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Chapter 34

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


34.1 The discussion in Chapter 33, An Investigation into the Systems in Place for Informing the Patients about the Risks - HIV/AIDS, sets the scene for this chapter. The previous chapter dealt with relationships between doctors and patients, from the beginning of the AIDS epidemic in 1982 to about 1985, with particular reference to HIV/AIDS. In that period, it became clear that NHS blood disorder patients had acquired the HIV virus and the focus in clinical and ethical practice shifted towards the management and care of patients infected, or suspected to be infected, with that condition. The lessons learned in that context were available to instruct doctors in the management and care of patients, as it came to be understood that non-A, non-B Hepatitis (NANB Hepatitis) was a potentially more serious disease than had generally been thought up to the end of 1985. In that period NANB Hepatitis was not entirely overlooked, even at the height of the AIDS epidemic. For the most part, however, it was a secondary consideration in an environment dominated by the threat of AIDS.

34.2 Developing knowledge of viral hepatitis has been traced in Chapters 14-16, Knowledge of Hepatitis 1 to 3. This forms the background to the discussion that follows.

Scope of the chapter

34.3 This chapter deals with the evidence on the information and advice given to patients, and where appropriate to their parents, in Scotland in the course of the reference period with regard to NANB Hepatitis/Hepatitis C. More specifically it considers:

  • Questions relating to the choice of therapeutic products in treating blood coagulation disorders and, in particular, understanding the risks of contracting NANB Hepatitis, from 1974 onwards.
  • The information given to patients about those risks.
  • The investigation and management of patients' conditions with regard to symptoms of NANB Hepatitis/Hepatitis C.
  • The understanding of risks associated with HCV once tests for infection had became available, including pre-test counselling.
  • The communication of results to patients who were found to be infected with HCV.
  • Practices at centres in Edinburgh, Glasgow and Dundee are examined in some detail as these developed over the reference period. Practitioners from these centres were able to give evidence to the Inquiry in relation to practices there.


34.4 The information available to doctors on which to base their advice to patients, having regard both to what was generally accepted in the medical profession and what was in the public domain, varied widely both over time and across the UK and other western countries. In Chapter 32, An Investigation into the Systems in Place for Informing Patients about the Risks - Ethical Context, Dr Charles Hay's evidence was relied upon as illustrating best clinical practice. That was appropriate since in some respects his practice reflected at an early stage an understanding of NANB Hepatitis that was not shared generally and involved a more demanding level of communication of NANB Hepatitis infection than would have been practised elsewhere. In this chapter it is appropriate to take note of distinctions between Sheffield, one of the places where he worked, and other centres.

34.5 As noted in Chapter 21, Haemophilia Therapy - Use of Blood Products paragraphs 21.161-21.171, on 26 April 2011 the Inquiry viewed two World in Action documentaries called 'Blood Money' which were first transmitted in 1975.[1] The programmes dealt with blood products and the transmission of viral infections in haemophilia patients receiving replacement therapy with factor concentrates. The programmes did not deal with the risks of transmission associated with transfusion of whole blood or blood components in general medical and surgical practice. In relation to HBV, which was then understood to be the main pathogen threatening recipients, the programmes were explicit reminders, if reminders were needed, that the risk of transmission of viral hepatitis was inherent in factor replacement therapy.

34.6 In one respect at least, patients with haemophilia or other blood coagulation disorders, or the patients' parents, were in a better position to inform themselves of risk than others receiving transfusions. It was clear from what patients and their parents said in the television documentary that in the 1970s many haemophilia patients were aware that there was a risk of contracting hepatitis from the use of factor concentrates. In the later years of the decade, there was published material on the risk of transmission that was available to members of the Haemophilia Society. David Watters, General Secretary of the Society between 1986 and 1994 (and Coordinator for five years before that), explained that this risk was discussed in Haemophilia Society Newsletters from 1978.[2] It is clear from the evidence of clinicians noted later in this chapter that the Society's leaflets were in circulation in haemophilia centres. There was a body of shared information, often backed by expert authors and commentators, available to patients and haemophilia clinicians alike.

34.7 The natural history of NANB Hepatitis was not well understood, however, until the second half of the 1980s, at the earliest.[3] In the mid-1970s discussions of viral hepatitis almost certainly referred to the then well-known risk of contracting Hepatitis B. By 1975, screening for Hepatitis B Virus (HBV) in blood donations had become standard practice in the USA and in Europe, though high sensitivity in screening tests was not achieved until the end of the 1970s. Progressively, there was increasing confidence in the effectiveness of the methods used to identify infected blood and to exclude it from therapeutic use.

34.8 The extent of the problem of transfusion-associated transmission of NANB Hepatitis did not begin to become apparent until about 1978.[4] Even then it was not generally thought to present a risk of comparable order to the risks associated with bleeding in coagulation disorder patients. Until the later 1980s there was no general consensus in the medical profession that NANB Hepatitis infection was associated with serious liver disease. Even at that point, some commentators thought that the condition was not a matter of serious clinical concern.

34.9 For the purposes of this chapter, it is interesting to compare the treatment of NANB Hepatitis in successive editions from around this period, of Dr Peter Jones' (Newcastle Haemophilia Reference Centre) book, Living with Haemophilia. The book is a guide that was widely distributed among patients and their families. The first edition, published in 1974, discussed 'serum hepatitis' briefly and described its transmission by the 'Australia', or 'hepatitis-associated', antigen. It was presented as a rare but important side-effect of blood transfusion. The second edition was published in 1984. The book now dealt with Hepatitis B extensively, less so with Hepatitis A, and only briefly with NANB Hepatitis. It identified hepatitis generally, inflammation of the liver, as one of the most important side-effects of blood transfusion. It commented that, 'if the infection is marked enough jaundice may result', and continued:

We know that many liver infections are not severe enough to result in the appearance of jaundice; they show themselves as mild, transient periods of feeling unwell, or only as changes in liver function measured in the laboratory. One of the reasons for following up people with haemophilia carefully is to monitor these changes.[5]

34.10 The second edition of the book noted the three types of viral hepatitis then known and said:

Hepatitis non-A, non-B results from infection with one of at least three viruses, none of which has ... been positively identified in the laboratory ....[6]

34.11 It commented on the NANB Hepatitis viruses:

The incubation periods for these viruses appear to be short, in some cases only a matter of days. There is evidence that haemophiliacs have multiple episodes of NANB Hepatitis, most going unnoticed, although the first attack is sometimes accompanied by the appearance of jaundice. The NANB agents are important because, as with hepatitis B, the infection they cause can lead on to chronic liver disease. No way of protecting recipients from NANB Hepatitis is known.[7]

34.12 The third edition (1990) introduced the term 'transaminitis' for the 'condition', identified by changes in liver function measured in the laboratory.[8] The comment on NANB Hepatitis was in substantially the same terms as the 1984 edition, but added that donor testing for Hepatitis C was just being introduced.[9] Dr Jones did not equate 'transaminitis' with NANB Hepatitis or otherwise suggest that liver function test biometrics were monitored as specific indications of infection with NANB Hepatitis.

34.13 There were two parallel trends: increasing confidence in the effective screening of donations to exclude blood infected with Hepatitis B and slow, and late, developing knowledge of the serious risks associated with NANB Hepatitis. Dr Jones' comments in the 2nd edition of his book indicate that by 1984 he was taking a more serious view of NANB Hepatitis than he had in the 1974 edition. These books form important background material in considering the provision of information and advice to patients who, generally, had underlying blood coagulation deficiencies that exposed them to the risk of serious, and in some case life threatening, episodes of haemorrhage.

34.14 In their 1974 report, the UK Medical Research Council (MRC) Working Party on Post-Transfusion Hepatitis included in their definition of 'hepatitis' a finding of enzyme elevation in association with other clinical indications of hepatitis, typically jaundice.[10] Since this was a definition of 'hepatitis' generally, it was as applicable to the postulated NANB Hepatitis as it was to Hepatitis A and B.

34.15 In August 1975, Dr John Craske of the Public Health Laboratory, Dorset, published data on an outbreak of hepatitis following the infusion of commercial Factor VIII in the Bournemouth Haemophilia Centre.[11] The criteria for diagnosis were jaundice or raised transaminase levels associated with compatible history and clinical signs of infection.[12] With this publication, NANB Hepatitis had been recognised and reported from a UK haemophilia centre.

34.16 In 1978 doctors at the Royal Hallamshire Hospital, Sheffield, published the results of liver biopsies carried out on haemophilia patients with persistent abnormal liver function test results.[13] A wide spectrum of chronic liver disease was found that bore no relationship to clinical history or biochemical findings using tests available at the time. They concluded that a large proportion of haemophilia patients receiving treatment with Factor VIII had chronic liver disease and that NANB Hepatitis may well have been an important factor. This was supported by observations in half of the cohort of patients studied. The paper did not say that abnormal liver function amounted to a diagnosis of NANB Hepatitis but it provided evidence that a clinical history of hepatitis was not essential for proof of infection.

34.17 On 4 July 1981, an editorial in the British Medical Journal (BMJ) stated that a NANB Hepatitis diagnosis was usually inferred from abnormalities in the results of hepatic biochemical tests rather than from clinical evidence.[14] It referred to the biopsy-based research at Sheffield as indicating that changes in liver architecture were consistent with previous viral assault. The editorial also referred to Scottish research by Stirling et al. That research looked at Edinburgh patients treated with SNBTS Factor VIII who, followed over a five year period, had no symptoms or other objective clinical evidence of liver disease but did have ALT abnormalities. The authors suggested that, 'Possible causes include repeated infection with as yet unidentified non-A, non-B hepatitis viruses'.[15]

34.18 The next stage was the research initiated by Dr Hay following his return to Sheffield in 1983 that resulted in publication in 1985 of the provocatively entitled article, 'Progressive Liver Disease in Haemophilia: An Understated Problem?'.[16] In the interval between 1978 and 1985 Dr Hay and his Sheffield colleagues were in the vanguard in recognising NANB Hepatitis as a potentially serious condition and in reporting it in the absence of objective clinical evidence before liver biopsy was widely practised, particularly on haemophilia patients. His evidence of what patients would have been told about the condition distinguishes him from others who continued to follow the MRC definition of hepatitis.

34.19 Dr Hay said that in the mid- to late 1970s very little would have been said to patients about the risk of viral infection. From the late 1970s most regularly reviewed patients would have had liver function tests conducted and he expected that most of those affected would have been told that they had NANB Hepatitis, but that it was probably nothing to worry about.[17] His evidence about a diagnosis of NANB Hepatitis prior to 1983 is unlikely to have reflected universal practice, however, given the general adherence to the MRC definition of 'hepatitis', but the advice that NANB Hepatitis was probably nothing to worry about would have been consistent with the prevailing view, which continued into the mid-1980s. Professor Sherlock's discussion of viral hepatitis in the 1981 edition of her standard textbook, Diseases of the Liver and Biliary System, indicated that the clinical course of NANB Hepatitis often involved a mild chronic hepatitis, but that the prognosis, while still uncertain, was probably benign.[18]

34.20 In the mid-1980s it began to be recognised, first by hepatologists and some other specialists and later by the medical profession more generally, that infection with NANB Hepatitis could potentially be associated with more serious liver disease than had previously been thought. The risk of acquiring NANB Hepatitis had become the predominant concern in respect of the transmission of viral hepatitis following the transfusion of blood or blood products. The view of relative risk highlighted in the World in Action programmes had become more significant although, ironically, by that time the risk of transfusion-acquired Hepatitis B (the 'hepatitis' of the 1975 documentary) had become negligible.

34.21 By the end of 1983, it was understood by haemophilia doctors that all factor concentrates, NHS or imported, carried a risk of transmission of NANB Hepatitis. Dr Craske's 1982-1983 Annual Report for the UKHCDO's Hepatitis Working Party, produced on 28 September 1983, noted that a prospective study begun in 1981 had confirmed that there was a near 100% risk of contracting NANB Hepatitis from Factor VIII concentrates on first exposure, whatever their source.[19] A report of that study, published on 10 December 1983, indicated that the diagnosis was based on elevated AST and ALT measurements and the absence of markers of other viral infections and clinical evidence of any other cause.[20] An editorial in the BMJ by Dr Jones noted that most post-transfusion hepatitis was now NANB.[21] However, he did not expressly link diagnosis to liver function test results, noting that abnormal results were found in most severely affected haemophilia patients who had repeated transfusions. There were conflicting views of the implications for patients of the changes in liver function then being observed. Dr Jones considered that most observed changes in liver function represented chronic persistent hepatitis rather than the more serious chronic active hepatitis.[22]

34.22 Other elements were to enter the wider picture, as noted in Chapter 33, An Investigation into the Systems in Place for Informing the Patients about the Risks - HIV/AIDS. The 'Tarzanoid' approach to imported US concentrates in about 1983 described by Dr Winter, reflected patients' views that Factor VIII concentrate of ('good') British origin was to be preferred over ('bad') commercial products. Dr Winter thought that patients were fully aware that they risked contracting hepatitis if they used US concentrates, as exemplified in the 1975 television programmes.

34.23 As the threat of AIDS came to be understood in and after 1983, the selection of products for therapeutic use became more problematical.[23] However, while the AIDS epidemic raised awareness of the risks of transmission of virus infection generally, it has to be borne in mind that understanding of the natural history of NANB Hepatitis had not matured. It is appropriate to consider in stages the provision of information and warnings to patients about NANB Hepatitis, as knowledge increased over this complex period. The first step is to examine what was said about viral hepatitis until 1983.

34.24 As is apparent from the discussion of practice in the three major centres in the Royal Infirmary of Edinburgh (RIE), the Glasgow Royal Infirmary (GRI) and The Royal Hospital for Sick Children, Yorkhill, Glasgow (Yorkhill), that product selection varied considerably between 1975 and 1985 and the response of individual clinicians to the perceived risks, and communication of those risks, must be considered in that context.

34.25 The data on product use accumulated by the UKHCDO has been set out in Chapter 21, Haemophilia Therapy - Use of Blood Products. In Scotland, with the exception of the two major regions centred around Glasgow and Edinburgh, there was little variation and, with the exception of a high use of FEIBA[24] in Aberdeen for particular patients, there was little use of commercial concentrates.

34.26 The risk of transmission of NANB Hepatitis was related to the prevalence of infection in the donor population. As discussed in Chapter 3, Statistics, estimating that value from time to time was difficult and there are questions whether a reliable pattern was established. However, there are some acceptable indicators of the general picture:

  • There was a statistically valid basis for estimating prevalence in September 1991.
  • Prevalence of NANBH infection in the donor population was negligible in 1970.
  • The introduction of self-deferral policies related to HIV/AIDS in 1984 is assumed to have had an immediate impact on prevalence in 1984 and a continuing impact from then until 1991.
  • While calculating actual and estimated prevalence values remains problematical, it is likely that historic peak prevalence was reached in 1983, followed by a fall in 1984 and a gradual progression to September 1991 values thereafter.

34.27 While none of this was, or could have been, known at the time, it appears that the risk of transmission of NANB Hepatitis was greatest for those treated first in the period up to 1983, fell significantly for those treated first in 1984 and grew gradually thereafter although by September 1991 it had not quite reached the estimated 1983 levels. The 100% prevalence of infection in haemophilia patients treated with concentrates found by Dr Craske at the end of 1983, coincides with the end of the period of highest exposure to risk. The information and advice that could have been given in the 1970s and early 1980s would not have pitched the level of risk at or even close to 100%, until the studies were published and the results validated for the UK generally and for Scotland in particular. In 1980 and 1985 respectively there were 408 and 443 Haemophilia A patients registered with Scottish centres. The vast majority of those would have been exposed to the virus by the end of 1983.

The evidence of patients and clinicians

Practice in Edinburgh and south east Scotland

The evidence of patients treated in Edinburgh

34.28 The witness given the pseudonym 'Mark' was treated in Edinburgh during the late 1970s and early 1980s and was introduced to home therapy in August 1981. Professor Christopher Ludlam wrote to Mark's local doctor on 13 August reporting his advice on the new treatment regime.[25] Mark recalled the risk of infection with hepatitis (and HTLV-III) being discussed at his clinic appointments, usually at the end of the appointment.[26] He described going down to England to stay with his grandparents and being given letters which he could hand over should he need to attend a hospital in England. The letters stated that he was to be treated with local Factor VIII only.[27] He told the Inquiry that he thought that there was more risk associated with commercial factor products[28] and that receiving only Factor VIII produced from voluntary Scottish donors was safer and carried less risk than the commercial products.[29] At Mark's regular clinic appointments blood samples would be taken and results from previous tests discussed. Mark knew that one of the tests was for hepatitis.[30] Although Mark believed that he was first made aware that he had Hepatitis C in 1997, his medical records disclose that, in December 1993, Professor Ludlam's clinical assistant had a long discussion with Mark about Hepatitis C after he was found to be antibody positive. The records also state that Mark was given an information leaflet about the virus and invited to attend a joint clinic.[31]

34.29 'James', the father of the witness given the pseudonym 'Frances', was aware of the risks of transmission of Hepatitis B when he was a patient of Dr Davies. In his case, Dr Davies agreed to experiment with early prophylactic treatment and recorded at the time, in April 1971, that the patient appreciated that there was a small risk of serum hepatitis from the transfusions.[32] At that stage, Hepatitis B was clearly the candidate virus. In a letter to the patient dated 9 July 1982, Professor Ludlam wrote:

Following our telephone conversation I enclose 2 letters. I hope they are satisfactory for your needs. I understand that you would like some factor VIII to take with you to [America]. If supplies permit we will try and let you have 40 bottles on [date]. Please could you phone in a day or two in advance to make arrangements to collect the factor VIII. If possible, whilst in [America] could you try and avoid the use of commercial factor VIII concentrates, as they may well give you hepatitis. I would suggest that you try and obtain cryoprecipitate for minor bleeds. Obviously, if you have a major bleed, then you will have to take the advice of the local [hospital] staff at the haemophilia centre and possibly have commercial factor VIII.[33]

In 1988 James, who had already been diagnosed with HIV, was referred by Professor Ludlam to Dr Niall Finlayson, Consultant Physician at the Gastrointestinal and Liver Service at the Royal Infirmary of Edinburgh as he was mildly jaundiced and his liver was enlarged.[34] Dr Finlayson diagnosed James with chronic liver disease and thought that this was probably caused by chronic non-A non-B Hepatitis virus from blood products. James died in 1990.

34.30 The witness given the pseudonym 'Elaine' told the Inquiry that her husband, Brian, was warned in general terms about the risk of a hepatitis virus.[35] As detailed in paragraph 5.235 of Chapter 5 it is likely that Brian was unaware before his death on 8 February 1992 (as a result of HIV) that he had acquired Hepatitis C. A blood test dated 13 January 1992 confirmed that he was positive for the virus. His wife, Elaine, did not find out her husband's diagnosis with Hepatitis C until 2002 when she went to her GP for testing after receiving information from the Haemophilia Society that patients who were HIV-positive were also very likely to be infected with Hepatitis C. She was concerned that she might have contracted the virus from her husband and have suffered, untreated, from the effects of it until 2002.

34.31 The husband of witness 'Laura', who has Haemophilia A and who transmitted Hepatitis C to Laura, was a patient of Professor Ludlam.[36] In 1993, he received a letter from the Haemophilia Centre in Edinburgh advising him that he might have been infected with a virus. He then attended the hospital for tests and, at a follow-up appointment, was told that he had acquired Hepatitis C. Laura's husband could not recall what was discussed at these appointments. Laura was tested by her GP for the virus, at her own instigation.

The evidence of clinicians: the use of blood products

34.32 In Edinburgh and the south east of Scotland, practice until 1980 reflected the policies of the Director, Dr Howard Davies. He used SNBTS material, cryoprecipitate and concentrates, almost exclusively throughout his period as Director. The pattern changed with the appointment of Dr (later Professor) Ludlam. There was a dramatic increase in the use of therapeutic products generally in 1980, and for the first time in the region that included, in 1980 and 1981, a significant amount of commercial Factor VIII concentrate. Thereafter use of commercial concentrate was relatively low, but sustained, until the late 1980s when transmission of hepatitis infection had ceased to be a material issue.

34.33 As Professor Ludlam understood the position, Dr Davies was very open with his patients about their situations. The patients he 'inherited' in 1980 had been looked after, as he put it, 'extremely well and obsessionally'.[37] They were very well-informed.[38] Professor Ludlam said that there was a lot of discussion in Dr Davies' period about how many different sorts of hepatitis viruses there might be and that Dr Davies felt that it was better for patients, if they were going to get hepatitis, to get 'the local type of hepatitis' because some of them might have immunity to it anyway having acquired the virus from the community, as happened with Hepatitis A for example.[39]

34.34 Having regard only to the pattern of use, Dr Davies' period was stable. Professor Ludlam's change of practice suggests that in 1980 and 1981 there was a new focus for clinicians and patients, with the emergence of new treatments and the way in which they were used, which might have included a review of practice relating to the provision of information, advice and warnings relating to risk.

34.35 From the record of products administered, Professor Ludlam's period in office began with fairly radical change. The use of SNBTS Factor VIII rose from 210,486 to 1,644,750 units. Use of cryoprecipitate rose from 694,190 to 1,212,470 units. In addition, 164,000 units of commercial product were administered. Over the next two or three years, most patients were put on home treatment with factor concentrates. By 1983 most patients with Haemophilia A registered with the Centre were being treated with SNBTS Factor VIII, though some received cryoprecipitate and some received commercial concentrates.[40]

34.36 Cryoprecipitate was used where clinically possible to treat patients who had either never or only infrequently been treated with concentrates, particularly people with mild or moderate Haemophilia A who were unlikely to require frequent treatment. Commercial concentrates were used where clinically indicated. Haemophilia B patients were treated with SNBTS Factor IX concentrate.

The evidence of clinicians: information about the risk of infection with NANB Hepatitis/Hepatitis C

34.37 Professor Ludlam provided the Inquiry with a statement on this topic.[41] In it he referred to a document entitled the 'Collective Response' of which he was one of the principal authors.[42] In his statement he said that the Collective Response reflected much of the practice in Edinburgh (and elsewhere).[43]

34.38 The Collective Response was prepared by current and recent haemophilia clinicians to set out the history of haemophilia care in Scotland. Professor Gordon Lowe explained that there had been discussions amongst past and present haemophilia doctors in their regular meetings at the Central Legal Office. It had been suggested by the legal team representing haemophilia clinicians that such a document might be a useful supplement to the various individual witness statements produced for the Inquiry, especially as it could encompass the views of people with relevant knowledge who were unable, or not required, to give statements in their own right. The document was drafted mainly by Professors Lowe and Ludlam, with the assistance of Dr Brenda Gibson, the Director of Haemophilia Care at Yorkhill Hospital during the period dealt with in the Collective Response.[44]

34.39 The Collective Response was written in sections. Professor Ludlam had already drafted a number of these as he had been involved in collating information over the years for various purposes. Around half of the completed document had been drafted by him from the perspective of the Edinburgh Haemophilia Centre.[45] Added to this was a section drafted by Professor Lowe and Dr Gibson giving their perspective on equivalent practices in the west of Scotland (GRI and Yorkhill). The entire document, as it then stood,[46] was sent to past and present Haemophilia Directors in Inverness, Dundee and Aberdeen to give them the opportunity to comment on its contents.[47] In the view of Professor Lowe, the revisions to the Collective Response at this stage were minor and there were 'relatively few changes' after he, Professor Ludlam and Dr Gibson had completed their drafts.[48] At the conclusion of the Collective Response there was a list of doctors and nurses who 'endorsed' its contents.[49] Professor Lowe ran through this list in oral evidence and gave a brief explanation of each individual's role.[50]

34.40 While the Collective Response was well-intentioned, not much weight could be given to it as evidence. Whether there was a general practice in Scotland is a question for the Inquiry, and not for the haemophilia clinicians, or for a sub-group of them. As the evidence was to unfold, it became clear that there was considerable variation in practice. However, Professor Ludlam was entitled to adopt the statement as reflecting practice in Edinburgh. He clearly wrote much of the document on the basis of his personal experience.

34.41 The Collective Response noted a problem that was common in Scotland and is accepted as accurate in this respect. Most patients with haemophilia who acquired NANB Hepatitis infection would have done so at the time of their first treatment with pooled factor concentrates or during their first several treatments with cryoprecipitate or fresh frozen plasma in the period following diagnosis. Many patients received their first treatment or treatments at a hospital that did not have a haemophilia centre.[51] In the south east of Scotland patients were treated at a number of district hospitals and in small hospitals in Edinburgh.[52] Local physicians may not have referred patients to haemophilia centres for many years and, when they did so, their referral letters would not usually state what information had been given to patients prior to their first treatment. In many cases, the information given in haemophilia centres would therefore have been given after the patient's first exposure to, and infection with, NANB Hepatitis/HCV.

34.42 In Edinburgh, haemophilia care was provided by a multi-disciplinary team that, from 1982, included a Haemophilia Sister who played a major part in interacting with patients on a day-to-day basis, especially in the early 1980s when very many patients still had to attend hospital in Edinburgh for treatment of acute bleeds.[53] Professor Ludlam said:

It was our policy to inform patients (and parents of children) of all the risks of haemophilia as well as its treatment, including hepatitis because virtually all recipients of blood products were likely to be at risk or suffer from, this complication .... This would have included the complications of haemophilia itself and of its treatment. Discussion of hepatitis, like inhibitors, would be important topics. Information leaflets and contact with the Haemophilia Society was encouraged.[54]

34.43 The Collective Response stated:

The risks of haemophilia and of its treatment, including hepatitis, were well explained by staff and regularly reinforced by haemophilia nurse specialists and doctors.


Such education started when patients were first referred to a Haemophilia Centre, and continued thereafter, e.g. at emergency attendance for treatment of acute bleeding episodes, clinic reviews, and enquiries by telephone, in writing or in person.[55]

34.44 From 1983 it was known that patients receiving clotting factor concentrates were at high risk of NANB Hepatitis infection.[56] The UKHCDO recommended the use of cryoprecipitate for patients with Factor VIII deficiencies and no, or limited, previous exposure to concentrates.[57] Professor Ludlam said that in the early 1980s he would have explained that he was administering cryoprecipitate to children to try to reduce the risk of contracting hepatitis, and avoiding the use of commercial concentrates because of the perceived increased risk of hepatitis in comparison to NHS concentrates.[58]

34.45 Professor Ludlam said that it was well known amongst patients in the early 1980s that there was a risk of hepatitis from treatment with factor concentrates and cryoprecipitate. Like others, he observed that in the 1970s and 1980s there was literature available from the Haemophilia Society that commented on the risks. Patients on home treatment or their parents signed consent forms in which the risk of infection was specifically mentioned.[59] The consent form was, however, very general in its terms, referring only to 'the risk of an allergic reaction ... and ... the problems associated with any transfusion, such as the risk of introducing infection or air into my vein'.[60]

34.46 Although Professor Ludlam said that he discussed the risk of hepatitis with some patients (if a patient became jaundiced then he discussed that with them and explained how it would have arisen, for example), he was unable to recall specifically whether or not he routinely discussed this issue with patients on an individual basis in the early 1980s.[61] While members of the multidisciplinary team may have implemented the general policy regarding the provision of information, it appears that Professor Ludlam himself would not have done so as a matter of course. He said that a lot of information provided to people with chronic disorders who are seen very frequently, is done on a 'need to know' basis as the need arises in their clinical care.[62] It seems that his practice was to give information as the occasion demanded, rather than as an aspect of programmed communication of information. He said that he probably would not himself have raised with his patients the topic of the different kinds of treatment that they could be prescribed, in the context of the emerging risk of NANB Hepatitis.[63]

34.47 Professor Ludlam explained that when patients first attended the Haemophilia Centre - usually having been referred by another hospital - it could be a stressful time, with the parents of children trying to assimilate a great deal of new information while also dealing with an upset child. He commented that these circumstances would not be conducive to the parents remembering everything that they had been told at that first attendance. These sessions were therefore followed up at an early stage by giving patients, and their parents, booklets about haemophilia, including information about hepatitis.[64] Patients and their families were also encouraged to make contact with the Haemophilia Society.[65]

34.48 The impression of a continuous educational process as described in the Collective Response, making use of every contact to provide information, was not sustained in oral evidence. Advice was given occasionally rather than universally, and the oral evidence of patients referred to above is consistent with Professor Ludlam's description of his practice: information was provided as he thought the occasion demanded, rather than in a structured and regular manner and this appears to have continued throughout the 1980s and into the 1990s.

34.49 Much of the circumstantial detail provided by Professor Ludlam supports this approach. Many of the patients had male relatives with haemophilia and they, or their parents, were aware of the risks of hepatitis from information circulating in the family. Severely affected boys on home treatment and their mothers were vaccinated against Hepatitis B and, when it became available in 1992, Hepatitis A. They were educated on the risk of hepatitis, and how to handle needle-stick injuries and blood spills. The patients had regular four-monthly liver function tests before a test for HCV became available.[66] The provision of information as the occasion demanded was clearly proportionate to need.

34.50 Professor Ludlam told the Inquiry that, because he was so keen for Edinburgh patients not to be exposed to commercial concentrates if possible, he gave them a small card to carry when travelling which said: 'this patient has only been treated with NHS concentrate. If possible please treat with cryoprecipitate or NHS concentrate'.[67] It was explained to them that the reason for this measure was to minimise their risk of contracting hepatitis from commercial concentrate. As it transpired, there was no material difference in the risk of acquiring NANB Hepatitis between UK public sector products and commercial US products, but this was not appreciated until the end of 1983. However, during 1982 and 1983, this 'NHS concentrate only' policy may have protected some NHS patients from acquiring HIV from commercial product.

34.51 Both medical and nursing staff took precautions to prevent infection during treatment. They wore disposable gloves and carefully disposed of needles, syringes, intravenous lines and blood or blood product packs.[68] This was obvious to patients.

34.52 Professor Ludlam said that his patients knew that he had an interest in using liver function tests to monitor the risk of hepatitis, and that test results would often be discussed with patients when they came back for review appointments.[69] He also commented that some patients were generous enough to make themselves available for teaching students. Some patients were in the hospital quite frequently early in the reference period, because of the limited treatment that was available, and they often allowed him to bring medical students to see them. The doctors would have quite full discussions about the risks of treatment. He thought that his views would have been known to and accepted by the patients.[70]

34.53 Professor Ludlam told the Inquiry that haemophilia patients in Edinburgh were kept up to date with developments during the 1980s when it came to be realised that NANB Hepatitis was more progressive than previously thought, and also later following the identification of HCV and the development of specific tests for the virus.[71] He said that patients and their families were aware of concerns about hepatitis because of frequent discussions at review clinics between clinicians and patients about the results of their liver function tests. He also thought patients were aware that the Haemophilia Centre was retaining blood samples for future virological testing.

34.54 A few documents reflected this understanding. On 27 January 1986, Professor Ludlam wrote to patients enrolled at the Edinburgh centre.[72] The letter stated that Factor VIII and Factor IX might cause hepatitis in individuals with haemophilia 'as you will know', and was very occasionally transmitted to other members of the family. He wanted to investigate the position in local families. The letter noted that blood samples provided by family members were held in storage and asked patients to request the approval of the individuals in question for the use of these samples in the proposed study.

34.55 Following the publication of a paper by Hoofnagle and others in 1986,[73] which established that Interferon could be successfully used to treat NANB Hepatitis, patients were informed of this development and studies were commenced to assess the use of Interferon.[74] As a result, from 1988 a few patients in Edinburgh with symptoms of NANB Hepatitis received treatment using Interferon.[75]

34.56 From 1988 patients not previously exposed to concentrates were given information on virally-inactivated SNBTS concentrates and invited to participate in a clinical trial.[76]

34.57 In the early 1990s an HCV patient information sheet and investigation check-list was developed for patients whose blood tests showed that they were HCV-positive.[77] The document, entitled 'Hepatitis C Liver Disease and its Treatment' stated that the patient's blood results showed that they had HCV. It stated that the virus may cause inflammation of the liver, 'known as hepatitis', and that in some individuals the inflammation may become chronic, giving rise to long-term damage which may in some cases be severe. The document then set out the investigations required to determine the patient's suitability for Interferon treatment and described the treatment and possible side-effects. It commented on the risk of sexual transmission and offered consultation to the sexual partners of infected individuals. It also contained advice on the use of alcohol.

34.58 Professor Ludlam said:

The information given to patients with non-A non-B hepatitis was continually updated with the developments in knowledge and practice. For example in the late 1970s and early 1980s it was a puzzling condition of uncertain aetiology but not known to be serious. At this stage there was no evidence that it might be sexually transmitted. It became clearer in the mid-1980s that it was a potentially serious and progressive condition although it has taken many further years of study to begin to obtain a reasonably reliable estimate of the risk of cirrhosis, liver failure and hepatoma development. Once it became clear that it was progressive and after Hoofnagle's paper in 1986, patients were informed of this and we consequently initiated studies to use interferon treatment.[78]

34.59 The patient information sheet illustrated a further development in this approach.

34.60 In general terms, Professor Ludlam thought there had been 'a very open policy of giving patients the most up to date information about hepatitis, their individual results and our assessment of their clinical situation'.[79]

The evidence of clinicians: testing

34.61 Professor Ludlam explained that the Edinburgh Haemophilia Centre carried out 'anonymous' testing of stored samples when an HCV test became available. This was an early, insensitive test. The results revealed that 85% of those tested were HCV antibody-positive.[80] He published a small study of this group in a letter to The Lancet in September 1989.[81] Samples from 61 patients were tested: 48 had received non-heated factor concentrates before 1985 and 41 of these tested positive for anti-HCV. It is implicit in the report that the treatment histories of all 61 patients were known.

34.62 Between 1990 and 1992 Professor Ludlam and colleagues assessed a series of different antibody detection methods. A paper submitted for publication in October 1991 reported a study of tests on stored sera from 85 randomly chosen haemophilia patients attending the Edinburgh Centre.[82] Of 78 patients previously exposed to non-virally-inactivated concentrates, 68 were confirmed positive by Chiron RIBA. Of the remaining 10, some were positive on some of the other tests applied. In addition, a virology colleague, Professor Simmonds, developed a polymerase chain reaction (PCR) assay to detect HCV viral RNA.[83] A study using this assay was carried out with 21 haemophilia patients and 27 intravenous drug users. From the results found and reported, Professor Ludlam said that it was clear that the first generation of the antibody test did not have sufficient sensitivity to 'identify all previously or currently HCV-infected individuals'.[84]

34.63 By 1992 'reliable and sensitive' assays for detection of the Hepatitis C antibody and virus were available. In his statement, Professor Ludlam said that 'it was at this point that we felt confident to provide the results of these tests to patients'. It seems, therefore, that patients were tested for research purposes during the period 1989-92 but not given the results of the tests.[85]

34.64 The process adopted for the first round of testing (in 1989) involved the selection of three sets of patients, grouped according to their treatment histories. The samples were labelled only according to these groupings and, when the results were received, the patients could not have been given their individual results. The use of an anonymous process was due, Professor Ludlam said, to his concerns about the reliability of the test.

34.65 He explained that in 1992 in all cases, including cases in which stored samples had been tested during the initial studies to validate the techniques, a fresh sample was sought from the patient after 'explanation and consent':

The patients being told that we considered that we had a sensitive and specific test for both the antibody and virus which was responsible for the majority of cases of non-A non-B hepatitis. The result would be essential in deciding who might benefit from anti-viral therapy, e.g., it might be appropriate to offer therapy to PCR positive, rather than PCR negative, individuals. The patient would be given the result at the next clinic visit (or earlier if specifically requested). In most instances there was no need for the patient to receive the result urgently. The HCV tests were offered to all patients who we identified as having been exposed to blood or blood products.[86]

The evidence of clinicians: communicating test results to patients

34.66 Professor Ludlam stated that the information given to patients with non-A non-B Hepatitis was continually updated with the developments in knowledge and practice. He stated that once it became clear in the mid-1980s that the disease was progressive, patients were informed of this and studies were initiated on the use of Interferon treatment.[87] A Hepatitis C Patient Information sheet and an Investigation Checklist were developed in the early 1990s. Leaflets from the Haemophilia Society and the British Liver Trust were readily available in the Haemophilia Centre.[88]

The practice at the Glasgow Royal Infirmary

The evidence of a patient who was treated in the Glasgow Royal Infirmary

34.67 David was treated with Factor IX in both Yorkhill and the GRI. He said he remembered Hepatitis A being mentioned to him during routine screening for this virus in 1984, but stated that he was not warned of the risk of infection with any other virus from his treatment for haemophilia.[89] His medical records showed that, in 1983 while he was being treated at Glasgow Royal Infirmary, David was found to have abnormal liver function test results. NANB Hepatitis was thought to be the cause of these results. David has no recollection of these test results being mentioned to him. David found out from Professor Lowe in 1991 that he had tested positive for the antibody to the Hepatitis C virus.[90] He said that Professor Lowe did not tell him much about the severity of the virus, its health implications or the risk of secondary infection. Professor Lowe told him that they would continue to monitor his liver function at his routine haemophilia clinic appointments.

The evidence of clinicians: the use of blood products and information about the risk of infection with NANB Hepatitis/Hepatitis C

34.68 For most of the reference period, Professor Charles Forbes was the Haemophilia Director at the GRI and he was in control of policy and practice in the Haemophilia Centre. Professor Lowe joined the Infirmary staff in November 1974. He was a Registrar and Senior Registrar from 1976 to 1985[91] and then Co-director of the Centre from 1988 to 2009.[92]

34.69 Professor Forbes said that in the 1970s to early 1980s, when, as he remembered it, the usual policy for haemophilia bleeding was the use of pooled cryoprecipitate, clinicians were all aware of the potential problems associated with giving material of human blood origin to individuals. They monitored patients for changes in liver function, using what at that time were probably the best and only available tests.[93] Changes in liver enzymes were a good indicator of infection.[94]

34.70 Professor Forbes said that it would have been very reasonable to have discussed with patients the risks of contracting hepatitis, and that would have been the Centre's policy at that time. He said that patients at the GRI Centre would certainly have been told that there was a possibility of hepatitis resulting from the use of concentrates or cryoprecipitate, and that they would be followed up after receiving blood products of any type. It is worth noting that in an article in the Haemophilia Society Bulletin 1 of 1980, Professor Forbes mentioned Hepatitis B as a 'serious side effect' of treatment with concentrates, but made no mention of NANB Hepatitis.[95]

34.71 Professor Lowe gave both written and oral evidence to the Inquiry on this topic and was one of the principal authors of the Collective Response. He said that he had discussed his recollection of events for the purposes of that document with Professor Ludlam and Dr Gibson. He agreed that it was possible his recollection of events had been influenced by other people's recall of the same events but said that his own statement,[96] submitted as a separate document, reflected his personal experience and was probably a better reflection of his own recollection of events concerning NANB Hepatitis and HCV, than his contribution to the Collective Response.[97] That is clearly correct, and it is inappropriate generally to rely on the Collective Response in relation to practice at the GRI.

34.72 One point already mentioned is material, however. The Collective Response emphasised that the problem arising from treatment of patients at local hospitals, before reference to haemophilia centres, was particularly significant in the west of Scotland.[98] In view of the territorial extent of the region, that clearly must have been the case.

34.73 Professor Lowe told the Inquiry that, when he began working in the University Medical Unit at the GRI at the end of 1974, the first thing he noticed was big red signs labelled 'Hepatitis'. Every room in the Haemophilia Centre had such a sign. From his first day at the unit he observed that patients were being tested for Hepatitis B and that liver function tests were being carried out. There was an emphasis right from the start on reminding patients to be careful with needles and blood and on the disposal of all equipment.[99]

34.74 Management of haemophilia in the mid-1970s included routine monitoring (usually annually at clinic reviews) for complications of the disease and of its treatment (including hepatitis). Routine blood tests included:

  • Full blood count including haemoglobin, differential white cell count (an assessment of the different types of white cells) and platelet count.
  • Assessment of blood chemistry including liver function tests - to assess possible presence and degree of hepatitis.
  • Assessment of clotting factor function - for example, Factor VIII level and the presence of any Factor VIII inhibitor.
  • Taking samples for virology, specifically for Hepatitis B antibody and antigen.[100]

34.75 Professor Lowe recalled sitting in on haemophilia review clinics listening to the Consultants telling patients that they were going to take blood tests to check for hepatitis, which was a risk associated with blood product therapy. He said that the majority of patients who attended the Haemophilia Centre had been treated since childhood and knew what the tests were for and that none of it was a surprise to patients.[101] In addition, the Haemophilia Society issued a lot of booklets and pamphlets over the years which included information on the risks of hepatitis.[102]

34.76 Professor Lowe gave evidence that haemophilia patients (and, in the case of children, their families) at the GRI were routinely advised by medical and nursing staff of the risk of infection by the blood-borne hepatitis viruses (HBV and NANB Hepatitis), both before and after their treatment with blood products. Furthermore, he thought that the risk of infection would have been apparent to patients from several of the routine practices at the GRI:

  • Both medical and nursing staff took obvious precautions to prevent infection during treatment. They would wear disposable gloves and carefully dispose of needles, syringes, intravenous lines and blood or blood product packs.[103]
  • Patients or their parents were provided with, or given access to, educational and information leaflets, such as those issued by the UK Haemophilia Society.[104] Professor Lowe considered that the Haemophilia Society was generally well-informed and was aware of the risks of hepatitis as knowledge developed. The Society issued regular information leaflets and other publications to its members. It also produced other, more occasional, publications for patients and their relatives and these were displayed in the waiting area and treatment rooms of the Haemophilia Centre at the GRI.[105]
  • Patients, or their parents, who requested further information about NHS or commercial clotting factor concentrates were given the information leaflets provided along with the concentrates themselves. These package inserts included details on the possibility that they might transmit hepatitis.[106]
  • A vaccination against HBV was introduced in the UK in 1985 and was offered to patients who lacked natural immunity. Patients were told that the vaccination was protective against HBV only, and not against threats from other hepatitis viruses, such as NANB Hepatitis. Similar advice was given when the HAV vaccine was offered to patients from 1992. The parents of children with haemophilia were also offered vaccinations and advised on the risks of hepatitis from blood spills and needle-stick injuries.[107]
  • A journal article published in 1983 made it clear that patients treated with clotting factor concentrates had a high risk of developing NANB Hepatitis.[108] As a result the UKHCDO recommended that cryoprecipitate be preferred to clotting factor concentrate for patients with mild haemophilia who had no, or limited previous exposure,[109] before 1988.[110]
  • From 1988, patients who had not been previously treated with concentrates were given information on, and invited to participate in, a clinical trial of virally-inactivated SNBTS clotting factor concentrates, to demonstrate that it would not infect them with NANB Hepatitis.[111]
  • When recombinant factor concentrates (artificially synthesised clotting factors free from the risk of transmission of viruses from blood donors) were licensed in the UK in 1995, haemophilia directors ensured they were made available for treatment of patients with haemophilia in Scotland. The first priority was patients not previously exposed to clotting factor concentrates.[112]

34.77 Professor Lowe stated that it was considered important to regularly monitor liver function and keep patients abreast of changing information about the disease.[113] The message to patients at the GRI prior to 1985 about how concerned they should be about this condition was:

[W]e would say that, "Non-A non-B Hepatitis is a concern. We need to monitor you for it. We will explain what we are doing collectively to minimise the risks through safer products and immunisation, and regular medical review is important and it gives us a chance to continue to update you on the significance."[114]

34.78 From 1985 it was known that the asymptomatic stage of NANB Hepatitis infection could progress to serious liver disease and this was communicated to patients or their parents at their clinic reviews.[115] Professor Lowe recalled that by this time every haemophilia centre in the UK was seeing one or two patients who had clear clinical evidence of liver disease. There was a hepatitis working group monitoring these studies and passing on reports to doctors and to the Haemophilia Society.

34.79 The Haemophilia Centre at the GRI was amongst those seeing a small number of patients with clinical liver disease and all patients in receipt of blood products were being more closely monitored as a result. Previously, patients with cirrhosis seen in the haemophilia unit at the GRI had been those infected with Hepatitis B or who were heavy alcohol users; in 1987 the centre in which Professor Lowe worked saw its first patient with early cirrhosis caused by NANB Hepatitis.

34.80 The message to patients at this point was similar to that given before 1985; but they were now advised that it appeared that a number of patients might progress to serious liver disease.[116] When talking to patients in his clinic, Professor Lowe found it helpful to give them a rough percentage of people who might expect to be affected. He stated that between 1985 and 1987 he would have advised all of his patients that those with NANB Hepatitis had a 25% risk[117] of progressing to cirrhosis as a result of their infection.[118]

34.81 At routine clinic sessions, Professor Lowe would enquire about a patient's recent health and ask if they had noticed any change in their well-being. Any incidence of jaundice would naturally be of concern but Professor Lowe would also routinely carry out a physical examination of his patients' abdomens to feel the condition of their liver and spleen. Blood samples would be taken for liver function tests and, if the results from a previous test had been abnormal, he would discuss the likely cause of that abnormality with the patient at their next review. In the absence of any other explanation, he would advise that the most likely diagnosis was NANB Hepatitis, which he would then discuss with the patient. Professor Lowe also said that, even for patients with normal liver function test results, the state of knowledge of the severity of NANB Hepatitis, as understood at that time, would be communicated to everyone at clinic reviews.[119] From 1985 patients (or their parents) were also told that it was hoped that concentrates could be successfully virally inactivated in the future and that this would reduce or remove the risk of transmission of NANB Hepatitis.[120]

34.82 Professor Lowe recalled that a few years later, around 1988-89, patients reviewed in his clinic were told the estimation of risk of cirrhosis following NANB Hepatitis infection had increased from 25% to 33%. He was of the view that his medical colleagues in the Haemophilia Unit at the GRI would be passing on the same information to patients.[121] There would be regular meetings within the haemophilia centre to ensure the clinicians and nurses[122] shared information, and were able to pass consistent advice to their patients.[123] It was helpful to the Centre that Dr Forbes, their Director, was at that time also the Chairman of the UKHCDO. Professor Lowe was asked what the Centre's policy about hepatitis was at this time. He explained that it was:

To tell patients about it and to explain ... that all patients should be asked about symptoms of liver disease, examined for liver disease, have blood tests taken for liver disease and to explain to them often at the time that you were discussing blood tests, you would say, "I want to check you out for Hepatitis B and non-A non-B, and the current situation with these problems in haemophiliacs in the United Kingdom is this, and this is why it's important that we do this", and, "Keep coming to the clinics and we will keep monitoring you for the complications".[124]

34.83 Professor Lowe also recalled that it was around this time that the risk of progression to liver cancer in those with NANB Hepatitis was becoming clearer, and that this was also discussed with patients at review appointments:

Yes, I think it would be about that time that liver cancer was being reported, associated with Hepatitis C, in the early 1990s.

So we would talk about cirrhosis, what was cirrhosis and what would the symptoms be, and what would the prognosis be for somebody who developed cirrhosis and what treatment would be given, and then to say that particularly patients who have developed cirrhosis - the liver as part of a cirrhotic process, it's prone to forming tumours .... "We will carry on examining you, doing the blood tests, and we may start doing liver scans but .... Once we get the tests to see if you carry the virus or not, if you do carry the virus, we will then be referring you to [the] liver clinic for more detailed information from the liver doctors, the experts ...." As we had already done for HIV a few years previously.

We said, "We will continue to follow you up and give you whatever advice and support we can as haemophilia doctors and nurses, but it's time for the specialists to start taking over your liver disease and they will give you full information about the up-to-date prognosis, estimates and further tests, like genotype and scanning. And the good news is that we have antiviral treatment starting to be developed .... The hope is that it will work in some people with Hepatitis C."

"So again, this is part of a journey, where we are all learning about the virus, we are all learning about the tests, the prognosis and the treatment, and we will keep you informed as much as we can."[125]

34.84 Professor Lowe stated that before the identification of HCV and the introduction of a specific test at the end of 1991, informed advice on the possible sexual transmission of NANB Hepatitis could not be given as not enough was known about the disease.[126] After that date, and as evidence of low rates of sexual transmission became clearer, the risk of sexual transmission of HCV was discussed with infected patients at their routine appointments at the GRI.[127]

34.85 In oral evidence, Professor Lowe agreed that the best method for a clinician to give information to a patient about treatment and prognosis was through direct, face-to-face communication. However, he noted research which had demonstrated that patients often do not take in all of the information they are given in an interview with their doctor or nurse and suggested that direct, face-to-face communication could be usefully supported by information leaflets.[128]

34.86 Professor Lowe added that any full, written protocol for use by doctors in haemophilia reviews would have been difficult to formulate. It would have had to be 'a pretty long-winded protocol and ... so general as to probably be counter productive'. He thought that the best way to cover the wide range of issues that arose in a haemophilia review appointment was to lead by example, with real patients, showing the range of subjects that might be covered, and how to interact with patients.[129]

The evidence of clinicians: testing

34.87 Professor Lowe could not recall if there were written policies or protocols relating to hepatitis testing in place at the Glasgow Haemophilia Centre in the 1970s and 1980s. He could, however, recall that the GRI produced written policies from around the 1990s, following the introduction of a specific screening test for HCV, which included HCV testing as part of liver function monitoring, along with vaccinations for Hepatitis A and B.[130] Following advice from the UKHCDO, from late 1991 the co-directors of the GRI Haemophilia Centre added HCV testing to routine surveillance for liver disease in haemophilia patients.[131] By then, second generation test kits of improved specificity and sensitivity were available from the Regional Virus Laboratory at Ruchill Hospital, Glasgow.

34.88 In the period 1990-95, patients were asked to give fresh blood samples at their clinic appointments. Professor Lowe and his colleagues would explain that, in addition to the routine blood tests patients were aware of, there was now a test for the recently discovered Hepatitis C virus. He would add further that, now that the virus had been discovered, it was possible that anti-viral treatment might become available for the patients found to carry the virus.[132]

34.89 Professor Lowe was asked to consider the report written for the Inquiry by Dr Hay. He considered that Dr Hay's description of his practice as a haemophilia clinician dealing with patients with NANB Hepatitis/HCV infection was entirely in keeping with both his own practice in the GRI, and practice in haemophilia centres in Scotland, in the early 1990s generally. As he understood it, 'practice was to inform patients about hepatitis C tests and outline what was known about HCV; and to inform the patient and their general practitioner of the results'. This had been the practice for HBV as knowledge about that condition increased and it was the opinion of haemophilia directors in the early 1990s that the practice should continue when dealing with patients with HCV.[133]

34.90 Professor Lowe also agreed with Dr Hay's view that there could be no useful comparison between procedures for HIV testing after 1985, and HCV testing in the 1990s, and expressed his disagreement with Professor Nathanson's view (as he understood it when giving evidence) that 'best practice' HCV pre-test counselling was comparable to that considered appropriate for HIV testing.[134] He noted that, at a meeting of the Haemophilia Directors of Scotland and Northern Ireland on 6 February 1990,[135] it was reported that the UKHCDO and Haemophilia Centre Directors were advised by their medical defence societies that HCV testing could be undertaken on the same basis as other liver function tests, and that 'HIV-type counselling' was not necessary.[136] Professor Lowe also recalled that Dr Iain Simpson, Chief Executive of the Medical and Dental Defence Union of Scotland, had attended a meeting of the UK Regional Haemophilia Centre Directors. Professor Lowe said that when asked whether haemophilia clinicians had to go to the lengths of the HIV pre-test counselling prior to taking a blood sample for an HCV test, Dr Simpson's opinion had been that 'if patients are well used to being regularly monitored for post-transfusion hepatitis, and Hepatitis C is being added to all these other tests ... he could see no special case'.[137]

34.91 Professor Lowe explained that he decided against giving HIV-style pre-test counselling to his patients in the early 1990s, because of the consensus that emerged after the lengthy discussions at the UKHCDO meetings, and because of Dr Simpson's advice. Patients were not tested without their knowledge or consent, however. Professor Lowe stated that 'we gave pre-test information about the test', although the type of pre-test counselling thought suitable for HIV testing was not considered an appropriate model for the equivalent HCV test.[138]

34.92 In his statement, Professor Lowe noted that patients were 'routinely informed that HCV tests were being carried out', although the Haemophilia Centre at the GRI did not call patients in especially to be told about the new HCV test. However, it was the practice there that every patient, even those very mildly affected, was seen at least annually for a review and more severely affected patients would typically have been seen earlier as they were reviewed more frequently. At review they would be told about the new HCV test once it had become available; they would then have been tested for the virus. Most patients were tested between late 1991 and late 1992.[139]

34.93 He said that explanations were given before blood was taken.[140] Professor Lowe's recollection was that, at the stage at which blood was to be taken, he would explain to his patients that a new test had become available for the most common cause of NANB Hepatitis:

"We are now coming to the routine blood tests and we would like to" - or we would want to - "this is now our policy," at which point patients could say, "Well, I don't want the test". If they wanted. I can't remember anybody saying no ... they already knew that they were being screened for non-A non-B hepatitis .... [141]

34.94 Patients who had received pooled blood products would be told to be prepared for a positive test result, as research had shown the majority of these patients had been exposed to the virus. At that stage, although the test could establish whether the patient had been infected and had developed antibodies, it would not indicate if they still had the virus that could lead to chronic liver disease.[142]

34.95 Professor Lowe went on to explain that, if a patient had a positive HCV test result, they would be sent notification of an early appointment for a clinic review, so that they would know within the following few weeks, or at most few months, about their test result and its implications.[143] The Centre would aim to see the patient for a half-hour appointment in a private room in the clinic to enable them to have a full discussion of the implications of a positive test result.[144]

34.96 Professor Lowe explained what he would say to a patient who had received a positive HCV antibody test result. He noted that the information available to clinicians improved over time as more came to be understood about the disease. In 1991 he was only able to tell a patient that they had been exposed to HCV at some point, but not when. At that time, a doctor could not advise if having the antibody meant the patient was immune from HCV infection in the future. Most importantly he could not tell the patient if they were still carrying the virus and what the chances were of the virus causing future problems with the liver, although different tests were being developed in the hope of answering those questions. Professor Lowe would emphasise the importance for the patient of continuing to attend the clinic for regular reviews and monitoring. Even if the HCV test was negative, he would still advise his patient that the test would be repeated annually as there were concerns about the accuracy of the first-generation tests. Patients were advised to take the same precautions with regard to sexual intercourse and blood spills that had been recommended since 1985.[145]

34.97 With regard to prognosis, if the later PCR tests demonstrated the patient was a carrier of the virus, they would have to be carefully monitored for liver disease and consideration of antiviral treatment.

34.98 As knowledge of the risks of transmission improved, haemophilia patients at the GRI who tested positive for HCV were advised that, as the virus could in rare cases be transmitted sexually, they should use barrier contraception and discuss the risks with their partner who could be tested for HCV by their GP.

34.99 Patients were also informed that treatment in the form of Interferon was being developed and becoming available, and that liver transplant was ultimately an option if required. Patients with a positive test result would also be referred to a liver clinic for monitoring of their HCV.[146]

34.100 Professor Lowe was referred in oral testimony to the supplementary statement from Professor Nathanson discussed in Chapter 32, An Investigation into the Systems In Place for Informing Patients about the Risks - Ethical Context, and in particular her views on the correct approach to testing for HCV between 1991 and 2000.[147] He agreed that Professor Nathanson appeared to be suggesting that, from 1997, best practice for HCV testing was to discuss the implications of the test and to give the patient time to consider whether to go ahead with it, as would happen with HIV pre-test counselling.

34.101 He did not think that the timing and context of what Professor Nathanson told the Inquiry applied to what he was doing at his haemophilia centre in 1991, however. He had tested all his haemophilia patients before 1997. He disagreed with what Professor Nathanson told the Inquiry about appropriate practice in 1991, but by 1997 he agreed that the best practice was to give HIV-style counselling for HCV testing. He was asked why he thought a different approach was required in 1997:

I think one factor has been increasing knowledge of the severity of Hepatitis C. In 1991 we were keen to find out which patients had been exposed to it so that that could clarify advice given to patients and for management. It was hoped, I think, initially, that rather like Hepatitis B before it, the majority of patients would have cleared the virus and only a minority would then progress to liver disease. And I think the part of the change in opinion, which Dr Nathanson has considered, is that during the 1990s, we now know that only about a third at most of patients clear the Hepatitis C virus and two thirds are carrying it, and we also know that the proportion of patients developing serious liver disease is increasing. So I think there is a change in the perception of the severity in Hepatitis C.[148]

34.102 Professor Lowe was then referred to the report written by Dr Charles Hay.[149] Professor Lowe noted the view of Dr Hay that there was no comparison between HIV pre-test counselling and HCV testing. He explained that hepatologists in Glasgow would not routinely give detailed counselling to patients when investigating them for liver disease: there could be a difference in approach between testing for HCV at the Haemophilia Centre and testing by a liver specialist. He thought that Dr Hay described a realistic approach in his report for the Inquiry, one that mirrored the practice at the Haemophilia Centre at the GRI at the material time.[150]

34.103 Professor Lowe was asked to comment on some patients' and relatives' recollections that they were not told that they were being tested for HCV, and were not immediately told the results of their tests or the implications of the diagnosis. He was of the view that doctors and nurses did discuss hepatitis with their patients, particularly in the 1990s after testing for HCV became available. He identified several deficiencies in early knowledge about HCV which made it difficult to inform HCV-positive patients of the meaning of their diagnosis, including the long time lag until becoming ill, the uncertainty of the accuracy of early test results and the uncertainty whether those who tested positive might remain asymptomatic carriers of the disease. He noted that conversations with patients over the 1990s changed as more became known about the natural history of HCV, and it became apparent that it was considerably more serious than originally thought for some patients. He thought that patients may have been reassured by early conversations.[151]

34.104 He also commented briefly on studies that have established that many patients do not recall what they have been told in an interview with their doctor. His view was that the policy in the GRI was always to have very open discussions with patients and to be available to them for their questions. He thought that, overall, he and his colleagues did their best to communicate adequately with their patients and assumed they had achieved that goal.[152]

34.105 Professor Lowe was referred to Professor Nathanson's suggestion that the way to deal with the phenomenon of some patients not absorbing bad news is to repeat the message and reinforce it at subsequent meetings. It was suggested to him that an explanation for the many patients who claimed not to have been given information was that this had not been done at the GRI. He was reluctant to accept that clinicians at the GRI may not have reinforced the details of the diagnosis at subsequent meetings with their patients. He was adamant that he and the Haemophilia Sister took significant steps to ensure that they were available for the patients to speak to and seek advice from.[153]

Royal Hospital for Sick Children in Glasgow (Yorkhill)

The evidence of parents of patients who were treated at Yorkhill Hospital, Glasgow

34.106 Neither 'Christine' nor her husband were warned that their son, John, was at risk of infection with Hepatitis C from his treatment for haemophilia.[154] She was not warned that there was an increased risk from prophylactic treatment as opposed to treatment in response to bleeds. John was treated at Yorkhill Hospital until 1991 when his care was transferred to the Glasgow Royal Infirmary. The referral letter noted that John was positive for the antibody to the Hepatitis C virus.[155] According to Christine this result was not conveyed to either John or herself. She found out that John had Hepatitis C only after his death in March 1995, when she asked a nurse. The nurse replied 'Oh yes, all of our boys have got it'.[156]

34.107 'Alex' was first treated in 1986 when he was about six months old. Alex's father said that he remembered his son's first treatment very well. He recalled a doctor coming into the ward to see them and saying that they needed to treat Alex with Factor VIII as this was all they could do for haemophilia. At that time Alex's parents did not know what haemophilia was. The doctor told them that they would give Alex a dose of Factor VIII, and that Alex would probably need to take Factor VIII for the rest of his life.

34.108 Alex's parents knew that the blood tests he underwent at each clinic appointment included a liver function test. At some point they were told that Alex was being tested for 'non-A non-B' but they did not know what that was.[157] They were not told the results of this test. Alex's mother was told that Alex had Hepatitis C in about 1993 at one of Alex's review appointments at Yorkhill Hospital. Alex's father stated that Alex's mother was not given any advice about the virus at that time. Neither of them knew then what Hepatitis C was.[158]

The evidence of clinicians: the use of blood products and information about the risk of infection with NANB Hepatitis/Hepatitis C

34.109 Dr Michael Willoughby was appointed Consultant Haematologist at Yorkhill Hospital in late 1973. He resigned in 1982 and took up an appointment in Australia. He was not traced by the Inquiry until October 2012, after the public hearings had concluded. He provided the Inquiry with two written reports.[159]

34.110 Dr Willoughby's initial remit on joining Yorkhill was to set up a department able to carry out the haematology tests necessary to diagnose and manage blood disorders. His main focus in practice was on the management of childhood leukaemia.[160] Treatment of those conditions and related clinical trials were his main professional interests. Over the years he became increasingly involved with the clinical management of blood disorders, including haemophilia, but Dr Willoughby said that there was no question of him establishing a Haemophilia Centre at Yorkhill in his time there.[161] Children with all types of blood disorders from the west of Scotland were referred to Yorkhill.

34.111 Dr Willoughby wrote a well-regarded textbook, Paediatric Haematology, published in 1977. Hereditary coagulation disorders and developments in their treatment up to the time of writing were discussed and set in the context of a busy haematology department caring for children with a wide range of illnesses.

34.112 In relation to treatment of haemophilia Dr Willoughby received advice from Dr Forbes. In the late 1970s, he heard of the success of home therapy and decided to introduce it for patients attending at Yorkhill. Dr Willoughby used the commercial Factor VIII concentrate, Hemofil, for this purpose on the view that it was easier for the parents of children to use. It could be reconstituted more easily than other concentrates, was administered in low volumes and was injected using a slender scalp-vein intravenous needle.

34.113 Dr Willoughby ordered the commercial concentrate through the hospital pharmacy. He considered the additional expense incurred over the use of SNBTS products to be justified for his young patients because of the advantages it offered in administration.[162]

34.114 Dr Willoughby's narrative of his practice in introducing parents to home therapy dealt exclusively with the practical procedures involved. Parents were warned of possible reactions to Hemofil and were prescribed chlorphenamine for use if there were adverse, allergic-type reactions, although he could not remember that being a problem with Hemofil.[163] Cryoprecipitate was not suitable for home treatment of his patients because of the difficulties associated with its administration. He understood that all concentrates, whether SNBTS or commercial, carried a high risk of transmission of NANB Hepatitis. He commented on the introduction of home treatment:

I think it would be fair to say that in most patients their quality of life improved to an unrecognisable degree, with a number playing football at school. I personally thought it was proving one of the best things we had set up, and I think the others involved felt the same.

We had no idea that we were exposing these patients to serious viral diseases. I believe that problem only started coming to light in around 1983, after I had left the U.K.[164]

34.115 In relation to the risk of transmission of viral hepatitis, he agreed generally with his successor, Professor Ian Hann: NANB Hepatitis was not seen as outweighing the risk of serious bleeding. It was known that all concentrates, commercial and NHS, carried a very high, virtually total, risk of transmitting hepatitis but Dr Willoughby felt that the risk never justified giving up the use of concentrates.[165] The risk of transmission of Hepatitis B was well known, but thought to be in the past, and NANB Hepatitis was generally thought to be a less serious condition.

34.116 Dr Willoughby left Scotland before the risk of transmission of HIV had become a reality and before the potentially serious consequences of NANB Hepatitis became apparent. His narrative of practice did not include the provision of information about the risk of transmission of viral hepatitis. It appears to be clear that he implemented the Yorkhill home treatment policy on the advice of Professor Forbes and found that it yielded the anticipated benefits in improving children's lives. With 'no idea'[166] that treatment was exposing patients to serious viral diseases, it also appears to be clear that he would not have discussed such an issue with the parents of his patients.

34.117 Dr Anna Pettigrew, who worked with Dr Willoughby from 1980, had no recollection of discussing with Dr Willoughby the risks associated with treatment. They were aware of the risk of Hepatitis B but she thought that, probably until 1983, they were not really aware of any other risks; it was known that there was a possibility of another form of hepatitis that could affect haemophilia patients, '[b]ut the main concern at that time was Hepatitis B.' However, she thought that the benefits of treatment generally and home treatment in particular were quite obvious.[167]

34.118 It appears that during Dr Willoughby's tenure there was not a systematic approach to providing information about the risks of transmission of viral hepatitis associated with therapeutic products at Yorkhill: there was no perception of a need for it at that time. As indicated by the scope of his textbook, Dr Willoughby was a paediatric haematologist, not a haemophilia specialist, and depended on Professor Forbes for advice on haemophilia.

34.119 Professor Hann moved to Yorkhill at the beginning of 1983 and brought a fresh perspective to practice at the hospital. With experience of treating childhood leukaemia, he already had experience of dealing with patients, and parents of patients, confronting a potentially fatal disease. It appears to be clear that his decisions on therapy were influenced primarily by his response to the threat of AIDS and have been dealt with in that context.[168] He quickly abandoned the use of commercial products at Yorkhill, preferring cryoprecipitate or NHS Factor VIII concentrate. However, that decision does not appear on the evidence to have been prompted by a view relating to the risk of transmission of viral hepatitis. By the time NANB Hepatitis was recognised as a potentially serious disease, in late 1985, Professor Hann's practice was firmly based on the use of SNBTS products, using cryoprecipitate and Factor VIII as the situation demanded.

34.120 Professor Brenda Gibson was appointed Paediatric Haematologist at Yorkhill in 1984 and became the Haemophilia Director there in 1988. She was the third principal author of the Collective Response. She also provided the Inquiry with a written statement.[169]

34.121 Professor Gibson recalled that the parents of patients at Yorkhill would receive advice on the benefits and risks of treatment and were 'routinely informed of the risk of hepatitis (B and non-A, non-B)'. The risks of hepatitis would be explained by both medical staff and the haemophilia nurse specialist. Parents of children who administered factor concentrate at home were educated to take precautions to avoid transmission of infection and the risk of hepatitis.[170]

34.122 Clinicians also relied on other sources of information from outside the hospital, such as that provided by the Haemophilia Society. The families of patients were encouraged to read the book Living with Haemophilia written by Dr Peter Jones, the Haemophilia Director in Newcastle-upon-Tyne, discussed above at paragraphs 34.9-34.13. Dr Gibson also referred in her statement to the large number of the mothers of Yorkhill patients who had male relatives with haemophilia and could gather information from them on the risks of hepatitis. Many of the families who attended Yorkhill with their sons would become friends and would share information.[171]

34.123 Professor Gibson also noted that parents who administered factor concentrates to their children at home would be able to read the information leaflets provided in the box with the concentrates. This information would include the risk of possible transmission of hepatitis.[172] (See paragraphs 34.163-34.169 below for further discussion on SNBTS package inserts at this time.)

34.124 From 1983 there was evidence that patients receiving factor concentrate had a high risk of developing NANB Hepatitis from initial exposure. As a result the UKHCDO, and others, recommended that 'boys who had never received clotting factor concentrate ... should receive cryoprecipitate in preference'.[173]

34.125 Professor Gibson went on to add that the information from 1985 onwards about the increased severity of NANB Hepatitis came from studies of adult patients and, as a result, the significance of the virus for children was unclear. From 1985 onwards patients and their parents could be told that it was hoped viral inactivation of factor concentrates would be successful in reducing or eliminating the risk of transmission of NANB Hepatitis.[174] She went on to tell the Inquiry that children would have been the first beneficiaries of virally inactivated concentrate and that 'the advantages, primarily the reduction in risk of viral transmission, would have been explained to parents'.[175]

The evidence of clinicians: testing and communication of test results

34.126 In her statement Dr Gibson said that the testing for HCV in children with haemophilia took place in the same timeframe as the testing of adults, once antibody tests became routine in 1991. In the period from 1990 to 1995, blood samples were taken from all patients who had received blood products. She added that patients and their parents were routinely told that HCV testing was being carried out. Verbal consent was considered to be enough for hepatitis monitoring as it was considered to be a routine test.[176]

34.127 If a patient proved to be HCV-positive, they and their parents were informed at their next scheduled clinic appointment, or at their next visit to the department. This gave patients and parents the opportunity to ask questions and discuss the significance of the test results. There was felt to be no immediate or urgent need to inform patients that they had tested positive.[177] The child's liver function test would be carefully monitored in future and they would be referred to a liver specialist for possible future treatment.[178]

34.128 Patients were also given information leaflets about HCV from the Haemophilia Society and the British Liver Trust. Professor Gibson could not recall the Haematology Unit in Yorkhill having any of their own written guidelines or policies on communicating HCV test results to patients and parents. Where possible they adopted the UKHCDO guidelines.[179]

Ninewells Hospital, Dundee

The evidence of a patient treated in Dundee

34.129 'Colin' received treatment for Haemophilia B on about six occasions prior to 1994, at Ninewells Hospital, Dundee. In 1995 Colin and his two brothers (who also suffer from haemophilia) were asked to attend Ninewells Hospital.[180] When they attended in August 1995 they were told that they should be tested for Hepatitis C. Colin's brothers were told in January 1996 that their blood test results were positive for this virus. As Colin had not heard the result of his own test he telephoned the hospital and was told in a short telephone call that if his brothers were positive for Hepatitis C, he would have it too. Colin and his wife then attended an appointment with Professor Cachia at which Hepatitis C and the implications of it were more fully discussed with him.[181]

The evidence of clinicians: the use of blood products and information about the risk of infection with NANB Hepatitis/Hepatitis C

34.130 Professor Philip Cachia was a Consultant Haematologist at Ninewells Hospital, Dundee, from 1992. He had trained with Professor Arthur Bloom at the University Hospital of Wales in Cardiff.[182] He provided a written witness statement to the Inquiry and gave oral evidence about the dissemination of information about NANB Hepatitis/HCV at Ninewells Hospital.[183]

34.131 Professor Cachia explained that local practice in haemophilia care at Ninewells Hospital developed in three distinct phases:

  • Before his appointment in 1992 there was no planned or managed process for discussing treatment or delivering ongoing care to patients with haemophilia. If counselling occurred it was on an essentially opportunistic, unstructured basis when patients were attending the hospital for other reasons.[184]
  • From 1992 Professor Cachia was in post and in about 1993/1994 he took on the role of lead clinician for haemophilia care. He started to see patients and began to build relationships with them and deliver the required standards of care, although this still tended to be delivered on a somewhat opportunistic basis as he developed protocols and procedures over time.[185]
  • A specialist nurse, June Ward, was appointed in January 1995 and helped to develop a formal appointment process. It was also around this time that a dedicated space for haemophilia care was found. Until that time a spare room in the day unit was used for interviews and delivering test results.[186]

The evidence of clinicians: testing

34.132 When Professor Cachia arrived at Ninewells Hospital in 1992, he discovered during his initial assessment that HCV tests had been carried out by the virology laboratory on stored frozen blood samples and that there were around 25 haemophilia patients (of around 30 tested) who were HCV-positive.[187] Professor Cachia's predecessor in haematology had a list from the virology laboratory of the names of those patients who had tested positive for HCV.[188] It was not immediately clear to Professor Cachia if patient consent had been obtained for the tests to be conducted. The patients who tested positive had not been told of the results.[189]

34.133 Professor Cachia discussed the matter with a consultant virologist at Ninewells who told him that the tests were performed on stored blood samples taken at previous appointments and that the tests had been performed 'more or less out of interest' when testing first became available, 'because they had the new assay'.[190] The consultant virologist was unable to tell Professor Cachia what patients had been told about why their samples were being taken and stored but was quite clear that, as far as he knew, consent had not been obtained prior to testing.[191]

34.134 Professor Cachia said that he was 'horrified' to discover this. In the first instance, he said that he would not personally have sanctioned such testing without prior consent. Additionally, he was concerned that his first meetings with patients would require him to explain that they had been tested without their knowledge or consent, with some testing positive for HCV, and that this would be a poor start to the doctor-patient relationship. It was not something that he felt he could continue to withhold, however, and while telling patients what had happened would not necessarily be the very first thing he would say at their next review, 'clearly it would be a vital piece of information that I wouldn't withhold from them'.[192] He therefore told patients that stored samples had been tested without their consent and asked for a fresh blood sample for further testing, after counselling the patients and obtaining their informed consent.[193]

34.135 Shortly before moving to Ninewells, Professor Cachia had been involved in MRC research as part of his post-doctoral studies which had included obtaining 'informed consent' for participation in research projects. Asked what he took 'informed consent' to mean at that time around (1991-92) and in that context, he explained:

[T]he crucial issue is that the patient has a clear understanding, in language and terms that he or she can understand, of, in this case, the reason for undertaking research, the potential benefits to them and to future generations of doing that research, any potentially negative consequences of participating in the research and that they have control of that agenda and can get the information that they require and can then make a decision on a personal basis as to whether or not they wish to participate in that research.[194]

34.136 Obtaining informed consent had to allow for variations in the understanding and comprehension of different patients:

[A] great deal of variation, and I think to really be able to obtain informed consent in that way, you need to firstly get to know and understand the patient. You need to develop trust as a mutual basis for the relationship, and once you have developed trust and know what their personal value systems are, what their intellectual capacity is, what their belief systems are, you can then have a real discussion that allows them to understand and, as I say, have control of the decisions that need to be made.[195]

34.137 It appears from his subsequent evidence that this earlier experience in obtaining informed consent in a research setting had a significant bearing on, and informed, his practice when he became responsible for clinical haemophilia care at Ninewells Hospital.

34.138 Professor Cachia told the Inquiry that the setting up of the Haemophilia Centre in Ninewells included establishing local protocols and guidelines for treatment and management of patients. He explained that the difference between a protocol and a guideline lay in the level of detail in each type of document and the purposes to which they would be put. A 'guideline' would be a regularly used document, perhaps printed, laminated and left in a ward for frequent consultation. A 'protocol' would be a more detailed document, not only setting out procedures to be followed but also providing a rationale for the advice, along with references to support it.[196]

34.139 Professor Cachia was shown two documents and asked to comment on them in terms of this difference. The first,[197] although headed 'Protocol for monitoring patients with bleeding disorders and Hepatitis C infection', Professor Cachia described as a 'guideline' in terms of the distinction given above: it was a single sheet which could be kept on the ward as a 'helpful aide-memoire' for use in a busy clinic environment, a reminder as to whether a patient should have a particular test conducted based on their particular circumstances.[198] By contrast, a protocol would have a more educational purpose. It would not necessarily be for day-to-day use due to its level of detail, but could be consulted as a reference document.[199]

34.140 The second document was Clinical Guidelines, dated 2008 and entitled 'Tayside Hepatitis C virus (HCV) managed clinical network'.[200] The document was not produced by the Haemophilia Centre at Ninewells. Professor Cachia described it as an NHS Tayside regional approach to providing care for individuals infected with HCV. Until the production of this document, which was focused on the treatment options, if clinicians wanted to offer Interferon therapy to a patient an individual case had to be made to the medical director through a hepatologist. This document was an attempt to standardise Hepatitis C treatment across all patient groups in Tayside on the basis of a protocol.[201]

34.141 He did not develop a haemophilia patient protocol specifically for HCV testing. He worked on this area with Dr John Dillon, who was the principal source of expert advice around Hepatitis B and C, and utilised his patient treatment protocols for people with haemophilia.[202]

34.142 From the point at which he took up his post in Dundee, Professor Cachia started to see haemophilia patients on a regular basis, including those who were not severely affected and might previously have attended the Centre only infrequently. As part of haemophilia care, he would monitor patients' general well-being, including the condition of their joints and their dental health, for example, but would also discuss health risks associated with treatment: the hepatitis viruses and HIV. His practice was to ascertain at an early stage what his patients knew about NANB Hepatitis/HCV and to build on that knowledge towards obtaining their informed consent for participation in ongoing reviews and assessments of their liver function and HCV status.[203]

34.143 He said that he would take care to ensure that patients took in the information they were given. He would take time to assess his new patients and try to determine their level of understanding at the outset of discussion. Some patients would be well informed because of their membership of the Haemophilia Society, through other patients or through informal contact with medical and nursing staff.[204] If the patient had no prior understanding he would start from the beginning and explain the risks of viral hepatitis as a consequence of treatment with blood products and the importance of testing.[205] Whatever a patient's level of background knowledge, he would explain what was known of HCV and about the test and then ask the patient to tell him what they had understood of the discussion. If they could not give an accurate account he would know he had not succeeded in getting the message across.[206] Patients were not simply told that a test would be carried out: after discussion, a patient would have the opportunity to decline to be tested and those who had their blood tested would all have given their informed consent.[207]

34.144 He went on to explain what 'obtaining consent' in this context would have involved:

[I]t would have to be individualised and based on what they already knew. I would then take the conversation forwards and explain the latest information we had about Hepatitis C, about the Hepatitis C test, if they had or hadn't been tested for it, and explain the potential benefits of that test.[208]

34.145 In retrospect, Professor Cachia felt that perhaps he had given too much information to his patients at their initial appointments. Conscious that 'there are limits to the amount we can assimilate, remember and truly understand' he now feels that, in retrospect, 'if I were doing it all over again, I might spread the load of information over two or three visits'.[209]

The evidence of clinicians: communicating test results

34.146 Professor Cachia was asked to describe practice at Ninewells in relation to communicating the results of a positive anti-HCV test, including whether patients were immediately told of their results. In relation to the early appointments (for patients previously tested without their knowledge or consent) described above, he said:

So for all of the patients, including those in whom we had been given the results from virology ... we took a fresh blood sample to confirm the test, and our aim was, in seeing a lot of these patients for the first time, to give them a follow-up appointment fairly rapidly, within a month or so, to discuss again the gamut of tests that we had undertaken. And if their HCV status was positive, we would take a second blood sample for a confirmatory test.[210]

34.147 Professor Cachia explained that he would discuss the implications of a positive diagnosis with a patient, even before he had conducted the confirmatory test:

[P]articularly if, you know, if there was other supporting evidence. If it was a patient who had had extensive treatment, then they almost certainly were HCV-positive. If they had evidence of abnormal liver function tests or clinical evidence of chronic liver disease, then I wouldn't necessarily wait for the confirmatory test.[211]

34.148 He would tell patients about the implications of their diagnosis, which would depend in each case on the clinical context:

[I]f they very clearly had evidence of chronic liver disease, you would have to be honest and say that, you know, 'There is evidence of progressive liver disease, so you may be in the group of patients who are going to go on and develop cirrhosis.' If somebody had no evidence and over a period had relatively normal liver function tests, you would tell them that they might be in the better prognosis group but that there was no guarantee of this ... So you would try and stratify the risk according to all of the evidence in front of you and give them an idea of progression over time. So over successive clinic visits you would either try to reassure them or to be honest with them about the risk of progression.[212]

34.149 What patients were told about the disease changed between 1992 and 1995 as knowledge of HCV increased. In common with other witnesses, Professor Cachia said it was becoming clearer that the condition was not necessarily as benign as previously considered, for at least some patients.[213] He would advise patients that there was a recognised risk of progression to cirrhosis, but in oral testimony was unclear whether the possibility of liver cancer was discussed at this time, as it was not until later fully identified as a risk. Once the link was established it became part of the discussion with patients as it became increasingly important to closely monitor HCV-positive patients.[214] This was also the time when early treatment for HCV first became available; this, too, entered into the discussions he had with his patients and this part of the discussion itself changed considerably over time as treatment options expanded.

34.150 Professor Cachia summarised the changing position at the time:

Knowledge of the complications and therapeutic options for HCV were continuously changing over the period from 1992. The approach taken ... was to have an open and frank discussion using non-technical terms to explain the nature of the infection and its origin, risks of spread including sexual intercourse (but not through normal social contact), the importance of monitoring clinical signs and blood tests, the potential benefits and risks of liver biopsy and treatment options as they evolved including Interferon, dual Interferon and Ribaviron and pegylated Interferon. Our aim was to enable patients to make informed decisions in relation to requesting approval for anti-viral therapy.[215]

34.151 With regard to a patient's lifestyle, he would advise on alcohol intake as it can adversely impact on liver disease. They would also review prescription medication for potentially hepatotoxic effects (those adversely affecting the liver) and discuss over-the-counter medication.[216] He would remind patients of the risk of transmission to third parties and the precautions to be taken to minimise that risk. As evidence emerged of low incidences of sexual transmission, advice would be given on the use of barrier contraception and partners were offered HCV tests.

34.152 Professor Cachia said that he did not approach the SNBTS around this time (mid-1990s) seeking advice on counselling patients with HCV.[217] He explained that the set-up in Dundee was unusual in that there was a regional transfusion service in the city that provided hospital blood banking. His team would have had a lot of contact with them with regard to blood for transfusion, and in relation to storage of factor concentrate, but not with regard to their working relationships with donors.[218]

The evidence of Nurse June Ward

34.153 When Professor Cachia became the Haemophilia Consultant at Ninewells in Dundee in 1992 he saw his patients alone. He did not have a dedicated haemophilia nurse until June Ward was recruited.[219] She was subsequently involved in counselling haemophilia patients and assisting with testing, having received training from Professor Cachia. He said that they both believed in 'patient centred care' and had similar views about how the service for haemophilia patients should be developed.[220]

34.154 Nurse Ward was employed as haemophilia nurse at Ninewells Hospital from January 1995. She provided the Inquiry with a short statement in response to two questions put to her about providing information on HCV, and communicating test results regarding HCV, to patients in the haemophilia ward from when she started in 1995.[221]

34.155 She stated that there was a list of patients who had been identified as having a bleeding disorder and were HCV antibody positive. Those patients were prioritised and invited to attend the clinics at the haematology day area. They were offered further confirmatory testing, monitoring and treatment for HCV.[222] One of her roles from the beginning was to assist in the identification of patients who had been exposed to pooled plasma products and were at risk of HCV but had not yet been tested.

34.156 There were no local (or indeed national) HCV guidelines or protocols in 1995. Nurse Ward told the Inquiry that the Haemophilia Centre at Ninewells followed the guidance provided by the NHS Scotland Management Executive, Provision of Haemophilia treatment and care, MEL (1994) 29, 23 December 1994. Over the next few years, the haemophilia service developed specific HCV protocols and Nurse Ward and Professor Cachia were involved in drawing up NHS Tayside HCV protocols, which have been reviewed and developed over the years to keep up with current knowledge.[223]

34.157 Patients were invited to attend for review in relation to their bleeding disorder and, as part of their review, their HCV status was checked and discussed. In most cases Professor Cachia would take the lead at the consultation with Nurse Ward in attendance, but in his absence she would see patients by herself and advise them along similar lines. In this manner they ensured that all haemophilia patients were seen by an experienced and familiar member of staff. For patients not previously tested for HCV they would discuss with the patient the value of being tested and give them enough detail to enable them to make an informed choice. The patients identified as HCV-positive were offered a PCR test to confirm their illness.[224]

34.158 She added in her statement that patients would be offered a combination of patient information booklets from the Liver Trust and the Haemophilia Society to back up the advice that they had been given verbally.[225] Test results were provided to the patient at an organised clinic within the haematology day area.

34.159 In 1995 only Interferon was available for the treatment of HCV and none of their patients chose to take it up. Often patients' partners or family members attended these clinics and testing was offered where appropriate.[226]

The evidence of patients or relatives of patients infected with Hepatitis C from blood transfusions or blood products

34.160 'Bridie's' mother, Molly, was infected with Hepatitis C from a blood transfusion.[227] Molly received the blood transfusion due to very severe complications during the birth of her fourth child at a maternity hospital in 1974. In 1994 Molly was found to have cirrhosis of the liver during an unrelated surgical procedure. The circumstances surrounding her diagnosis with Hepatitis C are set out at paragraphs 6.77-6.82 of Chapter 6. Despite investigation of the cause of her cirrhosis by a consultant physician, it was not until Molly's GP tested her for Hepatitis C at the same time as he tested her liver function that she was diagnosed with the virus. That was in 1996. Molly's GP then wrote to Molly to inform her that she had tested positive for Hepatitis C. Molly's reaction to this news was that she had AIDS and was dying. Molly's GP referred her to a consultant physician who monitored her condition. She was referred to a consultant gastroenterologist in 1997. Molly's medical records show that she saw a nurse at this appointment who gave her written information about the virus and support groups.

34.161 'Gordon' acquired Hepatitis C from a blood transfusion after emergency and life-saving surgery in 1975. During the follow-up to this surgery Gordon was found to have abnormal liver function test results and in about 1978 he was told by the consultant physician reviewing him that NANB Hepatitis was the most likely cause of these results. Gordon continued to attend the hospital for monitoring until 1982. He moved to England in 1985. He was diagnosed with Hepatitis C in 1995 after being admitted to hospital for investigation of weight loss and exhaustion.

34.162 'Christine', who gave evidence mainly about her son John's infection with HIV, also gave evidence about her own infection with Hepatitis C from blood products. As detailed in paragraph 6.363 of Chapter 6, Christine was transfused with infected Factor VIII when she underwent elective surgery in 1981. She did not feel that she needed this treatment and asked for it to be stopped as soon as she became aware that she was receiving it. Christine found out from the SNBTS in 1991 that she had Hepatitis C. She donated blood and a couple of weeks after doing so received a letter from the SNBTS asking her to attend a meeting at their office. At that meeting she was asked if she had ever taken drugs, before it was suggested to her that she had been infected by the Factor VIII infusion. She did not recall receiving much information about the virus at that meeting. She was in shock. Afterwards she attended her GP who referred her to a liver specialist for treatment.

Product inserts

34.163 Documents issued with SNBTS products contained information on risks associated with their use. These have been discussed generally in Chapter 33, An Investigation into the Systems in Place for Informing the Patients about the Risks - HIV/AIDS, paragraphs 33.75-33.92. The documents were described by Dr Robert Perry in an SNBTS document entitled 'Hepatitis Risk Warnings'.[228] Questions for Dr Perry were drafted by Messrs Thompsons. Dr Perry provided a witness statement responding to a list of eight questions.[229]

34.164 The fourth question posed for Dr Perry was: 'Why was it considered appropriate to include a reference to the risk of hepatitis transmission in the PFC factor concentrate inserts' over the period 1982 to 1985?

34.165 Dr Perry said that the wording used in statements relating to the risk of transmission of hepatitis in PFC product leaflets was prescribed by the British Pharmacopoeia and approved by the UK licensing authority further to the PFC licence application in March 1978. Between 1978 and 1985 the description used in leaflets accompanying Factor VIII and Factor IX products which had not been heat-treated included reference to screening of donated blood for Hepatitis B surface antigen by specified tests, but continued: 'Nevertheless none of these tests are of sufficient sensitivity to eliminate the possibility of transmitting hepatitis'. Similar warnings were given on vial labels, stating: 'This preparation is of human origin and cannot be assumed to be free of hepatitis virus'.[230]

34.166 Following the introduction of heat treatment of Factor VIII and Factor IX in 1985 the 'warning statements' in products' leaflets changed. The package insert for Factor VIII now stated that the product could not be assumed to be non-infective. Factor IX was heat-treated differently, at a higher temperature, and its product leaflet stated: 'The effect of this heat treatment on Hepatitis B and Hepatitis, non-A non-B has still to be elucidated and therefore, this product cannot be assumed to be non-infective with regard to the hepatitis viruses.'[231]

34.167 Dr Perry said that prior to and during the period 1982-85, hepatitis transmission by coagulation factor concentrates was widely recognised and documented. Accordingly, all manufacturers were required by regulatory authorities to include hepatitis warning statements with their product packaging and information leaflets.[232]

34.168 Dr Perry said that, as information leaflets were contained in the packaging of products supplied to patients for self-administration, patients on home treatment would have sight of such leaflets although they were not the primary intended recipients of the information prior to 1994. The information contained in package inserts at that time was detailed, technical and used specialist language.[233] They were designed for expert and experienced prescribers, in most cases haemophilia doctors. He did not think that such package inserts could be considered as providing relevant and material information for patients about the risk of transmission of viral hepatitis, including those patients on home treatment who might have had incidental sight of the information provided by the manufacturer.[234] Any discussion about treatment options and the risks involved was, he said, the responsibility of the doctor administering the treatment.

34.169 For present purposes, therefore, the provision of information in the terms employed on SNBTS package inserts is irrelevant to the knowledge patients may have had about transfusion-associated transmission risk for the same reasons as are set out in Chapter 33, An Investigation into the Systems in Place for Informing the Patients about the Risks - HIV/AIDS. If the SNBTS had an obligation to inform patients using concentrates directly of the nature and extent of the risk of acquiring hepatitis infection, the package inserts and information leaflets would not have been sufficient for that purpose. However, as the terms of the principal documents - the product licence applications - make clear, the procedure was regulated under the relevant Medicines Acts in force from time to time. In particular, the product constituents and specification had to be in accordance with the information contained in or supplied with the licence application. Hepatitis risk was identified as an aspect of the description of plasma. Until the regime changed in 1994 the SNBTS was not obliged to provide additional information to that prescribed.

The fallibility of memory

34.170 Before drawing conclusions - in particular on the practice in individual centres - it is appropriate to note evidence relating to the reliability of patients' recollections. It has been a common theme among the experts that patients often deny that they have received information or counselling and various reasons have been offered for that. It is understandable that stressful situations may affect the patient's ability to absorb information, and there may indeed be a reluctance to accept information about their condition and prognosis.

34.171 The issue was focused in the evidence of the patient given the pseudonym 'Alex', and his father.[235] By the time of his first treatment for haemophilia in 1986, the potential seriousness of NANB Hepatitis was becoming known. Alex's parents found his first admission a traumatic experience. They had no experience of haemophilia. His mother was with him during this admission and she was provided with further information about haemophilia and was introduced to other parents of older children with the condition. The diagnosis caused his parents considerable and continuing stress, as was no doubt the case for many families in a similar position.

34.172 These are not circumstances in which one could reasonably expect a clear and comprehensive account of what happened soon after the event. Twenty-five years later all of the factors apply that undermine the reliability of the evidence of those involved in or observing stressful events. Some positive elements will remain, but evidence of what did not happen or may not have happened is inherently less reliable. These are precisely the circumstances in which agreed and rigorously applied protocols are required to ensure that the patient is informed and that advice is also provided in written form that can be taken away and read and re-read as understanding of the condition grows. For treating clinicians, it is important that these events are recorded in patient case records at the time, to inform others co-operating in the patient's management both then and subsequently.

34.173 However, there is no basis for assuming, or concluding on the evidence, that medical practitioners themselves generally have perfect recall. In relying on the fallibility of the patient's recollection of what happened, there is a danger that the doctor may be seen as simply serving his or her own interests in suppressing a similar failure of recollection. Comparison between statements in the Collective Response of what 'would have been' common practice in Scotland and the evidence of the clinicians who gave written and oral evidence to the Inquiry of their own approaches, is sufficient in itself to dispel any view that the recollection among medical practitioners was infallible. The position is relatively clear where the patient's medical records note that information or advice was given. Where that evidence is not available, a general assertion of what the witness recollects of common practice is not necessarily reliable. In such circumstances a practice protocol can provide not only guidance but can generate a document of record of what happened. That approach to record keeping was not adopted.

Discussion and conclusions

Provision of information to patients

34.174 The evidence of practice from both patients and clinicians in the 1970s was that very little would have been said by haemophilia clinicians to their patients about the risk of infection with NANB Hepatitis. Dr Hay's evidence to that effect is accepted. The practice at the time was understandable against the background, firstly, of the widespread belief that NHS blood products (in particular Factor VIII concentrates) were less likely than imported commercial products to transmit viral hepatitis and, secondly, the understanding that NANB Hepatitis was a mild condition.

34.175 As the 1970s progressed, and into the early 1980s, most patients had liver function tests. That raises a question as to whether a change in the approach to providing information and advice about NANB Hepatitis was appropriate. Dr Hay thought that from the late 1970s most patients having liver function tests would have been told that they had NANB Hepatitis. From 1978 at the latest, there was published information that there was at least the risk of transmission of NANB Hepatitis from the use of factor concentrates. Mr Watters' evidence about the discussion in Haemophilia Society Newsletters from 1978 illustrates that.

34.176 It seems highly unlikely that asymptomatic patients would have been routinely advised of a relationship between the results of their liver function tests and the emerging risk of NANB Hepatitis, as long as overt clinical indications of hepatitis was a criterion for diagnosis.[236] The MRC definition of 'hepatitis', which included this criterion, was followed by most clinicians until at least the end of 1983 (when the article by Fletcher and others was published in the BMJ)[237] and by others until an anti-HCV assay was developed in 1989.

34.177 The second factor of importance mentioned in paragraph 34.174 above (the understanding until late 1985 that NANB Hepatitis was a mild condition) meant that the risk of the virus was not thought to be serious enough to weigh in the balance against the need for treatment of coagulation disorders. When product selection first became a significant issue, it was in relation to the emerging knowledge of AIDS and the risk of transmission of an agent causing AIDS and AIDS-related diseases.

34.178 In the circumstances, a uniform, invariable approach to the provision of information about NANB Hepatitis was not likely to be adopted by individual clinicians in the absence of authoritative advice from regulatory or advisory bodies or from the NHS. There was no advice until the late 1980s and none that was specific enough or relevant to HCV until the early 1990s.

34.179 With the benefit of hindsight, it is clear that it would have been in the patients' interests for protocols to have been developed and applied in the 1980s, rather in the manner that Professor Cachia and the Tayside Health Board approached practice at Dundee in and after 1992. However, Professor Lowe was probably right in saying that it would have been impractical to prepare a protocol if one had to envisage a document that anticipated every individual patient's needs. Something rather less ambitious might have sufficed if agreement could have been reached, however. It might have been practicable for the Scottish Haemophilia Directors to have promulgated a protocol that prescribed, for example, that what was known about NANB Hepatitis should be discussed from time to time with patients at risk, and as significant developments in knowledge occurred but without specifying the precise contents of the discussion or restricting the individual clinician's independence of judgement as to what was significant. No attempt to formulate a common approach was drawn to the attention of the Inquiry, however, and it is necessary to note individual practitioners' approaches and make such comment as seems appropriate.

34.180 Patients receiving coagulation therapy using PFC products were exposed to the risks of transmission of NANB Hepatitis, up to October 1985 in the case of Factor IX, and April 1987 in the case of Factor VIII. For the vast majority of patients receiving concentrate therapy up to those dates, advice on the real risk associated with NANB Hepatitis came too late: almost all had been exposed to the virus. Depending on their individual genetic characteristics, patients in treatment had not been infected, had been infected but had cleared the virus spontaneously, were carriers of the virus but remained and were likely to remain asymptomatic, or were at some stage in the progression towards serious liver disease. In view of the long natural history of HCV, some people in the final group would not survive (dying of unrelated causes) to develop symptomatic disease.

34.181 Whether a diagnosis of NANB Hepatitis would have been made depended on the position adopted by the clinician. Certainly until the end of 1983, those clinicians who applied the MRC definition of 'hepatitis' would have required clinical manifestations in addition to a finding of enzyme elevation. In the case of the Royal Infirmary of Edinburgh, Professor Peter Hayes' view was that few diagnoses of NANB Hepatitis would have been made. In their letter to The Lancet dated June 1987, Dr Dow and others commented that they had found reports in the west of Scotland of only 23 NANB Hepatitis cases in the previous eight years.[238]

34.182 In Professor Hayes' experience of working in a large liver clinic, before HCV was discovered patients who presented with abnormal liver function test results were not usually diagnosed as suffering from NANB Hepatitis. There were many non-viral causes of abnormal liver tests. He said:

So a diagnosis of non-A non-B wasn't really considered in patients where an alternative explanation could be found and it tended to be triggered - or it's likely that it would have been triggered if somebody had had a blood transfusion and then had abnormal liver tests .... So if somebody just had abnormal liver function tests, it's relatively unlikely that a putative viral diagnosis would be made, but on the other hand, if somebody had had abnormal liver function tests following a blood transfusion, then that's more likely. But my understanding is it was not a very common diagnosis.[239]

34.183 Until September 1983 the information that a haemophilia clinician would have been expected to give to patients about the risks of hepatitis infection associated with factor concentrates would have been that NHS products were safer and that, so far as there was a risk of infection, the disease was probably benign. In contrast, haemophilia was in fact associated with the risk of progression to serious and debilitating illness and possible death from haemorrhage. From September 1983, the NHS product would not have been thought less likely to transmit infection, but the perceived 'benign' prognosis for NANB Hepatitis would have remained the same until 1986 or 1987.

34.184 It appears that from about 1980 at the latest there was widespread knowledge amongst patients and their parents that the use of factor concentrates was associated with the risk of developing hepatitis. Up to 1983 some patients in Scotland were expressly advised that the use of factor concentrates carried a fairly high risk of contracting viral hepatitis. Although some patients may not have been expressly so advised, it appears very likely that by 1983 all adult patients and parents of patients would have come to know, directly or indirectly, about the risk as understood at the time. What is less clear is whether, even by 1983, patients were being told explicitly of the risk of NANB Hepatitis as distinct from Hepatitis B.

34.185 While in general terms the likely risks of 'hepatitis' from factor concentrate treatment were probably appreciated to a greater or lesser extent by most patients, what these risks truly were must have been less understood. Until 1985, no practitioner could have discussed the natural history of NANB Hepatitis infection in a fully informed way: the information was not available, and only began to be developed thereafter. No discussion of the risk of long-term progression to serious liver disease was likely to have taken place because no such risk was recognised. Any advice would have reflected the current understanding and that would not have reflected the reality of risk.

34.186 It is questionable whether, apart from previously untreated patients and those who had previously received very little treatment, discussion would have been of practical assistance to patients. The critical time frame for advice relates to the point at which the diagnosis of a coagulation disorder was made and an initial decision on treatment had to be taken. Once the patient was on an established course of concentrate therapy, the risk of transmission of NANB Hepatitis/HCV crystallised and, at least until new information of relevance to the treatment regime or some other material change of circumstances emerged, the opportunity to give relevant and meaningful information about treatment (as distinct from the consequences of infection) was likely to have passed.

34.187 In any event, even if some doctors, like Dr Willoughby, did not expressly advise their patients or patients' parents of the risk because at that stage they perceived that the risk of serious liver disease was negligible, Dr Nathanson's evidence was that she would not be critical of them on the basis of contemporaneous standards. In the 1970s and early 1980s medicine was more paternalistic and it was not unusual for doctors effectively to take decisions for their patients without discussing the balance of risks and benefits with them.


34.188 Professor Ludlam's evidence that patients were informed about the risk of transmission of viral hepatitis from time to time as knowledge increased, is accepted on the basis that he described. It was done as circumstances required in the exercise of his professional judgement rather than as a matter of routine followed with all patients. There is reliable evidence that he did give explanations to some patients and those explanations appear to have been adequate, given the information in the public domain and available to clinicians at the time. Professor Ludlam's evidence was consistent with the evidence given by the patient witnesses in this respect.

34.189 Professor Ludlam's practice throughout this period reflected his view that as far as possible his patients should be treated exclusively with NHS products. The slips issued to those travelling away from Edinburgh and the explanations given to patients would have left no room for doubt that his advice was that they should avoid commercial products because they carried a risk of transmission of viral hepatitis.

34.190 That was one example of the application of his view that much information provision to people with chronic disorders who are being seen very frequently is done on a 'need to know basis' as it arises in their clinical care. Another example was discussion of the cause of jaundice, when it occurred in one of his patients that called for an explanation of how it could have arisen. On the other hand, he did not inform patients generally or systematically of the risk of transmission of NANB Hepatitis. He said that he would not have raised with his patients the topic of the different kinds of treatment that they could receive in the context of the emerging risk of NANB Hepatitis.

34.191 Those of his patients who attended the local Haemophilia Society patients' group would have benefited from talks, by Professor Ludlam among others. Professor Ludlam provided leaflets and other Haemophilia Society publications. While it would not be appropriate for a clinician to rely on these as a substitute for giving information and advice directly, the general level of knowledge gathered from such sources, and from other casual sources such as media comment, would be matters to which a clinician would have regard. In particular it was appropriate to rely generally on the Haemophilia Society publications to supplement direct information and advice.

34.192 Without adequate records generally, it is not possible to form a firm view that patients were fully informed of the risks associated with the therapy that they received. Having regard to the expert evidence of Professor Nathanson and Dr Hay about patients' abilities to absorb information, and thereafter to remember what they have been told, there was at all times a risk that information was not effectively communicated to or retained by patients. Whether from fear of confronting the implications of infection, or from an over-optimistic view of risk, built up over years of reassurance, or from a well-founded assessment of relative risk of bleeding and slowly progressing hepatitis, patients may not have understood the reality of their position. Practice now would be different, as Professor Ludlam accepted, but it is clear that from the earliest period patients accepted, and were expected to accept, that 'doctor knows best' and that was reflected in clinicians' practice in giving information and advice. Until the late 1980s, however, by which time viral inactivation had eradicated the risk of transmission of the putative NANB Hepatitis virus or viruses, there was no commonly accepted ethical principle or rule that would have been infringed by Professor Ludlam's treatment practice.

Glasgow Royal Infirmary

34.193 Professor Lowe's evidence is accepted that, throughout his period at the GRI, clinicians discussed 'hepatitis' with patients. Having regard to Professor Lowe's evidence, many patients attending the GRI throughout this period were informed of the risks of transmission of viral hepatitis associated with factor concentrate therapy, so far as it was understood. Review clinic practice appears to have been well adapted to provide opportunities for discussion and the provision of relevant information.

34.194 The position with regard to providing information to patients about the specific risk of NANB Hepatitis is less clear. While Professor Lowe gave evidence of patients being advised prior to 1985 that NANB Hepatitis was a concern, and thereafter of the risk of developing serious liver disease, David recalled being warned only about the risk of Hepatitis A before being diagnosed with Hepatitis C in 1991. David was found to have abnormal liver function test results in 1983 and it was noted in his medical records that the likely cause of these was NANB Hepatitis. David did not recall being told of these results. There may be a number of explanations for this difference between the evidence of Professor Lowe and of David and, having not explored the matter in detail in evidence; it would be conjecture for the Inquiry to choose one. Whatever the explanation, David's evidence casts some doubt on the view that the risk of infection with NANB Hepatitis and the implications of the virus were consistently conveyed to all patients in the manner and detail stated by Professor Lowe.

34.195 Practice varied across Scotland, not only as among haemophilia clinics, but within any particular clinic as among patients. Although general information about hepatitis was produced by bodies such as the Haemophilia Society, it could not be found that there were well-established and generally accepted procedural protocols (either written or understood and shared by practitioners) for communicating information to each individual patient about the risks associated with the use of therapeutic products, the relative risks of avoiding therapy, and the nature of the choice that the patient had to make about their own condition and treatment for it. Indeed, for much of this period the choice as to treatment was made for most patients in Glasgow, the same way it was made in Edinburgh.


34.196 Christine's evidence of her experience at Yorkhill is consistent with the impression given by Dr Willoughby of practice during his period at Yorkhill. According to his written evidence he did not discuss the risk of transmission of viral hepatitis with children's parents. It appears that all major developments in the treatment regime applicable to Christine's son took place before 1983, when ethical practice would not have required discussion of such risks of transmission of NANB Hepatitis as were known to exist.

34.197 Practice changed when Professor Hann succeeded Dr Willoughby in 1983. Professor Hann's evidence was instructive. New to Yorkhill, and entering a new specialist practice at a critical time, he faced the uncertainty of the aetiology of AIDS and its association with therapeutic blood products, yet had to communicate his position to parents of young children concerned about risk. He was also on course to change radically the regime of his predecessor and give up the use of commercial concentrates. He had a particular need to formulate his views. He had a clear preference for cryoprecipitate and otherwise preferred SNBTS concentrates. Of importance is his evidence of advising new patients' parents: the advice focused on the need for treatment, warning of side effects, but ultimately the choice was between cryoprecipitate and SNBTS Factor VIII. Not treating the child was not an option.

34.198 Why Alex's parents may have been given insufficient information about the tests he underwent and about Hepatitis C generally can only, at this distance in time, be speculated upon. Equally, with whom responsibility for any such deficits lies can no longer be reliably ascertained. What can be said is that they found their experience in this respect to be unsatisfactory which underlines, should any underlining be required, the necessity for information to be provided to patients or, in the case of children, their parents.

34.199 There is insufficient evidence in relation to the practice at Yorkhill to establish that, during the period in question, there was any breach of any principle or rule of ethical practice in force at the material time.


34.200 In general, there is no evidence that haemophilia patients in Dundee had been told about the risk of NANB Hepatitis before Professor Cachia was appointed. Professor Cachia's evidence about the provision of information to patients was understandably limited by the fact that he did not start working at Ninewells Hospital until 1992. Professor Cachia's evidence was that until 1992 there was no planned or managed process for discussing treatment with or delivering ongoing care to haemophilia patients. Equally, counselling was then delivered on an opportunistic, unstructured basis. He sought to change and improve those practices including by discussing any health risks associated with treatment and devoting time to ensure that his patients understood any information provided by him. From the evidence available to the Inquiry, it appears that he and his colleagues succeeded in making significant improvements to the service in Tayside.

Testing and communication of test results

34.201 Routine blood tests in the course of management of coagulation disorder patients as described in this chapter do not raise any issue of ethical practice. Questions arise only where particular practices may have gone beyond the limits of implied consent and fallen into a category requiring specific or express consent from the patient.


34.202 In one respect, there is a question whether practice at the Edinburgh centre fell short of what was acceptable. Professor Ludlam instructed testing for anti-HCV of stored samples from 61 patients in 1989 and the study was reported in a letter to The Lancet in September 1989. The patients were unaware that their blood samples were being tested in this way. The testing and the published material were anonymous: no reader could have identified the patients. Forty-one patients tested positive for anti-HCV. In 1991 samples from 85 patients were tested and these tests were confirmed by further testing in Dr Simmond's laboratory. The 1989 tests must have been carried out using first generation assays. Patients were not informed of the results of any tests until 1992 when fresh samples were sought for confirmatory testing. Many patients were unhappy that data about themselves had been published when they were unaware even that they had been subject to the tests.

34.203 In 1988 the BMA guidance Philosophy and Practice of Medical Ethics had published the view that a patient should give consent before any investigation and treatment proposed by the doctor. (See Chapter 32, An Investigation into the Systems in Place for Informing Patients about the Risks - Ethical Context, paragraphs 32.43-33.44.) The publication of the results of the tests is not relevant: the data were anonymous. There are, however, issues as to whether testing the patients without informing them and obtaining consent to the study was contrary to the BMA guidance and whether there was an unacceptable delay in communicating the results. Dr Hay explained that at that time many practitioners did carry out testing on stored samples without consent. In addition, both he and Professor Nathanson explained that, in the context of patients who have already given consent to monitoring of liver function tests (LFTs), an anti-HCV test could be seen as an extension of that process.

34.204 It was Professor Ludlam's stated view that he had explained to his patients that there was a risk of contracting NANB Hepatitis from the use of concentrates and that his patients had given consent to have their LFTs monitored for signs of that disease. It was probably implicit in that consent that new biometric tests for NANB Hepatitis viruses would be employed as they became available. Testing was routine over a long period and it was clear from the evidence of the witness Mark that he was frequently offered information about the test data recovered in his case. However, HCV was a newly discovered virus and was unknown when consent to monitoring LFTs had been obtained. It might be suggested that, by 1989, it was for the patients to decide whether the deficiencies in the accuracy of the test were acceptable before their samples were subjected to it and that specific consent should have been obtained. However, expert opinion did not support such criticism, particularly as the samples were anonymised before they were tested and no patient-specific results were therefore available.

34.205 In relation to the second exercise in testing, which formed the basis of the 1991 paper, it is evident that this was conducted on named samples and therefore yielded results which could have been communicated to patients. It appears that the approach to communication of these results was not proactive: patients were instead offered a further test, with the appropriate explanation and consent, and then given the result of that at their next clinic visit. Inevitably, that meant there was a delay between the obtaining of the result for an individual patient in the course of the study, and the communication to that patient of the result of the further test.

34.206 In these circumstances, while it is inappropriate to be critical of Professor Ludlam's approach to testing stored samples in 1989 and 1991 without permission, once the results became available they should have been communicated to patients within a reasonable time. The information belonged to the patients and should not have been withheld. For any one individual, it will be a question of whether the time taken for them to learn their HCV positive status was reasonable.

34.207 With regard to the witness Elaine and her belief that her husband was not told of his diagnosis with HCV, as stated in paragraph 5.235 of Chapter 5, this may be explained by the fact that Brian's Hepatitis C positive test result was reported only a month before his death. If he was not told this diagnosis, any failure on the part of the doctors to disclose this diagnosis may be mitigated by the short interval between Brian's diagnosis with HCV and his death. Understandably, Elaine suffered some anxiety when she discovered that her husband had this virus. She was concerned that he could have passed the virus to her and that she could have had it for a number of years without knowing and without receiving treatment. As stated in paragraph 32.207 of Chapter 32, family members of competent adult patients had no right to know a diagnosis and so, while the failure to inform her caused her distress and anxiety, there was no duty on the part of those treating Brian to inform Elaine of his diagnosis.


34.208 There is no evidence of anti-HCV testing of stored samples without consent in the GRI or Yorkhill.

34.209 David's recollection that he was not told much about the virus when he was diagnosed with it in 1991 is consistent with Professor Lowe's evidence that, in the early 1990s there were several deficiencies in knowledge about the virus.[240]

34.210 According to Christine, her son, John, was unaware when he died in March 1995 that he had Hepatitis C. His medical treatment was transferred to the GRI from Yorkhill, in 1991 when he was 16 years old.[241] The referral letter recorded that John was positive for the antibody to Hepatitis C. Further tests will undoubtedly have been carried out at the GRI to confirm this diagnosis. There is perhaps a very remote possibility that John was aware of this diagnosis or even that he was told it, but due to the ongoing monitoring and treatment for AIDS, it did not register with him or even sufficiently for him to tell his parents about it. Against this possibility is Christine's evidence that John would have told her or her husband had he known. A further explanation is that the medical staff at the GRI assumed that John had been told he was positive to the antibody to the virus while still a patient at Yorkhill, and so did not discuss it further with him. These explanations can only be conjecture and no conclusion can be reached about what John was or was not told about his diagnosis with Hepatitis C. Whatever happened, the manner in which Christine found out that her son had the virus was insensitive, to say the least, and can only have added to her suffering.


34.211, There is no evidence that haemophilia patients in Dundee had given their consent to have their LFTs monitored or had consented to having samples stored prior to Professor Cachia's appointment. The available evidence from Professor Cachia suggests the contrary.

34.212 In relation to testing stored samples for anti-HCV, the timing in Dundee was substantially the same as in Edinburgh. Stored samples of sera were tested with the new HCV test when it became available in about 1989 and results were not communicated to patients until about 1992. That delay was inappropriate.

34.213 It appears that the system for communicating test results to patients broke down in relation to Colin who was told his diagnosis with Hepatitis C by telephone and in an insensitive manner. The system for informing patients of their test results, which Professor Cachia sought to implement, failed in Colin's case as systems sometimes do. The reason for this is unknown.


34.214 As noted in paragraph 34.3 above, practices at Edinburgh, Glasgow and Dundee have been explored in detail in this chapter as practitioners from these areas gave evidence to the Inquiry. A discrepancy arose in the evidence of Stephen, who was treated in Aberdeen, surrounding his diagnosis with Hepatitis C.[242] In summary, despite Stephen's medical records recording that Stephen had been found to have antibodies to Hepatitis C in 1992 and that he discussed his diagnosis with doctors in 1995, Stephen thought that he became aware that he had Hepatitis only in the late 1990s or early 2000s. No clinicians involved with Stephen's care gave evidence to the Inquiry and so this issue was not explored in detail at the public hearings. For this reason it is inappropriate for the Inquiry to form a view about when Stephen was told of his diagnosis with Hepatitis C. That said, this discrepancy may be an illustration of a point already made in this chapter which is pertinent to the issues in this series of chapters, namely that just because a diagnosis was conveyed by a doctor did not necessarily mean that it was heard by the patient.

Patients who received HCV from blood transfusions

34.215 The fact that it took almost two years, from 1994, for the cause of Molly's cirrhosis to be identified as Hepatitis C, is indicative of the lack of knowledge about the virus amongst more general clinicians (as opposed to haematologists) in the early days of the virus being discovered. The manner in which Molly was informed of her diagnosis was unfortunate, and is very likely to have contributed to her reaction to the diagnosis. Without specific guidance about conveying blood test results to patients, clinicians including GPs will have adopted their own approach to doing so. Many will have had little knowledge of the virus. As a result of this the manner in which blood transfusion patients, like Molly, were told of their diagnosis with Hepatitis C varied considerably.

34.216 This is borne out by the other witness statements obtained by the Inquiry. The extent of the information patients, like Molly, were given about the virus will have depended on the knowledge of the person diagnosing them. In the early days of the virus many clinicians, through no fault of their own, will have had little information to pass on to patients and so patients will have been diagnosed with a virus but given very little information about it. This is likely to have added to their distress and anxiety on receiving such an uncertain diagnosis.

34.217 Despite being diagnosed with NANB Hepatitis in about 1978, Gordon was not diagnosed with Hepatitis C until 1995 when he was admitted to hospital for investigation of his symptoms of the virus. It is unfortunate that his diagnosis with NANB Hepatitis did not trigger a test for Hepatitis C earlier, but by the time the test became available Gordon had moved to England. The procedure for testing patients with NANB Hepatitis for Hepatitis C in England is not within the remit of this Inquiry.

34.218 Anne was diagnosed with Hepatitis C in late 1995 by her GP after being identified in the UK look-back exercise as a recipient of infected blood. After agreeing to counsel and test Anne, Anne's GP was provided by the SNBTS with written guidelines entitled 'Transfusion-transmitted Hepatitis C: Guidelines for counselling patients April 1995' which ran to 25 paragraphs over five pages. These guidelines included an introduction and sections on background, implications of a positive test - prognosis, epidemiology, modes of transmission, avoiding infecting others, further assessment and follow up and notes about management at specialist centres. Despite these guidelines, when he diagnosed her with Hepatitis C, Anne's GP gave her the impression the virus was nothing to worry about. He gave her very little information about the virus or the implications of it. It is unclear why Anne's GP did not convey to Anne the information he had been given but the outcome for Anne was that she was worried and concerned for her future. She sought further information herself from her local hospital.

34.219 Christine's evidence is disturbing.[243] She did not want to receive Factor VIII in connection with surgery. She found that despite her wishes medical staff transfused her with Factor VIII, relying on a general waiver contained in her consent form to the surgery.

34.220 It is very unfortunate that she was treated with what transpired to be infected Factor VIII when she did not believe that she required such treatment. Those who treated Christine did so on the basis of her consent to the surgery and this was indicative of the paternalistic nature of medical practice at the time.

34.221 It is understandable that Christine was shocked when she was diagnosed with Hepatitis C at a meeting with a representative of the SNBTS in 1991. After all her son, she and her family had been through this must have been particularly difficult information to hear. Her reaction to this is unlikely to have been helped by the questioning she received about drug-taking.

Final comment

34.222 The ethical principles and rules governing clinicians' relationships with their patients in the period covered by this chapter were not settled. The transition from 'doctor knows best' to the current (and still evolving) principle of patient-centred care was prompted by experience of managing and treating patients exposed to the risk of HIV/AIDS infection and to the associated risks of social exclusion and financial difficulties that arose with it. The course of events has been traced in Chapter 32. For present purposes it should be noted that it was in 1988 that the General Medical Council published its guide HIV Infection and AIDS: The Ethical Considerations. AIDS had become 'dramatically apparent' in about 1982-83. But the medical profession took time to understand the implications for clinical practice and the need to adapt to the challenges presented by this new and emerging infection.

34.223 The risks of serious morbidity and of death associated with NANBH, later HCV, infection began to be generally understood late in 1985, in the middle of the AIDS period. The lessons from dealing with HIV/AIDS had not been fully understood and assimilated into general ethical practice by that time. The conclusions in Chapter 32 include that no criticism can be made of clinicians relating to their management and treatment of patients generally over the critical period down to the late 1980s. It would be the early 1990s before the position in relation to NANBH/HCV became clear and there was a basis in generally accepted principles and rules against which to measure the care of patients.

34.224 The conclusions reached in Chapter 32 address issues of ethical practice. Developments in the principles and practice of medical ethics now in general application should ensure that patients receive the information they need to reach informed conclusions on their illness and on treatment.

34.225 However, the complaints of patients and their families discussed in this chapter - very similar to those made in relation to the HIV virus - of inadequacies in the information provided to them about the Hepatitis C virus, in the manner in which their diagnoses were communicated to them, and about testing for infection without counselling and consent, serve to underline an important message for medical practitioners. Patients infected with a potentially fatal virus such as HIV, or infected with HCV and at risk of developing the serious complications of cirrhosis, possibly hepatocellular cancer, and other fatal complications, are entitled to this information and should not have to wait while the medical profession deliberates on general ethical issues. At a basic human level help is needed in real time as it becomes clear that the patient has acquired a serious infection or other illness.

34.226 The examples discussed in this chapter, and in Chapter 33, reflect the anger and dismay of individuals discovering that their medical advisers had information about them, or intended to investigate their condition, without involving the patient in discussion about his or her health and the clinician's response to it. The examples of blood disorder patients are particularly telling. They and their clinicians had been confronted in the first half of the 1980s with the unprecedented, extreme and worrying circumstances surrounding AIDS and, when it was established as the cause of the profound immune deficiencies leading to AIDS, the HIV virus. In the second half of the decade they were confronted by the reality that what had been seen, and represented to them, as a life-changing treatment which both extended life expectancy and promised an unprecedented quality of life experience, carried an additional risk, of developing serious and potentially fatal complications of a disease previously thought to be relatively benign. The result has been distress, anger and distrust of clinicians, clearly demonstrated by the evidence of witnesses at the public hearings and from witness statements received by the Inquiry.

1 Blood Money, World in Action, Transcripts of episodes broadcast on 1 and 8 December 1975 [PEN.013.1400]

2 Mr Watters - Day 87, pages 39-40. See also Haemophilia Society Bulletin, 1977, No. 3 [PEN.018.1262] and Haemophilia Society Report, 'Haemophilia Today', 1978 [PEN.018.1336]

3 See Chapter 16, Knowledge of Viral Hepatitis 3 - 1986 Onwards

4 See Chapter 15, Knowledge of Viral Hepatitis 2 - 1975 to 1985

5 Jones, P. Living with Haemophilia, 2nd ed, 1984, MTP Press, Lancaster [PEN.018.0754] at 0756

6 Ibid [PEN.018.0754] at 0757

7 Ibid [PEN.018.0754] at 0758

8 Jones, P. Living with Haemophilia, 3rd ed, 1990, MTP Press, Lancaster, [PEN.018.0761] at 0763

9 Ibid [PEN.018.0761] at 0765

10 Medical Research Council Working party on Post-Transfusion Hepatitis, 'Post-transfusion hepatitis in a London hospital: results of a two-year prospective study', Journal of Hygiene, 1974; 73:173-188 [LIT.001.0116]

11 Craske et al, 'An outbreak of hepatitis associated with intravenous injection of Factor VIII concentrate, The Lancet, 2 August 1975; 221-223 [LIT.001.0360]

12 Other clinical signs of infection included pyrexia and urticaria which had occasionally occurred with cryoprecipitate. The article commented that these signs did not occur with concentrates.

13 Preston et al, 'Percutaneous liver biopsy and chronic liver disease in haemophiliacs', The Lancet, 19 September 1978; 592-594 [LIT.001.0387] Details are given in the Preliminary Report, paragraph 6.71. Professor Thomas identified this as Dr Triger's work: Day 52, page 1292.

14 'Post-transfusion hepatitis' British Medical Journal, 1981; 283 [LIT.001.0227]

15 Stirling, Beckett and Percy-Robb, 'Liver function in Edinburgh haemophiliacs: a five year follow up', Journal of Clinical Pathology 1981; 34:17-20 [LIT.001.0748]

16 Hay et al, 'Progressive liver disease in haemophilia: an understated problem?' The Lancet, 1985; 1:1495-98. [LIT.001.0335] In oral evidence (Day 8, page 4) Dr Hay noted that the article title was a 'poke' at another paper, published the previous year, which had suggested NANB Hepatitis might be an over-stated problem: Stevens et al, 'Liver disease in haemophiliacs: an overstated problem?', British Journal of Haematology, 1983; 55:649-655 [LIT.001.0008]

17 Dr Hay's report on communication to patients about hepatitis [PEN.018.0961] at 0987

18 See Chapter 15, Knowledge of Viral Hepatitis 2 - 1975 to 1985

19 UK Haemophilia Hepatitis Working Party, Annual Report for the Year 1982-83 [SNF.001.0948]; see Chapter 15, Knowledge of Viral Hepatitis 2, 1975 - 1985, paragraph 15.122

20 Fletcher et al, 'Non-A non-B hepatitis after transfusion of factor VIII in infrequently treated patients', British Medical Journal, 1983; 287:1754-57 [LIT.001.0239]

21 Jones, 'Acquired immunodeficiency syndrome, hepatitis and haemophilia', British Medical Journal, 1983; 287:1737-1738 [LIT.001.0243]; see Chapter 15, Knowledge of Viral Hepatitis 2 - 1975 to 1985, paragraph 15.127

22 See Chapter 13, Knowledge of Viral Hepatitis Now, paragraph 13.43 for discussion of the difference between these two forms of hepatitis.

23 See Chapter 15, Knowledge of Viral Hepatitis 2, 1975 to 1985, paragraphs 15.121-15.128

24 FEIBA is a 'bypassing agent' used in the treatment of patients who develop inhibitors, or antibodies, to Factor VIII concentrates.

25 From medical records recovered in respect of witness Mark.

26 Mark - Day 32, pages 25-26

27 Ibid, pages 19-22

28 Ibid, page 19

29 Ibid, Page 19

30 See Chapter 5, An Examination of the Effects of Infection with HIV on Patients and their Families, Including Treatment, paragraph 5.248

31 Ibid paragraph 5.263

32 Ibid.

33 Excerpt from medical records recovered in respect of Frances' father

34 See Chapter 5, An Examination of the Effects of Infection with HIV on Patients and their Families, Including Treatment.

35 Elaine - Day 31, page 20

36 See Chapter 5, An Examination of the Effects of Infection with HIV on Patients and their Families, Including Treatment.

37 Professor Ludlam - Day 35, page 10

38 Ibid, page 11

39 Ibid, page 10

40 Chapter 21, Haemophilia Therapy - Use of Blood Products, Table 21.3

41 Professor Ludlam's statement on Topic C5 [PEN.018.0832]

42 Collective Response on behalf of past and present Haemophilia Centre staff in Scotland on Topic C5 [PEN.018.0649]

43 Professor Ludlam's statement on Topic C5 [PEN.018.0832]

44 Professor Lowe - Day 80, pages 2-3

45 Ibid, page 3

46 Professor Lowe thought that at this stage of drafting the contents of the Collective Response were divided equally between Edinburgh and Glasgow opinion; see Day 80, page 4

47 Professor Lowe - Day 80, page 10

48 Ibid, pages 4-5

49 Collective Response on behalf of past and present Haemophilia Centre staff in Scotland on Topic C5 [PEN.018.0649] at 0666

50 Professor Lowe - Day 80, pages 6-7

51 Collective Response on behalf of past and present Haemophilia Centre staff in Scotland on Topic C5 [PEN.018.0649] at 0650

52 Professor Ludlam's statement on Topic C5 [PEN.018.0832] at 0833

53 Ibid [PEN.018.0832] at 0833

54 Ibid [PEN.018.0832] at 0833-34

55 Collective Response on behalf of past and present Haemophilia Centre staff in Scotland on Topic C5 [PEN.018.0649] at 0651

56 See Chapter 15, Knowledge of Viral Hepatitis 2 - 1975 to 1985, paragraph 15.122

57 Collective Response on behalf of past and present Haemophilia Centre staff in Scotland on Topic C5 [PEN.018.0649] at 0654

58 Professor Ludlam's statement on Topic C5 [PEN.018.0832] at 0834

59 Note of a Meeting between Professor Ludlam and the Penrose Inquiry legal team [PEN.012.0774]

60 Day 35, pages 14-16

61 Note of a Meeting between Professor Ludlam and the Penrose Inquiry legal team [PEN.012.0774]

62 Day 35, pages 11-12

63 Day 39, pages 21-22

64 Professor Ludlam's statement on Topic C5 [PEN.018.0832] at 0834

65 Ibid [PEN.018.0832] at 0833-34

66 Collective Response on behalf of past and present Haemophilia Centre staff in Scotland on Topic C5 [PEN.018.0649] at 0652

67 Professor Ludlam's statement on Topic C5 [PEN.018.0832] at 0838

68 Professor Lowe's statement on Topic C5 [PEN.018.0839] at 0839

69 Day 35, page 9

70 Day 39, page 21

71 Professor Ludlam's statement on Topic C5 [PEN.018.0832] at 0836-37

72 Letter to patients, dated 27 January 1986 [PEN.018.0787]

73 Hoofnagle et al, 'Treatment of Chronic Non-A, Non-B Hepatitis with recombinant human alpha interferon', The New England Journal of Medicine; 1986, 315:1575 [LIT.001.3806]

74 Professor Ludlam's statement on Topic C5 [PEN.018.0832] at 0837

75 Professor Ludlam's response to questions from the Inquiry on information to patients [PEN.018.1246] at 1247

76 Collective Response on behalf of past and present Haemophilia Centre staff in Scotland on Topic C5 [PEN.018.0649] at 0654

77 Patient information sheet [PEN.018.0807]

78 Professor Ludlam's statement on Topic C5 [PEN.018.0832] at 0837

79 Ibid [PEN.018.0832] at 0837

80 Ibid [PEN.018.0832] at 0835

81 Ludlam et al, 'Antibodies to Hepatitis C virus in haemophilia',The Lancet; 2 September 1989; ii, 560-561 [LIT.001.3859]

82 Watson et al, 'Use of several second generation serological assays to determine the true prevalence of Hepatitis C virus infection in haemophiliacs treated with non-virus inactivated factor VIII and IX concentrates', British Journal of Haematology, 1992; 80:514-518 [SNB.004.6000]

83 Simmonds et al, 'Hepatitis C quantification and sequencing in blood products haemophiliacs, and drug users',The Lancet, 1990; 336:1439-72 [LIT.001.0287]

84 Professor Ludlam's statement on Topic C5 [PEN.018.0832] at 0835

85 Ibid [PEN.018.0832] at 0835

86 Ibid [PEN.018.0832] at 0835-36

87 Ibid [PEN.018.0832] at 0837

88 Ibid [PEN.018.0832] at 0838

89 Paragraph 5.171 of Chapter 5

90 Paragraph 5.186 of Chapter 5

91 Professor Lowe, in oral evidence, corrected a typographical error in his statement. He was a 'trainee' doctor from 1976 to the end of 1985, and not 1987. He became a consultant in 1985. Prior to that he was a Registrar and then a Senior Registrar and medically qualified to treat patients. Day 80, page 15

92 Professor Lowe's statement on Topic C5 [PEN.018.0839] at 0839

93 As stated in paragraphs 21.313-21.320 of Chapter 21, Haemophilia Therapy - Use of Blood Products. Professor Forbes' recollection about the pattern of use of therapeutic materials did not accord with the UKHCDO statistics on the administration of blood products at the GRI.

94 Professor Forbes' statement on information given to patients [PEN.012.0411]

95 Forbes, 'Innovations for haemophiliacs', The Bulletin, 1980; 1, The Haemophilia Society [PEN.018.0676]

96 Professor Lowe's statement on Topic C5 [PEN.018.0839]

97 Professor Lowe - Day 80, pages 9-10

98 Collective Response on behalf of past and present Haemophilia Centre staff in Scotland on Topic C5 [PEN.018.0649] at 0650

99 Professor Lowe - Day 39, pages 160-1

100 Collective Response on behalf of past and present Haemophilia Centre staff in Scotland on Topic C5 [PEN.018.0649] at 0660

101 Professor Lowe - Day 39, page 163. The patients at the Royal Infirmary were usually older children and adults who had previously been patients at Yorkhill during their earlier years.

102 Professor Lowe - Day 39, page 164

103 Professor Lowe's statement on Topic C5 [PEN.018.0839] at 0839

104 Ibid [PEN.018.0839] at 0839

105 Ibid [PEN.018.0839] at 0842

106 Ibid [PEN.018.0839] at 0839. See, however, paragraphs 34.163-34.169 below.

107 Professor Lowe's statement on Topic C5 [PEN.018.0839] at 0840

108 Fletcher et al, 'Non-A non-B hepatitis after transfusion of factor VIII in infrequently treated patients', British Medical Journal, 1983; 287:1754 [LIT.001.0239]

109 Professor Lowe's statement on Topic C5 [PEN.018.0839] at 0840; Letter from Professor Bloom and Dr Rizza to Haemophilia Centre Directors, dated 24 June 1983 [SGH.002.2175] and UKHCDO AIDS Advisory Document, dated 14 December 1984 [SGF.001.2388]

110 Professor Lowe's statement on Topic C5 [PEN.018.0839] at 0840; Recommendations on choice of therapeutic products... UKHCDO, 16 May 1988 [SNB.001.5606]

111 Professor Lowe's statement on Topic C5 [PEN.018.0839] at 0840

112 Ibid [PEN.018.0839] at 0840

113 Professor Lowe - Day 80, pages 21-22

114 Ibid, page 23

115 Professor Lowe's statement on Topic C5 [PEN.018.0839] at 0841; Day 80, pages 17-18

116 Professor Lowe - Day 80, page 26

117 This percentage figure was taken, by Professor Lowe, from liver biopsy studies.

118 Professor Lowe - Day 80, pages 28-29

119 Professor Lowe - Day 80, page 20

120 Professor Lowe's statement on Topic C5 [PEN.018.0839] at 0841

121 Professor Lowe - Day 80, pages 31-32

122 Ibid, page 48

123 Ibid, page 36

124 Ibid, pages 37-38.

125 Ibid, Pages 104-105

126 Professor Lowe's statement on Topic C5 [PEN.018.0839] at 0847

127 Ibid [PEN.018.0839] at 0844

128 Professor Lowe - Day 80, page 44

129 Ibid, pages 72-73

130 Professor Lowe's response to questions from the Inquiry concerning written protocols for testing [PEN.017.2663]

131 Professor Lowe's statement on Topic C5 [PEN.018.0839] at 0848; Day 80, page 55

132 Professor Lowe - Day 80, pages 61-62

133 Professor Lowe's response to questions from the Inquiry about the reports of Dr Hay and Dr Nathanson [PEN.018.1240]

134 Ibid [PEN.018.1240]

135 Notes of meeting of Haemophilia Directors for Scotland and Northern Ireland, 26 February 1990 [PEN.018.0793] at 0794

136 Professor Lowe's statement on Topic C5 [PEN.018.0839] at 0849

137 Professor Lowe - Day 80, page 76

138 Ibid, page 65

139 Ibid, page 66

140 Ibid, page 65

141 Ibid, page 64

142 Ibid, page 69

143 Ibid, page 93

144 Ibid, page 94

145 Ibid, pages 98-102

146 Professor Lowe's statement on Topic C5 [PEN.018.0839] at 0850-51

147 Dr Nathanson's supplementary statement [PEN.018.0419] at 0421

148 Professor Lowe - Day 80, page 87

149 Dr Hay's report on communication to patients about hepatitis [PEN.018.0961] at 0991

150 Professor Lowe - Day 80, page 90

151 Ibid, pages 111-112

152 Ibid, pages 113-114

153 Ibid, pages 114-115

154 See Chapter 5, An Examination of the Effects of Infection with HIV on the Patients and their Families, Including Treatment, at paragraph 5.9

155 Ibid, at paragraph 5.37

156 Ibid 5.37

157 See Chapter 6, An Examination of the Effects of Infection with Hepatitis C on the Patients and their Families, Including Treatment, at paragraph 6.321

158 Day 81, page 43

159 Dr Willoughby's first statement on the use of blood product concentrates [PEN.019.1265]; Questions from the Inquiry to Dr Willoughby [PEN.019.1272]; Dr Willoughby's second statement [PEN.019.1272]

160 Dr Willoughby's first statement on the use of blood product concentrates [PEN.019.1265] at 1265-66

161 Dr Willoughby's second statement [PEN.019.1272] at 1273

162 Dr Willoughby's first statement on the use of blood product concentrates [PEN.019.1265] at 1266

163 Dr Willoughby's second statement [PEN.019.1272] at 1274

164 Dr Willoughby's first statement on the use of blood product concentrates [PEN.019.1265] at 1267

165 Dr Willoughby's second statement [PEN.019.1272] at 1274

166 Dr Willoughby's first statement on the use of blood product concentrates [PEN.019.1265] at 1267

167 Dr Pettigrew - Day 20, pages 19-20

168 See Chapter 33, An Investigation into the Systems in Place for Informing the Patients about the Risks - HIV/AIDS, paragraphs 33.34-33.42

169 Professor Gibson's statement on topic C5 [PEN.018.0824]

170 Ibid [PEN.018.0824] at 0824

171 Ibid [PEN.018.0824] at 0825

172 Ibid [PEN.018.0824] at 0825. However note the comment of Dr Perry at paragraph 34.168 that the Product Information Leaflets were intended for prescribing doctors and not patients. It was not until 1994 that information leaflets for patients became mandatory

173 Dr Gibson's statement on topic C5 [PEN.018.0824] at 0826: this appears to repeat the Collective Statement, but has been presented by Professor Gibson as her own evidence

174 Ibid [PEN.018.0824] at 0827: this also appears to be an adoption of the Collective Statement

175 Ibid [PEN.018.0824] at 0826

176 Ibid [PEN.018.0824] at 0829-0830

177 Ibid [PEN.018.0824] at 0830

178 Ibid [PEN.018.0824] at 0831

179 Ibid [PEN.018.0824] at 0831

180 See Chapter 6, An Examination of the Effects of Infection with Hepatitis C on the Patients and their Families, Including Treatment, at paragraph 6.131

181 Ibid paragraph 6.133

182 Professor Cachia - Day 83, pages 8-11

183 Witness statement of Professor Cachia [PEN.018.0853]; Day 83

184 Witness statement of Professor Cachia [PEN.018.0853] at 0855

185 Ibid [PEN.018.0853] at 0857

186 Professor Cachia - Day 83, pages 44-45

187 Witness statement of Professor Cachia [PEN.018.0853] at 0856

188 Professor Cachia - Day 83, Page 25

189 Witness statement of Professor Cachia [PEN.018.0853] at 0856

190 Professor Cachia - Day 83, Page 26

191 Ibid, page 26

192 Ibid, page 27

193 Ibid, page 29

194 Ibid, pages 12-13

195 Ibid, page 14

196 Ibid, page 43

197 Protocol for monitoring patients with bleeding disorders and Hepatitis C infection, December 2005 [PEN.018.0930] provided to the Inquiry by Haemophilia Nurse Specialist June Ward with her statement [PEN.018.1225]

198 Professor Cachia - Day 83, page 44

199 Ibid, Page 44

200 Tayside Hepatitis C Virus (HCV) Managed Clinical Network - Clinical Guidelines - July 2008 [PEN.018.0932] provided to the Inquiry by Haemophilia Nurse Specialist June Ward with her statement [PEN.018.1225]

201 Professor Cachia - Day 83, page 43

202 Ibid, page 44

203 Ibid, page 46

204 Ibid, pages 37-38

205 Ibid, page 38

206 Ibid, page 48

207 Ibid, page 38 and Witness statement of Professor Cachia [PEN.018.0853] at 0861

208 Professor Cachia - Day 83, page 47

209 Ibid, page 47

210 Ibid, page 51

211 Ibid, page 52

212 Ibid, pages 52-53

213 Ibid, page 49

214 Ibid, page 49

215 Witness statement of Professor Cachia [PEN.018.0853] at 0862

216 Professor Cachia - Day 83, page 55

217 Screening for HCV was introduced for blood donors on 1 September 1991

218 Professor Cachia - Day 83, page 57

219 Ibid, page 36

220 Ibid, page 37

221 Statement of Haemophilia Specialist Nurse June Ward [PEN.018.1225]

222 Ibid [PEN.018.1225] at 1225

223 Ibid [PEN.018.1225] at 1226

224 Ibid [PEN.018.1225] at 1226

225 Ibid [PEN.018.1225] at 1226

226 Ibid [PEN.018.1225] at 1226

227 Chapter 6, The Effects of Infection with Hepatitis C, Including the effects of Treatment, on Patients and their Families, paragraph 6.72

228 Hepatitis Risk Warnings, SNBTS [PEN.012.0286]

229 Dr Perry's statement in response to questions on SNBTS package inserts [PEN.018.0543]

230 Dr Perry's statement on package inserts and NANB Hepatitis [PEN.018.0556] at 0556

231 Ibid [PEN.018.0556] at 0557

232 Dr Perry's statement in response to questions on SNBTS package inserts [PEN.018.0543] at 0547

233 Ibid [PEN.018.0543] at 0544

234 Dr Perry's statement on package inserts and NANB Hepatitis [PEN.018.0556] at 0557

235 See paragraphs 34.107-34.108 above

236 The 1974 report of the UK Medical Research Council Working Party included in its definition of 'hepatitis' a finding of enzyme elevation in association with other clinical indications of hepatitis, typically jaundice.

237 Fletcher et al, 'Non-A non-B hepatitis after transfusion of factor VIII in infrequently treated patients', British Medical Journal, 1983; 287:1754-57 [LIT.001.0239]

238 Dow, Mitchell, Follett, 'Non-A, non-B Hepatitis surrogate testing of blood donations', The Lancet, 13 June 1987; 1366 [LIT.001.0346]

239 Professor Hayes - Day 78, pages 46-47

240 See paragraph 34.103 above

241 See paragraph 34.106 above

242 Paragraphs 6.18-6.23 of Chapter 6

243 Christine - Day 28, pages 26-27

35. An Investigation into the Steps Taken to Identify the Individuals who were Infected (Look-back) >