PUBLIC HEALTH

Public healthTobacco industry efforts subverting International Agency for
Research on Cancer’s second-hand smoke study
Elisa K Ong, Stanton A Glantz
Scientific reports on second-hand smoke have stimulated legislation on clean indoor air in the USA, but less so in
Europe. Recently, the largest European study, by the International Agency for Research on Cancer (IARC),
demonstrated a 16% increase in the point estimate of risk in lung cancer for nonsmokers, a result consistent withearlier studies. However, the study was described by newspapers and the tobacco industry as demonstrating no
increase in risk. To understand the tobacco industry’s strategy on the IARC study we analysed industry documents
released in US litigation and interviewed IARC investigators. The Philip Morris tobacco company feared that the study(and a possible IARC monograph on second-hand smoke) would lead to increased restrictions in Europe so they
spearheaded an inter-industry, three-prong strategy to subvert IARC’s work. The scientific strategy attempted toundercut IARC’s research and to develop industry-directed research to counter the anticipated findings. The
communications strategy planned to shape opinion by manipulating the media and the public. The government
strategy sought to prevent increased smoking restrictions. The IARC study cost $2 million over ten years; Philip
Morris planned to spend $2 million in one year alone and up to $4 million on research. The documents and interviewssuggest that the tobacco industry continues to conduct a sophisticated campaign against conclusions that secondhand smoke causes lung cancer and other diseases, subverting normal scientific processes.
In 1978, a confidential study for the US Tobacco Instituteconcluded that public concern about second-hand smoke,also referred to as environmental tobacco smoke (ETS)and “passive smoking”, was “the most dangerous threat tothe viability of the tobacco industry that has yet
occurred”.1 The industry’s concern was borne out as threelandmark reports concluded that second-hand smoke didcause lung cancer and other diseases,2–4 leading tolegislation on smoke-free environments in the USA.5,6 Few
such studies had been done in Europe,7 and European
countries have been slower to implement smoke-freemeasures.8
This European situation was poised for change whenthe International Agency for Research on Cancer (IARC),a research branch of the World Health Organization(WHO), undertook, from 1988, the largest European
epidemiological study on lung cancer and second-handsmoke.7 Consistent with earlier studies (panel 1),2–4,9–12
IARC7 observed a 16% increase in risk for nonsmoking
spouses of smokers (95% CI 0·93–1·44), and a 17%
increase for nonsmokers’ exposure in the workplace (95%CI 0·94–1·45).7 The study was too small to detect, with
95% confidence, an increase in risk of around 16%, thesample size having been selected to have enough power todetect a relative risk of 1·3. The October, 1998 issue of the
Journal of the National Cancer Institute published the study
with an editorial concluding that the new study data, plus
previous evidence, presented “an inescapable scientificconclusion . . . that ETS is a low-level lung carcinogen”.13
Lancet 2000; 355: 1253–59
Institute for Health Policy Studies, Cardiovascular ResearchInstitute, Department of Medicine, University of California, San
Francisco, San Francisco, CA USA (E K Ong BA, Prof S A Glantz PhD)
Correspondence to: Dr Stanton A Glantz, Division of Cardiology,
Box 0130, University of California, San Francisco, CA 94143-0130,
USA(e-mail: glantz@medicine.ucsf.edu)

THE LANCET • Vol 355 • April 8, 2000

This journal publication was not, however, the first the
public had heard of the IARC study. On March 8, 1998,
the London Sunday Telegraph reported that WHO waswithholding a study that not only failed to show that
passive smoking caused lung cancer but also might evendemonstrate a protective effect.14 British American
Tobacco (BAT), which had held private media briefings15
to ensure “balanced” coverage of the forthcoming study,
was suspected to have fuelled the story.16 BAT responded
that it knew of IARC’s preliminary results from earlier
conferences and IARC’s biennial report,17 which hadreported the study’s progress by providing results but noconclusion. Despite press releases from WHO18 andPanel 1: IARC and major summaries evaluating risk of lungcancer in passive smokers
Organisation
7

IARC

Year

Country Relative risk (and 95% CI)

1998

Europe† 1·16 (spousal) (0·93–1·44)
1·17 (workplace) (0·94–1·45)
UK
1·20–1·30( N/A)

Scientific Committee 1998
on Tobacco and
Health9
California
Environmental
Protection Agency10

1997

USA

1·20 (N/A)

National Health and 1997
Medical ResearchCouncil11

Australia 1·32 (1·10–1·69)

US EPA4

1992

USA

1·19 (1·01–1·39)

1986

USA

1·34 (1·18–1·53)

1986

USA

1·53 (N/A)

National ResearchCouncil3
Surgeon General2*Confidence intervals are two-tailed 95%, except US EPA which is one-tailed 95% (two tailed
90%).
†Seven European countries.
N/A=not applicable.

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PUBLIC HEALTH

Glossary: Abbreviations
BAT
CIAR
EPA
ESEF
ETS
GEP
IARC
IEMC
NHANES
PM
PMCS
RJR
TASSC
WHO
WRA

British American Tobacco
Tobacco industry’s Center for Indoor Air Research
US Environmental Protection Agency
European Science and Environment Forum
Environmental tobacco smoke
Good Epidemiological Practices
International Agency for Cancer Research, Lyon, France
International ETS Management Committee
National Health and Nutrition Examination Survey
Philip Morris tobacco company
Philip Morris Corporate Services
R J Reynolds tobacco company
The Advancement of Sound Science Coalition
World Health Organization
PM’s Worldwide Regulatory Affairs

IARC19 noting that the study still awaited peer-review
publication and calling the Sunday Telegraphinterpretation of statistical significance “false andmisleading”,19 the allegations quickly spread around theworld, from Australia20 to Zimbabwe.21
To understand the industry’s strategy towards the IARC
study, we examined previously confidential tobacco
industry documents that reveal how Philip Morris (PM)spearheaded an extensive inter-industry effort to stop, affectthe wording of, delay, and counteract the IARC study.

Data sources
The tobacco industry documents are among 32 million
pages made public as part of the settlement of the 1998
legal case of State of Minnesota and Blue Cross/Blue
Shield of Minnesota vs Philip Morris Inc, et al. These
documents are deposited in Minneapolis and each
tobacco company has a searchable website archive.
Search terms included IARC, IEMC, WRA, GEP,TASSC, NHANES (see glossary), “confounders,” andthe names of key players. Most of the documents referredto here are on PM’s website.* We also asked IARC
investigators (see acknowledgments) to describe theirexperience with the industry and to confirm information
about themselves reported in certain documents.

Initial fears and organisation
The 1992 US Environmental Protection Agency (EPA)
report4 provided a comprehensive evaluation of secondhand smoke’s health effects that stimulated clean indoor
air laws in the USA.6 As similar legislation increased
worldwide,PM
began
monitoring
research
internationally to prevent further restrictions. By 1993,
Philip Morris Corporate Services in Brussels expressed
concern that the IARC study would become “Europe’s
EPA”. PM also feared that IARC would produce, fortobacco smoke, one of its authoritative monographs
reviewing and classifying carcinogens. The global respect
for IARC’s work led the chairman of the public relations
firm Burson-Marsteller to advise PM:“Let’s assume for a moment that IARC ‘confirms’ EPA thatETS is a probable low risk carcinogen. There is no way we canconvince the world that they are wrong. The critical regulatory
issues is what the world will do about [it]”.

PM decided on a proactive response rather than simply
reacting after publication. The 1993 “IARC Objectives”
were to:*www.pmdocs.com; on this website the documents are identified by“Bates number” and Lancet readers will find a list of the same
documents used in this article attached to the version freely available on
www.lancet.com. Some non-PM websources are also referenced.

1254“ ● Delay the progress and/or release of the study● Affect the wording of its conclusions and official
statement of results● Neutralize possible negative results of the study,
particularly as a regulatory tool
● Counteract the potential impact of the study on
government policy, public opinion, and actions byprivate employers and proprietors”

These objectives formulated the beginnings of acoordinated strategy for scientific, communications, andgovernment relations issues related to IARC. R W
Murray (chairman of PM Companies) was presented withthese details in 1993, and PM’s board of directors was
informed of the proactive measures to deal with the study
in 1995.
By September, 1993, PM had established a high-level,
multidisciplinary task force with representatives fromlegal, research and development, science and technology,
and corporate services departments (figure 1). The initialleader was Matthew Winokur of PM’s Worldwide
Regulatory Affairs (WRA), a department created in July,
1993 for “the strategy and coordination of activities
relating to environmental tobacco smoke and the social
acceptability of smoking”. WRA’s 1994 budget was $66·1
million, with $2 million earmarked for the IARC plans.
The IARC study is estimated to have cost $1·5–3·0
million over ten years.
PM also organised the industry worldwide, as Winokur(chair, PM IARC Task Force) reported on Jan 17, 1994:“PM initiated and chairs an industry-wide task force tomanage both the IARC monitoring and scientificintelligence gathering process and the development of a
global communications/government relations plan toaddress [the] impact of the [IARC] study”. Besides PM,
the group included R J Reynolds (USA), Rothmans(UK), Imperial (UK), BAT (British American Tobacco),and Reemtsma (Germany). The group’s objective was to“coordinate plans and resources among the companies
and in conjunction with National Manufacturers
Associations”. This industry-wide task force is theInternational ETS Management Committee (IEMC).
PM senior vicepresident andgeneral counsel

PM Corporate
Services, Brussels

SHB law firm

IARC Task Forceteam leader
Institut für
Biologische
Forschung

PM ScientificAffairs,
Richmond, VA

PM Science& Technology,
Neuchatel

CIAR
Figure 1: Philip Morris’ IARC Task Force structure
CIAR, responsible for producing studies to offset the IARC study, would
communicate with PM Europe Science and Technology and PM USA
Scientific Affairs. These scientific departments would report to PM’s IARC
Task Force team leader, who would communicate with the legal
resources, PM Corporate Services in Brussels, and PM senior
management.
Source=adapted from Bates 2023897132 at www.pmdocs.com

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PUBLIC HEALTH

Panel 2: Philip Morris’ approach on IARC methodology“1 To ascertain a range of information on the study objectives,
status, parameters, predisposition of IARC team/collaborators,
timing, likely results, etc.
2

To brief the country collaborators and the IARC team on theindustry perspective on ETS and to make them mindful of the
weaknesses of epidemiology that rely on survey questionnaires.
We recognise that there is [sic] down side to this in that our
input could help them improve the quality of the study. However,
it is considered that the benefits outweigh the risks if thecollaborators can be persuaded that the IARC methodology isinadequate (it does not take into account confounders or
measure actual exposure leading to misclassification).”National tobacco monopolies were also recruited. France’s
Seita financially contributed to the IEMC-funded
research, Japan Tobacco had a response plan to the IARC
study by 1997, and Indian Tobacco Company and Korean
Ginseng and Tobacco Research Institute were kept
informed of the IEMC’s Asia-specific IARC preparations.

Panel 3: Philip Morris’ 1994 plan to influence potential IARC
monograph“1 Encourage re-evaluation of IARC monograph priorities
Budgetary constraints of funders (US Cancer Institute,WHO, EU).
Funders have been identified. Possibility for influence agreed
as extremely limited.
Competing interests (within IARC) for other monographs
Contact envisaged direct with IARC via S&T [PM Science &Technology], C&B [Covington & Burling law firm] and SHB[Shook, Hardy, and Bacon law firm] consultants + CIAR.
2

Encourage balanced perspectives among experts in IARC
Monograph Working Group
It is expected that invitations will be issued by IARC to both[Peter] Lee [industry consultant] and a SHB consultant.
Efforts are ongoing to encourage IARC invitations to other“objective” scientists by encouraging them to be vocal on
the issue now . . .

3

Try to obtain observer status in IARC Monograph Working Group
Coffee precedent. Procedure to get observer status known.
Need to identify best industry representative(s).”Scientific strategy
IARC study
In early 1993 PM had asked Covington and Burling“through their consultants, to try and uncover as muchinformation as possible on the current status, etc, of the
IARC study” and requested “all those who receive a copyof this memo to use whatever internal and external
resources they may have or may know about to help us
get more information on the IARC study as quickly as
possible”. Covington and Burling, the industry’s
Washington, DC based law firm, had established a
network of sympathetic scientific consultants in Europe a
few years before, known as “Project Whitecoat”, to help
the industry “produce research or stimulate controversy”.
These consultants systematically approached the IARC
investigators, reporting back to the tobacco industry on
the study’s design, questionnaire, progress and authors’scientific viewpoints. Such efforts allowed PM to compile
a picture of the IARC study and to begin assessing thestudy design for weaknesses.
Unaware of PM’s coordinated plans, IARC
investigators were nonetheless cautious about discussing
the results with industry representatives, but theconsultants did not always disclose their industry
affiliations. For example, PM obtained its most detailed
intelligence about IARC in 1993–94 from the Italianconsulting firm SCR Associati. One anonymous report
described a meeting between the IARC investigators thatrecorded specific confidential results, including expected
relative risks from different centres participating in the
IARC study. The name of the consultant is not disclosed.
The IARC investigators were not aware of a consultant’spresence. SCR Associati’s source of information in
additional consultant reports about IARC was the late
Giuseppe Lojacono (former professor of healtheconomics, University of Perugia). Lojacono visited
IARC several times in his role as a journal editor andinquired about the IARC study, without disclosing his
relationship with the tobacco industry.
PM’s objectives in contacting the investigators went
beyond tracking the study’s progress; a PMCS Brussels
report describes its objectives (panel 2). PM was notcontacting the investigators to help them improve thestudy but to promote the industry’s perspective about the
study’s inadequacies.

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The executive director of the industry’s Center for
Indoor Air Research (CIAR) visited the IARC head
investigators, who did not understand at the time that
CIAR was funded by the tobacco companies. Winokur
listed ideas on how to use CIAR to engage IARC:
assisting IARC with future studies, encouraging IARC to
include an industry consultant in designing analysis
protocols, recruiting IARC investigators for CIARsponsored studies, and granting the senior IARC cohead-investigator funding or an advisory board position.
IARC decided not to collaborate with CIAR. The
industry did try to recruit individual investigators for a
CIAR-sponsored study and one IARC-affiliatedinvestigator did undertake a CIAR-funded study.
IARC monograph
In 1994, PM examined its options in influencing theoutcome of a potential IARC monograph reviewing thehealth effects of second-hand smoke (panel 3).
If PM could not shelve the monograph outright byredirecting financial or institutional priorities it would try
to participate in the process and produce a “balanced
perspective”. The inquiry into redirecting IARC’spriorities extended to the new IARC director, who, PM
anticipated, would “be dealing with a strangled budget”.
To its disappointment, PM later reported that the new
IARC director was a “‘fervent antismoker’ who believes
that ‘passive smoking is more dangerous than active
smoking’”. Regarding the memorandum’s reference tothe industry’s “balanced perspective”, the industry has
sponsored and promoted “special reviewed” (not peerreviewed) research projects awarded by industry
executives,22
review
articles,23
andsymposium
24,25
publications
that generally conclude that second-handsmoke is not harmful. The reference to a “coffee
precedent” refers to the preparation of an earlier IARC
monograph, when Covington and Burling’s consultants“were able to give General Foods [a division of Philip
Morris] considerable information about IARC’sevaluation of coffee as a possible risk factor for cancer”.
Anticipating the IARC study and monograph , IEMC
funded research “to expose the weakness of
epidemiology” through CIAR. PM commissioned two
types of study in the same countries in which IARC

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Panel 4: Philip Morris’ communication stratey“Develop a communications programme to build appropriate
public/policy climate in advance of the study results (PMCS,
S&T, Legal).
Develop a contingency plan, should the preliminary results beleaked.
Assemble a crisis communications team/plan to manage the impactof the release of the study . . .
Evaluate the pros and cons of conducting journalist briefings prior to
the release of the study.
Prepare pre/post public and leadership opinion surveys to evaluate
the impact of the findings on public attitudes towards ETS andthe need for smoking restrictions.
Develop a programme to generate support for ‘junk science’ andeducation on use and abuse of epidemiology, possibly through a
coalition on bad science . . .
Develop a communications programme to mute/neutralise smokingbans/excessive restrictions . . .”conducted its study and projected the cost at $4 million.
The CIAR studies were to be finished before publicationof the IARC study. PM sought “to develop means ofproviding IARC with relevant data so they will either
consider it in their report [monograph], or if they don’t,
we will be in a position to ask them why”.
The first type of study monitored nonsmokers’ secondhand smoke exposure using personal air samples. Pilot
studies were done by the US Oak Ridge National
Laboratory26,27 and UK Hazleton Laboratory;28 Hazleton
subsequently did studies in the same countries as
IARC,29–36 as well as in Asia and Latin America. Despite
the reluctance of Hazleton’s parent company, PM waseager to promote an interpretation of the studies’ findings;
later, the Aug 16, 1998, Sunday Telegraph reported thatthe studies demonstrated that “real-life levels” of secondhand smoke probably do not cause fatal diseases.37 The
pilot studies were shown to be unreliable sources of dataon second-hand smoke exposure at the US National
Toxicology Program;38 results for salivary cotinine (anicotine metabolite)39 were far below what was expected
for the reported air nicotine levels. The industry’s
prominent role in collecting the data may account for thisresult. RJR and its marketing research firm conducted allof the US study’s operations, with the author simply
analysing industry-provided data;40 Rothmans drafted
Hazleton’s protocols and questionnaires for the European
studies, which would also use the industry’s second-handsmoke personal exposure monitors.
The second type of study analysed the nonsmoking
population for confounding factors other than secondhand smoke exposure that might explain a risk for cancer.
Genevieve Matanoski and her colleagues’ analysis of a US
nutritional survey was funded by CIAR.41 PM also planned
to analyse similar large databases in Japan, Hungary,
Germany, UK, Sweden, and Switzerland. PM also
commissioned confounder studies from industry
consultant Ragnar Rylander (University of Gothenburg)42,43
and worked with the German Verband (similar to theindustry’s US Council for Tobacco Research) and the
GESOMED research institute. As of 1999, an IARC
investigator (Francesco Forastiere) was also conducting a
CIAR-funded confounder study. Matanoski and Forastiereboth acknowledged CIAR funding.

Communications strategy
PM planned a variety of programmes to deliver andreinforce the industry’s perspective on second-hand1256

smoke, described in the September, 1993 “Action Plan”(panel 4).
The industry implemented these programmes before
the IARC study’s release. Besides the programmes thatwere internally conducted, PM used third-party vehicles
that recruited other participants and funders andexpanded its “sound science” discussion to issues beyond
second-hand smoke, masking the industry’s role as theinitiator or sponsor of these programmes.
From 1993 to 1994, PM and public relations firm
APCO Associates worked to launch The Advancement ofSound Science Coalition (TASSC), a “grassroots”
organisation advocating “sound science” in policy
decision making. PM wanted a similar organisation in
Europe at the end of 1994, with potentially sympathetic
European scientists invited to a conference hosted by
TASSC. However, Burson-Marsteller research indicatedthat potential European members wanted independence
from any corporate sponsors; two people specificallymentioned PM as typical of questionable corporate
sponsors. It appears that the outcome was the European
Science and Environment Forum (ESEF), established in
1996,44 whose executive director sought funding from thetobacco companies. In December, 1997, ESEF andTASSC issued a joint press statement, in which bothorganisations have identical descriptions.45 ESEF now
states46 that its funding only comes from sales of its
working papers, one of which criticises IARC and theevidence on second-hand smoke. ESEF’s medical
demographer, Lorraine Mooney, published a Wall Street
Journal Europe opinion piece stating that the IARC
study’s possibly “trivial or nonexistent” true risk ratio
demonstrated the overstated health risks of second-handsmoke.47
Continuing the “sound science” theme, PM expanded
the promotion of “Good Epidemiology Practices” (GEP),
a guideline standardising the conduct of epidemiologicalresearch. The Chemical Manufacturers Association hadoriginated GEP in 1991 and the idea was being pushed inEurope by chemical companies. However, PM foundthose guidelines inadequate, as PM’s Thomas Borellicommented: “ . . . It lacks teeth and as written it does nothave enough meat to help us on ETS. However setting up
our own standards is a good project for us”. It would be“good offensive strategy” for their consultants to be “outthere trying to fix epidemiology instead of being critical
all the time”.
GEP was “urgently needed” to challenge themethodology of the IARC study and monograph review.
PM drafted revised guidelines, covering IARC, forendorsement by a sound science coalition and planned a
GEP seminar with members of European government
bodies interacting with selected epidemiologists, screenedout for anti-tobacco views. A European Council
resolution on GEP was drafted by John Rupp of
Covington and Burling. Seminars on good risk
assessment and GEP were conducted by PM-sponsoredFederal Focus Inc in the USA and UK,48 industry
consultant Myron Weinberg’s The Weinberg Group in
Europe, and CIAR in China.
The industry sought to manage and monitor the
public’s perception of the IARC study’s results. European
sentiment towards smoking restrictions was not reflectedin legislative action: a 1989 PM survey in ten European
countries concluded that “both smokers and non-smokers
in Europe desire more rules in the future against smoking

THE LANCET • Vol 355 • April 8, 2000

PUBLIC HEALTH% who believe that government should pass laws
restricting cigarette smoking in public places

100
90
80
70
60
50
40
30
20
10

UK
USA

Fin
Swe
den

tz
erm

Swi

WG

Italy
Fran
ce

Turk
Gre
ece
Spa
in

0

Figure 2: Results of large multinational survey, conducted by
PM International, of public opinion on regulation of smoking
1989 survey in 10 European countries with a random sample
representative of each population using 1000 smokers and 1000
nonsmokers, in each country.
Source=adapted from Bates 2500147468–2500147533 atwww.pmdocs.com

in public places” and that Europeans are less opposed togovernment involvement with smoking than Americans(figure 2). Public relations firm Burson-Marsteller wrote
a 13 page “Preparedness plans for the announcement of
the IARC study”, and organised IEMC members into
three teams for a coordinated interindustry response, tobe delivered within 48 hours, to IARC’s findings, and PM
management held “IARC simulation” response exercises.
PM realised that the tobacco industry had little
credibility in Europe, and it turned to the media topromote its messages. PM had even considered
producing its own journal to critique “the objective
validity of statements claimed to be scientific—and
therefore their technological or policy usefulness”. BAT
instigated the March, 1998, press articles about the IARC
study. A comprehensive press package included aprerecorded interview with BAT, background material on
IARC and statistical results of second-hand smoke
studies, and surveys of irritating behaviours. Winokur
reported that the “publicity generated by BAT” started
with the March, 1998, Sunday Telegraph story andcontinued with promotions in the USA, Australia, Brazil,
and other markets. BAT Bangladesh sent the Sunday
Telegraph articles to a Bangladesh newspaper that refuses
cigarette advertisements.49 Winokur noted that the timingof the Sunday Telegraph story seems to have been
designed to precede the release of the UK’s ScientificCommittee on Tobacco and Health report9 on passive
smoking three days later.

Government relations strategy
In September, 1993, PM planned to develop a lobbying
plan before and after the IARC study’s release. PMsought “key international government influence points”
in the IARC donor countries for “generating pressure forreorientation/reprioritisation of IARC priorities/budget

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allocations”, and planned to lobby regulatory bodies andsecure preemptive legislation against smoking restrictions.
In 1994, PM developed a “briefing book” about the
IARC study for the industry’s messengers, allies, andgovernment contacts to provide a standardised resource
to support PM’s plans. The table of contents indicatesthat the book assesses possible bias by the investigators,
criticises the study design, questions the role ofepidemiology as a basis for policy, and drafts arguments
for sympathetic allies and industries.
Besides the industry’s traditional concept of lobbying,
the GEP programme was to become a lobbying tool,
presumably to convince the EU to adopt a standard thatwould discredit the study. Indeed, the Commission of the
EU sponsored the Weinberg-organised seminar, which
had “the valuable concept of administrators being
moderators, and hence, the target of the expert
presentations in breakout sessions”. These moderators
included representatives from the EU’s Directorates
General V (Employment, Industrial Relations, and Social
Affairs) and XII (Science, Research, and Development),
the UK’s Environmental Agency, and Sweden’s EPA.
PM planned to commit $220 000 to repeat theconference in Asia with the Association of Southeast
Asian Nations.
The industry now cites the IARC study to governmentand regulatory bodies as evidence that second-handsmoke does not cause cancer, contrary to IARC’sconclusions,7 or that it has numerous flaws. Examples
include Imperial Tobacco’s (a Canadian BAT subsidiary)
published stance for legislators about smoking-related
issues,50 the Tobacco Institute submission about atobacco bill to the South African Parliament’s Portfolio
Committee on Health,51 and PM’s submission andtestimony to the US National Toxicology Program review
of second-hand smoke.

Discussion
The massive effort launched across the tobacco industry
against one scientific study is remarkable. Whereas overten years (1988–98) the IARC study is estimated to havecost $1·5–3·0 million, PM alone budgeted at least $2
million for “IARC” plans for just one year (1994) andproposed $4 million for studies to help discredit IARC’swork. The elaborate plans were developed by PM’s top
management, implemented by an elite task force, anddesigned to coordinate the international tobacco industry.
The complex plan relied on third-party vehicles that did
not reveal the extent of the industry’s efforts to shape thescientific, communications, and government relations
issues of secondhand smoke on a worldwide basis. Suchlong-term programmes, from scientific consultants to“sound science” coalitions to GEP seminars, were
instituted to influence the scientific basis of policymaking
and public perception on second-hand smoke more infavour of the industry. BAT’s March, 1998, media event
represented only the first public manifestation of theindustry’s effort. BAT took advantage of IARC
publishing the study’s results without an accompanying
conclusion in its biennial progress report, and timed its
efforts to undermine the credibility of the UK ScientificCommittee on Tobacco and Health report on secondhand smoke, which was released a few days later.
BAT’s media misrepresentation was not the first timethe industry misrepresented a second-hand smoke study’s
results as showing no risk. In 1981, Lawrence Garfinkel

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PUBLIC HEALTHof the American Cancer Society published a paper52
which, like the IARC study, reported an increase in risk
(relative risk=1·27) that did not reach statisticalsignificance (95% CI, 0·85–1·89). Garfinkel noted thisfailure might have been related to methodologicalproblems. The US Tobacco Institute ran advertisements
in major US newspapers and magazines claiming that the
Garfinkel study demonstrated an “insignificant”43,53,54 and“very little, if any” effect55 on lung cancer andnonsmokers. Finally, three years later, in 1984, Garfinkel
protested in a letter to the New York Times that theindustry had taken his work out of context and distorted
the results.55 After the Tobacco Institute of Australia ran asimilar advertisement in 1986, the Australian Federationof Consumer Organisations successfully sued the
Tobacco Institute of Australia on the grounds that theadvertisement was false and misleading.56
The IARC and Garfinkel examples demonstrate how
the tobacco industry has been trying to shape thescientific debate on the statistical interpretation of
second-hand smoke studies. The industry imposes a onesided interpretation of confidence intervals, focusing theentire discussion on whether the lower bound of the 95%
CI for a relative risk includes 1. By definition, if the lower
bound exceeds 1, then the risk is statistically significantly
raised (with p=0·05). Whether or not there is anything
magic about 95%, the true risk is equally likely to be
anywhere inside the 95% CI, including values above thepoint estimate. In environmental and health and safety
regulation, it is common to take the health-protective
approach of basing public policy on the upper 95%
confidence limit (1·44 and 1·45 for the IARC study7).
The industry’s discussions of the risks of passive smoking
ignore the upper end of the confidence interval.
The IARC study’s results did not reach statisticalsignificance, and the IARC investigators noted that thiswas due to the study’s low power. The IARC study was
originally designed to have a statistical power of 80% todetect a relative risk of 1·3,7 rather than a more realistic
expected risk of around 1·2. Detecting this lower risk with
95% confidence would have required a larger sample size
than the study used (because it was powered based on thehigher presumed risk of 1·3). Hence, despite a point
estimate above 1 for the risk in the study, this low power
produced a wide confidence interval, too wide forstatistical significance. The industry has represented thefact that the increase in risk observed did not reachstatistical significance as indicating that the study did not
find any increased risk.
The IARC study may, in fact, have underestimated thetrue relative risk of lung cancer associated with secondhand smoke. An industry statistical criticism, given muchconsideration by IARC and others, relates to themisclassification of smokers as nonsmokers. Such a
misclassification error would incorrectly raise thenumerator in the risk ratio because active smoking
increases the risk of lung cancer. This error, however, hasbeen repeatedly shown to be small,4,57–59 including in the
IARC report itself.7 In contrast, another misclassification
error, never mentioned by the industry, arises if people inthe “unexposed” group are actually exposed tobackground second-hand smoke. This error biases results
towards the null, leading to systematic underestimates ofthe effect of second-hand smoke. Repace, for example,
estimated the effects of background exposure tosecondhand smoke and found that properly correcting the1258

Garfinkel study52 for background levels increases the point
estimate of the relative risk from 1·2 to 1·7.60 The study
validating the IARC study’s questionnaire included
results suggesting that women are exposed to a
background level of secondhand smoke not reflected in
the questionnaire.61 The IARC lung cancer study7 only
adjusted for the industry’s form of misclassification bias
in the relative risk ratio’s numerator and did not similarly
adjust the denominator. The true point estimates of riskof lung cancer in the IARC study may very well be above
the reported 1·16 and 1·17.
Scientists and policy makers need to understand thatthey function in an environment that is heavily influenced
by covert tobacco industry efforts to subvert the normal
decision-making processes. The industry has in the past
submitted material to major scientific evaluations similar
to the potential IARC monograph in New Zealand,62
USA,63 Australia,11 and UK,64,65 when these countries
were evaluating the health effects of second-handsmoke.4,9,11,66 The industry has filed lawsuits over scientificdecisions to exclude this material.11,67,68 However, eachreport’s conclusions that second-hand smoke causes lungcancer and other diseases remains unchanged.
Contrary to the tobacco industry’s fears, IARC has not
yet decided to prepare a monograph on the health effects
of second-hand smoke. Public attention has been focusedon lung cancer, but it is important to remember that heartdisease, not lung cancer, kills most passive smokers.
Moreover, second-hand smoke’s health effects range fromasthma in children to sudden infant death syndrome, withrecent research suggesting breast cancer as anotherpossible health effect.69 The strenuous effort mounted by
the industry to subvert the IARC study and prevent an
IARC monograph is probably the most compelling
justification for IARC to prepare such a publication thatconsiders not just lung cancer but all the diseases that
second-hand smoke causes.
Supported by US National Cancer Institute grant CA-61021. We thank
Paolo Boffetta, Rodolfo Saracci, Lorenzo Simonato, and Francesco
Forastiere for informative discussions.

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