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1976, 27 July - BPL Elstree - Trial of FVIII Concentrates in Lord Mayor Treloar College
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.

1976, 27 July - BPL Elstree / PF Laboratories - Inspection Failings
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.

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: Haemophilia Centre Dr Aronstam 14 May 1979.pdf
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, 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: 1983 Andrew Veitch Medical Correspondent.pdf
Additional Source:
Type: Guardian Article, Circa 1983. Extra £30m could have kept out AIDS. Andrew Veitch Medical Correspondent
Location: UK
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1982, 11 January - Dr A. L. Bloom & Dr C. R. Rizza - Chimpanzees - Studies in Human Beings
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.

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.

Source: Bloom AL, Rizza CR. Letter to all Haemophilia Centre Directors. 11 January 1982. Chimpanzee Letter.pdf
Type: Internal letter
Location: UK
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1983, 22 March - PHLS - Trials of 'Hepatitis Reduced' Factor VIII
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."

Source: Craske J, Rizza C, Bloom A. Public Health Laboratory Service (PHLS) letter to Haemophilia Centre Directors. 22 March 1983 Letter 22 March 1983.pdf
Type: Draft PHLS Letter - Trial Protocol
Location: UK
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1987, 10 December - NANBH – Factor VIII Trial – Infrequently Treated Patients
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.]

Source: Fletcher ML, Trowell JM, Craske J, Pavier K, Rizza CR. British Medical Journal, Vol 287, 10th December 1987.
Type: Trial - Infrequently Treated Patients
Location: UK
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