Document JrZdb2enKo5X8e86Qe24naMaB

Vol . 1' / i". R L S- - 3 8 lb /& PLAINTIFF'S EXHIBIT / N IflSTlTUTE O f OCCUPATIONAL AND ENVIRONMENTAL HEALTH MONTREAL CANcna l37 g Code 17 36 38 63 70 80 LUNG CANCER AND MESOTHELIOMA DUE ING PROSPECTIVE SURVEILLANCE OF 1249 ASBESTOS INSULATION WORKERS, 1963-1974 * Jrvln J. ScM.ofT Envircr./ncntuf Scirntcs Lr. hcrdtry Sionnt Sinn: School of Medicine The City University of ?>cw York A'nv York, AViv York 10029 i Introduction In 1563, it `azs found that a large group of asbestos insulation workers in the New York metropolitan area had experienced unusual mortality during )9-l -1562.* Six hundred and th*rty*t*Ao men had been on the union's rolls on 3.:-.ua:y 1, 1943. Ey December 31, 1962. 262 men had died, nine before leachir.g 20 years erf the job. Of those who died after 20 years from fust err,ploy ment, lung cancer was found in marked excess; 6.02 such deaths had been expected, and 42 occurred. In addition, there were sexeral deaths due to pleural or peritoneal mesothelioma and a modest increase in deaths due to rcMicmk-stina) cancer, where 9.71 were expected and 29 were observed. There were 12 deaths due to y j!nonary ashestesis (Table 1). Ta*L I E-X r*iCT ID AND OBSERVED DFaTXS AMC"*C 632 ASOTSIDS 1NSULAHON We?lU.?.Sf New York-New Jersey. 20 cr Meat. Years Auer Onset of Work, Jas^aRY I, 1943 to Decevslr 31, 1962 , 7c:sl Czi hi, 2!! rai: -rj 7;:l! cir.crr. :!! T.'jrg crn:cr ?l:u;ai r-.ev:.:hcr;-.Tta P1: '% c i.z at 1:. t h ;: i c-:n a Career of :'OT..,rh, co`cn. rectum A!i oiler cs.-.ccrs /.sbc'tosii All ether ousts Creeled * 1?6 16 31.44 6.02 t t 9.71 15.71 t 164.72 CL.;r. 233 95 ^2 3 t 25 20 12 146 Nine men died before reaching 2U years bom .r:ni employment. Iixpit'.vd dc.-ihs arc based upon while male ncc->p.*cific Ucjih rate d.iij of the U $. National Ofucc of Vital StaiKtics Hem 1949 to 1962. Rates were extrapolated for 1943- 1V4X from rates for 1949-1935. Rates are not available, but ihr*e di'Cavcs arc rare causes of death in the general population. * Supported by ihc Health Revearch Council of l?>c City of New York (U-1272). 44$ --r* A230 M UCC 016003 SclikofT; I.u;i(j; C-mccr & Asbestos 4-; 9 ll lull previously hccn csi.ibltsti'ed ilul limp c.mccr iqi a formul.iiilc ; .,/.ird of ashcMus factor) workers- and llul lei ru'n.ition of cmpIoyiiH.Tt did in'; j'oorl \ the rini.; apparently. once Millie ten l espo-ure h.i il occurred with continued rcle.i- lion of asbestos within 11-.c lu:iy. risk remained. 1 his factor wj\ of cO.t.u .ruble concern, because a significant number of men were known In have we*:-cd ns asbestos insulation workers in the New York metropolitan area, and r,ur,;, '.sere Mill in I he trade. In addition lo the 370 survivors of the original 19-3 e .'.hurt. 890 men had joined the insulation union t during the period )9-l3-i96!. and S79 of them were alive on January I. 1963. Together, the two croups i onstilu'cri a total of 12-59 incr. who "ere either working regularly as asbestos i lsuialion workers in 1963 or svho had been recorded as having svorked regu-ariy at this trade fot shorter or longer periods in previous jears. Table 2 Mimbiss or AsncsTDS Wcasras' Union on Juiv 1, 1963. Adsihted to the Union Betorc December 31, 19*12. Classification nv Act and Smokinc Habits on or About Jam;art 1, 1963 (yr) 35-39 40-J4 4 5--9 50-?a 55-59 CO-64 65-69 7(3-74 75-79 S0-E4 Total Total No. 2 13 32 109 60 42 49 38 21 .4 370 Never Smoked Kegularly 1 7 2 12 6 7 6 7 3 2 48 pipe. Ex- Cigar cipaicUe Only Smokers* .. : __ 2 15 6 26 5 16 4 15 8 17 7 12 76 11 39 101 Curre nt Cicarcllc Smokers' 1-9/ Day ___ __ ' __ 3 -- 1 -- 1 __ -- 10-19/ 20-39/ Day Day _ .. __ 5 __ 12 5 33 3 20 __ 11 49 44 i3 ---- 40 + / Day -- 4 i? 24 10 4 5 3 1 -- J 17 97 63 Includes cigarette smokers who also smoked pipes or cigars. 111 __Bcferc_J963,. there had_ bccn_no_recular surveillance _of_ these asbestos woHtcrvbccjusc thcy.wcre not awarc-of their, special, risk. It was considered - that potential benefit might be obtained if a program of regular medical sur veillance could be iniiialcd. with special focus on the principal risks that had been identified, namely, bronchogenic carcinoma, pleural and peritoneal meso thelioma, gastrointestinal cancer, and asbestosis. Of these risks, lung cancer took first place. In addition to the risk associated with asbestos exposure, a majority of the men had been regular cigarette smokers (Tables 2 & 3). Such history, even in the absence of asbestos exposure, carried a lung cancer risk of ils own.1 (It was later lo be learned that the combination of the two factors, asbestos exposure and cigarette smoking, resulted in many more lung cancers than would be assumed from mere summation of tbc two clfccts. with asbestos exposure sharply increasing the lung cancer risk of cigarette smoking. -) t International Association cf Heal and Frost Insulators and Asbestos Workers, AFL-CIO. CLC. Locals 12 and 32. I _ ....------------- J A... ~V*` *.**-* 9* h233 k UCC 016004 U Annals Ni'.v York Academy o[ Sciences \ Cro / '2, c ' o O o o j1 G ^ 'jL c h 7 r< o ^'O-^OOOo ^ -=> ^ V< 2 O V7D D9 u< u ;c T - C"fl N i , -- -- -- O O O O c* *y -- OiNnoO - O r- r i; s. -- C. **" <o -= 2 >< -j 53 2< o> ! t-e - 'uw Vc) 11 v r Jr | c.i*c ; -- -y iuO I i -- O rsi -- -- OQOOOO tC 2 I !l D < II w-= Ss = c> c* 5 'C >o ^ * W< IT .J pO i -- p* O O -- -O 7o H-1 i---t N----,rvss ^---- o---- O7 rOj C'P'COOO rrcros A C tj * * \ *r r A239 -b UCC 016005 T*hli. 4 X-KaV Cmasci 5 in Asm sios Insui at ion Womki.kj* Onset of Expoxuic (yr) 40-f 30-39 20-29 0-9 No. 121 194 77 346 1117 Nonr.nl (5i) 5.S 12.9 27.2 35.9 51.5 Abnormal (5i) 94.2 S7.I 72.E 44.1 4B.5 AvbC'iO'xA (pf.n e) i 23 35 102 35 15S 366 5; 49 17 0 126 "* S IS 4 0 50 * From Reference 7. Prospective Clinical Surveillance The program of clinical surveillance lhai was ins:i:li;eel "as based on the realization l ho I the chest a ray offered Inc best method for early detection of lung cancer then avail.:bic.'- An initial pilot survey h.id demonstrated that the cooperation c( the norVers involved could be expected.7 Examination faculties, including x-ray equipment, were set up' in the union halls to facilitate attendance . of Ihc men; it ts not known whether equal cooperation would have as readily been achieved had it been necessary to site the survey in hospital-based facilities. The nature of the disease under surveillance required several modifications in usual chest x-ray survey design. First, it was considered that the standard "yeariy" chest Film would be inappropriate for many of the group (as it v-as later lo be shown to be inadequate for many other individuals as wellIn the preliminary survey, chest x-ray examination had shown that many of the men. especially those with more than 20 yeais from onset of exposure, already had considerable asbextosis (Taulf. 4).: If cancer were found, it would be best to discover it at a stage at which limited resection, as iobcctoiny or even segmental resection, was possible. Diminished respiratory reserve might make pneumo nectomy unavailable. cvcn if the neoplasm was otherwise resectable. Therefore, serial chest x rays were advised at 6-month intervals for workers with, more than 20 years from onset of exposure, yearly for those 15-19 years from onset, and e'ery 1-2 years for those with shorier histories of duration from onset. Further, rather thjn the usual posicroantcrior film alone being taken, four films were made at each examination, t'vo in the poslcroantcrior projection (one with increased penetration) and one in each of the two oblique ^projections. V.'ith x-ray changes of asbestos'::, predominantly to be seen in the lower lung fields, and with a known predilection for asbestos lung cancer lo be found in these areas, it was considered advisable lo visualize the lower lung fields as weii as possible. Other studies were simultaneously undertaken. Physical examination, with particular reference to the chest, abdomen, and oropharynx,J was supplemented by careful occupational, clinical, and smoking histories: fingers xvere examined for cluhbing. although it was recognized that this finding would have far less diagnostic utility in the presence of ashestosis than it would for lung cancer in general: urine, hematocrit, and scrum for rheumatoid factor xvere examined, and pulmonary function studies, including FVC and PEV, xserc performed. v Vv^* i j V'5','. . ' " *:v* .* ` ,, *L * r J i t i LI UCC 016006 After evaluation of the findings, each man n informed of the rexu s of ;hc examination. and. when retjuoiej. 3 detailed review of trie daln sx-ax sc lo ihc individual's phjS.c.nu. Cxmhc'cntiahty of ex.urn.~.ailor. results a-as care- fully guarded, with none of ihc individual iindmgs made i,nor, chair to the employer or !o ihc union, although statistical summaries of results were made available ;o both. In some instances, in which i; ji difficult for ihc worker lo auer. J for ihc examination (some rclired and were living in California, Florida, or o;n. r distant stales, and Olhcrs were residing up lo 150 miles from the unions- hcadipjaricrs), ihc worker w.-,s encouraged lo regularly visit his personal ph)sician for similar examination and to send the films obtained for review. Also, a unirn health plan included opportunity fer regular examination of the worker and his family in a program of general medical surveillance, and the advantages of participation in such surveillance were stressed. When an abnormality was suspected or found, immediate review with the worker's personal physician was sought, and details were provided. Cicsc co operation during the ensuing special studies wax offered, and. in many instances, the diagnostic and treatment facilities of the Mount Sinai Hospital were re quested and utilized. Lung Canoe* and Mesothelioma, 1963-1974 From January 1. 1963 to December 31, 1974. I9S of the 370 survivors of the original 1942 cohort died. The distribution of causes of death was very much the same as that in the previous 20 years, but the percentages within each category and the ratios between observed and expected deaths were appreciably altered (Tarle 5). Three factors influenced th.s change. First, as the indi- Table 5 Expected and Observed Deaths axiosg 370 Nf.w York-New Jersey Asbestos Insulation Workers. J angary !. 1963 to Deceahhr 31. 1974 deaths Total earner, ail sites Lung cancer F'tural rpesolheh'orr.a Peritone*! mciOinslioma Cancer of stomach Cancer of colon, rectum All other Csinccrs AsbeMosis AH other causes Number of men Pcrson*ycars of observation Expected * Obser-rd . 109.04 20.58 6.18 t 1.17 2.75 10.48 t 88.46 198 105 47 7 21 7 7 16 23 68 370 3075 ' Expected deaths are based upon age-specific "'hue male death rale data of the U.S. National (mice oT Vual btaiixticx from 1963 to 1973. Rales were extrapolated fur 1973-1974 fiom rales for J9aa-iy72. 7 U.S. deaih rates not available, bin ihexe discn'cx arc rare cauxex oT beam in ihc general poptilaiion. . - -___________.~4 '2 - *. - ,* - -,V . c.-_\ prv-Niv ___ _ UCC 016007 A239 i ? * . D II A H I I . I . U I I .... T* 111 r 6 Drains among K79 A'-m'.io1. In mu at ids Wuhviks. rivt Rtr.ivTiurn iv nr 111 Insui.atiun Wnau ii\' Union Janv*?.y I, 1747 in Dicimiu* 7], 1762. DuiunG Januah7 I. I 7(0 iu On lmiiu 31. 1774 Total doth* Tout c.inccr, all sites l.unj cancer Plcur.il it'.iLkotSc'ionia Pcritnncal mesothelioma Gastrointestinal canter AH other cancers Asbestos!* All other causes Number of Dcaihs 54 18 9 2 1 3 3 5 31 j viduals in the cohort accd. the distribution of death by cause would also be I expected to change, even in the absence cf an occupational disease influence. | Second, many of '.he individuals were still at v*.ork in 1963 and continued their i employment. The influence of total exposure on mortality would therefore be | evident; this factor might be of particular importance among indiv.duals with j clinical avbcstoxis,11 for xvhoni additional dust exposure would be particularly ; disadvantageous. Third, and perhaps most important, the lapsed period from onset of cllectivc exposure peogrevsi'cly lengthened, with increasing livelihood of clinical onset of malignant disease. Because the periods of clinical latency between onset of exposure and evidence of disease vary among the several | neoplastic risks of occupational asbestos exposure, it wouic be expected that there would be differences in incidence of these neoplasms during the decade of observation. In the event, 47 deaths of lung cancer occurred, while 6.IS had been expected; there were seven instances of pleura! mesothelioma and 2i of peritoneal mesothelioma, in addition to 23 deaths due to asbextosis. Also, more deaths due to cancer of the esophagus, stomach, coion. and rectum occurred than were anticipated. We has'c not yet analy7.rd the mortality experience of the S79 workers who first joined the union bcl'scen 1 9J3 and 1962 and were still alive on January l. 1963a These men were young, most with considerably less than 30 years from onset of exposure, and their risk of death during 1963-1974 was l.kcly to be limited. Observation showed that 54 deaths occurred, and Taiilf. 6 provides categorization by cause. Observation of these men continues, and il is antici pated that analysis of their mortality experience by cause, contrasting expected and observed deaths, will be able to be usefully undertaken within the next several years. Occuakence of I.ung Canceh and Mesothelioxia Altogether. 59 instances of bronchogenic carcinoma occurred among the 1249 asbestos in-iilation workers under our observation in the New York metropolitan area from January I. 1963 to December 31. 1974. Foriy-mne cases occurred among the 370 individuals who had already been members of Vn >- O ^ * U-vV A...- r w' ....v*-; * P it 2 3'3 yj UCC 016008 Annuls New Yotk Ac.iduny of Sciences Tabic 7 I.unc Cancer in New Yoxe-N. w Jijsly Asrisths Hsuiahon Wolltrs Janoahy 1. 1963 ui Di cr.M m> 31. i 974 Number as of January I, 1963 j.i-ng cancers lo January 31, 1974 Deaths due to lung cancer Admillcd lo Union Before *9-i3 J 943-;762 370 57! 49 r 48 <> the Insulation Workers' Union in 1947. ar.d 10 cases occurred imonc the S79 younger men uho first became members of the union 31 some time from January 1, 1943 to December 31. 1963 (Tant.E 7). Review of the clinical slates of these 59 men on January 1. 1975 showed that 57 were dead; two were alive. One. a member of the 1942 cohort, had been found to have a bronchogenic carcinoma during the Clinical survey under taken in 1963. Lobectomy was performed, and observation since has yielded no evidence of recurrence. He Mid works actively at his trade. The second man ,oincd the union in 1946. In 1972, he suffered hemoptysis, underwent lobec tomy. and has remained weii. Both men had been regular cigarette smokers', no instance of lung cancer wav seen among workers without h.story of regular smoking. Analysis is now underway to study the causes oT this dismal record. It is already evident that the usual causes lor failure in the management of bronchogenic carcinoma wctc also p.event here, in add.lion, there were other factors, such as peripheral location of the neoplasm and cariy pleural involve ment. important respiratory insufficiency, and occasional difficulty in radiologic diagnosis due to concomitant pleural and parenchymal asbestosis. Twenty-eight instances of pleural and peritoneal mesothelioma occurred in the 1942 ;phor;. and three c.iscs of these diseases occurred in the men who joined the trade more recently. Ail arc dead (TaplE S). There was no effective therapy available. Table * Mesothelioma amonc New Yore-New JmsKv Aspi.stos Insulation Wohlers. January 1, 1963 to Di.Ci.mbr.a 31, 1974 Number erf men Pleural mesothelioma Deaths Peritoneal mesothelioma Deaths Admitted to Union Before 1943 1943-1962 370 679 7 72 21 i 21 1 r UCC 016009 * . -> \ - SciikoiT: Lung Cancer & Asbciioa 455 -Summary >nd Conclumons Fifty-nine cases of bronchogenic carcinoma '.verc observed among I 1-9 asbestos insulation workers followed prospectively from January I. ',96? lo December 31, 1974 in ihe New York ineiropolii.in area. Despite the Tael hat these men, and their medical .attendants. were 'seil aw.,re oT ;;.cir risk pi such disease, and despile the jvjlbpiiiiy of a standard program of radic>,.oi.c and clinical surveillance, 57 of the 59 men died. It is clear that su."-'c.ll,ince tograms as niil./cd were insufficient lo appreciably improve the prognosis among seen individuals. At best. c.iriydiaenoMs of lale disease can be said to base been achieved during the surveillance. Far more effective measures of prcciii.ical diagnosis arc needed if anticipated disease in this group at high risk o.r cancer is to be effectively treated. The important influence of the lapsed period from onset of esposure was evident. Forty-nine Inn" cancers occurred among ihe 3~u '.vpri.crs ssho were in the union in 19-53, and 10 lung cancers occurred among the S79 men who first joined the Insulation Workers' Uniont, the Nc'v York metropolitan area during 1943-1962. Nine eases of pleural mesothelioma and 22 of peritoneal mcsoihclioma were seen. Effective treatment s'as absent, and ail 31 crc dead at the erd of the study period. Prospective surveillance with the likelihood of tariicr diag nosis failed lo appreciably improve prognosis in this disease. AOsNO'S'LtDCMENTS Janet S. KaiTen'nnrgh and Frances Pcrc7 made many important contributions to the clinic.il csumin.ilinns and surveillance. The fact that the entire group of 1249 men has been successfully followed is in large part the result of their skill, competence, and dedication, which arc gratefully acknowledged. References 1. Seiu-off, I. J., J. Cucr.c 4 E. C. Ksstssoso. 1954. Asbestos exposure and neoplasia. J. Arner. Med. Ass. 155: 22-26. 2. Dole, R. 1955. Mortality from lung cancer in asbestos workers. Brit. J. Ind. Med. 12: SI-66. 3. Hsmmosd, E. C. 1966 Smoking in relation to the death rates of 1.0C9.CCO men and women. In epidemiological Study of Cancer anj Other Chronic Diseases. Monogr. 19: 127-21)4. National Cartier institute. Ucthe'da, Md. .4. ScuKor'F. 1. J., E. C. Hsstmono i J. Citi'xc. 1968. Asbestos exposure, snicking and neoplasia. J Amcr. Med. A>s. 2(14: I0S-I 12. 5. Hammonu. E. C. 6 I. J. St.t.tsor r. 1973. Relation of cigarette smoking to risk of death of ash-.-Uos-av-ocinicu disease among i-.sulaiion workers in Use United Stales. In biological Effects of Asbestos. E. P. Uoguviki, cl ai., Eds. IAKC Sc. Pub. No. 8: 209-216. Lyon. Frame. 6. BuucoT, K. K,, D. A. Cooi'i.K & \V. Wise. 1970. The Philadelphia pulmonary neoplasm research project. Med. Clin. N. Amcr. 54: J49-J53. 7. SlLiKiirr, 1. J., J. Cuuttc k E. C. Hammond. 1965. 3 he occu.-rs-rce of ashesiosis among insulation workers in ihe United States. Ann. N.Y. Acad. Sci. 132: 139-155. - n. s -6 V. \ 456 Annuh New York Academy of Sciences 8. V.'mss, W.t H. Sliomsn A K. R. RorCOT. 1975. The pin! idclphia pulmonary neoplasm roe.uch project. Tim .irline f.uiors in periodic screening fm lung cancer. Anver. Rev. Rc\p. Dis. Ill: 2S9-297. 9. SkJ.KOI r. 1. J., E. C. IIvmmono L J. Comte. 1970. Mori..illy caper icnecs of robevtos instil,if ion wo/kers. hi PreumuconioMS. Proceedings of ibe Interna(tonal Conference, johnimcvhiirr, 1969. H. A. Shapiro, Ed.: 37-69. Oxford . University Tress. C;pcto" n, South Africa. 10. Pi.hnis. D-. H. C. Vrci.tAM I. J. Si i.imuk. 1V65. Rheumatoid factor in serum of individuals exposed to nsbeMos. Ann. N.Y. Acad. Sci. 102: 112-120. Ji. D-Of h, M. E., R. A. Haih.w. A. S. TuuMn*. A. Mu rnt&U. St iisin-r. 1970. pulmonary funclion and rndioprnphic chances in 59S workers with varying duration of exposure to asbestos J. Mount Sinai Hosp. \X.\\ II: 492-500. * "V' J *i >, -'V / L j j v J"`t ---- . -- K. y *> ' / UCC 016011 A 2 3 9 2 ",