Infected Blood Inquiry

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The taintedblood Timeline  -  what really happened...

"To no one will we sell, to no one deny or delay, right or justice."
Magna Carta - 15th June, 1215

 
No of entries selected: 6 of 711
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: Link #1
Type: Draft PHLS Letter - Trial Protocol
Location: UK
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1983
30 April
Investigation of Haemophiliacs in an Area Where AIDS Had Not Yet Been Introduced
By 3rd of March, 1983, there were eleven cases of acquired immunodeficiency syndrome (AIDS) in haemophiliacs who had all received factor VIII concentrate. These cases had been reported to the CDC in the USA.

By 30th April, 1983, a letter, entitled: 'Factor VIII Products and Disordered Immune Regulation' was published in the UK in The Lancet by Dr Robert S. Gordon, Jr. of the National Institutes of Health (NIH), Bethesda, USA. The letter stated:

"These observations are consistent with the hypothesis that AIDS is caused by a transmissible agent, presumably a virus, that can be included in blood products, and that some recipients of the agent have not (at least not yet) developed the complete clinical syndrome with its devastating complications."

"These alternative hypotheses might be distinguished through a study of T-lymphocyte subpopulations among similarly treated haemophiliacs in a geographical area to which AIDS has not yet been introduced. The resolution of this question by a timely investigation in some country, where cases of AIDS have not yet been reported would be an immense help to public health workers worldwide. In this situation "negative results" would be of great significance."

NOTE: Please click the 'Find Related Entries' link below to see how this Timeline entry relates to the one for 10th October 1983 regarding the Medical Research Council. It appears that Dr Gordon's letter somehow managed to engender a controlled AIDS study of UK Haemophiliacs; the Edinburgh Haemophiliac Cohort; a study which we believe to have been entirely unethical. TaintedBlood has members who have testified at the Archer Inquiry where they expressed belief that their infections where acquired as a result of this study. (see 2nd link below)

Source: Evidence of Robert and Alice Mackie:
Link #2
Type: Letter, The Lancet, 30th April, 1983
Location: Scotland
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1983
10 October
MRC Working Party - Controlled AIDS Study of UK Haemophiliacs
In an October 1983 meeting of the Medical Research Council, the Chairman, Dr Tyrrell, indicated the need to ensure that the best use be made of the special combination of suitable patients for study and the clinical, immunological, virological and other expertise that was available in the United Kingdom:

"The special features arising in relation to haemophilia were discussed and the possibility of identifying the role of imported Factor VIII concentrate used for UK patients was outlined. There followed discussion on the varying and considerable period of incubation (1 to 4 years) and the possible relationship between the size of inoculum of the PROPOSED AGENT and the length of latency." (page 2, point 3a, line 14)

"It was noted that blood product associated cases could enable some of these alternative hypotheses to be tested." (page 3, end of paragraph 4)

O"pportunities Special to the United Kingdom:"
"The Working Party sought to identify particular opportunities for research unique or special to the United Kingdom. The fact that the epidemic was lagging some three years behind that in the USA was considered an important factor in enabling the background against which AIDS develops to be delineated. This could enhance our ability to detect the emergence of AIDS and virological status of the high risk groups. The underlying immunological and virological status of the high risk groups BEFORE they encountered the "AIDS agent" could thus be defined." (page 4, point 4)

"The UK system for haemophilia treatment and for blood product organisation would allow detailed study of haemophilia associated cases which has not been possible in the USA due to their system of record keeping and organisation." (page 4, end of paragraph 3)

"The organisation of epidemiology in the United Kingdom was well suited to studying this problem. The importance of establishing such studies early in the emergence of disease was again stressed." (page 4, final paragraph, line 5)

"It was noted that in addition the UK offered particular opportunities to pursue carefully controlled and monitored therapeutic trials." (page 5, paragraph 2)

"It was thought that suspect blood products could provide valuable raw materials for work of this type. Indeed, the possibility of fractionating blood from patients with "pre-AIDS" in order to concentrate the agent was a notable suggestion." (page 5, paragraph 4, line 10).

Source:
Type: Minutes - Medical Research Council Working Party on AIDS. Dated Monday 10th October 1983.
Note: The following departmental observers were present at this MRC meeting: Dr W. M. Prentice (SHHD) and Dr Diana M. Walford (DHSS)
Location: UK
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1985
circa 26 February
Application for Ethical Approval - Consent Form
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?

Source: Second Source:
Link #2
Third source:
Link #4
Type: Penrose Evidence File
Location: Scotland
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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
1988
11 March
Dr Perry - History of Factor VIII Batch 023110090 Associated with HIV Transmission
Batch History of FVIII Batch No. 023110090 Associated with HIV Transmission to SHS Haemophiliacs:

"This batch was associated with the transmission of HIV to approximately 15 Edinburgh Haemophiliacs. The details of these seroconversions have been extensively reported in the literature of Dr Ludlam."

"FVIII Batch No 023110090 was manufactured in November 1983 from plasma collected in the Autumn 1983. Clearly this preceded the availability or introduction of plasma donation testing or product treatments to inactivate HIV (eg heat treatment) either in the UK or internationally."

"Following the reports of product infectivity, attempts were made to identify the specific donation(s) which led to the product being infective. These were unsuccessful."

"Attached is a summary of the action taken by Dr McClelland and Dr Cuthbertson to effect a batch recall after initial notification by Dr Ludlam of seroconversions."

"Batch No 023110090 was in all other respects compliant with the product specification at that time and there were no notable events during the manufacturing process."

NOTE:

Please click the 'Find Related Entries' link below to see how this Timeline entry relates to the one for 10th October 1983 regarding the Medical Research Council (MRC) and what should be referred to as a controlled AIDS study of UK Haemophiliacs; the Edinburgh Haemophiliac Cohort; a study which we believe to have been entirely unethical.

Source: Additional Source:
Link #2
Type: Scot Blood FOI Document - Summary of SNBTS Response to HIV Contamination of PFC Coagulation Factors. 11 March 1988.
Location: Scotland
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