THE PENROSE INQUIRY
Final Report

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Chapter 33

An Investigation into the Systems in Place for Informing the Patients about the Risks - HIV/AIDS

Introduction

Scope of the chapter

33.1 The background to the development of doctor/patient relationships during the reference period has been discussed in Chapter 32, An Investigation into the Systems in Place for Informing Patients about the Risks - Ethical Context. Particular matters dealt with in this chapter include: (i) the information and advice given by doctors about the risks associated with the therapeutic use of blood and blood products, (ii) the clinical information and prognosis given to patients and, where appropriate, their families in the investigation and diagnosis of HIV/AIDS and (iii) the testing of blood samples of patients in specific situations.

33.2 The HIV/AIDS epidemic had little impact on the treatment of blood coagulation disorder patients anywhere until 1982 and in the United Kingdom few patients (and none in Scotland) were known to be infected or to have AIDS until mid-1983. In late 1984 and in 1985 testing and screening for anti-HTLV-III/HIV^[1] disclosed a prevalence of infection, in particular in coagulation disorder patients, which had not been anticipated. The main events bearing on developing relationships between doctors and patients occurred for the most part in and after 1983.

33.3 Changes in knowledge of the risk of transmission of HIV, and of the threat that the infection posed for patients, did not occur uniformly throughout the UK, or within Scotland. There are few landmark dates that apply generally. The publication in The Lancet of 1 September 1984 by Cheingsong-Popov and others of their study of the prevalence of antibody to HTLV-III in AIDS and AIDS-risk patients in a number of English Haemophilia Centres was one such event.^[2] So far as Scotland is concerned, the first reports in late 1984 of HTLV-III/HIV infection in patients in the west of Scotland, treated with both NHS and imported products, and in the south east of Scotland, in patients treated with SNBTS factor concentrates exclusively,^[3] demonstrated that the findings of the Cheingsong-Popov study had direct relevance in this country and shattered any continuing belief that the AIDS epidemic was confined to those treated with commercially produced coagulation products.

33.4 The treatment of events in this chapter is largely chronological. Specific topics discussed include:

• Issues relating to tests of patients' immune functions carried out in Edinburgh and Glasgow in the period 1983-85.
• The circumstances in which testing of patients' sera stored from earlier investigations was carried out in research laboratories in Edinburgh and Glasgow following the advent of the first anti-HTLV-III tests.
• The problems which arose subsequently over obtaining informed consent for anti-HTLV-III testing and pre- and post-test counselling.

The evidence of the witnesses who spoke about the effects of their own or their relative's infection with HIV and/or Hepatitis C included evidence on some of the matters discussed in this chapter.^[4] Where appropriate the evidence of these witnesses has been referred to in order to give context to each topic. So as not to detract from the main purpose of the oral evidence of these witnesses (for the Inquiry to learn about the full effects of infection) the Inquiry did not investigate each criticism made by these witnesses but instead took account of them when considering and reaching conclusions about the practices of their treating doctors.

The threat of HIV transmission, haemophilia therapy in Scotland and the provision of information to patients

33.5 As noted in paragraph 32.3 of Chapter 32, An Investigation into the Systems in Place for Informing Patients about the Risks - Ethical Context, many of the patient witnesses who provided statements to the Inquiry stated that they were not warned about the risks associated with their treatment for haemophilia.

33.6 The evidence available to the Inquiry indicates that, as in other areas, individual haemophilia clinicians formed and followed their own views of the appropriate approach to telling their patients about therapy, and the risks associated with it. It is thus not possible to distil one single approach that might be described as common among them.

Practice in Edinburgh and south east Scotland

The evidence of patients in Edinburgh and south east Scotland

33.7 The witnesses who gave evidence about the effects of their own or their relative's infection with HIV and Hepatitis C included four patients or relatives of patients who were treated in Edinburgh.^[5] Three of them gave evidence about the provision of information to them or their relatives. As detailed in Chapter 5, An Examination of the Effects of Infection with HIV on the Patients and their Families, including Treatment, the witness given the pseudonym 'Mark' recalled the risk of infection with AIDS being discussed at his clinic appointments, usually at the end of the appointment, from 1983-84.^[6]

33.8 The witness 'Elaine' said that, had her husband, 'Brian', known about the risk of HIV/AIDS from his treatment, he would not have taken Factor VIII treatment. She believed that Brian would have reverted to the old treatment (with cryoprecipitate) instead.^[7] As detailed in paragraph 5.213 of Chapter 5, Elaine first heard of a person with haemophilia contracting HIV when she read a newspaper article while on holiday in Canada in the summer of 1984. When she discussed the article with Brian on her return home, he completely dismissed it and said that it wouldn't affect him because he was receiving blood products manufactured in Scotland from Scottish blood. It is, unfortunately, clear on the evidence that, unknown to all, Elaine's husband was already infected with HIV when she returned from Canada with the article. However, it would appear from her evidence that her husband had been aware of the risk of infection from commercial concentrates but had been advised that there was no risk, or much less risk, from SNBTS concentrate.

33.9 The witness given the pseudonym 'Frances' was unable to say if her father, 'James', was specifically warned about the risks associated with his treatment for haemophilia. James took an active interest in his treatment and liked to be kept fully informed, however,^[8] and it seems likely that he would have asked and would have received the explanations typically received by those of Professor Christopher Ludlam's patients who asked about HIV.

The evidence of Professor Ludlam

33.10 Professor Christopher Ludlam said that in 1982 very little was known about AIDS in haemophilia patients. By the end of that year a total of seven patients in the USA had been reported to have AIDS out of a population of 20,000 people with haemophilia.^[9] He did not discuss AIDS with his patients during 1982 unless they specifically asked him about it and he did not recall there being much concern about AIDS at that time.^[10] He said that if he had discussed AIDS in 1982 he would not have had a great deal to say to patients: all he could have said was that there was a possibility that AIDS might be transmitted by blood products.^[11]

33.11 He thought that by the spring of 1983 he had become convinced that AIDS was a syndrome specifically related to a transmissible agent like a virus.^[12] There was a meeting of the haemophilia and blood transfusion working group at St Andrew's House on 22 March 1983,^[13] which both he and Professor Charles Forbes attended. It is clear from the minutes of the meeting that there was concern at that time that AIDS might appear in the UK.

33.12 As the position was understood by Professor Ludlam at that time, the virus was likely to be transmitted through blood products but he did not think that his patients were at risk. It appeared to be a US phenomenon and most of the Edinburgh patients were receiving NHS concentrate manufactured from plasma collected in Scotland, where there was then no evidence of AIDS. The likelihood of the virus being in the Scottish donor pool was small.^[14] In early 1983 he therefore did not discuss with his patients the possibility of AIDS infection, or whether they wished to continue with concentrate therapy.^[15]

33.13 Professor Ludlam said that he would not have initiated a discussion about switching from concentrate therapy to cryoprecipitate with patients, although if a patient had asked him he would have discussed it with them. He would have told them that switching from concentrate to cryoprecipitate would not abolish the risk of AIDS but might (or might not) reduce it. He would not have encouraged patients to switch to cryoprecipitate if they were being given home treatment with concentrate.^[16]

33.14 He told the Inquiry that he was not aware of any haemophilia centres in the UK where clinicians initiated discussion of a switch to cryoprecipitate with patients, although he knew of one or two haemophilia centres at which patients had asked about the use of cryoprecipitate.^[17]

33.15 Professor Ludlam was unable to recall specifically whether or not he discussed this question with any particular patient on an individual basis at that time. He thought it was possible that he did, since the issue had been raised in an interview with Dr Peter Kernoff (Director of the Haemophilia Centre at the Royal Free Hospital in London) entitled 'AIDS and haemophilia', reported in one of the Haemophilia Society Bulletins in 1983.^[18] During that interview Dr Kernoff had been asked: 'should we stop using concentrates?' His response was:

[Y]ou have to realise that there's no treatment in medicine which doesn't have risks. In deciding to use a treatment, the risks have to be balanced against the benefits. I'm sure that you would agree with me that treatment with concentrates has massive benefits; and there's no doubt in my mind that the benefits far outweigh the possible risks. For people receiving regular treatment with concentrates, I see no reason to make any change from current practice. For particular patients, and at particular Centres, there may be reasons for preferring cryoprecipitate, but these reasons have little to do with AIDS.^[19]

33.16 Professor Ludlam said that if any of his patients had asked him about reducing the amount of concentrate (as distinct from changing to another form of therapy) he would have explained that his investigations into patients' immune systems (discussed below) had shown that there was nothing to suggest that using less concentrate resulted in a lower level of immune abnormalities.^[20] By 1983-84, after the AIDS epidemic had been publicised, if a patient had said that they did not want Factor VIII he would have offered them cryoprecipitate. He would have told them, however, that he could not guarantee that cryoprecipitate was free of a putative AIDS agent and that if they wanted cryoprecipitate they would have to attend the hospital for treatment. He could not recall any conversation of that kind taking place.^[21]

33.17 Professor Ludlam said that he made extensive enquiries during 1983 amongst colleagues who might have seen patients with AIDS and people who might collect statistics on AIDS but that he could not find anyone who had any experience of having an individual they thought might have AIDS or who had a 'pre-AIDS' condition or 'AIDS-related complex' disease. At that time there was much less intercontinental air travel and movement of people and the population in Scotland was much more static than in North America or even England. Scotland had a very stable population of people with haemophilia but also he thought the general population was stable. For those reasons he thought the risks were small and that is what he said he told the patients if he spoke about the risk.^[22]

Practice in Glasgow and south west Scotland: Glasgow Royal Infirmary

The evidence of patients at the GRI

33.18 The witness 'David', who gave evidence about the effects of his infection with HIV and HCV, was treated at the GRI. As detailed in Chapter 5, An Examination of the Effects of Infection with HIV on the Patients and their Families, including Treatment, at paragraph 5.171, he stated that he was not warned of risks of infection associated with his haemophilia treatment, apart from 1984 when he recalled being warned about the risk of Hepatitis A infection.

The evidence of Professor Forbes

33.19 Professor Forbes told the Inquiry that very early on in the progress of the HIV/AIDS story he became aware that it was a blood-borne disease probably transmitted by Factor VIII, perhaps more readily by concentrates than by cryoprecipitate.^[23] He was unable to recall an actual date for this realisation.^[24] He said that, because there was an element of choice of therapeutic products available, he would always discuss with his patients what he was going to do in terms of treatment. He thought that the doctors in the Haemophilia Centre at the Glasgow Royal Infirmary (GRI) would always give patients what was considered the best advice which, at that time, was that cryoprecipitate should be used.^[25] As detailed in Chapter 21, Haemophilia Therapy - Use of Blood Products, at paragraph 21.316 Professor Forbes frankly admitted that his recollection was not completely reliable. During his evidence, given the passage of time and despite his best intentions, Professor Forbes was often unable to recall specific matters and he spoke of his memory being 'defective' in certain respects.^[26] The Inquiry established that use of cryoprecipitate at the GRI was a small proportion of concentrate use, whether of SNBTS origin only or of mixed SNBTS and commercial origin.^[27]

33.20 Professor Forbes said that by 1983 most people thought that AIDS would appear in the UK in due course and that he was already starting to look differently at his patients to see if they had any of the symptoms that might be an early warning of AIDS.^[28] Although he could not now remember it, Professor Forbes attended the meeting at St Andrew's House already referred to at paragraph 33.11. He thought that by March 1983 he knew enough to be concerned about AIDS but not enough, even from his knowledge of the US experience, to be clear about what precisely was happening. He described it as still 'coming up on the horizon' at that point.^[29]

33.21 Professor Forbes said that patients were very aware of AIDS because it was widely talked about in the media, 'with some hysteria', and there was 'a lot of anxiety' amongst the patients.^[30] He said, however, that 'the bottom line' was that the patients needed to be treated; if they did not have treatment there was a real risk that they might die from bleeding. Up until the 1970s and into the 1980s, that was the usual problem. Not treating patients in order to protect them against the supposed danger of AIDS was not an option; they had to be treated and Professor Forbes felt that he had to choose what he considered to be the safest product from all points of view.^[31]

33.22 He said that he told patients about the risk of AIDS and advised them to continue with treatment.^[32] He said that the 'sensible ones' agreed that they had to have treatment and were usually, but not always, given cryoprecipitate.^[33]

33.23 Professor Forbes said that it was with some excitement that he heard that heat treatment of concentrates was a possibility in 1984. There was, however, a lot of concern about how effective this was and indeed one of the early heat-treated concentrates had transmitted virus, after which set-back it took some time to return to a degree of confidence in the heat treatment process.^[34] As indicated in Chapter 21, use of commercial concentrate at the GRI was low in 1982, high in 1983 and very low in 1984. There was significant use in 1985 and that continued thereafter. By 1985 heat treatment of commercial Factor VIII was well established.

33.24 It appears from his evidence that, at least initially, Professor Forbes did not discuss the possibility of using US heat-treated Factor VIII with his patients. When asked about this he said that he thought there was not enough evidence to say that the commercial heat-treated concentrates were totally safe. He also said that he was a little anxious that the heat treatment which was being proposed might in fact also destroy Factor VIII activity (the effectiveness of the concentrate to contribute to coagulation) and would make the treatment useless. That was certainly his personal view. It was only when clear evidence from studies came from the USA that he started to believe that effective heat treatment was a possibility.^[35]

The evidence of Professor Lowe

33.25 Professor Gordon Lowe had relatively limited contact with haemophilia patients from 1983 to 1985 when he was on secondment to the NHS Medical Unit at the Glasgow Royal Infirmary.^[36] He nevertheless kept an interest in haemophilia and continued to see haemophilia patients when he had the time, perhaps for a few hours a week, although he said that he saw few haemophilia patients at that time apart from treating occasional bleeds.^[37] He said that there was increasing concern about AIDS in 1983 and 1984 and some patients did voice concerns about their treatment, but he could not recall any specific patients asking him about AIDS at that time.^[38] He also could not recall whether he routinely raised the issue of AIDS with patients he saw.^[39]

33.26 Professor Lowe said that, in addition to telling the patients what he knew about the condition, he would have given them any educational material that was available and referred them to Professor Forbes or, prior to April 1983, Dr Colin Prentice (as the Director and Consultant) if they wanted more information.^[40] He said that patients were always encouraged to ask if they had any questions about their treatment.^[41]

33.27 From May 1983 to December 1984 the Haemophilia Society produced a series of Bulletins and other publications on AIDS and haemophilia, including 'Haemofact' fact sheets, which provided information to patients.^[42] Professor Lowe recalled that Professor Forbes arranged for these to be made available in the waiting room at the Haemophilia Centre and given to patients. The documents were distributed to patients, partners and families attending the Haemophilia Centre. They provided an update on the developing information on AIDS; gave the consistent message that, while patients should balance the risks for themselves, Haemophilia Centre Directors continued to recommend factor concentrate therapy, because the advantages of treatment far outweighed any possible risk; they stressed that patients should discuss their personal position with their Haemophilia Centre Director.^[43]

33.28 Professor Lowe accepted that the best way for a doctor to give information to a patient about treatment and prognosis was for the doctor to give the information directly to the patient; that had always been his belief. He agreed that it would not be acceptable for a doctor to rely on a patient getting that information from another source such as the Haemophilia Society.^[44] However, his assessment of the likely course of events in such a discussion remained hypothetical, since he did not recall any patient ever saying that they wanted to stop treatment. Nor did he recall any patient actually stopping their treatment.^[45]

33.29 He thought that during review clinics there would have been a discussion about the treatment that the patient was receiving at that time and that the patients would have been asked if they had any questions about their treatment, about hepatitis and, from 1983 onwards, about AIDS.^[46]

33.30 Professor Lowe told the Inquiry that if a patient had raised the issue of AIDS with him in 1983 he would have told them what he then knew about the condition: that some haemophilia patients in the United States had developed the condition; that it was possibly transmitted by blood products; that knowledge about the condition was emerging and there was a lot of research going on to try and find out what the explanation for it was. He said that, from memory, the main question that patients asked at that time was whether there had been any cases in Scotland or Britain. There had not been any reported until 1984.^[47]

33.31 Although there were a number of GRI protocols in place from the 1970s for the treatment of patients, Professor Lowe was unable to recall any specific protocol requiring junior doctors to initiate discussion with patients about the risk of AIDS.^[48] It seems unlikely that any such written protocol existed. He was adamant that a major decision about a patient's treatment - for example, not taking treatment at all, reducing it or changing to a different type of treatment like cryoprecipitate - should be discussed with a Consultant and said that that remained the position right up until he became a Consultant in October 1985.^[49] It continued even after then because Professor Forbes was the Director of the Haemophilia Centre and, as such, attended all the Haemophilia Directors' meetings and was intimately involved in all the research that was being undertaken. Professor Lowe said that, while he did his best to keep up with developments, he did not have the same level of expertise as Professor Forbes.^[50]

33.32 Having said that, he thought that most patients were very happy to talk through the risks and the benefits of treatment with him or any of the other junior doctors and take it from there.^[51]

Practice in Glasgow and south west Scotland: Yorkhill

The evidence regarding patients at Yorkhill

33.33 The witness given the pseudonym 'Christine', who gave evidence about her son's infection with HIV, stated that she and her husband were not warned about the risk of infection with HIV or HCV. Her son was treated at Yorkhill until 1991 when his treatment was transferred to the GRI.

The evidence of clinicians: Professor Hann

33.34 Professor Ian Hann's interests before moving to the Royal Hospital for Sick Children (Yorkhill) in 1983 had been in infections in patients with immune deficiencies and leukaemia and cancers associated with immune deficiencies.^[52] Those interests had alerted him to the emerging AIDS epidemic in the United States in 1982 and clearly influenced his clinical response as information about AIDS emerged over time.

33.35 As the new Haemophilia Director, Professor Hann inherited both stocks of therapeutic materials and a new constituency of patients to meet and become familiar with. He used up the limited existing stocks of commercial products at Yorkhill; thereafter, his treatment options were cryoprecipitate or SNBTS Factor VIII concentrate. This is reflected in the UKHCDO data on the use of clotting factors at Yorkhill over the period 1983 to 1985, as set out in Chapter 21, Haemophilia Therapy - Use of Blood Products, at paragraph 21.296 and Figure 21.9.

33.36 Professor Hann said that, in response to AIDS, he and his colleagues made great efforts to speak to every single patient and offer them the possibility of stopping concentrate therapy and returning to cryoprecipitate treatment. Many patients attended the Centre regularly and he instituted a clinic and a parent support group where these issues were discussed. The Haemophilia Society was also putting out information at that time. He said that it was a matter of regret to him if some of the patients 'fell through the net' and had not been offered this change to their treatment.^[53] Very young (and newly diagnosed) patients were usually managed as hospital-based patients.^[54] They would be offered cryoprecipitate treatment in the first instance if it was logistically possible to give it to them (that is, if their veins were adequate and they did not have any reactions). Professor Hann said that cryoprecipitate treatment may even have been recommended as the first option for these patients in the difficult interim period.^[55] That 'difficult interim period' lasted from May 1983 until late 1984 by which time the HTLV-III virus had been isolated and some of the patients were found upon testing to have antibody to the virus.^[56]

33.37 When he joined Yorkhill, most of the patients were already established on home therapy. He thought that it would have been extremely difficult, and unlikely to succeed, for home therapy to have been maintained with cryoprecipitate.^[57] Cryoprecipitate treatment was not suitable for all patients, such as those with 'difficult veins' or those who experienced extreme allergic reactions. Professor Hann recalled that adverse reactions to cryoprecipitate, including life-threatening episodes of anaphylaxis, had been one of the reasons early attempts at establishing home treatment programmes with cryoprecipitate had been unsuccessful during the 1970s, before the introduction of factor concentrates. A return to cryoprecipitate treatment would have meant returning to hospital-based treatment and the lives of patients and their families would have changed dramatically as a result. Professor Hann recalled that the Haemophilia Society made similar observations around this time. For these reasons, most patients and families in the UK did not revert to cryoprecipitate treatment.^[58]

33.38 However, established patients at Yorkhill were given the option to switch to cryoprecipitate in 1983-84.^[59] He thought that he and his colleagues would have discussed all possible therapies (including DDAVP) depending on the individual severity of the problem.^[60] When asked whether he would have offered a child who was already receiving Factor VIII concentrate in late 1983 the possibility of ceasing concentrate therapy and returning to cryoprecipitate he said that he believed that was what they had in fact done at Yorkhill.^[61] He said that he was almost certain that in late 1983 he did change some patients over to cryoprecipitate and that other patients, newly diagnosed or young children, remained on cryoprecipitate treatment for longer than would have been the case previously.^[62] His recollection was that there were certainly patients in 1984 who returned to cryoprecipitate treatment for a period of time.^[63] That is consistent with the record. UKHCDO data on product use show that use of cryoprecipitate at Yorkhill rose from 7050 units in 1982 to around 30,000 units a year from 1983 to 1985 inclusive.

33.39 However, Professor Hann stressed that it was not a matter of automatically switching every child over to cryoprecipitate. Although there were suggestions in late 1983 - from Dr Peter Jones (Newcastle Haemophilia Centre) and the UKHCDO - that children should be treated with cryoprecipitate, the decision had to be tailored to each individual patient.^[64]

33.40 Professor Hann said that in early 1983 it was not clear what was causing AIDS and there was a great deal of doubt over whether it was going to become a real problem in haemophilia.^[65] He thought that by that stage there had been reports of about eight or nine haemophilia patients who had developed AIDS in the USA; the first cases in the UK did not occur until later in 1983.^[66] There were many meetings with other haemophilia directors during the year and his recollection was that it was not plainly obvious until the second half of 1983 that AIDS was an issue of blood product transmission in haemophilia care.^[67] He said that it 'sort of hit' them later in the year that AIDS was going to be a 'major issue'^[68] and that it became clearer still later in 1983 or early 1984, when the first cases of AIDS were reported from Europe.^[69]

33.41 Professor Hann's approach to the provision of information was also illustrated in relation to new patients. He said that for those patients who were newly diagnosed with haemophilia he had a full discussion with their parents about the disorder and its treatment.^[70] The main emphasis in discussion was on bleeds and how to avoid them. In addition, he would have explained what factor deficiency was, how it came about and the genetic aspect of the condition. Parents would have been told how to access the hospital social worker. There would also be a discussion about treatment, which included what it was, when it was required and what the potential side-effects were. He emphasised that the information would not be imparted in one interview; rather, the provision of information was seen as an ongoing process.^[71] As well as the initial counselling of newly diagnosed patients, Professor Hann said that he had many discussions with patients following the initial descriptions of HIV transmission risks.^[72] He could not recall exactly when these discussions would have taken place but thought that AIDS became a real issue during 1983.^[73]

33.42 He said that he would have explained what he knew at the time.^[74] In 1983 he would have said that there had been a few cases of AIDS in haemophilia patients but that it appeared to be a 'rare risk'. He noted that even into 1984, after the prevalence of AIDS in Europe had been reported, experts like Peter Jones were quoting a transmission risk of one in 1200. He said that he hoped and believed that he and his colleagues were not just reassuring the parents but, rather, they were telling them that it was a possibility but that they did not know very much about it or what caused it.^[75]

The evidence of clinicians: Dr Pettigrew

33.43 Dr Anna Pettigrew started working at Yorkhill as a part-time Clinical Assistant in May 1980. She thought that she first became aware of the possibility that AIDS was caused by an agent transmitted by blood and blood products in 1983 but could not recall what triggered her awareness at that time.^[76] Her recollection was that during 1983 there was a more reliable supply of SNBTS Factor VIII and the doctors at Yorkhill tried to encourage parents to use SNBTS concentrate rather than commercial concentrate.^[77]

33.44 As she recollected matters, the option of stopping factor concentrate altogether and moving back to cryoprecipitate was never raised with parents because of the impracticality of such a change. Dr Pettigrew said that a number of patients were established on home therapy treatment with Factor VIII concentrate before she started working at Yorkhill Hospital and before the risk of AIDS being transmitted through blood and blood products had been confirmed.^[78] It would have been very difficult to institute home treatment with cryoprecipitate, although if parents asked about it then she would have discussed it with them.^[79]

33.45 She did not think that discussions about AIDS would necessarily have been recorded in the patient's medical notes because often parents called into the day bed area and she would not have had the child's notes with her. She said that she would only have had the child's notes if the child attended for medical advice or treatment.^[80]

33.46 When asked whether she would routinely discuss the risk of AIDS with parents even if they did not raise it themselves, she said that the majority of parents did voice concerns because they were a well-informed group and most of them were in contact with the Haemophilia Society and were therefore aware of the risk.^[81]

33.47 If parents voiced concerns, she told them that there was a possibility that AIDS was caused by an agent transmitted by blood but that there was no definite proof at that time. There was still a lot of debate, even among the experts, as to whether or not there was definitely an infectious agent and the advice at that time was that they should continue with therapy. She said that she would have been following the advice of her seniors at that time.^[82] She could not recall any specific policy regarding discussing the risk of AIDS with parents.^[83]

33.48 She could not recall giving initial counselling to parents of newly diagnosed haemophilia patients, although she did sometimes attend such appointments. The Consultant would normally have a full discussion with parents at this time, with the main aim of these initial meetings being to ensure that the parents understood the risk of bleeding episodes. Her recollection of the meetings that she attended was that Professor Hann would recommend concentrate therapy unless the parents specifically stated that they did not want it, in which case their wishes would have been respected. She did not think that any parents did so.^[84]

The evidence of clinicians: Sister Christine Murphy

33.49 Sister Christine Murphy provided evidence in a written statement. She began working in the Haemophilia Department as a part-time staff nurse in September 1983.^[85] She told the Inquiry that when she started working at Yorkhill there was no talk about HIV although Hepatitis B was spoken about and the children were being tested for that. She said that she presumed the parents had been warned about the risks of Hepatitis B. She thought it was 1984 or into 1985 when HIV was discussed, when it appeared in the press.^[86]

33.50 She said that Scottish Factor VIII was used when she worked at Yorkhill. Although there was 'a bit of panic to start with about the blood products', it was explained to the parents what would happen to their child if they did not use the blood products.^[87] She could not recall the exact words that were used but the parents were advised of the consequences of leaving bleeds untreated. They would be informed that joints could suffer irreparable damage and that any internal injuries or head injuries could be life- threatening, depending on their severity. They were also told that untreated bleeds would most likely cause problems later in life, although most parents already knew this.^[88]

33.51 She recalled that at one point one of the parents had their child put back onto cryoprecipitate rather than Factor VIII as at that point in time the parent felt that cryoprecipitate was safer. The child had severe haemophilia so had to have some treatment for bleeds. Eventually the child was returned to Factor VIII, on the commencement of heat treatment of blood products.^[89]

The wider context

AIDS and the Haemophilia Society

33.52 The Haemophilia Society performed two important functions in this context: it collected intelligence and data relating to what was happening to its members and it obtained and published the views and advice of medical experts. The Society was not responsible for the validity of the expert medical advice published in newsletters and fact sheets and it has to be emphasised that in narrating the evidence that follows, the Society is properly to be seen as a reporter of others' views and advice. However, what the Society put into the public domain inevitably bore the stamp of its authority among its members and helped set the context for their understanding of their condition and their expectations of the clinicians advising and treating them.

33.53 For present purposes, it is sufficient to note events from May 1983. The first article published by the Society which provided information on AIDS, by Dr Anthony J Pinching, a noted pioneering AIDS clinician from London, appeared in Haemophilia Society Bulletin 2, 1983.^[90] In the same issue, comments by Professor Bloom in a talk given to the Annual General Meeting of the Haemophilia Society in April 1983 were quoted. In respect of AIDS, he said:

I cannot end without a comment on one new problem which may turn out to be the greatest myth or the most significant reality of all.^[91]

33.54 Professor Bloom was then Honorary Director of the Cardiff Haemophilia Centre and Chairman of the UK Haemophilia Centre Doctors Organisation. His remarks provide a clear illustration of the extent of the uncertainty about the significance of AIDS within the medical community and, consequently, for the Society's members.

33.55 Professor Bloom underlined his opinion in a letter he wrote in response to what had been seen as unduly alarmist reports on AIDS in the media. The letter, which was published by the Society on 4 May, contained the comment that:

[I]t is important to consider the facts concerning AIDS and haemophilia. The cause of AIDS is quite unknown and it has not been proven to result from transmission of a specific infective agent in blood products .... [W]hilst it would be wrong to be complacent it would equally be counter-productive to alter our treatment programmes radically. We should avoid precipitate action and give those experts who are responsible a chance continually to assess the situation.^[92]

33.56 Leaving aside the media comments that had prompted the Society to approach Professor Bloom,^[93] Mr David Watters, General Secretary of the Society between 1986 and 1994 (and Coordinator for five years before that), explained that the Society's letter was intended to reassure members that there were no known cases of AIDS in the UK haemophilia population. He was confident that the letter had been circulated in draft to members of the Society's medical advisory panel. No one expressed dissent from what was said in the letter.^[94]

33.57 Dr Frank Boulton, a former Deputy Director of the SEBTS who had a long and distinguished career in haematology in both Scotland and England, proposed a theory to explain the Haemophilia Society's preference for continued use of existing therapy, which included commercial products. He said:

[A]t that time, the early 1980s, I think it would be fair to say that the Haemophilia Society was very reluctant to accept the validity - they wanted the risk of nasty things from their blood products to be really proved before they would agree to reducing the availability of material for their patients.

So there was a drive from the haemophiliacs themselves, including the Haemophilia Society, to maintain the amounts of therapeutic material available.

So there was, in other words, a feeling that the risk was probably acceptable.^[95]

33.58 An excerpt from the transcript of his evidence was read out to Mr Watters who commented that what Dr Boulton said sounded reasonable.^[96] He added:

I think that what he says is not too different from the attitude taken by both the Haemophilia Society and by the medical advisory panel of the Haemophilia Society. That is that people with haemophilia and the Society and the treaters were in a very difficult situation and they could either decide not to treat patients or to continue treating patients because there was no magic solution, and as such they took the judgment in the light of knowledge in those days - not in the light of knowledge in 2012 but in the light of knowledge available at that time - that it would be best to continue to treat with imported plasma products.^[97]

33.59 A similar view was taken by haemophilia clinicians. The Haemophilia Reference Centre Directors met on 13 May 1983 to discuss AIDS.^[98] By that stage, as they understood it, there was one suspected case of a haemophilia patient suffering from AIDS in the UK. The importance of immediate reporting of any suspected cases was stressed so that the clinical course of the patient could be followed and a definitive diagnosis of AIDS attached if the patient developed intractable disease, at that time the sole criterion for a positive diagnosis in the UK (applying the definition of AIDS adopted by the US Centers for Disease Control). General treatment policy was discussed and it was agreed that there was, at that point, insufficient evidence to warrant restriction of the use of imported concentrates in patients other than children and mildly affected haemophilia patients, in view of the immense benefits of therapy.

33.60 The Haemophilia Society's medical panel and the Reference Centre Directors collectively represented the views of senior, and eminent, UK haemophilia clinicians. Other experts may have taken different views, as noted below, but a balanced assessment of the position was given by Professor Andrew Lever. He emphasised that around mid-1983 there were competing hypotheses as to the cause of acquired immunodeficiency in patients, some of which had powerful advocates. He thought that the balance of evidence at that stage was in favour of an infectious agent.^[99] He continued:

However, as one knows, the amount of distress and concern and worry, sometimes unnecessarily, that you can induce in people by raising the fear of an infectious agent in something like a blood product would be undesirable unless it was absolutely the case, or as near certain as you could be that that was the case.

I think people would not necessarily have been very understanding had this turned out to be a false alarm and individuals had either bled or died by withdrawal of the clotting factors and then it having been found that there was not the threat which had been assumed.^[100]

The evidence of Dr Winter

33.61 Some haemophilia clinicians took the same view of the cause of AIDS as Professor Lever. Dr Mark Winter discussed his experience in England. He was appointed Consultant Haematologist at the Canterbury and Thanet Health Authority in 1983, and thereafter managed haemophilia patients throughout his career. In 1984 he was designated HIV physician for the area and was responsible for all patients who had AIDS. For the rest of his career he specialised in AIDS. He was also the medical officer appointed by the Department of Health (DoH) to serve on the MacFarlane Trust and the Eileen Trust.^[101]

33.62 With this background, Dr Winter was in a position to speak from first-hand experience about developments in the response to AIDS during the reference period. His contact with haemophilia patients had begun before 1983 while he was a Senior Registrar at Guy's Hospital, London where he discussed with his patients the risk of contracting the new virus. He would explain that there were worrying data which suggested that a new virus might be transmitted by concentrates but that, on balance, the advice was to continue with treatment because the risk of giving up treatment was greater.^[102]

33.63 Due to policy decisions in England and Wales, Dr Winter did not have ready access to NHS concentrates in his Kent centre, and largely had to rely upon licensed commercial concentrates of US origin.^[103] By 1984 he and his colleague, Professor Savidge (St Thomas' hospital) had concluded that NHS Factor VIII concentrates not only transmitted NANB Hepatitis but also probably contained the new virus.^[104] In May 1984 heat-treated concentrate from the USA became available on a named patient basis and he managed to obtain a small supply of the product.^[105] The heat treatment was intended to destroy viruses including NANB Hepatitis and HIV. That same month, he approached a small number of patients with mild haemophilia who required major surgery, or who had suffered acute trauma, and had received little or no Factor VIII concentrate in the past. He offered them a choice between the currently available licensed, unheated NHS concentrate, prepared from voluntary donations, or the new, unlicensed, heat-treated Alpha Therapeutics concentrate prepared from paid donations.^[106] He advised his patients to take the new American product in preference to the licensed, unheated US product and the unheated NHS concentrate.^[107]

33.64 He described it as an especially critical and difficult time because patients were being asked to switch from concentrate of UK origin to concentrate of US origin which they had always distrusted. He told the Inquiry that considerable time had to be spent with each patient and their family to explain the basis of this recommendation.^[108] He thought that he would have spent about half an hour with each patient.^[109]

33.65 During these meetings he conveyed the following information to the patients:

• There was increasing evidence that AIDS could be transmitted through the use of Factor VIII concentrate which was a matter of growing concern.
• There was a new type of Factor VIII concentrate which was heat-treated and therefore in theory might inactivate the (very recently discovered) virus that caused AIDS. There was however no proof of this at that stage.
• There was strong evidence that patients were likely to get hepatitis from unheated NHS Factor VIII concentrate if they did not already have it and that it might also contain the new virus that was causing AIDS.
• The new heat-treated commercial Factor VIII was designed to inactivate hepatitis viruses.
• The new heat-treated commercial Factor VIII came from US blood donors and was not licensed in the UK.^[110]

33.66 Many of the patients he approached instinctively resisted his advice, relying on their long-held belief that UK concentrates were safer than US concentrates. In the event, all agreed to the use of the heat-treated product.^[111] By July 1984 he was able to get sufficient supplies of the heat-treated Factor VIII and the heat-treated Factor IX, to switch all of his haemophilia patients to whichever product they required. From 1 July 1984 the St Thomas' centre and Dr Winter's centre in Kent used, exclusively, heat-treated concentrate.^[112]

33.67 On the evidence available to the Inquiry, the practice described by Dr Winter was followed in a few centres only. The majority of treating doctors in the UK in 1984 continued using unheated NHS Factor VIII rather than switching to imported, heat-treated commercial Factor VIII. Dr Winter said that to the best of his knowledge, only the centres in Sheffield, University College Hospital, St Thomas' and Canterbury made the decision to switch to heat-treated commercial Factor VIII in May 1984. The decision was criticised at this time at meetings of the UKHCDO by other Directors who thought that viral transmission of the HIV/AIDS virus through the use of concentrate derived from voluntary UK donors was unlikely.^[113]

33.68 In his evidence Dr Winter noted^[114] that what he did was contrary to what Professor Bloom had said a year earlier in the letter of 24 June 1983^[115] about heat-treated commercial product.

Developing UKHCDO advice: 1984

33.69 The UKHCDO response to imported heat-treated Factor VIII had, meantime, moved forward. On 29 March 1984, Professor Bloom sent a memorandum to all UK Haemophilia Centre Directors advising on the appropriate response to proposals by commercial companies to trial new heat-treated products.^[116] The memorandum listed different types of Factor VIII concentrate available for trial at that time, with another about to become available:

1. Heated products from Armour, Cutter, Travenol and Alpha Therapeutics. The three former are 'dry heat' preparations and the latter (Alpha Therapeutics) is a wet heat product.
2. NHS factor VIII prepared from a specially selected donor panel which is monitored for abnormal LFT's, hepatitis etc.
3. Heated NHS factor VIII; one brand is manufactured at the PFC in Edinburgh and will be shortly available. The second, manufactured at Elstree, should be available later this year.
4. A heated preparation manufactured by Behringwerke ....^[117]

33.70 The memorandum noted that clinical trials had already been completed on one product, the 'Hemofil HT' Factor VIII concentrate which was prepared using a dry heat method. The results indicated that there was still a 63% attack rate of NANB Hepatitis on first exposure in patients who had not received Factor VIII concentrate previously. The memorandum also noted that all products except those derived from NHS Factor VIII were made from plasma imported from the USA and therefore carried a putative risk of transmission of AIDS. The memorandum did not comment on the approach to be adopted in dealing with patients who might be appropriate subjects for clinical trials. That was left to individual practitioners.

33.71 Professor Ludlam was not willing to participate in the trials^[118] as he thought that there was nothing to be lost and the possibility of a lot to be gained by not using the heat-treated product.^[119] Professor Ludlam told the Inquiry that he did not discuss the possibility of using heat-treated commercial Factor VIII (as part of a clinical trial or on a named patient basis) with his patients because he did not think it was in their best interests. He considered that not only would the trials have exposed them to concentrate that was likely to contain hepatitis, but also the product was derived from a donor population that appeared to have HTLV-III and at that stage there was no evidence that heat treatment would inactivate it.^[120] Effectively, therefore, Professor Ludlam took the opposite view to Dr Winter at this time. The Inquiry recognises the logic of each position in its context.

Haemophilia Society publications 1984-85

33.72 Haemophilia Society publications continued to provide information and advice on treatment, backed by eminent practitioners. In Bulletin 1, 1984, K E Milne wrote:

We have no evidence as yet to whether AIDS may be acquired more readily from commercial Factor VIII than from the NHS product but, of course, if AIDS becomes established in the UK then NHS blood and plasma supplies are just as likely to transmit AIDS as commercial materials. All things considered, haemophiliacs have no reason to be worried about using commercial concentrates.^[121]

33.73 Having regard to the date of publication, and Dr Winter's evidence about supply, this was probably written shortly before the first heat-treated products began to be available. The comment was sustainable only on the assumption that there was no choice whether to have therapy and that the sole question was which form to use. That was a universally held assumption amongst clinicians at the time.

33.74 It was reflected in the views of haemophilia staff and of the mothers of haemophilia patients when they were expressed in Bulletin 1 of 1985:

All blood products cannot be guaranteed free of the viruses associated with hepatitis and other disorders such as AIDS. However, the minimal risks associated with this treatment are in our opinion outweighed by the advantages of using these products which ensure our children do not grow up crippled.^[122]

Product inserts

33.75 In the course of the Oral Hearings there was discussion of the function of the leaflets containing information on risks of concentrates, which leaflets were prepared by the SNBTS and issued with products manufactured by the PFC, Liberton.^[123] The information was brief and, if it had been directed to patients, was less than comprehensive. A series of questions specific to HIV/AIDS were drafted by Messrs Thompsons for answer by Dr Robert (Bob) Perry relating generally to the period 1982-85. In this part of the discussion, it is appropriate to deal with the period to 1984.

33.76 Dr Perry explained that the formal product documentation issued by the SNBTS was prescribed by regulatory standards and pharmacopoeia monographs in force at the time. He referred to the British Pharmacopoeia Monograph on dried Factor VIII fraction.^[124] The leaflets were included in the packages issued to patients, especially those on home treatment. However, at the material time, manufacturers were not permitted or expected to engage in direct contact with patients.^[125] Until 1984 the regulatory requirement was for Technical Information Labels only and the SNBTS leaflets were directed at health care professionals and were primarily intended for prescribing doctors.^[126] Until 1984 (and indeed later), the leaflets were not an appropriate vehicle for providing information to patients and were not prepared for that purpose.^[127] In 1994 it became a legal requirement to provide product information leaflets specifically for patients. The SNBTS then issued appropriate patient information with PFC products.^[128]

33.77 While this necessarily limited Dr Perry's attempts to answer the specific questions drafted by Messrs Thompsons, the questions were important to the patient core participants and it is appropriate to set out his evidence. The questions specific to HIV/AIDS related to:

• Discussions between staff about the possibility of including reference to the risk of HIV transmission on package inserts included with factor concentrates between 1982 and 1985.
• Why and by whom it was decided that there should be no reference to the risk of HIV transmission in PFC factor concentrate package inserts between 1982 and 1985.
• From whom the PFC staff took advice about the risks of transmission of HIV via PFC concentrates between 1982 and 1985.
• The advice given to the PFC over that time period about the risk of HIV transmission from PFC factor concentrates.
• Whether there was awareness within the PFC of the fact that US products had such warnings on their inserts from around October 1983.
• To what extent such awareness impacted upon the attitudes of PFC staff to include such a warning on their factor concentrate inserts.

33.78 The virus, originally LAV/HTLV-III and renamed HIV in 1986, was not generally understood to be the causal agent of AIDS until Dr Gallo announced in the spring of 1984 that he had discovered the virus.^[129] Consequently, the relevant period begins, at the earliest in the spring of 1984. Dr Perry's attempt to answer the first question in terms was not productive. He could not recall if he discussed the possibility of including HIV warnings in PFC product inserts with Mr Watt, the PFC Director in 1982 and 1983, and he did not know if Mr Watt had discussed that possibility with any others at the SNBTS.^[130] Dr Perry led a review of packaging systems for PFC Factor VIII and IX in 1982-83 but product warnings remained unchanged.^[131]

33.79 In answer to the second question, Dr Perry said that he had been advised by Dr Peter Foster that the inclusion of such an HIV warning had been rejected at a meeting in 1983. The SNBTS has found no record of this.^[132] Dr Perry pointed out that PFC products were produced for use by a small group of haemophilia doctors who were well informed about the situation concerning AIDS. He expressed the view that the amendment by the SNBTS of its product leaflet to include an unquantifiable risk warning would have done little to enhance doctors' knowledge or their communications and discussions with patients, especially as the topic of AIDS was being widely discussed by haemophilia doctors.^[133] The Inquiry subsequently took statements from Dr Foster and Professor John Cash on this point.

33.80 In his statement, Dr Foster said that he remembered attending a meeting on 14 November 1983^[134] when Professor Cash proposed that a product warning about AIDS should be added to the leaflets issued with PFC concentrates. However the haemophilia doctors were generally against that proposal because such a warning would cause 'unnecessary anxiety to patients'. He also stated that the Haemophilia Directors believed that there was little or no risk of AIDS being transmitted by PFC products.^[135] In his statement^[136] Professor Cash agreed in general terms with the recollections of Dr Perry and Dr Foster but recalled that his proposal had, in fact, referred to hepatitis warnings rather than to AIDS. He thought that after one of his trips to Australia he proposed that a hepatitis risk warning should be included. The proposal did not enjoy much support and a legal opinion was sought by Jim Donald (CSA General Manager). No risk warning was included.

33.81 Dr Perry explained that the PFC did revise its product leaflets in April 1985 when FVIII NY (Factor VIII heat-treated at 68°C for 24 hours) was introduced. The revised leaflet and package label stated: 'the freeze dried product has been heat treated but cannot be assumed to be non infective'. He explained that the term 'non-infective' was intended to encompass all potential blood-borne infections, including HIV/AIDS. In addition, when the new heat-treated Factor IX product, DEFIX, was issued in October 1985 it stated:

In addition, product, plasma pools and individual donations are tested for the presence of antibody to HTLVIII. The product has been heat treated at 80ºC for 72 hours in the freeze dried state. This treatment is expected to inactivate viruses associated with the Acquired Immune Deficiency Syndrome.^[137]

33.82 Dr Perry explained that he had been unable to find any evidence of a process whereby individuals had discussed the merits of the introduction of AIDS warnings. Prior to 1985, product information supplied by the PFC/SNBTS reflected the background of knowledge and guidance available between 1982 and 1984. He stressed that, prior to 1984, there was no consensus on a causal relationship between AIDS and treatment with coagulation factor concentrates. The inclusion of such warnings in product literature required some measure of evidence that a genuine risk existed. The inclusion of warnings could cause anxiety to patients who may have read the leaflets and might have caused them to reject life-saving treatment.^[138]

33.83 In answer to the fourth point, Dr Perry explained that there were various discussions and meetings involving the SNBTS and government health departments and other regulatory bodies but he did not recall that this produced any guidance or advice. The PFC maintained an awareness of international developments through its network of professional and scientific contacts and regular discussions with haemophilia directors and SNBTS experts such as Dr Boulton and Professor Cash.^[139]

33.84 Dr Perry mentioned that an application for a licence for the PFC product FVIIINY made in 1983 to the Committee on the Safety of Medicines included a product insert leaflet which made no mention of HIV or AIDS. The application was approved. He considered that this indicated that the Committee did not expect leaflets issued with plasma products derived from UK donors to carry warnings about AIDS. He stated that 'The PFC received no subsequent request or advice from the Licensing Authority ... to include AIDS warnings'.^[140]

33.85 Dr Perry did not recall the PFC receiving any specific advice or guidance concerning the risk of transmission of HIV/AIDS by its products. Even with the benefit of hindsight, he thought it was difficult to identify what advice could have been given to the PFC which could have been translated into warning statements.^[141]

33.86 In relation to North America, Dr Perry's attention was drawn to a passage from page 399 of the Report of the Commission of Inquiry on the blood systems in Canada (the Krever Commission) which mentioned that US fractionators included warnings about the risk of AIDS to the information in the product inserts.^[142]

33.87 Dr Perry commented that the quotation related to concentrates prepared from plasma collected in the USA. Page 400 of the Krever report noted that, although Cutter Laboratories did include warnings with its products prepared from US plasma, it did not provide such warnings in 1984-85 with products derived from plasma collected in Canada. Dr Perry suggested that the fact that the same company was adopting different positions in relation to the origin of the plasma indicated that the risk of AIDS was still considered to be primarily associated at that time with plasma collected in the USA from paid donors.^[143]

33.88 He explained that, although product literature from commercial companies was periodically received at the PFC, he was unable to recollect the extent to which these documents would have been examined at the time, either by him or other senior PFC colleagues. He would have been aware that products carried warnings of product infectivity but he could not recall if he was aware of specific AIDS or HTLV-III warnings.^[144]

33.89 He said he had been unable to find evidence for the precise time when mandatory AIDS warnings were universally required. His understanding was that different manufacturers adopted them at different times. He explained that when it became clear, in October 1984, that there was a risk from SNBTS products, 'we quickly issued heated NY product (68°/2hr) and subsequently modified the leaflet for inclusion with the later FVIII product (NY 68°/24hr)'.^[145]

33.90 In answer to the final question, Dr Perry responded that he could not recall any discussions amongst PFC staff, or with Professor Cash or Dr Boulton, concerning the introduction of AIDS warnings in PFC product inserts. He believed that the general view held by the PFC, the SNBTS and the Haemophilia Directors was that the epidemiology of AIDS in the US, and particularly amongst US paid donors, was quite different from that in the UK.^[146]

33.91 Dr Perry provided evidence on information leaflets enclosed in packages of PFC products from 1978. The exploration of these questions has not provided the Inquiry with relevant information on the topic of communications with patients and their families in relation to HIV/AIDS save in one respect. It is clear from the evidence of Dr Foster, Professor Cash and Dr Perry that, notwithstanding that there was no legal requirement, SNBTS officers discussed modification of the information documents to include warnings related to AIDS (and additional warnings related to hepatitis). Discussions in 1983 were clearly influenced by the views of haemophilia clinicians. Their views primarily reflected their own understanding of risk and their practice in relation to the provision of information, and have been dealt with in the course of this chapter. The concerns expressed were substantially those identified by Professor Lever in paragraph 33.60.

33.92 So far as the questions posed relate to the provision of information to patients about risks of transmission of HIV, the contents of the SNBTS product inserts do not raise, or provide a focus for, new issues relating to clinical practice in the period to 1984.

The testing of patients' blood samples

33.93 Two specific issues of some importance arise in relation to the testing of haemophilia patients' blood samples in the period to 1984. The first of these relates to studies carried out in Glasgow and Edinburgh of changes in the immune functions of patients receiving concentrate therapy. Questions arise whether the studies were directly associated with patient management (in which case they might at some stages in developing ethical theory have been considered to be 'therapeutic' research) or were research studies more broadly defined that required ethical consent from an appropriate regulatory research body, and in either case whether patient consent to the use of their blood was required. The second issue relates to testing carried out on stored samples of patients' blood or serum in the late autumn of 1984 following the development of the first assays for anti-HTLV-III. The question arises whether patient consent was required for these tests. There are then consequential questions that extend over some years following the receipt of the results of the tests that relate to the communication of test results to patients and the information and advice that was appropriate in the light of individual patients' results. To set the context for the discussion, it is necessary first to discuss practice relating to the routine testing of patients' blood over the period to 1984.

Routine blood tests to 1984: practice in Scotland

33.94 Throughout the material period, routine testing of coagulation disorder patients' blood for identifiable infections and for biometric indications of the progression of their primary condition and of possible infections was common in Scotland, as elsewhere, as an aspect of patients' general management. Use of stored samples of haemophilia patients' blood for comparison, or to enable a full assessment of a patient's condition to be made and reviewed, was routine.

33.95 Testing procedures were not static throughout the period, however. Routine testing inevitably changed as knowledge of the natural history of infectious diseases and of the risks of transmission of infection increased. Similarly, the technology available to assess risks and to respond to the implications for patients improved throughout this period. It is important to bear this background in mind as doctors were confronted by what were clearly, with the benefit of hindsight, new risks of transmission of viral infection and by the technology developed to identify and respond to those risks. In an ever-changing environment of therapy and patient management, what is truly new, requiring a step change in practice, may not necessarily appear so at first sight. In this, as in other areas, the scope for variation in clinical practice makes it necessary to look at practices in individual centres separately.

Edinburgh and south east Scotland

33.96 Professor Ludlam said that the Edinburgh Haemophilia Centre had a long tradition, starting in the 1960s and 1970s, of systematically studying the bleeding patterns of patients with haemophilia. It was among the first centres to assess hepatitis infection and the risks of virus transmission with the initial studies on Hepatitis B virus (HBV) infection.^[147] Blood was taken for testing when patients attended at review clinics for scheduled sessions, for out-patient treatment of acute bleeds, or when patients had been admitted to hospital. While not necessarily carried out on every attendance, taking blood samples for testing was a routine procedure associated with what became the long-term systematic assessment of the viral safety of treatment. Testing of samples to monitor patients' conditions was carried out in a laboratory in the Department of Haematology.^[148]

33.97 The frequency of a patient's attendances depended on their clinical situation. For example, in the early 1980s, when cryoprecipitate was generally used in treating patients at the hospital, those with severe haemophilia might attend the treatment room two or three times a week where they would be seen, reviewed and treated. If they had not been reviewed for a while or if there was something unusual about their clinical state, blood samples would be taken for review or to investigate why they were unwell.^[149] Other patients, such as those on home treatment, might only be seen for review every three or four months provided there were no problems. Part of their regular review would involve taking blood samples for routine monitoring.^[150]

33.98 Professor Ludlam explained the routine for taking blood. About a tablespoon of blood (15 millilitres) was taken.^[151] Although not a great quantity of blood, the procedure was nonetheless significant: the patient understood the process although perhaps not the precise range of tests then carried out. Professor Ludlam said that a sample would be taken for a full blood count, assessment of blood chemistry (for example, urea and electrolytes and liver function tests), assessment for the presence of inhibitors (resistance to Factor VIII treatment) and assessment for viral infection.^[152] He said:

It was important to make sure that the patient's haemoglobin and white [cell] count and platelets were in the normal range .... [O]ne of the complications, particularly of the early Factor VIII concentrates, was they contained antibodies to red cells and so you could get destruction of the red cells and hence anaemia.

The other reason for checking the haemoglobin was that sometimes patients had silent bleeding into their gastrointestinal tract. That was not uncommon. So this was a way of being alerted to that possibility.^[153]

33.99 At the laboratory a full blood count of the different types of cells in the patient's blood was carried out. This was a useful test for providing an overview of a patient's general state of health.^[154] Testing monitored the patient's total white cell count and the number of different white cells (polymorphs, eosinophils, monocytes and lymphocytes) in the samples. These measurements were routinely made and recorded without reference to the patient for consent.

33.100 Professor Ludlam said that in the 1980s he did not obtain explicit consent from his patients for each individual test.^[155] At that time he relied on implied consent. When a patient came for their routine visit they were used to having blood taken for tests that were deemed to be necessary for monitoring their health.^[156] It is very likely that the same practice was followed in many clinics, and for many diseases, throughout the UK at that time. He stated that his practice in this regard had changed (as indeed it had for medical practitioners generally):

I did not go through each individual investigation, like I think I would now. Times have changed and I would [now] very clearly go through [and] list the tests in the case notes and make a note that the patient agreed to these investigations.^[157]

Practice in Glasgow and south west Scotland: the Glasgow Royal Infirmary

33.101 Practice at the GRI was similar to that in Edinburgh: monitoring blood tests were undertaken as part of routine attendance at the clinic. Blood samples for monitoring were also taken from patients attending for treatment of acute bleeds and from patients who had been admitted to hospital.

33.102 Professor Forbes said that from about 1987 patients were asked for specific consent before testing but that often before that time they were not. In his experience, seeking consent to carry out tests came in gradually.^[158]

33.103 When asked what obtaining specific consent involved he said:

I think the important thing is that you are telling patients what is going to happen and why it's to happen and to ask their consent for it to happen. This was very much a change in the ethos of medicine. Until then the implication was that if you went to a doctor with a problem, he would do his best to find the cause of it, without asking your consent for blood samples or whatever, and that was how things were at that time.

I'm not saying that's the right thing because I think that now clearly it is not the right thing, and I think that before one does very much to people, there has to be implied consent and if you are doing anything invasive, like blood samples or endoscopy, you actually have to tell them exactly what you are doing, what it will find for them and what you can do about it and that is implied [sic - specific] consent and often [it] is now written down and that is certainly safer.^[159]

33.104 At the material time for present purposes, up to 1984, there was clearly no practice of obtaining patient consent to any specific tests carried out on the blood taken from patients on a routine basis in the centres in Edinburgh and the GRI.

Immunological studies: Edinburgh and south east Scotland

33.105 Professor Ludlam said that, by the spring of 1983:

[I]t was becoming clearer that there was [sic] some strange things happening to the immune system of people with haemophilia. A number of reports in the medical press of immune abnormalities in patients with haemophilia who were otherwise feeling well. It was - the interpretation that you could put upon those that was puzzling us. I would say that similar abnormalities were shown in gay men who were otherwise feeling well. And the question is in fact: were all these ... individuals in the United States already infected with a latent, if you like, AIDS virus?^[160]

33.106 The background is set out in Chapter 9, Knowledge of the Geographical Spread and Prevalence of HIV/AIDS 1, and Chapter 11, HIV/AIDS Aetiology. Until 1983 there had been very few reports of AIDS in haemophilia patients. Most reports of AIDS related to homosexual men and drug users. In patients with clinical AIDS, immune tests revealed a severe deficiency of T-helper (CD4) and an increase in T-suppressor (CD8) lymphocytes, together with disturbance in the normal ratio of CD4:CD8 cells. Many homosexual men who had no symptoms suggestive of AIDS were also found to have similar immune abnormalities although in milder form.^[161] A letter highlighting immune abnormalities in haemophilia patients in the USA was published in The Lancet on 30 April 1983.^[162]

33.107 These findings led to studies being undertaken in the USA to assess the immune status of apparently well, asymptomatic haemophilia patients. The initial studies demonstrated that many asymptomatic haemophilia patients had immune abnormalities similar to those found in asymptomatic homosexuals. The cause of the immune abnormalities was unclear and it was uncertain whether they were progressive. As with homosexual men, there were, at the outset, a number of possible explanations apart from an 'AIDS virus' for the abnormal immune test results found in haemophilia patients. In his statement, Professor Ludlam explained that the cause of the immune changes might have been related to the widespread prevalence of an 'AIDS virus' or due to some side effect of Factor VIII treatment or it might even have been a previously unreported feature of the condition of haemophilia.^[163] For him, the finding in 1982-83 of immune abnormalities in asymptomatic haemophilia patients in the USA was 'perplexing and worrying'.^[164]

33.108 With the possibility that some US haemophilia patients had apparent immune dysfunction which might have been related to their treatment, might have been progressive and might lead to an AIDS state, Professor Ludlam sought the help of a colleague, Dr C. M. Steel, at the Medical Research Council Unit at the Western General Hospital in Edinburgh, to investigate the possibilities. They decided to monitor the immunological status of some of Professor Ludlam's patients. This was called the 'AIDS study' and these words were written on forms used for requesting blood to indicate that the sample should be sent to Dr Steel for further analysis.^[165]

The 'AIDS study'

33.109 Professor Ludlam approached Dr Steel around January or February 1983. He thought it took a few weeks to negotiate what they wanted to do and that the first blood samples were probably sent to Dr Steel's laboratory around March 1983.^[166] The earliest available evidence known to the Inquiry of blood being taken for the 'AIDS study' is a haematology form so annotated and dated 14 March 1983.^[167]

33.110 In his laboratory, Dr Steel established a facility using specific antibodies to measure by microscopy the proportion of CD4 and CD8 lymphocytes in patients' blood. When patients attended the haemophilia clinic for review or for treatment, blood taken for routine investigations would be sent to the Haematology Laboratory in the Royal Infirmary of Edinburgh (RIE) as normal. There the full blood count would be assessed in the usual way by the haematologists except that instead of counting 100 white cells under the microscope to quantify the different types of white cells, as was usual, 200 cells were counted to obtain a more accurate estimate of the number of lymphocytes. Lymphocytes only constitute a relatively small proportion, approximately 15-25%, of the total number of white cells. Counting a larger number of total white cells made it more likely that a 'precise estimate' of the number of the lymphocytes was obtained before proceeding to divide the number of cells further into CD4 and CD8 lymphocytes.^[168]

33.111 No extra blood was taken for the lymphocyte studies. The same sample was processed and analysed by the RIE Haematology Laboratory and by the Western General Hospital, Edinburgh.^[169] Once the Haematology Laboratory had counted the 200 cells, the same blood samples were then couriered to Dr Steel's laboratory, where the proportions of CD4 and CD8 lymphocytes were assessed. By this means it was possible to measure the proportion of each type of lymphocyte in the blood, as well as their absolute number.^[170]

33.112 Professor Ludlam said that he did not specifically select particular individuals for study. The patients studied were attending the clinic for review or for treatment of an acute bleed and needed to have blood taken for their routine monitoring. He said that all the patients would have been seen by either himself or one of his Registrars. It had been agreed between Professor Ludlam and his Registrars that if blood was being taken from patients it would be assessed for lymphocytes. That would have arisen out of discussion, probably initiated by Professor Ludlam.^[171]

33.113 There may well have been patients who attended the clinic but did not have blood taken for the 'AIDS study'. Samples were taken from patients with severe and moderate haemophilia because they were the patients who had received large quantities of factor concentrates. Professor Ludlam said that if a patient with mild haemophilia attended the clinic they might not have sent a sample of their blood to Dr Steel because the patient might not have had any blood product treatment at all in their life. Even amongst patients with severe and moderate haemophilia, Professor Ludlam said that he might not have needed to take blood from them for other routine reasons and, in that case, he would not have taken blood just to do these tests. It also probably depended to some extent on the time of day a patient was seen. Because the samples had to be ferried across from the RIE to the Western General and processed the same day, if a patient came in late in the afternoon the technicians may not have put that sample through for the lymphocyte assessment due to time constraints.^[172]

33.114 Professor Ludlam estimated that 50-70% of his patients had samples taken from them for the purposes of the 'AIDS study' over the 'next little while'.^[173] Data published in the follow-up article in The Lancet on 30 June 1984 were derived from samples from a smaller cohort, 47 individuals, around 25-30% of his patients.^[174]

Characterisation of the 'AIDS study'

33.115 Professor Ludlam told the Inquiry that he did not obtain ethical approval for the 'AIDS study' because he considered it to be an extension of routine monitoring of his patients and not medical research. He considered that the lymphocyte studies became part of the general monitoring of patients for potential adverse effects of therapy in 1983: if the CD4 and CD8 cells could have been distinguished visually in the routine haematology laboratory procedures, there would have been no need to send them to Dr Steel.^[175] He said:

We viewed this endeavour as part of our obligation to monitor people with haemophilia .... [I]t was my responsibility to monitor patients for side effects of therapy ....

And as immune abnormalities had been demonstrated in apparently well haemophiliacs in the United States, it seemed appropriate that I should assess our patients here in Edinburgh, to see whether they had any immune abnormalities. This was something completely new and important as part of the monitoring process.^[176]

33.116 This led to discussion of the proper characterisation of the study, in light of accepted ethical rules at the time. Professor Ludlam distinguished the 'AIDS study' described above from a later extension of his study of the immune functions of his patients in 1984 - the 'skin test' series of investigations. It is important to compare and contrast his approach to the two studies in considering the position he adopted.

Skin tests

33.117 The skin tests were carried out after the lymphocyte studies and provided another immune function measurement. Professor Ludlam said that he wanted to look at the patients in a 'rather more holistic way' and that the skin tests assessed many more aspects of the functioning of the immune system than counting the CD4 and CD8 cells.^[177]

33.118 Professor Ludlam sought and obtained ethical approval for the new test by writing to the RIE Ethics Committee and explaining what he wanted to do. In particular, he sought approval to ask patients with haemophilia and about 15 or 20 controls if he could use a commercially available 'Merieux multitest' device on their forearm to measure their immune system to try and better define the apparent immune deficiency that had been shown up by the CD4 and CD8 counts.^[178] Professor Ludlam's letter dated 3 May 1984 seeking approval is not available but the skin tests were approved by the Ethics Committee by letter dated 24 May 1984.^[179] The letter, from Dr de Bono, is entitled, 'Skin tests in patients with congenital bleeding disorders'. It states that Dr de Bono considered that it would be 'perfectly in order to proceed with the tests outlined in your letter'.

33.119 The 'multitest' device was a much more holistic way of testing the immune system than measuring the CD4 and CD8 counts. Professor Ludlam thought that 20 or 30 patients were tested in this way. Although some of the patients may have been asked to attend the clinic for this purpose, he thought that it was likely to have been more opportunistic: he probably asked patients who were attending the clinic for review, for treatment or to collect home treatment if they would mind volunteering.^[180]

33.120 Professor Ludlam told the Inquiry that patient consent was obtained before the skin tests were done.^[181] He did not think that the patients' consent was recorded in their notes, however, and there was no record of any written consent for blood tests obtained at that time.^[182] He said that he obtained verbal consent which is what he had been asked to do by the ethics committee.^[183]

33.121 Professor Ludlam said that he explained to patients what the skin tests involved. It was slightly invasive and it inconvenienced the participants because they had to come back to the clinic two days later.^[184] He said that he would have told patients that he was testing their skin because the reactions that he could measure reflected the way in which the immune system was working. He was certain that he would have told the patients that this was part of a study into the lowering of the immune system of haemophilia patients in Edinburgh.^[185]

33.122 When asked what the difference between carrying out the skin tests and carrying out the investigation of CD4/CD8 counts was from a consent point of view, Professor Ludlam said:

[T]he skin tests, involved something being done to the patient. It was invasive ... and it wasn't quite as clear what we might gain out of this. So it was a much more speculative investigation compared with the CD4/CD8 counts.^[186]

33.123 Whether or not the line drawn between steps taken in 'monitoring patients' on the one hand and research on the other was correctly drawn, or was indeed fully rationalised at the time, is not clear. What is clear is that when his studies of the immune functions of his patients crossed what he perceived to be the line between routine management and research he sought ethical approval for what he proposed to do.

33.124 Some witnesses who were part of the AIDS study only found out that they were part of it when they recovered their medical records at a later date. From their perspective, a study was carried out on their blood samples and details of the study subsequently published in The Lancet without their consent or knowledge. Professor Ludlam said that he believed that he had implied consent to 'monitor' his patients by testing their blood for immunological abnormalities as part of general monitoring. Patients were used to blood tests being taken for various purposes. He did not require fresh blood samples for the study.^[187]

33.125 He told the Inquiry that he was sure that he would have explained to those people who were part of the immune studies, commenced in 1983, that there was a very new condition called AIDS about which very little was known and that there was a possibility that it might be spread by blood products. He thought that he would have tempered that by saying that the risk to patients in Edinburgh was minimal as they had received only Factor VIII prepared from plasma collected from donors in Scotland and at that time there were no cases of AIDS in Scotland.^[188]

33.126 It would have been understandable if his position in evidence had been that the study was no more than a preliminary investigation, that he did not set out systematically to inform patients about the study, that some may have got information about the study by asking questions or casually from observing documents but that he could not express any view as to the proportion of those in the study who knew about it. Unfortunately, the evidence became rather confused as Professor Ludlam sought to explain how patients would or might have become aware that the study was being carried out. The problem began with notations on the haematology request forms.

Haematology request forms

33.127 Professor Ludlam explained that there was a routine haematology request form in use at the RIE. The form started off beside the patient and went with the patient's blood sample to the laboratory. Normally the form did not go to Dr Steel but was returned to the haemophilia centre once routine haematology had been completed.^[189] The haematology forms accompanying samples destined for Dr Steel had the words 'AIDS study' written on them.^[190] That informed the haematology laboratory of the need to count 200 cells and send the sample on to Dr Steel. Professor Ludlam was referred to one of the forms and he explained how the form was filled out and what the various data recorded on it represented.^[191]

33.128 The labelling of the samples as 'AIDS study', intended as a form of shorthand to identify them for processing in Dr Steel's laboratory, was, as Professor Ludlam put it, 'unfortunate'.^[192] This was later to give rise to suspicion on the part of some patients that he was carrying out experiments on his patients. In the view of this Inquiry, that suspicion is entirely without foundation. In oral evidence, Professor Ludlam said:

We weren't studying AIDS, we were assessing CD4 and CD8 lymphocytes, but we were doing that because of the reports of immune abnormalities in people with haemophilia from the United States, who were well but had abnormal lymphocyte counts ....

And a few patients with haemophilia in the US developed AIDS .... The overall topic, the umbrella topic was ... AIDS ....

Subsequently it emerged much later on, when one or two patients asked for... copies of their case notes and they saw these report forms in the case notes, they wondered whether, I think, we had undertaken some sort of AIDS - some sort of different AIDS study, whether we had given people AIDS, whether we had given patients concentrates, clotting factor concentrate, that we knew was infected with an AIDS virus. One story that came to me was that we had put HTLV-III into bottles of clotting factor concentrate, heat-treated them and then given it to the patients to see whether the heat treatment was effective.^[193]

33.129 The emergence of these suspicions appears to be an important link in the chain of events which has led to this Inquiry. This is a matter to which the Inquiry will return.

33.130 These anecdotes emerged after the event and cast doubt on the extent to which patients knew of the study at the time it was carried out. However, as the evidence emerged, it became clear that the form was the first possible intimation to patients that they were involved in the 'AIDS study'. Professor Ludlam explained:

[T]o make sure that they were correctly carried out in the laboratory, I labelled the blood forms "AIDS Study". These would be forms that would be handed to patients to get their blood taken and, you know, patients could read it. So I must have explained something about AIDS because I wouldn't write "AIDS Study" on a form, which I then either handed to the patient or was sitting in front of the patient while they were having their blood taken, without some explanation.^[194]

33.131 When patients attended the review clinic at the Medical Out-patient Department there would be an opportunity to discuss what investigations were being carried out as the doctor was talking to the patient. Professor Ludlam thought that the doctors would have explained to their patients why the immune studies were being done at the point of completing the form. He thought that they would have said that there had been reports from North America of a few haemophilia patients developing AIDS and they were keen to do some tests to assess the immune function of patients at the Edinburgh Haemophilia Centre, who they did not think had been affected by whatever the AIDS agent was.^[195] Professor Ludlam told the Inquiry that the staff at the Haemophilia Centre were keen for patients to know about the immune function studies and that doctors had 'no inhibitions' about writing 'AIDS study' on the request forms which were then given to patients.^[196]

33.132 The patient would take the form (possibly along with one or two other routine monitoring forms) into another room and give it to a nurse who would take the blood sample. Professor Ludlam noted that until that time it had generally been deemed to be a doctor's responsibility to take blood and that the RIE haemophilia clinic was one of the first in which nurses were able to take blood.^[197] Sometimes the patient would have to sit in a queue with other patients and wait for the nurse with the form in their hands.^[198] After drawing the sample, the nurse would put the tube containing the blood sample into a polythene bag along with the request form and put it out for a porter to collect and take to the laboratory.^[199] Professor Ludlam thought that at that time the polythene bags had two compartments to them, with the blood sample put into one compartment and the request form put into the other before the bag was then sealed. Professor Ludlam was certain that the request form was not wrapped around the sample in case the sample leaked and the tube and form were covered in blood.^[200] Professor Ludlam stated that patients will generally examine forms if they are given to them: 'if you give them forms, they read them'.^[201]

33.133 He said that his Registrars and the nurses in the centre worked as a team and had agreed the approach described. He therefore thought that it was very likely that the nurse taking the blood would have told the patient about the study, although he did not think that he would have formally instructed them to do so. He accepted that it was an 'informal', although not 'casual', arrangement.^[202]

33.134 Samples were also taken from in-patients, such as those admitted for the treatment of an acute bleeding episode. In such cases, on occasion the forms would have been completed the previous day because the ward doctor would have a lot of patients to go round and take blood from: it was quicker if the forms were all made out in advance.^[203] The form would be taken to the patient's bedside and the sample taken and put in the polythene bag and sent off to the laboratory in the manner described above. The completed request form would often be put down next to the patient who would be able to read the request form while the blood was being taken.^[204]

33.135 If a patient had not been seen for a while or if there was something unusual about their clinical state, blood samples would be taken to investigate their condition. All samples would be taken when the patient was treated: the centre staff did not take blood for investigation and then puncture patients again later for treatment.^[205]

33.136 Professor Ludlam could not recall any written protocol for taking blood samples within the Haemophilia Centre or the hospital generally. He thought 'custom and practice' dictated procedures.^[206]

33.137 Professor Ludlam referred to a letter from Dr John Tucker, Consultant Haematologist at the Borders General Hospital, dated 11 January 2006, which explained the process of taking blood from patients. The letter states:

When patients were inpatients the medical staff completed the request forms and obtained verbal consent which included explaining the need for the samples. They would then draw the sample. This was my practice and I would expect that my colleagues behaved in the same way. Certainly no additional samples would be taken if the patient were to express any reservation or objection. In 1984 we were monitoring immune function of haemophilia patients and used the shorthand notation of 'AIDS study' when taking surveillance specimens. Again patients were aware of this practice when taking immune surveillance samples.^[207]

33.138 In her statement, Sister Billie Reynolds, who worked in the Edinburgh Haemophilia Centre from 1988, said that blood was usually taken first and then the label for the sample would be completed. She also said that she would be asked for samples by Professor Ludlam's Registrar. She would be told simply to tell the patient that the sample was 'for research'. Some patients would consent readily, while others would ask what the research was. If she did not know, she would refer the patient to the doctor who had requested the sample.^[208]

33.139 As the narrative of this evidence indicates, it would have been altogether simpler to have told patients directly and explicitly that studies in the USA had suggested that concentrate therapy might be associated with changes in patients' immune systems, that it was important to find out whether similar changes were happening in patients treated with SNBTS products and, if they were, to consider how best to deal with the situation. Professor Ludlam suggested that, up to a point, an approach along these lines had been taken.

33.140 Professor Ludlam said that he was not trying to keep the immune tests secret. He said that patients knew that he had an interest in monitoring the safety of clotting factor concentrates. He thought that the patients were aware that the immune function tests were being carried out.^[209] When asked whether the patients knew whether they were involved in the 'AIDS study' at the time, however, Professor Ludlam said that he was not sure if they all knew:

I can't assure you that every patient understood exactly what was done but we were making it clear that we were doing this.^[210]

33.141 He said that it was possible that not all patients were told about the 'AIDS study' but he considered that at least some were told, although he was unable to estimate how many patients that might have been.^[211]

33.142 However, he also said that he was not surprised that some patients did not understand that they were being involved in an AIDS study:

I think it's not always possible to convey ... information ... to people. They may have forgotten they had been told. We may not have told them. This was part of the monitoring of patients that was my responsibility ... if we had asked them exactly what was happening to the full blood counts that we had been doing for years they might be a bit vague and the same for the chemistry tests, and this was just another test that was important - it was something ... new, but it was my responsibility to do this and to see what the results were.^[212]

Findings of the immune function studies

33.143 Professor Ludlam said that it was observed from the initial studies in 1983, to great surprise, that the pattern of lymphocyte abnormalities in Edinburgh patients was similar to those observed in the USA; yet none of the individuals had any symptoms or signs suggestive of AIDS. As the majority of patients had only received blood components or products prepared from Scottish blood donors, and there were at that time no AIDS cases in Scotland, it seemed rather unlikely to Professor Ludlam that the lymphocyte changes were due to a possible ubiquitous AIDS virus. The cause of the immune changes in the Edinburgh patients was unknown but there were a number of possible explanations related to the underlying condition of haemophilia and its treatment. It was thought to be imperative to monitor the patients because, if the immune changes were becoming progressively more abnormal, there might be a risk of their developing opportunistic infections (such as Pneumocystiscarinii pneumonia or Kaposi's sarcoma) which were characteristic of AIDS.^[213]

33.144 Patients were only advised of the results of the lymphocyte studies if they asked.^[214] Professor Ludlam accepted that, since at least some of the patients were not aware that they were being studied, those patients could not have asked for their results.^[215] He said that he did not take any steps to advise patients of the results because he did not know how to interpret them. He was, he explained, 'perplexed' by the findings of the study and was not sure what their clinical significance was. The clinicians had expected them to be normal. They were themselves uncertain as to what the results might mean and it did not seem helpful to go back and pass on the information to the patients.^[216]

33.145 Professor Ludlam said that he was also a little hesitant because the technology that they were using was not what would be used today:

It doesn't have the high degree of sophistication for counting numbers of cells ... we counted cells manually. It's a very imprecise way, particularly when there are small numbers of lymphocytes.

So the results didn't seem to have the same degree of precision as I would have liked and I think these were not standard laboratory tests for which there were well defined normal ranges ....

This was not, and couldn't be at that stage, well quality controlled.^[217]

33.146 The results of the lymphocyte tests carried out were initially recorded on paper records.^[218] Professor Ludlam explained:

It was much later in fact, when we were moving hospitals, that we were tidying up and came across a box of these and one of my staff said, 'Well, what do we do with these?' I was told all the information was in the computer so should we not just throw them out? And I thought, 'Well, it's part of the clinical record, we should put it back in [the] case notes ....' so they were added very much later, about 2003.^[219]

33.147 He explained that they were not part of individual patients' case notes from the beginning because they had the information on computer along with a lot of other information. The forms had to be kept while they were waiting for the results to come back from the Western General and they did not all come back at the same time so they accumulated in a box. Professor Ludlam explained that when AIDS 'became more of an anxiety' there emerged a desire not to put such information in patients' case notes.^[220]

33.148 Three aspects of this evidence cause particular difficulty in classifying the immune studies as 'monitoring' of patients' immune systems. Firstly, the request forms referred to the exercise as a 'study'. The exercise was limited in scope, and did not involve structured follow-up or sequential studies of the patients. Secondly, the suggestion that comparison with contemporary technology made Professor Ludlam 'hesitant' about the investigation is irrelevant to the perception at the time: later technological developments could not have been anticipated in any but the most general of terms. Publication on the assumption that later technology might undermine the conclusions of the study is an unlikely occurrence. Thirdly, and perhaps most significantly, omitting the forms and results from patients' case notes inevitably meant that the information was not available to clinicians and others consulting the notes unless they had been involved in the study and knew of the existence of an independent record. Thus far, the evidence tends to support the notion that the 'AIDS study' was research.

Publications in The Lancet, May 1983 and June 1984

33.149 Professor Ludlam told the Inquiry that, as he had data showing abnormalities in his patients with haemophilia, who had been treated with blood products collected in a non-AIDS country but which were similar to those highlighted in US patients in the letter in The Lancet on 30 April 1983,^[221] it seemed important to submit the data for publication. He considered that the report would offer alternative explanations, other than widespread infection by a putative virus causing AIDS, for the immune abnormalities observed in US haemophilia patients.^[222]

33.150 A preliminary report of Professor Ludlam's findings was published in The Lancet on 28 May 1983.^[223] The study related to samples from 23 patients with severe haemophilia and von Willebrand's disease who had only received SNBTS Factor VIII, Factor IX or cryoprecipitate in the past five years. All were clinically well.

33.151 This preliminary report was followed up by a more detailed description of the observations in a further article in The Lancet on 30 June 1984.^[224] By this stage samples from 47 patients (including the 23 patients sampled previously) had been taken.^[225]

33.152 It is clear from the reports of these studies that as late as June 1984, Professor Ludlam had formed, and continued to hold, the view that something other than a putative AIDS virus, associated with possible 'antigen overload', was causing immune abnormalities in some at least of his patients, similar to but less severe than those associated with AIDS. He did not discuss the antigen overload theory with his patients because it was not clear what should be done if that was the cause of the apparent immune dysfunction.^[226]

33.153 Later, by analysing stored samples retrospectively, it was shown that at the time the samples had been analysed the patients were all negative for anti-HTLV-III. The changes in distribution of lymphocyte cells that were observed and reported in the published article were not associated with viral infection. However, retrospective examination also showed that, by the time the paper was published on 30 June 1984, some of the patients included in the study had become infected with HTLV-III in the interval.^[227]

33.154 Professor Ludlam said that reporting the results of his monitoring of the patients was not limited to the 1983-84 publications describing lymphocyte abnormalities:

[T]his stretched on into ... the [Edinburgh] cohort.^[228] It was new information that came out of examining the immune systems of these patients. So it was new information. In that sense it was research but I would call it "new information" - if I had not published it, it would have been monitoring. I don't see that it necessarily becomes research because I have published it. In a sense it's what we might call these days an "audit".^[229]

33.155 This answer added to the difficulty of accepting that the study was properly characterised as 'monitoring' of the patients. New information is, perhaps invariably, what one hopes to derive from research. Until it is published, it remains unpublished research. It is difficult to understand how a decision to withhold new information from publication of itself transforms it into monitoring of patients. It is less difficult to envisage a situation in which new information derived from research becomes relevant to monitoring as part of the follow-up of the patient: it might be hoped that would be normal. That would not, however, change the character of the exercise from which the new information was derived.

Immunological studies: the Glasgow Royal Infirmary

33.156 Immunological studies were also carried out in Glasgow. In contrast to practice in Edinburgh, Glasgow patients were exposed to a mixture of blood products, including imported concentrates. In this respect the context for the study was different.

33.157 Like Professor Ludlam, Professor Forbes said that early in 1983 a variety of investigations had shown evidence that haemophilia patients who had received multiple transfusions of Factor VIII and Factor IX concentrates had immunological abnormalities. Professor Forbes and his colleagues therefore undertook to look at their own patients to see if any abnormalities were occurring in them as a result of concentrate infusion.^[230] The minute of the meeting of the haemophilia and blood transfusion working group at St Andrew's House on 22 March 1983 already mentioned, indicates that Dr Forbes (as he then was) was conducting a study of the immunological status of haemophilia patients at that time.^[231]

33.158 He and his colleagues were able to show that there was indeed suppression of immunological function in their patients. Again in common with Professor Ludlam, it was not clear to Professor Forbes at the time that the suppression was necessarily due to the transfusion of blood products over a period of time. Although that was certainly felt to be a possibility there was some doubt. He explained that there might have been something else happening at the time to cause immune suppression, apart from a ubiquitous AIDS-causing virus, that they did not know about. He and his colleagues were cautious about drawing their conclusions.^[232]

33.159 In Glasgow, blood samples were taken specifically for the immunological study. The patients all knew about the study because they volunteered to give blood and all of the tests were carried out on fresh blood samples, although the patients were not informed in great detail of the implications of the study. It was not clear to Professor Forbes himself what the implications might be.^[233] He said that patients were asked if they would mind giving a sample of blood, that they were going to look at some immunological tests and required fresh blood samples to look at their cells and see if there was anything happening that they should know about. Professor Forbes said that it was probably mostly himself who asked the patients for samples, although Dr Madhok and Professor Lowe may also have asked.^[234]

33.160 Dr Froebel, who had participated in the running of the study, could not remember the exact date it had commenced, although she thought it was in 1982 when she moved into the new Department of Medicine research laboratory at the GRI.^[235] She was a post-doctoral research fellow at the time, working on the cellular immunology of rheumatoid arthritis. Soon after the move, Professor Forbes approached her about a new syndrome of immune deficiency that appeared to be affecting, among others, patients with haemophilia in California. She responded by saying that apart from one assay (the 'natural killer assay') which she thought that she would be able to develop, she was already able to apply all of the other tests that were used on the Californian patients. She suggested testing samples from 10 patients to see if there were any similarities. In the end she carried out numerical immunological tests, for proportions of lymphocyte sub-populations, and functional tests, looking at T cells and natural killer cells, for their response to mitogens and their natural killer activity, on samples from 19 patients.^[236]

33.161 After the study was completed the results and implications of the results were not communicated to the patients. Professor Forbes said that he was not sure if he knew that there were implications or, if there were, what they meant:

I don't think we understood what was really happening. We were able to show that using these particular tests, no matter how primitive they were, there was something happening and it seemed to be associated with the amount of material given to them.

Whether it was a direct effect of some component of the blood products given, we weren't clear. So this was very much a preliminary paper, suggesting that there were immunological abnormalities. What they meant, I don't think at that time we knew, and I'm not sure that we even know at this time.^[237]

Publication

33.162 An article by Dr Froebel and others entitled, 'Immunological abnormalities in haemophilia: are they caused by American Factor VIII concentrate?' was published in the BMJ on 15 October 1983.^[238] The article reported the study of cellular immunity in the group of 19 haemophilia patients at the GRI referred to above. These 19 patients were all treated at the Haemophilia Centre at the GRI and all had received different treatments over the preceding years.

33.163 Table 1 of Dr Froebel's paper showed a significant difference between the patients and the controls. She had presented it a meeting of the Scottish Medical Society, she thought, in the spring of 1983 and it was published soon after as an extended abstract in the Scottish Medical Journal (SMJ). She thought the SMJ paper was the first report in the UK of what was later understood to be HIV/AIDS.^[239]

Consent to publication

33.164 Professor Ludlam told the Inquiry that patient consent to publish was not obtained for his papers. He did not think that it would be necessary because the results were anonymised.^[240] It never occurred to him to get the patients' consent because that was not usual practice when patients were not identifiable from the information published and there was no information in the two publications that would allow the identification of any individual patient: it was group data. He thought that it would have been unusual at that time to go back to the patients and say 'these are the results, we would like your permission to publish them'. If he was going to publish a case report on an individual who might be identifiable then he would have discussed his intentions with the patient, explained why it was interesting and asked for permission. He thought that he would have done that for a (specific) 'case report' at the time, although it was not then an ethical requirement.^[241]

33.165 As already noted, Professor Forbes did not go back to his patients with the results of the Glasgow study.

Skin test: the Glasgow Royal Infirmary

33.166 It appears that the Glasgow skin test exercise was carried out later. It was referred to in a letter to patients circulated on 8 January 1985 as a test Professor Forbes and Professor Lowe wanted to carry out, indicating that it still lay in the future at that time.^[242] Whether ethical consent was sought is not known but patients were at least informed of the wish to test.

Testing for anti-HTLV-III

The UK context

33.167 Between 1982, when treating doctors first became aware of AIDS in the USA, and 1984, when the first tests became available, there was a lot of uncertainty about all aspects of the condition. By the end of 1983 most haemophilia clinicians would have accepted the view that the condition was caused by a blood-borne infectious agent which was transmissible by blood products. Commercially produced factor concentrates were thought by many to be more likely to transmit infections than concentrates made from local (UK) blood. However, the medical consequences of infection were unclear. The 'antigen overload' theory, that immune deficiencies in recipients of factor concentrates occurred without an infective agent of transmission, persisted (and was ultimately shown to be valid, at least to some extent in some cases).

33.168 The number of diagnosed cases of AIDS among persons with haemophilia was relatively low in 1983: possibly only two in the UK. The CDC definition of 'AIDS' had been adopted for reporting purposes. The CDC criteria stressed the importance of the diagnosis of opportunistic infection. A definitive diagnosis would be attached if the patient developed intractable disease.^[243] By November 1984, 21 cases of AIDS or AIDS-related illness (none in Scotland) had been reported to Dr John Craske of the Public Health Laboratory Service (PHLS).

33.169 Emphasis on this diagnostic test necessarily underestimated the prevalence of HIV infection in the haemophilia population, given the potentially long period before evidence of opportunistic infection might appear in individual patients. The focus changed in 1984 when testing for antibodies to HTLV-III had become a reality.

33.170 By July 1984, Professor Richard Tedder at the Department of Virology at the Middlesex Hospital, along with Professor Robin Weiss of the Chester Beatty Laboratories and a group of colleagues, had developed an early competitive radioimmunoassay test for the detection of antibodies to the putative virus causing AIDS. The test was still under development at that time and was considered to be a 'research assay', but it was used to carry out an extensive programme of research.^[244] The result was the article by Cheingsong-Popov and others already mentioned which was published in The Lancet on 1 September 1984. Two thousand people in the UK had been tested for antibody to HTLV-III.^[245]

33.171 Blood samples had been made available by healthcare professionals in a number of clinical areas: GUM physicians, haematologists looking after haemophilia patients and people providing care to intravenous drug users. Following this publication, clinicians caring for each of these risk groups contacted Professor Tedder asking him to test their patients, to delineate the size of the problem in their respective patient groups.^[246] Samples were submitted for examination from around the UK. Professor Tedder told the Inquiry that the period following the publication of the data in the September paper 'was an incredibly difficult and busy time'.^[247]

33.172 Professor Tedder had the only laboratory in the UK which could carry out HTLV-III antibody tests at that time without access to US technology and know-how. By the end of 1984, Dr Philip Mortimer at the PHLS was also carrying out the tests developed by Professor Tedder.

33.173 On 10 December 1984, the UKHCDO held a meeting to discuss recent developments in HTLV-III testing, although it is clear that, as in Glasgow and Edinburgh, some regional Haemophilia Centre Directors had information about the availability of tests before this meeting. The minutes show that it was known that Professor Tedder had a test available but that any expanded test programme would require large quantities of virus culture, which would depend on engaging third parties. Only the PHLS and Wellcome were interested in industrial scale production. After long discussion, it was agreed that each clinician would decide whether individual patients found to be antibody-positive should be informed but that, in general, information should be provided if asked for. Professor Tedder advised that information about the risks of sexual transmission should be provided.^[248]

33.174 On 14 December 1984, Professor Arthur Bloom (Chairman of the UKHCDO) sent a document entitled 'AIDS Advisory Document' to all Haemophilia Centre Directors, intended to express the position adopted at the meeting four days earlier.^[249] The document recommended that haemophilia patients should be tested for HTLV-III antibody and that antibody-positive patients should be informed, reassured and counselled regarding transmission of infection, including the possible use of barrier contraception. It noted that tests for HTLV-III antibody were available for haemophilia patients via Professor Tedder and Dr Mortimer. The intent of the letter of 14 December, read in the light of the discussion, appears to have been that information, reassurance and advice should relate to transmission of infection. The discretion of the individual clinician, discussed at the meeting, was not dealt with in the document.

33.175 Until mid-December 1984, there had been no 'universal' HTLV-III antibody testing of haemophilia patients in the UK. There had been no discussion among haemophilia directors. Nor was there any general agreement to test for HTLV-III antibody prior to this date. It appears that whether or not patients were tested prior to 14 December 1984 depended on whether the particular haemophilia director knew that Professor Tedder had a test available and had been in contact with his laboratory to arrange testing on an individual basis, or had contact with Dr Robert Gallo or Professor Luc Montagnier that provided for testing in their laboratories.^[250] The larger haemophilia centres were actively concerned about the whole situation and had started to contact Professor Tedder to see if he could test their patients.

33.176 The patients at Dr Winter's centre (at Kent and Canterbury Hospital) were informed in late 1984 that a test had become available and that their blood was being sent to Professor Tedder for testing. Dr Winter noted that a number of other haemophilia centres saw the availability of the new test as merely an extension of their pre-existing screening programme and did not perceive any need to inform patients.^[251]

33.177 Dr Winter's clinic did not have stored samples and it was necessary for him to make appointments to take a fresh blood sample from his patients. He explained:

If you had to call for the patient to have blood taken, as I did, that was different because the patient would come in and say, "Why have you called for me?" So if you like, in other centres because they had had to summon the patients, inevitably they would be saying, "I know you were only here a month ago for your review but we have asked you to come back because we have now got access to this new blood test and this is what it's all about".^[252]

33.178 Dr Winter's evidence highlighted the differences between centres which sent stored blood samples and centres (like his own and the GRI) which had to take fresh blood samples from patients. He explained that centres with stored blood samples would have probably 'just gone off to the deep freeze and thawed them and sent them because they would have thought this is just yet another virus test'. It would not have occurred to them to tell the patients because (1) it wasn't their practice to tell patients about blood tests; and (2) they were not having to bleed the patients so they were not actually seeing the patients.^[253]

33.179 Dr Winter said that in 1984 there was no pre-test counselling. This concept emerged one or two years later as a result of the HIV epidemic and as the impact that a positive test had on a patient's life generally, including the possibility of not obtaining life insurance and mortgages, became clear.^[254] He explained that it became apparent a few months after the AIDS test became available that, if a patient had this test performed, even if the result was negative, an insurance company or mortgage adviser might subsequently want to decline a proposal or increase the premium on the basis, presumably, of 'we think you might have been something of a risky individual to have wanted that test done in the first place'.^[255] He said:

Never before in medical practice had there been a blood test where just by having it changed your prospects for things like insurance and mortgages. Whatever the result was. So for the first time in medicine, I think, it became necessary to talk to patients who had come in and say - these are all patients - remember, I'm an HIV physician. A patient would come in and say, "I split up with my boyfriend 6 months ago and I'm in a new relationship and I would like to have this test done". To reassure them you would say to them, "Before you do that, there are things we need to discuss. If you have this test done, even if it is negative, you might find it more difficult to get life insurance. If you have this test done, even if it is negative, you might find it more difficult to get a mortgage." So you talked the patients through really what the consequence was of a negative result and what the consequence was of a positive result. And that was a completely new concept, now standard; and that was what pre-test counselling became.^[256]

33.180 Dr Winter said this completely new concept evolved from mid-1985 onwards. He explained that pre-test counselling subsequently became standard practice. He emphasised that at that time (late 1984) there was no stigma about having a blood test done and there had never been any impetus for doctors to tell patients that they were carrying out certain blood tests. The fact of simply having a test had never previously affected the patient.^[257]

Testing for HTLV-III: Edinburgh

33.181 Professor Ludlam knew Professor Tedder and, when he found out that an HTLV-III antibody test had been developed, he telephoned and asked Professor Tedder if he would test samples from some of the haemophilia patients at the Edinburgh Haemophilia Centre.^[258] Professor Ludlam said that, at the time that he made contact, Professor Tedder was inundated with requests from various sources and had only a limited amount of reagent to carry out the tests. Following some discussion, agreement was reached to test 10 samples from Edinburgh.^[259]

33.182 Professor Ludlam's recollection was that he had contacted Professor Tedder in October 1984,^[260] while Professor Tedder thought that he had tested the samples for Professor Ludlam sometime around August 1984. Unfortunately there are no paper records of this testing as Professor Tedder's laboratory was dismantled a few years ago and all papers from the early period of HIV were destroyed.^[261]

33.183 Whatever the precise date, the work carried out in Edinburgh in 1982-84 in pursuit of Professor Ludlam's immunological studies lost much of its significance, at least for the time being, when the first HTLV-III antibody test results became available. The belief among Scottish practitioners that the Scottish blood donor population was free from infection and that Scottish blood products prepared from Scottish plasma were therefore likely to be safe was undermined.

Selection of initial samples

33.184 The first group of samples sent to Professor Tedder were recent blood samples taken from storage in the deep freeze in the RIE Haematology Department. Blood samples routinely taken for virological testing were stored in the virology department and a parallel store was kept in the haematology department so that clotting assays could be carried out as part of the routine monitoring of haemophilia. Professor Ludlam thought that, at that time, the 'indefinite' storage of all blood samples was 'a very appropriate thing to do ... [and] seen as extremely good virological practice' and noted that this was done in many other centres throughout the UK.^[262] No fresh blood samples were taken to send to Professor Tedder for testing for HTLV-III.^[263]

33.185 Consent was not obtained from patients prior to their blood samples being sent to Professor Tedder. Professor Ludlam thought it unlikely that at the time that the samples were taken patients would have been told that they might be used for anti-HTLV-III testing:

I don't think they would have been told because we had no idea when the testing would become available, that a viral aetiology would be forthcoming. And these were samples that were laid down ... periodically when patients attended.^[264]

33.186 Professor Ludlam said that he may have instructed one of his laboratory staff to look out 10 recent samples from the deep freeze in haematology, probably from patients with severe or moderate haemophilia who were frequent users of concentrate.^[265] He could not recall whether he chose the names of the patients whose samples were sent to Professor Tedder himself or if he simply gave the instruction that 10 samples from patients with severe haemophilia were to be sent and left it to the laboratory staff to go through a list of patients and choose the samples.^[266]

33.187 On the first day of his evidence on this topic, Professor Ludlam told the Inquiry that he thought that he had specifically sent Professor Tedder 10 samples from patients who had only received SNBTS product.^[267] Upon reflection, however, he acknowledged that his initial recollection was probably wrong. He later said that he thought that the 10 samples were probably from a mixture of patients who had received only SNBTS concentrates and patients who had also received commercial concentrates.^[268]

33.188 Professor Ludlam did not think that the immune function results from the earlier study informed his selection of the samples. He pointed out that, in retrospect, at that stage the CD4 and CD8 counts of those who were found to be anti-HTLV-III positive were the same as those who were anti-HTLV-III negative, and had not started to decline. He said that he was 'pretty certain' that the selection was made on the basis of concentrate history and not on participation in the prior immune tests. He said that there were no clinical signs of AIDS at that stage in any of the patients.^[269]

Test results received 26 October 1984

33.189 Professor Ludlam said that he received the test results from Professor Tedder in late October 1984.^[270] He said that he remembered the conversation vividly and that Professor Tedder had telephoned him at home around 8pm.^[271] Professor Ludlam then telephoned Dr McClelland at home, within five to 10 minutes of getting the results, to inform him of the fact that the SNBTS blood supply appeared to be infected.^[272]

33.190 Dr McClelland recorded the initial disclosure in a memorandum dated 20 November 1984 which he sent to Dr Perry and Professor Cash. The memorandum stated that Professor Ludlam had telephoned him at home on the evening of Friday 26 October 1984.^[273]

33.191 Professor Ludlam's initial recollection was of being told that three patients had tested positive for HTLV-III antibody.^[274] He was subsequently shown a copy of Dr McClelland's memorandum, which he did not recall having seen previously.^[275] Paragraph one of the memorandum states:

On the evening of Friday 26/10/84 Dr Christopher Ludlam telephoned me at home to let me [Dr McClelland] know that six haemophiliac patients of his had developed antibody to HTLV3. He thought that three of these sero conversions could be attributable to the use of PFC products.^[276]

33.192 Professor Ludlam accepted that Dr McClelland's memorandum (which was written within a month of the phone call) was more likely to be accurate than his memory and that it was likely that six patients (not three) had been found to be HTLV-III antibody positive by 26 October 1984.^[277] Professor Ludlam offered an explanation for his initial recollection:

The figure of three sticks in my mind because these were people who had all received SNBTS-only material and there may have been another three who had had commercial material and who were positive. And I would have made the quick assumption that maybe they got it from the commercial material. This would be before we had looked at the transfusion records. So that is a possible explanation. It was a long time ago - I just remember the - there were three that got one batch. That's what impressed me ....

And it may be that there were three others who had got commercial and because - as I say, I assumed that that they, in the first instance, without inspecting the transfusion records - assumed that they might have got it from the commercial [products].^[278]

33.193 The telephone call from Professor Ludlam to Dr McClelland on 26 October 1984 was the first indication to the transfusion service that the SNBTS blood supply had been infected. By 1 November 1984 a specific batch of Factor VIII concentrate, batch 023110090, was deemed the most likely source of infection and was recalled. Subsequent investigation of the source of infection is described in Chapter 10, Knowledge of the Geographical Spread and Prevalence of HIV/AIDS 2.

Further testing by Professor Tedder

33.194 To investigate the situation further, Professor Tedder agreed to test additional samples from other patients^[279] and Professor Ludlam arranged for further samples to be sent within a few days of receiving the initial results.^[280] He could not recall how he selected which further samples were to be sent, although he thought that he might have selected samples from other patients who had received batch 023110090.^[281] The results of the further tests were received on Friday 2 November 1984, when Professor Tedder reported that a total of 16 patients in Edinburgh were apparently anti-HTLV-III positive.^[282] Fifteen of these patients appeared to have been infected by a single batch. The number of patients infected by the implicated batch was later thought to be 18. These patients became known as the Edinburgh Cohort and are discussed further in Chapter 10, Knowledge of the Geographical Spread and Prevalence of HIV/AIDS 2.

33.195 Professor Ludlam said that, in total, samples from between 50 and 70 patients were tested by Professor Tedder.^[283] He thought it unlikely that they were all tested in one batch given that Professor Tedder had limited supplies of reagents and was receiving a lot of requests. He thought that they would have been tested 'over a month or two or three' but admitted that this was a guess.^[284]

33.196 All of the samples that were sent to Professor Tedder were labelled with the names of the patients from whom they had been taken.^[285] Professor Ludlam said that this was the usual way of sending samples to the laboratory for testing because they were worried about transcription errors:

If identifying details about a patient, either their name or a number or an initial or a date [are used] ­­- every time it is written there is a finite chance there will be a mistake .... [If] you have got a row of tubes in a rack and someone is writing numbers, for example, on them. It is very easy indeed to get numbers a bit confused, not to remember to up to the next number when you number the next tube. So if you write a name, it is rather more specific and is probably less likely to result in error.^[286]

33.197 The effect of Professor Ludlam's evidence was that the question whether testing should be anonymised did not raise ethical issues in late 1984 and that it did not do so in this context until the 1990s, partly in response to the HIV situation. He said that when the HTLV-III antibody tests became available it felt as if at last clinicians had some control of the situation and that it would be useful to know whether individual patients were negative or positive for anti-HTLV-III. Therefore the samples were sent as named samples.^[287]

33.198 When asked whether he had anticipated the problem which would be caused by obtaining positive test results for patients who had been tested without their consent, Professor Ludlam said:

I think it fair to say that we hadn't, or we certainly hadn't anticipated all the consequences of testing and why informed consent became so important. This was at a time when AIDS was - increasing numbers of people were developing AIDS and we were desperate to have a reliable marker and that's why it was useful to have them on a named basis. I entirely agree that, come 1985 ... the whole picture of testing changed and it became desirable to talk to patients in advance of testing.^[288]

Testing for HTLV-III: the Glasgow Royal Infirmary

33.199 The history of the testing for HTLV-III antibody in Glasgow is confused. There is evidence that by the end of 1984 some patients from the GRI and Yorkhill Hospital had been tested for HTLV-III antibody. It is not clear who carried out the tests for Yorkhill hospital.^[289] While the RIE sent samples to Professor Tedder at the Middlesex Hospital for testing, as described above, the GRI sent samples to Dr Gallo in the USA. How that came about, and whether there was a connection with Dr Gallo that facilitated the test, remains unclear.

33.200 As he expressly admitted, Professor Forbes had difficulty recalling many of the events that had occurred nearly three decades ago. He informed the Inquiry that the initial testing of patients for the Glasgow Haemophilia Centre was carried out by Dr Mads Melbye at his laboratory in Denmark.^[290] After he had given evidence, however, Dr Karin Froebel provided a written statement to the Inquiry indicating that the initial testing had in fact been performed by Dr Gallo in the USA.^[291] The relevant paragraph for these purposes is:

Things were moving very quickly in the field. In the spring of 1984, two reports, from Montagnier in France, and Gallo in the US, claimed to have isolated a virus from patients with AIDS. Both were working on an antibody (ELISA) assay, a blood test that would show exposure to the virus. We were interested to know as soon as possible whether the Glasgow haemophiliac patients had antibody to the virus. In Glasgow there was a freezer-full of stored serum samples from an earlier study, which Dr Forbes suggested could be used. I wrote to both Montagnier and Gallo and had a reply from Dr Gallo directing me to send the samples to his research scientist. The samples (77) were located, I think by Dr Madhok, packed in dry ice, and Dr Forbes and I took them to Glasgow airport to be air-freighted to the laboratory in the US. At this point, I still thought the results would be negative; that we were dealing with something different in Scotland and I can still recall the shock when the news came back that 12 of our 77 samples, i.e. 16%, tested positive. Very soon after that, Mads Melbye appeared, and suggested writing a joint paper, pooling our results with his 22 Danish samples, and this resulted in the Lancet paper in December 1984.

At this point I recall Dr Forbes saying that he would speak to all the haemophiliac patients and tell them that they were at risk of infection, and should take the necessary safe sex precautions, ie use condoms. The test carried out in the US had not yet been approved by the regulatory body; therefore we could not say for sure that the 12 were definitely infected or that the 65 were definitely not. I also recall Dr Forbes telling me soon after, that he had spoken to all the patients. I had no direct contact with patients at any time.^[292]

33.201 Subsequently, in a letter to the Inquiry dated 27 June 2011, Professor Forbes advised that he was happy to defer to Dr Froebel's recollection of events on this matter and that what she described was a logical explanation of events although he did not actually remember sending samples to Dr Gallo.^[293] As noted by Dr Froebel, the stored samples were 'from an earlier study'. It is not possible to determine which study that was. The only near contemporaneous study about which the Inquiry has evidence is the immune abnormality study referred to at paragraph 33.159 above.

33.202 Professor Forbes could not recall when he started collecting the samples. In the article mentioned by Dr Froebel, it is noted in the section on the materials and methods employed that blood was taken from patients enrolled in the Regional Haemophilia Reference Centre, Glasgow, between December 1983 and July 1984.^[294] Professor Forbes agreed that the samples that were sent for HTLV-III antibody testing were taken from patients between those dates. There were other samples from the same patients going back to 1979 and they were later able to use the samples to determine dates of seroconversion.

33.203 When asked if the patients were told that their blood was being tested at this time, Professor Forbes said:

I think that the answer would be probably not at that time. It's difficult to remember but this was very much a moving situation and the whole question of consent at that time was very woolly. Certainly later on it tightened up immensely and has changed even more since then. So I don't think that we would be asking for consent for storing samples but they might be told that they were being stored. So I'm very unclear as to when all these things happened.^[295]

33.204 Questioned further, Professor Forbes said that he was 'quite sure' that patients were not asked for their consent to be tested. He said:

I don't think that at that time there was any concern about consent because we assumed that people would want to know about what was happening and what the implications of this new test would be. So I don't think that we asked for consent.^[296]

33.205 It is difficult to reconcile the careful practice of obtaining specific consent to take blood for the limited purpose of a preliminary investigation of immune abnormalities with the retention of the samples, without obtaining consent, for the potentially more serious exercise of testing for HTLV-III infection when a test became available. On the basis of Professor Forbes' evidence, however, and the December article, the procedure adopted in preparation for the test did not involve obtaining patient consent. If the timetable for collection was as described above, the dispatch of samples to Dr Gallo's laboratory could have happened in or soon after July 1984. Professor Lowe was unable to assist as he was on secondment at the material time. He told the Inquiry that he was not involved in collecting samples from patients or sending them to the laboratory for HTLV-III testing.^[297] His first exposure to the study which was published in The Lancet in December 1984 was when he read the draft paper.^[298]

33.206 The next witness who might have assisted in providing a date for Dr Gallo's investigation was Dr Patricia Wilkie, a researcher working at the GRI. In 1982 she was engaged in a study of the social and psychological implications of adult polycystic kidney disease and the implications for counselling.^[299] She initially told the Inquiry that she thought that she had begun working with Professor Forbes around March or April 1983, although she could not be sure of the date.^[300] She had found boxes of cuttings from newspapers and academic journals about HIV dating from 1983 onwards, which, she thought, showed that she was thinking about HIV at that stage, but accepted that she might have begun working for Professor Forbes in early 1984.^[301]

33.207 Dr Wilkie said that Dr Forbes contacted her and asked her to help with counselling haemophilia patients about AIDS.^[302] She said that he had wanted her to work with him for some time but that she had been reluctant to do so because she was much more interested in diseases that were transmitted in an autosomal dominant way, rather than haemophilia which had been well-researched.^[303] However, she said that there was an emerging realisation at this time that it was possible that a new virus, then called HTLV-III, might be transmitted through blood and blood products.^[304] HTLV-III was the designation of the isolate published by Dr Gallo in April 1984. If Dr Wilkie's recollection that HTLV-III was a material factor influencing her engagement with Professor Forbes is reliable, that must have happened in or after April 1984 and no earlier.

33.208 Her recollection was that Professor Forbes told her that he had recently returned from a haemophilia conference in the USA where it had been reported that HTLV-III had been found in the blood of some patients with haemophilia.^[305] She recalled that he told her that he had brought back some testing kits from the USA which were not yet licensed but which could test for the presence of HTLV-III in the blood. She said that Professor Forbes had told her that he had anonymously tested the blood samples of a couple of patients with haemophilia and discovered that both samples were HIV-positive.^[306] She added in oral evidence:

This is what he told me, and that he had realised that this should not go any further and that's why he phoned me ....

I was already a member of a research ethics committee in Edinburgh and I had a very great interest in ethics and how things should be done and consenting people and transparency, things that are still not quite with us.^[307]

33.209 Dr Wilkie said that the reason that Professor Forbes had contacted her was because he was agitated about the test results. He wanted her to use her skills to help his patients: to establish what people with haemophilia knew about HTLV-III, whether they knew about the existence of the virus and whether the patient thought that they may be affected. He also wanted her to find out if the patients would like to be tested for the virus if a test was available.^[308]

33.210 Professor Forbes told the Inquiry that he did not think Dr Wilkie's recollection about testing with a US testing kit was correct. He said that he certainly did not bring anything back from the United States in his hand but he was sure that they had some connection in which tests were provided to them.^[309] Asked if it could be the Melbye tests that he and Dr Wilkie discussed he thought that that was possible although he had no recollection of the discussion.^[310] When he gave this evidence, he was unaware of Dr Froebel's evidence and had not then deferred to her version of events. Professor Forbes also explained that he would not personally be able to do a test like that.^[311] He said that the initial samples were all labelled as he felt it was important to know who tested positive as action would require to be taken on the basis of the results.^[312]

33.211 Professor Lowe could not recall the precise month that Dr Wilkie came to the haemophilia unit but thought that she was coming regularly and speaking to the patients by the beginning of 1985. He said that she came to all the clinics and was always around and tried to see all patients who had been treated with blood products and were therefore at risk of having a positive result. She was very dedicated and made herself fully available to all patients, partners and relatives. He said that she spent a lot of time, particularly in 1985, discussing the implications of HIV test results.^[313]

33.212 Dr Wilkie explained that she was involved in two interconnected projects. The initial project was funded by the Scottish Home and Health Department (SHHD) and administered by Ivana Markova at Stirling University,^[314] to establish what patients knew about the genetics of haemophilia, what treatments the patients thought were available and what patients and their families knew about infections associated with haemophilia treatment and what could be done about them.^[315] Dr Wilkie told the Inquiry that she, Professor Forbes and Ivana Markova drafted the research proposal^[316] although Dr Wilkie does not appear to be named on the documentation. She said that, when the project started, patients had not been tested (apart from those subjected to the initial tests) nor had they been informed of the availability of tests, to the best of her knowledge, and it was not until a little later on in the project that a decision was made by Drs Forbes and Lowe that the patients should be told that tests were available and that they should be tested.^[317] After the Oral Hearings the Inquiry received more information from Dr Wilkie in a letter dated 7 August 2012. In it she said that she did not start interviewing patients until late summer 1985 and when she did start interviewing, none of the patients had been told their test results. In addition, she was not told of their results until she had completed the interviews.^[318] It seems likely that Dr Wilkie started work on the HIV project in early 1985.

33.213 Gradually, Dr Wilkie's role as a counsellor took over from her role as a researcher. She met patients both individually and with their partners or families. She would discuss the implications of being tested for HTLV-III and there being a positive result as well as the implications of not taking the test. This was done as part of the research interview, prior to testing being carried out.^[319]

33.214 When asked to expand on how an interview would proceed, Dr Wilkie said:

There was a schedule, which I sent in actually, and one would ask them first of all how haemophilia had affected them in their life, what were their fears ....

....

One would discuss the implications if they were tested, the implications for their partner, or partners ....^[320]

Dr Wilkie went on to say:

[O]nce I collected this information I fed this back to Dr Forbes - that these patients had been seen, this is what they knew and then there was a discussion about testing, that this patient was happy to be tested, that patient wasn't .... There were one or two who didn't want immediately to be tested.^[321]

33.215 Asking whether patients wanted to have a test, and counselling them about the implications of being tested, whatever the result, was a vital part of Dr Wilkie's work. If a patient told her that they did not want to be tested she would inform Professor Forbes and that information would go into the patient's notes so that their wishes were known.^[322]

Practice in Glasgow and south west Scotland: Yorkhill

33.216 The position at Yorkhill is unclear. Neither Professor Hann, Head of Department of Haematology 1983-87, nor Dr Pettigrew, a part-time Clinical Assistant in Haematology 1980-89, could recall who organised blood testing there. It was not possible for the Inquiry to ascertain how this testing took place.

Communication of the results of HTLV-III testing

The evidence of patients

33.217 The majority of witnesses who gave statements to the Inquiry did not know that they had been tested and did not consent to being tested for HIV before they were diagnosed with the virus. The patient or relative witnesses who gave evidence about the effects of their own or their relative's infection with HIV told the Inquiry of the circumstances surrounding their own or their relative's diagnosis with HIV. 'Christine' found out that her son 'John' had HIV when she attended a routine clinic appointment at Yorkhill Hospital in about 1984 or 1985.^[323] 'Amy' was told by her son's GP in about 1986 that her son 'Luke' had acquired HIV from a blood transfusion.^[324] Frances' father 'James' was told by Professor Ludlam that he had HIV on 21 December 1984.^[325] Elaine's husband 'Brian' arranged an appointment in December 1986 with the Haematology Department of the RIE so that he, his wife and his son could be tested for the virus. He found out that he had the virus when he returned to the department for the results of these tests that same month.^[326] 'David' was told by Professor Lowe at the Glasgow Royal Infirmary at a specifically arranged appointment on 2 December 1985 that he had acquired HIV.^[327] His diagnosis with HIV is discussed in more detail in paragraph 33.325. 'Mark' did not find out that he had acquired HIV until January 1991 when Professor Ludlam told him at a clinic appointment.^[328] The circumstances surrounding the communication of Mark's test results to him are discussed at paragraphs 33.304 to 33.307. 'Stephen', who was treated for haemophilia at a regional hospital, was told he had acquired HIV by the consultant treating him there in February 1986.

Meeting in November 1984

33.218 On 29 November 1984, a meeting was convened of Scottish Haemophilia Directors, SNBTS representatives and SHHD personnel to discuss the implications of the test results thus far obtained.^[329] It was expected that there would be a UK-wide meeting on 10 December. Professor Ludlam intimated the finding of anti-HTLV positive results in 16 patients treated exclusively with SNBTS Factor VIII concentrate. Professor Forbes described the findings in the Glasgow patients and said that a comparative study of infection in Glasgow and Denmark would soon be published in The Lancet. Professor (then Dr) Brenda Gibson reported that five out of 10 patients already tested at Yorkhill were HTLV-III antibody positive. The minute noted:

Views were exchanged on the very difficult ethical problems which had arisen. These included whether patients and patients' relatives should be informed and perhaps subjected to needless worry; whether publicity additional to that already provided should be given, and how directors should respond to direct enquiries or requests for advice. The chairman [Dr Bell] advised members that ministers had been informed and that SIO had been briefed. While a press statement would not be issued by the Department at present any enquiries would be answered. It was agreed that every effort should be made for patients to have the situation explained to them before the impending publicity.^[330]

33.219 The problem existed in haemophilia centres throughout the UK. On 10 December 1984, as anticipated at the 29 November meeting, there was a meeting of Haemophilia Reference Centre Directors at the BPL, Elstree.^[331] At that stage, testing had not been carried out in every centre. The notes of the meeting record that the chairman, Professor Bloom, said, in summarising the discussion, that testing should be instituted as soon as possible. It was also noted that:

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.^[332]

After further discussion:

It was agreed that haemophiliacs should all be given the same advice with selective advice being given based on the results of HTLV III testing.^[333]

33.220 In his summary, Professor Bloom repeated the view that information on test results should not be given automatically but only if asked for.^[334] It is significant that, at this stage, the Reference Centre Directors did not acknowledge an overriding ethical obligation to inform patients: it was left to the discretion of the individual director.

Meeting of 19 December 1984

Background

33.221 By this time, no steps had been taken in Edinburgh or Glasgow to inform patients who had been tested of their results. On Tuesday 11 December 1984, the day after the meeting, Professor Ludlam received a telephone call from a reporter at The Yorkshire Post.^[335] The reporter appeared to have all the details about what was then known of the seroconversions in Edinburgh. It is not clear how the reporter obtained these details but it appears that they may have been leaked following the meeting of Haemophilia Reference Centre Directors on 10 December.^[336] The reporter wanted to speak to Professor Ludlam about the story and indicated that he intended to publish it. Professor Ludlam agreed to meet with the reporter the following day.^[337]

33.222 On the evening of Tuesday 11 December 1984, Professor Ludlam telephoned Dr Bell at the SHHD. The call was reported in a note by Dr Bell written the next day:

I had phone calls last night from Dr McClelland, Dr Ludlam and Dr Cash (in that order) letting me know that that there is likely to be publicity in the Yorkshire Post, tomorrow, relating to the Edinburgh haemophiliacs with HTLV-III antibodies attributable to contamination of a Scottish batch of factor VIII. It has to be presumed that this has been leaked by one of the English haemophilia directors involved in last Monday's meeting of the UK Haemophilia Reference Centre Directors.

One of Lothian [Health Board's] Press Officers has been in touch with SIO. You may wish to discuss what should be the Department's response to this development. I understand that Dr Cash has also spoken to you direct.^[338]

33.223 On Wednesday 12 December 1984, the reporter travelled to Edinburgh and met Professor Ludlam. Professor Ludlam told the Inquiry that he begged the reporter not to publish the story as he felt it was no way for the patients to find out. He said that the reporter thought it was a scoop and was very keen to publish and that he had to negotiate fairly hard to delay publication for one week to give him time to organise a meeting for the patients. He promised that the information would not go out to any other newspaper in the meantime.^[339]

33.224 Having negotiated the extension, Professor Ludlam telephoned Dr Bell again on 12 December 1984 to inform him of the development. Dr Bell appears to have interpreted the information from Professor Ludlam as an indication that 'the haemophilia consultants' intended to hold a meeting. The second part of Dr Bell's note of 12 December 1984 reads:

Since dictating the above Dr Ludlam has informed me that the Yorkshire Post journalist has agreed to postpone his report until Thursday, 20 December. This will enable the Haemophilia Consultants to call a meeting of haemophilia patients to explain the situation. In view of this development I advise that SHHD should not publicise this matter before the patients themselves have been informed professionally.^[340]

33.225 Professor Ludlam explained that a meeting was called because '[w]e thought this was the quickest and most open way to start to inform the patients' about the situation.^[341] The purpose of the meeting was 'to inform patients that HTLV-III tests had been carried out and that some patients were positive for HTLV-III antibody and to tell patients what we knew about AIDS'.^[342] He acknowledged that such a meeting was not ideal for communicating the test results: 'It's a very public place, a meeting. People might be quite anxious about what was being said, quite concerned, and there is not much privacy in a meeting with lots of other people'.^[343] He told the Inquiry that, had The Yorkshire Post not taken an interest in the story, the meeting would not have taken place at the end of December 1984. Rather, he would have devised another means by which patients would have been informed. He said a meeting 'would not be my first choice, given a completely blank sheet and without other constraints'.^[344]

33.226 By the time The Yorkshire Post contacted Professor Ludlam, he had been in possession of some patients' results for almost two months, the first test results having been received at the latest on 26 October 1984. No steps had been taken to inform the patients prior to contact from The Yorkshire Post. Professor Ludlam told the Inquiry that was because he was still 'assessing the situation'.^[345] Professor Forbes had results from Dr Gallo at the latest in early October, having regard to the time required to prepare and revise the article published in The Lancet in December, but possibly earlier. He too had taken no steps to inform patients, although it appears that he had engaged Dr Wilkie to counsel patients.

The invitation to attend a meeting

33.227 On 12 December 1984, a letter was sent to all patients registered at the Edinburgh Haemophilia Centre. The terms of the letter were as follows:

Dear Patient/Parent

There has been much publicity in the press and television about the HTLV III virus and AIDS. Dr Forbes, Director of the Glasgow Haemophilia Centre, and I are holding a meeting to discuss with patients some of the anxieties and issues that have been raised. You, along with a member of your family are cordially invited to this meeting which will be held in the Large Surgical Theatre, Royal Infirmary, Edinburgh, on Wednesday, 19th December at 7:30pm.

Dr Forbes and I will each speak for a few minutes on AIDS, Haemophilia and Blood Transfusion. We shall then open the meeting for questions and general discussion. If you do not wish, or are unable to attend the meeting, but would like to talk to me, or another member of the Haemophilia team, we should be delighted to see you by appointment with my secretary.^[346]

33.228 Professor Ludlam thought that he had drafted the letter. His understanding was that letters had been sent out from each of the other haemophilia centres - Glasgow Royal Infirmary and Yorkhill in the west of Scotland and Dundee, Aberdeen and Inverness in the east - and that all of the haemophilia patients in Scotland were invited to the meeting. In the case of the east coast Haemophilia Centres, Professor Ludlam thought it likely that he had sent copies to each of the centres, possibly by fax, and asked them to send out something similar. He did not specifically recall doing so but was sure that was the course of action he would have taken.^[347]

33.229 In the case of the GRI, Professor Ludlam told the Inquiry that Professor Forbes would have written to his own patients. Professor Ludlam thought that he would have given Professor Forbes details of the venue and left the rest to him.^[348] Professor Ludlam could not say with any certainty that there were any Glasgow patients at the meeting. He told the Inquiry that there were quite a lot of people that he did not recognise at the meeting and he assumed that they had come from Glasgow or somewhere else in Scotland. By a process of elimination he concluded that patients from outwith Edinburgh had attended the meeting.^[349]

33.230 Professor Forbes said in his statement that he thought that the meeting was held to inform a group of patients from Edinburgh about what was happening with the virus and the implications thereof.^[350]

33.231 Professor Hann and Dr Pettigrew from Yorkhill Hospital were asked if they recalled sending invitations to the meeting to the parents of their patients. Professor Hann had no recollection of the meeting being held and did not remember being asked to write to any of the parents of his patients inviting them to the meeting.^[351] Dr Pettigrew also had no recollection of the meeting in Edinburgh, although she thought that a meeting had been held at the Glasgow Royal Infirmary to inform haemophilia patients about the situation regarding the transmission of AIDS through blood products.^[352]

33.232 The evidence of events at this crucial period is again confused. Professor Ludlam remembers the meeting as a joint arrangement, involving Professor Forbes and himself among others informing Scottish patients of the outcome of investigations to date. Professor Forbes remembered it as an Edinburgh exercise, in relation to which he was 'neutral'. None of the evidence heard by the Inquiry would have suggested that Professor Ludlam had been alerted to any preparations Professor Forbes already had in hand for dealing with his own infected patients.

33.233 The meeting was held in the large surgical lecture theatre at the RIE. It started at 7:30pm and ran for about an hour to an hour and a half.^[353] The Inquiry has been unable to establish even an approximate number of patients and relatives who attended the meeting because there is some discrepancy in the evidence. It is clear, however, that fewer people attended than Professor Ludlam had anticipated. Professor Ludlam said:

I thought a lot of people might come. As you know, there are about 400 people with haemophilia in Scotland and if each brought a friend, relative or spouse, that was potentially 800 people ....

I had reserved two large lecture theatres, anticipating that we might get a large number of people and if we had have done so, Dr Forbes would have spoken in one and I would have spoken in the other, and Dr McClelland would have spoken in both ....

But we had a smaller number. So they all fitted into the large surgical lecture theatre in the Royal Infirmary.^[354]

33.234 He said that he, Professor Forbes and Dr McClelland all spoke at the meeting.^[355] Mrs Geraldine Brown, a social worker, also attended the meeting in a listening capacity and did not speak.^[356] Professor Ludlam thought that there were between 30 and 40 people there.^[357] Mrs Brown thought that there were between 50 and 100 people there.^[358] Professor Forbes thought that there were around 20 people at the meeting but could not be sure.^[359] Dr McClelland could not recall how many people had attended the meeting.^[360] The attendees were spread out, with pairs and small groups of people sitting together and some people sitting alone.^[361] The group of patients and their families was, in any event, much smaller than Professor Ludlam had anticipated on his approach to it as a Scotland-wide exercise.

Order of speakers at the meeting

33.235 On 10 January 2012, the Inquiry obtained a statement from the wife of a haemophilia patient who was given the pseudonym 'Witness A'.^[362] She attended the meeting and took handwritten notes which have been provided to the Inquiry.^[363] In her statement she explained that she was accustomed to taking notes during meetings as a result of her work. The notes taken by Witness A indicate that Professor Forbes spoke first followed by Professor Ludlam. Dr McClelland is not mentioned in the notes, although it is clear from his own evidence and the contemporaneous newspaper reports that he did speak. The notes run to four pages and it appears that Dr McClelland's contribution is recorded at some point on pages three and/or four. It is not possible to be certain where it begins or ends.

What was said at the meeting

33.236 The Inquiry was fortunate to receive these contemporaneous notes of the meeting. They represent the most reliable evidence of statements made, although there will be omissions from the witness's record. It may even be that, as the wife of an Edinburgh patient, she did not record statements relating only to Glasgow. The Inquiry cannot know. From Witness A's notes, Professor Forbes appears to have spoken about the number of people infected in the UK and worldwide, the immune function studies ('tested when visiting hospital'), and the helper cell depletions and skin tests carried out by haemophilia centres. He referred to the fact that further investigation of supposed immune deficiency would be carried out on asymptomatic patients.^[364]

33.237 From the notes taken by Witness A, Professor Ludlam appears to have told the meeting that heat treating Factor VIII killed the virus and that the virus could be transmitted by semen, needle stick injuries, blood, or dental treatment.^[365]

33.238 He also made a number of recommendations for patients and their families:

1) Make up own & administer own factor VIII

IX

2) If not family wear gloves and aprons

3) Cinbins [for disposal of needles and other equipment]

4) Protective sheaths

5) Close members of family don't give blood^[366]

33.239 On the third page of her notes, Witness A has noted that the following was said:

1) [he was] prepared to inform if have antibody

2) Not having the antibody does not mean you have not been exposed to the virus 3-4 years for implications of antibody to become known^[367]

33.240 The notes continue as follows:

Link HTLV3 & AIDS does not mean

cause & effect

State of ignorance - Research going

very fast

Cryoprecipitate made from smaller pool

but not as effective

Virus easy to kill

Genetic engineering of factor VIII

far away yet - not made from

plasma from Gene therefore No chance of getting any virus

90% USA antibody

33% England

<10% Scotland^[368]

From the references to the future of haemophilia therapy and to rates of infection, it appears reasonable to deduce that all of the above represents Professor Ludlam's contribution.

33.241 On the final page, the following is recorded:

Science Correspondent - Observer & Times

fact sheet being sent out to all Haemophiliacs

Batches 1 or several batches

half developed antibody

What are your plans for heat treating

factor IX - technically more difficult

1/3 less patients get HTLV3 antibody

BTS procedure - less likely to be with factor IX

Mild Mod Haem A treat DDAVP

Live Virus HTLV3 used to test for Antibody

younger shorter incubation

older months - years

Saliva - Very late stages of disease

Not transmitted readily^[369]

From the references to heat treating, it is possible that these remarks were made by Dr McClelland but it is not possible to be sure. The Inquiry also heard evidence from Professors Forbes and Ludlam, and Dr McClelland about their recollection of the meeting.

Professor Forbes

33.242 Professor Forbes found it very difficult to recall any details of the meeting. He had 'a major blank' in parts of his recollection.^[370]

33.243 Professor Ludlam admitted that he could not actually recall the detail of what Professor Forbes had said.^[371] He thought it likely that Professor Forbes would have told the meeting some of the background to HTLV-III (ie that a probable virus that caused AIDS had been identified) and explained that a new test for HTLV-III antibody had been developed and that samples from patients in both Edinburgh and Glasgow had been tested and found to be antibody positive.^[372] Professor Ludlam thought that Professor Forbes would then have talked about the findings in Glasgow and that he would have talked about his findings in Edinburgh.^[373]

33.244 Professor Ludlam thought that Professor Forbes would have explained what was known about the implications of being antibody positive and what the chance was of developing AIDS. At that time it was thought that the risk of progression to AIDS was in the order of one in 500 or one in 1000. One of the important messages that they were trying to convey at the meeting was that patients' sexual partners could be at risk and that all patients should use condoms during sexual intercourse. Professor Ludlam thought it likely that Professor Forbes had addressed this issue. Professor Ludlam's recollection was that Professor Forbes dealt with the generalities of anti-HTLV-III testing and positivity.^[374]

Professor Ludlam

33.245 Professor Ludlam thought that he would have spoken for approximately ten minutes. He did not speak from a prepared script or notes.^[375] He told the Inquiry that he would have addressed what had been happening in Edinburgh: that blood samples from patients in Edinburgh had been tested for HTLV-III antibody by Professor Tedder and that some samples had tested positive. He thought that he would also have told the meeting that it appeared that a single batch of Factor VIII was responsible for the infections in Edinburgh but that other people might also be antibody positive:

It was a time of great uncertainly and we were very careful also to convey the message that if you were antibody negative, you weren't necessarily free of HTLV-III infection, and so the advice was for everybody to consider they might be infectious, everyone with haemophilia might be infectious, and ... the safety advice applied not only to the possibility of sexual transmission but if there was spillage of blood, it should be cleaned up carefully with gloves on and using dilute bleach to sterilise the surface.^[376]

33.246 Professor Ludlam said:

[T]he very clear message given out was that we hoped that patients would come and see us and ask about their situation. We were keen to discuss it with people individually. That was not just the people who were HIV positive. They didn't know who they were. We were keen to see everybody.^[377]

33.247 He said that he was keen for people to make appointments to see him to discuss whether there was an anti-HTLV-III result for them and whether they would like to know the result. He recalled telling the meeting that he would give patients their results if they wanted to know.^[378] He could not recall, but thought it likely that he would have told the meeting how many patients had tested positive for the antibody. He said that he and his colleagues were there to give out any information they had and, as there was a number available, he would have said something like: 'So far it looks like there were 15 or 16 people' who had antibody to the virus and that it had arisen from Scottish product.^[379]

Dr McClelland

33.248 Dr McClelland told the Inquiry that the purpose of his attendance at the meeting was twofold. In the first instance he was there in a very specific capacity as representing the organisation which had manufactured the product believed to have been the source of infection, the SNBTS. There was also a general knowledge element to his presence at the meeting: by the time of the meeting he had been actively involved in work around AIDS and was relatively well informed about AIDS generally and the issues surrounding the interpretation of HTLV-III tests results.^[380]

33.249 Dr McClelland could not recall what he spoke about at the meeting, although he thought it likely that he would have spoken in terms comparable to patient information leaflets about what he understood at the time from his own knowledge of the situation.^[381] He referred to an article in The Edinburgh Evening News on 21 December 1984^[382] and confirmed that the information contained in that article was the sort of information that he would have given in respect of what was understood at the time about the nature of the virus, the nature of the test and the likely prognosis for people who were found to be antibody positive. He thought that he would also have told the meeting about the measures that the SNBTS, as a manufacturer, was taking to try to minimise future risks in terms of donor selection and plans to introduce routine donor testing.

Question and answer session

33.250 After Dr McClelland had finished speaking, Professor Ludlam's recollection was that Professor Forbes as the chairman invited questions and Professor Ludlam, Professor Forbes and Dr McClelland answered them depending on what the questions were. The question and answer session went on until all the questions were exhausted - perhaps half an hour or three-quarters of an hour.^[383]

33.251 Dr McClelland also recalled the question and answer session at the end of the meeting:

[T]here were some questions from patients. I think they were probably fairly muted because I think they were probably in a state of shock and having considerable difficulty in orientating themselves. Partly because of the nature of the information, partly because it was a very strange spot. It was a very strange situation altogether. So I think it would have been very difficult for patients to really absorb what was happening at that time.^[384]

33.252 Professor Ludlam and Mrs Brown described a feeling of dismay among the patients. Professor Ludlam told the Inquiry that there was 'surprise and I think some dismay' that individuals who had been treated exclusively with SNBTS product appeared to have been exposed to the virus.^[385]

Dr Alison Richardson's evidence

33.253 Dr Alison Richardson, Clinical Psychologist, began seeing haemophilia patients from 1988 onwards. In her statement to the Inquiry she said:

Most of the patients I subsequently saw, after being referred to me by Dr Ludlam, recall being asked to come to an urgent meeting with Dr Ludlam. I am not exactly sure when this meeting was but I presume it was after these blood test results came back in about 1985. I think Dr Ludlam invited all the patients with haemophilia and not just those who were infected with HIV. Dr Ludlam wanted to warn them about HIV in the blood supply. I think that Dr Ludlam intended to persuade all the people with haemophilia to have a test for HIV. I was not present at that meeting, since this was before I had taken up my post. From what I have heard from the patients I spoke to subsequently, Dr Ludlam told them that some people with haemophilia in Scotland were infected with HIV. Two of my patients said that they were told at the meeting to use condoms when having sexual intercourse with their wives. From what I have heard from these two patients, the general feeling leaving that meeting was 'well, thank goodness, I don't have it, because if I had, he would have told me'. So, they left the meeting thinking that they did not have HIV.^[386]

33.254 In fact, these were two patients who had tested positive. Professor Ludlam was referred to this section of Dr Richardson's statement and was asked whether he would accept that these two patients did not appear to have received the message that they might be positive. He said:

They have not synthesised the information that was available to them, in that they ... would like to believe that they were in the larger group, who were anti HTLV-III negative.^[387]

33.255 Professor Ludlam told the Inquiry that he was clear that the message that he had given at the meeting was: 'you might be positive'.^[388] He said that he had emphasised that, if patients wished to know their test results, they were to contact their haemophilia consultant to discuss their individual situations.^[389] He said that the other side of that was that the majority of patients were in fact negative. As the majority of people had tested negative, Professor Ludlam believed that this may have influenced how attendees at the meeting assessed their own situation:

So there were a lot of people who were negative and more people actually who were negative than positive. So a patient might have gone away with the message, "Oh, well, I'm likely - because there were more people negative than positive, I'm likely to be one of the lucky ones." It's how one accepts bad news. We always like to think, to begin with, that we are on the winning side, if I can put it that way.^[390]

33.256 It was suggested to Professor Ludlam that the fact that patients were at risk didn't appear to have been effectively communicated to the patients. Professor Ludlam replied:

I would see it differently. They went away appreciating the need to use condoms. So they must have picked up that there was a possibility that they had got HIV or HTLV-III. That was why we were saying, "You have to use condoms" ....

I appreciate that they may not have seen it that way.^[391]

33.257 Professor Ludlam noted that patients were given condoms when collecting their concentrates from the Haemophilia Centre and that additional supplies, in plain paper bags, were placed on a shelf in the waiting room for patients to help themselves to.^[392]

Mrs Geraldine Brown's evidence

33.258 Mrs Brown told the Inquiry that, on the basis of what she recalled of the meeting, it would have been clear to anyone who attended that there was a group of patients infected in Edinburgh, that they might be a member of that group and that if they wished clarification of that, to know whether they were in the infected group and had tested positive, they had to approach Professor Ludlam and ask.^[393]

33.259 It was suggested to Mrs Brown that there were people at that meeting who did not appreciate that they would only be told their test results if they asked for them. In response to that, Mrs Brown said:

I think giving information to people of this kind, people who are in this situation, it can't just be a one-off thing. I think all sorts of things interfere with the way people process the information that you give them, which is why it was really important to have written information after the meeting, which people could read at their leisure and refer to ....

[I]t is difficult to give people information about such issues. I was ... a disinterested observer in the sense I wasn't personally involved. For me the information was quite clear but I can see that for other people perhaps it wasn't.^[394]

33.260 The Yorkshire Post published its article on Thursday 20 December 1984. In relation to the situation in Edinburgh it stated:

Dr Christopher Ludlam, a consultant haematologist and director of the haemophilia centre at Edinburgh Royal Infirmary, admitted yesterday that antibodies to the suspected AIDS virus had been found recently in 16 of his patients who were receiving only the NHS material. He told the Yorkshire Post:

'We picked up the HTLV 3 antibodies as part of a research project. We had hoped they would not be there. What this means is that these patients have been exposed to the virus.

We know it was not from an American blood product - because all these patients have been treated only with Scottish Factor 8. They may or may not still have the virus - it is something we cannot tell.

This amounts to evidence that the material in Scotland has been contaminated with HTLV 3 and this must have come from a donor or donors who have the virus.

I can categorically say that to date there have been no cases of AIDS in Scotland attributable to Scottish Factor 8. My patients are all clinically well at the moment.

On present evidence it would appear that although AIDS may be caused by HTLV 3 only a small percentage of people who become infected actually develop the disease'.^[395]

33.261 The article went on to say:

News of the positive testing was broken to haemophiliacs from Edinburgh and Glasgow at a meeting last night. They were told collectively that some of them were carrying AIDS antibodies.

Dr Ludlam said: 'If individual patients want to know where they stand I shall tell them'.

Patients were strongly advised that from now on they should wear contraceptive sheaths during intercourse to protect their partners from danger.

They were also urged to take every precaution when making up their Factor 8 for home injections, and disposing of needles, syringes and plastic gloves.^[396]

Follow-up in Edinburgh

33.262 Following the meeting Professor Ludlam wrote to Dr McClelland about the need for precautions, in a letter dated 31 December 1984:

Dear Brian

Thank you for your letter of 12 December concerning our recent discussions about the desirability of close family members of haemophiliacs not donating blood.

As we agreed in our discussion it would be better to disseminate this information in the haemophiliac community by our existing lines of communication, rather than add these potentially high risk donors to your 'formal' list as published by the SNBTS. At the meeting of haemophiliacs on 19 December, at which you were present, this point was made clear. To make sure that the wider haemophiliac community is made aware that they should not be blood donors, we are arranging for a circular to be sent to every patient with moderate and severe haemophilia A and B.

I hope this will prevent any further donations within the Edinburgh and Glasgow areas. We are planning to send the circular to the other three East Coast Haemophilia Centres asking them to distribute it amongst their patients.^[397]

33.263 Professor Ludlam also arranged for an advice sheet for adult patients and their families to be circulated.^[398] It was sent to all patients on the Edinburgh Haemophilia Centre Register (around 170 patients) regardless of whether or not they had already been tested.^[399] Paragraph 7(d) states: 'All relatives living in the same house with the family should refrain from giving blood. This is a simple precaution only'.^[400] Professor Ludlam told the Inquiry that the circular was prepared in conjunction with Professor Forbes and was intended to be sent to all haemophilia patients in Scotland.^[401] It is clear from the letter to Dr McClelland of 31 December 1984 that Professor Ludlam intended to send the circular to the other three east coast Haemophilia Centres.

33.264 In the end, the circular was not sent to patients at the GRI. Rather, Professor Forbes seems to have incorporated parts of it into a letter which he sent to his patients on 8 January 1985, discussed below.^[402]

33.265 It is not clear exactly when the circular was sent out to Edinburgh patients as the document is undated. Professor Ludlam thought that it was probably sent out on 31 January 1985,^[403] the same date on which letters were sent to GPs.^[404] He had a recollection of all the information being sent at once. He also thought it unlikely that he would have written to the patients without first informing their GPs of that fact as he considered it only fair to make sure that GPs were forewarned before patients began going to see them. GPs were not sent a copy of the circular unless requested.^[405] They were not given their patients' test results in these letters.^[406]

33.266 Professor Ludlam thought that the circular would have been sent out with a covering letter, although the Inquiry has been unable to locate a copy of such a letter. When asked for his recollection of what was in the covering letter, Professor Ludlam told the Inquiry that he thought that it would have referred to the meeting and would have said that the circular was being sent out to convey important information about AIDS to patients who had not attended the meeting. He thought that it would have mentioned that some patients had tested positive for HTLV-III in Scotland but that not all patients had been tested and that if patients would like to know the results of their test (which may or may not be available) they should make an appointment to see Professor Ludlam or to discuss the situation with Geraldine Brown.^[407]

33.267 Professor Ludlam thought that the circular, and in particular paragraph 6, combined with what was in his covering letter, was enough to get the message across to patients that they might be positive.^[408] Paragraph 6 stated:

6. What is the virus?

The virus probably responsible is called Human T-cell Lymphotropic Virus (HTLV III). Its main action is to reduce the effectiveness of a particular cell (T4 cells) in the immune process. Exposure to the virus results in the body making an antibody (HTLV III Ab) to the virus protein and this is now used as a marker of exposure to the virus. These tests are now available and will be carried out on your routine visits to your centre. About half the patients in England and about ten per cent in Scotland have had exposure and are HTLV III Ab-positive.^[409]

33.268 When asked why he did not make the letter more explicit, Professor Ludlam said:

I would have an obligation to inform patients of their antibody result if it was going to make a difference to either the way they lived or treatment that might be available for them. And at that time there was unfortunately no treatment available and there were some patients who clearly didn't want to know, and so, as there was no, in a sense, material gain from knowing, then it was a patient's prerogative not to know.^[410]

33.269 When asked why he did not simply inform all of his patients of their test results, Professor Ludlam explained that it took some time for clinicians themselves to come to terms with the results. That patients had been exposed to the virus was 'a surprise and a shock'. He added that it might have been the case that some patients would not have wanted to know their results and that, following the distribution of the circular, some patients were indeed 'hesitant' about knowing their results. In addition, there was already a great deal of stigma surrounding AIDS and Professor Ludlam believed that patients would have to consider that when deciding whether or not to obtain the results of their tests.^[411]

Communication of results

33.270 Professor Ludlam thought that it was the beginning of January 1985 before patients began contacting him asking for their results. He described it as an 'ad hoc, unstructured arrangement'. Sometimes patients would come to the clinic for other reasons, for example to collect home treatment, and would ask the nurse if he was available to see them. At other times the patient would come to the clinic and the nurse might initiate a meeting by asking if the patient wanted to see Professor Ludlam.^[412] Professor Ludlam told the Inquiry that the physical arrangements at the haemophilia centre at that time were unsatisfactory in terms of conveying results:

It's a time when we were very short of clinic space .... [A]t that time we had a single room with a small partitioned area off in one of the wards which we called our "haemophilia centre", which was for the treatment of acute bleeds, basically.

The patients were seen for their routine reviews in the general medical outpatient department. So I did not have anywhere else to see people with some degree of privacy, and I remember having to borrow rooms in one or two of the other wards [and having] to find out where there was a free room to see someone.

So it was unsatisfactory but I wanted to give the patients a bit of space and time and have a bit of privacy. The facility we had in ward 23, the partition wall between the waiting area and the tiny clinic room, was thin and I don't think there was even room to sit down actually in this little room. We had a couch and a filing cabinet. So I had to find other space. So it was not satisfactory but I had to make do.^[413]

33.271 He said that whether or not he initiated discussion about AIDS with patients attending clinics or encouraged them to ask for their results depended on why he was seeing them in the clinic. If patients came to the clinic with a specific medical issue that needed to be addressed (such as a bleed or a medical problem that required investigation) he would concentrate on that issue because that was what the patient had come for. He said that he would not have raised the topic of AIDS with patients in these circumstances because he felt that it would have been confusing for them.^[414]

33.272 If patients came to the clinic for a routine review appointment and he was having a more general discussion about their health (for example, how they were feeling, whether their clotting factor was working properly, whether they had been off work due to bad bleeds, etc) then he might have asked, as part of that general discussion, what the patient knew, if anything, about AIDS and taken it from there.^[415]

33.273 Professor Ludlam explained that he would not discuss AIDS if the patient had some other preoccupation. At a routine review without any other immediate concerns he would think about raising it with the patient but would not necessarily do so even then.^[416] He said that he would raise the matter if he 'thought it appropriate'. He told the Inquiry:

I raised the topic with patients when they came for review, not all patients, not all the time but some of them some of the time.^[417]

33.274 Subsequently, large-scale local testing for HIV was instituted from early in 1985. This is discussed separately below.

Follow-up in Glasgow

33.275 As noted above, Professor Ludlam's circular was not sent to patients at the GRI. Instead, a letter, signed by Professor Forbes and Professor Lowe and dated 8 January 1985, was sent to all patients registered at the West of Scotland Haemophilia Centre.^[418] Professor Lowe described the letter as an 'update' for patients in light of recent developments. He explained that the purpose of the letter was, firstly, to inform patients that there was an apparent HIV problem in the Scottish haemophilia population and, secondly, to invite them to the Haemophilia Centre to discuss the matter with one of the doctors who would then, after obtaining consent, take a fresh blood sample which could be tested for HIV. He did not think that the purpose of the letter was to invite patients to the Haemophilia Centre for Professor Forbes to give them the results of the Gallo research study tests.^[419]

33.276 The letter began by setting out the material background:

As you may know, there has been recent publicity in the newspapers and television concerning an increased risk of the disease known as Acquired Immune Deficiency Syndrome (AIDS) in haemophiliacs who have received treatment with clotting factor concentrates.

....

We do not yet have a blood test for the virus particle, but hope to have this within the next few months. However, we and other haemophilia centres do now have a blood test for antibody to the virus. If this antibody test is positive, this means that the person has been exposed at some time to virus particles. A positive test does not mean that the person will develop AIDS. Recent studies in England have found that about half of regularly treated haemophiliacs have positive antibody tests. We have recently tested stored blood samples from many of our patients, of whom about 10% have positive antibody tests.^[420]

33.277 The letter then set out what was to happen next:

Firstly, we enclose an appointment to see you. It is important that we take a blood sample from you for the virus tests, so that we can monitor virus exposure in all our patients who have received factor concentrates. We would also like to perform some skin tests which measure the body's defences against infections. At the same time we will be very happy to give further information and to answer any questions you may have about the virus and the tests.^[421]

33.278 Patients were advised that, if the enclosed appointment was unsuitable, they should contact the haemophilia Sister for an alternative appointment.

Communication of results

33.279 Professor Forbes said that his Haemophilia Centre 'always had a very open policy'^[422] and that he took the view that his patients should be told about their test results: 'we made a firm decision that we would tell the patients what had been found in the various tests that were done and the implications thereof'.^[423] His recollection was that patients were told as soon as practicable: 'we told them as soon as possible and we in fact had to make appointments for many of them especially and bring them in to tell them'.^[424] With regard to the initial Gallo tests he stated that the 12 patients who had already tested positive were informed of their primary test results before confirmatory testing by Dr Edward Follett.^[425]

33.280 Professor Lowe recalled that at the time the draft manuscript of the December article in The Lancet (with the results of the 12 positive tests) was being discussed, probably around September or October 1984, Professor Forbes said that he would see the patients with positive test results and arrange counselling. Professor Lowe stated that he had 'absolutely no reason' to believe that Professor Forbes did not do so.^[426] He described Professor Forbes as 'an extremely open person' who would spend hours with his patients discussing all manner of things and that he could not think of any reason why Professor Forbes would not have been open and honest with patients.^[427] Professor Lowe was not involved in communicating the Gallo test results, however, as Professor Forbes felt strongly that, as the Consultant, it was for him to speak to the patients and tell them about the situation.^[428]

33.281 Professor Lowe thought that Professor Forbes had some reservations about the reliability of the Gallo test because it was a research assay and had not yet been licensed for clinical use. He recalled that Professor Forbes thought that the best thing to do was to set up properly approved tests with Dr Follett at the local regional virus laboratory, inform the initial 12 positives of their (provisional, at that stage) results, offer them counselling and arrange for further, confirmatory testing when that became available. Professor Lowe thought that it was around this time that Dr Wilkie was appointed.^[429]

33.282 It is clear that by October 1984, well before the meeting in Edinburgh in December 1984, Professor Forbes had initial positive results on 12 of his patients. It is likely that by then he had made at least preliminary arrangements with Dr Wilkie for counselling patients testing positive for HTLV-III. Professor Forbes was asked whether he knew that he had 12 patients who had tested positive at the time he appointed Dr Wilkie. He replied:

I'm not sure. I don't remember the chronology of that but I knew that it was going to come that this epidemic would happen in Scottish haemophiliacs, as it did.^[430]

33.283 On Dr Wilkie's evidence Professor Forbes did know that some of his patients were infected when he approached her.

33.284 The letter of 8 January 1985 indicated that stored blood samples had already been tested, with about 10% antibody positive results (paragraph 33.276 above). To some extent - which cannot be quantified - patients' blood samples were also being tested in Dr Follett's laboratory in January 1985, before the development of a routine requiring prior counselling and consent. The way in which these samples were sent to Dr Follett can only be characterised from the patient's point of view as clandestine.

33.285 Equally, there is no reliable evidence that the results of the series of tests performed by Gallo, which from the patient's point of view were also clearly clandestine, were ever communicated to the patients involved. How far the knowledge of the Gallo results was known within the GRI is not clear. From Professor Lowe's evidence it appears that circulation of the information was limited, but Professor Forbes clearly knew who had been tested and what the individual results were. In the circumstances, the point of the reference in the letter dated 8 January to recent studies in England showing that about half of regularly treated haemophilia patients had positive antibody tests is not obvious. Indicating that a lower proportion of Glasgow patients was infected minimised the serious implications for the 10% of local patients who had positive antibody tests.^[431]

33.286 Communication of the results of the Gallo test series, available in October 1984, was left in the hands of Professor Forbes. Unfortunately, and as he was well aware, his recollection of the Gallo tests and matters related to them is not good. It seems likely, despite his recollection, that he did not pass the Gallo results on to the patients tested. Professor Lowe mentioned Professor Forbes' reservations about the accuracy of the Gallo tests as it was a research assay, and not yet licensed for clinical use. Dr Froebel also remarked on Professor Forbes' reservations due to the Gallo test's unregulated state. Given the life-changing effects of testing, whether the results were positive or negative, Professor Forbes might well have considered that confirmation of the Gallo tests was required prior to passing on any information to patients about their positive or negative status. His foresight in employing Dr Wilkie as an HIV/AIDS counsellor (his unit being the first in Scotland to do so) suggests that he was sensitive to the extensive ramifications of testing and, in particular, a positive diagnosis.

Local testing

Edinburgh

1985

33.287 Very early in 1985 it became clear that anti-HTLV-III testing would have to be set up in many centres in the country. Dr John Peutherer, a virologist with whom Professor Ludlam had worked previously, made enquiries about setting up HTLV-III antibody testing in Edinburgh. Professor Ludlam thought that by the spring of 1985 a number of different commercial kits were under evaluation.^[432]

33.288 Local testing was available by the spring of 1985 and was carried out by Dr Peutherer. Professor Ludlam said that patient consent was obtained prior to all local testing if a fresh blood sample was taken.^[433] He recalled that most of the patients tested were found to be HTLV-III antibody negative, with between five and 10 found to be antibody-positive.^[434]

33.289 Professor Ludlam also thought that he would probably have sent additional stored samples from those people who had already been tested by Professor Tedder, to confirm the initial result and, for those who had tested positive, to determine their date of seroconversion. He thought that this confirmatory testing had been carried out by Dr Peutherer on all of the results received from Professor Tedder. It appears, therefore, that so far as the original group is concerned (the 50-70 patients who had been tested without their consent), there may have been repeat testing by Dr Peutherer in 1985 by reference to archived material. Professor Ludlam thought that this was probably also done without their consent: the procedure continued under the original regime. He did not think that there was any other testing of patients without consent.^[435]

33.290 Local testing opened up the opportunity for many more individuals to be tested, not just people with haemophilia. The AIDS advisory committee in Edinburgh was established at Professor Ludlam's suggestion and held its first meeting on 19 December 1984.^[436] Dr Peutherer told the Inquiry that subsequent testing for HTLV-III infection started in 1985 once commercial tests became available. Professor Ludlam did not carry out any HTLV-III testing in his laboratory. All testing for patients from the RIE was carried out by the Hepatitis and HTLV-III/HIV Reference Laboratory within the University of Edinburgh's virus diagnostic service. The tests used were purchased from several companies, including Abbott, Wellcome and Ortho.^[437]

33.291 Professor Ludlam said that early in 1985, when testing became more generally available, there were calls from many different people - particularly surgeons - for screening of all patients. The difficulties around this issue and also, for example, enquiries from insurance companies wanting to know whether someone had been tested, grew very rapidly through 1985 and led to thinking about what is now called pre-test counselling. The whole complexion of testing changed.^[438] In 1985 Professor Ludlam drew up some guidelines for testing.^[439] He explained:

These were fairly primitive guidelines that - I think they must have been written in 1985, probably the end of 1985, because if I remember correctly ... they don't give a definitive view about the significance of being anti HTLV-III positive.^[440]

33.292 Professor Ludlam thought that he had drafted the guidelines after discussion with colleagues. He said that they were primarily for staff use and were a way of focussing the minds of staff members on the important things to think about:

[T]his evolved, if you like, out of ... our realisation that it was appropriate to get consent and to think about ... whether people want[ed] to know about positive results or ... want[ed] to be tested ....

So the degree of pre-test counselling ... evolved during 1985.^[441]

Discussions with Mrs Geraldine Brown

33.293 Mrs Brown told the Inquiry that she began working at the Edinburgh Haemophilia Centre in about December 1984 and started seeing patients very shortly thereafter, in January or February 1985.^[442] She noted that, at that time, there was no physical haemophilia centre in the way that there is now.^[443] Rather, in-patients were seen on the ward and out-patients were seen in the medical out-patients department or in doctors' offices. Mrs Brown told the Inquiry that the arrangement in early 1985 was that she would go to the medical out-patients department and meet with patients after they had been seen at the clinic to introduce herself. If patients were on the ward having treatment she would also go along and introduce herself there. She said that Professor Ludlam also made patients aware that a new social worker was attached to the unit and that she was available to see patients.^[444]

33.294 Mrs Brown told the Inquiry that she often spoke to patients about whether they should ask for their tests results and what the implications were prior to them making a decision. She described some of the difficulties regarding this to the Inquiry:

It was a very different atmosphere then in terms of knowledge and patients were very aware that they were identifiable as a group, haemophiliacs were identifiable as a group ... that they were already seen in the community as people who were potentially infected with HIV.

There was concern [that] the fact that someone ... had been infected with HIV [would interfere with the] provision of services to them ... on a financial level, insurance companies' questions, mortgage lenders' questions. There were concerns about discrimination in terms of the provision of medical services. There was concern that surgeons wouldn't operate on them if they were known to be HIV [positive]. There was a kind of feeling around at the time of this great anxiety about what would happen if people knew you were HIV positive.

There was also, of course, an acknowledgement that there wasn't really any treatment going to be available to patients. So knowing that they were HIV positive, it wasn't like getting another medical diagnosis which would immediately throw in a treatment programme, because at that point there wasn't really anything being offered in terms of treatment, although anyone who was infected with HIV would benefit from being followed up medically. The haemophiliacs were being followed up anyway because they were being seen regularly at the hospital. So people were weighing up the pros and cons really of knowing that they were infected with HIV.

And also, I think, for some people - I think the way you deal with significant medical information about yourself sometimes is you don't want to know. You might just put it aside and prefer to carry on ... as you are.

So people had lots of issues that they discussed really prior to asking for the information.^[445]

33.295 Mrs Brown said that patients began to ask for (and were told) their HIV status during the first three months of 1985. It was a gradual process after that with more and more people asking for their results during the course of the year. She thought that by the end of 1985 most patients would have known their HIV status but that there were one or two patients who had not asked for their results.^[446] She said:

I think the point to emphasise is that if people did not know they were infected, it was because they didn't ask. I think it was quite clear to people from the start that this information was available to them and they could have it and I think that in a sense the ball was in their hands, when they were told that a group had been infected. It was quite clear that they did need to make the approach and discuss it.^[447]

33.296 Professor Ludlam also thought that the vast majority of his patients were aware of their HTLV-III status by the end of 1985. This included patients who had tested positive and patients who had tested negative. His recollection was that by the end of 1985 there was only a small handful of patients who were known to be anti-HTLV-III positive and who did not know their results. He thought that by the end of 1985 probably only around three to five patients would not have known their HTLV-III status.^[448]

33.297 Those who did not know their results by the end of 1985 fell into two categories: (i) those who were adamant that they did not want to know and (ii) those who did not appreciate that they needed to ask for their results. Professor Ludlam said that he could think of only two individuals in the second category and one individual (the witness pseudonymised as 'Mark', discussed below at paragraph 33.304) who expressly said that he did not want to know.^[449]

1986

33.298 Professor Ludlam said that in late 1985 and early 1986 the picture was gradually evolving. By that time it was becoming clearer, firstly, that patients who tested positive for antibodies to HTLV-III probably harboured the virus and, secondly, that the risk of progression to AIDS in patients who were HTLV-III positive was greater than the original estimate of one in 500 or one in 1000. There was greater confidence about what an anti-HTLV-III positive result meant, and conversely there was a bit more confidence that those who were anti-HTLV-III negative did not have the virus.^[450] For those who had tested positive, emerging data also suggested the course of the disease might be worse than had previously been thought:

[T]he significance in terms of their prognosis was beginning to look a bit worse. There was still no treatment or no prophylaxis at this stage, nothing that could be done, in a sense, medically to improve their prospects.^[451]

33.299 Professor Ludlam knew the identities of those patients who were HTLV-III antibody positive but who had not received their results at the end of 1985.^[452] Weekly multi-disciplinary meetings were held where individual patients were discussed. The meetings were attended by a core group of Professor Ludlam and his registrar; Dr George Masterton, a psychiatrist; Michelle Jones, the Haemophilia Sister; Billie Reynolds, the Staff Nurse; and Geraldine Brown. Professor Ludlam stated:

This was ... a fairly quiescent period at one level because patients were all feeling well. It was a sort of phoney war time, if I can put it that way. All the patients were well and we discussed each week who we had seen, exchanged information that seemed relevant and increasingly worried about the small number of people who ... had tested positive and didn't know.^[453]

33.300 Although the group appears to have been discussing patients who did not know their results during this time, no positive steps were taken to inform those patients. Professor Ludlam told the Inquiry that this approach, of not insisting that patients know their results, did not change at this time.^[454]

33.301 The feeling of the group was that those patients who had not asked for their test results did not want to know them:

[T]here was the feeling that ... maybe patients didn't want to know. Maybe once they know they are antibody positive, there is no going back, and if you don't know, then you can believe that you are negative .... It was a very new situation for us and we wanted to be sensitive to the patients because once you have told someone, you can't untell them.^[455]

1987

33.302 Professor Ludlam said that his approach of not insisting that patients knew their results changed around the end of 1986/beginning of 1987. As he explained:

[A]t that point ... the possibility of treatment with Zidovudine was being talked about. There was the possibility of prophylaxis against pneumocystis, the awful pentamidine inhalations. At that time ... one or two patients were starting to become clinically unwell, I assume because of the virus.

So a time came when I felt that it really was in the medical interests of the patients to tell them ....

[I]t was a balance and I thought it was becoming more in their interests, medical interests, to know.^[456]

33.303 He began asking patients to come in and see him. He could not recall how strongly he would have put it or how insistent he might have been, but he said that he would have made it very clear that he thought there were good reasons for patients to know their status and that he would like to tell them. He told the Inquiry that he either wrote to them or someone would ring them up and ask them to come in to the clinic.^[457]

Mark

Sister Billie Reynolds' evidence

33.304 Ms Billie Reynolds worked in nursing posts at the Edinburgh Haemophilia Centre beginning in June 1986. She provided an affidavit in which she challenged some of Professor Ludlam's recollections.^[458] With regard to the patient given the pseudonym 'Mark' not finding out his diagnosis with HIV until January 1991, her impression was that Professor Ludlam 'could not face telling Mark his results'. She suggested that this reluctance stemmed from an earlier incident, when Professor Ludlam had given a positive test result to a patient of similar age in about 1986 and it had gone very badly.^[459] Initially, she confused Mark with the patient concerned. Her account of events was disputed by Professor Ludlam in a statement provided by him to the Inquiry.^[460]

Professor Ludlam's evidence

33.305 Professor Ludlam said that he repeatedly tried to tell Mark the results of his HIV tests and that Mark repeatedly told him that he did not want to know them.

33.306 Professor Ludlam said that to begin with he was hesitant to let Mark know of his results because of 'a number of social reasons' but felt that a time came when it was important for him to know. He told the Inquiry that he arranged to see Mark sometime in 1986 (he could not recall the date) and said that he had been 'quite taken aback' because Mark was 'quite categorical' that he did not want to know his results. Professor Ludlam said that he was 'a bit thrown' by Mark's reaction because he had not experienced a patient so determined that he did not want to be told. Professor Ludlam told the Inquiry that he informed Mark that he was telling everyone that they had to be very careful with blood spillages and sex. He was concerned that Mark might sustain injury in consequence of his manual employment.^[461] Professor Ludlam explained:

We tried on at least two further occasions to convey this information to him. One was to potentially visit him at home and the other was when he came up to the clinic and he saw one of our very able young doctors and she tried to persuade him, very strongly - this would be about 1988 or 1989 ....

So there were several occasions when we tried very explicitly to explain to him and he adamantly didn't want to know. And this wasn't talking about iron levels; this was talking about HTLV-III and AIDS.^[462]

33.307 Professor Ludlam referred to a note from medical records which he thought was dated 13 November 1986:

There is the sheet that was in my private notes, if I can put it that way, that was from 1986 ....

This was a record of my seeing Mark in 1986, wanting to tell him about his result and he not being keen to know - or didn't want to know the answer. I made a note of that and the advice that I gave to him and I felt it inappropriate to put it in his case notes for some of the reasons we talked about earlier, and I had a confidential file in my room, locked up, in which I kept that information. That information has now been returned to his principal case notes.^[463]

Glasgow

33.308 Subsequent to the original Gallo test series, the local virologist, Dr Follett at Ruchill Hospital, set up a specialist laboratory and thereafter testing of west of Scotland patients was carried out there. Professor Forbes told the Inquiry that he arranged for Dr Follett to confirm the 12 original positive test results. He said that he wanted to confirm the initial results using a slightly different test but that the 12 patients who had already tested positive were informed of their primary test results before confirmatory testing by Dr Follett.^[464]

33.309 Professor Lowe told the Inquiry that it took some months for Dr Follett to get HIV tests up and running in his laboratory. He said that Professor Forbes and Dr Follett were both concerned about the specificity of the early tests: there were lots of false positives and false negatives. Given the increasing concern about the implications of a positive result, they wanted the test to be as accurate as possible. He said that Dr Follett took great care when setting up the test.^[465]

33.310 Professor Lowe thought that Dr Follett probably carried out HIV tests over the summer of 1985 but he could not be more specific about the date.^[466] He recalled that, when patients attended the clinic centre in early 1985, after the 'update letter' but before local testing was available, a lot of time was spent talking to patients about AIDS and telling them that it was hoped that testing would be available in the near future. It was at this time that Dr Wilkie began counselling patients about the significance of HIV testing.^[467]

33.311 Dr Wilkie and her colleagues reported on the research exercise in a paper entitled 'Daily living problems of people with haemophilia and HIV infection: implications for counselling' which was published in 1990.^[468] According to the paper patients were told, by letter, at the beginning of 1986 of the forthcoming study and that they would be invited to participate. This date, like many relating to the Glasgow exercise, is problematic. It appears that it may depend on the formal project start date rather than the actual date of the work. However, by way of background the paper stated:

Before the start of the project patients came to the haemophilia clinic at six-monthly intervals for review of their condition and received information about, and were tested for, HIV infection. In addition, many of them had obtained information about AIDS from the news-sheets from The Haemophilia Society, from television and from the press, and had read AIDS and the Blood (Jones, 1985) recommended by The Haemophilia Society.^[469]

33.312 Professor Lowe said that he was involved in seeing some of the patients who came for the appointments that had been arranged in the January 1985 letter. When asked what he told the patients he saw during these appointments, Professor Lowe explained that he would go through the letter and discuss the precautions to be taken by patients as this was considered a priority. He would then explain that Professor Forbes was arranging for HIV testing to be performed at the regional virus laboratory and that it was hoped that testing would be in place during 1985. He would tell them that, before such testing was performed, it was important that they had more information about the implications of testing and of both positive and negative test results. Patients would then be seen by Dr Wilkie. Professor Lowe said that blood would not be taken at that time and that he would never have taken a blood sample for HIV testing until the patient had been through the counselling process.^[470]

33.313 Professor Lowe did not know whether he saw any of the patients who had tested positive on the Gallo tests. He said that he never knew the names of those patients.^[471] The appointments arranged in January were to discuss the risks, to emphasise the precautions to be taken, to talk about heat treatment and to explain that it was hoped that blood samples would be taken and tested in the future. By the time testing was ready to be carried out by Dr Follett, Professor Lowe considered that the patients had been 'pretty intensively educated and counselled' about HIV testing.^[472] It is difficult, however, to imagine a situation in which Professor Lowe could have had such a conversation with a patient who had previously been told that he was HLTV-III positive on the Gallo test without that fact becoming apparent.

33.314 In April 1985 a further letter was sent to patients.^[473] This was similar to the January 1985 letter but with some updating.^[474] The April letter also enclosed Dr Peter Jones' booklet 'AIDS and the Blood' mentioned by Dr Wilkie in her article.^[475] The letter and enclosed booklet were sent to all patients who were registered at the haemophilia centre at the time.^[476]

33.315 Professor Lowe told the Inquiry that, from that point, when patients attended the clinic and before any blood samples were taken for testing he would ask them if they had read the January letter, the April letter and the booklet.^[477] Professor Lowe said he made sure that all the patients that he saw at the clinic at which time blood was taken were fully informed about HIV testing and its implications.^[478]

33.316 Professor Lowe thought that the great majority of the patients registered at the centre had been tested by Dr Follett over the summer of 1985 and certainly by October 1985.^[479]

33.317 He said that the results went to Professor Forbes and that about a dozen patients tested positive. Professor Lowe recalled Professor Forbes saying that when it came to telling patients results of positive tests they should make 'special arrangements'. Professor Forbes wanted one of the consultants (Professor Lowe or himself) to spend 'a good amount of time' with each patient and fully discuss the implications of their positive test result.^[480] It is unclear how the twelve patients who tested positive in the bulk testing exercise described by Dr Froebel (paragraph 33.200) related to the twelve who tested positive in Dr Follett's series; however, it is reasonably clear that it was the patients identified by Dr Follett's study who had received pre-test counselling, and who had given informed consent, who were then informed of their results and counselled by Professor Forbes and Professor Lowe.

33.318 Professor Lowe told the Inquiry that Professor Forbes' policy was that patients would be told at the next clinic review after a positive test result was discovered.^[481] This usually took place within a few weeks of the blood sample being taken but would vary from patient to patient depending on when the results came back. No special arrangements were made for patients who tested negative. Professor Lowe said that, when a patient tested positive, he and Professor Forbes tried to make sure that they had time outwith the usual clinic routine where they could speak with the patient in private and have a long discussion. He said that often Dr Wilkie was present during these meetings and participated in the process of providing information and counselling to patients.^[482]

33.319 Professor Lowe thought that he would have passed positive results on to around half a dozen patients. In 1985 there were 12 HTLV-III antibody positive patients in the region and Professor Lowe thought that he and Professor Forbes had split the responsibility for communicating test results and counselling patients and had informed about half a dozen each. He said that none of the patients that he informed expressed any surprise at all at the result.^[483]

33.320 Dr Wilkie told the Inquiry that often she was the person who told the patients that they had tested positive for the virus. She could not recall how many patients she personally delivered results to.^[484] Professor Lowe challenged this evidence. He did not think that she would have had responsibility for informing patients of their test results herself but recalled that she would have been sitting with Professor Forbes or himself when the results were passed on.^[485] Dr Wilkie said that she didn't have any recollection of sitting in with Professor Lowe; although she may have done so on some occasions, she said it was nearly always with Professor Forbes.^[486]

33.321 When asked to describe how a post-test interview would proceed, Dr Wilkie said that it would normally take place in the clinic rather than in the counselling room. She said that she or Professor Forbes would say that they were there to talk about the results of the HTLV-III tests. Like Professor Lowe, she recalled that patients generally appeared unsurprised at positive test results: usually the patient would say, 'I know doctor that I will be positive'. She said that they would then talk about the implications.^[487]

33.322 Professor Lowe told the Inquiry that when passing on positive test results to patients he would start by reviewing their knowledge about AIDS and HIV testing. He would make sure that they had received full counselling about the test and the implications of a positive or a negative result. He told the Inquiry that he would not have given anybody a positive test result without making sure that they had been through the process of pre-test counselling and fully understood the situation. He would ask the patients if they had been counselled and what information they had been given. He said that all of the patients that he gave positive results to told him that they had been counselled about the test.^[488]

33.323 Professor Lowe said that he told patients that AIDS was caused by a new virus and that a percentage of patients who had a positive antibody test would go on to develop AIDS but that it was not clear what percentage that would be or what the time frame for developing AIDS was. He said that he would reassure the patients that, at that time, the majority of patients found to have a positive antibody test were well and it was hoped that they would remain so. He said that he made sure that they had the current information about the risk of progression to both the milder and the more severe symptoms. He then gave them reading material and suggested that they return within a few days, having thought about the matter, with a list of any questions they wanted to ask.^[489]

33.324 He said that he told patients that he would want to see them more frequently thereafter - initially every couple of months - and that part of their routine examination would now involve monitoring them closely for signs and symptoms of progression to AIDS. They would also be reviewed by the local infectious diseases department at Ruchill Hospital.^[490]

David

33.325 As stated in paragraph 33.217 above, David was told by Professor Lowe that he had acquired HIV on 2 December 1985. The circumstances surrounding his diagnosis are detailed in paragraphs 5.173 to 5.178 of Chapter 5, An Examination of the Effects of Infection with HIV on the Patients and their Families, Including Treatment. David was unaware that his blood sample was being tested for HIV and he was very angry that he was tested for HIV without being told or being asked for his consent. When Professor Lowe told him his test result David thought that he spoke to him in a matter of fact way and wished to convey the news and move on.^[491] Professor Lowe said that he had looked at David's medical records and that David had been seen by another doctor at the time that blood was taken for HIV testing.^[492] He said that, although all of the testing that he performed himself had been preceded by counselling and discussion with the patient, he often saw patients who had been seen by another doctor at the clinic at the time that they had given a sample for testing.^[493] In response to David's comments on the manner in which he was informed of his diagnosis with HIV, Professor Lowe stated that telling someone about their diagnosis at this time was very difficult due to the uncertainty at the time about the virus.^[494]

Discussion and conclusions

The threat of HIV transmission, haemophilia therapy in Scotland and the provision of information to patients

Practice in Edinburgh and south east Scotland: discussion

33.326 It is clear from the evidence presented to the Inquiry that Professor Ludlam's practice was that information was provided to his patients largely in response to questions posed by them and as, in his judgement, the occasion demanded it.^[495] One could not conclude that any particular proportion of Edinburgh patients was given information until late 1984 at the earliest about the risks of transmission of HTLV-III by blood products. Professor Ludlam acknowledged that there was clearly a risk of the agent that caused AIDS entering the Scottish blood donor population and therefore potentially infecting his patients. From the epidemiology and from what was then known about the agent, however, it had seemed to him that the risk in Scotland was very small. He did not therefore take the initiative to alert patients explicitly to the risk and to any patients who may have asked about the risk he would have said that he thought it was small.^[496] Advice was given occasionally and in response to questions or the need to explain the 'AIDS study' (discussed above at paragraphs 33.109 to 33.114) rather than universally. This was consistent with Professor Ludlam's view that there was no risk of transmission of HTLV-III with SNBTS products at the time.

33.327 This appears to have been Professor Ludlam's position until the point in October 1984 when he received test results from Professor Tedder showing that some of his patients were HTLV-III antibody positive.^[497]

Practice at the Glasgow Royal Infirmary: discussion

33.328 The evidence suggests that Professor Forbes would have discussed the threat of AIDS with his patients, whether in relation to product choice or in some other context. He said that he provided his assessment of the risk of AIDS but advised that they continue with their treatment.

33.329 It is reasonably clear that there was not in force any structured protocol, or series of protocols, for the provision of information about the risks of transmission of HTLV-III by transfusion of blood products. While anxious to emphasise his own relative lack of seniority at the time, Professor Lowe, as an interested observer, was well placed to note practice and to comment on his own approach when dealing with the management of haemophilia patients.

33.330 Clinical practice during review clinics provided an opportunity to deal with patients' questions, including questions about AIDS. The more significant question, however, relates to providing information about risk when discussing therapy. Professor Lowe's evidence is accepted: patients were told what was known about AIDS when the subject was raised, they were talked through the consequences of stopping treatment and told that, at the end of the day, they had to balance the risks and benefits of treatment. However, the provision of Haemophilia Society publications stressing the advice that patients should continue with concentrate therapy was also a significant element in the provision of information. Apart from 1985, and the fall-out from the discovery of antibodies to HTLV-III in Glasgow patients in 1984, the quantities of concentrate therapy dispensed reflected the practical emphasis on its continued use.

33.331 It appears that at the GRI, as at the Haemophilia Centre in Edinburgh, during the initial phase of the epidemic AIDS was not discussed systematically with patients as a factor bearing on treatment.

Practice at Yorkhill: discussion

33.332 Professor Hann's predecessor at Yorkhill, Dr Michael Willoughby, left before the threat of AIDS in haemophilia patients had become a reality. Dr Willoughby's evidence was that he had no knowledge of the risk of transmission of serious viral disease. The evidence of the witness given the pseudonym 'Christine' is consistent with the impression given by Dr Willoughby: parents were not told by him that there was a risk of transmission of viral infection generally when being advised about treatment. This appears to the Inquiry to reflect the limited understanding of AIDS in 1981 and 1982. The critical period for present purposes began in 1983 when Professor Hann took up his post. While there were obvious differences among the witnesses relating to practice at Yorkhill, Professor Hann's evidence was clear and consistent, and provides a reliable basis for factual conclusions.

33.333 Professor Hann joined Yorkhill as knowledge about the risk of transmission of a viral agent was first beginning to be disseminated, though his initial exposure to that information came, not in his new capacity as a haemophilia clinician, but in his previous post in London, where he had care of immuno-compromised patients. His position, on an objective view, was different from that of established haemophilia clinicians with a history of prescribing therapeutic products for haemophilia patients. It is therefore of some significance that his first strategic decision was to abandon Dr Willoughby's established practice of using commercial Factor VIII concentrates and adopt the exclusive use of cryoprecipitate and SNBTS Factor VIII. As shown in Chapter 21, Haemophilia Therapy - Use of Blood Products, at paragraph 21.300 and in Figure 21.9, cryoprecipitate accounted for a very small proportion of total therapy. Until 1991, Professor Hann did not use commercial Factor VIII concentrate, with the exception of Dr Willoughby's residue in 1983, and small quantities in 1984 and 1986. Professor Hann's practice reflects consistent confidence in the Scottish product.

33.334 The routine followed in dealing with patients or their parents during his period included discussions with patients about the relative benefits and risks of treatment options, so far as they were understood. It appears from the evidence as a whole that Professor Hann discussed HIV/AIDS to a greater extent than happened in Edinburgh and the GRI, although his advice, like that of Professors Ludlam and Forbes, was to continue with SNBTS therapy.

The threat of HIV transmission, haemophilia therapy in Scotland and the provision of information to patients: conclusions

33.335 The evidence available to the Inquiry illustrates the independence of clinicians to adopt individual practices in providing information to their patients about the potential risks of transmission of viral infection generally, and of the putative AIDS agent specifically, in the period to 1984. It is also apparent that different views as to the nature and validity of the evidence of a viral aetiology were held by the clinicians at the different centres. There was then no relevant professional standard. As discussed in Chapter 32, An Investigation into the Systems in Place for Informing Patients about the Risks - Ethical Context, it would be 1988 before published guidance from the GMC^[498] and the BMA^[499] was available to the profession. That guidance was developed in the light of experience in the critical years 1983 to 1985. In that period, clinicians were free to develop their approaches on the basis of their individual perceptions of risk, and of the options available to them in treatment, given the fundamental need to treat patients' primary conditions.

33.336 Professor Lever's observations (at paragraph 33.60 above) define, effectively and forcibly, the problem for clinicians. There was a need for caution in giving information and advice. Raising a fear of virus transmission would have caused distress and concern. If it should prove to have been unnecessary, that would be undesirable. People would 'not necessarily have been very understanding'^[500] (a restrained judgment of the position) if it proved to have been a false alarm and, in the meantime, patients had died from lack of treatment for their haemophilia.

33.337 Most senior clinicians would have been constrained by the knowledge that over the previous decade, as effective therapeutic concentrates had become available which had changed their patients' lives, they had prescribed concentrate therapy with confidence that, overall, the benefits conferred outweighed any disadvantages associated with their use. Professor Hann was an exception: he was new to haemophilia practice at this critical period, starting at Yorkhill in 1983, and had a quite different specialist background. In deciding his own approach to therapy, he proceeded quickly to near exclusive use of SNBTS products and, in becoming familiar with his patients, he was more active in initiating discussion of the options available in treating individual patients.

33.338 The period when patients treated with SNBTS Factor VIII concentrate were most exposed to risk of transmission of HIV extended from 1983 to the beginning of 1985. That was the period when information about the risk of transmission and discussion with patients about product selection might, at least hypothetically, have been material to the course of treatment of their primary condition. Some patients have stated that they were not advised of the risk of contracting AIDS from treatment and there is patent concern that this reflected a failure on the part of clinicians to provide information to them.

33.339 It is clear from the evidence that practice in relation to providing advice and information to patients about the risk of AIDS did vary. Professor Hann's practice at Yorkhill involved the most extensive discussion with patients and he appears to have adopted a proactive approach. Professor Ludlam's practice seems to have involved a more general level of discussion, and a more reactive approach, with information being imparted largely on a 'need to know' basis. His practice can be taken as an example of what happened to a greater, or lesser, extent at other centres. The overall picture that emerges from the evidence discussed in this chapter is that, generally, doctors in Scotland did not initiate discussions with patients about the risk of transmission of an AIDS agent because, for a significant part of the period, they thought that there was not a risk in Scotland at all and, towards the end of the period, they found it very difficult to assess the gravity of the risk that was beginning to be recognised. Nonetheless, if patients did enquire about the risk, the doctors would do their best to inform them, in the light of the then current state of knowledge about AIDS. Some clinicians at least also relied on the ready availability at clinics of publications from the Haemophilia Society.

33.340 By the spring of 1983, Professor Ludlam had become convinced that there was a syndrome, AIDS, very possibly related to a transmissible agent like a virus, although it appeared to be largely a US phenomenon. He believed that his patients were not at risk from it because he used exclusively Scottish materials. In their case, any immune abnormality was attributed to antigen overload, occasioned by therapy as distinct from an infective agent. His anxiety, and the measures he implemented in consequence of it, to protect his patients from 'foreign' materials when outside Scotland provide eloquent evidence of his views at the time. Until the infectivity of a batch of SNBTS concentrate was discovered in the autumn of 1984, he took the view that his patients should not be exposed to commercial concentrates if that could be avoided.

33.341 Professor Vivienne Nathanson talked about the uncertainties surrounding the risk of AIDS between 1982 and 1984. She said that all of these uncertainties made it extremely difficult for treating doctors to discuss the risks associated with their treatment because they were unable to categorise the level of that risk.^[501] At the beginning of the period the level of uncertainty about the risk was such that it was legitimate for clinicians not to mention it to their patients.^[502] The problem facing treating clinicians was that they did not have numerical data and therefore did not know the level of risk. The question at that time was, therefore, whether to wait for it to become clear from the statistics that the risk to patients was so common that they must be told, or to tell patients about the risk, regardless of the likelihood of their infection, because the consequences were so great.^[503] She said that it became less acceptable not to warn patients as clinicians began to understand the risks and as it became clearer that the risks were higher than originally thought.

33.342 Professor Nathanson was not critical of doctors who did not initiate discussions about the risk of AIDS from concentrate therapy in the early 1980s. It is clear that by modern standards a doctor could be criticised for failing to mention a risk to a patient that a particular treatment carries. However in the early 1980s it was commonplace for doctors simply to take decisions for their patients without discussion with them, the so-called 'paternalistic' approach to practice. As the exact extent of the risk was then unknown, a significant number of doctors would not have initiated a discussion about the risk of contracting AIDS by continuing with factor therapy even though by 1984 it was clear that there was a risk of death.

33.343 Until September 1984 (by which time it was generally accepted that HTLV-III was the agent of transmission of AIDS, and a high prevalence of the HIV virus in UK haemophilia patients had been found) there is no basis in the evidence for any criticism of any Scottish clinicians relating to their approaches to the provision of information and advice concerning the risks of AIDS associated with the continued use of therapeutic materials in the treatment of blood coagulation disorders.

33.344 There were no specific ethical guidelines for this unprecedented situation. Practice in Edinburgh and Glasgow was tailored to patients' needs as perceived by the various clinicians. Professor Ludlam's provision of information on a reactive basis was, inevitably, a reflection of his personal approach to clinical practice as was Professor Forbes' approach. Relevant to all the clinicians involved was the fact that knowledge of AIDS was limited and, consequently, that there was little that they could tell patients about it with any confidence.

33.345 The position towards the end of 1984, immediately before Scottish practitioners discovered the results of testing by Professor Tedder and Dr Gallo of samples from their patients, examined below, is that the risk of AIDS was not generally discussed. However, on the evidence of general practice prevailing at the time, particularly from Professor Nathanson, there is no basis for criticism of individual clinicians.

The testing of patients' blood samples

Routine blood tests to 1984: discussion and conclusions

33.346 Monitoring of patients by blood tests was a routine component of haemophilia care throughout UK haemophilia centres from the 1970s. Dr Winter described the background to this practice. He noted that, shortly after the introduction of factor concentrates in the mid-1970s, it became apparent that nearly all regularly treated patients displayed biochemical abnormalities of liver function of a type that would be compatible with a form of viral hepatitis infection. From that time on, haemophilia clinicians regarded it as their responsibility to monitor their patients regularly for the presence of new viral infections.^[504] It was absolutely routine to test haemophilia patients for viruses, whether directly or by means of surrogate indicators of disease, and, because it was seen as being a core part of patient care, it was not considered necessary for doctors to discuss it with patients.

33.347 Routine testing such as described was an ordinary aspect of diagnosis and of management and did not give rise to controversy at the time. However, in 1983 and early 1984 studies were carried out in Edinburgh and Glasgow that became controversial later. They arose from the discovery, initially in the USA, that haemophilia patients had developed immune abnormalities which were similar to those found in AIDS patients and reported to be found in some asymptomatic homosexual men. It is appropriate to re-emphasise that, until the immunological studies, the evidence of practice gathered by the Inquiry shows that blood tests for a wide variety of pathogens and for monitoring biometric data were carried out on a routine basis without prior discussion with patients as necessary components of the management of their primary condition.

Immunological studies: discussion and conclusions

33.348 The evidence suggests that Professor Ludlam may have found it difficult to explain to patients about his immunological studies. Some of his patients may have known that he was carrying out such studies but there was no structured or systematic approach to providing relevant information relating to it, or for obtaining consent for the use of patients' blood. Some patients may have understood from their haematology request forms that their blood was being tested in the 'AIDS study'. However, no reliance could reasonably have been placed on the forms as a means of informing patients of that fact, or of the significance of the studies. Equally, it seems that, at the time and in the retrospective analysis Professor Ludlam required to undertake for this Inquiry, he did not fully appreciate the possible impact on them of the language he used. This is, perhaps, best illustrated by his labelling, in the climate of the time, his immunological investigation as the 'AIDS study'. That choice of words gave rise to a suspicion, harboured by few people, that he had been experimenting on his patients with the AIDS virus. It should be noted that Counsel representing the Patients, Relatives and the Haemophilia Society explicitly acknowledged that there was no factual basis for such a suspicion.^[505] Furthermore, it is worth repeating at this juncture, that it is the view of this Inquiry that such a suspicion is without foundation.

33.349 There was good reason in 1982-83 for Professor Ludlam and Professor Forbes to be concerned about whether their haemophilia patients had been exposed to the transmissible agent then increasingly thought to be responsible for AIDS. The topic had been explored in the United States. The possibility of 'antigen overload' as an explanation of immunological abnormalities had been postulated as an alternative to viral infection. By the spring of 1983 the incidence of similar immune abnormalities in AIDS patients, some asymptomatic homosexual men and some asymptomatic haemophilia patients, was puzzling. It was a subject appropriately demanding investigation.

33.350 If Professor Ludlam had contemplated the range of possible reactions to this work on the part of patients, he would have been well advised, as he came to recognise, to have devised an alternative shorthand to 'AIDS study' to describe it. Much of the reasoning and explanations tendered in oral and written evidence would not then have been required. For example, the discussion of what patients 'might have understood' from a label on a form accompanying a sample appeared to be unhelpful at the time of the Oral Hearings and has remained so. In the end, discussion of the description, and of possible inferences that might be drawn from the use of the title, provided no help in characterising what was done and in developing views on the appropriateness of that course of action.

33.351 Several facts are established in relation to Edinburgh:

• Professor Ludlam was aware from international and UK sources that some clinically well haemophilia patients were developing immune abnormalities.
• He knew that the pattern of these abnormalities, though less marked in haemophilia patients, bore similarities to those found in some apparently well homosexual men and in AIDS patients.
• The cause was unclear and it was also unclear whether the condition was progressive. It might have been a previously unreported side-effect of therapy or of haemophilia itself.
• On the other hand, the changes might have been related to the prevalence of a blood-borne virus possibly leading to AIDS.
• The condition in his patients could be investigated by the addition to routine haematological lymphocyte counts of a more specific count of CD4 and CD8 lymphocytes, and an assessment of their relative proportions in the patient's blood, using the same blood as taken for standard haematology.
• Professor Ludlam made an arrangement with Dr Steel to have that test carried out on selected samples from patients with severe and moderate haemophilia who had received a lot of concentrate.
• Patients were not told routinely that the study was carried out or that their blood was used, and their consent was not obtained in advance.
• While some patients may have been told, or found out, it could not be concluded on the evidence that the study was known generally or that all patients involved knew of the study or that their blood was used in it.

33.352 However the study was in the best interest of patients. Finding out whether there was a pattern of immune abnormalities and, if so, its nature and extent could not but have been relevant to patient care whether it was caused by, or associated with, the selection and use of therapeutic products, or involved an agent of transmission of viral infection. The results of the study might be of particular importance in deciding on future therapy. The progressive development of immune abnormalities in patients receiving factor concentrates was a matter of legitimate concern in itself. At this stage, in 1982-83, the common perception in Scotland was that SNBTS Factor products were safe from AIDS and, to the extent it was understood, from an infectious agent associated with AIDS. That was an illusion, as events were soon to prove, but it was deeply embedded in the preference for the domestic product over imported products, especially those imported from the USA.

33.353 Attempting to differentiate the effects of 'antigen overload' from infection with an AIDS agent would also have been a legitimate concern. That was what lay behind Dr Louis Aledort's studies in America that prompted Professor Ludlam to carry out his own investigations. On any view, the study and the findings potentially had real significance in the context of patient management. If, without virus infection, immune abnormalities developed through the use of concentrates, that would have been important.

33.354 The question of whether patients should have been informed and whether their consent should have been obtained in advance of the immune studies is more difficult. It cannot be answered by reference to what was found: that was, of necessity, unknown when the material decisions were taken (or, more probably, not taken, since the test was clearly viewed as a simple extension of routine practice). It cannot take into account the emergence of HTLV-III positivity in Scottish patients: that still lay in the future. Similarly, many of the problems associated with HTLV-III/HIV testing that were to emerge in and after 1985, such as problems relating to employment, to travel and to insurance, were unknown in Scotland in 1983.

33.355 The matter was taken up with Professor Nathanson, who discussed the distinction between 'monitoring of patients' and 'research'. She said that, in essence, research involves testing a theory about, for example, a causation or the result of a treatment.^[506] She said that there is often a very fine line between medical research and treatment. She referred to the old version of the Declaration of Helsinki which talked about 'therapeutic' and 'non-therapeutic' research. Although the phrase 'therapeutic research' is not used today, it was at that time and Professor Nathanson thought that it lay on the fine line between 'monitoring of patients' and 'research' as such.

33.356 There are times when what a doctor is doing is not part of established therapy (including established protocols for continuing testing or routine tests) but is an aspect of the way in which the doctor is treating that patient, either finding out more information about the patient or seeking a better way to treat their condition. This has always been an area where it is difficult to say whether what the doctor is doing is better characterised as research or as treatment because some such actions straddle that line. Professor Nathanson said that she would characterise the immune function studies carried out by Professor Ludlam between 1983 and 1985 as being 'exactly on this borderline'.^[507]

33.357 When asked whether it would be fair to suggest that something might start out as long-term safety monitoring of patients and metamorphose into what might objectively be regarded as research, Professor Nathanson said:

I think that's absolutely the case. I think this is clearly the issue when you start off with work that is on this borderline, that you start off intending to simply monitor that you are getting the treatment right, that the patient's blood tests are going in the right direction or you are not seeing anything unexpected. You find something unexpected and it morphs into something that is different, and that's a very great difficulty and it's particularly difficult to then stop what you are doing and to redesign the whole thing and to say, 'We will now make this into a formal research protocol.' And I think that that's why, in times when the ethics approval for research was rather less rigid than it is today, that much of this happened. It didn't start off with malign intention, it just metamorphosed in exactly that way.^[508]

33.358 So far as the immunological studies are concerned, classification remains difficult. Viewed as a research project, the testing of those severely and moderately affected haemophilia patients who attended Professor Ludlam's clinic for treatment or review during the period of the AIDS study was not based on the random selection of patients from a wider population. Nor was there a defined research protocol for the study. On the other hand, routine monitoring might have been expected to require that the lymphocyte study should include all patients rather than only those who attended for treatment or review. As already commented, the results might also have been expected to be noted in patients' medical records.

33.359 While lacking such a formal structure, there are indications that the intent of the projects was research in a wider sense than the investigation of the individual patient's condition. It might not have met Professor Nathanson's definition of the essence of research. The 'theory under investigation' was, at best, the hypothesis that immune abnormalities found in haemophilia patients had an association with antigen overload rather than a ubiquitous viral agent. It was designed to obtain information, to find out whether there were immune abnormalities in the Edinburgh Haemophilia Centre patients generally and was therefore not focused on individual patient management. It might have been more consistent with the 'monitoring' of patients (as Professor Ludlam described it) rather than a form of unstructured research if all patients had been tested rather than a selection only. The immune studies resulted in published papers rather than in changes in the prescription of therapy. So far as the individual patients were concerned, Professor Ludlam clearly did not know what to do with the information gathered. He did not tell the patients; he could not interpret the results for them. The implications for management of the patients had not been considered at that time: apparently that had not been part of the plan.

33.360 It is not clear where these exercises would lie relative to the fine line between 'therapeutic' and 'non-therapeutic' research sketched out by Professor Nathanson. They were exploratory exercises aimed at finding out what, if anything, was happening to patients receiving blood product therapy. Professor Nathanson thought that the immune studies lay on the borderline and that is probably where they should be left. Her comment relating to studies that 'morph' into research in the fullest sense of the term is no doubt accurate in the abstract but it is not accurate in relation to the immunological studies in Edinburgh and Glasgow: there is no evidence that the studies changed in content, purpose or direction, which the word 'metamorphose' would suggest. So far as the evidence shows, what changed over time was the perception of the studies which came to reflect ethical rules developed after the work was carried out and reported.

33.361 In Glasgow and in Edinburgh, the immunological studies are probably best characterised as a preliminary enquiry. They were aimed at finding out whether the patients' lymphocyte 'scores' suggested that something was happening to their immune systems that might be related to therapy. Due to their unstructured, preliminary character, a full research programme following upon them would have been required if reliance was to be based upon their conclusions in instructing any changes in the approach to therapy. Professor Forbes characterised the Glasgow study as an investigation aimed at finding out whether there was any evidence of altered immunological status in patients who had received multiple transfusions with various products. He described the paper as 'very much a preliminary paper'. His team did not know where the results might lead them.

33.362 If there had been at the time a generally recognised ethical rule that patients should be informed of all research in which they were involved through the use of blood samples, and that their consent should be obtained before use was made of their samples, the conduct of the 'AIDS study', as it was carried out, would have infringed that rule. The Glasgow study, since consent was obtained, would not have done so.

33.363 However, as indicated earlier in this chapter, and in Chapter 32, An Investigation into the Systems in Place for Informing Patients about the Risks - Ethical Context, on the evidence available, from Professor Nathanson in particular so far as general theory is concerned, and from Dr Winter and others from the clinician's point of view, there was not a fixed rule before 1988 that would have required that the patient be informed or that the patient should consent to the immunological tests. There was no rule that took the decision whether to seek consent for immunological studies out of the clinician's discretion.

33.364 Professor Nathanson said that even at that time she would have encouraged Professor Ludlam to consider the work as research and follow the research protocols simply because of the benefits that would have brought.^[509] However, that plainly fell short of criticism that what had been done breached any ethical rule in force at the time.

33.365 Professor Nathanson's evidence is accepted. The immune studies were not simply the reflection of the insatiable curiosity of academic doctors confronted with an interesting project and an irresistible urge to research it. Professor Ludlam and Professor Forbes had a legitimate clinical interest in discovering whether concentrate therapy had an impact on patients' immune function. As events were to develop after the AIDS period, the 'purity' of intermediate factor products became an important issue for the SNBTS. In due course, pressure from patients and clinicians grew for the development of 'purer' concentrates, with lower levels of protein impurities than had generally been found in SNBTS intermediate purity products, and in particular SNBTS Factor VIII. A study that focused on the consequences for patients' immune systems of therapy with products of intermediate purity, with a clearly specified aim and supported by a research protocol, could readily have been classified in 1982 as 'therapeutic' research ancillary to patient management and treatment.

33.366 The immunological studies carried out in Glasgow were not a direct parallel of those conducted in Edinburgh, even though the objective was the same. The study in Glasgow was prompted by the same intelligence that influenced Professor Ludlam and was aimed at finding out whether there was evidence that patients who had received multiple transfusions had developed immune abnormalities. On Professor Forbes' evidence fresh blood samples were required specifically for the study and that necessitated discussion with patients.

33.367 As observed earlier, Professor Forbes' account of the procedure adopted was imprecise. The impression he gave was of a fairly informal approach to obtaining consent with little information about the purpose of the study imparted to patients. Dr Froebel's published report of the study does not indicate whether the patients gave their consent; it refers to the patients having been selected because of their treatment regime in the recent past.^[510] In the absence of any contrary evidence, it is appropriate to proceed on the basis that the patients were asked to participate in the study and gave their consent, albeit informally and with little specification of the purpose and significance of the study.

33.368 Like Professor Ludlam, Professor Forbes obtained results but did not know what to do with them in the context of patient management. He did not go back to the patients with their results because he did not know the implications of the findings. There was no follow-up to the results, so far as the specific patients were concerned. In the event, what he actually told his patients and how well informed they were about his immunological investigations are open questions. His approach can properly be described as paternalistic, in the sense previously defined, leaving patients with the impression that he was doing something for their own good but avoiding overloading them with information about it.

33.369 The 'skin tests' carried out in Edinburgh and Glasgow illustrate that clinicians did draw a line and seek ethical approval where they perceived that the work involved amounted to research. The investigation for the 'skin tests' was invasive: it was intended to test immune response by causing physical changes in the patient's skin.

33.370 Professor Ludlam viewed his skin test programme in 1984 as a research project requiring ethical approval. He took a different view of the immunological studies he carried out on stored samples. They did not require fresh blood samples to be taken, and were, in that sense, not invasive. That was a matter of judgment on which he was entitled to take a view at the time. There was little difference between them: they had the same objective, involved patients' immune functions and they both provided general information. The more invasive exercise received ethical consent when Professor Ludlam sought it. It is very difficult to see anything of substance turning on the failure to seek ethical consent for the immunological studies.

33.371 In retrospect, aspects of the conceptualisation and implementation of the 'AIDS study' could have been handled better, but it is not possible to say that there was any breach of any ethical rule prevalent or recognised at the time the studies were carried out.

Publication of patients' information: discussion and conclusions

33.372 Professor Nathanson explained that in contemporary practice where data is extracted from the files of a limited number of patients, where the researchers know the identity of the research subjects and especially if they comprise a small, defined and potentially identifiable group, the researcher is obliged to obtain the consent of the patient(s) to the inclusion of their data in the research. The GMC considers such cases in its supplementary guidance on research ethics, which makes it clear that identifiable data requires either patient consent or, where that cannot be obtained, separate independent permission to use such data.^[511]

33.373 She said that the main thing that most patients worry about in research publications is whether they can be identified from the description in the article. Today in almost all publications, patients are given a guarantee that the information will be aggregated or presented in such a way that they cannot be identified from it. This fits with the valid consent model and patient-centred practice. Patients are given the choice of either being in the research exercise or not. Another key component of research ethics is that a doctor should also make sure that patients understand that refusal to be part of the research will not change their access to healthcare.^[512]

33.374 Professor Nathanson also discussed 'anonymisation' and 'pseudonymisation'. Anonymisation is the practice of making sure that whatever is done with the information used in the research, such as actual files about individual patients, is treated in such a way that all identifiers are removed. Pseudonymisation involves the use of false personal information to conceal an identity. With anonymisation doctors have to be very careful that they are not presenting information which, even though they have removed the patient's name and date of birth, has enough detail to allow the patient to be identified. Nowadays the biggest research studies use fully anonymised data. Often they use aggregated data, which might look at information extracted from, for example, the population of 5 million in Scotland.^[513]

33.375 She said that the fact that the results were published made very little difference to any ethical concerns around the immune studies. She recognised that the use of patient information in medical journals, anonymised but without formal consent to inclusion in a published study, was fairly common in the 1980s. The important point about publication at that time was that it required consent if there was any likelihood of individuals being identified.^[514] All three of the articles mentioned were fully anonymised.

33.376 The publication in The Lancet of the results of the immunological studies from Edinburgh and Glasgow did not infringe any ethical rule recognised in 1983. On Professor Nathanson's evidence, they would not infringe current rules. The data were fully anonymised and there was no likelihood of individuals being identified. As Professor Nathanson said in this context, publication made very little difference in this case. It does not affect the legitimacy of either of the studies.

33.377 While the feelings of the patients on finding out that they were part of such studies without their knowledge are easily understandable, in the result there was no breach of any ethical rule or principle associated with the publication of the results of the immune studies.

Testing for anti-HTLV-III: discussion and conclusions

Glasgow

33.378 The evidence of the timing of events in Glasgow is confused and in some respects contradictory. Dr Froebel's evidence is accepted and is generally to be preferred to competing accounts. It relates most naturally to the reports, from Montagnier in France and Gallo in the US, claiming that a virus had been isolated from patients with AIDS and indicating that both laboratories were working on an antibody (ELISA) assay, a blood test that would show exposure to the virus (though attributing the date of spring 1984 to each, as Dr Froebel did, was incorrect). Her narrative of the assembly of samples and their dispatch to Dr Gallo has circumstantial detail that supports its accuracy. She cannot have written to Professor Montagnier and Dr Gallo before 4 May 1984 when Science published the articles on Gallo's research. The samples that were tested were recorded in the subsequent paper published in The Lancet as having been taken between December 1983 and July 1984. The samples therefore cannot have been sent prior to July 1984. The HTLV-III antibody testing of the Glasgow samples in Dr Gallo's laboratory must have been carried out thereafter.

33.379 The only evidence suggesting that Professor Forbes had knowledge of HTLV-III antibody test results for some patients before the report of the bulk shipment of named samples to Dr Gallo, was provided by Dr Wilkie, and concerned the kits. She made no reference to the Gallo tests. Whilst trying her best to assist the Inquiry she had, as she acknowledged, difficulty in recollecting certain matters including dates. In relation to the test kits, she said that she and Professor Forbes conversed on this matter once and then never again. Many matters referred to by her in relation to the kits would fit equally well in the context of the Gallo tests. Her description of Professor Forbes' agitation would fit his likely state on discovering from the Gallo test results that 16% of his patients had tested positive. Like the putative kits described by her, the Gallo test originated in the USA and was unlicensed. On the basis of either the Gallo results or the kit results, Professor Forbes would be concerned to find out what his patients knew about HTLV-III, whether they thought they might be affected and whether they would like to be tested for the virus. Neither Professor Lowe nor Dr Froebel referred to any test kits, and Dr Froebel stated that she expected the Gallo tests to be negative and was shocked by the positive results. She and Professor Forbes were collaborating and it is difficult to think of any reason why he would keep any pre-existing positive results from her. Furthermore, positive HTLV-III test results from patients at the GRI would, in all probability, have significance for the SNBTS and the PFC. Dr Wilkie described Professor Forbes as 'a very ethical man with far-reaching ideas'. Professor Lowe said he was 'an extremely open person who would spend hours with his patients, discussing all manner of things'. The weight of the evidence on this matter suggests that the first HTLV-III testing of GRI patients was by Dr Gallo.

33.380 It appears likely that when those first test results came to hand they would have caused the agitation Dr Wilkie described and provided the incentive she needed to abandon her own lines of research and agree to assist Professor Forbes. Her evidence that the reason Professor Forbes had contacted her was agitation about the test results and that had prompted him to ask for her help, is accepted.

33.381 The Inquiry endeavoured to ascertain the likely date upon which the Gallo test results first became available at the GRI. On 29 October 1984, Dr Froebel wrote to Dr Perry that, after checking records, she and her colleagues now thought that seropositivity for HTLV-III was strongly associated with the patients having received commercial concentrate mostly before 1981. Dr Gallo's results were clearly available before 29 October 1984. On 29 November 1984, a meeting of haemophilia directors and SNBTS representatives was held. Paragraph 4 of the minutes notes:

Dr Forbes described the findings relating to HTLV-III antibody sero-conversion in a comparative study of haemophilia patients in Glasgow and Denmark. This study would shortly be published in the Lancet.^[515]

33.382 The exact date that Professor Forbes received the results from the USA is not known but it must have been some time before this meeting since in the interval Dr Melbye became involved in the joint exercise with Glasgow, research was completed, and the joint paper was prepared, submitted for publication, reviewed and finally approved for publication all before December 1984. The article was published in The Lancet of 22/29 December 1984.^[516] It contains data on a patient who died in late October, but that could have been added in the review process. Professor Lowe is recorded as one of the authors of the article. He said that he was not involved in collecting blood samples from patients or sending them for HTLV-III testing.^[517] His involvement was limited to a critical review of the draft paper, probably around about September or October 1984.^[518]

33.383 On the evidence as a whole, it seems highly likely that Professor Forbes had the results of Dr Gallo's tests by late summer or early autumn 1984, in time for the work leading to the article in The Lancet. He may have had them by August or September. A date in October is less likely, notwithstanding the reference to the October death, given the spread of authors between Scotland, Denmark and United States, and the confirmatory tests referred to in the article.

Edinburgh

33.384 The timing of some events in Edinburgh is also open to doubt. On Professor Tedder's evidence, Professor Ludlam made an initial approach in August 1984. That would have been before the publication in the Cheingsong-Popov article of the results of the Tedder/Weiss research project in September. Since the approach was made on the basis of personal connection that is not at all unlikely, but at the time of the initial approach, on Professor Ludlam's evidence, Professor Tedder was already inundated with requests from various sources for HTLV-III testing, a situation more likely to relate to publication in September. The critical issue is related to the submission of the first particular group of samples that resulted in the positive diagnosis of infection. That places the event in October 1984 and for practical purposes, on the evidence as a whole, Professor Ludlam's timing is accepted.

The ethical considerations

33.385 From the accounts of the way in which events unfolded, already dealt with at length, it is clear that in both Edinburgh and Glasgow, the initial samples of sera for testing were selected from store and submitted without prior consent of the patients, though the samples were identified as belonging to identified individuals. The wide context is relevant.

33.386 In Professor Nathanson's opinion, the use of stored blood or tissue samples for research would have been contrary to the spirit of the Declaration of Helsinki if consent had not been obtained. However, if doctors were not using the information for research but rather as a part of the continuing monitoring of the patient that would have been legitimate. She noted that there is 'a very fine line' between the two uses of samples.^[519] This appears to be the difficult line between 'therapeutic' and 'non-therapeutic' research already discussed.

33.387 In her view it was clear that the spirit of the Declaration of Helsinki dictated that, if doctors had been in any doubt, they should have erred on the side of thinking that there was a need for a research protocol and gone through the relevant processes.

33.388 However, she said that although conducting research without consent might be contrary to the spirit of the Declaration, particularly as that is understood today, in practice it did occur quite widely in the early 1980s. Doctors often regarded what might now be considered to be research as part of continuing care, or a 'check and balance' on the quality of care a patient received. Although Professor Nathanson said that she would be critical of a doctor who had used stored samples without the patient's consent, she recognised that this was, in fact, common practice in the 1980s. As she put it: 'I would say it was not ... the gold standard but it was a common fault and it was commonly done'.^[520]

33.389 Throughout the United Kingdom, and across Scotland, there were haemophilia clinicians who used stored samples for testing without patient consent in the course of day-to-day monitoring of patients' progression.^[521]

33.390 Having regard to the discussions that led to the 1988 GMC guidance, and notwithstanding Professor Nathanson's opinion of what the spirit of the Declaration of Helsinki required, it is not possible to hold that there was an accepted or established rule of ethical practice that required patient consent for the submission of stored samples for testing in all circumstances in 1984. There are, however, substantial questions relating to the particular case of conducting HTLV-III/HIV studies on stored, and named, samples without consent of the patients involved. AIDS was already understood as a devastating disease in 1984 and the possibility of infection with an agent that might lead to the development of an AIDS disease, however remote, was a matter of real concern to patients and their families.

Communication of the results of HTLV-III testing: discussion and conclusions

Edinburgh

33.391 So far as concerns intimation to patients, the response to the findings was slow. After the initial flurry of telephone calls and memoranda at the end of October, nothing had been resolved in Edinburgh by the date of the meeting of Scottish Haemophilia Directors, SNBTS representatives and SHHD personnel convened on 29 November 1984. The position in Glasgow was the same. The meeting of the Haemophilia Reference Centre Directors at the BPL, Elstree, on 10 December 1984 left matters concerning whether and how patients with positive results should be informed in the hands of individual Haemophilia Directors with no real guidance on how to handle the situation. The approach in Edinburgh changed to crisis management with the threat of publication in The Yorkshire Post received by Professor Ludlam on 11 December.

33.392 At the present time, when protocols for managing relations with the media are rather better developed, the course adopted by Professor Ludlam may seem inapposite, even unwise. It should, however, be considered in the light of the circumstances then prevailing. The day after the long and difficult meeting on 10 December, he was contacted by a Yorkshire Post reporter who informed him that he knew about the Edinburgh seroconversions, wanted to publish that information and would like to meet him. The following day they met and Professor Ludlam begged the reporter not to publish, explaining that this was no way for the patients to receive such news. Negotiating hard, he managed to extract one week's grace. Later that same day he wrote the invitations to the meeting, thinking such a gathering would be the quickest, most open way to start to inform all the patients. Professor Ludlam said in his evidence that had The Yorkshire Post not intervened, he would have found a different way of advising the patients. In retrospect, and as he acknowledged, it is plain that a public meeting was not the best way either to disseminate important personal information or to provide sensitive advice. However, the evidence does not disclose any objection to the course of action that he took, and it was reported to Scottish Office officials at the time.

33.393 On the evidence gathered by the Inquiry it is clear that Edinburgh-registered patients and their families were invited to the meeting of 19 December 1984. Professor Ludlam concluded that some of those attending must have come from Glasgow as he did not recognise them. However, he also stated that he would have sent out invitations to the east coast haemophilia centres at Aberdeen and Inverness. The patients he did not recognise could have come from the other east coast centres. Unfortunately, the evidence in relation to Glasgow produces a less clear picture than that relating to Edinburgh, in part due to Professor Forbes' difficulties with his memory. Professor Ludlam believed that Professor Forbes had sent invitations to the meeting to his GRI patients. The Yorkshire Post, in its near contemporaneous account, stated that news of the positive testing was broken 'to haemophiliacs from Edinburgh and Glasgow'. Information for that article came from Professor Ludlam and that account would be consistent with his belief at the time. Dr Bell's memorandum, dated 12 December 1984, suggested that 'the haemophilia consultants' were going to call a meeting of haemophilia patients. On the other hand, Professor Forbes (who chaired the meeting) had no recollection of any Glasgow patients attending. Neither Professor Hann nor Dr Pettigrew appears to have sent out invitations. On balance, it seems likely that for some reason west of Scotland patients were not invited to the Edinburgh meeting and did not attend it.

33.394 After the meeting different courses of action were followed in Edinburgh and Glasgow and, as appears from the letter sent to patients by Professor Forbes and Professor Lowe on 8 January 1985, communication with Glasgow patients did not include any reference to the meeting. The tone of the letter was 'prospective': it proposed a fresh course of action that had no reference to an earlier meeting. It appears likely that Professor Forbes had already decided to pursue his own course by the time of the meeting and that he proceeded to implement his plan of action without reference to Professor Ludlam.

33.395 The invitation to attend the meeting suggested something like a general information session. It was, unfortunately, ill-adapted to inform patients and their families that, among the recipients of the letter, there were individuals who were already known to have been infected with HTLV-III. Yet, on Professor Ludlam's evidence, one of the two objectives of the meeting was to inform those who attended that some patients were positive for the antibody. Patients would not have been prepared for information to that effect. The evidence of what transpired at the meeting has been set out fairly fully. It is not clear that specific information was given about the particular centres at which the 'Scottish' patients who had been infected were treated. Since Professor Ludlam had anticipated that Glasgow and west of Scotland patients would have been invited as well as those in other regions, the information was unhelpful and could have left patients in confusion about what they might be told at the meeting.

33.396 For the reasons already discussed, the article published in The Yorkshire Post on 20 December 1984 cannot be treated as a wholly reliable account of what transpired at the meeting. In any event, it is not clear from its content what precise information was imparted to patients on that occasion. The article published in The Edinburgh Evening News on 21 December was brief and lacked specification of what had transpired at the meeting, commenting only that '[t]he situation was explained to haemophiliacs at a meeting with medical experts in Edinburgh this week'.^[522]

33.397 Plainly, the most reliable evidence in relation to the meeting is Witness A's note. It suggests, amongst other things, that practical information was imparted about how to avoid transmitting the virus together with additional information about HTLV-III and AIDS. From its terms, Professor Ludlam also seems to have indicated that he was prepared to inform his patients if they had the antibody to the virus. Mrs Brown believed he had communicated at the meeting that there was an infected group in Edinburgh, those present might be in that group and if they wanted to know if they were infected or not, they had to ask.

33.398 The notes of Witness A and Geraldine Brown's evidence both suggest that at the meeting Professor Ludlam did communicate that he was offering to inform any of his patients who asked him, whether or not they had the antibody. Frances' evidence of her father's position shows that some patients did take this on board. He sought and received his results on 21 December. However, the limitations of the meeting, and the scope for confusion that it generated, is attested to by the fact that two of Dr Alison Richardson's patients, both of whom had tested positive, left the meeting believing that they were negative. They believed that if they had been positive they would have been told that at the meeting. Professor Ludlam said that he was devastated on first hearing the news that some of his patients had tested positive. In all the circumstances, it is not surprising that haemophilia patients and their relatives, hearing the same news, should find it difficult to take in any information subsequently imparted. On any view, the meeting was an inappropriate means of conveying such news and any advice consequent upon it, although the Inquiry recognises that the media pressure probably left little room for choice in how to proceed.

33.399 Given the obvious limitations of the meeting some follow-up was clearly required. It is unfortunate that the covering letter Professor Ludlam sent with the circular on AIDS has not been recovered. His evidence that it would have mentioned that some patients 'in Scotland' had tested positive is consistent with other evidence of the degree of specification in his public statements, as is the invitation to his patients to make an appointment to discuss their position. That evidence is accepted.

33.400 It is clear, however, that Professor Ludlam's patients were not invited on an individual basis to attend the Edinburgh clinic. Whether patients had tested positive or negative for the antibody, Professor Ludlam had information about their health that they might have chosen to know. He could not have insisted on informing them but he could have followed the course adopted in Glasgow, at least from the summer of 1985, and sent an appointment to each patient inviting them to come individually for an interview. Such an invitation would have focused the recipient's attention on this important issue. In the climate of the time, some of them might have decided to remain in ignorance, since testing in itself, regardless of the result, might bring about adverse financial consequences. However, such a decision should have been theirs. That there was no treatment at the time would have been, no doubt, a factor in the patient's decision whether or not to discover if they had been tested. It is a matter of regret that Professor Ludlam did not issue such individual invitations. As a result, information reached his patients on a piecemeal basis over a long period of time and some were left ill-informed.

Mark

33.401 Mark's case is perplexing. Ms Reynolds' evidence cannot be accepted as it has no adequate time reference and is in too general terms to have dealt with the long period of time that passed before Mark was told of his diagnosis. During much of that time, Mark was seen by another doctor. Professor Ludlam explained that he felt that it was important for Mark to know of his diagnosis on a number of grounds. He spoke of an initial unsuccessful attempt to tell him in 1986, detailed in his notes, together with two further attempts. One was, potentially, to visit his home and the other was when he was seen by, as Professor Ludlam put it, 'one of our very able young doctors'. That doctor was Bernadette Auger. Dr Auger's note dated 20 March 1989 is a clear, contemporaneous and full account of her consultation with Mark and is accepted as accurate, true and reliable.^[523] It cannot be reconciled with Mark's evidence and especially the frequent repetition of the recollection that he always said: '[t]ell me if there's anything wrong', in resisting detailed information about test results. It appears that Mark did resist information about his test results more generally and that that was understood by the clinicians treating him.

33.402 There was considerable discussion with Professor Nathanson about this situation. The developing knowledge about AIDS was relevant. In 1984 the implications of a positive diagnosis were unclear. As Professor Nathanson explained, by 1988 it had become clear that positive antibody status usually meant that the patient had the virus and that the prognosis was very poor. From 1984 to about 1988 there was effectively no treatment for the condition. However, from about 1987-88 doctors were aware that an HIV positive patient was susceptible to certain AIDS-related conditions which had to be treated quickly and aggressively with antimicrobials.^[524] In particular it was important to treat a patient quickly with pentamidine if they developed PCP.^[525]

33.403 Professor Nathanson's general evidence has been set out at length. So far as it bears on Mark's case, it can be summarised:

• A doctor could not force a patient to know the results of tests.
• A patient who refused to learn his results should be advised to act as if positive, so as to protect others.
• As means of helping infected patients developed - specifically with the introduction of antiretroviral medication in this case - the doctor would increase pressure on the patient to know the results.
• A point could be reached at which the doctor might consider forcing the knowledge on the patient because of the advantage of obtaining treatment.
• Before 1988 a doctor could not be criticised for not forcing patients to hear the results of tests.

33.404 Applying the ethical rules and guidelines, as outlined by Professor Nathanson, it is not possible to find that Professor Ludlam was in breach. It is fortunate that in Mark's case his contemporaneous medical records assist in determining what probably happened over two decades ago. Conversations, at such a distance in time, are unlikely to be remembered accurately by their participants although the gist may remain clear to them. It is, of course, difficult to explain the difference between Mark's evidence and that of the practitioners treating him. It is trite that the message spoken is not always the message heard. For obvious reasons, medical practitioners would be particularly concerned to advise those testing positive of their results. Mark does not dispute that he was seen on a number of occasions where reference was made to his test result. It may be that he assumed that if he was positive the result would simply be passed on to him. That was not the policy at the RIE until treatment considerations arose. Whilst being offered a test result on a number of occasions might alert some to the probability that the result was positive, it would not do so with others. There is no doubt from his evidence, and that of Professor Ludlam, that when Mark received his diagnosis, he was surprised. He does not seem to have assumed from the attempts to tell him his result that it was, in all probability, because it was positive. Mark's evidence that he was 'stunned' on hearing the news of his diagnosis, is accepted.

Glasgow

33.405 It is not possible to reconcile the several sources of evidence of practice at the GRI, from Professor Forbes, Professor Lowe and Dr Wilkie. Specific difficulties with their evidence have been noted above. How and when patients were told the results of anti-HTLV-III testing is unclear.

33.406 Dr Follett had clearly been carrying out some HTLV-III tests as early as January 1985. The notes in David's case are unequivocal: he was tested and found HTLV-III negative on 25 January 1985. That was before any counselling protocol had been considered, much less implemented, and in particular was probably before Dr Wilkie became actively engaged in advising haemophilia patients about HTLV-III infection.

33.407 The circular letter dated 8 January 1985 which was sent to all patients registered at the West of Scotland Haemophilia Centre at the GRI contained no indication that the individuals found positive had been, or indeed would be, informed of the positive findings in their cases. On the contrary, the clear indication was of a new initiative to investigate virus exposure and monitor all patients who had received concentrate therapy.

33.408 From its terms, the letter of 8 January 1985 sent to patients registered at the Glasgow Centre was not addressed to people who were expected to have had prior knowledge of the results from the tests carried out by Dr Gallo or who had attended the meeting on 19 December 1984. Nor did it indicate that among the patients addressed were some for whom test results were available. The opening paragraph, referring to newspaper and television reports, would not be appropriate in a letter addressed to individuals who had been invited to a meeting at which Professor Forbes and Professor Ludlam had spoken on the topic of AIDS. The invitation to attend and have a test which 'we ... now' had available, despite the prior knowledge that 10% of patients had already been found antibody positive, may appear obscure unless the 'we' is taken as meaning Glasgow. The original testing was done in the USA. In any event, whatever reservations may exist in relation to the wording of this letter, it is clear from its terms that the recipient of it would not be aware after reading it that he had been tested and could obtain his results from the centre.

33.409 There is no contemporaneous documentation to corroborate Professor Forbes' recollection of communicating the results of the Gallo tests 'as soon as possible' after November 1984. Whilst Professor Lowe, who has a good recollection of events, made it plain that it was his colleague's clear intention to do so, he also indicated that Professor Forbes had reservations about the accuracy of the Gallo test. Professor Forbes said in his evidence that he considered that confirmatory testing of the Gallo results was necessary. Neither Professor Lowe's evidence nor Dr Wilkie's suggest that either of them dealt with any patients who had received their Gallo test result. There can be no doubt, in the climate of AIDS fear then extant, that any patient advised of a positive result would be likely to consider it something akin to a death sentence. The catalyst for the appointment of Dr Wilkie, a social scientist, appears to have been the obtaining by Professor Forbes of the positive test results, suggesting that he was alive to the possible social and economic consequences of a positive diagnosis. Undoubtedly, Dr Wilkie will have further refined Professor Forbes's understanding of the likely impact of a positive result. Other documentation suggests that HTLV-III test results were communicated at the earliest after March 1985 and, in some cases, after 1986. In the circumstances, it seems probable that Professor Forbes changed his mind and decided not to pass on the results obtained by Dr Gallo's unlicensed tests until they had been confirmed by Dr Follett. Whilst that sequence of events may not accord with Professor Forbes' memory, it would be consistent with his colleagues' high opinion of him and understandable in the circumstances then prevailing.

David

33.410 Professor Lowe's evidence, and that of Dr Wilkie, suggested that the policy at the GRI was that patients should not have their blood tested for HTLV-III before they had received counselling about the implications of the test. Regrettably, this does not appear to have happened in David's case, and his evidence in this matter is accepted. It seems, from the medical records, that when he was seen in January 1985 he was negative for the virus and was provided with Haemophilia Society leaflets. Dr Wilkie only began interviewing patients in the late summer of 1985. When David was seen on 8 November 1985 it was by an unknown doctor, who appears to have taken blood and submitted it for testing without either obtaining consent for the test or providing counselling. Consequently, when Professor Lowe saw David on 2 December 1985, his patient had not been prepared for receipt of his results. In the circumstances, it is entirely understandable that David should have felt angry. His reaction confirms the wisdom of the counselling programme pioneered at the GRI, but suggests that it did not always proceed as intended.

33.411 David's evidence about the manner in which Professor Lowe told him his diagnosis gives one patient's perspective of receiving such information from a clinician. It is, perhaps, illustrative of the difference which may sometimes exist between how a clinician believes he is conveying such a diagnosis and how the patient perceives he has been told of the diagnosis. A number of factors, in addition to the clinician's manner, will affect this perception. Breaking bad news is never easy, and Professor Lowe candidly admitted that he found providing such a diagnosis a difficult task to perform.

General comments

33.412 Until the events of 1982-84, and the questions relating to providing information to patients in 1985 and later, which raise specific issues, routine testing of patients' blood ancillary to diagnosis and the prescription of proper care and management was standard practice. Consent was not normally sought for specific investigations, as distinct from the physical act of taking blood which could clearly not take place without the patient's consent, either express or implicit, in the act of extending an arm for preparation by ligature, puncture and for the withdrawal of blood. Dr Winter's written evidence to the Archer Inquiry (see paragraphs 33.176 to 33.180 above) is accepted. For a considerable period before 1988, clinicians saw it as part of their responsibility to their patients to monitor for infections. It was perceived to be a core part of patient care and not something to be discussed with patients.

33.413 It is an almost inevitable consequence of the paternalistic attitudes in the early 1980s together with the relative ignorance of the significance of the AIDS virus at that time, that in the absence of appropriate professional guidance some clinicians would consider AIDS-related investigations to have the same character as established investigatory/monitoring tests for which no specific consent required to be sought. The rate at which doctors realised that this new infection required a different response, particularly in regard to the provision of information and the obtaining of consent for testing, would vary within the profession. Such realisation of the need for a change of approach would depend upon many things including experience and attitude.

33.414 As events were to prove, but unknown to clinicians generally until 1984, AIDS transmitted by an infective agent was a material risk associated with all forms of factor therapy in the early 1980s. The commercial pharmaceutical industry responded to the risk by introducing early forms of heat-treated products in 1984, although evidence of their effectiveness was lacking at that stage. Selection of products for therapeutic use had become more problematical. It is from mid-1984 and into 1985 that issues relating to the provision of information about the products offered and about the risks associated with them became real, ultimately giving rise to a need for informed consent to treatment on the part of the patient.

33.415 There is a distinction between the risk of transmission of AIDS and the risk of transmission of NANB Hepatitis which it is important to note. AIDS was a new disease. With the exception of those patients being introduced to factor therapy for the first time, most coagulation disorder patients at risk of NANB Hepatitis would have been exposed to the infective agent (usually the Hepatitis C virus, as events were to show) before it was realised that the risk of transmission was virtually universal from first treatment with factor concentrates, of whatever origin. When that was appreciated, there was little that could be done to protect established patients. AIDS presented a new and distinct risk to long-established patients as well as to previously untreated patients. When the risk became real, it was greater for patients with severe coagulation disorders, for whom effective therapy required heavier concentrate usage. It was also greater for those using commercial concentrates. Since a majority of those established on concentrate therapy in the early 80s were patients with severe coagulation disorders, there was a risk that a very significant proportion of patients would contract AIDS. The risk was higher in England and Wales due to their greater reliance on commercial concentrates.

33.416 A very significant number of patients did develop AIDS. This was not anticipated, however, and was not generally understood until late 1984 or later. Some clinicians in England and Wales did change from concentrate therapy to the use of cryoprecipitate in 1982 and 1983 but that was by no means general. The priority remained the provision of effective treatment for haemophilia and other coagulation disorders. That is the practical context in which the ethics of clinical practice must be considered.

Scottish practice: the ethics of providing information about HIV/AIDS, risk from treatment and seeking consent

33.417 It is clear from Professor Nathanson's evidence that today failure to discuss treatment with patients and to obtain their consent to treatment would be unacceptable. That appears from the General Medical Council booklet Consent: patients and doctors making decisions together discussed in Chapter 32, An Investigation into the Systems in Place for Informing Patients about the Risks - Ethical Context.^[526]

33.418 In contrast to her evidence on practice in relation to HCV, there was little controversy about Professor Nathanson's evidence relating to the ethical principles and rules applicable to clinical practice in respect of HIV/AIDS in relation to the late 1980s.

33.419 In respect of the provision of information relating to tests, again, context is important. As described by Professor Ludlam and Professor Forbes, routine blood tests were long-standing aspects of the treatment, or management, of the patient as an individual and provided information of immediate clinical importance to the patient. However, it is also apparent that in any teaching hospital with a research agenda, the accumulation of data from testing individuals would inevitably have wider significance, increasing general knowledge of the index condition and the direct effects and side-effects of any treatment that followed. It would not be unreasonable to expect the individual patient to understand that his data contributed to the general store of knowledge from which all other patients in the care of the one clinician or clinical team would take benefit and to expect that he would similarly benefit from advances in knowledge achieved from the management and investigation of other patients.

33.420 It is really inconceivable that it would be otherwise. Ordinary clinical practice, as described by Professor Ludlam, involved discussions in the course of ward rounds with junior doctors and students. Research projects were discussed, and patients were asked to cooperate by participating, in the ordinary course of events. In the real world of medical wards in teaching hospitals, patients are not insensitive to what happens around them. While his research interests, or those of his colleagues in Glasgow, may not have been understood, that they had research interests would have been known to regular patients and, through them, to the close community of coagulation disorder patients attending the hospitals as a whole.

33.421 It follows that a clinician intending to carry out a particular testing programme should have been conscious of the need to structure the approach adopted and, in particular, the information given to patients about the tests and any consent sought for the tests to be carried out, so as to reflect the likelihood that some information at least would become widely known among patients, as well as having a wider professional application. So far as the evidence shows, the issues around the approach to testing arose first in Edinburgh and Glasgow in relation to the immunological studies carried out on haemophilia patients in 1983.

33.422 As set out in paragraphs 33.173 to 33.174 above, the considered view of the UKHCDO in December 1984 was (a) that testing of patients should proceed; (b) that it was for individual clinicians to decide, having regard to the circumstances, whether an individual testing anti-HTLV-III positive should be informed of the result; and (c) that advice should be given to patients about the risks associated with sexual transmission and steps to be taken to protect spouses and other partners. There was no stipulation in Professor Bloom's advice of 14 December 1984 for patient consent to testing. Indeed it can be inferred that consent was not considered to be required since disclosure of the result was discretionary and that is inconsistent with a principle of patient involvement in the decision to carry out a test in the first place. This is significant in considering the steps taken in Edinburgh and Glasgow, since the advice of the Reference Centre Directors is a clear expression of the ethical stance of this professional group at a critical time in the evolving picture. It is important to bear it in mind in considering Professor Nathanson's evidence.

33.423 Professor Nathanson explained that in order to carry out an HIV test in accordance with BMA and GMC guidance current from 1988 it is necessary to (i) obtain a patient's valid consent and (ii) ensure that the results are offered to patients. She said that in current practice clinicians are expected to offer 'pre-test counselling' to patients before HIV testing. This will include full information about the test and the implications of a positive result. The practical result of following this procedure is that, if a patient tests positive, they will already know the implications of the diagnosis. Pre-test counselling helps to remove some of the shock and surprise that a patient might experience on being told of a positive diagnosis.^[527]

33.424 It is clear that the practice described by Professors Ludlam and Forbes of taking an apparently routine blood sample from a patient on an apparently routine visit, storing it in the deep freeze and later sending it for an HTLV-III antibody test without informing the patient would not be acceptable today. It is also clear, however, that standards were different in 1984.

33.425 As Professor Nathanson noted:

When the first diagnostic test for HIV disease (in fact a test for antibodies for what was then called HTLV III) became available in 1984 there was considerable debate over whether those for whom a test might be considered clinically relevant needed to be asked for consent to the test.^[528]

33.426 In the early days of testing many believed that HTLV-III antibody tests could and should be carried out without consent and that taking blood for the test at the same time as other routine medical tests would mean that necessarily implied consent had been given.^[529]

33.427 Professor Nathanson expressed the view that, while testing for HTLV-III antibody without consent was not the 'gold standard' of medical practice, it was common practice in the early 1980s. She said that she would not be critical of clinicians who had not conducted their practices in accordance with the 1988 guidance before that date. She explained that, until the GMC guidance was published, much of the advice on consent concerned consent to treatment rather than consent to testing. The advice published by the GMC in 1988 helped to close the argument about consent for testing.^[530] She explained:

The question is: does that mean that anything that the doctor wants to test that blood for, you have given necessarily implied consent for? And I would say that in the mid 1980s that was the issue about which people were discussing, and I think we really came to the conclusions that you might say that there were certain tests that were so routine, that are so often done, that you were necessarily consenting to them without being given the details.

....

But it was felt [by the date of publication of the GMC 1988 guidance] that a test for HIV was sufficiently different because of the clinical uncertainty, what did a result mean, and because of the social consequences, that you needed to get a specific consent to say that.^[531]

33.428 Professor Nathanson said that the current approach to HIV testing has not changed much since the 1988 guidance, which applies to consent to testing as much as it does to treatment. In contemporary practice clinicians are expected to offer full information to patients about all tests they intend to perform. To supplement the basic guidance set out in Good Medical Practice, the GMC produces a booklet on consent. 'Good medical practice' is not a body of formal rules, however, but rather a set of principles and values on which good medical practice is founded. The supplement, Consent: patients and doctors making decisions together (May 2008) provides more specific advice.^[532] The clear advice is that testing for HIV now requires specific consent.

33.429 However, Professor Nathanson explained that the 1988 guidance was the first time that the GMC was explicit on the topic. In the late 1970s, it would have been extremely rare to tell patients everything about their care. The 1988 guidance was part of the 'evolution towards patient-centred care'.^[533] She said that between 1984 and the 1988 guidance, not fully informing the patient 'wasn't best practice but it was understandable and widespread and something that was becoming less understandable and less widespread, if you like, diminishing'.^[534]

Glasgow and Edinburgh compared

33.430 At the end of 1984, Professors Forbes and Ludlam found themselves in the position of having HTLV-III test results for some of their patients. Those tested were unaware of the tests and, in many cases, unaware that they were even at risk of infection. Obviously, no pre-test counselling had been carried out. The initial attempt to communicate the existence of such results to east of Scotland patients at the meeting was largely ineffectual. Attempting to communicate such sensitive and life-shattering information by such means was ill advised. The response in the west of Scotland was more conventional and, in the long run, seems to have been more effective.

33.431 At the end of 1984 there was no consensus amongst haemophilia clinicians in relation to the communication of HTLV-III test results to patients. There were effectively three schools of thought on this matter:

1. All patients should be told their test results regardless of their wishes.

2. Patients should not be told their results and should all assume that they are positive.

3. Patients should only be told their results if they asked for them.

33.432 Professor Nathanson recognised that the situation was 'extraordinarily difficult' and that many doctors did not communicate results of HIV tests.^[535] She explained, however, that in 1984 the 'gold standard' for a clinician in that position was to offer the information to their patients. In Professor Nathanson's view, Professor Ludlam's approach of offering his patients information rather than simply telling them their results, and thus forcing them to know their antibody status, was reasonable. It would not have been up to the 'gold standard' for Professor Ludlam to have either withheld the test results from patients or to have told the patients their results without ascertaining whether or not they actually wanted to know them. Professor Ludlam's approach of not telling patients their test results unless they asked for them was consistent with the UKHCDO advice and it is clear that many doctors at that time considered that testing for HIV was simply an extension of the monitoring of patients which was already being done.

33.433 Professor Nathanson said that she would be critical of a clinician who had test results for his patients but did not make it clear to them that results for them were available. She felt that the way to do that was by writing to them. While this is more of a practical consideration than an ethical question, in her view a clinician who has decided to offer his patients information about their test results (and many did not at that time), in order to do so properly had to tell the patient clearly that information about them was available. When asked about how to approach communicating results she said:

I think that really depends upon how often you see the patient and what the relationship is with the patient. That would be equally true today in the sense of communicating results. The clear issue is of course to make sure that the patient knows, or is given the availability of that knowledge, as early as possible.

In 1984 that would almost certainly have meant writing to patients and saying, "We have information available, please make an appointment to come and see me if you want to know that information." If you have patients that have routine appointments within the next few weeks, you could probably not write to that group but you must make sure that they are seen, and if by any chance they don't come to those appointments, then make sure they get an offer of another appointment quickly.^[536]

33.434 Professor Ludlam was told by the reporter from The Yorkshire Post that he intended to publish the details of the positive test results in the Edinburgh haemophilia population. The Inquiry has not heard evidence from the reporter concerned. It is almost certainly the case that information was leaked to the newspaper by a person to whom it had been imparted on a confidential basis. The motives behind the decision by the newspaper to prepare and publish a report are not known. But the involvement of the paper was the immediate cause of hasty resort to a public meeting. This was an unsuitable mechanism for release of such sensitive information about the health of patients.

33.435 Dr Wilkie described, graphically, attitudes to HIV-positive individuals at about that time. She explained that they were viewed as 'lepers', or 'dirty patients' and subjected to humiliating, and unnecessary, precautions in order to ensure that they did not infect others.^[537] Out of fear of such consequences, sufferers routinely concealed their diagnoses. However, unlike the other groups particularly at risk of the infection such as IV drug users or homosexuals, haemophilia sufferers tended to be known in the communities in which they lived, their condition unconcealed from family, friends, workmates and acquaintances. Having begged the reporter to delay publication, and been allowed one week, Professor Ludlam wrote invitations to the meeting that same day. As a vehicle for the transmission of sensitive information, the meeting's shortcomings do not require to be re-rehearsed here. Considering the need to get information to as many patients as possible, imparted by him personally and as quickly as possible, it was the option he chose. It would not have been, he explained to the Inquiry, his 'first choice, given a completely blank sheet and without other constraints'.^[538]

33.436 It is clear from the evidence that Professor Ludlam attempted to prompt his patients into inquiring about their test results by means of the meeting, the circular and the covering letter. If they attended the RIE, he decided, depending upon the circumstances of their visit, whether to initiate a conversation about AIDS or encourage them to seek their results. His approach was based, in part, on his awareness of the consequences for them of knowing that they had been tested, and the significance of a positive or a negative result. It is clear that he considered two matters of particular relevance in making that decision. Firstly, the fact that no treatment for the condition then existed and, secondly, the fact that all haemophiliacs were being advised to adopt precautions as if they were infected. If a patient did not attend the RIE no communication was sent to them as a further prompt.

33.437 Despite the meeting of 19 December, the circular and these discussions, Professor Ludlam did not make it sufficiently clear to all of his patients that they had to ask him if they wanted to know their results. He could have made appointments for every patient who used factor concentrates to be seen by him, by Mrs Brown or by both. He could have sent out appointments with the circular in the way Professor Forbes did with his letters of January and April 1985. He could have started with the 40-50 patients who had already been tested. He could have met with patients in early 1985 and made sure that they were individually fully aware of the situation, that he had HTLV-III test results for them, where that was the case, and that he would give them the results if they asked for them. He could have been more explicit about this without insisting that they knew their test results. If Professor Ludlam had done something along these lines, it is likely that by the end of 1985 all patients would have known their HTLV-III status except for patients who did not want to know.

33.438 In the result, some patients were angry that they had not been told of their diagnosis sooner or at all, and some were glad that they remained in ignorance for so long. As might be expected, as his knowledge of the virus and its effects increased and the possibility of treatment emerged, Professor Ludlam became increasingly proactive in his approach. To modern sensibilities, paternalism and the 'Doctor knows best' approach are anathema but in considering judgements made in the early and mid 80s, it has to be taken into account. A quite different approach would be taken nowadays but that is in large part because of the effect that the emergence of the AIDS virus has had on medical ethics.

33.439 The position in the west of Scotland is complicated by the inconsistencies in the evidence relating to it, and Professor Forbes' memory difficulties. On balance, it is concluded that the only testing carried out prior to that executed by Dr Follett was that done in the USA by Dr Gallo. Further, it is concluded that, despite his recollection to the contrary, Professor Forbes did not pass on the results of the Gallo tests to his patients before confirmatory testing was undertaken by Dr Follett. It is clear that it was his intention to pass them on, Professor Lowe attested to that fact, but the evidence suggests that Professor Forbes must have changed his mind and the reservations he expressed about the reliability of the research assay provide both an explanation and a justification for that course of action. It cannot be concluded that that practice, in itself, involved any breach of the norms of ethical behaviour of the time.

33.440 It should be noted that with the emergence of AIDS, an entirely new disease, almost all haemophilia clinicians found themselves in an extraordinarily difficult situation. Due to the chronic nature of haemophilia, those clinicians had known and treated many of their patients since childhood. They had seen many of those patients' lives transformed by the introduction of concentrates, and rejoiced with their patients. As knowledge of the AIDS virus increased, so did the realisation amongst those clinicians that the treatment they had prescribed to alleviate their patients' primary condition, had also transmitted a potentially fatal viral infection. In the early days, they knew almost nothing about the disease and its natural history and could themselves only pass on the little they knew. As more was learnt about the virus, they endeavoured to alter their practice in accordance with that knowledge. They had received no guidance or training for the unprecedented circumstances in which they found themselves.

33.441 Whilst initially the medical profession knew little about AIDS, those they were treating knew less and depended upon the professionals for guidance. In a paternalistic age, those providing such guidance aim to reassure and to comfort the patient, on the basis that 'Doctor knows best'. Equally, those receiving such guidance do not tend to question it, feeling entitled to rely upon it. Inevitably, if that guidance proves wrong and patients suffer, or die, in consequence of it, some of those patients may, entirely understandably, feel both angry and betrayed. If a new, potentially fatal disease like AIDS were to emerge today it is likely that patients would be made aware of the medical profession's ignorance of it and share all the uncertainties and anxieties consequent upon that. Unfortunately, patients would, in all likelihood, still suffer and die. Anger against the disease and all of its consequences would probably be felt. But there would be no sense of betrayal. On the evidence, in relation to the procedures adopted for testing patients' samples for HTLV-III and the communication of test results, there was no breach in Edinburgh or Glasgow of any rule or principle of ethical conduct then applicable. In the circumstances, where many patients died, and many continue to suffer today, some crumb of comfort may be gained from the fact that due to HIV/AIDS and its fallout, all patients must now be treated in a patient-centred way and the last vestiges of paternalism have largely been swept away. Being informed is now the patient's prerogative.

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34. An Investigation into the Systems in Place for Informing the Patients about the Risks - Hepatitis C >