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"To no one will we sell, to no one deny or delay, right or justice."
Magna Carta - 15th June, 1215

 
No of entries selected: 3 of 711
1982
11 January
Dr A. L. Bloom & Dr C. R. Rizza - Chimpanzees - Studies in Human Beings

Oxford Haemophilia Centre Letter to All Haemophilia Directors:

4 Commercial Companies are about to release Factor VIII & possibly Factor IX products that have been heat-treated in an attempt of reducing the risk of transmitting Hepatitis B and Non-A Non-B hepatitis.

"Infectivity of initial batches is tested by injecting the product into Chimpanzees. However, it is stated that it is unlikely that Manufacturers would be able to ensure this form of quality control in all future batches."

Note: The letter states that it is important to find out in studies of human beings the extent to which infectivity has been reduced.

Use of Previously Untreated Patients (PUPs) that have not previously used concentrates form large donor pools is suggested.

Controlled Studies on a "named patient-basis" is deemed to be undesirable.

Source: Link #1
Type: Internal letter
Location: UK
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1983
9 May
PHLS / DHSS - Decision to Withdraw USA Blood Products
In a letter from Dr N. Galbraith of the Public Health Laboratory Service (PHLS) to Dr Ian Field of the DHSS in May 1983, the following is stated:

"... 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literature and come to the conclusion that all blood products made from blood donated in the USA after 1978 should be withdrawn from use until the risk of AIDS transmission by these products has been clarified.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.

Source:
Type: Recovered Document - Letter from Dr N S Galbraith of the PHLS to Dr Ian Field, DHSS. Dated 9th May 1983.
Location: UK
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1985
13 May
DHSS - Product Recall - Armour Factor VIII Batch Y69402
In May 1985, the DHSS writes to the Directors of the BTS (England and Scotland) regarding a recalled batch of Factor VIII Armour Y69402 (Product Licence PL/0231/0038):

"I am writing to advise you that [deleted name] have recalled batch number Y69402 of the above product because one of the US donors of the original plasma, although passing all screening tests at the time, has subsequently developed AIDS."

Note: See link to Chimpanzee Oxford Letter (below), "Use of products on a named-patient basis is often justifiable but by-passes these controls which have been established in the interest of patients".

Background: Also commercial products imported into the UK would have been sourced two years earlier at which time (circa 1983) a screening test for HIV was not officially available.

Source: Additional Source: Chimpanzee Oxford Letter:
Link #2
Type: Recovered Document - DHSS - Letter to Blood Transfusion Service Directors. 13th May, 1985
Location: UK
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