Document v1jX5YmrVZY9dBj1ZpzM7eNzR

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUIILIC HEALTH SERVICE CENTER FOR OlftCASC CONTROL Jf.M 1 0 `.TP January lii, l*)7f haiiokai itj -iiiini inr*htwpai . v . , i ;< *600 HL.I (t.KS LANI. ROCKVILLE, MAHYLANO J0I51 To: Attendees at Meeting on Pottstown Study, Akron, Ohio January 5, 1970 Prom: Acting Director, Office of Extramural Coordination and Special Projects Subject; Draft Minutes of above meeting Enclosed are draft minutes of the above meeting which you attended. You will note I attempted to capture the main points of the discussion in h d fvirr,;-r, ri* tH'., I r.oy five omitted some items you feel sr.culd be frs'u-.si. try cvrs'ts and s as you feel appropriate and they will be included in the record of the meeting. Attachment v J^&ck Butler, M.D. \ i. iv- > &;<-. ' t1 'f i '} .;? r: z i >.i V?'. I bt i i~--* i V-' i f AP66667428 Minutes of Mooting on Pottstov/n Study Akron, Ohio January 5* 1076 Attendees: See attached list. Purpose of Hooting: To discuss status of the NIOSH-CDC-University of Fjorth Carolina' Study on Vinyl Chloride conducted at tho Firestone Pottstown plant. Introduction: The meeting was opened at 1:00 p.m. by Dr. Jack Butler, NIOSH, He stated the purpose of the meeting was to.discuss the status of the study and to serve as a forum for exchange of concerns and comments among the parties involved in the study. In keeping with NIOSH policy, he stated that minutes would be kept and made available to the public under tho Freedom of Information Act. ' Summary of Discussions: No formal agenda was prepared for the meeting. However, the discussions can be summarized under the following topics: I. Collaborative Aspects of Study Dr. Ballou was concerned that HIOSH investigators had not abided by the collaborative agreement made at the start of the study, i.e., to release Information on the study only after the review and concurrence of the three participating investigators--by reporting unilaterally on the fetal wastage, aspect of tho study in Czechoslovakia.and through a letter to Dr. Diaz. He emphasized that he would accept arty findings of the study as long as these had undergone peer review by the scientists participating in the study. Mr. Belic2ky reviewed the agreement arrived at by the Union, Firestone, and the investigators at the start of the study. Dr. KcMichael of the University of North Carolina was to represent Firestone and the Union as one of the investigators in the tripartite agreement with NIOSH and CDC. Or. McMichael stated that a breakdown in the collaborative agreement had occurred when NIOSH publicized the fetal wastage data but felt that this would probably not occur again and all parties wore now in close communication on the analysis of the study da La. Dr. Infante acknowledged the breakdown in the collaborative agreement. He had only recently been employed by NIOSH and was not aware of the /7 Minutes of Pottstown Study - Page 2 agreement sinr* \ t was not in writing. He emphasized that further n.'.- 'i! 1 irvii .'I by olh r pari ins (ur-rut-d before public release. II. Significance of the Study Findings on Petal Wastage Or. KcMichael stated that collaboration did not necessarily Imply that all parties would concur on the significance of the findings. Both Dr. McMichael and Or. Heath discussed some of the weaknesses in the fetal wastage aspect of the study. These have been communicated to Dr. Infante and he has provided further information to them in answer to their questions. This information is now under review by the other investigators. At present, a letter to the editor of lancet Is being prepared and will be submitted within 2 weeks. Dr. Ballou felt this should not be done until the entire Pottstown study was completed. . Dr. Wagoner stated that this would take months and he felt the investigators had an obligation to inform the scientific community of the results of the fetal wastage study In a timely manner. Dr. McfVichael agreed that this was a proper course and that the contents of the letter would be reviewed by all parties concerned before submission. In anwer to questions by Mr. Bommarito on wh.it employees should be told, the investigators agreed that the study in and of itself.is not conclusive in implicating V.C. as a human mutagen. However, It is a carcinogen-and, in biologic and human tests, it has been.shown to cause chromosomal breaks. This lends support to the concern that it may be a mutagen and for this reason human studios, even with recognized limitations, should be reported. Dr. Wagoner and others felt that since V.C. is being controlled in the U. S. as a carcinogen, Lhis should be protective against possible mutagenic effects. This is not the case in some countries where workers are still exposed to high levels of V.C. III. Stutus of Study The final report on the full study at' Pottstown has ben delayed because of personnel changes within NIOSH. It was agreed by the group that Mr. Waxweiler, a NIOSH.staff member involved in the study and now in training at the University of North Carolina, would complete the first draft of the report in 4 weeks for review by CDC and NIOSH. The fetal wastage data would be submitted to Lancet within two weeks as a letter to the editor. The meetin adjourned at 3:00 p.m. Attachment Jack Butler, M.D. Acting Director, OECSP AP00007430 \ Meeting on Pottstown Study Akron, Ohio January 5, 1976 Attendees Dr. Laurence H. Ballou Louis S. Bellczky Carolyn Bell Dr. Hector Blejer Peter BommarUo Dr. Jack Butler Dr. Bobby F. Craft Robert HassmiUer Dr. Clark W. Heath, Or. Dr. Peter Infante Dr. Anthony McMichael Dr. Joseph Wagoner George Wilson Firestone URW URW NIOSH URW NIOSH NIOSH ' Firestone CDC NIOSH Univ. North Carolina NIOSH Firestone [ ii AP00007431