A response to: "Towards healthier communities in Nove Scotia: a Discussion Paper" - Part 1


Author: John Luik
Article Published: 1996


This response is a critical examination of the claims and evidence about the effects of Environmental Tobacco Smoke (hereafter ETS) that are advanced in the Discussion Paper. We propose to structure our response into three areas: an analysis of the claims of the Paper, an examination of the evidence adduced in support of those claims, and an analysis of the public policy recommendations made on the basis of that evidence.

Most tobacco issues are raised and discussed in an atmosphere of emotion and rhetoric rather than careful and rigorous analysis. But the same standards that mark the formulation of public policy in any other controversial area must also apply to tobacco. Public policy with respect to tobacco is not granted an exemption from the process of compelling evidence, clear and cogent argument and workable solutions that are the hallmarks of legitimate democratic public policy. Indeed such public policy, to be deemed legitimate must meet the following minimum conditions:


1 ) it is based on objective, substantial and careful evidence;

2) it is reasonable, coherent and consistent

3) it is carefully designed to achieve its stated ends and does meet those ends;

4) it respects and enhances the core values of a democratic society.


We wish to suggest that the Discussion Paper clearly and without exception fails to meet each of these conditions.

I. The Claims

The Discussion paper puts forward a variety of claims:

1) ETS is "a public health hazard" (p.1)

2) "The smoke that appears off the end of an idle burning cigarette is even more toxic than inhaled smoke" (p.1)

3) "When you sit in a smoky office, restaurant or bar, you can't help breathing in some of these toxic gases, particles and chemicals. Some of the tar stays in your lungs..." (p.1)

4) "Second-hand smoke increases the risk of death from heart disease by 20-30% for nonsmokers married to smokers." (p.2)

5) Second-hand smoke is the third largest cause of lung cancer, after direct smoking and occupational exposure to other hazardous substances." (p. 2)

6) Working in a smoke-filled environment has about the same long-term effect on a person's health as smoking ten cigarettes a day." (p.3)

7) "Restaurant workers have a 50 per cent higher risk of lung cancer than the general population." (p. 3)

8) "Statistics, scientific evidence, health care costs - these all support smoke-free legislation." (p. 6)

9) "We have overwhelming evidence that secondhand smoke is a major public health hazard." (p. 6)

10) "A no-smoking policy for all public spaces is the most cost effective solution and the one that provides for the best protection for both nonsmokers and smokers." (p.7)

11) "At least 80 nonsmoking Nova Scotians die every year from exposure to secondhand smoke." (P-1)


While the claims are various, what unites them is the central assertion that there is "overwhelming evidence" that ETS is a "major health hazard" that must be addressed. What also unites them is the fact that all of them are false - all of them are contradicted by the relevant scientific evidence. In effect, ETS is not a major health hazard and thus it does not warrant government legislation.

II. The Evidence

It is very difficult to reconcile the document's claim that there is "overwhelming evidence" that ETS is a public health hazard with the almost complete lack of evidence put forward in the discussion paper to substantiate this claim. It is particularly interesting, for instance, that whilst the Paper makes sweeping claims about the alleged effects of ETS an health, it does not produce a single piece of Canadian evidence to support these claims. It would appear that the authors fail to understand the basic difference between claims and evidence, between advancing a particular proposition and providing backing for that proposition. What we are offered as cited evidence are:

  • "The Health Effects of Tobacco Use" from the National Clearinghouse on Tobacco and Health
  • "Environmental Tobacco Smoke: Behind the Smoke Screen", a "fact" sheet from the Heart and Stroke Foundation
  • "Tobacco Smoke in the Workplace" from the CMAJ
  • "Involuntary Smoking in the Restaurant Workplace" from JAMA.

References are also made to the US Surgeon General's 1986 Report and to the 1992 US Environmental Protection Agency Report, though these are unreferenced.

We propose to examine this evidence in the following fashion:

1) We will not comment on the National Clearinghouse on Tobacco and Health citations as this is not a scientific, peer-reviewed study. In short, it does not constitute evidence in any recognized sense. For similar reasons we will not comment on the Fact Sheet of the Heart and Stroke Foundation.

2) We will comment on the claim that ETS smoke is more hazardous than inhaled smoke.

3) Since the only real scientific support for the Paper's claims is to be found in the EPA Report (1992) we will devote substantial attention to this Report.

4) We will not discuss the CMAJ article since it is now almost 13 years old and superseded by more current data.

5) We will comment at some length on the JAMA article as it is indicative both of the quality of evidence used in this discussion paper and on the entire process of misrepresenting scientific findings on the ETS issue.

6) We will also look at the entire range of FTS studies on both lung cancer and heart disease.

7) We will examine the ETS studies that have focused an the issue of occupational exposure to ETS.

8) Finally, we will look at the work of the Congressional Research Service and its analysis of the alleged health hazards of ETS.

 

A. ETS, Mainstream and Sidestream Smoke

The Paper claims that the smoke "that appears off the end of an idle burning cigarette" is "even more toxic than inhaled smoke" (p.1 ). But this claim is completely false for it assumes that ETS is in fact equivalent to sidestream tobacco smoke - the smoke produced by a smoldering cigarette. If ETS is sidestream smoke it is extremely diluted sidestream smoke. Indeed, in real- world settings in which ETS has been measured only a very few of the compounds present in mainstream tobacco smoke have been detected. As G. Gori notes:

"Several thousand components of mainstream smoke can be measured, but because of extreme dilutions fewer than two dozen components of ETS can be detected under field conditions. Even assuming that sidestream smoke remains unchanged as it ages and becomes ETS, the concentrations of its components would be between one thousand and one millions times below the corresponding levels permitted in workplaces by the Occupational Safety and Health Administration..." [1]

Even the EPA, which the Paper quotes elsewhere, notes that the equivalency of sidestream and mainstream tobacco smoke, let alone the enhanced toxicity of sidestream smoke, may not be tenable (EPA, 6.6)

 

 

B. The EPA Report

The second evidentiary problem, which again suggests the Paper's proximity to corrupted science is its uncritical use of the US Environmental Protection Agency 1992 Report. The Paper refers to the EPA work as the "most extensive recent review of the evidence of passive smoking and lung cancer" (p. 98). Quite surprisingly, the Paper fails to mention the extensive criticism directed at the EPA's ETS analysis, or the fact that. the EPA's findings are the subject of court action. Given the uncritical attention devoted to the EPA's work it is worth noting precisely how strong the evidence is which suggests that the EPA's science on ETS is corrupt science. The evidence that the EPA science on ETS is corrupt science falls into two categories: evidence about the substance of the science and evidence about the processes involved in creating and using the science.

 

The Substantive Issue

The EPA report Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders [2], claims that "Based on the weight of the available scientific evidence, the U. S. Environmental Protection Agency has concluded that the widespread exposure to environmental tobacco smoke in the United States presents a serious and substantial public health impact." Is this the case? In order to answer this question one must first know something about the data on which the EPA decision is based. The EPA report refers to the 30 epidemiological studies on spousal smoking and lung cancer that have been published from 1982-1990. It is important to note that while EPA Administrator Reilly in referring to the Report spoke about ETS and cancer in children and in the workplace and though the Report has been used as a basis for demanding smoking bans both in public places and in workplaces, the EPA did not examine those studies that look at workplace ETS exposure. The overwhelming majority of which do not find a statistically significant association between exposure to ETS and lung cancer in non-smokers: a fact that by itself destroys the legitimacy of any harm based demand for public or workplace smoking bans.


Thus, to begin with, the EPA case is based not on workplace or public place ETS exposure, but on the risks of non-smoking spouses contracting lung cancer from their smoking spouse. But what of the 30 studies? The 30 studies come from different countries and vary substantially in size. Some have fewer than 20 subjects, others are based on larger populations, with the largest study involving 189 cancer cases. Of the 30 studies, 24 reported no statistically significant association, while six reported a statistically significant association, that is a positive relative risk for those nonsmoking spouses. Now relative risks are further classified into strong risks or weak risks depending on the magnitude of the risk ratio. Within the 30 studies on ETS and lung cancer NONE reported a strong relative risk. Moreover, whenever the assessment of relative risk is weak there is a substantial possibility that the finding, the assessment, is artificial rather than real. That is to say, there is a strong likelihood that even the weak relative risk is a reflection not of some real world risk, but of problems with confounding variables or interpretative bias. There are, for instance, at least twenty confounding factors ranging from nutrition to socioeconomic status that have been identified as important to the development of lung cancer. Yet none of the 30 studies attempts to control for all of these factors. So in assessing the global scientific evidence about ETS and lung cancer the crucial conclusion is that none of the studies report a strong relative risk for non-smokers married to smokers.

 

 

Now the EPA report discusses all of these 30 studies, but it limits its statistical analysis to only 11 U.S. studies of spouses of smokers, and what do the 11 studies show? Of the eleven, 10 reported no statistically significant association between ETS exposure and lung cancer while one reported a statistically significant association. The EPA analysis of these 11 studies claims that they show a statistically significant difference in the number of lung cancers occurring in the non-smoking spouses of smokers such that they suffer 119 such cancers compared with 100 such cancers in nonsmoking spouses of nonsmokers. It is this finding of statistical significance, a finding based on only the 11 U. S. studies,10 of which found no significant association, that is the basis for the EPA decision to classify ETS as a "Group A" carcinogen. [3]


In order to arrive at its "conclusion" the EPA combined the data from the 11 studies into a more comprehensive data assessment called a meta-analysis. Meta-analysis is governed by its own rules, as not every study is a candidate for such combined analysis. In general, meta-analysis is appropriate only when the studies being analyzed together have the same structure. The difficulty with the EPA's use of meta-analysis of the 11 ETS studies is that it has failed to provide the requisite information about the structure of the 11 studies, information crucial for an independent assessment of whether the studies are indeed candidates for meta-analysis. Thus, the EPA conclusion is based on a meta-analysis that is difficult, if not impossible, to verify.

But even more crucial to the question of assessing the quality of the EPA's ETS science is the issue of confidence intervals, for even by limiting its analysis to only 11 studies, and even by lumping these studies together through a meta-analysis, the EPA could not have achieved the "right" result if it had not engaged in a creative use of what epidemiologists call confidence intervals. Essentially, confidence intervals express the likelihood that a reported association could have occurred by chance. The generally accepted confidence interval is 95%, which means that there is a 95% confidence that the association did not occur by chance. In as much as most epidemiologists use the 95% confidence interval, the EPA itself, until the ETS report, always used this interval. Indeed, all of the individual ETS studies reviewed by the EPA used a 95% confidence interval. Curiously, the EPA decided that in this instance it would use a 90% confidence interval, something that effectively doubles the chance of being wrong. Even more curious is the fact that when asked to justify this departure from accepted scientific procedure, EPA Administrator Reilly simply replied that the 90% confidence interval "was recommended to us by the scientific community as appropriate to this data." What Mr. Reilly really means by appropriate to this data is that without using this 90% standard, the EPA could not have found that the 11 U.S. studies were "statistically significant." Without employing a novel standard, without in effect changing the accepted rules of epidemiological reporting, the EPA result, already painfully coaxed into existence, would not have existed, ETS could not have been labelled a "Class A" carcinogen.

Thus, despite all of its careful selection of the right data, its meta-analysis and finally its relaxed confidence intervals, the conclusive point remains, as Huber, Brockie, and Mahajan note in Consumers Research in the United States (1991), that "No matter how the data from all of theepidemiological studies are manipulated, recalculated, 'cooked', or 'massaged', the risk from exposure to spousal smoking and lung cancer remains weak .... No matter how these data are analyzed, no one has reported a strong risk relationship for exposure to spousal smoking and lung cancer." [4]

 

 

The Process Issue

While a careful look at the substance of the EPA's ETS claims clearly shows why this science can be called nothing other than corrupt science in that it uses highly selected data, data that is then further manipulated in breach of accepted scientific norms, all without cogent explanation, to reach the "right" conclusion, an examination of the process underlying this science demonstrates even more clearly its wholly corrupted character. There are at least nine specific process issues worth noting, each of which highlights a slightly different dimension of the corrupted character of the EPA's ETS science.

 

First, EPA science issues from a health promotion perspective that finds its conceptual home in the Lalonde Doctrine propounded by former Canadian Minister of National Health and Welfare, Marc Lalonde. Lalonde argued that health messages must be vigorously promoted even if the scientific evidence was incomplete, ambiguous, and divided. Health messages must be "loud, clear and unequivocal" even if the evidence did not support such clarity and definition. What we have in the EPA is simply the Lalonde Doctrine as an institutionalized process. Clearly the substance of the ETS data does not support its "Group A" status, nor does it support public and workplace smoking bans on the grounds that ETS threatens the health of non-smokers. But the substance of the ETS data is to be ignored because the Lalonde Doctrine places the process of using such substance ahead of the substance itself; indeed, it requires that the substance be portrayed as something that it is not in order to further the health agenda. What this inevitably does is to build into the heart of the scientific enterprise a institutionalized motivation and justification for allowing ends extrinsic to science to determine the findings of science, for allowing science to be subject to an agenda not its own, for allowing science to lie with a clear conscience. Once one has come to see science as something that of necessity happens within the context of health promotion then the process corruptions of the EPA follow quite "naturally".

This explains why at one level those involved with the EPA decision on ETB are quite frank about their process. For instance, an EPA official responsible for the revised ETS risk assessment was quoted in Science (July 31,1992) as admitting that "she and her colleagues engaged in some fancy statistical footwork" to come up with an "indictment" of ETS. [5] (The footwork to which she refers is the novel 90% confidence interval.) Or to take another process example, the Science Advisory Board which reviewed the initial draft risk assessment on ETS, and found the case against ETS based on its association with lung cancer unconvincing, actually urged the EPA staff to attempt to "make the case" against ETS on the basis of the similarities between ETS and mainstream smoke. [6] To be fair, the consequences of the Lalonde Doctrine are not confined to the EPA's anti-smoking agenda. For instance, a 1989 JAMA article reported a study that claimed to show a link between ETS exposure and increased risk of cervical cancer. In response to critics who noted that such a link was biologically implausible and that the study had ignored confounding factors, the authors replied that the study was justified simply on the grounds that it might reinforce the dangers of smoking message. "While we do not know of a biologic mechanism for either active .... smoking or ETS to be related to cervical cancer, we do know that cigarette smoking is harmful to health. The message to the public, as a result of this study, is one that reinforces the message that smoking is detrimental to health." [7] It would be difficult to find a more succinct example of the Lalonde Doctrine at work. There is no compelling evidence to support our claim, the authors all but admit, but it is important, in the interests of health promotion that the public be made to think that there is scientific evidence of harm.

 

But second, while those involved in the EPA process are at one level open about the process, at another level they are profoundly dissembling. For instance, the EPA fails to mention that the "Group A" status for ETS was arrived at using a process that violates its own Guidelines For Carcinogenic Risk Assessment. Rather than acknowledging that this suggested that both the substance of its findings and the process were corrupt, the Science Advisory Board reviewing the ETS issue argued that this suggested a need not for concluding that ETS posed no threat to the health of non-smokers, but rather a need for changing the Guidelines For Carcinogenic Risk Assessment. Given that the right conclusion must be reached and the data do not support that conclusion, one must manipulate the data and revise the guidelines governing the process and the conclusion.


But second, while those involved in the EPA process are at one level open about the process, at another level they are profoundly dissembling. For instance, the EPA fails to mention that the "Group A" status for ETS was arrived at using a process that violates its own Guidelines For Carcinogenic Risk Assessment. Rather than acknowledging that this suggested that both the substance of its findings and the process were corrupt, the Science Advisory Board reviewing the ETS issue argued that this suggested a need not for concluding that ETS posed no threat to the health of non-smokers, but rather a need for changing the Guidelines For Carcinogenic Risk Assessment. Given that the right conclusion must be reached and the data do not support that conclusion, one must manipulate the data and revise the guidelines governing the process and the conclusion.

Third, the ETS risk assessment process has been corrupted from the outset by the fact that it has repeatedly violated the standards of objectivity required by legitimate science by utilizing individuals with anti-smoking biases. One member of the group working on the ETS issue at the EPA is an active member of U.S. anti-smoking organizations, while the Science Advisory Board that examined the EPA's ETS work included not only a leading anti-smoking activist, but several others strongly opposed to tobacco use. Finally, the EPA contracted some of the work on certain documents related to the ETS risk assessment to one of the founds of a leading anti- smoking group.

Fourth, the EPA changed the accepted scientific standard with respect to confidence intervals, without offering any compelling justification, in order to make its substantive findings statistically significant.

Fifth, the EPA's Workplace Policy Guide which as a policy document would, in the course of normal scientific process, be developed only after the scientific evidence was in, was actually written before the scientific risk assessment was even completed, let alone reviewed and finalized. [8] Quite obviously, science was to be made to fit with policy, rather than policy with science.

Sixth, the EPA fails to note that if the two most recent U.S. ETS studies were to be included along with its eleven other studies it would have resulted in a risk assessment that was not statistically significant, even using the 90% confidence interval. With its entire "conclusion" at risk, there are exceedingly compelling process reasons for the EPA to have excluded these two studies from their analysis.

Seventh, exclusion, however, was apparently insufficient, for the EPA does more than simply not use the studies, it actually refers to them in an appendix and misrepresents the one through claiming that it supports the EPA's ETS conclusions. The study, by Brownson, et al , which appeared in November,1992 in the American Journal of Public Health reported no statistically significant increase in risk between lung cancer and ETS exposure. In order to get round this politically unacceptable conclusion the EPA quotes Brownson as concluding that "Ours and other recent studies suggest a small but consistent increased risk of lung cancer from passive smoking." (ADD - l) But this is not the issue, as the EPA well knows. The question is not whether there is a small increased risk, but whether there is a statistically significant risk, which Brownson concludes that there is not. In effect, the EPA misrepresents a scientific finding through changing the terms of reference from statistical significance to just plain risk.

This penchant for misrepresentation is not, however, just confined to recent studies. For instance, the EPA analysis consistently makes reference to the Garfinkel, et al study. At 5-48 the EPA claims that the Garfinkel study presents "at least suggestive evidence of an association between ET and lung cancer..." [11] But a careful reading of Garfinkel does not confirm this at all.

Garfinkel actually says that "we found an elevated risk of lung cancer, ranging from 13-31 per cent, in women exposed to smoke of others, although the increase was not statistically significant." [12] The entire question of suggestive evidence is bogus: the relevant question is whether Garfinkel found a risk that was statistically significant. He did not, and the EPA misrepresents his finding.

Eighth, the EPA represents its process as a comprehensive and objective analysis of the ETS data. In the usual course of things this would imply a careful examination of the criticisms that have been levelled at the studies used to reach its conclusions. However, a careful examination of the Bibliography accompanying the Report suggests that this is not the case. Although the note with the Bibliography indicates that it is not a "comprehensive list of all references available on the topic" it is still a list of all references cited and reviewed for the Report. Yet, to take but one example, one would never know from the Report or its Bibliography that the work of Trichopolous had been subjected to significant criticism by both Burch and Heller, since neither is mentioned in the Bibliography. Nor indeed, despite its lengthy examination of the Hirayama studies, would one learn from either the discussion or the Bibliography that Hirayama was devastatingly criticized by Rutsch who noted that one could infer from Hirayama's data that lung cancer was more common in unmarried non-smoking women than in the non-smoking wives of smokers, a somewhat curious result.

Now the possible explanations for such selectivity are that:


1) the authors of the study are not familiar with such criticisms, which would suggest incompetence, or
2) they are familiar with the criticisms but have misunderstood them, ignored them or discounted them.


But even if one were to discount or ignore them it is still odd, if one is committed to objectivity and openness, to not cite them. To not cite them suggests that one wishes to act as if they didn't exist and to do this is to give rise to more than the suspicion that the EPA's ETS work is really an instance of a closed-loop process abuse. In a closed loop the circle is never opened up to divergent, dissenting views, views that challenge the orthodox conclusion. It is not simply that such divergent views are discounted, it is rather that, as the EPA discussion and Bibliography indicate, they simply never are heard, indeed judging from the Bibliography they don't exist. When one considers this closed loop process in the context not merely of what the EPA excluded in terms of dissenting voices, but in the context of what is sought in to include in terms of determining voices the anti-smoking movement - then it is hard to assign any degree of objectivity to the process.

Ninth, despite the significant difficulties that have been raised about the quality of EPA science, particularly by the Expert Panel in its report Safeguarding The Future: Credible Science, Credible Decisions, a report that noted that:


1) EPA "science is of uneven quality"
2) the "EPA has not clearly conveyed to those outside or even inside the Agency its desire and commitment to make high-quality science a priority"
3) "the science advice function -- that is the process of ensuring that policy decisions are informed by clear understanding of relevant science -- is not well defined or coherently organized within EPA"
4) the "Agency does not have a uniform process to ensure a minimum level of quality assurance and peer review for all the science developed in support of Agency decision making"
5) the "Agency lacks the critical mass of externally recognized scientists needed to make EPA science generally credible to the wider scientific community"
6) "science should never be adjusted to fit policy". [13]


Despite this the EPA process is incapable of correcting itself.

 

 

... continued...

 

 

 

 




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