Subject: Draft 16 of Spitzer ETS StudyAuthor: Mary E. Ward
PRIVILEGED AND CONFIDENTIAL
RJR Interoffice Memorandum
To: George 0, Newton Esq.
Samuel 0. Witt, III, Esq
From: Mary E. Ward
Subject: Draft 16 of Spitzer ETS Study
Date: March 15, 1989
George recently sent me a copy of the report of the Interuniversity Working Group on Passive Smoking labelled "Draft 16." This draft is distressing in many respects. I fear that no amount of polishing or wordsmithing can make this report a helpful document; what is worse, this document can be very damaging when we are confronted with it in legislative or litigation context.
The three areas of greatest concern to me are 1) ETS and lung cancer; 2) ETS and workplace respiratory infections; and 3) commingling ETS exposure and maternal smoking in the discussion of "passive smoking" effects in infants and children.
ETS AND LUNG CANCER
Despite numerous disclaimers about the quality of the epidemiological studies and their criticism of meta-analytic techniques, the authors' black-letter law on this subject is stated: "The weight of evidence is compatible with a positive association between residential exposure to environmental tobacco smoke (primarily from spousal smoking) and the risk of lung cancer." (p.11) What is worse than their failure to recognize that the epi studies are inconclusive on this subject ("The preponderance of positive studies is consistent with a causal relationship between exposure to ETS and lung cancer (P-13)). is the bootstrapping extrapolation from active smoking. "Nevertheless a cause-effect relationship between ETS and lung cancer is biologically plausible, since there 13 strong evidence in favour of active smoking as a cause of lung cancer' (p.13)
I believe that we have consistently maintained that there is no biological plausibility to extrapolating between exposure to ETS and active smoking. This report will play Into the hands of those (such as Darby-Pike) who claim a relative risk of lung cancer based on ETS exposure from as little as a tenth of a cigarette equivalent per day in the neighborhood of 1.5.
1. "Sidestream smoke contains most of the carcinogens found in mainstream smoke . . . . It is plausible, therefore, That sidestream smoke will be carcinogenic." (p.16)
2. "The carcinogenicity of mainstream smoke has been demonstrated in rodents .... (p.16)
3. "A Parallel experiment with mainstream smoke produced fewer tumors, indicating the greater potency of sidestream smoke condensate in this assay." (p.17)
4. "Nevertheless, the presence in ETS of potent carcinogens, mutagens, co-carcinogens and tumor promotors, is consistent with M* the positive association between residential exposure arid the risk of lung cancer . . . . " (p.17)
In light of the above, an not particularly comforted by the authors' comments on p.38-51 regarding some of the defects they found lit the studies.
ETS AND WORKPLACE RESPIRATORY DISORDERS
"The available evidence supports a relationship between exposure to environmental tobacco smoke in the workplace and public areas and respiratory infections and disorders." (p.18) This statement is deeply disturbing for two reasons; It is novel and it is fantasy. The Surgeon General himself had only the following to conclude on the subject: "Healthy adults exposed to ETS say have small changes on pulmonary function testing, but are unlikely to experience clinically significant deficits in pulmonary function as a result of exposure to ETS alone." (p.107, 1986 report) Elsewhere, the S. G.'s report states that chronic lung disease would not be expected in adults based solely on ETS exposure (p.62, 1986 report).
The evidence marshaled for the authors' conclusion is ridiculous. They cite the Seventh-Day Adventists study (the source of Repace's "data" for his phenomenonological (sic) model for predicting lung cancer deaths) which, to my knowledge, has not heretofore been used to show an association between COPD and ETS exposure The odds ratios from this one study are so low (1.07 for household exposure and 1.11 for workplace exposure) that they do not support any conclusion of this nature. They then cite two studies purporting to show lung function deficits. I do not have these references, but one is obviously the White and Proeb study and the other shows deficits in the same range, which nobody believes are clinically significant even if they were good studies.
"There is strong evidence for in association between ox exposure to ETS in both children _and adults_ and many chronic and acute respiratory illnesses." (p.20, emphasis added) I don't know where the evidence is for this assertion as it relates to adults because the citations in text are specific only to children. Let me emphasize again that the most ardent of our critics have not claimed an association between adult ETS exposure and either chronic or acute lung disease.
DEFINING "PASSIVE SMOKING" TO INCLUDE MATERNAL SMOKING EFFECTS ON FETUS
"We also define passive smoking, however, to include the exposure of fetus or an infant to tobacco smoke products and/or their metabolites from an actively or passively smoking mother." (p. 7-8) I believe that we have gone to a great deal of effort in the Prop 5 reproductive toxicant arena to
differentiate between ETS exposure and active smoking of the mother. That effort is entirely undermined by the authors' definition and the subsequent discussion on pages 29-30 of this report. Indeed, the discussion of hospitalization for respiratory illness (p. 19-20) and other discussion of respiratory effects as they involve children appear to be confounded by fetal effects from maternal smoking. I am aware that Tony Colucci vetted this group with an express purpose being to explain the difference between ETS exposure and the mother's active smoking, so I cannot believe the authors are unaware of this issue.
Other points from "perinatal effects" discussion:
1. "Potential confounders such as socioeconomic status , maternal height and weight were generally well accounted for." (p. 29-30) "Other confounders like socioeconomic status end diet were not taken into account in many of the above studies." (p.30) Confounders were either taken into account, or they weren't. Generally, it is my impression that confounders are often poorly accounted for, if at all.
2. "There is suggestive biologic evidence (to be reviewed in sections on toxicology) relating smoke exposure to teratogenesis and developmental defects, but _unfortunately_ no biologically plausible hypothesis has been presented that could link maternal smoking with the dozens of different defects . . . that have been catalogued in these studies." (p.36, emphasis added) It is difficult for me to understand why objective investigators would view this lack as unfortunate.
OTHER SHORTCOMINGS OF THIS REPORT
1. The title and references throughout to "passive smoking" and nonsmokers "passively smoking." Nonsmokers are either exposed to varying concentrations of ETS or they're not; they don't "smoke" the air they breathe.
2. "A randomized controlled trial of the chronic health effects of passive smoking would be unethical, even it if were feasible." (p. 6) I don't know exactly what this means if it means that it is unethical to expose persons to ETS, it is nonsense.
3. "Environmental tobacco smoke is the smoke that _contaminates_ the air surrounding a smoker." (p.7, emphasis added)
4, In the discussion on page 20 of a study investigating differences in use of a prepaid health program between ETS exposed and nonexposed children, the point is made there were no differences in use of inpatient services, but that nonexposed children received more preventive services. The authors do not draw obvious conclusions regarding lack of association between ETS and childhood disease or the apparent socioeconomic effects of seeking preventive health care.
5. "Evidence strongly supports a relationship between ETS and asthma among children." (p. 24 and following discussion) Again, our authors go beyond even the S. G., who states at p. 56 of the 1986 report; "Epidemiologic studies of children have shown no consistent relationship between the report of a doctor's diagnosis of asthma and exposure to involuntary smoking." The S. G. was only willing to say that maternal smoking eight affect the severity of
asthma but would not say either that ETS induced asthma or increased the frequency or severity of asthmatic attacks.
6. "There is an association between ETS exposure and symptoms of eye and upper airway irritation. (p.27) I quote the black-letter law. You have to read the following losing text learn they are talking about acute exposures rather than concentrations seen in most real-life situations.
7. "Although animal studies on the toxic effects of ETS are sparse at the present, the chemical and biologic properties of sidestream smoke and its components, and its similarity to mainstream smoke, make the observed respiratory disorders in passive smokers reviewed in the preceding sections unsurprising." (p.29) Here we see bootstrapping extrapolation applied to respiratory disorders ether than lung cancer.
8. In the concluding section of the report, the authors disclaim any intent to advocate policy. Yet they state: "[O]ur conclusions on evidence have been presented in a manner that permits sensitive policy makers at any level to invoke the information when formulating positions affecting the health and welfare of the public." In light of most of their conclusions, I am not comforted
I realize that I have not been commenting on the final draft and that Jim suggested waiting until a final draft is received before circulating it for comment. I suppose I am pessimistic that all of my concerns will disappear in that final draft. At present, I would not recommend funding any publication of this report. John Viren reported to me after his visit to this group that he did not believe there was any interest within the group for seeking publication. I hope he is correct.
When we do receive the final report, I recommend that Tony Colucci or some other consultant subject it to a critical review so that we know whether the company is justified is placing any reliance on its conclusions.
cc: W. W. Juchatz