Document 3QxNpamjXaj889KeMGr9ZazdD

FILE NAME: Johnson & Johnson (JAJ) DATE: 1972 Sept 25 DOC#: JAJ063 DOCUMENT DESCRIPTION: Memo to File RE Shower to Shower/Asbestos - FDA Meeting, Sept 211972 t i u 4 ' SEP 2 7 RECD Subject: SHOW ER-TO-SHOW ER/Asbestos FDA M eeting. S eptem ber 21, 1972 New Brunswick, N.J. S eptem ber 25, 1972 Memo to F ile D rs. F uller, Hildick-Sm ith, and 1 m et with D r. Schaffner before the fo rm a l m eetin g . We req u este d th a t o th e r in d u stry re p re s e n ta tives and CTFA not be present at our m eeting. Dr. Schaffner said that he was not aw are that we had m ade a point of this with D r. W e issle r when thiB m eetin g w as s e t up. He said it would be e m b a rra s s in g to h im to w ithdraw the invitation. We ag re e d on the basis of no p articipation by CTFA and other industry re p re sentatives.in the discussion. We also requested th at, in view of the fact that our data a re now conclusive and contain new inform ation on the com position of Italian talc which m ay explain the e rro rs of D r. Lewin, we be allow ed to p re se n t the data firs t, to give D r. Lewin a chance to gracefully withdraw from his position. Dr. Schaffner agreed. T he m eetin g w as s ta rte d on tim e and we w e re ask ed to p re s e n t o ur data. The data w e re p resen ted by our consultants in the o rd er se t up by D rs. Shelley and Goudie in a m eeting on S eptem b e r 20 as follow s: 1. D r. Pooley review ed in detail his com prehensive examination of the Italian m ine, showing that it contains no deposits of chrysotile asbestos and very m inor amounts of trem olite. He stated that m ining is done by hand selection of rocks, which reduces fu rth er the likelihood of significant trem olite in the pow der. He pointed out that the m ine contained two species of ch lo rite ore which show X -ray peaks which could be confused fo r chrysotile asbestoB. He also m entioned that the Italian Mining Institute at T urin has also determ ined no c h ry so tile a s b e s to s in the m in e. He p re se n te d data on SHOWER-TO-SHOWER and Italian talc sam ples provided by Johnson Sc Johnson England dating back to 1949 estab lish in g absence of chrysotile asbestos by various techniques (EM, diffraction, X -ray, and m icroscopy). Protected D ocum ent-Subject to Protective Order JNJAZ55_0000003SO Memo to File - 2- S eptem ber 25, 1972 2. I reported on a com m unication from our supplier citing an an aly sis indicating absence of ch ry so tile asb esto s in the talc supplied to us (actually this re p o rt w as signed by D r. Lewin but I did not m ention this fact). I also reported that analysis of Italian talc at HarwelLA. E. C. supported Dr. Fooley's .findings. 3. D r. Brown (Princeton) and D r. B u erg er ( M .I .T .): X -ray cam era technique - no chrysotile asbestos. X -ray special techniques - no chrysotile asbestos 4 M r. C an eer p re s e n te d h is findings on SHOWER-TO-SHOWER: X -ray - step scan - no chrysotile asbestos. Petrographic - no chrysotile asbestos. 5. D r. M cCrone, of M cCrone A ssociates, presented a petrographic technique which is specific to chrysotile asbestos detection. He a lso had a dem onstration w ith his own m icroscope fo r D r. Schaifner to look at. He stated that SHOWER-TO-SHOWER contains no chrysotile asbestos. 6. D r. Ian Stew art, of M cCrone, presented his data by electron m icroscope and diffraction, as w ell as petrographic and X -ray, showing absence of ch ry so tile asb esto s. 7. D r. Schelz of Johnson & Johnson p re se n te d h is technique of determ ining chrysotile by DTA. He showed that adding one p erce n t ch ry so tile to our SHOWER-TO-SHOWER c learly showed in the DTA graph, w here no peaks w ere apparent before, and concluded that SHOWER-TO-SHOWER contains no chry so tile. D r. Lewin provided two handouts of h is an aly sis of two lo ts of SHOWER TO-SHOWER, C512Z and 0709X1. In both cases he reported the p resen ce of two p ercen t chrysotile. H is findings showed an X -ray diffraction pattern for both lots w here a peak was labeled "chrysotile?" However, with the m icroscopy w ork, he could see it. He proposed a theory th at chrysotile w as in the p ro c e ss of being form ed inside the talc p la tele ts in a new form . D rs. Pooley and H ildick-Sm ith pointed out th a t only fibrous ch ry so tile is im plicated in lung problem s. D r. Lewin bad no com ment, Protected Document-Subject to Protective Order Memo to File 3 Septem ber 25, 1972 Dr. M cCrone reviewed the data by D r. Lewin and pointed put a logical explanation for what Dr. Lewin was seeing, nam ely, the talc had not one but th ree refractive indices, and D r. Lew in's observations only indicated this fact and not the p resence of chrysotile. D r. S tew art pointed out th a t D r. L ew in1s photographs indicated only talc shards. Several m ore questions and com m ents Were made by Dr. B uerger, D r. Brown, and M r. C aneer, criticizing D r. Lewin's conclusions. D r. Brown w as very positive in his statem ent that the X -ray pattern p resented by D r. Lewin clearly showed the absence of chrysotile. The m eeting w as beginning to d eterio rate into a nonfruitful pathway. I interrupted to suggest a com prom ise, nam ely, that D r. Lewin has c a rrie d out the pro ced u re we had agreed on in the la st m eeting. It was obvious that the X -ray scan did not show definitive chrysotile, that m icroscopy was indicated, and since Dr. McCrone is very fam iliar w ith this technique, I suggested that the decision be made that D r. Lewin w ork with D r. McCrone to establish the best m icro scopy technique to be followed. Dr. Schaffner obtained agreem ent from D rs. Lewin and M cCrone to im plem ent this suggestion. The m eeting with our consultants w as reconvened later at the hotel and they w ere asked to review th eir im pressions of the m eeting. They w ere unanimous, in th e ir c ritic ism of Dr. Lewin and his findings, and they all individually agreed to p resen t their views in w riting. Dr. F u ller suggested that we convey these views to Dr. Schaffner and in d icate th at Johnson fit Johnson w ill n o t accep t any publication of D r. L ew in's findings, w hich we co n sid er to be an outright lie . I called D r. Schaffner the next day and conveyed that m essage. A fter thinking about it. D r. Schaffner asked "Could we have these views in w riting? " I said, "Y es" and he said "Could you put together all the re p o rts and the view s of the e x p e rts in one s u b m issio n ? " I said " y e s . 11 I believe that D r. Schaffner is now fa irly convinced that D r. Lew in's findings a re not reliab le. I don't expect that he w ill allow the release of D r. Lew in's rep o rt. A lso, the assay schem e which w ill re su lt w ill be acceptable to both FDA and industry. Vo . W. Nashed w n/ cw Protected Document-Subject to Protective Order JNJAZ55_0000003SZ