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Philip Morris

Tobacco Industry Efforts Subverting the International Agency for Research on Cancer's Secondhand Smoke Study

Date: Nov 1999
Length: 22 pages
2505646347-2505646368
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Page 1: moy15c00
lung cancer, one cannot extrapolate any meaningful findings from such a population study to the subset of persons who develop lung cancer. The industry systematically attempted to shape the science behind secondhand smoke. Not only was this done by trying to influence the IARC investigators with viewpoints and through collaboration, but by producing research to help generate doubt about the validity of IARC's anticipated results. More importantly, the industry's research, conducted by other investigators to ensure credibility, would create a massive body of scientific literature to be included in IARC's anticipated monograph on secondhand smoke. This body of literature could help the industry argue against findings that secondhand smoke caused cancer and any subsequent regulatory actions to increase smoke-free areas. PM's intention to subvert IARC, rather than act as a scientific colleague, is underscored by the recurring paradoxical sentiment of presenting goodwill overtures to IARC while seeking to undermine IARC's work. N ~ O ~ ~ A o" CONFIDENTIAL DRAFT - Do Not Distribute 51 0
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I was invited to take part because I deal with questions related to IAQ [indoor air quality], and this report is being submitted because the main topic under discussion was a paper which, although currentlyresuicted to internal circulation will, presumably, sooner or later be available outside the IARC.... The researchers are oriented, as is the LARC for its future activity, towards widening the scope of their observation....[t]his approach, from pathological to epidemiological.... leads the IARC to operate in areas already covered, e.g. the EPA, USA, the WHO-EURO, Copenhagen.... ...the IARC has presented [an] impressive research project (directed by E. Riboli) to the EEC [European Economic Community], which should be approved in the next few days... ...Dr. E. Riboli...announced that from 1 April 1991, the research coordination will be undertaken by Dr. Paolo Boffetta M.D. M.P.H. of the IARC "' The 1991 report is vague about the study's specifics, but the established relationship Professor Lojacono had with the unsuspecting IARC investigators would be useful to PM later. Lojacono had a relationship with at least Philip Morris, having written a letter in October 1990 to Ian Marcovitch (Vice Director, S&T, PM Europe) of Fabriques de Tabaques Reunies in Neuchatel, PM's European scientific headquarters.128 Another report from SCR Associati dated November 1991 continues to report on the intelttal IARC working group meetings: All the research groups were represented.... The American centers have given up for lack of funds. :. The common convicpon of all the interested parties as well as the same research coordinators (Saracci and Boffetta of the IARC, both present), was that the conclusions concerning the contributing causes of ETS/lung tumours and also othcr probable relationships (cardio-vascular diseases, genotoxicity) will not be definitive.... ...research will not be concluded before 1994; in order to obtain data relative to almost 500 subjects. Perhaps only Turin will be able to finish in 1993 129.... Surprisingly, even with this inside source to the IARC investigators and the timeline of their study, memos expressing alarm did not yet appear. Perhaps the report's significance had been overlooked, because the vague reports had been sent along with accounts of Italian news events to several companies. Another possibility is that the EPA report, published in early 1992, may have presented a more immediate challenge to the industry. Although the IEMC was functioning as early as June 1991,103 IARC did not appear on the IEMC agenda until January 1994. On February 19, 1993, high level PM representatives began to gather facts about the IARC study, with PM IARC Task Force leader Winokur asking: "what do we know of the alledged [sic] report on ETS that IARC is preparing.... do we have any direct or indirect cntre to IARC?"130 PM in Neuchatel faxed an inquiry that same day about the study's timeline to Paolo Boffetta, IARC's co-principal investigator. In a reply six days later, Boffetta answered that the data collection could be expected to finish at the end of 1993 and the final reports would not be ready before mid 1995 131 Three months later, Robert Pages (director of Science and Technology for PM USA) wrote those who would become PM's IARC Task Force: We have asked "', through their consultants, to try and uncover as much information as possible on the current status, etc., of the IARC study. I would like all those who receive a copy of this memo to use whatever internal and external resources they may have or may know about to help us get more information on the LARC study as quickly as possible.... CONFIDENTIAL DKAFI' - Do Not Distribute 38
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We would also appreciate any assistance you [Covington and Burling] could provide to help us identijy those individuals [IARC investigators] and the nature of their involvement in the study. I hope that this information will be of value to you [Covington and Burling] and your colleagues [consultants] in helping us to learn more about the current status of the study; when it is expected to be completed and published; etc. As this research is likely to be among the largest case-control studies of ETS and lung cancer and will consist in large part of data gathered in Europe, it is obviously ojmajor interest and imporiance that we learn as much as we can as soon as possible.13A (emphasis added] Consultants like Peter Lee,133 Allan Crawford,t34 and "SWG- 13' had already been analyzing IARC's published work on smoking.39 Now Covington and Burling's European (International) Consultant Progratnl2t would help gather information. PM consultants and representatives systematically approached the IARC investigators. R.A. Walk, a scientist at Institut fiir Bioligische Forschung (a PM research institute in Hamburg, Germany) contacted at least three TARC investigators,t36-139 and reported on the study's size, questionnaire, data collection completion, and projected publication date to PM. Over the years, pathologist Angelo Cerioli asked detail0d questions of two Italian LARC investigators about the study's progress and composition, and reported it back to PM.laat4a Concerning my conversation with Dr. Merletti...l really had no problems at all in finding the right wave lenght [sic] with him.... ...Let me say_that Merletti answered without reluctance to these questions: 1) How many cases have been collected in Italy (Torino and Padova) for the on-going multicentricvial that is co-ordinated by IARC? Something in the order of 35. 2) Are all these cases being histologically confirmed as primitive pulmonary mmours? No. Clinically diagnosed as primitive lung tumours (my guess is that an histological diagnosis is available for about 50% of them and this includes lung adenocarcinomas). 3) Were cotinine levels measured in blood and urine of both cases and controls? Not in Italy. 4) To your knowledge were there levels measured in other centres participating to this study? Iin Sweden only, but even here probably not in 100% of the instances 5) Were other confounding factors (of course with the exception of the possible ones mentioned in the IARC questionnaire that are occupational and environmental only) considered? - Not in Italy . 6) Same question as 5 - somewhere else? To his knowledge exposure to radon which was assessed in the centre only... 7) How many cases have been collected all together? Of the order of 500 (All clinically ascertained as primitive lung turnouts. Not all histologically proven) 8) The last ad hoc meeting took place in Venezia. When is the next one taking place? Date not yet fixed probably at the beginning of 1995, possible location: Lyon 9) As far as concerns the identification of the cases is it to be considered as completed? In most centres yes, it will be complete however this year. Virtually completed in Italy.... On the basis of the informations (sic) I have been able to collect from Merletti you will certainly note that the amount of confounding factors other than occupational and environmental which were considered for this study is really minimal if not zero. N I find also quite disappointing the degree of validation of smoking exposure. See points 3 and 4.'42 (1+ O ~ ~ The IARC investigators did not reveal any results, but such detailed questions could allow PM to p rn w CONFIDENTIAL DRA.FI' - Do Not Distribute 39
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therefore the comments are based on shaky sources_ - 2. A table, which states the specifications of the IARC studies (same sources as 1.) And compares it with the Fontham et al. Publication, 1994. 3. A table showing the topics included in 2 types of questionnaires both apparently related (used?) to the LARC study. This material may be helpful for one of your consultants to evaluate the study.... tss While such preliminary analyses allowed PM to begin formulating its response, PM continued monitoring for the first public reports of results from the IARC study, finally appearing in 1997, through publications1S6 and conferences.tn The IARC study underwent meticulous scrutiny by the industry's consultants even before the study's publication. Reaching Out to IARC investigators By May 1994, PM had tracked its contacts made with 11 IARC centers and investigators.ts$ PM's objectives in contacting the'investigators went beyond tracking the study's progress, as a PMCS Brussels report describes: 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 the industry perspective on ETS and to make them mindtul of the weaknesses of epidemiology that rely on survey questionnaires. We recognize 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 ijthe collaborators can be persuaded that the lARC methodology is inadequate (it does not take into account confounders or measure actual exposure leading to misclassification).159 [emphasis added] - PM was not contacting the investigators to help them improve the study, but to sell the industry's perspective about the study's inadequacies and discourage IARC in its work. PM's objective was not scientific collaboration, but to influence the investigators and undermine the study before its publication. PM hoped to link the industry's CIAR with IARC and its investigators. In 1994, Max Eisenberg, executive director of CIAR, visited IARC and its head investigators. IARC co-head investigatoc Boffetta states he did not understand at the time that CIAR was funded by the tobacco companies.160 After these meetings, Winokur described several ideas to Reif on how to collaborate between CIAR and IARC by assisting IARC with future studies, encouraging industry consultant participation, recruiting IARC investigators for CIAR-sponsored studies, granting the senior IARC co-head investigator funding or an advisory position, and providing funds for a graduate student: The following five opportunities for varying degrees of collaboration between CLAR and IARC arose during recent discussions between CLAR and IARC (Boffetta. Sarracci and Riboli). 1. In addition to the multicenter, European ETS epidemiological study, IARC is undertaking individual ETS studies in Thailand, India, Argentina, Uruguay and Brazil. Boffetta acknowledged a weakness in LARC's overall approach to its ETS epi studies because they fail to account for ETS exposure specifically, although some may consider occupational exposures. Option: Assist tARC incorporate exposure measurements in their studies 2. The protocols for analyzing the multi-center study data has not yet been agreed upon. The next meeting of the principle investigators from the 10 study centers and the IARC staff is the CONFIDENTIAL DRAP"1' - Do Not Distribute 43
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Bremen,"' Stockholm,"Z Barcelona,13 Turin,14 Paris,"5 Lisbon,'76 Basel,"' and Prague."s A list of these studies demonstrates the Hazleton studies also extended into Asia and Latin America: CITY DATE OF STUDY PUBLICATION United States May 1993-June 1994 January 1997 Leeds, Harrowgate UK Oct. - Dec. 1992 November 1994 Stockholm. Sweden Dec. 1994 November 1996 Barcelona, Spain Jan. 1995 March 1997 'ihrin/Padua, Italy Feb. 1995 Submitted - Dec. 1996 Villejuif, France Mar. - Apr. 1995 Submitted - Feb. 1997 Bremen, Germany May 1995 Submitted - Jan. 1997 Lisbon, Portugal July 1995 Submitted-Mar. 1997 Bascl, Switzerland September 1995 Submitted -Apr. 1997 Prague, Czech Repub. November 1995 Submitted - May 1997 Hong Kong January 1996 Submitted -Jun. 1997 Kuala Lumpur March 1996 To be Submitted - July 1997 Sydney, AustraliaJune 1996 To be Submitted - Aug. 1997 - Beijing, China September 1996, 1997 Latin America 1997"' [original bold type and-asterisks removed] The rapid production of these industry-funded studies was akin to an industry international multi- center study on nonsmokers' exposure to secondhand smoke- For each subsequent Hazleton study, about 200 nonsmokers selected from each city wore a personal exposure monitor for 24 hours, provided sa]iva samples for cotinine analysis, and completed a detailed questionnaire about air quali[y and lifestyle. If clean indoor air regulations similar to that of U.S. OSHA arose as a consequence of the IARC study or monograph, the studies could serve as a reference for the amount of secondhand smoke exposure in each area. These pilot studies, however, were demonstrated to be unreliable sources of data on secondhand smoke exposure at hearings held by the U.S. National Toxicology Program in 1998. Salivary cotinine is a nicotine metabolite that can be used to verify a person's recollection or measurement of secondhand smoke exposure in recent days with actual biological intake.'80 Repace demonstrated the salivary cotinine results from the pilot Oak Ridge and Hazleton studies were 1-2 orders of magnitude below what was expected.18t The U.S. National Toxicology Program subsequently ruled that secondhand smoke is a human carcinogen in December 1998. The findings will be included in the ninth edition of the Report on Carcinogens, the U. S. government's official list of carcinogenic agents. The industry's prominent role in the design and implementation of the studies may account for the questionable findings. The Oak Ridge author described that R.J. Reynolds and its marketing research firm had conducted the US study's operations (e.g., personal monitor supplying, subject recruitment, field sampling, laboratory analyses, and data coding), and the author's role merely was to analyze the industry-provided data.'$Z Furthermore, in a memo to PM, the Oak Ridge author complained that the complex arrangement with the industry had led to "several recruiting 'irregularities"' like 50% participants from one city recruited from malls rather than the established telephone protocol, possibly compromising the random selection-'$' N w Helmut Reif (S&T Neuchatel) dismissed the complaint as "no principal difference can be seen as ~ all people have to go shopping once upon a time" but recommended to continue the telephone J? o>' w CONFIDENTIAL DRAFT - Do Not Distribute 47 ~
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scientists in early June 1994 for a Swedish confounder study19' and finally sent a detailed protocol to Ragnar Rylander, a professor at Sweden's University of Gothenburg and long-time industry consultant.19z''93 About two weeks later, Rylander submitted a formal proposal to CIAR for a $153,625 project that PM agreed to fmance.194 In 1997, Rylander wrote a similarly themed paper entitled "Dietary and lifestyle correlates of passive smoking in Hong Kong, Japan, Sweden, and the U.S.A.;"19S CIAR is not listed in the funding acknowledgements. PM planned for a German confounder study as well, which the German Verband (similar to the industry's US Council for Tobacco Research18) offered to fund for about $40,000 196 In February 1995, Klaus Riemann of the GESOMED research institute, which has links to the University of Freiburg197 and had done prior research with the Verband,'98•'99 submitted a $65,000 proposal to the Verband Science Policy Committee (which includes Reif and an R.J. Reynolds representative) to analyze Germany's nutrition studies.'96,'97 Through these confounder studies, the industry wanted to demonstrate that nonsmokers who live with smokers have risk factors, namely diet and lifestyle factors, besides secondhand smoke exposure that predispose them,to lung cancer. Such a conclusion might help generate doubt against any conclusions from IARC that secondhand smoke exposure could increase the risk for lung cancer. However, this premise is flawed; As Saracci from IARC notes (personal communication, Saracci), such a study does not study the differences between the population of subjects with lung cancer. The results from the population of nonsmokers living with smokers cannot be extrapolated to the subset of nonsmokers with lung cancer. The IARC study, which did compare a'population of lung cancer subjects, took into account potential confounding variables like diet and concluded they were unlikely to have affected the results. This result has been verified by other major studies. Summary Philip Motris's scientific strategy was the first phase of the inter-industry plan for the IARC study. Despite earlier reports from 1988-1991 to the industry that IARC had started dealing with their study, Philip Morris' senior management did not start to take action until 1993, the year after the production of the U.S. EPA report, when the industry had witnessed a surge in clean indoor air laws and faced the prospect of national-level clean indoor air regulations by U.S. OSHA. The IARC study, followed by a monograph on the health effects of secondhand smoke, presented the next likely major challenge on the horizon for the industry. The first step initiated by Philip Morris was to gather intelligence about the IARC study and analyze the situation the industry faced. Consultants from the International Consultancy Program, operated by the law firm Covington & Burling, were deployed to assist in approaching the IARC investigators about the study's design, progress, and results. PM received reports from a range of sources. Industry consultants who openly acknowledged their industry affiliation and even PM Neuchatel's head of Science and Technology, who headed the PM IARC Task Force's scientific activities, questioned the IARC investigators about the study on an informal, seemingly collegial basis. PM also solicited the help of consultants who interacted with the IARC investigators as colleagues, such as Professor Giuseppe Lojacono, who authored several reports for the industry and provided detailed confidential information about the IARC study's results CONFIDENTIAL DRAFT - Do Not Distribute 49
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(e.g. coffee, ETS, breast implants) and release findings via TASSC page - Release PM authored papers (as above) on ETS science and bad science/bad public policy20B TASSC is now defunct, but its former executive director Steve Milloy, an adjunct scholar at the Cato Institute (a libertarian think tank in Washington, DC), now produces a junk science" web page.210 Milloy's Junkscience.com website continues TASSC's original work in criticizing the science behind "distorted" public health and environmental issues. The Cato Institute has received funds from the industry, with $100,000 from PM and $50,000 from R.J. Reynolds in 1995,21 and its members have been vocal in criticizing the scientific evidence on tobacco's health effects and tobacco control efforts.uZ PM wanted a similar "sound science" organization in Europe213 at the end of 1994 with a budget of $50,000;214 TASSC members would help identify their European countetparts?ts Jim Lindheim, chairman of Burson Marsteller, presented the basic framework to Winokur for starting the European group, which similarly emphasized developing issues besides secondhand smoke and attracting the sponsorship of other industries and organizations: THE SITUATION * European'regulations proliferate despite scientific evidence - Ban on livestock growth hormone - Restrictions on chlorinc' - - Restrictions on biotechnology - EU Drinking Water Directive - Ban on BST (hormone for milk-producing cows) * Many industries trying to establish groups to "communicate science" and "to lobby" - EUFIC (food industry) - SAGB (biotechnology) - Heidelberg Appeal (global warming) but - Most stick to narrow grounds - Most are not effective at changing the tendency to regulate on basis of myth not science THE NEED * Create a strong scientific voice to - Articulate general need for policy based on sound science ~ - Praise good decisions; condemn bad ones - Educate policy leaders on how to use science better THE CONCEPT * Create a scientific "Network" or "Coalition" with a mission to - Identify bow public policy can better reflect good science - Educate opinion leaders/politicians on these issues - Speak out on selected issues * Link Coalition with - Existing European groups (EUFIC, etc.) - U.S. based "TASSC" * Members to be scientists and, perhaps, policy makers CONCEPT: CRITERIA FOR SUCCESS * An active communications/lobbying program * Seen as credible/ not a jront * Makes an impact on policy * Includes prestigious people, not necessarily large numbers of people * Fully recognized, ongoing and impacltul by 1996 CONFIDENTIAL DRAFT - Do Not Distribute 55
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protocol.1S4 Such extensive control by the industry over the study could only minimize the independence of the lead author's role. Rothmans tobacco company's Barrie Frost drafted the protocols and questionnaires for Hazleton's studies in the UK185 and other European's6't$' countries. The personal exposure monitors for the Hazleton studies were to come from R.J. Reynolds or Rothmans with quality control by Oak Ridge.187 Frost noted two limitations to the use of the personal monitors as performed in the Hazleton UK Study: The first problem was that the volume of air sampled (200 litres) was not large enough to give good precision at the low level of ETS to which most people were exposed.. Limits of detection in the new study will be improved in the new study by taking a larger air samples (1440 litres).... The second limitation was that the monitor measured particles from all sources (size cut-off about 50 microns) rather than only respirable particles from all sources (size cut-off 5 microns). This will be overcome in a modified filter holder by including an impaction trap at the entrance to the holder. Development of a suitable monitor is being carried out at Rothmans. A suitable pump has been selected and it has been shown that this will pump for at least 32 hours when attached to the personal monitor. Prototype monitors with impactors at the entrance are currently under test. The evaluation will be completed by the end of July 1994. An evaluation of the CLAR (RJR) personal monitor will also take place in July, following a visit of K. Phillips and B. Frost to RJR. Direct comparison with the monitor being developed at Rothmans will be made by parallel sampling. The RJR personal monitor could be used as an alternative if the modifications to the'Rothmans'monitor are not satisfactory.1B9 Rothmans' personal monitors had not yet been developed to accurately reflect secondhand smoke exposure. If R.J. Reynolds' personal monitors would be selected for use and similarly deficient, any inaccuracies from those monitors used in the Oak Ridge study would be replicated in the Hazleton studies. The industry's scientific collaboration and control over the investigations potentially compromised the study's results at a fundamental level. Confounding Factors for Cancer Studies The second type of study the tobacco industry sponsored analyzed the nonsmoking population for confounding factors, other than secondhand smoke exposure, that might explain a risk for cancer. These studies studied the differences in diet and lifestyle between nonsmokers who lived or did not live with smokers. Genevieve Matanoski (professor, Johns Hopkins University) conducted PM's pilot study analyzing elements of the U.S. National Health and Nutrition Examination Survey (NHANES I), a survey conducted in the early 1970s, and the early 1980s' NHANES I Epidemiologic Follow-up Study, which asked about spousal smoking exposure ten years later.'88 Using this as a model, PM planned to analyze large European databases,'89 in Hung tos ary, Germany, UK, Sweden, and Switzerland,t9o as well as in Japan.los PM also considered approaching IARC investigators to head the confounder studies;162 with the IARC investigator, Forastiere, now participating in one (personal communication, Forastiere) In expanding the range of countries for this type of study, PM tried to contact various CONFIDENTIAI. DItAFi' - Do Not Distribute 48
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first week of December 1994 in Lyon where they will make further/final adjustments to the protocol. Option: Encourage IARC to invite Dr. Matanowski [professor of epidemiology at Johns Hopkins University, and CIAR Scientific Advisory Board member who received 52.3 million from CLAR through 1998.]161 to the meeting to provide input on the final protoco7. 3. CIAR is now identifying candidates for principle [sic] investigators for the confounder (pilot and full) studies in Europe. Option: Select as principle [sic] investigatorsfor the CIAR-sponsored confounder study(ies) scientists involved with the JARC multi-center study. Eisenberg is arranging an exploratory meeting with Forestierre (Italy) [sic, an investigator with the IARC study] premised on a discussion of matters of mutual interest and a review of the results ofHazelton [sic] exposure study (described below in this chapter; industry study monitoring personal exposure levels to secondhand smoke]. 4. IARC is undertaking a prospective European study to assess the impact of diet/nutrition on disease to generate a database of 420,000 Euzopeans. No questions related to ETS exposure are on the questionnaire. While some of the field work from the 10 study centers is completed, others have not yet been completed. Option: Encourage IARC to add ETS questions to selected remaining study center questionnaires, thereby creating a database suitable for "paper" confounder studies. 5. Given IARC's apparent long term interest in and commitment to ETS research, how can we build bridges to IARC and'sustain/improve dialogue with them. Saracci is reported to be resigning from IARC at the end of 1994. He has indicated an interest in further, personal collaboration with CiAR. . Option: Saracci has indicated an interest in joining CIAR's Science Advisory Board while still at IARC. -I Option: Saracci has indicated interest in getting a CIAR grant to support research upon his retirement tn Pizza. However, his work would probably [be] with Poletti [sic, Paolo PaolettiJ who has strong views on the industry. Option: Fundsjor a postgraduate student at Lyon [written]. 162 (emphasis added] Winokur's memo reflects a desire to increase industry representation within IARC's activities, and establish a cooperative financial link. IARC decided not to take action with the proposed points (personal communication, Rodolfo Saracci). However, as of 1999, at least Forastiere has been undertaking one of the two types of CIAR-funded studies that the industry designed to counteract the IARC study (personal communication, Francesco Forasdere). Preparations for the potential IARC monograph A potential IARC monograph evaluating all of secondhand smoke's health effects would most likely have more of an impact around the world than the IARC study alone. In 1994, PM examined its options in influencing the outcome of a potential IARC monograph reviewing the health effects of secondhand smoke: All existing and proposed studies on confounders and exposure [funded through CIAR and IEMC to criticize the IARC study] once published should be included in the material which IARC will consider in producing the Monograph. 1. Encourage Re-evaluation of IARC Monograph Priorities -Budgetary constraints of funders (US Cancer Institute, wHO, EU [European Union]) 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. C&B and SFID [Shook, CONFIDENf'IAI., DRAFT - Do Not Distribute 44
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compile a picture of the study's magnitude and potential impact. In another detailed report, PM IARC Task Force member Helmut Reif sought to gather detailed information about the study, ascertain the head investigators' viewpoints, and establish a relationship with them in 1993.14`t Information was given by the two main researchers in the context of this project, Messrs. Riboli [IARC invesngator] and Saracci [co-coordinator of [ARC study].... Without being expressively asked he [Riboli] stated that he was strongly convinced that there was some risk in exposure to ETS.... Then Saracci joined in and asked me to fill him in on the main features of the EPA study as seen from the industry. I started by saying that the tobacco industry was confronted with a study of such deplorable quality that I wanted to see the real experts in this jeld at IARC and now ask them about their opinion on the validity of the report. Saracci showed not very much detailed knowledge of the report. In fact, he said that they at IARC have scanned it through, but did not deem it very good and important. He called it another product of these 'crazy Americans'. According to him the lay-out of this EPA report was a major reason why the IARC embarked on an own study.... Saracci promised me to sent [sic] me 'whatever he could send', i.e. possible the latest version of the questionnaire (the one I sent to Richmond [presumably Richmond, VA, where Philip Morns' research facilities are] was given to tne by P. Lee [Peter Lee, industry consultant)), or some available unpublished panial results of the ongoing study. I even invited him to Neuchatel [PM S&T Europe], which he laughingly accepted. However, as he laughs often and loudly, this would not mean very much.t`"[emphasis added] This report demgnstrates how PM sought to assess the investigators and establish a relationship in which further information or future collaboration opportunities could be gleaned. In December 1993, industry consultant Peter Lee described in a 22 page report to PM and BAT specifics about the IARC study, the opinions of IARC co-principal investigators about Lee's scientific criticisms, an assessment of the study, and other ongoing research at IARC.16S I invited myself to IARC mainly to discuss their ongoing lung cancer/ETS multicentre case-control study and to compare views on the evidence relating to ETS. I spent some four hours meeting with Dr P Boffetta (PB) and Dr R Saracci (RS) from IARC, and Drs J Tredaniel (JT), recently at IARC, and S Benhamou (SB).... I had previously sent to PB a number of copies of my presentation on ETS in Tokyo, published as a book by Karger. I also took my slides from the talk and went through them as a focal point for discussion. Most of the comments made were by PB and RS. There was no animosity, discussion being purely on a scientific basis.... ' I asked them if I could have detailed dara from this study by centre [sic]. It had been made available to Walls for the EPA report Appendix, but I had never seen these data- No clear answer emerged but I have raised the point again in a letter to Bofjetta....1a5[emphasis added] PM and its consultants seemed to approach the IARC investigators on a scientifically collegial basis. The detail of these reports back to the industry, however, reflect the underlying motive of gathering information to assist in preparing a countering industry response to the IARC study's publication. Despite the fact that they were unaware of PM's coordinated plans, the IARC investigators were cautious not to discuss the study's results with outsiders, but consultants did not always disclose their industry affiliations. Reif (S&T Neuchatel) writes to Pages (S&T) on July 18, 1993: w In addition to the complete questionnaire..I received some news on the same topic [IARC study] O from John Wahren who is, so to say, a neighbour to Pershagen. The study material is currently w ~ DN ~ CONFIDENfIAI. DRAFT - Do Not Distribute 40 ~ co

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