Document 3NJdb32a1E6KEDYar9N7GvkO0

To: From: Cc: Bcc: Received Date: Subject: Stuart Cagen (E-mail)<Szcagen@shellus.com> George Woodall <Woodallg@api.org> 2001-02-19 16:30: 13 GMT ConsortiumQA_Rev. rtf Attached Stuart, When I tried to send all three documents in Rich Text Format to you, it was bounced back as being too large. I am now sending each document separately, and will use this same text in all three. George Attachments: ConsortiumQA Rev. rtf SH ELL-MCCLU RG-055068 Q&A Studies of Benzene in China Page 1 The purpose of this document is to outline the answers to the questions most frequently asked regarding these studies. Glossary of Terms AML (Acute Myelogenous Leukemia): The hematopoietic cancer most commonly associated with exposure to benzene. Hematopoiesis: The formation of blood and blood cells, including red & white blood cells and platelets. NHL (Non-Hodgkins Lymphoma): Complex spectrum of malignancies of lymphoid tissues, most often arising in the lymph nodes. NCIICAPM (National Cancer Institue/Chinese Academy of Preventative Medicine) - The authors of a previous set of studies in China that found NHL associated with benzene exposure, the first study to show such a linkage. SMCDC (Shanghai Municipal Centers for Disease Control) - The Shanghai governmental agency responsible for occupational exposure monitoring and enforcement "Q. For the Case Contr~(S./t.ud(o/f//~HL/,/W/ ~J)./ f.//.~. \\ techniques. A number of viral infections are just perform a retro~ective study;,/wtuJt(that /'. \known risk factors for some forms of NHL. For / Inot be a quicker and n1Q~h les_~_.exPenve wro:) to get the same informationr- // ~-~./ ~xample, hepatitis C which is common in China. The presence of the planned laboratory on site in . / .A // //) _/ ShaI]~i assures us of consistent, state-of-the-art A. First and foremost, is the lack\.),wfllple'te a@-- ~diagnostlc capabilities under our control without verifiable diagnoses from a simpYe reybspective / / / / the ne~~ity of the logistic and bureaucratic study. A nUI?b~r of o~h~r cond~tion(can ~~i.0/ ,,/,,;foghynare ent~iled in shipping human tissue NHL, and mIsdIagnOSIS IS easy m the'a~.S:~nce of / / / samPles to.;tle 'US for testmg. sophisticated diagnostic procedures. ~g~O&tic " / / / \". samples are not routin~ly kept i~ Chi~a aIrel th~,./~5)jeiiev}:~at the"~~I/CAPM study finding of would be no opportumty to confIrm diagnoses)Or / /llcreaseq nsk~ ~h.m benzene exposed most cases. Secondly, assessment of exposur~. / ' / / wOJfers i~'fue t9.{fnrec6gnized confounding and confounding risk factors is complicated in a\. ( ...ffctci'rs. We do ilQt want fu repeat their mistake. ret~ospective .study.. In the case of dec~ased \ v// \../ . />. \\. patIents, details of lIfestyle and work hIStory must be obtained from relatives or other workers. Q. Why are we..J'riclu~ AMI:; III the AMLCase-Contfol s9rtly. is also in the Taking cases prospectively reduces the distance in Dise,siProg.ression study. Isn't this a time that one needs to go back in order to get du.plicatjml? needed exposure records. \,// A. Including AML, which we would expect to see Q. The diagnostic laboratory is a major expense. associated with benzene exposure, provides a Why is it necessary? Why can't we just do a positive control to defend against criticisms that standard case-control study? our methodology was somehow not adequate to see associations that do exist. There is some A. Non Hodgkin's Lymphoma (NHL) is an overlap in that the Case-Control study will serve aggregate category of ca. 20 distinct lymphocytic as one source of AML cases in the Disease diseases. In order to perform an NHL study that Progression study. conforms with the current diagnostic schema, the subtype of NHL should be known. These subtypes are distinguished by morphological appearance and characterization of cell surface markers by sophisticated immunochemical February 16. 200 J SH ELL-MCCLU RG-055069 Q&A Studies of Benzene in China Page 2 Q. One of the reasons for pursuing the Molecular Bioethics - Providing this higher level of Epidemiology study is that the Chinese diagnostic information to hospital physicians officials in Shanghai have requested this type improves the level of patient care which fulfills of data; why can't they use the existing the ethical requirement that the study benefit NCIICAPM study results? participants and the general community in which the research is performed. The NCI/CAPM study was roundly criticized for not providing a good measure of actual exposure; Q. If the Chinese are going to be the major for not accounting for exposures to multiple beneficiaries of this research, shouldn't they chemicals; for assuming that all AML, NHL, and contribute to the project? other blood-related diseases were causedJ;>, exposure to benzene alone; and with pp6r st1l4Y A. Although the Chinese are not providing direct design that did not account for conje5lmding '\ monetary contributions, they will be contributing factors (e.g, smoking) and otht<y-facto~1JSEP~ has taken the position that t~stu,Sl.Ycan!J6t be/ in-kind support. The laboratory space allocated to the project has been provided by Fudan University. used to calculate a qua9tit~tivegancepjsk frs/m /~\ The funds provided by API for the laboratory benzene exposure. 1(liis is p~cist~lYthe re./sop/ \\ space have gone toward renovation of that space this study will be so ~ortant:-/ / / / / /', '\0 make it acceptable for the purposes ofthis study, ,mlThe Chinese base their o'\c'2. upaii_o~'/s/ta/n/d//\ards/~//) ~ut we will not pay any rent for the use of the /Ispace during the period of our studies. The measurable effects on people, not9rt) __ / con~j~able resources of the Shanghai Municipal mathematical modeling of hyp(-,.lhe}ital,{sks (sTs- 2enters for Disease Control (SMCDC) have been typical in the U.S. and Europe. 'the 1)ICI/CA'PM / / / / of ered'~el ,including use of their database to studies did not rovide them with t t et~~ - //--;" en!-iy facilit~es and individuals to incl~de in ~he ~~...!..!..!~~~=~~=~~~~~=nt standards. Their current standard is bas~d 3J}...a / stydy as w~tlas...laboratory support for mdustnal \. 1{ygie,9ty'fuonitorlng analyses necessary to the decreas~ in white bl?od cell c~unts rather'than',>,/st~. AgW~ost. p6~nte~ly, the Chine.se provide leu~emI.a. They are mter~ste.d ~n the Molecula~</ /~ccess ~c(the SN~)ecW~Ithout whom It would be EpIde.mI~logy Study WhI~h I~ mtended. to proV1.de/ / / ll~P\'ssIbi'e~o copduct s~h a study. an obJectIve, measurable mdicator of nsk. '( " Q. Why are we taking on the expense of providing laboratory diagnostic services for hematopoietic diseases in Shanghai hospitals ./ \ // \.\ \,\ .f{. Why i~ this beip-g' underta~n primarily by the petroleum i~stry~d "l'fy have other industri.JS'~d/.9rinte~tional companies not beewpro~ed to help fund this research? during the course of the study? (' // A. AP}Splayed a lead role in getting this study A. These services provide crucial benefits to the underway, because the petroleum industry has a consortium research in two areas: major interest in better understanding risks to Research Data - As the central diagnostic human health due to benzene exposure. Other laboratory we will assure the quality and industries are being approached to help in this consistency of the diagnostic data. This role effort, as are international petroleum companies assures access to blood and bone marrow samples and trade associations. Presentations have been from study participants. Without this role we made to CONCAWE, IPIECA, and CEFIe. At would have to seek permission to perform a least one of our major supporters, BP, is second procedure to obtain these tissues for the headquartered outside the United States. research. Patients would be reluctant to undergo such a second procedure, which would complicate obtaining large numbers of participants. For more information contact: Lorraine Twerdok (API) at (202)682-8344 or twerdokl@api.org; or Patrick Beatty (Chevron) at (510)242-7037 or pVlbe@chevron.com February 16. 200 J SH ELL-MCCLU RG-055070