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
"It was agreed that there was insufficient information available from the U.S. experience to warrant changing the type of concentrate used in any particular patient. Moreover once the condition is fully developed it seems to be irreversible so that there would seem to be no clinical benefit to be gained by changing to another type of factor VIII." (page 2, paragraph 2)
"With regard to general policy to be followed in the use of factor VIII concentrates, it was noted that many directors have up until now reserved a supply of National Health Service concentrates for children and mildly affected haemophiliacs and it was considered that it would be circumspect to continue with that policy. It was also agreed that there was, as yet, insufficient evidence to warrant restriction of the use of imported concentrate in other patients in view of the immense benefits of therapy." (page 2, paragraph 3)
Prior to this meeting, physicians should reasonably have known the following:
- As early as 13th September 1982, Dr J. Craske was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States, and he suspected a remote possibility that commercial blood products were involved.
- On 15th January 1983, there had been an article in the Lancet by Dr Jones (a member of the UKHCDO) where AIDS had been linked to common cell immunity in haemophiliacs.
- By March 1983, the Directors of Haemophilia Centres were requested to report any cases of AIDS in haemophilia patients to the Oxford centre, to then be relayed to the Communicable Disease Surveillance Centre.
- On 23rd March 1983, in the USA, FDA regulations for the collection of plasma excluding donors from high-risk groups were introduced. However, use of pre-March 1983 stock was unfortunately NOT banned due to supply concerns.
- On 6th May 1983, the UK's CDSC telephoned the DHSS to inform them that a 23 year old haemophiliac patient from Cardiff was now showing symptoms of an AIDS diagnosis after having been infused with US Factor VIII.
- On 9th May 1983, the CDSC had written a crucial letter recommending that American FVIII should be withdrawn from use due to the risk of transmitting AIDS.
Type: HCDO Haemophilia Reference Centre Directors Organisation - Minutes. Dated 13th May 1983.
Location: UK
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- To take all necessary steps and measures in respect of AIDS.
- To avoid the use of coagulation factor products from large plasma pools, except when such a product is specifically indicated for medical reasons; this is especially important for those countries where self-sufficiency in the production of such products has not been achieved.
- To inform attending physicians and selected recipients, such as haemophiliacs, of the potential health hazards of haemotherapy and the possibility of minimising these risks.
- To provide all donors with information on AIDS, so that those in high risk groups will refrain from donating.
- To pursue rapid and full implementation of recommendations of R(80)5 and R(81)14.
Link #2
Type: Recovered Document - Draft Recommendations of the Council of Europe
Location: Lisbon / Europe
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- The significance of AIDS to the Committee was in relation to the effects with respect to the transfusion of blood and blood products, particularly with coagulation factor concentrates given to patients suffering from haemophilia. Absolute proof that AIDS is cause by a transmissible infectious agent is not yet available, but the consensus in the Committee was that it should be regarded as such that a recommendation should be made to the Council of Ministers at the meeting in June to take necessary steps to minimize the transmission of AIDS by the transfusion of blood products. (page 1, paragraph 4)
- With respect to the importation of plasma products, particularly from the USA, I find it difficult to believe that these can be phased out in the near future, since the Haemophilia Directors have always maintained that they require up to 100 per cent more Factor VIII for the treatment of haemophilia than can be produced from BPL. No doubt the opinion of the CBLA will be sought on these aspects. (page 2, point 4)
- It is important, I think to avoid "emotive over-reaction" amongst recipients, a phrase which will also appear in the recommendations. (page 2, final paragraph.)
- As will be evident from the above, the implications of AIDS in various aspects of blood transfusion practice kept appearing. Undoubtedly it is an important disease with a high mortality rate which has attracted considerable press publicity. Whilst it has not yet reached proportions in Europe as it has in the USA many members of the Committee considered that we may be seeing the beginnings of a problem which could escalate if appropriate steps are not taken now. (page 3, final paragraph)
Type: Extracts of an Informal Report by Dr H. H. Gunson on the Proceedings of the 6th Meeting of the Council of Europe, held in Lisbon, 16th-19th May, 1983.
Location: Lisbon
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Internal Correspondence from DHSS - Diana Walford dated 6 June 1983. Under the general heading "Possible Implications of AIDS for Plasma Supply and Manufacture at BPL:
"There are increasing indications that the AIDS may be transmitted by blood and blood products. Because of the number of donations to which they are exposed, haemophiliacs receiving large pool factor VIII concentrates (such as that manufactured at BPL) might be at greater risk than those receiving single donor cryoprecipitate or small pool products. At a recent Council of Europe meeting (16-19 May 1983) a draft resolution was accepted which recommends that the use of coagulation factors prepared from large plasma pools should be avoided except where such a product is specifically indicated for medical reasons. The implication in the resolution is that there should be greater use of single donor or small pool products."
Note: We have been unable to find this internal correspondence of 6th June 1983 in any of the FOI releases. We have also been unable to identify it in the evidence submitted to the Penrose Inquiry, and there is no mention of it in either the Preliminary Report or the Final Report. Therefore, we question whether it was ever released? ...
NHS single-donor cryoprecipitate | 17% |
NHS large-pool FVIII concentrate | 33% |
Imported large-pool (mostly USA) FVIII concentrate | 50% |
The DHSS circular continues:
"From these figures it can be seen that there is no option but to treat the majority of our haemophiliacs with large-pool products and thus it could be argued that the use of such products is specifically indicated for medical reasons since the risks of non-treatment are greater than the risks of treatment. However, this is a rather dubious 'let-out' and I think we should prefer to see the recommendation re-worded viz:"
- To avoid wherever possible [practicable] the use of coagulation factor products prepared from large plasma pools: this is especially important for those countries where self-sufficiency in the production of such products has not been achieved.
It is clear from these comments that there were attempts within the DHSS at 'skin-saving' and possibly cost-cutting apparently designed to mitigate or even circumnavigate the draft recommendations of the Council of Europe.
(See Related Entries link below for an astounding Kenneth Clarke comment made only 5 months later.)
Type: DHSS Circular from MED SEB, Room 1025A Hannibal House. Dated 13 June 1983.
Location: UK
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"The Chairman outlined the problems caused by AIDS. Since it appeared to be transmitted through blood and blood products then it should be considered by the Committee."
Note: We note that Dr Diana Walford (on behalf of the DHSS) was present at this meeting.
"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).
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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