Document YD8DREaxOn6dVxywe1eJRV9GV

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 oflymphoid 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 / / / ' ~/ / 1 / " Q. For the Case Contr~(Stud~f~{, w!lY ~/ \\,. techniques. A number of viral infections are just perform a retro~ective stUdy; }Vt)u)tfthat/, wif"not be a quicke~ and nn..~~_le!.px(eJlsfve \known risk factors for some forms ofNHL. For ,1xample, hepatitis C which is common in C?in~. to get the same mformatlOn~ / / / . / ...----//The presence of the planned laboratory on sIte In // // ) ~ / / Shagg~ai assures us of consistent, state-of-the-art A. First and foremost, is the lack'0f %mpite aia---- ~iagnosnc capabilities under our control without verifiable study. A diagnoses number of from other a simpYe ret1ospe~t'~:~ / condition(can )1ijt;I}kY V t!,Ie ne?,isity of the ,/jtiig~are en;.,ailed logistic and bureaucratic in shipping human tissue NHL, and misdiagnosis is easy in the~9fomce of ~. / s;mples t9-tlle''US for testing. /< \,\sophisticated diagn~stic proce?ures: ~..-<l}<).8~C 1\ / . samples are not routInely kept In ChIna ana the~. / / W~t5'eheve'\hat th~'fJCI/CAPM study findIng of would be no opportunity to confirm diagnosesJO'r . A6creas~ris~.~f~n benzene exposed most cases. Secondly, assessment of exposure\ ./v// w9\kers ~due ~rec~nized confounding and confounding risk factors is complicated in a\'/(/ /fiict~/We do "ItQ,~ want'tQ/epeat their mistake. retrospective study. In the case of deceased \ // // \ patients, details of lifestyle and work history must Q. Why are w~iliclud~ A~ in the Case- be obtained from relatives or other workers. !a~ing cases prospectively reduc~s the distance Control.,sfudy..A-ML )S'(Jso in the Disease ProFsi09-..sfudy. Isn't this a duplication? In tIme that one needs to go back In order to get (// needed exposure records. A. Incl#ng AML, which we would expect to see associated with benzene exposure, provides a Q. The diagnostic laboratory is a major expense. positive control to defend against criticisms that Why is it necessary? Why can't we just do a our methodology was somehow not adequate to standard case-control study? see associations that do exist. There is some overlap in that the Case-Control study will serve A. Non Hodgkin's Lymphoma (NHL) is an as one source of AML cases in the Disease aggregate category of ca. 20 distinct lymphocytic Progression study. diseases. In order to perform an NHL study that conforms with the current diagnostic schema, the subtype ofNHL should be known. These subtypes are distinguished by morphological appearance and characterization of cell surface markers by sophisticated immunochemical February 16,2001 SHELL-MCCLURG-051605 Q&A Studies of Benzene in China Page 2 Q. One of the reasons for pursuing the Molecular complicate obtaining large numbers of Epidemiology study is that the Chinese participants. officials in Shanghai have requested this type Bioethics - Providing this higher level of of data; why can't they use the existing diagnostic information to hospital physicians NCIICAPM study results? improves the level of patient care which fulfills the ethical requirement that the study benefit The NCIICAPM study was roundly criticized for participants and the general community in which not providing a good measure of actual exposure; the research is performed. for not accounting for exposures to multiple chemicals; for assuming that all AML, NHL, and Q. If the Chinese are going to be the major eoxthpeorsbulroeotdo-breelnazteednediasleoansee;sawnderwe ictahu~serd/bs.~ttt4y beneficiaries of this research, shouldn't they contribute to the project? design that did no~ account for coIJfounding \.~ ... . factors (e.g, SmO~I?g) and ot?~1"act~,o/.'\TSEP1 A. Although the C?m~se are not p:ovIdmg dI:ect. has taken the posItIOn that thiS stuqy cannbt by monetary contnbutIOns, they wIll be contnbutmg used to calculate a qu'>.n~6tiv)<~{nce}.F?sk f~ / / .\\ in-kind s~pport. The labora~ory space allocated benzene exposure. ~IS IS P~Is~ly'the roy \. to the project has been provIded by Fudan . . '\. ., ____-:-///,// <this study will be so i~ortanC--- ,/./ // //'\. \University. The funds provided by API for the The Chmese base theIr occupatIOnal' stan~ards o n/ laboratory /that space space ha.ve gone toward to make It acceptable for renovation of the purposes semeasurable effects on people, .sure(notprt) /,// of tlJj..8'~tudy, but we will not pay any rent for the mathematical modeling of hyp'6{h~r6~t1 flsks iSIs' of t~ space during the period of our studies. typical in the U.S. and Europe. the NC;I1CPM 1)1e co.niderable resources of the Shanghai studies did not rovide them with t , t o~ a /",jMuo/C'ipal 0Nlters for Disease Control (SMCDC) upon which to base a change in their c.~{ ~. / he bee ffet< d freel ,including use of their standards. Their current standard is bas''e,~ ~ty, atabC}.8(to identi{~ facilities and individuals to decrease in white blood cell counts ratherYhan \ / ' inchlde i~.th.,e studY'\as well as laboratory support leukemia. They are interested in the MoleculaV ' ./~r ind~trial~#\~onitoring analyses Epidemiology Study which is intended to proVide / ne~ssari'{.o the..study. \'A,nd most pointedly, the an objective, measurable indicator of risk. \/( ~hin\se,.p(ovide\ccess t6':the subjects, without \ / / whom"'it wouldylimpossib~to conduct such a Q. Why are we taking on the expense of providing study. / / /\,. / laboratory diagnostic services for hematopoietic diseases in Shanghai hospitals // /// \ .,// Q. WhJA{thi~lieing undertaken primarily by the during the course of the study? pdroley,nl industry, and why have other ind'llSfries and/or international companies not A. These services provide crucial benefits to the consortium research in two areas: been approached to help fund this research? Research Data - As the central diagnostic A. API has played a lead role in getting this study laboratory we will assure the quality and underway, because the petroleum industry has a consistency of the diagnostic data. This role major interest in better understanding risks to assures access to blood and bone marrow samples human health due to benzene exposure. Other from study participants. Without this role we industries are being approached to help in this would have to seek permission to perform a effort, as are international petroleum companies second procedure to obtain these tissues for the and trade associations. Presentations have been research. Patients would be reluctant to undergo made to CONCAWE, IPIECA, and CEFIC. At such a second procedure, which would least one of our major supporters, BP, is headquartered outside the United States. For more information contact: Lorraine Twerdok (API) at (202)682-8344 or twerdokl@api.org; or Patrick Beatty (Chevron) at (510)242-7037 or pwbe@chevron.com February 16,2001 SHELL-MCCLURG-051606