The taintedblood Timeline  -  what really happened...

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.

"....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).

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."

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

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.

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

"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?

• 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)

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

"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?

"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)

"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).

"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."

"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.)

"(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.

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.

"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.

"It required the patient to be treated in hospital"