THE PENROSE INQUIRY
Final Report

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Chapter 6

An Examination of the Effects of Infection with Hepatitis C on the Patients and their Families, including Treatment

Introduction

6.1 This chapter deals specifically with the effects of infection with Hepatitis C, on those who were infected by blood and blood products, and on the families of infected persons.

Hearings of evidence

6.2 The hearings of evidence on this topic took place on 8, 9, 13, 14 and 15 December 2011 and on 10 January 2012. The following patients or relative witnesses^[1] gave evidence to the Inquiry in respect of this topic:

1. Stephen
2. Bridie
3. Colin
4. Gordon
5. Laura
6. Anne
7. Alex

6.3 Their evidence is narrated in this chapter. Another witness, Christine, who gave evidence about her son's infection with HIV also spoke about her own infection with Hepatitis C from blood products. Her evidence, insofar as it is relevant to this topic, is also included in this chapter.

6.4 In addition, both Professor Howard Thomas and Professor Peter Hayes (Professor of Hepatology in the Liver Unit, Royal Infirmary of Edinburgh (RIE) with Honorary Consultant Physician status with Lothian Health Board), provided the Inquiry with a clinical view on the effects of infection with Hepatitis C on patients and their families. Their evidence is referred to, where appropriate, throughout this chapter.

Stephen

6.5 Stephen was 44 years old when he gave evidence. He is married and has a daughter. He lives in the north of Scotland and works in the financial sector.^[2] Stephen suffered from Haemophilia A and acquired both the HIV and Hepatitis C viruses from blood products.^[3]

Stephen's diagnosis with and treatment for Haemophilia A

6.6 In 1968 when he was 11 months old Stephen was diagnosed with severe Haemophilia A, having a clotting factor of less than 1%. His maternal great grandfather and a cousin also had haemophilia.^[4] He was treated as a child at the local children's hospital and, from about the age of 13 or 14 years, at the regional hospital.^[5]

6.7 The first haemophilia treatment Stephen received was in 1968 when Russell's viper venom was applied to stop bleeding gums.^[6] Stephen's next haemophilia treatment was in 1974 when he was treated with cryoprecipitate before and after dental extractions. Thereafter he continued to be treated with cryoprecipitate. The severity of his haemophilia meant that Stephen required treatment frequently: in 1974, on 13 separate occasions.^[7]

6.8 Stephen's mother recorded every treatment he received in a diary. On 2 February 1976 a diary entry records that Stephen received 'New stuff, not cryo ...'.^[8] It seems likely that this is a record of Stephen's first treatment with Factor VIII concentrate. The diary then records that, on 24 April 1976, Stephen was admitted to hospital with 'jaundice, serum hepatitis ... discovered eyes yellow'.^[9] He was treated with rest in isolation and remained in hospital for 32 days. This acute attack of hepatitis may have been acute Hepatitis B (screening of blood for HBV was still not completely reliable in early 1976) or conceivably an acute attack of Hepatitis C (NANB Hepatitis was barely recognised in 1976). Thereafter Stephen was treated variously with cryoprecipitate or Factor VIII until the early 1980s when his treatment became solely Factor VIII.^[10]

6.9 By early 1982, Stephen required treatment for his haemophilia approximately every third day. Each treatment involved a 64 mile round trip to the hospital. Stephen's mother usually took him for treatment as his father worked away from home a week at a time. Stephen missed school every time he attended for treatment but did not allow this to impact on his school work.^[11] To his credit he left school having passed five higher and nine 'O' grade exams.^[12] Contrary to the advice of his haemophilia consultant, he played golf, football and squash.^[13] After leaving school, Stephen started working at a bank and, in his spare time, studied for a degree in management accounting. Having obtained his degree, he subsequently became a member of the Chartered Institute of Bankers and was awarded a Fellowship of the Institute.^[14]

Stephen's diagnosis with HIV

6.10 In about February 1986, when Stephen was 18 years old, his then haemophilia consultant told him that he was HIV-positive.^[15] In a letter to Stephen's GP dated 27 February 1986, the consultant confirmed that Stephen's HTLV-III antibody status was positive and wrote:

I discussed the situation and some of the implications of this positive test with him when I told him the result. The immediate implication is simply that he has met this virus at some point in the past and has made antibodies to it - the fact that this test is positive does not mean that he has got AIDS. We know that a small but uncertain proportion of people with this positive antibody do go on to develop AIDS in the future, but we cannot identify those who will.^[16]

6.11 Stephen was unsure if the doctor told him all that is written in this letter but he remembers it being emphasised that although Stephen was HIV-positive, he did not have AIDS. The doctor warned Stephen of the risk of sexual transmission of the virus and of the care he needed to take discarding needles and if he were to cut himself.^[17]

6.12 Stephen knew what HIV was when he was told about his diagnosis. At that time there were 'hard hitting' advertisements on the television about AIDS featuring a falling tombstone.^[18] Notwithstanding this, Stephen did not worry about his diagnosis. Stephen stated that he was not a person who worried: 'you don't worry about much in life when you are that age .... I have never let it worry me. I have got it and I have to deal with it. It's just as simple as that'.^[19] Stephen immediately told his parents about his diagnosis but he cannot remember how they reacted to the news. He suspects that his parents may have hidden their reaction from him. He did not tell his sisters or anyone else at that time.^[20]

Stephen's treatment for HIV

6.13 Stephen continued to attend the hospital for monitoring and blood tests every three months.^[21] He commenced taking Zidovudine medication in August 1992.^[22] He suffered no side-effects from it and it had no impact on his day to day life.^[23] As Stephen's cousin's husband was the local pharmacist, arrangements were made for Stephen to obtain the medication from the pharmacy in a nearby town instead so that he could keep his diagnosis a secret.^[24]

6.14 Stephen's medical records show that triple therapy treatment for HIV was discussed with him in June 1998 but Stephen remained on AZT. Stephen accepted advice and recommendations of his doctors in relation to treatment.^[25] In June 1998, Stephen was noted to have swollen parotid glands (salivary glands which lie in front of and just below each ear), a symptom of HIV.^[26] In 2002 Stephen developed some degree of facial atrophy (wasting of fat from the face), a known side effect of AZT treatment.^[27] Other than swollen glands, Stephen has had few symptoms of HIV and his viral load has remained undetectable.^[28]

Specific impacts of Stephen's infection with HIV

6.15 Stephen's infection with HIV had an impact on relationships. In 1987 Stephen was in a relationship with a girl. Although he knew that he was not going to marry her, he felt 'forced to ... put her in front of the doctor to explain things ...'.^[29] Stephen asked the doctor not to tell her that he was definitely HIV-positive. In June 1987 Stephen and his girlfriend met with the consultant and had 'a prolonged and wide-ranging discussion of the implications of HIV and haemophilia'.^[30] In a letter following that meeting the consultant recorded:

We discussed the following areas:

1. The fact that all severe haemophiliac patients in Scotland should be regarded as having met the HIV virus at some stage in the past regardless of any blood test ....
2. The result of 1, is that it is sensible to regard all severe haemophiliac patients as potentially infective and of course the commonest means of transmission of the virus is by sexual activity. The most effective means of preventing such transmission is the meticulous and invariable use of sheath.
3. As a result of 1 and 2, it is clearly sensible for the partners of haemophiliac men to plan not to conceive in the immediate future ....
4. When asked about [Stephen's] future I gave what had to be a guarded reply saying that we could not guarantee that he would not develop AIDS in the future although he appears in very good health at present. We would of course be keeping a close eye on his well-being.

The consultant further recorded that he thought that the information he had given was more than enough for them to digest. He asked them to go away and think about the situation and to return to see him any time they wished so that any misconceptions they would have could be clarified and any new questions answered.^[31]

6.16 A further impact of Stephen's diagnosis with HIV was in relation to travel. In 1992 Stephen married.^[32] In order that he and his wife could travel to the USA for their honeymoon, they had to obtain the help of his then consultant. Unknown to Stephen at the time, she wrote to a local travel agent for advice about this. This travel agent was one of Stephen's clients and Stephen says that he was quite annoyed when he subsequently discovered the consultant had written to that company, although she had not specified Stephen's name. The letter was completely anonymous and could not have been understood to refer to Stephen. The travel agent, who had helped in dealing with the travel problems of other patients, in turn asked the US Embassy in London for advice. This advice in November 1991 was that aliens who were HIV-positive were ineligible for a visa under US law and therefore were ineligible to travel under the visa waiver pilot programme. This ineligibility could be waived in certain circumstances, including if the stay was 30 days or fewer and only for visits which involved public benefit outweighing public risk. Public benefit included family visits, medical treatment and business travel. A letter from a physician was required to support an application to waive the ineligibility, addressing the alien's current state of health, the risk to US public health and the risk of spread of infection.^[33] The consultant wrote in support of Stephen's trip to the USA and Stephen was granted the necessary waiver. With regard to the requirement for travel insurance, Stephen and his wife eventually found a firm which specialised in haemophilia, HIV and Hepatitis C related illnesses, but obviously it was not easy for them. When trying to obtain insurance, Stephen was uncomfortable disclosing to the insurance agent that he was HIV-positive and later Hepatitis C-positive, 'But it was over the phone, so they wouldn't have known me supposing I walked past them today .....'^[34]

6.17 Since his honeymoon Stephen has travelled a number of times to the USA. Now he no longer needs to apply for a visa waiver but still he is questioned at immigration. After 9/11 Stephen had to attend in person at the American Embassy in Belfast to obtain the necessary visa, which involved the time and cost of travelling to Belfast. On a number of occasions, while on the aeroplane to the USA, Stephen has been required to fill out a different coloured immigration form to the majority of other passengers. At one time one of the questions on this form was, 'Are you a Nazi, a terrorist or HIV-positive?'^[35] Stephen found these forms degrading. He considered they singled him out as different from other passengers.^[36]

Stephen's diagnosis with Hepatitis C

6.18 It is unclear when Stephen first became aware of the fact that he had acquired Hepatitis C. There is an inconsistency between his recollection of finding out and what is stated in his medical records.

6.19 Stephen can clearly remember being told he was HIV-positive, but he cannot remember ever having been told that he had acquired Hepatitis C: 'I don't remember the smack in the face that I remember with HIV'.^[37] Stephen stated that having Hepatitis C was something that he became aware of.^[38] He thinks that he first knew he had Hepatitis C in the late 1990s or the early 2000s. He stated that, had he known that he had Hepatitis C, he would have told his wife before they married in 1992 (he told her at this time he had HIV) or when she became pregnant in 1996.^[39] Furthermore, when Stephen's wife became pregnant he and his wife asked that she be tested for HIV. He stated that had he known he had Hepatitis C they would have asked for her to be tested for this too.^[40] In fact, on 26 September 1996 Stephen's wife was tested for both HIV and Hepatitis C, the results of both these tests being negative.^[41] Stephen and his wife said they were unaware that she was tested for Hepatitis C until they saw the result of the test in his medical records in 2008.^[42]

6.20 In contrast to Stephen's recollection, the first mention in Stephen's medical records of the fact that he had acquired the Hepatitis C virus is a letter from the consultant to Stephen's GP dated 8 January 1992. This letter recorded that various viral investigations had shown that Stephen had antibodies to Hepatitis C.^[43] Nothing in this letter suggests that Stephen was informed of this.

6.21 The next mention of Hepatitis C in Stephen's medical records is a handwritten note on the bottom of a letter from the haemophilia consultant addressed 'To whom it may concern' dated 27 April 1995. This note appears to have been written at a subsequent clinic appointment on 8 June 1995 and states '[K]nows about Hep C. Wife had Hep A three years ago'.^[44] A letter dated 9 June 1995 about this clinic appointment to Stephen's GP records, 'He is hepatitis C positive and does not want anything further done about this. He is, of course, HIV positive. His wife had hepatitis A 3 years ago but I have offered that we check her out if he wants to'.^[45] Stephen cannot remember this consultant ever speaking to him about Hepatitis C.^[46] She ceased being Stephen's treating consultant in about March 1996 when a different consultant haematologist was appointed.

6.22 A report from the Department of Medical Microbiology dated 28 July 1995 on a blood specimen obtained on 8 June 1995 recorded that Stephen was HCV PCR positive and that he had Genotype 3a of the virus.^[47] On 29 August 1995 the consultant wrote to Stephen's GP advising him of these results and stating that Stephen would be suitable for Interferon.^[48] At this time Stephen was undergoing liver function tests. Stephen stated that he used to have blood tests every three months which he thought were to check his CD4 ratio with regard to his HIV status. He accepted that 'liver function test' might have been mentioned to him but stated that he would not have associated that with Hepatitis C.^[49] An ultrasound on 9 February 1996 revealed that Stephen's liver was enlarged, measuring over 17 centimetres in diameter, there were several gallstones within his gall bladder and his spleen was enlarged.^[50] Stephen has no recollection of the ultrasound or of these results.^[51]

6.23 In a letter to Stephen's GP, dated 11 March 1996, his then consultant haematologist stated that at a clinic appointment the same day he discussed with Stephen 'the implications of HCV infection, our plans for its surveillance and the therapeutic options that are available for its treatment'. This letter records the doctor's impression that Stephen did not wish to have treatment with alpha Interferon 'in view of the side-effects and the very low rate of success for clearance of the virus and normalisation of ALT in HIV-infected haemophiliacs'.^[52] Once again Stephen has no recollection of this. This letter also records that Stephen agreed to undergo an endoscopy and that the doctor planned to try to arrange this for May 1996. Stephen pointed out that he did not undergo an endoscopy until 2004 and this was borne out by his medical records.^[53]

Stephen's discussions with doctors about treatment for Hepatitis C

6.24 Stephen remembers a discussion in the late 1990s/early 2000s with his consultant during which he was told that he should be more concerned about his infection with Hepatitis C than with HIV.^[54] At that time, Stephen had no idea that Hepatitis C could cause him more harm than HIV.^[55]

6.25 The timing of this discussion coincides with the time when the consultant, like other clinicians, started to understand more about the likely consequences of patients' infection with Hepatitis C. Having initially considered it to be a fairly benign condition, clinicians came to realise that a large number of patients would develop major complications as a result of the virus, including cirrhosis and its complications.^[56] This realisation impacted on clinicians' views about when to treat a patient, which also evolved over the years.^[57] Prior to 2004, NICE^[58] recommended that only those patients with severe disease should be treated and that the assessment of the severity of the disease should be based on a liver biopsy.^[59] Due to the additional risks of a liver biopsy for those patients with haemophilia, they were exempted from this requirement.^[60] In April 2004, at a Consensus Conference on Hepatitis C in Edinburgh, it was decided that a liver biopsy was no longer essential to the selection of patients for therapy. Then, in 2005, the Scottish Executive produced a 'Hepatitis C Action Plan for Scotland'.^[61] This highlighted the importance of treating as many people as possible rather than tailoring treatment to those persons clinicians believed needed it most.^[62]

6.26 At a clinic appointment on 20 March 2000, Stephen and his consultant discussed treatment with Interferon and Ribavirin.^[63] At this time the doctor was aware that being male and co-infected with HIV were major risk factors in the progression of Hepatitis C.^[64] It was noted that Stephen's HIV infection was progressing extremely slowly with no significant morbidity and no significant fall in his CD4 count.^[65] The doctor thought that there was no immediate urgency to start treatment. It was decided to await the outcome of further studies on the use of combination therapy for Hepatitis C in the context of HIV therapy, before deciding what treatment to pursue for Hepatitis C.

6.27 In May 2002 Stephen had a further discussion with his consultant about treatment for Hepatitis C. The doctor told him that there was data available which showed that HIV-infected patients with high CD4 counts could safely be treated with alpha Interferon and Ribavirin, along with anti-HIV therapy, without significant problems. He also told him that success rates of around 40% for viral clearance using Pegylated Interferon and Ribavirin had been reported.^[66] It was suggested to Stephen that one option which would inform the debate about treatment was to consider the possibility of a liver biopsy in order to ascertain the histological appearances of the liver. Stephen does not remember what he thought about a liver biopsy at this time.^[67]

6.28 Stephen tried to live life as normally as possible despite his diagnoses, but obviously they preyed on his mind to a certain extent. In November 2002, some fairly innocuous symptoms caused Stephen to become wrongly convinced that he had developed cancer.^[68]

6.29 At a clinic appointment on 17 February 2003 treatment for Hepatitis C, and the side-effects and expected outcomes of treatment were discussed once again with Stephen. Stephen did not wish to embark on the treatment over the summer holidays but indicated that he was happy to consider it in the autumn of that year.^[69] In May 2003 Stephen developed high blood pressure. An ECG suggested that he might have developed left ventricular hypertrophy (thickening of the muscle of the left ventricle of the heart) but an echocardiogram did not confirm this.^[70]

Stephen's treatment for Hepatitis C

6.30 Towards the end of 2003, Stephen decided that he wished to start treatment with Interferon and Ribavirin in an attempt to treat or at least slow down the progression of the virus.^[71] In April 2004, Stephen attended an appointment with a Consultant Physician/Gastroenterologist and a Hepatology Clinical Nurse Specialist to discuss this. It was noted at this appointment that Stephen's liver enzyme levels had been deranged for some time and that he looked mildly jaundiced. He had a raised level of bilirubin (a sign of damage to the liver) and an alpha-fetoprotein of 14, the latter being noted as indicative of hepatocellular carcinoma but more likely to reflect cirrhosis against the background of Hepatitis C.^[72]

6.31 Stephen was told that there was increasing evidence that Hepatitis C co-infection should be treated in patients with HIV and that Hepatitis C was now the major cause of death among co-infected patients. He was also told that he had Genotype 3a of the virus and although this was one of the more favourable genotypes to treat, if he had cirrhosis as well as HIV infection then his chances of viral eradication would be much lower. He was advised that it was likely he would require 12 months of antiviral therapy with significant side-effects and around a 25% chance of being intolerant of the treatment.^[73] The Consultant Physician told Stephen that if he did have cirrhosis then he would not tolerate the treatment and it may cause him to have hepatic decompensation. Stephen was provided with some literature on the treatment and given some web sources of information on it.^[74] It was agreed that Stephen would undergo an ultrasound of his liver to exclude hepatocellular carcinoma (cancer of the liver) and an endoscopy check for oesophageal varices (varicose veins in the stomach and gullet). Stephen found the prospect of starting treatment 'a bit daunting but [he] knew it had to get done'.^[75]

6.32 In June 2004 Stephen underwent an endoscopy.^[76] He did not know what an endoscopy was and so underwent it without an anaesthetic, something he will not repeat.^[77] The endoscopy disclosed that Stephen had four varices.^[78] The consultant would have prescribed Propranolol for Stephen to treat the varices but decided against it due to Stephen having suffered a life-threatening asthma attack in 1993.^[79] An abdominal ultrasound scan in July 2004 revealed that Stephen had moderate hepatosplenomegaly (enlargement of the liver and the spleen). His spleen measured 20cm at its widest. His liver showed evidence of cirrhosis.^[80]

6.33 On 31 March 2005 Stephen started antiviral therapy for Hepatitis C.

6.34 Treatment consisted of Pegylated Interferon Alpha 2b 150 mcg by subcutaneous injection once per week and Ribavirin capsules, 1200 mg daily divided into doses. It was planned that Stephen would receive 48 weeks of treatment with his Hepatitis C PCR response being checked at 24 weeks and a decision on whether to continue with the treatment for a further six months would be made at that time.^[81] This was in line with 'stopping rules' which became more refined over the years and were eventually documented in the SIGN (Scottish Intercollegiate Guidelines Network) guidelines on the management of Hepatitis C, dated December 2006.^[82] These rules defined when a person should stop treatment. For example, if a person with Genotype 1 of the virus failed to achieve an early viral response after 12 weeks of treatment then it was known that this person would be extremely unlikely to be cured and would simply suffer the complications and side-effects of the treatment.^[83]

6.35 The night he started his treatment, Stephen sat with his wife before giving himself the first injection of Interferon, wondering what effect it would have on him and how immediate such an effect would be.^[84] In the event, initially Stephen did not suffer any severe side-effects and he found the treatment 'okay'.^[85] In June 2005 the amount of Interferon Stephen was prescribed was reduced to 90 mcg due to a fall in his platelet count and neutrophils.^[86] These are known side-effects of the treatment. A detailed summary of the known side-effects of Interferon and Ribavirin is given in Chapter 13, Knowledge of Viral Hepatitis Now, paragraph 13.107. When his PCR level was tested after six months of treatment, the result showed that Stephen had cleared the virus. Stephen thought that this was good and that it was worth carrying on with the treatment. He understood that it was hoped that the treatment would clear the Hepatitis C virus, but that he may still eventually need a liver transplant.^[87] Unfortunately, Stephen's clearance of the virus proved to be temporary.

6.36 In about mid-October 2005, Stephen began to feel generally unwell and his condition changed markedly. At this time Stephen was working full-time in a business development role at the bank, which involved him 'being out and about a lot'.^[88] He usually worked 12 to 14 hours a day. Stephen felt tired and unable to work his usual working day. He was unable to do tasks which he normally took for granted. He would read things and not understand what he was reading. He found that he forgot what he had already read. His employers had been unaware of his diagnosis with Hepatitis C but Stephen felt that, due to these symptoms, the time had come to disclose this to them and ask them for their support. On hearing of his diagnosis, Stephen's employers were 'absolutely fantastic'.^[89] He was subsequently absent from work for 22 months and his employers paid him his full salary for this period.

6.37 Stephen experienced the following symptoms during the latter stages of his treatment which may have been due either to the side-effects of the treatment or to his liver disease: low levels of concentration, no energy, severe nose bleeds, loss of appetite, thinning of his hair, severe muscle cramps, including one occasion when he had cramp 'in just about every single joint in [his] body at the same time', insomnia, nausea and vomiting.^[90]

6.38 On 3 October 2005 Stephen was prescribed medication, namely GCSF 105 mcg three times weekly by subcutaneous injection, in the hope of raising his neutrophil count so that his dose of Interferon could be increased.^[91] His dose of Interferon was increased on 13 October 2005. At this time Stephen had a rash on his abdomen from the injection sites, had mild ascites (the accumulation of fluid in the abdomen) and was obviously jaundiced. He was prescribed Spironolactone 50 mg daily for fluid retention.^[92]

Deterioration in Stephen's condition and his admissions to hospital

6.39 On 17 December 2005 Stephen was admitted to hospital. On that morning he had passed a black stool and begun to vomit a large quantity of blood. On his admission to hospital his treatment with Interferon and Ribavirin was stopped. By this time Stephen had completed 37 weeks of this treatment. Stephen was noted as having been unwell for two weeks. He was lethargic, had a sore throat and dry mouth and his oral intake had reduced. Stephen was found to have bleeding from oesophageal varices and septicaemia. Stephen's condition deteriorated and he went into a coma. A couple of days after Stephen's admission to hospital, the treating doctor told Stephen's wife that Stephen had only a 40% chance of survival.^[93] Stephen was treated with intravenous antibiotics for staphylococcus in his blood. He underwent injection sclerotherapy (a procedure to treat blood vessels by injecting a solution into them) of his oesophageal varices and underwent two banding sessions (endoscopic placement of bands over the varices).^[94] He was found to have herpes simplex pharyngitis and this was treated with IV Acyclovir. He had hepatic decompensation with ascites and encephalopathy (damage to the brain characterised by confusion, cognitive impairment and lethargy) which required drainage, then control with diuretics. He had hypoalbuminaemia (abnormally low levels of albumin) and his INR, a measure of blood coagulation, rose to 2.7 at its worst. He developed a degree of renal impairment.^[95] He did not regain consciousness until 26 December 2005.

6.40 On 26 December 2005, a doctor in the GI Bleeding Unit advised Stephen's wife that the longer-term objective was to get Stephen assessed by the SLTU (Scottish Liver Transplantation Unit) in Edinburgh and that this depended on getting him through the current episode. She was told that the short-term objective was to treat the sepsis from which Stephen was suffering and to establish useful nutrition but that, at that time, they were not making progress. It was emphasised to her that the hospital would continue with active management but if Stephen's condition deteriorated, the hospital would have to review the treatment options and resuscitation preference.^[96]

6.41 Stephen made 'a remarkable recovery'.^[97] His condition improved with treatment and he was discharged home on 17 February 2006. In his subsequent referral letter to the SLTU, his Consultant Physician/Gastroenterologist described this episode as 'a stormy time' and wrote that Stephen 'was very lucky to survive it'.^[98]

6.42 On his return home Stephen was 'very very weak' and was confined to a wheelchair.^[99] He had no strength to walk. While he was in a coma Stephen's right knee, which had previously been a target joint (a joint which has repeated bleeding episodes), became stuck in the foetal position. This required intensive physiotherapy and also limited Stephen's mobility. He was unable to do anything himself. Stephen's wife was given leave of absence from her work to care for him. A ramp was installed at their home for the wheelchair. Stephen also required nutritional support but was unable to tolerate a nasogastric tube. He was prescribed nutritional drinks and milk shakes instead. At this time thoughts of his daughter kept Stephen going. There were days when he thought, 'What's tomorrow going to bring?', but he never gave up hope, 'maybe because of the type of person I am' but also because of his family.^[100]

6.43 On 25 February 2006 Stephen was re-admitted to the local hospital with mild encephalopathy secondary to dehydration. He was very confused and did not recognise his family. He was also complaining of back pain. After treatment with lactulose (a laxative used to treat hepatitis encephalopathy) he was discharged home on 28 February.^[101]

Stephen's assessment for liver transplant

6.44 Stephen was admitted to the SLTU on 23 April 2006 for assessment for liver transplant. During this admission Stephen was found to have moderate to severe aortic incompetence (aortic valve not closing properly) and there was concern that this might represent recent infective endocarditis (infection on one or more valves of the heart) as a result of his recent sepsis. A cardiology opinion was sought and he had an echocardiogram performed. In addition to this, Stephen underwent further investigations for possible renal impairment and diabetes. His viral loads of both HIV and Hepatitis C were checked. Most of these investigations were carried out at the local hospital. During this time Stephen tried to remain positive. It came as a shock to him that he might be diabetic and have a heart murmur.^[102]

6.45 Following these further investigations Stephen was diagnosed with diabetes mellitus type 2.^[103] Stephen believes his diabetes was caused by his liver disease and the pressure it put on his pancreas. The echocardiogram suggested mild, perhaps moderate, aortic regurgitation (the aortic blood leaks back into the heart after each contraction as the valve has failed to close completely). These complications were linked to his liver disease.^[104] He was put on the liver transplant list in July 2006. His HIV viral loads were checked monthly after this and it was a condition of him remaining on the transplant list that his HIV viral load did not become positive.^[105]

Period between Stephen's assessment for liver transplant and undergoing the liver transplant

6.46 Between the beginning of March 2006 and the end of January 2007 Stephen was admitted to hospital on 19 separate occasions. Most of these admissions were due to episodes of encephalopathy which gradually worsened over time. He was also admitted on occasion due to ascites and for variceal banding (to reduce the risk of bleeding). During the episodes of encephalopathy, Stephen became drowsy, confused, nauseous, agitated and had spells of vomiting. These episodes must have been very frightening for Stephen's family, particularly his daughter. Stephen often went into a coma during these episodes for a period of 24 or 48 hours. Stephen used to know when such an episode was coming on and the severity of it depended on how quickly he was admitted to hospital. He was concerned about the long-term impact of such episodes on his brain but was reassured that there should be no impact.^[106]

6.47 He also attended regular review appointments at the SLTU. At an appointment in August 2006, Stephen was noted to be frail, jaundiced and very thin with no nutritional reserve:

I came from a guy who had huge upper body strength to being a guy who could do nothing for himself, in a wheelchair .... I did a lot of weight training, a lot of exercise, and to be struck down within a matter of months into a wheelchair, it's not the best.^[107]

Latterly, his consultant told Stephen that he was becoming so weak that he might not survive many more episodes of encephalopathy. Stephen continued to suffer from ascites and eventually attended the hospital weekly to have the fluid drained.^[108]

6.48 Stephen was always told by the surgeons in Edinburgh that he needed 'a good liver'.^[109] He was offered the option of a transplant from a living related donor or a close blood match. Such transplants were very uncommon at that time and this perhaps reflects the seriousness with which the surgeons viewed Stephen's condition and their wish to do the best for him. This procedure involves a significant abdominal operation for the donor which carried with it a risk of mortality of about 1%. Due to these risks Stephen never considered this as an option. He felt that he could never have forgiven himself if something happened to a relative like his sister, for the purpose of his survival. Unknown to him at the time, two people offered to be such donors for him, but one person who was subsequently tested was found not to be a match.^[110]

Stephen's liver transplant

6.49 On 31 January 2007 Stephen was told that there was a liver available for transplant. By this time he was so ill he 'just wanted it done'.^[111] When he received the telephone call telling him the news, everybody around him was crying and he thought, 'At last'.^[112] He was keen to have the surgery carried out and then to try and rebuild his life as he best he could. He was admitted to the RIE that night and underwent various tests. There was concern that Stephen might have an infection as a result of his ascites but thankfully he did not.^[113]

6.50 On 1 February, Stephen underwent a liver transplant at the SLTU. During the surgery he was transfused with 17 units of white cell concentrate and a number of units of Factor VIII due to his haemophilia.^[114] Following the surgery Stephen made good progress. Eight days after the procedure, an Infectious Disease Specialist prescribed Stephen triple combination antiviral therapy for HIV, namely Abacavir 300 mg, Lamivudine 150 mg and two tablets of Kaletra, all twice a day.^[115] Unfortunately, but not unexpectedly, this therapy led to drug interaction with tacrolimus, the immunosuppressant which Stephen was also prescribed following the surgery to prevent rejection of the transplanted liver. As a result of this Stephen developed tacrolimus toxicity. His dose of tacrolimus was withheld for a period and then restarted at a reduced level. In addition to the tacrolimus toxicity, Stephen's recovery from surgery was also complicated by development of renal impairment secondary to a combination of urinary sepsis and tacrolimus toxicity. After treatment this improved. Stephen remained extremely physically wasted. He continued to be fed through a jejunostomy tube (a tube surgically placed into the small intestine) in addition to whatever food he managed to take orally. For a while Stephen suffered from symptoms of diarrhoea and abdominal cramping as a result of the jejunostomy feeding. On 23 February he was transferred from the SLTU to the local hospital where he continued his recovery and received physiotherapy, dietetic input and monitoring.^[116] He was discharged home from there on 6 April 2007. One outcome of the liver transplant was that the transplanted liver started producing Factor VIII and so Stephen no longer has haemophilia.^[117]

6.51 Stephen did not make the recovery he had hoped for from the liver transplant. He had a persistent high temperature. Various tests for the cause of this were inconclusive. On 13 April he was readmitted to the local hospital due to worsening peripheral oedema (swelling of the tissues in the lower limbs caused by the build-up of fluid) and marked shortness of breath. On 14 April an echocardiogram showed a grossly abnormal aortic valve and aortic regurgitation. There was also severe right and left systolic dysfunction (failure of the pump action of the heart). The cause of Stephen's aortic valve abnormality was infective endocarditis which had been caused by the septicaemia he had suffered in 2005.^[118] Stephen's renal function began to deteriorate.^[119] It was felt that Stephen needed urgent aortic valve replacement but the surgeons at the local hospital were extremely concerned about the risks to Stephen of this procedure and were not prepared to proceed with it.

6.52 On 18 April doctors explained the poor prognosis to Stephen and his wife. They told them that Stephen had two to three days to live. Stephen and his wife were understandably very upset and shocked by this news. At the time of his admission, Stephen and his wife thought that asthma was causing his symptoms and had no idea that they were attributable to his heart. Although they understood why the surgeon would not operate on Stephen, they did not agree with his decision. Stephen slept very little that night as he was very scared.^[120]

6.53 The SLTU was informed of the deterioration in Stephen's condition and agreed to admit Stephen for assessment. On 19 April 2007 Stephen was transferred by 'blue light' ambulance to the RIE. Initially, the surgeons there were also reluctant to undertake the surgery due to the risks involved. However, a further opinion was sought from the Freeman Hospital, Newcastle, and this opinion was that they would proceed with aortic valve replacement. The SLTU asked the Freeman Hospital if Stephen could be transferred there but this was not possible due to a lack of beds in the Intensive Treatment Unit there. Given the disparity of these opinions, a further opinion was sought from Mr Campanella, a Cardiothoracic Surgeon at the RIE. He agreed to carry out the procedure.^[121]

6.54 Stephen believes that, had it not been for his wife, in consultation with Mr Hidalgo, the Consultant Surgeon who performed his liver transplant, he would not have undergone further surgery.^[122] His wife insisted on the further opinions. She said she would rather tell her daughter 'that her Dad had died on the operation table than just ... left to waste away until he died at home'.^[123] Were it not for his wife and Mr Campanella, he would not be here today.^[124]

6.55 Stephen underwent aortic valve replacement on 26 April 2007. At the time of the surgery, Stephen was six foot three inches in height but weighed less than six stone. Stephen produced photographs of himself at that time for the benefit of the Inquiry, and he was barely recognisable as the man in the witness box. Before the operation Stephen was told '...[w]e need a miracle'.^[125] The odds of him surviving the surgery were less than 1% and as Stephen stated, 'You can't get worse odds than that'.^[126]

6.56 After the surgery, Stephen was managed in the Intensive Treatment Unit of the RIE. He required prolonged support there and was very slow to be weaned off ventilation.^[127] After a few weeks he was transferred to the High Dependency Unit and latterly to the ward. In July 2007 Stephen was transferred back to the local hospital to continue his recuperation there. At that time the remaining issues in relation to his care were nutrition, monitoring of his diabetes, treatment of the cause of the infective endocarditis, his treatment for HIV and his mobility. He returned to work part-time at the end of July 2007.^[128]

6.57 In the 19-month period between December 2005 and July 2007, Stephen spent 309 days in hospital: 202 of these in his local hospital and 107 in the RIE. This period was 'an extremely traumatic time' for his family; in particular, for his wife and daughter.^[129] Stephen's daughter was only about eight years old when he became unwell. Stephen's wife remained with him every day he was in hospital in Edinburgh and so their daughter was looked after by family and friends. She came to visit Stephen in hospital every second weekend but Stephen felt that he 'wasn't nice to look at' so the family protected her from this as best they could. At one point, Stephen and his wife told their daughter that Stephen was going to die. Stephen wanted to tell her as he did not wish this to be left to his wife to deal with. He will never forget her face during this conversation and, to this day, does not know what she was thinking at that time.^[130]

6.58 In her statement to the Inquiry, Stephen's wife said that during Stephen's period of illness, which began in December 2005, they had no family life. From December 2005 onwards, her life revolved around visiting him in hospital every day. She stopped working on 31 October 2006 for a period of 14 months. She stated that they had 'massive' family support throughout, without which she feels they would not have coped. She considered that she was fortunate to have been able to stay in Edinburgh while their daughter stayed with her grandparents. During that time her daughter's grandparents effectively became her parents. She and Stephen missed a lot of their daughter's life during this time including school concerts and parents' evenings. Their daughter was unable to have friends to stay. She had to grow up very quickly.^[131]

Stephen's condition now

6.59 Stephen has made a full recovery from his symptoms of liver disease and from his heart surgery. He required right knee surgery in June 2008 and a right knee replacement in 2009 to remedy the effects of the contracture of his knee during his coma in December 2005.^[132] He continues to attend both the RIE and his local hospital for review and monitoring of his liver, HIV and heart. Initially he underwent blood tests every three months and tests of his heart once a year. Now he has these tests every six months and every two years respectively. His medications have now reduced from 49 tablets a day to 13 tablets - Amoxicillin, Diltiazem, Lansoprazole, Ramipril, Tacrolimus and Kaletra, and insulin injections twice a day for diabetes.^[133]

6.60 Stephen continues to be infected with both HIV and Hepatitis C, although presently he does not think that he has symptoms of either. He has never had any symptoms of HIV and is not aware of any symptoms at present of Hepatitis C.^[134] With regard to HIV, his viral load remains persistently undetectable.^[135] He is aware that Hepatitis C is more aggressive in a liver transplantee. He knows that at some time in the future he will have to undergo treatment again for Hepatitis C and this is not something he relishes. As he is in a better physical state now, he is hopeful that the side-effects of the treatment will be less severe than those he experienced before.^[136] Nonetheless given what Stephen has been through in the past this must be a daunting prospect for him.

Specific impacts of Stephen's infection with HIV and Hepatitis C

6.61 Stephen came across as a very positive person and as such probably had a tendency to understate the effects of his infection on him.

6.62 Before he became unwell, Stephen was very active. He was a good golfer with a single figure handicap. His inability to play for four years has affected his golf and he believes that he is not as good as he used to be. Due to the problems he developed with his right knee, Stephen has been unable to resume playing badminton and squash. He is unable to run the distances he ran previously. He is able to weight train but finds it harder to build up to the level he was before, age being a factor in this.^[137]

6.63 Stephen's friends are unaware that he has HIV. They are aware that he has Hepatitis C but this has had no effect at all on their relationship with Stephen.^[138]

Financial impacts

6.64 Stephen believes that his ill-health has had a significant impact on his career and on his financial situation. Although Stephen did not suffer any loss of earnings as a result of his periods of ill-health, he believes that he incurred other losses. He normally received an annual bonus. He was paid this the first year he was absent from work but not the second. He believes that this bonus would have been at least £10,000. Stephen also believes that he missed out on promotion and the increased earnings this would have produced. Prior to his illness in December 2005, he was put forward for promotion. He was subsequently advised that, had he not then been absent from work, he would have been successful. This promotion would have resulted in a salary increase of at least £12,000 a year with associated increase of the salary related bonus. He has subsequently been promoted but due to the recession he did not receive the same salary increase as he would have done before.^[139]

6.65 Stephen's employment provides him with a number of benefits which he believes he would lose were he to find another job. He has a staff mortgage which includes life assurance in respect of the mortgage. He has no other life assurance. He believes that due to having HIV and Hepatitis C he would be unable to obtain any other life assurance. In about 1985 Stephen applied for life assurance from Scottish Amicable. His then consultant provided a report in respect of this application. The doctor was then asked by Scottish Amicable to carry out an HTLV-III test on Stephen. Rather than have Scottish Amicable refuse his application, as he thought it would do on receiving his test result, Stephen withdrew his application. Stephen is now anxious not to lose the life assurance he has as he does not wish his wife to be left with the debt of the mortgage, were he to die. He feels that she would have enough to cope with in such a situation without having to sell the house to clear the mortgage. His inability to obtain further life assurance precludes him and his family moving to a bigger house as they might like to do. His desire not to lose this life assurance has prevented Stephen from applying for other jobs which are better paid and have better benefits. He has also turned down a better job with a better salary and benefits.^[140] As a result he believes that his ability to further his career has been severely limited by his infections with HIV and Hepatitis C.^[141]

6.66 Stephen's work pension has a death-in-service benefit of four times his salary. Once again Stephen does not wish to lose this benefit and is sure that he would not be able to obtain such a benefit at a new job due to having both HIV and Hepatitis C.^[142]

6.67 Stephen's wife lost earnings of about £7500 during her 14-month absence from work to care for him.^[143]

6.68 Stephen has received payments from both the Skipton Fund and the MacFarlane Trust.^[144]

6.69 Due to his medical conditions, Stephen has had to pay significantly more for travel insurance than his wife each time they have travelled. As an example of this, in October 2011 he had to pay £854 for travel insurance for himself for a three week holiday to America. Some companies will not provide him with travel insurance. Due to his illness he has lost £700 in cancellation costs of a holiday.^[145]

6.70 He and his wife have incurred travel expenses attending hospital and medical appointments. They have also incurred car parking charges which Stephen estimates amount to over £1000. He regularly had to stay overnight in Edinburgh to attend appointments but was able to stay with family.^[146]

6.71 The financial impacts of Stephen's infection with HIV and Hepatitis C and, in particular, Stephen's inability to provide financially, as he would like, for his wife and child in the event of his death appear to be one of the most significant impacts on him of his infection with these viruses. His concerns for their future were he to die show that the uncertainty about his future weighs on his mind.^[147]

Bridie

6.72 Bridie is a civil servant and lives in central Scotland. She has an older sister and a younger brother and gave evidence on behalf of them all about their mother's infection with Hepatitis C and its tragic consequences. Their mother acquired Hepatitis C from a blood transfusion in 1974 and died as a consequence of this on 10 April 2009, aged 62 years. Their father died in 2007.^[148] For the purposes of this chapter, Bridie's mother will be referred to as 'Molly'.

Molly's blood transfusion

6.73 On 18 October 1974 Molly was admitted to a maternity hospital in central Scotland^[149] for the birth of her fourth child. The discharge note of this admission records:

Labour proceeded normally for about four hours when she suddenly took 'a fit' and became unconscious. She developed a marked tachycardia and, on examination was found to be almost fully dilated. At one point cardiac arrest occurred and the patient was resuscitated by external cardiac massage and given intravenous fluids.^[150]

6.74 Molly was then delivered by a low forceps application but sadly the baby girl died about 32 hours later. Molly bled profusely from the vagina and she was transfused in both arms under pressure, with the transfusions barely keeping up with the haemorrhage. Molly received almost three complete exchange transfusions. On examination a large cervical tear was found and a total hysterectomy was performed as this was thought to be the only way to save Molly's life. This surgery was complicated by hypofibrinogenaemia (acute bleeding caused by failure of the blood to clot) interfering with coagulation. During the surgery Molly deteriorated from time to time and for fairly long periods only a faint beat in the aorta could be detected. Initially the anaesthetist had 'great doubts about the recovery of her cerebral function as she remained deeply unconscious for some time'.^[151] After the surgery Molly began to improve slowly and steadily. The senior obstetrician and gynaecologist who treated Molly thought that the cause of her collapse was possibly an amniotic fluid embolism which caused the coagulation defect in the blood.^[152] Molly spent some time in the Intensive Care Unit of the maternity hospital before transferring to another hospital where she recuperated. This was a severe, life-threatening episode and there is no doubt that the blood transfusions Molly received contributed to saving her life.

6.75 Molly suffered long-term effects from this serious event. She became blind in her left eye, suffered weakness in her left hand side and had constant back and abdominal pains. She also became anxious and very worried about hospitals. When she attended an appointment at a hospital in 1988 she had an anxiety attack and felt hot, sweaty and faint at the thought of being in hospital again.^[153] This must be borne in mind when considering what Molly subsequently endured as a result of her infection with Hepatitis C.

Molly during Bridie's early childhood

6.76 As a child Bridie remembers her mother always being at home and everything being tidy and ordered there. Her mother did not work and Bridie and her siblings now believe that this was because she was unwell. They heard that, before they were born, their mother used to be 'the life and soul of the party' but from about 1980 onwards it seemed to them that their mother was always ill and in her bed, except for the odd night out.^[154] She complained of sore joints.^[155] Their father worked initially in manual type work and then latterly in offices. He worked 14-hour shifts and so, as children, Bridie and her siblings saw him infrequently.

Molly's diagnosis with cirrhosis

6.77 In January 1992 Molly underwent an ultrasound of her kidneys which revealed coincidentally that she had gallstones.^[156] She remained asymptomatic from these until about the middle of 1993 when she started to suffer from right upper quadrant abdominal pain radiating through to her back. On 4 July 1994 Molly was admitted to hospital for a laparoscopic cholecystectomy (removal of her gallbladder). During this procedure the surgeons noticed that she had what appeared to be cirrhosis of the liver. In order to help determine the cause of the cirrhosis the surgeons took a biopsy of her liver. Antibody studies were also carried out. The biopsy revealed changes of micronodular cirrhosis of indeterminate origin but there were some features suggestive of Hepatitis B infection.^[157] The discharge note from Molly's admission to hospital records 'The lady herself denied any excess alcohol intake'.^[158] It was common at the time for doctors to consider alcohol as a cause of cirrhosis. Molly and her family were shocked that she had cirrhosis and that it might have been caused by excess alcohol. Having had her drink spiked when she was younger, Molly only drank at Christmas time when she had a drink of Advocaat. Molly explained this to the doctors treating her but after she was diagnosed with cirrhosis she felt that she was treated differently by the staff as they presumed that she was an alcoholic. She heard people whispering about her.^[159] Molly was mortified by this and very upset. She was told never to drink alcohol again.

6.78 Unfortunately as alcohol is such a common cause of abnormal liver function test results and liver disease, to this day medical staff and others make incorrect assumptions about patients found to have these. As Professor Hayes stated in his evidence:

[I]t still remains common that people who have abnormal liver tests are referred up to the clinic and they have had a good telling off from their GP about drinking too much alcohol when they insist that they are almost tee-total.^[160]

This has been, and remains, a major issue for patients.

6.79 Molly was told that she required follow-up from a Gastroenterologist and she asked that she be referred privately. She was referred to a Consultant Physician. She saw him in about August 1994. The Consultant Physician noted that Molly had palmar erythema (reddening of the palms) and was mildly jaundiced. Her liver was palpable just below the costal margin (lower edge of the chest). His initial suspicion was that the cirrhosis was caused by a Hepatitis B infection contracted after the blood transfusion she had received in 1974.^[161] He also considered primary biliary cirrhosis or chronic auto-immune hepatitis as possible causes. He undertook further investigations of the cause of her cirrhosis including a liver blood test screen and a Hepatitis B surface antigen test but these were inconclusive.^[162] The Consultant Physician saw Molly for the third time on 10 October 1994. He noted that she had no symptoms of chronic liver disease although the previous findings on examination persisted.^[163] He noted that the latest liver function tests showed continual enzyme disturbance of a mild nature which was not significantly different from her previous visit. He noted also that there were antibodies to Hepatitis B surface antigen present in low titre, indicating a previous infection with an adequate immune response eventually. He concluded that she had developed Hepatitis B at the time of her blood transfusion. He suspected that she subsequently developed chronic hepatitis which damaged her liver although she eventually seroconverted and developed sufficient antibodies to stop the infection progressing. He told her to avoid alcohol and planned to see her at regular intervals. He saw her again in January 1995 when he noted that her liver function test results were not dissimilar to results from her previous visits. As her medical insurance had expired he planned to follow her up at a general hospital.^[164] In the event this follow-up did not occur. Molly failed to attend an appointment with the doctor on 18 July 1995 and it seems she made no further appointment with him.^[165]

Molly's diagnosis with Hepatitis C

6.80 In May 1996 Molly attended her GP to have her liver function monitored. As well as carrying out a liver function test, her GP also carried out a screening for Hepatitis C.^[166] The result of this was positive. On 31 May 1996 Molly's GP wrote to her and stated:

The repeat liver tests showed no significant change from your previous results. However, I took a blood test to test for a new form of hepatitis recently discovered called hepatitis C. This was positive. It is therefore likely that it has been hepatitis C which is the problem causing your liver abnormalities rather than hepatitis B.^[167]

6.81 Bridie remembers very clearly when her mother found out she had Hepatitis C. Bridie was at home in her garden and her mother and father arrived. Molly said to Bridie, 'I have just been told I'm dying. I have got AIDS'.^[168] Bridie stated that this was how her mother took the news that she had Hepatitis C as she did not know what it was and nor did her family. As far as Bridie is aware, Molly was not offered any counselling about the virus at this time.^[169]

6.82 Molly's GP referred her to Dr Datta, Consultant Physician. Molly's first appointment with him was on 26 June 1996. Bridie's father accompanied her to this and all her appointments as Molly was unable to travel to these on her own. Dr Datta found no abnormal clinical signs when he examined Molly. He carried out further blood tests and was of the view that she would need a repeat liver biopsy before a decision was made about treatment.^[170]

Molly's symptoms of Hepatitis C

6.83 Bridie was asked if she thought that her mother was suffering from symptoms of Hepatitis C at the time she was diagnosed with it. In response to this she stated:

[W]e didn't know what the symptoms of Hepatitis C were, so that wasn't until later on, when we discovered what they were, that everything that we knew or we took as being my mum as a normal person was the Hepatitis C obviously ... she had various mood swings and she was constantly tired and she was - I hate to say, she was actually classed as a hypochondriac and she was the joke of the family. Everyone laughed at her and nobody obviously knew until later that it was obviously her illness. Nobody knew she was ill. We just took that to be, that's what she is like.^[171]

She further stated:

She was always in her bed. She was always ill. She was always at the doctor's. She was always complaining of being sore, of being tired, of being sick .... I can't remember a time of her being anything other than in bed. She was in bed when I got married and I had my hen do. She was in bed upstairs while everyone was downstairs, and everybody took that to be she wanted to be the centre of attention, and everybody laughed at her. At that time we didn't know any better. We just thought that was what she was like.^[172]

6.84 In February 1997 Molly attended Dr Datta for further review. He carried out liver function tests and noted that Molly's AST (aspartate aminotransferase) and ALT (alanine aminotransferase) levels were marginally better than they were in July 1996.^[173] He considered the question of liver biopsy but did not think it necessary at that stage. He also reconsidered Interferon therapy but, having reviewed Molly's liver function test results, decided against it. Dr Datta also considered that, in the near future, the results of the combination trial of Interferon and Ribavirin might give better results for treating Hepatitis C.^[174]

6.85 In March 1997 Molly was referred to Dr Zoma, Consultant Physician in Rheumatology, due to increasing joint pains affecting her shoulders, arms, hands and knees. In his letter of referral her GP noted that Molly 'appears to be quite limited by her joint pains'.^[175] Dr Zoma's notes of Molly's first attendance at his clinic on 2 June 1997 record that Molly complained of 'Generalised aches and pains/cervical spondylosis for "many years". Now [complaining of] generalised pains involving neck, shoulders, elbows, hands, hips, knees, feet'.^[176] Molly told Dr Zoma that she had difficulty dressing and bathing and that her walking was slow and uncomfortable. Bridie remembers that her mother was unable to walk very far at all and did not even manage to walk to the shop across the road from their house without help. She was always sore and when she did walk she would 'end up in bed at the end of the day'.^[177] Dr Zoma considered that the overall picture was suggestive of an evolving inflammatory arthropathy and wondered if it related to her established active hepatitis. Dr Zoma asked Dr Datta if it was possible for Molly to be prescribed any non-steroidal anti-inflammatory analgesics in view of her liver condition.^[178] Although such drugs can affect the liver, Dr Datta agreed that they could be prescribed provided her liver function was monitored. In August 1997 Molly was prescribed Nabumetone 500 mg twice daily.^[179] Bridie does not think the medication helped her mother as she remained sore, regardless of what medication she was on.^[180]

6.86 In November 1997, Molly was referred to Dr Morris, Consultant Gastroenterologist as Dr Datta was retiring. On 4 December 1997 Molly attended the nurse-led Liver Assessment Clinic where she was seen by Margaret Neilson, Clinical Nurse Specialist. In her notes about this appointment, Ms Neilson records that she discussed Hepatitis C with Molly 'at length' and that Molly was concerned about the possibility of a liver biopsy.^[181] Ms Neilson advised her to wait to see if a liver biopsy was necessary. Ms Neilson also gave Molly information booklets about Hepatitis C, information about a support group and contact numbers.^[182] Bridie did not know that her mother had been given all this information and was very surprised to learn of it as neither her mother nor her father mentioned it to her.^[183]

Further investigations which Molly underwent

6.87 Molly attended Dr Morris' clinic on 19 January 1998 where she was seen by a Specialist Registrar. Her liver function test results remained elevated. An ultrasound of her abdomen done in January 1998 showed that her liver was 'of a patchy echogenicity, with irregular liver capsule suggesting underlying fibrosis'.^[184] There was no splenomegaly, varices or ascites. The possibility of a liver biopsy was discussed with Molly but it was noted that 'she is really not keen on this at the moment'.^[185] The ultrasound also revealed that Molly had multiple gallstones in her gallbladder. As she had undergone a cholecystectomy, the presence of gallstones caused some confusion among those treating her. While this was investigated it also caused Molly some distress.^[186] Subsequently, an MRI scan revealed that unusually Molly probably had a second gallbladder which was not removed during the cholecystectomy.^[187]

6.88 On 1 June 1998 Molly attended a clinic appointment with another Specialist Registrar. At this time it was noted that Molly had been reluctant to undergo a liver biopsy as she was unsure of the risks involved.^[188] Molly was told that there was a risk of bleeding or even death but that this risk was reasonably low in a patient who is well. She was also told that the test could be done under ultrasound guidance if she wished it as she had multiple adhesions (fibrous bands which form between tissue and organs). Molly agreed to a liver biopsy on this basis. On 8 June 1998 the liver biopsy was carried out. Molly was admitted to the ward at 10 am for the biopsy to be carried out in the afternoon. She was told not to eat or drink anything after 8 am that morning. After the biopsy she was kept in the ward overnight.^[189] Given Molly's fear of hospitals this must have been a difficult experience for her. Bridie thought that that her mother found the biopsy painful.^[190] The histology report of the liver biopsy noted that there appeared to be 'a moderate increase in fibrous tissue and a suggestion of nodularity ...'.^[191] It concluded that 'The overall appearances are entirely consistent with a hepatitis C related chronic active hepatitis'.

6.89 In November 1998 Molly was prescribed oral Prednisolone for her rheumatoid symptoms.^[192] It is unlikely that her bad joint symptoms were related to Hepatitis C. Her general malaise at the time may have been associated with Hepatitis C, or a combination of that and arthritis.

Molly's treatment with Interferon and Ribavirin as part of a clinical trial

6.90 In March 1999 Molly started treatment with Interferon and Ribavirin. She received this treatment as part of a clinical study entitled 'Viraferon plus ribavirin for the treatment of chronic hepatitis C'.^[193] Prior to starting this treatment, Molly signed a Patient Consent Form confirming that she had been given a copy information sheet and the nature, purpose, duration and foreseeable effects of the study had been discussed with her.^[194] Being included in a controlled clinical trial did not necessarily mean that the patient received the new treatment, as half of those participating in a trial received the standard treatment and half the new treatment.^[195] However, on 9 March 1999 Molly was prescribed 6 million units of Interferon three times per week by subcutaneous injection and Ribavirin 1000 mg daily taken orally.^[196] Molly was taught to self-inject. Bridie remembers that her mother 'was never keen on needles' and so this must have been difficult for her.^[197] In the event her joint pain made it difficult for her to self-inject and so Bridie's father administered most of the injections of Interferon.^[198]

The side-effects of treatment which Molly experienced

6.91 Molly looked forward to starting the treatment and dreaded it at the same time. She was keen to get rid of the virus.^[199] On 15 March 1999, a week after she had started treatment, Molly attended the nurse-led clinic for review. In the notes of this appointment it is recorded that, during the first week of treatment, Molly suffered from general fatigue and sore bones.^[200] Her mobility was affected and she had a dull headache which was relieved with paracetamol. She was irritable and emotional. Molly continued to attend this clinic weekly. On 22 March 1999 it was noted that she continued to suffer from the same symptoms as before. On 29 March 1999, three weeks after starting treatment, Molly was noted to be suffering from general fatigue, loss of appetite, weight loss (she had lost four pounds), nausea and a skin rash on her arms and trunk.^[201] She was tearful and irritable. Arthritis and general fatigue caused her reduced mobility and her haemoglobin had reduced by 4 gm/dL in two weeks.^[202] At this time her dose of Ribavirin was reduced from 1000 mg daily to 600 mg daily and the Interferon from 6 million units to 3 million units three times a week.

6.92 The notes of the next appointment on 8 April 1999 record that initially Molly felt better on the reduced doses but unfortunately this improvement did not last. She then stopped taking the Ribavirin for a few days and felt better. She described general fatigue, nausea and sleeplessness. It was noted that she was struggling to cope with the treatment. One of the doctors was consulted and he recommended that she stop taking the Ribavirin for a week and increase the dose of Interferon back to its original dose of 6 million units three times a week.^[203] A week later Molly reported a marked reduction in side-effects. Her appetite had returned and she was suffering from fewer headaches. So she continued on Interferon monotherapy. Four weeks later, in May 1999, it was noted that Molly was suffering from general tiredness - she was sleeping a lot, and had poor appetite and general aches and pains with arthritis. On 3 June, having completed 12 weeks of Interferon treatment, Molly continued to suffer from fatigue and to sleep a lot. Her platelet count was reduced. Her dose of Interferon was again halved to three million units, three times a week.^[204]

6.93 A virology result dated 18 June, 12 weeks after Molly started treatment, was HCV PCR negative showing that the virus had been cleared. It is unclear if this information was conveyed to Molly. Bridie was unaware of this test result.^[205] As a result of the negative PCR test it was planned that Molly continue with treatment with Interferon monotherapy with a view to completing a year's course of it.^[206] Molly continued to suffer from general fatigue and to sleep a lot. Bridie recalls that her mother's 'days and her nights were turned round about and ... she was always sore'.^[207] Candidly she admitted, 'you tended to listen to my mum and it went in one ear and out the other, because you got to a stage where you got fed up hearing it'.^[208] In August 1999 Molly was prescribed sleeping tablets by her GP and she found these helpful.^[209] She completed the prescribed Interferon course of 48 weeks of treatment on 14 February 2000. At that time it was noted that the nails on both her hands and her feet were splitting and she was trying to stop taking the sleeping tablets.^[210] A month after the treatment had stopped it was noted that Molly remained tired but that her appetite had improved. A further blood test dated 1 March 2000 confirmed that Molly remained HCV PCR negative at the end of her treatment.^[211] Once again it is unclear if this result was conveyed to Molly and Bridie was unaware of it.

6.94 As was standard procedure, a further HCV PCR test was carried out six months after Molly's treatment finished. Unfortunately the result of this test was positive. Molly was told this result at a clinic appointment on 11 September 2000. She attended this appointment with her husband and was seen by a Research Fellow and Sister Neilson. In a letter to Molly's GP about this appointment, the Research Fellow wrote that Molly had 'a tearful reaction to the news' but that they stressed to her the importance of remaining positive.^[212]

Molly's condition after treatment and her deterioration

6.95 Molly continued to attend Dr Morris's clinic for monitoring of her rheumatoid arthritis. The discomfort she suffered from her arthritis and her difficulty sleeping persisted.^[213] Doctors from both these clinics liaised about appropriate treatment for her rheumatoid arthritis. Dr Zoma had no doubt that her joint symptoms were linked to her chronic Hepatitis C infection.^[214] Around this time she was prescribed low dose Prednisolone, Tramadol (pain relief medication) and Lansoprazole.^[215]

6.96 On 9 September 2002, at Dr Morris's clinic, Molly discussed treatment for Hepatitis C with the Specialist Registrar she saw.^[216] The issue of retrying combination therapy was raised. Molly told the doctor that she felt she had not tolerated the treatment before as her sister had recently passed away and she was feeling quite depressed. This suggests that perhaps Molly thought she might tolerate the treatment better under different circumstances and she was obviously keen to try it again. The Specialist Registrar arranged for Molly to be reviewed by the Liver Specialist Nurse so that she could discuss this further. On 28 July 2003, Molly attended an appointment with Dr Morris. He wrote to her GP that he had had a detailed conversation with her about the information she had received at her previous appointment about re-treatment. It was his opinion and that of Sister Neilson that Molly should not be reconsidered for treatment of combination Interferon and Ribavirin because of the marked side-effects that she experienced when this was tried initially. He further wrote, 'I am unclear why her expectations were raised in this manner but have offered my apologies for any undue anxiety caused'.^[217] It must have been very disappointing for Molly to believe, for 10 months, that she might receive further treatment when in fact this was not the case.

6.97 At a review appointment on 12 July 2004, it was noted by a Senior House Officer, that Molly remained asymptomatic from her Hepatitis C.^[218] An ultrasound of Molly's abdomen performed in May 2004 was normal and liver function test results showed slight overall improvement. Once again, Molly raised the question of treatment and she asked about Pegylated Interferon therapy. This doctor reiterated that this treatment was not in her best interests as her previous treatment had been unsuccessful and she had also experienced significant side-effects.^[219]

6.98 Around this time Molly started suffering from recurrent urinary tract infections. In 2004 she attended the renal department of the Glasgow Royal Infirmary (GRI) for investigation of this. An abdominal ultrasound in May 2004 demonstrated normal kidneys.^[220] She was also found to have high blood pressure and started receiving treatment for this.^[221]

6.99 Molly continued to attend the hospital for monitoring. In 2006 Dr Stanley, Consultant Gastroenterologist, became the consultant in charge of her care. A liver ultrasound in May 2006 showed liver cirrhosis and this was in keeping with her blood tests at the time.^[222] The doctor who saw Molly at her clinic appointment on 31 July 2006 discussed the possibility of a liver biopsy to clarify whether or not she was cirrhotic. Molly was not keen on this and said that she would only consider a further liver biopsy if it could be carried out under general anaesthetic. This was not an option and so the doctor proceeded on the assumption that Molly was cirrhotic and, on the basis of this assumption, commenced screening her for varices and hepatocellular carcinoma.

6.100 Molly underwent an endoscopy on 28 September 2006. The report of this noted that Molly was 'very anxious' and that the endoscopy was 'very poorly tolerated'.^[223] The endoscopy revealed four Grade 2 varices.^[224] There was no evidence of bleeding. Molly was subsequently prescribed Propanolol as primary prophylaxis in respect of the varices.

6.101 In 2007 Bridie's father died very suddenly as a result of a heart attack. Until his death he had been Molly's main carer. His death had a significant effect on the whole family. Following his death Bridie took over caring for her mother while also trying to continue with her full-time job. She described this as difficult and when asked to explain what caring for her mother entailed she stated:

It probably would have been easier moving in with her. [O]bviously I had to take her to and from hospitals and doctor appointments. She couldn't do her shopping on her own, so I had to collect her, do her shopping with her. And she couldn't carry anything on her own. She couldn't actually get into the bath and out of the bath. So I had to arrange my time when she needed a bath to actually be in the house to make sure she could get herself organised that way. And I was on 24-hour call almost, just simple things. I think about the only thing she could do was get herself almost dressed and cook herself a bit of dinner. Everything else was me.^[225]

6.102 Molly tended to be wakeful during the night and then mid-afternoon would lie on the couch with a blanket. Bridie and her sister received numerous phone calls from their mother during the night. In retrospect, the reversal of her normal sleep rhythm was a sign of early encephalopathy.^[226]

6.103 Having taken over the care of her mother, Bridie and her siblings realised what their father had endured during the last ten years of his life. Bridie's parents had been together since her mother was 15 years old. Bridie described them as 'lifetime soulmates'.^[227] Previously Bridie's father was an active union man with a deep love of politics. He lived life to the full and had an interest in junior football and local pool leagues. He was pool champion and won numerous awards and trophies. He was the focal point of his immediate and extended family. As the burden of caring for Molly began to take its toll on him, his life changed. In March 1998, at the age of 55 years, Bridie's father, who had been unemployed for about a year and looking for work, decided that he needed to stop work and care for his wife due to her deteriorating health.^[228] He lost contact with his work mates, stopped socialising with his friends and stopped playing and watching sports. He eventually became 'a virtual recluse'.^[229] On one occasion Bridie's father broke down in tears when Bridie's sister was visiting as he was so worried about his wife. Molly confided in Bridie that she had been advised after her diagnosis with Hepatitis C to cease sexual relations and so Bridie's parents close physical relationship ended at that time. Bridie thinks that this affected them profoundly and on a level she will never be able to understand.^[230]

Molly's diagnosis with hepatocellular carcinoma

6.104 In February 2008 Molly's alpha-fetoprotein was found to have risen to 26.^[231] As a result of this she attended an urgent clinic appointment with a Specialist Registrar, on 3 March 2008. At this appointment she was noted to have lost a lot of weight. Bridie stated that Molly 'wasn't eating at that point' due to the death of her husband.^[232] She underwent an ultrasound scan which showed that the extra-hepatic biliary tree was 'essentially normal'.^[233] It was decided at this clinic appointment that Molly should undergo a triple phase CT scan to test for hepatocellular carcinoma. On 28 March 2008 Molly attended for the CT scan. Unfortunately, she was so scared that she ran out of the room without undergoing the scan.^[234]

6.105 On 1 September 2008 Molly attended for a further review with a Specialist Registrar. Bridie accompanied her mother to this appointment. At this time Molly was reported to be 'keeping well'.^[235] She had no symptoms or signs of hepatic decompensation and the doctor considered the overall clinical picture to be 'reassuring'. He discussed with Molly her fears about undergoing a CT scan and, in particular, her fear that she would be enclosed during the CT scan. Molly had previous experience of an old-style scanner which she had found extremely claustrophobic. At Bridie's suggestion Molly was able to view the scanner to try to alleviate her concerns about it. She subsequently underwent a second ultrasound scan and had repeat alpha-fetoprotein measured. The ultrasound suggested a 3.8cm left liver lobe lesion. Her alpha-fetoprotein had risen from normal in 2007 to 26 in February 2008, and to 42 in September 2008. Dr Stanley was suspicious that there was liver cancer.

6.106 She and Bridie then attended a further appointment with Dr Stanley on 23 September 2008. In his letter to Molly's GP about this appointment, Dr Stanley stated that he spoke with Bridie and her mother and explained the suspicion of a primary liver cancer.^[236] Bridie was adamant that no one mentioned the suspicion of cancer or used the word 'cancer' to either her or her mother at that time. She stated that she would have remembered had he or someone else done so and she would not have kept it from the rest of her family. In the letter dated 6 October 2008 referred to below, Dr Stanley referred to 'the liver nodule' (another way of describing cancer), and it may be that he used this expression during his discussions with Bridie and her mother as opposed to using the word 'cancer'. At the time of giving evidence, Bridie did not understand what 'liver nodule' meant and accepted it was possible that Dr Stanley had used this expression instead of the word 'cancer' when he spoke to them.^[237] During this appointment Bridie was aware that the doctors wished her mother to undergo an urgent CT scan 'because they saw something'.^[238]

6.107 Following this appointment, on 26 September 2008, Molly attended for and underwent a three-phase CT scan. The report of this concluded that there was hepatocellular carcinoma with high suspicion of tumour invasion of the left anterior portal vein.^[239] Dr Stanley then wrote to Molly by letter dated 6 October 2008:

We have now reviewed your CT scan in the context of the discussion we had at clinic regarding the liver nodule. The scan remains indeterminate and the unanimous view of those present at the meeting is that you now require an MRI scan of the liver to optimise the information we have prior to discussing treatment options.

I appreciate the difficulties you have tolerating these imaging procedures, but I emphasise that it is extremely important that you attend and undergo the test so that we have all the information required to manage this problem. You should be hearing from the radiologists regarding the date and time to attend for the test, which may be undertaken at Gartnavel due to their speciality interest. Please let me know if there are problems regarding this.^[240]

6.108 On 13 October 2008 Bridie's brother took their mother to the Gartnavel Hospital for the MRI scan. Once again, she was very nervous about the scan because of feelings of claustrophobia. Bridie's brother wore a lead vest and stood by her side throughout. He described the experience as 'very traumatic' for them both.^[241] The report of the MRI scan described that Molly 'did not tolerate the procedure very well and the liver specific scans could not be performed'.^[242] The impression given by the MRI scan taken together with the recent CT image was thought to be consistent with a diffuse type hepatocellular carcinoma within segment 3 of the left lobe, extending into the portal vein branch. Molly and Bridie attended an appointment with Dr Stanley on 18 November 2008. Bridie remembers that Dr Stanley told them that they had found a 3cm growth on Molly's liver and that he would refer her to the RIE as that was where the relevant specialist was. He advised them that, due to Molly's age, she would not be a candidate for a liver transplant but they would discuss whether they could cut or burn the growth off. Again, Bridie does not remember the word 'cancer' being used and so she and her mother remained ignorant that her mother had cancer. In his letter to Molly's GP about this appointment, Dr Stanley stated that the recent MRI confirmed the CT findings of 'a likely 8cm diffuse hepatoma in the left liver lobe'.^[243] He stated in the letter that he had explained the findings to Bridie and her mother but it appears that the fact that Molly had a liver cancer was not understood by them.

6.109 On 23 December 2008 Molly, Bridie and her brother attended an appointment with a Consultant Surgeon at the RIE. At this time Bridie and her brother reported to the surgeon that their mother was experiencing episodes of confusion and dizzy spells.^[244] The surgeon told them that Molly had hepatocellular carcinoma. This was the first time anybody had mentioned the words 'hepatocellular cancer'.^[245] They were all extremely shocked as they had not realised how seriously unwell she was. Molly cried and was inconsolable. Bridie said, 'I think [the Consultant Surgeon] was quite shocked because we were shocked'.^[246] The surgeon told Bridie's brother on a one-to-one basis that the prognosis was not good.^[247] It was decided that Molly should be referred for chemoembolisation treatment as there were no other available treatment options due to the size of the tumour and vascular involvement.^[248] Bridie's brother was told that the success rate of this chemoembolisation treatment was poor, and that Molly probably had about four to six months to live. Molly told Bridie and her brother that she did not know how long she had to live, and had no wish to know so Bridie and her brother decided not to tell her.

Molly's treatment for hepatocellular carcinoma

6.110 On 18 January 2009 Molly was admitted to the RIE. The chemoembolisation treatment was carried out the following day. Following this procedure Molly was sleepy and sore. On 21 January, Bridie telephoned the hospital and spoke to her mother who seemed to be confused and 'wasn't herself'. On 22 January Bridie's brother visited his mother and was extremely shocked at what he saw: 'she was an old woman who didn't recognise me and couldn't get up from bed'.^[249] Bridie's sister visited her mother from England on 23 January and she, too, was shocked and extremely upset to see her mother in such a state. On 27 January Molly was discharged from hospital. On her return home Molly was very difficult to live with. She was confused and aggressive towards Bridie and her siblings.^[250] She suffered from mood swings and was unable to carry out simple tasks.^[251]

6.111 Three days after her discharge from hospital, on 30 January 2008, Molly became very confused. She was unable to dress herself so Bridie and her siblings called an ambulance. Molly threw the paramedics out of her house, but eventually her GP persuaded her to go to the hospital. The GP's letter of referral stated that, as well as becoming more confused and aggressive, she had developed worsening abdominal swelling and leg oedema.^[252] An abdominal ultrasound carried out on admission revealed a small amount of ascitic fluid.^[253] Molly's encephalopathy was treated with oral Lactulose and she was discharged home on 4 February 2009.

6.112 At the beginning of February 2009 Bridie's GP signed Bridie off work and she began to care for her mother full-time. Due to the amount of time she spent caring for her mother Bridie saw less of her own son so her partner began to work part-time so that he could help look after him. About this time, Molly started to receive home help twice a day and this help assisted Molly with dressing and meal times. This was funded by the Social Services Department. Initially Molly hated having home help, but then she became dependent on it.^[254]

6.113 Molly had a further admission to hospital between 6 and 11 February 2009 due to symptoms of encephalopathy. At this time she was dark yellow in colour. She was constantly dozing, and her day and night were interchangeable. Her short term memory was affected.^[255] A few times her behaviour bordered on violent and, as Bridie stated, 'She wasn't my mum really'.^[256] Caring for their mother became a 24-hour occupation for Bridie and her siblings. Molly's GP was a great help to them. Bridie's brother researched other treatment options which might be open to their mother and, as a result of this, Molly went to see a professor at the Beatson Oncology Centre in the hope of being prescribed a drug called Sorafenib.^[257] In order to assess if this drug was likely to be of benefit to Molly, he repeated her blood profile to calculate her Child Pugh score.^[258] The result of this was 9 and this meant that there was no evidence that Sorafenib would provide any benefit to her.^[259] This must have been extremely disappointing news for both Molly and the family to hear.

6.114 Molly was again admitted to hospital between 16 and 25 March 2009 due to increased confusion, nausea and vomiting.^[260] Her family was told that she had only weeks to live. They felt that she had no quality of life in the hospital and so they asked that she be discharged home on 25 March. They took her home in a wheelchair. Molly received palliative care from MacMillan nurses, and various alterations were carried out to the house. These included the provision of a hospital bed, a frame to enable her to use the toilet, a bath lift and chair.^[261]

6.115 As late as March 2009 Bridie's family were unaware of the risk of transmission of the Hepatitis C virus. By this time Molly had semi-constant faecal soiling and her family used to assist her in the hospital, and at home. They were not advised to wear gloves or aprons and they did not do so when they helped her.^[262] As stated above, Molly was provided with information about the Hepatitis C virus and, as Bridie stated, she and her siblings were dependent on their mother to pass on such information.^[263]

6.116 Molly continued to deteriorate. On the evening of 5 April 2009 she became very upset, confused and agitated. She was convinced that someone was going to take her away. She was very frightened and made the comment 'I am not ready for this'.^[264] It took Bridie, her sister and the MacMillan nurse to settle her. She required subcutaneous sedation via a syringe driver and then further sedation during the night. The following morning Molly did not wake up as expected and she fell into a coma. She remained in a coma until her death a week later. During this period Bridie stayed at her mother's home, only returning home for an hour each day to see her son. Bridie and her siblings felt unprepared for their mother's death as they had expected her to wake up after being sedated.^[265]

6.117 Bridie and her siblings did not have a good relationship during the 1980s and 1990s. They all felt that they were driven out of the house because everyone's attention was focused on their mother, and they rarely spoke. Their mother's deterioration brought them 'back together' and Bridie stated that they have never been closer.^[266]

Financial impact of Molly's infection with Hepatitis C

6.118 Other than one unsuccessful part-time job in the 1980s, Molly did not work.^[267] Bridie believes that her mother would have worked had she not suffered from symptoms of Hepatitis C. This meant that only Bridie's father's salary supported their household and money was tight. When they were younger Bridie and her siblings used to wear second-hand clothes as their parents could not afford new ones. Bridie and her siblings were unable to go on school trips due to the cost of these. Other than visiting relatives in England on a couple of occasions, they had no family holidays. When they left school Bridie and her siblings obtained work so that they could bring money into the family home instead of attending further education. Had she been able to, Bridie would have liked to attend Art school. Her sister would have liked to study catering. Due to his Molly's symptoms of Hepatitis C and his father's main focus being to care for his wife, Bridie's brother's attendance at school was poor. He believed that his parents did not care whether he went to school or not. He left school with few qualifications. He has since obtained various qualifications through his work.

6.119 Molly never claimed unemployment benefit. When Bridie's father stopped working, Molly applied for Disability Living Allowance and was awarded the lower rate of this allowance. On numerous occasions Bridie's parents had to borrow money from family members to pay the mortgage and to buy food. After her father made the decision not to work again, in 1998, Bridie's uncle paid off the mortgage on Bridie's parents' house so they no longer worried about losing their home. He also gave them money to buy a car so that Bridie's father could drive his wife to her hospital appointments. Bridie and her siblings used to give their parents money for food, bills, car repairs and petrol. When Bridie's parents cared for Bridie's son, Bridie used to bring food and anything else he might need so her parents did not need to buy it.

6.120 Bridie's parents had no pension and no life assurance as they could not afford either. On the few occasions that her parents went on holiday, her mother travelled without travel insurance. Her parents incurred the expenses of her mother's prescriptions until she was 60 years old, petrol for travelling to and from medical appointments and extra heating costs. Molly felt the cold and so their house used to be kept very warm. During the last 18 months of their mother's life, Bridie and her siblings incurred significant expenses, namely the cost of petrol both driving Molly to and from medical appointments, visiting her in hospitals - including the RIE, hospital car parking charges and the cost of buying food for their mother, as she would not eat hospital food. Each of the children, at some point, took time off work to care for their mother. Bridie used annual leave for two weeks before being signed off work sick to care for her mother. She estimated that she lost about £150 a month, for at least two months, in flexi-time payments. She used up her sick pay entitlement during the period she cared for her mother. This affected her rate of sick pay afterwards and meant that, for a while, she felt unable to take any time off work sick. Bridie's sister incurred travel costs from her home in England to visit and to care for her mother. She too took sick leave from work to care for Molly. The time she spent caring for her mother used up her entitlement to sick leave and so when she was absent from work subsequently, she was only entitled to Statutory Sick Pay.

6.121 Molly received two payments from the Skipton Fund.

Colin

6.122 Colin was 57 years old when he gave evidence to the Inquiry. He is married and he and his wife have three grown-up children. He lives in Scotland.^[268]

6.123 Colin is the third of four brothers. He had Haemophilia B, as did two of his three brothers. All three brothers with Haemophilia B contracted Hepatitis C from their treatment with blood products. Both of Colin's brothers have received treatment for the virus, and one has received a liver transplant.^[269]

Colin's diagnosis with and treatment for Haemophilia B

6.124 Colin was diagnosed with Haemophilia B when he was about three years old.^[270] As a child, he was treated at Maryfield Hospital, Dundee until 1973 when his care was transferred to Ninewells Hospital, Dundee.^[271] He was told that he had severe haemophilia with a clotting factor of less than 1%. He used to carry a green card in case of an accident and this stated that he had severe haemophilia. A letter in his medical records dated 13 November 1973 recorded Colin's Factor IX assay as 8%.^[272] It is likely that, as Colin himself stated, his Factor IX assay varied over the years.

6.125 Colin was first treated for a bleed (in his right ankle) when he was about seven years old, in 1961. He was admitted to Maryfield Hospital. He was treated with rest, a compression bandage with a wire splint and then an Elastoplast stirrup strapping. He remained in hospital for about two weeks.^[273] He had a further bleed in the same ankle the following year. He was treated with bed rest and a compression bandage. His foot was then splinted with Kramer wire.^[274]

6.126 Having haemophilia did not affect Colin greatly as a child:

I led quite a normal life. At times I didn't even bother about it. I used to play football, which I was told I shouldn't do. Even late on in my teens, I was a good skier. I used to water ski, snow ski, things that you should never do.^[275]

6.127 Colin recalls being admitted to hospital in 1972 when he was 18 years old, due to a bruised and swollen hand. He then received treatment with fresh frozen plasma. Unfortunately, he suffered an allergic reaction to it known as 'Stevens-Johnson syndrome'. This reaction was successfully treated. The discharge letter from this admission states that Colin 'once again' developed an allergic reaction to fresh frozen plasma, suggesting that this may have not have been his first treatment with this product.^[276] There is, however, no record in Colin's medical records of an earlier treatment with fresh frozen plasma or any other blood product.^[277] As with all haemophilia patients, over the years Colin's treatment became Factor IX instead of fresh frozen plasma. The first note in his medical records of Factor IX being administered is when he had a tooth extracted in 1981.^[278]

6.128 Colin was reluctant to receive treatment for bleeds as in his mind it weakened his immune system. He only went to the hospital for treatment if he had a severe bleed. He thought that if he had a bleed and received Factor IX treatment, the effects of a further 'bump' were more severe than if he had not just had Factor IX.^[279] Colin estimates that, prior to 1994 he received treatment for bleeds a maximum of half a dozen times and each time in hospital. Some of these treatments were to cover dental treatment. His longest stay in hospital was three or four days, and there was a period of many years when he was 'never near a hospital'.^[280]

6.129 Colin left school when he was 15 years old. He started working in the men's sales department of a national clothing retailer and in his first year of employment, won the sales person of the year award for the retailer's 52 stores. After 18 months the retailer closed the store where he worked and Colin started his own small clothing company. It was apparent that Colin has a strong and impressive work ethic. He did not let his haemophilia interfere with this: 'when I was working, rather than go and get treatment, I used to go to work with black and blue legs and arms ....'^[281] Colin ran his clothing store for about seven years. Sourcing products involved a fair amount of travelling. Due to the limitations on the income from this clothing shop, Colin also began doing door-to-door deliveries of morning rolls for extra money. He and his brother began producing their own rolls and then they opened a baker's shop.^[282] A company in Glasgow later took over the business and Colin became the general manager.^[283]

6.130 In 1994 Colin became very unwell with a high temperature and rigors. He was admitted to King's Cross Hospital, Dundee with a two-week history of malaise and lethargy, and a four-day history of dysuria (painful urination), right loin pain and rigors. He underwent blood tests and urinalysis revealed protein and blood. He was given morphine for the pain. Colin felt very unwell and stated that he looked so ill that his friends who came to visit him 'didn't think that I was going to be coming out'.^[284] He was diagnosed with right pyelonephritis, (a kidney infection) and discharged home after treatment with IV antibiotics on 10 April 1994.^[285] With regard to his recovery, Colin stated, 'It actually took me longer to recover from that than it did from my liver transplant. That took so much out of my system that ... my whole body was wasted. It was very difficult'.^[286] It took him a long while to build up his strength after this episode.^[287]

Colin's diagnosis with Hepatitis C

6.131 In 1995 Colin and his two brothers were asked to attend Ninewells Hospital, Dundee. When they attended there, they were told that they should be tested for Hepatitis C. A letter dated 29 August 1995 from Professor Cachia, Consultant Haematologist, to Colin's GP, records that Colin attended the hospital on 11 August 1995.^[288] It was noted in this letter that Colin had never attended the hospital for regular review as he had few bleeding problems and had enjoyed an active lifestyle without developing any chronic joint problems. It was further noted that Colin had been tested, and found to be negative, for antibodies against Hepatitis B and HIV. A blood sample was taken from Colin at this appointment. The report of the sample dated 15 August 1995 confirms that Colin was found to be positive for Hepatitis C.^[289]

6.132 Colin's two brothers were informed in January 1996 of the results of their blood tests for Hepatitis C. They were both positive. As Colin still had not received the result of his blood test he telephoned the hospital to ask for it. He cannot remember who he spoke to. He told this person that his two brothers had received their results, but he had not received his. Colin was told that if his two brothers were positive for Hepatitis C then 'of course you have got it'.^[290] Colin commented, 'It was actually a very short conversation'.^[291]

6.133 Colin and his wife then attended an appointment with Professor Cachia on 19 January 1996. The note of this appointment records that Hepatitis C was discussed fully with Colin, including the risks of developing cirrhosis and hepatocellular carcinoma, monitoring, treatment and the risk of sexual transmission. Colin's abnormal liver function test results were discussed, his ALT at this time being 213. The note also recorded that Colin 'Drinks regularly. Current intake 26 units per week'.^[292] Colin disputes that he told Professor Cachia that his intake was 26 units a week. He stated that there were long periods when he did not drink at all and he would never drink that number of units in a week, except 'maybe if I had been away somewhere with the guys for a week' and added: 'with the amount I used to try and work and was working, alcohol was very low in my priority list as far as that's concerned'.^[293] Colin was advised of the potential interaction between Hepatitis C and alcohol and advised to stay within the government's current recommendations for alcohol intake.

6.134 Colin's wife was subsequently tested for the virus and found to be negative. Colin's Hepatitis C PCR test dated 6 April 1996 revealed that he had Genotype 1a of the virus. Colin was told that this genotype was the easiest to get rid of when in fact it is the hardest genotype to treat.^[294] Colin considers that the advice he received about the virus was 'very low key':^[295]

We were all told, 'There is bad news and good news. The bad news is you have got Hepatitis C but the good news is you have got a strain of the virus that is a low strain and it will probably never affect you. So go on and lead a normal life'.^[296]

Colin stated that it was now 'common knowledge' that in 1992 there was screening of haemophilia patients for Hepatitis C in the Dundee area and that these patients did not know what they were being tested for.^[297] He and his brothers were not included in this.

Colin's symptoms of Hepatitis C

6.135 Colin started to attend the Haematology Clinic, Ninewells Hospital, regularly for monitoring. He reduced his alcohol intake. Colin's health then began to deteriorate:^[298]

It was funny how it started to happen. I was losing strength, losing concentration, and I just put it down to maybe having a bug. In my whole life I have never had the flu. I don't know what the flu is. I very rarely take colds. So for being haemophiliac, general illnesses I was never bothered with. But I started getting aching pains, aching joints and it wasn't right. I thought I had a bug for a while.^[299]

6.136 Initially Colin started to have a few bad days once a month. On these bad days Colin felt tired and sometimes had aches and pains too. Then the bad days gradually increased so that he had more bad days in a month than good ones.^[300] Colin's liver function tests deteriorated too and the hospital told him that the virus was causing his symptoms. During one 18-month period he suffered from several bouts of cellulitis (a common skin and soft tissue infection caused by bacteria), each requiring antibiotic treatment. By this time Colin had stopped working due to his symptoms.^[301] He received incapacity benefit and found living on benefits 'just a nightmare'.^[302]

6.137 In 1998 Colin was referred to a liver specialist, Dr Dillon, Consultant Physician. Colin attended a clinic appointment with him in July 1998. At this time Colin continued to be troubled with lethargy and muscular aches and pains. He also suffered from periods of breathlessness and episodes of severe sweating. Both of these symptoms were investigated but no cause was found. Over time the periods of breathlessness had stopped. At this appointment the option of a liver biopsy was discussed with Colin. He was aware that there was an increased risk to him from such a procedure due to his haemophilia. This risk concerned Colin so he decided that he wanted a biopsy only if his liver function tests were severely abnormal. The option of combined antiviral therapy with Interferon and Ribavirin as part of a clinical trial was also discussed with Colin. Colin pushed to start treatment as he wished to try anything to stop the decline of his health. As he stated 'being a generally active person, I wanted to try and get the problem resolved, if it could be resolved'.^[303]

6.138 Around this time Colin started taking milk thistle. He did this at his own instigation having read up on hepatitis and the liver. He discovered that this was something which people took to cleanse their liver and to help their liver function. He believes that it helped him.^[304]

Colin's first course of treatment with Interferon and Ribavirin

6.139 In October 1998 Colin started treatment with Interferon and Ribavirin. Colin was told that he was the first haemophilia patient in Ninewells Hospital to receive this treatment. Before starting it he was warned that he would suffer flu-like symptoms. He was also told that it had different effects on different people depending on their basic wellbeing. Initially the treatment did not cause him any problems but after a week he began to suffer side-effects of it. He felt unwell with a feeling of exhaustion and joint aches which were more severe than those he had experienced before. Despite this he was keen, at this stage, to continue with the treatment. By 10 December 1998 Colin was suffering from severe side-effects namely joint pains and aches, muscle weakness and feeling 'completely washed out, weak and exhausted'.^[305] The effects were severe enough to make him want to stay in bed sometimes all day, several times a week. At these times he had to crawl to the toilet on his hands and knees.^[306] Colin's neutrophil (a type of white blood cell which protects against infection) count also dropped. As a result of this his prescribed dose of Interferon was halved. His white cell count then returned towards the normal level. His liver function test results also returned nearer to normal with his ALT dropping from 283 in June 1998 to 119 at the beginning of November 1998, although these measurements did fluctuate.^[307] During this period Colin was assessed as being entitled to Disability Living Allowance.^[308]

6.140 On 6 January 1999 Colin received the result of a PCR test which had been taken the previous December. The result of the test was that the Hepatitis C PCR remained positive which the doctors took as an indication that the treatment was not working satisfactorily.^[309] At this point, approximately 12 weeks after starting the treatment, Colin was advised to stop it. He understood that the reason for this was that his immune system 'was so low'^[310] but it seems likely that this PCR test result was an important factor in this decision.

6.141 Colin felt 'devastated' at having to stop the treatment, particularly having seen some positive benefit of the treatment with regard to his liver function test results. However, he knew that he was unable to continue with the treatment as the side-effects were so severe.^[311] It took 'quite a while' for the side-effects of the treatment to wear off and some wore off more quickly than others. Following this Colin then had 'a reasonable period of stabilised health ... where I was only suffering from the aches and pains but my wellbeing was good. It seemed to have done some good to the liver function'.^[312]

Colin's condition after treatment with Interferon and Ribavirin

6.142 Colin continued to attend the hospital on a regular basis for monitoring. Around this time Colin felt well enough to resume working. He felt unable to work for someone else due to the days when he was unwell and so he decided to work for himself. He bought a franchise for sweet sales. The sweets had a long shelf life and were pre-packed. He planned to sell the sweets when he felt well enough to do so. He built the business up to be 'quite a reasonably good going business over the months'.^[313] After time he employed someone to work alongside him. This person worked the days Colin did not and the business then operated five days a week.

6.143 In March 1999 Colin underwent an endoscopy to check for varices. This revealed none.^[314] As time went on his condition worsened and it was decided that Colin should undergo a liver biopsy to determine the state of his liver. Colin read a Patient Information Sheet about Laparoscopic Liver Biopsy for those with haemophilia which explained the procedure. He understood that it was 'pretty straightforward'; although since he had haemophilia he would be required to remain in hospital for about four or five days after the procedure.^[315] Colin underwent the liver biopsy on 19 October 1999. This required him to have two PICC lines (peripherally inserted central catheters) inserted for intravenous access, one for the factor treatment and one for taking blood samples. Unfortunately following the procedure he developed a left axillary (armpit) vein thrombosis, an unusual complication for a person with haemophilia. He was subsequently told that he was the only person on record as having severe haemophilia and developing a thrombosis.

6.144 Following the biopsy procedure, Colin's face began to swell: 'my face was out about four or five inches'.^[316] His mouth was so swollen that he was unable to swallow and he was dribbling. He developed pains in his body. His whole body started to bruise: 'My whole chest was black and blue and down my arm was black and blue ...'.^[317] In order to ascertain what was causing these symptoms Colin underwent a number of x-rays but each of them came back normal. After a number of days a venogram (an x-ray of the veins) revealed that Colin had developed a thrombosis. It was difficult for the doctors to treat. He was prescribed tablets to thin his blood and Factor IX to prevent any internal bleeding. Colin was told that if his blood was thinned too quickly then there was a risk of a clot coming away and that this could be fatal. It was a slow process and there were times when Colin was concerned that he would not live. In the event, the treatment was successful and Colin was discharged home on 1 November 1999.^[318] He had to be re-admitted to hospital a week later due to a viral infection. He remained in hospital for four days.^[319]

6.145 Colin's liver biopsy revealed appearances consistent with chronic Hepatitis C. The intensity of inflammation corresponded to Grade 2 and the degree of fibrosis to Stage 2.^[320] The appearances fell short of cirrhosis.^[321]

6.146 Colin continued to experience symptoms of the virus:

You never knew from day to day what it was going to be, to be honest, and as I say, you could have three or four days where you thought, 'Oh, there is nothing wrong with me, apart from a few aches and pains,' and you could get up the next morning and you would be just sore all over and sweating and not right, like the flu symptoms again. That's just the way it went.^[322]

6.147 He continued to take a close interest in available treatments for his condition. He gleaned information about this from discussions with Dr Dillon, internet searches and meeting with other people with haemophilia. At the meetings, it appeared to Colin that patients from Glasgow and Edinburgh were better informed than those in his own area. In his oral evidence to the Inquiry, Colin stated that he had heard from Dr Dillon that Pegylated Interferon was likely to become an option to treat Hepatitis C. Dr Dillon told him that it was slow release and the side-effects would be less severe than Interferon. Colin believed that this would be a better treatment option for him as his liver function test results had improved for a while during his previous treatment with Interferon and he believed the severity of the side-effects he had suffered previously had been a factor in stopping the treatment. Colin stated that he 'fought' to be treated with Pegylated Interferon but, initially, the hospital would not give him this treatment due to its expense.^[323] Colin sought help from his local MSP and offered to pay for part of the treatment himself. Colin's medical records show that, in fact, the treatment Colin wished to start was Ribavirin monotherapy.^[324] Whichever regime it was, this shows that Colin was keen to receive further treatment for Hepatitis C and was very proactive in trying to obtain it.

6.148 Colin's efforts to obtain further treatment added to the stress which he was already under due to his symptoms of Hepatitis C. In April 2000 Professor Cachia referred Colin to a psychiatrist to give Colin 'the opportunity to discuss his feelings and concerns about his health now and in the future'.^[325] In his referral letter Professor Cachia noted that '[Colin's] symptoms have become more and more disabling over the last few months .... [Colin] is very angry about the Hepatitis C infection and the lack of options that we can offer to improve his health at present'. The psychiatrist concluded that although Colin described various depressive features which generally 'wax and wane' with his general health, he did not consider that there was evidence to warrant a diagnosis of co-morbid depressive disorder. He noted that much of Colin's concern centred around uncertainties about his prognosis and possible treatment strategies: 'Consequently, he has not yet made the psychological shifts necessary for him to come to terms with his deteriorating physical health, although I got the impression that this was perhaps now beginning to happen'.^[326] Colin stated:

In my mind it wasn't depression, that's obviously why they sent me there. My attitude has always been if there is something wrong then you sort it, but unfortunately I couldn't sort this. It was something that was just getting worse.^[327]

This highlights one of the difficult features of Hepatitis C and its treatment - the inability at times of a patient to take treatment and effectively to tackle the virus head on, no doubt resulting in feelings of helplessness and frustration. This would have been particularly so at a time when new, possibly improved, treatments were recognised but were not yet available.

6.149 In October 2000 Colin was referred to the Pain Clinic at Ninewells Hospital in relation to the muscular pains he suffered. He was provided with a TENS machine. This seemed to exacerbate Colin's muscle spasms and so he stopped using it. He was also prescribed Dihydrocodeine. He declined morphine.^[328] About this time Colin started to experience what he called 'shutdown':

[I]t was like your whole body shut down. Even when I was driving, I could feel that - you were losing the feel of even the steering wheel, and it was just your whole body was on - it was like somebody had flicked a switch and your system wasn't working. You couldn't concentrate, you couldn't think. It was debilitating totally, and that was just the way it was, that - and I could have that two or three times in a week and not have it for a fortnight. It was one of these things that would come and go, and when it came - you could feel it coming on and it was like being partly paralysed but you weren't ....^[329]

Colin's treatment with Pegylated Interferon and Ribavirin

6.150 On 4 May 2001 Colin started treatment with Pegylated Interferon and Ribavirin as part of a trial. Once again he was warned about the side-effects of the treatment. He was also told that, as the first treatment had failed, there was only a slightly higher chance of this treatment being successful. Five days after starting treatment Colin attended the hospital for review. It was noted that, within four to six hours of receiving his first dose of Pegylated Interferon, Colin had shaking, nausea, sweatiness and a feeling of being unwell which waned as the day progressed. He continued to suffer from nausea in the mornings. At this appointment Colin also mentioned that about a week to 10 days before that appointment he had suffered an episode of melaena.^[330] Colin then underwent an endoscopy to discount varices as a cause of the melaena, and no varices were found.^[331]

6.151 At his next review on 21 May 2001, it was noted that since the first review Colin had been suffering from increasing side-effects such as chest tightness, palpitations and widespread aches and pains.^[332] He was also suffering from lower back pain spreading to his legs, earache, reduced haemoglobin and reduced neutrophils. Analgesia was having little effect. At this time Colin wanted to stop the treatment. He was seen by Professor Cachia and it was decided that Colin should continue taking Ribavirin but skip his dose of Pegylated Interferon that week. It was planned to admit Colin to hospital if these symptoms worsened.

6.152 One week later Colin was feeling 'much improved'.^[333] He had experienced slight chest tightening and palpitations two to three hours after a dose of Ribavirin. It was agreed that Colin would continue taking Ribavirin and recommence Pegylated Interferon at a reduced dose. Colin was keen to continue with the treatment.

6.153 At the review the following week, on 4 June 2001, Colin complained of suffering from chest pain and palpitations after most Ribavirin doses.^[334] He had missed a dose of Ribavirin due to these symptoms. He also complained of pain over his abdomen/kidneys and continued to suffer from general aches and pains, joint and muscle pain and sweats which were attributed to Hepatitis C. At this appointment Colin's neutrophils were noted to be reduced. Following discussion with Professor Cachia, it was agreed that due to these side-effects Colin should miss his dose of Interferon and stop Ribavirin. It was planned that Professor Cachia would discuss Colin's treatment with Dr Dillon, Consultant Physician, and the pharmacist. Colin was keen to continue with the treatment and asked especially if he could continue taking Ribavirin only. It was noted at the next review appointment that if Colin's palpitations persisted then consideration should be given to Colin undergoing a 24-hour ECG.

6.154 At the next review appointment a week later, Colin reported continuing to feel very unwell with kidney pain, palpitations and chest tightness. He had once again stopped taking Ribavirin himself the previous week. Colin stated that due to the side-effects of the treatment and the detrimental effect on his quality of life he wished to stop taking the treatment. He stated 'I knew myself I couldn't continue on it but also once again my immune system got so low that they advised me that even if I wanted to continue it would be unwise'.^[335] About five weeks after starting the treatment Colin stopped taking it. It was a difficult decision for Colin to take as, 'I knew that there was nothing else out there. I knew after that there was nothing else going to be able to help me'.^[336]

6.155 After Colin's treatment stopped he felt better for a while. He felt that the treatment had 'done some good'.^[337] He continued to experience 'shutdown' episodes. On good days Colin had a tendency to do too much, and this would make him worse:

[I]t's very difficult when you have worked all your life, a lot of time, and worked for yourself, you put a lot of hours in, and to sit and do nothing wasn't in my nature. So if there was anything I could do when I was feeling good, I did it. And of course, I then paid the consequences for it, but as the months past I realised I just had to do nothing and accept it.^[338]

The deterioration in Colin's health

6.156 Once again Colin's health deteriorated. During 2001 Colin was often bed-ridden. He found that he was operating his business from his house, and often from his bedroom. His employee effectively became the full-time worker. In 2002 he reached the difficult decision to sell his sweet sales business. By this time there was little profit left after paying his employee's wages and expenses, '[s]o the headaches and the cashflow outweighed the benefits of the business'.^[339] Colin started claiming Incapacity Benefit again and was awarded the higher rate.^[340]

6.157 Colin's wife started to spend more and more time caring for him and his illness took its toll on her. She had worked as a classroom assistant for 13 years without a day's illness. She became unwell with the stress of Colin's illness, and by 2004 she had given up working.^[341] Although this meant that money became 'exceptionally tight', Colin thinks that his wife having stopped working helped her. For a while, after she had finished her college course, Colin's daughter came to the house every day to give Colin his lunch. Colin's wife attended her GP and he prescribed medication for a period in respect of her stress and anxiety.^[342]

6.158 In March 2004 Colin's symptoms were exhaustion, blotchy skin and generalised arthralgia (joint pain) and myalgia (muscle pain) with associated sweats. His ALT level was 115. An ultrasound scan then revealed evidence of portal hypertension and significant splenomegaly, the spleen measuring 15cm in length. A subsequent endoscopy revealed four barely visible varices and Colin started treatment with Propranolol for these.^[343]

6.159 By July 2005 it was clear that Colin had developed cirrhosis. An ultrasound scan and gastroscopy revealed splenomegaly and gastric varices. Colin wished to meet a hepatologist to discuss the possibility of liver transplantation.^[344] On 27 July 2005 Colin attended an appointment with the Specialist Registrar to Dr Dillon.^[345] Colin took some clippings from the Daily Mail about stem cell transplantation. Dr Cotton explained to Colin that this was at the very early stages of experimentation and was not a routine treatment. Dr Cotton told Colin that he was not yet at a stage where they would consider liver transplantation. It was agreed that Colin would continue to attend the Haematology Department in respect of his Hepatitis C and that he would be seen at the Hepatitis C Clinic as and when required.

6.160 Colin's condition continued to deteriorate. His wife and family started to notice that when he was talking to them there were gaps in his conversations. He often appeared as if he was drunk when, in fact, Colin had not taken alcohol since 1994: '[o]nce I found out I had a liver problem, I didn't touch alcohol, not even at New Year'.^[346] Colin had stopped drinking to make sure that his liver was not being damaged by anything else. At one of his appointments in March 2006, Colin's wife asked about the cause of these episodes. She was told that it was caused by the effect of Hepatitis C on Colin's liver and the build up of toxins in his body.

6.161 In November 2006 Colin sold his home in order to release equity and down size. By this time his sons had left home. The following month Colin and his wife moved into a residential caravan where they lived until they moved into their new home in April 2007. The selling of his home, which Colin had had built for the family, was a disappointment to both him and his wife:

I mean, you work hard ... you try to build something up. Then really to live as near normal as you can, not extravagant but, if that's what you have got to do, that's what you have got to do. There's no point in getting into debt.^[347]

6.162 The new home Colin and his wife bought was a flat overlooking a river. It was not ideal for Colin, but he was so unwell by this time that he bought it for his wife. He wanted to ensure that, were he to die, his wife would not be left with any debt. By this time Colin was bed-ridden and he described this time as 'the grim period'.^[348]

Colin's assessment for liver transplant

6.163 In April 2007 Colin was referred to the Royal Infirmary of Edinburgh (RIE) for assessment for a liver transplant. In the following June he was admitted there for tests. Colin stated:

[I] knew that the only way for me to stay alive was to get a transplant. It was as simple as that. It was a daunting prospect but you have to be realistic and look at it and hope that all being well, that I would live through it.^[349]

6.164 Colin underwent numerous tests and scans:

What I wasn't prepared for was the answers on the Friday. I was - my wife was asked to come down, you are taken into a room. You have got all the senior people in front of you and the chap that spoke to me, he said, 'Well, there is no doubt about it, you need a liver transplant.' He said, 'You could get two years, you could live another two years, you might live a year, but I'll give you six months.' And at that you could have picked me up off the floor because although you know you are ill, you are not putting a term on your life ....^[350]

6.165 Colin was put on to the liver transplant list. He had to attend the RIE for regular review appointments. At a review appointment in August 2007, Colin was noted to be jaundiced with low grade encephalopathy.^[351] He was also suffering from significant peripheral oedema and fluid retention. Colin had a long discussion at this appointment with the surgeon about the implications of being on the waiting list. Colin knew that there was no guarantee that there was going to be a liver which would be a match so 'it was a waiting game'.^[352] He was told that he could not go further than half an hour away from his house. This was not a problem for Colin as he was so unwell by this time that he remained at home. The prospect of Colin being transplanted by means of a non-heart-beating donor (a donor who had just died and whose heart had stopped, as opposed to a donor whose heart beat was being maintained until shortly before the liver is removed) and also having a transplant from a relative was also discussed with Colin. He was unaware at the time but one of his sons asked to be tested by the hospital to find out if he could donate half his liver to his father. In the event these tests were not concluded before Colin received his liver transplant.

Colin's liver transplant

6.166 In September 2007 Colin received a telephone call from the Transplant Unit at the RIE telling him that they had a liver available to transplant. He was taken immediately by ambulance to the hospital and prepared for surgery. He was ready to go to surgery when he was told that the liver had arrived and was unsuitable for transplant as it had been drug abused. Colin described this as 'very, very difficult' for him and his family.^[353]

6.167 Colin continued to deteriorate and in the last weeks of October 2007 he became delirious due to hepatic encephalopathy, secondary to dehydration. He was jaundiced and also had ascites. He had bilateral pitting oedema to mid-shin. On 24 October 2007 he was admitted to Ninewells Hospital where he was treated with intravenous antibiotics and an ascitic tap.^[354] He remained in hospital until 29 October. During this period Colin's name was removed from the transplant list due the fact that he had an infection. Colin had not realised how jaundiced he was until he saw his skin next to the white shirt of one of the doctors: '[t]hat was when I realised how bad it was'.^[355] The hospital wanted Colin to remain as an in-patient but Colin wished to go home as he did not want to die in the hospital. At this time, Colin's name was reinstated on the transplant list.

6.168 At 9pm on Thursday 1 November 2007 Colin received another telephone call from the transplant unit at the RIE advising him that a liver was available. Colin asked if they could check that the liver was suitable as he did not think that he would survive the trip to Edinburgh and back. He was told that the liver was good. He was then taken to Edinburgh by a 'blue light' ambulance. Within three-quarters of an hour of arriving at the hospital Colin was in theatre. In the early hours of 2 November he received a graft from a non-heart-beating donor. Colin subsequently discovered that his new liver had come from the north of England as all the transplant units in that area were busy carrying out transplants, and so it was surplus: 'it was a lucky day for me'.^[356]

6.169 Colin became independent of infused Factor IX on 4 November and initially recovered 'extremely well'.^[357] He felt fine. However, on 7 and 8 November there was deterioration in his liver function test results. Tests revealed that there 'was a kink in the recipient hepatic artery'. Colin's mental state deteriorated and he became quite confused. This gradually settled along with his abnormal liver function test results. Colin was discharged home on 18 November. During his admission it was noted that his glucose levels were elevated before meal times. Colin was told that, as with a number of people who undergo a liver transplant, he had developed type 2 diabetes. He was prescribed Gliclazide. In addition, Colin had to continue taking a number of medications including anti-rejection medications, anti-fungal medications and antibiotics.^[358] He continues to take two anti-rejection medications.

6.170 Colin felt very well after the liver transplant: '[i]t was a big change'.^[359] He initially attended the Scottish Liver Transplantation Unit (SLTU) at the RIE weekly for review, then fortnightly and then monthly. He now attends the SLTU's Outbound Clinic at his local hospital every six months for review. He attends the RIE annually for a liver biopsy.

6.171 In September 2008 Colin returned to work as a manager for a stocktaking company working in large stores. The work was flexible in that Colin was able to tell the company when he was available to work the following month. This could be three or four days a week. Colin loved the work, but as he was working in the management side he had to travel a lot. One day he could be working in Aberdeen, the next Berwick and then back in Aberdeen the following day. Colin started to suffer from joint pain again. He also began to feel unwell at times. Occasionally he had difficulty concentrating as he drove. His hands became blotchy, and his face puffed up. He found it stressful trying to manage 30 people when he felt unwell. Initially he cut his working hours down to 16 a week, but the travel remained difficult. He left this job to work in a supermarket as a night-shift shelf stocker. He initially worked three nights a week there but found that all he did between shifts was sleep. He then reduced his work to two nights a week. Two or three times he nearly collapsed at work, and so Colin realised 'enough was enough'.^[360] He accepted medical advice that working night shifts was significantly contributing to his symptoms, and that he should retire. He retired in late 2010 at the age of 56. Given his strong work ethic, this was difficult for him: '[retirement] doesn't come easy, I can tell you that'.^[361]

6.172 A liver biopsy in November 2008 showed evidence of fatty change which may reflect metabolic causes, for example, diabetes or other causes, such as development of the Hepatitis C virus. It also showed no evidence of rejection. A liver biopsy in November 2009 showed no significant scarring, or fibrosis.^[362]

Colin's current symptoms

6.173 Colin continues to suffer from aches and pains. He is prescribed Tramadol and takes paracetamol to alleviate these. These pains are mostly joint and muscle pains, particularly in his hands. At times they become very 'puffed up'.^[363] Also, he stated:

My ankles puff up and it's hard to walk. Then you are not bothered with it, it will go away again. I have always got the shoulders and arm pains. They do not go away, they are there all the time but you get used to that, but to me that's not being ill. That's just having a pain. You just accept that and get on with it.^[364]

6.174 Colin continues to attend the haemophilia meetings, although he no longer has haemophilia. He does so in order that younger people attending the group may see the benefits of a liver transplant.^[365]

6.175 With regard to future treatment, Colin has been told that Ninewells Hospital has funding for the new treatments but that it is the decision of the RIE if he receives either of these treatments or not. The new treatments that Colin referred to are Boceprovir and Telaprevir.

6.176 It is likely that the addition of these treatments will cause more severe side-effects for patients.^[366] These new treatments are discussed in more detail in Chapter 13, Knowledge of Viral Hepatitis Now, paragraph 13.115.

6.177 When Colin attended a review appointment at the RIE in about March 2011 he spoke to one of the doctors about these new treatments. The doctor seemed cautious about Colin receiving the treatment as 'we don't want to make you ill. We have just made you better'.^[367] Colin believes that if he is going to try and eradicate the virus, it is better to take the treatment when he is well. He plans to discuss this again with the doctor at the RIE at his next appointment.

Specific impacts of Colin's infection with Hepatitis C

6.178 As a result of his infection with Hepatitis C, Colin feels that he has missed a large part of his children growing up. He knows that his daughter, the eldest, was very concerned about him. His sons used to see him in bed ill and bring him cups of tea. There were long periods of time when Colin was unable to do activities with them, such as skiing. He believes that his illness put 'a lot of stress on them'.^[368]

6.179 Colin's close friends knew about his infection with Hepatitis C. His illness had a big effect on his social life. For a number of years he was unable to socialise as he was not well enough to do so. He was unable to go on holidays. He was unable to pursue his hobbies of skiing, sailing, fishing and walking. Since Colin's health has improved he has managed to have a couple of sailing trips.^[369]

6.180 The financial impacts of Colin's infection with Hepatitis C have been described to a certain extent already. The greatest impacts were Colin having to stop working, and being forced to sell his family home to release some capital. In addition, Colin had a small pension. When he became unwell, and stopped working in the mid-1990s he made it 'fully paid up'.^[370] Colin has life assurance which he took out before his diagnosis with Hepatitis C. It is a whole-of-life policy. He had a repayment mortgage which has not been affected by his diagnosis with Hepatitis C. He has taken out travel insurance since his diagnosis, but although he disclosed his haemophilia he did not inform the insurers that he had Hepatitis C. He has incurred travel expenses and parking charges, attending numerous hospital appointments both in Dundee and Edinburgh. He has received two payments from the Skipton Fund.^[371]

Gordon

6.181 When Gordon gave evidence he was 65 years of age and he lived with his wife in England. Before he retired he was a senior academic.^[372] Sadly, Gordon died in the summer of 2013.

6.182 Gordon lived in Edinburgh between 1965 and 1985. He acquired Hepatitis C, Genotype 1, from one of a number of blood transfusions he received at the RIE in December 1975 and/or early 1976.^[373]

Gordon's blood transfusions

6.183 In October or November 1975, when Gordon was 29 years old, he had a respiratory tract infection with pleural effusions.^[374] On 1 December he was diagnosed with pericarditis (inflammation of the membranous sac surrounding the heart) and was admitted to the City Hospital, Edinburgh.^[375] Constrictive pericarditis was diagnosed in mid-December. On 27 December he was transferred to the care of a Cardiothoracic Surgeon at the RIE, for an urgent pericardiectomy (surgical removal of the pericardium). His condition was sufficiently serious to warrant opening the cardiothoracic theatre which was usually closed between Christmas and New Year. Gordon underwent the pericardiectomy on 29 December. He suffered excessive blood loss in the early post-operative period, and required to undergo further surgery on about 29 or 30 December to rectify bleeding from the operation site. About 1.5 litres of blood and clot were removed from the pleural cavities. Gordon received a number of blood transfusions between 29 and 31 December. As Gordon stated, at that time, he was 'distinctly, critically unwell'.^[376]

6.184 Gordon's recovery was complicated by a number of conditions including septicaemia, cardiac arrest, low cardiac output, bilateral pneumothorax, renal failure and a gastric stress ulcer. In January 1976, while still a patient at the RIE, he received a further transfusion of whole blood and packed red cells after a series of haematemeses (vomiting of blood). He was eventually discharged home in mid-March, having first been transferred back from the RIE to the City Hospital, Edinburgh.^[377]

6.185 Gordon accepted that the operation and the associated blood transfusions were 'necessary and potentially life saving procedures'.^[378] Although he discussed the risks of the pericardiectomy with the cardiothoracic surgeon, he very much doubted that there were any discussions about the risks associated with blood transfusions. Prior to his surgery, he expected that if he needed a blood transfusion then it would have been available to him.^[379]

6.186 Gordon was told by nursing staff and a number of people who visited him in hospital, including his late mother, that between the pericardiectomy on 29 December 1975 and the series of haematemeses in January 1976 he became severely jaundiced. One of the people from his work who visited him left the ward immediately after he saw him in this condition. His jaundiced state was also noted in a discharge letter from a Registrar to Gordon's GP: 'he developed severe jaundice which was progressive. However the aetiology of this remained obscure although halothane appears to be incriminated'.^[380] Halothane was subsequently discounted as a cause for Gordon's jaundice.^[381] A likely explanation for this episode of jaundice is that it was caused by 'shock liver', hypoperfusion (decreased blood flow) of the hepatic artery which kills liver cells. This condition often follows major cardiac surgery particularly when there is a very significant fall in blood pressure. Thus, it is unlikely to have been related to Gordon acquiring Hepatitis C from the blood transfusions.

Investigation of Gordon's abnormal liver function test results

6.187 Gordon's recovery from these operations and subsequent complications, was good. He returned to work in June 1976. He continued to see a General and Gastrointestinal Surgeon at the RIE in respect of gastric symptoms, from which he suffered following the surgery in January 1976. During these follow-up appointments Gordon's liver function tests were found to be abnormal. It was noted that before the pericardiectomy, apart from a minor elevation of alkaline phosphatase, Gordon's liver function tests were normal. In September 1976 the surgeon noted that Gordon's ALT level was raised, at 139. At the suggestion of the surgeon, Gordon subsequently abstained from alcohol for three months, but his ALT level remained elevated.^[382]

6.188 In early 1977, the surgeon referred Gordon to Dr Niall Finlayson, Consultant Physician at the RIE, for his opinion on the cause of Gordon's persistently abnormal liver function tests. Gordon attended to see Dr Finlayson in about March or April of that year. Gordon found Dr Finlayson to be very thorough. Dr Finlayson reviewed Gordon's case notes and examined him. Gordon gained the impression that he was puzzled about the liver function test results and keen to investigate their cause. Tests for Hepatitis B antigen and antibody were negative as were tests for other diseases - Q fever, toxoplasmosis and infectious mononucleosis. At this time Gordon was 'not terribly worried' about his abnormal liver function results although he was 'not entirely happy to see that he had persistent hepatitis'. He was energetic, back at work and 'generally enjoying everything [he] did'.^[383]

6.189 In September 1978 Gordon underwent a liver biopsy. This showed 'a mild persistent hepatitis'.^[384] Gordon does not recall being told the results of the biopsy.^[385] About this time, Dr Finlayson concluded that non-A, non-B Hepatitis was the most likely cause of Gordon's abnormal liver function test results as he had excluded all other known possible causes. Gordon remembers Dr Finlayson telling him about NANB Hepatitis which at that time was presumed to be viral. He remembers that Dr Finlayson mentioned to him that he was aware of recent research that an agent, just found to be transmissible in chimpanzees, was a possible/probable candidate.^[386]

6.190 Between 1977 and 1982 Gordon continued to attend appointments with Dr Finlayson for monitoring. During that period Gordon did not display any symptoms of NANB Hepatitis. In 1985 Gordon moved to England as he was offered a good position there. After he moved, there was no further monitoring of his condition by the NHS in Scotland. Gordon married in 1987. Before marrying his wife he told her that he had an illness and was not clear what the outcome of it was likely to be.^[387]

6.191 In March 1988, while carrying out an experiment as part of his work, Gordon measured his own blood ALT and found it to be high. He mentioned this to a personal friend, a Consultant Physician, who agreed to take a blood sample and check the ALT level. This doctor subsequently wrote to Gordon and stated that 'the hepatocellular enzymes are indeed quite high and I personally would be a little unhappy to ascribe them to chronic persistent hepatitis'. He suggested that Gordon seek further advice 'as at the very least, they require further monitoring'.^[388] Gordon then attended his GP and asked him to refer him to Professor Losowsky, a Gastroenterologist and Hepatologist as well as Professor of Medicine at St James's University Hospital in Leeds. Gordon was acquainted with Professor Losowsky who had told Gordon that he would be delighted to see him. Gordon's GP refused to refer Gordon to Professor Losowsky, and instead advised him to abstain from alcohol. Unsurprisingly, this had no effect on Gordon's ALT levels and at that stage no monitoring of Gordon's liver function was undertaken.^[389]

6.192 Until 1995, Gordon continued in good health and felt remarkably well. He successfully developed his career which he obviously relished and he assumed more responsibilities at work. If he felt tired occasionally, he put this down to having a lot of commitments. He did not worry about his health. As he stated, 'I found plenty to fill every moment and every moment wasn't just for work'. He enjoyed fishing and photography too.^[390]

Investigation of Gordon's symptoms of Hepatitis C and diagnosis with the virus

6.193 In early 1995 Gordon started to suffer from exhaustion. In addition, he lost a considerable amount of weight over two to three months. He attended his GP, who was by now a different GP to the one Gordon saw in 1988. This GP carried out some blood tests, including a liver function test. Gordon returned a week later for the results of these tests and was told that his liver function test results were highly abnormal. From his GP's demeanour, Gordon formed the impression that the doctor thought that the results were very bad indeed. His GP examined him and agreed with Gordon's suggestion that he be referred to Professor Losowsky. At the end of the appointment his GP gave him a strong handshake and it felt to Gordon as if he was saying a final farewell to him. Gordon was very surprised and very shaken by this reaction.^[391]

6.194 Following the referral to him, Professor Losowsky arranged for Gordon to be admitted to St James's University Hospital for full investigation of his weight loss and fatigue. Gordon was admitted there in April 1995 and remained an in-patient for about 19 days while wide-ranging investigations were carried out. As a result of these investigations, which included a liver biopsy, Gordon was told that he had acquired Hepatitis C and that he had cirrhosis of the liver. He 'was not unduly surprised or devastated ... by the Hepatitis C bit, but the fact that I had cirrhosis was very unpleasant ...'.^[392] Gordon knew that cirrhosis was irreversible. He did not remember having any discussions with Professor Losowsky, or any other doctor, about the severity of the virus or about its health implications. He was not offered any counselling. Gordon did not feel that the doctors were deficient in this respect, and appreciated that his infection was acquired very early on in the timescale of knowledge of the Hepatitis C virus. Those treating Gordon were aware of his professional background and his ability to access medical information. Gordon would have felt patronised had they spent time explaining the virus to him.^[393]

6.195 The letter written on Gordon's discharge from hospital records that Gordon's alpha-fetoprotein level was found to be significantly elevated, at 200.9. It also records that at that time Gordon was drinking approximately 40 to 50 units a week.^[394] Gordon accepted that he was a regular drinker, but considered that these figures were an overestimate of his weekly intake. On his discharge from hospital Gordon was told to abstain from alcohol, which he did for four years.^[395]

6.196 Following his discharge from hospital, Gordon attended out-patient appointments with Professor Losowsky for monitoring. He felt 'optimistic'.^[396] In her statement to the Inquiry, Gordon's wife recalled being advised at a subsequent appointment which she attended with Gordon to consider having protected sex. Gordon does not recall this matter being discussed.^[397]

Gordon's treatment with Interferon

6.197 In January 1996 Professor Losowsky offered Gordon treatment with Interferon. By this time his ALT level had increased and Gordon was continuing to feel tired. Professor Losowsky told Gordon that the likelihood of response to the Interferon was small 'in view of his age, duration of disease, presence of cirrhosis and relatively little inflammatory change on the liver biopsy'.^[398] Gordon's alpha-fetoprotein level remained raised at 90. A further CT scan of his liver in February 1996 showed no lesions.^[399]

6.198 Gordon and Professor Losowsky agreed that, in order to cause the least disruption to Gordon's work, he should start treatment with Interferon during the Easter holidays. On 2 April 1996 Gordon was once again admitted to St James's University Hospital for a repeat liver biopsy and commencement of treatment with Interferon. The ultrasound-guided liver biopsy showed 'the presence of established micronodular cirrhosis with some portal inflammation consistent with Hepatitis C infection'.^[400] The degree of inflammation had not changed since the previous biopsy in 1995. Gordon was commenced on three million units of Interferon, three times weekly. He initially suffered a slight temperature but no other complication was noted. Gordon was discharged home on the same dose of Interferon.^[401]

6.199 During the course of the treatment with Interferon Gordon suffered from substantial fatigue and flu-like symptoms. He found day-to-day living 'a struggle'.^[402] The flu-like symptoms did not abate much during the course of the treatment because, as soon as Gordon felt he was recovering from a dose of Interferon, it was time to take the next dose. He 'ached and felt miserable'.^[403] He continued to work throughout the course of the treatment. Gordon stopped taking the Interferon treatment after five months as his ALT level remained elevated and he remained HCV PCR positive.^[404]

The period after Gordon's treatment with Interferon

6.200 Gordon continued to attend St James's Hospital for monitoring by Professor Losowsky, and then by his successor Dr Davies, a Consultant Hepatologist. Gordon described his life at this time as 'a progressive struggle' and 'a battle'.^[405] He developed considerable tiredness and became more prone to minor infections, such as colds and spots on his skin. Gordon's ability to carry out all aspects of his work began to suffer. In order to fulfil his teaching commitments, Gordon had to reduce the amount of time he spent on research. This must have been very difficult for Gordon as he obviously took great pride in his work, and wanted to carry it out to the best of his ability. In her statement, Gordon's wife describes this period:

From 1995 to about 2001 my husband still managed to work but he suffered from extreme tiredness. He developed sleep problems in that, although he was tired, he was unable to stay asleep. It was a struggle for him to get up in the mornings but he did so in order to go to work as normal .... Intellectually he remained sharp but he was physically exhausted. His appetite was poor and he was run down and unable to keep warm, usually having cold hands and cold feet. His condition made spontaneous home and social life minimal. My husband's mood became more thoughtful and introspective but he remained confident, in control, analytical and stoic.^[406]

6.201 In 1996 and 1999 Gordon was found to have minor varices which were ligated or otherwise treated.^[407]

6.202 The possibility of Gordon receiving treatment with Interferon and Ribavirin was discussed with him in 1998 but it was decided that, as he had cirrhosis and had been a non-responder to Interferon, the risks of side-effects of this treatment would outweigh the chance of Gordon deriving any benefit from it. In about 1999 or 2000, Gordon attended an appointment with one of Dr Davies' registrars. Gordon indicated to the registrar that he 'was very tired and not really coping'.^[408] Gordon's wife, who also attended that appointment, pressed the registrar about what she proposed to do about Gordon's condition. It seems that she felt a degree of frustration at the fact the doctors were simply monitoring Gordon's condition, and were not treating his symptoms. The registrar suggested to Gordon that, in light of his symptoms, he might require a liver transplant but Dr Davies contacted Gordon the following morning to advise him that the risks of such a procedure would outweigh the benefits. He did, however, make it clear that if Gordon's condition progressed to hepatocellular carcinoma or liver failure his advice would be reversed.^[409]

Gordon's diagnosis with hepatocellular carcinoma

6.203 In April 2001 an MRI scan and ultrasound revealed that Gordon had probably developed hepatocellular carcinoma. The report of the MRI scan dated 19 April 2001 revealed 'several (5 at least) hypervascular nodules suggestive of HCC'.^[410] Gordon was initially told that hepatocellular carcinoma was strongly suspected, with about a 1 in 100 chance of the result having been wrongly interpreted. This was 'perhaps the most drastic thing' Gordon had ever been told about himself.^[411] A number of factors mitigated the shock of this news - first, having been aware that his alpha-fetoprotein level was raised and having been referred for both MRI and ultrasound scanning, (which he felt would not have been arranged without some 'serious suspicion'), Gordon knew that hepatocellular carcinoma was 'a possible scenario' and so was 'a little bit prepared' in his mind; secondly, Dr Davies told Gordon about this possible diagnosis 'in a most kindly way'. He telephoned Gordon, saw him and his wife and arranged Gordon's admission to hospital in the same day. Gordon found Dr Davies to be 'incredibly efficient' and his 'middle of the road approach' in giving him this news gave him confidence and 'was a sort of calming influence'.^[412]

6.204 Gordon's wife's reaction to her husband's diagnosis with hepatocellular carcinoma was 'pretty bad'. She was very supportive of Gordon but this was an 'unhappy time' for her. She had been 'tense' since his diagnosis with Hepatitis C.^[413]

Gordon's liver transplant

6.205 Four days after his diagnosis with hepatocellular carcinoma, Gordon was signed off work. On 8 May 2001 he was admitted to St James's Hospital for assessment for liver transplantation and remained there until 11 May. One test was problematic, and Gordon had to wait until a respiratory specialist returned to perform a bronchoscopy on 25 May. Gordon's wife described these weeks as 'harrowing' and added 'the "ifs'' and "buts'' were too hard for me. I felt helpless and unable to do anything which would change anything. It was like walking on eggshells'.^[414] Her father had died of cancer previously which made this time harder for her. She stated:

We were waiting and hoping to be admitted to the transplant list. Another patient came back from seeing a consultant and said to my husband that they could not offer him a transplant and so he was being sent home to die.^[415]

Gordon agreed with the proposition that this was a 'very difficult, emotive time' for him and his wife.

6.206 On 8 June 2001 Gordon was admitted onto the transplant list. He was advised to live normally and keep his bag packed. He remained signed off work. On 30 August Gordon received a telephone call advising him that a liver was available and he was admitted to hospital that night, for surgery at 6 am the next morning. Immediately following the liver transplant Gordon suffered two complications. The first of these was internal bleeding post-operatively. The evening after the surgery, Gordon was 'in considerable pain' and had 'tremendous abdominal tenderness. [He] was just covered with a sheet and if anyone just touched the sheet, [He] would wince in pain...'.^[416] An ultrasound scan revealed the cause of this and Gordon was re-admitted to theatre for tying off of some blood vessels and the removal of a blood clot. The second complication was breathing problems which Gordon developed a few days after the transplant. As a result of this, he was taken from the High Dependency Unit to the Intensive Care Unit and was given C-PAP (continuous positive airway pressure) ventilation for a period of time. Gordon stated that he 'did not like' that experience. His wife was 'frightened for him' when she saw him back in the Intensive Care Unit being treated with this form of ventilation. The diagnosis of hepatocellular carcinoma in his explanted liver was confirmed.^[417]

6.207 Thirteen days after the liver transplant, Gordon was discharged home. He was 'delighted to be alive' and 'overjoyed at the success of the operation'.^[418] Although Gordon's wife expected him to be confined to his bedroom on his return from hospital, Gordon was keen to be up and about. He returned to work in April 2002. He was very glad to be back and was able to resume most of his work-related activities. At that time his liver function tests were virtually normal, but Gordon had been advised by Dr Davies that it was certain that the Hepatitis C virus would recur.^[419]

6.208 By 2003, Gordon's liver function tests had started to deteriorate and his energy levels were falling. A liver biopsy in October of that year revealed 'considerable portal fibrosis'.^[420]

Gordon's treatment with Pegylated Interferon and Ribavirin

6.209 On 30 January 2004 Gordon started treatment with Pegylated Interferon and Ribavirin. In order that Gordon was able to minimise time spent away from his work, one of the doctors arranged to see Gordon for his regular review appointments just before the start of the clinic at 2 pm. Gordon described the side-effects of this treatment as 'horrendous'.^[421] Once again he experienced substantial fatigue which he found particularly troublesome, especially for the first two or three days after each weekly injection. He also suffered flu-like symptoms, nausea, headaches, shortness of breath and aches and stiffness in his knees. He developed a rash which required treatment by a dermatologist. His haemoglobin fell. He lost 7 kilograms in weight. He experienced two episodes of syncope (fainting) which he described as 'very humiliating'.^[422] These happened at work in front of a large number of people. The first episode was 'absolutely frightening'. Gordon suddenly became unconscious and hit his head on a bench causing a cut on his head which, as he said, looked worse than it probably was. He was taken by emergency ambulance to the local hospital. A month later the second episode occurred. After this Gordon was told to stop driving until he was reviewed by a neurologist. In order to expedite this review, Gordon arranged to see a neurologist privately. The neurologist concluded that Gordon was unwell and 'the side effects from his treatment have affected him perhaps more than he thought'.^[423] After seeing the neurologist Gordon was allowed to drive again. Gordon also attended an appointment with a cardiologist and underwent a 24-hour ECG to rule out the episodes having a cardiological cause.^[424]

6.210 With hindsight, Gordon later considered that he perhaps had misjudged how much he could do while he was taking the Pegylated Interferon and Ribavirin treatment. The episodes of syncope brought home to him what a precarious position he was in while he took the drugs, and the dangerous nature of the treatment. Gordon was also aware that there was some controversy at the hospital as to whether he should be receiving treatment at all, being a non-responder to previous treatment and having received a liver transplant.^[425]

6.211 As there was no drop in Gordon's Hepatitis C viral count, he stopped taking the Pegylated Interferon and Ribavirin treatment after 24 weeks, in summer 2004. He thought that he had recovered fairly quickly from the side-effects of the treatment. As soon as he stopped taking the treatment his weight started to increase and he was 'able to get back to a reasonable life'.^[426]

The period since Gordon's treatment with Pegylated Interferon and Ribavirin

6.212 In 2005, at the age of 59 years, on the advice of those treating him, Gordon took early retirement on the ground of ill-health. It is to his credit that he had managed to continue to work except during his few hospitalisations. Due to the symptoms he suffered, particularly the fatigue, he was unable to fulfil aspects of his work, which damaged his opportunities for career advancement. By 2005 it was clear to Gordon that he 'was not functioning as was essentially required of [him]'.^[427] His early retirement, and the fact that the last 10 years of his employment were much less productive than he would have liked, was a matter of 'considerable disappointment' and frustration to him. The outlet for his intellectual interests was largely abolished. He found it very hard to adjust after having had a reasonably prolonged career in one area of work, finding that he missed both the work and contact with people in the same field.^[428]

6.213 Since 2005 Gordon had continued to suffer from fatigue, loss of stamina, loss of muscle strength and arthritis and arthralgia. Due to the immunosuppressant treatment he was required to take since the liver transplant, he had suffered some severe dental infections and teeth were extracted as a result of this. In 2007 he was found to have impaired glucose tolerance and, in June 2010, he was diagnosed with diabetes. This is thought to be a consequence of both Gordon's immunosuppression and the Hepatitis C virus. In about 2011, Gordon was diagnosed with interstitial lung disease and the immunosuppression treatment, tacrolimus, was suggested as a possible factor in Gordon's development of this disease. He suffered from breathlessness and, in 2010, had suffered a number of moderately severe chest infections and lost a lot of weight. At the time he gave evidence Gordon was being investigated for pulmonary hypertension. As Gordon stated 'there always seems to be something looming on the horizon, which does seem to have some links going back to either the Hepatitis C virus ... and/or the immuno-suppressant agent'.^[429]

6.214 Gordon continued to attend St James's University Hospital for monitoring. A liver biopsy in August 2010 reported 'recurrent Hepatitis C infection with fibrosis stage 4 and necroinflammatory grade 3'.^[430] A Specialist Registrar on the Liver Unit stated in a letter to Gordon's General Practitioner in October 2010 that the Stage 4 fibrosis was unchanged from 2003. He noted that Gordon had moderate inflammation at Grade 4 but overall the biopsy was reassuring and that there has been no progression over the past seven years to cirrhosis. He stated that it was agreed that Gordon would undergo an annual biopsy follow-up although, until he saw a copy of this letter, Gordon was unaware of this.^[431]

6.215 With regard to his prognosis, Gordon was told by Dr Davies when he developed cancer in 2001 that unless he received a successful liver transplant, his condition would be terminal. The prognosis for Gordon's recurrent Hepatitis C was never explained to him except that he was told that it is a progressive disease. Gordon did not ask about his prognosis as he suspected 'the answer is not known ... I feel that nobody knows and nobody will be too surprised if I had an early demise or if I carried on for quite a few years yet'.^[432] Gordon had been told about the advent of the new generation of protease inhibitors but at the time he gave evidence had not been told if he was considered a candidate for them. He expected there to be a discussion about this in the near future although he wondered what impact his failure to respond to previous treatment and his age would have had on this.^[433]

Specific impacts of Gordon's infection with Hepatitis C

6.216 One of the greatest impacts of Gordon's infection with Hepatitis C has been the effect of this on his wife. She has suffered from depression and anxiety since Gordon's diagnosis with hepatocellular carcinoma and his subsequent liver transplant in 2001.^[434] Gordon spoke very eloquently and honestly about this. Understandably, he wished part of his evidence on this sensitive matter to be kept confidential, and so not all of what he said is narrated here although it has been considered by the Inquiry.

6.217 With the benefit of hindsight, Gordon and his wife could see that every individual episode Gordon had experienced as a result of Hepatitis C had imposed an incremental psychological stress on her. This resulted in 'a big change in all sorts of aspects of her behaviour'.^[435] Gordon described her experiencing episodes of agitation and becoming jittery, uptight and angry on occasion. She worried and was often quite tearful. There were times when Gordon was an in-patient when he was 'torn because [he] was looking forward to having her as a visitor, very keen to see her, but also dreading that she would react ....'^[436] While he liked to read literature about Hepatitis C and followed the progress of this Inquiry, she found this upsetting and it made her feel very anxious. Good friends of theirs noticed the change in her behaviour.^[437]

6.218 In her statement to the Inquiry, Gordon's wife described in detail the distress and anxiety she experienced during each stage of Gordon's illness and, in particular, during the process involved in his liver transplant. At that time, she did not receive any support and she felt ignored because it was her husband who was ill. Each time her husband had an investigation she would become anxious about the procedure and the result. She candidly stated that she had episodes of moodiness and behaved inappropriately at times. 'I fear I embarrass him by my forthright actions sometimes. It is my way of coping ....'^[438] She stated:

The care I feel that my husband needs from me is more emotional support than physical help, but I am short-tempered with him and react angrily when events that others see as insignificant happen, and this distresses him further ... I feel that I have lost the ability to support him properly.^[439]

6.219 She acknowledged having felt so low that she did not care if she did not wake up the following day. She stated, 'That is hard to say, think and acknowledge to someone who has been through the diagnosis of Hepatitis C, cancer and a transplant'.^[440] Gordon described the times when she expressed an attitude of 'I have had enough. I don't care about anything'. He found it difficult to know how to respond to these episodes.^[441]

6.220 Gordon's wife has been prescribed medication by her GP, undergone a course of cognitive behavioural therapy from a clinical psychologist and attended sessions with a psychiatrist. At the time of the public hearings she was taking a high dose of one antidepressant medication and a moderate dose of another. If she ever forgot to take the medications, 'she [was] really unable to function coherently and very agitated and tearful, very tearful'.^[442] All the medical professionals Gordon's wife has seen considered that Gordon's medical history has been a key feature in her depression. Gordon met with his wife's psychiatrist who was of the view that his wife's depression 'was very intimately linked' with Gordon's illness.^[443] He also commented to Gordon and in a letter to Gordon's GP that he thought Gordon, too, was suffering a degree of reactive depression although not such as to require intervention. Gordon's wife noticed that his self-confidence was reduced and this too affected Gordon's quality of life. Gordon realised that the events he had experienced as a result of his infection with Hepatitis C have presented a prolonged psychological challenge and he struggled to cope.^[444]

6.221 Gordon's wife's depression had 'an ongoing significant effect' on their quality of life.^[445] As Gordon stated 'we have got ... really quite a complicated situation which is not really getting better'.^[446]

6.222 Gordon's wife has had a varied and good career which was affected both by Gordon's illness and by her own depression. She left one job as it involved too much travel and she wanted to remain closer to Gordon. As she began to suffer symptoms of depression, Gordon's wife found her work increasingly difficult. One job ended 'essentially, in tears' as she was not coping and her employers were very unsympathetic.^[447] This was clearly a very difficult and stressful time for both of them. At present Gordon's wife is working in a part-time teaching post 'which she is mainly coping with but occasionally, when the going gets tough, she is quite agitated'. This work may be the subject of cut-backs.^[448]

6.223 With regard to the financial impacts of his infection, while he continued to work Gordon did not incur any loss of earnings. This was due both to his admirable strength in continuing to work when he was more than likely unfit to do so, and to the goodwill of his employers. He considered that, but for his illness and the effect of this on his ability to carry out all aspects of his work, he would have had several increments in his salary. Had he been fit to do so, Gordon would have liked to continue working until he was 65 or possibly 67 years old; the latter being an option under his work contract. His pension income was substantially less than his earned income would have been had he been able to continue working. He calculated this cumulative difference to be at least £152,450, not taking account of any increments he might have been awarded. He acknowledged that it was very difficult to assess this loss reliably although considered this figure was likely to be an understatement. At the age of 65 onwards, his superannuation pension was expected to be about £3200 per annum less than it would have been had he been able to continue working.^[449]

6.224 Gordon had also incurred the costs of his own private referral to the neurologist and his wife's private psychiatric referral. He incurred expenses in travelling to the numerous hospital and other appointments he was required to attend. He received both available payments from the Skipton Fund. His mortgage and associated endowment policy were both initiated before his diagnosis with Hepatitis C so these were not affected.^[450]

6.225 Gordon had found that relatively few travel insurance companies were willing to consider insuring someone with his medical history, which obviously included his medical history prior to his diagnosis with Hepatitis C. He found it problematic finding insurance but managed to obtain cover although at a much greater premium than his wife. On one occasion his travel insurance for one week's travel within the UK or Europe was £130 more than his wife's for the same trip.^[451]

6.226 The impacts of Gordon's early retirement have already been stated above. Also, Gordon's activities in retirement reduced from what he had expected due to his limited energy and general arthralgia. This became a further source of disappointment to him. Gordon's hobbies were fly fishing, post vintage and classic cars, photography and Hebridean history. Instead of managing a full day's fishing, he found himself restricted to one or two hours of fishing on rivers and loch banks. He could no longer walk to remote hill lochs to fish. He readily felt the cold and this restricted his outdoor activities. He found it difficult to crawl under his vintage car for basic maintenance, but was able to do some work provided that he rested afterwards. His use of the car was reduced in comparison to before.^[452]

6.227 Gordon wished to put on record that he greatly valued the conscientious attention he received from most of his doctors. He recognised that his survival at 10 years post-transplant was a tribute to a great deal of NHS expertise.^[453]

Laura

6.228 Laura was 47 years old when she gave evidence. She is married with two children and lives in Edinburgh. Her children were born in 1987 and 1992. Laura acquired Hepatitis C from her husband. He has mild Haemophilia A with a Factor VIII level of 32%. Over the years he has been treated with plasma, cryoprecipitate and Factor VIII. As a child, Laura's husband was treated at the Royal Hospital for Sick Children, Edinburgh, and as an adult at the RIE.^[454]

Laura's husband's diagnosis with Hepatitis C

6.229 In 1993 Laura's husband received a letter from the Haemophilia Centre at the RIE advising him that he might have been infected with a virus. Laura's husband had no idea what this letter might be about. He attended the hospital for tests and, at a follow-up appointment in August 1993, was told that he had acquired Hepatitis C. Tests revealed that he had antibodies to Hepatitis C in his blood, but the PCR test did not show the presence of the virus. Laura's husband was told that he had cleared the virus, but continued to attend the hospital for blood tests.^[455]

6.230 At the time he was diagnosed with Hepatitis C, Laura asked her husband if it was possible for the virus to have been passed on. Laura's husband was unsure about this and posed the question to Professor Ludlam, Consultant Haematologist, at the RIE. Professor Ludlam told Laura's husband that the virus 'probably' could not be passed on. His response was in keeping with the state of knowledge at the time about the risk of transmission of the virus. Laura was not offered testing for the virus by the Haemophilia Centre.^[456]

Laura's diagnosis with Hepatitis C

6.231 A few weeks after her husband's diagnosis with Hepatitis C, Laura attended an appointment for one of their children with the family GP. During this appointment, the GP asked Laura generally how the family was. Laura told her about her husband's diagnosis with Hepatitis C. Laura's impression was that the GP did not know much about the virus, but offered her a blood test to put her mind at ease so Laura gave a sample for testing.^[457]

6.232 Laura did not receive the result of this blood test until she attended a routine appointment with her GP about four to six weeks later. At this appointment, she mentioned that she had had the blood test and had not heard anything. The GP replied, 'Oh yes, it came back positive'.^[458] Laura was shocked that she had not been informed of the result of this test. She asked the GP about Hepatitis C as she had never heard of it before her husband's diagnosis. Her GP told her that Hepatitis C was known as non-A, non-B Hepatitis but this did not mean much to Laura. She told Laura that the virus could be present in the body for some time before it came to light, but was unsure about treatments for the virus. Laura felt that her GP was not clear what the implications of the virus were. The GP suggested to Laura that she contact the Haemophilia Centre as they might be able to give her more information.^[459]

6.233 Laura took her GP's advice and telephoned the Haemophilia Centre at the RIE. She had known the staff there for some time but she cannot remember who she spoke to on this occasion. Laura informed the person she spoke to that she had tested positive for Hepatitis C. When Laura explained that she thought she had contracted the virus from her husband, that person seemed sceptical and told Laura that this was unlikely. Although the person with whom Laura spoke gave the impression that Laura's infection with Hepatitis C was nothing to do with the Haemophilia Centre, Laura was invited to attend the Centre for a further blood test to 'double-check'.^[460] She felt that the Haemophilia Centre was doing her a favour.^[461]

6.234 Laura underwent both a Hepatitis C antibody and PCR test with both coming back as positive. On 17 August 1993 Laura and her husband attended an appointment with Professor Ludlam and Professor Hayes, Senior Lecturer at the Liver Clinic. They explained to her that the virus could cause damage to her liver and Laura agreed to undergo an endoscopy, laparoscopy and liver biopsy. She understood that the liver biopsy would show what effect the virus had had on her liver.^[462]

Investigations of the source of Laura's infection with Hepatitis C

6.235 The Haemophilia Centre undertook further investigations to ascertain if Laura had acquired Hepatitis C from her husband. These investigations included ascertaining her virus genotype to see if it matched her husband's and contacting the Edinburgh and South East Scotland Blood Transfusion Service to ascertain whether she had received a transfusion when she sustained severe lacerations to her hand in 1983. The outcome of the latter investigation was negative. Laura had never heard of genotypes of Hepatitis C and is unaware which genotype of the virus she has. It is not specified in her medical records which the Inquiry recovered. In response to questions by the doctors, Laura told them that she had had no other sexual partners nor could she have acquired the virus by 'household spread', ie by sharing razors or toothbrushes. Following these enquiries, the source of her infection was not discussed again with Laura but it 'niggled at the back of [her] mind'.^[463] In about 1997, Laura asked a Clinical Assistant to Professor Ludlam about how she might have contracted the virus. At that time, the doctor told Laura that they were now aware of a few other cases where the Hepatitis C virus had been transmitted sexually to a partner and so they now realised that 'it was more than likely ... that that was how [she] had contracted it'.^[464] This doctor subsequently confirmed on Laura's application form to the Skipton Fund that she had contracted Hepatitis C from her husband.^[465]

Testing of Laura's children for Hepatitis C

6.236 At the time of her diagnosis, Laura and her husband were very concerned that the virus might have been transmitted to their children. This was exacerbated by the uncertainty about how Laura had acquired the virus, and the fact that they knew from their discussions with the doctors that the virus could be transmitted by, for example, the sharing of toothbrushes. Although they did not share toothbrushes, as she said, 'young children sometimes help themselves to things.'^[466] Furthermore, their youngest child was only one year old at the time Laura was diagnosed and Laura was worried that she had the virus while she was pregnant. She felt that no-one seemed to know, at that stage, whether in these circumstances there was a risk to her youngest child.^[467]

6.237 At the appointment on 17 August 1993 Laura and her husband asked for their children to be tested for Hepatitis C and the Haemophilia Centre arranged for this to be done. Obtaining a blood sample from Laura's youngest child proved difficult so she was transferred to the special baby unit, at the Simpson Memorial Maternity Hospital, Edinburgh, for this to be carried out. Both children were very upset when their blood samples were taken and Laura and her mother, who took them to these appointments, found the whole experience distressing. Both children were negative for the virus.^[468]

Laura's symptoms of Hepatitis C

6.238 Looking back, Laura thinks she may have been experiencing some symptoms of Hepatitis C in 1992 and 1993. She feels that, following the birth of her second child in 1992, she did not recover or regain the energy levels the way she would have expected to.^[469] She felt 'quite run down' during the summer of 1993.^[470] She put it down to having a young child at the time.

6.239 In January 1994 Laura was admitted to the RIE where she underwent an upper GI endoscopy and a laparoscopic liver biopsy. Laura remembers that the endoscopy was 'particularly horrible'. The liver biopsy was 'uncomfortable' and she had mild sedation for this. She remembers being in the theatre for these procedures and she found the whole experience 'quite traumatic'. She was worried about the outcome of both.^[471]

6.240 The endoscopy revealed no evidence of varices. The laparoscopy revealed that the liver was slightly increased in bulk, with yellow areas, suggesting fatty infiltration. The liver biopsy reported 'focal fatty change and a periportal chronic inflammatory infiltrate ... with piecemeal necrosis'.^[472] Laura was told these findings at a combined liver clinic with Professor Hayes and Professor Ludlam on 10 February 1994. She remembers that she was told that these findings meant that it was likely that she had been infected with the virus 'for some time'. This upset her. She had previously been told that 'the sort of life expectancy, if you like, from contracting the virus to ... a critical stage was 10 to 15 years'.^[473] As these findings suggested that she had had the virus for a while, she felt that her life expectancy was much less than 10 to 15 years. This caused her a lot of distress because she had a young family. She does not remember discussing this with the doctors at that time although she believes that it was apparent to them that she was upset.^[474]

Laura's treatment with Interferon

6.241 The doctors told Laura that Interferon was the only course of treatment available but, given the extent of their understanding about the effectiveness of this treatment at that time, they were unable to give her any guarantees about it. Laura asked what the worst case scenario was if the Interferon did not work. She was told that, in certain cases, if the virus continued to develop that a liver transplant might be necessary.^[475] It was agreed that Laura would start treatment with Interferon at a dose of 3 million units three times a week. She was warned to expect flu-like symptoms following the first six to eight injections. She was told that it was usually better to inject the treatment in the evening and to take a couple of paracetamol tablets at the same time in the hope that the symptoms would have subsided by the morning. Laura was warned that a mild degree of depression occurs in some patients but that hair loss is not a problem with such a low dose of Interferon.^[476]

6.242 Laura commenced treatment with Interferon in February 1994. Prior to this she attended the Haemophilia Centre for pre-treatment blood tests and to be shown how to give herself injections of Interferon. As she stated 'the thought of injecting yourself, I don't think appeals to anyone' and she found the treatment 'quite scary'.^[477] This was exacerbated by the fact that in order to administer the treatment, she had to break open a glass vial of sterile water. Since sustaining a severe laceration when she put her hand through glass when she was younger, Laura has had 'a bit of a thing about glass'.^[478] As a result she was not confident in handling glass. When she was being taught to administer the treatment to herself, she was very nervous opening the vial and cut her finger quite severely. She then had to be 'rushed over' to another part of the hospital for treatment of the finger.^[479] Laura found the staff very helpful, and she made the decision that she had to learn to take the treatment and she did so.^[480]

6.243 While being treated with Interferon, Laura felt extremely tired. She physically ached, had no appetite and lost weight. She suffered from headaches for which she was prescribed co-codamol. She also suffered from thinning of her hair. She felt generally miserable and depressed, describing herself as feeling 'completely flat'.^[481] She 'found everything quite an effort' and she remembers her daughter's birthday party as an example of this.^[482] On one occasion her menstrual period was late and the hospital gave Laura a pregnancy test which was negative. As the safety of Interferon for pregnant women was not established, it was recommended that patients use contraceptives while taking it.^[483]

6.244 The treatment had a significant impact on Laura's life. During this time, she was trying to look after her two children, who were then aged about five years and one year, as well as running her own business.^[484] She had started this business in the year before her second child was born. She did not want to work full-time, and the business allowed her to work while her husband was at home so that they did not need to find childcare for their daughter. Laura had studied for 18 months and taken the necessary exams to qualify for the work. 'I was so excited about qualifying, just because it was something I had achieved that I had always wanted to do and I enjoyed it'.^[485] Laura had built up a good client base for the business by the time she started treatment. The effects of the treatment meant that she found the work 'very difficult'. On one occasion, while with a client, she found herself nodding off, which put both of them at risk. She was very scared and found it frightening 'to be supposedly in control and knowing that you are not in control at all'.^[486] Laura's ability to concentrate was also affected by the treatment, and she found it very difficult to maintain her concentration during her work.^[487]

6.245 Laura was certified by her GP as unfit for work from 30 May 1994.^[488] Despite this Laura continued to work. She was concerned about financial commitments in respect of her business and the family finances. Laura's husband was working full-time. He realised that she needed more help and found it increasingly difficult to cope. There were times, at weekends, when Laura asked her husband to take the children out swimming or on another activity so that she could have a rest. Laura's parents both worked full-time but they and Laura's sisters tried to help when they could, especially with the children.^[489] Looking back at this period now, Laura thinks that she 'wasn't a fun mum at the time. I wasn't very good at maybe spending time with them because I just didn't feel I had the energy ... I did what I had to do ...'.^[490]

6.246 As was standard practice, Laura's Hepatitis C PCR level and liver function were monitored during the treatment. There was usually a delay in receiving the results of these tests and Laura found this a nerve-racking time.^[491] Initially, Laura had a good response to treatment - her ALT level halved after two weeks of treatment and then further reduced after four weeks of treatment. However, there was no change to Laura's viral load. Laura recalled that initially it seemed that she had a good response to treatment and she was quite optimistic. However, after eight weeks of treatment Laura's ALT levels rose. There was no reduction in quantitative Hepatitis C PCR and after 12 weeks she developed a binding and a neutralising antibody to Interferon.^[492] Due to her failure to respond to the treatment, Laura's treatment was stopped after 27 weeks, on 30 August 1994.^[493]

6.247 Laura was devastated that the Interferon treatment had failed and she found this news very difficult to cope with. She felt that, although she was young and had a young family, she was living 'on borrowed time to a certain extent'.^[494] No one was able to tell her when another treatment might become available and so she felt that nobody was able to offer her 'a solution or a treatment to give me some sort of hope'.^[495] After the treatment stopped, Laura continued to feel 'very low'. She felt unable to shake off a feeling of dread that she felt all the time.^[496] She considers that she is quite an optimistic person but 'that was quite a dark time'.^[497] She was prescribed anti-depressant medication, Amitriptyline and then Prozac, by her GP to help her sleep. Laura found that that the anti-depressant medication helped a little. A record of Laura's attendance at a clinic appointment in November 1994, three months after she finished Interferon, noted that Laura was tired and seemed down. It noted she had had a lot to cope with over the past year and was working very hard.^[498]

The period after treatment and the effect of Laura's symptoms on her business

6.248 After finishing the Interferon treatment Laura attended the Haemophilia Centre for regular monitoring. She continued to have both good and bad spells, both physically and emotionally. She was told that she needed to build up her immune system. At these appointments, Laura was advised to give up work to give her body a chance to fight the virus, especially if new treatments became available. Although it was not specifically stated to her, she felt that there was an implication that she had not given the Interferon treatment a chance due to working so hard and being so busy. Laura's parents were also very concerned about her and they, too, tried to encourage her 'to ease up on work' and offered to try to help out financially.^[499]

6.249 Laura continued to work part-time due to financial commitments. However, her condition worsened as time went on and, in 1996, she gave up her business completely. This was a very stressful time for her and her husband. By this time, Laura's business was unable to make the necessary repayments to the finance company which had financed one of her business assets. Laura and her husband were struggling to pay domestic bills and their outgoings exceeded their income. Laura had always been in charge of the family finances and took pride in ensuring bills were paid on time and everything was in order. Other than having a mortgage, she and her husband had never been in debt before, and they found it very distressing to be in debt. Over a number of months Laura negotiated with the finance company with regard to the return of the business asset. She found that this company was not very understanding of her position. It seemed, to her that the company did not want to know what she was going through and the reason she found herself unable to make the payments. When the asset was subsequently repossessed Laura found it 'just terrible'. She felt that she had let everyone down.^[500]

Laura's treatment with Wellferon

6.250 In February 1996, at a clinic appointment with Professor Ludlam, two options were discussed with Laura. The first of these was that her Hepatitis C status be monitored every few months and further treatment considered when new drug regimes became available. The second option was for Laura to start on a course of Wellferon, a mixture of alpha interferons. It was noted that there was some evidence that Wellferon was useful in individuals like Laura who developed anti-interferon antibodies. Laura was warned that the side-effects were likely to be similar to her previous treatment.^[501] Laura was keen to start treatment as soon as possible so she did not care about the side-effects. 'I would have put up with anything just to be able to start some sort of treatment'.^[502]

6.251 There was a slight delay in starting the treatment to allow Laura time to stop taking Prozac. She was never happy taking Prozac and worried that the longer she took it, the harder it would be to stop taking it. Also, she was concerned that it would interfere with the Wellferon treatment. However, her attempts to stop taking it, at this time, were unsuccessful. 'I wasn't a very nice person when I wasn't on them because I was so down'.^[503] So she continued to take this medication.^[504]

6.252 In March 1996 Laura commenced treatment with Wellferon. Once again, she had to inject herself with the medication three times a week. She injected herself in her stomach area, and in her legs, but over time found that she ran out of areas to use. She found the injections increasingly uncomfortable, particularly putting the needle through the skin. She asked the hospital for EMLA cream and found that this helped.^[505]

6.253 Laura felt 'dreadful' during this treatment. She 'functioned on auto-pilot and at times could not get out of bed'.^[506] She was constantly tired and irritable. She suffered aches and pains in her neck and shoulders. Eight weeks after she had started treatment, in May 1996, Laura's blood test results were very encouraging. Her ALT had returned to normal and the Hepatitis C virus was undetectable by quantitative PCR test. Laura was aware that the test results were looking positive and that the doctors were pleased with these results. However, by July 1996, her blood test results revealed that she had relapsed. Professor Ludlam and Professor Hayes believed that Laura might benefit from combination therapy of Interferon and Ribavirin. At that time ethical approval was still awaited for the use of Ribavirin in such circumstances. Laura was understandably keen to try this combination therapy.^[507]

Laura's treatment with Ribavirin and Interferon

6.254 In August 1996 Laura commenced treatment with Ribavirin and Interferon as part of a clinical trial. At the same time, Laura stopped taking Prozac for a while as she feared an interaction between it and this new treatment. By this time, Laura had obtained part-time clerical work. Due to their financial situation, Laura felt that she had to earn an income but wanted to find work which was not too big a commitment. This position was a temporary job and was mornings only. Her family helped out with child care.^[508] When she started this treatment, Laura was aware that the side-effects of it were likely to be similar to those she had experienced from her earlier treatment.

6.255 Those treating Laura were obviously aware of Laura's mental state and were concerned about this. In a letter to Laura's GP, Professor Ludlam stated that if Laura were to become more depressed on this treatment then 'we must seriously review her Interferon therapy. The difficulty is that she is keen to proceed with treatment and her worry is related to the state of her liver'.^[509]

6.256 In September 1996, Professor Ludlam's Clinical Assistant referred Laura to a consultant psychologist, for psychological help through relaxation and stress management. Laura described her two main problems to the psychologist as being unable to relax, and becoming emotional when she spoke about Hepatitis C.^[510]

6.257 A further matter Laura discussed with the psychologist was the effect of her diagnosis with Hepatitis C on her relationship with her husband. Laura's husband was involved in a serious road traffic accident in about 1988. As a result of this his memory was impaired and, initially, he only trusted Laura. Gradually he recovered, but Laura felt that one of the lasting effects of the accident was that her husband became less responsible. After her diagnosis with Hepatitis C, Laura felt angry that her husband had not asked more about Hepatitis C when he was diagnosed with it. She thought that he should have asked more about what his diagnosis meant and how it could affect her. Also, she considered that he should have asked more questions about his treatment for haemophilia and the implications of it. As a result of this, for a while, Laura blamed her husband for the fact that she had acquired Hepatitis C and thought that perhaps it could have been avoided, had he been better informed about his haemophilia treatment.^[511]

6.258 Laura felt that her husband did not cope well when she was first diagnosed with Hepatitis C:

He kind of stuck his head in the sand and he didn't really want to know. He couldn't cope with it, and I felt I was having to cope on my own and cope with the children and cope with the financial worries as well. And for all those reasons I was quite angry with him at the time. I felt quite let down.^[512]

6.259 Also, Laura felt that she did not get the support she needed from him. For example, she usually cooked all the family meals and her husband does not cook. On the occasions when she did not feel well enough to cook for the family, he did not know what to do, and in the end she had to cook. Laura felt that this, taken together with having had to cope with the after-effects of her husband's road traffic accident, had a major effect on their relationship.^[513] In his written statement to the Inquiry, Laura's husband described the strain of Laura's diagnosis with Hepatitis C as having had 'a devastating effect on our relationship'.^[514] He stated that 'the guilt I felt for being the one to infect her was almost impossible for both of us to come to terms with'.^[515] This guilt must have been compounded by the fact that Laura's husband cleared the virus spontaneously and never suffered any symptoms of it.^[516]

6.260 Another factor contributing to the strain Laura was under was the fact that she did not talk about her condition or treatment to anyone. Other than her parents and sisters, Laura did not tell anyone that she had Hepatitis C or about the treatment she was receiving. Laura felt that if there was anything in the media about Hepatitis C, people often confused it with HIV. People seemed not to know about Hepatitis C and she did not want to start explaining it to people. A further concern to her was that people had the wrong idea about how the virus could be passed on, and she was concerned that this lack of understanding might result in her losing her job.^[517]

6.261 Laura met with the psychologist on a few occasions when she attended clinic appointments. Laura felt that she was not good at accepting counselling as she found it hard to talk to people but benefited from the relaxation tape which the psychologist gave her.^[518]

6.262 The side-effects Laura experienced of Interferon and Ribavirin were 'flu-like symptoms'. She became susceptible to colds. Once again she lost weight.^[519] Laura's Hepatitis C RNA became undetectable after starting treatment with Interferon and Ribavirin. By December 1996 her liver function tests were normal. Having relapsed previously after three or four months of treatment, Laura was concerned that this might happen again. However, her blood test results remained normal and when the Interferon and Ribavirin treatment finished, in July 1997, her Hepatitis C PCR remained negative. At this time Laura was told that she was now clear of the Hepatitis C virus. She was told that she would continue to be monitored so that if the virus returned, it could be dealt with. Initially Laura was monitored by the Haemophilia Centre every month, then every three months, then every six months until latterly she was monitored annually.^[520]

6.263 The side-effects of the treatment persisted for a while after Laura had finished it. For a long time after the treatment, Laura felt tired. During the treatment she had restarted Prozac and she continued to be prescribed Prozac. The family's financial situation continued to worry her.^[521]

6.264 At a review appointment in April 2000, Laura was told that her blood test results remained encouraging, 'but that we still do not have enough knowledge about the natural history of hepatitis C to say with complete confidence how the disease may progress in the future'.^[522] This uncertainty about the future was always 'in the back of [Laura's] mind'.^[523] Despite this, Laura tried to bring some sort of normality back to family life. In particular, feeling more energetic than she had done previously, she made an effort to do more activities with their children.^[524]

The period since Laura's treatment with Interferon and Ribavirin

6.265 In 2000, Laura was diagnosed with breast cancer. She was treated for this at the Western General Hospital, Edinburgh. Laura was told that the cause of the cancer was unclear. She had no family history of this type of cancer. She was told that hormones and stress could have contributed to this diagnosis. Laura had concerns that the treatment for Hepatitis C, and the stress she suffered, contributed to her diagnosis with breast cancer. She mentioned this at one of her appointments at the hospital and nobody said that this could not have contributed to it. This concerned her.^[525]

6.266 Laura was treated with a mastectomy, reconstructive surgery, chemotherapy and five years of hormone drug treatment. Those treating Laura were aware of her previous diagnosis with Hepatitis C and the virus was taken account of when treatments for the breast cancer were being considered. Laura's Oncology Consultant discussed matters with Professor Ludlam's Clinical Assistant and with Professor Hayes. She was told that despite Laura being Hepatitis C PCR negative, Laura should still be considered 'at risk during surgical procedure'.^[526] Professor Hayes was also asked whether chemotherapy would reactivate her Hepatitis C. His response to this was that as Laura was PCR-negative:

[W]e would hope that she is cured of hepatitis C and therefore if the virus has gone she would not reactivate even if this is immunosuppressed. However, of course a certain number of people do relapse after treatment and it is possible, although we cannot detect it that she might still be harbouring hepatitis C somewhere.^[527]

He suggested that Laura undergo a PCR test every two to three months. Laura was unaware that these matters were being discussed by her doctors. Although there was a note in Laura's medical records of her concern about the impact of the chemotherapy treatment on the Hepatitis C virus, Laura does not remember being overly anxious about this.^[528]

6.267 Laura completed her chemotherapy treatment in about April 2001. It had no effect on her liver function. At a review appointment at the Haemophilia Clinic on 30 April, Laura was noted to be keen to have a quantitative Hepatitis C PCR test. Laura was advised by letter dated 18 June that year that this test, and her ALT, was normal. Laura's treatment for breast cancer was successful.^[529]

6.268 Laura continued to attend the Haemophilia Clinic for review annually. After the doctors there had taken the advice of Professor Hayes, Laura was discharged from this clinic in November 2006.^[530]

6.269 More recently Laura has developed inflammatory bowel disease. Once again, while being treated in hospital, 'there was a lot of talk in hospital about the fact I have had Hepatitis C'.^[531] She has been treated for her bowel disease with steroids. She was unable to take another medication for this as there was concern about the effect it might have on Laura's immune system, due to her previous diagnosis with Hepatitis C.^[532]

Specific impacts of Laura's infection with Hepatitis C

6.270 Laura believes that one consequence of her infection with Hepatitis C is that her children are more protective of her. At the time she took her treatment for the virus, she was very careful to hide it from the children. She hid the needles she used to inject herself. They were unaware that she was taking treatment. However, she considers that her son was old enough to sense that his mother was unwell and that 'things weren't quite right'.^[533] He is now very protective of her. As a toddler, her daughter was loath to let her mother out of her sight and she is much more insecure than Laura expected her to be.^[534]

6.271 Laura considers that her infection with Hepatitis C had the greatest effect on her relationship with her husband. Although Laura and her husband tried to keep the strain in their relationship from the children, Laura believes that the children sensed it anyway and 'were inevitably going to be affected by it'.^[535]

6.272 As detailed in paragraphs 6.257 to 6.259 above, Laura's diagnosis with Hepatitis C, and the consequences of it, had a significant and detrimental impact on her relationship with her husband for a number of years. In about 2008, Laura and her husband attended a series of couple counselling sessions: 'our problems reached a point where it was either a case of we gave up on our relationship or we went for counselling'.^[536] She stated that neither of them was inclined to give up too easily which she believes is a reason why they remained together. Another reason was that, for a time, they could not afford to separate due to the debts they had incurred. Initially Laura's husband found it difficult to accept the idea of counselling. During the counselling sessions Laura and her husband talked a lot about how they both felt 'during ... the Hepatitis C period'.^[537] Laura stated:

[I] learned a lot about how he felt and I think that helped me to sort of accept that it wasn't all his fault. And I knew deep down it wasn't but I think his way of handling the situation also contributed to the problems and we both ... faced up to things and our relationship is much, much better now and back on track. It has just taken a long time. That has been a lot of years before we reached that point.^[538]

6.273 Laura feels that it would certainly have helped her husband to have been offered counselling sooner, perhaps when she received counselling from a psychologist, but this was not offered to him.^[539]

6.274 Some of the financial impacts of Laura's infection with Hepatitis C have already been stated in paragraph 6.249 above. As a result of the debts the family incurred when Laura had to wind up her business, the family acquired a bad credit rating. They had planned to move from their two-bedroom flat to a house to give their children more space, but this was delayed by about five years. Due to their bad credit history, they found it difficult to obtain a mortgage. A local broker assisted them with this but the mortgage they obtained had a slightly higher interest rate than the average. Laura was unable to obtain new life assurance to cover the mortgage. She had a policy which she had acquired prior to her diagnosis with Hepatitis C. Furthermore, she was unable to afford the premiums quoted to her for income protection insurance, due to her infection with Hepatitis C, and so her husband obtained this and she did not. In addition, Laura has incurred inflated travel insurance premiums due to her infection with Hepatitis C. She has also incurred travel expenses attending regular appointments at the hospital and prescription charges. Laura and her husband remain in debt: 'We have never really managed to get back on track ...'.^[540]

6.275 As a result of the stigma attached to the Hepatitis C virus, Laura still has not told many people that she had it. Her current employers do not know that she had the virus. She found it difficult to take time off work to attend hospital appointments during her treatment with Interferon and Ribavirin but her employers were understanding and did not ask about the reason for the appointments.^[541]

6.276 On one occasion, Laura had to attend hospital for a tooth extraction. Although she was one of the first patients to arrive for the procedure that day, she was kept waiting until the end of the day. When she enquired why she was having to wait so long she was told by a nurse that it was due to her having Hepatitis C. The operating list was re-arranged so that Laura was last as she was deemed a risk in the theatre. She understood that the theatre required to be disinfected after her procedure. She was shocked and upset by this. In addition, Laura was given a paper gown although everyone else that day wore a cloth one. This made her feel as if she had a 'horrible disease' and that nobody wanted to come near her.^[542]

6.277 In describing the effects of her infection with Hepatitis C on her and her family, Laura said, 'This whole period in my life was a nightmare for me and my whole family. It has taken many years to recover from most of the effects, and some effects we will never recover from'.^[543]

Anne

6.278 At the time of giving evidence, Anne was 57 years old. She lives in Ayrshire and works as an administrator.^[544]

Anne's blood transfusion

6.279 Anne contracted Hepatitis C, Genotype 2b, from a blood transfusion she received in a local hospital in January 1986. At that time Anne was 31 years old. She was admitted to hospital for a myomectomy (surgical removal of fibroids) and as a result of this procedure, Anne required a blood transfusion. Anne is uncertain how many units of blood she received, but she thinks that it was more than three units. This is the only blood transfusion which Anne has ever received. Anne was a blood donor prior to receiving this blood transfusion but, due to low haemoglobin levels, did not donate afterwards.^[545]

Anne's diagnosis with Hepatitis C

6.280 In 1995 Anne's sister, who provided a statement to the Inquiry, had a routine appointment with her GP. This GP was also Anne's GP. He asked Anne's sister to ask Anne to make an appointment to see him but did not explain why. Anne's GP had been advised by the Scottish National Blood Transfusion Service (SNBTS), by letter dated 16 October 1995, that Anne had been transfused with 'a presumed hepatitis C positive blood component' in January 1986.

6.281 Anne's sister conveyed this request to Anne. Anne considers that this was 'a very strange way' for her GP to initiate 'such important contact with [her]'.^[546] Anne made an appointment to see him on 24 November. At the time of this appointment, Anne was 41 years old. She did not feel unwell. Anne's memory of exactly what happened at the appointments with her GP around this time is understandably hazy in view of both the time which has elapsed since, and the impact of the news she received. Having considered her medical records as well as Anne's evidence, it appears that at the appointment on 24 November, Anne's GP told her that it was likely that she had acquired Hepatitis C and a blood sample was taken to confirm this.^[547] At the following appointment her GP confirmed her Hepatitis C diagnosis. Anne's GP gave her the impression that Hepatitis C was nothing to worry about. He said to her 'not to worry about it because it didn't really mean anything'.^[548] Anne had never heard of Hepatitis C.^[549] She did not receive any advice from him about the implications of a positive result. She did not receive any counselling or advice about her future health. Her liver was not discussed. All he told her was 'Don't drink, and tell your dentist'.^[550] Anne believes that her GP did not realise the seriousness of the virus.^[551]

6.282 Despite her GP's assessment of her diagnosis, Anne realised it was something to be concerned about and she was worried about it: '[I]f you have a virus, it's obviously something'.^[552] She made contact with the local hospital to try to obtain an explanation as to how she had become infected and what her prognosis was. Sometime in 1996 she met with a representative of the SNBTS and a hospital representative at the local hospital. She did not find the meeting helpful. She found the attitude of the hospital representative upsetting, although the doctor from the SNBTS was helpful.^[553]

Anne's treatment for Hepatitis C

6.283 Anne's GP referred Anne to Dr Mills' Hepatitis Clinic at the Gartnavel General Hospital in Glasgow. On 12 March 1996 Anne attended her first appointment there. She was seen by a Senior Registrar. On examination Anne was found to look well and there were no signs of chronic liver disease. The doctor had a long talk with Anne about the implications of Hepatitis C infection. This included the prognosis for someone with Hepatitis C, the risks of liver disease, sexual transmission and treatment options; namely Interferon. Anne was 'gobsmacked' as this was the first time she understood the full implications of the virus. She was told that 'anything that was likely to happen would probably be about 20 years down the line'.^[554] This worried her as she realised that she had already had the virus for about nine or ten years. The doctor suggested that Anne have a liver biopsy.^[555]

6.284 Anne felt shocked after this appointment. She returned home and relayed the information she had been given to her mother and sister. They did not know anything about the virus either, and they all started to try to find out more about it.^[556]

6.285 On 26 June 1996 Anne underwent an ultrasound-guided liver biopsy. She found this a very invasive and painful procedure: 'I am not a coward but I found this very hard'.^[557] The biopsy revealed 'a mild hepatitis consistent with Hepatitis C'.^[558] It was suggested to Anne that she start treatment with Interferon. Anne knew that she had to take treatment for the virus. At the time she was experiencing flu-like symptoms.^[559]

6.286 Since her diagnosis with Hepatitis C she has had five liver biopsies. Anne subsequently became aware of the risks associated with liver biopsies and believed that this 'amplifies the actual and real risks' which she has been subjected to as a result of the virus.^[560]

Anne's treatment with Interferon

6.287 Anne started Interferon treatment on 29 January 1997. Prior to starting this treatment Anne was taught how to inject herself. She was warned about the side-effects of the treatment. She was warned that she might experience flu-like symptoms, hair loss, tiredness, depression, dry mouth and bone marrow suppression.^[561] Anne had to inject herself three times a week.^[562] It was noted in Anne's medical records two weeks after she started treatment that on the first day of treatment she experienced 'slight flu symptoms with a headache persisting all next day. Cold during the night.'^[563] It was noted after Anne had completed four weeks of treatment that she was suffering from 'slight flu symptoms, easily coped with. Cramp in legs during night'.^[564] After eight weeks of treatment the leg cramps had settled, but the headaches and slight flu symptoms persisted. These symptoms were worse the day after Anne injected herself and settled with paracetamol. Twelve weeks after starting treatment Anne continued to suffer from headaches, and was tired especially after injections. She also suffered from hair loss. At this time Anne was noted to be Hepatitis C PCR-negative with a reduction in serum transaminases to normal. At this time Anne was told that she had cleared the virus although she was also told that the virus could 'hide and come back again'.^[565] Unfortunately, after 24 weeks of treatment, Anne was once again PCR-positive with an elevated AST. At this time Anne was also found to have hypothyroidism, a known side effect of Interferon treatment. Anne started treatment with thyroxine, which she continues to take now.^[566] Anne's dose of Interferon was increased at this time. After a further 12 weeks of treatment at this level, Anne's dose of Interferon was reduced for the final 12 weeks of treatment. She stopped taking treatment 48 weeks after starting it.^[567]

6.288 Anne gained about half a stone in weight during the Interferon treatment.^[568] She managed to keep working throughout the course of treatment. She had to attend the hospital for appointments and initially these were once a week to collect the Interferon to bring home and keep in her fridge. She used flexi-time to allow her to do this. This added to the pressure of the treatment on her.^[569]

6.289 On 17 December 1997 Anne underwent a further liver biopsy. The features of this biopsy were similar to the previous one.^[570] Anne was told that the Interferon treatment had not been successful and that there was no real change in the state of her liver. She was told that she would attend the hospital annually and that 'probably there would be treatment in the future, but obviously that would be a few years down the line'.^[571] Anne was glad that the treatment was over. The side-effects of it persisted for a further few months.

6.290 At a review at Dr Mills' clinic in December 1999, it was noted that Anne remained well, apart from 'some slight discomfort in the muscles of her upper legs'.^[572] Dr Mills discussed possible improvement in treatment for Hepatitis C but noted in a letter to Anne's GP that 'It seems likely that it will be at least three years away until the next generation of treatment becomes available for her'.^[573]

6.291 Anne continued to attend Dr Mills' clinic annually for review. In July 2002 Anne was noted to be in 'reasonably good health' although she was complaining of having more flu-like symptoms than previously, having headaches in the morning and feeling tired each day at about three o'clock. The possibility of Anne being treated again with combination Pegylated Interferon and Ribavirin was discussed, but Anne decided to postpone this treatment. She reached this decision as, having found the treatment so invasive the first time, she wished to carry on for a further year without it and to keep working.^[574]

6.292 At the review the following year, Anne was noted to be remaining well, although she was occasionally tired and went to bed an hour and a half earlier than usual. Once again, she decided to postpone treatment for the same reasons as before. She knew that at some point she would have to undergo further treatment but she still wanted to put it off.^[575]

6.293 In October 2004 Anne underwent a further liver biopsy to aid the decision as to whether she required to make a further attempt at treatment. Once again, this showed similar appearances to the previous biopsies and no evidence of progression. Her liver function tests remained normal and she had no particular symptoms of the virus.^[576] On the basis of this, once again, Anne decided to postpone treatment. She continued to attend for annual review.^[577]

6.294 Gradually Anne began to suffer more symptoms of Hepatitis C. She began to suffer flu-like aches and pains, constant tiredness, intermittent insomnia and alopecia. At a clinic appointment in December 2008, Anne stated that she had noticed that her fatigue had become more pronounced and as a result she was no longer able to attend the gym. Prior to this Anne had for many years gone to aerobic classes at the gym. As she stated, it was 'a big deal when I had to stop that'.^[578] An ultrasound scan of Anne's abdomen on 14 April 2009^[579] revealed that Anne's liver was mildly enlarged. Anne was told this but was not told what it meant. Anne was also told that there was no tumour on the liver.

6.295 As a result of the impact of her symptoms on her daily life, Anne felt that the time had come to start considering treatment for the virus. She considered that starting treatment was 'a big commitment' which impacted on both her working and private lives.^[580] One factor Anne took account of in deciding when to start treatment was the impact of this on her job. Anne was warned by management at work of the risk of potential redundancy. As a result of this she decided to put off the treatment as long as possible so as not to jeopardise her employment.^[581] The threat of redundancy remains to this day due to changes in Anne's area of work.^[582] A further difficulty for Anne in receiving treatment was that, although she could drive, she did not drive to the hospital due to the effects of the treatment, especially the fatigue. This meant that she was required to take two trains there, and back, amounting to a three hour return journey. Anne stated that she is a private person and would rather not have told her employers that she was undergoing the treatment. However, due to the length of time involved in attending clinics and regular reviews, she felt that she had to tell her employer's Human Resources manager about the treatment.^[583]

Anne's treatment with Pegylated Interferon and Ribavirin

6.296 On 16 September 2009 Anne started a six-month course of Pegylated Interferon and Ribavirin. This involved Anne injecting herself with Interferon and taking Ribavirin orally in tablet form. Anne deliberately arranged to start this treatment on the Wednesday before a holiday weekend so that it would not impact on her work. She took annual leave on the Thursday of that week as she knew from her previous treatment that she would experience bad side-effects. In fact, Anne found the side-effects worse than she had remembered. She suffered from very bad flu-like symptoms and had to spend the rest of the holiday weekend indoors. She felt that her holiday weekend 'was completely wasted'.^[584]

6.297 Anne developed a routine during the course of her treatment whereby she took her Interferon injection on a Wednesday evening. In order to allow herself more time to recover from the injection and to enable her to cope with her 45-minute commute to work, Anne obtained permission from her employer to start work three and half hours late on a Thursday, and finish early on a Friday. On a Thursday she did not take any breaks and worked right through the day. She found that reducing her hours helped her manage to continue working while taking the treatment. She had to attend regular clinic appointments during the course of the treatment, initially fortnightly and then monthly, and so missed further time at work. Her reduced working hours and her absences due to clinic appointments did not affect her pay.^[585]

6.298 This second course of treatment with Interferon and Ribavirin affected Anne greatly. She suffered both physical and psychological symptoms which she described as 'intense'.^[586] With regard to the physical effects, she had continuous flu-like symptoms. During the first three weeks of the treatment, she took no fewer than six paracetamol tablets daily and thereafter took paracetamol regularly. She described some of the other side effects as follows:

My temperature fluctuated. I felt cold and clammy. I was shivery. I felt hot. I had a dry mouth. I produced less saliva due to interferon treatment. I had dry skin and suffered alopecia. I saw my hair on the pillow and in the shower. I suffered from poor concentration. In the first two months of treatment my concentration was exceptionally low. On a scale of one to ten, it was zero to one only. Towards the end of the treatment I was living with concentration levels at, say, five out of ten. My immunity to fighting infection was compromised. I had a non-productive dry cough for the first six weeks of treatment followed by a serious chest infection which lasted four weeks requiring antibiotics. My appetite was suppressed. I did not feel hungry. I had to force myself to eat. In the early weeks of Interferon treatment I skipped many meals and ate tiny portions. I was unable to eat starchy foods such as potatoes.^[587]

6.299 Initially, Anne lost weight during the treatment but, due to a craving she developed for ice cream, she regained this prior to finishing the treatment. During the treatment Anne never had a good night's sleep. She often had vivid nightmares which caused her to wake early, about 4 am, and remain awake for the rest of the night. She used to take a nap during the day which she never did before starting treatment. Anne's stamina was reduced. She estimated that, on a scale of one to ten, her stamina was only three. If she went shopping with her sisters, she had to sit down for 20-minute spells at least three times during the course of an outing. In September 2009, she had to stop swimming which she had previously enjoyed.^[588]

6.300 In addition to these physical symptoms, as a result of the treatment, Anne was diagnosed with symptoms consistent with Interferon-induced mood disorder and associated insomnia. Although she did not notice it at the time, her mood and personality began to alter as the treatment progressed. She became irritable and anxious. She suffered from panic attacks. She experienced episodes when she lost her self-control. At times she shouted, 'Get out of here' or 'Please go away' to people.^[589] She spent one weekend in bed communicating with no one. She experienced a form of claustrophobia as she was unable to cope if she found her immediate doorway or exit being blocked. In such situations she had to pinch herself to try to make these feelings subside. She developed a strategy of taking herself for a walk to calm down and used this many times both at home and at work. At one point, Anne told her sister that she could understand how someone might be driven to suicide. Now that her mental state has improved, Anne cannot believe that she said this.^[590]

6.301 Anne's sister provided a statement to the Inquiry.^[591] It was provided eight months after Anne commenced this second course of treatment and so the events she described in her statement were recent. Anne's sister was on holiday at the time Anne started the drug regime. Before she left, Anne was very tense about starting the treatment. On her return from holiday Anne's sister immediately noticed changes in Anne's personality and became very worried about her:

Anne was irritable and narky. I could not say anything to her without her reacting in an extremely confrontational manner. She was twisted and volatile and really hard to live with. It was a very difficult time. [Anne] had episodes of daily anger .... [Anne's] behaviour was really destructive. I worried about how I would speak to her because she became hypersensitive. She became a 'monster'. In a rage she would behave with eyes flaring and voice blaring. I became really worried and had to keep a daily eye and check on how things were .... [Anne] was out of control, snapping and being like a huffy, moody teenager. My son who is a loving nephew aged 20 years old avoided [Anne] for months ....^[592]

6.302 The description Anne's sister gave of Anne during the treatment was hard to reconcile with the person who appeared in the witness box at the Inquiry hearings. This highlighted the extreme psychological effect the Interferon had on her. Anne's sister described the change in her sister in September and October 2009 as 'very frightening'. Anne's sister stated:

The Interferon treatment was horrendous for [Anne]. The side effects of the drugs have placed the entire family under pressure. We could not possibly have envisaged the violent effects of this medication. It is upsetting today to recall all of this.^[593]

6.303 Anne's behaviour had a significant impact on her 85-year-old mother with whom she lived. Anne's mother felt threatened and vulnerable living with Anne during this period. On one occasion Anne's other sister witnessed 'a huge volatile row' between Anne and her mother and had to intervene to protect their mother. Anne is aware that her mother bore the brunt of living with her, the symptoms she suffered from Hepatitis C and the Interferon and Ribavirin treatment. Anne's sister stated that she knows that Anne's behaviour has 'deeply upset' Anne herself.^[594]

6.304 On one occasion Anne was so consumed with 'uncontrollable and involuntary anger' that, to prevent herself kicking her mother, Anne kicked a door.^[595] She was so ashamed of her actions that she 'jumped in [her] car and took a long drive in tears'.^[596] Shortly after this episode Anne attended a review appointment at the hospital at which she was asked to complete a questionnaire on how she was feeling. Anne reacted to this by having 'a mini breakdown' and she told the nurse how bad she felt. Anne felt that the nurse understood her problems and told her that she considers the psychological side-effects of Interferon very seriously. This was the first time Anne connected how she was feeling to Interferon, although she had been warned that the treatment might affect her mood.^[597] The nurse suggested two options to Anne - the first being to attend her GP and to ask for anti-depressant treatment, the second being to speak with the psychiatrist at the Brownlee Centre, Gartnavel Hospital, Glasgow.

6.305 Anne decided to follow the second option and so, in October 2009, attended an appointment with a psychiatrist at the Gartnavel General Hospital. The psychiatrist considered that Anne's clinical presentation with regard to her mood and sleep disturbance was entirely in keeping with a diagnosis of Interferon-induced mood disorder and associated insomnia. Anne was prescribed anti-depressant therapy. It took three weeks for this medicine to improve Anne's symptoms. Anne attended a number of appointments with the psychiatrist. He noted that Anne continued to experience intermittent bouts of anxiety until the completion of her treatment in March 2010. In the last two to three weeks of the treatment her sleep pattern again deteriorated, with nocturnal disturbance secondary to disturbing dreams.^[598] The psychiatrist suggested that Anne stop taking the antidepressant medication at the end of her treatment, but the nurse attached to the Hepatitis C clinic considered that it was too soon for Anne to stop it. Anne continues to take this medication and is 'not too anxious to come off it'.^[599]

6.306 To her credit, despite the severity of the side-effects of the Interferon and Ribavirin treatment, Anne continued to work during it.^[600] Anne had been told by the Specialist Nurse that there was an 80% success rate of the treatment in those people, like her, who had Genotype 2 of the virus. Anne was 'exceptionally hopeful' that the treatment would be successful. She nearly gave up taking the treatment, due to the effect of it on her mood, but the antidepressant medication enabled her to continue with it.^[601] One month after she started the treatment, blood tests revealed that Anne was Hepatitis C negative.^[602] However, a blood test taken when Anne finished the treatment in March 2010 revealed that she was Hepatitis C positive. Anne discovered on 30 March 2010 that the treatment had failed. Understandably she was very upset. The Specialist Nurse was shocked that the virus was detectable so soon after she finished treatment. A further blood test in September that year confirmed this positive result. Anne has been classed as 'a non-responder to combination anti-viral therapy'.^[603]

6.307 Anne's sister described in her statement how upset the family was that the treatment did not work:

[N]o one envisaged the treatment failing so quickly. My sister and mother are very upset. My mother continues to worry about [Anne]. Her life has been so challenging. We have all been affected with the effects of Hepatitis C in some way.^[604]

Anne too realises that her mother worries about her. She added that her mother has worried about her for 25 years and 'that is most unfortunate'.^[605]

Anne's present symptoms

6.308 For a couple of months after the treatment finished Anne continued to suffer from some anxiety and panic attacks, but these have now resolved. Anne continues to suffer from flu-like symptoms and aches and pains. Her stamina remains poor, and she has been unable to return to her hobbies of aerobics and swimming. She continues to suffer from fatigue and goes to bed earlier than before. According to Anne's sister's statement, 'She is ill just now. She tires very easily. She cannot even cope physically with going shopping and has to sit down every hour for a long rest'.^[606]

6.309 Anne now attends the liver clinic annually for monitoring.^[607] With regard to her prospects Anne states, 'I do not know what my future holds for me. My future is very uncertain'.^[608] Anne understands that there may be more treatment for Hepatitis C in a few years but she is unaware what that treatment may be.^[609]

Specific impacts of Anne's infection with Hepatitis C

6.310 Anne described the impacts of her infection with Hepatitis C as follows:

[It] has had a profound impact upon my life. This has reduced my life opportunity in terms of maintaining personal relationships, obtaining employment chances and the subsequent economic disadvantage suffered by me as a result. In my opinion this is why I remained single and did not progress or encourage potential marriage options. I was a young woman when this happened to me. I did not encourage any long-term relationships. You have to draw the risk of transmission of this virus to someone's attention right away. My confidence to do so was non-existent. I have missed out with the opportunity of potentially raising a family of my own.^[610]

6.311 Her infection with Hepatitis C has exacerbated Anne's anxiety about her work situation. Anne has worries about how she would be able to obtain a new job in light of her condition and, for example, whether she would need to declare to any new employer that she had Hepatitis C. 'My age together with Hepatitis C will rule out many employment options available to me.'^[611] At present her work situation has settled but, as she stated, the threat of redundancy 'raises its head every now and again ...'.^[612]

6.312 With regard to financial consequences of her infection with Hepatitis C, Anne has a mortgage but she did not have to disclose her diagnosis to her mortgage provider. She worries about being unable to pay the mortgage were she to lose her present job. She has no life assurance as she does not wish to discuss her diagnosis with potential insurers. She has obtained travel insurance, but has not divulged the fact that she has Hepatitis C to the insurers. She has incurred travel expenses attending many clinic and other appointments at the hospital. She received the first Skipton Fund payment in 2004. When her GP signed the Skipton Fund application form for her, he remarked that only three of his patients had Hepatitis C and they were all drug users. It appeared to Anne that he did not differentiate her status, as having acquired it through no fault of her own, from theirs.^[613]

6.313 Anne is concerned about the stigma attached to the Hepatitis C virus. She likes to keep such a personal matter to herself and is keen to preserve her privacy. She lives in a small community. She has told very few people about her diagnosis.^[614]

Alex

6.314 Alex is presently in his mid-20s.^[615]

6.315 Alex has severe Haemophilia A and was infected with Hepatitis C, Genotype 1a, from his treatment with blood products.^[616] He was infected with the virus when he was very young and he was assisted in the evidence he provided to the Inquiry by his father, who also provided the Inquiry with a witness statement,^[617] and by referring to reports and notes which were kept by his late mother.

Alex's diagnosis with haemophilia and his treatment for this

6.316 Alex is the youngest of four children. He has two brothers and one sister. As a child Alex's family lived in a remote part of Scotland. In October 1986, when Alex was about six months old, he developed a swollen right thigh and was distressed. His GP referred him to a local hospital. Initially it was thought that Alex had developed osteomyelitis (bone infection) and he was treated with medication for this. On 22 October Alex was referred to a regional hospital. There, a coagulation screen revealed that Alex had Haemophilia A. It was noted that this appeared to be the result of a spontaneous mutation as the Factor VIII levels in Alex's mother, and in his two brothers, were normal. As there was no family history of haemophilia, Alex's parents had no knowledge or experience of haemophilia. The discharge document from Alex's admission to the regional hospital states that '[Alex] was given an infusion of cryoprecipitate before going home so that his parents could see what was involved, although he did not have any bleeding disturbances at that time'.^[618] Alex's father remembers this first treatment very well, although until he saw the discharge letter recently, he thought that Alex's first treatment was with Factor VIII concentrate. Alex's father stated that nothing was discussed with him or his late wife about the treatment Alex was given. He remembers 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 said that they would give him a dose of Factor VIII, and that Alex would probably need to take Factor VIII for the rest of his life.^[619] It is possible that this is how the doctor referred to the cryoprecipitate since it contains Factor VIII.

6.317 Alex's parents clearly found this first admission to the regional hospital a traumatic experience. It took eight days for Alex to be diagnosed with haemophilia.^[620] During this period Alex gave a number of blood samples for tests. Each time he was taken away from his parents and they would hear him screaming while the sample was being taken. He returned to them with bruises on his arms.^[621]

6.318 In January 1987, Alex developed swelling of his left thigh. Initially he was admitted to a local hospital where he was treated with three doses of Factor VIII concentrate. The swelling did not improve, and so the local hospital decided to refer him to a larger hospital for further review. At Alex's parents request this referral was made to the Royal Hospital for Sick Children (Yorkhill) in Glasgow instead of the regional hospital.^[622] Alex was admitted to Yorkhill Hospital on 22 January 1987. He was treated daily with cryoprecipitate. This resolved the bleed and Alex was discharged home on 28 January. During his admission Alex's Factor VIII level was checked again, and was found to be less than 1%, indicating severe haemophilia.^[623] Alex's mother, who accompanied him during this admission, was provided with further information about haemophilia and was introduced to parents of older children with the condition.

6.319 In March 1987 Alex fell and cut his tongue on his teeth. Initially he was treated at home with Factor VIII, but this failed to stop the bleed. So he was admitted to Yorkhill where he was treated with two bags of cryoprecipitate and then tranexamic acid (a drug used in the control of bleeding). It was noted in the discharge letter from this admission that Alex's parents were under considerable stress. Alex's father explained in his evidence to the Inquiry that their stress was due to Alex's diagnosis with haemophilia, and the fact that they lived in such an isolated place. 'We had nobody in our area with the same problem and there was nobody we could discuss it with'.^[624] With the help of their GP Alex's parents found out about two other families in their local area who had experience of mild haemophilia. One was an 80-year-old man, and the other was a family who had lost their son before Alex was born. They did not wish to discuss haemophilia with Alex's parents. According to Alex's father there was stigma about haemophilia, which is likely to have been due to the publicity surrounding HIV at that time.^[625]

6.320 Alex usually attended his GP if he had a bleed. He attended Yorkhill for review appointments every three or four months. One of his parents accompanied Alex to these appointments, while the other parent stayed at home to look after their other children. Each appointment usually involved a round trip of two days, and staying overnight in Glasgow. Alex did not enjoy staying in the city. At one point Alex's parents considered moving to Glasgow to be nearer Yorkhill.^[626]

6.321 At each of Alex's review appointments he underwent a blood test. Alex's parents were told that these tests were to check his factor levels and his liver function. At some point Alex's parents were told that he was being tested for 'non-A, non-B' but they did not know what it was.^[627] It was not explained to them. Alex's father recalled asking on one occasion what non-A, non-B was and he was told 'It is just a test that we do'.^[628] He knew that everyone with haemophilia was being tested for this. Alex's parents were not told the results of these tests. In April 1991 Alex underwent an abdominal ultrasound, the results of which were normal.^[629]

6.322 Alex started prophylactic treatment with Factor VIII concentrate in about October 1990 when he was four years old. It was usually Alex's mother who gave him the injections of Factor VIII, but if she was unable to access a vein, or it was 'a struggle', the GP would administer the treatment. Alex hated the injections: 'I understood why I had to get them but it just wasn't very nice having to have a needle stuck into your arm'.^[630] This home treatment was obviously distressing for Alex and his family, in particular his mother. Alex continued to attend Yorkhill every three months for monitoring, which included blood tests.^[631] These blood tests included liver function tests. It seems that, at this time, Alex's parents were unaware that his liver function was being monitored.^[632]

6.323 Alex started school in August 1991. He suffered recurrent bleeds once or twice a week. These were usually in his ankles and knees. When they occurred Alex was unable to weight bear for several days, and had to be carried everywhere by his mother. As a result of these bleeds Alex missed a considerable amount of schooling.^[633] Alex was provided with a wheelchair to use when he had a bleed. This was used both at home and at school. Alex's school installed stair lifts to allow Alex to access the upstairs classrooms. Alex hated his wheelchair: 'it wasn't very cool to go to school in a wheelchair ... I would have to get pushed around as well and it wasn't very pleasant'.^[634]

Alex's diagnosis with Hepatitis C

6.324 Alex's father was unsure when he and his wife discovered that Alex had acquired Hepatitis C. He thinks that it may have been roughly a year before Alex started treatment with Interferon: he started this treatment in April 1994.^[635] He remembers his wife returning from one of Alex's review appointments in Glasgow, and relaying the news to him that Alex had Hepatitis C. His wife was very upset and so was he. They did not know what Hepatitis C was, and Alex's father stated that no explanation about the virus was given to his wife at that time. They eventually discussed it with Alex's GP who was very good to the family over the years. He explained to Alex's parents 'what Hepatitis C meant, what the implications were, the long-term and it wasn't nice'.^[636] Alex's parents were not given any advice on how, and if, to tell Alex of his diagnosis. They were not offered counselling. None of the family was offered testing for the virus.^[637]

6.325 Alex was about seven years old at the time his father believes they found out he had Hepatitis C. Alex does not remember being told that he had Hepatitis C: 'there was never one point where I was sat down and told, it was always just kind of there. I had haemophilia, I had Hepatitis C'.^[638] Alex remembers asking his mother on the way to one of his review appointments what Hepatitis C was, and why he needed treatment for it. She told him that it was like a scar on his liver and that it was not very good that he had it.^[639] Alex's parents only told a few members of his immediate family about his diagnosis with Hepatitis C: 'it has been kept very, very secret, within the family ...'.^[640] They considered that there was already a stigma in respect of Alex having haemophilia and they did not wish to add to it. They believed that living in a small community made this worse.

Alex's treatment with Interferon

6.326 It appears that Interferon treatment was first discussed with Alex's mother in around 1993.^[641] Alex and his father recalled that Alex's mother wished him to receive treatment for Hepatitis C, but she was apprehensive about the benefits and negatives of it.

6.327 In January 1994, it was decided that Alex would start treatment with Interferon during the Easter holidays. Other than abnormal liver function test results, Alex was not displaying any symptoms of Hepatitis C although, looking back, now Alex feels that he suffered from bouts of tiredness, 'At the time ... I would never have associated the two but looking back, it did seem a bit strange that I would go a couple of days where ... I would just want to stay in bed. I guess for a young child I was quite tired'.^[642] His parents were advised that the reason for starting the treatment was to delay the progression of the virus.^[643] It was arranged that Alex would spend two weeks in Glasgow at the start of the treatment. Although Alex was supposed to be taking prophylactic treatment for his haemophilia, by this time he was not taking as much treatment as was prescribed. He was 'always quite resistant' to taking this treatment, and this was difficult for both Alex and his parents.^[644] As the Interferon treatment was going to involve further injections, and in the hope that compliance with Interferon would be better, Professor Gibson, Consultant Haematologist, did not reinstate prophylactic treatment in January 1994.^[645]

6.328 Alex's parents felt that they were given 'sparse' information about the treatment by Yorkhill, so Alex's mother contacted the Haemophilia Society and enrolled to attend a symposium in Glasgow on Hepatitis in early 1994.

6.329 On 30 March 1994 Alex underwent an abdominal ultrasound scan. The result of this revealed mild hepatomegaly (enlarged liver) but was otherwise normal.^[646]

6.330 On 1 April 1994, when he was eight years old, Alex started treatment with Interferon. His treatment with Interferon was given as part of a study entitled 'A Prospective Study of the Efficacy of Human Alfa [sic] Interferon in the Treatment of Chronic Liver Disease in Haemophilia'.^[647] Over the months leading up to the trial, the implications of treatment for Alex and his family were discussed by Professor Gibson and the Haemophilia Nurse Specialist with Alex's mother, and a plan was made, including training, to deal with these. Alex's mother signed the consent form for this study after these discussions. The consent form records that the nature of the study and the side-effects of Interferon were explained to Alex's mother. Alex's father believes that his son was the youngest person in Scotland to become infected with Hepatitis C from blood products, and to receive Interferon treatment.^[648]

6.331 Alex's GP was obviously keen to support the family during the treatment. By letter dated 31 January 1994, Alex's GP wrote to Professor Gibson stating that he understood that Alex was due to start treatment with Interferon at the end of March. The GP asked Professor Gibson for 'any further information regarding Interferon treatment which you may be able to send me, and [I] would also appreciate copies of any information which is provided to [Alex's parents] in order to facilitate any discussion with [them]'.^[649] In her reply to this letter, dated 3 February, Professor Gibson wrote 'If the decision is taken to go ahead with Interferon therapy for [Alex] then I will keep you very informed of the risks and side effects'.^[650] As stated above, Alex started this treatment on 1 April 1994. Professor Gibson did not keep Alex's GP informed about this treatment. On 16 August 1994 Alex's GP wrote to Professor Gibson that '[Alex's mother] tells me that he has been back to Yorkhill several times as his Interferon treatment continues. The last typed letter I have from yourself is dated 3 February 1994 and I wonder if it is possible to have an update on [Alex's] treatment since then?'.^[651] In her reply to this letter dated 23 August, Professor Gibson stated that Alex tolerated the treatment 'very well' and that they had seen Alex at monthly intervals.^[652] She noted that Alex had minimal local inflammation at the injection site but no other side-effects. She noted that there had been a little improvement in Alex's recent AST and ALT results but that they remained above the normal range.

6.332 The injections of Interferon were administered to Alex by the community nurse at his house. When asked how he found taking the Interferon treatment Alex stated:

I hated it. I couldn't stand it. And I did feel sick from it. I just felt drained. [A]fter my first treatment I was really sick. I had ... extreme flu symptoms and hot sweats. It was never as bad as the first time but it was bad enough carrying on, and I also - because I hated going to the hospital so much, I hated having to go for my appointments - I never wanted to make a big deal about it in the hospital. I always tried to play down any illness I had.^[653]

6.333 The reason Alex did not stress these symptoms to the hospital was that he was worried that if he did, he would have to stay at the hospital: 'it was always such a horrible place to be'.^[654] Alex remembers also feeling generally unwell. Alex's first treatment was around the time of his birthday. When he returned home after this he had a birthday party. Alex remembers that he did not wish to be around anyone. He did not wish to have to play with anyone and he stayed in his room. Alex's father stated that although the side-effects of the treatment had been explained to Alex's mother it was 'awful' when Alex received the treatment: 'I can't even go into the detail of what it was like. It was horrible, absolutely horrible to give it to a young child, these injections, the district nurse used to come in every day and every one of the family used to cringe to hear'.^[655] When describing the effect of the Interferon treatment on Alex, his father stated '[I]t doesn't bear to think about what he went through'.^[656]

6.334 Alex's transaminase levels became normal within eight weeks of starting Interferon, and remained normal for the following month.^[657] However, this improvement was transient, and by October 1994, six months after he had started the treatment, both his AST and ALT levels were elevated. Alex was consistently Hepatitis C PCR positive on all but one occasion in the first six months of his treatment; the one occasion apparently being of doubtful significance. As his liver function test results were abnormal at weeks 20 and 24, he fulfilled the criteria for trial failure and withdrawal from the trial. Alex's mother was informed at a review appointment in October 1994. She was understandably very disappointed by this, and after discussion with Professor Gibson it was agreed to continue Alex's treatment with Interferon for a further month. In fact, Alex's treatment continued until 17 February 1995. One of the reasons it was continued this long was that Alex's HCV RNA was negative in December 1994, but unfortunately it became apparent that this was another 'one off' result. At some point Alex's parents were told that with hindsight it might have been better had his treatment been stopped after six months.^[658]

6.335 Alex believes that he was 'quite happy' to stop the treatment as it meant that the injections stopped. At his age, the fact that the treatment had not worked did not mean much to him. He knew that having Hepatitis C was bad and that he needed to get rid of it.^[659] He described his understanding about Hepatitis C as being 'a long period of discovery'.^[660] Alex's father described the failure of the treatment with Interferon as '[V]ery, very disappointing, very hard to deal with, because there was no improvement whatsoever. He was still the same as he was before he started his interferon'.^[661]

Alex's condition after the Interferon treatment and the effect of both his haemophilia and Hepatitis C on his schooling

6.336 After his treatment with Interferon was stopped, Alex continued to attend Yorkhill Hospital for monitoring and annual ultrasound scans. His liver function test results remained mildly abnormal, but not sufficiently to cause concern. In 1996 there was some discussion among the doctors there about whether Alex would benefit from further treatment with Interferon at a higher dose, but these proved inconclusive.^[662] In January 1997 Alex's mother, who was keen to pursue treatment options for the virus, was told by Professor Gibson that it was unlikely that Alex was eligible for the combined Interferon and Ribavirin trial which was about to start, as this was principally for patients who had become Hepatitis C negative during their treatment with Interferon, and had subsequently relapsed following its withdrawal. After his experience taking Interferon, Alex was not keen to take further treatment for Hepatitis C. In fact he continued to be reluctant to accept prophylactic treatment for his haemophilia.^[663]

6.337 In the late 1990s Alex started secondary school. His school was aware that he had haemophilia but did not know that he had Hepatitis C. When asked to describe how he found starting secondary school Alex stated:

I found it pretty hard. I found it quite hard to make friends. I never really had any best friends because I always felt like I had a tonne of secrets and baggage that I had to carry around .... It was hard enough to tell people that I had haemophilia let alone anything else. I felt quite withdrawn because of that, because I knew I had something to hide and I never really felt like I could open up or explain why I was going away every other month or what I was doing. I still do to this day. I am still quite closed.^[664]

6.338 Alex's bleeds changed at this time, and he found that he could go to school when he had a bleed although he probably should not have done so. He chose not to use his wheelchair: 'I didn't like being the disabled boy at school. I felt like I was labelled with that anyway because I was the only one with [haemophilia]'.^[665] When Alex had a bleed, instead of going to school in a wheelchair, he often rested at home and then returned to school. He continued to miss a lot of school due to his bleeds. His target joints were developing and he had persistent bleeding into his right knee and his left ankle. In the event of Alex having a bleed at school, the school contacted Alex's parents either by the home telephone, or via a pager which the parents carried. They would then collect Alex and take him home for treatment there.^[666] At one point Alex's school insisted that he wore a helmet to participate in gym lessons. Alex felt stigmatised by this and a doctor from Yorkhill Hospital wrote to the school advising that this was unnecessary.

6.339 When Alex was younger and in primary school he did not think that having Hepatitis C was 'a big deal' and so he probably mentioned it to everyone. In secondary school Alex only told his best friend that he had the virus due to the stigma surrounding it. He felt isolated at school and ashamed of his condition.^[667]

6.340 In November 2000, when Alex was 14 years old, his Consultant Haematologist at Yorkhill sought the advice of Dr Morris, Consultant Gastroenterologist, on further treatment of Alex's Hepatitis C. Alex and his mother attended Dr Morris' clinic on 19 February 2001. At this appointment Dr Morris discussed the possible benefits of combined therapy with them and told them that it was their policy to consider liver biopsy in patients they intended to treat with this therapy. It was agreed that Alex and his mother would consider the pros and cons of further therapy and the potential risks of liver biopsy, before returning to the clinic in three months.^[668] At this time Alex did not want a liver biopsy and was not keen on treatment:

At that time I didn't want [a liver biopsy]. I didn't see the point. I didn't feel like I had any main symptoms from it. To be honest, I just kind of ignored it. I didn't think about it too much. I didn't feel like I was sick at that point. So there wasn't anything to treat almost. I was also - I was quite worried about having a liver biopsy as well, obviously being a haemophiliac, and also I kind of heard that the combination of ribavirin and interferon, the side effects can be quite extreme. So ... I just didn't really consider it.^[669]

6.341 As he grew older Alex began to consider what the virus might mean for him and so he started on 'a personal quest for information'. He was scared of what he was going to find out. He obtained booklets from the hospital.^[670] He gained the impression that those infected with Hepatitis C generally lived for 15 to 20 years. He saw other haemophilia patients dying. As a result of this, he did not think that he would live long past his teen years. He stated:

[I]t is hardly surprising that I lacked the motivation and ambition to work hard and gain qualifications for a 'future' that no-one could assure me I would have .... So I just didn't try. I gave up before I had even started and at the age of 16 dropped out of education with few standard grades and no ambition.^[671]

The period after Alex left school

6.342 Alex started to attend Dr Morris' Liver Clinic annually. An abdominal ultrasound in August 2001 was normal.^[672] In 2002, at the age of 16, Alex began a course at his local college. He spent less than a year on this course and then moved to Glasgow to study on another course. He completed the first year of this course. He found it difficult being away from home and thinks that he was perhaps too young to have moved away from home. At his annual reviews at Dr Morris' clinic his position with regard to treatment remained the same:

I was quite happy just to go in and ... get them done and leave really. Also, I didn't find I had any problems relating to my Hepatitis C at that point. I wasn't really interested in treatment or exploring anything any further. I did look into treatment myself a little bit but I didn't want to pursue it.^[673]

Throughout this period Alex suffered from fatigue. He would suddenly become 'really, really tired' but he did not associate it with Hepatitis C.^[674]

6.343 Over time Alex became more concerned about the progression of the virus. When asked what caused this he stated:

I think it was a combination of a lot of things. I was finding it quite hard living in Glasgow and getting around the city, just even my joints and things were starting to seize up. My knee was getting especially bad and I think I - over a short period of time I just started to care a bit more that I had Hepatitis C and I started to almost think about it and research it. And I guess over a period of time it just hit me that it is actually really serious.^[675]

6.344 During his research Alex found something on the internet or elsewhere that said that patients with Hepatitis C can expect to live for 20 years. As he was nearing his 20th birthday he thought that his 'time was getting kind of close'.^[676] Also at this time Alex's mother became unwell. Alex voiced his concerns to an Associate Specialist in the haemophilia and thrombosis centre at Glasgow Royal Infirmary. In April 2007, this doctor wrote to Dr Morris and asked him to see Alex ahead of his next appointed clinic time, with a view to discussion of possible biopsy and treatment. Unfortunately, Dr Morris was about to take a sabbatical and so was unable to see Alex until the appointed clinic in October 2007. When Alex attended this appointment he was seen by a junior doctor. During this appointment Alex asked this doctor some questions. A number of times the doctor left the room to discuss Alex's questions with Dr Morris, who was in the room next door. Having reconsidered the possibility of treatment, Alex would have liked to have had the opportunity to speak to Dr Morris personally on this occasion. At this appointment it was decided that Alex should undergo an ultrasound-guided liver biopsy which required him to be admitted beforehand to correct his clotting, and then afterwards for observation.^[677]

6.345 Later in 2007 Alex attended the Glasgow Royal Infirmary (GRI) to undergo the liver biopsy. Before attending for this procedure Alex researched it on the internet. He found a lot of information but was unsure which details were correct, 'But I had made a mental decision that maybe now is the time to do something about it and if I have to get a biopsy to get the treatment, maybe it's worth it'.^[678] Having been admitted to the hospital for the procedure, and had a cannula inserted into his hand, Alex changed his mind about having a liver biopsy. One reason for this was that the liver specialist nurse came to speak to Alex to make sure that he wanted to go ahead with it. She asked Alex if he knew what genotype of the virus he had, and Alex told her that he did not know. She told Alex that the genotype of the virus he had would have 'a massive impact on the treatment and the success rate'.^[679] She went away to find out his genotype. On her return she told Alex that he had Genotype 1 and so he had a much lower chance of clearing the virus than if he had one of the other genotypes. Another factor which contributed to Alex's decision to postpone the procedure was that his Haemophilia Consultant came from upstairs to check on Alex. He told him that it was a fairly serious procedure for a person with haemophilia to undergo, and seemed to want to make sure that Alex understood fully the implications of having a liver biopsy. Alex believes that, until his discussion with the Haemophilia Consultant, he had not fully appreciated the risks of a liver biopsy. The fact that two people checked on him and asked him if he wished to continue with the procedure scared Alex: 'At that point [he] said, "Maybe I need to think about this. Maybe I need to think whether I'm doing the right thing".'^[680] He left the hospital without undergoing the procedure.

6.346 In February 2008 Alex moved from Glasgow to another city in the UK. By this time Alex had managed to complete only two years of his college course in Glasgow. Alex's attendance on the course was poor. He believes that this was due to his haemophilia and the fact that, during this period, he became preoccupied with the fact he had Hepatitis C. He also found it difficult to concentrate.^[681] He found it hard to get close to people and was quite withdrawn.^[682] Alex decided to move to this new city as his girlfriend at the time lived there, and he knew that there was a good hospital there. On moving Alex started attending a joint hepatology and haemophilia clinic at the local hospital every six months. He believes he receives good care there. This care includes Fibroscans. These scans use transient elastometry to measure the amount of liver stiffness, from which the level of fibrosis can be assessed. His Fibroscan result in 2010 was 6.8kPa.^[683]

6.347 His blood test results from April 2010 revealed an albumin 46g/L, alkaline phosphatase 77iu/L, AST 62 iu/L, ALT 107 iu/L and bilirubin 10 mmol/L. His viral load was 1.7 million, suggesting that that there was not major liver fibrosis, that the liver was functioning well, but that the virus was still actively reproducing.

The present position

6.348 Alex has been advised by the doctors in this new hospital that he should consider treatment for the Hepatitis C virus while he is healthy enough to withstand the side-effects. Understandably this change in advice has caused Alex to become confused about what would be the best course of action for him. Some time in 2011, Alex was offered treatment with Interferon and Ribavirin and was on the verge of accepting it. His doctor then advised him that he might be better waiting for the new treatment of protease inhibitors.^[684]

6.349 Alex believes that he has suffered from symptoms of Hepatitis C throughout his life although 'sometimes [he] did not realise the full extent of them'.^[685] He has often been depressed, angry, tired and lethargic. Alex has never received treatment for depression although he did once mention how he felt to his GP in Glasgow.^[686] Alex's father stated that after Alex started his treatment with Interferon he:

[W]as just going away all on his own, wouldn't come out. He would spend days and he would hardly eat and we just thought, well, it's just the effect of the interferon that's causing it, but obviously it wasn't. It was just an ongoing thing right up until he moved away from home ....^[687]

He told the Inquiry that he found it hard to speak to his parents or anyone else because 'all my experiences of going to the hospital were very negative, so everything surrounding having haemophilia and Hepatitis C was all really negative'.^[688] He tried on occasion to speak to his mother about it but 'it wasn't a very nice thing to do. I always found it ... really hard'.^[689] Alex's family, especially his mother, cared for him extensively as he grew up and Alex now relies heavily on his girlfriend.

6.350 Alex has been given limited advice about the prognosis for his condition. He has tried to research it himself but has never fully understood it.^[690] He believes that:

[I]t is so complicated to even consider having children that I just don't bother. The risk of passing on an infection and then the thought of not being around to see my children grow up really prevents me from planning any kind of family life.^[691]

He has discussed this with his doctor and has been told that there is a risk of passing on the Hepatitis C virus. He understands that there are alternatives, such as IVF, which would lower the risk of infecting his partner but, although Alex would love to have children when he is older, he is not considering it at present.

Specific impacts of Alex's infection with Hepatitis C

6.351 Alex's father stated that the family is very close and that it has been 'heart breaking' that one of the five of them has had Hepatitis C. It had a 'huge' effect on Alex's late mother, and Alex appreciates that his having haemophilia and then Hepatitis C was 'a lot to go through'.^[692] He feels responsible for having put his parents through this. It was apparent from Alex's evidence that his diagnosis with haemophilia and then Hepatitis C has put a strain on both his parents, in particular his mother as his main carer, and his family life. Although they are close, Alex described himself as 'quite closed' and stated that '[A]s a family we generally don't talk about it. It's always there, obviously, but it's hard to talk about'.^[693]

6.352 The diagnosis with Hepatitis C has affected his social life. He finds it difficult to get close to people because then he feels that he needs to tell them about his condition:

It's this whole big thing that you have to explain. It's not like you can tell every person you meet and have a quick explanation of 'Oh, that's a shame. It's terrible that could have happened'. You have this whole other big baggage of information that you have to carry and explain. I almost feel like I have to defend it if I do tell anybody, which is why I generally choose not to.^[694]

6.353 As a result of this he does not have a large circle of friends and does not become involved in community life. Alex worries that he may sustain an injury causing him to bleed, and then he will have to tell people he has Hepatitis C.^[695]

6.354 In 2009 Alex underwent an arthroscopy to repair damage to his right knee, one of his target joints. This had a good effect. Alex is generally confined to non-physical activities which is due both to his haemophilia and Hepatitis C. He is unable to play impact sports of any kind. He finds it difficult to do activities which keep him fit as he finds that he tires easily.^[696]

6.355 After Alex left Glasgow he started studying again. Now he has part-time, unpaid work, the nature of which he wishes to remain confidential. This work is relaxed in that he can take breaks when he wishes and he can work from home. The people he works with are accommodating with regard to his haemophilia. Alex told his employers about this when he started working there. He hoped that his work there would become full-time within the next month or so. In the past Alex has found it difficult to sustain any level of work. His lack of qualifications on leaving school limited the career options open to him. During the time he was at college Alex tried to work in bars and coffee shops but he found such jobs difficult to maintain due what he described as 'the immense bouts of fatigue' from which he suffered and the unpredictability of them.^[697] He stated that, on occasion, he has had to turn down or leave other work due to his symptoms of Hepatitis C.^[698] As a result of this Alex felt that he was unreliable in the work place and not the best kind of employee. 'I feel like a bit of a failure on the work front and it is always difficult when I compare myself with friends my age who seem to be progressing with their lives'.^[699] Due to his uncertainty about his future, motivation has been hard for him.

6.356 For number of years Alex has had to rely on benefits. Nobody else in his family has ever claimed benefits and the fact that he does so is something he feels guilty about: 'I have never enjoyed it or been proud of it'.^[700] Over the years Alex has accumulated debts, including an overdraft and credit card bills, amounting to about £18,000. He stated that he was reckless with money as he was immature and did not think he was going to live long enough to have to pay these debts off. At one time he was called by debt collectors almost every day and this caused him a lot of anxiety. He has now consolidated his debts and feels that he is more in control of his finances. He has started to make payments to reduce the debt and hopes eventually to repay it. In 2004 Alex received £20,000 from the Skipton Fund, and he paid off some debts, gave some money to his family and paid rent on his accommodation in Glasgow.

6.357 Alex believes that his diagnosis with Hepatitis C precludes him from obtaining a mortgage and so he is unable to consider buying a house. He has never applied for a mortgage but has researched obtaining one. The expense of travel insurance, and Alex's financial situation makes it difficult for him to travel abroad. On one occasion Alex travelled to the USA with his parents. His parents' travel insurance cost £32, but Alex's cost £109 due to his haemophilia and Hepatitis C. He wishes he was able to travel more.^[701]

6.358 When Alex was a child, the costs of his travel to the Haemophilia Unit at Yorkhill, and that of the parent who accompanied him, were paid for by the Health Board. They usually stayed with Alex's aunt. They were given an allowance of £28 a night for accommodation. This was insufficient to cover the cost of this, particularly if they were unable to stay with a relative. Alex's parents paid the rest of their costs of these trips from their savings. Alex's father stated: '[I]t was quite a big chunk of any savings that we had'.^[702] A disadvantage for Alex of staying with his aunt was that after each hospital visit he had to answer her questions, and explain what had happened, at the appointment. He found this difficult and gave the impression he would have preferred not to have had to speak about his appointments.

6.359 Alex feels the cold and has bad circulation in his toes and fingers. This may be a symptom of Hepatitis C. As a result of this he has incurred increased heating costs. Occasionally when Alex's symptoms of Hepatitis C are severe, he employs a cleaner and a handyman. He bears the cost of this. He stated that his girlfriend often has to look after him now.^[703]

6.360 In a written statement to the Inquiry about the financial effects of his infection with Hepatitis C, Alex wrote:

I feel like I have lost my future. I find it hard to assess exactly how much financial hardship I have faced as a result of my illness because it is difficult to measure potential. I can compare myself to my siblings and peers, all of whom have successful jobs, own their own houses and have a good quality of life. At the age of ... I have none of these things and I can only put this down to being different and the difference is my illness. I know I am intelligent, I know there are a lot of things I would have loved to have done, but my illness, and in particular the lack of support and information I was given growing up, has prevented me ever achieving anything. I can't hold down a job as I am just not reliable, I would not employ me and I [am] embarrassed that as a ... year old man I have never really achieved anything. I just want a fresh start but I feel trapped in my situation - I rely on benefits and don't have the finances to re-enter education and start my life again. I feel I will always be reliant on others for my life and the burden of that makes me just want to give up.^[704]

Christine

6.361 Christine's son contracted HIV from contaminated blood products and she gave evidence during the Oral Hearing in support of Chapter 5, The Effect of Infection with HIV, Including the Effects of Treatment, on Patients and their Families. Christine herself contracted the Hepatitis C virus from blood products, and her account of some of the effects of this on her, and her family, is narrated below. It is likely that these are understated as Christine's evidence to the Inquiry mainly focused on her son's infection with HIV. In order to gain a fuller appreciation of the impacts of Christine's infection with Hepatitis C, what is written below should be considered together with the evidence narrated at paragraphs 5.5 to 5.62.

How Christine acquired Hepatitis C

6.362 At the date of the hearing Christine was in her mid-50s.^[705] She had a family history of haemophilia, with her two brothers, a cousin and an uncle being diagnosed with it.^[706] In 1975 following the birth of her son, who was referred to in evidence as 'John', and his diagnosis with Haemophilia A, Christine was investigated and found to be a carrier of Haemophilia A.^[707]

6.363 As a result of being a carrier of Haemophilia A, Christine decided to undergo sterilisation. She found this a very difficult decision to make. The surgery was carried out in December 1981 at a hospital elsewhere in the west of Scotland. Prior to the surgery, Christine's Factor VIII levels were checked by her son's Consultant Haematologist at Yorkhill Hospital and were found to be 26%. She had never had any bleeding problems.^[708] But when she regained consciousness after the operation, Factor VIII was being administered to her. Christine asked the medical staff to stop this treatment. She felt that they were 'making a mountain out of a molehill'.^[709] Christine made her unhappiness clear and was told that she had signed a waiver consenting to the administration of any treatment thought necessary.^[710] She later learned that the administration of Factor VIII had been at the suggestion of the Haemophilia Unit at Yorkhill, with the Factor VIII being sent over in a taxi from Yorkhill at the time of her operation.^[711] It was 2800 units of Armour Factor VIII, batch number VC2103, which proved to have been infected with Hepatitis C.^[712] This was the only time Christine received human Factor VIII concentrate.^[713]

6.364 Immediately following the sterilisation procedure, Christine had acute jaundice and felt extremely nauseous for a week. She was treated for this by her GP. Having not been warned specifically of any risks associated with Factor VIII, she did not think there was any link between it and her symptoms. Christine was told by one of the nurses that, as a result of her having suffered jaundice, the batch of Factor VIII which she had received was withdrawn from use as a safety precaution.^[714] The cause of Christine's episode of jaundice was investigated by her GP, and markers for Hepatitis A and B were negative. There was no further follow-up of liver function tests or other viral markers.^[715]

6.365 In December 1981 Christine was referred to the Haemophilia Unit at the Glasgow Royal Infirmary to be registered as a haemophilia carrier. She has attended the Haemophilia Unit annually for routine blood tests. Since 1981 she has had synthetic desmopressin (DDAVP) cover for all major and minor surgery, including for a hysterectomy in November 1988.^[716]

Christine's symptoms of Hepatitis C

6.366 After 1981 Christine suffered from skin itching, arthritis and painful feet. She had episodes of insomnia and extreme tiredness but generally kept good health. She attributed her tiredness to a combination of factors, namely caring for her elderly mother and working hard, as she did.^[717] Later she had also to deal with the challenges presented when her son was diagnosed with HIV.

Christine's diagnosis with Hepatitis C

6.367 Christine did not find out that she was infected with Hepatitis C until 1991. A couple of weeks after giving blood at a mobile blood transfusion centre she was asked to attend a meeting at the Glasgow offices of the SNBTS. She did not know what the meeting was about. At this meeting she was told by an unidentified individual that, having tested her blood donation, it had been discovered that she was positive for Hepatitis C. Christine could not believe this and was in shock. After she was questioned about whether she had taken any drugs or medication, it was suggested to her that she could have acquired the virus from the Factor VIII she was given in 1981. It was never confirmed to her that this was the source of her infection. She does not recall being given any information at this meeting about the virus except that she was told that she should not donate blood again and not to consider organ donation. She stated that if she was given any more information than that, she was in too much of a shock to absorb it. She was advised to attend her GP.^[718]

6.368 Christine believes that she was not properly counselled when she was told she had Hepatitis C. She was not told to practise safe sex and she was not warned that she could be at risk of HIV from the Factor VIII she received in 1981. She believes that had she not donated blood, she would not have discovered that she had the virus.^[719]

Christine's treatment for Hepatitis C

6.369 As suggested to her, Christine attended her GP and he referred her to the Hepatology clinic of Dr Mills, Consultant Hepatologist at the Gartnavel General Hospital, Glasgow. Christine attended this clinic in 1991. There she was advised by Dr Mills to start treatment with a 48-week course of Interferon and she did so. During the treatment she suffered side-effects and described the treatment as 'horrible'.^[720] Immediately after taking the treatment she felt very ill. She suffered from flu-like symptoms, her joints were sore and she became very tired. She was working full-time and in order to cope with the treatment, she used to inject herself with the Interferon in the early evening, and then immediately go to bed. Unfortunately, tests 12 weeks after the treatment started showed that it had been ineffective and so, in accordance with practice at the time, the treatment was stopped. Christine was very disappointed.^[721]

6.370 Thereafter, Christine continued to attend the liver clinic for monitoring once a year. Liver biopsy was considered to be too risky for her. She has had annual liver function tests and Hepatitis C RNA tests. She has a two-yearly liver scan performed. In January 2010 Christine underwent a new sonar pulse scan which produced a 3D picture of her liver. She was told that her liver was no more affected than to be expected for a person of her age. Later in 2010, Christine started a 48-week course of treatment with Interferon and Pegylated Interferon. The side-effects of this were similar to those she experienced during her previous course of treatment. She felt very tired and she felt sick.^[722] She stated, 'I must have been a nightmare to live with because I felt as if I was living a nightmare'.^[723] Christine completed this course of treatment shortly before she gave evidence to the Inquiry in June 2011. At the end of the treatment she was negative for the virus, but was warned that the virus could still return.

6.371 Christine received a payment of £20,000 from the Skipton Fund.^[724]

Patients' experience - Conclusion

6.372 Chapters 4, 5 and 6 have dealt with the experiences of the patients and relatives. In conclusion the Inquiry is very grateful to the many witnesses who came forward and provided evidence about the effects of their own or their relative's infection with HIV and/or Hepatitis C.^[725] At the heart of this Inquiry lies the fate of people who, simply by accepting treatment for a medical condition, contracted either HIV or Hepatitis C, or both these viruses. In many cases the infections were acquired because of treatment for a blood coagulation disorder, such as Haemophilia A or Haemophilia B. Those with these disorders had already suffered to varying degrees as a result of their underlying conditions. Others became infected as a result of a single blood transfusion, sometimes being unaware until later that they had even been transfused. Whatever the route of transmission, suffering resulted - whether to the patients themselves or to their relatives. The pain they felt cannot be quantified. Many people have had their lives shaped and overshadowed by a loved one's illness. Many people have had to watch their loved ones, including children, suffer. In some cases, they have had to watch them decline and die.

6.373 The stigma which some feel persists, even today, in relation to both viruses, made it particularly difficult for some witnesses to contact the Inquiry. These witnesses had to overcome fear of disclosing their own identity in order to do so. The Inquiry put in place a number of measures to maintain confidentiality. These are described in Appendix 2 to this Report.

6.374 Hearing the personal stories was a fundamental part of the Inquiry and it would not have been possible without the witnesses being so willing and open. For many, giving statements was their first opportunity to share the experiences of what had happened to them in the course of NHS treatment. Some told of adverse consequences which they had not disclosed to even their closest family members. It is hoped that by telling their stories to the Inquiry and making them available for publication these witnesses felt that they had been heard.

6.375 As was stated at the start of this section of the Report, the evidence of the patient and relative witnesses makes its own impact and it would be inappropriate to single out particular aspects for comment. What can be said is that the Inquiry heard many tales of truly extraordinary bravery in the face of adversity. There were also tales of resignation and tales of rage. For all patients and relatives the consequences of infection were at least distressing, for many they were devastating and, for some, tragic.

6.376 The Inquiry is particularly indebted to those witnesses who agreed to give oral evidence to the Inquiry. In doing so, these witnesses opened their lives up to intense scrutiny by others. As will be apparent from the narration of their evidence, each of these witnesses was both candid and brave. In recounting their stories they required to revisit very difficult, painful and sad times in their past as well as recounting ongoing effects which, understandably, they might be trying to forget. Some of the witnesses became visibly distressed when giving their evidence while others showed quiet stoicism. The impact of their evidence was felt by all those present and everyone was moved by it. It is hoped that the narration of the evidence of each of these witnesses in such detail is able to convey, as closely as possible, the power of it. This evidence illustrated just how far into a person's life the impacts of infection could reach. Of course it must be remembered that for each of these stories there are others, every one unique and compelling in its detail.

6.377 Finally, it is a matter of sorrow to the Inquiry team that some of the witnesses who provided statements and Gordon, who gave oral evidence to the Inquiry, died before this report was published. Gordon impressed all those who heard his evidence as a dignified and intelligent man. Like others, he took a great interest in the work of the Inquiry and he did all he could to assist with its task.

7. An Investigation into the Deaths of the Reverend David Black, Mrs Eileen O'Hara, Mr Alexander Black Laing and Mr Victor Tamburrini >