The taintedblood Timeline  -  what really happened...

In a document called "Blood Products and Plasma Fractionation Laboratories", it states on page 4 that there is an active collaboration between Elstree and Oxford in 3 clinical investigations (TRIALS):

"Trial of factor VIII concentrate in prophylaxis BPL Elstree, Lord Mayor Treloar College, Alton." (page 4, paragraph 4)

Note: We have to wonder whether the pupils' or parents' consent was gained prior to a trial being conducted in a school? Using a new medicine for the sake of improved health, or improved yield of Factor VIII is one thing, but using the new concentrates as part of trials connected to a collaborative study is quite another.

In a document entitled "Blood Products and Plasma Fractionation Laboratories" there is clear knowledge of the shortcomings of both BPL and the PF Laboratory in July 1976:

"PF Laboratory has been inspected. BPL will be visited in October." (page 7, paragraph 2, line 1)

"It is not unlikely that the accommodation of both laboratories will be criticised and, in certain respects, found inadequate. Both were designed before the Medicines Act was passed and therefore several years before those responsible for applying this Act had formulated the criteria to be met." (page 7, paragraph 3)

Note: It is quite disgusting that these failings at BPL Elstree coincide with the use of their factor VIII concentrates in trials involving children at the Treloar boarding 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?

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.

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.

In a draft letter outlining the protocol of a trial of "hepatitis reduced" factor VIII, under the heading Procedure it states: "Patients attending any of the collaborating Haemophilia Centres during the course of the project who fulfil the criteria given will be admitted to the study."

"The object of the study will be explained to them, and their consent or that of their parents obtained, if under 16 years of age."

In a trial of thirty previously untreated and infrequently treated patients, a 12-year-old haemophiliac boy with 11% factor VIII level is infected with Non-A Non-B Hepatitis from NHS factor VIII. Prior to the trial, he is a previously untreated patient PUP who has never received NHS or Commercial factor VIII. He has no previous hepatitis, and there was no serological evidence of past hepatitis B.

During the trial the young haemophiliac patient develops raised transaminase activity of 894 IU when prior to the study, he had levels of only 5 IU.

Note: This 12-year-old haemophiliac boy was deliberately allowed to acquire hepatitis for the sake of a trial. [Clinical diagnosis of hepatitis defined by raised aspartate and alanine transaminase activity of over 150 IU; at least four times the upper limit of normal.]

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.