Select Committee on Health Minutes of Evidence


Memorandum by The Haemophilia Society - continued

4.  ISSUES RELEVANT TO THE INQUIRY

    In this section we cover issues relating to the Inquiry's three areas of interest.

How was the contaminated blood products occurrence investigated?

  4.1  Unlike other countries where patients with haemophilia were also infected with HIV and hepatitis C through contaminated blood products, there has been no full investigation into the occurrence in the UK. Canada has held a four year full public inquiry, whilst the Irish Government has recently voted to do the same. In this country, despite the fact that almost the entire patient group was infected, and concerns about blood safety persist in the light of CJD, there has been no systematic national approach to investigation and follow up as might have been expected when such a large scale adverse clinical outcome had taken place. Only some individual health authorities or hospital trusts appear to have investigated and implemented systematic follow up procedures.

  4.2  The Society's evidence, gathered through a number of research projects and illustrated in the case histories attached at appendix one, is that:

    —  Approaches to tracing, testing and counselling infected patients varied widely between haemophilia centres.

    —  In many cases patients were tested without their knowledge or consent and not informed as to the results.

    —  This failure to inform meant that patients could not take appropriate precautions to prevent infecting those close to them as a result some partners and wives were infected and also meant they were not able to make lifestyle changes to safeguard their own health (eg reducing alcohol consumption in the case of hepatitis C). Some 80 partners were infected with HIV in this way; no figures are collected for HCV.

    —  Equally there has been no systematic attempt to ensure that all patients-infected with HIV or HCV through their NHS treatment were provided with the best possible treatment for their HIV of HCV. In fact there have been instances where people with haemophilia have been denied appropriate treatment on grounds of cost, and campaigning by the Haemophilia Society has been necessary to secure this.

  4.3  The Society wishes to draw particular attention to the following key points which illustrate the patchy and uncoordinated response to the HIV and hepatitis infection of people with haemophilia, and the lack of an effective national follow up strategy to ensure that patients who had been infected through their NHS treatment were properly traced, counselled and treated to minimize the adverse outcomes for their own health and that of their families.

Tracing those Infected by Contaminated Blood

  4.4  Patients with haemophilia were not the only patients to be infected with HIV and hepatitis via contaminated blood. However, whilst the last Government in 1995 ordered a look back exercise to trace those infected with hepatitis C by blood transfusions, no action was taken to ensure all those with haemophilia who might have been infected with hepatitis C were also traced.

  4.5  In a recent parliamentary answer Health Minister John Hutton justified this decision of the previous Government by stating that ". . . haemophiliacs are in constant contact with their clinicians (so) the need to include them in the tracing exercise did not arise as they would already have been known to the service"(written answer 10.5.99).

  4.6  Unfortunately whilst this argument might hold true for those with severe haemophilia, those with mild haemophilia may only require treatment very occasionally in a lifetime. We include in appendix A the case history of a man of 28 who has only been treated three times in his life, one of those treatments in 1981 infected him with hepatitis and has only been informed of this within the last 10 months. Thus for a 17 year period he has been infected and unknowingly may have passed on this infection, and was given no counselling, information, advice on his condition.

  4.7  This is not an isolated instance: the Society still receive a few calls each year from people with haemophilia and hepatitis C who have only just found out about their infection. As recently as 4 June 1999, the Society received a call from the very distressed sister-in-law of a man with moderate haemophilia whose family had only just been notified of his diagnosis. The results of a positive hepatitis C test had apparently been given to this man and his wife without any further information or advice being given on the condition leaving them to cope in extreme distress and shock.

  4.8  One of the results of the failure to trace and identify all people with haemophilia who were infected with hepatitis C is that to date there is still no accurate official figure for the precise number infected, nor any official figures to indicate how many of these are receiving treatment for their hepatitis, how many have advanced liver disease. Even the national clinicians organisation the UK Haemophilia Centre Directors Organisation (UKHCDO) which publishes annual statistics on haemophilia patients does not include in this statistics for those with hepatitis.

Testing for HIV and HCV

  4.9  Following from the fact that there was no national strategy to trace, test, counsel and if necessary treat people with haemophilia who had been infected, the approach to testing varied widely between haemophilia centres. By contrast with the look back initiative ordered for those infected via blood transfusions, no national guidelines were issued by the Department of Health to instruct clinicians and health authorities on best practice.

  4.10  The following particular problems are identified in research carried out for the Haemophilia Society and are illustrated in the case histories presented at appendix A

    —  Testing people with haemophilia, or a related bleeding disorder, for both HIV and hepatitis C frequently took place without individual consent (Sexton 1995, Cheetham 1996, Roberts 1999).

    —  In the case of hepatitis C people were often not informed to their results until several years after they had first been tested, and then often "accidentally" (Cheetham, Roberts, and see case histories). This delay in informing people of their results prevented people from making active decisions to improve their health (eg going on interferon treatment to try to clear the virus, reducing alcohol consumption), and also increased risks of transmission of the virus to others (Roberts 1999).

    —  We have many examples of how the informing of minors of both HIV an hepatitis C infection was handled badly (see case histories—Jan Hardy's example). In some cases minors were informed without their parents being present. In other cases boys/young men with HIV were not told of their status until long after they became sexually active, and had infected partners.

    —  Several people with hepatitis C were only informed of their results by post (Cheetham and see case history for Mr X)—a situation, which caused a lot of distress and anxiety.

    —  Retrospectively, many centres said that pre and post-test counselling would have been appropriate for both HIV and HCV. It appears that the mistakes made with HIV were repeated, or magnified, with HCV, perhaps because the impact of HIV was so great on the haemophilia community and its treaters, that there was a reluctance on the part of clinicians to face up to the seriousness of HCV.

  4.11  The evidence gathered by the Haemophilia Society indicates serious failures to inform, advise and counsel individuals and their families about the impact of HIV and hepatitis on their health and life prospects. In the field of HIV it is now widely regarded as good practice to offer pre and post test counselling; however this practice has not been followed as the norm for people with haemophilia infected with either HIV or hepatitis.

  4.12  Both HIV and hepatitis viruses have a considerable impact not only on an individual's health but on many aspects of their own and their family's life, and great distress has been caused in many cases by the way testing has been carried out and the results have been made known to patients.

  4.13  In view of the fact that these patients had contracted the viruses through their NHS treatment it seems not unreasonable to expect that the Department of Health and NHS as a whole should have adopted a more pro-active strategy to ensure that all who might have been infected were properly tested and counselled. The difference in the approach adopted towards those infected via transfusions and those infected via haemophilia treatment cannot be justified, particularly in view of the experiences recorded by the Haemophilia Society.

Legal Issues and the Government Response

  4.14  Following the discovery that patients with haemophilia had been infected via contaminated blood, the immediate focus was on HIV, for which at that time there was no treatment and the virus was regarded as being almost inevitably fatal. Public concern about HIV in general was at a very high level. The Haemophilia Society mounted a concerted campaign from the mid 1980s for compensation for the 1,200 people with haemophilia who had been infected with HIV, whilst at the same time some 900 HIV positive haemophiliacs pursued a group legal action against the Government on the basis that they had been infected by their NHS treatment. During this period people with haemophilia were dying of AIDS at a rapid rate, estimated at one a week.

  4.15  The combination of public pressure, press and media publicity—the Sunday Times ran a high profile campaign—and the widespread court actions eventually persuaded Government to provide a financial assistance scheme as a form of recompense for those infected with HIV via their NHS treatment. The Macfarlane Trust was created to administer this scheme in 1988, with £10 million funding provided by Government. Further top-up grants of £5 million in 1993; £2.5 million in 1996 and £3 million in 1998 have been made by Government.

  4.16  However, the Government in providing this money continued to deny responsibility for the infection, and referred to payments as ex gratia. Those who had been engaged in court actions were required to sign an undertaking when accepting the money that they would not pursue further legal action against Government either for HIV or for hepatitis C. Today there are serious questions as to the legality of this undertaking, and particularly the concern that seriously ill people were required to sign it in circumstances which could be viewed as under duress.

  4.17  However, the situation with hepatitis C has been very different. The virus itself was only identified as hepatitis C in 1989; and knowledge about its progression and impact on health is still developing. Thus during the time of mass legal action on HIV, there was probably insufficient knowledge of hepatitis C for it to be included in the litigation. Public and professional awareness of hepatitis was nowhere near the level it reached with HIV.

  4.18  As the serious impact of the hepatitis virus has become known many individuals have sought legal advice about taking action. Some have succedded in legal action against particular health authorities where they were able to demonstrate treatment negligence. A very small number are sitll pursuing such action against health authorities; another small number is engaged in an ongoing action against the National Blood Authority under the Consumer Protection Act. However, this only applies to individuals infected with hepatitis after 1988, hence excludes the vast majority who were infected before 1986 when viral inactivation was introduced.

  4.19  It is likely that current reforms of legal aid will make it still more difficult for the remainder of those infected with hepatitis C to seek redress through the courts. Already many of those infected have given up hope of legal redress because of prohibitive costs. Although all these are people who were infected with contaminated blood products used in their NHS treatment the law appears to offer little prospect of any form of compensation for the lossses suffered as a result.

  4.20  In rejecting the Society's appeal for financial assistance for those infected with hepatitis C in July 1998 the Health Secretary Frank Dobson stated that because the harm done was inadvertent and non-negligent no compensation was due. This policy was not applied in the case of those infected with HIV where equally it could have been argued that the harm was inadvertent and non-negligent. Mr Dobson justified this apparent discrepancy by arguing that the previous Government had made a special case for those with HIV because of the stigma attached to the virus and fears of transmission within families. The experience of those with hepatitis contradicts this justification: evidence of stigma attached to hepatitis is powerful, so too is the anguish felt by parents fearful of infecting their children and by husbands aware of the danger of infecting their wives. The Secretary of State also stated that for those people with haemophilia infected with HCV their needs would be met from "the benefits available to the general population". Yet, the Society's evidence is that Social Security benefits are wholly inadequate to compensate for lost income and additional costs of the medical condition.

  4.21  The current situation remains inequitable and is widely felt as deeply unjust and discriminatory within the heamophilia community. The Health Secretary has stated that he wishes to keep the NHS out of the courts. If this is to be Government policy there must be far more robust systems put in place to protect patients when there is a wide-scale adverse treatment outcome such as the one experienced by people with haemophilia. It is not appropiate in this instance to be arguing about whether the harm was negligent or not: an entire patient group has suffered disastrously as a result of a particular type of treatment provided throughout the NHS over a specific period. This situation is one in which the case for "no fault" compensation is very strong.

Were there adequate mechanisms to support and advise patients and their families?

  4.22  As discussed above, there has been no systematic national approach to follow-up action after the infection of patients with haemophilia via contaminated blood. The Haemophilia Society has performed a very important role in providing information and support to infected people, and for a number of years has employed a dedicated HIV worker and a hepatitis worker to provide this service. We have produced publications, held events and organised peer support networks in an attempt to meet the very widespread need for information about the viruses, about the possible treatment options and to try to alleviate the distress, anxiety and isolation experienced by those infected and their families. Many of those infected mention the Society as their main source of such support.

  4.23  The case histories in appendix A illustrate the difficulties infected individuals and their carers have experienced in securing information about their condition and support to live with it. In some instances individuals have had to fight hard to receive the information they were entitled to from within the NHS.

Management of patients after diagnosis

4.23.1 Patients with HIV

    —  The management of patients infected with HIV has varied greatly across the UK. In the early years after diagnosis there was a great deal of denial and misinformation from Haemophilia centres, eg telling people not to take notice as only a tiny percenatge would go on to develop illness and telling people that they had a nothing in common with others with HIV as the infection was "different". (Sexton 1995).

    —  Standards of clinical care have varied. In 1995 Sexton reported that there was no common set of standard among centres, and whilst some contres had encouraged their patients to utilise services of HIV dedicated agencies outside their centres, others were "unwilling to let people to into the outside world".

    —  Perhaps in part because of this reluctance of some centres to encourage thier patients to seek expert support/clinical services for HIV, a recent report found that people with haemophilia and HIV were less informed about HIV than any other group of HIV-infected people (Anderson and Weatherburn 1999).

    —  Some patients have had access to specialist counselling/social work support, but this has not been universal. Recently the number of social workers has been reduced considerably (UKHCDO Social Work Survey, Jones 1998).

4.23.2   Patients with Hepatitis C

    —  Service provision for people with haemophilia and hepatitis C is extremely patchy throughout the country, and while some patients have easy access to HCV clinical expertise eg through joint clinics organised by the haemophilia centre with the liver unit, other patients have very limited access to specialists, if at all, and can suffer from being under the treatment of a haematologist with a poor understanding of hepatitis C. We had a shocking example of this recently when Haemophilia Society staff visited a haemophilia centre treating about 70 patients, and discovered that the Centre Director had not yet properly tested most of his patients for hepatitis C, and was ignorant of the test he should use to detect current infection.

    —  Information about treatment options and access to treatment varies throughout the UK (Roberts 1999). In part this is because there is no national strategy for dealing with hepatitis C, and there are no national guidelines for treatment and management of the disease. In the recent past individuals have been refused access to treatment on funding grounds. (Cheetham 1996). Many patients also strongly object to having to pay prescription charges for their interferon for an infection they contracted from their NHS treatment.

    —  Desire for up-to-date information about the all aspects of living with the virus was "by far and away the biggest single need" identified by people with haemophilia in Cheetham's 1995-96 research study, but provision of information about hepatitis C has been largely left by the NHS to voluntary organisations (Roberts 1999).

    —  There are many uncertainties about how the disease will progress in individuals, and this can give rise to a great deal of anxiety for patients and their families (Cheetham, Roberts and see case studies). The availability and quality of support for people in dealing with the emotional impact of hepatitis C is very variable throughout the UK. Generally, counselling facilities are not available, and here is a particular need for counselling/support services among young people and their families. (Roberts 1999)

    —  Our experience at the Haemophilia Society is that support services for those end-stage liver disease, and those awaiting a liver transplant are patchy and sometimes extremely poor.

    —  There is a lack of research and information about the particular health problems faced by people co-infected with-hepatitis C and HIV.

  4.24  Other areas where patients require support, advice and information:

    —  Bereaved relatives often receive no structured bereavement care after the death of the patient.

    —  For those whose health is affected by HIV and/or HCV they face reduced income from having to reduce their hours of work, give up opportunities for promotion, take a less demanding job and in many cases give up employment completely. Those affected in this way have become increasingly dependent on state welfare benefits. Patients frequently require information and support to help negotiate their way around the complex benefits system, and with the decrease in the number of social workers attached to haemophilia centres patients sometimes fail to get the help they need to ensure that this happens.

The legal, professional and other obligations on doctors and institutions to disclose information

  4.25  The contaminated blood occurrences raises many questions about these obligations. In this situation evidence was mounting over a relatively long period that blood treatment products were transmitting infection; there were reports in the medical and scientific journals and growing awareness amongst individual clinicians, both doctors and nurses. As early as 1972 it was known that a hepatitis virus, known then as "non A, non B" was transmitted through blood. In at least two cases known to the Society individuals with haemophilia were advised by a health professional (in one case a nurse in the other a biochemist) of the risks of HIV contamination in blood products, and appropriate steps were taken to avoid using the products. In one of these the patient himself actually refused treatment with factor product for a number of years despite considerable pressure from clinicians to accept it.

  4.26  Against this background the question arises of whose responsibility it should have been to pick up these evident warning signs and act on them. It appears to patients that neither the professional organisations for the clinicians concerned nor the Department of Health felt a responsibility to act. This point is especially relevant to the issue of prevention. For individuals with mild to moderate haemophilia, treatment with factor product could in many instances have been regarded as elective rather than essential to preserve life ie had the individuals concerned been advised of the risks of viruses in the blood products in use at the time they might have been able to exercise an informed choice to refuse.

  4.27  It was apparently not routine to advise such patients of these risks and it is a fact that as a result there are many with mild to moderate haemophilia who have suffered far greater health problems from blood borne viruses transmitted via their treatment than they would have from their bleeding disorder. A similiar point can be made with regard to patients who were minors at the time of treatment, and whose parents, unaware of the risks, gave consent to treatment with what are now known to have been contaminated products. This has caused tremendous guilt and anguish on the part of parents, and anger that they were not told the risks before consenting to treatment for their children.

  4.28  It is not clear at this moment whether if a similar situation were to arise today the newly constituted National Institute for Clinical Excellence (NICE) or the Commission for Health Improvement (CHI) would have a role. Equally with the greater emphasis now being placed on clinical governance and audit in the NHS can we be confident that warning signs indicating widespread adverse clinical outcomes of this nature would be quickly detected and followed up. The issue is one of both collective and individual responsibility on the part of the health service as a whole and individual clinicians working within it. Those patients with haemophilia who were infected with viruses through their treatment frequently ask why they were not informed of the risks, why action was not taken earlier to minimize risks, why they were not given the opportunity to make informed choices knowing the risks and whose responsibility it should have been to provide this information.

  4.29  The Society hopes the Committee will investigate these points. This may not achieve much for our patient group who have already suffered widespread adverse outcomes, but these are critical issues for ensuring the quality of our future healthcare and avoiding similar tragedies.

  4.30  The issue of informed consent is central. As has already been stated many patients were tested for HIV and hepatitis without their knowledge or consent. Their results were not disclosed to them and they were not given information and advice on their infection and how to minimize harm to their own health and those of their families. We would hope that health professionals today receive clearer instructions as to their responsibilities with regard to informed consent, and hope the Committee will look closely at professional practice and guidance in this area.

  4.31  Another issue relating to professional responsibilities to patients concerns the provision of information about possible legal action. The Society has come across very little evidence that patients found to be infected were informed by their clinician or the hospital authorities of the possibility of taking legal action or making a formal complaint

  4.32  This may be because of conflict of interest: individual clinicians may have been concerned that they would find themselves facing legal action. Whilst that anxiety may be understandable, patients surely have a right to expect that whenever there is an adverse clinical outcome systems are in place to inform them of the possiblity of taking action. Many remain deeply angry that they have still received no proper explanation or apology for the infection they have received via their NHS treatment.

  4.33  A further important concern is the impact on health professionals themselves of a treatment disaster of this kind. Doctors and nurses who saw large numbers of their patients die as a result of HIV have suffered also.

5.  RECOMMENDATIONS

  The Haemophilia Society puts forward the following recommendations arising from the adverse clinical outcome suffered by people with haemophilia infected with HIV and hepatitis through their NHS treatment.

5.1  Specific to people with haemophilia

  (1)  The UK Government should ensure that a full inquiry 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 with hepatitis C infected 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.

5.2  General

  (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 affected by adverse treatment outcomes and clear responsibilities laid down for health professionals, and institutions.

REFERENCES

  Cheetham, M. Haemophilia and Hepatitis C Research Report, Haemophilia Society publication 1996.

  Sexton, S. Keeping in the family—Access to information and service provision, findings from a study on behalf of the Birchgrove group and the Haemophilia Society 1995.

  Anderson, W and Westherburn, P. Taking Heart? The impact of combination therapy on the lives of people with HIV, Sigma Research on behalf of Lambeth, Southwark and Lewisham Health Authority, Camden and Islington Health Authority, and Kensington & Chelsea and Westminster Health Authority 1999.

  Roberts, J and Bond S. Report to the Haemophilia Society on the pilot study of the socio-economic impact of hepatitis C, Health Services Research Unit, London School of Hygiene and Tropical Medicine abstract May 1999.

June 1999


 
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