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QUESTION: Moving to your time in Glasgow in 1976 to '79, you 143 said something of it originally, but what kind of interaction, if any, did you have with haemophilia patients? ANSWER: Well, I, having moved to Glasgow, I was involved with -- we were collecting blood samples from patie nts to check on their Factor VIII levels after treatmen t, and looking at things like half lives and those sor ts of things.
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QUESTION: The half life of a Factor VIII product that they'd been given? ANSWER: Yes, yes.
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QUESTION: Did you conduct any other routine blood tests on th ose patients at that time? ANSWER: No. Just factor assays.
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QUESTION: Would you actually draw the blood yourself? ANSWER: No, no, it was drawn by a nurse or a doctor.
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QUESTION: And are you able to assist at all with what the consenting process was that the patient went throug h before giving that blood? ANSWER: There wasn't -- as I recall, there was no consentin g process.
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QUESTION: So the blood would be taken from the patient withou t the patient being told what the blood was going to be used for? ANSWER: It might have been. It might have been. 144
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QUESTION: You personally weren't involved in those discussions -- ANSWER: No -- no.
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QUESTION: -- with the patient? ANSWER: No. I can't tell you if there were bits of paper signed or whatever was done. It wasn't that appare nt, because the number of patients within a haemophilia unit -- the whole haemophilia unit is very much sor t of like a family. And patients were coming in all the time to get their treatment and knew the haemophili a directors and the nurses intimately, because they w ere there quite often, and I don't think -- I don't kno w what consenting processes would have been involved.
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QUESTION: What, other than checking the blood for the effect of the Factor VIII products, what other roles did you undertake at Glasgow at that time? ANSWER: Well, I actually looked at the Factor IX concentrat e that -- the Defix Factor IX concentrate, and the Supernine concentrate, and looked at using differen t assays to look at that thrombogenicity.
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QUESTION: That was research work that you were doing -- ANSWER: Yes.
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QUESTION: -- on the products rather than -- (overspeaking) -- the patients? ANSWER: Yes, on the products, yes. While I was there. 45 I also did things to do with Factor VIII assays, recoveries after exercise and various other things. I worked with who is now Professor Lowe at the time and we did some work with recovery of Factor VIII w ith exercise, and things like that, physiological effec ts.
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QUESTION: What links did you have at that stage with your for mer colleagues at the PFC? ANSWER: Well, I was still working -- Peter Foster was there at that time. I suspect Jim Smith had left, I think. And he knew what I was doing, because we subsequent ly wrote the paper about Supernine and PEG concentrate . So he knew what I was doing.
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QUESTION: Did you have any links with pharmaceutical companie s at that stage, while you were at Glasgow? ANSWER: No, the only reason -- the only pharmaceutical comp any that happened while I was in Glasgow was that David Heath, who you've heard mentioned, came into the lab while I was working to speak to my boss, Dr Prentice, who was the haemophilia director, and started to talk about polyelectrolytes. Within my hearing. So that's how it came about that I ended up working for Speywood.
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QUESTION: You've pre-empted my next question. ANSWER: Right.
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QUESTION: It was how you were recruited to Speywood in 1979. 146 Was it from that -- ANSWER: Essentially I heard that conversation about polyelectrolyte. I also -- and -- yes, I wrote to David and said -- because I wanted to actually get back to something more production-orientated, and explained my experience, and I got a letter by retu rn of post saying: Yes, when are you going to start? So that's what happened.
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QUESTION: You then moved to Speywood. Physically, where were you based when you were working for Speywood? ANSWER: Wrexham.
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QUESTION: In Wrexham? ANSWER: Yes.
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QUESTION: Did you have anything to do with the office in Nottinghamshire? ANSWER: Not really. We occasionally -- we went over there occasionally. Myself and the production, I guess y ou mean the production director, Dr Costello, (?) ** and -- he was in charge of the Wrexham site. We occasionally went over there, but just to talk abou t progress with porcine Factor VIII.
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QUESTION: So you're essentially going there for meetings, but never being based there; is that right? ANSWER: No, never been based there.
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QUESTION: Your title was chief scientist? 147 ANSWER: Yes.
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QUESTION: What did that role entail? ANSWER: Well, I sometimes thought it was because I was the only scientist. At the time. It involved -- my going there was primarily to develop porcine Factor VIII. There was a problem w ith the current product, which was not soluble, and couldn't be used. I subsequently sorted that probl em out -- actually, quite quickly -- then went over to the States to pick up the polyelectrolyte, which seemed to have been now working for Factor VIII. S o that's the way it went. I then came back and scale d the polyelectrolyte method up to produce Hyate:C.
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QUESTION: That's the porcine product? ANSWER: The porcine product.
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QUESTION: But when you say you went over to the States, shoul d we understand that to be literally -- ANSWER: -- (overspeaking) -- Dr Johnson's lab.
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QUESTION: Did you stay there for long and conduct research or was it literally to pick up the polyelectrolyte -- ANSWER: Well, I stayed there -- I think I stayed there thre e or four weeks, just to make sure that the method worked, and to -- because I didn't -- because it previously hadn't, for Factor VIII, but it did work . So I then picked up the polyelectrolyte, brought it 148 back to Wales, which is where we were, to Wrexham.
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QUESTION: So that we are clear, this is for polyelectrolyte t hat was being licensed from Monsanto? ANSWER: Yes, it was.
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QUESTION: The accountant's report from 1981 that we looked at earlier -- and I know you were in the room when we were going through the presentation earlier -- it referred to there being 21 staff in Wrexham. I am not going to ask you for what each one of them did, as of 1981, but what kind of roles were those people doin g? What were people doing in -- ANSWER: Initially, there were not 21 but there was -- initially, there was a technician in the lab who wa s doing Factor VIII assays, mostly, and there were a collection of three or four or maybe five individuals who were responsible for collecting the blood on the abattoir.
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QUESTION: The pig blood? ANSWER: Yeah, collecting and separating it.
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QUESTION: Then there was you, as chief/sole scientist? ANSWER: Yes. And then there was Dr Costello (?) ** who, actually, was a botanist but he was obviously a scientist, as well. But he was in overall charge of the site, and the personnel.
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QUESTION: Who gave you directions about what it was that you 49 should be doing? ANSWER: Me.
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QUESTION: We heard in the presentation about the importation of Koate and Humanate -- ANSWER: Yes.
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QUESTION: -- and its sale within the United Kingdom. What ro le, if any, did you have in the importation and sale of Koate and Humanate? ANSWER: I had no -- very little knowledge of it. I certain ly had no input at all.
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QUESTION: We saw from the data sheet that it was -- the addre ss given was the Nottingham address. ANSWER: Yeah.
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QUESTION: So far as you're aware, was the Koate and Humanate business run from Nottingham -- ANSWER: Yes.
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QUESTION: -- or from Wrexham? ANSWER: No, from Nottingham.
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QUESTION: Were you ever involved in the processes of seeking product licences or dealing with the DHSS, insofar as it related to Koate and Humanate? ANSWER: No.
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QUESTION: I'm going to quickly ask you, before we have a brea k, about porcine Factor VIII and Hyate:C. You said -- you've explained how you went and you picked up 150 a polyelectrolyte and understood that it now worked in respect of Factor VIII, and then you solved the problem that they had been having with it. In your statement, I won't take you to it, but at paragraph 14 you say: "I developed a production scale process to recover porcine Factor VIII." ANSWER: Yeah.
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QUESTION: Then at paragraph 37 you say that you had little involvement in porcine Factor VIII thereafter. ANSWER: I had -- after scaling up, yes, I showed the method to others, the other people, and they were perfectly capable of handling it. It was a very easy process , really. The difficulty with any Factor VIII or Factor IX concentrate, it's not so much making it, it's knowing you've got the right thing at the end of it, in terms of assays, and analytical work, and knowing that there's no potential for clotting when you don't want clotting. So thrombogenicity, as we call it.
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QUESTION: Did you have any role in that aspect of the work in terms of Hyate:C? ANSWER: The assay?
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QUESTION: The assay and the checking, the quality control and -- ANSWER: Yes, to an extent, because I had experience of -- 151 Factor VIII assays are particularly difficult to standardise, and we did have a problem with porcine Factor VIII because the kinetics of the production of porcine Factor VIII are different between human and pigs. And there was a pig standard which was suppl ied by a commercial company, which turned out to be wro ng because of the way it was -- had been assayed. So yes, I had quite a lot of input into that. It's an interesting topic, the kinetics of blood clotting i n pigs versus human. Sorry.
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QUESTION: I won't go into too much detail about that, and you 'll forgive me. But were you involved in any of the applications for product licences for Hyate:C? ANSWER: Somebody else wrote them, because I wasn't there at the time.
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QUESTION: But you left the company by that stage? ANSWER: I was either -- I may not have left. I might have been somewhere else, like at Elstree or in Paris, o r I also worked on deficient plasmas and various othe r things. So I was away from, sometimes away from Speywood, and I don't think that licence was applie d for until the facility, the manufacturing facility, had been built. And so I was -- I'm not -- I did - - don't think -- I might have done. I don't remember whether I did or not. 152
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QUESTION: I haven't found many papers with your name on in connection with the Hyate:C -- ANSWER: The product. The product licensing or --
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QUESTION: And indeed the product licensing. ANSWER: Yes, well, okay, in that case I didn't.
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QUESTION: We haven't looked at this in the presentations and we will come back to that at a later date, but we know that the application for the product licence was ma de on 29 November 1983 -- ANSWER: Oh, right. Okay.
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QUESTION: -- and the licence was granted on 3 December 1984. ANSWER: Right.
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QUESTION: Would you have still been working at Wrexham for Speywood at that time? ANSWER: Um ... well, no, I don't -- now you come to mention it I actually don't know, because I did have a very -- I didn't really work full time at Wrexham, for a lo ng time before -- a long time after -- after I went an d worked down at the -- at Elstree.
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QUESTION: At BPL? ANSWER: At BPL. And I don't know -- if you ask where I was , I know I was doing work at the Royal Free on deplet ed plasmas, for example, and I just was working in oth er people's labs, I think.
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QUESTION: Is it fair to say, then that, certainly from your 53 current recollection, you didn't have a great deal of input into the finalisation of the product Hyate:C? ANSWER: No, I don't think I did. Well, in the sense that I did formulate it, and I did run -- develop assays, and various other thin gs, and I did have an interaction with NIBSC, N-I-B-S-C , about the assay, because that caused us all a lot o f confusion at one stage. So I was doing that.
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QUESTION: Were you involved in, for example, directing the thinking about where this product should be used, a nd which cohort of patients it should be used with? ANSWER: Not really. It was inhibitor patients, as far as I was concerned.
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QUESTION: That's where my question is leading to. When the product licence went in, we'll look at this in due course, it is very expressly said to be for inhibit or patients. ANSWER: Yeah.
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QUESTION: One question that the Chair may wish to consider, i n due course, is why porcine Factor VIII, in the mid-1980s at a time of risk of both hepatitis and AIDS, was directed towards inhibitor patients rathe r than the wider population of -- ANSWER: Of patients without an inhibitor?
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QUESTION: Yes, exactly, without inhibitors. 154 ANSWER: Yeah.
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QUESTION: Are you able to give any insight into that question from your perspective? ANSWER: Well, from what I knew, first of all, porcine -- original porcine Factor VIII had a shocking reputation. This is before Hyate:C. It was a real ly toxic product. It produced thrombocytopenia, plate let reduction because of this so-called platelet activating factor, which was thought to cause this problem. They had allergic reactions to the protei n, et cetera. When it came to Hyate:C, it was much mo re highly purified and actually was very well tolerate d by patients. But there was the concern that it wou ld, potentially, in non-inhibitor patients, produce a cross-reacting inhibitor to human Factor VIII.
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QUESTION: It follows from that, that by taking this product, they would then render themselves incapable of taki ng a human -- ANSWER: Yes.
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QUESTION: -- Factor VIII plasma product in the future? ANSWER: Yes, and that was the big unknown concern.
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QUESTION: Were there any other reasons, you think, that -- ANSWER: Well, I think you were going to be giving pig prote in to people and, again, that might be a risk of creat ing allergic reactions to the pig protein, which had be en 155 seen in the past, with much more -- much less pure products, so I don't think people wanted to use it.
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QUESTION: Ms Middleton, I'd like to turn now to the fractionation of human Factor VIII, by the polyelectrolyte method. I won't take you to your statement but you say in it that shortly after, relatively shortly after joining Speywood, you were seconded to BPL, and you subsequently spent some ti me 156 in Paris as well at the CNTS lab. ANSWER: Yes.
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QUESTION: I think that was in April, from April 1981. We heard in the presentation about how there was some optimism about the product in 1981, which gave way fairly quickly to a more pessimistic view of th e prospects of the product. ANSWER: Mm.
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QUESTION: Can I ask, you have said in your statement that yie lds were variable, and that problems soon became appare nt with the product. Could you explain what those problems were, and how quickly they became apparent to you, and to others? ANSWER: Well, as you probably know, blood clotting is a very -- it's quite a complex process. It's a cascade. That's to make the blood clot. There a re also a lot of mechanisms in there to stop blood clotting when it's not supposed to. So it's quite a complex system to deal with. And if you are maki ng Factor VIII, purifying it, depending on the startin g material, you, have plasma which is in various -- o nce you collect plasma or blood from the body, it's immediately not as stable as it was when it was in the body, because you've exposed it to surfaces, you've generally exposed it to the air and you've generall y 57 changed the profile of it. And the inhibitors to blood clotting and the procoagulant. So, particula rly with the polyelectrolyte, the Factor VIII, it prove d to be very difficult to control the clotting, if yo u like, because the Factor VIII became -- was probabl y becoming activated during the process. And how activated it became depended on the quality of the starting material, quite often. But it did result with -- with huge variability, trying to control the process, and it proved, in my hands anyway, very difficult to control it with any of the sort of different parameters that I tried. So you absorb onto the polyelectrolyte and then you wash off. That's essentially what you have to do. By controlling -- the way you absorb it, or the thi ngs you add to it to try to keep it stable, the way you elute it off, can all affect what happens in terms of the stability of the final product, and what it pro ved to be -- relatively easy, you could elute things of f, and you could measure a Factor VIII level that seemingly was high, remembering that the assays themselves could sometimes not discriminate as to whether you'd got an activated system or not, and then, as you stored it, let it stand, the activity dropped off because the Factor VIII was becoming 158 activated and lost. So it proved very difficult to control and that in essence was confirmed, because when we made Factor VIII sequencing, that was Professor Tuddenha m's project, he had to use a very serious anti-proteoly tic agent -- it was actually nerve gas -- to stop the clotting factors prevent activation of the clotting cascade, in order to get pure Factor VIII at the en d of it.
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QUESTION: If I can just interject there, a couple of things arise from that. The variability of the product. ANSWER: Yes.
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QUESTION: Does that make it hard to translate from a laboratory-based product on which you can do your experiments and test the potential, into a mass produced product which could actually be marketed? ANSWER: Yes, the main thing you have to remember when you'r e producing any product is quality, safety, and efficacy. If you're getting variability yields and you don't know why, then you don't have the quality . And not the safety, either.
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QUESTION: The process you were talking about with Dr Tuddenha m there -- I'm going to come on to recombinant shortl y, but there's an article that he's written that I kno w that you have seen. I'm not going to bring it up, but 159 the reference is HSOC0022968. And he is describing how he worked with you and with others in order to try to purify Factor VIII that he can then go on to use in gene sequencing which would then give rise to recombinant products? And he said that by 1982 he had devised a multi-step procedure, which had -- which led to that -- in cooperation with others, I should emphasise. ANSWER: Mm.
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QUESTION: And he said: "The bulk processing capacity of polyelectrolyte, combined with the exquisite specificity of monoclonal antibodies, overcame all remaining problems, although Frances Rotblat and Do n O'Brian (?) ** in my laboratory found that they nee ded to use large amounts of highly poisonous nerve gas type enzyme inhibitors to keep the Factor VIII stable." ANSWER: Yes.
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QUESTION: So that is what you were referring to a moment ago? ANSWER: Yes.
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QUESTION: I don't think it needs to be stated why using a ner ve agent -- ANSWER: Yes. 160
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QUESTION: -- as part of a product -- ANSWER: Not suitable for a therapeutic product, no.
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QUESTION: Thinking back now, are you able to put a timescale on when you became aware that these problems were goin g to be insurmountable in terms of bringing a product to market? ANSWER: Well, I think I became aware of it when I was actua lly at Elstree.
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QUESTION: This is 1980 to 1981? ANSWER: Yes. If that's when it was, yes. And I spent a couple of months after that in Orsay, in Paris, a nd we had the same problems. We couldn't get the thin g to be stable. You know, one day, we got something that we thought was 75% yield, then if you left it on the bench, it had gone down to 25 per cent. So it was really not looking very viable at this stage in Elstree.
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QUESTION: You were in Paris from April 1981, according to paragraph 17 of your statement, for a few months? ANSWER: Yes, for a few months, yes.
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QUESTION: By that stage do you think you were aware that this wasn't really going to be -- ANSWER: Well, it did just never seemed to -- no, I ...
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QUESTION: I am just going to ask from a document to be brough t up on the screen. It's BPLL00016007_018, please, 61 Soumik. BPLL0016007_018. This a letter which is written to Mr Heath from Dr Allain in Paris. ANSWER: Mm.
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QUESTION: I know you have seen this in the files we provided you with. He says: "Dear David. "I enclose a summary of the results of PE5 phase 1 which has worked out very well. "We are presently doing some additional experiments on filtration and freeze drying that lo oks very promising. The loss in yield seems quite reasonable. "I have done all the background work for the next step and the raw material is now being prepare d. I am confident that step 2 will be as successful as step 1." So that's Dr Allain's view in this letter on 27 May 1981. ANSWER: Yes.
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QUESTION: I'm cautious about reading too much into one letter in a snapshot in time, but around that time, had you already doubts developing in your mind? ANSWER: I did. And obviously Jean-Pierre Allain and I work ed together on the preparation in stage -- I think it was step 2, in Paris, and, we had the same problems as I'd 162 had at BPL. So I think his letter was optimistic.
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QUESTION: This letter, of course, is referring to him at the end of step 1. ANSWER: Yes.
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QUESTION: You subsequently worked with step 2 -- ANSWER: Yes.
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QUESTION: -- and it was disappointing? ANSWER: Yes. And we never really went to step 3, I don't think.
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QUESTION: We heard earlier, I believe you were in the room fo r it, about Dr Tuddenham's lecture from some point in 1981 in which he expressed some optimism. ANSWER: Mm.
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QUESTION: There is also a paper -- I won't bring it up, but BPLL0016007_026 -- the authors are Tuddenham, Lane, Rotblatt, Johnson, Snape, you and Kernoff, "Respons e to infusions of polyelectrolyte fractionated human factor VIII concentrate ..." ANSWER: Yes.
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QUESTION: "... in human haemophilia A and von Willebrand's disease. ANSWER: Yes.
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QUESTION: Both of those -- both the lecture and the paper -- express some hope for the method? ANSWER: Yes. We made a batch at BPL with carefully 163 collected -- in fact I think it was almost fresh -- cryoprecipitate, from very good quality -- specifically for those clinical trials, because it was done on four patients, I think, three haemophiliacs and one von Willebrand.
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QUESTION: Yes. ANSWER: Yes. And specifically for that. It was made in th e clean room at BPL, and -- specifically for that experiment. And that showed that the Factor VIII t hat we got was good recovery, which suggests it was qui te good Factor VIII, and that it didn't work in von Willebrand's disease, which is what we might ha ve expected because of the nature of the protein at th at point.
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QUESTION: So an example of how, when it is done in very close ly controlled circumstances, it could work, but that - - ANSWER: Yes, and that was probably due to the fact that the cryoprecipitate was very good quality. The stuff - - the product I was working with at BPL was mostly freeze-dried product that had failed quality contro l for some reason. Mostly due to pyrogenal bacteria, or pyrogen really, or something of that order. So I worked on that, which had been freeze-dried and w as not terribly good quality. The stuff that probably -- the cryo that I 164 worked with on this -- on that product, was possibl y fresh and probably never been even frozen. It was probably made straight from that. So if you had perfectly good quality cryo, then maybe it would wo rk.
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QUESTION: You also wrote a short paper on viral inactivation which is dated October 1983. ANSWER: Yes.
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QUESTION: I won't bring it up, but it's ISPN0000409_009. ANSWER: Viral separation.
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QUESTION: Sorry, viral separation, my error. If I may summarise the paper, it's that the in vitro experiment that you did showed viral separation. ANSWER: Yeah.
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QUESTION: But as per Dr Tuddenham's lecture, there was a need to look at that in clinical trials if that were to be proved to be safe and efficacious? ANSWER: Yes, we showed that in Professor Thomas's lab. We added hepatitis to the concentrate and then worked it over the polyelectrolyte, and that showed that ther e was no absorption of the virus to the ion-exchange resin.
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QUESTION: Meaning that the ultimate product would be free -- ANSWER: Yes.
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QUESTION: -- of hep B? 65 ANSWER: Would be separated from it, yes.
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QUESTION: Was there any expectation that it would also clear NANB hepatitis? ANSWER: Possibly for the same reason.
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QUESTION: You say "possibly" but that, of course, couldn't be tested for at the time? ANSWER: No, no.
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QUESTION: Hence the need for clinical trials. We will come b ack to the clinical trial in a second. Before I do, we know that you developed your concerns about how via ble this was going to be as a product. Did you share those concerns with Mr Heath? ANSWER: Yes.
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QUESTION: This was at a point in time when Mr Heath and Speyw ood 166 was seeking a £4 to 5 million investment, half of which was coming from public funds. In that contex t, do you think that that claim was one that could reasonably have been made? ANSWER: Um ... with hindsight, it was perhaps a bit economi cal with the truth.
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QUESTION: Were you involved in any way in the -- ANSWER: No, no.
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QUESTION: If you had been involved, what would you have said to Mr Heath about it at the time? ANSWER: Well, I would have said -- I would have suggested t hat he moderated his language.
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QUESTION: Sorry -- ANSWER: Well, I think I should say something about David, because he was very entrepreneurial, and he was entrepreneurial from very early -- he took on a porcine Factor VIII; why on earth would he do tha t? He was a pharmacist. It was a very strange thing t o do. But he saw the potential in it. He took on th e polyelectrolyte fractionation to improve that porci ne Factor VIII, which, again, was very entrepreneurial . And obviously the recombinant Factor VIII came from him and he worked on it. But the trouble was that he was very -- not very good at man management, and people let him down in 167 some of the things they did and that was a shame. And he also ended up -- he could very easily, because h e was the way he was, put people's backs up, and that was certainly the case with the bio products laboratory, because of the different cultures. Bio products was there to make blood products, and get as much as possible out for the population. David was constantly looking into the future, and trying to raise money, in those days, was difficult, and therefore you tend to overpromise, o r he was over-promising. The porcine Factor VIII was working very well, mainly because I think a lot of the clotting that happened and the problems with clotting happened before the plasma ever got from the abattoir to wha t we were working with, and we were left and the yiel ds were probably pretty dreadful from porcine blood, b ut it was easier, in that sense, because we had -- but with Factor VIII you were so totally dependent on fresh frozen good quality human plasma, human blood that you had to be so careful about the yield. So he had -- he was optimistic because the porcine was going well. He maybe thought that the human should be going well because the porcine was, and that was his -- probably his reasons for doing it. 168
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QUESTION: But by July 1981 he was aware, was he, of your reservations? ANSWER: He knew but he probably thought I was just being, y ou know, slightly negative on the subject, quite likel y.
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QUESTION: You were the chief scientist of Speywood, and he wa s a pharmacist by trade, as I understand it? ANSWER: Yes, he was.
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QUESTION: The clinical trial of Mono C, (sic) the Factor VIII product. Were you involved in putting the applicat ion for the clinical trial together? ANSWER: Well, I must have been but I don't remember doing i t. But we must have done it.
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QUESTION: We know that it went in at some point in 1982, and we also know that progress on the product had slowed b y that stage. What was the purpose of having a clini cal trial in those circumstances? ANSWER: I think it was to -- well, basically to check to se e whether it was safe and whether the concept of Factor
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QUESTION: Was there any feasible prospect, as of 1982, of bringing this to a product that could be placed on the 69 market? ANSWER: At the time of clinical trial?