Select Committee on Health Minutes of Evidence

Memorandum by The Haemophilia Society



Executive Summary

  1.  Introduction

  2.  Background Information

  3.  The adverse treatment outcomes suffered by people with haemophilia

  4.  Issues relevant to the Inquiry

  5.  Recommendations

  APPENDIX A: Case Histories[1]


  The Haemophilia Society is the national patient group for people with haemophilia, von Willebrand's disease and other bleeding disorders. Our submission is on the infection of haemophilia patients with HIV and hepatitis A, B and C viruses transmitted through contaminated blood products used in their NHS treatment prior to 1985-86. Over 95 per cent of patients treated were infected in this way: an adverse clinical outcome on a very wide scale. It draws on evidence collected from patients through three formal research studies and our day-to-day contact with our members and service users. It is therefore based on the actual experiences of patients themselves. (paras 1.1 to 1.4)


  Blood products were first introduced to haemophilia treatment in the late 1960s, and were then widely used in the 70s and 80s. Viral inactivation processes were introduced in 1985-86 to prevent blood borne viruses from contaminating the products, but by then an estimated 4,800 people with haemophilia had suffered hepatitis C infection; of these 1,200 were also infected with HIV. Much, but not all of the infection, can be traced to use of commercial products from the USA where blood was collected from so-called "skid-row" and other paid donors from high risk groups. (paras 2.1 to 2.4)


  Patients with haemophilia have suffered serious adverse outcomes as a result: over 700 have died of AIDS; at least 90 have died of hepatitis related liver disease. Both HIV and hepatitis C (HCV) are life threatening viruses, which are very difficult to treat. There are additional complications for people who are co-infected with both. Treatment regimes are very demanding with unpleasant and uncertain outcomes. (paras 3.2 to 3.5)

  Social and economic impacts of these viruses include stigma, affecting relationships and employment; fears of transmission; and actual loss of earnings due to impaired health. Many have become dependent on social security benefits which cannot compensate for these financial losses nor the additional costs arising from their medical condition. Life insurance and mortgage protection are a major problem for those with HIV and/or hepatitis: many companies will not provide cover or only at prohibitively high premiums. (paras 3.6 to 3.11).


  Unlike other countries (Canada and Ireland) where patients with haemophilia were also infected through contaminated blood, in the UK there has been no full investigation of the occurrence, and no systematic national follow up of patients. Only some health authorities and trusts appear to have investigated.

  The Society's evidence is that approaches to tracing, testing, and counselling patients varied widely between haemophilia treatment centres; in many cases patients were tested without consent and/or not informed of the results. This meant that infected patients could not take appropriate precautions to prevent infecting those close to them or to make lifestyle changes to safeguard their own health (eg reducing alcohol in the case of HCV). Nor were steps taken to ensure all those infected were provided with the best treatment for the viruses. The Society has examples of patients denied necessary treatment (ie interferon for HCV) on grounds of cost.

  By contrast with the approach adopted by the Department of Health with respect to patients infected with hepatitis C through blood transfusion, there were no national follow up strategy on patients with haemophilia. It was apparently assumed all haemophilia patients would be traced by their haemophilia centres, yet the Society still has cases today of individuals who are only just being tested for HCV. One result of the failure to trace all those people with haemophilia infected with HCV is that there is no official figure for the precise number infected, and of those suffering impaired health and receiving treatment for the virus. (paras 4.1 to 4.8)

  Good practice has not been followed routinely with regard to testing patients with haemophilia for HIV and/or HCV: in many cases pre and post test counselling was not offered, information was not given on the medical and social implications of these viruses, minors were sometimes informed without their parents being present. (paras 4.9 to 4.13).


  The infected patient group has had to battle through the courts and to use public campaigning to seek redress. A group legal action against Government for some 900 of those infected with HIV eventually led to an ex gratia out of court settlement. The Government continues to deny formal liability for the occurrence. Others with HIV and HCV have pursued legal actions against individual health authorities; some action is ongoing against the National Blood Authority.

   Campaigning by the Haemophilia Society supported by public opinion persuaded the previous Government to set up a financial assistance scheme for those infected with HIV. The Macfarlane Trust was set up as a result in 1988 with £10 million from Government (subsequently topped up with further Government grants).

  The situation for those with hepatitis C is very different: legal action offers very little hope for the majority of this group The Government has refused the Society's appeal for financial assistance for them on the grounds that the harm was inadvertent or non-negligent. This leaves the majority of this infected patient group with no means of seeking redress, and, because of the different response to those infected with HIV, is widely felt as unjust and discriminatory within the haemophilia community.

  The Society questions whether this is an appropriate response to such a large scale adverse treatment outcome and wishes the Committee to consider whether in such a situation a "no fault" compensation system should apply (paras 4.14 to 4.21)


  Much of the task of providing information, advice and support has been undertaken by the Haemophilia Society. The management of patients after diagnosis with HIV and/or HCV has varied greatly within the NHS with varying standards of clinical care.

  There has been a reluctance in some haemophilia centres to encourage patients to seek expert HIV care/support: a recent report found patients with haemophilia and HIV were less informed about their condition than any other HIV patient group studied.

  A study for the Society in 1996 found the need for up-to-date information on HCV was "by far and away the biggest single need" amongst patients with haemophilia. (paras 4.22 to 4.24)


  The experience of patients with haemophilia infected over a long period of time by their NHS treatment raises the question of whose responsibility it shoud be to pick up and act on early warning signs of adverse treatment outcomes. We hope the Committee will examine the future role of NICE and CHI in such circumstances.

  Patients were not routinely warned of the risks of blood borne viruses in haemophilia treatment products at the time: this is a particular issue for those with mild haemophilia who might have chosen not to accept treatment or parents who gave consent to treatment for minors. Those infected now want to know why they were not warned, why action was not taken sooner to prevent transmission of blood borne viruses.

  The issue of informed consent is central with regard to both treatment and HIV/HCV testing: we hope the Committee will look closely at this, particularly at professional and NHS guidelines.

  It also appears that patients were not provided with information about possibility of complaining or taking legal action when they were told that they had been invected via their NHS treatment. (paras 4.25 to 4.33)


Specific to people with haemophilia

  (1)  The UK Government should ensure that a full enquiry is conducted into the way in which patients with haemophilia were infected with viruses through contaminated blood, the impact this has had on their health, social and economic circumstances and that of their families, and whether adequate support has been provided. This inquiry should look carefully at how other countries such as Canada, Ireland and Italy have responded to the tragedy of contaminated blood, and how similar approaches could be adopted in the UK.

  (2)  The Government should ensure that all patients with haemophilia—not only those aged up to 16 years—have access to recombinant treatment products to avoid the risks of CJD and other blood borne viruses.

  (3)  Financial assistance should be offered to people with haemophilia infected with hepatitis C via their NHS treatment and not only those with HIV as is the case at present. This is the approach in Ireland and Italy where financial assistance is provided for both HIV and HCV.

  (4)  Government funding for the Macfarlane Trust should be continued to enable the Trust to carry on providing financial help for people with haemophilia infected with HIV.

  (5)  Government should continue to fund the Haemophilia Society and other relevant bodies to provide information, advice and support to people with bleeding disorders infected with HIV, hepatitis C or both via their NHS treatment.

  (6)  Government should ensure that social work posts are maintained or re-established in all larger haemophilia centres to provide advice, support and access to social services support for all those who were infected via their NHS treatment.

  (7)  Government should ensure that no people with haemophilia infected with HIV or hepatitis through their NHS treatment should be denied treatment which is clinically essential for the virus infection on grounds of cost. Guidance should be issued urgently to health authorities and trusts to ensure that interferon treatment for HCV is provided whenever clinically required.

  (8)  Government should carry out an urgent exercise to ensure that all patients with haemophilia infected with hepatitis C have been traced, tested, counselled and, if necessary, treated in view of evidence that this is not currently the case.

  (9)  The Health Select Committee should conduct an in-depth inquiry into contaminated blood, as has previously been requested by the Society, looking not only at the history and outcomes, but also the issues of blood safety now and in the future, which is a major public health concern.


  (1)  It should be the responsibility of Government in future to make sure that a full public investigation and appropriate follow up is carried out when there is a wide-scale adverse outcome of the kind experienced by people with haemophilia.

  (2)  Some mechanism must be put in place to offer redress to patients harmed "inadvertently" or "non-negligently" through their NHS treatment, such as those with haemophilia who have suffered as a result of contaminated treatment products used nationally throughout the NHS. Neither the legal system nor the normal NHS complaints procedures meet this need, and consideration should be given to a "no fault" compensation scheme to cover this sort of exceptional occurrence.

  (3)  The role of NICE, CHI and the relevant health professional bodies should be reviewed to ensure that more effective early warning mechanisms are in place to pick up and act upon the signs of widespread adverse outcomes such as that experienced by people with haemophilia.

  (4)  There must be more effective systems to inform, advise and support patients by adverse treatment outcomes and clear responsibilities laid down for health professionals, and institutions.


About the Haemophilia Society

  1.1  The UK Haemophilia Society is the national patient group for people with haemophilia, von Willebrand's disease and other related bleeding disorders. Our aim is to secure the best possible treatment, care and support for all people with these bleeding disorders and their families. Founded in 1950, the Society is an organisation of and for people with bleeding disorders who are involved and active at every level from the Trustee Board to our 23 local volunteer-run groups throughout the UK.

Subject of this Submission

  1.2  The Society welcomes this opportunity to present evidence on the infection of patients with haemophilia and other bleeding disorders with HIV and hepatitis via contaminated blood products used in thier NHS treatment. This is an adverse clinical outcome on a very large scale: over 95 per cent of patients with haemophilia treated before 1986 were infected with HIV, hepatitis C or both. This means almost every patient now aged 13 years and over has been exposed to one or other of these life-threatening viruses.

  1.3  As such there are many questions raised by this occurrence, and lessons to be learned about the Government, NHS and legal responses to a large-scale adverse clinical outcome of this type, which we hope the inquiry will consider carefully.

  1.4  This submission focuses on the two life threatening viruses HIV and hepatitis C (HCV) which were passed on through contaminated blood products, but it should not be forgotten that people with haemophilia have also been infected with many different types of hepatitis, including hepatitis B, which can also be life threatening, and possibly other blood borne viruses not yet identified. Despite modern viral inactivation techniques introduced from 1986 to the manufacture of plasma derived treatment products, at least three viruses (parvovirus, hepatitis A and TTV) have been found to escape the process. The evidence presented is drawn from the reported experiences of people who were infected, collected via research studies for the Society and our day to day contact with members.


About Haemophilia

  2.1  Haemophilia itself is an inherited condition for which there is still no cure. It is rare: some 11,000 people in the UK are registered as having either haemophilia or von Willebrand`s disease. For those with the conditions the blood fails to clot properly, leading to painful, disabling and even life-threatening internal bleeding if not effectively treated. Thus people with haemophilia and other bleeding disorders are reliant throughout their lives on NHS treatment, which is generally provided through 100 specialist haemophilia centres located in hospitals. Modern treatment involves injections of the missing blood clotting factors to prevent such bleeding and minimise the risks of joint damage and other problems.

The history of contaminated blood products

  2.2  Closing factor treatment products have been manufactured from human blood since the late 1960s. Only very recently, genetically engineered synthetic products (recombinants), which do not rely on human plasma, have become available. In the `60s, `70s and `80s, when the first plasma derived clotting factors were-introduced, the majority of haemophilia patients treated were infected with blood borne viruses, including HIV and hepatitis A, B and C, passsed on through contaminated blood products. At that time the UK was unable to produce enough home manufactured product to meet demand, and large quantities were imported from the USA. Much, but not all, of the infection has been traced back to the use of so-called "skid row" and other paid donors form high-risk groups in the USA.

  2.3  Viral inactivation processes were implemented in1985-86 to prevent such contamination but by then an estimated 4800 people with haemophilia had been infected with hepatitis C and 1,200 of these co-infected with HIV. Over 700 of those infected with HIV have now died, and of the 475 survivors almost all are HCV/HIV co-infected. Over 90 people with haemophilia are estimated to have died of liver disease, although in the absence of an official Government figure the total may well be higher

  2.4  The infection of 95 per cent of haemophilia patients with HIV and/or hepatitis has been described as one of the greatest treatment disasters in the history of the NHS. In response the Haemophilia Society has consistently campaigned for all patients to have access to recombinants to reduce the risks of blood borne viruses. Since 1998 the Government has required all haemophilic children under 16 to be treated with recombinant products which are regarded as safer with regard to blood borne viruses and the "theoretical risks" of CJD. There is still no screening test for CJD , and it is also known that certain viruses (parvovirus, hepatitis A and TTV) escape the inactivation procedures. Nevertheless the majority of adults and teenagers over 16 years are still being treated with plasma derived products.


  3.1  The impact of contaminated blood products on the haemophilia community has been devastating, and the aftermath is still being coped with today. Within such a small and often close knit patient group, few families have been left unscathed. This section briefly describes the medical, social and economic impacts of the HIV and HCV infection suffered by people with haemophilia. All these can be seen as adverse outcomes of the treatment with contaminated blood products.


  3.2  One of the major problems for those infected has been uncertainty. Knowledge about both HIV and hepatitis C is still evolving. Both viruses have been only relatively recently identified, and treatment methods are still developing. It is often not possible therefore for clinicians to tell those infected exactly what their prognosis is. Added to the knowledge the fact that many have lost friends and relations to these viruses, this creates considerable stress and anxiety.

  3.3  What is clear is that when most people with haemophilia received their HIV diagnosis the condition was as inevitably fatal. They did not expect to live. For the minority who have survived, their co-infection with HCV presents particular medical difficulties. Combination therapy is proving successful for some in extending life, but the treatment regime is extremely demanding, and has unpleasant side effects, one of which is that it places great strain on the liver, hence worsening the effects of HCV.

  3.4  For those with HCV, up to 80 per cent may go on to develop chronic liver disease and up to 20 per cent of these will develop cirrhosis, possibly leading to liver cancer. This progression can take between 20 and 40 years, however many with haemophilia have been infected now for over 25 years. Symptoms of HCV include extreme fatigue, skin and digestive problems.

  3.5  Interferon was until recently the only licensed treatement for hepatitis C. The success rates among people with haemophilia are around 10 per cent. In clinical trials improved success rates have been achieved with a combination of interferon and ribavarin, only just licensed in this country, but still only about 40 per cent. Again the treatment regime is demanding, with unpleasant and debilitating side effects, which some cannot tolerate, and the treatment is contra-indicated for some patients. The treatment of last resort is liver transplant, and there are currently 6 and 7 people with haemophilia on the waiting list for transplants. No special priority is afforded to this group despite the fact that they have developed their liver disease as a result of NHS treatment.


  3.6  Both HIV and hepatitis B and C viruses carry considerable social stigma. Research carried out for the Society documents many experiences of infected people, which provide evidence of that stigma. Many of those infected continue to keep this secret from friends, neighbours and work colleagues for fear of negative reactions.

  3.7  Relationships and family life are affected by both HIV and hepatitis. Fears of transmission are great, and this puts pressure on relationships. In a number of cases wives and partners have become infected with HIV or hepatitis. For younger couples who wish to have children the fear of viral transmission can cause difficulties and distress.


  3.8  Deteriorating health has forced many of those infected either to give up or cut down on work. It is not only the symptoms of the infection which are debilitating; both combination therapy for HIV and interferon/ribavarin treatment for hepatitis C can have extreme side effects which make it difficult or impossible to carry on working. The Society knows of individuals with family responsibilities who have postponed accepting interferon treatment because they cannot afford to take the financial risk of being forced to give up work by the side effects of the treatment.

  3.9  Many have already suffered loss of earnings and employment prospects and have been forced into dependency on welfare benefits. The social security benefits available, however, cannot compensate for these financial losses and hence many individuals and families face a severely reduced standard of living.

  3.10  In addition, infected people face added costs due to their medical condition. This may be due to special dietary requirements, or the need for adaptations to the home, to expenditure on medication.

  3.11  Life insurance and mortgage protection policies present a major problem for those with HIV or hepatitis C infection. Many companies will not offer life insurance to people with these viruses, or only at prohibitively high premiums. Those with family responsibilities are thus unable to provide properly for their financial security in the future.

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