Infected Blood Inquiry

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Inquiry into Contaminated Blood

The taintedblood Timeline  -  what really happened...

"To no one will we sell, to no one deny or delay, right or justice."
Magna Carta - 15th June, 1215

 
No of entries selected: 19 of 711
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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1981
December
Lancet
The Lancet reports first UK case of AIDS in a homosexual.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Lancet Report
Location: UK
1982
16 July
DHSS Had Early Awareness of Concerns over the Safety of American Factor VIII
In a DHSS letter of 16 July 1982, we read of an early awareness of research which fairly conclusively demonstrates that:

"....plasma taken from homosexual drug-takers contains a sort of virus which goes undetected when the plasma is tested because it is suppressed by the drugs. However, when used for Factor VIII, it becomes active again."

The DHSS letter states that information has been received from the American Bureau of Biologics (via NIBSC) indicating there may be considerable publicity in the next couple of weeks concerning the safety of American Factor VIII.

From the following comment, it appears the DHSS are complacent at this stage:

"In any case with our voluntary unpaid donor system we do not have the same problems as in the States where drug addicts are tempted to give blood simply for the money. However, about half of the Factor VIII bought from commercial companies is imported from the USA."

Note: In terms of knowledge in the United Kingdom, this is one of the earlier dates (16 July 1982) which demonstrates that the DHSS had advance "private" knowledge of the safety risks from US commercial factor VIII almost 10 months earlier than we previously thought. This DHSS letter went out 1 year prior to the infamous July 1983 CSM meeting (reported in the Guardian by Sarah Hall on Friday May 25, 2007).

This early knowledge by officials also pre-dates (by 2 months) our earliest known point of awareness of AIDS by the UKHCDO (which was in September 1982). We know that Dr Craske was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States.

Source: Link #1
Type: DOH FOI Documents
Location: UK
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1982
13 September
UKHCDO - Dr Craske - Knowledge of US Haemophiliac AIDS Cases
In a Haemophilia Centre Directors' Organisation meeting in September 1982, there is not only knowledge of AIDS infecting haemophiliacs in the USA, but also, there is some understanding of the possible involvement of commercial blood products.

Dr Craske is tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States. HCDO minutes state that: "It appeared that there was a remote possibility that commercial blood products had been involved."

Source: Link #1
Type: HCDO Minutes
Location: UK
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1983
March
FDA Introduces New Regulations for the Collection of Plasma
FDA introduces new regulations for the collection of plasma excluding donors from high-risk groups.

The use of pre-March 83 stocks are not banned owing to concerns that this would lead to a crisis in supply.

Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Regulations. Taken from DOH Self-sufficiency Report
Location: USA
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1983
3 May
Dr Vaughan, ex Health Minister, Was Warned in 1981 of Danger of Contaminated Blood
In an Oral Question in Prime Minister's Question Time on Tuesday 3rd May 1983, Mr Race makes it clear that Dr Gerard Vaughan, former Minister for Health, was warned 2 years earlier, circa May 1981, of the danger of contaminated blood supplies from the USA:

Mr. Race: "As the House of Commons' favourite own-goal merchant, the Minister for Consumer Affairs, was warned two years ago by his own Department of the danger of contaminated blood supplies coming from the United States, will the Prime Minister rectify that deplorable and disgraceful mistake by immediately authorizing the necessary expenditure within the National Health Service to make Britain independent in its blood supplies?" (see first column, para 9.)

Note: This Oral Question reveals that Dr Gerard Vaughan, then Minister for Health, knew sometime in 1981, possibly from as early as May, of the threat of contaminated blood supplies which were being imported from the United States. This is one of the earliest warnings that we are aware of so far and we are astonished to learn of how early this awareness was, and that so little was done. Clearly, we are not being told everything.

Source: Additional source (see para 5)
Link #2
Type: Oral Answer, Prime Minister's Question Time. 3rd May 1983. Additional Source: Health and Social Services Journal, May 12, 1983. Article by Michael White. (see paragraph 5)
Location: UK
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1983
18 May
UK Haemophilia Society - An Appeal Not to Ban Imported Blood Products
The Haemophilia Society appeals to the UK Government not to ban imported blood products and urges patients not to stop treatment in response to concerns over potential risks.

Click here to read the original Sun article for 18 May 1983

Source: link; Toulson L. US Gay Blood Plague Kills Three in Britain. The Sun. 18 May 1983.
Type: Haemophilia Society Appeal
Location: UK
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1983
23 May
Dr Bloom - Recommendation that Imported US FVIII Meets New FDA Regulations
In a letter of 23 May, 1983, Professor A. L. Bloom writing to Dr Bolton states the following:

"I do not think that anyone is complacent about the situation but I think that we all agree that it would be counter-productive to ban the importation of blood products at this moment." (Line 6)

Prof. Bloom: "We are however taking steps to recommend that imported products from the U.S.A. at least meet with the new F.D.A. regulations." (Line 8)

"Your comments about the use of cryoprecipitate and N.H.S. factor VIII concentrate have been incorporated into our advice although at the moment we are not rigidly differentiating between cryoprecipitate and N.H.S. concentrate as far as severely affected patients are concerned at any rate." (end of line 9)

Note: It seems that this recommendation, that imported blood products from the US meet the new post-March 1983 FDA Regulations, was not adhered to. WHY did Physicians decide to keep using the 'pre-March 83' high-risk concentrates?

Source:
Type: Letter, Professor A L Bloom writing to Dr F. E. Bolton. 23rd May 1983.
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
13 July
CSM - Biologicals Sub-Committee - Possible AIDS Risk from Hepatitis B Vaccines
In a meeting of the Biologicals Sub-committee of the CSM, the safety of Hepatitis B vaccines are considered. Although there is no evidence at this time of any risk from vaccine material licensed in the UK, the Committee recommends that manufacturers be asked to provide ongoing data relating to "the safety of the product in relation to AIDS".

It is understood that ARVI have recommended that the PHLS undertake surveillance of recipients of Hepatitis B vaccine.

Source: Link #1
Type: Minutes - Committee on Safety of Medicines
Location: UK
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1983
13 July
Committee on Safety of Medicines - Biologicals Sub-Committee
In a meeting in July 1983, the Biologicals Sub-Committee of CSM is aware of clotting factor manufacturers preparing advertising material for use within the UK that makes unjustified claims regarding safety in relation to heat-treated factor VIII. Fears are expressed by the Sub-Committee that the unlicensed material might be used in trials on a 'named-patient' basis.(Minutes Agenda Point 5.7, page 3)
Source: Link #1
Type: Minutes - Committee on Safety of Medicines (CSM)
Location: UK
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1983
13 July
Introduction of this Disease into the Virgin Soil of the United Kingdom
In the summary of main points from a consideration of AIDs in relation to licensed blood products by the Committee on Safety of Medicines (Biologicals Subdivision) in July 1983, we read the following:

"There is need for research work on AIDS in the UK, especially in relation to the possible new introduction of this disease into the virgin soil of the United Kingdom.
The Sub-Committee was glad to learn that a number of groups, including the Medical Research Council, are planning and have started research work."

Note: We fail to understand why they talk about the "possible new introduction of this disease". Are we to believe that they somehow helped introduce it to the UK?

Source: Link #1
Type: Penrose Evidence File
Location: UK
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1983
circa August
DHSS - Lord Glenarthur - Decision Not To Ban Pre-March 1983 US Factor VIII
In a DHSS letter from The Lord Glenarthur to Clive Jenkins Esq., the following is stated in reference to the continued importing of high-risk pre-March 1983 factor VIII stock:

"Although future supplies of FVIII both for export and for use in America will of course be manufactured from plasma collected in accordance with these regulations, there is still a quantity of stock, some already in this country and more in America awaiting shipment here, which has been made from 'pre-March' plasma" (Paragraph 4, line 3)

"We have to balance the risk of AIDS against the severe risks to haemophiliacs of withdrawing a major source of supply of Factor VIII which cannot be made good from elsewhere in sufficient volume." (Paragraph 4, line 9)

"Haemophilia Society is aware of the situation and has in fact made known to me its opposition to any move to ban American FVIII." (Paragraph 4, last 2 lines.)

Background: The mention of 'pre-March' plasma is a reference to the point in March 1983 where the FDA introduced new regulations for the collection of plasma that excluded donors from high-risk groups. It should be remembered that any plasma intended for FVIII products was likely to have been collected up to 2 years previously. Therefore, even as the FDA restriction came in around March 1983, the products available then could have been made from high-risk 1981-2 plasma.

Note: It is also worth noting that it should have been possible for cryoprecipitate to have been used instead of high-risk Factor VIII - at least until alternative arrangements could have been made, except the production facilities for cryo in the UK were no longer adequate. Just 1 month earlier, in a July meeting of the CSM, the possibility was considered of withdrawing clotting factors from the market and replacing them with cryoprecipitate, except it was concluded that this was not feasible in the UK on grounds of supply. (CSM Minutes Agenda Point 5.3, see additional source below)

Source: Additional Source:
Link #2
Type: Recovered FOI Document - DHSS letter from the Office of the Joint Parliamentary Under Secretary of State. Circa August 1983.
Location: UK
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1983
10 October
MRC Working Party - Controlled AIDS Study of UK Haemophiliacs
In an October 1983 meeting of the Medical Research Council, the Chairman, Dr Tyrrell, indicated the need to ensure that the best use be made of the special combination of suitable patients for study and the clinical, immunological, virological and other expertise that was available in the United Kingdom:

"The special features arising in relation to haemophilia were discussed and the possibility of identifying the role of imported Factor VIII concentrate used for UK patients was outlined. There followed discussion on the varying and considerable period of incubation (1 to 4 years) and the possible relationship between the size of inoculum of the PROPOSED AGENT and the length of latency." (page 2, point 3a, line 14)

"It was noted that blood product associated cases could enable some of these alternative hypotheses to be tested." (page 3, end of paragraph 4)

O"pportunities Special to the United Kingdom:"
"The Working Party sought to identify particular opportunities for research unique or special to the United Kingdom. The fact that the epidemic was lagging some three years behind that in the USA was considered an important factor in enabling the background against which AIDS develops to be delineated. This could enhance our ability to detect the emergence of AIDS and virological status of the high risk groups. The underlying immunological and virological status of the high risk groups BEFORE they encountered the "AIDS agent" could thus be defined." (page 4, point 4)

"The UK system for haemophilia treatment and for blood product organisation would allow detailed study of haemophilia associated cases which has not been possible in the USA due to their system of record keeping and organisation." (page 4, end of paragraph 3)

"The organisation of epidemiology in the United Kingdom was well suited to studying this problem. The importance of establishing such studies early in the emergence of disease was again stressed." (page 4, final paragraph, line 5)

"It was noted that in addition the UK offered particular opportunities to pursue carefully controlled and monitored therapeutic trials." (page 5, paragraph 2)

"It was thought that suspect blood products could provide valuable raw materials for work of this type. Indeed, the possibility of fractionating blood from patients with "pre-AIDS" in order to concentrate the agent was a notable suggestion." (page 5, paragraph 4, line 10).

Source:
Type: Minutes - Medical Research Council Working Party on AIDS. Dated Monday 10th October 1983.
Note: The following departmental observers were present at this MRC meeting: Dr W. M. Prentice (SHHD) and Dr Diana M. Walford (DHSS)
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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1984
20 November
Dr Seale - Attempts for 2 Years to Alert Public Health Officials of AIDS Threat
In an article in The Standard, it states that Dr Seale had been trying to alert public health officials to the implications of the threat of AIDS for nearly two years:

Dr John Seale: "I wrote to both Mrs Thatcher and the Public Health Laboratory Services to suggest blood transfusion policy changes then." (paragraph 4)

Note: This article shows that both Margaret Thatcher and the PHLS were notified circa November 1982 and could reasonably have been expected to know about the threat of AIDS to the Blood Transfusion Service and thus to haemophiliacs.

Source:
Type: Recovered Document - Article in The Standard, by Alan Massam. 20th November 1984
Location: UK
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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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2002
11 June
Ms Hazel Blears, MP - Cryoprecipitate Disadvantages
"There are no plans to hold a public inquiry or to investigate haemophilia treatment practices in the 1970s."

"We understand that treatment with cryoprecipitate carried a number of disadvantages compared to pooled clotting factors."

"It required the patient to be treated in hospital"

Source: Link #1
Type: Hansards Written Answers
Location: UK
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