Document gbJ1QMx58qwVqMwrb1qbMDj8L

74 1 industry. 2 A That last one was study of the employees of the 3 factory, th. e> plant In which Messrs Wallace and Dendinger worked. 4 Q Have you reviewed that study? 5 A I have studied the report, yes. 6 Q And that was the report prepared by Dr Shindell? 7 A Yes. 8 Q Did you know of Dr Shindell before you saw his report? 9 A No. 10 Q Going back for a minute to Dr Chiazze, were you aware 11 that Dr Chiazze's initial work was paid for by the Trade Industry 12 for the PVC manufacturers of the United States? 13 A 1 cannot recall that but if he says it, I am sure it 14 was. 15 Q And your suggestion with regard to the conclusions or 16 hypotheses that Dr Chiazze derived from his study, vas that they i 17 should be further analysed and were, and that further research 18 should be done? 19 A Yes. 20 Q Are you aware of any efforts by the American PVC 21 industry to sponsor further studies of PVC fabrication employees 22 in the light of the results reported by Dr Chiazze in his 1981 23 work? 24 A I have no idea what they have done, I am not in touch 25 with the industry. Tennyson & Company - Court Reporter* London. England 01144-12424164 L ilia n URL 11613 1 Q Vsb your .recommendation, however, that follow-up 2 studies be done? 3 A 1 think that would be a reasonable thing to do, yes 4 and Or Shindell, of course, could be cited, 1 suppose, as one 5 such study. 6 Q Then let us talk about Or Shindell's study. Do you have 7 a copy of that with you, doctor? 8 A I could get it, yes. (Pause) Yes, 1 have. 9 Q 1 would like to direct your attention if I could to 10 Table II in Dr Shindell*s study that appeas at page 12. Do you 11 have that in front of you, sir? 12 A Yes. 13 Q What is your understanding as to the job categories 14 in which Mr Wallace and Mr Dendinger were employed? 15 A My understanding is that they were employed in the 16 categories described there as inspection shipping - - no, 1 am 17 sorry, coating and finishing. 18 Q Your understanding is that both----19 A 1 am sorry, I think I may be wrong on this. I thought 20 one was inspecting, was he not? 21 Q Let me make a representation. 22 A Can you remind me? 23 Q It is my understanding that Mr Wallace was classified 24 as a coating finishing employee and Mr Dendinger was classified 25 as an inspection shipping employee. Tannyaon & Company Court Repontr, London, England 01144-12424164 76 1 A In other words I was right in both cases but _or the 2 wrong reasons. 3 Q I suppose so. What I would like to do doctor, is to 4 have you contrast the Shindell study with the Chiazze study. 6 How would you classify this study that Dr Shindell did In terms 6 of epidemiologic categories? 7 A This is e cohort study end as such is the type of stud> 8 that one likes to carry out to test a hypothesis. 9 Q One of the hypotheses that Dr Chiazze proposed in his 10 1981 article was that there was an increase in the proportion 11 of total cancer deaths among white male PVC fabrication employees 12 A Yes. 13 Q So one of the follow-ups that you would have suggested 14 to confirm or disprove Dr Chiazze's hypothesis was the cohort 15 study done by Dr Shindell? 16 A Yes. ^ r1 CT` J* 17 Q What I would like to do. Dr Doll, is to have you look > i 18 at Table II and the total cancers reported in the coating finishing 19 and the inspection shipping categories, in which my clients 20 decedents worked. If we can take the coating finishing category 21 first in which Mr Wallace was employed and determine the total 22 number of cancers that would have been expected in a general 23 population, we could take that by adding the 1.4 expected 24 respiratory cancers and the 2.47 expected other cancers. Would 25 that be correct? Tennyson & Company Court Reporters London, England 01144-12424164 1 A Yes. 2 Q Could we go off the record for just s minute, please? 3 (Whereupon there followed a discussion off the record) 4 BY MR DELLI BOVI: 6 Q Dr Doll, referring to Table 11 in Dr Shindell's study 6 end the two categories of employees which Mr Dendinger and 7 Mr Wallace worked, there are data reported in both of respirator) 8 cancers and other cancers, correct? 9 A Yes. 10 Q And these are categories that were set up by Dr Shindel 11 for purposes of his analysis? 12 A Yes. 13 Q 1 would like to direct your attention to the exhibits 14 that we have on the easel which 1 will mark as Plaintiffs Exhibit 15 Doll 3. I would like, if you would, to refer to the respiratory URL 1161 16 cancer deaths and the other cancer deaths in the job classifi 17 cations in which Mr Wallace and Mr Dendinger were classified and 18 tell me whether or not the figures that are on Exhibit 3 are Ol 19 identical to those appearing in Dr Shindell's study? 20 A Yes, they are. 21 Q What I would like--- 22 A 1 have not checked the addition but I am assuming the 23 addition is correct. 24 Q I hope so. What 1 would like you to do, Dr -Doll, is 25 * to do something Dr Shindell did not do in his study and that is Tennyson ft Company - Court Reporters London. England 01144-12424164 78 1 to determine in terms of total cancers in the job categories in 2 which Hr Wallace and Mr Dendinger were employed, the significance 3 of the observed deaths, versus the expected deaths.r Would you 4 be able to' do that, sir? 5 A I would have to look at the tables of significance. 6 From my general experience 1 would guess the coating end finishing 7 one was not significant statistically, but the inspection and 8 shipping was, but that is a guess and I would have to look at 9 the table. You can doubtless tell me. 10 Q Let me go back to the findings that Dr Shindell came 11 to himself. With regard to the respiratory cancers among the 12 coating and finishing employees. Dr Shindell calculated the 13 expected deaths at 1.4, correct? 14 A Yes. 15 Q What does that indicate, doctor? ac? 16 A That had the people in those particular sections of 17 the industry died at the same rate as the people of the same CT, cr, 18 ages in the United States as a whole, from respiratory cancer, 19 that 1.4 of them, if you esn accept 0.4 of an individual, would 20 have died of respiratory cancer. 21 Q As opposed to the 1.4 expected deaths. Dr Shindell 22 reported actual deaths among employees at the plant where my 23 clients' decedents worked? 24 A Yes. 25 Q Did Dr Shindell determine that that number of observed Tannyson & Company * Coon Raponar* London, England 01144-12424164 7? 1 deaths versus the number of expected deaths was statistically 2 significant? 3 A Yes, he said it was but when I looked It up in my .X 4 tables 1 found it was not but it is a quibble because it is 5 round about 51 probability and whether it is 41 or 61 is scientifi 6 cally of trivial importance. Actually, 1 make it nearer 61 than 7 41. 8 Q And that means what, doctor? 9 A That means to have observed four or more deaths from 10 respiratory cancer in that particular group of people of those 11 ages over that period in the United States would have turned up 12 only about once in twenty such groups that you looked at. 13 Q Next I would like to direct you to the inspection and 14 shipping category of employees in which Mr Dendinger worked and 15 to the other cancers. According to Dr Shindell's method of 16 classification, would those other cancers include the colon 17 cancer from which Mr Dendinger died? 18 A Yes. 19 Q In that category. Dr Doll, one would have expected, 20 assuming the death rate from these other cancers among inspection' 21 shipping employees at Chrysler, was the same as that among a 22 comparable general population, 1.95? 23 A Yes. 24 Q And in fact at Chrysler there were five employees who 25 died of cancers otheT than respiratory cancer? Tennyaon & Company - Court Reporters London, England 01t44-124241$4 URL 1161? 80 1 A Yes. -- 2 Q Is that number again. Dr Doll, statistically signifi 3 cant?. 4 A `This time I have no difficulty in agreeing with 5 Dr Shindell. 6 Q In terms of testing Dr Chiazze's 1981 hypothesis of 7 an increase in overall cancers among PVC fabrication employeesP 8 is it fair to total these four categories of employees to arrive 9 at sum total figures? 10 A No. 11 Q Why is that, doctor? 12 A Because you have subscribed the population and picked 13 out some groups with higher mortalities than other groups. You 14 have left out the production and maintenance group which did not 15 show such an excess. It showed, I think, 4 cancers against 3.72 16 expected and you left out the management and clerical group l 17 which showed no cancers against 1.79 expected and when you sub 18 divide and look at a number of separate groups, then inevitably 19 you are going to find some with statistically significant 20 excesses; Had the prior hypothesis of Dr Chiazze been that 21 people in the coating finishing and inspection shipping groups 22 had a higher than expected mortality from cancer, then that would 23 be a fair thing to do, but it was not. It was that all the 24 employees of the PVC fabrication industry had an excess and, 25 therefore, you have to look at the total. Again, you get'your- URL 11618 Tennyeon & Company Coun Reporters London. England Ot 144-12424164 81 1 self into a situation In which you create another hypothesis 2 when you find an excess In some subdivisions. You find now an 3 excess in the coating finishing and inspection shipping divisions 4 and that constitutes a new hypothesis which will have to be tested 5 by further experience of those workers. I would like to .carry 6 that a little further because In testing a hypothesis 1 think 7 it is important that you take into account the area In which the 8 people were working. Or Chlazze'a hypothesis was based on the 9 workers in, I think, seventeen plants, but my memory may be 10 fallible about that, scattered throughout the United States and 11 he, therefore, very properly or reasonably took the whole of the 12 United States mortality experience as a standard to compare with 13 it. If, however, you are looking at a plant in Ohio, then you 14 need to see what the mortality from cancer is in Ohio, how that 15 compares with the rest of the United States. I have not got the 16 figures for that, it is a highly industrialised State or part 17 of it, 1 believe is and I would expect the expected mortality 18 from cancer to be higher than is estimated from the national 19 United States rates. 20 Q To a significant degree? 21 A Yes. 22 Q Have you been presented with data for Ohio by any of 23 the ?VC manufacturers? 24 A No. 25 Q Did you consider the cancer deaths reported at the Tennyson & Company Court Reporters London, England 01144-12424164 7Hn w 82 1 Chrysler facility by Dr Shindell in coming to the opinion's that 2 you have suggested today? 3 A Dr Shindell'a paper via not available at the time 1 a 4 Bade ay review. 6 Q When did you flrat see Dr Shindell*s paper? 6 A About two veeka ago* one week, ten daya ago. 7 Q In terms of Mr Dendlnger and Mr Wallace, I. take it you 8 do not have an opinion as to the cause of either gentleman's 9 cancer? 10 A No. 11 Q Were you provided with any information about their age 12 at the time of death, their diet, their family history or known 13 history of cancer, their inhallation of tobacco smoke, if any, 14 or their use of alcohol, if any? 15 A Yes, some limited data. Certainly precise data for 16 age and some details for the other things that you mention but 17 none of them in fact are relevant or would be regarded as 18 relevant to theaetiology of their conditions. When I say that, 19 1 do not mean diet is not relevant to theaetiology of cancer of 20 the colon, all I mean is the sort of Information that could be 21 given about the individual would not affect my assessment 22 because one cannot really assess an Individual's diets sufficientily 23 precisely to be of any value on deciding if it is a cause of his 24 cancer. 25 Q In terms of your opinions that you have expressed today. Tannyaon & Company Court Raponar, London, England 011441 2424164 ozq11 iy n 1 you have not relied on the Shindell study at the Chrysler plant, 2 the Chlazze study of PVC fabrication employees, the Molina study 3 of PVC fabrication employees, is that correct? 4 A No. Z have certainly taken them all into full account 5 and weighed the evidence that they have produced before 6 expressing ny opinion which is an opinion based on all the data 7 I have seen Including the ddta which you have provided me with 6 and which 1 was provided with in the last few months. 9 Q What determined whether or not a particular study made 10 your list of references at the conclusion of your paper? 11 A Whether it was relevant to the conclusions which 1 12 reached in it. I did not list quite a number of studies which 13 I read, including the Chiazze study because I did not think it 14 was relevant to the conclusion which I reached. 15 Q Your belief then was that Chiazze was not relevant? 16 A I thought that Chiazze's study was not helping in any 17 way assess what the effects of vinyl chloride were. 18 Q That Molina was not relevant? 19 A Molina was definitely not relevant. 20 Q And Shindell was not relevant? 21 A Shindell I only recently took into account in expressing 22 my opinion today. 23 Q The report with the review that you authored .and 24 appeared in the Scandinavian journal, was commissioned-by the 25 Manufacturing Chemists Association? 0 URL 11621 Tennyson & Company - Court Reporters London, England 01144.12424164 84 1 A It depends what you mean by `'commissioned". _Lf by 2 "commissioned", you mean was I paid to do ltv the answer is no. 3 If by "commissioned" you mean was I asked to do It in an 4 honorary capacity, the answer Is yes. I said I was glad to do 6 it. it was an interesting and important subject and I would do 6 it on the understanding they made a contribution to a charity 7 which I named. So. depending what you mean by "commissioned", 8 there is my answer. 9 Q And, if you do not mind my inquiry, could you tell me 10 the amount of the contribution KCA agreed to pay? 11 A Oh, I will have to look it up. It might have been 12 $10,000, 7,000. It was not paid to me, it was paid to the 13 charity. 14 Q Can you tell me for certain whether or not the study 15 was commissioned before or after 1985? 16 A No, I cannot. I think it was before, probably. I knovJ 17 it was about two years before 1 could start on it. 1 did the 18 work in 1986. I would guess it was 1984 I was asked to do it 19 but it might have been 1985. * i c ^ 20 Q Could you tell me, doctor, precisely what assignment 5 21 you received from the MCA? 22 A I cannot remember the exact wording. It was about 23 three lines to review the evidence on the effect of vinyl 24 chloride on man with specific reference to whether there was any 25 Increase of any cancer other than angiosarcoma of the liver. Tennyson & Company - Court R*pon#rs London, England 01144-12424164 85 1 I think that was the way it was put. 2 Q Do you know whether ot not that study was sought by 3 the MCA after Mr Dendinger and Mr Wallace filed their litigation' 4 A I have no idea. I do not know when they filed it. 5 Q Of the four major studies that youT article reviews, 6 three were - at least at the time you wrote the article * un 7 published? 8 A Yes. They are published now. 9 Q Are all four of the studies that you have reviewed 10 published? 11 A No, the American study, to my knowledge, has not been 12 published yet although I believe it is available to anyone who 13 asks for it. 14 Q How did the United States study come to your knowledge' 15 A It came to my knowledge because when I started doing 16 the review I was dealing with a lot of separate papers about 17 populations exposed to vinyl chloride in the United States and I I 1 18 there was one of them done by an American organization, I forget ; 19 the name. Equitable and Environmental Health Inc., that covered 20 a substantial number of plants and there was a follow up study 21 to this by a man beginning with C----22 Q Cooper? 23 A Cooper, and 1 wondered whether the individual studies 24 reported by other authors were included in these two studies. 25 Clearly, in a review you do not want to add in the same amount URL 11623 Tennyson & Company - Court Reporters London, England 01144-12424164 URL 11624 1 of data three or four tines as reported by different pv&ple. 2 It Is lnportant you only Include one set of data on one occasion, 3 so I enquir. ed of the chemical Industry through the Imperial 4 Chemical Industries In England, whether I could be told whether 5 these studies of Cooper and Tabershaw and Gaffey covered, the. 6 other studies and 1 was told that they did and then I vas told 7 also that another study was being carried out and 1 said that 8 a follow up study was being carried out and I said it Is silly 9 for me to give an opinion until I had seen the follow up study, 10 so 1 waited till 1 had seen the follow up study. I made the 11 same inquiries in England. I had a report of Fox and Collier 12 of the British Industry and I wrote to the Health and Safety 13 Executive in England to ask if they were doing any further 14 studies and they told me there was this government study that 15 covered the whole industry in England and I said: "I must wait 16 and have the results of both these studies before I can give an 17 opinion." Could we go off the record for a moment while the 18 refreshments come in? 19 MR DELLI BOVI: Yes, why don't we go off the record. 20 (Whereupon there followed a short adjournment) 21 BY MR DELLI BOVI: 22 Q Dr Doll, I am going to hand you what I have marked as 23 Plaintiffs Exhibit 4. Would you review this document and tell 24 me whether or not this is a copy of the study that is.cited in 25 your review that was prepared from the Chemical Manufacturers Tennyson & Company * Court Reporters London, England 01144-12424164 87 1 Association. (Document handed to the witness) --- 2 A Yes, that is the one. 3 Q .To*. your knowledge* that study remains unpublished? 4 A Yes. What I am saying by that Is Z do not know if it 5 is published. 6 Q One of the other studies referred to in your reference* 7 as reference 16 Is a 1976 study by Equitable Environmental 8 Health entitled: "Epidemiological Study of Vinyl Chloride 9 Workers: Final Report to Manufacturing Chemists Association." 10 Do you have a copy of that report with you this afternoon? 11 A No, I do not have a copy of that with me. This was 12 subsumed in this later report and it is a long time since I read 13 it. It is not relevant to my review. 14 Q So* among the references that you cited in youT review 15 are references that are not relevant to it? 16 A I cited and gave reasons why 1 have not incldued them, 17 saying the data in it has been subsumed in the later one, but 18 I cited it because otherwise people might have wondered why 1 19 did not mention it. 20 Q Where did you obtain the 1978 Equitable Environmental 21 Health Report? 22 A I cannot remember now. I am guessing, probably from 23 Imperial Chemical Industries or 1 might have had it from Cooper 24 himself. 1 think that was the one that Cooper published, was 25 it not? URL 11625 Tennyson & Company Court Reporter* London, England 01144-12424164 URL 11b2b 88 1 Q Was that study, to your knowledge, ever published? 2 A Not to my knowledge, no. 3 Q Im perial Chemical Industries--4 A Balt a minute. Be have got Cooper as a separate one, 6 have we not? 6 Q Yes. 7 A Now, this one, I think that was a preliminary report 8 to Cooper so Cooper would be regarded as the publication of 9 number 16. I think that Is right. So, the answer, therefore, 10 would be yes it vas published if 1 am correct, but I really have 11 to check to make sure 1 am being correct on that. Earlier 12 observations, that is right. Yes, yes. Without going back and 13 looking at the data, my recollection is that 12 vas the publi 14 cation in effect of 16, but I would not want to swear to it 15 without checking. 16 Q Dr Doll, can you tell us what a carcinogen is? 17 A I wish I could. What one means by a carcinogen is 18 any agent which will cause cancer in any animal if that animal 19 is exposed to it in any conditions the experimenter likes to 20 think. An agent capable of causing cancer in some circumstances. 21 Q Is vinyl chloride a carcinogen? 22 A Yes. 23 Q What is a human carcinogen? 24 A A human carcinogen is a carcinogen shown to.cause cancer 25 in humans. Tannyaon & Company - Conn Reporter, London, England 01144-12424164 URL 11627 89 1 Q 1b vinyl chloride a human carcinogen? 2 A Yea. 3 Q What Is a mutagen? * 4 A That la very much more difficult to define because it 5 has a very vide connotation of meanings given to it by different 6 workers. Essentially, It la something which damages the DNA in 7 a cell, causes the DMA which is the material that holds, all the 8 codes as to how that cell Is to operate, which causes that DNA 9 to be altered in some say. 10 Q Is vinyl chloride a mutagen? 11 A Yes. 12 Q Is it your understanding that prior to the 1970 work 13 of Professor Viola, there were a large numberof studies done 14 concerning the acute, the sub-acute and the chronic health effectjs 15 on humans of over exposure to vinyl chloride? 16 A Yes. I 17 I Q Could you outline for us some of the scute, the sub- < 18 acute and chronic effects of exposure to vinyl chloride that were 19 reported prior to 1970? 20 A The first effect, of course, is just unconsciousness, 21 if it is a sufficiently high dose of the gas, but once the con 22 centration to which individuals are exposed is kept down to 23 lover levels, then it is found that chronic exposure at these 24 lover levels would cause some damage to the liver, they would 25 cause damage to the terminal phalanges, the bones in the fingers. Tennyson & Company - Court Reporters London, England 01144*12424164 URL 11628 90 1 1 forgettta technical tern aciD-ostiolytiB. AIbo that it voultj 2 have 9omteffect on the circulatory ayaten, producing symptoms 3 that areteown medically as Raynaud phenomena. Those are the :* 4 principal effects 1 can recall* 5 Q Id you recall whether or not much of the work done .intc 6 the healtl effects of exposure to vinyl chloride prior to 1970 7 was done la the Eastern European nations? 8 A I know of one report from the Soviet Union, but no, 9 1 am afraid 1 cannot answer that. 10 L BUNDA: I am going to interpose an objection that 11 the cross examination is going beyond the scope of the 12 direct examination. 13 BY MR DELU BOVI s 14 Q feve you looked Into the history of the medical and 15 scientific articles dealing with the toxicity of vinyl chloride 16 as part of your assignment for the CMA? j 17 A Only levels below those which produce the so-called | 18 vinyl chloride syndrome which I did not think was necessary for 19 me to investigate because that was well established and as far 20 as I knew was ' agreed by everybody and not controversial but 21 I certainly looked to Bee if there were any other long teTm effects 22 on individuals which would show up in mortality rates from 23 diseases other than cancer. 24 Q Is it your understanding that evidence of the carcino25 gencity of vinyl chloride was first reported by Professor Viola Tennyson & Company Court Reporters London, England 01144*12424164 URL 11629 9Tl 1 in 1970? -- 2 A Yes. 3 MR BUNDA: 1 would like to interpose continuing 4 objection on the basis the cross examination is going beyonc 3 the scope of direct examination. 6 BY MR BELLI B0V1: 7 Q I would like to hand you, doctor, a aeries of medical 8 journal articles and have you Identify them for me, if you would. 9 Can we go off the record for just a second while I find them. 10 Never mind, 1 have them. 11 MR BUNDA: 1 would like to go off the record for a 12 second. 13 (Whereupon there followed a discussion off the record) 14 MR BUNDA: I am also going to object to the introductiojn 15 of these exhibits or the shoving the witness these exhibits 16 in their present form since they have stickers all over them; 17 and I think that that is prejudicial. If you have any clean | 18 copies I have no objection to the doctor being questioned 19 about those. 20 MR DELLI BOVI: I have no clean copies. 21 MR BUNDA: Then I object. 22 BY MR DELLI BOVI: 23 Q Doctor, I show you Exhibit 5. You can feel free to 24 ignore all stickers on there other than those that refer to your 25 testimony. (Document handed to the witness) r Tannyson & Company - Court Reporters London. England 01144-12424164 t 92 1 MR BTJNDA: Objection, I move to strike. ~ 2 BY WR DELLI BOVI: 3 .Q Have you seen that document before in that form or any 4 other form? 5 A Yes, 1 believe this is one of the documents I vas , 6 provided when I vas asked if 1 would give evidence in this case. 7 1 had not seen it before then. 8 Q The first time you saw Dr Viola's 1970 publication in 9 the Italian medical journal vas in 1985? 10 A No, I said 1988, just a week or so ago. I had not 11 thought it necessary to look for this article as 1 knew, of 12 course. Dr Viola's publication of 1971 and it seemed to me that 13 subsumed the earlier evidence and 1 did not think it necessary 14 to go to the preliminary report in 1970. 15 Q Well, Dr Doll, you had to have seen that document prior 16 to 1988. 17 A Did 1? Yes. 18 MR BUNDA: Objection. Argumentative. i i 19 BY MR DELLI BOVI: 20 Q Is it your testimony you first saw that article this 21 year? 22 A I am confused slightly. I think there is an article 23 by Viola of 1971. 24 Q That Is correct, in Cancer Research. 25 A As far as I can recall I have only read Viola's article URL 11630 Tannyaon & Company - Court Reporters London. England 01144-72424164 URL 11631 93 1 of 1971 before this last few weeks. 1 saw no reason for looking 2 up Violafs article of 1970 and I am not aware of having seen it 3 before. 4 % MR BUNDAs I am also going to Interpose an objection 6 on the basis there has been no other occasion that that* 6 document is in the form in which it appeared in the Italian 7 journals. My understanding is that it Is a translation and B on that basis I believe the questions are improper because 9 they infer that that is a copy of the form in which the 10 articles were published and I think that is not borne out 11 by the facts. So I do not have to continue to object, I 12 believe there will be a second article following the 13 objections which I made with regard to the stickers and vitt 14 regard to the fact it is a translation, also applies to that 15 article, also authored by Dr Viola. 16 BY MR DELLI BOVI: I 17 I Q 1 would like to refer you to an article you co- authoredt 18 in 1985. Would you take a look at that and indicate whether your 19 first reference in that 1985 work was to Dr Viola's 1970 publi 20 cation, in the medical journal article. (Document handed to the 21 witness) 22 A Yes, it was. 23 Q So, you were aware as early as 1985 of Dr Viola's 1970 24 publication? 25 A Oh, I have been aware of it earlier than that but as Tannyaon a Company * Court Rtportars London. England 0114412424164 UHL 11632 ---------------------------------------------------------------------------------------------------------------------------- ----------------------- 1 I said, I did not regard it as necessary to read it, as-'Or Viola 2 published a paper in 1971 which was the definitive results of 3 his study end I based ell my conclusions on Viola's 1971 paper. 4 This was e paper Jointly by nyself end three other colleagues 5 end they doubtless thought if you ere referring to Viola it was 6 only reasonable to give the first reference to Viola, but the 7 one that 1 read end studied is the 1971 one. 8 Q When were you first aware whether or not you read of 9 the findings reported by Dr Viola in 1970? 10 A I cannot recall that I was aware of them reported in 11 1970. I was aware of them reported in 1971 - - oh, I suppose 12 in 1975. When did I first start getting interested in vinyl 13 chloride? When 1 gave a paper, joined in a discussion at the 14 New York Academy of Sciences which must have been in the mid 1970|st 15 I cannot remember the exact year, but 1 would say 1974 or 1975 16 I was aware of the 1971 paper. 17 Q What about the 1970 paper? 18 A It must have -- it was drawn to my attention when I 19 read the 1971 paper because there was the reference presumably 20 in it but 1 cannot recall having seen it until this last week 21 or two. 22 Q Would you take a look at Professor Viola's 1971 document 23 and see if there is in fact any reference to his 1971 publication 24 (Document handed to the witness) 25 A No, there is a reference to his 1969 one, which I had Ttnnyton & Company - Court Reporters London. England 011441 2424164 95 1 heard of* of course. 2 Q Have you ever reviewed that publication, sir? 3 A No* because I have worked with Maiton! who continued % 4 his work end Maltoni told me all about the work and I had* 5 therefore* known about this work* Viola's since the middle 1970s, 6 Q Do you know whether Dr Viola In his 1969 presentation 7 at the International Cancer'Congress in Tokyo discussed the 6 subject of carcinogenicity of vinyl chloride? 9 A I cannot answer that with certainty. My belief is that 10 he reported it in 1969. That is my understanding but I could 11 not be held to that. 12 Q Whether or not it was reported in 1969* certainly by 13 1970 Dr Viola had authored a publication in one of the Italian 14 medical journal articles* dealing with the carcinogenicity of 15 vinyl chloride in animals? 16 A I dare say. i i 17 Q You, however, were not aware of either his 1969 or his I IB 1970 publication until some years later? 19 A I was not aware of it until after the occurrence of 20 the two or three cases of angiosarcoma in the Goodyear works 21 in the early 1970s. 22 Q If the Goodyear angiosarcoma deaths were announced in 23 1974* then you would not have been aware of Dr Viola's 1970 paper 24 until that time? 25 A That is right, yes. URL 11633 Tannyaon & Company - Court Reporters London, England 01144.12424164 URL 11634 96 1 Q Is Cancer Research a European publication? 2 A No. 3 Q Where Is that published? 4 A The United States. 5 Q Are you aware of any evidence of an effort by the 6 polyvinyl chloride industry in the United States to hide 7 Or Viola's 1970 publication front Its customers, from the United 8 States government and from the general public? 9 A No. 1 10 Q Would you regard such an effort, if it occurred, as 11 evidencing a lack of corporate responsibility on the part of 12 vinyl chloride and polyvinyl chloride manufacturers -- 13 MR BUNDA: Objection. Dr Doll, wait a second, let me 14 Interpose an objection on the basis it is speculative and 15 is not based on any facts which are properly in evidence. 16 You can go ahead and answer the question if you recall what 17 it is. 18 BY THE WITNESS: 19 A No, it is too hypothetical for me to give any answer 20 to. 21 BY MR DELLI BOVI: 22 Q Then, Dr Doll, I would like to make the question some 23 what more concrete. Would you look at Plaintiffs' Exhibit Doll 24 6, please and tell me whether you have seen this document or 25 reviewed this document before? (Document handed to the witness) Tannyaon & Company Court Raportars London, England 01144-12424164 URL 11635 97 1 MR BUNDA: Again, I an interposing an objection on the 2 basis it goes beyond the scope of the cross examination and 3 further more, it is irrelevant. 4 BY THE WITNESS; 5 A I an very happy to anaver it because I have never seen 6 it before. 7 BY MR BELLI BOVI: 8 Q 1 would like you also to take a look and tell me vhethc r 9 you have seen, prior to today. Plaintiffs' Exhibit 7 which is 10 entitled: "Cancerogenic Effect of Vinyl Chloride, P.L.Viola 11 (Regina Elene Institute for Cancer Research) Rone, Italy, 12 presented at the Tenth International Cancer Congress, Houston, 13 Texas. May 22-29, 1970". 14 MR BUNDA: Can I see that please? (Document handed 15 to counsel) Again I an going to interpose an objection on 16 the basis that this document contains multiple stickers and I 17 i is prejudicial in Its 'presentation. Furthermore, it appears 18 to be a summary and it is difficult to determine where it 19 comes from. So, I object on the basis of authenticity as 20 well. 21 BY MR DELLI BOVI: 22 Q Have you seen Plaintiffs' Exhibit 7 before today? 23 (Document handed to the witness) 24 A Well, I find that difficult 'to answer because I attende d 25 this conference , in fact I gave the opening lecture 'at it and Tennyson A Company Court Reporters London. England 01144-12424164 98 1 it is possible this is a photocopy of an abstract* in vhTch case 2 I night have seen it* but I cannot recall having seen it and my 3 interest in vinyl chloride as a carcinogen only arose In 1974 a 4 or so when' I heard about the angiosarcoma cases* so Whether 1 6 sav it or not I do not know. It is possible X did* but it 6 certainly nade no inpact on ne if I saw it. 7 Q You Indicated earlier that you had not seen Plaintiffs 8 Exhibit Doll 6 before. Is that correct? (Document handed to 9 the witness) 10 A I indicated that. I would like to read it again just 11 to make quite sure that 1 am not misleading you. (Pause) No, 12 1 am not aware of ever having seen that before. 13 Q You were a professor of epidemiology at Oxford College 14 1970, 1971, 1972, 1973 and during those years you had not seen 15 Dr Viola's 1970 article. It had not come to your attention 16 during those years? j 17 A I was actaully a professor of clinical medicine techni^ i 16 cally but my research was all in the field of epidemiology. I 19 was au fait as I taught with the cancer research work throughout 20 the world. 1 discussed nany carcinogens with many cancer researcjh 21 workers and I can never recall anybody mentioning vinyl chloride 22 as a carcinogen at all until after the angiosarcoma cases occurre{d 23 in the Goodyear works. 24 Q In 1974? 25 A In 1974, yes. I certainly would not claim to have been 1)636 Tennyson A Company * Court Reporters London, England 01144-12424164 URL 11637 99 ;i 1 completely up to date end obviously I vss not, but there^were 5 2 a lot of things going on and certainly in the cancer research 3 world generally, vinyl chloride was not being discussed as a * 4 potential hazard. 5 Q Please do not infer from my question that I am finding 6 any fault at all In that fact but the fact is that you were an i 7 expert in epidemiology in the early 1970a and prior to 1974 none 8 of Dr Viola's work or Dr Maltoni's work had come to your attentic n? 9 A That is true, yes. Of course, there were many, many 10 animal carcinogens which had not been drawn to my attention at n the same time. 12 Q Do you feel. Dr Doll, as a physician, that.when a man 13 ufacturer of a product learns of studies that indicate a potentit 1 14 cancerogenic problem with that product, that they have a duty 15 to disclose that Information to their workers and to their 16 customers? 17 MR BUNDA: Objection. I am going to interpose an 18 objection on the basis it is speculative, it is a vague 19 question, it improperly states the facts of the situation 20 and further more, 1b Irrelevant to this particular case. 21 BY THE WITNESS: 22 A My answer to the question would be I cannot give an 23 answer to it because it depends upon the situation. I am very 24 much opposed to frightening people unnecessarily. If you asked 25 me whether on the basis of such findings, inquiries should be Tannyaon & Company - Court Reporters London, England 01144-12424164 100 1 i&ade as to whether there were any hazards to humans. butr~l would 2 aay unhesitatingly yes. but the question of disclosure is always 3 a very difficult one. There are so many things which can cause 4 cancer In certain circumstances, and one has to. as a research 5 worker, use your judgment as to what is proper information and 6 what is scaremongerlng and 1 would not feel that I could pass 7 judgment on actions taken many years ago on the basis of a 8 totality of evidence of which 1 am not wholly aware. 9 BY MR BELLI BOVI: 10 Q Do you regard Dr Maltoni's 1970 and 1971 publications 11 which has been marked as Doll Exhibits 5.7 and which I will mark 12 as Doll Exhihit 8----- 13 MR BUNDA: Hang on. Did you miss-state yourself. You 14 mentioned Dr Maltoni. Did you mean Dr Viola? 15 MR DELLI BOVI: Dr Viola. 16 MR BUNDA: What is the exhibit number? 17 MR DELLI BOVI: 5, 7 and 8. 1 t 18 MR BUNDA: Again 1 object to the numerocity of the 19 exhibit numbers. 20 BY MR DELLI BOVI: 21 Q Do you regard those documents. Dr Doll, as documents 22 calling into serious question the carcinogeiiclty of vinyl chloride. 23 (Documents handed to the witness) 24 A 1 regard the one in 1971 in Cancer Research .as so doing. 25 The others 1 regard as preliminary reports and 1 think one would URL 11638 Tannyaon & Company * Court Raportars London. England 01144-12424164 101 1 be unwise to drew any conclusions, any Important conclusions fron 2 them but the peper in 1971 by Viola, Bigotti and Caputo is 3 certainly an Important paper to which attention should be paid. * * 4 Q Is your understanding that Or Viola, at the time he 5 authored these papers, was employed by one of the European PVC 6 manufacturers? 7 A I have no idea who he was employed by. 1 know 8 Or Maltoni personally but I do not know Dr Viola, I have never 9 met him. 10 Q You indicate in your 1965 publication: "The idea that 11 vinyl chloride might cause cancer was first suggested by Viola 12 in 1970 as a result of experiments in rats". Correct? 13 A Yes, I said that but clearly it is wrong because he 14 reported it in 1969, verbally, did he not, at the Houston 15 conference. 16 MR BUNDA: I am going to object and move to strike. 17 I think the Houston conference is 1970. 18 THE WITNESS: Ah, 1970. 19 BY MR DELLI BOVI: 20 Q Tokyo was 1969? 21 A 1966. 1 do not know what conference that was. The 22 cancer conference was Tokyo, 1966. 23 Q The 16th Congress on Occupational Health. 24 A Oh, I did not know anything about that conference. 25 Q You indicated earlier that you were not aware of any i < URL 11639 Tannyson & Company-Court Rapontra London. England 01144-12424164 102 1 efforts by any PVC manufacturers in the United States keep 2 the 1970 findings of Dr Viola from being published in the United 3 States? 4 A Yes. 5 Q Is it your belief. Dr Doll, that the PVC manufacturing 6 industry after the publications of Dr Viola In 1970 and 1971, 7 had an obligation to disclose Dr Viola's findings to their 6 employees and to their customers? 9 MR BUNDA: Objection, I think It calls for speculation, 10 it is a vague question, it is over broad and it is irrelevar t 11 to this case and mischaracterises the information which is 12 in evidence and the status of the situation which existed 13 in 1970. 14 BY THE WITNESS: 15 A I do not think I could give an answer about what 16 happened at that time. I was not aware of what was going oh and 17 it would be too speculative. IB BY MR DELLI BOVI: i 19 Q Dr Doll, 1 am not asking you to tell me or to tell this 20 jury what happened. What I am asking you as a physician specia 21 lising in epidemiology, whether, based on the 1970 and 1971 22 studies of Viola, the PVC industry had a duty to disclose those 23 findings to its customers and to its employees? 24 A I cannot answer that question because I am a scientist, 25 not a politician and I spend my time trying to decide what data URL 11MO Tennyson & Company Court Reporters London, Englend 01144-12424164 ltr9lnan io: 1 neans. I do not tell people what they should do and I-nnot 2 express an opinion on what people should have done or what people 3 should do now. It is not ny line. 4 Q You do not* in your capacity here st Oxford* advise 5 industry or the Government on whether they should or should not 6 disclose particular epidemiological data? 7 A No* I do not think so. 1 am trying to think If 1 do. 8 1 just publish my results in the scientific press end I think 9 that is the responsibility of the scientist. Then* ,`otheT people 10 have to decide what they do about it. I remember when we first 11 discovered that smoking caused cancer of the lung* we were always 12 being asked what the Government should be doing about it and we 13 said: "That is nothing to do with us." It took them seven years 14 to tell the public that smoking caused cancer of the lung and 15 1 did not express an opinion on that. 16 Q Did you feel, based upon the initial results of your 17 studies, that the public had a right to know what you found out? i 18 A I do not feel things - - well, that is not true, I 19 obviously do as a human being* but I try not to feel anything 20 on a scientific matter as that can prejudice my scientific judg 21 ment as to what the cause of disease is. I try to keep quite 22 separate from that field. I try to do work to find out what 23 causes disease, publish it openly and then it is for others to 24 decide what should be done* not for me. 25 Q I would like to read you an excerpt from Plaintiffs' Tannyaon & Company - Court Reporters London, England 01144-12424164 104 1 Doll Exhibit 6. I am going to xepresent/^8u that this was an 2 internal memorandum prepared by R.N. Field of Union Carbide, as 3 the result o* f a meeting of the Occupational Health Committee of 4 the Manufacturing Chemists Associations. The date of the memor 5 andum Is November 23, 1971. "Publishing of Dr Viola's work in 6 the United States could lead to serious problems With regard to 7 the vinyl chloride monomer and Tesln industry. These are as 8 follows:- 1) The Delaney amendment bans the use of any material 9 in food that can cause cancer. 2) A law exists in Pennsylvania 10 banning carcinogens from the air i.e. the allowable threshold 11 limit is zero. 3) The present political climate in the United 12 States is such that a campaign by Mr R. Nathan and others could 13 force an Industrial upheaval, via new laws for strict interpre 14 tation of the pollution and occupational health laws." Did the 15 CMA, when they furnished you with materials for you to review 16 in connection with your 1988 review in the Scandinavian medical 17 journal, ever furnish you with a copy of that memorandum, sir? 18 A No. 19 Q Are you aware of any efforts by the polyvinyl chloride 20 Industry between 1970 and 1974 to make publicly known or to make 21 known to their customers or to make known to their employees, 22 the findings of Dr Viola? 23 A No. 24 Q Are you aware of any efforts by the polyvinyl chloride 25 industry in the United States between 1970 and 1974 to conduct URL 1164 nj Tannyaon a Company - Court Raponars London, England 01144-12424164 URL 11643 ---------- -------------------------------------------------------------------------------------------------------------------------------- --------------------- HJ3- 1 epidemiological research of PVC fabrication employees, foTTowing 2 the findings of Dr Viola. 3 MR BUNDA: I am going to interpose an objection to the 4 whole' line of questioning as 1 have done before, on the 5 basis that it Is irrelevant. I am also going to object on 6 the basis that there is no foundation having been laid that 7 this witness has any knowledge about this area of inquiry 8 at all and I move to strike the whole line of questioning. 9 BY THE WITNESS: 10 A I can answer it very simply, I do not know anything 11 between 1970 and 1988, I am just not aware of what the American 12 industry has been doing apart from what is published. 13 BY MR DELLI BOVI: 14 Q Dr Doll, you presented a discussion paper to the New 15 York Academy of Sciences in 1975, did you not, at a conference 16 specifically held to discuss the cardnogertcity of vinyl chloride? 17 A Yes. I think my paper was a summing up, was it not. 18 A conclusion to the discussions. 19 Q I am going to hand you what I will mark as Plaintiffs' 20 Exhibit Doll 8. Could you identify that document, please, sir? 21 (Document handed to the witness) 22 A Yes. This is a report of my discussion and my contri 23 bution to the discussion. 24 Q That was at a conference discussing the carcinogenicity 25 Of vinyl chloride approximately a year after the public ahnounce- Tartnyton & Company - Court Raporttrt London, England 01144-12424164 la 1 ment of the Goodrich angiosarcoma deaths? ---- 2 A I cannot remember the whole discussion. Certainly 3 vinyl chloride was part of it but 1 do not remember whether 4 there were* other things discussed or not* 1 have a very poor 6 memory of the discussions. 1 only remember that in the report 6 of it I was made to say something which 1 did not say but that 7 is another matter. 8 Q Sure, and that particular point had nothing to do with 9 vinyl chloride? 10 A Mot that point, no. 11 Q In fact, that point is corrected in that exhibit? 12 A Yes. 13 Q That exhibit reflected your presentation in 1975 and 14 does so accurately? 15 A Yes. 16 Q Is it your opinion that for any human carcinogen, in- 17 eluding vinyl chloride, there is a safe level of exposure at i ! 18 which no potential carcinogenic effects will occur? i 19 A That is something I wish I could answer. I really have 20 not got an opinion on that. In cancer research we work on the 21 assumption that unless there are strong reasons otherwise, we 22 postulate that an effect is produced proportional to dose down 23 to vanishingly small levels but whether this is so or not is a 24 matter of great debate and which we really have no firm scientifi: 25 evidence one way or another. We act oh the assumption in' the URL 11644 Tannyaon & Company Court Raportars London, England Ot 144-12424164 107 1 same way as we are acting on the assumption now that other people's 2 tobacco smoke in a room will cause a risk to the peqrple who are 3 not smoking,* but the scientific proof that this Is *o is such 4 that 1 really have not got an opinion. What I have is a working 6 rule, but not an opinion. 6 Q What is your working rule? 7 A The working rule is to assume that there is an effect 8 proportional to dose down to vanishingly low levels, given that 9 the material is a mutagen. If it is not a mutagen, then my 10 working rule would be that is probably not the case and there 11 would be a threshold below which it had no effect. 12 Q Vinyl chloride is a mutagen? 13 A Yes. 14 Q Therefore, your working rule is what? 15 A My working rule is that you would assume there was an 16 effect proportional to dose down to vanishingly small levels. 17 A vanishingly small effect but an effect. 18 Q A vanishingly small effect with regard to the general 19 population, exposed, but a very--20 A Yes. 21 Q But a very real effect for that person who develops_ 22 the cancer? 23 MR BUNDA: Objection, calls for speculation. You can 24 go ahead and answer. 25 URL 1164' *.n Tonnyson & Company Court Reporters London, England 01144-12424164 ; ToT1, 1 BY THE WITNESS: -- 2 A Yes, this Is true, but I believe society has to accept 3 that there is such a thing as a negligible risk, otherwise * 4 society is not possible to run, it becomes socially impracticable 6 Q Let us have a look at vinyl chloride in this concept 6 of no safe level. You are aware, are you not - - let me back' 7 up one step. There are many types of cancer? 8 A Yes. 9 Q One of which is angiosarcoma of the liver? 10 A Yes. 11 Q Angiosarcoma of the liver is an exceedingly rare cancel? 12 A Yes. 13 Q And occurs approximately to one person out of every 14 10m or 20m? 15 A Approximately once to every 10m each year. That is, 16 once to every 10m in a population in a year, yes. 17 Q You are aware of studies, are you not, postulating 1 i IB increased risk of cancer from vinyl chloride at exposure levels 19 in the parts per billion? 20 A No. Oh, I am aware of some evidence that there may 21 have been some cases produced in the surroundings of some 22 factories in New York State where the concentrations to which 23 people were exposed were of the order of parts per billion. 24 Whether they really did cause cancer or not is difficult to say. 25 What I have said and my policy in Interpreting such &ata and. URL 11646 T#nny*on & Company - Court Aaportara London. England 01144-12424164 T 1091 1 of course, this Is coning up at the present noment in regard to 2 clusters of leukaemia in regard to nuclear installations * first 3 of all you have to decide is there a greater instance of this 4 particular fype of cancer In that neighbourhood. If you cone 6 to the conclusion there is a greater one than it would be 6 reasonable to expect, you then have to Bay, well, what could it 7 be due to and it is very easy to Jump to a conclusion that it 6 Is due to a particular factory or a particular anount of waste 9 that is being released, environmental pollution, just on the 10 grounds that that naterial is known at high dose levels to 11 cause some cancer. But, to conclude that the two are connected, 12 you have to have some evidence that the amounts to which the 13 people are exposed might reasonably be thought to produce the 14 effect that is observed, otherwise you may be blinding yourself 15 to some other causes and I can only conclude that the effect is 16 due to the postulated pollutant if one can decide on the basis 17 I of the totality of the evidence available that the sort of hazard i 18 observed is of the order of magnitude of the sort of hazard that 19 might be anticipated, so that the situation, the problem in each 20 case is a difficult one which needs a lot of evidence. I left 21 it open in relation to vinyl chloride and the vinyl chloride 22 producing plants because we have not yet got sufficiently clear 23 evidence of the dose to which people are exposed that have 24 produced the measured risk we have been able to measure in the 25 industry concerned. ? URL 11647 Tannyaon ft Company - Court Reporters London, England 01144*12424164 TTo"l 1 Q It is your opinion, however, that vinyl chloride as a 2 carcinogen and as a mutagen la capable of producingTcancers at 3 exposure levels in the parts per billion? r 4 A 'No, I would not express it as my opinion. I would 5 express it saying it la my belief we have to consider that as 6 a possibility. 7 (Whereupon there followed a short adjournment) 8 BY HR DELLI BOVI: 9 Q Dr Doll, are you aware of any human carcinogens that 10 Hermon Dendinger or Fred Wallace were exposed to at Chrysler 11 other than vinyl chloride? 12 A I am not sure. Was not one of them exposed to ethylene 13 dioxide? I am not sure. X have not looked into it. 14 Q Have any of the polyvinyl chloride manufacturers that 15 are Defendantsin this case presented you with any evidence in 16 dicating Mr Dendinger or Mr Wallace were exposed to any other 17 human carcinogen? 18 A 1 should need to refresh my memory, to look at the 1 i i l 19 papers I have had. 20 Q You indicated in your 1975 presentation to the New 21 York Academy of Sciences: "Cancer Is a process in which several 22 factors are likely to participate. A particular chemical carcin 23 ogen is only one factor which interacts with a number of others 24 -that may depend on the environment or on the functional state 25 of the body, and a simple linear relationship with one factor SHunan Tonnyaon & Company Court Rtponars London. England 01144-12424164 111 1 'nay be seen in all aorta of complex situations." Do you agree 2 with that statement' today? r 3 A Ye* s and no. I would not put it quite in that form 4 today. At- that time 1 wrote that I was fairly confident in my 5 own mind that there was a real effect creating a risk of cancer 6 down to vanishingly low levels. In the past twelve or thirteen 7 years 1 have learnt more about the repair mechanisms of the cell 8 and I would be more open minded now as to whether that actually 9 was the position or not. I would still say that that is a 10 possibility but I will be much more open minded to the possibilii 11 that the human body was capable of dealing with very small 12 amounts of carcinogen and thereby repairing the damage done than 13 I was in 1975. 14 Q By the time you made that presentation in 1975, dozens 15 of workers exposed to vinyl chloride had already died of angio- 16 sarcoma of the liver? 17 A 1 do not think that is quite true, is it. 1 would 1 18 have thought it was under 20 by 1975, but we have the register 19 of cases. That will tell us how many there were. How many were 20 there? 21 Q There were 23 by the end of 1974 and I do not think 22 we can tell from the way the data is presented how many there 23 were in 1975. 24 A That is what I said. Mot dozens but of the.order of 25 20 is 1 think what 1 said. i Tannyson & Company - Court Raportars London, England 0114412424164 ;9U'W ' 112 1 Q At your presentation in 1975 you were critical were 2 you not, of the polyvinyl chloride industry's lack <>f monitoring 3 Its work force over years prior to 1975? 't 4 A Yes, I had been critical of many industries at their 5 failure to maintain on-going studies or cohort studies of their 6 work as I had been teaching this for the last thirty years. 7 Whether the Industry was in fact, had In fact started one then, 8 I do not know* The Tabershaw and Gaffey study, when that was 9 first commissioned, 1 cannot remember now, but it was certainly 10 my view at that time that the industry ought to be organising 11 a cohort study of its workers. 12 Q By 1968 or 1969, when Herman Dendinger first came to 13 work at Chrysler, there had already been within the industry 14 9 angiosarcoma deaths? 15 A That certainly was not known at that time. 16 Q But was that not precisely the point you were making, . 17 that if the industry had done these cohort studies and follow j 18 ups of their workers, that they may well have discovered years ( 19 prior to 1974, the carcinogeiicity in humans of vinyl chloride? 20 A That was a criticism I made of industries throughout 21 the world, not specifically of the vinyl chloride industry. 22 Their behaviour was no different from all industries in all 23 major countries. Some industries do no cohort studies at all. 24 In the Soviet Union they do not do any at all and 1 have been 25 nagging them for years that they should. \ Tonnycon & Company - Court Reporter, London. England 01144*12424164 URL 11651 113 1 Q Let me read a email excerpt from your 1975 presentation 2 and afterwards my question will be if you still subscribe to 3 this statement today. *'1 should like to re-emphasise a point 4 that has already been made several times in this conference; 5 that is, the one made by Dr Schweitzer when he said that all 6 responsible industries - certainly all those that are large 7 enough to employ a doctor - should maintain an on-going perspec 8 tive study of the health of their working force. That does not 9 mean keeping an eye on them while at work only; it means keeping 10 an eye on them when they leave if they have been employed in 11 the industry for (say) five or more years. Professor Schilling 12 and many other people have been urging this for a long time. 13 How we can have a situation in which a new risk is discovered 14 in a major industry and then have to set up a prospective study 15 to find out what is actually happening to process workers is 16 Incomprehensible to me.11 j 17 I A Yes, 2 have been teaching that since the middle 1950s.j 18 Q You referred in your direct examinaiton to an article j 19 - - maybe you did not. One you wrote in 1986 called: "Cancer 20 - a preventable disease" and that was a presentation that you 21 made to the Royal Society of Medicine ? 22 A Yes. 23 Q I would like to read to you from page 20 of your 24 -presentation in 1986 that dealt with animal studies.* .My questior 25 will be the same as it was with the last paper, that is whether Tennyton ft Company Court ftaponarg London, England 01144-12424164 UfiL 11652 114 1 you subscribe to that statement today. "Animals, howeVlY, vary 2 greatly In the way they absorb, metabollise and respond to 3 different chemicals and there are no observational data to a 4 Justify such an assumption. That is not to say that we should 6 ignore the results of laboratory tests in small rows, as there 6 are sufficient grounds for believing that agents that cause 7 cancer in one animal are quite likely to do so in others and it 8 would be criminal to allow anyone to be exposed unnecessarily 9 to a new chemical that was found to be a powerful carcinogen 10 in several animal species Just because there was no human 11 evidence." 12 A Yes. 13 Q With respect to the cancer sustained by Fred Wallace, 14 the mucoepidermoid cancer, you indicated that you did not believe 15 that vinyl chloride was the source of that cancer because such 16 cancers had not been produced in animal experiments? J 17 . A Yes and not in humans, in the human population or ! 18 animal experiments . 19 Q Those were two different grounds for your opinion? 20 A Yes. 21 Q And you have reviewed the pathology report for 22 Mr Wallace to know what cancer he died from? 23 A Yes. 24 Q I would like to refer you to Dr Viola's 197J paper and 25 the summary which reads in part: "The cutaneous tutrtours which Tannyaon S Company Court Reporters London. England 01144-12424164 115 1 "always appeared/^Se area in which submaxillary and parotid 2 glands are located,' have been histologically recognised as 3 epidermoid ca* rcinomas, papillomas, and mucoepidermoid carcinomas 4 A Yes. 5 Q At page 518 of his 1971 article. Dr Viola states, does 6 he noti "A few tumours showed little nests of isolated pale 7 cells of three types: mucin-producing cells (originating from 8 the duct epithelium of sweat glands or salivary glands); squa 9 mous cells; and intermediate cells with minor tendencies to 10 wards differentiation." 11 A Yes. 12 Q Was it your understanding that Mr Wallace died of a 13 poorly differentiated squamous cell, mucoepidermoid carcinoma----- 14 A Yes, that is of a different organ to the ones that IS Viola is describing. Viola's description has been discounted 16 since 1974, when it was appreciated that the tumours that Viola I 17 was describing were not tumours that had anything to do with the i 18 salivary glands at all but they were related to a zimbal gland 19 of rats which is a serpaceous gland and has no relationship what* 20 soever to a salivary gland. This is uniformally accepted by 21 every cancer research worker to whom I have spoken. At the time 22 Dr Viola made his first observations he was not very experienced 23 with the rat pathology and he attributed them incorrectly. His 24 error has been corrected ever since 1974 and it is not questioned 25 now. v i ES9U1H0 Tannyaon & Company - Court Raportars London, England 01144-12424164 116 1 Q Have you reviewed other scientific articles or cqse 2 studies associating'buccal cavity or cancers of the/pharynx with 3 exposure to vinyl chloride? r 4 A l liave read one article relating a cancer of the buccal 6 cavity to someone who chewed plastic. That is the only article 6 which I could think of which night be relevant to your question. 7 Q Did Tabershaw and Gaffey report an excess of buccal 8 cavity and cancers of the pharynx in 1974 MCA study? 9 A That is quite possible but 1 would not pay any 10 attention to that because 1 looked at their longer follow-up 11 when they had the more complete data that is preliminary data 12 and theiT final data do not show any excess tumours in that cate* 13 gory. There may be one excess compared to the expected, I can 14 not remember. 15 as compared to 13.5. 15 Q Have you referred or been furnished for your review 16 prior to today, with any portions of the hearings held by the 17 Occupational Health and Safety Administration in the United IB States relating to regulating vinyl chloride following public 19 announcement of the Goodrich cancer deaths in 1974? 20 A Frankly, Z find them too tedious to read and 1 never 21 read those hearings, I prefer to read the basic science on which 22 they are supposed to be based. 23 Q Do you know Mr Thomas Mancuso of the Pittsburgh School 24 of Public Health? 25 A Yes, I do. I w g irw n Tannyson & Company - Coun Reporters London. England 01144*12424164 117 1 Q Are you very familiar with work in areas of beryllium? 2 A Yes and several other areas. * 3 Q Do you regard him as an expert in the area: in which 4 he practises? B A Ho, I regard him as a very unreliable person. 6 Q I would like to refer you to a portion of Dr Mancuso's 7 testimony before the Occupational Health and Safety Administrati^ 8 and 1 would like to know after I read that extract whether or 9 not you agree with it. "Further, the skin tumours frequently 10 develop near the ear and submaxillary or the same areas as the 11 salivary glands. It was postulated by the original investigator! 12 that vinyl chloride may enter the salivary gland system." Do 13 you have opinion on whether vinyl chloride or its active meta14 bollites, enter the salivary system in humans? 15 A I should be surprised if they do. 1 do not see why 16 they should go up against the saliver, but I do not know of any 17 results analysing the saliver in the salivary glands so I have IB not any positive evidence but it seems an unlikely thing. 19 Q "If this/4fibsequently confirmed, it raises the questior 20 whether tumours of the parotid glands can also occur as has been 21 demonstrated in the rubber industry and this has been confirmed 22 now by the testimony this morning that cancer of the parotid 23 gland has been observed in animals." 24 A Well, he is incorrect in talking about it &$ing observed 25 in animals. He is basing himself on the erroneous Report's of URL 11655 Tennyson a Company - Court Reporters London. England 01144-124241S4 URL 11656 118 1 Viola and 1 an not aware of any excess of cancer of the parotid 2 glands in the rubber industry. Certainly none of t$e very L 3 detailed studies thst have been carried out in thisrcountry in 4 the rubber *industry have shown any such effect. 5 Q How rare a cancer is a parotid gland carcinoma? 6 A I cannot give you a figure but it is a rare cancer. 7 Q There was a statistically significant increase in the 6 deaths for parotid gland cancers at the Chrysler plant in Ohio, 9 was there not. Dr Doll? * 10 MR BUNDA: Objection. 11 BY THE WITNESS: 12 A Not to my knowledge. Was there? I have seen no 13 evidence of that. 14 BY MR DELLI BOVI: 15 Q 16 ICDA8? How is a parotid gland cancer classified under the 17 A It is classified with the cancers of the buccal cavity) 18 and pharynx. j 19 Q Do you know whether a parotid gland carcinoma has its 20 own number? 21 A It has a sub-number, a fourth digit number. I think 22 it is separate from the submaxillary gland. It is a fourth digit 23 number I believe. 24 Q Are you aware of any attempts by Tabershaw- and Gaffey 25 or by any of the other scientific investigators, to break out Tennyaon & Company Court Reporters London. England 01144-12424164 URL 1165? 119 1 from the category of buccal cavity and cancers of the pharynx, 2 parotid gland cancers, so as to report those results* separately? 3 A No. r 4 Q You do not know then whether or not there nay, within 6 that group of buccal cavity and cancers of the pharynx, be an 6 excess of parotid gland carcinomas based on the form on which 7 the data has been presented to date? 8 A No. One can be sure it is not a big excess but you 9 cannot be sure that within that group there was not three or foui 10 cases. 11 Q And that brings me to the United States study that you 12 reviewed versus the United Kingdom study. In the United States 13 study, the organisation hired by the MCA only broke down the 14 number of cancers into about 33 categories? 15 A I do not know about only, it seems to me a very large 16 number. It was a very good effort to break them down to as many 17 as that. < i 18 Q Did not the United Kingdom study use 58 separate cancer 19 categories for reporting purposes? 20 A "No, they had 68 different causes of death but nothing 21 like so many cancers. I think there were probably less cancers 22 than in the American study but of the same order. 23 Q Did the United States study report an increase in the 24 total number of cancers among the polyvinyl chloride- workers 25 study? ? Tannyton & Company Court Reporters Condon, England 01144-12424164 UfIL 11658 120 1 A Total number of cancers you said? ___ 2 Q Yes. sir. f 3 A The answer is no - - sorry, the answer is eyes in 4 comparison With the United States. 383 against 343. 383 agaim t 5 341-73. I must correct that. 1 am sorry. That Is not what they 6 reported. That is the adjustment that I made. They reported 7 less than that. I Increased the amount to take account of the 8 deaths of unknown cause. I forget now precisely how many they 9 reported. It could only have been about 360. I should think. 10 What 1 did was to say, well they were not able to find out the 11 cause of death of about 7X of the men that died and whereas they 12 of course, included them in the total deaths when comparing the 13 total 1500 deaths against the expected 1700. they did not in 14 clude them in the individual causes and whether it is justifiable 15 or not to assume that the deaths for which they did not discover 16 a cause were evenly distributed, were equally distributed among 17 all causes in the same way as the deaths for which they did 18 discover a cause, is, of course, anybody's guess. What I did 19 was assume they were and add those deaths on so as to get a i ! i 20 worst possible place and that Is the figure that I published, 21 but it is not the figure that they reported. That may not be 22 clear. I would be very glad to elaborate on that if that is 23 a confusing point. 24 Q No, I understand what you are saying. Dr Doll. In 25 v terms of other cancers, did the United States study indicate a Tannyson & Company - Court Reporters London, England Ot 144-12424164 659 m a n 121 1 statistically aignlficant Increase? --* 2 A 1 do not think they did for any other cancers. 1 am 3 just refreshing my memory. Apart from the liver, of* course. 4 Q Would you look at pages 71 ----- & A Yes, the brain Is down here. Significant excess of 6 cancers of the brain. I am not suTe about lympho-reticulo 7 sarcoma. That might be significant. 8 Q On page 71 of your paper on other cancers, do you show 9 a statistically significant excess? 10 A Page 71 is not referring to the American study, is it? 11 You are talking about cancer of the lymphatic----- 12 Q No, I am referring to the other cancers, right-hand 13 column, page 71 about two-thirds of the way down? 14 A Ah, yes. Fine. This was the summation, not from the 15 American study, this was the summation of the four studies which 16 I regarded as providing the really important evidence, the main j 17 contribution of which came actually from the United Kingdom i 18 study. The American study did not show a significant excess of 19 this group of other and unspecified cancers. The four studies 20 added together does and as you will see in the report, I thought 21 the most likely explanation of this was the mis-diegnosis of a 22 few cases of angiosarcoma of the liveT which would have appeared 23 as secondary liver cancers. 24 Q Your studies showed an increase in the rate.of lung 25 cancer to those who wete heavily exposed? * Tannyaon A Company * Court Aaportert London, England 01144-12424164 UPL 11660 - It depends what you mean by "increased" - Notr, I thini, 1A 2 a significantly increased one. The lung cancer mortality as a 3 whole amongst the vinyl chloride exposed workers war almost 4 precisely what was expected on national data, though I think 5 national data are very hatardous to use in comparison with 6 observed deaths from lung cancer because the mortality rate does 7 vary so from one part of the country to another and 1 do prefer 8 to use regional rates but when you broke the lung cancers down 9 to groups of people employed for a longer period against shorter 10 period or observed more than twenty years after first employment 11 compared with those observed for shorter periods, sooner after 12 first employment, then you invariably got a higher mortality in 13 the groups that one might regard as the more likely to show an 14 excess, but the differences in total were not such as to lead 15 to a clear evidence of an excess from lung cancer but Just to 16 suggest that there might be such an excess. I 17 i Q Did the German and Swedish studies, were they consistenI t 18 with that? i 19 A No. I will have to refresh my memory. The German one 20 was not, if I remember rightly, but I will have to check. Where 21 are we now. No, the German one did not show an excess, that was 22 23} against 24} expected. The Norwegian and the Swedish ones 23 did, from tiny numbers, both added together, was 5 against 4} 24 - - 8 against 4} expected and the Italian did not shoy any, so 25 when you added the four studies together you got an ^observed of Tennyson & Company Court Reporters London, England 01144-12424164 123 1 31$ - the half cones in because of some of the adjustments the 2 Cermans made against an expected of 30.7, so I would' *ay the 3 aubsidiary atudies really supported the idea there was no excess e 4 from lung cancer but I do not think you should put too much 5 freight on the subsidiary studies. I regarded them as subsidiary 6 studies because so much of their period of observation were at 7 a time before any occupational cancer could be expected to occur 8 that is to say the first twenty years after observation and the 9 evidence from the studies is really scientifically trivial. The 10 only thing of any importance amongst them is that they did show 11 that angiosarcoma were occurring in all these plants. That is 12 the only thing I put my money on. 13 Q You say angiosarcomas occur in cases with nine years' 14 latency? 15 A Not angiosarcomas. One. 16 Q And you have seen angiosarcomas with exposures of less 17 than fifteen years? 18 A Yes much less than fifteen years. 19 (Whereupon there followed a short adjournment) 20 BY MR DELLI BOVI: 21 Q Dr Doll, if a chemical is found as a result of animal 22 studies to be a potential carcinogen, do you have an opinion as 23 to whether the manufacturer of a product that contains that 24 chemical has responsibility to disclose to its customers that 25 that chemical is in its product? \ Tennyson a Company Court Raportars London, England 01144-12424164 124 1 MR BUNDA: Objection. -- 2 BY THE WITNESS: f 3 A That is en impossible question to answer*c It depends 4 on circumstances too much. 5 BY MR DELLI BOVIt 6 Q Do you know whether or not any polyvinyl chloride 7 manufacturer in the United States prior to 1974 disclosed to its e customers that its product contained vinyl chloride? 9 A 1 know nothing about what the polyvinyl chloride man URL 1166 10 ufacturers disclosed to its customers in 1974 or 1988. I am not ii aware of their activities. 12 Q Dr Doll, are people in the United States continuing r-j 13 to die from cancers that they contract as a result of occupation*1 14 exposure to vinyl chloride? 15 A Oh, of course. 16 Q In terms of angiosarcoma deaths, how many have we -seen i 17 to date, reported cases? j 18 A Worldwide or in the United States? ^ 19 Q Worldwide. 20 A Worldwide, something of the order of 120. 21 Q Do you have an opinion or have you expressed an 22 opinion as to how many more angiosarcoma cases we are likely to 23 see as a result of occupational exposure to vinyl chloride? 24 A Yes. 25 Q What is your opinion, sir? :. v Ttnnyson & Company - Court Rtporters London, England 01144 12424164 125 1 A I said that I thought it night be something nf^the 2 order - I an speaking from memory - 250, but I night be out by 3 50. r 4 Q So your opinion then in terms of angiosareoma deaths* 6 is that ve have not yet reached the halfway point? 6 MR BUNDA: Objection. I am going to object again to 7 this questioning on the grounds that it exceeded the scope 8 of direct examination and also on the basis of relevancy. 9 THE WITNESS: Where does this put me in relation to 10 answering questions. We do not have a judge to say he n objects to the question or not. 12 MR DELLI BOVI: For the purposes of the questions, you 13 answer my question regardless of his objection----- 14 THE WITNESS: And subsequently? 15 MR DELLI BOVI: They decide if the question will stand 16 or not. i 17 THE WITNESS: Would you repeat the question? j 18 BY MR DELLI BOVI: 19 Q Certainly. In terms of the number of angiosarcoma 20 deaths that you would anticipate would result from occupational 21 exposure to vinyl chloride, we have not yet reached the halfway 22 point? 23 A I think that is probably true, yes. 24 Q If, in fact, vinyl chloride causes cancers: in humans 25 v other than angiosarcoma of the liver, there may in fact have been URL 11663 Tannyaon & Company Court Reporters London. England 01144-12424164 URL 11664 126 1 many more people who have died and will continue to die--as a 2 result of occupational exposure to that chemical, f 3 MRBUNDA: I am going to object again on the same 4 groundi as before and also because it calls for speculation 5 So that I will not be interrupting the tape constantly, 1 6 am going to have a continuing objection to this line of 7 question. 8 BY THE WITNESS: 9 A My estimate is there will be no such deaths occur in 10 the future. 11 BY MR BELLI BOVI: 12 Q On what do you base that opinion, doctor? 13 A I base that opinion on a mixture of animal evidence 14 and human evidence of what we have seen to date of people that 15 have been heavily exposed to vinyl chloride. 16 Q The studies that you have referred to in your review, 17 include only employees that worked in the PVC industry for one 18 year or more? <j 19 A Yes, 1 think that is true. I am just wondering, I 20 think some of the studies included people for shorter periods 21 but I tried to exclude them and I think I did in the principal 22 studies. 23 Q What is the reason for using a one year minimum exploy- 24 -ment period as opposed to say, three months? ?. 25 A It is a matter of practicality. There is s big turn- Tennyton & Company Court Reporters London, England 01144-12424164 127 1 over in many Industries and the turnover occurs in the early 2 period. By the time people have been employed for ** year they 3 ere likely to stay for a good deal longer and if you-have a 4 shorter period, a much shorter period, you are likely to under 5 estimate the effect that you will observe by including a lot of 6 people with very short periods of exposure. It is a matter for 7 arbitrary decision just which people you should include. Some 8 times people go so far as to Include only people who had five 9 years exposure. 1 have done that in some studies and it was 10 done in one of these vinyl chloride studies. Some people include 11 people that have had only one day's employment. I personally 12 think that Is a very unwise thing to do because you have a very 13 big turnover of short term employees who give you very little 14 details about the effects of short term exposure and make the 15 study very, very difficult to do because you are tracing very 16 mobile people. There is a third reason. People who change 17 their jobs very quickly are a very unrepresentative group on the * i 18 population and there are a number of studies recently that have 19 suggested as a group they have more accidents, more cirrhosis 20 of the liver, various diseases because of their personal charac 21 teristics. My general rule is to take a year as a practical 22 working rule. That avoids the big turnover of very short term 23 employees but does not reduce the size of the population too 24 much, but it is an arbitrary decision and I would go with other 25 people using other cut off periods. $ S9SU too Tannyaon & Company * Court Reporters London. England 01144-12424164 URL Mb'bb 128 1 Q Does the use of e substantial shorter cut of-#--period 2 in a minimum period, say, three months, for example/ have the 3 effect of diluting the potential effects from exposure to the * 4 chemical In question? 6 A That Is my belief although not all epidemiologists 6 vould take that view. 7 Q And you are aware that in this case. Dr Shindell's B study of the Chrysler employees used a three months minimum 9 employment duration rather than one year or more? 10 A Yes. 11 Q It is your opinion then that that would have the effec : 12 of diluting the effects from exposure? 13 A I would think it vould. 14 Q Let us take a look also at the cut off period for the 15 study. It is your opinion, of course, that occupational cancers 16 have a latency period? I 17 A Yes. [ 18 Q That is, that they take and may take many years betweet 19 the time of initial exposure before the cancer manifests itself? 20 A Yes. 21 Q Is it, therefore, important when you are doing an 22 epidemiologic study, to use a cut off date, a sufficient number 23 of years prior to the time you do your research in order for the 24 latent effects of exposure to the potential carcinogen or mutager 25 in issue to manifest themselves? v Tennyson & Compeny Court Reporters London, Enpisnd 01144-12424164 129 1 A You can do it that way, yes- I certainly think there 2 is not much point in including people that started to be employe^ 3 just in the last year or two. A better thing, of course, to do 4 is when yon present your results, to present them separately 5 for people that have been observed in the first five years of 6 their employment, five to nine years afterwards, ten to twenty 7 years afterwards at cetera. That is the best thing to do and, 6 of course, it is because of this that I have put so much more 9 stress on the four principal studies because they are all studie > 10 in which a very substantial number of observations were made on 11 people more than twenty years after their first exposure and 12 many of the other studies that I did not include, including 13 Dr Chiazze's study where they know nothing about the study of 14 exposure, time since first employment, these will all be effected. 15 They will all be affected by the high proportion with the short 16 time since first exposure. That is really equivalent of saying 17 they are not really relevant evidence. Occupational studies, 18 unless you have a type of cancer which appears very quickly as, 19 for example cancer of the bladder did following exposure to 20 najWhylamine, the evidence within the first ten years, even 21 within Che first fifteen years, the first employment does not 22 tell you much about cancer hazards. 23 Q Would you agree that the incorporation into an epidemi4~ 24 logic study of recently employed members of a cohort* also has 25 the effect of diluting the effects of exposure to the chemical Tannyaon & Company Court Rtpontrs London, England 01144-12424164 i^ m a n 130 1 in question? 2 A Yes, it certainly does though, of course,*a lot of 3 people will include then because they will have in mind continu 4 ing the study for longer end you already have then Included. 5 If you begin by excluding then, then in ten years' tine when you 6 want to do a follow-up, you suddenly find you have not got some 7 of the people you would like to have in, so most people, when 8 doing an epidemiologic study, do Include people who have been 9 employed relatively recently so that they have the material 10 prepared for a continuation study. 11 Q But in terms of the reporting of the analysis that 12 recently employed portion of the cohort would be separately 13 analysed? 14 A That is right. 15 Q Again, if we look at Dr Shindell's study, have you 16 learnt that he included in his study, individuals first employed1, 17 potentially as little as 90 days before the cut off period? j 18 A I cannot remember honestly whether he did that. 19 Q If he had done that, would that also have the effect 20 of diluting the effects of exposure to the chemical in question? 21 A Yes, but of course, it does not imply that he would 22 necessarily have observed a greater risk if he had cut them off 23 because I do not think from memory that he described exactly 24 the date of first employment of all the people, but `if he did, 25 then that is a bald point. t URL 11668 Tannyaen & Company Court Reportars London, England 01144-12424164 699 m a n 131 1 Q Have you ever attempted to analyse the fourteen cancer 2 deaths in the job categories in which Messrs Dendinger and 3 Wallace were employed, to determine the latency period? 4 A My understanding is that none of them are likely to 5 have had a long enough latent period to be of any interest, but 6 1 must check, 1 am not sure of the details of this study. 7 Q Incidentally Dr Doll, that binder of material you are 8 going through, could you tell me where that came from? 9 A Yes, this was provided for me by the attorneys for the 10 defence. 11 Q What does that binder consist of? 12 A It consists of 26 different sets of papers Including 13 most of the ones which you have discussed with me today. 14 Q Could I see it please? 15 A Yes. (Document handed to counsel) 16 Q Did you review all of the materials contained in this 17 binder? 18 A If by that do you mean have I read them before today, 19 yes. 20 Q And are the opinions that you have expressed today 21 based in part on your reliance on the materials contained in * 22 this binder? 23 A No. My opinions that I have expressed today are based 24 essentially on the review which I carried out and ha-5.been 25 published in April, but of course, to that I have had to add Tennyeon & CompanyCourt Reporters London, Englend 01144-12424164 URL 11670 132 1 the details about Mr Wallace and Mr Dendinger which 1 -knew 2 nothing about. 1 have refreshed my memory about the early papers 3 of Dr Viola and there are one or two new ones like the one of 4 Dr Shindel`1 you have talked about and there are some reports of 6 the industrial hygiene reports of the amount of vinyl chloride 6 detected, 1 think, by NI05H inspectors in the Chrysler plant, 7 but I need to refresh my memory as to who exactly made those 8 measurements. I think those are the principal new bits of 9 evidence that they drew to my attention. 10 Q One of the documents in that binder is the Molina 11 Swedish study from 1981? 12 A Yes. 13 Q Does that study report: "An elevated risk of morbidity 14 and mortality from tunours in the digestive organs"? 15 A Yes, if you remember, we discussed that before and I 16 included in my review and decided it was a paper that was too j 17 unreliable to mean anything. The digestive organs that it refers ! 18 to there, I think, I forget the exact number, but it does not 19 separate out - -no, I cannot comment on that without refreshing 20 my memory, but my view is that that paper is not really, cannot 21 really be regarded as evidence. There are too many weaknesses 22 in the paper. 23 Q Rendering your opinions with regard to the aetiology 24 of the cancers of Fred Wallace and Herman Dendingeror your 25 v opinions relating to the potential implication of vinyl chloride, Tannyaon & Company * Coun Reporters London. England 01144-12424164 W 9inan 133 1 did you rely at all upon the indexes or summaries of their 2 depositions that were provided to you and that you *ead? 3 A No, no. 1 would not feel able to do that^without 4 seeing the-entire thing. 5 Q You are aware of the 1964 article by Maltoni that is e not cited in your review, reporting angiosarcoma cases among 7 workers In the TVC fabrication industry? B A No, I had not come across that until I was sent that 9 report. That was news to me. 10 Q Did you receive this document after you authored your 11 report that appeared in the Scandinavian journal? 12 A Yes. 1 would not have Included it anyway - * yes, 1 13 would have included the statement that there were angiosarcomas 14 reported in that plant, but I was not covering fabricaters and 15 so the probability is that 1 would not have included anyway, 16 but I had not seen it. When was it published? 17 Q 1984. Did you personally review or conduct the I i i 18 literature review for the report that you authored or did you 19 have a research assistant perform that task for you? 20 A No, I did it myself which is to say, of course, one 21 also made use of the automated techniques which medical libraries 22 provide for you. 23 Q In forming the opinions you expressed regarding the 24 cancer sustained by Fred Wallace and Herman Dendinger, did you 25 rely at all on the industrial commission reports that are Tonnyson & Comp*ny Court Roporttrs London, England 01144-12424164 1 contained In the binder that Mr Bunda presented to you2. 2 A No, 1 based ray opinion entirely on the faCt that those 3 two types of.cancers are not seen In people heavily^exposed to 4 vinyl chloride and not produced by vinyl chloride in 5 experiments. animal 6 Q In connection with your assumptions concerning the 7 vinyl chloride levels in the workplace at Chrysler, did you 8 rely at all on the letters of August 25, 1986 and April 7, 19S7 9 by Jack Peterson? 10 A That is the only information I have had. 1 think thos 11 are the only ones in that book, are they not? I have had no 12 other information other than what is provided in that book about 13 the levels at Chrysler works. 14 Q Is it important for an epidemiologist who is invest!- 15 gating a particular chemical, not to establish preconceived 16 notions or assumptions as to what cancers that chemical can and 17 cannot produce? j 18 A Yes. 19 Q Have you read at all prior to today, the sworn testi 20 mony of Dr Shindell? 21 A No. 22 Q Have you been furnished prior to today with his testi 23 mony? 24 A No. 25 Q Have you read prior to today, the sworn testimony of Ttnnyson & Company * Court Raporitrt tortdon. England 01144*12424164 135 1 any witness in this case? 2 A Ho. t 3 Q Have you read prior to today the sworn testimony of 4 Herman Dendinger and Fred Wallace? 5 A No. 6 Q In the Environmental Health Associates Study of 1986 7 - and I would like you to refer to your report if you would* at 8 page 62, the right-hand column - it indicates that he studied 9 a total of 10,173 men? 10 A 1 am sure that Is right but I cannot see where you are 11 pointing-- 12 Q The first paragraph of the United States study. 13 A Page 62, 1 am sorry 1 was looking at 63. Yes. 14 Q That was his cohort? 15 A Yes. j 16 Q Included in that 10,173 men were 1,176 men in five j 17 plants that produced homopolymers and copolymers with or without [ 18 vinyl chloride monomer or polyvinyl chloride? 19 A Yes. 20 Q Is that correct? 21 A Yes. 22 Q So at least potentially incorporated into his data of 23 a cohort of 10,173 men, were 1,176 men that may not even have 24 been exposed to the chemical? ? 25 v A 1 think that is unlikely the way it is phrased: URL 11673 Tannyaon & Company Court Raporter* London, England 01144*12424164 URL 11674 136 1 "with .orttithout", but I am afraid you would have to aslu-a more 2 expezflava* chemist than myself as to the implication of the 3 homogaDpems and copolymers. r 4 42 If"we look, at page 1 of your review, did all four of 6 the pi Bar Ifl studies you relied on, the United States, the 6 United Magdom, the Canadian and the Italian study show an 7 increase dhove the number expected of the number of observed 8 cancemm ii the polyvinyl chloride workers? 9 A in comparison, with the national expected, ,yes.` The 10 Canadian ues not the national expected, it was the Quebec 11 mortality sates. 12 Q But each of the studies showed sn increase in the tota 13 numbers of cancers? 14 A Yes. 15 Q Br Doll, do you know why, in terms of the United State: 16 figures, in Table I there is no data presented at all with respect 17 to liver cancers? 18 A Yes. The authors were working with a particular 1CD 19 category in which liver and gall bladder were put together as 20 one in the 1CD category but they did, of course, publish 21 separately a listing of the 39 cases, using the 7th revision, 22 that they were using, they had not got the separate numbers, 23 they had not got the separation of liver and gall bladder and 24 that is a weakness of their study, but I think we can.assume that 25 the deaths were practically all cancers of the liver. The expected Tannyson & Company - Court ftaportars London, England 011*4-12424164 f URL 11675 TTT 1 deaths for cancer of the liver, 1 think I am right in rtying, 2 were not available separately from the American datd at that 3 period, but that may be wrong. r 4 Q If we look at Table 4, did the results of the four 6 principal studies. United States, United Kingdom, Canada and 6 Italy, show an increase above that expected for cancers of the 7 mouth and pharynx in the polyvinyl chloride and vinyl chloride 8 workers? 9 A They showed 18 deaths against 16.6 expected. 10 Q For a PMR of 109? 11 A Yes. 12 Q If we go down to Table 5 which reports the studies fron 13 Germany, Norway, Sweden and Italy, encompassing 14 plants, did 14 those four studies combined reveal an increase above the number 15 expected of digestive system cancers excluding cancer of the 16 liver? 17 MR BUNDA: Objection. I am going to object to the form 18 of the question on the basis that when we are talking about 19 an Increase you have to have a data point from which you 20 show an Increase. I think it is a mischaracterisation of 21 what the table shows. The table shows there is a greater 22 number but I do not know if that is an increase or decrease. 23 BY THE WITNESS: 24 A The table showed a greater number but the excess was 25 smaller than the deficiency in Table 4 in the principal studies Tannyaon & Company Court Rtponar* London, England 01144-12424164 gL9ln a n 138 1 to which you have not drawn my attention which, of cour*e7~was 2 125 deaths against 166.4 expected. When you combing the two, 3 you get an observed which is less than that expected. 4 BY MR DELL! 0VIi 5 Q One of the problems/'ttiS&e studies, when they are 6 combined, la that the researchers have not reported their results 7 In a uniform consistent manner? 8 A That is one of the difficulties that one has in 9 combining them and one of the reasons why several of the sub 10 sidiary studies were regarded as subsidiary. The Swedish study, 11 for example and the Norwegian study, both report their data in 12 such an incomplete way they could not be usefully used, whereas 13 the three of the principal ones reported them in a very detailed 14 way. The Canadian one was not as detailed as one would like. 15 Q The Canadian one only dealt with a total of twenty 16 deaths? 17 A Yes. i 18 Q And the Canadian one was even less than the total 19 number of cancer deaths at Chrysler? 20 A Yes. 21 Q The Italian study only dealt with 30 deaths? 22 A Yes, but they are both good and Important studies in 23 the sense that they had observations on people more than 25 years 24 after they were first employed and they both had cases of angio 25 sarcoma of the liver in them so they were relevant to include Tannyaon & Company Court Reporters London. England 01144-12424164 URL 11677 139 1 and It would have been improper to have excluded them. .Although 2 the numbers are small, they are of real value in th$t they 3 report relevant data. r 4 Q -in terms of the angiosarcoma deaths in the United 5 States, you indicated in your 1985 article in British Journal 6 for Industrial Medicine that 23 of the 33 cases that had been 7 reported to date In the United States Involved Just two factories. 8 Could I refer you to that document. (Document handed to the 9 witness) 10 A Yes. 11 Q Have any of the FVC manufacturers disclosed to you at 12 which of their facilities these large increases in the angio 13 sarcoma deaths were experienced? 14 A 1 am afraid I cannot answer that question. 1 cannot 15 remember whether it is in the angiosarcoma register or not. It 16 has not been a question I have been asked. 17 Q Let me combine that point, that is the concentration 1 18 of angiosarcoma deaths at a relatively small number of plants, 19 with the differences In the results of the data you have reviewer. 20 Some show an Increase in brain cancer, some show an increase in 21 thyroid cancer, some show an increase in melanomas, some show 22 an excess in the digestive system, some show an excess in lung, 23 some do not. Could those differences and the seeming irrecon 24 cilability of all the data, be due to what you described in one 25 of the articles we talked about earlier as the need tto consider Tenny*on & Company Court Reporter, London, Engtand 01144*12424164 UHL 11678 140 1 each facility and the cohorts exposure and the peculiarities of 2 those facilities or the peculiarities of the particular vinyl 3 chloride or polyvinyl chloride resin produced or used by those 4 facilities* into account? 5 A No* that is not the natural interpretation. The 6 natural interpretation is this is exactly vhat you would expect 7 to find If you look at 25 different reports and look at 25 8 different cancers in each of then. 1 guarantee whatever the 9 chemical was, if you looked at as many different cohorts as have 10 been looked at in relation to vinyl chloride and looked at as n many different cancers in them, you would find precisely this: 12 It is inevitable. This is exactly what chance means. If you 13 look at 25 different types of cancer, one will show a signifi 14 cant excess by chance. That is the definition. If you look at 15 20 plants and 20 factories, then you are going to get 20 times 16 that number of excesses and they will all be different. If you 17 want to find an excess which you are going to relate to the j 18 particular conditions of the plant, you want to show that it is 19 consistent in other plants that have the same chemical exposure, 20 you want to show it occurs at the right time after exposures 21 and it is concentrated on people who have had longer rather than 22 shorter terms of exposure. All these are things you take into 23 account. What you have described is what 1 would expect to find 24 in any series of studies no matter what chemical you ware looking 25 at, irrespective if it was not a carcinogen. - Tnnyson & Company - Court Raportart London, England 011*4-12424164 Tzrr 1 MR DELLI BOVI: Could we go off the record for just 2 a minute? r 3 (Off the record) r 4 BY MR DELLI *0VI* 5 Q Finally. Dr Doll, there are a number of exhibits that 6 I would like you to identify for me. 1 understand that a.number 7 of those are your only copy and 1 will be more than happy to B substitute a copy of that document for the original but 1 would 9 like to get the documents marked so we are clear what we do and 10 do not need copies of. 11 A May I just ask. Will you pay for the photocopying of 12 them or who shall I charge? 13 Q Absolutely, I shall be more than happy to. as well as 14 the time of who does it for me. Would you first identify 15 Exhibit Doll 9.(Document handed to the witness) 16 A Yes. 17 Q What is that? 18 A A version of the United Kingdom report which has been 19 published in the Scandinavian journal. Work, Environment and 20 Health in June this year, provided me by Dr Jones in January, 21 1987. I see that it says the version I received in 16th January 22 It is not the press version and I cannot guarantee that it is 23 precisely the same as that on which I based my final conclusions 24 but it is certainly near enough it. * 25 Q Did you indicate in your review who commissioned Tennyson & Company Court Reporters London, England 01144.12424164 142 1 Dr Jones to conduct that study? 2 A Yes, this was carried out by the Government, 1 suppose 3 the equivalent of NIOSH. Our health and safety executive, 4 Q Would you identify Plaintiffs' Exhibit Doll 10, please' S (Document handed to the witness? 6 A Yes, this is a translation of an Italian article that 7 I arranged to have. The Italian article was sent to me by ICI 8 in this country, it had not been published at the time. It has 9 subsequently been published in English, but I have not got a 10 copy of the English translation, only of the one I had made 11 personally. 12 Q ICI is a European --- 13 A ICI is a big chemical industry that makes polyvinyl 14 chloride. 15 Q Do you know Dr David Duffield? 16 A No, 17 Q Plaintiffs' Exhibit Doll 11 contains a number of your j 18 publications that 1 have requested, does it not? (Document | 19 handed to the witness) 20 A Yes. 21 Q Your preference is that we not mark the originals of 22 those publications but you will provide me at my expense with 23 copies of the publications that are listed on that exhibit? 24 A Yes indeed, they are my only copies of my <own work and 25 I prefer not to have them marked, but I am very happy to let you o a s in tift Tannyaon & Company Court Raponara London, England 01144-12424164 143 1 have copies. Do you want copies of the two books? 2 Q I have reviewed then earlier. I do not have a need 3 for copies of either of those. * 4 A -If you could be so good as to Initial or that Is not 5 necessary. I an sure you will accept ny withdrawal of the 6 appropriate two? 7 HR DELLI BOVIt Certainly. 8 MR BUNDA: Rather than sending then directly to 9 Mr Dell! Bovi, since we are attaching the list* let us 10 attach the articles to the transcript. So, why don't you 11 provide then to the Court Reporter and she can attach then 12 to the transcript. 13 THE WITNESS: Whatever you suggest. 14 BY MR DELLI BOVI: % 15 Q Finally, Plaintiffs' Exhibit Doll 12 is a binder of c 16 materials that were presented to you for your review and which 17 you have In fact reviewed concerning this case? 18 A Yes. 19 MR DELLI BOVI: That is all I have, Dr Doll. Thank 20 you. 21 RE DIRECT 22 BY MR BUNDA: 23 Q I have a couple of questions. I realise the hour is 24 late and we are all tired doing this but I just want; to go over 25 one or two things. V I would like to refer you if I could to the Tennyson A Company Court Reporters London, England 01144-12424164 TO 1 1981 study done by Or Chiazze. Do you have that before you, 2 that Is Exhibit 2. ; 3 A Well, we have It in here so I can look at fit here. . .* 4 Q Let's nake sure we have the exhibit. Do you have that * 5 MR DELLI BOVI: Certainly 1 have a pile of materials 6 here. 7 THE WITNESSt I have it here. Exhibit 2. 8 MR DELLI BOVI: Do you mind, we have three copies of 9 this study, could I have one of them please? (Document 10 handed to counsel) Thank you. 11 BY MR BUNDA: 12 Q Did Dr Chiazze when he was doing this study, attempt 13 to determine whether or not those people that he studied in the 14 cohort deaths that he looked at, whether or not all of those 15 people had had exposure to vinyl chloride? 16 A No. In fact, it is quite clear that a lot of them 17 had not. 18 Q How can you tell that? For example, look at Table 19 5, please. 20 A Yes, that is the table I had in mind where 611 of the 21 women with breast cancer had no exposure and 72.4T of the 22 controls also selected from women who had died of other diseases 23 had had no exposure and another substantial proportion who had 24 had improbable exposure. 25 Q Of the cohort or deaths that you looked at in your stu<$ URL 11682 T*nny*n & Company * Court Reporter* London, England 01144-12424164 145 1 did those people ell have exposure to polyvinyl chloride or 2 vinyl chloride? ? 3 A Ve* il# there is possibility that a few did not that 4 worked in these plants producing hoappolymers and copolymers. S I am not quite sure whether they have exposure. Some of- them 6 may not have, but the great majority o all the others certainly 7 did have. 1 would have to check my memory on the United Kingdom 8 study as to whether there were any that had no exposure. I am 9 not quite sure. 10 Q So would it be Improper to compare the Chiazze study 11 with your study in terms of comparing the number of deaths? 12 A Oh completely Improper. They bear no relation to one 13 another as far as hazards of vinyl chloride are concerned. 14 Q Getting back to the Chiazze Btudy for just a second, 15 why were those particular people in Table 5 looked at to deter 16 mine their exposure? 17 A If I may elaborate, my previous answer -- 18 Q Oh, I am sorry. 19 A I was checking on the United Kingdom study and all 20 5,500 men who were employed had potential exposure to VCM for 21 25Z of the work week. I thought that was the position but 1 22 wanted to check. Sorry, what waB the first question? 23 Q Getting back to the Chiazze article of those people 24 in Table 5 that we looked at before, what was the reason why 25 the exposure information was determined for them? URL 11 683 T*nny*on & Company Court Roportors London, England 01144-12424164 W 9VVW 146 i 1 A Because there vas an excess* a higher proportion~of 2 deaths were attributed to breast cancer among the fdmale workers 3 than would be expected if the distribution had beenrthe same * 4 as deaths in the United States as a whole and he wanted to in 5 vestigate this further and he did the proper thing for an epidem - 6 iologist to do in this situation which is to do a nested case 7 control study that is to say one in which you make special e inquiries about the affected patients and then you choose a group 9 of other people who did not develop the same disease but who 10 were matched in certain respects, same age and similar charac ii teristics like that and compare the exposures of these two group;. 12 That is what Dr Chiazze did. 13 Q What happened when he did that? 14 A Well, he found that of those with possible or definite 15 exposure there were 4.5% of women who died of breast cancer and 16 a possible or definite exposure in 7.5% in their matched controls. 17 In other words, a higher proportion had had possible or definite 1 18 exposure in the women that did not develop breast cancer but 19 both proportions were extremely small. | i 20 Q It also showed, did it not, that a large percentage 21 of women who had breast cancer had no exposure? 22 A It did. 75% had no exposure or improbable exposure. 23 Q What effect did that have on the hypothesis that vinyl 24 chloride was somehow related to breast cancer? 25 A Oh, I think it made it quite clear that It vas not Tnny*on & Company Court Reporter, London, England 01144*12424164 T7TT 1 related in any way. --- 2 Q During the cross examination we heard in the discussioi 3 of this article about a significant statistic with regard to a 4 all cancers'and large Intestine cancers. This breast cancer 6 statistic was also deemed important by Dr Chiazze at first, was 6 it not? 7 A Yes. 8 Q Is this case control study which he thereafter did, 9 an example of the pitfalls that you can run into if you jump 10 to conclusions about proportionate mortality results? 11 MR DELLI BOVI: Objection, leading. You can go ahead 12 and answer. 13 BY THE WITNESS: 14 A I think it was a perfectly natural thing to do if you 1 15 were wanting to see whether the findings that you had found from 16 a proportionate mortality ratio study did have any significance 17 in relation to the exposure to which the individuals were con 18 cerned. In this case it said certainly as far as the breast 19 cancer was concerned, exposure of vinyl chloride was Irrelevant. 20 Q Similarly we have no information available concerning 21 whether those people who were shown as having colon cancer in 22 the study, had any exposure to vinyl chloride? 23 A No such information. 24 Q Dr Doll, you were also asked how payment was made by 25 the CMA to you after you were asked to do this comparison study $89u iyn Ttnnyaon Si Company Court Raponars London. England 01144-12424164 --------------------------------------- --------- *---------------------------------------------------------------------T7F 1 which was recently published and you indicated a donation wra 2 made to charity. Do you recall that? * 3 A Yea. 4 Q Can you please explain to the jury what Is the relatio^i 5 ship or hov payment is being made to you as far as your consul 6 tation for the Defendants in this case? 7 A In the same way. I have always refused to take money 8 from industry for any purpose in order to retain my Independence 9 and I made it a condition of appearing as a witness 'in this case 10 that the normal consultation fee should be paid to charity and URL 71666 11 not to me directly. 12 MR BUNDA: Thank you, sir. That is all the questions 13 I have. 14 FURTHER CROSS EXAMINATION 15 BY MR DELLI BOVIs 16 Q I would like you to assume that the trade industry 17 for polyvinyl chloride manufacturers in the United States, 18 Chemical Manufacturers Association, the Manufacturing Chemists 19 Association sponsored and paid for Chiazze's initial work. As 20 a result of that, would the raw data from Chiazze's original 21 work be In the possession of that industry? 22 MR BUNDA: Objection, there is no foundation laid 23 whether he has such knowledge. 24 BY THE WITNESS: 25 A It depends on the conditions under which Dr Chlazze Tannyaon & Company Court Rtportars London, England 01144-12424164 149 1 undertook the work. If I were to have undertaken the work, 2 although as I pointed out I have never undertaken work for pay- % 3 vent by Industry, the condition would be I would be^entitled a 4 to publish- anything I wished about the data, it would be for 6 ve to dispose of. If that was Dr Chlazze't case, I just do not 6 know. 7 BY MR DELLI BOVI: 8 Q Are you aware of any efforts by the American polyvinyl 9 chloride manufacturers industry to sponsor a follow-up study 10 of Chia22e's proportional mortality ratio study of PVC fabri 11 cation employees to test his hypotheses regarding the statisti 12 cally significant increases in all cancers, large intestine 13 cancers and other unspecified cancers in both males and females? 14 A 1 think your question includes a few postulates which 15 1 would not accept but perhaps it is not necessary for us to 16 go over that. It is a question of the use of the term "statistij 17 cally significant increases." J 18 i Q Statistically significant proportional distributions? 19 A Thank you. It is a point of some substance. No, I 20 have no knowledge of what the PVC fabrication industry in the 21 United States is doing at all in regard to anything. 22 MR DELLI BOVI: Thank you. 23 FURTHER RE DIRECT 24 BY MR BUNDA: 25 Q Doctor, I have one more question addressed to the last m u ian Tannyton & Company - Court Reporter* London. England 01144-12424164 150 V question put to you. The continuing updating and following--ef 2 the workers in the polyvinyl chloride manufacturing'industry, 3 the people who make polyvinyl chloride and the people who make 4 vinyl chloride and the Tabershaw and Gaffey study updated by 5 Cooper and updated again by the MCA, would that or would it not 6 be relevant to the same question regarding issues raised in the 7 Chiazze study? 8 A I do not have in mind what Issues were being raised 9 by the last question, but it seems to me a comparable question, 10 yes. 11 Q I am sorry, what I meant by the issues raised were 12 the concerns concerning intestinal cancer, proportional increase > 13 in total cancer and questions concerning breast cancer. Would 14 those be addressed by the study Involving polyvinyl chloride 15 manufacturers done by the MCA? 16 A Insofar as there was any suggestion that those cancersj 17 were produced by exposure to vinyl chloride, yes. ! 18 MR BUNDA: Thank you. j 19 (Whereupon the deposition concluded at 6.40pm) 20 21 22 23 24 25 URL 11688 Tonnyton a Company - Court Reporters London, England 01144-12424164 151 URL A '689 1 CERTIFICATE OF COURT REPORTER ? 2 3 I. CHRISTINE MARY ARMSTRONG, Accredited Court 4 Reporter, do hereby certify that I took atenotype .notes 5 In the foregoing deposition and that the transcript 6 thereof la true and accurate and executed to the best 7 of my skill and ability. 8' 9 10 11 Christine^* Armstr, Tennyson 6 Company 12 13 14 15 16 17 18 19 20 21 22 23 24 25 URL 11690 152 1 CERTIFICATE OF WITNESS 2 3 I hereby declare that the foregoing la a transcript 4 of my deposition; are the questions asked of me and 5 my answers thereto; that I have read same and have made t the necessary corrections, additions or changes to my 7 answers that 1 deem necessary. 8 In witness thereof, I hereby subscribe my name this 9 day of , 198_____________________________________. 10 11 12 13 14 15 16 PROFESSOR SIR RICHARD DOLL 17 18 19 20 21 22 23 24 25 Tonnyaon Cr Co Court Hipomri 01 242 4tM 0463 66356 1 2 3 4 & 6 7 B 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 T*nny*on fr Co. Court fWpomrt 01-242 4104 04S3 U3&8 Correction (signed) ERRATA 153 Line Wo. Page No. t t vi (date) I t 691