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QUESTION: "... were of the opinion that it was better to make a gradual change to NHS products that could be sustained rather than a sudden switch in times of g lut and then a sudden transfer back of all patients to 115 commercial material. This was the sort of thing th at had been happening at that time." Then...
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QUESTION: "Therefore it did not appear unreasonable at that t ime to propose that patients who had been using Armour for several years should continue to do so. There was never at any time sufficient NHS Factor VIII availa ble to treat all patients and the decision of Dr Hill a nd myself was that patients should...
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QUESTION: You referred there to limited supplies of NHS material, and then times of glut, and having to 116 transfer patients between different products. What , if anything, can you recall about that? ANSWER: Well, I don't think we ever had a glut, actually, b ut we did -- there was -- there were times when the...
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QUESTION: We might sense that from the tone of your letter to Dr Lane, Professor Franklin. If we have a look at it, BPLL0000853_002, please, Henry. So this is your letter, 24 May 1984, so a couple of months after th e letter that we don't have but we have seen describe d in your letter to Dr Ala, and you are say...
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QUESTION: "It appears that we will now be in the position of having to treat patients with commercial material w ho may never have been exposed to this in the past. T his situation is particularly regrettable given the current interest amongst haemophiliacs in the acqui red immune deficiency syndrome." Obviousl...
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QUESTION: Then if we just -- ANSWER: It wasn't a trial or formal --
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QUESTION: Not as far as your involvement's concerned? ANSWER: No.
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QUESTION: Then if we look at the next paragraph: "Could you perhaps let me know of the likely future supplies of NHS material so that I may plan the treatment strategy for my patients." You go on to say that you find: "... the sudden swings in supplies with no due notice to clinicians involved in the treatment o...
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QUESTION: We see that in his second paragraph: "... Regional Transfusion Centres, and not the Blood Products Laboratory, determine the issuing policy within individual regions." 119 If we skip down to the fourth paragraph of the letter he says, in relation to the sudden and unexpected shortfall: "Regional Tran...
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QUESTION: Okay. It would seem that you received your supply of NHS Factor concentrate from the Regional Transfusio n Centre? ANSWER: Yes, I think we got all the supplies from there but I'm sure -- well, you were speaking this morning ab out the contracts, and so on but -- I think it was all stored over there, ye...
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QUESTION: So the cryoprecipitate was from the Regional Transfusion Centre? ANSWER: Yes, that would have been made locally.
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QUESTION: The NHS Factor concentrate was made by BPL at Elstr ee but supplied to the Regional Transfusion Centre and then to you? ANSWER: Yes.
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QUESTION: Then the commercial products, we'll look at the contracting arrangements in a few minutes, but your recollection is they were delivered to the RTC and then hospitals would call them off -- ANSWER: I think we called them off as we needed but it's a long time ago. I'm not 100 per cent sure.
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QUESTION: If it assists you, Professor Franklin, the documentation suggests that for Queen Elizabeth, although not the children's hospital, that that was probably the case. ANSWER: Yes.
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QUESTION: Just generally, in terms of the treatment policies, what use was there in this period 1982, 1983, 1984, of cryoprecipitate? ANSWER: Well, there was use. I remember doing it. I think your previous chart suggested that we were using it for von Willebrand's disease. I would have thought we were using i...
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QUESTION: What about DDAVP? ANSWER: We certainly did use that. It was very useful, but it was really good for things like dentistry in less severe patients. As I'm sure you know -- I mean, DDAVP works by releasing Factor VIII from the body from the blood vessels. So if you are a very severe -- a person with...
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QUESTION: We saw reference this morning in the 1970s to cryoprecipitate being used to provide cover for surgery. Was that something which was still happen ing when you joined QEH? ANSWER: Yes, I think it was, yes.
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QUESTION: Then, in terms of NHS product, as opposed to commercial, how were decisions taken as to which patients would receive NHS product and which would receive commercial; can you recall? ANSWER: Yes, difficult. To be quite honest, I can't rememb er. I'm sure that if we had a young man transferring fr om the...
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QUESTION: Presumably your product and batch policy would mean the converse as well: if you had a patient transfer red from the Children's Hospital who had been receiving commercial concentrate, as we know many of the children did, you would have been likely to keep th em on that? ANSWER: Probably. It's unlikely i...
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QUESTION: Was there any specific policy or approach or practi ce 123 in relation to patients who were previously untreat ed patients? ANSWER: Well, I don't remember ever treating -- well, other than possibly some with DDAVP, who were very mild, I don't remember treating any totally new patients.
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QUESTION: The arrangements for obtaining the commercial produ ct, we know that there was a regional contract in place , and it appears to have been with Armour at the time at which we're talking when you arrived in 1982. As f ar as you can recall, was all your commercial product at QEH obtained pursuant to that ...
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QUESTION: The criteria for awarding the regional contract for commercial product, before we look at any of the 124 documents, your statement refers to Professor Hill suggesting that one might question suppliers of Fac tor concentrates about their donor pools. If we just l ook at your statement, I think it is you...
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QUESTION: What you say is, you talk about -- in the early yea rs of your time working at QEH you recall there being a committee of doctors in the region which determined which clotting factors were to be bought, and we wi ll look at the documents in a moment. What is it you can recall about Professor Hill talking...
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QUESTION: You say he had certain views about certain companie s. What can you recall about his views about particula r companies? ANSWER: Well, there is a letter in the papers from a surgeo n in Stanford University to the then head of BPL, Dr Maycock, being really quite damning about one company's product, and...
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QUESTION: That's the letter from Dr Garrott Allen -- ANSWER: It is.
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QUESTION: -- to Dr Maycock, 1975? ANSWER: Yes.
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QUESTION: Can you recall any other particular discussions you had with Professor Hill about specific companies? ANSWER: No. None beyond that, no.
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QUESTION: If we could just look at three meetings, one before you arrived -- well, one whilst you were there but before you took over as director, and then two afte r you became director, just to get a sense of how decisions were taken. Could we please have? Henry, FHIN0000030. This is a meeting of the West Midla...
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QUESTION: If we go to the second page, we can see under the heading "Regional Contract": "It was agreed that Mr Stanton should invite tenders ..." And then: "Mr Shinton, Dr Hill and Mr Stanton would meet to adjudicate when the tenders had been received." So the process appears to have been, and we see it late...
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QUESTION: Would invite the tenders from a range of commercial companies, and then there would be involvement of t wo of the Haemophilia Centre Directors here, Dr Shinto n, who was Coventry, Dr Hill, the Children's Hospital, and Mr Stanton adjudicating. Then we can see three criteria there set out, or points to be ta...
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QUESTION: Then the second point: "Where firms have their donor facilities in the United States." So that goes back to the issue that you were discussing a few moments ago. ANSWER: Well, I did think they all did. Maybe Immuno didn' t. I know possibly Bayer didn't, but Bayer I think nev er made a lot of product...
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QUESTION: This appears to be looking at where in the United States the donor facilities were. ANSWER: I see, I'm sorry. Different meaning of "where", I beg 128 your pardon. Yes, where in the United States they had their collection facilities, yes, which would be away fro m major conurbations and places where ....
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QUESTION: Then we see the third point that's identified to be taken into consideration is: "Any public pressure for a change of products (eg to heat-treated Factor VIII) should be resisted until another product had been proved to be more satisfactory." Do you know what the reference to "public pressure" refer...
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QUESTION: We can see that as at June 1983 there's a reference to heat-treated Factor VIII. We'll come on to how and when QEH moved to using heat-treated products, whic h was either at the very end of 1984 or the beginning of 1985 as far as we can tell. Do you recall any consideration being given in the course ...
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QUESTION: If we go to the next page, please, Henry -- sorry, actually we'll go back to the previous page. My apologies, Henry. If we just look at the bottom part of the page, Professor Franklin, under "Supplies of Cryoprecipit ate and Freeze-dried Factor VIII", we can see there there's a discussion about the -- we...
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QUESTION: Then the next page, please, Henry, if you go to the heading "Funding of Commercial Factor VIII". I don't know whether you can assist, Professor Franklin, in understanding what's being discussed here. In the second paragraph it's refer red to -- or, there's an issue about deducting from districts with hae...
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QUESTION: Don't worry. We will move on then to the first of these meetings that you did attend. SHIN0000029, please, Henry. So we can see this is a meeting on 5 December 1983. You had taken over as director by this time, although Professor Stuart was there, you were there, Dr Hill was there. ANSWER: Yes.
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QUESTION: And a number of others. If we look down the page towards the second half of the page, we can see und er the heading "Regional Contract" that: "Dr Ala informed the committee that the lowest tender was forwarded by the present supplier - Armo ur Pharmaceutical Corporation, and no change was envisaged." ...
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QUESTION: No. If we go to the next page, just two further points to pick up, we can see that under "Any Other Business", Professor Stuart informing the committee that this would be his last attendance and in futur e you would attend as sole representative. Just go d own the page. So we see that under "Any Other ...
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QUESTION: Then just going up from that, the paragraph headed "AIDS" -- so this is now December 1983, there's reference to there being a handout at donor session s at the blood transfusion centre, and then it says this: "It was agreed that if any case of AIDS was suspected, then the Regional Public Relations Offic...
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QUESTION: Then if we go on to the next meeting, which is SHIN0000028, so we're now in May of 1984, you weren 't in fact at that meeting. You sent your apologies. But if we go over the page, we can see in the top section of the minutes it says: "From the annual statistics and supply of BPL expected, there could b...
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QUESTION: And Dr Franklin, so yourself? ANSWER: Yes.
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QUESTION: And then: "It was agreed that the following points should be taken into consideration ..." 134 And then we see the same three points there articulated. So this is for the next round of the contract? ANSWER: Yes.
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QUESTION: Can you recall anything about that subsequent adjudication process? ANSWER: I'm afraid I can't. I don't remember that at all.
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QUESTION: So you don't know whether it would have been an informal or formal process or records kept of it? ANSWER: Well, ideally they would have been kept but I don't recollect any such meeting.
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QUESTION: Do you know what, if any, steps were taken to get t he information that would help you consider point 2, t he point about donor facilities, what questions were asked or when enquiries were undertaken? ANSWER: Well, the only enquiries I remember were those that I think I also did ask in -- having been tra...
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QUESTION: Okay. I think we can see some evidence, when we ge t to about 1986, of perhaps a more structured approac h, but we don't have anything very clear in this stage . Apart from the reference to donor facilities, we 135 can see that there is no express reference to any other aspect of safety or risk. Can y...
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QUESTION: In your witness statement at -- let me just find th e paragraph -- yes, so two passages I wanted to ask y ou about. Paragraph 13. Do you have a copy of your statement? ANSWER: Yes, I do.
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QUESTION: We can put it up on screen, Henry. It's WITN4032001, please. If we go to page 14. So paragraph 13, this is now talking about the particular products for treat ing patients. You say this: "The particular products used for treating patients at the Centre depended on availability - which changed over time...
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QUESTION: Then you say: "... and also the specific reason for treatment being needed." What does that refer to? ANSWER: Well, I would think if you had someone who may have been a less severe haemophiliac who you might try t o use DDAVP for tooth extraction or possibly cryo for , I don't know, a hernia operation, a...
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QUESTION: Then if we go, please, to page 22, paragraph 18, yo u say in the first sentence: "Decisions were taken on the basis of an assessment of risk and availability." We have covered availability. What did you mean by an assessment of risk? ANSWER: Sorry can you just run back up to the precise question?
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QUESTION: Yes, of course. ANSWER: Right, there we are. Well, I think probably I've kind of explained that. If the risk was relatively low, tooth extraction something like that, then you might -- y ou definitely try to use DDAVP if you could, and then so on down to some sort of major cancer operation. I think I...
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QUESTION: What role did patients have in decisions about what treatment to have at this time '83, '84, '85? ANSWER: Well, any patient is at liberty to refuse any treatment at any time. I realise that might sound a bit glib but it's true. Beyond that, probably no t a lot. I mean, we would have recommended what w...
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QUESTION: Can you recall whether patients were ever offered a ny kind of choice of treatment? So you correctly observed there's obviously an entitlement and principle to refuse? ANSWER: Yes.
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QUESTION: Were they ever given a choice between, for example, NHS concentrate and commercial concentrate? ANSWER: To be honest, I'm not sure I ever had that choice t o 138 offer them. The supply of the NHS product was insufficient, so I think possibly not, really.
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QUESTION: What about a choice between concentrates and cryoprecipitate; was that a choice that was offered ? ANSWER: I don't remember offering that as a choice, no.
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QUESTION: You talked about assessment of risk and much might depend upon the circumstances of the patient and th e risk of, for example, the bleed. Could we just loo k at your evidence, your written evidence, to the Archer Inquiry. There's just one point I wanted to pick up with you. Henry, it's ARCH0000443. C...
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QUESTION: Are these your annotations? ANSWER: I don't think so. It's not my writing, no.
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QUESTION: We didn't think so either. If you could go to page 5, please, it's the top paragraph. I'm going to come back at a later stage in your evidence and ask you about the precautionary principle, Professor Frankl in, but you say this about six lines down: "... the regular use of Factor VIII as a home therap...
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QUESTION: Professor Franklin, I'm going to ask you to consider now your knowledge of the risks of hepatit is and, in due course, AIDS. Before we look at any specific documents, what, if anything, can you recall being taught in your general medical training and then your haematology training about the risks of...
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QUESTION: Just before we look at some of the materials that y ou have referred to in your statement, what kind of journals, medical journals or other sources of information did you routinely have access to and wo uld read? ANSWER: Well, it varied a little over time. I mean, throughout my career that would be the...
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QUESTION: In your evidence to the Archer Inquiry -- which we' ll look at, ARCH0000008. If we go to page 27, I think it should be -- next page, please -- you say this about non-A, non- B hepatitis, picking it up four lines down: "Certainly to my mind it was not taken that seriously until a publication from the Shef...
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QUESTION: In your witness statement, if we go, please, to WITN4032001, and we go to page 26, picking it up in the last two paragraphs you talk about non-A, non-B hepatitis being considered "mild and relatively benign", and say that: "Unfortunately this reflected a lack of knowledge of the full long-term history of ...
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QUESTION: We'll just look at those briefly, and then the textbook you refer to, as I think those are the particular documents you suggest that you were influenced by. Before we do that, you say you would have learnt more about non-A, non-B hepatitis from the reports by Dr Craske at the UKHCDO. Would you have see...
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QUESTION: So only from 1983 onwards? ANSWER: Yes.
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QUESTION: Then we'll just look at the other documents that yo u refer to. So the Manchester paper is WITN4032009 I hope, Henry. No. ANSWER: That's the Manchester paper.
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QUESTION: It's certainly not the report I've got. Do you have PRSE0002564, Henry? So this is a full copy of the Manchester paper? ANSWER: Yes.
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QUESTION: This I think is the paper you're referring to, "Liv er disease in haemophiliacs: an overstated problem?" 1983. We can see it refers to: "... biopsy ... on 12 multi-transfused haemophiliacs from the Manchester area with persistently abnormal liver function tests." If we go please, Henry, to -- it's page...
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QUESTION: "... with progression to micronodular cirrhosis. F our other patients had only mild chronic active hepatit is. We suggest that the true incidence of it severe histological liver abnormality in multi-transfused haemophiliacs may be less than previously reported but similar to the more recent results of ...
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QUESTION: Do you recall any discussions with Professor Hill about non-A, non-B hepatitis or the risks of liver disease? ANSWER: Well, I think we did. I mean, can I remember a particular moment? I mean, no, I can't. I think my knowledge of non-A, non-B hepatitis was quite limit ed until I started looking afte...
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QUESTION: What I was going to ask you about, Professor Frankl in, it's a study of 12 patients, I think. ANSWER: It is -- the only thing I would say, it's a very sm all study we're looking at.
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QUESTION: As indeed many of them are. ANSWER: Yes.
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QUESTION: Then if we look at the reference to Aledort, which was a slightly bigger study -- ANSWER: Yes.
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QUESTION: -- 16 per cent CAH and cirrhosis, it's not a small figure, it's still a significant figure? ANSWER: Yes.
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QUESTION: Do you recall whether either you or Dr Hill at the 148 time had any opportunity to discuss this issue with liver specialists in Birmingham? ANSWER: Well, we did have liver specialists there. I don't remember discussing this -- discussing that, sorry. I do remember Frank Hill and myself talking about whe...
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QUESTION: Yes. ANSWER: The -- not that money was the issue, but you need a lot of Factor VIII to safely do this. So we deci ded we wouldn't do that. 1983, the liver unit was only just starting at the Queen Elizabeth Hospital. The re was a liver expert there, a guy called Elias, very good. He used to come and ...
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QUESTION: Then the 1985 Hay and Preston paper -- Henry, I'm hoping I've got the right reference here, PRSE00042 29. Do you have that? Thank you. So this is the 1985 study that you referred to in The Lancet, and we can see there it refers to th ere being: "... an eight-year study of 79 unselected patients with ...
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QUESTION: You've also referred in your statement to the publication by Sheila Sherlock and, again, I think in fairness to your evidence, we should probably look at that because you say you did recall consulting this textbook? ANSWER: Yes. I mean, I did. That was my source of knowled ge about liver disease, real...
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QUESTION: You have referred in your statement to two passages . Sorry, you referred in your statement to one passag e then more recently another? ANSWER: I've since realised there are two passages relevant to non-A, non-B in this book, yes.
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QUESTION: So we will look at the passage you refer to express ly in your statement, first of all. Henry, it is WITN4032021, please. So this is page 290 of the bo ok. We can pick it up at the bottom of the page, "Chron ic non-A, non-B hepatitis": "Serial studies have shown that patients with acute non-A, non-B ...
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QUESTION: Then, if we just look at the next page, which was t he second -- I'm sorry, Henry, it's a different reference: WITN4032022. Then we can see the clinical features set out: "Chronic hepatitis can follow both the long and short incubation types." It says: "Chronicity ... may develop insidiously and the acu...
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QUESTION: I am just checking. ANSWER: Counsel has the volume but I think it is a single-author text -- only her name on the --
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QUESTION: It's certainly only her name. I can look in more detail, sir, at the preface and acknowledgements bu t there isn't another author whose name is given on t he text. You have also drawn the Inquiry's attention to an earlier passage in the book pages 257 to 259. Henry, those are at WITN4032023. Is there ...
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QUESTION: Yes, certainly the plate only contains her name, yo u are right, Professor. So we see here, this is the other passage that you have drawn attention to, pages 257 onwards "Non-A, non-B hepatitis": "The elimination of hepatitis A and hepatitis B from transfused blood did not eliminate post-transfusion he...
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QUESTION: In terms of the materials that you recall seeing at the time, bearing in mind that you were assuming responsibility for people with bleeding disorders i n 1982/1983, other documents that we have looked at, you recall looking at this book, you recall the Manches ter report, you recall the Hay/Preston 1985...
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QUESTION: The Inquiry sent you some earlier and other materia ls from the second half of the 1970s through to 1980. I am very happy to go through them with you if it would assist, Professor Franklin, but they include publications in The Lancet from Prince and then in 1978 an earlier study from Professor Preston w...
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QUESTION: We have sent you also some material from Dr Craske from 1978 reporting some American information about liver biopsies with 50 per cent showing changes compatible with cirrhosis. I think we sent you a letter, which we've looked at with a number of witnesses, from Dr Kernoff to Dr Colvin, describing non...
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QUESTION: As I say, I'm happy to go to each of those material s if it would assist Professor Franklin but, in an attempt to short-cut it, would you agree that, looking at that material, which you may not have se en at the time, that paints a rather different picture of non-A, non-B. It doesn't suggest it is nece...
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QUESTION: I think one of our witnesses used a term that there may have been a degree of wishful thinking on the p art of haemophilia clinicians not wanting to think of non-A, non-B hepatitis as something serious, becaus e of what was seen as the very great benefits that factor concentrates had brought. Do you fee...
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QUESTION: Can I just see whether we're looking at the same document. Is that the "HIV in the blood supply and analysis of crisis decision-making"? ANSWER: Yes.
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QUESTION: Sir, we've got that, I hope, at WITN4032024. Is that the right document, Professor Franklin? ANSWER: Yes, I think so. Yes, it is.
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QUESTION: What was the page you were referring to? ANSWER: That's a good question. If you could run down. It 's not far from the front. It should be four bullet points, I think. Two hypotheses. A bit further please, next page.
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QUESTION: Ah, yes. I think it is your second point. ANSWER: Here we are. 160
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QUESTION: "Hepatitis was viewed as an acceptable risk by the Government regulatory agencies responsible for the safety of blood and blood products, the plasma fractionation industry, the physicians who treated the individuals with haemophilia ..." Pausing there. That, I think, is the bit you are associating you...
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QUESTION: In terms of the 1985 Hay/Preston research, would yo u accept that that wasn't something which showed something radically new or different, it was rather perhaps confirmatory of earlier fears; would that b e a fair way of putting it? ANSWER: Yes. Well, I think it was the final -- yes, the fi nal sort of...
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QUESTION: Move on to HIV/AIDS. I think I understand from your statement you think you would have seen the MMWR report in 1982? ANSWER: I started looking at them. They weren't easy to fi nd but yes, I did, because that was where -- I think I mention in my report that the pre-internet era, the -- actually knowled...
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QUESTION: So the July 1982 report we know is the report about PCP being observed in some haemophiliacs in the States? ANSWER: Yes.
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QUESTION: You also, I think, read the New England Journal of Medicine January 1983 Desforges article, and you no ted there the recommendation to switch back to cryoprecipitate. ANSWER: Yes, I wasn't responsible -- I was looking after people with haemophilia, that was on my rota, but I wasn't responsible for it a...
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QUESTION: Then if we have up on screen, please, PRSE0002647. This is the note of a meeting on 162 24 January 1983. It was with Immuno, to look at hepatitis-reduced Factor VIII. We know -- if we go to the last page please, Henry -- from the list of attendees that Professor Hill attended, Professor Stuart did not....
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QUESTION: Yes, that's absolutely -- ANSWER: And it wasn't yet published. But that goes to show the importance of bush telegraph-type communication s.