Document QJveZY0X6va4Ynny5wRaY7Rpo

FILE NAME: Johnson & Johnson (JAJ) DATE: 1972 Sept 19 DOC#: JAJ093 DOCUMENT DESCRIPTION: Letter to Barry Castleman from J&J, Dr. Gavin HildickSmith J- S e p te m b e r 19 1972 M r. B a r r y X. C aB tlem an 305 W est Biddle S treet B a ltim o re , M aryland 21201 D ear M r. C a9tlem an: I am taking the lib e rty of replying to your le tte r dated A u g u st 3, a d d re s s e d to D r. T . H . S h e lle y , D ir e c to r o o u r C entral .R esearch L ab o rato ries. F irs t, let m e ex p ress our ap p reciatio n of your bringing to o u r atten tio n your co n cern about the po ssib ility that talc by its e lf m ay be a carcinogen. As we m arket talc we have rea l concern about any potential harm ful effects it m ay have and have been m onitoring on a continuing b a sis the w orld lite ra tu re on the biological activ ity of ta lc . We a re p rim a rily in te re ste d in d eterm in in g w hether the cosm etic use of talc can cause any harm ful effects and at this tim e have no reaso n to believe th at talc alone w ill induce neoplastic changes. The publication by K leinfeld (A rch, E xper. H ealth, 14; 663-7, 1967) th at you m entioned in your le tte r ia fam iliar to us and, as you know, rep o rts on the incidence of pulm onary cancer in m in ers w orking in talc m ines which contained trem o lite and s e rp e n tin e . Xam subm itting som e points which support our position th at pure talc is not a carcin o g en w hich m ay be of in te re s t to you. 1. The m onitoring of a d v erse effects, relatin g to the com m ercial use of a product that has been m arketed for over 70 y ears by us and used cosm etically for centuries. 2. The continuing review of the w orld lite ra tu re on talc shows that it has been used therapeutically when introduced into the p leu ral cavity, has been Protected Document-Subject to Protective Order 1 of 3 JNJ 000261539 Pltf JNJ 00038618 My. Barry I. Castlemaa . 2 September 19. 1972 /? V } introduced into the perito n eal cavity from raptured surgical loves and has been respired by in d u stria l w o rk e rs, in both the pleural cavity and the peritoneal cavity talc producoB local fib ro sis in the tissu eo and to data we have not been able to find any re p o rts of c a n c e r in the oKtonaiva m edical lite ra tu re on this subject. E x c e ssiv e ex p o su re to talc c a u se s talc os is in m in e r s , and I know o f no d a ta to in d ic a te th at c a n c e r o the lung o c c u rs in su c h m in e r s exposed to talc free of a sb esto s. $ 3. C ontrolled stu d ies have baen conducted in h am sters In w hich talc w as in tro d u ced into lungs and p leu ra and thn re s u lts showed no can cer developm ent when the an im als w ere followed for th eir life. These d a ta w ere in c o n tra s t to re s u lts obtained when. a sb e sto s was used in place of ta lc . A p aper on these studies w ill shortly be reported in the m edical lite ra tu re . (V ' 4 , la o r d e r to c o n firm th e fin d in g s r e p o r te d in *3`, two se p a ra te , extensive anim al studies a re being con 1 ducted independently in which the an im ala w ill inhale } tslc for d ifferen t tim e p erio d s and w ill be followed i for th eir lifetim e and thou exam ined histologically. Your com m ent concerning the follow up of talc m in e rs to d eterm in e the cauae of th eir death is p ertin en t but ie tim e eonoum lng, and the num bers involved a re relativ ely em ail. H ow ever, in o rd e r ^ to o b ta in e p id e m io lo g ic a l d a ta m o re r a p id ly , w a r e c u r r e n tl y fo llo w - ^ lag an tensive epidem iological su rv ey of the cau se of death in a larg e group of in d u stria l w o rk e rs exposed to talc w ith a view to d e te r m ining w hether they d iffer from other ap p ro p riate populations. la a d d itio n wo a r e a tte m p tin g to o b tain d a ta on the c a u s e o d e a th of *Van O rstran d , H .D .: T alc pneum oconiosis, C hest, 58(1):2, July, 1970 Protected Document-Subject to Protective Order 2 of 3 JNJ 000261540 Pltf JNJ 00038618 Mr. Barry . Castloman -3- September 19. 1972, talc m in ers and determ ine if the cause of death differs from other populations. I am hopeful that the com m ents 1 have subm itted w ill be of assista n c e to you. We a p p re c ia te your in te re s t in w ritin g to us and look forw ard to supplying you w ith p ertin en t published data as they becom e a v a ila b le . Sincerely yours, GHStMMS cc: M r. L. Foster M rs. D. M atsu D r. W. Nashed D r. T. Shelley Gavin H ildickSm lth, M. D ,, F. A, A. P. D irector of C linical R esearch Protected Document-Subject to Protective Order 3 of 3 JNJ 000261541 Pltf JNJ 00038618