Philip Morris
Environmental Tobacco Smoke Hearing Before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce House of Representatives One Hundred Third Congress First Session
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nonsmoker rather than on urging the smoker
her own benefit, [antismoking legislation]
to quit for his or
reduces smoking
because it undercuts the social support network for smoking by
, implicitly defining smoking as an antisocial act."y
Neutral and dispassionate scientific inquiry often
yields inconvenient results from the perspective of the social
activist. So it'has been for EPA with Alar, PCBs and dioxin,
to cite only a few examples. ETS must now be added to the
list.
The scientific data simply do not support EPA's
classification of ETS as a"Group A" carcinogen. Of the more
than 30 epidemiologic studies of marriage to a smoker and lung
cancer among nonsmokers, the overwhelming majority report no
statistically significant association. The studies focusing
on ETS exposure in the workplace also generally have not
reported a statistically significant increased risk. The most
recent and largest U.S. case control study, by Brownson and
coworkers, confirms the general no-association patternY
Although the Brownson study was published in November 1992,
two months before EPA completed its report on ETS, the EPA
report failed even to cite the Brownson study. The reason,
Y S. Glantz, Achieving a Smokefree Society, Circulation,
vol. 76, pp. 746-752, 747 (1987).
`-/ R.C. Brownson et al., Passive Smoking and Lung Cancer in
Nonsmoking Women, Am. Pub. Health, vol. 82, pp. 1525-1530
(1992).
10
,
- 7 -
undoubtedly, is that EPA's conclusions on lung cancer could
not survive inclusion of the Brownson data.
Even without the Brownson data, the classification
of ETS as a Group A carcinogen required substantial stretching
by EPA. To reach that conclusion, the EPA report combined
eleven spousal smoking studies from the United States in a so-
called "meta-analysis." Of the eleven studies, however, ten
reported no statistically significant increase in cancer among
nonsmokers purportedly exposed to ETS. To ensure that the
meta-analysis would produce the desired results, therefore,
EPA had no choice but to manipulate the numbers.
Although in the past EPA and the scientific
community have used a 95% confidence interval as a means
ensuring that study results did not occur by chance, EPA
of
adjusted the confidence interval downward -- to 90% -- in its
report on ETS. As James Enstrom, an epidemiology professor at
the University of California, Los Angeles, explained, "[t]hat
doubles the chance of being wrong."Y To put it in lay
terms, EPA's statistical maneuvering is the equivalent of
moving the goal lines at a football game in order to score
more touchdowns. The implications of EPA's willingness to
lower scientific standards in selected cases are profoundly
troubling. As Michael Gough of Congress's Office of
Technology Assessment has pointed out, ".[yjou cannot run
si
Investor's Business Daily, su a note 1.
C~
cl~
I
11
-a-
science with the government changing the rules all the
time."6/
The only claim made in the EPA report for which
there is at least statistical support is that ETS can affect
the respiratory health of very young children. Most of the
studies on that issue are so flawed, however, that it is
premature to conclude that the association is causal in
nature. In the final analysis, it must be remembered that
epidemiologic studies can show only a statistical association.
They cannot prove causality. After all, there is a strong
association between increased life expectancy and increased
consumption of junk food in affluent countries but no one
6/ Ibid. In addition to these deficiencies, classification
of ETS as a Group A carcinogen cannot be reconciled with EPA's
own Guidelines for Carcinogen Risk Assessment. The Scientific
Advisory Board that reviewed the risk assessment acknowledged
that the document did not adhere to the Agency's guidelines,
but dismissed such concerns with the suggestion that the
guidelines simply be changed. The report also selectively
uses data that support its conclusions while omitting evidence
that does not. For example, the report completely ignores
workplace and male exposure data, which do not show any
association between exposure to ETS and lung cancer.
Such treatment by both EPA and the SAB is
unprecedented. No other substance has been classified as a
Group A carcinogen in the face of a clear majority of
epidemiologic studies showing no statistically significant
association or on an assumed similarity with another
substance. Other substances that have been considered for
classification as known or probable human carcinogens,
including electromagnetic fields and diesel exhaust, have been
accompanied by considerably stronger evidence of
carcinogenicity in both human and animal studies than ETS.
Comparing those risk assessments to the ETS report only
reinforces the view that the report is intended to support a
policy decision to restrict ETS exposure and not to assess
risk objectively.
12
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contends that one is the cause of the other.
argue the converse.'-/
In fact, many
In light of the weaknesses in the pertinent data,
the procedures that have been utilized in "developing the case
against ETS" take on a special significance. As one of the
world's leading epidemiologists, Dr. Alvan Feinstein of Yale
University Medical School, put it in a recent article:
In the investigations of [ETS], * * * the
various studies are contradictory, some
going in positive directions and others
not. The inconvenient failure of the
evidence to comply with a prime requisite
of scientific reasoning for causality,
however, has not inhibited the causal
accusations. The "prosecution" has simply
ignored the inconvenient results and
emphasized thosethat are (in a memorable
term) "helpful."=
A report produced by the Advocacy Institute, a major
antismoking organization, entitled Media Strategies for
'-/ The risk assessment does not address the data concerning
ETS exposure and cardiovascular disease. Two earlier
documents prepared by EPA staff, however, an ETS "technical
compendium" and a related "workplace policy guide," asserted
that ETS exposure is a cause of cardiovascular disease. In
fact, exposure to ETS has not been proven to cause or
exacerbate cardiovascular disease among nonsmokers. In 1986,
the U.S. Surgeon General and the National Academy of Sciences
reviewed the data and concluded that there was insufficient
evidence even of an association between ETS and cardiovascular
disease. U.S. Surgeon General, The Health Conseauences of
Involuntary Smoking, U.S. Department of Health and Human
Services (1986); National Research Council, Environmental
Tobacco Smoke: Measuring Exposures and Assessin"c Health
Effects (1986). No studies have been published since 1986
that would alter their conclusions.
e/ A. Feinstein, Criti
que of Review Article, Environmental
Tobacco Smoke: Current Assessment and Future Directions,
Toxicologic Pathology, vol. 20(2), pp. 303-305, 304 (1992).
.
. .
13
-10-
Smokinq Control: Guidelines (NIH 1989), provides a striking
illustration of this strategy. Behind every story detailing
the "risks" of ETS, the report stated, could be found "(a]
scientist wise in the way of 'creative epidemiology,' i.e.,
the presentation of data -- both scientifically sound and
artful -- so as to catch the glint of media attention ***"
(NIH Report at 7). The report describes "creative
epidemiology" as follows:
Michael Daube, who coined the term,
defines creative epidemiology as "the
ability of the good epidemiologist to
rework data so that what is essentially
the same information can be presented in a
new and interesting form." Thus creative
epidemiology marries the science of the
researcher with the art and creativity of
the media advocate (id. at 21-22).
Similarly, Jonathan Samet of the University of New
Mexico recently acknowledged that there is much that we do not
know and indeed may never know about whether ETS poses a
health risk. Notwithstanding those evidentiary deficiencies,
however, Dr. Samet made clear that "[i]n the case of
environmental tobacco smoke, it would be unfortunate if
potentially irresolvable scientific uncertainties thwarted
control."9l
As a result of this strategy, there is enormous
pressure on researchers and scientific bodies investigating
ETS to come up with the "right" conclusion. The Brownson
2/ J.M. Samet and M.J. Utell, The Environment and the Lung:
Changing Perspectives, J. Am. Med. Ass'n., vol. 266, p. 673
(1991).
14
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study, for example, apparently caused considerable dismay
because it produced the "wrong" results. Defending his
decision to pub'lish the study, Dr. Brownson lamented, "I wish
our findings had gone in the exact pattern the public health
community-would like ***. But one of the criticisms of
medical research is that the only thing findings ever show is
some kind of health risk. I feel it's important to publish
findings, no matter what they show.";0/ Dr. Brownson's
eagerness to please the public health community is widely
shared. His willingness to release data not in accord with
the political objectives of that community unfortunately is
not.
Again, Dr. Feinstein of Yale has offered a revealing
insight. According to Dr. Feinstein:
[I]n the current fervor of anti-smoking
evangelism, what young scientists would
want to risk their career and what older
scientists would want to risk their
reputation by doing anything that might be
construed as support for the "bad guys" of
the tobacco industry? What governmental
agency would fund research in which the
established "accepted" anti-smoking
doctrines were threatened by a study
proposed by someone -- an obviously
deranged skeptic -- who wanted to do an
unbiased, objective investigation?
(p. 304).
In the same article, Dr. Feinstein revealed that he "recently
[had] heard an authoritative leader in the world of public
health epidemiology make the following statement: 'Yes, it's
li Risk Studies Differ on Passive Smoking, Washinaton Times,
November 20, 1992, p. A3.
15
- 12 -
rotten science, but it's in a worthy cause. It will help us
get rid of cigarettes and become a smoke-free society '', (p.
303).
Because the debate over ETS has been caught up in
the larger, highly emotional controversy about active smoking,
the role of EPA in collecting, evaluating and disseminating
scientific information about ETS becomes even more important.
The Superfund Amendments and Reauthorization Act of 1986
("SARA") gave EPA the role of "providing information and
guidance" to the public on indoor air and radon. 42 U.S.C.
S 7401 note. SARA required EPA's research agenda to be
reviewed by the Agency's independent Science Advisory Board
("SAB"). The SAB consists of scientists from outside EPA
whose role is to assess the factual and theoretical bases for
EPA's research and reports. The SAB is supposed to operate as
a check on the Agency's use of science in the formulation of
regulatory policy -- to ensure that objective scientific
inquiry is not subverted to serve political rather than
scientific ends. Unfortunately, the SAB has not operated
intended in the case of ETS. As a result, there has been
little or no brake on the antismoking proclivities of
individual EPA staff members.
B. Early EPA Staff Initiatives ConcerninQ ETS
as
y
EPA's policy of promoting restrictions on smoking
seems to have begun with James L. Repace, an "environmental
protection specialist" in EPA's Indoor Air Division. In 1980,
16
even before the first major ETS health claims
appeared in the
scientific literature, Repace wrote with A.H. Lowrey an
article reporting on particulate matter in the air of various
environments such as bars, restaurants and bingo parlors,
without distinguishing whether those particulates were from
ETS or some other substance or activity.ll/ The only
"office" measurements made by Repace were in an experimental,
enclosed room in which thirty-two cigarettes were smoked in
less than one hour, generating ETS levels grossly in excess of
those encountered in the real world. Subsequent research has
discredited both the methodology and conclusions of the 1980
Repace study.lZ/ On the basis of these observations,
however, the article claimed that "indoor air pollution from
tobacco smoke presents a serious risk to the health of
nonsmokers ***[that] deserves as much attention as outdoor
air pollution."1'/
A few years later, Repace published (again with A.H.
Lowrey) an article purporting to show that ETS was riskier
ui A.H. Lowrey and J.L. Repace, Indoor Air Pollution,
Tobacco Smoke and Public Health, Science, vol. 208, pp. 464-
472 (1980).
lZi ee, e.a., S. Turner, et al., Measurements of
Environmental Tobacco Smoke in 585 Offices, Env. Int., vol.
18, pp. 18-28 (1992); C. Proctor, N. Warren, and M. Bevan,
Measurements of ETS in an Air-Conditioned Office Building,
Env. Tech. Lett., vol. 10, pp. 1003-1018 (1989).
i'/ Repace and Lowrey (1980), supra note 11, at 471.
17
than "all regulated
industrial emissions combined."L" This
second article by Repace and Lowrey, which represented a crude
attempt at-quantitative risk assessment, has been roundly
criticized by both government and private sector
scientists.lsi
Repace's extensive work with political advocacy
organizations such as the Group Against Smoke Pollution
("GASP") and Action on Smoking and Health ("ASH") and his
1-IV J.L. Repace and A.H. Lowrey, A Quantitative Estimate of
Nonsmokers' Lung Cancer Risk From Passive Smoking, Env. Int.,
vol. 11, pp. 3-22, at 12 (1985). This study was not funded or
sponsored by EPA. Repace apparently undertook the study on
his own initiative. The source of his funding has never been
revealed.
15, Reviews critical of the Repace and Lowrey risk
assessment, calling their methodology and conclusions into
question, were completed by EPA's Carcinogen Assessment Group
prior to publication of the Repace and Lowrey paper. See
E. Anderson, Repace and Lowrey's Estimate of the Lung Cancer
Risk from Passive Smoking (undated); H. Gibb, Repace and
Lowrey's Estimate of the Nonsmokers' Lung Cancer Risk from
Passive Smoking (undated). In addition, the Repace and Lowrey
paper was criticized by the Congressional Office of Technology
Assessment in Passive Smoking in the Workplace: Selected
Issues, pp. 21-22 (May 1986). Other scientific articles
criticizing the Repace and Lowrey risk assessment as well as
their earlier work on ETS include A. Gross, Risk Assessment
Relating to Environmental Tobacco Smoke, Environmental Tobacco
Smoke, Proceedings of the International Symposium at McGill
University, D.J. Ecobichon and J.M. Wu, (eds.), Lexington
Books, Lexington, Mass., pp. 293-302 (1990); N. Balter et al.,
Causal Relationship Between Environmental Tobacco Smoke and
Lung Cancer in Non-Smokers: A Critical Review of the
Literature, Proceedings of the 79th Annual Meeting_of the Air
Pollution Control Association (1986); A. Arundel et al.,
Nonsmoker Lung Cancer Risks From Tobacco Smoke Exposure: An
Evaluation of Repace and Lowrey's Phenomenological Model, ~
of Env. Sci. and Health, vol. 84(1), pp. 93-118 (1986); M.
Lebowitz, The Potential Association of Lung Cancer With
Passive Smoking, Env. Int., vol. 12, pp. 3-9 (1986); P. Burch,
Health Risks of Passive Smoking: Problems of Interpretation,
Env. Int., vol. 12, pp. 23-28 (1986).
a
18
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private and professional focus on smoking raise questions
about Mr. Repace's ability to evaluate indoor air issues in a
balanced manner. Since the 1970s, Mr. Repace also has been
appearing as a paid witness in numerous lawsuits and
testifying before various legislative bodies to support
governmental restrictions on smoking. Consider in this regard
Mr. Repace's statements to the press in reaction to the defeat
of an antismoking legislative proposal in Maryland:
People aren't going to stand for this.
Now that the facts are clear, you're going
to start seeing nonsmokers becoming a lot
more violent. You're going to see fights
breaking out all over. Washington Star,
April 5, 1980, p. D-1.
Based on my own experiences with Mr. Repace, I do
not find these accounts surprising. In 1991, at the
invitation of EPA Administrator Reilly, my staff interviewed
several EPA employees as part of my and the Oversight
Committee's efforts to gather the facts about EPA's procedures
in preparing ETS-related documents. When he presented himself
in my office, however, Mr. Repace categorically refused to
answer any questions. He was accompanied by John Banzhaf,
ASH's Executive Director, and Mr. Nantkes of the EPA General
Counsel's office. Both were said to be serving as
Mr. Repace's attorneys. Within minutes after Mr. Repace left
my office, my staff received inquiries from the media
characterizing my efforts as "intimidation."
During the late 1980s, Mr. Repace became the driving
force behind EPA's push to classify ETS as a "Group A"
y
