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Magna Carta - 15th June, 1215

 
No of entries selected: 2 of 711
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
27 October
ASTMS Disagrees with the Department's View on the Issue of AIDS
In a reply letter of October 1983 to Lord Glenarthur from the Association of Scientific Technical and Managerial Staffs, it is clear that the Association (ASTMS) does not agree with the Department's view on Acquired Immune Deficiency Syndrome (AIDS):

"You say that there is no conclusive evidence that AIDS is transmitted through blood products. I would argue that the evidence is very strong. There are now about 20 American haemophiliacs with AIDS, and this figure is likely to underestimate the risk because of the apparently long incubation period." (page 1, point 2)

"I also draw your attention to a paper prepared jointly by DHSS staff and the HSE which was submitted to a recent meeting of the Advisory Committee on Dangerous Pathogens (ACDP/83/P9). This paper states quite specifically that "there is now strong circumstantial evidence that AIDS may be transmitted by blood products." I am tempted to ask you what you would consider to be conclusive evidence, particularly in the circumstances where the agent or agents for AIDS are as yet unidentified?" (page 1, point 2)

"I think you are placing undue reliance on the Regulations introduced by the U.S. Food and Drug Administration. These Regulations rely on the use of interviews and questionnaires to identify donors from high risk groups; ...."

"The companies also do not intend to recall contaminated lots after manufactures." (point 3)

"I do not regard the situation concerning "pre-March" plasma to be satisfactory because, in effect, it means that despite the introduction of the above Regulations we are essentially carrying on as before. In such circumstance there must be a real danger that the UK will become a dumping ground for USA companies to get rid of their non-regulated products. I think for this reason your Department should reconsider its rather passive response to the need for Regulations." (Page 3, point 4.)

Source: Link #1
Type: Letter to the Lord Glenarthur - Joint Parliamentary Under Secretary of State from the Association of Scientific Technical and Managerial Staffs, ASTMS. Dated 27th October 1983.
Location: UK
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