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?

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.

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 letter from Dr N. Galbraith of the Public Health Laboratory Service (PHLS) to Dr Ian Field of the DHSS in May 1983, the following is stated:

"... I have reviewed the literature and come to the conclusion that all blood products made from blood donated in the USA after 1978 should be withdrawn from use until the risk of AIDS transmission by these products has been clarified. Appended is a paper in which I set out my reasons for making this proposal. Perhaps the subject could be discussed at an early meeting with haematologists, virologists and others concerned so that a decision may be made as soon as possible."

"In conclusion, I say that I am most surprised that the USA manufacturers of the implicated blood products have not informed their customers of this new hazard. I assume no critical warning has been received in the United Kingdom?"

Note: Why did the DHSS not agree with PHLS (CDSC)? After all, the PHLS were the people who should have had the last word.

In May 1985, the DHSS writes to the Directors of the BTS (England and Scotland) regarding a recalled batch of Factor VIII Armour Y69402 (Product Licence PL/0231/0038):

"I am writing to advise you that [deleted name] have recalled batch number Y69402 of the above product because one of the US donors of the original plasma, although passing all screening tests at the time, has subsequently developed AIDS."

Note: See link to Chimpanzee Oxford Letter (below), "Use of products on a named-patient basis is often justifiable but by-passes these controls which have been established in the interest of patients".

Background: Also commercial products imported into the UK would have been sourced two years earlier at which time (circa 1983) a screening test for HIV was not officially available.

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.]