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Dissent (A) Environmental tobacco smoke: A public health conspiracy? A dissenting view
J Pergamon
08954356(93)EOOO9-Z
Clin Epidemical Vol. 47, No. 4, pp. 335-337, 1994
Elsevier Science Ltd. Printed in GreatBritain 08954356194 $7.00 + 0.00
Dissent (A) ENVIRONMENTAL TOBACCO SMOKE: A PUBLIC HEALTH CONSPIRACY? A DISSENTING VIEW WILLIAM FARLAND, STEVEN BAYARD
and JENNIFER JINOT
U.S. EnvironmentalProtection Agency, Washington, DC 20460, U.S.A. (Received
10 August
In the preceding article, Gori has chosen to present the case for health risks of environmental tobacco smoke (ETS) as speculative and unscientific, as driven by well-intentioned policy, and as yet another indication of unethical behavior by scientists [l]. As three of the scientists responsible for the centrally discussed EPA report on ETS [2], we take great exception to this characterization and, in brief fashion, provide an alternative and dissenting view. Our position on the respiratory health effects of exposure to ETS is explicitly and thoroughly discussed in the 530-page EPA report, which is strictly an assessment of the scientific evidence and contains no regulatory policy. The EPA report was extensively reviewed and endorsed by independent scientific experts. A summary of the scientific evidence and a detailed response to the specific scientific issues raised by Gori are presented in the paper by Jinot and Bayard which also appears in this issue [3]. In addition, we think it is important that readers considering Gori’s views of the “speculative” nature of health risk assessments keep several facts in mind: Risk assessment requires scien@c judgment and inference in the absence of deJinitive scientiJic evidence. This position was clearly articulated
by the National Academy of Sciences (NAS) in The views expressed in this paper are those of the author(s) and do not necessarily reflect the views or policies of the U.S. Environmental Protection Agency. The U.S. Government has the right to retain a nonexclusive royaltyfree license in and to any copyright covering this article.
1993)
1983 when they developed their analysis of risk assessment [4]. In brief, the NAS report provided a framework for a “weight of the evidence” approach to risk assessment, and indicated the importance of using informed judgment and scientific inference to reach conclusions regarding potential risks rather than waiting for irrefutable evidence of toxicity in exposed humans. This methodology often involves relying on structure-activity relationships, ancillary data from laboratory studies, and well-controlled, high-dose studies on laboratory animals. While this approach carries some uncertainty, confidence in hazard and risk predictions increases as both direct and indirect data from humans become available for assessment. Few chemicals or environmental pollutants have a data base as extensive as that of ETS for the assessment of cancer and noncancer eflects.
The information base for ETS is extraordinarily large and contains substantial evidence from actual human studies, including evidence by analogy with active smoking and direct evidence of ETS effects. Furthermore, in contrast to epidemiology studies of high occupational, therapeutic, or accidental exposures used in the assessment of many other environmental agents, the direct human evidence of ETS effects is from exposure to typical environmental levels. For example, the EPA’s assessment of childhood respiratory effects analyzes over 100 studies, most of which consider the effects of ETS exposures from parental smoking, certainly an 335
336
WILLIAMFARLAND et al.
“environmental” exposure to ETS. Overall, these studies demonstrate statistically significant and biologically plausible effects, and clear evidence of respiratory impairment. These effects occur at the same exposure levels that Gori characterizes as “very low” and questionable with regard to posing “conceivable risks.” Yet, as the respiratory effects in children illustrate, these exposure levels are able to elicit not just chronic effects from long-term exposure, but also acute effects from shorter periods of exposure. A “weight-of-evidence” approach to the assessment of the respiratory effects of ETS relies on a detailed review of individual studies but, more importantly, on a reasoned evaluation of the total body of evidence. The EPA’s characteriz-
ation of the lung cancer hazard of ETS is based on the well-documented risks of lung cancer from active smoking plus the similarities between “active” and “passive” smoke plus results from laboratory studies plus evidence from 30 epidemiology studies of ETS and lung cancer in never-smokers. In our examination of these epidemiology studies, standard statistical tests of significance and tests for trend were performed, high exposure groups were considered, and a weighted combining of tests, or “metaanalysis,” was presented. These analyses provided a consistent picture of increased lung cancer risks in never-smokers exposed to ETS. For the biostatistician or epidemiologist evaluating a large data base, this multi-test, multilevel analysis would be better characterized as rigorous than as “tortuous and implausible” as Gori alleges. The conclusions on the noncancer respiratory effects of ETS exposure are similarly based on an assessment of the total weight of evidence, including mechanistic information and data from over 100 epidemiology studies. The final report is a result of Review and Consensus, not Conspiracy.
The methodologies and conclusions in the EPA report were subjected to extensive peer review and received strong consensus support from a committee of 18 independent scientists [5]. Gori’s essay would have us believe that this support was merely based on a lack of scientific credibility in our reviewers who would sacrifice, to a person, their own integrity for the sake of advancing public health policy, or maintaining funding for their work. We contend that that truly represents an example of tortuous and implausible thinking. Having challenged the science behind any concern for the respiratory effects of ETS, Gori
further suggests such a conspiracy, for which he presents no evidence. He claims it is a case of policy driving science and accuses the general scientific community not only of allowing it to occur but of supporting it. He suggests that this is not unusual, and names several other “examples,” for which he again presents no evidence. His argument is that these cases represent deception on the part of policy makers who knowingly influence or use science to support their decisions when no support exists, in the name of “paternalistic prerogatives.” Despite the fact that the EPA has no regulatory authority over ETS and this scientific report is purely part of the EPA’s ongoing assessment of major indoor air pollutants, Gori tries to connect ETS to these other “examples,” without separating the scientific risk assessments from the final agency actions. Is he worried about the scientific basis for public health concern regarding radon, lead, dioxins, and asbestos, or is he disturbed about the final regulatory outcomes? He must know, based on his involvement in the regulatory field, that the policy making, or risk management, decisions are driven by much more than the science. While it is convenient to argue the science behind regulatory decisions to control exposure to such agents, risk management requires consideration of social, political, technological, and in some cases, economic issues. To challenge risk management decisions by federal, state, or local officials simply on the basis of the available science is naive. To suggest that these are a product of a broad-based conspiracy of unethical public health scientists is absurd. Gori drives this point further to suggest that we and others in our field are guilty of scientific misconduct, perhaps, he suggests, even “hardcore fraud.” Since the respiratory health effects of ETS have been recognized by both government-the U.S. Surgeon General [6], the National Institute for Occupational Safety and Heath [7], and the National Cancer Institute [8]-and nongovernment scientists-the National Research Council of the National Academy of Sciences [9] and an academic working group headed by one of the editors of this journal [lo], the numbers of scientists involved in this alleged conspiracy to defraud the “trusting public” must be large. In fact, this conspiracy must extend even beyond our borders, since many of the studies showing adverse effects are from other countries. Thus, Gori portrays a Kafkaesque world in which science is
Dissent (A): Environmental
manipulated by a global conspiracy of public health institutions, civil servants, academicians, and other researchers, while the critics of this manipulation face the “wrath of all-powerful funding agencies.” To defend ourselves against Gori’s accusations of fraud becomes impossible under Gori’s depiction, because he includes as co-conspirators everyone who agrees with us. We can only, as we do above, expose his argument as preposterous, and wonder whether, as a consultant who has long received “occasional support from tobacco interests,” Gori can really be objective on this issue. We believe that the EPA analysis of ETS belies Gori’s conclusion of misuse of science. The EPA report (which took 4 years to complete) intensively assesses the evidence on the respiratory effects of ETS. It contains no evaluation of cardiovascular effects or other potential health risks of ETS exposure and, thus, may in fact understate the total public health impact from ETS. The assessment was developed through a deliberate, extensive, and open process of presentation and scientific review. Its conclusions are based on the weight of all the evidence and are widely endorsed by independent scientific experts and organizations. Gori, in his attempt to discredit the report, must resort to innuendo and unsubstantiated accusations of a broad-based conspiracy. We believe the evidence and the report speak for themselves.
Tobacco Smoke
33-l REFERENCES
1.
2.
3.
4.
5.
6.
I.
8.
9.
10.
Gori GB. Science, policy, and ethics: the case of environmental tobacco smoke. J Clin Epidemiol 1994; 47: 325-334. U.S. Environmental Protection Agency. Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders. Office of Research and Development, Office of Air and Radiation, Washington, DC; 1992: EPA/600/6-90/006F. Jinot J, Bayard S. Respiratory health effects of passive smoking: EPA’s weight-of-evidence analysis. J Clin Epidemiol 1994; 47: 339-349. National Academy of Sciences (NAS). Risk Assessment in the Federal Government:Managing tbe Process. Washington, DC: National Academy Press; 1983. Science Advisory Board. An SAB report: review of draft passive smoking health effects document, 1992: EPA-SAB-IAQC-93-003. U.S. Department of Health and Human Services. The health consequences of involuntary smoking. A report of the Surgeon General. U.S. DHHS, Public Health Service, Office of the Assistant Secretary for Health, Office of Smoking and Health, Washington, DC; 1986: DHHS Pub. No. (PHS) 87-8398. National Institute for Occupational Safety and Health. Environmental tobacco smoke in the workplace: lung cancer and other health effects. Current Intelligence Bulletin 54. Cincinnati, OH: U.S. Department of Health and Human Services, NIOSH; 1991. National Cancer Institute. Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders. Smoking and Tobacco Control. Monograph 4. Washington, DC: National Institutes of Health; 1993: NIH Publ. No. 93-3605. National Research Council. Environmental Tobacco Smoke: Measuring Exposures and Assessing Health Effects. Washington, DC: National Academy Press; 1986. Spitzer WO, Lawrence V, Dales R, Hill G, Archer MC, Clark P, Abenhaim L, Hardy J, Sampalis J, Pinfold SP, Morgan PP. Links between passive smoking and disease: a best evidence synthesis. A report of the working group on passive smoking. Clin Invest Med 1990; 13: 1742.
08954356(93)EOOO9-Z
Clin Epidemical Vol. 47, No. 4, pp. 335-337, 1994
Elsevier Science Ltd. Printed in GreatBritain 08954356194 $7.00 + 0.00
Dissent (A) ENVIRONMENTAL TOBACCO SMOKE: A PUBLIC HEALTH CONSPIRACY? A DISSENTING VIEW WILLIAM FARLAND, STEVEN BAYARD
and JENNIFER JINOT
U.S. EnvironmentalProtection Agency, Washington, DC 20460, U.S.A. (Received
10 August
In the preceding article, Gori has chosen to present the case for health risks of environmental tobacco smoke (ETS) as speculative and unscientific, as driven by well-intentioned policy, and as yet another indication of unethical behavior by scientists [l]. As three of the scientists responsible for the centrally discussed EPA report on ETS [2], we take great exception to this characterization and, in brief fashion, provide an alternative and dissenting view. Our position on the respiratory health effects of exposure to ETS is explicitly and thoroughly discussed in the 530-page EPA report, which is strictly an assessment of the scientific evidence and contains no regulatory policy. The EPA report was extensively reviewed and endorsed by independent scientific experts. A summary of the scientific evidence and a detailed response to the specific scientific issues raised by Gori are presented in the paper by Jinot and Bayard which also appears in this issue [3]. In addition, we think it is important that readers considering Gori’s views of the “speculative” nature of health risk assessments keep several facts in mind: Risk assessment requires scien@c judgment and inference in the absence of deJinitive scientiJic evidence. This position was clearly articulated
by the National Academy of Sciences (NAS) in The views expressed in this paper are those of the author(s) and do not necessarily reflect the views or policies of the U.S. Environmental Protection Agency. The U.S. Government has the right to retain a nonexclusive royaltyfree license in and to any copyright covering this article.
1993)
1983 when they developed their analysis of risk assessment [4]. In brief, the NAS report provided a framework for a “weight of the evidence” approach to risk assessment, and indicated the importance of using informed judgment and scientific inference to reach conclusions regarding potential risks rather than waiting for irrefutable evidence of toxicity in exposed humans. This methodology often involves relying on structure-activity relationships, ancillary data from laboratory studies, and well-controlled, high-dose studies on laboratory animals. While this approach carries some uncertainty, confidence in hazard and risk predictions increases as both direct and indirect data from humans become available for assessment. Few chemicals or environmental pollutants have a data base as extensive as that of ETS for the assessment of cancer and noncancer eflects.
The information base for ETS is extraordinarily large and contains substantial evidence from actual human studies, including evidence by analogy with active smoking and direct evidence of ETS effects. Furthermore, in contrast to epidemiology studies of high occupational, therapeutic, or accidental exposures used in the assessment of many other environmental agents, the direct human evidence of ETS effects is from exposure to typical environmental levels. For example, the EPA’s assessment of childhood respiratory effects analyzes over 100 studies, most of which consider the effects of ETS exposures from parental smoking, certainly an 335
336
WILLIAMFARLAND et al.
“environmental” exposure to ETS. Overall, these studies demonstrate statistically significant and biologically plausible effects, and clear evidence of respiratory impairment. These effects occur at the same exposure levels that Gori characterizes as “very low” and questionable with regard to posing “conceivable risks.” Yet, as the respiratory effects in children illustrate, these exposure levels are able to elicit not just chronic effects from long-term exposure, but also acute effects from shorter periods of exposure. A “weight-of-evidence” approach to the assessment of the respiratory effects of ETS relies on a detailed review of individual studies but, more importantly, on a reasoned evaluation of the total body of evidence. The EPA’s characteriz-
ation of the lung cancer hazard of ETS is based on the well-documented risks of lung cancer from active smoking plus the similarities between “active” and “passive” smoke plus results from laboratory studies plus evidence from 30 epidemiology studies of ETS and lung cancer in never-smokers. In our examination of these epidemiology studies, standard statistical tests of significance and tests for trend were performed, high exposure groups were considered, and a weighted combining of tests, or “metaanalysis,” was presented. These analyses provided a consistent picture of increased lung cancer risks in never-smokers exposed to ETS. For the biostatistician or epidemiologist evaluating a large data base, this multi-test, multilevel analysis would be better characterized as rigorous than as “tortuous and implausible” as Gori alleges. The conclusions on the noncancer respiratory effects of ETS exposure are similarly based on an assessment of the total weight of evidence, including mechanistic information and data from over 100 epidemiology studies. The final report is a result of Review and Consensus, not Conspiracy.
The methodologies and conclusions in the EPA report were subjected to extensive peer review and received strong consensus support from a committee of 18 independent scientists [5]. Gori’s essay would have us believe that this support was merely based on a lack of scientific credibility in our reviewers who would sacrifice, to a person, their own integrity for the sake of advancing public health policy, or maintaining funding for their work. We contend that that truly represents an example of tortuous and implausible thinking. Having challenged the science behind any concern for the respiratory effects of ETS, Gori
further suggests such a conspiracy, for which he presents no evidence. He claims it is a case of policy driving science and accuses the general scientific community not only of allowing it to occur but of supporting it. He suggests that this is not unusual, and names several other “examples,” for which he again presents no evidence. His argument is that these cases represent deception on the part of policy makers who knowingly influence or use science to support their decisions when no support exists, in the name of “paternalistic prerogatives.” Despite the fact that the EPA has no regulatory authority over ETS and this scientific report is purely part of the EPA’s ongoing assessment of major indoor air pollutants, Gori tries to connect ETS to these other “examples,” without separating the scientific risk assessments from the final agency actions. Is he worried about the scientific basis for public health concern regarding radon, lead, dioxins, and asbestos, or is he disturbed about the final regulatory outcomes? He must know, based on his involvement in the regulatory field, that the policy making, or risk management, decisions are driven by much more than the science. While it is convenient to argue the science behind regulatory decisions to control exposure to such agents, risk management requires consideration of social, political, technological, and in some cases, economic issues. To challenge risk management decisions by federal, state, or local officials simply on the basis of the available science is naive. To suggest that these are a product of a broad-based conspiracy of unethical public health scientists is absurd. Gori drives this point further to suggest that we and others in our field are guilty of scientific misconduct, perhaps, he suggests, even “hardcore fraud.” Since the respiratory health effects of ETS have been recognized by both government-the U.S. Surgeon General [6], the National Institute for Occupational Safety and Heath [7], and the National Cancer Institute [8]-and nongovernment scientists-the National Research Council of the National Academy of Sciences [9] and an academic working group headed by one of the editors of this journal [lo], the numbers of scientists involved in this alleged conspiracy to defraud the “trusting public” must be large. In fact, this conspiracy must extend even beyond our borders, since many of the studies showing adverse effects are from other countries. Thus, Gori portrays a Kafkaesque world in which science is
Dissent (A): Environmental
manipulated by a global conspiracy of public health institutions, civil servants, academicians, and other researchers, while the critics of this manipulation face the “wrath of all-powerful funding agencies.” To defend ourselves against Gori’s accusations of fraud becomes impossible under Gori’s depiction, because he includes as co-conspirators everyone who agrees with us. We can only, as we do above, expose his argument as preposterous, and wonder whether, as a consultant who has long received “occasional support from tobacco interests,” Gori can really be objective on this issue. We believe that the EPA analysis of ETS belies Gori’s conclusion of misuse of science. The EPA report (which took 4 years to complete) intensively assesses the evidence on the respiratory effects of ETS. It contains no evaluation of cardiovascular effects or other potential health risks of ETS exposure and, thus, may in fact understate the total public health impact from ETS. The assessment was developed through a deliberate, extensive, and open process of presentation and scientific review. Its conclusions are based on the weight of all the evidence and are widely endorsed by independent scientific experts and organizations. Gori, in his attempt to discredit the report, must resort to innuendo and unsubstantiated accusations of a broad-based conspiracy. We believe the evidence and the report speak for themselves.
Tobacco Smoke
33-l REFERENCES
1.
2.
3.
4.
5.
6.
I.
8.
9.
10.
Gori GB. Science, policy, and ethics: the case of environmental tobacco smoke. J Clin Epidemiol 1994; 47: 325-334. U.S. Environmental Protection Agency. Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders. Office of Research and Development, Office of Air and Radiation, Washington, DC; 1992: EPA/600/6-90/006F. Jinot J, Bayard S. Respiratory health effects of passive smoking: EPA’s weight-of-evidence analysis. J Clin Epidemiol 1994; 47: 339-349. National Academy of Sciences (NAS). Risk Assessment in the Federal Government:Managing tbe Process. Washington, DC: National Academy Press; 1983. Science Advisory Board. An SAB report: review of draft passive smoking health effects document, 1992: EPA-SAB-IAQC-93-003. U.S. Department of Health and Human Services. The health consequences of involuntary smoking. A report of the Surgeon General. U.S. DHHS, Public Health Service, Office of the Assistant Secretary for Health, Office of Smoking and Health, Washington, DC; 1986: DHHS Pub. No. (PHS) 87-8398. National Institute for Occupational Safety and Health. Environmental tobacco smoke in the workplace: lung cancer and other health effects. Current Intelligence Bulletin 54. Cincinnati, OH: U.S. Department of Health and Human Services, NIOSH; 1991. National Cancer Institute. Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders. Smoking and Tobacco Control. Monograph 4. Washington, DC: National Institutes of Health; 1993: NIH Publ. No. 93-3605. National Research Council. Environmental Tobacco Smoke: Measuring Exposures and Assessing Health Effects. Washington, DC: National Academy Press; 1986. Spitzer WO, Lawrence V, Dales R, Hill G, Archer MC, Clark P, Abenhaim L, Hardy J, Sampalis J, Pinfold SP, Morgan PP. Links between passive smoking and disease: a best evidence synthesis. A report of the working group on passive smoking. Clin Invest Med 1990; 13: 1742.