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?

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 1985, circa 26 February, a consultant with the initials C.A.L. made an application for ethical approval to the Ethics of Medical Research Sub-Committee for Medicine and Clinical Oncology. Each protocol being submitted for ethical approval was required to have an accompanying "consent" form. The form asks a number of important questions with serious implications, however, the answers the consultant provides leave a lot to be desired:

5. What is the Object of the Project? (explain in terms appropriate to an intelligent layman)

"To follow up haemophiliacs negative for anti HTLV-III (viral cause of AIDS) who are treated with heated SNBTS Factor VIII in which it is anticipated the virus will have been killed."

According to the Penrose Inquiry transcripts, on Day 39, Tuesday, 28th June, 2011, Professor Christopher A. Ludlam appeared again to give oral evidence. His answers to the questions on the form in LOT0014973 were cross-examined, as follows:

Under Question 16: "Will informed consent be obtained from all subjects?" Mr. Di Rollo: And your answer is?

Prof. Ludlam: "Their cooperation will be sought."

Mr. Di Rollo: Is there something wrong with not just a simple "yes" there? What's the difference between "yes" and "their cooperation will be sought?"

Under Question 18: How will consent be recorded?

Prof. Ludlam: "I was not planning to record this."

Q. Were all of the patients who were looked at here aware that they were HIV positive?

Prof. Ludlam: A lot of these patients were HIV negative.

Q. Yes, I understand that. That was a bad question. I'm sorry. The question I meant to ask you is: all of those who were HIV positive that you were looking at, were they aware that they were HIV positive?

Prof. Ludlam: They might not have been.

Q. Those that aren't, how would they give informed consent for this work?

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.

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.]