u.. .• ../ BABY PRODUCTS COMPANY October 15, 1974 Talc/powder Safety Studies Review Meeting September 27,' 1974 SUBJECT: This meeting was held in the Medical Conference'Room on September 27th with the following in attendance: Mr. Mr. Dr. Mr. Dr. Mr. 1. W.H. Ashton G. Heinze G.' Hi1dick-Smi fh G. Lee G. Lord J. Murray, Dr. Dr. Dr. Dr. Dr. W. Nashed D.R. Petterson B. Se'mp1e T.H. Shelley W.C. Waggoner MRCStudies No ad.ditiona1 status reports, have been, received from MRC and Dr. Hi1dick-Smith agreed to get from .Dr.Gilson details of what· experiments are actually underway and their findings.' .' . Dr. Lord recounted that during the June, 1974 N.LR. meeting the MRC test dosages had been critized as being excessive. ACTION: After this meeting, Dr'. Hildick-Smith confirmed through Dr. C. Wagner of the MRC that they were not proceeding with further talc studies, other than the chronic inhalation study underway. 2. Tenovus Dr. Hi1dick-Smith suggested that he would attempt to probe the Tenovus findings by requesting from Dr. Gilson a copy of the submitted Tenovus abstract· for the 1975 Edinburgh meeting. It was proposed that an inquiry to D-r. Pooley may also give us a fix on the Tenovus activitie~s. ------_...- Protected Document--Subject to Protective Order JNJAZ55_000004628 . ~ . 1. __ . • ~,-- __ _._.~ -2- , , ACTION: Dr. Wagner (MRC) has reported to Dr. Hil?ick-Smith that the Tenovus abstract indicated data to show that "talc is present in various normal and cancerous tissues of the human body, but that Tenovus indicates that the presence of talc does not necessarily mean that ,talc is cancer producing". Dr. Hildick-Smith has requested Dr. Rolle to contact Dr. Pooley for any intelligence which he may have. 3. Asbestos Identification -"CTFA~Task Force, The analytical schemes utilizing X-ray Diffraction and, DTA proposed by the Task Force were outlined. Grave concern was expressed by the meeting with, the inclusion of TEM as an alternative follow-up to Optical Dispersion, if the sample fails DTA and passes Optical. Dr. Nashed stressed that the FDA is looking for practical monitoring methodology which would not require theTEM. ACTION: G.Lee would convene a separate me~ting with Drs. Nasbed and Rolle to resolve the difficulties-surrounding the TEMrecommendation. 4. Italian,Miners Epidemioloqical Study Dr. Hildick-Smithreported on the preliminary overview of the Rubino Data which dispells cancer concern associated with exposure to talc. The group was informed that Professor Rubino will deliver a prelimi'nary paper 'on this study at the October 7th meeting of' the Italian Society of Occupational Medicine in Turin. Dr. Hildick-Smith is reviewing the collected data and will consider any questions raised by our conunittee during this detailed analysis. ACTION: Dr. Hildick-Smith will conduct a comprehensive review of the data. It has been proposed that Professor Rubino give his data the following exposure. 1. Paper to be pUblished in the Journal of the Italian Society of Occupational Medicine, February March, 1975. Protected Document--Subject to Protective Order JNJAZ55_000004629 • -3, . 2. Paper to be submitted for publication in the U.S. Journal of occupational Medicine. 3. Papers to be presented at the following meetings: American Occupational Medical Association San Franc~sco~ April 13-17, 1975. 18th International Congress on Occupational Health, Brighton, England, September 14-19, 1975. 4th International S~posium on Inhaled Particles and Vapors, Edinburgh, September 22-26, 1975. 4. Summary of Rubino data will be included in a review paper to be submitted for publication by Dr. Hildick-Smith in October, 1974 to the British Journal of Industrial Health. [ 5. Messrs. Hildick-Smith,Petterson,. Waggoner and Lee will meet with Mr. L. Foster to discuss appropriate press releases covering the above presentations. Battelle Inhalation Study .. Dr. Lord reported the status of this study to be the following: Group 1 2 3 4 5 6 7 Exposure Days Group 30 30 30 l7~ months 300 l4~ months 300 Control Control % Mortality 88 95 92 54 55 92 60 Autopsies of the hamsters still indicate no treatment related deaths but slight alveolar thickening is noted. 6. NIOSH - Harvard Talc Workers Study NIOSH has recently contacted Windsor Minerals to request a review of the workers' health records. Dr. Hildick-Smith suggested to Windsor that they engage .Dr. Green as a consultant in this matter and provide 'a medical interface with NIOSH. Protected Document--Subject to Protective Order JNJAZ55_000004630 . ; -4- It was suggested that we also invite Dr. Green to New Brunswick to present his data and hence spur him on towards completion of his study. 7. FDA - Lovelace Aerosol Study The Lovelace Proposal for the FDA - sponsored Aerosol study has been presented to the CTFA for comment. It is the intention of Johnson & Johnson to input with respect to the Aerosolized Talc protocol through Dr. Paul Finkelstein who is chairman of the CTFA interindustry subcommittee responsible for providing indus.try CGmmen·t ·and informational 'guid'ance. Johnson & Johnson can provide considerable experience in talc , characterization, methodology and r.ealistic exposure dosages gained through the Battelle Study. Dr. Petterson suggested that we consider dissuasion of FDA from conducting studies with aerosolized talc by demonstrating that commercial volumes of this product commodity were minimal and not worthy of concern. ACTION: G. Lee and Dr. J.E. Willson will provide informational requirements through Dr. Finkelstein. G. Lee will convene a meeting of Messrs. Steinberg, .Stites .and Petterson to discuss Dr. Petterson's idea outlined. above. 8. World Data Pert Chart and strategy Dr. Hildick-Smith presented his chart of the various talc studies and highlighted three studies which are reviewed as being contentious, namely MRC, Lovelace and Tenovus. It was proposed that we anticipate MRC's Inhalation ~~st by having Battelle present interim data at the April,' 1975, San Francisco occupational Meeting. This paper could describe the approach taken to dose calculation, th~ test protocol and the interim results. . It was further proposed that Dr •. Lord deliver a review paper covering the literature concerning animal talc . toxicology. Protected Document--Subject to Protective Order JNJAZ55_000004631 · ' -5- , , Strategy-wise we should concentrate on the Frisco Meeting and the two British meetings in 1975. ACTION: Proposed papers will be submitted to the' intended meetings. We will add the BIBRA and Consu1tox studies to the original Outline of Talc Research Studies. paj Protected Document--Subject to Protective Order JNJAZ55_000004632