The taintedblood Timeline  -  what really happened...

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 the minutes of 16th meeting of the United Kingdom Haemophilia Reference Centre Directors in October 1985, Dr Ludlam and Dr Craske present a comprehensive questionnaire that is designed to study HTLV-III (now HIV) prevalence in household / sexual 'contacts' of haemophilia patients:

"Dr. Hill (Birmingham) agreed that back-up counselling was needed for the patients and families involved."

"Professor Bloom wondered whether, a comprehensive questionnaire could be handled by the peripatetic expert in sexual epidemiology."

"Dr. Jones (Newcastle) said that the proposed study had been discussed by the Reference Centre Directors at 2 recent meetings and he had made known his strong objections to the study. He thought the proposed study was insensitive, unscientific and unethical. It would cause great anxiety to the families and it did not take into account bisexuals or homosexuals."

"Professor Bloom emphasised that no one was forced to participate in the study. The Haemophilia Society's representatives were asked for their views and Mr. Knight replied that the Society was not yet convinced that Haemophilia Centres were the right place for this kind of study to be done."

"Dr Hill felt that patients would co-operate with Centres as they were already asking these questions about the risk of antibody positivity and transmission to wives. The validity of the study was queried if Centres provided only numbers of patients and contacts involved, rather than identifying individual patients and households."

"Dr. Craske replied that he would prefer the individuals and their families to be identified, rather than simply be given total numbers by each Centre."

Background: Two years earlier, the UKHCDO possessed detailed knowledge of the risk of AIDS to the spouses of haemophiliacs. That was in October 1983. Why then, 2 years later, are these physicians having difficulty deciding whether to issue an epidemiological questionnaire to haemophiliac patients and their families? There was NO question; the patients needed to know their status in order to avoid transmission to partners/spouses.

Note: We are asking ourselves whether the questionnaire was designed to reinforce known statistics already held regarding transmission of HIV to partners, or was it designed to investigate possible modes of infection by seropositive haemophiliacs. We would suggest the use of the word 'epidemiology' implies that the questionnaire was merely a study of the incidence and distribution of HIV? This is further supported by Dr Craske's intriguing comment that: "In due course when the few HTLV III [positive] sexual partners are identified...". Does this mean that Craske was already aware of the number at this point?

A letter from R.J.Perry to Dr Frank Boulton of the Blood Transfusion Service at the Royal Infirmary, Edinburgh, reports the disturbing news that non-A non-B hepatitis had been transmitted to a "virgin" haemophiliac patient.

NANB Transmission in Virgin Haemophiliacs:

"Could you let me know the batch of FVIII involved in the transmission of NANB Hepatitis to Dr Ludlam's virgin patient. While this outcome of treatment is not surprising we need to know the batch number and dose to keep our surveillance cross referencing records complete."

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.