Document zdyN9KKDL8NO96ax4XMvqy27z

Draft: September 16, 2003 Shanghai Health Study - Forward Plan Funding continues to be a concern. Aggressive recruitment has yet to identify any new sponsors. Therefore, the forward plan focuses on sizing the study to meet available funding. Plans are progressing on engaging government and non-governmental organizations. An "opening ceremony" is be held in Shanghai in the future to formerly solidify the relationship between the US and Chinese investigators and government agencies. The second annual meeting of the consortium is planned for August 2004, in California, the site of this year's meeting, with future sites to include Shanghai and Europe. SHELL-MCCLURG-068189 Shanghai Benzene Study Update November 2003 The objective of this memo is to provide an update on the Shanghai Benzene Study. Additional and more detailed information can be found at http://www.shanghaihealthstudy.org/Secured-Committee/SHS_Updates/SHS_Update.htm Username: Password: We anticipate providing internal updates on a quarterly basis, beginning in January 2004 as well as other communications on an as needed basis. Background: Shell Chemical is participating in a multi-stakeholder health study in Shanghai, China, which aims to better define the hazards and health risks from exposure to benzene. The project participants include a wide range of stakeholders including the Fudan University Medical Center, University of Colorado Health Sciences Center; Applied Health Sciences, Chinese public health agencies, Shanghai hospitals as well as several peer energy and chemical companies. This study, which is part of our commitment to product stewardship, will help clarify previous assumptions regarding benzene health risks and will also help address some recent questions about benzene hazards and exposure. Further, this information will provide the industry with information, which we can use to determine what, if any, improvements are needed in existing protocols. The study will examine past and current exposures in Shanghai-area manufacturing facilities (none are Shell facilities and the benzene not a Shell product). In order to accomplish this goal, a state-of-the-art clinical and molecular laboratory was built on the Fudan Medical University campus to support the research project and the Shanghai medical community. Chinese technicians have been trained to operate the lab. This facility will remain at Fudan once the project is completed. Current Status: The Shanghai Health Study Launch Ceremony is scheduled for December 9th, 2003. As agreed with Shell China, Henry Wang, Corporate Planning Director for Shell China, will represent Shell at this event. Attendees will include Richard Spelman, Consul General of the US, and a Vice Mayor of Shanghai, along with Fudan University officials. The event will be open to all collaborators and participants in laboratory operations. Annual Meeting: The First Annual Meeting of the Shanghai Health Study was held August 25-27,2003 at the Asilomar Conference Center in Monterey, California. The meeting was the first faceto-face gathering all the various groups involved with the study: the Principal Investigators (both Chinese and American research team members), Scientific and Ethical Review Panel members and the project sponsors. A summary of the meeting can be found at. http://www.shanghaihealthstudy.org/Secured-Committee/SHSUpdates/SHSUpdate.htm SHELL-MCCLURG-068190 Project Status: The study has begun accepting cases. The study is fully funded - at a level below the original budget. However, the sponsors have been assured that a scientifically rigorous study can been accomplished at the new funding level. Financing: The study was initiated with a recognized gap between the budget and the committed funds. Four of the originalS sponsors have agreed to provide additional funding. The project is being re-scoped to meet the available committed funds. The project sponsors continue to seek additional funding support. Shell and other Consortium members have some recommendations for improving the oversight process including further document review and control of API management as well as a more rigorous approach towards project management; implementing cost management and controls. Communications: The Communications Committee has recommended that in order to ensure credibility a public website for the SHS should be maintained by Fudan University and/or the University of Colorado and Applied Health Services. The Committee is in the process of determining the website capacity at both sites. A final media plan will be presented at yearend to the Oversight Committee. In general, a proactive, low-profile media approach is recommended. During the launch ceremony in December, the Shanghai and Beijing media will be briefed on the project. APCO is providing consulting on public affairs strategy and plans for the study. Other media milestones have been identified, including the 2005 Symposium on Benzene, a review of the National Cancer Institute study results in 2004 and the SHS results. These and other milestones present opportunities and/or challenges for the SHS and need further assessment as to appropriate communication regarding them. The Committee will also meet with the University of Colorado press office to ensure SHS media protocol fully adopted and utilized by the participants in the study. Stakeholder engagement with the scientific community, government, and NGOs will begin in the near future. We are currently finalizing the strategy and protocols for the engagement now that funding is complete. The Communication Committee budget may be reduced considerably to meet the budget commitment. The regrets need to be identified. SHELL-MCCLURG-068191 Shanghai Health Study - Project Update - Q4 2005 November 5, 2005 The objective of this memo is to provide an update on the Shanghai Health Study (SHS). This study, sponsored by the Benzene Health Research Consortium of which Shell Chemicals is a member, is a multi-stakeholder health study in Shanghai, China, which aims to better define the hazards and health risks from exposure to benzene. The SHS held its third annual meeting in November 2005 in Fairfax, Virginia. California. The meeting brought together the Principal Investigators (both Chinese and American research team members), the Scientific and Ethics Review Panel members and the industry sponsors. The objective of the meeting was to provide a forum for reviewing the study's progress to date and expectations going forward. The two-day meeting included Opening plenary session where investigators presented progress reports followed by a Q&A session. Highlights include: The Ethics and Scientific Review Panels met to discuss what they heard in the investigators' presentations and progress against study protocols. The sponsors met with the investigators to begin putting a time-line together Patsy Clegg, Shell Chemical's Benzene Product Steward and Chair of the Benzene Health Research Consortium Oversight Committee, opened the session emphasizing the participating companies' ongoing commitment to product stewardship; the importance of the industry's commitment to better understanding the potential effects of benzene exposure and the study's role in helping industry effectively manage and minimize risk. Patsy also emphasized the importance of the cooperative and collaborative relationships that have been established among the researchers, the Scientific Review Panel and the Ethics Review Panel. Participants offered their views on some key accomplishments and milestones including: The launch of the start-of-the-art lab Joint Sino-U.S. Clinical and Molecular Laboratory (JCML) at Fudan University in December 2003 Partnership with 30 Shanghai hospitals that have allied themselves with the JCML Since January 2004, the inflow of cases into the JCML has exceeded expectations by two times the original estimate. No cases or controls have refused to participate in the study Several factories have agreed to participate and formal data collection is underway for 34 factories; the PI's conducted preliminary analyses on one factory, a Shanghai rubber factory. Preliminary results indicate that the study will indeed make a difference and help bring new clarity to the field. Some of the key challenges noted at the conference include: Efforts to recruit factories and current workers to participate Data gathering and measurement of the workplace environments Quality control associated with recruiting of participants SHELL-MCCLURG-068192 In closing, the participants emphasized the importance of accurate exposure assessments to achieving the goals of all three studies, seeking to establish dose-effect relationships between benzene exposure and adverse health consequences. The participants also highlighted the importance of ensuring that the JCML continue to operate, providing diagnostic services and support for research long after the SHS concludes in 2006. The 2005 meeting would be held in Shanghai the first week of November. Background on the SHS: Shell Chemical is participating in a multi-stakeholder health study in Shanghai, China, which aims to better define the hazards and health risks from exposure to benzene. The project participants include a wide range ofstakeholders including the Fudan University Medical Center, University ofColorado Health Sciences Center; Applied Health Sciences, Chinese public health agencies, Shanghai hospitals as well as several peer energy and chemical companies. This study, which is part ofour commitment to product stewardship, will help clarifY previous assumptions regarding benzene health risks and will also help address some recent questions about benzene hazards and exposure. Further, this information will provide the industry with information, which we can use to determine what, ifany, improvements are needed in existing protocols. The study will examine past and current exposures in Shanghai-area manufacturing facilities (none are Shell facilities and the benzene not a Shell product). A state-of-the-art clinical and molecular laboratory was built on the Fudan Medical University campus to support the research project and the Shanghai medical community. Chinese technicians have been trained to operate the lab. This facility will remain at Fudan once the project is completed. For additional information or inquiries, please contact Patsy Clegg at 713 -241-2521 or patsy. clegg@shell.com. SHELL-MCCLURG-068193