Memorandum by The Haemophilia Society
4. ISSUES RELEVANT
In this section we cover issues relating
to the Inquiry's three areas of interest.
How was the contaminated blood products occurrence
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
In many cases patients were tested
without their knowledge or consent and not informed as to the
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
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
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
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,
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 historiesJan 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
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
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 publicitythe Sunday Times ran a high profile
campaignand 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
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
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
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
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.
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 haemophilianot only those aged up to 16 yearshave
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
(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 affected by adverse treatment
outcomes and clear responsibilities laid down for health professionals,
Cheetham, M. Haemophilia and Hepatitis C Research
Report, Haemophilia Society publication 1996.
Sexton, S. Keeping in the familyAccess
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.