Factor 8

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Lord Simon Glenarthur

WS Questions

  • 6.11 - Given this, would he agree that it would be unwise for him, or anyone else unqualified, to significantly alter “lines to take” provided by those who were doctors advising him?

  • 13.3 - At this time, what was his understanding of the numerous ways in which Factor VIII can be given? Eg Cryo, FFP, concentrate

    • What was his understanding of pool sizes used to make concentrate?

    • He says "the risk of blood products being contaminated were described to me as small" - was that in relation to Hepatitis and AIDS, or just AIDS?

  • 14.2 - He says haemophiliacs in the USA were being “infected” with AIDS - so his understanding was that haemophiliacs were being “infected” with AIDS? (This would confirm he understood AIDS to be a transmissible agent).

    • This whole paragraph reads as though he understood AIDS to be an infectious agent capable of transmitting via Factor VIII. But he simply thought the cases were not going up quickly enough to take action?

  • 16.4 - To what extent did he observe fear of “upsetting the homosexual community” impacted upon general decisions relating to blood donation policy? Can he expand upon this para.

  • 16.5 - Should the purpose of both have been to simply tell the unambiguous and clear truth as it was then known?

  • 20.4(ii) - So, he thought “there was clear evidence that AIDS could be transmitted by blood products” but the public line was that “there was no conclusive evidence”?

    • Did he tell the haemophilia society that he thought “there was clear evidence that AIDS could be transmitted by blood products”?

    • Did he tell parliament that “there was clear evidence that AIDS could be transmitted by blood products”?

  • 23.5 - In what timescale does he think it should have been produced?

    • Did it occur to him to dictate a fixed timescale?

  • 24.2 - Was there consideration of a separate leaflet for recipients?

  • 25.5 - Does he accept that (in hindsight or otherwise) press reports were not sensationalist, and were actually reflective of reality (Eg killer blood)?

    • Is it possible that DHSS was simply reluctant to face / deal with that reality?

  • 25.8 - Does he think “beyond doubt” was a reasonable basis upon which to base the position?

  • 25.12 - What is his understanding of the incidence of intracranial haemorrhage in haemophiliacs?

    • What is his understanding of various treatment options for such aside from concentrate?

    • Is he aware that it was documented in 1968 that “"The present availability of cryoprecipitate makes the temporary correction of the hemostatic defect in classical hemophilia possible, and allows full investigation and surgical treatment of intracranial or other hemorrhage, as in a normal person. A timid approach to surgery in the hemophiliac patient is no longer justified." - https://drive.google.com/file/d/1Zcq3ApOXLuzIMGUdT_Sb4svAy6kzJPj0/view

    • He says “"haemophiliacs who would suffer from not being able to accept treatment with blood products” - does he accept that haemophiliacs could be treated with cryo, rather than concentrate? So he accepts it is incorrect to frame this statement in the context of “not being able to accept treatment with blood products”?

  • 26.3 - Does he have any idea of what that advice might have been?

  • 27.2 - The date of his reply is in 1984, he says here, twice, it is in 1985. Can we clarify / correct? He seems to get it correct in 27.1

  • 27.4 - He seems to be mixing up all the years again here - need to clarify

  • 30.3 - Does he think he should have seen it?

  • 36.1 (v) - when he says “imperil the lives” - Is he talking about convenience of day-to-day life, or, literally that he thought all haemophiliacs would die?

    • If the latter, on what basis was this his view?

  • 37.4 - Did he ever consider the quantity of Factor VIII required for current levels of clinical use, as opposed to clinical need?

    • When he says clinical need here, does he really mean clinical use?

    • What is his understanding of clinical “need” and how need is determined

  • 39.2 - "there was no suggestion that cryoprecipitate could replace Factor VIII" - Was he aware that Factor VIII concentrate, in fact, replaced cryo in the mid 70s as the mainstay treatment?

  • Was he aware that a paper published by Arthur Bloom (Whom he references here) in 1968 about cryo said:

  • "cryoprecipitate AHF is now an established and effective theraputic material"

  • "Our experience confirms the observations of other workers that cryoprecipitate antihaemophilic factor is effective in the treatment of haemophilia."

  • "cryoprcipitate represents a major advance in the treatment of haemophilia"

  • "Cryoprecipitate is eminently suitable for out-patient therapy and is a particulary valuable for the treatment of infants and children in whom high levels of factor viii can be obtained with relatively small doses, thus permitting even major surgery to be safely performed"

  • "Side effects due to cryoprecipitate were uncommon"

  • "There were no instances of serum hepatitis"

  • 40.5 He says "risks of not treating haemophiliacs would be life-threatening” - Is he attributing this as his own opinion or the HS’s?

    • In any event, does he know on what basis that was said?

  • 40.6 - If that is the case, does he know on what basis the society formed that view?

    • Did he ask on what basis the society formed that view?

    • Did he know from whom the society received medical advice? Or if they received medical advice at all?

  • 40.13 - Does he mean Dec 1983? Or is describing over a year later as “in due course”?

  • 44.4 - Does he know in what ways a “trial” may have impacted the scale of production and/or distribution of the leaflet?

  • 61.3 - Was he ever asked to decide upon additional funding or resources for BPL, specifically in relation to developing HT products?

    • Is he aware of any such requests being made to anyone else by BPL or officials?

  • 75.2 - He says “in detail” - is this to mean he was aware, but not in detail, of some statements on the issue?

  • 75.5 - Last sentence - If it was not thought relevant, should it have been?

    • Are these facts he feels he should have been made aware of?

  • 89.8 - When he says “not providing Factor VIII” here, is he specifically talking about concentrate only? This is an important clarification as to whether his judgements were rational based on the realisation of cryo as an option.

    • What was his understanding of the incidence of “life-threatening” bleeds in order to make a rational judgement in the way he describes?

    • When he says “latter risk”, what did he understand that “latter risk” to be in comparison to the former?

  • 90.4 - Does he think officials failed to place enough emphasis on safety when discussing self-sufficiency?

    • Does he think increased emphasis on safety would have provided greater motivation in terms of willingness and speed?

  • 93.5 - Does he mean 1985, not 1995?

  • 108.1 - He says “best advice” - does he accept (in hindsight or otherwise), it was the wrong advice? (Eg not switching to cryo, not withdrawing product)

    • Given it was the wrong advice (whether he thought or not to be at the time), can he truly say it was the “best” advice?

  • Non-WS Questions

  • In relation to this article - https://www.newspapers.com/clip/27500955/

    • Was he aware of this at the time? Was he aware high risk donors were continuing to give blood?

  • There are numerous times in his statement where he talks of toning down language about risks, due to fears alarming messages may have led to blood supply shortage. To what extent did he / officials consider a promotional campaign to increase donations specifically from lower risk donors (eg young women) explaining why they were needed at a critical time.

  • Did, at any time, officials bring to his attention that the german company Behringwerke had been producing a heat treated product which had been shown to inactivate Hepatitis B since 1981? (Source: https://www.ncbi.nlm.nih.gov/books/NBK232415/)

    • If he had been made aware of this, would he have sought to explore it as an option for use (or to manufacture a comparative product) in the UK?