Document nmEwwKMEQ9RqYDMaB4Yxz17B2

FILE NAME: Johnson & Johnson (JAJ) DATE: 1969 Apr 15 DOC#: JAJ077 DOCUMENT DESCRIPTION: Memo RE Alternate Domestic Talc Sources C / co Subject: A L T E R N A T E D O M ESTIC T A L C SO U RCES P r o j e c t C ode #101 New Brunswick, N. I. A p ril 15, 1969 M r, W. H, Ashton: Y our in q u iry of A p ril 9th, 1969 a d d re s s e d to D r, G. H ild ick -S m ith h as been re fe rre d to m y attention fo r rep ly . O ver the y e a rs, I have review ed the lite ra tu re on the h azard s relatin g to the in h alatio n of ta lc p a rtic le s on s e v e ra l d iffe re n t o c c a sio n s. In your m em orandum , you indicate th at T rem olite does have needle-type c ry sta ls and th at our po sitio n has been th at th ese could p e n e trate the skin and cause irrita tio n . A ctually, to the b e s t of m y know ledge, we have no factu al in fo rm atio n on th is su b ject. It would seem lo g ical th at it could o ccu r, although w hether or not it would be of clin ical significance would be co n jectu ral. We have been concerned to a m uch g re a te r extent w ith re g a rd to p o ssib le d angers relativ e to the inhalation of the talc w ith a spicule or n eed le-lik e c ry stallin e stru c tu re as com pared w ith the flat, p la te le ttype of cry stallin e stru c tu re . T here are rep o rts in the lite ra tu re concerning ta lc o sis w hich, as you know, is a fo rm of pneum oconiosis attributed to the inhalation of ta lc . R eported studies have suggested th at th is does not occur in connection w ith the fla t, p late le t-ty p e of ta lc , but does occur in connection w ith the sp icu le-ty p e of c ry sta llin e stru c tu re c h a ra c te ris tic of T re m o lite . The rep o rte d in sta n c es have been ex trem ely few but have, w ithout exception, involved inhalations of high co n cen tratio n s on an occupational b a sis of m any y e a rs d u ratio n . F u rth erm o re, we have occasionally received inquiries from various individuals, including G eneral Johnson and se v e ra l p ed ia tric ia n s, ex p ressin g concern over the p o ssib ility of the ad v erse effects on the lungs of bab ies o r m o th e rs who m ight inhale any su b sta n tia l am ounts of o u r ta lc fo rm u la tio n s. In the p a s t, we have re p lie d to the effect that since our talc is essen tially a ll of the p latelet-ty p e of cry stallin e s tru c tu re , and is of a siz e w hich w ould n ot be lik ely to e n te r the p u lm o n ary alv eo li, we would n o t re g a rd the u sag e of o u r po w d ers as p rese n tin g any h a z a rd . O bviously, if we do include T re m o lite in m o re than unavoidable tra c e am ounts, th is so rt of negation of such in q u iries could no longer p e rta in . JNJNL61 000001534 M r. W. H. Ashton - 2- A p r il 15th, 1969 Upon various occasions we have d iscu ssed the p o ssib ility of carry in g out studies on anim als which m ight provide factu al inform ation with reg a rd to w hether o r not v ariab le exposures to talc suspended in the environm ental atm osphere m ight be productive of fib ro tic an d /o r inflam m ato ry reactio n s in lungs. F o r a v a rie ty of rea so n s, these have never been carried out h ere. Since pulm onary d ise a se s, including in flam m ato ry , fib ro p la stic , and n eo p lastic ty p es, ap p ear to be on the in c re a s e , it would seem to be p ru d en t to lim it any p o ssib le content of T rem o lite in our pow der form ulations to an absolute m inim um . To the b est of m y know ledge, we have n ev er been faced with any litigation involving e ith e r skin o r lung p e n e tra tio n by ou r ta lc fo rm u la tio n s. Som e y e a rs ago, we w ere faced with a m o re o r le s s se rio u s p ro b lem resu ltin g fro m w hat we co n sid er to have been an u n ju st accu satio n of danger due to the p re se n c e of a sm all am ount of b o ric acid in o u r ta lc . T his cre a te d such a fu ro r th at we w ere m o re o r le ss com pelled to rem ove b o ric acid fro m the form u latio n . It is conceivable th at a sim ila r situation m ight eventually a rise if it becam e known that our talc form ulations contained any significant am ount of T re m o lite , Since the usage of th ese products is so w id esp read , and the existence of pulm onary d isease is in c re a sin g , it is not inconceivable th at we could becom e involved in litigation in w hich pulm onary fib ro sis o r o th er changes m ight be rig h tfu lly o r w rongfully a ttrib u ted to inhalation of our pow der fo rm u la tio n s. It m ight be th at som eone in the Law D epartm ent should be consulted with re g a rd to the d efen sib ility of our position in the event th at such a situation could ev e r a ris e . It is m y p erso n al feeling that until we have at le a st su bstantial evidence, b ased on an im al w ork, to the effect th at the p re se n c e of T re m o lite in our talc does not produce ad v erse effects, we should not extend its usage beyond an absolute m inim um p r ' ' " TM TjJAG cc: D r, R, A. F uller D r, Gavin H ildickSm ith M r, W. J. Ryan D r. G. H. Lord D r. J. E. W illson D r. J . B othw ell JNJNL61 000001535 A ttachC ount B e g A tta c h C onfidentiality C ustodian DateM od E n d A tta c h FileN am e FileS ize JN JN L61_000001534 Metadata 0 JNJNL61_000001534 Y Bill A s h to n c/o L o re n a T e lo fski 04/15/1969 12:00 AM JNJNL61_000001535 K 000089108.TIF - K 000089109 TIF 0 .0 0 O R IG IN AL O R IG IN A L O R IG IN A L O R IG IN A L O R IG IN A L O R IG IN A L O R IG IN A L O R IG IN A L