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QUESTION: Carry on. ANSWER: It is -- thank you. It is possible that I wrote th is letter as a follow-on to the first generation study that we did and, as we got results back -- confirmatory testing results back, I drafted this s o that Dr Collins could contact those. There is something in that letter, if I rec...
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QUESTION: Yes, the first paragraph says: "When you donated blood recently, we included two new tests for a form of Hepatitis or Jaundice virus." ANSWER: Okay. So this letter does refer to the comparative first generation study we did.
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QUESTION: Thank you. That was what I -- ANSWER: So this is as the results of that study -- yeah. That's where it came from, then, because it says tw o 57 tests.
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QUESTION: Then, just in terms of once testing was fully operational across for the Northern Region, I think there came a point in the course of 1992 when it appears that you learnt that Dr Collins had not bee n communicating to donors who had tested positive the fact of their positive test and what steps they sho u...
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QUESTION: The reference, just for the transcript, I don't propose to go to it is NHBT0003991. How had that happened and what steps were taken to rectify that situation? ANSWER: Steps to rectify: as soon as we found out, we sort of piled resources then to get the letters out, dedica ted a secretary to help with...
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QUESTION: Dr Lloyd, I'm going to move in a moment to three further short topics of questioning I have for you, but before I do so, on the question of the introduction of hepatitis C screening, is there anything further that you would want to say or that we haven't covered or haven't covered in your statemen t? A...
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QUESTION: So I'm going to move now to an issue about the introduction of hepatitis B core antibody testing. Not as a surrogate measure for non-A, non-B hepatit is but in relation to hepatitis B itself. If we pick this up at WITN6935033. This is a memo from you. I think it's an internal memo from the names. 159 ...
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QUESTION: 18 May 1983. It refers to you having spoken to Dr Gunson regarding hepatitis B core antibody testi ng. "He says that the results of the trial have now been completed and are being presented to the appropriate Department of Health Committee on Virological Safety." Then the next paragraph discusses the t...
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QUESTION: And the reference to being "as usual ... incredibly slow in their deliberations", is that harkening bac k to the then not too distant past of the issue relat ing to hepatitis C screening, do you think, or were the re other issues that you had in mind? ANSWER: No, I think I was just referring to hepatitis...
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QUESTION: Is this right: that the Newcastle Centre or the Northern Region, had been involved in the trial of the anti-HBc test kits? ANSWER: Yes, I think we had. I think I've seen somewhere a little -- a few sheets of paper sort of showing s ome results, so yes, we did do some work on it. I can' t remember the...
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QUESTION: Just for the transcript -- 61 ANSWER: But I notice in that --
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QUESTION: Carry on. ANSWER: Sorry. I notice at the bottom of this that we're talking about the information they had available fr om the Liverpool study. I haven't seen -- I may have seen it at the time, but obviously that was a study that I thought at the time was of note.
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QUESTION: And I won't go to it but there's a letter from Dr Gunson to you in February of '93 which refers to your participation in the trial of test kits from Abbott and Pasteur, and the reference for the transcript is NHBT0018413. Can I then pick up this issue about anti-HBc testing with a meeting in July of '93...
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QUESTION: Yes, it was a meeting on 27 July '93 of RTDs/chief executives/general managers, and you wer e present along with a number of others who fell into that category. 162 If we look at page 4, picking it up at paragraph 6.1, under the headed in "UK Advisory Committee on Transfusion Transmitted Diseases", you...
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QUESTION: Then if we pick matters up towards the end of 1993, at NHBT0005291_003. This is a letter from you dated 8 November '93 to all consultant haematologists, finance managers and blood transfusion contract holders. This particular letter is addressed to Dr Hamilton. "As you know, we included provision for ...
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QUESTION: Then we can see next paragraph: "At the beginning of this year we were asked not to start this test and to wait until the whole coun try 65 started testing. We have now been informed that th is test is not to be introduced, this instructio...
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QUESTION: It would appear that Dr Hamilton, to whom this was addressed, was troubled by the decision. We can se e 166 that from NHBT000 -- ANSWER: He would be.
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QUESTION: -- 5291_002. So Dr Hamilton, who was Dr Peter Hamilton, a haematologist at the Royal Victoria Infirmary, wa s here three days later seeking advice from solicitor s. He referred to the letter he'd received from you, a nd then said: "As the Consultant in Administrative Charge of Blood Bank at this hospi...
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QUESTION: Just one further document, I think then, on this issue, which is at NHBT0097150_007, please. This i s a newspaper article in The Times, April 1995, so it 's a year and a half, or so, later. If we just pick i t up in the middle column, second paragraph down from the top. I think we can leave the whole ...
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QUESTION: An accurate reflection of your views, as at 1995? ANSWER: Yes, it is. Apart from a comment in the second section right-hand column, right at the end: "Dr Lloyd, however, agrees with the Health Department's decision in this case." I don't know how that comment came about because it does not match anyt...
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QUESTION: I think that's a reference to testing for HTLV-I, Dr Lloyd. ANSWER: Is it? Oh, I see.
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QUESTION: Yes. That's how I read it. ANSWER: Yes, thank you for that. Yes, you're quite right.
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QUESTION: As opposed to the anti-HBc. ANSWER: Okay. But anti-HBc, yes, I -- that was my feeling at the time. I think that's a fairly accurate reflect ion of what I was thinking and we see some -- you know, Dr Peter Hamilton was good at coming forward and stating the point clearly, and I have to agree with him. ...
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QUESTION: Then, whether by reference to those SHO years or th en in the 1980s when you began to concentrate on haematology and transfusion and you had some experience with blood banking, and so on, do you recall what the position was in terms of record keeping? Were there -- how meticulous or rigorous an approa...
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QUESTION: Then if we could look at document you've exhibited to your statement please WITN6935018. This is headed "Transfusion -- Do We Have Any Choice?": "The answer is Yes and No! "In many instances there is no choice, but in some cases there is a choice. "The main choices can be summarised as follows: 174 "...
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QUESTION: I just wanted to ask you a little more about the second and third of those choices. The "Make judgments on clinical state not just on the value", what did you mean by that? ANSWER: Well, not just on the value of the haemoglobin. So 175 ...[frozen screen]... look at the clinical state of the patient. ...
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QUESTION: And do you know when that process of having -- this idea of the maximum blood order schedule, when that was introduced in the region? ANSWER: Oh, it wouldn't have been introduced across the reg ion as a single process but, you know, you have to remember in the Northern Region most of the haematologists ...
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QUESTION: And I think we can see a reference to -- ANSWER: I can't remember --
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QUESTION: We can see a reference to those meetings and to hospital transfusion committees at NHBT0009710. These are the notes of a November '91 visit to the RTC by Dr Ala and Dr Hewitt. If we just go to page 2, we pick it up at the bottom half of the page first of all, paragraph 1.3, "Regional Transfusion Commi...
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QUESTION: Do you know when that weekly practice started? Was it already ongoing when you came back to the Centre in 86/87? ANSWER: It was -- that was going back -- that was operating back in 1981. I recall going into it as a registra r being in -- Dr Collins saying, "You know, you shoul d get across to that me...
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QUESTION: Then the next paragraph refers to three-monthly haematology audits. It says there: "... topic-orientated and have included transfusion matters." Is there a system with which you were -- or a process with which you were involved at the Transfusion Service, was that done with the region and the hospita...
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QUESTION: And if we look at the top of the page we can just p ick up the reference to hospital transfusion committees . It says: "Twenty/twenty-one Hospital Transfusion Departments are serviced by the RTC and of these, three/four have set up Hospital Transfusion Committees. These generally meet at three-monthly...
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QUESTION: November 1991, the date of this. ANSWER: Dr Ala and Dr Hewitt, yes. When Dr Hewitt and Dr A la visited. So I think there was a hospital transfusi on committee at the Freeman Hospital before that, when 179 I was still perhaps a senior registrar. But they would have been one of the sort of -- one of th...
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QUESTION: Looking back now, Dr Lloyd, do you think there is m ore that could have been done, whether by the Regional Transfusion Service or by the hospitals within the region or, indeed, nationally perhaps, by the Chief Medical Officer or the Department of Health, to reinforce the message about using transfusion ...
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QUESTION: Then last on this topic, NHBT0072687_001. This is a letter from you to a consultant cardiothoracic surgeon at the Freeman Hospital, Dr Hilton, 11 June 1990. It says: "Following the recent episode in which you phoned myself requiring that we provide blood bags for you to collect blood from staff in thea...
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QUESTION: Then my final topic, Dr Lloyd, is in relation to record keeping. We've covered already in your statement, and the documents we've got refers to th e record-keeping systems at the Centre and your introduction of the various computerised systems, s o I'm not proposing to ask you more about that, but y ou...
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QUESTION: Do you not have it on your screen? ANSWER: I don't, no. We've not moved on from Dr Hilton's letter yet.
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QUESTION: Ah, let's try again. Could you reload it, Sully, because it was on my screen. Have you got it there ? ANSWER: Yes, I have 1.1, "Introduction". Thank you. 183
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QUESTION: Yes, so it says: "Transfusion Centres store a wide range of documents and records ..." Then if we skip down to the third paragraph: "Each group of documents or records can be viewed as having to be retained for certain minimum periods to satisfy specific legal requirements ..." Then you say: "The need ...
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QUESTION: If we go to page 7, please, Sully, top half of the page. We can see outline recommendations and you identify there three categories: "Long Term", where the recommendation is to keep the records for 30 years: "This covers Donor and Donation records and policy and management records as well as records d...
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QUESTION: I think the Inquiry has heard some evidence or received some evidence that the Red Book guidelines around this time were 15 years, in relation to the kind of records you were here identifying should be kept for 30 years. ANSWER: Yes.
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QUESTION: Was that your understanding and was the intention, therefore, to essentially depart from the Red Book guidance and create a longer term storage system? ANSWER: Yes, definitely. I think the three of us recognise d that you couldn't, sort of, rely on things, you kno w, just saying, oh, well, you know, it...
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QUESTION: Don't worry, if you don't know, you don't know. The next question is about donor exclusion on the basis of previous transfusions. You'll recall we looked yesterday at both the national guidance and 190 then the Northern Region zone guide or booklet on donor selection, which looked at deferral of donor...
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QUESTION: Then when donors were either excluded or deferred - - and this next question is not limited to previous blood transfusion -- what were the circumstances in which a donor might be advised to go and see their GP and have further testing? ANSWER: I mean, that usually -- that was sort of a rather 191 indi...
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QUESTION: Yes. ANSWER: Very different requirement to go and see somebody.
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QUESTION: Then if you had a donor who was being deferred or s ent away because they'd had a blood transfusion in the 192 past -- I appreciate the period of time might vary depending upon the particular set of guidance in operation at that time, but if you were doing that, was there any practice of telling donors ...
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QUESTION: Cases of possible transfusion-associated hepatitis, is it right to understand that you did not report such cases to the CDSC? ANSWER: Well, if a patient had a transfusion -- well, had a transfusion and then developed hepatitis, that -- I don't think -- I don't think we were informing th e CDSC ourselve...
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QUESTION: Do you think it would have been helpful to have som e kind of reporting obligation and a body, whether it was CDSC or another body, to whom all such cases of transfusion-associated hepatitis should be reported ? ANSWER: Oh yes, definitely it would have -- it is the sort of thing that, you know, you look a...
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QUESTION: Then next can I ask you to look at your statement, WITN6935001. Page 108, please, Sully. If we look at the bottom of the page, paragraph 171, there's the reference there to "Maxi mum benefit at minimal cost". And then I'm not asking you about the first sentence in the context of the question. I've j...
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QUESTION: Next -- ANSWER: I hope that helps you.
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QUESTION: Thank you. The next question relates to the delays in the introduction of hepatitis C screening. One of the concerns expressed in documentation at the time is about false positives. What was your view on the issue of false positives and how to deal with donor s or the possible situation of donors be...
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QUESTION: In the Northern Region, could you just help us with understanding who was undertaking the screening. I f we leave aside at the moment the Teesside office an d talk about the rest of the sessions, whether they w ere general public sessions or industrial sessions in t he Northern Region -- ANSWER: Okay....
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QUESTION: -- was it a donor session clerk with, then, referra l to a medical officer in some instances? ANSWER: Yes, the donor -- actually it was the same for both the Teesside office and the new -- sessions out of Newcastle. At both sites we employed people who we re specifically looking after donor issues. So...
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QUESTION: When in May/June of 1991 there was a backlash in relation to your decision to introduce hepatitis C screening ahead of the common start date, what was the response, if any, of your Regional Health Authority ? Were they supportive of your position? ANSWER: Yes. I had absolutely no problem. I had no ad...
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QUESTION: And then the last question is this: did you get any sense during the decision making in relation to hepatitis C testing, whether from Dr Gunson and -- ANSWER: Sorry, could you --
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QUESTION: Yes, I'll start again. ANSWER: I'm sorry, I'm going to have to ask you to start th at question again.
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QUESTION: No problem. 199 During the introduction -- the decision making about the introduction of hepatitis C testing, or indeed after you'd introduced it, did you get any sense that litigation, in particular the fact that there had been the HIV Haemophilia Litigation again st the Department of Health, and oth...
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QUESTION: Sir, we are turning to the issue of domestic production of blood products and questions around t he self-sufficiency. There will be a series of presentations in the coming weeks and then some ora l witnesses as well. We are beginning with a presentation on production of blood products in England and ...
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QUESTION: Yes. ANSWER: We are going to bear in mind, are we, that there may have been sources of production if one viewed the whole as United Kingdom.
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QUESTION: Yes. That is something that will be touched upon today and examined in more detail next week by Mr Boukraa. Northern Ireland will be dealt with more with Scotland because that is where product began to be made in the 1980s for Northern Ireland. Again, it will be touched upon today and some evidence ...
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QUESTION: Yes, we will be looking at that. In preparing these presentations, we are very conscious of the f act that you have heard oral evidence. These presentations aren't an effort to try to surpass th at oral evidence or even to try to analyse it. They a re a piece of a jigsaw to go with the oral evidenc...
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QUESTION: Exactly so, sir. These are not our submissions. These are an account of what the documents seem to us to show. ANSWER: And you will be open to others who look at the documents to interpret them in a differ ent way, if they think that is appropriate, and to persuade me in their submissions that that...
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QUESTION: Absolutely, sir. Two people can look in good faith at the same document and come to differing conclusions, and that will be -- there will be an opportunity for all Core Participants to make those submissions in due course. ANSWER: Yes.
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QUESTION: This presentation that I'm going to start today, and I'm sure will go into tomorrow as well, doesn't attempt to be comprehensive. It is inevitably base d upon a selection of the documents, otherwise we wou ld be here for many, many weeks. 4No special status is gained by a document being included or e...
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QUESTION: I think that's right, sir, yes. It brings me on to where we are with this presentation which begins in the 1970s. There are other places where one can begin, as the fractionators have, back in the '50s. You, sir, have looked at some documents in the past from the 1960s, and in particular a letter fr...
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QUESTION: Exactly so, sir. Perhaps we can bring it up as good a place to start as any. ANSWER: It might be a place to begin. It's a contribution to the debate.
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QUESTION: It is, and Dr Biggs is an important player in that debate, as we will see in the 1970s as well. It's DHSC0100025_62. We can see from the heading - - 7ANSWER: I was wrong about the April. It's August.
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QUESTION: It's August. 22 August 1967. We can see from the heading, should anybody need the reminder, that Dr Biggs was from the Oxford haemophilia centre, addressed to Dr Godber, Chief Medical Officer and w hat the letter says is this. The first paragraph is ab out thanking Dr Godber for an invitation to join...
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QUESTION: That's right. That's right. ANSWER: When did that come in?
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QUESTION: That comes in the mid-1970s when, firstly, there is a reference to units and then it becomes international units. That refers to the end produc t, how much is actually made. The way that how much plasma goes in to make that end product is describe d in various ways, initially from donations, later i...
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QUESTION: Yes. 12 ANSWER: -- which we've heard, again perhaps, a lot about just recently.
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QUESTION: Yes, that will be something that comes up again repeatedly in the '70s. Of notice, the fact that t he letter was addressed to Dr Godber at the Department of Health -- ANSWER: Yes.
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QUESTION: -- or, as it was then called, the Ministry of Health, later becomes the Department of Health and Social Security. I will be coming on to the '70s shortly but, just so there is a route map of where we are going to go, the intention of a presentation is to trace the rise in demand for Factor VIII concent...
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QUESTION: Exactly, exactly. That is not something that we will be looking at in detail this week, because the focus is rather at the other end of the telescope about how fractionators and civil servants and regional administrators responded to what they understood the demand to be. It is not a question of how...
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QUESTION: Yes, absolutely. It's the top-down and bottom-up approach. ANSWER: -- how those two, personal autonomy and clinical decision making or, for that matter, strategic decision making, fit together.
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QUESTION: Yes. The fourth theme that we've identified is the importance of the availability of commercial produc ts in pushing forward both demands for self-sufficienc y and pressures on clinicians, on politicians and civ il servants, and on fractionators. Those commercial products threatened, at least in som...
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QUESTION: This is an attempt to calculate the total number of patients. We will see later in the document tha t 32 there is an estimate of the number of most severely affected. ANSWER: Well, the reason I say that is if we look at the top of the page, she starts off talking about the United States estimates, ...
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QUESTION: I think so, sir. A problem with many of these documents is that it's not entirely clear what it i s that -- or what the numbers represent, whether or n ot this is intended just to be people with severe haemophilia or others as well. As we will see in the debate that follows, there is a number that is...
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QUESTION: I think that's right, sir. The test gradually improves in its sensitivity over the years as well. ANSWER: So what she is reporting on is material which was -- some of which probably was collected and manufactured into product, so far as it was concentrate, before it was screened.
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QUESTION: Yes. 39 Going back to the paper, we can see that the next issue that Dr Biggs turns to is the amount of Factor VIII concentrate required to treat haemophiliacs in Great Britain. And we can see fro m the paragraph that follows that she bases many of h er calculations on work that was done at Treloar'...
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QUESTION: She refers to Great Britain. ANSWER: Great Britain, so that's the UK?
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QUESTION: I think that may be -- yes, a misonym For Great Britain and Northern Ireland. ANSWER: When she spoke about the 50,000 earlier, she spoke about it on the basis of "our practice", and her own reference in, I think, the 1 earlier letter ...
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QUESTION: Yes. ANSWER: So this may not be comparing like with like --
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QUESTION: No, I was about to say, sir, it is not a direct comparison. She does refer to "our practice" and - - ANSWER: Which may mean Oxford, and Oxford was recognised as a centre, wasn't it?
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QUESTION: It does and, from the context of her letter, she refers not just to Oxford but to patients who were coming into Oxford. ANSWER: Yes.
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QUESTION: So it is a significant proportion of England, but it is not the same figure here, which is betwee n 400,000 and 750,000. Of course, Dr Biggs, in her 1 967 letter, wasn't seeking to project into the future t he demand that would be required in six or seven years ' time; she was talking about what, in ...
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QUESTION: Yes. Yes. So it's not saying that is the total number of people with severe haemophilia in the country. ANSWER: Yes.
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QUESTION: I'm just mentioning in parenthesis here, sir, 44 that the assumption that is made there about home treatment, and that it shouldn't involve the use of more concentrate than in hospital, is an important assumption, which plays out in the estimates that follow. It is one that is later challenged. Ther...
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QUESTION: There is a debate which emerges about this. There is a sense that the higher use of home treatment, initially, is making up the previous under-treatment, which was done in hospital, and th e reference to "good hospital care" by Dr Biggs may b e hinting at that. There is also a subsequent debate, whic...
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QUESTION: That would certainly fit with what we see in terms of the demand curve, once home treatment beco mes more widely used. ANSWER: Indeed, it was, I think, one of the suggestions made at the time that people became awa re of the risk that blood products might transmit whatever it was that was causing A...
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QUESTION: I think, sir, we will see in some of the later papers that there is an acceptance that the assumpt ion made here by Dr Biggs is not one which is borne out in practice. Dr Biggs goes on in the paper to discuss the economics of treatment. This is a short section in 46 which she points out that the co...
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QUESTION: Optimum treatment is 700,000 or 750,000. ANSWER: Yes.
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QUESTION: The requirement for on-demand treatment, as she puts it, is 400,000. So, in her analysis, there is , at that time, under-treatment, and that's consisten t with what she has said in her letters and what Dr Rizza has said in his. As mentioned earlier, th at figure should be the same whether that treatm...
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QUESTION: Impracticable and, at that time it wasn't 51 necessarily clinically advised either. We will see -- I'm not going to go through the debate on prophylac tic treatment in the 1970s but, every now and again, it crops up in the papers and we can see that it is something which has been considered at this ...
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QUESTION: Sir, a couple of points of housekeeping just at the start. First of all, the presentation I understand is now up on the website and so people will be able to access it there. It should also ha ve been provided on the CP work spaces. The second point is that I earlier referred to some paragraph numbe...
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QUESTION: Turning back to where we left off, sir, which was the expert group on the treatment of haemophili a and its first meeting on 20 March 1973. We've looked at Dr Biggs' paper which was considered by t he group. Dr Maycock also provided two papers dealing firstly with capacity figures for the production ...
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QUESTION: "Close co-operation between England (including Wales and Northern Ireland) and Scotland will be required in order to co-ordinate and optimise blood collection and transport, the fractionation process es, distribution of the therapeutic agents, and utilisation of other blood fraction by-products." Yes,...
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QUESTION: Dr Douglas from Aberdeen. That was what the expert group said. The response to that group within the DHSS can be seen in a series of letters, which are summarised in the written presentation. I won't take you to those. I will, however, flag the fact that one of those letters from Dr Reid to Dr Wait...