Infected Blood Inquiry

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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: 9 of 711
1977
13 January
HCDO - Agreement to Send Haemophiliac Boys to Treloar School
In the minutes of a meeting of the HCDO on 13th January 1977, Dr Rainsford, of the Lord Mayor Treloar College, drew attention to the fact that the number of haemophilic boys applying for admission to the college had decreased and that there were only 4 applications that year compared with 7 the year before.

He wished to know if Haemophilia Centre Directors were changing their policy with regard to sending boys to the College. The comment was made that the decrease in haemophiliacs applying for admission was in all likelihood a reflection of the improvement in haemophilia treatment throughout the United Kingdom both at Centres and by home therapy.

Note: We would like to pose the question as to whether there some sort of agreement between Haemophilia Centre Directors that they would 'channel' their patients toward the school each year on behalf of Dr Rainsford?

Who, then, decided to send the haemophiliac boys to the school? Was it the Local Authorities, school headmasters, GPs or local haemophilia centre Consultants, or did the school approach families direct?

Background: Unfortunately, we have reason to believe that in some cases children were actually 'forced' to go to the school by their Local Education Authorities on the supposed grounds that it was the only way the LEA felt able to fulfil their legal obligation to provide an adequate education... and parents would have been 'forced' into it as well. Also, we would like to point out that some children with haemophilia came from unstable family backgrounds and were encouraged to be just dumped at the school.

Source: Additional Source: Testimony of Former Member of the Lord Mayor Treloar College.
Type: Extract from the Minutes of a meeting of the HCDO 13th January 1977
Location: UK
1979
14 May
PHLS Suggestion to Use Hepatitis-Implicated Factor VIII in the Treloar School
In a letter to the PHLS from Dr A. Aronstam of the Lord Mayor Treloar Hospital, it is clear in May 1979, that there is an intention from the Public Health Laboratory Service (PHLS) of transfusing mild haemophiliacs with a questionable Factor VIII 'material' which would have caused mild haemophiliac patients to develop hepatitis.

Dr Aronstam strongly disagrees with the PHLS suggestion:

"We have not had any cases of hepatitis following N.H.S. Factor VIII. As far as your suggestion about transfusing mild haemophiliacs with this material is concerned, I totally disagree with this concept. I do not wish any of my mild haemophiliacs to develop hepatitis in any form and therefore adopt the policy of either using D.D.A.V.P. or Cryoprecipitate."

Note: It should be pointed out that the Lord Mayor Treloar College was in fact a boarding school for children. It is disturbing to read that the PHLS were trying to persuade the school to adopt some other type of Factor VIII material which would have caused the pupils to develop hepatitis.

What on earth was the PHLS doing contacting a school to 'promote' hazardous medicines?

Source:
Type: Recovered Document - Letter to PHLS from Dr A Aronstam of the Lord Mayor Treloar Hospital. Dated 14th May 1979
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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1981
1 February
Treloar School Alton - 10 Children Contract Hepatitis from Commercial Factor VIII
UK Health ministers are warned about the dangers of importing contaminated blood products from the United States:

In February 1981, 10 children at the Treloar specialist school in Alton, Hampshire are infected with hepatitis from contaminated Factor VIII in what we believe to be a second outbreak of hepatitis B. There then follows a warning regarding infected Factor VIII supplies being imported from the USA.

The Department of Health admitted at the time that they knew there was a risk of infection and the then Health Minister, Dr Gerard Vaughan, claimed that the £1.29m being invested in the BPL Elstree would resolve the problem.

Note: We have to wonder if this second outbreak of hepatitis was as a direct consequence of an approach made by the Public Health Laboratory Service (PHLS) two years earlier on 14th May 1979? We can determine from documentation that there was the intention from the PHLS of transfusing mild haemophiliacs with a Factor VIII 'material' which would have caused mild haemophiliac children to go on to develop hepatitis.

In a reply letter of May 1979 to the PHLS from Dr A. Aronstam of the Lord Mayor Treloar Hospital, we read that Dr Aronstam totally disagreed with the PHLS' suggested concept and he adamantly stated that he did not wish any of his mild haemophiliacs to develop hepatitis in any form.

Source: Additional Source:
Link #2
Type: Guardian Article, Circa 1983. Extra £30m could have kept out AIDS. Andrew Veitch Medical Correspondent
Location: UK
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1982
30 March
Factor VIII Study Group - Prospective Trial of First Time Haemophiliacs
In the minutes of the Second Report of the Factor VIII Study Group of 30th March 1982, we read of further discussion of Chimpanzees:

"It is clear that chimpanzees can be used at a much younger age than was previously mentioned (2 yrs vs. 3 years). It is also rumoured that NIH costs (contracted to a colony in U.S.) are lower than those in Liberia." (Page 4, point b)

On page 5, under the heading "Procurement of Infective Material" we read that:

"Various people were contacted in the U.K., but none had much to offer. C. Rizza in conjunction with J. Craske are running a prospective trial of "first time" haemophiliacs receiving NHS and commercial concentrates." (Page 5, point 3.)

Note: We have to ask what the reference to "first time" haemophiliacs really means in practice? We would suggest that in order to meet the criteria for trials such as this, the haemophiliac subjects should not have been exposed to large pool concentrates - which would almost certainly mean that they were either a young child PUPs (Previously Untreated Patients), or moderate to mild haemophiliacs, who were again likely to be children, but might also have been adults.

Source:
Type: Freedom of Information (Scotland) Document - Second Report of Factor VIII Study Group, Safety Action Group Liberton. Dated 30th March 1982.
Location: Scotland
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1982
post November
Oxford Haemophilia Centre - Cirrhosis in Children
In a document entitled: "A Prospective Study of Hepatitis in Haemophiliacs first treated with Factor VIII or IX Concentrate" it is suggested by the study that with regard to the risk of contracting transfusion hepatitis, there is no difference between NHS and US commercial factor VIII. (Page 1, end of paragraph 2)

"Since there are as yet no confirmed laboratory tests available for non-A, non-B hepatitis the only sure way of assessing the risk of transfusion hepatitis associated with new brands of concentrate where attempts have been made to inactivate hepatitis viruses by heat, ultra-violet light and propiolactone or other methods, is by use of chimpanzee inoculation experiments, or TRIALS of each product compared with an UNTREATED product in a group subjects where the susceptibility to hepatitis is known to be high. We have demonstrated such a group in the patients with mild coagulation defects already studied at Oxford. (Page 1, paragraph 4)

"Some children with cirrhosis have received concentrate for 6-7 years. (Page 2, under "Complications", 16 lines from the bottom of the page.)

Note: The worst thing we are seeing here is that it is seems to be acceptable to these physicians that CHILDREN should have cirrhosis. It should be noted that this is coming from the very people who said that they weren't aware or didn't think that hepatitis was a serious problem.

Source: Link #1
Type: Recovered Document - Prospective Study - circa November 1982. Dr C.R. Rizza. Dr. J. Craske
Location: UK
1985
6 July
Colombo et al - The Lancet - Infectivity Trials of NANB Hepatitis in Children
In an infectivity trial in human beings contrasted against an animal model involving chimpanzees, 11 out of 13 Previously Untreated Patients (PUPs) go on to develop Non-A Non-B Hepatitis after being administered commercial heat-treated Hemofil-T made from around 5,000 North American pooled plasma donations, collected in 1982, 1983, and 1984.

The findings were contrasted with the absence of non-A, non-B hepatitis in chimpanzees given the same heated concentrate. The Hemofil-T lot numbers were: 820628A, 820817A, 840120A, 830121A, 833010A.

Of the 13 patients, 9 of them were aged between only 3 months old and 15 years of age. Five of these patients were just 12 month-old babies. In fact, there were only 2 patients who were over the age of 18.

Consent:
On page 2, under the heading 'Patients', it states that those who met the criteria "gave their written informed consent".

Note: Eight of these patients were in the age-range of a 3-month-old baby up to 3 years of age and would therefore not even have been able to write. In the case of the 9 patients under the age of 18, their parents would have been required to give their informed written consent.

We have to wonder if ANY parent would knowingly consent to hepatitis infectivity trials of this kind, especially if they were genuinely informed and cognizant of exactly what was involved.

Source: Link #1
Type: Recovered Document - Copy of Lancet Article Within the DOH FOI Released Documents
Location: UK
1990
12 February
Haemophilia Centre Directors Discuss the HIV Litigation and HCV Testing Data
In the minutes of the Nineteenth Meeting of the AIDS Group of Haemophilia Centre Directors held at The Royal Free Hospital on 12th February 1990, a discussion takes place in relation to the ongoing Haemophilia HIV litigation and situation with HCV testing data. Dr Aronstam, of the Treloar Haemophilia Centre, Alton, is placed in a somewhat questionable position by his colleagues at this meeting.

"Dr Savidge raised the point that one member of the AIDS Group was acting as an expert on behalf of the Plaintiffs' and wondered whether it was acceptable for him to take part in the Group's discussions on Litigation and the Defence of the main statement of Claim. Dr Aronstam said he was the person referred to. He had not been asked to be a medical expert witness for the plaintiffs. If the group felt it was awkward for him to be present he would leave the meeting. He pointed out that some other directors were in a similar position and more might be in the future..."

"Dr Rejman said that the cases of Plaintiffs in the Wessex Region were being held back at present and would follow on after the lead cases had been considered. Dr Aronstam said he knew of at least two cases involving his patients which were going ahead as lead cases; it was news to him that Wessex cases were being put back."

"With regard to Health Authorities' Defence to the Re-amended Statement of Claim, Dr Savidge said that he had been using heat-treated Factor VIII as early as 1983 and he was trying to get the Defence's Statement amended as it said heat-treated factor VIII was not used until the end of 1984."

"Dr Lowe suggested that Dr Simpson's advice should be sought regarding the Haemophilia Society's request for information on hepatitis. Was hepatitis likely to be another item for which haemophiliacs would seek litigation and was it advisable for the Haemophilia Centre Directors to continue to collect data? Dr Simpson said it would not be advisable for the Directors to stop collecting data as they had already started to do so. Dr Hill pointed out that hepatitis was not a new thing; only the test was new. After further discussion, Dr Simpson agreed that the Haemophilia Society should not be given hepatitis data."

"Dr Lowe thought there was a difference between testing LFTs and testing for Hepatitis C and he wondered whether the patient's consent to testing should be sought… …Prof Bloom didn't see why permission needed to be asked for Hepatitis C tests as this was just another LFT. Dr Savidge said that patients were now becoming more and more conscious of what tests were, so he would advise caution at present."

Prof Preston quoted results presented at a recent meeting on prevalence of anti HCV in spouses of haemophiliacs. A figure of 20% was found which he thought was very worrying.

Note: The Joint Secretary of the 3 Defence Unions was present at this meeting, as was Dr A. Rejman, Senior Medical Officer (SMO), haematologist and DH Secretariat to the ACVSB.

Source:
Type: Penrose Evidence File
Location: UK
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2011
13 October
Most Patients Included in These Figures Will Have Been children When Treated
In Chapter 22 of the Penrose Inquiry Final Report, our worst fears are confirmed as to the prevalence of children testing positive for HCV:

"Of the 29, six - all Haemophilia A patients - tested positive for HCV. The status of 14 patients (with Haemophilia A or B, von Willebrand disease, or, in one case a Haemophilia B carrier) was not known. Most patients included in these figures will have been children when treated."(9)
Source 9:
Professor Lowe: "And I think at that time all haemophilia directors were asked to look back at their patients during the period of time that you mentioned and produce data for that Inquiry as to how many patients at each haemophilia centre were treated for the first time with a blood product, and out of those 13 in the West of Scotland, my memory is that the majority of those would be children attending Yorkhill Hospital, the children's haemophilia centre, because obviously it's as a child that most patients with haemophilia get their first exposure to a blood product."
Source: Link #1
Type: Penrose Evidence File
Location: Scotland
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