Philip Morris
Tobacco Industry Efforts Subverting the International Agency for Research on Cancer's Secondhand Smoke Study
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- 2505646347-6368 Tobacco Industry Efforts Subverting the International Agency for Research on Cancer's Secondhand Smoke Study
- 2505646369-6388 Tobacco Industry Efforts Subverting the International Agency for Research on Cancer's Secondhand Smoke Study
- 2505646389-6414 Tobacco Industry Efforts Subverting the International Agency for Research on Cancer's Secondhand Smoke Study
- 2505646415-6418 Tobacco Industry Efforts Subverting the International Agency for Research on Cancer's Secondhand Smoke Study
Related Documents:
Document Images
APPENDICES ................................................................
Figure I- Philip Morris' IARC Task Force Structure
Figure 2 - 1989 PM Public Opinion Survey
Table A-1 - IARC Study Authors and Investigators
Table A-2 - Tobacco Industry Members and Allies
Table A-3 - Names from a "Partial Listing of Selected International Involvement of
TASSC Scientists"
Table A-4 - Covington & Burling's List of `B2" and "B3" Epidemiologists
Table A-5 - The "London Panel" of experts on Good Epidemiology Practices convened
by
Federal Focus, Inc.
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Introduction --------------------------------------------------------------
-----------------------............................... 67
Traditional Lobbying Activitics .......... .....- ---------...-----
-------------------------------------------------- 67
The "Good Epidemiology Practice" Program
------------------------------------------------------------------- 69
Industry Use of the IARC Study in Regulatory Settings ---------- .----
.----------------------------------- 79
Summary
....................................................................................................
.......... ............ 81
CHAPTER 8: CONCLUSION ..................................
.------------------------------------------- ......... ............... 82
REFERENCES ...---°
....................................................................................................
.................. 85
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I certify that I have read this thesis and in my opinion it
is fully adequate, in scope and quality, as a dissertation
for the degree of Master of Science
Stanton A. Glantz, PhD
Advisor, Department of Medicine
University of California, San Francisco
I certify that I have read this thesis and in my opinion it
is fully adequate, in scope and quality, as a dissertation
for the degree of Master of Science
Mark A. HIatky, M.D.
Chairman, Depar[ment of Health Research and Policy
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+r-
Tobacco Industry Efforts Subverting the International
Agency for Research on Cancer's Secondhand Smoke Study
A thesis submitted to the Department of Health Research and Policy
and the Committee on Graduate Studies of Stanford University
in partial fulfillment of the requirements
for the degree of Master of Science
By
Elisa K One, BA
November 1999
w~-A lieC
-4
; d C ~ ; a 4T (~ '41`
Information on oranizations like European Science Environment Forum, Federal Focus, and the
International Ert4emie4ef~Association were obtained from their websites. The series of
international studies assessing secondhand smoke exposure with personal monitors were listed
on the publishing company website www.elsevier.corn. In addition, key IARC investigators were
contacted by electronic mail to describe their experience with the industry and to confirm
information described about themselves in certain documents.
X
N
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effect29 British American Tobacco (BAT), which had held private media briefmgs3O to ensure
"balanced" coverage of the forthcoming study, was suspected to have fueled the story.31 BAT
responded that it knew of IARC's preliminary results from earlier public conferences and IARC's
mandated Biennial Report.32 Despite press releases from WHO33 and IARC34 noting that the
study still awaited its peer-review publication and calling the Sunday Telegraph interpretation of
statistical significance "false and misleading,"34 the allegations quickly spread around the world
from Australia35 to Zimbabwe.3s
The confusion in the media represented only the first public manifestation of the
industry's interest with the IARC study; the industry had been developing a proactive strategy
against the IARC study starting five years before the study's publication. Our analysis of internal
industry documents reveals that industry leader Philip Morris (PM) spearheaded an extensive
effort to "stop," "miugate," "delay," and "counteract"37 IARC's activities. The IARC study was
seen by the industry as the first step toward an increase in international smoking restrictions, and
PM organized both multinational companies and national monopolies around its plan.
We describe the scientific, communications, and government relations components of the
industry's resulting comprehensive strategy against IARC. The industry programs implemented
include intelligence gathering, research designed to counter IARC's results internationally,
"sound science" coalitions, and the Good Epidemiology Practice (GEP) project. The outcome of
these plans demonstrate a sophisticated effort to shape the scientific perception of secondhand
smoke issues for the IARC investigators, general scientific community, public opinion, and
policymakers'at large. An ironic twist is that these same target audiences were at times
integrated into participating in the industry's programs against the forthcoming IARC study,
lending a credibility that has helped mask the industry's primary involvement.
The industry's planning processes and implementation has important implications for the
conduct of science and health policy. Effective health policy needs to be based on good science.
The industry not only continues to argue against unfavorable scientific findings and produce
contradictory evidence, but is attempting to shape the definition of good science on a greater
scale to serve its economic self-interest rather than the public health.
- N
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jTable 1: Health Effects Associated with Exposure to Environmental Tobacco Smoke12
rrr~ects Causally Associated with ETS Exposure
evelo mental Effects
etal Growth: Low birthweight or small for gestational age
V=udden Infant Death Syndrome (SIDS)
es irato Effects
cute lower respiratory tract infections in children (e.g., bronchitis and pneumonia)
thma induction and exacerbation in children
hronic respiratory symptoms in children
ye and nasal irritation in adults
ddle ear infections in children
arcino enic Effects
ung Cancer
asal Sinus Cancer
ardiovascular Effects
eart disease mortality
cute and chrogic coronary heart disease morbidity
Jfffects with Suggestive Evidence of a Causal Association with ETS Exposure
evelo mental Effects
pontaneous abortion
dverse impact on cognition and behavior
es irato Effects
xacerbation of cystic fibrosis
ecreased pulmonary function
Carcinoeenic Effects
Qervical cancer
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produce accurate coverage of the situation. However, this coverage could not stem the continued
reports from the tobacco industry and allied supporters that the study demonstrated no link
between passive smoking and lung cancer. ASH's formal complaint about the Sunday Telegraph
article to the UK PCC may not have been upheld by the PCC due to the conflict of interest
established when Sunday Telegraph editor Dominic Lawson joined the PCC before the
adjudication of ASH's complaint. Instead of publishing a WHO letter of response, the Sunday
Telegraph was allowed to continue repeating its same statements and apply its own interpretation
on IARC's work.
British American Tobacco (BAT) played a prominent role in promoting the notion that
the IARC study did not demonstrate a link between passive smoking and lung cancer. BAT
publicly acknowledged it had been tracking the IARC study through public scientific conferences
and the biennial report, and conducted media briefings on the IARC study starting a month
before the Sunday Telegraph article. The motivation for the article may have been preempting
the UK Scientific Committee on Tobacco and Health announcement two days later concluding
that passive smoking caused lung cancer and other diseases. Months later, in contrast to the
Sunday Telegraph, with which BAT had discussed its interpretation of IARC's results, BAT
quietly backed down when the IARC study was published and changed its comment about the
IARC study's resiilts from demonstrating "no risk" to "dtinimal risk."
In all these events, Philip Morris (PM) did not appear as a critical voice. However, as
demonstrated below from the industry's previously confidential documents, PM was the company
that initiated a plan to manage the IARC study's impact and organized the entire industry to
implement its plan. These plans started five years prior to the Sunday Telegraph March 1998
article. The long-term programs devised by PM were much more extensive and subtle than
BAT's involvement with the media for the IARC study.
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CHAPTER 1: INTRODUCTION
The Science of Secondhand Smoke
Secondhand smoke is the material emitted from a smoldering tobacco product or exhaled
by a smoker. This smoke shares many of the same constituents as mainstream smoke, the
material inhaled by a smoker which contains over 4,000 individual constituents. Under
California's Health and Safety Code established by Proposition 65, over 50 compounds in
tobacco smoke have been identified as carcinogens and six identified as developmental or
reproductive toxicants. Chemicals present in secondhand smoke include irritants and systemic
toxicants, mutagens and carcinogens, and reproductive toxicants.'?
The health effects of mainstream smoke as the subject of scientific studies started in the
1940s, but studies undertaken for secondhand smoke studies started in the 1970s. One of the
first systematic reports of secondhand smoke's health effects was reported in the Lancet in 1974,
in which Walter Holland's group in London reported that home exposure to secondhand smoke
was associated with increased respiratory disease in children.3 In 1981, the first secondhand
smoke case-control epidemiologic study4 demonstrated that nonsmokers married to smokers had
a 40% greater risk of lung cancer than those married to nonsmokers. By 1986, 13 studies had
been done on passive smoking and lung cancer, and the U.S. Surgeon General issued the first
report on passive smoking concluding that "involuntary smoking causes disease, including lung
cancer, in healthy nonsmokers;"5 the National Academy of Sciences also issued a similar report
reaching the saine conclusions.6 By 1992, the U.S. Environmental Protection Agency produced a
risk assessment report of the health effects of secondhand smoke,7 identifying secondhand smoke
as a Group A (known human) carcinogen, a category that placed secondhand smoke along with
potent cancer-causing agents like benzene and asbestos. Glantz and Parmley demonstrated that
secondhand smoke accounted for more deaths due to cardiovascular disease, and estimated the
total mortality caused by secondhand smoke at 53,000, placing passive smoking as the third
leading cause of U.S_ preventable deaths, behind active smoking and alcohol.
Other major and more recent reports on secondhand smoke, similar to the 1992 U.S. EPA
report, have been produced around the world_ Australia produced its first review in 1986 $ in
which the identified risks were substantial enough to recommend the introduction of policies and
practices to reduce secondhand smoke exposure; the second review in 1997 concluded that
passive smoking causes lung cancer, respiratory illness in children, and possibly coronary heart
disease 9 The California EPA produced a report' in 1997 concluding that secondhand smoke
exposure is causally associated with developmental, respiratory, carcinogenic, and cardiovascular
effects (Table 1); this report has now been reproduced as a National Institute for Health
Monograph on Smoking and Tobacco Control in 1999.2 The UK Scientific Committee on
Tobacco and Health reported in March 1998 that passive smoking caused lung cancer, ischemic
heart disease, serious respiratory illness and asthmatic attacks in infants and children, sudden
infant death syndrome, and likely middle ear disease in children.10 The scientific consensus that
secondhand smoke causes morbidity and mortality continues to cross international borders.
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The study validating the IARC study's questionnaire indicated results suggesting that
women are exposed to a background level of secondhand smoke not reflected in the
questionnaire.79 However, the IARC case-control study2' only adjusted for the industry's form of
misclassification bias in the relative risk ratio's numerator. The LARC study did not similarly
adjust the denominator, resulting in a depressed estimate of the relative risk. The point estimate
of risk in the IARC study may very well be above the reported 1.16 and 1.17.
Sumwnary
The Sunday Telegraph s March article was the first public manifestation of the tobacco
industry's strategies to manage the impact of the IARC study's findings. At the time, BAT
seemed to be the only involved tobacco company, with its direct quotations in the Sunday
Telegraph article and press releases_ Subsequent media coverage from various sources
perpetuated the allegations, even after press releases to the contrary issued by WHO and IARC.
Those continuing to promote such messages included tobacco company R.J. Reynolds and
industry allies like the National Smokers' Alliance_
The allegations targeted the reputation and the work of the WHO and IARC. The WHO
was criticized for withholding scientific research out of embarrassment that the results
contradicted its official stance, despite the fact that the IARC study was still undergoing pcer
review and that the WHO tobacco control office did not coordinate with IARC's activities. The
IARC authors' findines were misrepresented as demonstrating "no link" between nonsmokers'
exposure to secondhand smoke and lung cancer, even after IARC published its conclusions in a
peer-reviewed joumal. LARC and its work were subject to manipulation when its mandated
biannual report of ongoing research described the preliminary results.
The concept of statistical significance was misused in the interpretation of the IARC
study's results, creating a faulty basis for the "no link" allegations between passive smoking and
lung cancer. Statistical significance denotes a relationship between two groups of observations
indicating that the difference between the two is unlikely to have occurred by chance alone. A
result that does not reach statistical significance does not necessarily mean that the result is
negative. In the case of the LARC study, the results did not reach statistical significance, but the
increased point estimate of risk is consistent with the body of evidence from previous studies.28
In contrast to the statistical misrepresentation of "no link", the LARC study may have
reported a lower point estimate of risk than the data actually justified. The IARC investigators
considered only one type of misclassification error in their analysis, the error that could inflate
the risk estimate. The other type of misclassification error would have required the LARC
investigators to factor in the background levels of secondhand smoke to which all the subjects
were exposed, as demonstrated by an earlier LARC study, and could have depressed the point
estimate. The latter error was left out of IARC's study. As a result, IARC may have
underestimated the point estimate of risks of 1.16 and 1.17.
Formal measures to clarify the misinformation were only partially successful. The press
releases issued by WHO and LARC helped the scientific community and major news sources to
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