Tobacco Documents Online

IARC STUDY IARC ETS STUDY • Data collection by collaborating centres complete • In June 1994, IARC is holding a 3 week meeting to review all ongoing tobacco related studies; the ETS study will be discussed. During the meeting the IARC team and country collaborators are expected to agree common statistical procedures for each centre to analyse its data. • Once the data is analysed per centre according to the same methodological criteria, IARC is likely to do a meta-analysis of all centres' results. Result of meta-analysis expected mid 1995. The IARC meta-analysis would differ from that of the EPA in that for IARC the same questionnaire and the same statistical procedures for data analysis will be used. IARC study is thus methodologically more sound. The two key weaknesses are lack of real exposure data and insufficient regard for the role of confounders. MOBILIZE SCIENTIFIC RESOURCES IN THE 8 PARTICIPATING COUNTRIES • CONTACT INDIVIDUAL COUNTRY COLLABORATORS AND IARC STAFF We are using S&T and C&B/SHB scientific consultants to contact the scientists that are conducting the 11 epidemiological studies in the 8 countries as well as to contact the IARC team in Lyon.

Status: Study centres: Coun Contact Bv Whom ? Italy (2) established S&T (MR) Germany (2) established S&T (HR)/PM Laboratory Spain (1) planned J. Brana Portugal (2) planned C&B UK (1) planned ? France (1) ) not planned - collaborators philosophically Sweden (1) ) opposed Austria (1) IARC Team : 2 meetings (S&T (HR) + P. Lee) have been taken place 1 foreseen by C&B consultant in June 1994 (during C&B sponsored IAQ conference in Dijon). The Italian collaborators have accepted a visit to Neuchatel in principle for Autumn. This visit should establish a precedent to establish relations with Portuguese and UK collaborators. Austria, through lack of cases is apparently to drop out of the study. This would bring the number of countries involved to 7, and collaborating centres to 10. Our objectives in establishing relationships are : 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 mindful of the weaknesses of epidemiology that rely on survey questionnaires. We recognize that there is 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 the collaborators can be persuaded that the IARC methodology is inadequate (it does not take into account confounders or measure actual exposure leading to, misclassification). 2

• CIAR : THIRD PARTY SCIENTIFIC NETWORK CIAR (US centre for indoor Air Research) is involved with two new major research studies in the US : one seeks to measure actual levels of exposure to ETS on non-smokers, and the second study examines the impact of confounders (diet, family history, occupational exposure environmental pollution). CIAR has volunteered to meet with the IARC staff in Lyon to explain the importance of confounders and that existing studies show minimal levels of exposure to ETS. UNDERTAKE ORIGINAL RESEARCH IN EUROPE TO EXPOSE THE WEAKNESSES OF EPIDEMIOLOGY • STUDIES TO MEASURE ACTUAL LEVELS OF EXPOSURE TO ETS • STUDIES TO MEASURE THE ROLE OF CONFOUNDERS Together, solid data on exposure and confounders significantly undermine the validity of even the best epidemiological studies. Exposure studies reveal that far more non-smokers actually smoke than they report when they're surveyed, leading to misclassification. They also demonstrate real exposure levels as much lower than indicated by questionnaires. Confounder studies reveal other, much stronger lifestyle factors which influence disease development (lung cancer, cvd) and further serve to demonstrate geographical disparities in lifestyle factors. CIAR would sponsor exposure studies in key European countries where IARC is conducting the studies (Germany, France, Sweden, Italy (?) and Spain (?) are being considered. ($ 250,000 per study) An exposure study has recently been completed in the UK (Hazelton). The approach will be modelled on the ongoing US study (see above). European data should have greater impact vis-a-vis the IARC study. The protocols used for the US confounder study (Matanowski) would be used for a Europe based study, probably in Germany, and possibly Sweden. 3

The results of these studies, assuming budget approval, will be communicated to the scientific community, regulators and media by C&B/SHB consultants, S&T, CIAR and the study researchers. The studies should be completed before the IARC study is published. A presentation is scheduled to Steve Parrish for June 2nd, for budget approval. Budgets would be shared by PM and other tobacco companies. Prior to the studies being published, peer review articles exposing the weaknesses of epidemiology are being commissioned. 4

IARC MONOGRAPH All existing and proposed studies on confounders and exposure 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). 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 SHB consultants + CIAR 2. ENCOURAGE BALANCED PERSPECTIVE AMONG EXPERTS IN IARC MONOGRAPH WORKING GROUP It is expected that invitations will be issued by IARC to both P. Lee 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. One of the consultants is preparing a paper on the monograph process and is finding out about the invitation process. 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). 2501347172 5

BRIEFING BOOK Briefing papers are being prepared by C&B, SHB, S&T, PMCAE on all aspects of the study/ETS. WRA will be responsible for editing. Subjects to include: IARC Agency description and previous activities on tobacco, study description (incl. outcome scenarios), review of scientific literature on ETS in the eight collaborating countries, literature reviews on the scientists involved in the study (bias?), identification of key confounders (other risk factors for lung cancer), analysis of study questionnaire, IARC internal guidelines for conducting epidemiology, description of ETS, status of scientific literature on ETS (both general and specific to workplace, restaurants and the home), arguments tailored for employers, unions, government, Horeca, critique of EPA, role and weaknesses of epidemiology, examples of misuse of epidemiology, criteria for good epidemiological practices, examples of other "low level" risks. Timing: summer 1994 • Scientists (S&T, C&B, SHB consultants) to brief technocrats, scientific advisors, scientific and policy media • CAs to brief politicians, government officials, allies, general media • Think tank types to talk on government intervention, corrupt science to policy/general media END w 6