Dr Peter Foster
DR PETER FOSTER - QUESTIONS SUBMITTED TO THE INFECTED BLOOD INQUIRY
Confused by the narrative and timing he paints of the US MDL-986 (14.1), perhaps he can clear this up. I’m no expert in this area but the main point of contention is that he says: "I believe that this was shown at a number of court hearings, all of which found in favour of the Defendants".
We know that much of the MDL was subject to a $600m+ settlement,each family received $100k from the drug companies - https://www.newspapers.com/clip/97307838/asbury-park-press/
There were, though, those who went on fighting, and there are examples of cases found in favour of plaintiffs, and elsewhere, which achieved much higher settlements. For example these parents were awarded $2m for their son when the jury found against Bayer in 1998 - https://www.newspapers.com/clip/97307874/evansville-press/
Back to “MDL 986”, this was still going in the 2000s, at least to 2009 from what I can see,, including the Baum Hedlund stuff. My understanding is that some of those cases reached settlement, globally.
“After the cases were filed in the California courts, they were transferred to multi-district litigation, MDL-986” - https://www.baumhedlundlaw.com/hemophilia-aids/taiwanese-hemophiliacs-lawsuits/
Maybe it’s the case that his evidence was only used in a small number of settings, maybe he is guessing the outcome and he is wrong. As long as the Inquiry is not of the impression that all MDL-986 claims were “found in favour of the Defendants”, maybe none of them were.
16.2 (iii/vii) - Is it right he undertook no work on HT’ing FVIII prior to 1981?
Is it right he undertook no work on HT’ing FIX prior to 1976?
What proportion of his time was spent on this work?
Who else was involved / how many people?
What level of budget, if any, was provided?
19.4 (ii)
Why hadn’t this been authorised?
Is it correct that had this been authorised in the mid-1970’s, some work carried out making use of it later (eg vi), could have been done sooner?
Vii - Should BPL / PFL have been doing this also at this time? Is he aware of their thinking at the time?
Did he think this was important to do? (he must have, given the process he outlines) - Why?
17.c(ii) - Did that list include anything about viral inactivation?
What priority, if any, did you, and separately, Mr Watt, give to viral inactivation in… 1974? 1976? 1980? 1982? Important to understand prioritisation, if any, at different points in time.
Did your and Mr Watts priorities always align?
17.c(iii) - Were there any prioritisation differences that stand out to you between Mr Watt and Dr Cash?
22.2(ii) - Is it correct that Dr Cash was not prepared to allow HT FIX to be used in humans until the theoretical suspicion of a possible hazard (thrombosis) could be ruled out?
Would he agree that is a sensible approach to therapeutics?
Would it have been wise for Dr Cash to allow the use of a product for which he suspected there might be a risk of a life-threatening hazard?
22.2 & 22.3 - Is it correct to understand from these sections that prior to 1983/1984, he recalls no collaboration between PFC & BPL on the pasteurisation of Factor VIII?
28.1 - In what he outlines throughout this section, is he aware of what consideration was given to the Nuremberg Code given the basis of the general approach?
Specifically in relation to points 3, 4, 5, 7 of the code. Could we take him to each of these points and ask him if the approach he outlines, in principle, conforms to that point of the code?
29c(b)(ii) - Would you have attended UKHCDO meetings if asked to?
Would you have read UKHCDO meeting minutes if they were made available to you?
29c(iv) By taking it “extremely seriously”, how did that manifest itself?
On Page 50 he says “Research on heat treatment (pasteurisation) was begun at PFC “as soon as it became known that this might be feasible”...
“became known that this might be feasible” to whom? Clearly those at Behringwerke and also Cutter (Redacted) thought this “might be feasible” in the 70s. Why was there a difference of thought at PFC and by whom?
What level of resource was given at PFC once it was thought, by those at PFC, that it “might be feasible”?
What priority level was given at PFC once it was thought, by those at PFC, that it “might be feasible”?
33.1(xiii) - Not a question, but, I can say with 100% confidence that this is not the view of Shaw or Weinberg. Foster is guessing and he is wrong. Hopefully the IBI can confirm this directly with them.
In the film Bad Blood: A Cautionary Tale at approx 52 minutes in, Shaw makes the case that heat treatment could have been done “years earlier”, Weinberg is also featured in this segment talking about Behringwerke and delays etc. I assume Foster has not seen this film.
This confusion probably comes from what appears to be Foster's misguided view of the scale of the MDL as referred to above.
35(vii) - IS he saying BPL was limited by supply of plasma (not capacity) based on what Glenarthur told him?
If it turns out that what Glenarthur told him about plasma supply was incorrect. Would his view have been different in relation to this point and the point he makes next? If so, how so?
39(i) As per point 11 above, he says earlier in his statement “Research on heat treatment (pasteurisation) was begun at PFC “as soon as it became known that this might be feasible”...AND… He says at 33.1 “I first learned from Dr Cash in October 1980 that pasteurisation (heating in solution) was being applied to factor VIII by the German company Behringwerke”...BUT… he says at 39 “development of heat treatment began at PFC in 1981” We see at 43.11 this was infact September 1981.
So that’s a year later?
41(vi) Does he have any observations about the use of HTLVIII (As opposed to HIV) and “Acquired Immune Deficiency Syndrome” (as opposed to AIDS) - the latter being terms which would be familiar to patients/public, at this time in October 1985, on the label?
Did he consider the April 1985 warning to be adequate?
42.1(iii) - Does he recall Dr Cuthbertsons reaction to this news?
Did Cuthbertson tell him about the news? If so, how, what did he say directly to him?
43(iv) - Was there any view by him or his colleagues, at the time, on BPL having 8Y but continuing to issue unheated FVIII into 1985?
On Page 73 under the heading “Dry Heat Treatment” - Is it correct to understand that there was no disadvantage to this form of heat-treatment? In other words, it hadn’t been proven to consistently eliminate NANB completely, but, there was no known disadvantage?
43.2 - Was there collaboration with BPL with this? If so, to what extent? Details.
43.3 - The problem he mentions relating to Fibrinogen is dealt with within the text of the published Behringwerke patent. Were they not aware of this?
"can be surmounted by simple modifications of these processes and that is is thus possible to prepare hepatitis-safe factor VIII concentrates free from fibrinogen"
“separating fibrinogen and factor VIII quantitatively by means of a precipitation with amino acids”
43.4(iv) What weight (if any) was given by PFC to Mannucci’s criticism?
43.4(v) Did Baxter’s process inactivate Hepatitis B?
43.5(iv) Would the lack of space to carry out pasteurisation at BPL have provided them with a disincentive to explore the Behringwerke process in 1980/1981 as, even if they were able to do it, they wouldn’t have the space?
43.5(vii) If he is attributing the discovery of HIV to Gallo, the announcement was april 23 1984, not May 1984.
43.5(viii) Is it possible that this question was prompted by Dr Perry having knowledge of what he describes at 42.1(iii)?
What relationship did Dr Perry have with Dr Richard Tedder?
How often, prior to this date,, would Dr Perry ask for updates on virus inactivation studies?
43.5(xi)-(xvi) - Is it correct that within 1 working day of learning this information, PFC was conducting studies?
And in about 1 month, HT product was distributed to clinicians/patients?
If you set aside state of knowledge, purely from a logistics perspective, is there any reason that couldn’t have been done sooner?
Why was unheated product recalled and what level of importance was given to this?
Did he have any observations at this time about the fact that BPL were not recalling unheated product?
43.6(iii) When did that discovery happen? How long did it take from discovery to implementation?
43.6 - Would he agree with the general observation that, from what he describes, it appears as though the intensity, focus and resulting speed of progress on viral inactivation was much greater at this time than it had been previously? For example in the 1970s?
43.8(ix) Should Armour have realised this? It seems to be a very basic concept ie oven temperature does not = product temperature. Isn’t this a massive oversight?
43.11 - We understand from this that, there are no key dates re heat treatment before October of 1980, at PFC?
43.12(v) - 60c - 30 hours - Is it correct that, in the right conditions, this process could kill HIV?
60c - 72 hours - Is it correct that, in the right conditions, this process could kill HIV?
43.12(vi) - Isn’t it correct that there was *Some* evidence long before this due to what was known about Albumin?
44.3(xi) This answer seems very much time dependent. For example, throughout the 70s, PFC were doing little to no research in this area. Would he agree his answer would be different in the context of the 1970s?
Is his answer based on a certain time period?
49(i) Earlier he says this point was in October 1980, here he says 1981. He must acknowledge there was a 1-year delay documented in his own statement.
Page 109, last para) - Did this strategy take into account the impact of subjecting those already infected to repeated increased viral load, even if already infected?
Page 112 - When he says “12 months supply” can he provide an estimate of how much that would have been in terms of vials or units?
Section 5(i) Presumably PFC could have produced single donor Cryo if tasked to do and provided with the necessary resources?
Page 126, point iii - Getting the supernatant to PFC, would that have been fairly simple?
Could he outline a process of how that could have worked?
Would this be broadly similar to how FFP made its way to PFC.
IF so, would he disagree with Walford’s summary when she gave evidence (from 20th July transcript) that….
“The cryoprecipitate supernatant needed -- was the material that was needed to then go on to fractionation for all the other products that BPL had to produce. So if, in fact, you ended up making an awful lot of cryoprecipitate in Regional Transfusion Centres, you had to devise a really quite complicated system of taking off the supernatant -that is the fluid which is left after you have centrifuged the plasma, which is then taken, needs to go to BPL in order to make albumin…”
61.2(vi) Does he recall this “objective”, set by the government, changing at any stage between circa 75 - 85?
61.2(vii) By batch size, he means the size of the plasma pools?
63.(ii) - How significant was that error?
66.1(vii) - How did this compare with BPL?
66.2(iv) - Is it correct to understand that one of the disadvantages of the 8-hour system was that time was required either side to start-up/shut-down (warm-up/cool down) equipment at every shift which reduced the amount of time the PFC machinery was actually in operation, a situation that did not arise with 24-hour production?
66.3(iii) - In other words this argument was a red herring?
Page 158, point (iv) - Was this perhaps exacerbated by the increasing knowledge of AIDS?
Page 162 (vi) - Did he inform the inquiry of this error?
75.2(ii) - From when did he appreciate this?
