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Magna Carta - 15th June, 1215

 
No of entries selected: 6 of 711
1976
12 August
Factor VIII and Cryoprecipitate Supplies - Targets
In a letter dated 12 August 1976, the target of factor VIII production from all sources was a usage of over 40 million international units per annum. Plans had been agreed to produce 35 million i.u. per annum. It was pointed out that in theory this level of production had already been achieved in England and Wales, assuming a yield of 60 i.u. of factor VIII activity per donation of plasma processed to cryoprecipitate.

"We know that in addition clinicians are buying and using or accumulating commercially produced factor VIII concentrate at the rate of 10 million i.u. per annum." (paragraph 3)

"There is some highly potent cryoprecipitate about. I understand that the Edgware product contains levels of 100 i.u. factor VIII or more consistently." (paragraph 4, lines 1 and 2)

Source:
Type: Recovered Document - Letter ref. Factor VIII Supplies, 12 August 1976
Location: UK
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1977
23 March
Limited Amounts of Cryo may be Produced Literally Overnight
The following was included in the evidence submitted to the Penrose Inquiry, yet made little or no difference.

In "Blood Transfusion for Clinicians" (1977), Dr John Wallace writes about the advantages of cryoprecipitate over Factor VIII concentrates:

"The one great advantage which cryoprecipitate has over the other concentrates of factor VIII is that it can be prepared quickly. With an average daily intake of 500 donations it is possible to maintain a daily production of 100 single donations of cryoprecipitate, and the processing of donations to the finished product takes only 24 hours. On the contrary, the complete processing of large batches of fresh frozen plasma to provide intermediate concentrate of factor VIII may occupy two to three months from start to finish. The total yield of the respective products may be virtually the same over the long period of months, but limited amounts of cryoprecipitate may be produced literally overnight."

Note: Although this entry relates to 1977, the situation with regard to cryo production is pretty much the same in 1984 (see Related Entries link below).

As soon as even the slightest warnings over AIDS started to emerge, it is clear that between the DH and Transfusion Centres (RTCs), they could have mustered up sufficient cryoprecipitate to treat only the most serious of bleeds, and they could have done this much more quickly than we have ever been led to believe...

The tragedy that unfolded was compounded (even caused) by a terrible decision made by the Committee on Safety of Medicines in July 1983, where those present dismissed the possibility of withdrawing clotting factor concentrates from the market and replacing them with cryoprecipitate. The reason cited was that it was not feasible in the UK on grounds of supply.

Source: Link #1
Type: Penrose Evidence File
Location: UK
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1983
13 July
Committee on Safety of Medicines - Biologicals Sub-Committee
The Biologicals Sub-Committee of CSM recommends that very little is done about the threat of AIDS to haemophiliacs.
  • The possibility is considered of withdrawing clotting factor concentrates from the market and replacing them with cryoprecipitate. It is concluded that this is not feasible in the UK on grounds of supply. (Minutes Agenda Point 5.3)
  • The possibility is considered of withdrawing US preparations from the UK. It is concluded that this is not at present feasible on grounds of supply. Moreover, the perceived level of risk does not at present justify serious consideration of such a solution. (Minutes Agenda Point 5.4)
Source: Additional Sources: Haemophilia HIV Litigation, Advice on Settlement Doc., pp 56-58.
Link #2
Type: Minutes - Committee on Safety of Medicines
Location: UK
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1983
17 October
Haemophilia Centre Directors Meeting - Unlimited Supplies of Cryoprecipitate
In the minutes of the 14th meeting of the UK Haemophilia Centre Directors' Organisation on Monday, 17th October 1983, the following is stated regarding "unlimited supplies of cryoprecipitate":

"Dr. Chisholm raised the problem of patients refusing to take up commercial factor VIII concentrate because of the AIDS scare. She wondered in view of the worry of the patients whether the Directors could revert to using cryoprecipitate for home therapy."

"Professor Bloom replied that he felt that there was no need for patients to stop using the commercial concentrates because at present there was no proof that the commercial concentrates were the cause of AIDS. Dr. Chisholm pointed out that there was a further problem in her region because of problems in getting large amounts of commercial concentrates whereas she could get unlimited supplies of cryoprecipitate."

"Other Directors reported that they had the same problems. After discussion it was agreed that patients should not be encouraged to go over to cryoprecipitate for home therapy but should continue to receive the NHS or commercial concentrates in their usual way."

Background: This mention of an 'unlimited' availability of cryoprecipitate, right in the middle of the AIDS crisis in October 1983, demonstrates that there were viable, much safer alternatives for haemophiliacs in the UK.

Note: This statement regarding unlimited availability of cryoprecipitate directly contradicts what was stated in the 13th July 1983 meeting of the Biologicals Sub-Committee of the CSM. During that meeting, those present considered the possibility of withdrawing US clotting factor concentrates from the market and replacing them with cryoprecipitate, but they hastily concluded that this was not feasible in the UK on grounds of supply. (CSM Minutes, Agenda Point 5.3, 13th July, 1983.)

Source: Additional source:
Link #2
Type: Minutes. UK Haemophilia Centre Directors Organisation, dated Monday, 17th October 1983.
Location: UK
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1984
2 February
Cryoprecipitate Could be Produced in Emergencies
In the minutes of a Meeting of the Directors of the SNBTS and Haemophilia Directors on 2nd February 1984, there was a discussion about the production of cryoprecipitate:

"(ii) Members discussed the suggestion that the production of cryoprecipitate could now be reduced. Dr Ludlam said that cryoprecipitate was preferred in the treatment of children at present, because of the new danger of AIDS. Dr Hann concurred..."
"...A policy seemed to be emerging however to use less cryo for haemophilia A patients."
"...It was agreed that a certain minimal amount of cryo was required and Dr Cash pointed out that TDs (Transfusion Directors) could produce it in emergencies."

Note: We have to ask what would constitute "an emergency"? Perhaps the fact that by this time, February 1984, we were several years into the AIDS crisis. The DHSS knew all too well that as much as 50% of the Factor VIII requirements of the United Kingdom were being imported as large-pool commercial concentrates, mostly from the USA. There had been numerous warnings (from the CDSC to the 1983 FDA regulations) yet, the DH and HCDO were still conducting trials on PUPs or as the physicians liked to call them 'virgin haemophiliacs'. This was after January 1983, when Desforges published an article in the NEJM on Hemophiliacs and AIDS, recommending that cryoprecipitate rather than concentrate be used, and in August 1983, the first UK haemophiliac had already died of AIDS from US Factor VIII.

So much for the emergency.

Source: Link #1
Type: Penrose Evidence File
Location: UK; Scotland
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1985
Haemophilia Society Bulletin - Allegation against the Press Dramatizing the AIDS Problem
In the Haemophilia Society's Bulletin, Volume 34 of 1985, under the heading "AIDS PROBLEM", the following rather unbelievable statement is made:

"And although the press has been dramatizing the AIDS problem and the risk of imported blood coming into this country, I think it is very important not to forget that without the imported product the quality of life of those who need Factor VIII and Factor IX would have been much poorer."

Background: What was known: In August 1983, the UK's CDSC reported the first case of AIDS in a UK haemophiliac, a patient from Wales, who had received factor VIII concentrate imported from the United States.

By October 1983, the USA had seen 15 AIDS cases in haemophiliacs and the UKHCD (Haemophilia Centre Doctors) were privy to this information and could reasonably have been expected to be able to work out that the risk from US commercial products was much higher. With reference to the U.K. Situation, 2 haemophiliac cases of AIDS (A1 and A4) were also known about in October 1983.

Note: The Bulletin statement speaks for itself. However, it should be noted that cryoprecipitate could have been used. [Edgware made highly potent cryoprecipitate that had levels of 100 i.u. of factor VIII or more - consistently.] Moreover, on 17th October 1983, in the midst of the AIDS crisis, we know that a doctor present at a meeting of the UKHCDO stated that she could obtain "unlimited supplies of cryoprecipitate". The Press were right to dramatize, when more than two-thirds of the infected haemophiliac community have since passed away. 'Quality of life' hardly comes into it.

Source:
Type: Recovered Document - The Bulletin, Haemophilia Society, Vol 34, No.1 1985
Location: UK
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