Document 3ev5MzQaEkBw10mq0Rz8JyYg6

i Harrison, M.e. (Myron) From: Sent: To: Subject: Dr. Baruch Brody [bbrody@bcm.tmc.edu] Wednesday, January 17. 2001 7:46 PM myron.c.harrison@exxon.com; Iynn.b.russo@exxon.com; PWBE@chevron.com; arschna@erenj.com; bbrody@bcm.tmc.edu; woodall i.org; OltoWong@aol.com; richard.irons@uchsc.edu; heroldra@bp.com; twerdokl api-org possible issues for discussion at Monday's conference call (II) This second memo relates to the material sent to all of us by Rich. It considers first the material related to the proposed disease progression study. As I now understand the study, it is a case control study for patients with AML, which involves no routine followup, and a case control study for BP, AA, and MDS which involves followup every 6 months (section 2G). It differs from Otto's study primarily in this followup to assess disease progression (which is why it covers BP, AA, and MDS) and in the resolution of certain basic science issues related to the!;?; diseases and to AMl. . 1l~ Questions which seem to me to need discussion: fir (a) burden on subjects-- biological material obtained ot er their diagnosis in a scienti Ica . same con Ir Ion which will be done for Otto's protocol)? What questions abou onfounde and cofac 0 II be asked (this is the same as the question from Otto's protocol a ou e questionnaire)? Are there any burdens and/or risks associated with the storage of material for further study, especially for further genetic studyI and ffrom the extra analyses? (b) benefits to subjects and to Shanghai-- These seem to be the same as in ~Uo's study, with the extra point (really relevant to both protocols) that a diagnostic laboratory of the highest quality will be developed and left for them. Whether there needs to be any further justification in terms of the benefits to the subjects depends on the answer to (a). The suggestion, that there is additional bene!= in light of better management made possible by better diagnosis, should be clarified. (c)control over publication-~ the basic principle is clearly enunciated ,..-- (d) issues needing clarification and/or development- we need a communication of resul n, a clarification of the payments issue, the det~Qnsent form, a c of the re aboUftf'ie confounCfers, aiidii discussion ofi,Ytenm monitoring We also need a data management plan abouTIne preservation of confidentiali and ab etween thElJwo studies (Otto's and this stu y) Finally, we nee to discuss how disease progression information will be shared with the subjects and with their clinicians. I turn now to the material related to the shoeworker's study. This has always been the most sensitive' . study, and I must confess that I am not confident about forming any judgement about it until we can get a better picture of what is involved in the study in terms of initial testing and followup. how it adds to the information from the disease progression study, the management of discovered dangerous workplace exposure and discovered disease, etc. One good thing is that Rich has concluded that es e expos ," so our initial fear that we will be exp oiting workers by the s u y s 0 OWIng em as they remain in clearly unsafe conditions is no longer present. . , I Would like to suggest that we have a preliminary discussion of these issues on Monday and we then ~ l.":.1:1"~ ....,,J,"":!8 HAZ-SHA-000053 see'what can be reported to Friday's meeting. BARUCH 2 HAZ-SHA-000054