Document 1g5dL3XKmR9pYYkr9mz91MvGX

09 May 2005 BHRC Benzene Health Research Consortium Draft Conference Call Minutes Scientific & Ethics Review Panels (SRP/ERP) o October conference call/Munich Benzene meeting o Exxon/Mobil contributions to on-site staffing/advisory activities: Chinese Speaker and industrial hygienist (Yimei Zhou) Consultant familiar with benzene issues and with China (Gary Krieger) Since the report was issued, budget-based responsibility/ownership for Exposure Assessment elements has been resolved and delineated Helmut Greim noted that Fudan's Progress Report honestly identified problems and proposed solutions ilt'mm: Dick Albertini requests clarification of "clinical physical" group ilt'mm: confirm that PI inter-communication has improved Richard Irons (DP & ME) YE2004 Progress Report Rich Irons noted that case accrual expectations should be met by Dec. 2006 Harvey Checkoway asked about SRP/ERP review of manuscripts (topic deferred to later in this call) Report states that ME phase 2(b) will be collapsed into ME2(a) olllliimN: Request clarification from Dr. Irons: what does "collapse" mean? Is bone marrow collection being scrapped? 2 SH ELL-MCCLU RG-OS7786 09 May 2005 BHRC Benzene Health Research Consortium Draft Conference Call Minutes Scientific & Ethics Review Panels (SRP/ERP) Otto Wong (Case Control) YE2004 Progress Report Otto needs to adopt current nomenclature (versus shorthand, per report) in publications and presentations 111,11: ask Otto if exposure classifications will be reviewed and confirmed ... o Who is the "exposure assessment committee"? o How is thei r work checked? 111nll: Progress Dr. Krieger's proposed review of exposed/control sample o Review 10 exposed /10 control individuals; ensure a "reasonably random" sample Summer 2005 site visit - Fudan University Concept: panel representatives should visit Shanghai, before annual meeting o Panelists agreed that a site visit is a good idea... Discussion: how many should go? A representative contingent, or full panels? o Helmut proposed full panel representation Who should participate? o Jerry to counter-propose to the funding Consortium that full panels should visit Shanghai, and a sub-team could then report at the annual meeting o Full panel representation is far preferable, providing comprehensive representation of skills When? o After June 30th mid-year reporting period o Proposal: Mon 29 Aug ~ Fri 02 Sep (up to 5 days in Shanghai, plus travel?) 3 SH ELL-MCCLU RG-OS7787 09 May 2005 BHRC Benzene Health Research Consortium Draft Conference Call Minutes Scientific & Ethics Review Panels (SRP/ERP) Logistics? o Ilm!QN: Bruce to work hotel accommodations, etc. 111,11: Jerry will send a proposal to host investigators, and then to the sponsor Consortium by email 2005 Annual Meeting (01-03 November, Fairfax VA) SRP/ERP suggestions on content and recommendations are solicited Jerry recommends a less-rigorous schedule for plenary Session; with more time provided for discussion o Shorter plenary presentations, or o Fewer plenary presentations Manuscript Review Richard Irons has expressed anxiety over pre-submission circulation; noting that Journals require "first view"; o Panels will respect confidentiality for professional review Investigators send ready-for-submission manuscripts to Jerry, who now distributes to topic-specialists for review and feedback o Helmut instead suggested full distribution, and review by all panelists o Decision: circulate draft manuscripts to all panelists, with request to specific topic feedback Ilm!QN: Jerry will provide to Bruce, for circulation to group: 4 SH ELL-MCCLU RG-OS7788 09 May 2005 BHRC Benzene Health Research Consortium Draft Conference Call Minutes Scientific & Ethics Review Panels (SRP/ERP) o Munich manuscripts (PDF files of SHS manuscripts were requested from Elsevier on 09 May; these are currently in press, as a special issue of ChemBio Interactions will be compiled for the printer on 12 May) Note Rothman, Hayes & Irons declined to submit papers for the proceedings o Irons' BIMDS manuscript, when current revision becomes available (this was originally proposed for submission to Nature Medicine) o On any new manuscripts, Jerry will indicate which need review FYI ... Associated Press & Houston Chronicle newspaper / media reports of Shanghai Health Study alleging incorrectly that the purpose of the SHS is to refute the NCI study o Letter-to-editor should be considered, if this receives further public attention o Jerry will then draft & circulate rebuttal letter, on behalf of both Panels, if further media reports appear that repeat the original mis-information. Next Call: May 1yth review call for any Panel members who could not participate on May 9th . 5 SH ELL-MCCLU RG-OS7789 Benzene Poisoning in Shanghai, China: Preliminary Findings. Irons, RD (1,2,3,4,5), Ye, XB(1,2), Bao, L(1,5), Wang, X(1,2), Ryder, J (4), Armstrong, T(6), Zhou, Y(6), Miao, LZ(2), Gross, SA(1,3), Fu, H(2). (1)Sino-US Joint Clinical and Molecular Laboratory (JCML), Shanghai, China, (2)Fudan Univ., Shanghai, China, (3)Dept. of Pharmaceutical Sciences, School of Pharmacy, Univ. of Colorado Health Sciences Ctf., Denver, CO, USA, (4)Dept. of Pathology, School of Medicine, Univ. of Colorado Health Sciences Ctf., Denver, CO, USA, (5)Div. of Human Genetics, Univ. of Cincinnati Children's Hospital Medical Ctf., Cincinnati, OH, USA. (6)ExxonMobil Biomedical Sciences, Inc., Annandale, NJ, USA. We report preliminary findings from an ongoing evaluation of 18 workers from a rubber sealing products factory who were chronically exposed to benzene and diagnosed at JCML during 2003-2004. Prior to 2002, time weighted average (TWA) exposures ranged from 100-380 ppm benzene with typical peak exposures of 500 ppm. After 2002, the TWA has ranged between 30-75 ppm. Exposure duration varied between 9 months and 22 years with the first cases of benzene toxicity identified in 2001. Initial clinical findings, reported an average of 3 years prior to subject evaluation at JCML, included dizziness, fatigue and bleeding, with all cases presenting with pancytopenia, thrombocytopenia, lymphocytopenia or anemia. Diagnoses, which were established analyzing morphologic, immunophenotypic, fluorescence in situ hybridization (FISH) and cytogenetic data, according to the World Health Organization (WHO) classification, include: 14 myelodysplastic syndromes, 1 aplastic anemia, 1 thrombocytopenia, 1 bilineage cytopenia and 1 normal. Exposure analysis and clinical evaluation of these workers is in progress; however, our initial results suggest that perhaps MDS previously has been under-reported as a long term consequence of chronic exposure to high doses of benzene. This study was supported by a grant from the Benzene Health Research Consortium. SH ELL-MCCLU RG-OS7790