The taintedblood Timeline  -  what really happened...

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.

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.

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.

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.

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."

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."

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.