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Magna Carta - 15th June, 1215

 
No of entries selected: 5 of 711
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
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
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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