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Magna Carta - 15th June, 1215

 
No of entries selected: 10 of 711
1980
November
NIBSC - Armour AHF Batch J70902
According to the National Institute for Biological Standards and Control (NIBSC), in November 1980, Armour AHF Batch no. J70902 is reported to have given rise to 3 separate incidents of various types of hepatitis in 3 persons with haemophilia.
Source: Link #1
Type: Library Samples of Armour Batch J70902
Location: UK
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1981
circa January
Sir George Young, Under Secretary of State - Warning over Hepatitis Risk
Sometime in January 1981, Sir George Young, Under Secretary of State in the Department of Health, gives a warning of the "possible risks of hepatitis" from imported products, particularly from those made from plasma supplied by paid donors.

Sir George Young's warning was reported the following month in the Sunday Telegraph (on 01.02.81) in an article entitled: "10 Sick After Factor 8 Doses". The article goes on to say:

"Imports worth an estimated 10 million of Factor 8, the missing factor in a haemophiliac's blood, come from America, Germany and Austria in powdered form to supplement the limited amount made in Britain."

Dr Charles Rizza: "There might be a greater degree of risk from commercial products."

"The National Institute for Biological Standards and Control, [NIBSC] which tests all foreign blood products imported by Britain, rejects a "small amount," believed to be about 5%, of the millions of bottles of Factor 8 brought in each year."

Note: The Under Secretary of State's warning came just one month after the damning Medicines Inspectorate report of the laboratories of BPL Elstree on 9th December 1980 which gives insight into the state of domestic production. This warning over the risks of imported products from paid donors was either ignored or came too late for 10 of the haemophiliac boys attending the Lord Mayor Treloar School in Alton as by the beginning of February, they contract hepatitis from commercial Factor VIII.

They were only children, aged between 9 and 14.

Source:
Type: Article
Location: UK
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1982
1 March
NIBSC Leeway in Assaying FVIII Material before Release to Hospitals
In the Minutes of the Fourteenth Meeting of the Haemophilia Reference Centre Directors on Monday 1st March, 1982,

Professor Bloom welcomed Dr. Aronstam to the meeting and said that he felt sure that the Reference Centre Directors would benefit from Dr. Aronstam's special experience of managing adolescent haemophilic boys.

6: "Assays on commercial concentrates"
"Dr. Kernoff said that he thought NIBSC were responsible for checking factor VIII preparation for assaying the material before it was released for use in hospitals throughout the U.K."
"He had therefore heen very surprised by the letter in the Lancet describing discrepancies between the 'labelled' potency and the 'found' proteins. NIBSC allowed 20%-leeway on the assay value of the material."
"He thought that NIBSC should have been the people to have known about the discrepancies and that it should not have been necessary for the discrepancies to have been brought to light by a Haemophilia Centre. There was some discussion about the functions of NIBSC."
Note: It seems that Factor VIII potency was not the only leeway being allowed for by NIBSC. The licensing authority imposes a "batch release" condition on all foreign blood products under which samples must be supplied for initial batch testing by NIBSC. We know that only the year before, it was recorded that NIBSC was only rejecting a small amount (in the region of 5%) of foreign blood products imported into Britain.
Source:
Type: Penrose Evidence File
Location: UK
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1982
16 July
DHSS Had Early Awareness of Concerns over the Safety of American Factor VIII
In a DHSS letter of 16 July 1982, we read of an early awareness of research which fairly conclusively demonstrates that:

"....plasma taken from homosexual drug-takers contains a sort of virus which goes undetected when the plasma is tested because it is suppressed by the drugs. However, when used for Factor VIII, it becomes active again."

The DHSS letter states that information has been received from the American Bureau of Biologics (via NIBSC) indicating there may be considerable publicity in the next couple of weeks concerning the safety of American Factor VIII.

From the following comment, it appears the DHSS are complacent at this stage:

"In any case with our voluntary unpaid donor system we do not have the same problems as in the States where drug addicts are tempted to give blood simply for the money. However, about half of the Factor VIII bought from commercial companies is imported from the USA."

Note: In terms of knowledge in the United Kingdom, this is one of the earlier dates (16 July 1982) which demonstrates that the DHSS had advance "private" knowledge of the safety risks from US commercial factor VIII almost 10 months earlier than we previously thought. This DHSS letter went out 1 year prior to the infamous July 1983 CSM meeting (reported in the Guardian by Sarah Hall on Friday May 25, 2007).

This early knowledge by officials also pre-dates (by 2 months) our earliest known point of awareness of AIDS by the UKHCDO (which was in September 1982). We know that Dr Craske was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States.

Source: Link #1
Type: DOH FOI Documents
Location: UK
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1983
28 March
NIBSC - AIDS Problem in Relation to Licensed Blood Products
In a letter from the National Institute of Biological Standards and Control (NIBSC) in March 1983, we learn that they thought it would be advisable to consider the problem of AIDS in relation to licensed blood products at a meeting of the CSM(B) (Committee on the Safety of Medicines Biologicals Sub-committee).

The following is stated: "Attached are letters recently released by FDA, on or about the 17th March 1983. You will see that the US are taking steps to avoid the use of blood from high risk groups in the preparation of certain blood products."

Source:
Type: Letter from NIBSC, National Institute for Biological Standards and Control. Dated 28 March 1983.
Location: UK
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1983
10 May
DHSS - Licensing of Imported Blood Products and Batch Release Conditions
In a DHSS circular of 10th May 1983, the licensing situation in relation to the import of blood products is discussed. The following passages are quoted verbatim from the circular:

IMPORT OF BLOOD PRODUCTS

"Imports of blood products into the United Kingdom for medicinal purposes have to be licensed under the Medicines Act 1958. Licensed products must satisfy the requirements of the Act for safety quality and efficacy."

"It is made a condition of product licences in this field that the licence holder exercises proper quality control, which involves accounting for the source and quality of the blood, its processing and final product examination. On all blood products the licensing authority imposes a "batch release" condition under which samples must be supplied for testing by the National Institute for Biological Standards and Control [NIBSC]."

"Although all medicinal products require a product licence if they are to be promoted for medicinal use, a doctor may prescribe an unlicensed product provided this is on what is known as a "named patient" basis."

Source: Link #1
Type: DHSS Circular from HS1A Med SEB on
Location: UK
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1983
31 May
Stocks of Pre-24th March 1983 Factor VIII Awaiting Batch Clearance by NIBSC
In a Paper on the background of AIDS in May 1983, it transpires that there are large stocks of Factor VIII awaiting batch clearance by NIBSC. It is stated that:

"..this almost certainly includes material made from pre - 24th March plasma." (Page 1, point 2).

"MB4 advise that all FVIII concentrates are subject to full "Stop Orders", which require the manufacturers to submit protocols and samples from every batch they propose to sell in the UK, to Dr Duncan Thomas's department at NIBSC." (Page 1, point 2).

"The content of an individual manufacturer's protocol is very much a matter for agreement between Dr Thomas and the company. Date of plasma collection is thought not to be a requirement at present, but probably could become so if it were thought desirable." (Page 1, point 2).

Note: We are completely dismayed to discover that people knew that stock-piled imported Factor VIII almost certainly included material made from pre-24th March '83 plasma.

Source:
Type: Recovered Document - AIDS Background Paper III. Dated 31st May 1983.
Location: UK
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1984
17 February
SNBTS / NIBSC - Clinical Trials in PUPs - Virgin Haemophiliacs
In a letter of February 1984, from the Scottish National Blood Transfusion Service to the Department of Haematology in Cardiff, we learn of plans for limited clinical studies in haemophiliacs to be held in September 1984, where the author of the letter, Dr John D. Cash, hopes to have sufficient wet heat-treated Factor VIII made available. Note the awful wording in the following:

Dr Cash: "We are particularly keen to see part of this product is put into "virgin haemophiliacs" and would much appreciate the assistance of the U.K. Haemophilia Centre Director's Working Party on Hepatitis."

Note: This letter makes very upsetting reading. At the time this letter was written, February 1984, they were several years into the AIDS crisis. There had been numerous warnings (from the CDSC to the 1983 FDA regulations) yet, we still find trials being conducted on PUPs or as this letter so horrifyingly words it 'virgin haemophiliacs'.

These Doctors knew that there was no cure for AIDS.

Source: Additional Source (with name of author visible):
Link #2
Type: Recovered Document - Scottish National Blood Transfusion Service. Letter dated 17th February 1984
Location: Scotland
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1985
4 July
DHSS Request an Assurance That No Further UK Haemophiliacs will be Infected
In a DHSS internal circular of 4 July 1985, the author asserts that all UK-produced Factor VIII has been heat-treated at Elstree as of April 1985.

"[Deleted name] of NIBSC has just informed me that since 19 December 1984, all imported Factor VIII cleared by NIBSC has been heat-treated. All Elstree material received since April has been heat treated and Scottish supplies have been heat treated since the 23 January 1985."

At the end of the circular we discover the following handwritten request:

"Can you please translate this into an assurance I can give to the SoS next week that no haemophiliacs will be infected in the UK from now on."

Note: Whether of not this assurance was given to the Secretary of State, we are saddened to report that in the same month (July 1985), there were two cases of seroconversion in haemophiliacs associated with the use of Armour's H.T. Factorate - an apparently heat-treated factor VIII concentrate.

Background: With regard to UK-produced Factor VIII, it should be pointed out that within just 4 more months, evidence is found of haemophiliacs seroconverting to become HTLV-III (HIV) positive, despite being given heat-treated Factor VIII manufactured in the United Kingdom.

Source:
Type: Internal Circular DHSS. Dated 4 July 1985.
Location: UK
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1993
6 November
NIBSC Batch-Testing Of All Blood Products Released for Use in the UK
On Saturday, 6 November 1993, an article in The Scotsman entitled "Assurance After AIDS Contamination Scare" reveals a surprising statement that NIBSC batch-tested all blood products released for use in the UK, yet found no contamination with HIV...

A statement from the Department of Health said:

"The National Institute for Biological Standards & Control have batch-tested all blood products released for use in this country including those from IMMUNO. No HIV contamination has been found in any products authorised for release by the NIBSC."

NOTE:

If no HIV contamination was found in the products authorised for release by NIBSC ~ which from the mention of Immuno clearly included imported products ~ how was it possible that 1,200+ UK haemophiliacs became HIV positive which led to the deaths of over 900 of them?

Legal Note: Should the batch release certificates ever be disclosed by NIBSC to our solicitors, we dare say that NIBSC could be held liable for releasing contaminated products which were batch-tested and deemed safe. We believe Crown Immunity will be of little use as a defence since the products being tested included imported commercial concentrates. The very fact that these were not manufactured in the UK from 'altruistically' donated blood weakens the aegis of Crown Exemption that applied to all NHS bodies and premises until 1st April 1991. NIBSC may well find that the provisions of the Medicines Act are, in fact, binding on them in this case.

Source:
Type: Press Article. The Scotsman. Assurance After AIDS Contamination Scare. 6th November 1993
Location: UK
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