Document 8V17KqX82mmmpdnbDNw3Mv1LZ

FILE NAME: Johnson & Johnson (JAJ) DATE: 1971 Aug 13 DOC#: JAJ 114 DOCUMENT DESCRIPTION: Confidential Memo RE Asbestos in Talc by Dr. R.A. Fuller ( Subject: Talc (j'IWnmJ^o tv m v n CONFIDENTIAL #503 % New Brunswick, N.J. A u g u s t J 3, 1971 Dr. R. A . F u l l e r At the r is k of o v e r- s u m m a riz in g the a s b e s to s - ta lc situation, perhaps the following will put c e rta in facets in p ersp ectiv e: A. We have a n a ly z e d s e v e n s e p a r a t e and d i s t i n c t s a m p l e s of t a l c f r o m W in d s o r M i n e r a l s and two s e p a r a t e s a m p l e s of baby powder. None were found to contain asbestos.- This information was verbally subm itted to the FDA in the recent m ee tin g and will be fo rw ard e d in w ritin g by D r. N ashed as soon as all written reports are received. B. A nalysis of G ran th am talc, the fem inine d eo d o ran t talc, SHOWER-TO-SHOWER* Powder, and Medicated Powder a r e underw ay and should be available v e ry soon. We have re c o m m e n d e d that lab o ra to ry w ork be instituted,, directed to the rem oval of M icrocel from the latter. C. The B u r e a u of M ines e x p e rt who te stifie d at the behe$;t of the FDA com m ented on the pure grade talc in our W indsor mine ut m entioned the ore next to the outlying ro ck could contain a s b e s t o s . It is im p e r a tiv e that c a re fu l se le c tio n of the ore be m aintained at the m ines. It is alw ays possible that the FDA may inspect the mines and our reco rd s. D. duality Control should be upgraded ana the possible presence of a s b e s to s be d e te rm in e d on periodic s a m p le s. E. We owe the FDA detailed analytical p r o c e d u r e s for the p re se n c e cf a s b e s to s in talc. T h e se should be expedited as we ap p ear o have a good rela tio n sh ip with the FDA, w hich we w ish to ontinue. F. I )r . C r a l l e y of the U. S. P u b l i c H e a lth S e r v ic e has published his concern, which he stated at the FDA m eeting, re m etal content of talc, p a rtic u la rly nickel; this as a possible c a rc in o gen. We have an unusually high content of nickel in V erm ont talc which does not a p p e ar am en ab le to rem o v a l. We m ust delv e into this s u b je c t, which we thus f a r h a v e ig n o re d . D r . R, A . tier C U JN JfiJU ijiM T L A i-, 2- A u g u s t 13, 1971 It is g e n e r a l l y a c c e p t e d t h a t the l u n g - d a m a g i n g p a r t i c l e s of m i n e r a l s a r e b e low 10 m i c r o n s . R o u g h ly , we ha ve about 5 -8% of su ch in o u r talc. Iviost of this can p ro b a b ly be rem oved, b i sed on e x p e rim e n ts by Bill A shton and the C olorado School of Mm e s . Such will affect the ch aracter of the finished powder a nd p e r h a p s a l t e r p e r f u m e s t a b i l i t y . It i s p r o b a b l e t h a t s o m e fi nes m a y be r e g e n e r a t e d on shipping but s u c h would probably be m inim al. Of m o re concern a re our different blending ethods in the plants. Rem oval of fines would ra is e production cdsts ! H. S likoff et al, a s D r . H i l d ic k - S m i th h as d e s c r i b e d , r a i s e d the b gaboo of talc p e r se in the lungs. T his should and will be s ljudied in a n im a l m odels as D r. H ild ic k -S m ith indicated. An a tte m p t m u st be m ade to m ake the te s t re a lis tic ; e. g. , we are not particularly concerned about constant exposure such as tbat of talc m i n e r s , but r a t h e r n o r m a l c o n s u m e r e x p o su re , it is probable that all inorganic m in e ra ls in sm all particle s ze can produce lung fibrosis with m assive exposure. Our te sts should be re a lis tic - -and should probably co m p are reg u lar P? w d e r w ith th a t f r o m which the fin e s a r e r e m o v e d s in c e s u c h fi nes a r e g e n e r a l l y a s s u m e d to be the p h y s io lo g ic a lly active fr) a c t i o n s . I. fa c e t of the situation not yet c o n s id e r e d is that of the efficacy of body powder. A considered approach to all "health products" is that of benefit v e rs u s risk . While it has generally been believed that baby powder provides lubricity, thus reducing chaffing, may absorb m oisture, e tc ., this has not been proven i ris o f a r a s w e k n o w . T h e r e h a v e b e e n c e r t a i n f r i c t i o n t e s t s a n d w a t e r h o l d i n g t e s t s c a r r i e d o u t b y v a r i o u s p e o p l e in R &D in th e past but none a re really scientifically rigorous. What should b c o n s id e r e d a r e studies such as have been c a r r ie d out on a dhesive bandages where it was scientifically and ethically m o n s tr a te d that they do aid in healing. Such studies a re phrt of the p ro g ra m Dr. H ildick-Sm ith alluded to in the fifth p a r a g r a p h of his m e m o of A u g u s t 10 and m u s t be f u r t h e r d i s c u s s e d . A m a jo r objective of the f o rm a tio n of the C entral R e s e a r c h L a b o r a t o r i e s of the DOC was the c a r r y i n g out of such basic research. rese n t and incomplete information indicates Grantham talc m ay contain tre m o lite . If this is the a s b e s to s -form variety , vje m a y have to r e c o n s i d e r o u r p lan s in this m in e . The s e a r c h V Dr. R. A. F uller CONFIDENTIAL' A u g u s t 13, 1971 for new so u rc e s of talc then should be reactivated or at le a s t re c o n s id e re d . M r. Ashton is planning this ana will need the d e c is io n shortly. K. A n a l y s is of o ur o v e r s e a s talc will be u n d e r t a k e n by P r o f . P ooley at the U niversity of W ales and the re s u lts subm itted to M r . E . S te w a rt. L. J JU J G r e a t B r i t a i n h a s i n s t i t u t e d t r a c e r s t u d i e s of t a l c m igration in the body at the B ritish Atom ic E nergy C o m m is s io n L a b o r a to rie s . This was in re s p o n s e to the Tenovus publicity. We will follow this and keep them inform ed of our work. M. F i n a ll y , now that we have a p p a r e n t l y won the f i r s t battle, I should like' to ack n o w led g e the effo rt of s o m e of those who assisted Dr. Nashed, Dr. Hildick-Smith and m yself during the past m onth. We e ssen tially began fro m ground zero. The turning period came from Dr, Sundberg's acquaintance ship with D r. Pundsack, V ic e -P r e s id e n t of R e s e a r c h and D e v e lo p m e n t at Jo h n s -M a n v ille . We w e r e given extensive briefing by D r. Pundsack and his asso ciates, num erous reports a rd the n a m e s of the experts who late r helped us. P a rtic u la r r e c o g n itio n should go to D r . Goudie and D r. R olle and their a s s o c ia te s in the A nalytical L ab o rato ry , who w orked nights ar.d w eekends and whose scientific co m p eten ce provided the basis for the effort. me cc: Mr . W . A shton M r . D. R . C l a r e Mr . J . T . D e t t r e D |r. E . R , L . G a u g h r a n D r. A. J. Goudie D r. G. H ild ic k -S m ith D r. G. H. L o r d Mr. R. M iller - Vermont Shelle y Mr. R. T. M ortim er D r . W. N a s h e d Dr. F. R . Rolle M r. W. N. S teinberg M r . E . W. S t e w a r t M r. H. G. S tolzer Dr. R. L. Sundberg M r. J. C. Walcott