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CONFIDENTIAL Dr. Giovanni Viegi’s links to the tobacco industry

as revealed by tobacco industry documents Pascal A. Diethelm

7 March 2006

1) At the request of Archie Turnbull, Executive Director, European Respiratory Society,

I have done a search of tobacco industry documents to find possible links between

Dr. Giovanni Viegi and the tobacco industry. I used the following websites:

Philip Morris USA Documents Site (http://www.pmdocs.com)

Legacy Tobacco Documents Library (http://legacy.library.ucsf.edu/)

British American Tobacco Archives (http://bat.library.ucsf.edu/)

2) I searched for “viegi” and inspected visually all the documents which matched this

search criterion, and then doing “snowball” searches for some documents to find

other related documents, using Bates number proximity or file proximity.

3) I also used other documents from the same websites, which I had already identified

and kept in my own collection.

4) The first two topics presented below are included because they are needed to

understand the context in which the facts described in this document took place. The

rest of the document follows a chronological order.

The Center for Indoor Air Research (CIAR)

5) The Center for Indoor Air Research was created in 1988 by three US tobacco

companies, Lorillard, Philip Morris and R.J. Reynolds. According to a letter from the

Tobacco Institute, which coordinated the creation of CIAR, the “principal purpose of

the research center would be to establish mechanisms for funding and supervising

industry-sponsored research on indoor air quality.” CIAR operations were supervised

by a Board of Directors, consisting of representatives of each company, with a

representative from the Tobacco Institute serving as secretary. (Bates No.

2025858523/8525)

6) Thomas Osdene, of Philip Morris, who was in charge of the establishment of CIAR

(Bates No. 2025856205/6208), made the following description of the purpose of

CIAR:

I think many of us have conceptualized the ETS issue as a battlefield in which the arena

is dominated by public relations and legal issues while the ammunition which is used

happens to be science. It has been the purpose of CIAR […] to provide ammunition in

this fight. (Bates No. 2046594609/4613)

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7) Another Philip Morris document gives further indication on CIAR:

CIAR has three classes of membership: Charter Members - tobacco companies who

established the Center (PM, RJR, and Lorillard) and provide the majority of the

funding; Regular and Associate Members - corporations that are interested in indoor

air quality research (regular members can be represented on the Board of Directors (the

Board) - none are, at present – while associate members are not).

The Center has an independent Science Advisory Board (SAB) which develops the

research agenda for approval by the Board. The SAB recommends proposals for

funding after they have been peer reviewed. Proposals can only be funded subsequent

to approval by the Board. A second class of research projects – Applied Studies – are

also funded if approved by the Board: such projects are not normally reviewed or

recommended by the SAB. (emphasis added - Bates No. 2021528170)

8) Although its bylaws included the possibility of regular and associate members, CIAR

remained throughout its brief existence entirely controlled by its charter members, the

tobacco companies. For example, the 1994 budget of the Center amounted to USD

5,646,078. 99,3% of this amount was shared among four tobacco companies: Philip

Morris (52,8%), RJR (38,3%), Lorillard (8.9%) and Svenska Tobaks for a fixed

amount of USD 150'000 dollars. CIAR budgets for 1994, 1995 et 1996 all include a

line labelled “Associate members”, who are not identified, with a fixed amount of

USD 40'000 for each year, i.e. 0.7% of the total budget. (Lorillard - Bates

No.89273190/3191)

9) It is important to note that CIAR funded two kinds of projects: regular projects were

submitted to the SAB for review, while “Applied Studies” bypassed the peer review

process and went directly to the Board of Directors, for approval by the

representatives of the tobacco industry. This scheme and its consequences are well

summarized in the abstract of the article by Barnes and Bero (Industry-funded

research and conflict of interest: an analysis of research sponsored by the tobacco

industry through the Center for Indoor Air Research. J Health Polit Policy Law. 1997

Oct;22(5):1279-93):

The Center for Indoor Air Research (CIAR) was created by three United States tobacco

companies in 1988. Its stated mission is to fund high-quality, objective research related

to indoor air, including studies of environmental tobacco smoke (ETS). Because CIAR

is financed by the tobacco industry and funds research related to tobacco, it fosters an

inherent conflict of interest. We consider whether this conflict of interest has affected

the content, quality, or use of research funded by CIAR. We hypothesize that the

tobacco industry might be using CIAR to develop scientific data to support its position

that ETS is not harmful to health. CIAR funds two types of projects: "Peer-reviewed"

projects are awarded after peer review by a group of scientists, whereas "special-

reviewed" projects are awarded directly by tobacco industry executives. CIAR's

special-reviewed projects are more likely than its peer-reviewed projects to be related to

ETS, to support the tobacco industry position, and to be used by the industry to argue

that smoking should not be regulated in public places. Our findings suggest that the

tobacco industry is funding special-reviewed projects through CIAR to develop

scientific data that it can use in legislative and legal settings. The industry may be

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financing peer-reviewed projects through CIAR to enhance its credibility, to provide

good publicity, and to divert attention from ETS as an indoor air pollutant. CIAR's

stated mission of funding high-quality, objective research has been compromised by

conflict of interest, and at least some of CIAR's projects are being used to promote the

tobacco industry's agenda.

10) The CIAR was dissolved in 1998 by the Master Settlement Agreement, among other

front organizations of the US tobacco industry, such as the Council for Tobacco

Research and the Tobacco Institute. The dissolution became effective in 1999.

Confounders studies

11) Confounder studies were launched by the tobacco industry, under the leadership of

Philip Morris, in the context of their strategy to “mitigate” the results of the IARC

large epidemiological study on ETS and lung cancer, as is clearly stated in an internal

presentation made in May 1994 by Steven Parrish, General Counsel and Senior Vice

President, Corporate Affairs, Philip Morris Management Corporation (Bates No.

2025494471/4490). Parrish’s plan includes the following objective:

SPONSOR ORIGINAL RESEARCH ON CONFOUNDERS AND EXPOSURE TO

CONTRIBUTE TO THE DEBATE ON THE STUDY AND MONOGRAPH AND

LOBBY ON THE SCIENCE.

12) Richard Carchman, Manager, Bio-Chemistry Research, Philip Morris Incorporated,

made a presentation to an industry group on 8 June 1994 in London (Bates No.

2028363271/3280), in which he proposed an industry response to the IARC study on

lung cancer in non-smokers. His proposal comprises five points, including the

following three:

2) Response plan to IARC ETS study:

a) Communication with scientists at IARC and at the collaborative centers

b) Execution of studies on confounders and exposure

c) PR response plan

3) Proposed studies are intended for use primarily in Europe, but results can be used

world-wide

[…]

5) Studies will be organized by and funded through CIAR.

(emphasis added)

Carchman also proposes a budget of USD 2,600,000 for the confounders

epidemiological studies.

13) The tobacco industry used as model for the planned European confounders study a

study undertaken for CIAR by Genevieve Matanoski in the United States. The results

of the Matanoski study were published in July 1995. The conclusions were, according

to a internal Philip Morris presentation on CIAR (Bates No. 2043704149/4173):

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NS women who were exposed to husbands who smoked were more likely to be “older”,

have lower education, live in the city, and have other health behaviors that could

increase their risk of lung cancer…

Many of the differences that the authors observed between the women who were

exposed and non exposed to passive smoking could affect the risk of cancer.

1995-1996: the Italian pilot confounders studies

14) At the meeting of the CIAR Board of Directors of 12 April 1995, Max Eisenberg, the

Executive Director of CIAR announced that “he and Dr. Genevieve Matanoski would

be meeting with Dr. Francesco Forastiere and Dr. Rodolfo Sarracci in Lyon at the end

of April.” (Bates No. 2050764815/4816) This visit to IARC was part of a plan which

is detailed in an internal Philip Morris document entitled: “CIAR AND IARC -

NEXT STEPS AND OPTIONS”:

CIAR is now identifying candidates for principle [sic] investigators for the confounder

(pilot and full) studies in Europe.

Option: Select as principle [sic] investigator for the CIAR-sponsored confounder

study(ies) scientists involved with IARC multi-center study.

Eisenberg is arranging an exploratory meeting with Forestierre [sic] (Italy)

premised on a discussion of matters of mutual interest […].

(Bates No. 2028381588)

15) It will be shown below that the principal investigator that CIAR was eventually able

to recruit was Dr. Viegi, with Forastiere as co-investigator. This contact between

CIAR representatives and WHO/IARC collaborators is described in the WHO report

entitled “Tobacco Company Strategies to Undermine Tobacco Control at the World

Health Organization” (WHO, July 2000, pp. 206-208). The WHO report adds the

following:

In an interview, Boffetta [another Italian staff member of IARC] said IARC did not

pursue any proposed collaboration once he became aware of CIAR’s industry

connection. Saracci did not join CIAR’s Advisory Board or accept any grants for

research, once IARC realized that CIAR was funded by members of the tobacco

industry. One IARC collaborator (Forastiere) did, however, conduct a study for CIAR

on confounders. Boffetta expressed disappointment in Forastiere’s decision to conduct

a study for CIAR, because by then, IARC understood CIAR’s industry’s

connection. (p. 207 - emphasis added)

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16) A Philip Morris document, dated 10 October 1995 (Bates No. 2057790220/0230),

suggests for the first time that the industry is considering the involvement of G. Viegi

in one of its projects. This document is a paper copy of the slides of a presentation on

one industry project, “Determination of personal exposures to environmental tobacco

smoke in Europe.” At the end of this presentation, an apparently unrelated slide gives

the list of “potential collaborators” of the “European Confounders Study,” and list

Dr. Giovanni Viegi among three other names (Dr. Francesco Forastiere, Dr. Rodolfo

Saracci and Dr. Genevieve Matanoski).

17) On 9-10 November 1995, the CIAR Board of Directors met in Hong Kong. The

Italian confounders study was discussed on both days. The notes from one participant

summarizes the discussion as follows:

C.I.A.R. BOARD OF DIRECTORS MEETING

Hong Kong, November 9, 1995

[…]

Matanoski has advised several Italian investigators re conduct of analyses of NHANES-

like databases in that country. Pilot studies have been completed, and results reported

(Eisenberg phone call last week) look much like the U.S. NHANES analyses. The

investigator has submitted an abstract for the 1996 American Thoracic Society

Meeting. That Society’s newly-adopted policy on publication of tobacco-funded

research is attached; it will be interesting to see whether the abstract is accepted if

CIAR is acknowledged as it should be. (Bates No. 88246845/6846)

C.I.A.R. FAR EAST MEETING

Hong Kong, November 10, 1995

[…]

Dr Matanoski’s role in assisting three Italian researchers in the conduct of confounder

studies on NHANES-like Italian databases was described. Pilot study results from these

Italian workers were available about 1 week ago; results are reportedly similar to

Manatoski’s findings in the U.S. One of these Italian professors has submitted an

abstract describing his pilot study to the American Thoracic Society’s annual meeting

this summer. (Bates No. 88246838/6840)

The Italian professor who has submitted the abstract is Viegi (Bates No.

2057790441). The abstract was accepted by the ATS. (Bates No. 2057790440)

18) The above strongly suggests that the Italian pilot studies on confounders were in fact

projects directed by CIAR and undertaken by Viegi on behalf of CIAR. In 1995,

the Scientific Advisory Board of CIAR recommended 24 proposals for approval by

the Board of Directors, out of which the BoD selected 10 (Bates No. 528439146/9148

and Bates No. 83205217/5218). Among theses proposals, there is no trace of the

Italian pilot studies. Neither are they included in the list of 20 project proposals

recommended by the SAB in 1996 for funding in 1997. (Bates No. 566938612,

517577797/7798 and 566938773/8778). The Italian pilot studies clearly follow the

track of “applied studies”, completely bypassing the SAB review process.

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19) The fact that the Italian pilot confounders studies are activities initiated and directed

by CIAR is confirmed by several documents. In the 1994-1995 annual performance

review of Dr. Max Eisenberg, the Executive Director of CIAR (dated August 1995),

one of the “accomplishments” listed is “Developing contacts with reputable

researchers in Europe that is leading to a research proposal on confounders”. (Bates

No. 517578756/8758). One year later, the 1995-1996 performance review of Dr.

Eisenberg highlights the following: “Two pilot studies on confounders undertaken in

Italy by Dr. Giovanni Viegi, National Research Council, and Dr. Francesco

Forastiere, EPI – Asssociazione per la Ricerca in Epidemiologica. Dr. Viegi

presented a poster at the American Thoracic Society meeting in May 1996.” (Bates

No. 517578761/8762) It should be noted that the SAB reviewed projects are not

singled out in Dr. Eisenberg’s performance review, but are just collectively covered

in one item: “Receipt of a large number of research proposals, peer review of the

applications, monitoring the supported projects and reporting progress, requiring

financial responsibility, and ensuring completion of funded research.” (ibid.)

20) Two page highlights of the CIAR activities for 1995-1996 and for 1996-1997 also

single out the Italian pilot studies undertaken by Dr. G. Viegi. (Bates No.

2063651367/1370).

21) The Italian confounders study must have been an important responsibility of Dr.

Eisenberg. Indeed, when his post description was revised in 1998 by the Board of

Directors, under “Scientific Responsibilities”, one finds the Italian study in prominent

place among the Executive Director’s responsibilities:

Scientific Responsibilities: […] Confounders study in Italy by Dr. G. Viegi, National

Research Council, and Dr. F. Forastiere, EPI-Associazone per la Recercia in

Epidemiologia, with Dr. Sarracci of IARC and Dr. G. Matanoski, John Hopkins

University, acting as consultants. (Bates No. 2063651442 and 2063651443/1446)

The confounders epidemiology studies

22) The pilot studies produced what the industry must have considered very “promising”

results. Indeed, the abstract submitted by Viegi to the 1996 International Conference

of the American Thoracic Society claims that women exposed to passive smoking

differ markedly from the unexposed:

[…]ETS exposure was significantly associated with: marital status, use of oral

contraceptives, dietary regimen, type of heating, property of house, crowding index,

type of job. Directions of associations were somewhat different in the two populations.

In conclusions, we confirm that women exposed to ETS differ from those

unexposed for several factors which should be taken into account in future studies

on health effects of ETS. (Emphasis added - Bates No. 2057790441)

The conclusion does not leave much room for doubt: it is confirmed that women

exposed to passive smoking are different. Interestingly, there is no mention that this

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is a pilot study. This was exactly the type of result the tobacco industry was looking

for, and wanted to support financially.

23) In 1996, CIAR awarded Dr. Viegi, as principal investigator, two contracts to conduct

confounders epidemiology studies aiming at “evaluating whether some of the risk

factors that have been associated with cardiovascular or respiratory diseases and lung

cancer occur differently among women with and without exposure to ETS in three

areas of Italy.” (Bates No. 2063813786/3788) Contract 96-18 was for an amount of

USD 853,985 and contract 96-18A for an amount of USD 878,318, totalling USD

1,232,303 (over 1.2 millions US dollars). The first contract was to end on 31

December 1997 and the second on 31 December 1998, with the possibility of a no

cost extension to 31 March 1999.

24) Again, this full-fledged confounders epidemiology project appears to have

completely bypassed the SAB review process of CIAR. Indeed, this project, as was

the case for Viegi’s pilot studies, does not appear in the list of the 20 project

proposals recommended by the SAB in 1996 for funding in 1997. (Bates No.

566938612, 517577797/7798 and 566938773/8778). The project was instead placed

directly under the responsibility of Dr Max Eisenberg, the Executive Director of

CIAR, as is shown in his revised post description discussed above.

The publication of the study results

25) Among the tobacco documents, I have found copies of three published articles in

which the results of the Italian confounders study were reported:

F. Forastiere, et al. (19 co-authors in total, including Viegi) Characteristics

of Nonsmoking women Exposed to Spouses Who Smoke: Epidemiologic

Study on Environment and Health in Women from Four Italian Areas,

Environmental Health Perspectives, 109: 1171-1177, 2000 (EHP article for

short) (Bates No. 3006484883/4889)

S. Farchi, et al. ( 7 co-authors, including Viegi) Exposure to Environmental

Tobacco Smoke Is Associated with Lower Plasma β-Carotene Levels

among Nonsmoking Women Married to a Smoker, Prevention Vol. 10,

907-909, August 2001 (CEBP article). (Bates No. 2067632186/2188)

M. Simoni, et al. (7 co-authors, including Viegi) Characteristics of women

exposed and unexposed to environmental tobacco smoke (ETS) in a general

population sample of North Italy (Po River Delta epidemiological study)

European Journal of Epidemiology 17:363-368, 2001 (EJE article) (Bates

No. 3006440149/0153)

26) The EHP article acknowledges funding by CIAR, although only as the last item in the

acknowledgment section, saying that “this work was funded in part by the Center for

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Indoor Air Research” (emphasis added). This declaration does not do justice to the

fact that CIAR contributed over 1.2 millions US dollars to the project. One may

wonder, if this was only a partial contribution, what were the amounts provided by

the other financial contributors, who are not acknowledged.

27) Furthermore, there is no indication of a potential conflict of interest (this is in breach

of the instruction to authors of this publications, which are very explicit and strict on

this question1), while the authors could not have ignored at the time of publication

(and as Viegi probably knew since the onset of the study) that the financing came

from the tobacco industry, through CIAR. Perhaps the other co-authors of the article

did not know, but it would be extremely surprising that it had escaped Dr. Viegi’s

attention that CIAR had been dissolved by the MSA because it was a tobacco-related

organization, considering that Viegi’s project was closely monitored by CIAR and

that therefore Dr. Viegi must have kept in close contact with Dr. Eisenberg, who was

supervising the project from January 1997 until the dissolution of CIAR.

28) Notwithstanding the incompleteness of the conflict of interest declaration, the article

appears otherwise of good quality. The results must have somehow disappointed the

financial sponsor of the study, since they do not confirm Matanoski’s findings, but

rather tend to contradict them:

Considering that most of the variables related to a preventive behaviour were also

similar between the two groups, it seems that in the Italian situation, after having

1 Extract from the EHP guidelines to authors: “EHP has a long-standing requirement for authors to disclose

competing financial interests. Corresponding authors are required to submit with the manuscript a declaration

of competing financial interests on behalf of all authors. When in doubt about the need to report, authors

should always err on the side of caution and report all interests that might in any way be perceived as

representing a competing financial interest. The form is available online and can be downloaded

(http://ehp.niehs.nih.gov/cfi.pdf). If the article is accepted for publication, the statements are published with

the article disclosing either a competing financial interest, along with a brief description, or a declaration of

no competing interests.

Competing financial interests may include, but are not limited to, grant support, employment (recent, present,

or anticipated), patents (including pending or applied for), payment for expert testimony, and personal

financial interests by the authors, immediate family members, or institutional affiliations that may gain or lose

financially through publication. Increasingly, researchers are compensated through a host of financial

arrangements such as travel funding, consultancies, advisory board positions, patent and royalty

arrangements, stock shares, bonds, and the like. Diversified mutual funds or investment trusts do not

constitute a competing financial interest. Further, authors are required to certify that their freedom to design,

conduct, interpret, and publish research is not compromised by any controlling sponsor as a condition of

review and publication.

In order to provide full disclosure, please include a sentence in the “Acknowledgments” of your manuscript

identifying any competing financial interests, remembering that employment can be a competing financial

interest. For authors employed by a for-profit organization or an advocacy group, a simple statement of

employment is adequate.

Scientists are aware of the absolute necessity to maintain the personal integrity upon which science depends.

It is this integrity that full disclosure of competing financial interests hopes to preserve. Therefore, it is

imperative that authors and readers understand that a disclosure of a competing financial interest does not

imply that the information in the article is questionable or that the conclusions are biased. Authors must also

understand that the omission of a pertinent financial interest could, if later revealed, deal a severe blow to the

authors' integrity and the credibility of their research.)”

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considered age and social class differences, women married to a smoker do not differ to

a great extent from women married to a non-smoker. […] Our results also suggest that

the extent of confounding from other factors, if any, is minimal. In conclusion, we

found few differences in socioeconomic and dietary characteristics among non-smoking

Italian women exposed and not exposed to spouses who smoke.

29) The second article, the CEBP article, suffers from the same problem in terms of the

lack of declaration of the full extent of the source of funding, acknowledging only

partial funding by CIAR, without mentioning any other source of funding, and failing

to declare the situation of conflict of interest arising from the link with the tobacco

industry via CIAR. Although the publication policy of CEBP is not as strict as that of

EHP, it still requires authors to declare their conflict of interest. However, it is

possible that the authors communicated their situation of conflict of interest to the

editor, who then decided not to publish it.2

30) As with the previous article, the result must have been slightly disappointing for the

financial sponsor, since it does not fully correspond to what the tobacco industry may

have expected, as it does not exonerate exposure to passive smoking from being

causally associated with lung cancer, but rather provides “findings that may help

interpret the biological mechanisms linking ETS exposure to lung cancer and

cardiovascular diseases.”

31) It should also be noted that this second article includes in its references the reference

to the EHP article, as one would normally expect.

32) The third paper, the EJE paper, is more problematic. The acknowledgement section

contains what appears to be an attempt to conceal the real extent of the contribution

by CIAR. Not only this contribution is mentioned as the last item, behind three other

contributions, but it is labelled “an educational grant from the Center of Indoor Air

Research, Linthicum (MD), USA”. It seems to me that this description does not

correspond to reality and conceals the true nature of CIAR’s contribution. Nowhere in

any of the documents I have seen was there any indication that the money that CIAR

awarded to Viegi as principal investigator of the Italian confounders study was for

educational purposes. And it seems that a grant of over 1.2 millions US dollars is

quite a substantial educational grant, and one is left wondering who benefited from

such a grant for his or her education. This would therefore need to be clarified.

2 Extract from the CEBP guidelines to authors: “Conflict of Interest. Journal policy requires that authors and

reviewers reveal to the Editors-in-Chief or Senior Editors any relationships that they believe could be

construed as resulting in an actual, potential, or apparent conflict of interest with regard to the manuscript

submitted for review. Authors must disclose this information in the covering letter accompanying their

submission. The existence of financial interests or other relationships of a commercial nature is not

necessarily regarded as creating a conflict of interest. Rather, journal policy represents a recognition of the

many factors that can influence judgments about research data and a desire to make as much information as

possible available to those reviewing the data. If in the judgment of the Editors-in-Chief the information

revealed does represent a potential conflict of interest, notification concerning the relationship may be

published. If such action is deemed necessary, the authors will be informed before publication.”

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33) The authors of the EJE paper do not declare any conflict of interest either, although

the policy of this journal appears to be much more lax in this respect than the two

preceding journals.

34) The paper re-analyses the data of one of the areas included in the EHP article, taking

the exact same sample of 1499 females, of which 867 never smoking women were

selected. This figure of 867 never smoking women does not reconcile with the figure

indicated in the main study of 805 who had reported never being smokers. The paper

does not provide any explanation for this discrepancy. In fact, the EJE paper makes

no reference at all to the EHP article. This is surprising, since it was accepted on 22

August 2001, and therefore the authors had therefore plenty of time to refer to it (as

did the CEBP article). This lack of reference to a very closely related publication is

not in line with good publication practice, as stated in the COPE guidelines: “At the

time of submission, authors should disclose details of related papers, even if in a

different language, and similar papers in press.” (Rule 6.4 – see

http://www.publicationethics.org.uk/guidelines/reports/2003/2003pdf15.pdf)

35) The methodology used in the article is not just rudimentary, it appears to me as

grossly deficient (but this is not my field of expertise – my assessment needs to be

cross-validated by an epidemiologist). The sample of 867 women aged 8-73 was

reduced to a sample of 661 women of age 20+. This sample was then divided in two

groups, the women currently exposed to passive smoking, and those unexposed. The

two groups were compared by looking at the means of a number of variables,

comparing percentages, and using logistic regression. However, all of this was done

without controlling, as is done in the main study, for age.

36) The study found that the exposed women were significantly younger (by 9 years)

than unexposed women. This big difference can actually be easily explained. As most

of the exposure is at home (74.8%), the greatest source of exposure comes from the

women’s husbands, who, on average, have the same age as their wives. Therefore, the

likelihood of being exposed in any age group will be determined by the prevalence of

smoking among men in the same age group. The average age of the exposed women

will therefore tend to be close to the average age of the male smokers, and will

therefore be pulled towards young age, as the smoking prevalence curves climbs

rapidly from age 14 to reach a peak at or before age 25 and then continuously

decreases, i.e. the curve is skewed towards zero. On the other hand, the likelihood of

being unexposed will mimic the complement of the smoking prevalence distribution

over age, and the average age will be pushed towards the old end of the range.

37) But regardless of whether this explanation holds or not, all other differences observed

in the paper can be assumed to derive from this age difference of 9 years between the

two groups. Exposed women were found lighter (by 1.5 kg), as indeed younger

women are in general, taller (by 1cm), as is indeed the new generation, not living in

their own house (young people cannot yet afford to live in their own house), etc.

Omitting for a moment the exposure to passive smoking, it can be hypothesized that

if one took two random samples from the population of the Po River Delta area

exhibiting a difference of nine years between their average ages, one would probably

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observe very similar differences with respect to all the characteristics exhibited in the

paper. These results are therefore most likely not attributable to exposure.

38) The authors nevertheless make a conclusion which contradicts the findings of the

main multicenter study published in EHP.

In conclusion, we have provided the distribution of ETS exposure in a general

population of Italian women and we have confirmed that many life-style characteristics

are associated with ETS exposure. These characteristics should be taken into

account while studying the relationship between ETS and respiratory health,

although it seems unlikely that these factors may obscure the relationship of ETS and

health outcomes (emphasis added).

The emphasized sentence in the above quotation is the recurring motto found in the

conclusions of all the confounders studies sponsored by the tobacco industry.

CIAR’ successor: Philip Morris External Research Program

39) CIAR ceased to operate in 1999 and was effectively dissolved. In 2000, Philip Morris

replaced it with the Philip Morris Research Program, using a similar structure, with a

Science Advisory Board, replacing the Board of Directors with the counterpart

mechanism inside Philip Morris, the Scientific Research Review Committee (SRRC),

consisting of Philip Morris staff members, and adding a group of Peer Reviewers. As

of 2000, Dr Viegi’s name appears in the list of peer reviewers of the Philip Morris

Research Program. (Bates No. 2082039342/9373)

* * *