelonephr[tfe. Ctrculntlon, V: 243-248, 1550. 94. Kocfcr, E,0„ Svlnten, N,1t„ Atklnten, R,P, and S:uatere, S,C,t Pxnel dtacuul+n on chranlc ulcerotlve cnlltib An. l, Ceatroenterol., 29: 355-373, 1959. 95. Arar, N,A. and Sxnere, S.C.: Retraperltonml tctoplp senlnal erlcle cammn7eatln with a eanernlnter4 sslttery kldney- Report of a raee- J. Ural., 79: 94-J9g, 1958. - 96. $ainere, 9.C„ Relraan, A,S. and dnlthul<k, R,16t Nltoloi/p studies of kidney binpq apeelaena Irom patlenta with hypertension. An. J, Path., 34:605415, 1958. 97. Sx,eev, S,C,: Con.tltutfinel aepectr of dattrte carcinoma. Areh. Path. 66: 4g7-493, 1950. S0. Ullrlck, N,C„ Lrntlnl, [,A. and Somera, S,C,: OeYgen eoneunptfon of partmaten human hearr, cvecle. Proc. S'c. E~:par, BIoL 6 7kd.,99: 246-247, 195C. ' 99, SLante, A,N., Coddnrd, J.N, and Sxnere, S,C,tA etuAy of the edrsnal atntur in hypertension. J, Chrnn. D/e., 0: 507-595, 1050. r 699 , IOD. dllveyP, end Samere, S.C.: Ren An.l, Ned- dc1„ 236;700.104, 1a95Cl blapey chnrRer with pheahrmocytma, . 101. Reffleq R., Lenaan, It, atnf 9arner., d,C;t Cerelrnue erlaing 1. nlmr .ellvary Slend duete of the lover Ilp. An, J, Surg., 97: )9-02, 1959. and IOL 60* 764-169, (95gSomen, S.C.: SA'nct6dente cerctnaeo, Arch. Otnl.rynyr 1U/. Vllken., R,V, and Sanora, S,C,: Clloieoyatholodfe Cinlerence, Enlargaoeut ' of ehe heart, cardlac lnllure snd loaae, dry acaly rkln. An- J, Cltn, Patb., 31: 66-72, 155S. IOt. Sae.ere 0: SDO-6,21, S,C19,:59Pltultap eell relatbne to body etatea, Lab. Inveet., . 103. Co5(n.n, J.D, .nd dmreu, S,C,: re.ll/el peeudonenth,rna elertlcun and valvul.r heart dleeaee, Clrculatlon, 19:242450, 1955- 106. Scatere, S.C„ Patholagy of the Kldney and brenel Bland in relattonrhlD Ypertene/an. In: Rypertemlon" N,S, Seund.re Co„ 23, 1958. 107. AMrluakle, C,0, and Sam¢re, S,C,i C./terle of thynle caneer nnd cltn[cat corrtintbna of thym/c tunae. J, Thoraclc Sur6., 37: 273-2J0, 1959. IDp. Andraubepnulaa, N,A, aM SA,rvre abR eL 6 CYneo., IAt 245-240, 195 ,9 B,C,: hrtmempouql .ndwaet rl )tb. . IC). gllrlek, N,C„ Lentinl, E;A, end 6.wnert, S,C,: Summetlvn and tetonu. In paetmartee huewn haert cvrcle, J, Appl. Phyvlel„ 14: 567-560, 1959- I10. R>ItaMCt, A, and dw.eere, S,C,: Current core ol lepreoetau. le etid-teat E.ellll In eplderNa- Conn- Ned., 2): E50-654, 1559- uterine prcey, Itl. 7Eayaq C-L, and dovoeu, 6.C,: N:et factan in curclnmza ol the ceevlK. An, J, Cbeteb. 6 c yne<., )g: 3C6-3i2, IS35. I17. EI 0, »dv)reh, J,M~O; and E:uc.era, S,C,: "Clrrlntie glsreruli¢Ierorlr^, L ren19S9ealun e.eelet.d Ith hePrlc clrrhoete, Lab. Invret., 0;t62- 113, puller, C,N, ntel Sa:nera, S,C;: ihe thyroid etatu. In rolstlon tn erterbecipmtle dhtenae. E,IS7, 1U: 1-2, 1939, •
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• 910 157. 255. 259. • ualler, Thrrap. J. and 5omers. S.C.: tulnlnant :51-54, 19T5. I Cltn. Heports, l laeal aclerudenn. Mer. J, or ffsher. _ E.g.. Gregor/n, g.M., Flsher, g. and Sommers, S.C.: The path- olvgy nf invasfve breasr cancer. Cancer, )6:1-95, 41, 1975. Smmaers, S.C. and Carter, N.E.: Adrenoeurticel poatirredlatlon fibtosls. Arch. of Palh., 99:411-423, 1975. 260. Terxakls, J.A. so®ers, S.C. Snyder, N.N. and Sabbath, M.: X-ray mlcro- ana lysls of hepatic thorwn depositions. Arch. Path., 9g:241-242, 19T4. 261. earbeq B.g., Soemere, S.C., Snyder, g. and Nuon, T.N.: Histologic and nuclear grading and atronal reactione as indlcea for prognosis in ovarlan cancer. mter. J. of Obscer. & Gynecol.. 121:795-g07. p6, 1975. 262. Bnrelltt, 8.1. and Sonverr,S.C.: Response. to drug therapy to ulcerative coiltls: Evaluauon by rectal bioysy and hbtnpathologaa1 changes. Mer. J. of Las<menurol., 64e365-370, 1975. 263. PathalugY Derennlala (1 voluaea), Appleton-Century-Crofte, :a- icnk Ci:_} Edllor by S.C. Samers, 1975. 264. Sor.mers, S.C.: Nypothalamic Aepects of INlclple vrhsry Cancers. Peru6ls Conferznae, Petu6la. ttaly. vublished. 1975. 265. Could, V.E., Snmmere, S.C. L TevaYie, J.A.: Sauamaat d/1lerentlatfon and oasal lanine deposition gn endametr(al adenotea-.e.o-a. '-+ l. Pathol., _~,25-08, 19)6. ~ 2R6. gorelltr, 9.I. and Soanera, S.C.: Nnyonres tn drug r4rrrev In 267. nlceretiue colttis: E~aluatlun by rectal biopsy and nvrmrl cell cmm.s The Amer. J. DIR. Dia.. 21:441-447, d6, June 1976. Snnmrrs, S.C.: 9nuauei manlfNtatinna of cacer. Lseerpta lledica Inren:at. Cangresa Series No. 384, Proc. of the L4 Fopld Con6reee of Anatonlc 6 Cllnical Path., Sydney. fletober 1975. 268. Korelitt, 9.I. and Srmross, S.C.: Hectel Bitpsy in PatlMts Rith Cmim's Disease. JMpr., 237:2742-2744, 125, J;me 20 1977. 269. potteldan, H., Korelite, B.I., and Strmars: S.C.: Mlcro;lranulanas in Cressly Norral 1@ctal Hucosa in Cmtm's Disease. Mer, J. Clin. Path., 67:550-554, [6, Jmte 1977. 270. Barber, H.N.K., Graher, E.A., Sannas, S.C.. Nei~say B. ard guar, T.N.r Canc•u of the endmetrlrm. IB:ade 141. g1ed.J., 50,259, Jvw 1975. 271. Kotelitt, e.11 and 8an;ere. S-C. t Pyadevre 9ergrwpnm tv:pllutlstg Crdn's disease. Amr J Gsatnoaltetul 68;2, 171-176, Algust 1977. 772. Could, Vt. Ysnnopoulos, AD, Soa.en, SC and Tereekia, JA: Neuroendocrin. cella In dysplastic bronchi: plttatructur.l abservatlnna and quantitatlve analysis of secretory granules and the Colgi coeplex. Ae J Pathology 90: 49-56, Jen. 1978. 711 273. 27/. 275. 276. 271. 278. 279. Moukl... M, Aleea FA, Hung MS, Somners SC. Klinger gP, pomney SL: the «ventble behavior of locally /nvaslve rndnoetrlnl ... clnnmo in thromnaomally .psate (45,K/46,xr(x)) ynung eonen trearnd vpth Clomld. Canccr 40: 86, 2957-2966, Dccembcr 1917. So.mers, Sheldon C.: Cannon Lecture: Ulcerative and granulamatous colltb. Aner 3 Noentgenol 110:81F, Mey 19Tg. Parsons L, Sorreara SC: Cynemtogy. Second edition. N.6. Saundera Co., Philadelphla, Nay, 1978. So. n, Sheldon C.l tntreduction, Sympoefum on Endocrine Pathology. Unwn Pathology 9_: 375; July 1978. V 4r6ar Hgl, S.ra, S.C., Nutterda., N., gvnn T: Vascular Invaaion . s pregnoatlc factor /n Stage 1S cancer of the eervLa. Obstet Cmecol 52: 347-d8, Septasbar 1970. Saagnere, Sheldon C.t Pnatrnopauul asarogene and endosetclal cancer: . patholaglatA ovar.lev, In ESTgOCENS AND CANLLA, ed. by Sllverberg and Major, John Nlle7 g Sona. Inc. 1978, pp. 43-34. Sooners, Sheldon C.: Dlfferentiation of .<tastaaee tron nultlple prinary eancen. Pree. Th1rd Internatlond Sympoalua on Detection and Preventeon of Cancer, N.y., 1976, py. 933-935. IM. gudoff pp, Sonewan SC: gaerogen-proReeterone therapy in perlmenopausal lrl IS7. 283. vawn. J genrndurt Mrd 7l)/1-taJ, 9se 1919. enr.. eCl.a wtn[q(a d. 1. ralul. ulr.rn.. y granalomatosa. ae.batn. .n Gutrn.nurnlryla, Lg qrn:nAea e AOf DePaula, edn., Arerntlna, 1919. pp 7)5-71n Sowan, Sheldon C. : Tr1N by medte. An J D]ag Cyn Obatet 1: 3, Spring 1979 eell-Thomann J, Mlssler P, Snmeeere SC; Lung earcinoma arlsing in brnnchu- pul:mnap ae9ueatratlon. Cancer 44: 334-9, 1979. Igla. Sonners, Sheldon C. Carcinoma ln situ of the endanetrlum. Letter to the edltoq M J Cl1n Pathot 72: 130, July, 1979. 186. gntterdan NL, Sorwers SC: 1gC lynphoplaamecytlc /nteetinal lyeyham.: a case report. Henty rord Noap Had J 27: 218-22, 1979. 185. Smeers, Sheldon C.: Polyqettc ovaries revisited. l.endmrrb In Path 1: 221-232, 1910. - 266. Mater gCe Sotwere SC: Mediastlnal lynph node hyperplula, hypeqamvg7obolln- eala, and meefa. J Theua cardiova.c Surg 79, g60-g63, 19go homey 8L, Snwnr. SC: Neoplutic graath. ]n gonney St. CraY'p, Little Ag, Merrill JA, Qullllg.: EJ, Stander gl/: C.ynecologv and Obseetrlce. Neu torA, HcCrau-N111, 1980, Chap 12, pp 261-293 •
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• J 712 • • • • 71, • ]88. Sn:mers `L, G+rter H, Palmer E: haginNn9 of the Nev York Stn1c Hentel Hygiene lidical Drvie.+ Board 1976-1980. Am J Forensic Hed PaUol 1: 161_)6j 1980. r:. Ernn.ra. Q: N.at ls tb mle of e,qql.f.o~, ~ re In InflaneatorY bl>`el disw, xt In -Inflemmetc.ry Bo-el 1 Y 289. Samcrs 2: 1'reeelionant lesions of tJm e,dwctrlun. In foldsmitA's . R. orelitz. John Nright PSG Inc., Boston, 1982, Oa Practice of Surgery m Nlllia:m ledl, 1lnyerstam, Ilarper L Rw, 1980. 303. F°a'xrs• Xe ',e Problero arising in diagnosis of dyepla ~li9nant lesion in ultrratite tolitls i ' 290. so,ners L: Dr. Shields Warrm - an obituary. Nltrastruct Pathol 1: 589, . n Inflm.mtnry ed. B.I. Pnrelitz, P9C Irc.. Boston, 1982. Q:ap. 27, pp 16 1980. . 101. Cuold, VE. 8amers. 9C: ldrenal nedulle i plregarglla, 1]ap In JI9 Bi°od. U 291. Ynss W, Cranet D, Ferencry A. Wraide 8, Reagan .7N, Sllterl PR, Sun,ers ,; i qr l M" p:docrLrc Patholo9y Williams 4 NilkL fL., ed, 1982, 995 pp. Pecv d advances in aala:etrial nnplasla. Aetw Cytnlog ca 24: 478-493, 1980. 392. Forelitz BI, Fparlnuttes N, Sommera BC, Waye JU, Shapiro S. SNm N, Ibffzau, 1, Fefn N, Htchsler eL: Careinom tvlpliceting ulc,irative eolitin. Dig Dis Sd 25, 216-327, 1990. . 293. Srnrrere BC, Gould VG: I]docrlne aetivitiea of turore (ectnpic hotnqma). In lidocrine Patlnlogy, 2nd ed, JN3 Blmdwrth (ad). Baltinore, Willian® a Wilkins, Q,ap 9. 221-243, 1982. 294. srnncrs OC: Ihytoid 91and. In Bdacrira Patlnlogy, 2nd ,.d. JF@ Blarlwrth Isl), Daltbmre, Nillimn; c Wilkins, Chap 6, 155-203, 1982. 295. Fnmers 9C, Norelitz el: D,ndanl biopsy cell tanta and histopathology, in Crolm"s disrase. In Pecent Advanres in (Sdm's Disense, Vol 1. Proceed- ings of the 2nd International Wikst:op ae Qvim'a Disease. Leiden, No11aM, Pens AS, tkttenvn IT, 9ooN CC L Sttober N(edsl, The INg,K.'. !Hrtinus Nijboff, 1981, pp 97-51. 296. Ibttcrdam 11, ~s 6C: Biopsy Dla9nosie vf the Digestive Tract. Biopsy lnterpretation Series, N.Y., Raven Press, 1981, 482 pp. - 297. Ibrwitz RI, reinstein AR, Vida,e M, Smmers 9C, Ibbboy S1: ILLstnpatholo9le distinctions in the relationship of estrogens s erdmetriel cam!r. SA1W 246! 1425-1427, 1981. 298. Barber H.R.N., Smr.ers 2: Cnrcinure of the 1ldaretriun. fNSsal P„bl. Co., Nev York, 1981, 240 PP. 299. Could VE, tlamll VA, Dardi L, Sobel N, Samere B', .Iohelneseen Jv, Neutoen- docrine rucinonts vith mtltiple innvqreective paptidea i nelanln production. Vltxasttmt Pathol 2: 199-217, 1961. 300. Morelitz B1, Wal'e .7D. Brela:irl9 3, Sassera Bc, FbiD lo. Bedn[ 3, Gelbe[g D1, 301. Crohn's disease in endoscopic biopfee of the gastric antton and duodenus. Nmx J Castroentetol 76: 103-109, 1981. Parrish t9., 'hrzekls JA, Sm:mss 9C: Ovarian nelaosecxetory-type cells In 1Ln:er's syrdtn,e. Arch Patiol Inb llyd 105: 512-514, 1981.
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• 714 Stata..nt Professor T. U. Sterling I a. Theodor StarlLn{, UofvecaftT Reuarch Protessor ac St.on fueer Unlva[s1tT, purnaby. pritL.h Cclu.bla. I hara al.n pu{ht at cha [o11ov1o{ unfverstttes: ALbau. Clneinnatt,_ Mlchlkao State, Prlvutou, and Washington Unlseralty .t St. Louis. 1 have eetved as an advtser to the pood and Drug Ad.inistration, the federal trade Co..ite(on, the National Science ebundatlon, the Mational Security A{ancy, the National Acadeey of Sciences, and the vaterana Ad.inlstratlon. I a. a Fellow of the A.erlcan Auocfarloo [ar the Advanae.eut of Sclenee snd of the Aserican Statistical AssocLatlon. My .aJar professional work concern, the collection and lnterptetaelon of scientific date and the design, exeeueioo tad aualfsla nf axperl.ener and of survey studies. Much of q reeaarch haa centered on learntn{ about the effects of anvlrou.antaL exposures an thr.haalth ot anl.ale and .en. I wish to coxaent on the proposed Co.prehansive S.oking Preventuun gducatton Act of 1981. I a. oppnsed to this proposed le{lslatlou bneauaa I believe its far-reaching "flndtngn" do not have adequate scientific support. Purcher, if it beeu.o lav, this Act could uururnnably divert attentlon bnd resources away Lroa cruclally i.portant areaa of public health research. My couauta are based on .1 analyses of [aporca of ather lnvestlgatora and .y own rataarch efforts in the suoking aod haelth arcae. S.oktog and Health Studlu 11y interaut in the porslble health ef[acts of ci{aret u s.oking goes beck to the lata 1950'a. In a no.ber of published artielas, I have expressed .y concern about eaey r.okin{ and health studlea, pri.arily hecause the approachea taken have ovarr/.p1/flad what to reality 1r an extra.ely ee.plax probleu. I have pointed oet apeclflc flan. Sn the de.l{u and exscutlon of .any of thu. atudlar. The bulk of the data oo s.okLn3 aod hedth co.es fro. atudiee of Populatton gceups, that is, fro. aplde.Lolog3cal atudlea. Lhese data are aualyaed ualvg statistical .athods to determine whether chara are aeaoclatLona ba[waen ceru fn factors tad di.etee eed-pnlnts. As a statistician. I e. feaauently astonished to see how .any people, evan .any who should know better, treat statistical asroclatlonr u proof of cau.a-and- effect relatfnvrhlps. tha ffndinga in the proposed Aet seen to be a perlact example of this alause of statistics. Sclentlscs 715 eed oooecLevttec. .11ke .uet hand the vords of a veil-knovn ,p/deatoLa{lst, who very receoclT said: {pLde.lologlcr(1 studies, even prespective anu eannot prove c -and-effect vh.n tha eod-polvt, .f[sctu e{s . ouecome e( a ehroule oon-coaaunicable cendltion.l Io order far statlatlcal assoctatlone to provide ,eliabla dlraet/oua for further research, the data fton vhtcb they ar. derived .uat ba accurate and theee date xuat be euaSyrad using appropriate .athuds, taking all Poastble confaund- tng facton leto aeeoaet. Unfortunately, theee acienetflc tendarde frequently have eut b.ee aet tn epldeeloluglcal studles p of saoking and hadth. I have evaluated Ln depth tvn of the ra]or prospectfve sortality atudlar. Sha largest of these vu the "rlllion persons" atudy conducted by the A.er(ean Cancer Society (ACS) saae yeers qo. Although evs would hope that resulte lrom such a large and ,epenalee study would be relfable, after detailed cunalderacion. I flod that tha reneluslena about the possible ratationshlp of poking end .ortallty aq not b. valld be~.yee of cha blued prncedures used to stlect the populatlon. ihe data from this Large study population were gathered by voluotaar oorkera, end It appears that nany of the volunteers bad preconceived vlaws on aaoking and dlsease. In other worde, rfeee the purpust of the study vas to ehov a ILnk between seoking and dlseaua, the voluntura would be aore likely to chooae ill eobJects who aaakad. Iudead, so.e of the dlseese patterns of the ACt populatlon are quite different fro. those of the U.S. pupula- tlov. rer axaiple, the ACS wo.en had twice the percentage of brrast cancer deathr and three e1.as the percentage of lung caeear deuthe, co.paredto U.S. fe.alu panerally. Likevise, che prcent of ACS sales wryb died of lung <anoer was twice that of all U.S. .ales. Yet thr overall death rata for ACg ren was about the aa.a ae that far U.S. .aler and that for ACS women was somevhat laver thau that for U.S. vo.en. the ACS Populatlon xaa alao very different Iro. the gavaut D.S. pepulatlon with respect to age distribution, eduea- tlnnal attain.knt, raelal atructure and place of res(dence. It fe elear that thur aue Sllian .av aud vo.ev vere net representativa ef tha U.S, papulatloo. Certainly, resulta of the ALS study cennut lapitLatdy be projected to the taneral population, yet thla haa baso and 1r still being done. And estoul.hingly, the Ac3 hae recently aunouncrd it will con begin a second "e(llion par^ane^ a[udy, nriog cha aa.e procedure of subJect rwcroltaene by dedlc.tad^ voluntuu: ) •
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• 716 A smaller Amdtican mortality atudy, which is still - widely quoted, ueed inforution obtained from U.S. veterans. I have ettenslvely re-avalysed these date end have found that approximately tventv-flre percent of the aubf=cts had been miaclasstfled with respec[ to seuking hablts. Foe example, large nu.bera of elsclsselfl<atiens vere eade amnng current ookers of mnre than one form of tobacco and uon8 al1 cacegorlea ot former xmokere. Theme misclasslficatlon errors dlrecely allact the oamber of deaths by smoking ela.sea and nuober of Fsate at risk used to det.rmlma mortallty zatlos. Thue, lt ts appropriate to ask vhetber conclusions based an these utenetve mlaclass/fte.tlone can posstbly be valid. Thts-quastion is partlcaLtly slgntflcant since the vaterans' data are perlodicaity updmced end th. results used as [urthar avidance of the• adverse health effects of smoking. . As everyone Sa svare, ameklnN haf also been atatlstLcelly 1lnked vith "excess" mnrbtdLtT, that is, "emeaas" Sllness snd dLabtllty. I have re-analyzed the data from the Health int.ervlev Survp,5 un vhtch this alelm le satd to be baeed, and I hare found that theae data may mnt, Lo fact, rareant the concluslnn that cigarette snoking leads to lncreased disease and diubllity.6 Speclflully, I found that fa.ala smnkars by and large report - fever dlseasee and dlsabllltlas than female non-amokets. Atso, .oderate smokers, both eale and female, very often report the levest nu.ber of dleearas and hase the lowest prevalence ratu even vhen coepared to noe-smokera. I did not u.m special methods to malysa the data to arrive at theaa conclustons -- these same absereetlons far faaale smokers and modeute amnkera eppeer clearly lo the Tables Lo the chapter en murbldlty In the 1979 Surgeoe Geneul'e Report on Smoking and Nealth 1. Iu addition, vhen I eaamined the Health Interview Survey methods, I observed that several potential sources of bias were at.ply tgnored. For example, much of the information ,.as obtained from proxy tuponna, tha method used to adjust for age dlstribution didferences between seokara and non-smokers .ey have been lnapproprinte, and some knovn dlfferencas batvean seukece end non-e.okrte, euch ee eceupatlan, vera not consldered. The following stateaeot, Aeo from the morbldity chapter in the 1979 Surgeon emeral'm gaport on Smoking aad Hulth, clearly supporta q contention that studie. nn amoking and health have ignored posalbla coslcuodlo8 factors. Ncat larke aeate atudlaa un emukla{ and health hava taoded to lnveatipte the role of amoking _ indapendently of other behavioral variables, sueh as alcohol eonaumptlon and other Lile style fectnre, occupattonal and environmaecal hasarde, and cerulo pqchologlcal factors. Theae varl- ablea are koovn to be related to health status and maoy are mlen related to smokLng hablts.7 T 717 ptrv atlooal ex oaures aod Smokln for many years, I have been coecerned with and have arediad in depth the elfactA of various envlronmental agente on tbe health of mm. Modern society has created a aultltude of aourcea for toxic eirbarne particlee and fuoes. All of us cerry so aeeumulaeLea body burden from by-products of carbonlzatlon, itae dustm, and itom a uriety of chemicals and subsunces vhlch are released Lmto our .arLron..o[. The sources are as different ss the etoyl cover of a anta, the kitchen ges stove, the heating elt duct, tha automoblla ta11 pipe, and the huge emokesucks of a ateet m/t1. let nnvheo are people exposed to euch high concentra- ~ tloss oe fumes and toxic dusta as they are ln che industrial vnrkplace. • Tet thara has baan comparuclvety llttle effort to collect and analyat dati on occupational exposures. Fur exauple, as difficult as 1t maq be to believe in 1981, I knov oe only a single cancer reSlatry that collacte appropriate detailed lnformat.iod oe oecupatlom and Lifetime work exposure amonf all the many tsoctr reSistriea that Lnqu[re about the s.oking habits of the resplrstoq cancer caaea le their ellee. It vae not uncLl I910 e6at an inatltuta (NIOSH) to study the diseas.s of the vorkplsce vts utabltahed. In the np/nlon of many, gIOSg was not funded .de9uately until 1916 -- snd even thrt relatively uodest funding vas cut yals recently. And it vas not until 1980 that the lserlcan Lung As/ociatton convaned a special Task Force on uccvpstlonal Naalth. In contrast, there have been uny, many publicly funded studies seeking to ataociate eaoking with dleeue and slmultsne- eosly oeglectlnN the environment of the amoker. Papulatlnn ttudls such as the ACS and veterene' studles either did not abtsls Information on Sndusttlal exposurea or, Lf some Linlted Isformatlos vu aeallablm, it vaa oat subJected to critical asalysls. Unless ve byle to attend to the Luportance of the eorkplaee and emposutes to chaadcala 1n the past, we may depr{ve orr.Qeea of the abilLty to take effective eeesures to prevent the coaatast Lnctaasea 1. raspiratury dlsease rates. Only racentlF hars studies appeared which have addressed [ha queation of the health experience of special groups of lndus- triel vorkeaa. For eaample, aebestoe workers, uraniue workers .ed ehe.le.l eorkerm have rmaalved attention frne eptdesiologlscs. I heve observed that ..mm manF of these Snvestlprtars gather daca oa smokie8 habltm vitb mucb motm thoroughness ohsn they do data aa type and durattoo of mxpoaurea. Their analyaes of the observed dlseese patterma, 1n my v1a., planm dlapropurtlenete emphasls on aaoking histories 1. drawing concluelona. My ovn lovestiptions have juatlftad my concern cha[ a earruv focus on a.okln8 has maaked the afCects of mlcro-chemlcal ed aeeupatlenal aovlrnomaotm. I hare bean prompted by q ruultx 4 •
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• 718 to ark: doer uoking kill vorkers or vorklnt klll seokers'g presrnudlatetheoAVerlcan LunttASSOclatlon'seOecup tlondp0ealth Task Forea Neettng 1n April, 1960.9 gere I will briefly eunnarlte that pepar• uhlle there are vany reasons for the confusion the pusslble effects of a.oking and other v.rlables. the va1or cc.pllcatton arlses beceuse the prevalence of s.oking 1s highest ..ong thoae individuale vho aee axpuaed to poeslbla deleterloua oceupat/onal factore.10,11 For tnstunce, 11 percent of construction peinters are cur{Snt a.ckers vh(le only 27 percent of tuchere have thet hab/t.1 In (act, vhrn accupatlone are arranged by prev.l.ne. of s.okiop 29 nut-of d0 oceup.tlons 1. vhteh ..oking 1e .ott pra.atent aee a1en those with high exynsure to dust.sp end prevalenceloflsvekint6ate vorkera expnaedoto aueh harardsa'o there 1s a strong tendency for .e.arturlndi ldu.ls lndlvlduals vho do dirtT vork to e.oke. co.P vho do clem work. thve, Ln a statlscleal sanea, the c.te6ory .eokeu may be privarlly an loder for vorker ex nae eo oecu°atlonal esaeds. it follovs that auy covparlsonbetveen s.okirs end nan- seo rs i.plles a comparison betveen group, that probably differ agnlflcaotly in thetr axpow[es to dusta and fu.ea in the vorkplace, eased /ncldeoce of dl.easee asaribed to s.oking l in short, t e oer h f s • • • 719 sther.ls ehe author. Y. Meles, who Sr known for hls slllcanc oppositloq Co uqklntr ob..rv.d: "Yhe data .nggest that conelnued cigarette s.oklnt antatled a facter vhlch pertlally tnhlblted the csretnepntc effecte of chlora.ethyl echere." Plntnl6 found elevated lung cencer oortality rates in his study populatlnn nf arunlc exposed worker,, compared to the tenenl poPolatlon. (le cu..ented Ehat cht.e elevated rates vere eot dua to avoklnt° Lu his vorkars. Further, he reported thet `h: [n[..ra`coussbetveen the elevated standard aortellcy ratl°s ln t p(s.ckera, ex-suokevs and non-suckers) were not atetlstlcally slgnuicaet. . A study of chrTaotlle ubesta. slners ln Canedt17 tqorted thet "Lung cancer death. occurred in oon-..okt[e, end shnved e greater Ineruse of 1ncldeoce the surker with lncraering exposura then did lung caneer in a.ekera . " Thls tr e e uf the vary fee studlu [Aat eetl.aed levele nf esbeetos dusc erposure avang e. 5004 aclentiete heve elaleed that uccupatlanrl erposwres ted dprette a.oking lncraeae the rlsk of dleease, tn fact, fladint (6) of g.k. 4957 accepts this view, The recent studies dlscusssd abo.a do oot euppurt this hypothesla. In fact, Arelson end 4tlss eeparetvly t.le,ed the posslblilty ehet tnoktnA ney heve /rotectlve properties for an.e typee of wovk. or by eplde.iologlcal atudles that fall to control adeeustel7 oecupeti°n, could vell be due to occupational factora. Obtatning an accurate occupattonal hfatory le difficult and time consuving, partlcularlT beceusa lrportant erposures uy have uccurred twenty or aore year. a6o. The claim of lnteractlon le heard most oftan regerdlns stbestes aod smoking, but eveo hete ehe evedence needs to be terrleed carefully. Although th w 1 knoun study of tnsulacion .orksrs by Xee/ond and gellkofflj,i~,~ll hea lnd/ceted en e Isrp effect on luot eencer rates due to the clafred inter~etfontly of saeklot and ubutnel that "effect" hu beco.a l 9tudlu uf Indc.tdal Workers s.e ler vlth .eece..1." reporta, ae tneresaing nu.bere of lung cancers occur troe om-e kl I turn oov to & dlacuefiou of recent and long overdue g .o np vorkere, It L l.portent to note that the Ist.st report by theae lovutltatoes hee shown a fi - dfseaue 10 oecupvtlonelly exposed workers; sove l ve-teld relative :bk of lune cancve .ortallty for sauking a d studles of ung ent effeet due to clgsratte ft a non-s.oking workers yosad to asbutoa e of these have failed to find any slgnl , e.oklnb, vhlle nthere heve fouud even higher dlselue rates e.ont In addltl nn-snokers than a.ont s.okers. on. there are serinue problevs vleh t t q he eaeued-Sellkoff study. For e[a.ple th In a study of tlsc aod laud ./ner., Axelson, et a1.12 red , ara rreea no s.aktng LlstnrLee evellable for o.er 6e000 of eha 11,600 insulation '°rtera Thl report a toeaeer risk for lung cancer a.ong nun-e.nkere compa to a.okers. Another study of vloer.' .ortality by pahltren, reported Sn 1979, ehoved that non-eroking aneet hed a htther .ortellq fror luet eanner th6u smoking .lnera.i7 Axalson e.pheslrad that these Svedlsh studlea daal vlth a lifetime fulLow-up of anera vhereee enet othet .1o1op populatlone heva been studfed by eans of eohorts vlth a fnllne-up of not .ose than about 25-30 el In other vords, the ro.pletan.rs of the follow- ears or lass . a prompted a eaoe.r re.eerchee to oote ' the larN lneetoo of eubleeta with unknavo s.okinp habits aakes teekloefo .nT quantitattva rssess.eqt of the folnt effeet of t aad eebesto..^2l Alan. I have polnted nut ehet In thase letutatl°n vorkere: the prupottlon nf rtte adeaths due to cencer of ell a es the aue for both svokers end ooo-sveker..6 Approxlnately Ut °f all death. vare due to caneer in these varkers. In contraec. ~ke prapurtlao of ax ec~te_d~ death. fro- eaocer (b d 4t lt . y up laada to results with dd.d reliability. c ase on age- l c o.3. .o[[e11tT raeu for vhite .ele.) vae enl9 about .tt' These flguree strlkl An Inreree ralatlonehlp betvean saokiot and lung cancer nay iodlcau the dvogers of .eDeetos ep°r°re for .jl vorken, vhathar they saoks or not •s. also found among uorkers exposed to chluro.ethyl ethyl . 6 i •
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0 'auamuo+inua l.aT.a4a-ua>in a4a lu apvunbaavo> 4oTsaq s41 Ja auotaa8laaanuT uT aarTaa n u 4u74n voTrn/uoa pus avu.Taq.T 1. alr1• aaa sa nlulaaLlaaau yTnow IT laaaollaqaTr.4 >iTqnd acaa.Ad pacr aar 11 Ppr Pinow uolar1a19aT rT41 'ra.p auaia171nau1 uo pa]uaarad ancll7q a9a uT „a9uIPUT1„ r4t aa4a uoTava]voa [. laaddaa 4 I caary a4a ]a4] anaTTr9 I'vop.nTauoa vI -1maPida nos3 uaTluanv aua > alrT>ll-l0 4vpa4 aTT4nd pur qal9nio T 131nc panTa>aa aou ar 'u. d aan a41 uT lauq v9naaaa ,clcnp >Taoa Pua ca.n3 aTllaloa lo auol]uavaaeeo ei4a 3a Paaodea aae a1doad tur. ar4a a>al `41 -aaaaalaaa ,uov+e] la4>r9 uodnlPad1aaaTTra+ oa o9a aaaaL Aloawa u ]uillf 4 cva/ataiaa r4q TTaosa oa LTVO vpaso rou •adnoa9avoTal>ndoAlanbaPa uaaq +ou c.4 •..e. L9 `aa.drns ylno4aP auamuoafnu. Ap a9ari 30 4 P 3110" 043 uo aovanTlnT aoCa. r saans P-oI-AaP a4l a'41 aaPl a4] •asuauoo u1 '+a>ura uo a+aa>rq aTAlv-alli ulaa+aa yo uaqla aVl uo paaa8,admexa + aal+ra PauoTauan Apnar Laa1aog +aoua] uroVa.y wau a41 ~ 1 J '8uT9ona •aaanoa o a91 . •a/ lo y°aT +o aclaaava •uuTll+anu a. 4anc c 1 al4a4 Pus P nPinTpul•TnPinO4TpaaTula oe scaaalP cull oa aPam [Iluvuauo> aa. aadmaaly 'cTrnpin3PU/ 10 aoTFaa-a11I Fo' W I lolnr4a4 a4a ul `cavalP lo cap`Paaaava ao3 4>+caa a4a -- pcTauapc 4aTaa4 go yasoaddr auaul•op a4a araq o4 av4w aaao3nira oa Puao pinon uollrasPTCUUa aaDun 1Tiq a4] ]r4] PTr+3r ma 1 -aaattaon lm 411964 044 vo aaaTd>f+an r4a go .oaaPla aTq/aaad a4a saoo9l aq anu1aona Par 9ui4o•a aaasarBTa a.a14 ATiv>TaaTld.Tr na rnulpuoa rn Il aaald.oaol vTr.aa 1,1 . avmarlP 9unl 3o cauapmarqur a4a anoqa afpaiwanll lanva3 a41 'xold.aa L749T4 •1 ai '1aq ul 'aaoaTP 2001 30 aaae 042 uI 'aTdmi' lou al P1VOw Traa a4a pur •rrcac7P aacnro anaTla4 aw 1.4. 433- pauvrauoa lou al 'Pua4 +a4ao a41 00 •svna.M •AT+rpaa Pua aldqa PTUOw ano daa4 04 saTY.P ana lo a1d.a.. 9uT41a1c ]ru. a'ada4aad •vi aaraalp 9unT aol ]uap.aalur ao(c. a4a aT 9uliou aa]aarfla ar4a iul]raqauomaP so paadaaar usaq 1r4 aaurpTn` fuTaalxs a4a 4a/4w 4]ln acauipraa a41 'paapul 'a+anaur rTdar a4 01 apddr ar4n Y lalT`+ 4aln dcra8 aq 'pTaan YaTd.oa L19ulusa49Y) r ui 9u1n1T cursn4 ay 'Pa19ueauaalP ua.q aaL IOU anr4 aannaadxa Taua11rdn>ao pue 9uTxonc 3o aaaa3la a141ccud a4a lrqa paaralavu.ap LTaaaT> anr4 1 anaTlaq 1sacraalp aTUna4a 1o APn+a allPuaiaa a4u P» apuT4 LT.nu}aac a...q As. 9ul+lomc a]uaar9l> uo anaap an1VnTuxo acnvTr ua aa41 no4a .,a Vur •paaallqnd ATapln aou aaa ar4a auoT]r9Tlvanul >13PValaa go allna.a avua nuaaoad o] varq ar4 aoa4 acodand Rp cunlanpuo3 •pa4enTcna-a+ ATalaTdoo> aq oa an.4 Aam aaaaclp ]uo4 Pur 8u14o.c uaanaaq ana4ao Aq Paaaodaa uoTari>oca• Iral]cllraa a4a 'a¢ald.q> aa 'laAlaue uarP ua4n Daarlaueaa9na an c9ulPo/1 [dau/qlrud ano Il 'paapul •Paa.aae9.aa ATavTimlc aq Aa. 9u17oo Puc avrulP aaea4 uaanlaq „uol»1>oa¢a„ PaaT>liqnd-4>nc a41 •paaaPlruoa aou aaaw aaoaa.q aa91a acnrvaq Pa111u8cn AT]ra+/ uaaq ca4 c+sauq Laoavnldcaa Pua fuqom. uaan1aq Paaiela ATanoTnaad uo/laPorer r4i 1r41 araia vcala4aaanau ei aT •aaaTdmoa laA iuu ai aaaP +nu Ilr go rTaLTaur a4a a114u •aaancodaa 4>nr Aua go puaaaa a4a Pus •cpv.a.y leuolaatln>ao oa paeadea uaaq ar4 TvnPlnTpuT uv aayaa4n aulnaaaay o] arnpa>oad 9ulnaTnaaquT lr>iaaaad a puv aaYuooi=lcanb 4fno+n4u r PaduTanaF anr4 `C 'caolnaaa 11214604 aa4ln pvr Trluap 'aaca4 'naouro •iunl ul cnualnvd uo aamnl pur aanp a/aoa oa aancadaa puv9u11oua go Aaeqal4 a311 a41 lo caavan1)u1 alqlcaod a41 a11uqun ol BuTalaa Apn]s r ui an pauiu( anvy [a/a+snlup unoay 1^ lalidaup Porlal aPo49 a4a Pur atona4 ul Tqidaoq TouT9 a4a aa caarl>ocar 3o +aqmnu a'PTun ae40 171; 01 aapao ul •uot0ednuoo Pue fulYOae Io uoTq>aaalul alqTvcod aq4 9ulaanTana po aaa an ccaa xa a4a aoy. pau9TCap aalPnaa nal uaaq anc4 aaa4L 'a4Yno4]aaqlr ur lcomlr s+an ea+nsodaa ieualuedno>o Pue 9ulYeme qo aa>aPya anlaaTa+ a141¢aod a4a anoqc cuolanT>uoa •caTpmc Palaoda+ aca41 lo duru ul a al Pn]SW.I.VuU 0ZL •
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• ( 722 • 72:1 • kaferencea oahlgrenS f.. "Lung Canret. •erdl~.e.cuI er ol...,. " enn seaking Ln a nreup of Mtner., t.kxr[tdntngen rn <911- a814, 1979. Eeye, A., er al. , "The 01at and A11-Ceuata Death Rate tn the )I Aaelaou, 0., "Sffecte of Lav Level d D ht " P and eackground R adlatlon " Lancet Il: 38-61, Se.eo Countries Study July 11. 1981. nn aug ere, reaented at from Ra Vancouver, e.C., Rnyel , Coe.faaton Meartn(s, January, 1980. Sterling, 7., "A Crltlcal gaaateasment of the Evidence " aaring om Smoking ea the Caure of Lung Cancer," Am J Public I3. The Clgarette Factor ln Welsa• V•• t C h h " Lang Cancer Due to Health 63(9): 939-953, Septe.ber, 1973. t era, Chlo[oaet 3 Oecup Med 22: 527-529, 1980. 7 N t l i " E t 6 P(nto, 8., at al., "Mortality Experlence of Arsenic-ex osed e n -varta e SCatlsclcal Problema In t Soerling, t., ( C ologfeal) , 1 p " Arch E vl H Sur.ey.," Canadlan J Scac 7(2): 203-213, 1979. Vorkera, n roo ealth 33: 323-331, 1978. Sterlfng, T. end J. Valnkae, "Vhat Nappena When Major Errors I/, McDonald, J., at al., "Duet Exposure and Mortality in ll Ml i 1 " are Discovered Long After an Important Mport ha. Been e Chqevt e ag, 910-75, Br J[nd Hed 37: 11-24, 1980. Published?," Presented at the American Stetistfcal Aeaocl.- " tloo Annual Meeting 1979. August 16 Ig, gammond, L. aod [. Seliknff, Reletton of Cigarette Smoking , . to Risk ef Death of Aebeatea-asaoclated Dlseese Among arette Smoking and Health Public Health Service U "Ci S Inaulatlon Vorkera 1. the United Statee " Slologlcal Effects , . g . " Unfted Stataa -- July 1964-June 1963 Characterlttlca , of Aabotoa, ed. P. Dogovek/ (Lyon, France: IARC 1973) , , Vital and Mealth StatLCtee, PNS Publtcetfon No. 1000, , , pp. 312-317. Serfer 10, Mo. 34, Vaahlegton, D.C.: U.S. Covern.ent Printing oftlce, 1967. p, Sellkoff. I. and S. M.mmood, " / " Multlple Rlsk Factors ln Enrlrunmaota Cancer, Peraon. at Nlgh Risk of Cancer, ed. Starling, t., "A Review of the Cla1m that,Exceae Morbidtty l. Fraumeol (Nev York: Acadeu ic Pre,a, 1975). pp. 467-483. and Disability Can Sm Aacribed to Smoking," J Am Stat Aseoc 66(334): 231-257 Jmea 1971 20. gammond, B., et al., "Aabestos Exposure, Cigarette Smoking , , , aod Death Iletea," Ann NY Aced Scl 330: 473-490 1979 " " , . Smoking Chapter 3. Morbldlty, U.S. Pubtic Health Ser.leR, ecn CeneraL Departmenc of ort of the Sor ,od gulth A Re 2L Sareecl, R., "Asbeapoa and Lung Cancer: An Analyals of the , . p g NggY Publlcatlee Mo. (PMS) Vealth and Velfara Eduutlon Epldemlologfcal Evidence oo the Asbestoa -Smoking tnteractlon " , , , 79-30066, 1979. let J Cancer 20: 323-331, 1977. , 8. Starling, t., "noea Smcklog Kill Worker. er Vnrkfng Kill Smokara7," tnt l gealth lare 6(3): 437-4D2, 1978. 9. Starllugy T.. "Smoklogy Oceupatlon and Reaplotory Diaeaae," Proentad at the Amerlcma Lang ,Uaoelation Occupational Oaalth Taak Forta Meating, April 9, 1980. 10. Starling, T. and J. Vminkam, "Smuking Characterietic. by Type of Emplotment," J Oeeup Med 1g(1U : 743-734. 1976. 11. Sterling, T. md J. Velnkam, "Saokleg Patterne 4, Oceupa- tlom, toduatr7, Sea, and Raee," Areh Envirora Health 33(6): 313-317, 1975. 12. A.alson, 0. and L. Suodell, "Mlning, Lung Caneer and S.oking," Scaod J Work So.lron Health 4: 46-52, 1978. 9
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• • • • 724 CURRICULUM VITAE Theodor D.Sterling • • EDUfATIll:: g.A. (COM LAUOE), 1949, N.A., 1952, University of Chicago; ph,D, 1955, Tulane University. PROFESSIONAL AFFILIATIONS ' Pre.ent: Umlverait7 Research Profeesor, The Faculcy af Ir.terdfsclpllnary Studies and Department of Computing Sclente, Simon Fraser University. Prcvlousn Vtsit(ng Pro(essor, Department of Statiatics, PrSnceton Un.verxlty, (78). Chalrman, Department of Computing Sclence, Sibn Frsser Unfvenity, (72-77). Professor 1. the Department of Applled Metheaatlcs and Computer Science, Washington University, St Louis, R(s.ourl (66-72). Also Joint appointment as Profeswr tn the Department of Sociology (66-6g), and Visiting Professnr in Corputers and Humnltfes, Rebrev Union College, Cincinnati, Oh1o (68-70). Professor of glostatistles and Director of the Computing Ccncer, College of Mediclne, University of Cincinnati, Oh/o (58-66). Previously lnsttueted In the Depertment of Statlstlce, • Nlchigan State Un:verdty and Department of Mathematlcs, Unlven(t7 of Alabna. PRO:ESSIONAL ACTIVITIES President of the Coeputer Science Association of Canada (75-80); Chairaan, Ombudsmw Cooittee, Canadian Information Processing Society (73-g0); CLairrn, presldent of Biological Information Processing Organltation (64-65); Chalrasn, CtPS Special Interest Croups, Huemnizatlon of Information gystens (73-80); Chsiran, SICCAS Comittee of Information and Public Policy (72- ); President of Mlssouri Chaptet, Ameriean Aseocfat/on of Workers for the glind (70-72); Member of the Panel for glology. Manage.ent, and Socfal Sciences of the Mathematics Association of America (62-67): Chaira.n, Cotmlttee an Professional Activities of the Blind of the Association for Computimg Machinery (63-71); Chairman, Ad Hoc Comuittee un Accreditation, Association for Computing Machinery (66-67); Committee w Radiation Doslmetrf, Ameriean Association of Phslcists In Medicine (66-69); Natlonal Lecturer for Association f~r Conputfng Machinery (72-3, 73-6). E:ITORIAL ACTIVITIES: Associate Editor - Canadian Jo-jrnal of Statistics (73-78); Editorial 6oerd - Intereetlonal Journal of Biomedical Cneputing (69- ); Canputera end Applied Mathematics (73- ), Humanlst In Canada (73- ). • • 725 • • Cpyfi't1t21R AND fITHER SERVICES: Consultant/advlaer: (In Canada) - Environment Canada, The Royal CormUslon (g.C.)= Consumers Association of Canada; Society fnr profeulonal and Environmental Control. (In U.S.) - MIH; PNS; EPA; FTC; SRA; U.S. National Academy of Sclence, National Research Couec-l; Amertcan Lung Association; Natural Resource Board (gUcocsln); Envltanmental Defense Fund, MECCA (Mlnnesata); Clefzenc Against Toxic Sprays (Oregon). (In Kuuatt) - Ministry of Health. f[p."-55I0N.LL AGD HONORARY SOCIETIES, HONORS, AWARDS Fellow, Aner. Assoc. for Advancement of Science; Fellov, Aaer. Stat. Assoc.; Can. 10. Proc. Soc.; Can. Comp. Scl. Assoc.; Assoc. Co.p. Machinery; Amer. Math. Assoc.; Math. Sec.; 1nst. Math. Stat.; Amer. Stat. Aawc.; etucettlc So,c.; N,y. Acad. Sc1.; Amer. Assoc. Phys. Hed.; Assoc. Re.. plthssolegy; Sigma I1; Pi Nu Epsilon, Morrlson Cressy Avard in Netfonal Science. •
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0 726 STATEMEML• OF PROF£SSOR y0 .-VN J. WIND FOR SU6MI55ON TO THE 5U3CO7T:4i7TEZ ON "r.£AL:> 11ND THE ErNi7GHdGNT I am Yoram (Jerry) Wind. Since 1973 1 have served as Professor of Marketing at the Wharton School of the Universit., of Pennsylvania, and em the past editor of the Journal of Mar:<eP i~n .: have been on the faculty at Wharton since teceiving my doctorate degree from Stanford University in 1967. My soec_alty in marketing research, with particular emphasis on the ar.alysis and measurement of consumer behavior. During the past fifteen years I have served as a reeearch consultant for ca_iocs government agenciee and about 100 companies and have publiehed exteneively in many areas of marketing. A resume of .ry educa- tional background and professional activities, and a bibl5ography of my publications, are attached to this statement. I have been asked by The Tobacco InstStute to present my views, as an expert In marketing and consumer behavior, on the theoretical and factual support for certain of the provisions of E.R. 5653. My testimony will deal with the proposed !icdings that existing government and private programs, lncluding the Surgeon Ganeral'a warning statement, have not adequately !..- formed the pubLic about smoking and health issuee, and the proposal to replace the current warning statement with a rotational system of seven different warning statements. My commente are based an an evaluation of a document Sssued in May 1981 by the Staff of the Federal Trade Commiseion er.titled Report on the Cigarette Advartising Invut'_gation, ahich I r 0 • • 727 understand was submitted to Congress and was based on a • rationale that appears to be similar to that underlying the LabeLing provisiona of the present bill. I also have reviewed the consumer etudlea and surveys that are principaLly rel!etl upon in that Report. My conclusion can be stated in one sectence: to the extent that the labeling and advertieing proposals contained in H.R. 5653 are based an the reeommendations and cor.ciuslens aet forth In the FTC Staff Report, those propos are without factual or theoretical support and are unlikely to achieve is bi11's objective. I base that conclusion on two key poir.te: First, the level of public awareness about various smoking and health issues, as demonatrated by the stud:es and surveys cited in the FTC Staff Report, is extraordinasily high -- much higher than one would expect to result from normal advertiaing and marketing methods. The efforts of the FIC Staff to minimize the extent of public awareness or. these iaaues are based an misinterpretation and misuse of the atudles cited in the Report and a fundamental confusion bet:+een avare- ness and belief. The conclusion presented in the proposed bill that "praaent Federal, State, and private initia lves have been inauffieient in conveying the health meesages to the American Public" (See. 2(7)), is not consistent with the findings of the studies relied upon by the FTC Staff Report Seeond, there is neither theoretical nor emn!,ical suPport for the proposition that the rotat:onai warcing system 40
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• y • 728 • proposed ln H.R. 5653 and recommended by the FTC Staff would have any positive Smpact on the level of public awarenesa about smoking and health issues. Replacement of the current warning statement with seven different rotational warnings thus would be totally arbitrary. - I would like to elaborate on each of these points. I. With respect to the existing level of public a::are- nees, the FTC Report begins lts analysis with the ada.ission that "most people are generally aware" of the claims about smaking and health. The report cites a'1978 Gallup Opinion poll, which indicatss that more than 90 percent of the pubLic believes that smoking is hazardous to health. Similar high percentages respond affirmatlvely to more specific issuee: over 90 percent of the public beLievea that heart disease has been found to be associated with smoking; almost 90 percent believes that smoking during pregnancy can affect the amoker's baby; 87 percent of adults are of the v!ew that smoking has been found to be associated with cancer of the mouth and wiC`t chronic bronchitis; weil over 80 percent either "think" or "know" that smokers are many more times as likely to Cevelop lung cancar as nonsmokers. Thaee responses are remarkable. National surveys and polls consistently identify subetantial segments of the American public who are uaaware of major public Sssues and • 729 (arts -- the energy crisis, the identity of the President and other public leaders -- the examples are numerous. A measured level of 90 percent awareness can be cor.- stdsred "deficient" only if it 1s compared to a standard of l perfect awareness. But it should be obvious that such a etan- dard is both theoretically and practically Lmposs!ble. The i/mits of human cognitive abilities and selective perception ,chanisms insure that 100 percent of any group will nrrer be aware of or in agreement about any fact or Lssue. T-hat is why there is a distribution of responses Sn any test, particularly a tast involving multiple choice questions such as the studies cited in the FTC Staff Report. An equally important defect is the FTC Staf" s fundamental misinterpretation of the results of the consumer studies an which it relies. Six major misir.terpretations can be identified. lirst, the Staff improperly focussed on responses to npecific questions, rather than on patterns of responses. The Staff assumed throughout its discussion of public awarer.ess e.hat Sf a numbir of people are not awara of a apec!f!e deta!1 about the smoking and health lseue -- for exa.ipLe, the ciaim that smoking during pregnancy increases the risk of still birth and miscarriage -- those people are not aware of the general proposition that encompasses that detail -- t*.at is, the assertion that smoking during pregnanc7 hcreases the risks of adverse effects on the baby. •
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• 730 This assumption is contrary to the actual results of the studies cited In the report, which show that most people are aware of a11 of the significant claims about amoking and health. it also violates fundamental principles about measure_ ment of knowledge or awareness, which call for the development of an overall knowledge score or scores based on response to multiple items. Can your knowledge of a subject, let's say economics, politics or health, be assessed accurately by your response to a single question on each topic? Yet this is analogous to the FTC Staff's reliance on the response to a single question on the health effects of,smaking. The second area of misinterpretation is the Staff's assumption that anyone who responds incorrectly to multiple choice questions lnvolving detailed statistics or medical knowledge is insufficiently aware of the fact or issue in- volved in the question. Respondents were asked numerous questions involving precise details, such as "Out of every hundred people who get lung cancer, how many die from it," and were provided with six alternative answers. According to the Staff, anyone who picked other than the answer that the Staff called correct -- 95 -- "did not appreciate the severity of 1un9 cancer." In fact, however, the vast majority of respondents chose either 45, 75, or 95, indicating that they believe that lung cancer has a high mortality rate of at Lust 1 of every 2 of those suffering from the dleeaae. -Sat beiief hardly supports the Staff's conc!usion. • 731 Similarly, the Staff interpreted "don't know" .nswers to such questions as a lack of awareness on the part of the respondent. But such an answer is equally susceptible to the interpretation that the respondent is aware of the statement presented but ls unsure of the precise statisticsv involved. In my previous example, a person who believed that most people with lung cancer die from that disease, but who vas not sure whether the correct proportion is 55, 90, 95, or 97 out of 100, mlght anewer "don't know." The 3eport would erroneously have lncluded that person in the category of those rho "do not apprec!ate the severlty of lung cancer." Stfll another Interpratatfon of the "don't know" ansver 1a the one offered by Mark T•+aln In Llfe on the Misd sslevi, "[ was gratified to be able to a:s-aer promptly, and I did. Ia1d I didn't know." Recognizing this, the Interviewer's Manual of the Survey Research Center of the univereity oC Michigan points out that the answer "I have no opinion on that" can mean merely "wait a minute, I am thinking" and edviNs that it is a good idea to probe all "don't know" responses. No probing wne conducted In the studies reliYd upon by the FTC Staff. Third, many of the so-called "incorrect" respcr.ses to the studies could have resulted from simple lack of under- standing of the questions. The tudies pr!marily relled upon In the Report on the issue of public awareness were based on •
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• 732 • "Ia e telephone surveys. In e':ch interviewa, it is not reasonable to expect a high percentage of correct answers to complex questions such as those that were asked in the studies. Let me give you an example of one such question. Imagine that I have called you out of the blue, explained who 'I am, and ask you a long seriee of questions. Even if you have remained interezted and alert throughout the intervlev, you must respond to such questions as this one: "How many Amoricane living today will eventually die from diseases related to smoking cigarettes? None, cne out of two, one out of six, one out of ten, or ar.e out of a hundred?" The ambiguity of the phrasing -- does the word "Americans" r+fer co all Americans or only those who smoke?.-- as well as the precise statistical answers presented turn such surveys into a guessing game rather than a test of knowledge or awareness. Fourth, none of the studies cited in the Report in- cluded supporting data aa to the reliability and validity of their findings. That is, no evidence was offered to show that the series of questions aaked were a reliable measure of public awareness or knowledge about any particular lssue. For example, how many respondents would provide the ame answers !f they were reintervlewed a few weeks Later? Furthermore, no validation of the results was provided. Indeed, given the focus of the ETC Staff Report an substantive concluslons, if it were submitted to a professional publication such as the ~._Ura1 of Marketing during my editorship, or Marketing Science today, it would be rejected due to the lack of any validation procaduree far the studies upon which its concluslone are based. iifth, neither the Staff Report nor the studies r prasanted any norm against which to compare the survey results. [n the classic text on testing. Educational Heasureme;t, William Mgoff of the Educational Testing Service etates: "By now St has become almost axiomatic that raw scores on a test yield no meaning unless they are accompanied by relevant nupplemer.tary data that will place the score :n an appropr!ate interpretive context." In other words, it Sa lmpoeslble validly to conclude that the answers to a particular survey item represents a high, low or medium level of awarenees in the absence o! a standard that would show what answers are to be expected. Sixth, and most fundamentally, the Report's cor.clu- slons, and to a large extent the studies upon which those con- cluaions are baued, reflect a hopeless confusion of the very distinct concepts of awareness versus knowledge and belle'. The Staff Report defSnes "unaware" aa: " . those who say they do not believe true siatements ; believe false seatame~'ade - eatisate on a multlple chuice questlon or answer Tdon't know' or gncartain." (ETC Staff Report at p. 17 note b, emphaa!a added) There 1s no conceptual justification for combining t`:eae !ive diverse responses. Belief is not awareness or knowledge; looking for exact response on a multiple cho!ce question in
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• 734 search of the precise "correct" answer Ss not reasonable, "don't know" is both a function of the question word<-ng and the item of concern; and uncertainty does not necessarily represent lack of awwrenees. ' One example of this faulty de!initlon of "awareness" is the FTC Staff's misuse of the 19R0 Roper Stvdy cited in the Report. That study asked people "how true you personally think" a particular statement is. The intervie•wer was in- structed to introduce those questions to the reepcr.denta es follows: "Now I'm going to read you some statements about smoking and health, and for each one I'd'like you to tell me your beliefs about how true the statement is." Respondents were permitted to answer only "know it's true," "think it's true," "don't know if it'e true," "think it's r.ot true•" or "know it's not true." The Staff concluded that those respor.d- ing in the latter three categories are "unaware" of the ir.forma- tion conveyed by the specific statements made. It is obvious, however, that a respondent could be aware of a claim (for example, that smoking increases the risk o! heart attack) yet disagree with it. The FTC Staff consistently misused the studies in this respect to support its erroneous conclusions about awareness. Let me read another example from page 3-19 of the Report: "According to the Gallup Opinion Index, Juna, 1978, 19% of the population do not beL'eve that smaking causes Lung cancer. . . Among all smokers, 28,", did not believe smoking caused lung cancer while among heavier smokers• nearly one-third -- 31'y, -- did not believe or 735 know about the link. . Prc]ected nation- wide, these data suggest :ha: ~ens of miLliocs of Americans, both smo;tera and ton-smokers, do not know that cigaret]e smcki^; causes t_cg cancsr~~-- The Staff's conclusion simply does n^-t follow !rcm the data. p This fundamental type of error -- con:us_::g consumer awareness yith consumer belief -- undermines any recomnendatGor.s that might be based on a premise that the public is not adequately. informed about smoking and health. II. The FTC Staff Report -- and presumaSLy t!;e present bill -- proceed from the premise that the puhLto is inadeevately infermed about smoking and health issues to the conc'usion that a new system of warning statements is necessary to zectify this inadequacy. As I have ettemp`ed to de:ncastrate, the available data do not support the pre^tise. 3ut it is equally disturbing that the new system of •.arning statements recommended by the Report and by F..R. 565] are not likely to achieve any positive impact on consumer awareness aSout smoking and health issues. There is no evidence that specific warn!r.gs such as those proposed in R.R. 5653 would result in any lncrease Sn Public awareness. The only study of which I an aware tha`t relates to this issue is a study conducted !or the Fm_C Staf`- bY Burke Marketing Research to test the recall of diL!et_nt types of proposed warning statements and '_o:-aa=s. ?his s_udy
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• I J • 736 • has three major limitations. One, it is restricted to arni,g statements in cigarette advertising, not packaging. T•no, tye sample of respondents le not representative af the American public, and thus the projectability of the study's results is y-uestionable. Three, the study included only two new warning ptatements and the current'statement as a control; the two statements tested are not among those proposed by the present bill. Given nheae limitations, it is clear that the study does not provide empirical support for the present proposal. But even were one to assume away the limitations and accept the results of the study as valid, they demonstrate only that consumers beet recall those matters that they already had learned from the present warning statement and from the numerous other sources a! informatlon about smoking and health. Thue, for example. the study found that a specific lung cancer warning was "no more effective than the non-cancer warnings in eliciting mentions of the relationship between smuking and cancer." Indeed, it !s quite possible that the rotational warnings proposed by B.R. 5653 would have an opposite aftect of what is intended by the bill's sponsors. The present Surgeon General's warning statement is embedded in the pub- Llc consciousness, as well or better known than tfie propoe:- tion that people should wear seat belts. If Snstead appear statements Linking smoking to specific health probLems, • • 737 s conaumers might weli conclude t7:a: the Surgeon General has chenged his opinion and no longet cona!ders smcking to be ,anerally hazardous to health. Moreover, by focuseing an epeclfic problems, the warnings beccme significantly less relevant to various segments of the population. Teenagers, (ar example, are unlikely to b, concerned about emphysema or heert disease: single man and ,lder women are not likely to Pay attentlon to a warning that smoking may cause problems during pregnancy. Neither the eTC Staff Retort nor t._ present bill appears to have given any consideration to these potential consequences of a rotational varnir.g system. fII. in conclusion, nothing in the studies cited by the FTC Staff or the rationale suggested jn the bill itself auo- parta (a) the diagnosis that the public ls unaware of the claimed health haaards of smoking and (b) the prescription that the replacement of the current Surgeon General's varn- ing with a rotational system of seven diLferent vzrnings will have any positive effect on consumers' awareness about smoking and health issues. The labeling proposals aimply are unsupported by facts or theories about consumer behavior. Rance, I urge this Subcommittee to reconsider the advisability nf the labeling provisions of R.R. 5653. •

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