The taintedblood Timeline - what really happened...
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."
- Lederman reports widespread immunity abnormalities, possibly linked to AIDS.
- Menitove states that AIDS has a 40 per cent mortality, and reports widespread cell abnormalities.
- Desforges recommends Cryoprecipitate rather than concentrate because of the risk of AIDS.
Type: Articles: New England Journal of Medicine
This man had been infused with American Factor VIII.
Type: Recovered Document - DHSS Letter. American Factor VIII. Cardiff Haemophiliac. Dated 6th May 1983
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"... I have reviewed the literature and come to the conclusion that all blood products made from blood donated in the USA after 1978 should be withdrawn from use until the risk of AIDS transmission by these products has been clarified. Appended is a paper in which I set out my reasons for making this proposal. Perhaps the subject could be discussed at an early meeting with haematologists, virologists and others concerned so that a decision may be made as soon as possible."
"In conclusion, I say that I am most surprised that the USA manufacturers of the implicated blood products have not informed their customers of this new hazard. I assume no critical warning has been received in the United Kingdom?"
Note: Why did the DHSS not agree with PHLS (CDSC)? After all, the PHLS were the people who should have had the last word.
Type: Recovered Document - Letter from Dr N S Galbraith of the PHLS to Dr Ian Field, DHSS. Dated 9th May 1983.
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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.
|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.
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"Over the next three years the blood products laboratory will be redeveloped at a cost of £21m. When completed the laboratory will be of a size capable of making England and Wales self-sufficient in blood products".
Note: Mr Kenneth Clarke has clearly made the most of the way in which the original question was worded. This is a crafty answer, in that if the question had specified 'blood products' then he would have had to divulge information that indicated that blood products have, in fact, been imported into the United Kingdom since 1972. (Source: "Haemophilia Treatment in the United Kingdom from 1969 to 1974" Rosemary Biggs)
Background: There was no question that blood products (as opposed to plasma) were being imported from the USA when Mr Kenneth Clarke made this statement in 1983:
- In August 1983, Lord Glenarthur of the DHSS failed to ban pre-March 1983 imported American factor VIII. "Regarding blood products from the USA, in March this year the US Food and Drugs Administration (FDA) initiated new regulations for the collection of plasma designed to exclude donors from high-risk groups."
- It should also be pointed out that the MHRA's CSM (Committee on the Safety of Medicines) sub-Committee on biological products were reviewing product licences between March 1983 and July 1984 for commercial companies Armour, Alpha and Travenol with respect to their factor VIII products and antihaemophilic factor bulk cryoprecipitate.
- Five months earlier, (June 1983), written evidence can be found from the DHSS that as much as 50% of the Factor VIII requirements of the United Kingdom were indeed imported large-pool commercial concentrates, mostly from the USA.
"The use of factor VIII concentrates is confined almost exclusively to designated haemophilia centres whose directors and staff are experts in this field."
"Professional advice has been made available to all such centres in relation to the possible risk of (AIDS) from this material".
How much proof did he need?
- In a Haemophilia Centre Directors' Organisation meeting in 13 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.
- Then in January 1983, Desforges publishes an articles in the New England Journal of Medicine on Hemophiliacs and AIDS, recommending that cryoprecipitate rather than concentrate be used because of the risk of AIDS.
- By 6th May 1983, the CDSC telephones the DHSS to inform them that a 23 year old haemophiliac patient in Cardiff is now showing the appropriate symptoms for an AIDS diagnosis. N.b. This man had been infused with American Factor VIII.
- In a letter of May 1983, Dr N. Galbraith of the PHLS writes to the DHSS stating that he has reviewed the literature and come to the conclusion that all blood products made from blood donated in the USA after 1978 should be withdrawn from use until the risk of AIDS transmission by these products has been clarified. Both this suggestion and warning were ignored.
- Even when the Council of Europe made their draft recommendations on coagulation factors and AIDS at their meeting in Lisbon (16-20th May 1983), the UK seems to have difficulty remotely following these resolutions - which were, incidentally, accepted. The Council of Europe recommended that the use of coagulation factors prepared from large plasma pools should be avoided except where such a product was specifically indicated for medical reasons.
- In August 1983, the first UK haemophiliac dies of AIDS from US Factor VIII administered in December 1981.
Type: Hansards Written Answers
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Also, as only haemophiliacs have died and they may have had Factor VIII from American blood, is it the case that we have not had one AIDS fatality from blood donated in this country yet?"
'...only haemophiliacs...' What does he mean by this? Whatever he meant, only 6 weeks later we find distasteful comments from the DHSS Finance Division regarding the potential SAVINGS that could be generated when haemophiliacs died. (see related entries link below)
Kenneth Clarke, 22 January 1985: "Do we need this and heat treatment of the blood?"
Note: The extent of naivety in these comments should not surprise us. We only need to remind ourselves that this apparent lack of understanding emanates from a man who had already stated 13 months earlier (in October 1983) that as far as he knew no human blood plasma was imported into the United Kingdom by the NHS. What rubbish. There should have been no question in his mind as to whether blood products (as opposed to plasma) were being imported from the USA in 1983.
Note: Even more remarkably, in November 1983, Mr Kenneth Clarke (then Minister for Health) offers us further counsel without knowledge: "There is no conclusive evidence that (AIDS) is transmitted by blood products." He obviously wasn't paying attention to the Council of Europe Recommendations on coagulation factors and AIDS at the Lisbon meeting in May 1983. (see related entries link below for a plethora of proof.)
No wonder in recent correspondence (2007) with Taintedblood, Mr Kenneth Clarke unfortunately appears to be experiencing 'selective memory loss'.
Type: Kenneth Clarke Internal Circular. Dated 22 January 1985
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