Document n9aRxovGZgpLgQ7DGDwZJ274z

CM CHEMICAL MANUFACTURERS ASSOCIATION September 23, 1988 Dear Vinyl Chloride Panel Members: The conference call tentatively scheduled for September 29 or 30 is cancelled. A new date will be set up after checking with Panel members for maximum participation. Meanwhile, please review the enclosed September 15 letter from Dr. Bill Gaffey that summarizes his meeting with Dr. Brian Bennett of ICI, England. The background information leading to this meeting was sent to you earlier, but also is enclosed for your ready access. At our conference call in early October, we will discuss the EHA's interim report that was sent to you earlier and a course of action for resolving discrepancies between the EHA study and the Angiosarcoma Registry. Sincerely, Hasmukh C. Shah, Ph.D. Manager Vinyl Chloride Program cc: Vinyl Chloride Research Coordinators Calcasieu Pari**. 2501 M Street, NW, Washington, DC 20037 202-887-1100 Telex 89617 (CMA WSH) CMA 0123-99 For Distribution by CMA SPECIAL PROGRAMS DIVISION From ~tkLQ_2oh Ref. No. VC- 9 Date 3.3 ITV Monsanto Monsanto Company 800 N. Lindbargh Soulavard St. Louis. Missoun 63187 September 15, 1988 ENVIRONMENT, SAFETY & HEALTH Dr. Hasmukh shah CMA 2501 M St. NW Washington, DC 20037 Dear Has: Dr. Bennett and I went through the Registry cases and the EHA cases, but I realized afterwards that we hadn't really come up with any specific things that could be done to resolve the remaining inconsistencies. Therefore I went through the data and rearranged the results somewhat. The net results are pretty much what Richard Doll found, but with some specific things that might be done. The Registry includes 29 cases (all deaths) that occurred in U.S. workers up to the closing date of the EHA study, and these are potentially eligible for inclusion in that study. The EHA study lists 37 liver and biliary cancer deaths, using death certificate diagnosis, 15 of which are ASL. One of the Registry cases, No. 24, is in fact a cholangiosarcoma. It appears to be EHA Case No. 36 (listed by EHA as non-ASL) although the beginning date of exposure differs by 2 years in the two lists. I omit this case in what follows, so that we have 28 Registry cases and 36 EHA cases. I matched the two lists using date of birth, date of first VC exposure end date of death, which were common to the two lists. I considered a Registry case and an EHA case to be the same if each of the three items agreed within a year, with one exception. There were 20 matches, as Doll says. CONFIDENTIAL Subject to Protective Boas v. Conooo, Ino., Ho. 90-40.^ ^ a4th judicial District Court .Calcasieu Parish, Louisiana , c g Registry No. 01 02 03 04* 05 06 07 11 13 16 17 19 21 22 26 27 28 29 30 31 EHA No. 25 20 26 23 22 27 15 08 10 18 28 37 35 19 17 11 13 31 01 12 "A" means EHA called death an ASL A A A A A A A A A A A A A A *Birth and death dates matched exactly, but first exposure began in 1952 in the Registry and 1949 in EHA. rnwFIDBNTlA.h_ 'Subject to yso0r90-4837 CHA 012351 Dr. Hasmukh shah September 15, 1988 Page 3 The above list tells us 3 things. First, there are 8 Registry cases for which there are no apparent matches in the EHA listing. These are Registry numbers (08, 09, 10, 12, 18, 20, 23, 32). (Case 32 actually matched EHA's Case 31 but the former is the only Monsanto case while the latter is one of 13 from the same factory, so the match cannot be correct.) Second, there are 16 EHA cases (02, 03, 04, 05, 06, 07, 09, 14, 16, 21, 24, 29, 30, 32, 33, 34) that are not in the Registry, Case 07 is ASL according to the death certificate. This agrees with Doll's figures. Third, EHA cases (01, 08, 20, 23, 35, 37) were actually ASL deaths although the death certificate did not so state. This is true because they were in the Registry and therefore histologically confirmed by that source. Therefore as of our present state of knowledge 20 of the 28 Registry cases were actually found by EHA, but not all of them were identified as such because the death certificates did not all mention ASL. This leaves two questions. First, where are the remaining 8 Registry cases? Second, are there any new ASL deaths among the 16 EHA deaths that were not in the Registry? (EHA case 07, for example). Of the Registry cases, names are missing for 4. It is possible that these could be obtained from the companies involved (Goodyear and Great American). It seems to me that Otto could search the EHA cohort to see if he could match them with cohort members. Depending^on the results we would conclude that (a) they were included but the death certificate cause was something other than ASL (b) they were included but were counted as alive or lost to follow-up or the death certificate was not found, or (c) they were not included in the original VC study either by accident or design. Of course, in the last case it could also be true that the identifying information was wrong in one or both of the two sources. nfvWFIDIBflTlA.L Subject to Protective Order 571 ^ Ross v. Conoco. Ino^. Ho. 90 *0 --TZ+h Judicial District Cour * Dr. Hasmukh Shah September 15, 1988 Page 4 The second question may not be answerable. Those 16 deaths are among the 37 that EHA is trying to verify, and that effort may not be successful. I think we have squeezed all of the information out of the Registry and the EHA study that can be obtained without further date from Otto. Yours sincerely William R. Gaffey, Ph.D. Epidemiology Director /if 14th Jvidic Calcasieu