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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: 6 of 711
1980
15 September
Dr Diana Walford - DHSS: Non-A, Non-B Hepatitis Could be Rapidly Fatal
In a letter of 15 September 1980, Dr Diana Walford, a doctor working for the DHSS, recorded that the majority of the hepatitis infections following blood transfusion or treatment with blood products in the USA (and elsewhere) were caused by non-A, non-B hepatitis (NANBH) and that these viruses could be rapidly fatal.

The following was recorded in writing by Dr Walford in 1980: "I must emphasise that 90% of all post-transfusion (and blood-product infusion) hepatitis in the USA and elsewhere is caused by non-A, non-B hepatitis viruses which (unlike Hepatitis B) cannot, at present, be detected by testing donor blood."

Dr Walford goes on to state: "This form of hepatitis can be rapidly fatal (particularly when acquired by patients with pre-existing liver disease) or can lead to progressive liver damage..."

NOTE: We would like to draw attention to the level of knowledge that the DHSS possessed in 1980. This is the knowledge they had then; the very same information that the haemophiliac community are only discovering now. However, this is not a question of government only having the ability to understand the situation with regard to fatalities from viral hepatitis after they had happened, this letter of 1980 demonstrates full comprehension by the DHSS of the gravamen of such infections from commercial imports. Therefore, we must ask why any preventative action wasn't taken by the DOH and why was it that a complete myth was somehow propagated that NANBH was "mild and often asymptomatic"?

Source:
Type: Dr Diana Walford, MED SM4. Letter to Mr Harley. 15 September 1980
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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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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1983
21 June
AIDS Appeared to be Transmitted Through Blood & Blood Products
In the Minutes of the CBLA (Central Blood Laboratories authority), Central Committee for Research and Development in Blood Transfusion, held on 21 June 1983, we can learn more about when the DHSS actually started to make the link between AIDS transmission and blood and blood products:
"The Chairman outlined the problems caused by AIDS. Since it appeared to be transmitted through blood and blood products then it should be considered by the Committee."

Note: We note that Dr Diana Walford (on behalf of the DHSS) was present at this meeting.

Source:
Type: Penrose Evidence File
Location: UK
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1984
9 February
Hepatitis Considered a Well-Recognised Side-Effect
In the Draft Minutes of a Meeting on the Infectious Hazards of Blood Products, at NIBSC in February 1984, we learn that those present knew that NANB-hepatitis had been shown to cause 100% infectivity from first exposure to pooled concentrate:

Dr Thomas (NIBSC): "The undoubted therapeutic benefit of Factor VIII concentrates was clouded by a well recognised side-effect, namely hepatitis, and also, more recently, AIDS. It has been shown that the first exposure to concentrate, from whatever source, is associated with a hundred per cent infectivity with non-A, non-B hepatitis."

Note: We are dismayed to read that they dared to consider hepatitis merely a well-recognised side-effect, and to include AIDS in the same context is deplorable. The minutes state that NIBSC was the Institute that gave 'scientific advice to the Licensing Authority and the Committee on the Safety of Medicines'. So this cannot be excused.

Source: Link #1
Type: Penrose Evidence File
Location: UK
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