Document xzJRbyQDKvyNqg10pmD0Rk0jm

OVA vaoo a \^a w~- m, jp i Johns-r/iuiv'illc Internal Corresnonclsnce ' All Environmental Com.'Members & Division Managers Group* r,i*nF. J. Solon, Jr. - 4 North August 21, 1973 Cov^-pilc t Chrono saki<i Lcwinsohn-Selikoff *W. R. Goodw't F. H. May W. P. Albc J. S. Autry J. F. Pall L. J. Bartolanzo R. M. Billings L. R. Blair E. P. Burke R. P. Carter A. L. Cini R. H, Cuje I. M. Dienstbach J. B. Dorsey E. M. Fenner W. F. Goodwin M. Harris K. K. He-1airy J. E. Hesse D. E. Hillier W. A. Hindon J. R. M. Hutcheson M. B. Jamin H. R. Keefe C. C. Keller G. P. Loubert D. H. Lyons A. B. Marchant E. F. Marriner, M P. A. Martinson S. J. McDuff J. A. McKinney H. B. Moreno R. E. Naylor R. Nebel P. C. Nikitovich G. E. Parker F. L. Pundsack W.. B. Reitze Ivan Sabourin S. W. Schulmeyer C. E. Shepperly R. V. Smith T. R. Smith F. J. Solon, Jr. J. J. Spangenberg W. C. Streib C. J. Sulewski W. L. VanDcrbeek C. W. Wattson H. J. White W. C. Winblad F. A. Wintcrhalte: G. W. Wright, M.D Attached is a copy of Dr, Selikoff's reply to Dr. Lewinsohn's letter of July 12. It seems to be well documented though there is much of it wo laymen admittedly do not fully understand. The important factor will be the British reply and we, will forward it ds soon as received. & PLAINTIFF'S EXHIBIT JM-2152 OODH\M'An Dr^rlmml / Ctmmumity "Wn/ici* Hilton C. Lcwinsoh. M.B., Chief Medical Officer Turner Brothers Asbestos Company, P. 0. Box -10 Ruchdlu, England Ltd, Dear Dr, Lcwinsohn: I have read your letter of July 12, 1973. Its burden seems to bo that you and Dr. Koines feel that the results of two sets of x-ray studies of asbestos workers at the Turner Brothers Asbestos Company factory In Rochdale, one made by Dr. Knox In 1966 and another by you In 1970, are not contradictory. You believe I was In error In suggesting that there are Important discrepancies In the reported results of the two surveys. Attached Is a memorandum responding to the questions raised. ! do not consider that your objections are material or valid nor do I find that you have dispelled the doubts held by me and by many other scientists. Indeed, the failure of your polemic to establish coherence and identity between Dr. Knox's study and yours eight make ono all the more concerned that such identity does not exist. Correspondence between us is not the best way of settling the ratter and it must be settled. The problem is a serious one. Reports of re sults of x-ray surveys at the Tus-ner Bros, asbestos Co., Ltd. have been used to formulate industrial hvjtcue asbestos dust exposure standards, regulatine the permitted dustiness in workplaces in which hundreds of thousands of men and women are employed. If the x-ray surveys have been inaccurately evaluated, then the standaras are wrong and these workers are at serious risk of irreversible, often fatal, disease. The essential contradiction is: Dr. Knox reported to the British Occupational Hygiene Society that he x-rayed 290 production employees with more than 10 years of exposure at the Turner Trow, farmery In 1966. He Interpreted th* fllna as-shovin'; thac b naj changes "posTIFly ashes to tic" (2.7?-). I. reproduce the cable: (From: Ann. Occup. Hyg. 11: ' - r-' rv-r'*. #- '' J1 H. C. Lewlnsohn a /13/73 Tams 1. Cunkal axo aAOKXoctCAt. assusmwt or Ttxras asmxtos woauas narr nmano Amu 1.1.19)) ano urtofts roi 10 vtAas and wwaim Number hnbttm rhonchi present hr cen* of croup Basal raka 2*> 32 .71 K 'Includes ) *u? rsic<u ior asbcMotia. hr cast of Beep J-J X-ray dnnprs M ubctiotte 12 . X-ray damn pewiMy aabntotk hr can* f sroep * 2*7 2. It was on tl'ese data "...Bade available to the ccBBlttee by th*> Asi.cfos '''u5try...'' that the new standard "... la primarily based." (page 49). 3. You reported that you re-x-rayed all 1,287 workers at Turner Bros. (production, maintenance, research, quality control) In 1970. Your results are reproduced In the attached sheet, duplicating Figures 2 and 3 of your paper in the Royal Society of Health Journal In 1972. It Is evident that among male workers the following were found: Years from first exposure Abnormal x-rays Pulmonary fibrosis 10-19 20-29 30-39 Bore than 33% M " 30% " " 70* Bore than 20% " " 30% " ** SO* Among female workers: Years from first exposure______ Abnormal x-rays 10-19 20-29 30-39 Bore than 20% " " 33% " " 33% (ulaonary fibrosis Bore than 40% " 0* " " SO* I omit reference to your 40-49 year group since Knox re ported no coraparablo group. 4. Differences exist in the two studies (different tlaes; 1966 and 1970; changes in factory staff; different x-ray In terpreters and interpretation; different methods of recording etc.) But it was the some factory and, for the older em ployees for whom the comparison Is Bade, largely the saae workers who were x-rayed. The, differences In recorded pres- C...C -/ -^normalities arc not iiivial, and require* explanation. 74 <1' THE MEDICAL SURVEILLANCE OF ASBESTOS WORKERS YEARS SINCE FIRST EXPOSURE Finn l TV ftrtrmat* incidmt of normal iW abnormal X-ray k man rtterrf to 10 star tiponrt yrcuot. I Thr iatuUne* of pUvai tiurktm tag bat brm caicxijird Of b;s+;jif uli is.4 fiTK^nui ttiunbatsooi of tkkkenimf irrcx?*ctt+t of h>c ..w rr,*t i/too oot afern S Jnoiv*4 M Om mJmmwmm. ,uw .tjJFtOir <*/ tr. Ai eiu '*4j tilt ommerF of mAjetti muitmf to tkt ktfk ptrctntaj*/.v*tt.)\.PI-fUmrad thkitto S+m*J 7V prfrmtoft imeidtmet of oormat 1-4 obmrmol X-*mrt ki mum rtititl9o fO fom txjotwt H. C. Lewlnsohn -3 - t/13/73 3. Explanation la possible. The 1966 x-rays exist la the flics of the Turner Bros. Asbestos Co., as do the 1970 ' x-rays. Both sots of films can be reexanined sad re appraised. This Is what many of us assumed to have been promised by Dr. Holmes when he said In Lyon on Oct. 2, 1973, Thus the information, although the best available at the time, was, to sey the least canty for the purpo* and some of us who wore ~oclated with it have become Increasingly concerned with the authority with which it has become Invested in the international field. The time has therefore probably arrived for an up-to-date re-appraisal of the original data and the study of new data which has sines became available elsewhere." It may turn out that reappraisal of the x-rsys will prove Or. Knox to have been correct and that the figures published by you do not mean what they seem to mean. It may result la the opposite: that Or. Knox's evaluations were In error. Perhaps you were both correct, and differences are more apparent than real. Without reappraisal, one cannot be sure. Z as confident that skilled Independent British experts will be able to provide an accurate answer to this unresolved question. 6. The reappraisal is long overdue for another reason. The standard derived from the data made available by the Turner Bros. Asbestos Co. Ltd. refers only to prevention of asbestosls. The BOBS com mittee, on which Dr. Knox and Dr. Koines served, stated In its 1968 report that "...the quantitative relationship between as bestos and cancer risk Is not known.,.consequently It Is not possible, at this tine to specify an air concentration which Is known will be free of risk in this respect.1' (page 34). Unfortunatoly, asbestosls Is only one serious hazard of asbestos workers. In some cohorts approximately 800,) of excess doaths have been found duo to one or another type of asbestos -- associated cancer. Such cancers, cs mesothelioma, can occur at dust exposure levels below those which result in asbestwais. This unhappy omission of cancer from consideration in the setting of asbestos exposure standards, makes it all the more necessary to be diligent and prudent in evaluating data related * - ^stabllshncnt of such standards. Sincerely yours, US: vr Irving J. Scllkoff, M.D Professor f' i.u.ms Memorandum: Review of letter of Or, M.C. Levinson mnd Or. S. Holmes to Dr. l.J. Selikoff, July 13, 1*73. Documents A. Or. Sellkoff's remarks at the American Industrial Hygiene Conference, May 21, 1973, .as recorded and transcribed by undisclosed sources submitt t by Drs. Lewlnsohn and Holmes. B. Committee on Hygiene Standards of the British Occupational Hygiene Society. Ann. Occup. Hyg. 11:47-69, 1968. C. H.C. Lewlnsohn. Hie .Vcdlcal Surveillance of Asbestos Workers. Boy. Soc. Health J. 92:69-77, 1972... 0. C. Berry. Hygiene Standards -- Theory and Application. Lyon, Oct. 2, 1972, Paper 22. E. S. Holmes. Criteria for Environmental Data and Bases of Threshold Limit Values -- Environmental Data in Industry. Lyon, Oct. 2, 1972, Paper 20. Cor.;r.crits (reference to numbered paragraphs in Levinsohn-Holmes letter). 1(a) The paper "...was not intended to Justify or verity the BOHS standard." Nowhere did I say it was so Intended. 1(b) "The results presented in HCL's paper were preliminary results." It is possible that you will have furthor' findings but at the time of my presentation only those were Available that you had published, and defined in your paper as follows: "Figures 2 and 3 illustrate the incidence of radiological changes, in ten years exposure groups, in 970 males and 317 females exposed to asbestos. In tho previous report9 it was shown that radiological abnormality was dependent upon exposure, age ar.d smoking habits but that exposure appeared to be the most important single factor." (Document C, pg. 74.) 1(c) You argue that it was clearly stated In your Discussion that "From the information currently available only tentative opinions can be expressed." I fail to see the relevance of the implied complaint. Nowhere did I quote your opinions. 1 - ... rus ted only in your d.U, 2(a) You state that the populations reported by Knox and HCli wore not Identical nor were "the vary large majority" "comon to both surveys.H I would be Interested In data to support this assertion, with reference to the employment categories specifically referred to bv ne in ay presentation, l.o., those 10-19, 20-29 and 30-39 years 1rota onset, and re produced In ay tables [see 3(a)]. These wore the groups la which r-iiologlcal changes were seen, and to which reference was asade. (Document A, pp. 10-11.) The thri * of my discussion, and the contrast to which Z pointed, *e on the individuals x-rayed by Knox (Document B, p. 55) in 1966. All of these Individuals were at least 10 years Iron onset and, unless no longer working at Turner Bros., re in .9/0 groups A-rayed by you. Do you contend they were not? If so, please explain. I made no Issue of individuals 40+ years from onset, nor were they Included in the graph (see 5) since they had begun work before 1933, and were not Included in Dr. Knox's report. 2(b) Insofar as you would have proferred that I had designated the additional individuals x-rayed by you as "quality control and research staff" rather than "office workers" I can only plead the shorthand of an extemporaneous presentation designed to fit a limited tine allotment. Incidentally, my experience with U.S. r<<*rch staffs is that they do spend a good deal of time in offices. 3(a) You complain that I stated that Knox reported on 913 men with at least 10 years exposure.. You misquote me. My exact words were: "Dr. Knox had examined only men in the scheduled areas ---that Is, the production areas, 913-, whereas Dr. Lewlnsohn Included all employees...." (Document A, p. 10.) The figure 913 was given to compare a production area group with the larger population (1,287) x-rayed by you. Mo statement was made by me that such a number was In the 10 year or over groups. (Document A, p. 8.) Indeed, my references to Dr. Knox's findings were specific snd exact, since I showed s slide which presented the precise date contained In the tables in the paper published In 1968 (Document B, p. 51) and attributed to Dr. Knox (Document b, p. 54). Group 1 Years employed Number exposed flbres/cn^ X-Ray changes 10- 58 11 72 11 2025- 29 46 to 30- 6 27 0 1 2 3 1 211 T * Tears employed 1015202530- Number exposed 22 20 10 . 20 7 70 flbers/cma 3.5 3.5 to .o X-ftay chances 0 0 0 1 0 1 The tables iron which this slide was abstracted follow: Yean . employed !0-- li20-- as-- so- Hygiene tuodardj for chrysolite nlwlw duM Omw I \ Number exposed Mean dual concentration Namber affected partkles/cm' ftbra/cm* Rhocchl Iml (tee Note]) (ice Note 2) f ralea X-ray dunges JJ :?c 72 J90 29 46 to 6 940 21 8 1 It It 1 1 to *, 74 14 t 2 1 27 2t t Yon employed 10IS202S-- JO- Number exposed 22 20 10 20 7 Gaoual Mean dust concentration partidca/an* fib-o/em* Oca Note 1) (ice Note 2) I6J JS I6S JJ is IS 290 6-0 ' Number affected Rbondu laid ralea X-ray chans** 10 S0 0 1 1 J0 0 0 1 My exact extemporaneous comments were: "In the departments where the dust counts were 10 to 15 fibers per cc, of the large number of workers there employed, 7 showod some x-ray abnormality which could have b-.en asbestos is. On the other hand, of 70 or 80 peoplo wotting at 3 to 4 fibers per cc, only ono was reported to have an abnormal x-ray." (Document A, p. B.) -4- The designations "10 to 15 fiber* per cc" ar,d 3 to 4 fiber* per cc" were derived from Mr. Derry's t-uie in 1973 (Document D, p. 11). He gives them a* 10.9 tb 15.2 flb*r*/cm3 and 3.4 to 4.1 flbcrs/cm . X believe my referenco Is accurate. 3(b) My use of the phrase "...could have been asbestosis" (Docisaent A, p. 8) was based upon the column heading In tho 19$8 paper (Document B, Tables 1 and 2, p. 55), "X-Ray changes possibly asbestotic," and therefore seems entirely faithful. You illi note, too; that ay tabLcs listed 290 men with sore than 10 jars, exactly as reported in 1968. These were compared with the results in those workers x-rayed by yru ir. th~ r-. r_l -.uploymcnt categories, l.e., 20-29 years, 30-39 years, '10+ years" from first employment." Tills Is admittedly not absolutely identical with your predecessor Dr. Knox's " years employed" but, if anything, your employment categories ("years from first employment") could not have re flected nore than Dr. Knox's ("years employed"). It could have been less (if some workers had periods out of work), but not more. Therefore, if anything, your x-rays should have shown loss disease than Dr. Knox's, by employment category. 4(b) You complain that the term "asbestosis" was used on tho graph. This word was used by Knox while you used tbe term "pulmonary fibrosis." We therefore had the option of using ellhwr. Per haps you night advise me If you think I was Incorrect in using Dr. Knox's "asbestosis," and if you believe it is stretching things to so label your "pulmonary fibrosis," when you describe such x-ray findings in workers employed in an asbestos factory for 20, 30, 40 or more years. I seem to remember an old English saying, to the effect that circumstantial evidence Is very strong, as when one finds fish in the milk. 5 You say that you did not attempt to calculate fiber years/cc. I did not say you had. 1 did show a graph prepared by Dr. William J. Nicholson of our Laboratory comparing your x-ray findings with Dr. Knox's using an overall average cumulative exposure for the entire population.. Tho exposure experience was not taken out of thin air but was derived from the very complete Turner Cros. dust data analysis presented by Mr. G. Berry In Lyon on October 2, 1972 (Document D). These data were given a3 the latest available. Unfortunately, you did not pre sent comparable results in your own paper -- we would have liked to have seen then. The astestos exposures used on the graph In my presentation were estimated as follows: The dust levels reported by Derry (Document D, p, 11) and presented at Lyon served as tho basis for estimating cumula tive exposures prior to G.30.66. To each of these integrated exposures was added 22.5 flbors/cc-ycars, wnich w;is obtained by .'vrraglng the dust level data listed In Table 4, pago 57, of Document B for the flborlztng, carding and spinning depart* ments and multiplying by 4.3 years. Ten year average exposures vero obtained by averaging the data in appropriate 9 year cate* gories, weighted by the number of non working In IBM. Because we had no way of associating observed x-ray changes with la* dividual* in high and low 10 year exposure categories and tn order to be as conservative as possible, the dust exposures assigned to groups of workers were those of the highest ex posed workers although 1/3 to 1/2 of the individuals repre sented by each point were exposed at levels 1/3 less. The estimates of the number of Individuals affected were also as conservative as possible. All questionable parenchymal x-ray changes and all pleural changes not consistent with asbestosls were considered as negative. As can be seen by comparing the graph with your figures 3 and 3, our conservative approach has resulted In the graph showing less x-ray abnormality than do your figures. I would appreciate either reworked or new dust data to go with your x-ray results and will then prepare another graph. In the meantime, we will have to use dust data presented froa Turner Bros, by Dr. Holmes in 1968 (Document B, p. 57) and by Mr. Berry In 1972 (Document D). Since Dr. Knox Included in his recorded x-ray changes pleural abnormalities as well as parenchymal disease, it nay well be that there were even fewer than 8 cases, of those he reported, with only pulmonary fibrosis. The 1968 paper does not make this clear. If this were so, then the contrast with your 1970 "pulmonary fibrosis" category would be even greater and the dlscrepency even more puzzling, since we compared all of Dr. Knox's "possibly asbestotlc" x-rsy changes (Document B, p. S3) with your more limited category "pulmonary fibrosis." A further point is in order. The BOUS paper in 1968 was con cerned with earliest evidence of disease resulting from asbestos exposure. (Document B, p. SO.) Indeed, It deemed It advantageous to so consider basal rales since those could occur before x-ray change. You state you used "the U.I.C.C./ILO classification" (mislabeled; it is the 1LO V/C classification!) to analyse your radiological findings. Your appropriate use of this international x-ray classification system rather than a personal one has surely allowed you to approach the goal of the BOHS committee, the use of "the earliest demonstrable effects on the lung due to asbestos," ss the criterion for "asbestosls." 1 believe your recorded x-ray findings (Document C, Figures 2 and 3, p. 7*1) are likely to be accurate, and the reported presence of parenchyt. al and pleural abnormal' tie.- ".existent with' Asbestosis to x xxoct what actually exists among workers at the Turner Bros. Asbestos Co., Ltd. Basal rales. I made no reference to basal rales since your paper did not report on these (Document C, pp. 74-75) and compnrl son of 1966-Knox and 1970-Le'vinsohn was thus not possible. Parcntliot lc:iUy, neither did I compare pulmonary /unction /lad ings, which were reported by you but not by Knox (Document C, pp. 75-/0). 8(a) also see 4(b) Did you have any cases recorded by you as "pulmonary fibrosis" which did not have characteristic apbcstntic Interstitial fibrosis If they later came to post-mortem.7 8(b) You state that l Ignored "...the fact that the number of cases of usees to*is in 1`J68 among 335 employees (men and women) ex posed for 10 years or more since 1933 In Rochdale and still employed, was 1.12?. (l.e., 4 cases) as compared with Merewether's finding of -H.-lCa (I.K., 59 cases) among 133 workers exposed 10 years or more in the sare industry In 1929. This lower iacidvr.cc has occurred in spite of the fact that the Pneumoconiosis Medical Panels arc better equipped to diagnose asbestosis than Mercwether was." I charitably made no reference to this observation of yours (contained :n Document C, Table If, p. 71), since it was such an obvious error: indeed, I regret that you have again called attention to it. "Tie Pneur.oconiosis Panel cases were Eew cases first diagnosed in 1968; ilcrewethcr's data gave the results of a study of the prevalence of asbestos is among a group of workers in 1929. One should ..not confuse annual incidence of a disease, with its prevalence. (You- Table II follows.) Tuu n New coses of A .br.tosis {stilt eo~Jcycsf) diagnosed in 1968 {with no employment price to 1.1.1933} compared with the doto of Aunifii* and Mere*ether*1*. No. of years emnin.-ed 1C-U . IS-1) . 20-24 4 ovtr TOTAL Pduo.vnil 196S Men 90 86 28 238 Women 49 24 28 101 Total 139 110 M 333 No. of coses 1 1 2 4 1968 Ceoup incidence % 0-72 091 2-30 112 Outs or Anuma J9S7 No. of costs 1 i Gmp Incidence 04X4 71 1 300 3 10 1930 Incidence A J14 00* M You voice displeasure that the contents of a "private correspondence" were co-c.unicatcd. I hardly think that a paper published in the Royal Society of Dealth Journal is "private correspondence." I requested that you :c:id r r nu-.hvrs to translate the figures and you did; my references were then -..vie only to what you reported in your published paper. You did rof) ei' ' "''a;.rning pulmonary lunclion abnormalities ar.d relation o( x-ray nbnoitaalitics to smoking that were given in a paper by you at Salford) but I made no reference to theso data since, while I had tt.e r> and h:'o you n.~d mice bibliographical reference to them (fh.i... e C. n 'r.-.ice 1C, p. 77), they had not yet appeared in print, and oth.-rn coald therefore not readily study them.