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the Epa Review Draft: Health Effects of Passive Smoking: Assessment of Lung Cancer in Adults and Respiratory Disorders in Children

Date: 28 Sep 1990
Length: 115 pages
87654175-87654289
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Adlkofer, F.
Ahlborn, W.
Anderson
Anderson, L.
Aviado
Baker, R.R.
Balter, N.J.
Bayer, C.
Berglund, B.
Berwick, M.
Biber, A.
Bibi, A.
Bieva, C.
Binder, R.
Black, M.
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Eatough, D.
Ecobichon, D.J.
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Good, B.
Goren
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Handler, J.
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Holma, B.
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Kabat, G.
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Martin, C.
Matsushima, T.
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Mccullough, J.
Melia, Rjw
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Mitchell, E.
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Mueller, B.
Mumford
Mumford, J.
Muramatsu, M.
Nordvall, S.L.
Nystrom, C.
Ogden, M.
Oldaker, G.
Orssaud, G.
Osborne, J.S.
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Ownby, D.
Perry, R.
Platt, S.
Pope, C.
Proctor, C.
Pron, G.
Quackenboss, J.J.
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Reynolds, G.L.
Robertson, G.
Rubin, D.
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Rylander, R.
Salzman, M.
Sandler, D.
Schenker
Scherer, G.
Schilling, Rsf
Schwartz, S.
Sega, K.
Sherman, C.
Shimizu
Shore, D.
Sidney
Sidney, S.
Sobue
Sorsa, M.
Speizer, F.
Spengler, J.
Sterling, T.
Strachan, D.
Svensson
Terry, R.M.
Tewes
Thompson, C.
Traynor, G.
Trichopoulos
Uberla, K.
Varela, L.R.
Viren, J.
Wald
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Watkins, C.J.
Watts
Watts, R.R.
Weber, A.
Whichelow, M.
Winding, O.
Witorsch, P.
Witorsch, R.
Woodland, C.J.
Wu, J.M.
Wynder, E.
Yocom, J.
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Page 1: pur21e00 Log in for more options!
THE EPA REVIEW DRAFT: HEALTH EFFECTS OF PASSIVE SMOKING: ASSESSMENT OF LUNG CANCER IN ADULTS AND RESPIRATORY DISORDERS IN CHILDREN COMMENTS OF PHILIP MORRIS INC. SEPTEMBER 28, 1990
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TABLE OF CONTENTS EXECUTIVE SZJMMARY . . . . . . . . . . . . . . . . . . . . . . 1 The "Weight of the Evidence" Criteria . . . . . . . . . . . . 5 Problems in Analysis . . . . . . . . . . . . . . . . . . 5 The Weight of the Evidence . . . . . . . . . . . . . . . 12 Studies Not Considered in the Draft _ . . . . . . . . . 22 References . . . . . . . . . . . . . . . . . . . . 2 4 Exposure Assessment . . . . . . . . . . . . . . . . . . . . • 27 Animal Studies . . . . . . . . . . . . . . . . . . . . . . . 34 Re f erences . . . . . . . . . . . . . . . . . . . . . . . 3 6 Short Term Tests . . . . . . . . . . . . . . . . . . . . . . 37 Re f erences . . . . . . . . . . . . . . . . . . . . . . . 4 0 Epidemiological Studies on ETS and Lung Cancer ....... 41 Appropriateness of Meta-analysis . . . . . . . . . . . . 41 Published Criticisms of the Hirayama Study . . . . . . . 46 References . . . . . . . . . . . . . . . . . . . . 51 Published Criticisms of the Trichopoulos et. al. Study . 53 Re f erences . . . . . . . . . . . . . . . . . . . . 5 7 Comments on the Varela Dissertation . . . . . . . . . . 58 Other Epidemiological Studies . . . . . . . . . . . . . 63 . m ~ (i) A M+
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Studies from the U. S . . . . . . . . . . . . . . . . . . 66 Re f erences . . . . . . . . . . . . . . . . . . . . 7 0 Studies of the Workplace . . . . . . . . . . . . . . . . 71 Re f erences . . . . . . . . . . . . . . . . . . . . 7 4 Childrens Respiratory Disease . . . . . . . . . . . . . . . . 75 Overview . . . . . . . . . . . . . . . . . . . . . . . . 7 5 Synopsis of Negative Studies . . . . . . . . . . . . . . 75 Methodological Issues . . . . . . . . . . . . . . . . . 83 Confounding Factors . . . . . . . . . . . . . . . . . . 86 Other Reviews of the Literature . . . . . . . . . . . . . 96 Scientific Symposia on ETS in the 1980's. . . . . . . . . . . 99 References . . . . . . . . . . . . . . . . . . . . . . . 104 The Double Standard . . . . . . . . . . . . . . . . . . . . . 105 Studies Not Considered in the Review Draft ......... 108 Appendix I . . . . . . . . . . . . . . . . . . . . . . . . . 1-9 Appendix II . . . . . . . . . . . . . . . . . . . . . . . . . 1-12 (ii)
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EXECUTIVE SUMMARY We vigorously maintain that the Review Draft's classification of ETS as a Group A carcinogen is in error because it is not supported by the scientific evidence. The determination is based solely on an uncritical acceptance of several human epidemiological studies. Data from animal studies and short-term tests for genotoxicity in body fluids of nonsmokers do not support the epidemiologic estimates and are neither mentioned nor discussed in the Draft. Moreover, the exposure assessment in the Review Draft is inadequate; many studies showing that nonsmoker exposure to ETS is minimal are not referenced or discussed. In addition, the Review Draft does not follow EPA's own guidelines for the evaluation of epidemiological studies (EPA 1986). For example, the notion of the strength of association is not applied to the epidemiologic studies on ETS. The cumulative increased risk estimate of 1.4 reported in the Review Draft is, by that very criterion, considered "weak" and explainable by confounding factors. Individual weaknesses and published criticisms of the various epidemiological studies are not mentioned or assessed in the Draft. For example, the fact that no actual exposure data were collected in anv of the epidemiologic studies was not addressed by the authors of the Draft.
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The notion of "statistical significance" for the individual epidemiologic studies was essentially ignored. Nineteen of the 24 studies mentioned in the Draft do not achieve statistical significance. This means that the data in those studies do not support rejection of the null hypothesis, i.e. there is no association between ETS and lung cancer in nonsmokers. The-Draft further ignores signif-icant differences in the study designs, populations and protocols among the epidemiologic studies. Despite this, a meta-analysis is performed on the studies. The largest study on the issue was omitted from this analysis, while the most heavily criticized studies were included. The Draft did not address any of those published criticisms. Similarly, other published meta-analyses which do not agree with the Review Draft are not discussed. The Review Draft addresses only one type of possible systematic bias in the epidemiologic studies; other sources of bias (e.g., exposure misclassification) and confounders (heredity, diet, use of cooking fuels, occupation, lifestyle), all of which are documented in the literature, are not mentioned. The Draft does not address studies which assess workplace exposures (they report no significant increased risks), and it incorrectly characterizes epidemiologic studies conducted in the - 2 -
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U.S. as representing a statistically significant increased risk for nonsmokers exposed to ETS. The conclusion in Chapter Five of the Review Draft that ETS exposure affects the respiratory health of children is also scientifically unjustified. Many studies reporting no statistically significant increased risks between parental smoking and children's respiratory health are not addressed or discussed in the Draft; and equally important, many documented confounders are Mft considered. Of particular interest is the inconsistency displayed by the Draft in the application of EPA's own guidelines for risk assessment. Recently, a draft risk assessment of electromagnetic fields (EMF) was released by the EPA. That risk assessment examined 44 epidemiological studies and AU the available animal studies and short-term tests on the subject. It reported that the relative risks from the various studies averaged 3.0, and the authors concluded that those reported risks were not compelling enough to establish EMF as a GrouD B carcinogen. The ETS Review Draft, on the other hand, looked at only 2g studies which averaged h= the increase in risks (1.41) noted in .itudies on EliF, and failed to consider pertinent animal and exposure data. The Draft nevertheless concluded that ETS j& aGrouv A "(known human) carcinogen!" - 3 -
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We do not believe that the Review Draft presents an objective or balanced analysis of the issue, and we urge rejection of its recommendation to classify ETS as a Group A carcinogen. 4
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EPA'S "WEIGHT OF THE EVIDENCE" CRITERIA PROBLEMS IN ANALYSIS COMUNTARY ON: The EPA's Review Draft `Health Effects of Passive Smoking: Assessment of Iung Cancer in Adults and Respiratory Disorders in Children" The Review Draft's recommendation to classify ETS as a Group A carcinogen is based upon a "weight of the evidence" argument which does not comply either with accepted scientific procedures or with the EPA's own guidelines for risk assessments. The analysis presented in the Review Draft does not satisfy the EPA's own "weight of the evidence" procedure for determining human carcinogenicity. Those guidelines are as follows (EPA, 1986): The overall scheme for categorization of the weight of evidence of carcinogenicity of a chemical for humans uses a three-step process. (1) The weight of evidence in human studies or animal studies is summarized; (2) these lines of information are combined to yield a tentative assignment to a category and (3) all relevant supportive information is evaluated to see if the designation of the overall weight of evidence needs to be modified. Relevant factors to be included along with the tumor information from human and animal studies include structure-activity relationships; short- term test findings; results of appropriate physiological, biochemical, and toxicological observations; and comparative metabolism and 5
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pharmacokinetic studies. The nature of these findings may cause one to adjust the overall categorization of the weight of evidence. (Fed. Reg., 1986) A. The Review Draft's analysis for the classification of ETS as a Group A carcinogen is based on the (uncritical) acceptance of human epidemiological studies along. B. The data from animal inhalation studies on ETS (sidestream smoke) are not considered: (Two published studies) 1. One sub-chronic (90-day) inhalation study (Adlkofer, 1988) reported no significant histopathological changes in the lungs of exposed animals; 2. A lifetime animal inhalation study using sidestream smoke reported no marked increase in tumor incidence among exposed animals (Haley, 1986, 1987, 1988). 3. None of the constituents in sidestream smoke identified as "potentially carcinogenic" has induced pulmonary cancer in animals under experimental conditions. - 6 -
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C. Studies reporting results from short-term (in vitro) tests of ETS are not addressed in the Review Draft. A number of recent studies have reported no mutagenic activity in the body fluids of nonsmokers exposed to ETS. (Hoepfner, 1987; Scherer, 1987; Sorsa, 1989; Mohtashamipur, 1987; Martin, 1989, Scherer, 1990) D. Exposure monitoring studies for ETS constituents published after 1985 were not considered in the Review Draft. A number of recent studies employing state-of-the-art sampling equipment and procedures have concluded that nonsmoker exposure to ETS is minimal and, in some instances, orders of magnitude lower than levels predicted in the dose model developed in the Review Draft. (Appendix) E. The Review Draft addresses only one form of potential bias in the human epidemiological studies on ETS. Other potential biases are not discussed and a number of substantiated confounding factors are ignored. 1. A commonly applied criterion for the adequacy of an epidemiologic association, namely, strenq.th of association, is not mentioned in the Review Draft. 9 CA H m 7 - ~i1

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