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46,800 | 346 | QUESTION:
Then a much broader question next. Following the
82publication of the Lindsay Tribunal report, has that
had any broader effect in terms of culture change in
Ireland in terms of the approach to treatment and
patient safety?
ANSWER:
Absolutely. I think when you look at
the recommendations from the Lindsay Inquiry, which
were fairly broad, talking about the need for
a committee to look at blood products, and doctors and
patients to work more closely, I think we put a lot of
work before the end of the Lindsay Inquiry into
recommendations for the future and a lot of those have
come to pass. So you had the establishment of
a statutory National Haemophilia Council, which brings
together the four haemophilia treatment centres,
the Irish Haemophilia Society, the Health Service, the
Department of Health and a couple of key experts.
And crucially that Council recommends policy to
the Minister, but really sets priorities for the year
for the whole service. And it's really led to
a position where we now have a co-designed service
where the Society are involved in all of the major
decisions in relation to the implementation of the
haemophilia care service in the country.
Secondly, we had the establishment on
a non-statutory basis of the Haemophilia Product
83Selection Monitoring Advisory Board, which carries out
the tenders and procurement for the haemophilia
treatments. And I think that's now been running since
2002 and in that period of time our availability of
treatment has remarkably improved in terms of both
quantity and quality. I think we're the first country
in the world to switch every patient with haemophilia
to extended half-life factor concentrates, one of the
first to make the new subcutaneous treatments
available across the board to everybody who wanted it,
and, crucially, that's been done in a way where
the patient organisation and the doctors are formally
involved in the decision.
And ironically, despite the fears of the
Department of Health when this was agreed, it has
actually turned out to be cost effective. It has
saved them a lot of money because we've made it much
more competitive and efficient and effective than it
had been here before.
|
46,801 | 346 | QUESTION:
Just --
ANSWER:
Sorry, just again to expand, I mean I think
the culture has changed. I think everybody realised
that this can't be allowed to happen again, so, you
know, there is a co-designed approach to the
Haemophilia Service, major decisions were taken in
84consultation with the patient organisation, and
especially now, as we're entering an era of, you know,
therapeutic choices, new therapies, new types of
therapies, gene therapy, where you absolutely have to
have shared decision-making, so I think the culture
has been changing, has changed, and I think will have
to evolve even more in the future.
|
46,802 | 346 | QUESTION:
Do you have any sense of the extent to which that
culture change has extended beyond the haemophilia
community? For example, the other bodies,
organisations you mentioned, those involved with
the -- advocating on behalf of those who were infected
through transfusion or infected through anti-D, would
they, do you know, report a similar shift in terms of
culture and patient involvement and shared
decision-making?
ANSWER:
No. Not at all. And, in fact, quite sadly, I think
the organisation which represented the women infected
through anti-D imploded. The transfusion group have
just -- they really have just concentrated on
the issues around the card and on compensation but
they haven't got involved in any sense in terms of
policy.
But, of course, haemophilia is different. If you
had a blood transfusion, you had an underlying
85condition which could be anything. With haemophilia
and bleeding disorders there was a core set of the
same treatments, the same ideals, that go right
through that. So -- but I think none of the other
organisations have been involved in policy in that
sense, although we do have a statutory hepatitis C
consultative council which does include
the organisations whose members were affected, and we
sit with the Department of Health and we monitor the
implementation of the HAA card and also the council
would organise information days every couple of years.
|
46,803 | 346 | QUESTION:
Then just going back to the work of the Compensation
Tribunal. Do you know what approach is taken to
the assessment of compensation if there is a dispute
between family members? So there may have been --
there may be competing claims in terms of care or
dependency. Do you know whether that's arisen at all
in the Tribunal?
ANSWER:
I can't really answer that. I think, again, you could
talk to our legal team and they'd be able to clarify
that for you, but I know that, I mean, there have been
cases where several family members have been granted
awards for taking care of a person at different points
in time.
|
46,804 | 346 | QUESTION:
Then the awards made by the Tribunal, are they taken
86into account for the purposes of any applications for
welfare benefits?
ANSWER:
No, they're not, they're specifically excluded. And
in fact, because of the arrangements we've made with
the Revenue Confidential Service, they can't even know
about them.
|
46,805 | 346 | QUESTION:
And in relation to taxation, you've explained
the position in your statement, but for the benefit of
those who may not have been able to read through your
statement, what in short is the position in terms of
taxation and the compensation awards?
ANSWER:
The compensation awards are tax-free. That's clear.
But we also made submissions to the Revenue that there
is a section 189 in the Taxes Consolidation Act which
states that if an individual is permanently and
totally incapacitated then the income arising from
the award can also be tax exempt or exempt from
capital gains tax. And we made a submission which was
accepted that, in fact, every person with haemophilia
who got hepatitis C or HIV would fall under
section 189, so their awards are tax-free but also any
income or capital gains earned from the awards, income
from the awards, is also tax-free.
|
46,806 | 346 | QUESTION:
And then last question arises from your involvement
internationally, you've been involved both in terms of
87the World Federation and the European Consortium.
Do you know to what extent the measures that
you've been describing in Ireland, in particular in
relation to the insurance scheme and the HAA card,
whether those are schemes or measures that have been
set up in other countries?
ANSWER:
Not that I'm aware of, no.
|
46,807 | 347 | QUESTION:
1
Closing statement by MS MONAGHAN KC
on behalf of 4 individual Core Participants
ANSWER:
Yes, Ms Monaghan.
|
46,808 | 347 | QUESTION:
Good morning, Sir. Good morning.
Sir, I speak a behalf of four Core Participants,
Mr AK, Paul, Robert James -- whom I shall refer to as
Robert -- and Mr AH, all of whom gave evidence before
you, Sir.
They have asked me first, please, to thank you, sir
and the whole of the Inquiry team for the way in which
this Inquiry has been conducted. They have asked me to
convey in their own words that they have during this
Inquiry felt listened to, treated with respect and felt
safe in participating.
They have also asked me to say something about the
participation and conduct of the Department of Health.
The Department of Health and Social Care, of course, are
centrally involved in the events being examined in this
Inquiry and bear responsibility, we say, for much of
what occurred, that is an avoidable catastrophe leading
to the deaths of hundreds of people, pain, hurt,
life-changing infections of many more, and profound
distress and bereavement of yet more.The Department of Health, as you will recall, were
allocated four hours to make closing oral submissions.
At some point beforehand, it appears a short time
beforehand, they apparently indicated that they needed
only an hour. That is, the Department of Health, they,
chose to limit their oral submissions -- before a public
hearing, at the end of a public inquiry, addressed to
those infected and affected in the room and listening
remotely, they decided to limit their oral submissions
to a mere 35 minutes.
Indeed, Sir, if one takes out your questions,
probably more like 30 minutes. My clients consider that
derisory, contemptuous and disrespectful. I hope it is
clear -- I don't think Ms Grey is here -- but I do hope
it is clear that's not a criticism of Ms Grey, that's
the Department of Health. But perhaps even worse for my
clients is the vacuousness of the purported apology.
You will remember, Sir, and it is perhaps important
to remember, that the Department of Health made
an opening statement, and when they made their opening
statement in the Inquiry hearing room, they were
listened to carefully and respectfully by those here,
and those included people who had a right to be angry
with the Department of Health and, if they had expressed
that anger there and then, they could probably have beenforgiven for doing so. But they listened. They
listened graciously, courteously and carefully.
As you will recall, Sir, those in the room
expressed -- indeed, expressed their warmth at the
involvement of the Department of Health, or at least
their counsel, for all to see. You may remember that,
Sir.
In that opening, four and a half years ago, as you
picked up on Wednesday, Ms Grey said on behalf of the
Department of Health that her clients accepted things
went wrong, things happened that should not have
happened, and so she said, on behalf of her clients,
unreservedly -- unreservedly -- that they were sorry and
that they were sorry that this happened when it should
not have happened.
In their closing submissions too, they said that
things happened that should not have happened and that
they did not depart from their unreserved apology for
the fact that that was so.
On Wednesday, Ms Grey referred to the sincerity of
her apologies and to do what can be done to provide some
real and practical assistance. Sincerity of the
apologies. When asked by you, Sir, what wrong the
Department had in mind when acknowledging a wrong,
Ms Grey was able to say only that the Department didn'thave a position to offer you. There was no meaningful
then, Sir, admission of wrongdoing, no meaningful
apology, they were empty words and the Department of
Health through Ms Grey is unable to explain why they
admitted a wrong when they say they didn't know -- are
unable to identify what wrong that might be.
It is difficult to think otherwise than it was
an endeavour to close things down: "There, we have
apologised, that's the end of it". And it was only when
you inquired, Sir, following Mr Snowden's raising of the
issue, that something apparently had gone wrong and
Ms Grey was stumped in answering the question.
My clients consider the Department of Health's
conduct deeply and grossly offensive. That might be one
thing. But it causes them concern too, Sir, about what
the Department might do in response to this Inquiry.
I will come back to that at the end but it is
an important matter that these are vacuous apologies,
empty admissions and a contemptuous response to
an important public hearing ending this Inquiry.
Before I come to our substantive submissions, there
are two further introductory observations I would like
to make. First of all, again, it concerns the
Department of Health but a rather different point.
In their submissions, Sir, the Department of Health
5refers to the passage of time and the impact on memory.
I don't need to go to that but, for your note or for the
note of anybody who might be interested in reading it,
that's at paragraph 1.16 of their submissions. They
refer in particular to discussion in the case law on the
process of setting, resetting and rewriting and the
limitations of memory.
My clients would like to remind the Inquiry, please,
Sir, and no doubt you will have this well in mind, that
for those affected and infected, their experiences are
very much seared into their memory in a way that might
not be true of others. But it is certainly true of
them, and they have continuity of memory because they
live with their experiences every day and the recalling
of them is not punctuated by larger lapses in time.
So for that reason, Sir, it is our submission that
considerable weight should be afforded their evidence.
Second, Mr Snowden has expressed disappointment with
the way in which the pharmaceutical industry has chosen
to respond to this Inquiry. As Mr Snowden said, it is
understood that the companies that might be expected to
engage are following the Inquiry but have chosen not to
actively participate.
This has meant that the examination of the
pharmaceutical companies, that I am sure everybody wouldhave wanted to see and hear, has been lost, through no
fault of anybody except the pharmaceutical companies.
It is them that have decided not to actively engage.
And for the avoidance of doubt, Sir -- for the avoidance
of doubt -- we do not make any criticism of the Inquiry
in that respect.
As to my clients then, by way of brief introduction,
Mr AK, Paul, Robert and Mr AH, all of whom, as I have
said, the Inquiry heard from, are all infected with HCV
and HIV. All of them experienced testing without
consent, secrecy, stigma, harsh disclosure, an absence
of support from mainstream services, a lack of empathy
from treating clinicians and misinformation. Three of
my clients, adults at the time of their infections,
unlike the fourth, benefited from support from
organisations and clinicians supporting gay men and drug
users.
I will touch upon their particular experience as
I go along but, with that little introduction or that
short introduction, I want to say something about what
binds them together as a group of Core Participants,
because there's nothing obvious about their personal
circumstances that would draw them together.
But what binds them together are those matters that
we identified in opening, that is the stigma associatedwith HIV and hepatitis C, and the impact of that, which
I will come to, and a human rights framework. That is
human rights norms that my clients invite you, Sir, to
have in mind when addressing the issues that you will in
due course address and, in particular, those human
rights norms include the right to life, dignity, bodily
autonomy, health and nondiscrimination. Well-understood
human rights norms observed internationally, regionally
and increasingly domestically.
As to the overarching themes that I have just
summarised, they are best encapsulated by the words of
Robert in his witness statement, his second witness
statement, that important extract, to which we refer in
our closing submissions, is set out in the written
submissions but, mindful that this is a Public Inquiry
and perhaps few people, relatively, will have had the
opportunity to read all the submissions, I would like to
read that extract because it identifies the approach
that my clients take to this Inquiry.
So can we please have WITN1004002. Thank you.
I would like to look -- this is Robert's second
witness statement and he addresses the concerns, the
impetus for engaging in this Inquiry and identifying the
themes that he and the other Core Participants in my
group want addressed and, if I can start by paragraph 3,it is a long extract but it means I don't have to
summarise the points in my submissions. So he says:
"I have come to see the issues raised by this
Inquiry as centrally engaging human rights."
That is a point adopted by all Core Participants, as
is indeed the whole of this statement:
"I have approached the making of this statement with
that in mind. I believe there is a universal right to
be treated with dignity, regardless of an individual's
situation. I think the state should only restrict or
temporarily suspend a person's rights when that person
has interfered with or violated the rights of another.
I believe the state has failed me and other
haemophiliacs in this infected blood scandal. They have
failed by first removing the dignity of the groups that
became most affected by HIV and viral hepatitis;
promoting and reinforcing a stigmatised view of those
groups; failing to prevent this stigma from affecting
the decision-making of those in positions of knowledge
and authority [a matter I will come back to]; failing to
acknowledge and implement risk reduction strategies; and
ultimately failing to stop a significant number of
vulnerable and disabled people in its care from becoming
infected with debilitating and frequently fatal
infections.
9"From the first appearance of AIDS, there were
suggestions it was 'a judgment from God' and that people
with the syndrome deserved to die from it. This
perception came on top of state-legitimatised stigma
against gay people, drug users, sex workers and
migrants. Immediately, it led to a separation between
those with HIV that were infected through blood products
and others with the condition. This implicitly divided
all people with AIDS as either innocent and worthy of
care (haemophiliacs) and others as guilty and worthy of
blame (gay men, sex workers, [intravenous] drug users).
This division denied those deemed guilty of their human
dignity and ultimately demeaned those deemed innocent.
Those of us infected through blood or blood products
were routinely exceptionalised and separated from the
general service provision for people with HIV [again
a matter I will come back to]. I feel strongly that
this haemophilia exceptionalism affected the initial
risk perspective in the early stages of AIDS; the
approach to the management of blood products; the
provision of clinical to those affected with AIDS, and
the availability of community support services."
So stigma and human rights informs my clients'
engagement with this Inquiry and will inform the
submissions I make orally today, Sir.
10That's the statement of Robert, as I have said, but
it is a contribution adopted by all of my clients.
Moving then, please, to human rights. I will come
to some factual matters in due course but I do want to
lay out, if I may, shortly this framework because it is
important for my clients.
There are three key human rights instruments, we
say, that shed light on the treatment and experiences of
those infected and affected: the European Convention on
Human Rights, the International Covenant on Economic,
Social and Cultural Rights and the UN Convention on the
Rights of Persons with Disabilities.
Now, at the time of the events we are concerned
with, these instruments did not form part of domestic
law but at all times they bound the UK as a matter of
international law and importantly too they both
establish and reflect ordinary human rights norms now
expected to be conformed -- to be complied with, states
to act conformably with, by at least liberal, democratic
states. So these are human rights norms.
So the fact that they are not incorporated or only
incorporated in part, in respect of some of them,
doesn't matter to the approach we say you can take to
them and, of course, we are not suggesting, for obvious
reasons -- or for a number of reasons, in fact, but we
11are not suggesting that the Inquiry make a finding of
any legal wrong and that, therefore, I hope, establishes
our position.
It creates a framework for understanding.
ANSWER:
You are saying that the principles
which I should apply, or I should recognise as applying,
are those the state has agreed to internationally and
one would be surprised if it were to accept any
different principles in dealing with its own citizens.
|
46,809 | 347 | QUESTION:
Precisely, Sir. That's precisely the point we
make and, indeed, the UK has agreed to adopt those human
rights norms but it is right to say, as well, that these
are broad international covenants, certainly the UN
Covenant is one that's 1966 and widely adopted --
a large number of states are signatories to it and have
ratified it. But the point is, as you have probably
identified, if I may so say, sir, is that these are
established human rights norms, they are international
norms and if there were any doubt about it, we can be
satisfied too that the United Kingdom has decided
positively that it will conform to those international
norms by binding themselves, as a matter of
international law, to comply with them.
So that's our introductory observation.
If I can take you please to the key extracts that we
12invite you, Sir, to have regard to. First of all, the
context, the background is the Universal Declaration of
Human Rights, adopted by the UN General Assembly in
1948.
We have that at RLIT0001983. Thank you.
I don't need to read all of this, of course, and you
may well be familiar with it, Sir, but it is one of the
foundational documents of the UN, one of the
foundational human rights documents. And importantly,
in the preamble, the first page of the preamble refers
to dignity. A point picked up I think by Mr Snowden
more generally in his submissions.
So:
"Whereas recognition of the inherent dignity and of
the equal and inalienable rights of all members of the
human family is the foundation of freedom, justice and
peace in the world,
"Whereas disregard and contempt for human rights
have resulted in barbarous acts which have outraged the
conscience of mankind ..."
Skipping the next paragraph. The last paragraph in
the preamble:
"Whereas the peoples of the [UN] have in the Charter
[UN Charter] reaffirmed their faith in fundamental human
rights, in the dignity and worth of the human person and
13in the equal rights of men and women and have determined
to promote social progress and better standards of life
in larger freedom,
"Whereas [Members] have pledged themselves to
achieve, in co-operation with the United Nations, the
promotion of universal respect for and observance of
human rights and fundamental freedoms ..."
That is the preamble. Then we get to the
substantive articles. Article 1, again, dignity.
Foundational to all of these instruments is the
concept of dignity and equality. And we see it there at
Article 1:
"... born free and equal in dignity and rights."
At Article 2, a non-discrimination guarantee, seen
again in all the main human rights instruments.
Protecting or requiring that discrimination is
prohibited, that equality is secured not just in respect
of those classes whose status is enumerated but also
other status, which will include those with haemophilia
and, importantly too, for the approach my clients are
taking, those with hep C and HIV.
Article 3, the right to life.
Article 5: "torture", "inhuman or degrading
treatment".
Inhuman or degrading treatment.
14Those are all the extracts -- no, in fact I shall
take you to one more which is Article 25(1). This is
picked up in the next instrument that I'm going to take
you to. Article 25(1):
"Everyone has the right to a standard of living
adequate for the health and well-being of himself and of
his family ..."
Health is a matter picked up in the next instrument
I would like to take you to, and that's the covenants.
So the UN Covenant on Economic, Social and Cultural
Rights. I have got it in shorthand. And, again, as
I have said, that's one of the older conventions, one of
the older treaties.
And if I can ask you, please, Lawrence, if you
wouldn't mind, to turn that up. That's RLIT -- ah,
you're ahead of me. Thank you.
If I can ask you then to, please, look at that and
in the first instance -- again, the preamble, simply to
observe in the third substantive paragraph -- let's go
to the second just to remind ourselves:
"Recognising that these [human] rights derive from
the inherit dignity of the human person ..."
And referring in the next paragraph to the Universal
Declaration of Human Rights, that which we have just
looked at. Then, if I can turn, please -- invite you to
15turn to Article 2.
We see there 2.1:
"Each State Party to the present Covenant undertakes
to take steps, individually and through international
assistance and co-operation, especially economic and
technical, to the maximum of its available resources,
with a view to achieving progressively the full
realisation of the rights recognised in the present
Covenant by all appropriate means, including
particularly the adoption of legislative measures."
Again, a duty -- a duty -- to progressively realise
the rights contained in the Covenant. And 2, again,
a non-discrimination guarantee encapsulating or
protecting those whose status is not specifically
enumerated but whose status can be described as another
status, which plainly is the case here.
Then if I can take you please to Article 12. This
is a specific provision, a particular provision,
targeted provision, addressing health.
So Article 12:
"1. The States Parties to the present Covenant
recognise the right of everyone to the enjoyment of the
highest attainable standard of physical and mental
health.
"2. The steps to be taken by the States Parties to
16the present Covenant to achieve the full realisation of
this right shall include those necessary for ..."
And moving straight to (c):
"The prevention, treatment and control of epidemic,
endemic, occupational and other diseases;
"(d) The creation of conditions which would assure
to all medical service and medical attention in the
event of sickness."
So a health guarantee that the UK has promised to
progressively realise.
In relation to that health guarantee, there's been
a general comment by the Committee on economic, social
and cultural rights and, as you will probably recall,
Sir, that's the body that reviews monitoring data and
state reports, but it also provides general comments
which are designed to assist in the interpretation of
the treaty provisions.
So they are important documents but they are
important too because they are not adding to the
Convention's substantive rights. They are simply
telling states what they mean and, therefore, what they
have already subscribed to.
So if I can take you, please, to the General Comment
No. 14. RLIT0001985.
This is General Comment No. 14 (2000). As I have
17indicated, it is a document to assist
with interpretation, not a new set of provisions.
Paragraph 1 emphasises the importance of health, as it
is the right to health, as it is found in the covenant:
"Health is a fundamental human right indispensable
for the exercise of other human rights. Every human
being is entitled to the enjoyment of the highest
attainable standard of health conducive to living a life
in dignity."
Again, dignity is the key threshold, the key test
for compliance.
And at paragraph 3 it acknowledges, we say this is
certainly true:
"The right to health is closely related to and
dependent upon the realisation of other human rights ...
including ... human dignity, life, non-discrimination,
equality ..."
As well as, the next line, "access to information".
Then, please, if I can ask you to turn to
paragraph 8, the "Normative content of Article 12":
"The right to health is not to be understood as
a right to be healthy."
Of course.
"The right to health contains both freedoms and
entitlements. [They] include the right to control one's
18health and body ..."
Bodily autonomy as I shall describe it.
"... and the right to be free from interference,
such as the right to be free from torture,
non-consensual medical treatment and experimentation."
And the last sentence refers again to equality of
opportunity.
You will see at paragraph 10, which I needn't read
to you, but starting -- in fact it is the last sentence,
although it is rather a long one, HIV and AIDS is
referred to in terms, noting the particular difficulties
and, we would say, stigma and lack of support for that
growing number of people, populations, experiencing or
contracting HIV and AIDS.
So those are the main human rights -- the general
human rights instruments.
ANSWER:
Do you want to refer me to the last
sentence of paragraph 11?
|
46,810 | 347 | QUESTION:
Yes, thank you, sir. So, consequently, the
rights that -- health must be understood as the right to
the enjoyment of a variety of facilities, goods,
services and conditions necessary for the realisation of
the highest attainable standards of health.
In fact, it will be as well -- certainly I would
invite you to look at the whole of the comment because
19you will see over the page -- again I won't read it all
out, but if you want it take a moment to read it now or
later, Sir, it is a matter for you -- but you will see
that it identifies the constituent elements or the
conditions that must be met, if the obligation in
relation to health is to be met.
So availability, accessibility, economic
accessibility, information accessibility -- one of the
things that did not occur here -- acceptability and
quality. But I commend the whole of it to you because
it provides, as I have said, a more detailed structure
for examining the extent to which the article 12
obligation in the Covenant has been complied with.
So just in relation to that and perhaps summarising
where we get to, the general comment is a helpful source
for summarising that, but we do say that, looking
through the prism of the rights contained in the human
rights instruments -- I will come to the Convention of
the Rights of Disabled Persons in a moment, but looking
at the events that occurred through the prism of those
human rights instruments, we say the Inquiry will want
to consider the failure, among other things, to meet the
pledge to ensure self-sufficiency in blood products; in
relation to HIV and hep C; core obligations would
include facilitating or providing early public health
20information particular to people with haemophilia
receiving blood products; information about the risks
associated with Factor VIII and the risks associated
with non-A, non-B hepatitis, hep C, in the 1970s and
1980s; the risks associated with commercial US products;
the creation of an authoritative and centralised channel
for disseminating public health information; and steps
in place to mitigate imminent virological risks,
self-sufficiency, alternative treatment, proper
licensing, blood security and, importantly, as I will
come back to it, appropriate services and dignity.
The last instrument I should like to refer you to,
Sir, is the Convention on the Rights of Persons with
Disabilities. That's RLIT0001986. I rather suspect you
might have read these, Sir, but I shall, if you don't
mind, I do want to touch upon them because we are --
ANSWER:
I have but, as you say, you are here
in a public sphere saying what your clients would want
the public to hear.
|
46,811 | 347 | QUESTION:
Thank you. Sir, if I can ask you, please, to
look firstly at the "Preamble", simply to observe again
that this is a convention inspired by the UN's
foundational documents, the Charter, we see that
referred to at paragraph (a), and at paragraph (b) The
Universal Declaration that I took you to a moment ago
21and then, if we look, please, at Article 1, the purpose
of the Convention is identified. That is:
"... to promote, protect and ensure the full and
equal enjoyment of all human rights and fundamental
freedoms by all persons" --
ANSWER:
There we are. You were just ahead of
the screen.
|
46,812 | 347 | QUESTION:
I'm sorry. I'm not quite used to this, Sir,
and you told me about hurrying or somebody did, so I'm
terribly sorry. Are we there now?
ANSWER:
We are. If you want to check ever it
is on the screen to your right, the big screen.
|
46,813 | 347 | QUESTION:
I think it is here but I was concentrating on
my notes and not the screen, but there you are.
Apologies.
ANSWER:
You may want to start Article 1 again.
|
46,814 | 347 | QUESTION:
Thank you. So Article 1 identifies the
"Purpose", and:
"The purpose of the ... Convention is to promote,
protect and ensure the full and equal enjoyment of all
human rights and fundamental freedoms by all persons
with disabilities, and to promote respect for their
inherent dignity."
Persons with disabilities are described inclusively
and they include persons with long-term physical
22impairments, which:
"... in interaction with various barriers may hinder
their full and effective participation in society on
an equal basis with others."
So I know you will know, Sir, this embraces a social
model of disability. So it is concerned less about the
focus on a person's impairment and more about the way
society, the state, services here respond to those
people with impairments.
Of course, our clients are disabled for a number of
reasons: haemophilia, HIV, and hepatitis C.
Article 2, if I can take you please to the third
paragraph "Discrimination". Again, prohibits or
requires states to prohibit or guarantee -- prohibit
discrimination and guarantee non-discrimination, noting
too that discrimination means:
"... any distinction, conclusion or restriction on
the basis of disability which has the purpose or effect
of impairing or nullifying the recognition, enjoyment or
exercise, on an equal basis with others, of all human
rights and fundamental freedoms", in all the spheres
identified there.
Then if I can ask you, please, to look at Article 3.
Article 3, the "General principles" are identified and
emphasising again dignity, "Respect for inherent
23dignity", and also now and, importantly as with general
comment number 14, "individual autonomy, including the
freedom to make one's own choices and independence of
persons", and non-discrimination, participation, respect
for difference, equality of opportunity, accessibility,
equality between men and women and respect for evolving
capacities of children.
So discrimination, bodily autonomy, individual
autonomy and non-discrimination.
Then at Article 4, reflecting the language used in
the Covenant and seen in other international
instruments, Article 4:
"States Parties undertake to ensure and promote the
full realisation of all human rights and fundamental
freedoms for all persons with disabilities without
discrimination ..."
For that purpose, States Parties are required to
adopt appropriate measures, designed to secure that.
(c):
"To take into account the protection and promotion
of the human rights of persons with disabilities in all
policies and programmes;
"(d) To refrain from engaging in any act or practice
that is inconsistent with the present Convention and to
ensure that public authorities and institutions act in
24conformity with the Convention ..."
So a prohibition in engaging in acts and practices
inconsistent with the convention and to take appropriate
measures to eliminate discrimination:
"(f) To undertake or promote research and
development of universally designed goods [and]
services ...
"(g) To undertake or promote research ..."
"(h) To provide accessible information ..."
Something that has a question of information has
emerged many times and I will touch upon it in one
moment:
"to promote the training of professionals and staff
working with persons with disabilities ..."
In the development -- 3, so paragraph -- so
subparagraph 3. Thank you Lawrence:
"In the development and implementation of
legislation and policies to implement the present
Convention, and in other decision-making processes
concerning issues relating to persons with disabilities,
States Parties shall closely consult with and actively
involve persons with disabilities, including children
with disabilities, through their representative
organisations."
What we know here is that there was no sharing of
25information, no targeted appropriate services, and no
participation in decision-making. But I will come back
to that in a moment. Over the page, in my page it is,
Article 5, again, a non-discrimination guarantee,
needn't take you to that.
Article 8 "Awareness raising":
"States Parties undertake to adopt immediate,
effective and appropriate measures:
"(a) To raise awareness throughout society ...
regarding persons with disabilities, and to foster
respect for the rights and dignity of persons with
disabilities ..."
Highly relevant to what my clients say and what in
due course I will say about the impact of stigma.
Then, relatedly at (b):
"To combat stereotypes, prejudices ..."
Then 2:
"Measures to this end include:
"(a) Initiating and maintaining effective public
awareness campaigns ...
"(i) To nurture receptiveness to the rights of
persons with disabilities;
"(ii) To promote positive perceptions and greater
social awareness towards persons with disabilities ..."
Just finally, although I can -- finally on this
26section, still the same Convention but this part, if we
look please at Article 15, part of the civil and
political rights part of the Convention, Article 15, we
have there the prohibition on torture or, for our
purposes, inhuman or degrading treatment:
"In particular, no one shall be subjected without
his or her free consent to medical or scientific
experimentation."
Highly important. And of course it was important
post-war for very obvious reasons, and so we see that
issue flagged many times, in the various documents.
Then at Article 25, that's the last section I need
to take you to:
"Article 25
"Health
"State Parties recognise that persons with
disabilities have the right to the enjoyment of the
highest attainable standard of health without
discrimination on the basis of disability."
And appropriate measures must be taken:
"... to ensure access for persons with disabilities
to health services that are gender-sensitive, including
health-related rehabilitation."
To that end, (a), State Parties shall:
"Provide persons with disabilities with the same
27range, quality and standard of free or affordable health
care ..."
Then (b):
"Provide those health services needed by persons
with disabilities specifically because of their
disabilities, including early identification and
intervention as appropriate, and services designed to
minimise and prevent further disabilities, including
among children and [as will become more important to my
clients] older persons."
Then, (d):
"Require health professionals to provide care of the
same quality to persons with disabilities as to
others ..."
Free and so on. And:
"... informed consent by [among other things]
raising awareness of the human rights, dignity or
autonomy and needs of persons with disabilities through
training and the promulgation of ethical standards for
private and public health care ..."
So very significant human rights measures, very
significant human rights obligations, a focus on
autonomy, dignity, non-discrimination and positive
obligations on the state to ensure that there is
a true -- a true -- and realisable right to enjoy
28health, dignity, equality in services, appropriate
services, and non-discrimination.
The very last document I will take you to, and
I know you will be extremely familiar with this, but
I will take it just briefly if I may, again.
And that's -- that one! Thank you.
This is the last document as well.
Sir, we have here the European Convention on Human
Rights. I know I needn't ask you to study it but just
to flag again -- internal number page 5, please,
Lawrence -- the preamble.
Again, the first substantive paragraph referring
again to the declaration -- the Universal Declaration of
Human Rights. So, again, inspired by those fundamental
human rights values that we see immediately post-war.
Then at page 6, if we can, we see at Article 1 what the
state promises to do:
"The High Contracting Parties shall secure to
everyone within their jurisdiction the rights and
freedoms defined in ... this Convention."
The material parts.
Article 2, the right to life. I will come back to
that.
Article 3, prohibition on inhuman or degrading
treatment.
29Then if I can go to internal number -- page 11,
please. This is article 8, Sir:
"Right to respect for private and family life.
"1. Everyone has the right to respect for his
private and family life ..."
You will know, Sir, that the concept of private life
engages personality, both physical and intellectual or
mental, emotional and so on -- it is concerned with
personality as well as physical privacy. So, important
guarantees.
Then, at Article 14, again, a prohibition on
discrimination.
As we have said in our written submissions, and
I know will be familiar to you Sir, Article 2, although
appearing as a negative obligation, imposes two
particular obligations: the negative obligation,
prohibiting a state from depriving a person of life; and
a positive duty to ensure that the right to life is
protected.
But beyond that there are particular obligations
imposed in the case of particular individuals or classes
of individuals where there is a known risk to life. So
there is a duty arising under Article 2 -- you will
remember the Osman line of cases -- a positive
obligation under Article 2 to take protective measures,
30preventative measures in the case of an individual or
class of individuals, where there is a risk to life.
There is also a procedural obligation -- and this is
for historical purposes only now -- but there is
a procedural obligation, as you know, to undertake
a prompt and effective investigation. And I probably
needn't say more about that because I think the
observations that could be made about that are obvious
and have been made by many others.
Similar positive obligations arise under Article 3,
prohibition on inhuman degrading treatment, as those
that arise under Article 2. That is where there is
a risk that there will be -- or that substantive right
will be violated. So there is a risk of inhuman or
degrading treatment. And importantly, as I have said
about Article 8, it protects one's personality, one's
interests as they touch upon oneself. They also,
therefore, touch upon bodily integrity, autonomy and
dignity.
And Article 14, as you have seen, is the
non-discrimination guarantee.
So there is a succession of human rights
instruments, starting immediately post-war, emphasising
the need for respect for human dignity in the case of
all people, and then specific aspects: life, prohibition
31on degrading treatment, health, and so on.
Those are, as I have indicated, important matters
for my clients.
With that context, then, I should like to make some
observations on the facts, some submissions on the
facts.
Firstly, as to knowledge of risk and the response to
it, mindful, as I have already indicated, about the
positive obligations inherent in the conventions, the
duty on the state to do something where risk is
identified, the timing of the emergence of risk or the
emergence of knowledge of risk is important, obviously,
because it tells us how things developed. But it is
important for my clients too, and no doubt many, many,
many others of the Core Participants, because it helps
them understand not only whether the transmission of
infected blood could have been prevented at particular
times, but whether, in the case of HIV, it could have
been eliminated at the very outset, and whether or not,
therefore, they may not have contracted hep C or at
least HIV themselves.
So timing is important for my clients and, no doubt,
everybody else participating in this Inquiry, for their
personal reasons as well as the broader public interest.
We had the benefit and I had the benefit of hearing
32Mr Snowden speak on Tuesday, I think it was, about the
emergence of evidence concerning risk, a viral
transmission associated with blood and blood products.
We adopt what Mr Snowden says. Along with our written
submissions, we don't -- that is, Mr Snowden's
submissions and our written submissions in general
comprise the submissions that we would wish to make
today.
And so that those listening understand the position
we are adopting, it is no benefit to the Inquiry to
repeat submissions that have already been made by others
where there's no disagreement and where we have set them
out in the written submissions. So they are extremely
important matters but it isn't necessary for me, Sir, to
repeat them before you and before those in the hearing
room, remotely or physically.
Having said that, there are a couple of matters
I would like to draw your attention to in relation to
chronology, but keeping repetition, I hope, to the very
bare minimum.
What is clear, we say, is that the risk of
transmission of viral infection, hepatitis in
particular, through the transmission of blood and blood
products, was known a very, very long time before the
events with which this Inquiry is primarily concerned,
33post-transfusion hepatitis, as it was then described,
was known of by the 1940s and the relationship between
pool size and transmission -- increased risk of
transmission relative to pool size -- was known of well
before factor concentrates came to be used in the United
Kingdom. As we heard too, by the early 1970s at the
latest, evidence had begun to emerge indicating the
existence of another hepatitis causing agent, non-A,
non-B and with the development of tests for hepatitis A
and B it became clear that non-A, non-B, hep C,
evidenced -- let me just start that sentence again.
I have expressed that very badly.
What was known were the development of tests for
hepatitis A and hepatitis B and the discovery therefore
of non-A, non-B hepatitis, what came to be known in
consequence is that unknown viruses could be transmitted
through blood and blood products.
So by the time we are in the '70s, known viral
infections can be transmitted; known pool size is
relevant; known that unknown viruses could be
transmitted and, soon afterwards, in the case of non-A,
non-B, hep C, it was particularly understood that pool
size was significant for determining the extent of risk.
ANSWER:
Are you submitting to me that non-A,
non-B was an unknown virus? The reason I ask is this:
34it may be thought that much of the material which starts
in the 1940s, if not before, identifies that there is
something which causes after transfusion the effect of
hepatitis and it is identified in the 1940s, if not
before, that that is most probably the virus. In one
sense, it is unknown because no one isolates the virus,
no one can test for it, no one can see it under the
electron-microscope, or whatever microscope was used in
those days.
But there was no doubt that blood had or could have
a virus in it or viruses in it, which would cause
effects amongst which, importantly for this Inquiry, was
the consequence of hepatitis.
|
46,815 | 347 | QUESTION:
Yes.
ANSWER:
But non-A, non-B might be thought,
unless there is evidence that it is an actual late
comer, which evidence isn't apparent, I think, in the
document, but I will listen to any submissions to the
contrary, was always there, it was always part of the
viruses that were causing hepatitis. So it was not
unknown in that sense, what was unknown about it was
that it was -- that part of the virus cohort, the virus
army that was attacking liver hadn't yet been
identified.
|
46,816 | 347 | QUESTION:
Yes.
35ANSWER:
So that is what you are submitting to
me, is it?
|
46,817 | 347 | QUESTION:
That's what I'm submitting. So when I talk
about an "unknown virus", I'm talking about a virus that
hadn't been identified, and the significance for us of
drawing attention to that is it was plain, therefore, by
then that viruses generally were able to move through
blood, blood products and the fact that one couldn't
identify it didn't mean that there was an absence of
risk. What was known therefore ought to have informed
decisions later on, both in respect of hepatitis C but
also HIV.
ANSWER:
In simple terms, you are submitting
you don't need to know how something is caused if you
know that it is caused by doing something?
|
46,818 | 347 | QUESTION:
Yes.
ANSWER:
So A simple example, you press
a button over there and a light comes on over there, you
press a light switch, you know that if you do that, that
happens. You hope, as long as the bulb is working. But
you do not know how, you don't have to understand
electronic theory or electricity or anything, or
incandescence in order to work that out: you know it
happens.
|
46,819 | 347 | QUESTION:
Yes.
36ANSWER:
On a simple level, is disease, do you
submit, like that, that if you know you do this that may
happen?
|
46,820 | 347 | QUESTION:
Yes, precisely, and the fact that one can't
identify the virus at a particular time doesn't mean
that one can't identify the risk factors associated with
the transmission of viruses: large pools, commercial
blood products, and so on. So it is emphasising the
importance, we say, of understanding that HIV didn't
come out of the blue, in the sense that, of course it
was a different virus, of course it hadn't been
identified, but the fact that there was a virus that
hadn't been identified wasn't something that ought
necessarily have taken everybody by surprise. Viruses
were known of. They were transmissible by blood
products, the risk factors -- large pools, commercial
products -- were known about and had been known about
since the 1970s.
So it is really identifying that there is no sudden
discovery. HIV is the discovery, what causes viruses to
be transmitted and the risk factors associated with that
was something that was known about from the 1940s
onwards, increasingly.
Of course the other feature I talked about, size of
the pool, but of course paid donors was the other
37matter. Commercial products was known to be a risk
factor in the 1970s, so these risk factors ought to have
been well in the minds of those dealing with people who
needed the transmission of blood products like people
with haemophilia.
Given that what was known -- given that it was known
that large pool plasma, large pool blood products,
commercial products were known to increase risk of
transmission -- in the case of hepatitis -- the extent
of the risk associated with Factor VIII ought to have
been apparent very early on, particularly commercially
produced Factor VIII, but what we see is that those
risks were consistently underplayed, consistently
minimised by clinicians, pharmaceutical companies and
others involved in the administering and supply of blood
products.
There are a number of reasons for that, we say.
First of all, there was a general but considerable
resistance to anything that might suggest that the
distribution of what was seen as a new wonder drug
which -- should be disrupted. Clinicians using
Factor VIII expected gratitude from patients and perhaps
generosity from pharmaceutical companies which in turn,
made vast profits from the production of Factor VIII at
times when they knew the risk.
38So risk must have been obvious by the late 1970s.
The risks associated with Factor VIII, however, were
downplayed for a number of reasons, including
an investment among clinicians in what was seen to be
a wonder drug and what they could do for their patients
and, of course, as we have already heard several times,
perhaps informed in part by clinicians' relationships --
some clinicians' relationships -- with the
pharmaceutical companies. So a downgrading of risk.
We see that reflected early on. I don't need to
take you to the documents. Some of them you may have
seen but I hope I have managed to not repeat. But we
see early on correspondence, for example -- we remember
this from counsel to the Inquiry's presentation -- but
Dr Jones, director at the Newcastle Haemophilia Centre
and a key player in the UKHCDO -- wrote to colleagues in
1974 confidentially -- you may recall that, Sir -- that
the link between commercial concentrate and hepatitis
had been proved and that it carried the risk of jaundice
but that it was generally agreed that the advantage and
indeed the necessity of concentrate outweighed the risk
of hepatitis.
At around the same time, you may recall, Sir, he was
writing to colleagues describing the risk of hepatitis
contamination as "very worrying". So there were
39frictions between what was said at various times and to
whom but what was certainly the case was that, in
assessing risk and whether it was worth taking, there
was no discussion or involvement of patients.
The position, we say, didn't change, that is
minimising risk when the indicators of what came to be
known as HIV/AIDS began to emerge in the very early
1980s, in all probability for the same reason,
additional to stigma that I will come to.
Again, as with hepatitis C, I won't track the
emergence of the evidence because Mr Snowden has done
that for you on Wednesday (sic). But, again, I should
like to pluck out a couple of points in particular.
First of all, the minute in which Mr Gunson's report
is referred to, the early minutes, July 1982. You will
recall there is a Department of Health -- or DHSS as it
was -- minute. He was described as consultant adviser,
and he was also Chief Medical Officer, as I understand
it. When he gave evidence, you will remember, in the --
ANSWER:
I don't think he was Chief Medical
Officer. He was the adviser to the Chief Medical
Officer.
|
46,821 | 347 | QUESTION:
I beg your pardon. I had seen two things and
that's why I was -- adviser to, thank you. Adviser to
the Chief Medical Officer.
40ANSWER:
I think the Chief Medical Officer at
the time was Sir Henry Yellowlees.
|
46,822 | 347 | QUESTION:
Thank you.
Just then to re-wind. You will recall the
Department of Health minute, I think, in which his
observations were recorded. He was consultant adviser,
as you have just reminded me, to the CMO. When giving
evidence in the HIV Litigation, you may recall he said
he first suspected -- and there was a presentation given
to us about this -- the link between haemophiliacs and
AIDS during 1982, when there were incidences of
haemophiliacs who contracted immune deficiency.
We saw thereafter, in July 1982, the minute I just
referred to, when it was reported that he said there was
likely to be considerable publicity over the following
weeks concerning the safety of American Factor VIII.
So very early on, again, noting concerns about the
safety of American Factor VIII given the emerging new
virus, HIV.
Notwithstanding that, notwithstanding the fact that
that would indicate that he was following closely what
was happening in the US, we see that he was minimising,
in due course, the extent of the risk.
So while he says in his memo, or while it is
recorded as him saying in the memo, that the voluntary
41unpaid donor system adopted by the UK was safer than the
US system, no action was taken in relation to that. We
come to see what happened about that.
But what we say, Sir, is that immediately upon him
acknowledging and recognising that, the risks associated
with Factor VIII and the emerging virus, HIV,
immediately that warning sign ought to have been met
with action: unequivocal warnings to patients and their
carers, and a pause in the use of Factor VIII at least.
As I already indicated, it didn't come out of the
blue. The risk of transmission of viruses was known and
the risk factors associated with it, size of the plasma
pools, paid donors, were well known. Nothing was done
at all.
Evidence continued to emerge -- we will come back to
what Mr Gunson says, having identified it at that early
stage -- of evidence continues to emerge, as you heard
from Mr Snowden -- the San Francisco baby case, the
20 year old man in Cardiff -- but still nothing was done
promptly. And instead we hear from Professor Bloom,
giving reassurance to The Haemophilia Society that it
had not been proven that AIDS was transmitted through
blood products and so there was no need for the
haemophiliac community to be unduly concerned.
So risk was known of, it was a risk potentially of
42a fatal illness. The risk factors associated with the
transmission of viruses were long since known but no
action was taken at all. Not only was no action taken
at all but Professor Bloom, a key player in the UKHCDO,
was telling the haemophiliac community that there was
nothing to be worried about.
Clear warnings then ought to have been acted upon
but weren't. We saw then the frightening memo written
by Dr Galbraith on 9 May, or dated 9 May 1983, in which
it is observed that the mortality rate of AIDS
exceeds 60 per cent one year after diagnosis and is
expected to reach 70 per cent. Still nothing happened.
And as I say, rather than sticking to his guns, so
to speak -- that is not a good pun -- we see Dr Gunson
rowing back on the concerns that he apparently had in
summer 1982.
So, in July 1983 Dr Gunson, having already flagged
the risks, concluded, together with Professor Bloom and
Dr Galbraith, that a return to cryoprecipitate wasn't
recommended since the perceived level of risk at present
does not justify serious consideration of this solution.
So, again, a playing down of risk, a reduction
apparently in the concern expressed by Dr Gunson earlier
on and matters continued in that vein. So in October
1983, as we heard, at a UKHCDO meeting, Professor Bloom,
43the dominant voice, as I have said, an important voice,
said there was no need for patients to stop using
commercial products because at present there was no
proof that commercial concentrates were the cause of
AIDS. Of course, as you know, Sir, proof is not what is
required, a risk assessment is what is required and
a risk assessment is required not just as a matter of
good clinical practice and the precautionary principle,
but also having regard to the obligations under the
human rights instruments that I have just identified for
you.
Proof is not required. Risk is the focus and
a proper assessment of risk, bearing in mind that the
impact of that risk being realised is death or in all
likelihood death.
But no steps were taken. Much was left as we heard
repeatedly to the judgement of individual doctors.
I can see it is 11.15. I'm going to pick that point
out, it is a slightly fresh point, so I wonder if this
would be a convenient moment to break.
ANSWER:
Let's pick it up then at 11.45 am.
(11.16 am)
(A short break)
(11.45 am)
|
46,823 | 347 | QUESTION:
Thank you, sir.
44ANSWER:
Yes.
|
46,824 | 347 | QUESTION:
I was about to say -- I started by observing
a moment ago or before the break that no steps were
taken centrally to address risk and instead much was
left to the judgement of individual doctors.
Sir, we heard from Dr Winter as you may recall, that
the absence of centralised guidance meant that there
were major variations in treatment and care and so he
said, Sir:
"You would be utterly bemused by the different ways
in which ten patients could be treated by ten different
doctors. I mean, it was astonishing and something that
will surely come out of this Inquiry is the great
variability of care."
So an absence of urgent action when risk became
apparent and, even then, as matters proceeded, no
central or authoritative guidance, but instead letting
haemophilia clinicians get on with the job in the way
that they saw fit.
So no central standard setting.
We have observed throughout our written
submissions -- my clients have observed, their shock at
the response to risk that we have seen but, importantly,
before I come to my next point, in our submission, it is
important to observe that this was not a situation where
45there were rogue doctors. One or other doctors making
problematic decisions in a particular case. This
decentralised ad hoc variable decision-making, without
central standards and the diminishing of risk, was
something that was endemic. It fed through the whole of
the practice of haemophilia clinicians and so,
inevitably, there were differences in approach and
problems emerging from that.
In addition to the doctors and the difficulties that
we see emerging because of the absence of central
standards, there is a case -- of course, the question of
the pharmaceutical companies that I have already raised.
My clients, in their opening, observed that, for
them, they were concerned whether there were incentives
from pharmaceutical companies for doctors or Haemophilia
Centres to offload what were cheap and, in the event,
infected products, despite risks.
My clients' concerns have become more concrete
having heard the evidence, in particular, for example
and by way of illustration only, the meeting at Heathrow
Airport and the evidence of Professor Tuddenham, when he
spoke of lavish entertainment, showered on doctors by
pharma in the expectation that they might gain influence
and the funding of research that might be affected --
the outcome of which might be affected by conscious or
46unconscious bias.
So we have the clinicians, no standard setting,
minimising of risk; we have the pharmaceutical
companies, again, minimising risk as they inevitably
would, given the huge profits to be made; and if not
improper relationships, certainly relationships that
give rise to concerns about corruption that I will come
to in one moment.
So loading off dangerous products in a context where
there are no central standard-setting. Indeed as you
heard, Sir, the pharmaceutical industry only took action
in relation to Factor VIII when compelled to do so and
when they appreciated that not taking action might cost
them more in revenue than taking action.
You will recall, Sir, that when compulsory screening
was introduced, it was resisted, in the first instance,
and when introduced in the mid-1980s, you will remember
Armour, for example, insisting that there was no risk
inherent in Factor VIII, albeit at the same time
voluntarily withdrawing unscreened products.
So, as I have indicated right through, doctors with
the pharmaceutical industry minimising the risks
involved, no overarching standard setting or regulation.
At the third cohort or institution, of course, were
blood services. They could have properly been expected
47to have played a leading role in apprehending and
responding to risks but instead, we were told -- you
were told, Sir, in the presentation from counsel to the
Inquiry, that the blood transfusion services were
a fragmented and disorganised shambles.
So, again, no central standard setting, no guidance,
no unified national regulatory systems. So Sir,
bringing that all altogether for the moment, having
regard to the framework that I invited you to consider,
the absence of risk, the response of the clinicians, the
pharmaceutical industry and blood services is such that
those important rights guaranteed in the instruments
I took you to were wholly undermined and violated.
The right to life, the right to bodily autonomy, the
right to health, the right to dignity, and the right to
non-discrimination. All engaged and if any regard had
been taken to those rights and obligations, and there
plainly wasn't any regard, urgent steps would have been
taken and they were not.
That's risk, Sir. I'm going to move now to
patients. I don't think, Sir, that the Inquiry has
heard from many if any infected or affected persons who
was said that they were treated entirely properly by
clinicians and services responsible for their care or
the care of their loved ones.
48Certainly from the perspective of my clients, based
on their own experience and the evidence they have seen
and heard, there was a universal or almost universal
ignoring of the rights of patients to information and to
give or refuse consent to treatment. Patients and their
parents or carers were not warned about the risks
associated with Factor VIII, including of the enhanced
risks associated with particular products, commercial
products, for example. Instead, patients were largely
marginalised from their own care.
As we have said in our written submissions, the
approach of clinicians was epitomised by paternalism,
"doctor knows best", and this idea, this notion of
clinical freedom: doctors' freedom to make their own
choices as to treatment, without regard to the wishes of
patients or the interests of patients.
Misinformation was widespread. This included, as
I have already alluded to, the minimising of the extent
of the risk posed by Factor VIII and the right to
information about their health status in the case of
patients, including my clients, was not respected.
Again, all matters addressed by the human rights
instruments that I identified and took you to this
morning, Sir.
So products were chosen and administered without
49proper consent. We heard about what that means from the
medical ethics expert group. That means agency,
autonomy and liberty. Again, core interests reflected
in the human rights instruments that I took you to.
Risk assessments were made without the involvement of
patients, no systems were in place to empower patients
in the making of treatment choices.
The response to the identification of risk arising
from the link between HCV, HIV and Factor VIII, and the
experiences of those infected and affected by HCV and
HIV, were both affected by stigma. Clinicians and
policymakers were resistant to the notion that innocent
people with haemophilia could be affected. While people
with haemophilia who were infected, like my clients,
faced stigma and marginalisation.
As Robert said in evidence, the association with
homosexual men, sex workers and drug users made it very
much a disease nobody wanted to be near. High levels of
paranoia, bombardment of tabloid stories, presented as
the worst disease associated with bad people, and the
characterising, as he has said, of people with
haemophilia as "innocent victims" did nothing and, if
I may say so respectfully, does nothing to remove
stigma. It merely reflects the stigma attaching to HIV
and HCV and dumps blame on marginalised communities.
50As we have said, that stigma was institutionalised.
Bigotry was widespread. You will remember the words of
the Chief Constable of Manchester: "People with HIV
swirling in a cesspit of their own making".
So inadequate engagement with patients, no
information, no consent, and affected by stigma.
The fact that there were these distinctions between
the "good" patients, people with haemophilia, and the
"bad" patients, sex workers, drug users, homosexual men,
meant that there was a division of services, as you
heard from Robert. So the whole approach of the patient
being in charge of their treatment was lost.
Notwithstanding that had they been directed to
specialist HIV services, they would have experienced
very different care. But the bifurcation of those who
had contracted HIV and HCV meant that my clients, along
with many others, did not secure the specialist services
that international human rights instruments insist they
are entitled to access, because of stigma and prejudice.
My clients make the point, as they have already,
that everybody is deserving of respect, care and
empathy, wherever, whenever and however they were
infected. And importantly, had that approach been
adopted during the AIDS crisis, the likelihood is that
people with haemophilia would have received better care.
51So the reduction of stigma, the taking away of
stigma, respect for the dignity of all people who
contracted HIV in all likelihood would have helped
everybody, including those who had contracted it through
blood transmission but who were deprived of access to
specialist services because of the stigma associated
with that cohort. The "dirty" cohort.
We also saw evidence, considerable evidence, of
haemophilia clinicians objectifying patients and
treating them with a lack of empathy. You will recall
Professor Ludlam writing to Dr Craske in 1980, accepting
an invitation to serve on the Hepatitis Working Party of
the UKHCDO, in which he stated that he was very
conscious of the "almost unique group of haemophiliacs
we have in Edinburgh because they have never received
commercial concentrate, and therefore, as you are aware,
they are useful material" for a variety of studies.
Useful material.
Sir, the dehumanising of haemophilia patients, the
objectification of them, is utterly stark.
We see that too in the observations of Dr Rizza and
his reference to chimpanzees and the need to find
a human cohort to administer and test concentrates on.
Again, a dehumanising and an objectification of real
life people.
52Also evidence including, as occurred in my clients'
case, of samples being taken from patients and then
stored and tested, sometimes for research purposes
without consent. Evidence of a failure to secure
ethical approval for research, for which such research
would have been required. Research was undertaken,
anticipating that injury might be caused, see Rizza.
Tests were taken, HIV and HCV tests were taken from
patients without consent. And where positive, there was
often delay in communicating results, creating risk for
loved ones and others.
So systemic practices right across the board
depriving patients of their bodily autonomy and those
aspects -- those rights embraced by the right to health
caught by the human rights instruments that we went to
this morning.
As to each of my clients, they experienced many of
the experiences I have just identified. I will say
something briefly about them because they are obviously
important. I won't have time to recite everything but
I will make a few observations. Mr AK was infected with
hepatitis B as a child. He was later notified in 1990
that a blood sample had been taken in August 1980, ten
years before: no consent. Tests taken, sample kept, not
notified until many years later.
53He was given no warnings or advice about risks
associated with Factor VIII nor was there any discussion
with his clinicians about the choice of factor product
that might be available and he, to the best of his
recollection, has never in the whole of his adult life
been given a choice of blood clotting treatment.
He tested negative for HIV on 3 August 1982. His
positive result was on 18 December 1984. So he was
infected at some point during that period after, we say,
the link between Factor VIII, hepatitis C and HIV was
known.
He did not ask whether he wanted his blood tested
for HIV and he did not know about it until he was told
after the event at a hospital appointment.
ANSWER:
He couldn't have known about the
August '82 event, could he, because by then there was no
test, that was obviously a retrospective test.
|
46,825 | 347 | QUESTION:
Sorry, I'm not sure I'm understanding that,
Sir.
ANSWER:
Yes. There wasn't a test for the
presence of HIV until the HIV virus had been identified
and isolated. That was done at least definitively in
1984, in April it was announced in the US. It was very
shortly after that that there was a test for the
presence of the antibodies to HIV, this is my
54understanding -- and it was that test which was then
applied to a number of serological samples which had
been taken from patients.
If there was a test done on blood which is dated
August '82, it was obviously one of the samples that had
been taken, it was sitting there waiting to be tested
for whatever it might be tested for at some stage in the
future. That was the point I was making.
|
46,826 | 347 | QUESTION:
I see.
ANSWER:
It supports your argument that he
didn't know that his blood was going to be tested.
|
46,827 | 347 | QUESTION:
Yes, I understand the distinction. Yes, I'm
sorry. Yes. So the blood had been retained, so they
were able to test it presumably having identified the
date on which it was taken -- and I have got lots of
nodding from the members of the public, thank you. They
are giving me a lesson on testing. Thank you.
You can come up here if you like!
So, yes. So the sample must have been retained and,
as you have said, Sir, tested later on, once testing had
become available. So he was able to deduce that he
contracted HIV during the period of 1982 and 1984, 1984
being the date of the positive test.
ANSWER:
What I understood from your client's
evidence was that he didn't know that a sample had been
55taken for the purpose of testing at some referred time
in the future for something.
|
46,828 | 347 | QUESTION:
No, no, as you have said, there was no consent
given to testing at all. No consent given to the
retention of samples. These were all done without the
not only or consent of indeed all of my client group.
This was a feature of the treatment afforded people with
haemophilia and the transmission of viruses.
As you have just alluded to and I was about to say,
he wasn't asked whether he wanted to be tested and he
didn't know he had been tested until after the event.
He was told in a way which was unempathetic, asked if he
wanted to know his status, said yes. "I'm afraid you
are positive", was the answer. No explanation about
what the diagnosis meant. No counselling or information
to help him manage and understand the infection and, as
he described it -- you may have his statement there,
I don't know if he described it to me or in his
statement -- but the experience was a lonely one, as he
describes it.
He had very little support at the outset from
outside the Haemophilia Centres and he makes the
observations, as you may have picked up, Sir, that the
two positive experiences he had in the NHS mainstream
services came -- the two positive experiences arose from
56contact with people outside the mainstream Haemophilia
Centres, so a counsellor and a young doctor on
secondment: the only positive experiences he had.
Otherwise, like my other two adult clients at
material times, the support he obtained was outside
mainstream services: Body Positive, Terrence Higgins
Trusts, Mainliners, and they ought to be given credit
those early organisations, early NGOs operating in
a hostile environment and putting out a hand to support
those who had contracted HIV, whatever their
circumstances.
The advantage of that, as you have already heard, is
that they were specialists. They knew how to access
support services and they were able to assist him.
As to Paul then. Paul, again he received no advice
or information about the risks of Factor VIII, nor were
his parents.
By November 1976, he had been given US commercial
Factor VIII. By 1977, he had developed acute
hepatitis B as a result of infection and he and his
family were told they had been "unlucky".
He was told of his infection with HIV in June 1985
at a short appointment to briefly discuss one or two
results, he was told. He was not prepared for that
appointment, given any support and nor was he given
57support afterwards. He was told that he would probably
only have a couple of years before developing symptoms
and a few years to live, and he was told to keep his
diagnosis secret because of stigma.
As he says, the stigma in the mid-1980s through to
the mid-1990s was one of vile hatred and fear. The
impact on him, like Mr AK, was devastating.
But, again, he assumed he had been unlucky because
he had read the 1 in 1,000 story, the Haemofact leaflet,
authored by Dr Lee and Dr Kernoff and it was just bad
luck.
Eventually Paul was referred to an HIV clinic, that
is outside haemophilia support services, where as he
said, his experience of health services improved
significantly. He met gay men, drug users, much of the
advice he received came from organisations like Terrence
Higgins, Body Positive, Mainliners and similar
organisations, and importantly he was able to provide
support to them too because of his knowledge.
He was told he had HCV in 1992 but not to worry
about it because the HIV would kill him first. As to
Robert, again, neither he nor his parents were told that
there was an increased risk of infection associated with
Factor VIII. He was not aware at any point of being
asked or his parents being asked whether he wished to
58revert to cryoprecipitate. He was diagnosed with HIV in
1985, when he was 18 years old. And again, as with the
others, he was not informed in advance that he was being
tested for HIV.
He was told of his HIV diagnosis when he called to
make an appointment to see a haemophilia doctor. And if
he hadn't done so he anticipates he would not have been
informed until some time after that.
Just before I come to Mr AH, the youngest of my
client group, I emphasise, as my clients have, and
I have emphasised more than once but it is important to
do so, that organisations like Terrence Higgins, Body
Positive and Mainliners were concerned with ensuring
that their human rights, their fundamental rights and
their dignity rights were protected. And there was
a complete distinction between organisations like that,
and specialist HIV services supporting gay men and drug
users, a complete distinction between the care and
specialist services and Haemophilia Centres;
HIV clinicians were collaborative, warm. A complete
contrast to the patriation, distant attitude of those
clinicians in HIV centres.
The last of my clients then is Mr AH. He was 7 when
his parents were informed that he was HIV positive and
his parents were not warned of risk at any time. When
59they were told of Mr AH's infection they were told they
should prepare for his death.
He was in fact told inadvertently -- well,
negligently -- aged 12 by a supervisor at the hospital
of his diagnosis, causing him considerable distress.
Mr AH was a child, as I have said, and while in his
early teens, so still a child, he developed AIDS,
causing physical illness but also considerable mental
distress. And as with others, his family experienced
the negative consequences of the stigma attached to
AIDS, that is while he was still a boy.
So their experiences were typical, unique to each of
them, each experience is unique, but they were typical
to the extent that no consent was sought, no information
was provided, testing and treatment occurred without the
provision of information, without empathy and support,
and without access, save when they sort it out
themselves, to specialist services.
I'm now going to move to my next topic, Sir.
I suppose I ought to say, although I think it is
obvious, if I were to round up the observations I have
just made about my clients, I would say, again, that
those experiences fit comfortably within a human rights
model, and one could test whether the response of the
state through NHS services met the standards set by
60those human rights instruments by looking at the
provisions in them.
So my next topic is care and support. Leaving aside
for the moment the direct contact with Haemophilia
Centres, the lack of empathy, the lack of support,
counselling and so on; care and support generally
provided to patients following infection was wholly
inadequate and largely depended upon the awful financial
system schemes about which we have heard.
Establishment of those schemes were largely
motivated by the need on the part of government to
acknowledge public sympathy but at the same time to
avoid hints of admission of legal liability.
Even with the inadequacies in those schemes there
was evidence of resentment amongst some operating in
this area, resentment that even those schemes had been
established.
Sir, you will remember Professor Lee describing
herself as irritated by the establishment of a funding
scheme because it suggested liability, she said. And as
she put it, "The idea that we would give somebody some
treatment that they knew would cause harm is frankly
ridiculous and it is actually quite hurtful for those
people, those many people who cared for patients."
It is our submission, Sir, that there can be no
61doubt now that that is precisely what happened.
Products were administered that were known to cause harm
and her assertion that it is frankly ridiculous to
suggest otherwise simply reveals her own lack of empathy
in relation to these matters. She is irritated by the
prospect of support for these patients.
That absence of empathy and indeed self awareness
can be spotted elsewhere. You heard, Sir, of a Daily
Mail test from Mr Stevens, trustee of the Macfarlane
Trust, in deciding how to calculate how the sums to be
paid, asking himself "How would it look to the readers
of the Daily Mail?"
Barely credible. Significant problems with the
financial schemes, as you heard in great detail, and
I only touch upon a couple of points. First of all, the
institutional arrangements meant that they lacked
independence. It seems that trustees hadn't appreciated
what their obligations were in charity law but, in any
event, the arrangements lacked independence from
government.
The Macfarlane Trust, for example, seemed to think
that they were simply administering a fund for the
Department of Health. In addition the way in which
these organisations, these funds, carried out their
functions in relation to intended beneficiaries, was
62often arbitrary, hostile and demeaning. Decisions were
often made without any principled basis for determining
outcome.
Again, as you heard from Mr Stevens, of the
Macfarlane Trust, he told you:
"I was simply, as it were, on my own, a free agent
doing, giving, making such decisions, giving such
judgement as seen to be right, really, as
an individual."
Utterly arbitrary, utterly unprincipled. We also
heard that potential beneficiaries were kept at
a distance. We heard about the postbox, so as to avoid
having to make contact directly with patients or
proposed beneficiaries. Applications were routinely
required to be processed through local Haemophilia
Centres resulting in an element of postcode lottery and,
importantly, in the experience of my clients, was that
awards were made often following demeaning --
demeaning -- means testing, about which there was
widespread resentment.
The trustees of the Macfarlane Trust in particular
were derisory, disrespectful to intended beneficiaries.
You will recall the reference to the "great unwashed" in
correspondence between Mr Clarke and Mr Stevens, along
with other examples explored in evidence of grossly
63offensive and contemptuous remarks.
It is almost impossible to believe.
Certainly, and this is apparent just from the short
observations I have made, the trusts managed their funds
and managed applications without generosity, without
compassion, without empathy and in the absence of
a culture of kindness.
My client, Paul, described in his witness statement,
but I could find other examples, that seeking assistance
from the Macfarlane Trust was tantamount to a begging
bowl.
He had to justify any application and all funding
was linked to rules and restrictions that didn't fit his
lifestyle. He experienced financial hardship, and you
heard from Robert too that he avoided, unless absolutely
impossible to do otherwise, applying for one-off grants
because he disliked the system so intensely.
So, again, no support, demeaning, absence of
dignity, absence of access to proper care and services,
all embraced by those human rights instruments and no
evidence of compliance and, indeed, utter disrespect and
an absence of concern and respect for the dignity of all
of these human beings.
Sir, my last subject is accountability, and I just
have a few observations to make about this, so I will,
64I'm happy to say, finish within my allocated time.
So, accountability. Relevant, of course, more
generally for the Inquiry but also relevant for the
purposes of the instruments I have taken you to. They
are all addressed to states: where does accountability
lie? And I want to just say something about that.
Almost all of the key actors involved in the matters
that have been explored, were employees or agents of the
state. So that's easy. The state bears responsibility
for their acts.
Those acts were largely the acts of the Department
of Health, but also other NHS bodies and clinicians.
But as to private actors, the pharmaceutical companies
in particular, we say the state also bears
responsibility for their acts in providing and
supplying, without warning and appropriate protections,
Factor VIII, because they had not put in place -- that
is the state had not put in place -- proper apparatus or
institutional arrangements regulating the activities of
pharmaceutical companies, so ensuring the safety of
commercially produced Factor VIII.
So far as the instruments that I took you to earlier
this morning, Sir, responsibility in those circumstances
would fall within the state, because it is their
obligation, first of all, to protect against risk
65wherever that risk comes from, as long as it is known,
and the state obligations under the specialist
conventions, like the UN convention on the rights of
disabled persons, address in particular a need to ensure
safe access to health services, as indeed does the
covenant.
So the convention, plus the UN instruments, make
clear that there is an obligation on the state to ensure
safe access to appropriate services, and the state can't
escape that responsibility by delegating any obligations
to private companies. Instead, it is their duty to put
in place proper institutional arrangements. And they
didn't.
So the Department of Health, which bore
institutional responsibility for the safe delivery of
health care, did not, for example, set standards
referred to earlier. No specific clinical advice was
imparted in the early years to Haemophilia Centre
doctors. No broad assessment of risk to be fed down but
instead, as I've indicated, doctors were left to sort it
out themselves. Advice was on an ad hoc basis, often
downplayed risk, and was often wrong.
You will recall the evidence of Dr Walford that she
relied on the UKHCDO to do the job of working out risk
and dealing with it. And when she did step in, it was
66to underplay risk and impose a threshold for risk, which
was wrong and outwith the requirements of human rights
law, but outwith ordinary clinical standards.
So she said that she insisted upon firm
microbiological or virological evidence, rather than
epidemiological -- that was the second word I practised
this morning -- after cryoprecipitate -- no, now I can't
remember that one either -- epidemiological association.
So she was not concerned, she said, with simple
association but rather firm microbiological or
virological evidence. So a playing down of risk, no
setting of standards and no clinical guidance imparted
centrally.
We also heard about the foot dragging approach to
self-sufficiency. Again, inexcusable state failures.
There was a lack of genuine interest for
self-sufficiency as we heard. So funding and capacity
was not made available.
The importance of that cannot be overstated. I just
pluck out one piece of evidence. That's the evidence of
Professor Tuddenham, who said that the:
"... provision of home produced concentrate would
have reduced the number of HIV infected patients so that
we would have had half or less antibody positive cases
that we have now, had Factor VIII sufficiency been
67reached in 1977."
So the importance of self-sufficiency cannot be
overstated and, as I have already said in relation to
regulatory oversight, accountability issues, we heard
that the blood security or the blood services were
a shambles.
Finally in relation to accountability, no proper or
robust regulatory or licensing arrangements were in
place. So pharmaceutical companies were able to operate
without proper restraint. Since, as we have heard, the
industry is worth billions, there was inevitably going
to be very little incentive for the industry to regulate
themselves safely: why would they? That ought to have
been secured through a robust regulatory regime.
Instead, the licensing regime was weak and the
relationship between doctors and pharmaceutical
companies, as I have said more than once and you have
already heard from others, unhealthily close and even
corrupt.
As to licensing, you heard from Professor Sir
Michael Rawlins, a member of the Committee on Safety of
Medicines, advising licensing authorities, on that
committee from 1979 onwards. He said he had no
recollection of any discussion after he joined of either
the source of blood donations for factor concentrates,
68an example from prisoners or high risk areas or any
discussion about pool sizes and their significance.
So no discussions in that body that ought to have
been advising on licensing requirements and regimes.
He said that there was a power -- he could see no
reason why there wouldn't be a power -- to attach
conditions to a licence, wide-ranging conditions to
a licence. So, for example, requiring manufacturers to
provide information about pool size, only use pool sizes
of a certain magnitude or restrict the sources of blood
donations. Those could have been imposed, he said, but
they didn't consider it. Instead assumptions appear to
have been made throughout.
As I have said and I will finish on this in the hope
that I don't completely bore you death about it, but it
is again important. I referred you to the expression
"covert bribery". That was something about which we
heard from again from Sir Michael. Evidence of
practices, as I have said, excessive hospitality,
sponsoring doctors to go overseas but, in addition,
perhaps shockingly, treating clinicians appearing before
his committee to advocate on commercial companies.
So that's everything, Sir, except not letting
Government, and ministers in particular, get away with
it. So this is my last point. Stigma and ministers.
69Much like social contagion, stigma can be
eliminated, Sir, by challenging it, by putting positive
public messages out there, respecting and celebrating
those communities affected. But the state did nothing
during the '80s and '90s to address stigma. Stigma
obstructed the identification of risk, safe treatment
responses, impacted on the care of patients, and was
utterly undermining of the dignity of my clients and the
communities affected more widely.
This was primarily a government issue and government
ministers should not be let off the hook for not
addressing it. And this is not a party political issue,
it is a governance issue.
But just by way of example, the only example I can
find -- there may well be others -- Lord Fowler told the
Inquiry that at critical times there was a complete lack
of engagement in relation to the AIDS crisis on the part
of the Prime Minister, Margaret Thatcher. She was also,
he said, difficult to work with, and personalities can
matter in addressing social issues.
But the reasons she gave for disengaging or not
engaging are evidently in part because of her own
homophobia and the stigmatising that she engaged with in
relation to those infected with HIV.
So as Lord Fowler told you, her own concern on this
70was actually a rather odd concern -- pausing there, not
odd, just typical of homophobic and stigmatising
response, but in any event. Her own concern on this was
that if young people read the warnings they would be
introduced to things that they had never heard about,
which might well have been the case, but the implication
was if they heard about it, if they'd be introduced to
them, they would race away and do them, they would race
away and become homosexual.
So prejudice, stigma and ignorance runs through the
whole of this history, we say, and it is important to
observe, and you may feel able to observe Sir, it's of
course it is a matter for you, that that stigma hasn't
evaporated. That stigma is still there. My clients
still experience it and there is still secrecy and cover
up among some parts of the community because of the
knowledge of the impact of stigma.
So stigma and human rights, I end with, and those
are my submissions unless there's anything in particular
I can help you with. I'm a little early but I hope
I won't be criticised for that.
ANSWER:
No, not at all. Thank you very much
indeed. You have given us an interesting and slightly
different perspective, as you set out to do. So thank
you.
71 |
46,829 | 347 | QUESTION:
Thank you, sir. Thank you.
ANSWER:
Ms Richards.
|
46,830 | 348 | null |
46,831 | 349 | null |
46,832 | 350 | null |
46,833 | 351 | null |
46,834 | 352 | null |
46,835 | 353 | null |
46,836 | 354 | null |
46,837 | 355 | null |
46,838 | 356 | QUESTION:
Professor Franklin, I'm going to ask you
first for an overview of your career. You undertoo k,
96 I think, various house officer and senior house
officer roles in Leeds between 1974 and 1976?
ANSWER:
Yes, I did.
|
46,839 | 356 | QUESTION:
And then between I think 1977 and 1980 you were
a research training fellow for the Medical Research
Council?
ANSWER:
Yes.
|
46,840 | 356 | QUESTION:
Your work then, I think, was predominantly related to
sickle cell anaemia?
ANSWER:
Yes, the research was, yes.
|
46,841 | 356 | QUESTION:
Did you undertake any clinical work during that
period?
ANSWER:
I did nothing for the first year and then I used to
attend a sickle cell anaemia clinic at The London
School of Hygiene and at University College about
a couple of times a month, and that carried on for
those -- the last two years, and in the final year
I used to go and help a general haematology clinic at
the now defunct Royal Northern Hospital.
|
46,842 | 356 | QUESTION:
Then from 1980 to 1982, you were a senior registrar in
haematology at University College Hospital?
ANSWER:
Yes, based there, yes.
|
46,843 | 356 | QUESTION:
That was your specialist haematology training to
achieve membership of the Royal College of
Pathologists?
ANSWER:
Yes.
|
46,844 | 356 | QUESTION:
Your statement and your CV tells us that between
October 1980 and February 1981, you worked for
approximately three months at Great Ormond Street
Hospital under Professor Hardisty?
ANSWER:
That's right, yes.
|
46,845 | 356 | QUESTION:
So you would, in the course of that period, have se en
children with bleeding disorders. You said you did n't
have a decision-making role in terms of what treatm ent
to provide to them?
ANSWER:
No, I didn't. It was observational, I would say.
|
46,846 | 356 | QUESTION:
Can you recall anything about what the treatment
policies were at Great Ormond Street at that stage?
ANSWER:
I can't really. I remember they had Lister
Factor VIII. I think that was the first time I had
heard of Lister Factor VIII. I don't remember whet her
they had commercial product and I don't remember
seeing cryoprecipitate used either.
|
46,847 | 356 | QUESTION:
Then from March to September 1981 you were training in
blood transfusion medicine under Dr Barbara at the
North London Regional Transfusion Centre in Edgware ?
ANSWER:
Well, I didn't work with him. He taught me about
transfusion virology but also Dr Marcela, now Dame --
Professor Dame Marcela Contreras was the haematolog ist
who was actually leading my training.
98 |
46,848 | 356 | QUESTION:
You said in your statement that the focus in terms of
what you recall learning there was on hepatitis B. It
would seem likely that there must have been some
discussion of non-A, non-B hepatitis and its risks at
that time. Can you --
ANSWER:
I think there was some. I mean, I have to say outs ide
the world of haemophilia, I would say even in gener al
haematology, there was probably a lack of appreciat ion
of the level to which blood transfusion red cells a nd
so on could transmit non-A, non-B hepatitis. I mea n,
I think there was -- I'd heard of it. I think ther e
was -- generally there was a feeling that it was
something that largely happened in the United State s
because of paid donors and that the volunteer donor
base in the UK was much safer.
So from that point of view there wasn't a lot of
exposure to knowledge of it.
|
46,849 | 356 | QUESTION:
Then you moved to St Albans City Hospital, where yo u
spent, I think, around three months doing general
haematology work?
ANSWER:
Yes, yes.
|
46,850 | 356 | QUESTION:
Then January to August 1982 you were at UCH. You'v e
said in your statement you were mainly concerned wi th
the development of a bone marrow transplant program me?
ANSWER:
Well, my boss, Professor Tony Goldstone, was settin g
99 out the programme there. He had been doing that fo r
a year or so. I was involved to a very small degre e
while I was still a research fellow but then, yes,
I was quite involved with the early transplant
patients that were starting off what is now a very big
unit.
|
46,851 | 356 | QUESTION:
You have said there was no involvement with the car e
of those with bleeding disorders, save for the odd
patient?
ANSWER:
Well, yes. I mean, I remember seeing the occasiona l
person with haemophilia on the wards but, really, i t
was a haemophilia centre but couldn't have had many
patients, I think.
|
46,852 | 356 | QUESTION:
Did you have any involvement in decisions as to how to
treat those occasional patients?
ANSWER:
Don't remember having any such role, no.
|
46,853 | 356 | QUESTION:
Do you have any recollection of what treatment was
routinely provided?
ANSWER:
No, I'm afraid not, no.
|
46,854 | 356 | QUESTION:
Then on completion of that specialist training you
gained membership of the Royal College of
Pathologists?
ANSWER:
Yes.
|
46,855 | 356 | QUESTION:
Then in September 1982, you took up your post as
a consultant at the Queen Elizabeth Hospital in
100 Birmingham?
ANSWER:
Yes.
|
46,856 | 356 | QUESTION:
You were around 33 years old at the time?
ANSWER:
Just about, yes.
|
46,857 | 356 | QUESTION:
Your statement suggests that your appointment was
principally to develop a bone marrow programme beca use
of your sickle cell experience; is that correct?
ANSWER:
Yes. I mean, they had quite a large sickle cell
population, which I think made me attractive but th ey
particularly wanted to start doing -- we call them now
stem cell transplants, bone marrow transplants, yes .
|
46,858 | 356 | QUESTION:
So in terms of haemophilia care, Professor Stuart w as
still the director of the haemophilia centre at tha t
point?
ANSWER:
He was.
|
46,859 | 356 | QUESTION:
For that first 12 months, your statement describes you
only dealing with the care of patients with bleedin g
disorders when you were on call?
ANSWER:
Yes, so if we had haemophilia patients in the ward,
you would see them on the ward, the ward round, dur ing
the day and then if there were any issues deal with
them at weekends or at night and, as you are fully
aware, the haemophilia care was a 24-hour service.
Men could come up for treatment to be seen on the
ward -- the treatment room was next to the ward --
pretty much any time of the day or night. So I'd g et
involved, to some extent, in those episodes.
|
46,860 | 356 | QUESTION:
I will ask you a little more about that in a few
minutes.
You then took over as the director of the
haemophilia centre after approximately a year, so
September 1983 or thereabouts?
ANSWER:
Yes.
|
46,861 | 356 | QUESTION:
Did Professor Stuart continue as a consultant or di d
he retire completely?
ANSWER:
No, he -- obviously, he was a professor. He had
a research interest and he continued to provide
out-of-hours cover on a one-in-three rota and at
weekends, but he largely retained responsibility fo r
the laboratory and the clinical -- the hospital
laboratory and his research.
|
46,862 | 356 | QUESTION:
So is it fair to say that at the point at which you
became a director of the Haemophilia Centre at the
Queen Elizabeth Hospital your direct experience
relating to the treatment of patients with bleeding
disorders had been largely limited to those three
months at Great Ormond Street and then the first
12 months at QEH, working with --
ANSWER:
Yes, I was quite inexperienced really.
|
46,863 | 356 | QUESTION:
You remained consultant haematologist and director of
102 the Haemophilia Centre at the Queen Elizabeth Hospi tal
until the end of July 1992 --
ANSWER:
Yes.
|
46,864 | 356 | QUESTION:
-- and then moved to Glasgow --
ANSWER:
Yes.
|
46,865 | 356 | QUESTION:
-- to take up a role as a consultant focusing on bo ne
marrow transplantation?
ANSWER:
Yes.
|
46,866 | 356 | QUESTION:
You then worked for a number of years thereafter in
the Blood Transfusion Service, initially locally an d
then as SNBTS's National Medical and Scientific
Director?
ANSWER:
Yes, I started as National Medical and Scientific
Director in early 1997.
|
46,867 | 356 | QUESTION:
I think you remained a professor of transfusion
medicine throughout that period as well.
ANSWER:
Yes, and I continued to work on the transplant unit s
as well.
|
46,868 | 356 | QUESTION:
Then 2011 to 2014, you had a similar role at the Ir ish
Blood Transfusion Service?
ANSWER:
Yes, that was just solely the medical and scientifi c
director, with no other hospital role.
|
46,869 | 356 | QUESTION:
As I think you know, the questions I ask you today are
going to be focused upon your work at Birmingham.
ANSWER:
Yes.
103 |
46,870 | 356 | QUESTION:
I'm not going to be asking you about your work in
Scotland, although that may be something that the
Inquiry will need to ask you about at a later stage of
its hearings.
In terms of working parties or organisations you
belonged to, you were, once you became director of the
Queen Elizabeth Hospital Centre, a member of UKHCDO ?
ANSWER:
Yes. I think that sort of went with the territory.
|
46,871 | 356 | QUESTION:
I think we've only got a record of you attending tw o
meetings, one in 1983 and one in 1984. Does that
sound about right?
ANSWER:
Yes, I don't remember -- well, it was a long time a go.
I didn't actually remember many of the West Midland s
working parties either, other than the early ones b ut
I don't think I did go to them after that.
|
46,872 | 356 | QUESTION:
As you just alluded to, you were a member of the
Working Party On the Treatment of Haemophiliacs for
the West Midlands Regional Health Authority, and we 'll
look at some of the minutes of that in the course o f
your evidence.
You gave evidence to the Archer Inquiry?
ANSWER:
I did.
|
46,873 | 356 | QUESTION:
You, I think, had some involvement in some litigati on
against the West Midlands Health Authority. You ha d
to provide some schedules, I think you said, in
104 relation to patients. Without, obviously, discussi ng
any individual case, can you recall the nature of y our
involvement?
ANSWER:
There were four legal cases, I remember. Two of th em
related to areas of relevance to this Inquiry but n one
of those -- I don't think any of the cases got to
court. I think those two were both -- well, they
didn't proceed.
The other two related to issues with care of
haemophiliac -- people with haemophilia and I belie ve,
but I'm not sure, that they were settled out of cou rt.
|
46,874 | 356 | QUESTION:
Can I ask you just to give us an overview of what t he
facilities were at the Haemophilia Centre at QEH wh en
you took up your post as director in 1983?
ANSWER:
Well, first of all, I had a co-director,
Dr Frank Hill, who came to the hospital once a week to
do the clinic, as I remember, in the morning, and t hen
we would meet through the afternoon to discuss
problems with particular patients and strategy,
I suppose. We had a single room which was like
a large office, which was a treatment room with
a treatment couch, where patients could have their
treatment administered, whether that was Factor VII I,
those not on home treatment.
I remember us giving FEIBA in there as well. It
was just one room. We had patient records in there .
Definitely patient records of home treatment, so th at
would be sheets that the patients themselves had
filled in.
I don't remember whether we had all of the
patient records in there. I don't believe we could
have done. I think they must have been stored
somewhere else, in medical records, but we certainl y
had quite a lot of filing cabinets with records.
We stored working stock of Factor VIII
concentrate. It was quite a busy room. I think cr yo
was stored down in the blood bank, not in that room .
We only had facilities in there to treat one
patient at a time -- for reasons of confidentiality .
So that was a bit limiting. We had one nurse, of
sister grade, who was full time for haemophilia car e,
and she would see patients who attended whether for
home therapy advice or supplies or people not on ho me
therapy with a bleed. She may be able to manage a lot
of those, otherwise she would then refer to doctors ,
which would depend on who was around really on the
main team.
Medical support, in addition to myself and
Dr Hill were provided by a senior registrar, one
registrar and a couple of senior house officers, ab out
106 four junior level doctors.
We had quite a good coagulation laboratory,
which was down in the hospital laboratory, but that
was about it really. There was no -- well, I suppo se
we had a room -- two rooms and an out-patient clini c,
but that was part of the general out-patient
facilities. So really, in terms of special
facilities, there was really just this one room and
one person, one nurse.
|
46,875 | 356 | QUESTION:
In terms of doctors -- we'll come back to your role
and Professor Hill's -- you've mentioned in your
statement already, and your evidence relating to
Professor Stuart, but there was a Dr Brian Borton . ..?
ANSWER:
Boughton.
|
46,876 | 356 | QUESTION:
Boughton. Did he --
ANSWER:
I do know he was a senior lecturer. He really only
was doing the same as I was doing in the first year ,
which was one in three nights and one in three
weekends covering.
|
46,877 | 356 | QUESTION:
Were there registrars, senior registrars, who
participated in the work of the clinic over the yea rs
that followed?
ANSWER:
Yes, yes, depending on -- they, a bit like me in my
training, would rotate through the department. The re
were other hospitals in the area, Coventry, the
107 Children's -- Birmingham Children's Hospital,
General Hospital. So they all had junior doctors w ho
would then rotate, move round, to ensure that their
training was -- covered all the specialties.
|
46,878 | 356 | QUESTION:
So Professor Hill would come and do clinics jointly
with you at the Queen Elizabeth. Did you have any
involvement in clinics at the Children's Hospital?
ANSWER:
No, never.
|
46,879 | 356 | QUESTION:
Can you recall when you started at Queen Elizabeth
Hospital? So first appointed as a consultant but
before you took over as director a year later, was
there any particular guidance or training that you
recall being given by Professor Stuart?
ANSWER:
You know, I don't remember, to be honest.
|
46,880 | 356 | QUESTION:
How did the relationship with Professor Hill, and t he
fact that you were co-directors, how did that work in
practice?
ANSWER:
I think it worked pretty well. I mean, I had a bit
more time to spend than him, but he was a trained a nd
experienced haemophilia -- well, I would say,
haemophilia expert. He'd trained at Great Ormond
Street, he'd trained in Oxford, and the systems,
although barely sufficient for the management of th e
bleeds in the men with haemophilia, I thought it wa s
actually quite well organised in terms of managing the
108 treatment.
|
46,881 | 356 | QUESTION:
You said in your statement that you were, to some
extent, guided by Professor Hill because he was mor e
experienced. You also told the Archer Inquiry that
because you were -- I'm not directly quoting from y ou,
but you were relatively inexperienced --
ANSWER:
Yes, I accept that.
|
46,882 | 356 | QUESTION:
-- you needed guidance from more haemophilia expert s
and tried to follow a consensus opinion. Is that
correct?
ANSWER:
Yes.
|
46,883 | 356 | QUESTION:
Let's have a look in terms of a rough idea of numbe rs
of patients, Professor Franklin.
Could we have UBFT0000252, please, Henry.
This is a report prepared jointly by you and
Professor Hill in April 1986. It was a request for
further resources, and we'll come on to that at
a later stage of your evidence, about funding probl ems
for the care of those with HIV.
But if we just look at the second paragraph on
this page, please, Henry, we can see it said:
"The haemophiliac population within the
West Midlands represents 11 per cent of all the
haemophiliacs in the [UK]. The majority
(about 75 per cent) are registered with the
Queen Elizabeth Hospital or Birmingham Children's
Hospital ... At the Queen Elizabeth there are
423 patients registered as having a bleeding disord er
... of these approximately 90 attend regularly for
therapy or use Factor VIII concentrate at home."
So that's an accurate snapshot, is it, of the
numbers?
ANSWER:
I think so, yes.
|
46,884 | 356 | QUESTION:
I don't think we need to go to it but in a report t he
following year you described Queen Elizabeth Hospit al
as effectively the fifth largest haemophilia centre in
England and the largest not to receive any bespoke
funding as a reference centre?
ANSWER:
Yes. I don't particularly remember that. In fact,
I only really realised how large we were until I wa s
preparing for this inquiry. But yes, it was clearl y
quite a big centre.
|
46,885 | 356 | QUESTION:
I think it's right that during the time you were
director, the QEH didn't have the status of
a reference centre?
ANSWER:
No, I think they changed -- they seemed to be quite
obsessed with the rules around what a reference cen tre
was, the UK Haemophilia Centre Doctors' Organisatio n.
I think the Children's Hospital became a comprehens ive
care centre.
110 |
46,886 | 356 | QUESTION:
Yes, in 1989.
ANSWER:
Yes. So I think they changed the nomenclature, but
no, I think the adult centre remained the same stat us.
|
46,887 | 356 | QUESTION:
Can we look at the annual return for 1983. Again,
just to get an idea of what treatments were being u sed
at that stage.
Henry, it is HCDO0000206_002.
So this is for the treatment of patients with
haemophilia B, and we can see it's a 1983 return.
Director: yourself and Dr Hill. Nine patients with
haemophilia B and the sole treatment there, NHS
Factor IX concentrate, and we can see both hospital
and home treatment.
ANSWER:
I think I have a different one --
|
46,888 | 356 | QUESTION:
I am looking at the wrong paper document.
I am so sorry.
Yes, sorry, this is the 1983 return for
haemophilia A patients, carriers and von Willebrand 's
disease. So we can see 83 patients treated during the
year with haemophilia A, three carriers of
haemophilia A treated during the year, and 13 with
von Willebrand's disease treated during the year.
111 Then we can see the products being used:
cryoprecipitate, 97,090 units, and that's just for
hospital treatment.
So no cryoprecipitate for home therapy by that
time. Does that accord with your recollection?
ANSWER:
Yes, I don't remember any patients still -- if they
ever were, still being on cryoprecipitate at home.
|
46,889 | 356 | QUESTION:
Then NHS factor concentrate we can see being used b oth
in hospital and for home treatment?
ANSWER:
Yes.
|
46,890 | 356 | QUESTION:
338,000-odd in hospital, 569,000-odd for home
treatment. But then the predominant product is the
Armour Factor VIII, so the commercial product,
a smaller amount used in hospital but 1.2 million u sed
for home treatment?
ANSWER:
Yes.
|
46,891 | 356 | QUESTION:
We will look at some of the contracting arrangement s
in a little while.
So that's haemophilia A patients.
Von Willebrand's we can see treated solely with
cryoprecipitate.
And then if we go to the document I had been
looking at -- sorry, Henry, HCDO0000206_004 -- we c an
see there nine patients with haemophilia B, no
carriers, and the sole product used both in hospita l
112 and for home treatment is the NHS Factor IX
concentrate?
ANSWER:
Yes, I think we always -- as far as I remember, we
always had enough NHS Factor IX.
|
46,892 | 356 | QUESTION:
You've said in your statement that the home treatme nt
programme was established before you took up your
post.
ANSWER:
Yes.
|
46,893 | 356 | QUESTION:
You didn't remember actually starting anyone on hom e
treatment yourself; is that correct?
ANSWER:
No, I don't remember doing that, no.
|
46,894 | 356 | QUESTION:
Was there any programme of prophylactic treatment a t
the time?
ANSWER:
No, I don't -- well, I don't remember that, and
certainly I don't think there was in the adults.
Prophylaxis was still -- was talked about and
considered to be beyond our ability to afford it,
I think, probably.
|
46,895 | 356 | QUESTION:
One of the treatment policies in operation when you
joined was a policy of trying to keep patients on t he
same product. Can you explain how that worked.
ANSWER:
Yes. Well, as taught to me, and I think it does ma ke
sense, the idea was that once you were exposed to o ne
batch of product, it would be best if you continued to
use that and not be given either different batches of
the same product or lots of different product.
And the idea there, I think, is to -- well, is
to try to restrict the number of donors to which
a particular person is exposed. You are still goin g
to be exposed to a lot of donors but if you had -- say
you had three treatments from the same batch of a U S
product, that might be a 20,000 donor exposure, whi ch
sounds a huge number, but if you have one treatment
from one company, one from another and one from
another company, that could be 60,000 donors. So t he
chances of becoming infected with something would h ave
been much greater.
I think it did make a bit of a difference in
terms of HIV but I don't think it made much differe nce
for hepatitis.
|
46,896 | 356 | QUESTION:
First of all, it was a policy you inherited?
ANSWER:
Oh, yes. It wasn't my idea, no.
|
46,897 | 356 | QUESTION:
The rationale was to reduce the risk of infection?
ANSWER:
Reduce donor exposures and therefore, hopefully,
reduce the risk of infection.
|
46,898 | 356 | QUESTION:
How did that work in practice? How was a particula r
batch secured for a particular patient?
ANSWER:
I can't actually remember exactly how. I mean,
I think once a person was on a particular batch, th at
would be on their record in the treatment room. So if
114 they were not on home treatment and were coming up for
ad hoc treatment, the same batch would be given if
available. And if they were on home treatment and
coming up to replenish their home stock, they would be
given the same batch if at all possible.
|
46,899 | 356 | QUESTION:
We'll just look at a couple of documents about this .
So could we have UBFT0000156, please.
This is a later letter, written in the context
of HIV haemophilia litigation, but it's referring t o
an earlier letter from March 1984, and we don't hav e
the earlier letter, Professor Franklin, which is wh y
we are having to look at this as our best evidence of
it. You refer to a letter you had sent to Dr Ala, the
regional director of the transfusion centre, in
March 1984, outlining reasons for seeking continuit y
in Factor VIII supply.
Then you talk about:
"... supplies of material NHS material had been
very limited and both myself and my colleague ..."
Presumably that would have been Dr Hill?
ANSWER:
Yes.
|
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