Document zzdKZrgzx0Q3Oe8zkzwQwgYNB

The Shanghai Health Study Patsy Clegg/Stuart Cagen March 2003 SHELL-MCCLURG-068137 The Shanghai Health Study :~::.::~: Path to developing the study: IJ Pre-97: 97::::H::::: Benzene exposure associated with AML NCI published conclusions from China study that: - Benzene can cause NHL - AML develops at exposures lower than previously known - no threshold observed NCI Methodology criticized Feasibility studies in Shanghai Benzene Health Study Consortium formed to: - do a study to test conclusions - answer questions of disease progression and biomarkers SHELL-MCCLURG-068138 Benzene exposure and cancer Conclusions from pre-1997 Epidemiology :~:~:I:~::~ Only acute myelogenous leukemia (AML) associated with benzene :t!::I: No risk at exposures < 1ppm III: Clear risk at exposures > 20 ppm I:i::::: Insufficient data at 1-20 ppm to assess risk SHELL-MCCLURG-068139 The Shanghai Health Study 1. Case Control Study Traditional epidemiology study to determine risk of AML, NHL among benzene exposed workers 2. Disease Progression Study Prospective study on relationship of non-cancer bone marrow disease and benzene induced AML 3. Molecular Epidemiology Study Prospective study to establish quantitative relationship between exposure and effect SH ELL-MCCLU RG-068140 Benzene Health Research Consortium Sponsoring Companies 'Y BP 'Y ChevronTexaco 'Y ConocoPhillips 'Y ExxonMobil 'Y Shell Chemicals, LP SH ELL-MCCLU RG-068141 Benzene Health Research Consortium Organization Oversight Committee Technic~mmtnication Jecruitment Legal 11 Scientific Review Panel APeD Ethics Review Panel API Administrative Support SH ELL-MCCLU RG-068142 Shanghai Health Study Study Participants Principal Investigators: Dr. Richard Irons, U of Colorado Health Sciences Center Dr. Otto Wong, Applied Health Sciences Dr. Fu Hua, Fudan University Collaborators: ExxonMobil Biomedical Sciences Chinese Participants: Fudan University School of Medicine 16 area Shanghai hospitals Shanghai Municipal Center for Disease Prevention Shanghai Hematology Society Shanghai Pathology Institute for Public Health Supervision Sha nghai Pu blic HeaIth Bu rea u Internal Review Boards U of Colorado, Fudan University SH ELL-MCCLU RG-068143 Shanghai Health Study Aug 2001 3/4Q01 2002 1Q03 2Q03 Aug 03 2007 Study Ti me Li ne Consortium Formed Protocols Reviewed Lab Constructed and Equipped at Fudan Begin accepting cases Opening Ceremony in Shanghai First Annual Meeting Report SH ELL-MCCLU RG-068144 Shanghai Health Study .:. Budget Costs $22.5M .:. Funding $16.5M .:. Recruitment Plan to gain additional support SH ELL-MCCLU RG-06814S Shanghai Health Study Summary :~:;:{:~: Opportunity to obtain a better understanding of the mechanism of benzene induced disease in humans. =:!i:f'f::!:= Significant impact on benzene risk assessment. =~{:;:~: Highest Quality of Science: tHI employ state-of-the-art biological and epidemiological science :!}I represent sound product stewardship t{!: exemplify best practices in research ethics }{!: depend upon partnership of industry, governments, academia and public SH ELL-MCCLU RG-068146 Shanghai Health Study 1) Study justification :::H::::: In addition to prior NCI study, more recent studies from Australia have raised additional hazard and new risk questions. While EU industry groups(CEFIC and CONCAWE) are considering additional work for clarification, the Shanghai program addresses these questions in a more fpurnodgaremsesi.notna.l way, particularly with regard to disease I::::::: Shanghai study will also help focus of children's health assessments, regardless of outcome of tier 1 VCCEP case. t{::: External affairsjNGO opportunities are recognized. SH ELL-MCCLU RG-068147 Shanghai Health Study 2) Problems 1m Under fu nd ing : Cu rrent shortfa II critica I. Without additional $ 6 million, investigators suggest lack of closure for all studies. API 'safety net' uncertain. Prolonged uncertainty can be pa ra Iyzing. E:; Distractions: investigators might seek outside (eg NIH) funding of 'side' projects. 1m Accountability: uncertainty regarding connections between funding timeline and study milestones. Study completion cost overruns ('surprises') possible, with sponsors currently under informed. rm Transparency: With time, losing added value of engaging non-industry participants (government and NGO). SH ELL-MCCLU RG-068148 \}Shell Chemicals SH ELL-MCCLU RG-068149