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Reassessment of the Long-term Mortality Risks of Active and Passive Smoking 1) “The Long-term Reassessment of the Long-term Mortality Risks of Active and Passive Smoking 1) “The Long-term Mortality Risks of Active Smoking and the Need for a Reassessment” James E. Enstrom, Ph. D. , UCLA 2) “Reassessment of the Mortality Risks of Passive Smoking in the United States” Geoffrey C. Kabat, Ph. D. , Einstein College of Medicine, New York 3) “Silencing of Science: The Phenomenon and Its Impact on Passive Smoking Epidemiology” Sheldon B. Ungar, Ph. D. , University of Toronto 4) Additional Discussion: “Trofim Denisovich Lysenko and Pseudoscience in the Soviet Union (1927 -1962)” 1

Rationale for Symposium 1) Important epidemiologic findings regarding active and passive smoking have been Rationale for Symposium 1) Important epidemiologic findings regarding active and passive smoking have been ignored or mischaracterized in prior assessments 2) Rigorous scientific principles require that all epidemiologic findings must be fairly and consistently assessed 3) “Silencing” of politically incorrect epidemiologic findings is ethically and scientifically wrong 4) The credibility of epidemiology is seriously damaged when ideology and politics replace rigorous scientific principles 2

Goals for Symposium 1) To present evidence that the long-term mortality risks of active Goals for Symposium 1) To present evidence that the long-term mortality risks of active smoking are greater than generally believed and the long-term mortality risks of passive smoking are less than generally believed 2) To establish the credibility of this largely ignored or mischaracterized epidemiologic evidence 3) To make the case that future research and future assessments need to be conducted objectively and transparently, free of ideology and politics 3

17 May 2003 British Medical Journal 4 17 May 2003 British Medical Journal 4

Background on Enstrom 33 years of epidemiologic research at UCLA 28 years of conducting Background on Enstrom 33 years of epidemiologic research at UCLA 28 years of conducting and/or analyzing prospective epidemiologic cohorts: California Mormons California Physicians Prevention Magazine Subscribers Alameda County Study Cohort United States Veterans Cohort NHANES Epidemiologic Followup Study Cohort California Cancer Prevention Study Cohort Themes: low-risk subgroups and different perspectives 5

California Cancer Prevention Study 1) 1, 078, 000 total subjects in 25 states enrolled California Cancer Prevention Study 1) 1, 078, 000 total subjects in 25 states enrolled by American Cancer Society with late 1959 questionnaire and followed for mortality during 1960 -1972 (CPS I) 2) 118, 000 California subjects followed for mortality during 1960 -1998 and a 1999 questionnaire survey--at UCLA with special permission from ACS (CA CPS I) 3) This is the largest epidemiologic cohort followed for at least 39 years 6

Need for Reassessment Regarding Active Smoking 1) BMJ Table 10 shows strong 39 -year Need for Reassessment Regarding Active Smoking 1) BMJ Table 10 shows strong 39 -year relationship between active smoking and lung cancer 2) 90% reduction in US tar-adjusted per capita cigarette consumption 3) Continuing high US lung cancer death rate with 160, 000 deaths per year 4) Population impact of smoking cessation not fully understood or evaluated 7

BMJ Table 10 1960 -1998 Active Smoking and Lung Cancer Deaths Late 1959 Males BMJ Table 10 1960 -1998 Active Smoking and Lung Cancer Deaths Late 1959 Males Females smoking status RR (95% CI) Never Former Current 1 -9 cpd 10 -19 20 21 -39 40 -80 1. 0 3. 5 (2. 8 -4. 4) 1. 0 1. 5 (1. 1 -2. 0) 4. 1 (2. 9 -5. 8) 7. 9 (6. 1 -10. 1) 12. 5 (10. 0 -15. 6) 16. 4 (13. 0 -20. 8) 18. 7 (14. 5 -24. 0) 2. 0 (1. 5 -2. 6) 5. 1 (4. 2 -6. 1) 9. 1 (7. 7 -10. 8) 15. 1 (12. 3 -18. 7) 15. 8 (11. 8 -21. 1) All current 11. 9 (9. 6 -14. 7) 6. 2 (5. 4 -7. 2) 8

1900 -2005 U. S. Per Capita Cigarette Consumption and Tar-Adjusted Consumption Number of cigarettes 1900 -2005 U. S. Per Capita Cigarette Consumption and Tar-Adjusted Consumption Number of cigarettes Per capita Tar adjusted Data source: Tobacco Outlook Report, Economic Research Service, U. S. Dept. of Agriculture. 9

1930 -2005 U. S. Age-adjusted Lung Cancer Death Rates Deaths per 100, 000 Total 1930 -2005 U. S. Age-adjusted Lung Cancer Death Rates Deaths per 100, 000 Total population Never smokers Data Source: NCHS Vital Statistics; Death rates are age-adjusted to 2000 US standard population. 10

Conventional Benefits of Smoking Cessation (Enstrom & Heath EPIDEMIOLOGY 1999) CA CPS I Males Conventional Benefits of Smoking Cessation (Enstrom & Heath EPIDEMIOLOGY 1999) CA CPS I Males Lung cancer death rate ratios by smoking status at entry 1960 -1969 Late 1959 smoking status Death Rate Ratio Current Former Quit < 1 year (1959) Quit 1 -4 years (1955 -58) Quit 5 -9 years (1950 -54) Quit 10 -19 years (1940 -49) Quit 20+ years (<1939) Never 12. 3 13. 0 8. 9 4. 7 2. 7 1. 8 1. 0 11

Natural Experiment of Smoking Cessation (Enstrom & Heath EPIDEMIOLOGY 1999) Cigarette smoking prevalence among Natural Experiment of Smoking Cessation (Enstrom & Heath EPIDEMIOLOGY 1999) Cigarette smoking prevalence among CA CPS I subjects who smoked in late 1959, based on follow-up surveys of survivors. Sex 1959 1965 1972 1999 Males 100% 74% 51% 7% Females 100% 86% 66% 7% 12

Natural Experiment of Smoking Cessation (Enstrom & Heath EPIDEMIOLOGY 1999) Relative risk of lung Natural Experiment of Smoking Cessation (Enstrom & Heath EPIDEMIOLOGY 1999) Relative risk of lung cancer death in CA CPS I cohort: 41, 000 current cigarette smokers as of late 1959 compared with 50, 000 never smokers Follow-up period (by decade) Sex 1960 -1969 1970 -1979 1980 -1989 1990 -1997 Males 12. 6 12. 1 12. 5 10. 2 (7. 9 -20. 2) (8. 1 -18. 0) (8. 5 -18. 4) (6. 1 -17. 0) Females 2. 5 6. 3 7. 0 7. 8 (1. 7 -3. 8) (4. 7 -8. 3) (5. 4 -9. 0) (5. 8 -10. 4) 13

Additional Natural Experiments of Smoking Cessation 1) US Veterans Study: 106, 000 males followed Additional Natural Experiments of Smoking Cessation 1) US Veterans Study: 106, 000 males followed 1954 -1979 (Enstrom J Clin Epi 1999) 2) NHEFS: 700 males & 1100 females followed 1971 -1992 (Enstrom J Clin Epi 1999) 3) Iowa Women’s Health Study: 37, 000 women 1986 -1999 “decline in excess lung cancer risk among former smokers is prolonged compared with other studies. . . excess lung cancer risk persisted up to 30 years” (Ebbert, et al. J Clin Oncol 2003) 14

Randomized Controlled Trials With A Smoking Cessation Intervention 1) Whitehall Civil Servants Study 1, Randomized Controlled Trials With A Smoking Cessation Intervention 1) Whitehall Civil Servants Study 1, 445 high risk male smokers from London advised in 1970 (JECH 1978, JECH 1982, JECH 1992) 2) Multiple Risk Factor Intervention Trial (MRFIT) 12, 866 high risk US males enrolled in 1972 (JAMA 1982, Circulation 1996, Ann Epi 1997) 3) Lung Health Study (LHS) 5, 887 US/CN male and female smokers enrolled in 1986 (JAMA 1994, AJRCCM 2002, AIM 2005) 15

Smoking cessation in three RCTs: intervention group (I) versus control group (C) Intervention Average Smoking cessation in three RCTs: intervention group (I) versus control group (C) Intervention Average Cessation Study period (years) during intervention period Intervention Control Whitehall 1 ~60% ~25% MRFIT 6 ~45% ~20% LHS 5 ~35% ~15% 16

Initial RCT lung cancer deaths and relative differences, (I-C)/C, and 95% CI (%) Study Initial RCT lung cancer deaths and relative differences, (I-C)/C, and 95% CI (%) Study Follow-up years Lung cancer deaths (I-C)/C & 95% CI I C (%) Whitehall* 10. 5 22 ~24* - 8. 3 MRFIT 7 34 28 +21. 4 LHS 5 20** 19 + 5. 3 TOTAL 76 71 + 7. 0 (-15. 5 to +33. 7) *deaths & incident cases, which are scaled (714/731) **only “special intervention—placebo” group included 17

Full RCT lung cancer deaths and relative differences, (I-C)/C, and 95% CI (%) Study Full RCT lung cancer deaths and relative differences, (I-C)/C, and 95% CI (%) Study Follow-up years Lung cancer deaths (I-C)/C & 95% CI I C (%) Whitehall* 20 45 ~50* - 10. 0 MRFIT LHS TOTAL 16 14. 5 135 117 +15. 0 77** 89 - 13. 5 257 256 + 0. 4 (-11. 5 to +13. 5) *deaths & incident cases, which are scaled (714/731) **only “special intervention—placebo” group included 18

Tobacco Smoke and Involuntary Smoking IARC Monographs on the Evaluation of Carcinogenic Risks to Tobacco Smoke and Involuntary Smoking IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Volume 83 May 2004 1452 pages Coverage of Smoking Cessation 1) Standard comparison of lung cancer rates among former smokers, current smokers, and never smokers 2) Nothing on population impact versus successful quitters 3) Nothing on “natural experiments” 4) Nothing on randomized controlled trials 19

THE HEALTH BENEFITS OF SMOKING CESSATION A Report of the Surgeon General 1990 (628 THE HEALTH BENEFITS OF SMOKING CESSATION A Report of the Surgeon General 1990 (628 pages) PREFACE BY THE SURGEON GENERAL “Taken together, the evidence clearly indicates that smoking cessation has major and immediate health benefits for men and women of all ages. ” MAJOR CONCLUSIONS “ the health consequences of smoking cessation for those who quit smoking in comparison with those who continue to smoke: 1. Smoking cessation has major and immediate health benefits for men and women of all ages. ” 20

SUMMARY: Active Smoking & Cessation Long-term mortality risk of lung cancer due to active SUMMARY: Active Smoking & Cessation Long-term mortality risk of lung cancer due to active smoking is greater than generally believed because it less reversible by cessation than generally believed based on evidence presented 1) The lung cancer mortality risk ratios for self-selected former smokers compared with never smokers do not accurately reflect the population impact of smoking cessation 2) Long-term “natural experiments” in cohorts within the United States do not show convergence of smoker and never smoker death rates in spite of substantial smoking cessation 3) Randomized controlled trials involving smoking cessation do not show a significant reduction in lung cancer deaths in the intervention groups relative to the control groups 21

Factors Impeding Reassessment 1) Complex Issue: population impact of cessation versus focus on successful Factors Impeding Reassessment 1) Complex Issue: population impact of cessation versus focus on successful quitters 2) “Wrong Message”: negative findings supposedly discourage smokers from quitting 3) Uncertainty: implies lung cancer etiology and benefits of cessation are not completely understood 4) “Silencing”: ignored in major consensus reports and general information to the public 5) “Conflict of Interest”: some of the above research has been funded by the tobacco industry 22

May 2006 EPIDEMIOLOGY Lead Editorial: “On Conflicts of Interest” Five Commentaries: “Kafka's Truth-seeking Dogs” May 2006 EPIDEMIOLOGY Lead Editorial: “On Conflicts of Interest” Five Commentaries: “Kafka's Truth-seeking Dogs” “What to Declare and Why? ” “He Who Pays the Piper, Calls the Tune…” “Why Focus Only on Financial Interests? ” “A Conflict-of-Interest Policy for Epidemiology” 23

Conflict of Interest & BMJ Paper 1) Because the final portion of the funding Conflict of Interest & BMJ Paper 1) Because the final portion of the funding for the CA CPS I study came from the tobacco industry, attention was diverted from the substance of the BMJ paper to allegations of tobacco industry influence 2) Because the BMJ findings do not fit the anti-smoking advocacy agenda, the ACS and key anti-smoking activists have conducted an ongoing campaign of ad hominem attack, character assassination, and “silencing” with regard to Enstrom & Kabat 3) Most troubling are the false and misleading statements made about the BMJ paper by certain powerful US epidemiologists, which will be presented following the discussion of Lysenko & Soviet pseudoscience 4) The Enstrom & Kabat experience illustrates the difficulty of conducting “politically incorrect” tobacco epidemiology 24

Reassessment of the Mortality Risks of Passive Smoking in the United States Geoffrey C. Reassessment of the Mortality Risks of Passive Smoking in the United States Geoffrey C. Kabat, Ph. D. 25

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Background n ETS contains many carcinogens and toxins n exposure is widespread and involuntary Background n ETS contains many carcinogens and toxins n exposure is widespread and involuntary n active smoking is a major cause of avoidable morbidity and mortality 27

Environmental tobacco smoke n n n ETS is a mixture of sidestream smoke from Environmental tobacco smoke n n n ETS is a mixture of sidestream smoke from the burning tip of the cigarette (70 -90%) and exhaled mainstream smoke (10 -30%). Over time the mixture ages and is deposited on surfaces. ETS is both different qualitatively and much more dilute than the smoke the active smoker inhales -- how much more dilute? 1/10 th? 1/100 th? 1/1, 000 th? the effects of ETS can only be studied in never smokers 28

Need for reassessment of passive smoking n n n implausible that ETS could cause Need for reassessment of passive smoking n n n implausible that ETS could cause a 30% increase in CHD risk given that ETS is much more dilute than actively inhaled smoke and RR for active smoking is ~1. 8 -2. 0 strength of association depends on which studies are included in meta-analysis issue is difficult to assess objectively because of enormous political stakes 29

Meta-analyses of ETS and LC RR 95% CI US EPA (1992) – US studies Meta-analyses of ETS and LC RR 95% CI US EPA (1992) – US studies 1. 19 (1. 04 -1. 35)* Hackshaw et al. BMJ (1997) 1. 23 (1. 13 -1. 34) IARC (2004) -- females 1. 24 (1. 14 -1. 34) IARC (2004) – males 1. 37 (1. 02 -1. 83) *90% CI 30

Meta-analyses of ETS and CHD RR 95% CI Law et al. BMJ (1997) 1. Meta-analyses of ETS and CHD RR 95% CI Law et al. BMJ (1997) 1. 30 (1. 22 -1. 38) He et al. NEJM (1999) 1. 25 (1. 17 -1. 32) Thun et al. EHS (1999) 1. 25 (1. 17 -1. 33) 31

Estimates of US deaths due to ETS Lung cancer 3, 000 -- 5, 000 Estimates of US deaths due to ETS Lung cancer 3, 000 -- 5, 000 CHD 35, 000 – 60, 000 32

Follow-up of California CPS I cohort n n followed for mortality from 1960 through Follow-up of California CPS I cohort n n followed for mortality from 1960 through 1998 118, 094 adults, of whom 35, 561 were neversmokers with a spouse ETS exposure based on smoking status of the spouse in 1959, 1965, & 1972 7, 159 respondents to 1999 questionnaire provided assessment of their self-reported total ETS exposure 33

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Deaths for analysis of active and passive smoking – 1960 -1998 Total cohort Never Deaths for analysis of active and passive smoking – 1960 -1998 Total cohort Never CHD 19, 485 5, 932 Lung Cancer 2, 970 156 COPD 2, 243 264 smokers 35

Active smoking and CHD death, 1960 -1998 Males Active smoking status n n RR Active smoking and CHD death, 1960 -1998 Males Active smoking status n n RR 95% CI Females RR 95% CI Never smoked Former smoker Current smoker • 1 -9 cpd • 10 -19 • 20 • 21 -39 • 40 -80 1. 2 --(1. 1 -1. 3) 1. 0 1. 2 1. 4 1. 6 1. 8 1. 9 (1. 1 -1. 3) (1. 3 -1. 5) (1. 5 -1. 7) (1. 6 -1. 9) (1. 7 -2. 1) 1. 1 1. 4 1. 8 2. 0 2. 4 (1. 0 -1. 2) (1. 3 -1. 5) (1. 7 -1. 9) (1. 8 -2. 3) (2. 0 -2. 9) All current smokers 1. 5 (1. 4 -1. 6) (1. 5 -1. 6) --(0. 9 -1. 1) 36

ETS and CHD death, 1960 -1998 All 1959 participants followed 1960 -98 Never Former ETS and CHD death, 1960 -1998 All 1959 participants followed 1960 -98 Never Former Current 1 -9 cpd 10 -19 20 21 -39 40+ RR Males 95% CI 1. 00 --0. 94 (0. 78 -1. 12) 0. 94 (0. 75 -2. 22) 0. 97 0. 86 0. 92 1. 16 1. 29 (0. 78 -1. 21) (0. 70 -1. 05) (0. 74 -1. 15) (0. 79 -1. 69) (0. 75 -2. 22) Females RR 95% CI 1. 00 --1. 02 (0. 93 -1. 11) 1. 01 (0. 93 -1. 09) 1. 13 1. 04 0. 95 0. 83 (0. 97 -1. 33) (0. 91 -1. 17) (0. 92 -1. 16) (0. 80 -1. 12) (0. 65 -1. 06) 37

Active smoking and lung cancer death, 1960 -1998 Active smoking status n n RR Active smoking and lung cancer death, 1960 -1998 Active smoking status n n RR 1. 0 3. 5 Males 95% CI Never smoked Former smoker Current smoker • 1 -9 cpd • 10 -19 • 20 • 21 -39 • 40 -80 --(2. 8 -4. 4) 4. 1 7. 9 12. 5 16. 4 18. 7 (2. 9 -5. 8) (6. 1 -10. 1) (10. 0 -15. 6) (13. 0 -20. 8) (14. 5 -24. 0) All current smokers 11. 9 (9. 6 -14. 7) Females RR 95% CI 1. 0 1. 5 --(1. 1 -2. 0) 2. 0 5. 1 9. 1 15. 8 (1. 5 -2. 6) (4. 2 -6. 1) ( 7. 7 -10. 8) (12. 3 -18. 7) (11. 8 -21. 1) 6. 2 (5. 4 -7. 2) 38

ETS and lung cancer death, 1960 -1998 Males RR 95% CI Females RR 95% ETS and lung cancer death, 1960 -1998 Males RR 95% CI Females RR 95% CI All 1959 participants followed 1960 -98 Never Former Current 1. 00 --0. 92 (0. 37 -2. 30) 0. 69 (0. 34 -1. 39) 1. 00 1. 08 0. 93 --(0. 73 -1. 60) (0. 65 -1. 33) 39

Summary of BMJ results n n n exposure to spousal smoking was not associated Summary of BMJ results n n n exposure to spousal smoking was not associated with increased mortality from lung cancer or CHD (3 follow-up intervals) exposure was weakly associated with increased mortality from COPD active smoking showed strong dose-response relationships with lung cancer, CHD, and COPD (BMJ table 10) 40

Conclusion of BMJ paper “The results do not support a causal relationship between ETS Conclusion of BMJ paper “The results do not support a causal relationship between ETS and mortality, although they do not rule out a small effect. The association between ETS and CHD and lung cancer may be considerably weaker than generally believed. ” 41

American Cancer Society n n ACS cohort studies CPS I and CPS II account American Cancer Society n n ACS cohort studies CPS I and CPS II account for the vast majority of data on ETS and CHD ACS contends that CPS I cannot be used to address passive smoking because in 1960 s everyone was exposed 42

Response to ACS criticisms n not true that everyone was exposed to ETS n Response to ACS criticisms n not true that everyone was exposed to ETS n majority of women in CA CPS I cohort were “homemakers” n n in their 1999 meta-analysis, Thun et al. saw fit to include 2 cohort studies initiated in the 1960’s ACS has the ability to check our analysis for 1960 -1972 43

Misclassification of ETS exposure spousal exposure may not reflect total ETS exposure since there Misclassification of ETS exposure spousal exposure may not reflect total ETS exposure since there are other sources of exposure misclassification was lower in certain sub-groups 1999 questionnaire showed that smoking status of spouses was directly related to a history of total exposure to ETS misclassification was not sufficient to obscure a true association between ETS & CHD, particularly in women 44 44

Spousal smoking vs. self-reported ETS exposure among CA CPS I never smokers -- females Spousal smoking vs. self-reported ETS exposure among CA CPS I never smokers -- females 1959 spousal smoking Never Current 1 -19 cigs/day 20 -39 cigs/day 40+ cigs/day History of regular ETS exposure as of 1999 (%) None Light Moderate Heavy 62 26 20 16 24 29 21 13 11 39 41 48 3 6 18 24 Enstrom & Kabat, BMJ 2003 45

ETS and CHD: comparison of CA CPS I and CPS II Females Enstrom (CA ETS and CHD: comparison of CA CPS I and CPS II Females Enstrom (CA CPS I) Spousal smoking Never Former Current 1 -19 cpd 20 cpd 21 -39 cpd 40+ Current – total Ever Steenland (CPS II) 1. 00 --1. 02 (0. 93 -1. 11) 1. 00 --1. 00 (0. 90 -1. 48) 1. 07 (0. 96 -1. 19) 1. 04 (0. 92 -1. 16) 0. 95 (0. 80 -1. 12) 0. 83 (0. 65 -1. 06) 1. 01 (0. 93 -1. 09) 1. 01 (0. 94 -1. 08) 1. 15 (0. 90 -1. 48) 1. 07 (0. 83 -1. 40) 0. 99 (0. 67 -1. 47) 1. 04 (0. 67 -1. 61) 1. 10 (0. 96 -1. 27) 1. 04 (0. 95 -1. 15) 46

New meta-analysis US CHD studies Enstrom & Kabat, Inhalation Toxicology (2006). n includes published New meta-analysis US CHD studies Enstrom & Kabat, Inhalation Toxicology (2006). n includes published studies of CPS I and CA CPS I n applies consistent criteria for inclusion of results RRcurrent/never = 1. 04 (0. 99 -1. 10) RR ever/never = 1. 04 (0. 99 -1. 10) Thun et al. , Environ Health Perspect (1999) RRexposed/not exposed = 1. 22 (1. 13 -1. 30) 47

Meta-analysis of US lung cancer studies n n case-control & cohort studies includes Enstrom Meta-analysis of US lung cancer studies n n case-control & cohort studies includes Enstrom & Kabat, 2003 RRever/never = 1. 10 (1. 00 -1. 21) 48

Jenkins, “ 16 Cities Study” (1993 -94) n n n 100 nonsmokers in each Jenkins, “ 16 Cities Study” (1993 -94) n n n 100 nonsmokers in each of 16 metro areas collected 24 -hr air samples both at work and away from work using personal monitoring participants filled out questionnaires about their exposures and gave a pre- and post- saliva samples were analyzed for 10 markers of ETS, including RSP and nicotine 49

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Estimates of ETS exposure n n Jenkins (1996): mean ETS exposure ~ 8 cigarette Estimates of ETS exposure n n Jenkins (1996): mean ETS exposure ~ 8 cigarette equivalents/year Phillips (1998): housewives with heaviest exposure could inhale up to 11 cigarette equivalents/year 51

Richard Peto testimony before House of Lords Feb. 14, 2006 Question: “Sir Richard, I Richard Peto testimony before House of Lords Feb. 14, 2006 Question: “Sir Richard, I wanted to start by asking if you could give us your assessment of the health risks associated with passive smoking in the home or at work and in other public places. It would be helpful if you could give us an indication of both absolute and relative magnitudes of the health risks and also the degree of uncertainty attached to the available statistical evidence. ” Peto’s response: “I am sorry, I know that is what you would like to be given, but the point is that these risks are small and difficult to measure directly. What is clear is that cigarette smoke itself is far and away the most important cause of human cancer in the world – that is, cigarette smoke taken in by the smoker – and passive smoking, exposure to other people’s 52 smoke, must cause some risk of death from the same diseases. Measuring that risk reliably and directly is

Factors impeding reassessment of effects of ETS on mortality n incomplete analysis of largest Factors impeding reassessment of effects of ETS on mortality n incomplete analysis of largest available data sets (CPS I and CPS II) n minimal research funding n publication bias against null findings n ideological and political agendas 53

Conclusions n n Estimates of the association of ETS with CHD and lung cancer Conclusions n n Estimates of the association of ETS with CHD and lung cancer appear to have been overstated. From the scientific and public health viewpoints, the focus should be on the very large and certain effects of active smoking rather than on the very small and highly uncertain effects of passive smoking. 54

View of Major ETS Reports NAS 1986 n Surgeon General 1986 n US EPA View of Major ETS Reports NAS 1986 n Surgeon General 1986 n US EPA 1992 n California EPA 1986 n IARC 2004 n California ARB 2005 n 55

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Additional slides—to be used during Lysenko session 57 Additional slides—to be used during Lysenko session 57

Silencing of Science: The Phenomenon and Its Impact on Passive Smoking Epidemiology Shelly Ungar Silencing of Science: The Phenomenon and Its Impact on Passive Smoking Epidemiology Shelly Ungar University of Toronto 58

Consider this… n n 1 in 3 Americans is convinced Darwinian evolution is “definitely Consider this… n n 1 in 3 Americans is convinced Darwinian evolution is “definitely false” 1 in 7 is convinced it’s true 59

George Bush on Intelligent Design n “Teach the debate” n Bumper sticker: • “God George Bush on Intelligent Design n “Teach the debate” n Bumper sticker: • “God Said It, I Believe It, and That Settles It. ” 60

Scientists as Secular Shamans n Deliver the goods • Invested with authority n But Scientists as Secular Shamans n Deliver the goods • Invested with authority n But scientific authority is precarious • No infallible source n Ideally open to debate and revision • Internal disinterested debate n BUT… 61

Vulnerable to “agenda science” n Partisans • Not disinterested, or truth-seeking n unreasoned allegiance Vulnerable to “agenda science” n Partisans • Not disinterested, or truth-seeking n unreasoned allegiance to belief or cause or $ • aim to conscript science to own ends n use of a wide range of tactics • Publication bias n Selective disclosure • silencing 62

Silencing n n efforts to prevent the making of specific scientific claims in arenas Silencing n n efforts to prevent the making of specific scientific claims in arenas in which these claims are typically reported. Range from gagging to publication bias • Can morph into fraud n (Note too: not all claims of silencing are valid) 63

State Silencing n USSR n n Denmark n n Lomborg, The Skeptical Environmentalist US State Silencing n USSR n n Denmark n n Lomborg, The Skeptical Environmentalist US n n n Lysenkoism Climate Scientists Reproductive issues Canada n Climate Scientists 64

Corporate Silencing n Pharmaceutical industry Vioxx n Paxil n n Food corporations n aspartame Corporate Silencing n Pharmaceutical industry Vioxx n Paxil n n Food corporations n aspartame 65

Silencing by scientists n Lomborg, n n The Skeptical Environmentalist Climate Scientists n skeptics Silencing by scientists n Lomborg, n n The Skeptical Environmentalist Climate Scientists n skeptics n AIDS research (? ) n Tobacco research 66

Silencing by advocates n Environmentalists Climate change n Lomborg n n Health authorities (& Silencing by advocates n Environmentalists Climate change n Lomborg n n Health authorities (& laypersons) n Second-hand smoke 67

Enstrom, J. , & Kabat, G. Environmental tobacco smoke and tobacco related mortality in Enstrom, J. , & Kabat, G. Environmental tobacco smoke and tobacco related mortality in a prospective study of Californians, 1960 -98. British Medical Journal, 2003: 326, 1057 -1100. 68

Silencing skirmishes start BMJ turns tabloid: Thanks for turning back the clock on public Silencing skirmishes start BMJ turns tabloid: Thanks for turning back the clock on public health decades or more. We don’t need this kind of negligence from what used to be a professional medical publication. I seriously wonder who got paid off at BMJ to publish this utter garbage. Dale Jackman Seriously Annoyed I won’t dignify this rag with my credentials 69

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 Level of Expertise Evaluation of Publication Decision Expert Knowledgeable Layperson* Total Positive 5 Level of Expertise Evaluation of Publication Decision Expert Knowledgeable Layperson* Total Positive 5 12 11 28 Negative 20 44 19 83 Neutral 6 12 5 23 Total 31 68 35 134 * Includes those who provide no credentials 71

“Irresponsible Journalism” I was genuinely shocked to see this splashed across the front page “Irresponsible Journalism” I was genuinely shocked to see this splashed across the front page of this week’s BMJ, tabloid-style. An industrysponsored, methodologically flawed study with inconclusive results but with major potential public health implications especially once the press get hold of it. “Passive smoking may not kill. ” How much would the tobacco industry pay for such a soundbite in a major peerreviewed journal? Since when did I pay my subscription so that you could do their dirty work for them? 72

Level of Expertise Target of Negative Evaluations Expert (N=20) Level of Expertise Target of Negative Evaluations Expert (N=20) "Knowle Laypers dgeable" on (n=44) (n=19) Article per se 4 10 5 Flaw in the article 15 13 5 Tobacco/Autho 10 rs 22 13 Journal/Editor 1 24 11 Media/Public 3 21 8 Total 33 90 42 73

“From hero to pariah in one easy jump” Richard Smith BMJ Editor May 18, “From hero to pariah in one easy jump” Richard Smith BMJ Editor May 18, 2003 “We long ago decided that we would not have a blanket policy of refusing to publish research funded by the tobacco industry, as some journals have done. Our argument was that a ban would be antiscience, systematically distorting the scientific record. . Once the research has been done it should be published, and if it passes our peer review process it can be published in the BMJ. . I find it distrubing that so many people and organisatons -including the BMA, our owners-- refer to the flaws in the study without specifying what they are. . We judged this paper to be a useful contribution to an important debate. We may be wrong as we are with many papers. That’s science. But I remain convinced that it would have been wrong to reject the paper simply because it was funded by the tobacco industry. ” 74

Fear of Media Coverage “The study has already been widely cited by the lay Fear of Media Coverage “The study has already been widely cited by the lay press and is being used by the tobacco industry to block public health efforts to enact smokefree policies. ” 75

& Use by Tobacco Industry “As the industry is already demonstrating, this ‘result’ will & Use by Tobacco Industry “As the industry is already demonstrating, this ‘result’ will be pumped throughout the globe in industry PR, in the mouths of its front organizations, as ‘controversy’ over passive smoking. ” 76

Multi-pronged search of international newspaper coverage n Not even a “blip” of coverage • Multi-pronged search of international newspaper coverage n Not even a “blip” of coverage • Silencing by media About 60 articles worldwide n Minor papers n • Gwinnett Daily Post, Georgia. 77

Interactive research Email: “I can tell you that I have closely followed the effects Interactive research Email: “I can tell you that I have closely followed the effects of this article in the Dutch press. It's incredible how little newspapers have reported on this study. Only two Dutch newspapers have published it… this E&K study looks to be self-censored by the public Dutch media” (Maessen, Forces). 78

Not “balanced” coverage “A new study downplaying the effects of secondhand smoke on the Not “balanced” coverage “A new study downplaying the effects of secondhand smoke on the health of smokers’ spouses is being condemned even before it has appeared in print…” [It’s a] “pretty crappy piece of science” (California) Sacramento Bee 79

4 articles defend publication “To believe that second-hand smoke may not be very harmful 4 articles defend publication “To believe that second-hand smoke may not be very harmful has become a thought-crime almost akin to Holocaust denial. Those who dare express doubts must expect hysterical abuse from every point of the PC compass. ” (Toronto) National Post 80

Misuse of the Study? n Tobacco companies n n Not trumpet it heavily Smoker’s Misuse of the Study? n Tobacco companies n n Not trumpet it heavily Smoker’s rights groups n Enshrine as proof that threat is exaggerated 81

The Washington Times Ban the bans By Jay Ambrose Published March 26, 2006 …nonsmokers The Washington Times Ban the bans By Jay Ambrose Published March 26, 2006 …nonsmokers with easily offended nostrils and who are probably mostly ignorant of the most exhaustive research project ever completed on secondhand smoke. The study involved 118, 000 Californians. It followed their health history for four decades, and was conducted by highly respected scientists and published in the highly respected British Medical Journal. Here is what it said: There is no evidence of a "causal relationship" between "exposure" to tobacco smoke in the air around you and death. A "small effect" cannot be ruled out, the scientists reported, but that's it. Period. 82

Misunderstand science n No single study definitive • Especially when dealing with “small risks” Misunderstand science n No single study definitive • Especially when dealing with “small risks” research • Same overestimation of ‘outlier’ climate studies 83

Mismeasure of science n Not covered by media because… • Changes nothing n “regime Mismeasure of science n Not covered by media because… • Changes nothing n “regime of truth” surrounding smoking • Cannot be intelligibly questioned • Not about dueling scientists 84

Smokers are deviants of choice n Secondhand smoke created a moral panic • Smokers Smokers are deviants of choice n Secondhand smoke created a moral panic • Smokers as folk devils 85

Google Alert Secondhand… n Study Finds DNA Risk From Secondhand Casino Smoke n Secondhand Google Alert Secondhand… n Study Finds DNA Risk From Secondhand Casino Smoke n Secondhand smoke can affect pets' health n Exposing infants to secondhand smoke could contribute to cancer risks later in life n STAT Medical News: Secondhand Smoke Detectable in Babies n Cigarette smoke, even secondhand smoke, can weaken bones n Stroke Prevention…avoid exposure to secondhand smoke n Secondhand smoke linked to acting out [by children] n Small children exposed to secondhand smoke are more likely to develop ear infections, upper respiratory infections and asthma. n A link exists between secondhand smoke and type 2 diabetes. 86

Eurobarometer poll, 2005 n n 95% said smoking in the presence of a pregnant Eurobarometer poll, 2005 n n 95% said smoking in the presence of a pregnant woman could harm the baby 75% said they would not smoke in the presence of a child 75% said they were aware smoke could be dangerous for non-smokers 53% of people aged 15 to 24 were worried about second-hand smoking 87

Eurobarometer poll, 2005 n SUPPORT FOR BANS • Office/indoor workplace: 86% • Any indoor Eurobarometer poll, 2005 n SUPPORT FOR BANS • Office/indoor workplace: 86% • Any indoor public space: 84% • Restaurants: 77% • Bars or pubs: 61% 88

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Ministers accused of exaggerating risks of passive smoking By JANE MERRICK, Daily Mail 08: Ministers accused of exaggerating risks of passive smoking By JANE MERRICK, Daily Mail 08: 50 am 7 th June 2006 Peers said the ban was not justified by the relatively low risks of passive smoking Ministers exaggerated the risk of passive smoking to force through a blanket ban on lighting up in public, a report has claimed. The Government ignored scientific research on the effects of secondhand smoke in enclosed public places, according to the report from the Lords economic affairs committee. It says that the smoking ban, which comes into effect in all pubs, clubs and workplaces next summer, was a political decision by Labour's nanny state tendency - and not justified by the relatively low risk of passive smoking. 90

pariah. We long ago decided that we would not have a blanket policy of pariah. We long ago decided that we would not have a blanket policy of refusing to publish research funded by the tobacco industry, as some journals have done. (1) Our argument was that a ban would be antiscience, systematically distorting the scientific record. I would try to dissuade anybody from accepting tobacco company money, and I resigned from Nottingham because it did so. Isn't it thus hypocritical to publish research funded by the industry? To my mind it isn't. With some difficulty, I'm setting the ethic that all science should be published above the ethic that you shouldn't take money from the tobacco industry. Once the research has been done it should be published, and if it passes our peer review process it can be published in the BMJ. Our way of making decision on research papers is first to ask if we are interested in the question. We are certainly interested in the question of whether passive soming kills, and it's clear to us that the question has not been definitively answered. Indeed, it may well never be answered definitively. It's a hard question, and our methods are inadequate. We then peer review the study. Two top epidemiologists-- including George Davey-Smith--reviewed the paper. Then the paper went to our hanging committee, which always includes a statistician as well as practising doctors and some of us. Everybody reads every word of every paper. We asked for extensive changes to the paper, and the paper we published was different from the paper submitted--which is usually the case. We are planning to post on our website all the comments of the reviewers, our statistician, and the hanging committee. I hope that they will be up soon after the weekend. Of course the paper has flaws --all papers do-- but it also has considerable strengths-91 long follow up, large sample size, and more complete follow up than many such studies.

Trofim Denisovich Lysenko & Pseudoscience in the Soviet Union (1927 -1962) 92 Trofim Denisovich Lysenko & Pseudoscience in the Soviet Union (1927 -1962) 92

Trofim Denisovich Lysenko was a self-promoting Soviet agronomist who invented a procedure called vernalization, Trofim Denisovich Lysenko was a self-promoting Soviet agronomist who invented a procedure called vernalization, which he claimed would lead to dramatically increased crop yields. Lysenko's claims violated Mendelian genetics and never faced a rigorous test. However, Joseph Stalin was impressed because Lysenko promised improved agricultural output unbounded by hereditary constraints. Lysenko was portrayed as a genius and rose rapidly in power and prestige with the backing of Stalin and the media. He was especially skillful at denouncing geneticists who disagreed with him as enemies of the state. The result was purges that sent hundreds of dissenting Soviet scientists to the gulags or killed. 93

Lysenko and his theories dominated Soviet biology for over thirty years. However, vernalization never Lysenko and his theories dominated Soviet biology for over thirty years. However, vernalization never increased crop yields and there were two major famines that killed millions. Current Russian biology still has not entirely recovered from the Lysenko era. This episode dramatizes the dangers of political ideology influencing science and of uncritical media promoting false concepts. A crude analogy can be made with certain aspects of tobacco epidemiology. With the goal of reducing smoking, activists exaggerate the dangers of passive smoking and attack scientists want to do objective work in this area. In this climate attention is diverted from the real dangers of active smoking and from a complete understanding of lung cancer etiology. And the lung cancer epidemic continues. 94

Statement of Major Points of Symposium 1) all epidemiologic findings must be evaluated in Statement of Major Points of Symposium 1) all epidemiologic findings must be evaluated in a fair and consistent manner in order to obtain an accurate assessment of the mortality risks of active and passive smoking 2) epidemiologic findings must be judged on their merits and not on extraneous factors 3) additional epidemiologic research in this area needs to be conducted free of partisanship. 95