Infected Blood Inquiry

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

 
No of entries selected: 19 of 711
1983
17 October
UKHCD - Early Knowledge of Risk of AIDS to Spouses of Haemophiliacs
In the notes of the 14th Meeting of the UK Haemophilia Centre Directors on 17th October 1983, it is clear that the Directors have early knowledge of the risk of AIDS to spouses of haemophiliac patients:

Under the heading "AIDS UK Situation" the following is stated:

"Spouses of patients who received FVIII will also be followed. Choice of control group for the above study not decided as yet but is considered critical to the study." (Page 1, circa line 21)

On page 4, under the heading "U.K. Situation", the minutes state:

"Twenty-two patients have N.I.H diagnostic criteria for AIDS - many through contact in USA. 10 patients have so far died. Details of haemophiliac cases (A1 and A4) are contained in Appendix B and the follow-up protocol is to be circulated in due course."

The following comment, made during the AIDS crisis also doesn't bode well:

"...Neither Dr Boulton, Dr Ludlam or myself considered it appropriate to discuss publicly the details of our current 'clinical trial' on heat treated FVIII" (Page 1)

Note: Rather than focussing on control groups and studies, it would have been prudent and more ethically sound to commence an immediate notification exercise with the imparting of advice to the spouses of patients with haemophilia.

Source:
Type: Notes of the 14th UKHCD Meeting, Oxford RHA. Dated 17th October 1983
Location: UK
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1984
January
Annals Internal Medicine - AIDS Reported in the Spouse of a Hemophiliac
There is a report of AIDS in the spouse of a hemophiliac.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Report - Spouses
Location: USA
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1984
10 September
Reports on Factor VIII Batches Received by Cardiff & Bristol AIDS Cases
In a letter entitled 'Current Situation Regarding AIDS', the Public Health Laboratory presents a table and accompanying histograms based upon reports received from Haemophilia Centres about the patients who received the same batches of blood products as the Cardiff and Bristol AIDS cases.

The batch numbers in question are detailed in the following table:

1097900980
0418004980
0017900679
S1010112078
T40405 12378
R5910R2709
R97906R6511
09M07980110477P1
A12710M6375

Note: This shows that Haemophilia Centres had a good enough system of record-keeping so as to be able to identify and trace which patients had received which batch. We have to ask whether patients were warned so that they could inform and protect their partners/spouses?

Source:
Type: Public Health Laboratory Table and Histograms. Dated 10th September 1984
Location: UK
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1984
4 October
Wessex RTC - Recall of Contaminated BPL Factor VIII - Batch HL3186
In a letter from Wessex Regional Transfusion Centre (WRTC) to the Head of Quality Control, BPL, we learn of a male blood donor who has been admitted to "a Bournemouth hospital; the clinical diagnosis is almost certainly AIDS."

The letter outlines the previous donations of the male donor, who had donated blood in November 1982 in Leeds, and three more times at Bournemouth in September 1983, March 1984 and September 1984.

"There is also the possibility of a donation before November 1982 in this region, which we are attempting to trace." It appears that the September 1983 and March 1984 donations were already used.

Note: We cannot help but wonder why there aren't any recommendations here to alert patients?

In another WRTC letter from the Deputy Medical Director to various Consultant Haematologists in the South, including the Lord Mayor Treloar school, the author explains the reason for the recall. The Deputy Medical Director makes the following unethical request of the centre directors:

"In order to prevent undue worry to your patients, may I ask for your discretion here and, for the time being at least, to keep this news to yourself."

Note: We are perturbed to read that Doctors are specifically told not to tell patients, thereby putting partners/spouses at risk.

Source: Link #1
Type: Letters from Wessex Regional Transfusion Centre to Head of Quality Control BPL. Dated 4th October 1984
Location: UK
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1984
5 October
DHSS - HS1 - AIDS Contamination of Factor VIII Concentrate
In handwritten briefing notes entitled 'AIDS Contamination of Factor VIII Concentrate' from DHSS HS1 division, we learn that there were substantially more vials of contaminated Factor VIII made from the suspect donation of March 1984.

In fact, a total of 885 units were supplied as follows:

  • 485 vials were sent to Wessex RBTS on 10th August 1984
  • 400 vials were supplied to Cardiff RBTS on 17th August 1984

The notes go on to say that: "They were passed down to Haemophilia Centres for supply to patients. Thus it is known by the Centres precisely which patients received supplies from this batch. BPL are recalling the batch and this is under control."

Note: It is interesting to observe that the title of these briefing notes makes use of the term 'AIDS' when the diagnosis of the donor wasn't officially confirmed until eleven days later (on 16th October 1984).

Source:
Type: DHSS HS1 Handwritten Briefing Notes Reference - Contaminated Factor VIII - Batch HL3186 - DHSS HS1 AIDS Contamination of Factor VIII. Dated 5th October 1984
Location: UK
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1984
8 October
Wessex RTC - 390 Contaminated Vials Unreturned - FVIII Batch HL3186
In a letter from the Wessex Regional Transfusion Centre (WRTC) to BPL, the details of a contaminated Factor VIII batch HL3186 are discussed along with how many vials were unreturned. Of the 485 that had been sent out, only 95 were returned.

  • This clearly leaves 390 contaminated vials unaccounted for.

Note: We are extremely concerned to read that 167 vials of this contaminated batch were used up at the Lord Mayor Treloar College, Alton - a well-known specialist school, catering for boys with haemophilia. Only 33 vials out of a total of 200 were returned from the Treloar school.

Note: We believe that there was a good chance that the WRTC were aware that most, if not all, of the 390 unreturned vials had already been transfused into patients. Presumably these patients could have been easily traced and informed?

Source:
Type: Letter from Wessex RTC to BPL Dated 8th October 1984.
Location: UK
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1984
16 October
Wessex RTC - Contaminated BPL Factor VIII - Batch HL3186
In a letter of 16 October 1984, from WRTC to all Haemophilia Centre Directors in Wessex, we find confirmation that: "the diagnosis of AIDS has now been confirmed." The Deputy Medical Director goes on to say that further contact will be made: "within the next day or so" regarding follow-up of patients, but that: "in the meantime I have been asked to suggest a policy of discrete surveillance be pursued."

Note: It is disgusting to read that despite the donor having a confirmed AIDS diagnosis, the official line of the Deputy Medical Director and the WRTC is still not to inform patients.

Then in a letter from WRTC dated the same day, a Consultant Pathologist is notified at the Royal Naval Hospital, Gosport, Hants. This correspondence is obviously the first the RN Hospital has heard of the contaminated batch - and for some reason 12 days later than anyone else.

In a third letter of 16th October 1984, the WRTC write to the Queen Alexander Hospital, Portsmouth, where we learn of another hospital where this notification is the first they've been told about receiving the contaminated batch.

Note: As with the Naval hospital, why weren't these hospitals informed earlier?

Source: Link #1
Type: Letters from Wessex RTC Ref. Contaminated BPL Factor VIII Batch HL3186
Location: UK
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1984
23 October
PHLS - Dr Craske - Contaminated BPL Batch - HL3186
A letter from the Public Health Laboratory Service (PHLS) in Manchester, details the discovery of a batch of Factor VIII [Batch No. HL3186] that was made from pooled plasma where one of the donors was later confirmed to have antibodies to HTLV-3 (HIV). The letter also confirms that epidemiological follow-up studies are to be carried out on the recipients of that batch.

  • We know that Dr Craske had detailed knowledge about the situation regarding AIDS in the USA, especially since he was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States in September 1982.
  • Dr Craske even knew about the connection between AIDS and US commercial blood products.
  • We also know that from October 1983, the UK Haemophilia Centre Directors had considerable, documented awareness of the risk of AIDS to the spouses of haemophiliac patients.
With this in mind, we strongly believe that the physicians involved in this BPL product recall were remarkably casual in their approach to dealing with it. The delays incurred in telling patients meant that their wives and partners were put at risk. We would suggest that this was because of directives from Dr Craske.

Source: Link #1
Type: Letter
Location: UK
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1984
23 October
Dr Craske - PHLS - Whether or Not to Inform Patients of Exposure to HTLV-III
In a PHLS letter of October 1984, two alternative strategies for the follow-up of haemophiliac patients who have received an HTLV-III implicated batch are deliberated. Surprisingly, the option of NOT INFORMING patients is considered:

Dr. Craske: "An alternative strategy would be not to tell the patient of the risks involved but to observe him at regular clinical review four monthly, to collect serum specimens for HTLV-3 antibody examination and send them to me at Manchester." (page 3, section ii)

"There is evidence that HTLV-3 infection can be transmitted by sexual contact. Therefore some sexual partners of recipients of factor VIII contaminated with HTLV-3 may be at risk." (page 2, point 5)

Investigation of spouses:

"This will be at the discretion of the Haemophilia Centre Director, and will depend upon whether it is decided to inform the index patient of the possibility that the batch of factor VIII was contaminated with HTLV-3 virus." (page 3, section d)

Note: Even after Dr Craske knew that HTLV-III infection could be transmitted to spouses by sexual contact, he was still deliberating the option of not informing patients. In an Appendix on page 5, Dr Craske does eventually state that the option of informing the patient is "the only one tenable on moral and ethical grounds." However, this conclusion should not even have required discussion, never mind arriving at it almost as an afterthought.

Source:
Type: Recovered Document - PHLS Letter from Dr Craske. Dated 23 October 1984.
Location: UK
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1984
10 December
Dr Kernoff - Informing Patients of Testing Results Considered Irrelevant
The notes of a meeting of the Haemophilia Centre Directors held at BPL (Blood Products Laboratory), Elstree, on 10th December 1984, show a somewhat laissez-faire attitude to testing for AIDS:

Dr Jones: "A long discussion took place on whether persons found to be +ve were to be informed. Several differing views were expressed. It was agreed that each clinician would decide for each case depending on the facts of the case but in general to provide information if asked for." (page 4)
Dr P. Kernoff commented that as some 70% of haemophiliacs are now +ve it may be considered irrelevant if one tells or doesn't tell the results of testing. (page 5)
Note: These doctors should have given a strong line of advice to follow - that patients and spouses should not only be informed of the test results, but also that they had a right to know. Dr Kernoff might have considered it "irrelevant", but we doubt that the intimates and spouses of the patients with haemophilia would have thought so.
Source: Link #1
Type: Penrose Evidence File
Location: UK
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1985
19 January
Lancet - Heterosexual Transmission of "Pre-AIDS" to Partners
In a Lancet Article published on 19th January, 1985, the issue of transmission to partners and children is discussed:

"...Concentrate-treated haemophiliacs may transmit this agent to their spouses or children, resulting in pre-AIDS or AIDS."
"Our observations support the theory that pre-AIDS can be transmitted heterosexually to partners not otherwise at risk for AIDS and suggest that AIDS can be transmitted to the offspring of haemophiliacs either vertically, through the female sexual partners, or through close maternal-infant or paternal-infant contact."
Source: Link #1
Type: Penrose Evidence File
Location: UK
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1985
21 October
Patients Asking Questions about Risk of Transmission to Their Wives / Partners
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?

Source:
Type: Minutes of the 16th Meeting of the UKHCDO. 21 October 1985. See page 6, paragraph 3.
Location: UK
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1985
24 October
Sir Donald Acheson CMO - Draft Speech to PHLS on AIDS
In the final draft of a speech by the then CMO, Sir Donald Acheson to the PHLS in October 1985, we discover a certain overconfidence regarding his belief that no new cases of AIDS infection should occur in the future in the haemophiliac group...

Sir Donald Acheson, October 1985: "These data show that HTLV3 infection:

  1. has increased in prevalence among homosexuals in London. Elsewhere it may also be increasing in prevalence but remains less common that [than?] in the capital;

  2. It is prevalent among haemophiliacs, particularly sufferers from Type 'A' haemophilia. Fortunately however no new cases of infection should now occur in this group;

  3. it has appeared, so far at low prevalence among female partners of haemophiliacs;

  4. it remains relatively uncommon among drug abusers."

NOTE: We must point out that the CMO's comment was somewhat overconfident since that very same month, there was the third is a spate of cases of seroconversion in UK haemophiliacs associated with the use of an imported commercial concentrate; Armour's H.T. Factorate - and this was only 2 and a half months after the Deputy Chief Medical Officer (Dr E. Harris, DCMO) had expressly stated that:

"all commercial Factor VIII imported into this country is also heat treated. There would thus appear to be no longer any need to use un-heat-treated Factor VIII concentrate." (August 1985).

Apart from the complete underestimation of the ongoing risk to spouses, by November 1985, there is hearsay evidence that even more haemophiliac patients are seroconverting to become anti-HTLV III positive despite having received heat-treated Factor VIII. Even as late as February 1986, we still have a new HIV infection in a UK haemophiliac caused by Armour batch A28306.

Source:
Type: DOH FOI Document - CMO Final Draft of Speech to PHLS on AIDS. 24 October 1985.
Location: UK
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1986
12 June
Armour - Heat-Treated Factor VIII - Spouses Left Exposed to Infection
In a DHSS internal circular of 12 June 1986, we read of evidence that seroconversion has occurred in a haemophiliac patient after having received Armour 'Heat-Treated' Factor VIII. Clearly, the author of the circular and treating doctors are in no hurry whatsoever to inform the person concerned:

"The patient who remains well has yet to be approached and this will not occur until the physicians return from annual leave."

Note: A rather poor decision was made not to approach the patient until the physician returned from annual leave. This meant that the patient himself was not informed as to the results of his test and was thus NOT able to protect his sexual partner(s).

Background: As early as October 1983, the UKHCDO had shown knowledge of the risk of AIDS to the spouses of haemophiliacs, and we believe it to be quite outrageous that 3 years later physicians are still putting partners at risk.

Source:
Type: Internal DHSS Circular
Location: UK
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1990
12 February
Haemophilia Centre Directors Discuss the HIV Litigation and HCV Testing Data
In the minutes of the Nineteenth Meeting of the AIDS Group of Haemophilia Centre Directors held at The Royal Free Hospital on 12th February 1990, a discussion takes place in relation to the ongoing Haemophilia HIV litigation and situation with HCV testing data. Dr Aronstam, of the Treloar Haemophilia Centre, Alton, is placed in a somewhat questionable position by his colleagues at this meeting.

"Dr Savidge raised the point that one member of the AIDS Group was acting as an expert on behalf of the Plaintiffs' and wondered whether it was acceptable for him to take part in the Group's discussions on Litigation and the Defence of the main statement of Claim. Dr Aronstam said he was the person referred to. He had not been asked to be a medical expert witness for the plaintiffs. If the group felt it was awkward for him to be present he would leave the meeting. He pointed out that some other directors were in a similar position and more might be in the future..."

"Dr Rejman said that the cases of Plaintiffs in the Wessex Region were being held back at present and would follow on after the lead cases had been considered. Dr Aronstam said he knew of at least two cases involving his patients which were going ahead as lead cases; it was news to him that Wessex cases were being put back."

"With regard to Health Authorities' Defence to the Re-amended Statement of Claim, Dr Savidge said that he had been using heat-treated Factor VIII as early as 1983 and he was trying to get the Defence's Statement amended as it said heat-treated factor VIII was not used until the end of 1984."

"Dr Lowe suggested that Dr Simpson's advice should be sought regarding the Haemophilia Society's request for information on hepatitis. Was hepatitis likely to be another item for which haemophiliacs would seek litigation and was it advisable for the Haemophilia Centre Directors to continue to collect data? Dr Simpson said it would not be advisable for the Directors to stop collecting data as they had already started to do so. Dr Hill pointed out that hepatitis was not a new thing; only the test was new. After further discussion, Dr Simpson agreed that the Haemophilia Society should not be given hepatitis data."

"Dr Lowe thought there was a difference between testing LFTs and testing for Hepatitis C and he wondered whether the patient's consent to testing should be sought… …Prof Bloom didn't see why permission needed to be asked for Hepatitis C tests as this was just another LFT. Dr Savidge said that patients were now becoming more and more conscious of what tests were, so he would advise caution at present."

Prof Preston quoted results presented at a recent meeting on prevalence of anti HCV in spouses of haemophiliacs. A figure of 20% was found which he thought was very worrying.

Note: The Joint Secretary of the 3 Defence Unions was present at this meeting, as was Dr A. Rejman, Senior Medical Officer (SMO), haematologist and DH Secretariat to the ACVSB.

Source:
Type: Penrose Evidence File
Location: UK
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1990
2 November
Government - Change of Minister
William Waldegrave is now Secretary of State for Health.
Source: Link #1
Link #2
Type: Political climate
Location: UK
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1990
11 December
Mr Waldegrave - Health Minister - Liability in relation to Crown Immunity
Mr Waldegrave: "We believe that our case is legally strong and that the plaintiffs would not succeed in proving negligence on the part of the Department of Health. None the less the Government have always recognised the very special and tragic circumstances of the haemophiliacs infected by HIV and of their families."

"The Government have therefore agreed in principle to meet the Steering Committee's proposals."

"...the proposed settlement will require the formal approval of all individual plaintiffs, and in the case of minors, of the court,..."

Note:
It is interesting to note that the Health Minister is surprisingly confident concerning Department of Health liability in relation to Crown Immunity, especially considering that he had only been Minister for just over 1 month.

Source: Link #1
Type: Commons Hansard
Location: UK
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1991
10 June
Mr Waldegrave - Secretary of State for Health
"I welcome the announcement today in court of the conclusion of this litigation and the acceptance of the terms of a settlement by the overwhelming majority of those in England and Wales who were pursuing action. The Macfarlane Trust special payment [2] set up on May 3rd has already begun to make payments."
Source: Link #1
Type: Haemophilia Ex-gratia No-liability Recompense
Location: UK
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1992
17 February
Mr Waldegrave - Payments to Apply to Spouses, Partners and Children
Mr Waldegrave, Health Secretary:
"I have decided that the special provision already made for those with haemophilia and HIV is to be extended to those who have been infected with HIV as a result of National Health Service blood transfusion or tissue transfer in the United Kingdom. The payments will also apply to any of their spouses partners and children to whom their infection may have been passed on. The rates of payments are shown in the table. Similar help will be available throughout the United Kingdom."
Source: Link #1
Type: Hansard Answers
Location: UK
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