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TABLE OF CONTENTS 24235125i8

THIS ISSUE BINDER IS INTENDED TO PROVIDE' A BASIC, COMPREHENSIVE REVIEW OF THE SCIENTIFIC LITERATURE REGARDING A SPECIFIC TOPIC ON ETS AND THE HEALTH OF NONSMOKERS. PRIMARY STUDIES AND REVIEWS HAVE BEEN HIGHLIGHTED TO IDENTIFY (1) USEFUL OR HELPFUL INFORMATION (YELLOW HIGHLIGHT ) AND (2) ADVERSE RESULTS OR OPINIONS ( BI,iIE HIGHLIGHT).

TABLE OF CONTENTS VOLUME I TAB PRIMARY STUDIES ON SPOUSAL SMOKING AND LUNG CANCER.......... A Introduction ..................... United States studies............ (Tables 1 and 2) Asian studies .................... (Tables 3 and 4) European studies.................. (Tables 5 and 6) Workplace exposure................. (Table 7) Childhood exposure ............... (Table 8), References ....................... P• 1 p. 2 p. 5 p. P• P- P• 6 7 8 10 Individual studies, with summaries Hirayama, 1981, 1984a, 1984b...................... 1 Trichopoulos, et al., 1981, 1983.................. 2 Garfinkel, 1981 .................................. 3 Chan and Fung, 1982 ............................... 4 Correa, et al., 1983 ............................. 5 Buffler, et al., 1984 ............................ 6 Gillis, et al., 1984/Hole, et al., 1989 .......... 7 Kabat and Wynder, 1984 ........................... 8 Garfinkel, et al., 1985 .......................... 9 Lam, W.K., 1985/Lam and Chen:g, 1988............... 10 Wu, et al., 1985 .................................. 11 Akiba, et al. 1986 ............................... 12 Lee, et al., 1986 ................................ 13 Brownson, et al., 1987 ........................... 14 Gao, et al., 1987 ................................ 15 Humble, et al., 1987 ............................. 16 Koo, et al., 1987/Koo, et al., 1984................ 17 Lam, et al., 1987 ................................ 18 Pershagen, et al., 1987 .......................... 19 Geng, et al., 1988 ............................... 20 Inoue and Hirayama, 1988 ......................... 21 Shimizu, et al., 1988 ............................ 22 Svensson, et al., 1988 ............................ 23 Janerich~, et al., 1990/Varela, 1987............... 24 1

TAB Tozzi, 1992/Correspondence ...................... 20 Layard, 1992........ .............................. 21 Fleiss and Cross, 1991/Spitzer, 1991/Peto,1992.. 22. Tweedie and Mengersen, 1992 ..................... 23 10777503 V

in~the Stockwell, et al., study, including the overall risk estimate for spousal smoking, were not statistically significant. The third recent study, by Brownson, et al., is a very larg,e case-control study, conducted in Missouri.33 The authors of this study report no statistically significant risk estimates for any "'quantitative'"' estimates of ETS exposure. Unlike the Fontham, et al., and Stockwell, et al., data, Brownson, et al., reported no statistically significant risk estimates when their d!ata were analyzed by cell type.

TAB RISK ESTIMATES BASED UPON MODELING........................ Introduction ..................... p. 1 References ....................... p. 5 Individual papers D Repace and Lowrey, 1985........... ............... Arundel, et al., 1986 ........................... Arundel, et al., 1987 ........................... Additional Criticisms of Repace and Lowrey......................................... Darby and Pike, 1988.............................. Criticism of Darby and Pike...................... Lee, 1991......... ................................ Siegel, 1993 .................................... 1 2 3 4 5 6. 7 8 VOLUME III CONFOUNDING FACTORS........................................ Introduction ..................... p. 1 References....................... p. 15 Individual papers E Wynder, et al., 1982 ............................ 1 Butler, 1991/Katzenstein, 1990 .................. 2 Smith, et al., 1992 ............................. 3 Rylander, 1990 .................................. 4 Gori and Mantel, 1991 ........................... 5 Katzenstein, 1992.. ................................ 6 LeMarchand, et al., 1991 ........................ 7 Koo, 1984, 1989/Koo, et al., 19:88 ............... 8 Cade and Margetts, 1991 ......................... 9 Thompson and Warburton, 1992 .................... 10 Sidney, et al., 1989 ............................ 11 Waller and Smith, 1991 .......................... 12 Smith and Waller, 1991 .......................... 13 Shibata, et al., 1992 ........................... 14 Candelora, et al., 1992........................... 15 Fontham, et al., 1992........ ..................... 16 Tewes, et al., 1990........... .................... 17 Chen, et al., 1990........... .................... 18 Anonymous, 1986/d'eSerres and Matsushima, 1986........... ................................. 19 Geng, et al., 1988........ ....................... 20 Mumford, et al., 1987.............................. 21 Chapman, et al., 1988..... ....................... 22 111

PRIMARY EPIDEMIOLOGIC STUDIES ON SPOIISAL SMORING AND LUNG CANCER Introduction Currently, 34 epidemiologic studies examining lung, cancer incidence and spousal smoking have been published or are`available as dissertations or conference presentations.1-34 The material in Section A of this notebook is discussed according to geographical area: United~ States (Tables 1 and 2), Asia (Tables 3 and 4) and Europe (Tables 5 and 6). For purposes of comparison, the relative risks (point estimates) given in the tables are the overall point estimates for spousal smoking reported in the papers. In some cases, the risk in~ the table was selected from numerous point estimates presented in the paper, based on different definitions of exposure, break-down of the sample by histological type, etc. Tables 7 and 8 summarize the workplace and childhood exposure data currently available. Brief synopses and copies of the papers associated with these studies follow this introduction, at Tabs 1 to 34. For several of the more recent papers, copies of letters to the editor concerning the study may be found following the primary paper. The extensive criticisms of the Hirayama and Trichopoulos, et al., papers, however, are discussed in Section C of this notebook. The copies are highlighted in yellow for useful information and in~ blue for negative statements.

TAB Du and Ou, 1990 ................................... 23 Liu, et al., 1991/He, et al., 1990, 1991........ 24 Wang,, et al., 1989 .............................. 25 Wu-Williams, et al., 1990, 1993................... 26 Xu, et al., 1989 ................................ 27 Sun, et al., 1992................................. 28 Shimizu, et al., 1988 ........................... 29 Sobue, et al., 1990........... .................... 30 Gao, et al., 1987 ............................... 31 Qu, et al., 1992............ ....................... 32 Alavanja, et al., 1992 .......................... 33 Shaw, et al., 1991 .............................. 34 Holst, et al., 1988.. .............................. 35 Kohlmeier, et al., 1992.... ........................ 36 Gardiner, et al., 1992..... ...................... 37 Britton and Lewis, 1992/Correspondence .......... 38 Smith and Phillips, 1992 ........................ 39 Morabia, 1992..... ................................ 40 Butler, 1992...... ............................... 41 VOIX7ME IV ~ META-ANALYSIS ............................................. F Introduction ..................... p. 1 (Tables 1, 2 and 3) References ....................... p. 14 Individual papers Mann, 1990 ...................................... 1 Buffler, 1989 ................................... 2 Spector and Thompson, 1991 ...................... 3 Dickersin and Berlin, 1992........ ............... 4 Thompson and Pocock, 1991......................... 5 Goodman, 1991 ...................................... 6 Andersen and Harrington, 1992..................... 7 Felson, 1992 ............. .................................... 8 Lee, 1992 ....................................... 9 NRC, 1986 ....................................... 10 ~ Wald, et al., 1986.............. .................. 11 .© Blot and Fraumeni, 1986 ......................... 12 ~ Wells, 1988 ..................................... 13 ~ Letzel and Uberla, 1990......... .................. 14 U.S. EPA , 1990 ........... .................................. 15 ~ Layard and LeVois, 1991............................ 16 ~ Layard, 1991 .................................... 17 Layard, 1992 .................................... 18 U.S. EPA, 1992..................................... 19 iv

United States Studies Fourteen of the available studies on spousal smoking and lung cancer in nonsmokers (two cohort, twelve case-control) were conducted in the United States (Table 1),3,5,7-9,11,14,16,24,25,30- 33 None of the overall relative risks (RR) for spousal smoking reported in these fourteen studies is statistically significant. The United States Environmental Protection Agency's 1993 Risk Assessment on ETS relied heavily upon eleven of the U.S. studies in reaching its conclusion.3,5,7-9,11,14,16,24,30,33 Although none of the studies originally reported a statistically significant overall risk estimate for spousal smoking, EPA used these studies to arrive at its conclusion that ETS exposure was associated with a statistically significant risk of lung cancer in the United States. In its analyses, EPA recalculated 90% confidence intervals for the risk estimates, instead of adopting the more commonly used 95% confidence interval. At 90%, one study, by Fontham, et al., had an overall risk estimate that was statistically significant. Nevertheless, ten of the eleven studies cited by EPA were compatible with the null hypothesis of no association between N spousal smoking and lung cancer risk. Q ~ W Cll Among the more recently published papers, the paper by ~ Janerich, et al., is based upon an unpublished dissertation by ~ CT~ - 2 -

TAB Kabat, 1990 ...................................... 25 Kalandidi, et al., 1990...... ..................... 26 Sobue, et al., 1990... ............................ 27 Wu-Williams, et al., 1990........................... 28 Liu, et al., 1991 ............:..................... 29 Butler, 1988...................... .................. 30 Fontham, et al., 1991/Correspondence.............. 31 Stockwell, et al., 1992/Correspondence............ 32 Brownson, et al., 1992 ........................... 33 Du, et al., 1993 ................................. 34 VOLUME II ADDITIONAL STUDIES ON LUNG CANCER ......................... B Introduction ..................... p. 1 References....................... p. 6 Individual studies Knoth, et al., 1983/Heller, 1983.................. 1 Sandler, et al., 1985a, 1985b, 1985c/ Selected Criticisms ............................ 2 Dalager, et al., 1986 ............................ 3 Lloyd, et al., 1986 .............................. 4 Katada, et al., 1988 ............................. 5 Lam and Cheng, 1988 .............................. 6 Chen, et al., 1990 ............................... 7 Miller, 1990....... ............................... 8 CRITICISMS ................................................. C General criticisms ............... p. 1 Criticisms of the Hirayama study.... ........................ p. 8 Criticisms of the Trichopoulos study ........................... p. 10 References ....................... p. 12 Selected critical publications General criticisms .............................. 1-7 Re: Hirayama ................................... 8-20 Re: Trichopoulos............ ..................... 21-23 ii