Document yk371eOabM04vKrY85p1M3mpD

FILE NAME: Johnson & Johnson (JAJ) DATE: 1972 June 17 DOC#: JAJ055 DOCUMENT DESCRIPTION: Memo to File RE Talc/Asbestos Subject: Talc/Asbesto fwwow ! New Brunswick, N.J. June 17, 1972 Memo to File i I i I v | ) i | j j J i To the best of my recollection, the following describes the events of June 16, 1972. Following the appearance of an article in the New York Times today (attached), I was asked by Mr. Burke to inform the FDA of the article and the fact that actual data presented to the FDA proved our . talc to be free of asbestos. . * I called Dr. Sohaffner, FDA, and read to him the pertinent portions of the article and pointed out that the findings by Dr. Pooley, McCrone Associates, Colorado School of Mines Research Institute, and Johnson & Johnson, which have been filed with him,, prove con clusively the absence of asbestos in our powder, and I reminded him that Dr. Langer of Mt. Sinai Hospital had stated in*the August 3 meeting with FDA that "you don't have to worry about Johnson fc Johnson. " I also read to him FDA's summary of the meeting, especially page 5, item 4 (see attached). Dr. Schaffner appreciated our informing him ahead of time. I also participated in a conference call to Mr. Marshall, Environ mental Protection Administration, N.Y. Mr. Smoyer and Mr. Foster asked Mr. Marshall to issue a correction in view of the data presented at the FDA conference last year. They pointed out that the ' article has caused a great deal of unwarranted concern among the mothers using our baby powder. Mr. Marshall said he will have to consult with his superiors. 2was next asked by Mr. Clare to contact Dr. Langer of Mt. Sinai. Dr. Langer told me that they were furious about the article since they have not been consulted before publication. He said he thought that the E .P .A ., N.Y. should have better tilings to spend their time on than baby powders. 1 asked Dr. Langer for a quotable statement and he dictated the following: "The N.Y. Times article quoted our original report to E .P. A. which had very, very preliminary findings by means of light microscopy. These findings are meaningless since we found later that the fibers.we thought to be asbestos were indeed talc." Protected D ocum ent-Subjeit to Protective Order M em o to file V. - 2- June 1?, 1972 I asked D r. L anger if he can state th at our baby powder is fre e of a s b e s to s a s a re s u lt of th e c o n fe re n c e and rev iew of A ugust 3, 1971 w ith the FDA. He said he s till thinks th a t Johnson 8c Jo h n so n 's p ro d u ct contains m inute tra c e s of asb esto s and he believes he can find asb esto s fibers after breaking down the platelets by ultrasonic energy. I asked him if Dr. Selikoff, who is quoted in the a rtic le , is w illing to com m unicate th e ir feelings to M r. K retchm er, He said, "Not likely, since D r. Selikoff and M r. K retchm er have not been on speaking te rm s for the la st 9 m o n th s." He mentioned that he had already talked to M r. M arshall of E .P .A . and had read him the "rio t a ct. " A lso, D r. H ildick-Sm ith w as asked to contact D r. Selikoff. Although D r. Selikoff sym pathized with our point of view, he felt that D r. L an g er's contact w ith M r. M arshall was enough to bring th eir point of view to the attention of the E .P .A . * A fter reporting my conversation with D r. L anger to M r. F o ster and M r. C la re , I w as ask ed to c o n ta c t M r. R o m er, N. Y. D ep artm en t of A ir R e s o u rc e s . I told M r. R o m er th a t the s to ry in th e N. Y T im es has caused a great deal of consternation among the m illions of u sers of baby powder and that on the basis of D r. L anger's com m ent, the inform ation given to the N. Y. T im es is in e r r o r , 'and I asked him to take steps to c o rre c t the inform ation. M r. R om er said that he would have to consult with his C om m issioner. I pointed out to M r. R om er th at he attended the FDA m eeting on A ugust 3 and it w as obvious at that tim e from both our findings and D r. L a n g e r's com m ent th a t Jo h n so n 8c Johnson B aby P o w d e r is fr e e of ,asbestos. M r. Rom er said that he understands that our powder may still contain tra c es of asbestos and since D r. Selikoff had previously said that the only safe level is zero , he still feels that we have not proven that our powder is com pletely safe. I pointed out also that D r. L a n g e r's contention th a t tra c e s of a sb e sto s fib e rs w ere seen w as not confirm ed by electron diffraction, since he did not have that piece of equipm ent, w hile M cCrone A ssociates who did a thorough job 10,000 grids (with electro n diffraction) - found no asb esto s. He com m ented that we had not subm itted these re p o rts to him . I suggested to M r. Rom er that if he does not rem em ber, -as/he pointed out, a ll the d e tails of the A ugust 3 m eetin g , it would be in o rd e r fo r him to call both D r. Langer and the FDA to confirm the fact that our product is fre e of asb esto s. He agreed to pursue this and call m e back. Protected Docum ent-Subjert to Protective Order JN JNL61_000001124 > A iI ii tl i i ( 1 i\ i I I1 f t1I j | i 1i j ! \II Memo to file 3 - ` June 17, 1972 He requested that we give him full reports, on the product which he wants to study and" review with Dr. Selikoff. I told him this is OK with us; however, we need immediate action to correct the false report in the N. Y. Times. He promised to call back after consulting with his Commissioner. I was later informed that Mr. Marshall told Mr. Foster that he in tends to issue a correction which states that Johnson k Johnson Baby Powder contains trace amounts of asbestos (which is not acceptable to us). Mr. Foster intended to give to the N. Y. Times and E.P.A . the names and phone numbers of our consulting laboratories who reported on our talc. Accordingly, I contacted both Mr. Caneer of Colorado School of Mines Research Institute and Mr. Ian Stewart of MeCrone. Both expressed readiness to testify to the fact that our powder contained no asbestos. Xpassed this information on to Mr. Foster with the appropriate phone numbers. 1 later called Dr. Sehaffner of the FDA and brought him up to date on the conversations with Dr. Danger and the fact that the information is not reliable and is not supported by Dr. Danger. He volunteered that his office has been receiving various calls and that his answer has been what we discussed earlier today-. He also pointed out that Dr. Dewin has been doing analyses for FDA on a contract basis. He has completed testing of 40 commercial products; only one had shown the presence of asbestos above 1%. He further stated that Dr. Dewin's report on our powder was "no detectable asbestos." I asked Dr. Sehaffner if he is willing to call Mr. Marshall and/or Mr. Romer confirming this and he said he would ahd asked me for their phone numbers which 1 provided. I asked him if he is willing to give the same information to the N*Y, Times and he said "y es." I later checked with Mr. Foster who confirmed that the N. Y. Times had been in toueh with Dr. Sehaffner-after (his conversation. Dr. Sehaffner also asked that, after "the dust settles," we meet with him and review (he whole talc plan for Johnson k Johnson. I agreed that we will do so. WN/cw Attach. Vj . N W. Nashed ` * J Protected Docum nt-Sut>5*ct to Protective order V JNJHLS1JWOO01128