Document 50mraav2m44zg3J97qDDG18VV

From: Sent: To: Cc: Subject: Attach: brian. e. doll@exxonmobil.com Friday, September 16, 20058:51 PM (GMT) Clegg, Patsy M SCC-CHSE-PC <patsy.c1egg@shell.com> benzconsort-cc@listserve.api.org; benzconsort-oc@listserve.api.org; benzconsorttc@listserve.api.org; Matt Todd <ToddM@api.org> RE: SHS: Study Summary Revised Summary for symposium BEDoll.doc Patsy, et. aI., I have made a few changes for your consideration that builds on Jennifer's draft. The following changes are consistent with the "Committee Roles and Responsibilities" document on the SHS website: -- Consistently capitalized "Principal Investigators" -- Added "Review" to "Ethics Panel" to make it "Ethics Review Panel" -- Added "independent" to the descriptions of the people on both the SRP and ERP The following were more worksmithinglchanges in style and are open to debate: -- I do not particularly like calling this a "study" in the first paragraph and then saying it is "actually 3 studies" in the second paragraph. In our "Main Messages" document on the website, we refer to this as a "project" when talk about the whole thing, and to 3 studies when talking about the parts. I adopted this convention for the paper. -- I think the word "benzene" should be in the first paragraph unless someone can think of a good reason why it should not be. -- In the last paragraph, would it be more accurate to say it is the "results of the studies" rather than the "study" that we want to become a part of the body of scientific research on benzene? Have a good weekend. Regards, Brian (See attached file: Summary for symposium BEDoll.doc) "Clegg, Patsy M SCC-CHSE-PC" <patsy.clegg@s To hell.com> "Matt Todd" <ToddM@api.org>, <benzconsort-oc@listserve.api.org>, <benzconsort-tc@listserve.api.org>, 09/16/05 01 :23 <benzconsort-cc@listserve.api.org> PM cc Subject RE: SHS: Study Summary Revised Good rewrite. My spell-check identified that well-managed should not be hyphenated. Patsy -----Orig inal Message----From: Matt Todd [mailto:ToddM@api.org] SH ELL-MCCLU RG-052992 Sent: Thursday, September 15, 2005 10:59 AM To: benzconsort-oc@listserve.api.org; benzconsort-tc@listserve.api.org; benzconsort-cc@listserve.api.org Subject: RE: SHS: Study Summary Revised BHRC Committee Member: Due to significant comments and changes to the SHS Summary document, please review the attached, revised version instead of the document that was circulated on 9/13. The deadline for review and comment remains October 7th. Regards, Matt From: Matt Todd Sent: Tuesday, September 13, 2005 12:09 PM To: BHRC Oversight Committee (benzconsort-oc@listserve.api.org); BHRC Technical Committee (benzconsort-tc@listserve.api.org); BHRC Communications Committee (benzconsort-cc@listserve.api.org) Subject: SHS: Study Summary BHRC Committee Member: Please review the attached SHS Study Summary and provide comments back to me by COB October 7th. This document will be distributed to the SHS Symposium attendees to provide an overview of the study. Regards, Matt Matthew Todd American Petroleum Institute 1220 L Street NW Washington DC 2005 www.api.org SH ELL-MCCLU RG-052993 Shanghai Health Study Descriptive Overview DRAFT In December 2003, a gathering in Shanghai, China marked the opening of the Joint Sino-U.S. Clinical and Molecular Laboratory. This opening marked the formal beginning of the Shanghai Health Study, an unusual a cooperative research project involving leading researchers from the U.S. and China, facilities at Fudan University, a network of Shanghai hospitals, with U.S. oil and chemical company support. The research project has been underway since then to further the understanding of the human health effects of benzene, with data collection scheduled for completion late next year (2006). Purpose: The project is a series of studies designed to advance the medical and scientific understanding of the relationship between benzene exposure and the risk of certain hematopoietic diseases (certain blood and lymph related disorders). The sponsor companies consider the project an important element factor in their product stewardship programs. A unique set of circumstances in Shanghai enabled investigators to launch this meaningful benzene research. These include a long history of working with occupational exposures and qualified, experienced investigators familiar with the local scientific, medical and regulatory establishments. The studies should contribute to the scientific literature regarding a number of issues that have long complicated benzene health risk assessment. The Studies: The program involves three inter-related studies: Case-Control Study - A hospital-based case control study investigating the potential relationship between exposures to benzene, other diverse variables and both Non-Hodgkins Lymphoma (NHL) and Acute Myelogenous Leukemia (AML). Disease Progression Study - A hospital and clinic-based investigation of the potential relationship between non-cancer diseases of the bone marrow and AML to determine if effects on bone marrow progress through non-cancer stages to an ultimate leukemia. This study is also attempting to define the shape of the dose response for possible "precursor" diseases. This study could result in characterization of unique identifiers of benzene-induced AML. Molecular Epidemiology Study - An investigation of whether there is a quantitative relationship between benzene exposure and potential early biological indicators of both exposure and effect in a focused population of workers. The combined studies apply new technologies to advance the medical and scientific knowledge of benzene-induced disease. The investigators are leading experts in their fields. The three Principal Investigators are Dr. Fu Hua of Fudan University, Dr. Richard Irons of the University of Colorado Health Sciences Center, and Dr. Otto Wong of Applied Health Sciences (an independent U.S. research firm). Benefits: Beyond advancing knowledge of benzene toxicology, these studies will further assist the contributing companies in their continuing efforts to achieve the provide highest quality product stewardship geals and continuous development improvement of their risk management programs. In addition, the studies may contribute to analyses conducted when governments debate future regulatory standards. 1 SH ELL-MCCLU RG-OS2994 Challenges: The studies have met several technical and ethical challenges. Technical- Scientific Review Panel In order to stand up to rigorous scientific standards, studies must pass scientific scrutiny, be well-managed, and incorporate the best technology. State-of-the-art research is absolutely necessary to make real progress in developing a sound risk assessment. To that end, a Scientific Review Panel was assembled, made up of independent leading experts from a number of fields relevant to these studies. They reviewed, commented on, and after revisions, endorsed the research protocols. Additionally, the protocols also met the rigorous requirements of three separate Use of Human Subjects Committees (Institutional Review Board or IRB), two in the US and one in China. The Scientific Review Panel has also met with the Principal Investigators to hear about progress and provide their perspectives on issues that arise. They will remain available to the investigators throughout the research program. Ethical- Ethics Review Panel To address ethical issues posed by the project, the protocols have undergone a thorough analysis to ensure that they meet international standards for research involving humans (guidelines established by the Council for International Organizations of Medical Sciences or CIOMS). An Ethics Review Panel is part of the oversight for the proj ect. It consists of independent bioethicists from the U. S., China and Europe. This panel also consults with the Principal Investigators during the course of the research. Collaboration: A key to the program's success is local partnerships. Collaborators on these studies include researchers from the Medical School at Fudan University, the Institute for Public Health Supervision, and the Shanghai Municipal Centers for Disease Control and Prevention (the latter two are responsible for occupational exposure monitoring and enforcement in Shanghai). Equally critical is the Joint Sino-U.S. Clinical and Molecular Laboratory which was developed for this research project. This state-of-the-art clinical and molecular laboratory operates on the Fudan Medical University campus. It supports the research studies as well as providing diagnostic services for over 30 major hospitals in the Shanghai region. The facility will remain at Fudan once the project is completed. This sustainable technology transfer is an important aspect of the project design. Conclusion: The project sponsors (listed below) are committed to seeing that the Shanghai Health Study is conducted in an open manner, and with the assurance of the investigators' research independence in conducting the studies, analyzing the data, and publishing their conclusions. The sponsors' goal is for the results of the studies to become an important part of the body of scientific research on benzene. BP Chevron ConocoPhillips ExxonMobil Shell Chemical With Additional FlUlding from Marathon 2 SH ELL-MCCLU RG-052995