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Brussels PHILIP MORRIS CORPORATE SERVICES INC. Rue Joseph 11,166 1040 Brussels INTER-OFFICE CORRESPONDENCE Ru; S;o+J To: David Greenberg Date: September 2, 1993 From: Joanna Sullivan C.C.: David Bushong Subject: IARC Study Situation analysis Cynthia von Maerestetten The International Agency for Research on Cancer (IARC) began a multinational case control study in 1989 to determine the health effects of passive smoking. The study involves 11 centres 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 centres. This approach distinguishes it from the EPA Risk Assessment which conducted a meta-analysis of existing studies. Indeed, IARC initiated its own study partly in response to the methodology employed by EPA. The study is designed to investigate the relationship between lung cancer and exposure to ETS and other environmental risk factors in subjects who have never smoked, using a survey questionnaire, cross checked by personal interview. It is intended as the largest ever study of its kind; 1200 cases are sought. The study has been extended by one year, because of the difficulty researchers are having in finding sufficient subjects. 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. The results are anticipated to have significant credibility both because this study consists of original research and because IARC itself has a solid reputation. Preliminary indications suggest that the study may find a very weak, but positive link between ETS exposure and lung cancer in non-smokers. However, regardless of the statistical conclusions, the official statement is likely to be manipulated by WHO to serve their political agenda. The results will inevitably serve to stimulate additional restrictions on public smoking and are likely to precipitate a complete risk assessment by IARC. The WHO will certainly be responsible for releasing the study to the media and national health agencies on a global basis. IARC, although financially and structurally independent, operates as the research arm of WHO, which is represented on IARC's Governing Council. IARC studies on the cancer risks associated with tobacco have been used extensively by WHO in its anti-tobacco campaigns and are often cited by national health authorities, the European Commission and critic groups. Control actions on carcinogenic agents by national occupational health and safety authorities (and the EC) are often based on IARC studies and data.

Recent IARC studies include the effectiveness of legislation and health education in reducing smoking incidence, the link between smoking and pancreatic cancer, and between smoking and cancer and cardiovascular diseases in developing countries. IARC has also conducted a survey of anti-smoking legislation in the EC and has launched standardised tobacco surveys in 10 African countries. Objectives 1. Delay the progress and/or release of the study. 2. Neutralise possible negative results of the study. 3. Counteract the potential impact of the study on Government policy, the media and on public opinion. ra e While the current state of intelligence is not sufficient to make firm strategic determinations it is clear that one global strategy, closely linked with regional and national strategies and plans will be essential. Additionally, it would seem that at least initially, we need to move along parallel tracks, simultaneously seeking to slow down progress at the national clinical level while seeking to take advantage of budgetary constraints and a new IARC Director with new priorities, to fully exploit any openings to get the study shelved altogether. In tandem, we need to build a solid foundation of scientific criticism which can be activated with respect to the methodology, junk science and the misuse of epidemiology within that context. Finally, we need to be simultaneously working to create a regulatory and public opinion climate which will mute the impact of negative study results. Action plan Actions to Date • Direct contact with study-co-ordinator and some country researchers established (Neuchatel and Richmond). • Preliminary background and intelligence on IARC (structure/attitudes/funding/brief and scope of study) (Richmond, Neuchatel, PMCS, Legal, Worldwide Regulatory Group, C & B). • Tentative and preliminary exploration of feasibility/viability/risks of generating pre-emptive counter study (Legal, Worldwide Regulatory Group). • Initial focus group work to determine marketability of various "messages"/positions vis-h-vis ETS (PMCS).

Proposed Steps Determine responsibilities • Establish IARC multi-disciplinary team and leader to co-ordinate overall strategy, actions regionally and nationally. • Establish regional working groups to ensure strategy and plans adapted and implemented globally. • Identify and establish small scientific "third party" team in each of project countries and major PM "influential" markets to form intelligence and influence network with national research teams and form nucleus of scientific critiques and programme development. • Establish third party vehicle for generating methodology critiques. • Identify and establish third party intelligence/influence link with new IARC Director. Determine the project outcome • • Oct 1/93 Oct 1/93 Dec 1/93 Nov 1193 Oct 1193 Assess the feasibility/desirability/risk/benefit of pre-emptive study. Assess the predisposition towards ETS of all the country researchers. (Neuchatel, Legal) Sept 1 /93 Nov 1/93 • Obtain the best information about the status and likely findings of the study via friendly scientists links with the country researchers. (S&T, Legal, C&B) • Determine the feasibility of communicating relevant information to the IARC study co-ordinator, and to the country researchers at the preliminary results stage. (S&T, Legal, C&B) • Identify key national Government influence points within the 16 IARC doner countries; establish the feasibility for generating pressure for reorientation/reprioritization of IARC priorities/budget allocations. (S&T, Legal,. C&B) Nov 1/93 Dec 1/93 Oct 1 /93

Address the impact qf'the study Communications • 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 be leaked. • Assemble a crisis communications team/plan to manage the impact of the release of the study. • Develop communications points for spokespersons to use with the general media. • Identify and prepare spokespersons in each critical country. • Prepare a critique of the methodology targeted to the scientific community. (S&T, Legal) • 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 and the need for smoking restrictions. • Develop a programme to generate support for "junk science" and education on use and abuse of epidemiology, possibly through a coalition on bad science. • Develop a communications programme to mute/neutralise smoking bans/excessive restrictions. Oct 1 /93 Jan 1/94 Dec 1/93 Feb 1/94 Feb 1/94 Nov 1/93 Dec 1/93 Nov 1/93 Nov 1 /93

Government Relations • Assess the impact of similar past studies. Nov 1/93 • Identify regional and national regulatory bodies that have authority to act on the IARC findings. (PMCS) Nov 1/93 • Prepare briefings on the "facts" of ETS. (S&T, Legal) Jan 1/94 • Develop a lobby plan for use pre/post release. (PMCS) Jan 1/94 • Identify resources that could intervene to offer criticisms of ETS • epidemiology. Develop a plan for securing pre-emptive protective legislation for smokers in key markets. Oct 1/93 Follow up 0 Sustain contact with relevant groups following the study release.