Tobacco Documents Online

20-09 '93 14:36 3nussels L $`0032 2 2878048 PMCS [a 003 PHILIP MORRIS CORPORATE SERVICES INC. Rue JoSeph II, 166 1040, Brussels INTER-OPIFICE CORRESPONDENCE R TU; R. W. Murray Date, September 15, 1993 From, David I. Greenberg 1Juv__ C.C;: Subjoct: YARCStudy Situation analysis The International Agency for Research on Cancer (IARC) began a multinational case control study in 1989 to determine the health effects of ETS. The study is designed to investigate the relationship between lung c:ancer and exposure to ETS arid! utkaer enVirunrnentai risk factors in subjects who have never smoked, using a survey questioiunaire, cross checked by personal interviews. It is intended as the largest ever study of its kind~; 1000 cases and 2000 controls are sought. The study has been extended by one year,, because of the difficulty researchers are having in finding sufficient subjects. The study involves 11 centers in Europe, North America and Asia (Canada, France, Germany, India, Italy, Portugal, Spain, Sweden, and Switzerland). IARC will base its findings on original epidemiological research conducted in the 11 collaborating centers. This approach distinguishes itt from the EPA Risk Assessment, which conducted a meta-analysis of existing studies. Indeed. IARC initiated its study partly in response to the methodology employed by EPA. The most significant improvements in methodology include the size of the sample, the measurement of plasma cotinine levels (a means of viologically, measuring ETS exposure -- not done in the EPA review), geographic distrihution, inclusion of niembers of both sexes, and certain verifiGation processes desioned~ to reinforce the validity of the data collected from questionnaires. Though of better design, and less subject to political motivations, the IARC study has the weaknesses inherent in all epidemiologieaJ studies. Data is expected to be pooled toward the end of 1993. Preliminary results will then be sent to the collaborating researchers for comments, following which a formal' statement of results will be issued mid-late 1994. Preliminary indications suggest that the study may find a weak, but positive link between ETS exposure and lung cancer in non-smokers. The results will have signi~ticant credibility both because this study consists of original research and liecause IARC itself has a solid reputation. Indee.d, uur scientists go as far as to state that 1ARC is virtually unassailable. Although it is financially and structurally independent, 1ARC operates as the research arm, of the WHO, which is represented on IARC's Governing Council. 1ARC studies on the cancer risks associated with tobacco have been used extensively by the WHO in its anti-tobacco campaigns and are often cited by national.i health authorities, the European Commission and critic groups. Recent tARC studies include the effectiveness of legislation and health education in reducing smoking incidence, the link between smoking and pancl-eatic cancer, and between smoking and cancer and cardiovascular disease~ in developing countries. IARC has aNo conducted a survey of anti-smol.~inb legislation in the EC.

20- 09 ' 93 1-1 : 37 $0032' 2 2878048 PMCS Q ood Control actions on~ carcinogenic aaents by national occupational health and safety authorities (and the EC) are often based on IARC' studies and data. Accordinaly, almost regardless of the statistical conclusions, the official statement of the reyuits is like1'y to be used by the VJI+IQ to serve its anti- smoking agenda, and at national levels to promote smoking bans -- particularly in the workplace. R The criticati issue for us is less a question of public opinion th1n the regulatory, implications of labeling ETS as a careinogen, however weak. That could throw ETS into a category along with industrial ehernicals, etc: whose presence must be controlled, particularly in~ workplaces. This would give the EC greater justifieation to look at ETS as a workplace hazard. 4bjiectives 4. Delay the progress and/or release of the study. Affect the wc,rding 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 by private employers and proprietors. Strategy 1. Through scientific and political contacts, to gain on-going intelligence on the study, its review process, and the process for deciding its final conclusions. Use this information towards achieving the objective of no report or a report which di•aws mild conclusions from its dat.a. 2. Build allies and messages which help n utra ize a negative conclusion by assuring, an understanding (among unions, industrialists, regu atvrs) that acting on such a low, level risk would be a "Pandora's Box" for regulation in the future. 3. Explore the rislJbenefits of asking for an IARC Risk Assessment with formal industry participation, and make a near-term recommendation to senior management. Action plan Actions to Aate • Preliminary background and intelligence on IARC (structurc/attstudes/funding/brief and scope of study) (Bob Pages, Helmur Reif (S&T), Tony Andrade. C&B(Legerl.). Worldwide Regalcrrnry Group). • Indirect contact with study-co-ordinator and two country researchers (Germany, Sweden) established. (FH'eImut Reif(S&T))i (Shook Hardy & Bacon) • Preliminary analysis of methodology undertaken. (Helirrur Reif - S& I') • Initial focus group work to determine marketability of various °messages"/positions vis-a-vis ETS (PMCS). N 0 N N W ~ ~ ~

20-09 '93 14:38 'a0032 2 =5780-18 PMCS P_roposed Steps De ennine rps,ponsihiliries • Formally establish IARC team and' appoint leader Leader : PMCS : David Bushong/Joann a Sullivan/Helene Lyberopoulos Cynthia von Maerestetten S&T : Helnwt Reif/Richard Carchman/Bob Pages e al : Tony Andrade (SH&B), Chuck Lister (C&B). W"VrTRCi: M.att Winokur • Fstablish regional working groups to ensure strategy and plans adapted and implemented globally. Group ad re : US - Jan Goodhart Latin America - Cathy Lieber Asia - Don Harris Australia - David Davies EC - David Bushong EEMA - Michael Parsons Third 12aMv action • Establish link with new 1ARC Director. • Establish small scientific team in key project countries to undertake scientific critiques and have professional contacts with country research teams. Assess tlte =gress and lilcely outcnrm, of the stutly P Oct 1/93 Oct 1/93 Oct 1/93 Dec 1/93 Asscss the predisposition towards ETS of alfi the country researchers. (Xlelmut Re f(S&T), Shook, Hczrdy & I3acorr, via Tony Andrurle (Legal) ; C&B via Bob Pages (Sd'cT,)) Nov 1/93 • Obtain the best information about the status and likely findings of the study via friendly'scientists links with~ the country researchers. ("elnaur Rerf (S& T), Tony Andrude (L;egal), CBaB. Sh.vok, Hurrly & Bu.con) Nuv 1/93 11: • Determine the feasibility of communicating a critical point of view O N to the TARC study co-ordinator, and to the country rescarchers at the preliminary results stage. (Legal, S& T) Jan 1/94 N ~ ~ ~

20-'09 ' 93 14: 38 'a003'2 2 2878048 PMCS Pre-emnt/rancel the stiedv • Assess the risk/benefit and feasibility of a pre-emptive or alternative study, as well as a full blown risk assessmtnt. (Worldwide Regul.a.t.orv Group) Nov 1/93 • Ideiitify key national Governnient influence points within the 16 IARC donor countries; establish the fcasibi)ity for generating pressure for recasting of IARC priorities.. (S& T, Legal, C&B, AVICS) A ffect Conclusions/WordinZ • Gather materials on other "low risk" substances based on, epidemiological studies, in order todetermine what conclusions are appropriate to what statistical resul,ts. • Prepare argumentation applicable to various statistical results for tltis study. A'ddress the tmnact of the ,strcdy t"nmm.r.cn:ictrtians it Nov 1 /y'i Dec 1/93 Dec 1/93 • Prepare a critique of the methodology, and of the conclusions which might be drawn from the statistics. (S&T, Legal). Nov 1 /93 • Obtain and assess IARC lnternal Guidelines on ri5k assessment. (Shook, Hardy & 13a.con., Legal) Nov 1 /93 • Prepare a critique of the core survey questionnaire. ($lzaok, Hardy & Bacon) Nov 1 /93 • Assess the communications pattcrns of past IARC studies of a • similar nature. (P)Llf CS)! Assemble a crisis communications te.am/plan to manage the impact Nov I /93 of the release of the study. 1lfiara Winokur, Helene Lyberopoul.os. .l-lelmur Reif (S&T), Michael Parsons, Jim Linrlheir9?; Tony Andrade (Legul)) ~ Dec 1/93 0

20- 09 ' 93 1=1 : 38 $`0032 2 2878048 PMCS Qj 007 • Develop a contingency plail to use if the prtliminQ.ry results are leaked. (PMCS, Worldwitle Regulatory Group) Goverrunerit RelClli{J1A5 Jan 1/94 R • Develop EC/national lobby plans for use pre/post rele~'tse with, key targets. (PMCS) Jan 1/94 d~llv Devel,nnrnenr. • Develop expertise in workplace risk manage.merte: the players, the issues, the language, etc. to see where ETS nnicht fit in_ Dcc /93 • Identify potential allies for "this could open a Pandora's Box" argument (i.e., industry associations) or "this wili reduce worker freedom's armument"' (i.e., unions). Jan /94, Conduct briefings of allies and start dial.ogues on upcoming study to encourage helpful responses to any regulatory initiatives which result. Ongoing 94