Document X7B5a0z4OE5JjzBpNMdLBXp1J

The Shanghai Health Study Patsy Clegg Chair, Oversight Committee Shell Chemicals, LP May 2004 SH ELL-MCCLU RG-06S474 What is the Shanghai Health Study? ::i:::i!::} A long-term clinical study to investigate the potential causes and development of Iympho-hematopoietic diseases (diseases of the lymphoid organs, blood and bone marrow) as related to benzene ::i:::i!;:} A project of Fudan University Medical Center; University of Colorado Health Sciences Center; Applied Health Sciences - an independent U.S. research firm; Chinese public health agencies; and Shanghai hospitals SH ELL-MCCLU RG-065475 Shanghai Health Study Purpose C) To gain a quantifiable understanding of the relationship between benzene exposure and potential associated cancer risks SH ELL-MCCLU RG-06S476 Path to developing the study: t:;::::~:: Pre-9 7: 97::~: :;:;: : : 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 th reshold observed NCI Methodology criticized Feasibility studies in Shanghai Australian Institute of Petroleum's (AlP) Health Watch Study - Association with all leukemias, including chronic lymphocytic leukemia - No association with NHL or multiple myeloma Benzene Health Research Consortium formed to: - do a study to test conclusions - answer questions of disease progression and biomarkers SH ELL-MCCLU RG-06S477 Benzene exposure and cancer Conclusions from pre-1997 Epidemiology '::::11:I!l1::::: Only acute myelogenous leukemia (AML) associated with benzene ::::!{::1 No risk at exposures < 1 ppm :::::=::::1 Clear risk at exposures > 20 ppm Iit:il Insufficient data at 1-20 ppm to assess risk SH ELL-MCCLU RG-06S478 The Shanghai Health Study 1. Case Control Study Traditional, prospective epidemiology study to determine risk of AML, NHL among benzene exposed workers - 450 AML and 450 NHL patients into study 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-06S479 Uniqueness ofShanghai Study Prospective resea rch::::I!:;;!I::::: Ii'::::l Patients at participating hospitals suspected of having a lymphoid, blood or bone marrow disease will be referred to the SHS ::::g:::l Patients' diets, environmental exposures and family histories will be recorded If::::l Patient disease progression followed at supporting hospitals SH ELL-MCCLU RG-06S480 Uniqueness ofShanghai Study ::::1::;;:1::::: Study will be able to examine primary diagnostic and medical data in real time ::::::::1:1::::::: First-hand exposure reports are more reliable than second-hand or reconstructed information ::::::::11::::::: State-owned databases document worker histories SH ELL-MCCLU RG-06S481 Uniqueness ofShanghai Study :~::~:;:~::i: Robust data set ::::g:::l State-maintained benzene exposure and health effects databases documented from 1970s :~:;:~:l Benzene related health effects are #2 in reported chronic occupational health hazards in China in 2001 (Source: Ministry ofPublic Health) :~:I:~:l Large range of exposure levels from a variety of occupational sources :~:~:;:~:i: Regulatory authorities interest in improving benzene exposure regulation and enforcement SH ELL-MCCLU RG-06S482 Quality, Independent Science :~t:;:!:: All protocols reviewed and approved by external Institutional Review Boards (IRB's) IIi Govern use of human subjects tm u.s. and China independently :::!::i!i!} Shanghai Health Study independent review panels nm International Ethics Review Panel II:l International Scientific Review Panel 12 members 6 scientific disciplines tIl Involved during entire project SH ELL-MCCLU RG-06S483 Benzene Health Research Consortium Sponsoring Companies ~ BP ~ ChevronTexaco ~ ConocoPhillips ~ ExxonMobil ~ Shell Chemicals, LP Marathon/Ashland providing additional support SH ELL-MCCLU RG-06S484 Benzene Health Research Consortium Organization Oversight Committee / 1I Techrcal/BUdget commutcation Recruitment Legal Scientific Review Panel Ethics Review Panel APeD API Administrative Support SH ELL-MCCLU RG-065485 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 26 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, AHS SH ELL-MCCLU RG-06S486 Shanghai Health Study Study Ti me Li ne Aug 01 3/4Q01 2002 3Q03 Aug 03 4Q03 Aug 04 2007/8 Consortium Formed Protocols Reviewed Lab constructed, equipped at Fudan; technicians trained Began accruing cases First Annual Meeting Opening Ceremony in Shanghai Second Annual Meeting Report SH ELL-MCCLU RG-06S487 Shanghai Health Study .:. Budget .:. Funding Costs $ 21.0BM $ 21.0BM SH ELL-MCCLU RG-06S488 Shanghai Health Study Summary :~:\:.:!:~: Opportunity to obtain a better understanding of the mechanism of benzene induced disease in humans. ti,:,:!i::: Significant impact on benzene risk assessment. :~:;:i} Highest Quality of Science: !:}!1 employ state-of-the-art biological and epidemiological science :!}:} represent sound product stewardship :r,:r exemplify best practices in research ethics iI}::i:i depend upon partnership of industry, governments, academia and public SH ELL-MCCLU RG-06S489 The Shanghai Health Study Patsy Clegg October 2002 SH ELL-MCCLU RG-06S490 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-065491 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 SH ELL-MCCLU RG-06S492 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-06S493 Benzene Health Research Consortium Sponsoring Companies 'Y BP 'Y ChevronTexaco 'Y ConocoPhillips 'Y ExxonMobil 'Y Shell Chemicals, LP SH ELL-MCCLU RG-06S494 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-065495 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-06S496 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-06S497 Shanghai Health Study .:. Budget Costs $22.5M .:. Funding $16.5M .:. Recruitment Plan to gain additional support SH ELL-MCCLU RG-06S498 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-06S499