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QUESTION: Yes. I'm going to take you to a meeting of a minute from March 2001 to try to understand your evidence about what happened in that interim period between the Panel being set up and the framework agreement bein g published in, looks like, March 2004. So it is DHSC0020723_087. Now, this is a "DRAFT Min...
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QUESTION: If we look at paragraph 2 we can see why the meetin g has been called and what the incident is. It is: "The incident [involving] blood products derived from pooled plasma, which ... [was] donated in 1996 and 1997 by a person who later developed vCJD. The possible size of the cohort could be up to 40,000...
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QUESTION: So you don't -- you have no recollection of that? ANSWER: No.
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QUESTION: And then the second issue that I wanted to ask you about was in relation to the conclusions that we looked at on the previous page about the risk from blood and blood components, so paragraph 11 there. Paragraph 10, conclusions were that it was: "... fractionated blood, (ie plasma products) would only h...
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QUESTION: We'll come on to look at some of those later docume nts in a moment. But is it -- it's right to understand then that the focus here was to ensure that those that were being contacted would take public health precautions -- don't donate blood, don't donate org ans or tissues, and tell clinicians if you ...
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QUESTION: But the focus wasn't -- and I think this is what Professor Collinge's concern was, was that the focu s 24 wasn't on ensuring that the patients understood tha t they actually should probably go and have specialis t referral, have -- and be under the clinical care of somebody that knew about vCJD. ANSWER:...
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QUESTION: And so key to that strategy is that the GPs underst and what the risk is and understand what vCJD is so the y can give proper information and advice to their patients; is that right? ANSWER: Yes. So we set up -- I mean, again, this came out -- it was something from -- that I think you were talk ing a...
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QUESTION: And the document reference -- we don't need to look at it -- which sets out the list of those people in th at cadre of experts is PHEN0002466_003. How was it anticipated that these experts would be accessed by the GPs? ANSWER: They would come through us at Colindale, so -- beca use we didn't want to so...
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QUESTION: And were the GPs informed that this list existed, t hat this was a -- ANSWER: I can't remember if that was established by the -- at 2003. I'm trying to think because the document I found was, I think, from 2005, so I'm not sure. It may have been something that we had more informally or 27 we just ...
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QUESTION: Just for the transcript, the date of the document t hat I read the URN out for is 22 July 2005. Can I take you to a document from December 2003, NCRU0000180_010. Now, this is an inter-office memorandum, and it appears to be an inter-office memorandum for the National CJD Research and Surveillance Unit....
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QUESTION: And it sets out -- it's from Richard Knight from th e Surveillance Unit, and it sets out a record of the details of a conversation that he had on 29 December from somebody who phoned to speak to someone in the unit because she'd been informed -- she'd been notified that she was a recipient of vCJ D blo...
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QUESTION: The question I asked was whether you understood tha t this was the position taken by the Research and Surveillance Unit, and I think what you've told me is, well, actually, there were two members of the Resea rch and Surveillance Unit on the Panel, so -- and they would have known what the position was. A...
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QUESTION: I'm going to now look at the further communications with this patient group, so sticking with the group of patients who were notified in December 2003 as a result of having blood and blood components. PHEN0002406. So this is a letter from the Health Protection Agency dated 6 February 2006 to a -- what ...
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QUESTION: Certainly, you carried out a -- you got some feedba ck from the GPs following the notification, didn't you ? ANSWER: Yes. We wanted to ask them how it went.
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QUESTION: And so we can see here that the multiple purposes o f this letter, more news about the risk, and then 3 a nd 4, the issues that Professor Collinge had been raising, is this right, that -- Professor Collinge told us that he had been raising these issues with the Department of Health and with the Health P...
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QUESTION: Then we see at the bottom of the page that informat ion is given about the third case of vCJD infection, an d right at the bottom that last sentence, it's messag ing about the risk: "This case further increases the level of concern about the risk that variant CJD may have be en transmitted to patients ...
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QUESTION: Then a leaflet was sent with that, which we -- can we look at, which is PHEN0002415_002. So "Information for patients, February 2006", and it sets out information for those patients who have been informed by their doctor that they are at risk from having blood transfusions. Then if we go over the page, p...
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QUESTION: Then there are other documents sent, and I'm not go ing to go to them, I will just read them for the transcript. Another example of a document being sent by the Health Protection Agency in January 2007, PHEN00024 65. Correspondence sent in February 2011 about Professor Collinge's direct detection assay,...
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QUESTION: Yes, I think that's right. ANSWER: That would be -- I wouldn't -- that would be a sort of -- yeah, the DH might well have that kind of thi ng. Our press office and their press office would often have discussions about lots of things, about who di d a press release, what -- you know, how that -- the 40 ...
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QUESTION: So there's nothing -- (overspeaking) -- surprising there to you? ANSWER: It sounds like a general -- what I can imagine is t hat the official sort of said to them, "These are the plans", and they are saying, "Yes, fine but just th is little bit we don't want."
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QUESTION: Can we then look at how -- the sort of mechanics of the notification process by looking at the report t hat the Health Protection Agency gave to the Panel abou t the notification. That's at WITN7091004. Now we can see this is the report from the Health Protection Agency, and it is not authored by you, it...
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QUESTION: Can we turn, please, to page 6, where the process i s set out. If we can just run through the process. So, this is how the HPA identified the process. First of all: "4.1. Identify vCJD cases who were blood 1 donors ..." That was for the ...
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QUESTION: Then, if we carry on down the document we can see 4 .6: "Stratify risk of implicated batches according to the likelihood of a recipient crossing the 'at-risk' threshold." So there the Panel -- the Panel's recommendation -- and we went over this briefly wit h Professor Ironside yesterday -- that implica...
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QUESTION: So what's set out there is that: "Patient group management strategies were developed through negotiation with professional and patient group representatives, with the aid of expe rt opinion of condition-specific professional representatives, the UK national blood services, an d NHS Trust medical directo...
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QUESTION: Then if we just pick that up, please, on page 14, w e can see at 4.10: "Trace recipients potentially 'at-risk' and assess 'at-risk' status according to the patient gr oup strategy. Inform 'at-risk' recipients of possible exposure and the public health precautions they are asked to take ... "The assess...
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QUESTION: Ie if you had enough of it you would reach the 1 per cent threshold? ANSWER: That is correct.
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QUESTION: So that's why the individual calculation for the individual patient had to be undertaken? ANSWER: Yes.
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QUESTION: But if you were somebody who had taken what's calle d a high risk product, so Factor VIII or Factor IX, where one dose was enough to get you over the one p er cent threshold, that individual calculation was not undertaken for you? ANSWER: No, I think they were just able to find out if they 48 had receive...
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QUESTION: Then we can see the outcomes on page 15: "By the end of December 2004, a total of 9 UK plasma donors are known to have developed vCJD. Collectively they have made 23 blood donations wher e the plasma has been used to make plasma products. "The donated plasma has been used to manufacture a total of 187 ...
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QUESTION: So certainly the information that that group of patients with bleeding disorders received was: you are at risk of vCJD, you must take these health precautions; if you want to know whether or not you have received an implicated batch, you can find out . So they would presumably be told, "Yes, you have rec...
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QUESTION: Then if we go over the page, please, to see the outcomes for the "Patients with other conditions", at 5.4: "By the end of December 2004 a total of 73 traceability questionnaires had been received fr om NHS Trusts, of which 53 reported having received implicated plasma products. Of these 16 reported b...
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QUESTION: I think we will come on to see that that's what happened in later notifications. ANSWER: Right.
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QUESTION: But I'm not aware of any -- I haven't seen anything -- ANSWER: This would be the report that would explain it, and if 52 it doesn't ...
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QUESTION: Then it says: "By the end of December 2004, the HPA CJD Section had undertaken a total of 1826 individual exposure assessments for patients suffering from ot her conditions, of which 0.7% (n=12) had had sufficient potential exposure to vCJD implicated plasma produc ts for patients to be considered 'at-r...
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QUESTION: And was consideration given to giving different messages to different -- to patients who had had 60 perhaps more plasma than others -- plasma products? ANSWER: Within the -- okay. There are lots of different groups of at risk patients that the CJD Incidents Panel created really or developed through it...
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QUESTION: So whichever clinician was responsible for notifyin g the patient would have had to make a decision about whether or not there was any counselling available, presumably? ANSWER: Yes. I mean -- yeah, there -- and the idea of it being through the clinician who knew the patient be st would be that they wou...
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QUESTION: And do you recall any discussions or consideration being given to the fact that for quite a large numb er of these patients who have been notified, they had 63 already had this devastating history of infections, sometimes multiple infection as a result of their treatment with blood and blood products, a...
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QUESTION: Can I take you to the House of Commons Science and Technology Committee report from 2014. TSTC0000052 . Before I ask you a question on this, is this a document that you think you have received from th e Inquiry? ANSWER: Yes.
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QUESTION: Can we just -- just so we understand what this is, if 64 we just look at -- we can see it's dated July -- published on July 2014. We can see it's the House of Commons Science and Technology Committee. It is called "After the storm? UK blood safety and the r isk of vCJD". If we look very briefly at ...
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QUESTION: If we can just turn to page 40, please. We can see this is in the section where they're setting out th eir reasoning and conclusion, and it's the bold at 70, and I just want to get your response to this: "People who are notified that they may have been exposed to CJD will inevitably be alarmed by this ...
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QUESTION: Now, you've indicated that the group of transfusion blood component recipients was treated differently to 67 the other groups that were notified. In terms of keeping in contact with the group that was notified in September 2004, so the plasma product recipient group, was it a different strateg y? ANSWER...
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QUESTION: And so any communication in respect of changes in risk, developments in testing and so on would have been done from the HPA to the UK Haemophilia Centre Director Organisation, with the expectation that th at would then be passed on to their patients if 68 appropriate. ANSWER: With an agreed plan of c...
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QUESTION: And we've certainly got one you've exhibited to you r, statement I think -- I think it's your statement. One example of that which we don't need to go to, but f or the transcript, it's in February 2009 when haemophi lia centre doctors were told about the finding of the person with haemophilia being -- t...
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QUESTION: I don't intend to ask you anything more about that. For those that are interested, there's been a paper published by Dr Hewitt and others about that notification exercise, and that can be found at RLIT0000156. I'm going to come then onto ask you about notifications that took place in 2006. If we could lo...
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QUESTION: Yes, I think you might be right there. I don't thi nk we know who authored it. I think you must be right . Again, I ask you the same question: is this a document you've received from the Inquiry? ANSWER: I can't remember whether I gave it to the Inquiry o r 70 received it from the Inquiry, but I've c...
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QUESTION: Yes, okay. I just want to read the summary which i s on the first page, please: "The English and Welsh blood services, supported by the HPA, carried out a further plasma product notification exercise in November 2006 to inform 13 1 hospitals of four batches of plasma product which h ad been manufactur...
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QUESTION: It took place just over a couple of years later -- ANSWER: They thought -- I think -- I was looking through so me of the documentation for 2004, and it said -- somewhere or other it said there were four untracea ble batches, and then obviously someone then did trace them.
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QUESTION: We can see there that the same process is undergone as we looked at in that report of the 2004 notificatio n; is that right? ANSWER: Yes.
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QUESTION: It's the same process. Then in your witness statement, which -- can we turn up, please. It's WITN7091001 at page 21. You have identified a further blood notification exerci se that took place, and I understand that has come fro m one of the CJDIP annual reports. If we look -- I think it starts, in fac...
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QUESTION: So those were the subject matter of the notificatio n. Do you know or do you have any -- can you give us any help on how it is that in Scotland they were able to trace 90 recipients, a smaller country, whereas in England only 20. Is there a reason for that? ANSWER: It looks to me that they just had a ...
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QUESTION: Yes. ANSWER: If you go back to paragraph 71.
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QUESTION: Yes. Which starts on the earlier page. ANSWER: Right. The ESOR was actually -- that's a team with in the Department of Health. I can't remember what it actually stands for, it is their modelling analytic al team, it is not the European School of Radiology.
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QUESTION: Ah, so that is where the error is. I have got that 75 written down -- ANSWER: I can't remember what it actually stands for.
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QUESTION: I can't either. Then I just want to ask you one question then about the 2010 -- a notification in 2010. We get this from an annual report of the CJD Incidents Panel. WITN7091016. This is an exhibit to your witness statement. Here we go. 1 January to 31 December 2010 annual report. If we could just g...
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QUESTION: So it is not -- looking at that, it looks like ther e might be a seven-year delay between the 2003 incide nt and then the notification, but you are saying that' s not the case? 7 ANSWER: No, if you look at this, it is patient notification ,...
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QUESTION: The point being made here is that there was a delay in implementing Panel advice? ANSWER: Yes.
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QUESTION: Was that -- I asked Professor Ironside whether or n ot there was an obligation on trusts -- NHS trusts to implement Panel advice and he wasn't entirely sure of the -- ANSWER: No, but I think with this particular -- I think what -- in normal practice you would expect a hospi tal to do what the HPA reco...
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QUESTION: So is this right, to draw from that, that the Panel gave advice to NHS bodies in relation to notificati on, and then the Panel was kept up to date as to whethe r or not those had been implemented? ANSWER: Yes. So we kept a tally of what -- you know, who h ad traced -- who had taken instruments out of ci...
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QUESTION: You could escalate it, effectively -- ANSWER: Yes.
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QUESTION: -- up the chain, and then steps could be taken? ANSWER: Yes. So that was basically the route. But it was not a straight -- it wasn't an obvious route. It didn' t generally happen, it was just that was a particular issue.
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QUESTION: So that was the next question, is, was it common th at NHS bodies were unwilling to implement panel recommendations? ANSWER: No, I remember there were two difficult -- this one and there was -- well, this was one where an individual -- someone disagreed with Panel advic e in the hospital. You know, the...
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QUESTION: Then you left, as we discussed this morning, the CJ D unit in May 2012. So it is right, is it, that you didn't take part in the 2013 denotification process ? ANSWER: No.
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QUESTION: That was led by Dr Katy Sinka, is that correct? ANSWER: If that's on the documents. I mean, everyone did different roles at different times, so ...
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QUESTION: And the Inquiry has a witness statement from her. I just have one last area of questioning for you. Can we look, please, at HSOC0016641. This is an article published in Haemophilia co-written by you, "Risk reduction strategies for [vCJD] disease transmission by UK plasma products a nd their impact on p...
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QUESTION: In fact the 2003 recommendation has a footnote 58, and in fact it makes it clear in the footnotes that -- that it's a -- that the recommendation comes from t he ACDP "Transmissible Spongiform Encephalopathy Agents: safe working and the prevention of infectio n". So in terms of promulgating those kinds o...
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QUESTION: In your discussions with and your communications wi th NHS trusts as a result of Panel recommendations, wh at was the impression that you got as to how successfu l that 2003 -- how successfully that had been distributed, that 2003 message? ANSWER: I wasn't -- I mean, we -- I'm trying to think. Sor ry,...
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QUESTION: And then we see from the extract from the article t hat we have just looked at that in 2008, Department of Health "provided central funding for the refurbishm ent of suitably quarantined endoscopes used on patients at risk of vCJD". Did you have any -- did the HPA have any role in implementing that sch...
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QUESTION: When we looked at the report from the Health Protection Agency to the CJDIP giving a summary of what had happened and so on, and we were looking at the outcome, and it said in there that the haemophi lia people had been thought to have been notified. Was that an assumption by the Health Protection Agency...
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QUESTION: Again sticking with the 2004 plasma product notification, in terms of the decision to have an umbrella notification, can you recall what weigh t was given to the individual patients' well-being, a s opposed to the question of public health protection when the decision was made to have an umbrella notifi...
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QUESTION: Again sticking with plasma product notification in 2004. Is it right to understand your evidence that the notification for those patients with bleeding disorders was managed by, in the case of people wit h haemophilia, their haemophilia clinicians? ANSWER: Yes.
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QUESTION: And that it was a matter between the haemophilia clinician and the patient as to whether there would be a follow-up appointment. The Health Protection Age ncy would expect one to be offered, but whether it was taken would be a question between -- a choice for t he patient? Is that what the HPA unders...
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QUESTION: So the question of whether or not an appointment wa s going to be offered was a matter that was left to t he decision of the haemophilia clinicians themselves? ANSWER: I believe so.
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QUESTION: And does it follow from that as well that the Healt h Protection Agency didn't have any communication wit h those patients with bleeding disorders' GPs? All t he 90 communication on the notification went through the clinician that dealt with their bleeding disorder, rather than communicating with their...
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QUESTION: Again sticking with the -- ANSWER: Sorry. It would definitely have been because we didn't have these patient IDs. We didn't have thei r details to contact the GPs.
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QUESTION: Sticking again with the 2004 plasma product notification. With the benefit of hindsight, shoul d there have been a list sent out to GPs of specialis t counsellors with information about the risks in the 2004 notification so that patients could have contacted them, or should a set of specialist counsell...
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QUESTION: I may have misunderstood your evidence. I understo od that this group of specialist experts was there to support the clinicians rather than the patients? ANSWER: Well, sometimes, or sometimes the clinicians might have referred. Because we had nurses -- some of th em were nurses, some were counsellors,...
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QUESTION: Again still on the 2004 plasma product notification . Should everyone have been offered and/or written to by the Prion Centre to be able to have a specialist evaluation, instead of leaving the communication of that up to the GP during -- at the time they were notified? So we looked at the February 2006...
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QUESTION: So effectively for a specialist evaluation is what the question is, so that they could go and have a discussion with, an assessment if necessary, or whatever would be suggested by the Prion Unit. ANSWER: I mean, the Prion Unit were most -- as John Colling e was explaining -- were most keen to work with...
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QUESTION: Were there instances, to your knowledge, of the wro ng people being notified that were at risk for public health purposes? For example, were you aware in 20 04 that the Royal Free hospital notified recipients, o r do you know whether the Royal Free hospital notifie d recipients of all blood products th...
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QUESTION: And were you aware of any other instances of the wr ong people being notified and then having to be contact ed and de-notified, other than in that 2013 -- ANSWER: Well, there were other de-notifications as the risk assessments changed. Not just the -- there were ot her issues. But I wasn't aware of an...
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QUESTION: Was any support given to people that were de-notifi ed? And was any consideration given to that? ANSWER: I -- it would have -- there would have been the sam e contact list available through the GP. You know, t hey would have had the same list of, you know, these ar e the national centres and these are...
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QUESTION: I'm now asking you a question about some of the evidence that Professor Collinge gave. He gave som e evidence last week about the product that he was involved in developing, the pre-soak in order for instruments he used on those at risk of vCJD could be decontaminated and sterilised. I'm asked to ask ...
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QUESTION: Another question in relation to surgical instrument s, and I think this might arise from the passage we looked at in the article co-authored by you about this. Were quarantined endoscopes reserved for particular individual patients, or could they be us ed on any patient considered to be at risk? ANSWER...
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QUESTION: Then, lastly, you gave some evidence in relation to questions about those who had been highly transfuse d group, and the question is this: as for the ethical issues about notifying those with multiple blood transfusions about the possible risk to them, what consideration was given to their right to be not...
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QUESTION: Yes. What consideration was given to their right t o be notified? ANSWER: The people who received many blood transfusions?
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QUESTION: Yes. ANSWER: Well, everything was -- well, I think the decision -- first of all, I'm not sure what actually was resolv ed, because that was after I'd left CJD, and these discussions were going on and the risk assessments were going on. And there was a big discussion, one about what the actual risk was,...
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QUESTION: And the second part of the question was: was it too difficult to even find out who these people were? So what was the difficulty in finding out who they were? ANSWER: As we discussed with the chasing of batches, I thin k when you are trying to figure out who has received how many doses of blood -- I me...
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QUESTION: -- starting as a medical reporter? ANSWER: Indeed. Yes. 2
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QUESTION: You were the medical correspondent for The Mail on Sunday in 1983? ANSWER: I was and I'd just started at that point on that pa per and the newspaper was fairly new, at that stage.
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QUESTION: Then in 1988 you moved to the Daily Mail as Assista nt Editor in charge of features coverage. ANSWER: That's correct.
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QUESTION: Then you were Deputy Editor of The Sunday Times fro m 1991 -- ANSWER: Yes.
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QUESTION: -- and Editor of the Sunday Express from 1995? ANSWER: Yes.
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QUESTION: Subsequently, you've had executive roles with Conde Nast and Trinity Mirror Group? ANSWER: Correct.
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QUESTION: The role this Inquiry is particularly interested in is of course your role as medical correspondent. Can you tell us, first of all, how you came to be appointed as medical correspondent at The Mail on Sunday? ANSWER: I was working purely on shifts at the Daily Mail. That's how many people -- it's alm...
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QUESTION: Before we come to the particular articles that you wrote, I'd like to just explore with you the proces s of a story then reaching the front page of the paper. ANSWER: Sure.
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QUESTION: What can you tell us of the process that's followed before something is published? ANSWER: So it's different for each faction of the paper but for a specialist, which is slightly different from a ro ving reporter, the specialist is -- your brief is to loo k at 4your subject, tunnel vision, inside out, ...
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QUESTION: You might have a story that you want to be publishe d but what checks are in place before that story is publi shed? ANSWER: First and foremost, you have to have some kind of intuitive sixth sense about what's interesting and what isn't quite the story and what people don't really know about and, frankly...
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QUESTION: Just to go back to the general point of you might h ave a story, you might have a story bubbling, but what 6checks are in place by the paper before it's publis hed? ANSWER: Right. So the very first thing you do as -- this i s a good story, before you go off and investigate and spend time and money, you...