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2,500 | 27 | QUESTION:
You retired from that post in 2011.
ANSWER:
Yes.
|
2,501 | 27 | QUESTION:
Then, in terms of your membership of or involvement
with other relevant organisations, you were a membe r
of the United Kingdom Haemophilia Centre Directors
Organisation from late 1983 until 2011?
ANSWER:
Yes, as are all Haemophilia Centre doctors.
|
2,502 | 27 | QUESTION:
I think, during that time, you were at various stag es
on UKHCDO working parties of one kind or another?
ANSWER:
I was.
|
2,503 | 27 | QUESTION:
You became a designated HIV physician for the area --
was it the whole of Kent, or the Margate area?
ANSWER:
It was for the health authority. This was really a n
unusual step. As we'll doubtless discuss, we had
a particularly significant HIV problem, and the AID S
Control Act, which I think was 1985, stipulated eve ry
HIV -- every health authority had to have a nominat ed
HIV physician. So they said to me, how would I lik e
to be that person, as I seemed to be the only one w ho
had any HIV expertise. So from that moment on, I o nly
did haemophilia and HIV.
But that, I think, gave me different insights,
because I think I was the only haemophilia doctor w ho
was an HIV physician, so I had people with haemophi lia
and HIV, and some people with HIV who did not have
haemophilia.
|
2,504 | 27 | QUESTION:
You're right. We'll come on to that in more detail
later.
You were a medical trustee appointed by the
Department of Health for the Macfarlane and Eileen
Trusts from 1996 to 2009?
ANSWER:
Yes. I think that came out of the -- you know, the
rather unique HIV situation. I was a choice to be the
trustee which -- the dates you say.
|
2,505 | 27 | QUESTION:
Again, I'll ask you some more about that at a later
stage.
You had some involvement with The Haemophilia
Society. As I understand it, you were on their
treatment and care committee -- and I'm taking thes e
dates from your CV -- from 1987 to 1991. You were on
their General Services Committee from 1992 to 1996,
6and their Medical Advisory Panel from 1999 to 2005?
ANSWER:
I was. I was particularly involved with them when we
were trying to pressurise the Government to set up
what became the Macfarlane Trust. So I acted with
them as a sort of media liaison and medical support ,
and we went around -- we went to the House of Commo ns
a few times and made presentations and lobbied
politicians. So, yes, I was actively involved with
the Society.
|
2,506 | 27 | QUESTION:
Then you were one of the founders of an organisatio n
called the Haemophilia Alliance. Again, I'll ask y ou
a little more about that later. That was establish ed
in 1999?
ANSWER:
It was.
|
2,507 | 27 | QUESTION:
Now, you also have given evidence to both the Arche r
Inquiry and the Penrose Inquiry?
ANSWER:
I did.
|
2,508 | 27 | QUESTION:
I'm going to take your evidence to those inquiries as
read, Dr Winter. I'm not going to go through it.
Although, inevitably, my questions will cover some of
the same ground, and we may look at a handful of
extracts from your evidence.
I want to start, if I may, by asking you about
the four years or so that you were at Guy's Hospita l,
so from 1979 to 1984.
7Guy's was an accredited haemophilia centre, but
a small one; is that right?
ANSWER:
Well, it was because it was only barely a mile from
St Thomas' which was a major centre. So, in a way, it
was quite curious that it was seeing people with
haemophilia at all, but there were some haemophilia cs
who historically had gone there and chose to stay
there. Neither of the consultants had an interest or
expertise in haemophilia; so, together with another
senior registrar, I started to get involved and tha t
would be the first time really that I got involved
with haemophilia patients.
|
2,509 | 27 | QUESTION:
Roughly how many patients were registered with Guy' s
-- haemophilia patients -- during that period?
ANSWER:
Well, there probably was sort of 30 or 40 registere d,
but there was a hardcore of sort of ten to 15 sever ely
affected patients of all ages.
|
2,510 | 27 | QUESTION:
I think your statement suggests mostly adults, but
there were a small number of children.
ANSWER:
There were.
|
2,511 | 27 | QUESTION:
The director of the Haemophilia Centre was Dr Percy
Barkhan?
ANSWER:
He was an expert in vitamin K metabolism.
|
2,512 | 27 | QUESTION:
Yes. You have said in your statement, in practice,
the haemophilia patients were managed by the senior
8registrars. I think one of the other registrars wo uld
have been Dr Clarke; is that right?
ANSWER:
No. He was the other consultant. He was also not an
expert in haemophilia.
|
2,513 | 27 | QUESTION:
Can you recall who the other registrars were?
ANSWER:
I can. They were a husband and wife team, Dr Hugh and
Yvonne Williams.
|
2,514 | 27 | QUESTION:
Now, your statement explains that, as a registrar a t
Guy's, you weren't involved in the procurement of
blood products.
Can you help us with whose decision it was as to
what products to source and use at Guy's? Was it
Dr Barkhan's?
ANSWER:
Well, I was certainly not part, in any way, of the
procurement, as you say, because I had no role in s ort
of day-to-day managerial functions as, effectively,
a trainee. My recollection was that we received fr om
a transfusion centre supplies of such NHS-derived
Factor VIII concentrate as was available, and that
almost certainly was never enough. So to top that
up -- I'm sure they supplied to nearly all centres --
we had to purchase some commercial concentrate to m eet
needs.
There was a particular issue in the south.
Every health authority was supposed to have its own
Blood Transfusion Service, but for reasons that wer e
never clear, the south-east Thames did not have its
own Blood Transfusion Service. So the Tooting cent re,
the Tooting Blood Transfusion Unit, covered two ver y,
very large regional health authorities. It covered
the south-east, and it covered the whole of the
south-west, and that really led to a lot of problem s
because that service was inevitably under a great d eal
of pressure, in terms of clinical demand.
I don't recall, I think, that some -- you know,
we went to the pharmacy and said, you know, we're n ot
receiving enough Factor VIII concentrate that is
NHS-derived. We're going to need to buy some
commercial concentrate. I can't remember which one we
used, and, as I say, I was not part of the contract ual
arrangement.
|
2,515 | 27 | QUESTION:
The way you've put it in your statement is your
recollection that you received an allocation of NHS
concentrate, and then a shortfall was covered by th e
usage of commercial concentrates?
ANSWER:
Yes.
|
2,516 | 27 | QUESTION:
I'm going to ask you more about cryoprecipitate in
a while, but just dealing with the use of it as
a matter of fact, your statement says that at Guy's ,
cryoprecipitate was not used, although it was
10 available.
ANSWER:
It was used on occasions. If we had, for instance,
a patient with mild haemophilia or von Willebrand's
disease -- already, you know, late 1970s -- we'll b e
talking more about this, doubtless. But we're alre ady
aware of the evolving data about abnormal liver
function, suggestive of hepatitis. We were trying to
limit the exposure of patients to Factor VIII
concentrates if they were not regularly treated
patients.
So I think, occasionally, if they were children,
if it was a rarely treated child, particularly if t hey
were adults, maybe on occasions if the products wer e
in short supply, we certainly did use occasional
cryoprecipitate. Cryoprecipitate is so laborious t o
give up you don't forget giving it and, you know,
I can remember days when we sat there drawing it up
and giving it to patients, but there weren't very m any
of those days.
|
2,517 | 27 | QUESTION:
Maybe you don't know the answer to this, but do you
know whose decision it was at Guy's to make only
limited use of cryoprecipitate? Was that
Dr Barkhan's?
ANSWER:
No. Everything -- all those clinical decisions wer e
left to the two registrars running the programme.
11 |
2,518 | 27 | QUESTION:
So that was effectively your decision and the decis ion
of the colleagues you've mentioned?
ANSWER:
Yes.
|
2,519 | 27 | QUESTION:
I'll come on later to the pros and cons of
cryoprecipitate, Dr Winter.
You also said in your statement that when you
started at Guy's there was no home treatment
programme, but you established one. Can you just
explain a little more how you went about it, what
discussions took place?
ANSWER:
Well, it's only, as we've said, a pretty small numb er
of patients. But, you know, factor VIII concentrat es
came in, what, '73/'74, and they instantly and
immediately revolutionised the quality of life for
people with haemophilia, and by the mid-1970s, most
centres had established this package of comprehensi ve
care which included the home treatment programme. So
this wasn't anything controversial. It was surpris ing
that Guy's, you know, for patients with severe
haemophilia, didn't have such a programme establish ed.
So I spoke to Dr Barkhan, and he thought, you
know -- I mean, his attitude was he wasn't going to
get involved with the management of haemophilia car e,
even though they were a designated haemophilia cent re,
and he was very happy for us to take the matter
12 forward. It didn't involve very much in the way of
financial input. It was really logistics. It was
training patients how to give their own injections,
training parents how to give injections, getting
transport arranged so we could get Factor VIII to t he
home setting. There wasn't a great deal of expense
involved. It was really quite a straightforward
undertaking.
|
2,520 | 27 | QUESTION:
Was any consideration given as to whether setting u p
a home treatment programme would increase the deman d
for concentrates and, therefore, potentially increa se
the need for commercial concentrates to be used?
ANSWER:
Well, I think there's data that the use of Factor V III
was already increasing at that time, and, in
particular, people were beginning to start to use
prophylaxis; that's to say, Factor VIII given not t o
treat a bleed but to prevent a bleed. People with
haemophilia, once they were established on home
therapy, which was such an enormous advantage, they
could take Factor VIII to their school or to their
work and inject it in the place where they were. Y ou
know, their life didn't revolve around haemophilia
centres any longer. It just gave them, you know,
complete independence. They then began to look at
their lives and say, "Every Tuesday evening I play
tennis and it seems to me sensible because it's a r isk
activity but one that I very much enjoy, I'm going to
talk to the doctors about whether I might give myse lf
an injection to target that period of activity".
So prophylaxis was, you know, pioneered by the
Swedish, really, that were starting to be there as
part of haemophilia management and something that m ost
particularly for children, later for adults, was
something that was really effective.
So Factor VIII was growing in usage from the
mid-1970s onwards.
|
2,521 | 27 | QUESTION:
What information or advice did you or your fellow
registrar colleagues give to patients or parents of
patients in relation to home treatment and the use of
Factor VIII?
ANSWER:
Well, I mean, there were criteria that you had to j ump
through to be able to get onto the programme. You' d
be able to do your own injections if you were an
adult. If it was a child, we needed to be satisfie d
that the parents had the ability to recognise a ble ed
and then to implement the Factor VIII therapy
promptly. To keep records. So there were a number of
hoops the patients had to jump through from our poi nt
of view, and then we obviously informed them as to,
you know, the nature of concentrate, to look out fo r
14 any side effects, even though the side effects were
much less than with cryoprecipitate, which really d id
quite commonly cause significant side effects.
I can't remember whether we gave them, at that
stage, any written publications. It's more than
40 years ago. I can't remember -- I can't remember
whether we said anything to them about the evolving
evidence about non-A, non-B.
We certainly would have spoken about hepatitis
viruses because part of being on a comprehensive ca re
programme, including home therapy, is to come in ev ery
two or three months and have a full clinical review ,
and that included blood tests which included hepati tis
markers. So the patients certainly were aware that
they were being screened every three months or so. We
didn't have hepatitis B vaccine at that stage, but
they were aware that part of the package of care th ey
were getting was a range of blood tests which have to
be carried out on people with haemophilia. Most
especially for trying to see whether they had
developed what we call an inhibitor. About
10 per cent of people with haemophilia develop an
antibody which recognises the Factor VIII and destr oys
it, and that's a very significant clinical developm ent
because it makes future treatment with Factor VIII
15 really difficult. So people with haemophilia need
regular blood checks anyway as well as wellness
checks, and part of that package of blood tests was to
do hepatitis markers.
I was certainly aware of the evolving data
around non-A, non-B. I can remember us talking abo ut
it. I can't recall at this distance of time whethe r
we spoke to the patients about our concerns.
|
2,522 | 27 | QUESTION:
I'll ask you a little more about that at a later st age
but, again, just dealing with what, as a matter of
fact, was established at Guy's, what you've said in
your statement is, in terms of the treatments that
were used for patients, with severe haemophiliac
adults you would use either the BPL, Elstree produc t
or commercial depending upon supplies.
Do you have any sense or recollection as to how
often it was that you had to use commercial product s
because there wasn't enough Elstree material
available?
ANSWER:
No, but it was such a recurrent thing for the next
seven or eight years really, extending into my
consultancy. Factor VIII was always in short suppl y
nationally, as we all know, but it was in especiall y
short supply in these two health authorities becaus e
it was being served by one transfusion centre, who
16 were working flat out and who just couldn't cope wi th
demand. So it was a very regular feature that you
would have to top up with commercial.
|
2,523 | 27 | QUESTION:
Do you know or recollect whether anything was said,
for example, by you or your colleagues or Dr Barkha n
or others about this shortage and this particular
problem of having to depend on Tooting, which was
covering these two large Thames Regional Health
Authority areas? Was that problem raised with the
Blood Transfusion Service; do you know?
ANSWER:
Well, not to my knowledge. As I say, I wasn't
a consultant. I was a doctor in training so I had no
sort of managerial/administrative roles, and althou gh
it was a designated centre, you'll see, one of the
papers you sent me of a UKHCDO meeting, I represent ed
Dr Barkhan, and I can remember Dr Barkhan didn't ev er
go to haemophilia meetings. He used to ask me to
represent him, which I was happy to do. But I had no
sort of managerial responsibilities in doing that.
|
2,524 | 27 | QUESTION:
Then in relation to moderate haemophiliacs, so agai n
this is still at Guy's, your statement says that yo u
would use DDAVP or, wherever possible, BPL
concentrate?
ANSWER:
Yes, moderate haemophiliacs, some do respond to DDA VP,
some don't, so you would have to assess the situati on.
If they did respond, fine, you would use that,
depending on what was the need for Factor VIII. If
they were about to have major surgery, the DDAVP
wouldn't be enough.
|
2,525 | 27 | QUESTION:
Where you say "wherever possible, BPL concentrate",
does that mean that, in all probability, some moder ate
haemophiliacs would have received commercial
concentrate because of the shortfall?
ANSWER:
Yes. I mean, all these deliberations were based on an
evolving understanding that you really did not want to
use commercial concentrates if at all possible, as set
out so unforgettably in the World in Action
documentary which we had seen.
So this was something that we didn't really ever
want to do. You know, if you had said to us, "What
sort of Factor VIII would you want?", we would have
said, "We want BPL Factor VIII for our patients and we
don't want to use anything else". But the reality was
there just weren't the supplies to do that, so it w as
with reluctance, great reluctance, that we used
commercial product.
Then we obviously, as recommended by UKHCDO,
started to say, "Well, who should we prioritise to
give the BPL product to?" It was obviously childre n,
mildly affected patients, patients that weren't hav ing
18 Factor VIII very often, because we were especially
sensitive to the possibility of giving them viruses if
they were only going to have a few life-time
treatments.
|
2,526 | 27 | QUESTION:
With mild haemophiliacs and those with von Willebra nd
disease, your statement suggests that the first
treatment of choice would have been DDAVP.
ANSWER:
Yes, we would have assessed them to see whether the
DDAVP -- response to DDAVP is variable, you have to
assess it, but we would have assessed them. I mean ,
von Willebrand's is a particular case because, in
fact, Factor VIII is usually not an appropriate
treatment. So all von Willebrand's we would have
expected to treat with DDAVP, and mild haemophilia we
would have expected to but it would have depended o n
how much rise in Factor VIII could the DDAVP treatm ent
lead to.
|
2,527 | 27 | QUESTION:
With mild haemophiliacs, if you couldn't use DDAVP, is
it possible that at Guy's, because of the shortfall
that you have explained, mild haemophiliacs might h ave
been treated with commercial concentrates?
ANSWER:
It is possible. It very much depended on the clini cal
context. If it was a mild haemophiliac and if DDAV P
wasn't going to work -- which was unusual for mild but
something that happened -- then you were in
19 a different situation. Then it really depended on the
answer to the question: why does this person need
Factor VIII? If the answer was because they are
having a hernia, which is a minor surgical procedur e,
you might say, "I really don't -- you know, this mi ght
be the only time in their life this patient gets
Factor VIII, I might do a wait and see policy here.
I might not give Factor VIII and see if we can get
away with it, with local measures."
But if on the other hand they were having open
heart surgery, I they would -- you would say, "Well ,
DDAVP doesn't work. This patient will have to have
Factor VIII."
|
2,528 | 27 | QUESTION:
You would give Elstree if it was available but if i t
was not available and you felt you had to use
Factor VIII, for the reasons you have given, it cou ld
be commercial?
ANSWER:
Correct.
|
2,529 | 27 | QUESTION:
Then you have alluded to the position of children
already but your statement says, as you've confirme d,
children were prioritised to receive treatment with
BPL supplies, if available effectively. So again,
with children, is it possible/probable that, on som e
occasions at least, they may have had to be treated
with Factor VIII concentrates that were commercial
20 concentrates because you didn't have enough Elstree
product?
ANSWER:
Well, we had -- each month there was a supply, and the
particular dynamic was, as I recall, the policy was
Elstree sent out, in terms of Factor VIII -- there was
a formula related to the amount of plasma that had
gone in from the local Blood Transfusion Service. So
how much Factor VIII came to your region was relate d
to how much plasma Tooting had sent to Elstree. Th ere
was this formula.
But we did every month -- it was monthly, as
I recall -- get a supply which came into pharmacy.
Now, children would have been our priority, and of
course they need less Factor VIII than adults. So my
recollection is that I don't -- you know, this woul d
have been the first choice, that a child always got
BPL. I can't remember giving a child commercial bu t
I couldn't be absolutely sure.
|
2,530 | 27 | QUESTION:
The formula that you've mentioned, that the amount
provided by way of BPL Factor VIII concentrate was
related to the amount of plasma supplied, did that
make it difficult to plan, because you would have n o
control and presumably no knowledge of how much pla sma
had been supplied by the transfusion centre to
Elstree?
ANSWER:
It was a very long-running and thoroughly
unsatisfactory difficulty and, of course, there was
then this great variability of financial need. You
know, haemophilia doctors all round the region didn 't
know whether they were going to need to top up or n ot.
The finance departments hated this sudden appearanc e
of a haemophilia doctor saying, "We didn't get as m uch
BPL Factor VIII this month as we expected, I'm goin g
to need to spend another £50,000 topping up." They
hated things like that. So it was a recurrent
difficulty. When we talk in a minute about the
future, I remember in particular that Dr Savidge at
St Thomas', and when I was at Canterbury, because w e
had -- we had contracts set up with our pharmacies, we
had close contact with our pharmacy divisions,
I remember for some years we directed the BPL produ ct
to the smaller centres because the doctors there
didn't have -- you know, they didn't have resource to
go and order commercial, they didn't have designate d
budgets, they were essentially leukaemia doctors.
Of course if we had that policy, St Thomas' and
the Canterbury centre were buying in bulk, so it wa s
much better for the NHS because we could drive down
the price because we were buying such large amounts .
But I remember for several years the smaller centre s
22 got the priority of BPL, which was never enough for
the two regions, and then we, the two major centres ,
in with two -- South West Thames, South East Thames ,
topped up with commercial.
|
2,531 | 27 | QUESTION:
Now, can I just go back to the question of prophyla xis
at Guy's. What you've said in your witness stateme nt
is that for adults there wasn't, at that stage,
a programme of prophylactic treatment unless it was
short-term for target joints or surgery.
ANSWER:
Yes. Prophylactic treatment for adults didn't real ly
take off until later than that, although it was beg un
to be talked about. But there was a couple of clea r
indications which is really, as you say, if somebod y
had had surgery they would need Factor VIII for
a couple of weeks to make sure that the wound didn' t
break down and that they would re-bleed.
The other particular indication is that one of
the major clinical problems in haemophilia is that if
you, in those days, started to talk to, say, a ten
year old boy with haemophilia and say, "How are you r
joints?" They would very often say, "I have one
particular problem." So the major clinical event i n
haemophilia is a bleeding into a joint, the joint i s
damaged, and because it's damaged it's then more
likely to bleed. So you get into a cycle of bleedi ng
23 causes joint damage causes bleeding. So a very com mon
finding was that patients would have one joint in
particular that was a bad one because they'd got in to
this cycle.
So these were called target joints and there
would be occasions where they would, you know, get
a lot of bleeds. We'd see them for review and they
would say, "Well, I've had three bleeds into my rig ht
knee in the last month", and we would say, "Well, w e
want to calm this down by giving prophylaxis rather
than waiting for the knee to bleed again. So for t he
next month we'd like you to inject yourself three
times a week at home" and that would calm the whole
thing down.
So those were the two very clear-cut indications
for prophylaxis in adults at that time. Years late r
it changed very significantly.
|
2,532 | 27 | QUESTION:
Would those adults falling within either of those t wo
categories, would those generally tend to be severe
haemophiliacs rather than mild or moderate?
ANSWER:
Oh, yes. These features I'm discussing were only f or
severe haemophiliacs. In mild and moderate
haemophilia you don't get that degree of bleeding.
|
2,533 | 27 | QUESTION:
Then in relation to children, again we're still at
Guy's here, you say in your statement that children
24 were treated with prophylaxis if deemed appropriate .
Can you expand upon that, please.
ANSWER:
Yes, I've covered some of that already. So it's qu ite
an undertaking and, you know, you are using very
expensive material. It needs to be given into a ve in.
It needs to be given promptly by parents who recogn ise
a bleed. So there's a number of hoops that parents
needed to jump through to be able to do home
treatment.
Firstly, which wasn't always the case, the child
needed to have good veins. Realistically, you don' t
get prophylaxis going until the child's about three
years old. When the children were about three we
would start teaching the parents how to administer
Factor VIII. But that was the hurdle number one.
Some, I would say about 10 per cent of children, th eir
veins were too poor, and on those circumstances, if
the child was severely infected, we would insert
central venous devices called portacaths. So they
would have to be put in under a surgical procedure,
and it would be like a little disk, like an old hal f
crown, which you could feel underneath the skin, an d
then the parents were taught to inject straight
through the disk, and that would take into a --
straight into a blood vessel. But those could get
infected so we were reluctant to do that. You had to
be scrupulous with hygiene. But that was the first
hurdle.
Secondly, you know, it's a big commitment. So
we needed to be convinced that the parents were tak ing
this seriously. If it was from, you know, a family
with social difficulties, single-parent family, if we
weren't confident that the mother was going to be a ble
to do this, then we would discuss with her whether it
was actually -- whether she felt able to do this.
They had to be trained how to spot a bleed -- you
know, which was done by the nurses. The nurses wou ld
go and visit the home. That was a key part of it.
They would go and see the facilities. Sometimes th e
nurse would come back and say, "I really don't thin k
this is going to work, you know, the social
arrangements are so poor." So those were more
criteria. They had to be able to communicate. You
know, we absolutely needed to know if a child was
having problems. If a -- you know, we didn't want
a mother to come in and say, "Three weeks ago I gav e a
treatment every day for a week because there was a bad
bleed", we'd say, "Why didn't you ring us?" We
absolutely wanted to know if there was a problem.
So these were the sort of things we addressed.
26 Having said that, it was pretty unusual if we said,
"I don't think this is going to work", but it did
happen in a few families.
|
2,534 | 27 | QUESTION:
So the children who went on to prophylactic treatme nt
would all have been severe haemophiliacs?
ANSWER:
Severe.
|
2,535 | 27 | QUESTION:
Was the product that was given to their families fo r
them to use at home on a prophylactic basis always NHS
product or was it --
ANSWER:
By choice, yes, very much so.
|
2,536 | 27 | QUESTION:
To what extent at Guy's were patients given a say o r
a choice in the type of treatment that they had?
ANSWER:
None, I would say, because in those days -- I mean,
I don't think the doctors were given a choice in te rms
of what sort of commercial concentrate. I think
that -- you know, there was a manager in the centre .
I would go and say there was a BPL shortfall and th e
manager would go and order some commercial concentr ate
from the pharmacy, who didn't really know a great d eal
about Factor VIII concentrates as it's not a drug,
it's a blood product, but they would come to some
arrangement with the commercial company for the sup ply
to come in. So we would certainly be talking to
patients about the types of concentrate and that we
had hoped to get them BPL concentrate, but that the y
27 might notice on some months, when the supplies -- w e
would have a van that would send out the supplies t o
the parents' homes or, sometimes, if the patients w ere
coming in for review, they would pick up supplies a nd
goes home with supplies -- they were certainly awar e
that concentrates came in two different generic typ es.
There was the British type and the American type an d
the patients were understandably very keen and anxi ous
to have the British Factor VIII. You know, they us ed
to say to you, "You are going to give me British
Factor VIII this month, aren't you?"
If they had to have commercial Factor VIII,
there wouldn't have been any sort of conversation
about which particular product it was. I think it was
perceived, at that time in any case, there wasn't a ny
clinical difference in efficacy across the differen t
commercial concentrates, and we had no evidence the re
was any difference in risk of infection across the
commercial concentrate. So as doctors we didn't ha ve
any sort of impetus to start making noises with the
powers that be to say, "We don't really like giving
commercial concentrate but we understand why -- the re
isn't enough BPL -- but we really want to have a sa y
as to what sort of commercial concentrate". That s ort
of conversation didn't take place.
28 |
2,537 | 27 | QUESTION:
You have said that patients would express a prefere nce
for British concentrate. What was your understandi ng
of the reasons for that preference?
ANSWER:
Well, haemophilia is a small and close-knit communi ty.
All patients are encouraged to join The Haemophilia
Society. The Haemophilia Society used to produce l ots
of written information for them and we used to have
these residential seminars. Once or twice a year,
there would be a national seminar and we very much
encouraged our patients to go. The weekends were f ree
and they were of great benefit to the patients. Th ey
could be given lectures by doctors or nurses about
matters of interest. There would be little worksho ps
they could go and attend. There would be a dinner and
a few drinks on the Saturday night. They could mee t
other parents. It was something that was terribly
valuable. And this sort of very strong feeling, wh ich
we'll talk about later on, in terms of the critical
times coming five years later, there was this very,
very strong feeling amongst the British Haemophilia
Society population of -- I previously described it as
a sort of Tarzan-oid philosophy, you know: "British
good, American bad. I don't want to have American
Factor VIII."
A lot of that came from publications from The
Haemophilia Society, or it came from these resident ial
weekends and meeting other patients. Of course no
internet in those days.
|
2,538 | 27 | QUESTION:
Do you recall whether, during the years you were at
Guy's, you had conversations with patients about th e
pros and cons of British concentrate versus commerc ial
concentrate?
ANSWER:
Yes. I mean, we had conversations with them, and T he
Haemophilia Society publications were saying that t he
commercial concentrates theoretically carry more ri sk
and we're not happy about that and, as you know, by
this time UKHCDO were beginning to have dialogues w ith
Elstree and the transfusion services and there was
Dr David Owen's initiative, et cetera. So the
patients were well aware of the theoretical
differences. Which is where this philosophy came
from, which you have to completely understand. The y
very much wanted to have British Factor VIII becaus e
it was perceived as being less likely to transmit
viruses.
Of course at that time that phrase meant
"hepatitis" -- nothing known about AIDS.
|
2,539 | 27 | QUESTION:
What about concentrates versus cryoprecipitate?
Again, I'm going to come in more detail to what you
say in your statement about disadvantages of
30 cryoprecipitate but, as a matter of fact, do you
recall whether you had conversations with your
patients at Guy's explaining to them that there was
this other treatment, cryoprecipitate? Many of the m
would presumably have known that from earlier in th e
'70s. Did you explain to them your views of the
relative merits of cryoprecipitate versus
concentrates?
ANSWER:
Well, these are patients who, unless they were
a child, would previously have been treated with
cryoprecipitate, which was available in the late
1960s. So all of these patients, apart from childr en,
knew about cryoprecipitate because it was their
previous treatment before the concentrates came in and
then they didn't need any persuading at all. As
you've seen from the various documentaries that hav e
been on recently, it was such a sea change, to move
from cryoprecipitate -- which was the first treatme nt,
but it really was not, by any measure, a good
treatment, which we will talk about -- to suddenly
this treatment, which is what everybody, doctor,
nurse, patient had wanted, which was small volume,
kept in a domestic fridge, you knew the amount of
Factor VIII on the bottle, didn't have to be in a d eep
freeze, reasonable supply, easy to draw up, quick t o
31 give. From every perspective, the concentrate was so
much better and it was a much more effective
treatment. You know, cryo was not a very effective
treatment at stopping bleeding. You couldn't use i t
for prophylaxis.
So the patients were fully signed up to
concentrate. No patient ever said to us, "Can I go
back onto cryoprecipitate?" They would have had to
come off home therapy.
|
2,540 | 27 | QUESTION:
Did you explain to patients the relative degree of
viral infection risks of cryoprecipitate versus
concentrate; in other words, that there was a great er
risk with concentrate because of pooling?
ANSWER:
Well, I didn't know for certain that that was the
case. I mean, in theory, because cryo might come f rom
ten donors and the concentrates come from 20,000,
there were these theoretical risks. But, again,
I think the patients were well-informed as to how
concentrate was made, and I don't think they had an y
reservations at all. No patient ever said to me, " I'm
really not happy about being on concentrate because of
this number of donors that the concentrates are
derived from. I want to go back to having
cryoprecipitate." It was known about. People mayb e
didn't feel very comfortable about it. The doctors
32 didn't feel comfortable about it. It was recognise d
as being an Achilles heel of a treatment that was
otherwise spectacularly successful.
|
2,541 | 27 | QUESTION:
You left Guy's in late 1983. Did you ever find out
how many of the patients you cared for at Guy's wer e
infected with HIV?
ANSWER:
No. There were one or two that moved down to Kent and
came under my care who obviously I did know what
happened to but the rest of them at Guy's I didn't.
I say, these weren't very large numbers. There wer e
probably, as far as I can recollect, ten to fifteen
patients on home therapy.
|
2,542 | 27 | QUESTION:
I want to turn now, please, in more detail to some of
the matters you have alluded to about the developin g
knowledge of risk from concentrates.
Can I start by asking you what you were taught
as part of both, first, your general medical traini ng,
and then your specific haematology training, about the
risks of viral transmission from blood and blood
products.
ANSWER:
Well ...
|
2,543 | 27 | QUESTION:
I know I'm asking you to think back a long time,
Dr Winter --
ANSWER:
A very long time.
|
2,544 | 27 | QUESTION:
-- as best you can.
ANSWER:
I don't recall in my medical training anything abou t
that, but then I qualified in 1973. I now know tha t
there was data from the late 1960s about hepatitis
transmission. Of course then, once I'd entered
haematology training, I was working both at the
Middlesex and Guy's for doctors who were not
haemophilia specialists, so they didn't teach me
anything about that either because they didn't know
anything about it. So the answer is, no, I didn't get
any teaching, but then I wasn't expecting it becaus e
there wasn't anybody, when I was in training, as it
were, to be teaching me about haemophilia. I got m y
information from other sources, by reading and by
going to meetings.
|
2,545 | 27 | QUESTION:
Just in terms of reading material, written material ,
what journals or periodicals would you typically ha ve
read in the late 1970s/early 1980s?
ANSWER:
I think there was a staple diet really. Everybody
read the British Journal of Haematology, so you wer e a
member of the British Society of Haematology. That
was -- you know, it wasn't much haemophilia in that ,
but you read it. Everybody, as members of the BMA,
had the British Medical Journal. There wasn't much
haemophilia in that. There was The Lancet, probabl y
the most important medical journal in Britain, and
34 there was the New England Journal of Medicine. Tho se
were your two main sources, because they would carr y
important articles about haemophilia. Both at the
Middlesex and Guy's we had a weekly journal club,
I remember. So the registrars were told by the
professors to make a presentation each week on an
article of interest from one of those journals.
|
2,546 | 27 | QUESTION:
Then what other sources did you have of information ?
Leaving aside for a moment UKHCDO as a potential
source, which I'll come on to in a moment, what oth er
kind of conversations or meetings would you attend in
the late '70s or early '80s where you would receive
information about matters such as infection risks o r
other hazards?
ANSWER:
Well, very little really. I mean, there's -- when
you're training in haematology, you have already be en
through one postgraduate examination, which is the
membership of the Royal College of physicians. So the
later doctors, like of my generation, went into
general medicine, did another exam to get what's
called the MRCP. Then to be accredited, you had to
pass yet another exam, the membership of the Royal
College of Pathologists. So there were training
programmes for that, as I reflect on your question.
I remember going over London on one afternoon a wee k
35 to a series of seminars that were put on by the
Hammersmith Hospital by the Medical Research Counci l.
So there were MRC path training programmes.
They were mainly general haematology, but they were
for registrars in training who were building up to
this really quite substantial examination which too k
three days, including practicals, which you had to
pass in order to be accredited and to become
a consultant.
A very small fraction of those meetings, if you
were lucky, might be about haemostasis and thrombos is.
|
2,547 | 27 | QUESTION:
Do you recall whether any of those meetings would h ave
covered viral risks from the use of blood or blood
products?
ANSWER:
No. I mean, as we're having this conversation, I'm
getting these memories. The predecessor of Dr Savi dge
at St Thomas' was Professor Ilsley Ingram, who I ca me
to know socially and he I remember going to listen to.
He was one of the tutors on that course. So he was
professor of haemophilia at St Thomas'. He must ha ve
spoken to us about haemophilia. I think in his
department was Professor Mannucci as a trainee, and
that's when DDAVP was discovered by Dr Mannucci whe n
he was a registrar working for Professor Ingram. T hat
would be 1970s. So I'm pretty sure that
36 Professor Ingram would have spoken to us about the
work that Dr Mannucci was doing with DDAVP. I don' t
remember anything, even though I'm -- suddenly, you
have taken me back to a sort of thing I haven't
thought about. I don't remember anybody discussing
with us, if you like, the word non-A, non-B. That was
a concept that was only circulating in haemophilia
centres that was beginning to evolve sort of mid-19 70s
onwards.
|
2,548 | 27 | QUESTION:
Then Dr Barkhan was an infrequent but occasional
attender at UKHCDO meetings. There are a very smal l
number we tracked down that he went to. Did he eve r
come back from UKHCDO meetings and share any of the
information he'd gleaned with you?
ANSWER:
No. I think he saw it as a managerial event.
|
2,549 | 27 | QUESTION:
Again, in this period when you're either at the
Middlesex or at Guy's, so before you take up your
consultant post, did you ever see UKHCDO minutes,
either of the Reference Centre Directors meetings,
which was the meetings attended by ten or so, or th e
bigger meetings attended by all directors, or to wh ich
all directors were invited?
ANSWER:
My recollection is we wouldn't have seen the AGM
minutes which happened just once a year, but I thin k,
as I've already said to you, we were aware of the
recommendations about minimising concentrate exposu re
in non-severe patients. So I think we would have s een
the advice given by the smaller working groups of
UKHCDO to be aware of that.
|
2,550 | 27 | QUESTION:
You mention having become aware of publications or
information from the late 1960s about risks of
hepatitis. The Inquiry has seen evidence dating ba ck
certainly to the 1940s to suggest that the risk of
hepatitis -- then referred to usually as serum
hepatitis, sometimes post-transfusion hepatitis -- was
known to be the major risk from blood transfusion a nd
had been known for decades.
First of all, do you accept that as correct?
ANSWER:
Yes.
|
2,551 | 27 | QUESTION:
Do you recall when you were first to become aware o f
that?
ANSWER:
Well, I can -- although we've just spoken about whe n
I was a student, I was aware that there were two ty pes
of hepatitis, and that they were different, and tha t
hepatitis A was not usually transmitted by blood, b ut
hepatitis B was and we knew all about Australia
antigen, and it was, indeed, even called "serum
hepatitis". So, exactly as you say, by the end of the
1960s at the very latest, it was very well establis hed
that, of the two known types of hepatitis, one of t hem
38 could be transmitted by blood.
|
2,552 | 27 | QUESTION:
You were I think aware, from what you've already sa id,
that commercial concentrates were made using large
pools of material from paid donors?
ANSWER:
Yes.
|
2,553 | 27 | QUESTION:
I think you may have already referred to this,
Dr Winter, but do you recall watching the 1975 Worl d
in Action programme at the time in 1975?
ANSWER:
Not at the time, but I've seen it, and I know it ve ry
well because I've seen it so many times since.
|
2,554 | 27 | QUESTION:
Do you recall whether, although you didn't watch it at
the time, you became aware of it? Was it a topic o f
discussion after its broadcast in late 1975 in
haemophilia circles?
ANSWER:
No. I have no recollection of that.
|
2,555 | 27 | QUESTION:
I'm just going to ask to play a short extract from an
interview you gave in 1988, so you are going to see
your younger self on the screen in a moment, Dr
Winter. It's MDIA0000111. It is the first of the two
clips, please, Henry.
(video played).
I think you have seen that this morning, and you
accept that as an accurate account of your knowledg e
at the time?
ANSWER:
I don't think I regret any of that, is my immediate
39 reaction.
|
2,556 | 27 | QUESTION:
Now, your witness statement says that you knew, or
clinicians knew by 1979 that commercial Factor VIII
was contaminated with non-A, non-B hepatitis and th at
this caused cirrhosis in regularly treated patients .
I want to take that in two stages.
First of all, the existence of non-A, non-B
hepatitis. Can you recall, roughly at least, when you
became aware of the existence of this third type of
hepatitis?
ANSWER:
So the easiest way to deal with this is to do
a timeline. Let's say 1973, concentrates are comin g
in; you're setting up a comprehensive care programm e
with home therapy; you're working out which blood
tests to do; and, as we've just been discussing,
you're going to monitor the patient for known
hepatitis viruses, for hepatitis A and hepatitis B.
So that's already established in 1973 and 1974.
There's this revolution. The patients are all
saying to you, my life is totally, utterly changed.
This is wonderful. We've always called this the
golden interval, a little two-year gap, about 1974 to
about 1976, where suddenly, after years of darkness ,
disability, pain, inability to work properly, have to
go to a special boarding school, suddenly there's t he
40 land of milk and honey, home therapy concentrates,
everything is wonderful, people are feeling really
good, their joints are good, started to do sports
again. Everything is really, really coming along
well. Then 1975, I recall -- again, we were just
talking about him. Professor Mannucci had gone on to
be head of the very large centre in Milan and he,
amongst several other people, produced data that
showed about 45 per cent, I think, in his paper of
regularly treated patients had abnormal liver funct ion
tests of a hepatitic pattern. They didn't have
hepatitis A, and hardly any of them had hepatitis B .
So this was the very start, as far as I'm concerned ,
of this theoretical concept of, we think we're deal ing
with a third virus.
This term non-A, non-B came from the haemophilia
doctors. You know, we started to realise something
else is going on in here. It looks like many of ou r
patients have been exposed to it.
However, they are not -- the pattern of the test
results is not changing very much. Obviously every
three months they came in and had the results check ed.
The results weren't changing very much. There were no
signs of patients getting any clinical liver
disorders. The patients kept saying to us, "I've
never felt as well as this, I never want to change,
this is the treatment I've always wanted". So I th ink
there was a feeling across the haemophilia doctors
that we've noted this. It looks like there's a thi rd
virus, you've to speculate. If it is, it doesn't s eem
to be doing any harm. You know, viruses are variab le.
Maybe -- you see, cytomegalovirus can affect the
liver. It doesn't do a lot of symptomatology. May be
this is something like CMV. It's just causing
a little bit of mild inflammation. The massive
benefits of the new therapy are there for all to se e.
We're just going to keep an eye on this. So this w as
the first phase of what's going to change in a minu te.
All of that changed radically around about
1978/79, again, of various studies. You are going to
be talking to Professor Preston. The Sheffield gro up,
in particular, did a study where they bravely did
liver biopsies on patients with haemophilia who had
abnormal liver function tests, and what their resul ts
from that study blew out of the water instantly the
idea that this was nothing to worry about because
their study showed, as did other studies, that most of
these patients had very significant chronic liver
disease biopsy. They had chronic active -- there's
a range of different histological stages, ranging f rom
42 chronic active hepatitis to cirrhosis. Most of the se
patients were along that pathway.
So this was a dramatic finding and this changed
haemophilia doctors completely to believe this is n ot
something that we can just relax about and just kee p
a look at and ignore -- not "ignore" but not get
excited about. This is a really serious evolving
clinical problem and we really have to look very ha rd
at, you know, how can we minimise exposure to this
third virus (non-A, non-B as we still called it), w hat
steps can we take to minimise further exposure to t he
patients already seen to have it and what steps can we
take to minimise exposure to those patients who nev er
received the concentrate?
|
2,557 | 27 | QUESTION:
So, given that knowledge of hepatitis B, why would one
expect non-A, non-B hepatitis to take a significant ly
different course?
ANSWER:
Because, as I've said, different viruses have
different effects on the liver. You see, if you ha ve
glandular fever, that usually -- if you measured
somebody's liver function tests, you would find tha t
part of a glandular fever episode that those tests
were not normal. So viruses cause a whole spectrum of
degrees of inflammation in the liver. Cytomegalovi rus
is another one where the degree of liver inflammati on
is relatively modest. I am sort of listening to
myself saying this to you. I'm not a liver expert,
but that's my understanding.
So viruses have different pathogenic effects on
the liver and the point I was trying to make before
the break was that we originally thought that non-A ,
non-B might be just a mild virus and nothing to wor ry
about, and then things changed radically with these
studies that we're about to talk about.
|
2,558 | 27 | QUESTION:
If we have up on screen, please, Henry, PRSE0001431 .
This is an article published in The Lancet in
August of 1974 by Prince and others. We can see it 's
entitled:
"Long-Incubation Post-Transfusion Hepatitis
without Serological Evidence of Exposure to Hepatit is
B Virus."
There are just two passages I'm going to ask you
to look at, Dr Winter. The first is just the summa ry:
"An agent other than hepatitis B virus seemed to
be the cause of 36, 71 per cent, of 51 cases of
post-transfusion hepatitis identified during
prospective biweekly serological follow up of 204
cardiovascular surgery patients. The sera of the 3 6
cases showed no evidence of the antigen or antibody
response expected to accompany infection by HB viru s
and to be detectable by the sensitive assays used.
Incubation periods and clinical and epidemiological
features were inconsistent with hepatitis ANSWER:
Cytomegalovirus-associated seroconversion was no mo re
common among the HB-negative cases than among the
HB-positive cases or among patients who did not
develop hepatitis. The data suggest that a large
proportion of long-incubation post-transfusion
hepatitis is unrelated to hepatitis B and that cont rol
of the post-transfusion hepatitis will require
identification of a hepatitis virus(es) type C."
Then, Henry, could we go to the last page of
this, and we'll just pick up one more passage,
46 Dr Winter. If you could zoom in on the top left-ha nd
column, please, Henry, picking up the third line do wn:
"The fact that non-B hepatitis cases are less
frequently associated with serious acute illness do es
not imply that such cases are of lesser importance.
Long-term complications of acute hepatitis B
infection, such as chronic hepatitis, cirrhosis, an d
hepatoma, have been reported to follow mild anicter ic
infections more frequently than severe icteric case s;
consideration must thus also be given to the
possibility that non-B hepatitis may play a role in
the aetiology of some forms of chronic liver diseas e."
So that's the first one. I'm going to show you
four and then ask you some questions. As a matter of
fact, do you think you would have read that at the
time? It's The Lancet, but you were still in gener al
medicine.
|
2,559 | 27 | QUESTION:
I am going to show you four, I think, and then ask you
to discuss them. So that's the first.
So you might have seen it, but you can't say one
way or another?
ANSWER:
I cannot remember papers I read 45 years ago.
|
2,560 | 27 | QUESTION:
That's understandable.
47 The second document -- Henry, could we have
PRSE0000381. This is a publication in the Yale
Journal of Biology and Medicine in 1976. "Non-A,
non-B hepatitis". Purcell, Alter and Dienstag.
If we could go, please, Henry, to the fourth
page, and if we could zoom in on the paragraph
beginning "Although type non-A, non-B". That's the
one there. Thank you. So this is now 1976, and th is
particular paper says:
"Although type non-A, non-B hepatitis is
associated with less severe acute illness than type B
disease, as judged by frequency of jaundice and
magnitude of SGPT elevations, the long-term prognos is
for the two diseases may be similar. Thus, elevati on
of transaminase values persisting for six or more
months has been observed more frequently following
non-A, non-B disease than following type B hepatiti s.
Others have reported similar results. Transaminase
elevations have been documented for several years i n
some patients. Three such patients at the NIH
underwent liver biopsy; two had histopathologic
changes in the liver compatible with chronic active
hepatitis, and the other was diagnosed as having
chronic persistent hepatitis. Thus, chronic non-A,
non-B hepatitis is not necessarily a benign infecti on
48 and may be the cause of a significant proportion of
chronic hepatitis not identifiable as type B diseas e."
Again, I'll come back to the content. As a
matter of fact, do you think it's likely that you
would have read in 1976 this, which is the Yale
Journal of Biology and Medicine?
ANSWER:
No.
|
2,561 | 27 | QUESTION:
Then the third one, Henry. Could we have
NHBT0000092_002. This is the report in -- of an
international forum in Vox Sang, 1977. You will se e
the title is:
"How Frequent is Post-Transfusion Hepatitis
After the Introduction of Third Generation Donor
Screening for Hepatitis B? What is Its Probable
Nature?"
It appears to be the text of a speech delivered
by Harvey Alter in the international forum, or a
publication for that purpose.
If we could just go to the second page, please,
Henry. The last paragraph of the article. If you
could zoom in on that:
"Although non-A, non-B hepatitis is, on the
average, less acutely severe than type B hepatitis, it
can cause severe acute disease and, more disturbing ,
it appears to have considerable propensity to progr ess
to chronic hepatitis. The major thrust of
post-transfusion hepatitis research must now be
directed at developing detection methods for the
non-A, non-B agents, or developing some reliable
method of viral inactivation or removal which would be
independent of testing."
Again, before we consider the content, this is
now 1977, so you're, I think, undergoing your
specialist training by then, but is this the kind o f
publication you would have seen at the time?
ANSWER:
Which journal was this?
|
2,562 | 27 | QUESTION:
It's Vox Sang?
ANSWER:
Vox Sang was really a sort of blood transfusion
journal. I wouldn't have read that routinely.
|
2,563 | 27 | QUESTION:
Then the fourth document, Henry, is RLIT0000228. T his
is another publication from 1977. It's by Hoofnagl e
and others. The publication, Dr Winter, is Annals of
Internal Medicine. Could we go to the last page bu t
one, Henry. It should be the sixth page. Could we
zoom in on the right-hand column. It's quite a lon g
passage, Dr Winter. I am going to read it, as much as
anything, for the benefit of those listening:
"Several clinical and epidemiologic features of
non-A, non-B hepatitis have become clear from studi es
such as the present one. First, non-A, non-B
50 hepatitis closely resembles type B hepatitis. The
incubation period, the clinical symptoms and signs,
and the potential for chronicity appear to be simil ar
to type B hepatitis. Undoubtedly, what was once
referred to as serum hepatitis included both type B
and non-A, non-B hepatitis. Second, non-A, non-B
hepatitis appears to be spread predominantly by the
parenteral route. Most cases have been described i n
association with transfusion, intravenous drug use or
serum inoculation."
Then if we skip down to his third point:
"Third, non-A, non-B hepatitis appears to be
associated with a chronic carrier state and chronic
liver disease. In this study, sero taken from HB
negative donors 149 to 385 days after an implicated
transfusion were found to be infectious. These
implicated blood donors were, for the most part,
asymptomatic, although liver function tests and liv er
biopsy examinations frequently showed evidence of
underlying chronic hepatitis. Finally, non-A, non- B
hepatitis appears to be common. Three of the five
infectious donor studied here transmitted this non- A,
non-B hepatitis."
Can we scroll down a bit further, Henry. Then
it goes on to suggest that more than 90 per cent of
51 post-transfusion hepatitis may be due to non-A, non -B
hepatitis.
That's 1977 Annals of Internal Medicine. Is
that a journal that you would have read at the time ?
ANSWER:
That was on my reading list at that time.
|
2,564 | 27 | QUESTION:
Now, we then get, obviously, to 1978 and
Professor Preston's publication which you've referr ed
to and which you recall and you have already
described. Just looking at those materials, and
Dr Winter, I accept that you were in training at th is
time or, indeed, in general medicine at the first
time, but looking at that material now, would you
accept that if clinicians in the mid-'70s had forme d
the view that non-A, non-B hepatitis was a mild or not
clinically significant condition, they were wrong t o
do so at that time?
ANSWER:
One of the major problems of all this is we did not
know what we were dealing with. The term "non-A,
non-B", there was talk very often this might be
several viruses. This might be hepatitis C, D and E.
It might not even be a hepatitis virus at all.
Somebody getting non A non-B after a blood
transfusion, 1 pint, how does that compare with
someone getting non-A, non-B after being exposed to
Factor VIII concentrate from 20,000 blood -- 20,000
52 donors?
So I think those were all difficulties in
interpretation really. I mean, as I recall, I don' t
think that haemophilia doctors dismissed the abnorm al
liver function tests. The major dynamic I can only
stress to you because I remember it so clearly was, if
you like, there was a sort of unwillingness to thin k
it might be a problem because this new treatment ha d
brought such spectacular benefits and because the
patients were so enthusiastic about it that I think
that people were reluctant, if you like, to say thi s
is a serious problem.
There is a point here that we should have made
a few minutes ago. When you get non-A, non-B, most
but not all patients are asymptomatic. Some people do
have symptoms. If you get Hep B, most people are
symptomatic. When, 1991, whatever it was, I got He p C
testing, and I told all my positive patients, most of
them said, I've never had any symptoms of jaundice.
I don't recall an acute attack. Nobody ever said t o
me I was yellow. You know, this is a surprise to m e
because I've never felt unwell. Other patients ver y
much did. So there are differences there.
I think it was just -- I do think the fact that
it was linked into such an obviously tangible thera py
was one aspect of this, but I don't think it's true to
say that haemophilia doctors dismissed it. We just
maybe -- you know, if we'd known then what we were to
know five years later, we might have done things
differently, maybe in terms even of doing liver
biopsies.
I mean, one of the major features that we learnt
subsequently, which is a very important observation ,
is that when you take a blood test and look at
somebody's liver function tests, you know, the leve ls
might be twice the normal range or four times or si x
times. It turned out there was very little link
between the degree of abnormality and what their li ver
biopsy looked like. So that's very important. It was
totally invalid to say to somebody, oh, your liver' s
less inflamed than three months ago because your AS T
level was 140, and now it's only 80, so that's good ,
isn't it? All that was completely not right.
This, again, of course, was another major
difficulty about monitoring the state of non-A, non -B.
We came to realise, just to do somebody's liver
function tests didn't actually tell you anything
informative, and the only real way to see what
clinical effect the hepatitis was having was to do
a liver biopsy, and nobody wanted to do a liver bio psy
54 on someone with haemophilia. There was a patient w ho
died after having a liver biopsy. You know, these
people have the most profound bleeding tendency kno wn
to medical science. You're probably spending £5,00 0
worth of Factor VIII beforehand and afterwards to m ake
sure they don't bleed. You really need a jolly goo d
reason to want to do that.
|
2,565 | 27 | QUESTION:
I understand that there were uncertainties. Again,
just looking at this mid-70s period. I understand,
and the materials we've just looked at show this, t hat
there were differences observed in the acute stage of
the illness as between hepatitis B and what was
becoming known as non-A, non-B hepatitis.
What I'm really trying to do is try to
understand -- and in some respect, Dr Winter, you'r e
the vehicle for doing so -- try to understand why
clinicians worked or seemed to have worked, to some
extent at least, on the assumption that the long-te rm
consequences, beyond the acute stage into the chron ic
stage, of non-A, non-B hepatitis was going to be le ss
severe than hepatitis B.
You have given us -- you've pointed to
uncertainty, you've pointed to what might have been an
unconscious unwillingness or even a conscious
unwillingness to look beneath this golden therapy.
55 Are there any other reasons that you can think
of why clinicians don't appear to have fully graspe d
that non-A, non-B hepatitis in its chronic stage co uld
be very serious, until Professor Preston's
publication?
ANSWER:
Well, I think the initial symptomatology is another
part of it. I mean, if you've got somebody with
hepatitis B who's really sick at presentation, then
the patient will never forget that, and that's an
important part of the history that comes with the
patient.
I think part of it also were these patients were
not only well, they'd always been well. They hadn' t
sort of come in with diagnoses of acute clinical
jaundice. So I think that's another feature.
I mean, subsequently, the UKHCDO always had
a liver disease working group, and it seems to me,
looking back now to this time, in view of all the
uncertainties that you're perfectly reasonably
raising, I wonder why, unless -- you know, why didn 't
they constitute a liver working party at that time and
ask some liver specialists to get on board?
I mean, you're asking me all these questions
about the way in which haemophilia doctors thought.
Haemophilia doctors are not liver specialists, and,
56 you know, we don't have specialist expertise in
matters of hepatitis.
So I don't know the answer to your questions but
it seems to me, in retrospect, I wonder whether
anybody had thought of forming a hepatitis working
party with some liver specialists on board. Becaus e
that's certainly what happened in the 1980s. I don 't
think I was ever on one but I remember such working
parties existing and there were liver specialists f rom
the Royal Free in particular, I remember, who gave
very valuable advice about the management of
hepatitis.
|
2,566 | 27 | QUESTION:
There was, as a matter of fact, and there's no reas on
why you would have personally known this at the tim e,
Dr Winter, there was a Hepatitis Working Party
established by UKHCDO in the 1970s -- I can't remem ber
off the top of my head the precise date -- with
Dr Joan Trowell, who was a liver specialist part of
it.
Before you joined Guy's and you were at
Middlesex, is it right that Professor Stewart was t he
director there?
ANSWER:
Professor Stewart.
|
2,567 | 27 | QUESTION:
Did Professor Stewart ever report back to his
registrars information he'd gleaned from UKHCDO
meetings about non-A, non-B hepatitis or liver
disease?
ANSWER:
No, it was a very small centre and a major haematol ogy
centre. So haemophilia was a very -- you know, it was
a very small part of the workload as far as
Professor Stewart was concerned.
|
2,568 | 27 | QUESTION:
Lest you wonder me why I ask that, there was
a presentation by Dr Craske of the Hepatitis Workin g
Party in 1978 at the UKHCDO AGM which was attended by
both Professor Stewart and Dr Barkhan. But, in any
event, whatever they may have learnt from that was not
shared with you at that time?
ANSWER:
No.
|
2,569 | 27 | QUESTION:
You've already mentioned Professor Preston's resear ch
which was published in The Lancet in 1978. That
appears on any view to you to have been a very
significant development, from the evidence that you
were giving before the break.
Would you accept that, at least from 1978
onwards, haemophilia clinicians should have worked on
the basis that non-A, non-B hepatitis was potential ly
a very serious condition?
ANSWER:
I mean, Professor Preston's was not the only study, as
I recall. This -- you know, doctors always -- not --
cynical's the wrong word, but you read a paper from
58 a particular group that puts as -- a new observatio n,
you want to see it confirmed by somebody else from
another centre and these observations were. So the re
didn't seem any doubt at all for -- you know, any
reason why a doctor should look at this data and sa y,
"Well, I'm not sure I believe that". Sometimes
doctors do read papers and say, "I don't think
I believe that". The evidence seemed to be very
strong.
So, for me, this is one of the sort of key
moments -- in the whole of the viral epidemic among st
haemophilia patients of contamination, this was an
absolutely key moment, where any haemophilia doctor
should have switched from a viewpoint which was "I' ve
noted the abnormal liver function tests of my patie nts
but they are very well and I'm just keeping an eye on
it and they have probably got a mild form of a viru s"
to "I'm very concerned about what appears to be liv er
biopsy demonstrable significant damage of a range o f
abnormalities, from chronic active hepatitis to
cirrhosis, in these patients which doesn't seem to
bear any relationship to the state of their liver
function test, so I'm not going to be able to monit or
this accurately, I can't tell whether it's getting
worse or better except by doing a liver biopsy and
59 I absolutely don't want to do that on somebody with
severe haemophilia."
So we've used the word "sea change". This is
one of the great sea change moments in the history,
and I would have expected every haemophilia doctor to
say all the rules have changed on this one and chro nic
liver disease is a major clinical problem in
haemophilia.
Spilling out from that, more activity around the
question of self-sufficiency. You know, Dr Owen's
initiative has been and gone, things have gone into
not much in the way of progress '77/'78. We're sti ll
importing significant amounts of imported blood.
Elstree's about to be closed down, I think, because of
the unsatisfactory state of the building.
You would think the other thing that would have
come out of this would have been increased politica l
pressure from the UKHCDO on the Department of Healt h
to say look at this data, you know, this is a reall y
different way of looking at this problem. It now
really does seem to be severe -- nothing known abou t
AIDS -- and it underscores what we've been saying f or
the last few years about the importance of becoming
self-sufficient.
|
2,570 | 27 | QUESTION:
Before I ask the question, let me show you a docume nt.
60 This is March 1979, The Lancet, so it's one you may
have seen. It's PRSE0004067.
So this is The Lancet, March 1979, "Transmission
of non-A non-B hepatitis to chimpanzees by Factor I X
concentrates after fatal complications in patients
with chronic liver disease". It's a number of
authors, including, as you will see,
Professor Zuckerman.
Could we just go, Henry, please, to the last
page, last paragraph. No, that's not it. I'm sorr y,
the last paragraph of this article. So it's the
left-hand column, Henry, my apologies. Beginning
"Until blood donors". No, not that bit, the paragr aph
above.
So this was the view expressed by Professor
Zuckerman and others:
"Until blood-donors can be screened for the
non-A non-B hepatitis agent, it would seem wise to
restrict the use of both commercial and non-commerc ial
concentrates to life-threatening situations."
Then they go on to say that:
"In particular, their use in patients with
chronic liver disease should be avoided ..."
Do you think it likely that you would have seen
this article in The Lancet in '79?
ANSWER:
I probably would. I mean, there are two obvious
problems with this paper, talking about doctors
looking at papers and raising their eyebrow.
Firstly, we came to have no faith at all in
chimpanzees, anything to do with a chimpanzee. The re
was a very famous study evaluating a new form of
Factor VIII which was given to chimpanzees and they
were absolutely fine and it was then introduced int o
clinical practice, and several patients got hepatit is.
So it became clear that chimpanzees were a totally
unreliable model for looking at hepatitis. So, as
a doctor reading that, I wouldn't have been very
impressed about -- just because it's involving
chimpanzees.
The second thing, I mean, these people are not
blood specialists. They want to restrict the use o f
concentrates to life-threatening situations.
Haemophilia is a life-threatening situation. There 's
a very high incidence of very serious bleeding. So
I couldn't accept that bit. I could accept about
restricting the use of commercial concentrates
wherever possible. Doubtless we'll talk at some
stage, today or tomorrow, about haemophiliacs not
having treatment and maybe avoiding the risk of vir us
infections. It's a very -- well, it is the most
62 severe bleeding tendency known to medical science. So
the idea of not treating it, to a clinician like me ,
is not acceptable.
|
2,571 | 27 | QUESTION:
I will come back to that, Dr Winter, but do you rec all
whether there was any discussion about this
recommendation? Were you at Guy's by then?
ANSWER:
No, it wouldn't. I can say for sure that it would not
have got off the ground if it had been presented at
a haemophilia meeting. The haemophilia clinicians
were completely signing up to the principle of
continuing to give treatment, as were the patients,
and, of course, including The Haemophilia Society, who
wrote a letter to the DOH imploring them not to sto p
importing commercial concentrate. So this wasn't j ust
the doctors who wanted to carry on the treatment, i t
was the patients' organisations as well.
|
2,572 | 27 | QUESTION:
Do you accept that, given what you have said about the
change following Professor Preston's work, that
patients should have had that explained to them, sp elt
out to them, that there was now a risk that they mi ght
get non-A, non-B hepatitis which was now understood to
be potentially more serious than had previously bee n
thought?
ANSWER:
I mean, patients already knew they had presumptive
non-A, non-B because, you know, they were told -- a t
63 least in our centre and I'm sure in, you know, othe r
centres -- that, you know, one of the things that
happened at a comprehensive care review was review of
the previous visits' blood tests, and doctors like me
would sit down and say, "You know, you've done your
blood tests again and, as you know, you've got this
abnormal pattern of liver function, but it doesn't
seem to be changing". As I've said to you, we now
know it wasn't a valid statement as to in any way
predicting what their liver inflammation was going to
be in vivo, as it were, and patients were aware tha t
we were trying to, as a country, move over to
a situation of self-sufficiency, and they were
supportive of that. Very, very strongly. As I sai d
to you, they really did not want to have American
concentrate if at all possible.
|
2,573 | 27 | QUESTION:
I understand your evidence that patients may have b een
aware of non-A, non-B hepatitis as a concept -- at
least you say your patients would have been aware o f
that -- but given that you have told us that
clinicians, until 1978, or some clinicians at least ,
in the world of haemophilia didn't think it to be
necessarily a particularly serious condition
until 1978, when the risk of chronic liver disease
became apparent, unless the haemophilia clinicians
64 tell the patients that it's now known that there's
a risk of chronic liver disease, patients aren't go ing
to know that, are they, because they are not going to
be reading Professor Preston's publication in The
Lancet?
So would you accept that patients should have
been told in or after 1978 of this new understandin g
of the seriousness of non-A, non-B?
ANSWER:
I mean, they were getting -- already getting advice
about healthy lifestyle. So they would have been t old
how to minimise the chances of their liver problems
progressing. So, you know, eat a healthy diet, not
too much fats, particularly obviously about alcohol
usage.
So we get into quite an interesting area here.
Let's just walk through. I'm a doctor dealing with
a patient like that. I now believe that the liver
disease might be more significant than previously.
I'm already following the patient. I'm monitoring
him. Should I say to the patient, "There's a recen t
paper that says that people like you actually might
get cirrhosis, and I'm just telling you this even
though I've got no way of monitoring you and no way of
treating you"? We get into quite philosophical
territories here about -- this is actually somethin g
we'll talk about with variant CJD as well, which is
similar. I worked as a doctor by believing that th e
patient should have the truth, but does that go dow n
to being every single paper that said the following
things might happen to you even -- you know, how mu ch
can you and should you tell a patient? You obvious ly
must tell them the core things about their illness.
I can't remember, 40 years later, whether I discuss ed
these papers with the patients. I wasn't even
a consultant. I can't remember.
I think it's very important that the patients
were aware that their liver function tests were
abnormal because they needed to follow the
instructions I've just outlined to you. I don't --
I can't express a view as to whether they should ha ve
been told about what Professor Preston's papers had
shown.
|
2,574 | 27 | QUESTION:
I understand that you might not descend to the deta il
of specific papers with patients, Dr Winter, and
I understand also the difficulty of being asked to
recall what your advice would have been in the late
1970s. But you've posed the philosophical question ;
I am going to pressure you to answer it.
Do you accept that in 1979 the patients should
have been told that there was a possible risk of
66 chronic liver disease from the treatment they were
receiving?
ANSWER:
I really do accept that, yes. And I think because it
would help to reinforce the point (which for some
patients, you'll understand, they were reluctant to
follow) that they really needed to take this issue
seriously and, for some of them in particular, that
really did mean moderating their alcohol intake.
So I think as a sort of lever for patient
compliance as well as a process of giving the patie nt
information, I do accept that patients should have
been aware that not only did they have a form of
abnormal liver function, which I'm sure they all kn ew,
but that there was evidence that it could have been --
you know, this matter might be more serious than ha d
been thought previously.
|
2,575 | 27 | QUESTION:
You said in your statement that the information tha t
would have been given to patients -- this isn't
specifically as at 1979, but would have been strong ly
in favour of the expectation of a positive improvem ent
in lifestyle.
I think what I'm suggesting, and I think you
probably agreed with this, is that that's one side of
the coin, that's the great advantage of the
concentrate treatment, and the other side of the co in
67 is the potential risks and patients would need to k now
both, not least because, as you've said, they would
need to take seriously the lifestyle and other advi ce
that clinicians would be giving them.
ANSWER:
Yes. I mean, I can't stress to you enough the
difference that the concentrate made. In the
documentary, you know, one of the mothers said, "Yo u
know, my son went to hospital 79 times last year an d
missed 35 days off school on cryoprecipitate."
It was not at all a good treatment. It was
a treatment.
I think there was an element, too, you've quite
rightly got these two sort of scales: benefit and
risk. We were so full of benefit. This was the fi rst
time -- haemophilia was around in biblical times. In
2,000 years of early death from bleeding at the age of
about 20 on average, for the first time there's
a decent treatment. The boarding school is closed,
people can work, people can play sport, people got
their lives back and, if you like, they didn't want to
see the risk. And I think that applies to not only
the patients, it very much applied to the doctors.
And I -- you know, there are ways in which
doctors and patients look at illnesses, and I think
I accept the point maybe it was understated at the
68 time. It's so difficult 40 years later. I don't
think the patients wanted to hear about risk and
I think the doctors, you know, didn't want to hear
about risk. That's the way the brain works. They --
everybody was so full of "this is incredible, the
change".
You know, to see a patient with haemophilia
brought up before concentrate, or who'd never had
Factor VIII concentrate in their life, if you went to
a World Federation of Haemophilia you'd see these p oor
people with, like, the worst arthritis you have eve r
seen in their life. They'd be just shuffling along .
None of their joints moved. If you watch televisio n
footage, there is some, of the tsarevich in Russia,
he's 13 years old, before his murder. He's being
carried. He is being carried by a sailor. He can' t
walk.
So this is what life was like for people with
haemophilia. Even on cryo. Cryo was a treatment, but
it wasn't a good treatment.
So suddenly, for the first time ever for this
dreadful disorder, there is a decent treatment.
People don't want to hear, oh, there might be
a problem. I'm just making a point about the way t he
illness was looked at.
I accept the points you make but that's the way
it was perceived. I fully accept -- because it was
difficult to get patients to comply, some patients,
because some human beings like to drink and some
people obviously felt, "You don't want me to have
alcohol" -- that's the ideal -- "I've got this
hepatitis", and to be able to say -- or you've got to
say to them, you know, "There's recent evidence tha t
this thing might be more serious than we had
originally thought", that should have been made cle ar
to them. Of course I accept that.
|
2,576 | 27 | QUESTION:
I know it's hard to remember what you did, as a mat ter
of fact, say, over four decades ago or four decades
ago. Do you think, however, it's more likely than not
that in your personal case -- not talking about oth er
clinicians -- that you advised your patients about
this change in understanding, albeit potentially in an
understated way?
ANSWER:
I just can't remember. They would certainly have b een
told their liver function tests. They would have b een
given information from me and written information
about diet and alcohol avoidance. I just can't
remember as to whether I spoke about
Professor Preston's paper.
|
2,577 | 27 | QUESTION:
Before we turn to consider HIV, just a more general
70 question, again, thinking about the 1970s in genera l,
rather than any specific year within that.
Would you have consciously understood and
thought about the risk that pooled products, whethe r
they were imported or domestic, might contain virus es
not yet known to medical science? Is that somethin g
that clinicians would have had in mind, that
possibility that there could be something there jus t
not yet known about?
ANSWER:
Very much so. A central mantra for all the time th at
I was working was, it wasn't the virus you knew abo ut;
it was the virus that you didn't know about. If yo u
looked at the history of blood products, every few
years you would come -- there would be a new virus
apparent and, most importantly, it would then becom e
apparent (as we'll discuss with HIV and obviously w ith
hepatitis C) that it had been there for some time. So
we used to have a system in the hospital where we w ere
told to bag up high risk. Somebody had hepatitis;
they had to go in a special blood sample. And
I vehemently opposed that because I said to the
microbiologist, but all blood is -- all blood and
blood products are risky because, you know, how do you
know what we're about to discover in three years?
What's built up from that is, when you are
71 trying to get Factor VIII for your patients, there
were two aspects to that safety. There's the virus es
you know about, but there's also the purity of the
concentrate. I had great difficulty trying to
persuade or to get enough finance to enable me to g et
a treatment that was not only very safe, away from the
viruses we knew about, but was very pure.
Concentrates contain proteins. Even recombinant
contain proteins. So I felt that the more pure the
product was, it was more likely, too, to be getting
rid of any viruses you hadn't yet encountered.
So your points, actually, are really important.
At all times, we were wary of the possibility of ne w
viruses coming through, and, you know, that hadn't yet
been discovered. There was this work going on for
self-sufficiency. It wasn't just to combat the
viruses we knew about and the theoretical ones --
non-A, non-B -- that we were -- you know, when we
spoke about non-A, non-B in the mid-1970s, we were
right. There was a non-A, non-B, and 15 years late r,
we were proved to be correct. So there were a lot of
conversations about, you know, what if? What if th ere
are other viruses? So that was a very central part of
the thinking.
|
2,578 | 27 | QUESTION:
Just before we go there, if I may,
may I just ask you this, doctor: you have described
the unwillingness of colleagues, others in jobs suc h
as yours, to accept that the factor concentrate tha t
they were having might have this dangerous virus we
now know as hepatitis C, then non-A, non-B.
Why do you think -- what do you think was the
consequence of accepting that it did that they fear ed?
ANSWER:
Well, I hope we haven't been at a misunderstanding.
I've not tried to say that haemophilia clinicians
thought that their patients, the majority of regula rly
treated patients. Had some form of chronic hepatit is.
I think everybody accepted that. The issue was: ho w
serious was it? The point I tried to make was, for
several years, particularly in tandem with the
tangible benefits, it was accepted as being there, but
the patients were well, so we'll just keep an eye o n
it. And then suddenly to this very profound change
when these reports of abnormal liver biopsies start ed
coming through. I think that's the major point I'v e
been trying to get across, you know, throughout thi s
conversation.
I don't think for a minute any haemophilia
doctor denied that there were issues around the
abnormal liver function in these patients who were
regularly treated.
|
2,579 | 27 | QUESTION:
Dr Winter, so turning to HIV, we'll look at,
please, Henry, PRSE0000523. This is really just to
give us a date to work with, Dr Winter. This is th e
MMWR for 16 July 1982 and the Centers for Disease
Control reports of three cases of PCP pneumonia amo ng
patients with haemophilia ANSWER:
That, obviously, is i n
the context, and I'm confident from your testimony to
Lord Archer and to Lord Penrose that you know the
pre-history of earlier reports from, in particular,
through 1981 and the first part of 1982 of the
increasing number of cases of what later became
referred to as AIDS.
So this is a report of cases amongst patients
with haemophilia. Would you have at the time seen
MMWRs?
|
2,580 | 27 | QUESTION:
I'm just going to ask you to look at the way you pu t
it in your evidence to Lord Penrose. Henry, it's
76 PRSE0006016. This was your evidence in April 2011.
Could we go to page 8, please, Henry.
We can see the way in which you put it, picking
it up at line 10. This is part of your answer:
"So shall we say September 1982 there is
uncertainty. There is this very small number of
cases. We don't have an agent. What does it mean?
There are other theories. Most of the patients are
gay."
And then you say this, and I'm just going to
read it aloud for the benefit of others as well:
"By December 1982 that theory is no longer
tenable because you have now ten patients with
haemophilia, but most particularly you have this
case."
That was the San Francisco baby case I think you
were referring to there, Dr Winter:
"Any clinician looking at this data would have
to believe that AIDS was a transmissible disorder a nd
that it could be transmitted by blood and by blood
products. It was the only clinical interpretation of
the data that was available. There was no other wa y
that this child could have acquired this very unusu al
condition; very unusual for a baby to have these
series of opportunistic infections. So it was very
highly likely that it must be AIDS and must have be en
caused by the blood transfusion from the donor who
subsequently developed AIDS. So here is a really
critical moment. Doctors everywhere now have to
believe that AIDS is a transmissible disorder."
That is effectively the same answer that you
have already given a few minutes ago, but would you --
does that remain your view?
ANSWER:
Yes. So at this moment in time, we're now really
believing that there are two major problems with
concentrate therapy. Firstly is, the liver disease is
much more significant than we thought. Secondly,
we're at the start of something which we are really
very concerned about. This sounds -- this new dise ase
sounds like a transmissible disorder, and we very
rapidly need identification of what the agent is,
a test for it, and some understanding of how to
respond to it. But it is underscoring -- set again st
the extraordinary benefits of concentrate therapy,
it's really stressing the dangers of concentrate
therapy.
|
2,581 | 27 | QUESTION:
In addition, too, by December 1982, understanding a s
you explained there and have explained again that t he
likelihood that this is a -- something transmissibl e
by blood, would you accept that it is also clear at
78 that stage, December 1982, that this is a condition
with a very high mortality rate?
ANSWER:
Well, that seemed to be the case. Obviously, you a re
dealing with very, very small numbers of cases.
|
2,582 | 27 | QUESTION:
It was also evidence, by that stage, that there was
potentially a significant lapse of time between the
initial infection or transmission of the agent and
symptoms presenting themselves.
ANSWER:
Well, we didn't know that because we didn't know -- we
didn't know when the gay patients had been infected if
it was an infectious agent and we didn't know,
similarly, with the haemophilia patients because th ey
would have been multi-treated, and we didn't know
which batch might have had the agent in it.
|
2,583 | 27 | QUESTION:
You have already referred to the New England Journa l
of Medicine, and we'll just look at that. I know y ou
are familiar with it, Dr Winter. It is PRSE0002410 ,
please.
This is January 13, 1983. You see on the
right-hand side, "AIDS and the preventative treatme nt
in haemophilia". We will just look at the last
paragraph of this article which is on the next page ,
Henry, bottom of the left-hand column. It says thi s:
"The fact that haemophiliacs are at risk for
AIDS is becoming clear. If the use of cryoprecipit ate
79 will minimise this risk, the current home infusion
programme needs to be revised. The studies reporte d
in this issue demonstrate in vitro abnormalities of
immuno-regulation, but the numbers are too small fo r
definitive comparison of the risks of different mod es
of treatment. Unfortunately, the data are consiste nt
with a greater potential for AIDS in the population
treated with concentrate. Physicians involved in t he
care of haemophiliacs must now be alert to this ris k.
Preventing the complications of the present treatme nt
may have to take precedence over preventing the
complications of haemophilia itself."
Now, I'm going to come back to or come on to in
a while the question of the use of cryoprecipitate.
But you recall, as I understand it, reading that
article at the time?
ANSWER:
I do.
|
2,584 | 27 | QUESTION:
We're just going to play a second extract from that
1988 documentary, so be prepared for your younger s elf
on the screen again, Dr Winter. MDIA0000111, and i t's
the second excerpt, please, Henry.
(Video played)
You would, I think, agree, given your evidence
thus far, that this was a warning that haemophilia
clinicians could not and should not ignore?
80 ANSWER:
Well, however many alarm bells a human being has, t hey
should all have been ringing at this stage.
|
2,585 | 27 | QUESTION:
Now, you were still working at Guy's at this time, end
of 1982, and indeed for most of 1983. Can you reca ll
what discussions took place between you and your
colleagues, your fellow registrars who are managing
the haemophilia patients, or with either of the two
consultants about this issue?
ANSWER:
Well, what I recall is that UKHCDO had responded to
the evolving situation, in terms of issuing
recommendations to minimise risk. So we certainly
implemented trying to avoid the use of concentrate
where at all possible. So DDAVP, obviously, for
mildly affected patients with haemophilia where at all
possible; could surgery be postponed if it was a co ld
surgery and the patient didn't need to have the
surgery too quickly; the use of cryoprecipitate may be
in children very reluctantly. These were the sort of
factors that UKHCDO were recommending as a sort of
holding measure that haemophilia centres introduce.
There was no recommendation that concentrate
should be withheld or withdrawn. As I've said to y ou,
the patients wanted to go on with treatment. The
Haemophilia Society wanted to go on with treatment.
That was really the sort of only interventions we
could do, or modifications if you like, of the curr ent
programme to minimise risk.
Parallel with this, one would like to know, if
it hasn't, you know, come out in the Inquiry alread y,
why were all the alarm bells not ringing at the
Department of Health, you know, in terms of
accelerating a process of redeveloping our blood
fractionation plants so that this country could be
self-sufficient in blood products, as other countri es
had achieved. So this alarm bells question, of
course, isn't just for clinicians; it's for
politicians and people who plan the supplies of the
concentrates that we were using.
|
2,586 | 27 | QUESTION:
We will certainly be looking at that.
The UKHCDO advice -- it was June 1983, but
I just want to -- and, again, I know I'm asking you
about events a long time ago, but I just want to go
back to the beginning of 1983. So for the first ha lf
of 1983, there's no published advice from UKHCDO. Do
you recall whether you began to make the adjustment s
you have described at the beginning of 1983, or was
that only after the UKHCDO recommendations from Jun e
of 1983?
ANSWER:
I can't remember. I mean, I certainly read the
Deforge paper, and we were aware of it, and we had
82 taken what steps we could. So I'd like to be able to
say we introduced those changes that UKHCDO
recommended a few months later at that time, but in
all honesty, I can't remember whether we did or
didn't.
|
2,587 | 27 | QUESTION:
You have said in your statement that, in relation t o
children, BPL product was prioritised. You already
were prioritising it, so is it right to say it beca me
a greater priority?
ANSWER:
Well, we already were. We would have been
extremely -- it already was the first priority, and we
had enough BPL supplies coming in to treat children
because, obviously, the amount you needed for the
children was less than adults, and there weren't in
any case many children. So I'm sure that we went o n
treating these children with BPL product. But we v ery
much sort of concentrated things around when the
concentrate was actually needed. I mean, it's
possible that we might have suspended prophylaxis
programmes. I just can't remember. But we
certainly -- to senior registrars, we would have sa id
to each other -- the key message was, do not give
concentrate unless the patient absolutely needs it.
|
2,588 | 27 | QUESTION:
What would the criteria have been for absolutely
needing it, then?
83 ANSWER:
Well, a patient with a significant bleed, which is
normally meaning joints and muscles. Obviously, an y
period of internal bleeding, most especially cerebr al
or gastrointestinal. Patients who had had trauma,
significant trauma, that wasn't settling down with
conservative measures, and patients who needed majo r
surgery which could not be postponed because they h ad
cancer or something like that. Those would be the
sort of major indications.
|
2,589 | 27 | QUESTION:
So the aim would have been to use concentrates only in
those kind of occasions, and would that only have b een
for severe haemophiliacs by then?
ANSWER:
Mainly, but if you had a mild haemophiliac who had
bowel cancer and needed major bowel surgery, you wo uld
have to give them Factor VIII.
|
2,590 | 27 | QUESTION:
Do you recall whether given this, as you say, this
second new risk, were any attempts made to get more
BPL product to reduce the size of the shortfall
through discussions with Tooting or elsewhere?
ANSWER:
Certainly not by the consultants who I worked for w ho
had really devolved haemophilia care to us and, in any
case, it was a long-running issue (the shortfall of
BPL, as I've described to you) in these two Thames
regions. It was a very long-running and
unsatisfactory saga and there was nothing, as
84 registrars, that we could do to increase the supply .
Everybody wanted more supplies from BPL and the rep ly
was always the same: you're only getting so much
because Tooting are only sending so much to Elstree .
|
2,591 | 27 | QUESTION:
Then the next question, Dr Winter, is, given what y ou
say should have dawned on haemophilia clinicians by
the end of 1982, do you accept that this is
information that should have been shared with
patients?
ANSWER:
About what in particular?
|
2,592 | 27 | QUESTION:
About the view, as described by you to Lord Penrose
and in your evidence here today, that the AIDS was in
all likelihood caused by blood or blood products an d
haemophiliacs might be at risk?
ANSWER:
Oh, yes. Because, you know, it really was
a significant concern. There was a clear policy of
moderating concentrate usage. So we would have sai d
to patients, "You know, we want you to go on using
concentrate for occasions when it really is needed" --
and we would have outlined that -- "but, you know, we
want you to be absolutely sure in the home setting
that you give it for a good reason."
I mean, the reality of haemophilia life is that
patients didn't always give Factor VIII for a good
reason in the home setting, and we wanted to make s ure
that they were only using it under the sort of
clinical indications that I've just given to you.
|
2,593 | 27 | QUESTION:
To ensure that, do you accept, first of all, that
patients should have been told of the possible risk of
AIDS?
ANSWER:
I do.
|
2,594 | 27 | QUESTION:
Do you recall that that was information that you
yourself gave to the patients at Guy's at the time?
ANSWER:
I do. In any case, around this time there are
communications from The Haemophilia Society to
patients, are there not, about this new disease
I think?
|
2,595 | 27 | QUESTION:
There are.
ANSWER:
You are going to know the answer to this better tha n
me.
|
2,596 | 27 | QUESTION:
There are. Whether those are communications which
correctly conveyed the risk is another matter which
the chair will be considering in due course.
ANSWER:
Yes. But suffice it to say that the new disease, i f
we call it that, was being widely discussed through out
the wider haemophilia community, in terms of
Haemophilia Society meetings, seminars, the bulleti ns
that went out to each of the patients, in addition to
the information that patients were getting from the ir
own centres.
86 |
2,597 | 27 | QUESTION:
Now I want to move to ask you some questions about
cryoprecipitate. In your witness statement -- and it
may assist if you have your witness statement befor e
you, I think you've got a hard copy of that?
ANSWER:
I haven't got one. It's in the other room.
|
2,598 | 27 | QUESTION:
In that case we can always rectify that after lunch
because it will probably take longer than seven or
eight minutes. But in your witness statement at
paragraph 35.3 --
(Handed)
ANSWER:
Thank you.
|
2,599 | 27 | QUESTION:
So if you turn, Dr Winter, to paragraph 35.3.
ANSWER:
35?
|
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