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2,600 | 27 | QUESTION:
Yes, 35.3. So it's on page 6 of 25. Under the
heading "Cryoprecipitate", you have identified ther e,
and over the page, seven disadvantages of
cryoprecipitate, and I want to ask you about those.
The second disadvantage you have identified is
it wasn't effective in Factor IX deficiency. I am
going to ask you to leave that to one side because
that might be relevant, obviously, to treatment
decisions in relation to treatments with haemophili a B
but wouldn't be relevant to treatment of patients w ith
haemophilia ANSWER:
So could we start then with the view there set
87 out that cryoprecipitate which was much less effect ive
clinically than Factor VIII concentrate.
First of all, can I ask you to explain what you
meant by that.
|
2,601 | 27 | QUESTION:
I am going to try and unpick a number of those, whi ch
I'll largely do after lunch looking at the time.
There's just one factual question I wanted to ask y ou
first about supply.
Let's leave aside for the moment the question of
supply on a national scale and what the Committee o n
Safety of Medicines may have been advised or
understood.
Your witness statement says that
cryoprecipitate -- this was talking about it when y ou
were at Guy's -- wasn't used but was available. Wa s
there a particular supply problem with cryoprecipit ate
local to your area, to Tooting? Because we know, n ot
least, for example, from what Dr Chisholm raised at
a UKHCDO meeting in the autumn of 1983, she had no
difficulty in her area getting cryoprecipitate
supplies, and the minutes record agreement by other
directors that they are in the same position. So i t
may be a variable picture geographically.
What about your area, Dr Winter?
ANSWER:
There was a problem with all supplies from Tooting.
Blood, whole blood, fresh frozen plasma. This was
a centre under enormous pressure because it was the
only centre serving two regions. Not only that, th e
regions were London regions, with enormous -- some of
92 the biggest hospitals in Britain. So nobody got wh at
they wanted from Tooting.
|
2,602 | 27 | QUESTION:
Did anyone from Guy's or, to your knowledge, any of
the other haemophilia centres served by Tooting
approach Tooting at this point in time and say, "We ll,
what we actually need now is some more cryoprecipit ate
because of the risks of Factor VIII concentrates"?
ANSWER:
No, because nobody -- I don't think anybody
considered -- apart from the subgroups I've mention ed
to you, which were few and far between, nobody was
considering, for all the reasons I've said, switchi ng
the therapy of a patient with severe haemophilia ba ck
to cryoprecipitate.
|
2,603 | 27 | QUESTION:
There's no need to stand when I come
in if you are more comfortable sitting. It's entir ely
a matter for you.
ANSWER:
Okay.
|
2,604 | 27 | QUESTION:
Can you hear okay?
ANSWER:
No. I've changed my battery.
|
2,605 | 27 | QUESTION:
Can you hear me now?
ANSWER:
Not as well as I could this morning.
|
2,606 | 27 | QUESTION:
We won't start until we have sorted this
out.
ANSWER:
Something seems to have happened after he changed m y
battery. I can hear myself, but I'm not getting th e
loop.
|
2,607 | 27 | QUESTION:
Dr Winter, we were talking about
cryoprecipitate. One of the observations you made was
that it was not suitable for home treatment. Now,
I should say the Inquiry has had evidence that
94 cryoprecipitate was used for home treatment at Grea t
Ormond Street, at Birmingham Children's Hospital, a nd
we know it was used by Katherine Dormandy at the Ro yal
Free.
I can entirely see that it may have been -- or
the concentrate home treatment might be more
straightforward, less laborious and so on, but I th ink
it is not right to say that it was impracticable or
impossible to have cryoprecipitate as home treatmen t?
Would you accept that?
ANSWER:
But you have to have a deep freeze, and that was
a problem.
|
2,608 | 27 | QUESTION:
Certainly, Dr Dormandy at the Royal Free made those
arrangements for her patients.
ANSWER:
Right.
|
2,609 | 27 | QUESTION:
Do you accept that cryoprecipitate posed a lower ri sk
of infection for HIV and non-A, non-B hepatitis?
ANSWER:
Yes, because it only came from -- you know, gave
somebody 20 bags; that was exposure to 20 donors
rather than to the 20,000 with an infusion of
concentrate.
|
2,610 | 27 | QUESTION:
You have explained why you thought cryoprecipitate was
less clinically effective than concentrate, but wou ld
you agree that cryoprecipitate could be used, and
indeed had been used, to raise Factor VIII levels, and
95 so it was clinically efficacious, even if it took
longer or was a more laborious process than
concentrate?
ANSWER:
Yes. I've already stated that. It was just not as
effective.
|
2,611 | 27 | QUESTION:
Then, in terms of side effects, as I understand you r
evidence from before lunch, the side effects from
cryoprecipitate that you were describing, the chill s
and shakes and need to be monitored, so, as you say ,
certainly not pleasant, but not long-term and serio us
side effects?
ANSWER:
No. They were just transient, maybe lasting a few
minutes, but they needed to be monitored.
|
2,612 | 27 | QUESTION:
You also suggested that cryoprecipitate couldn't be
used in children, although I think your answer was
young children. As we'll come on to see, you have
already made reference to, the UKHCDO recommendatio n
that emerged in the middle of 1983 did actually
include a recommendation to use cryoprecipitate for
children. So it was, as a matter of fact, somethin g
that could be used for children, I think?
ANSWER:
Yes. It just had practical problems if the child w as
young, as you say.
|
2,613 | 27 | QUESTION:
So we come, essentially, to a number of practical
issues in relation to cryoprecipitate -- it took
96 longer, you might need a deep freeze, but if in
hospital you would have that facility, but it would
take longer; it would need medical staff. So those
are practical disadvantages, but would you accept t hat
one has to set against that the fact that it was
safer? Why would the practical disadvantages outwe igh
the safety of the product?
ANSWER:
If you're moving towards why didn't we use cryo on
everybody, I've already told you, there was just no
supply. Secondly, there was massive -- there would
have been massive antipathy from the patients, and
there would have been great reluctance from the
doctors. It was -- I don't ever recall any
haemophilia doctor ever suggesting, in response at
this critical moment, that we should switch all
patients to cryoprecipitate. I have no recollectio n
of any haemophilia doctor thinking that that was
a possible way forward.
I think there was Dr Ratnoff in Cleveland
I think he was. I think he was always remembered a s
the one doctor who kept his patients on
cryoprecipitate, but it was just not considered as
a realistic option in this country.
|
2,614 | 27 | QUESTION:
Yes, and we may hear some evidence at least to the
contrary, but I understand that to be your
understanding.
In terms of supply, if there wasn't enough
available for an immediate switch of everybody from
concentrate to cryoprecipitate, would there have be en
enough to ration it so that cryoprecipitate was use d
for children and previously untreated patients or m ild
haemophiliacs?
ANSWER:
Well, that's what UKHCDO was recommending, wasn't i t,
and that's what happened at Guy's, to my recollecti on.
|
2,615 | 27 | QUESTION:
Would you agree that if there was a switch from
reverting to cryoprecipitate instead of concentrate ,
there may have been an ability to catch up, in term s
of supply issues, because you could utilise the pla sma
that would previously have been required for
concentrate to make cryoprecipitate?
ANSWER:
That would only be the British plasma, obviously.
|
2,616 | 27 | QUESTION:
Yes.
ANSWER:
Of which there wasn't very much.
|
2,617 | 27 | QUESTION:
What about the option of switching to cryoprecipita te
for more patients on a temporary basis until more w as
known about the risk of AIDS, or more known about t he
possibility of viral inactivation? Was that an
option?
ANSWER:
Isn't that the same thing as we've just been
discussing?
98 |
2,618 | 27 | QUESTION:
I think we've discussed using cryoprecipitate for
children and the other categories identified in the
UKHCDO --
ANSWER:
So we're 1983, aren't we?
|
2,619 | 27 | QUESTION:
So we're 1983.
ANSWER:
Yes.
|
2,620 | 27 | QUESTION:
What about using cryoprecipitate for a wider range of
patients, including adults who are severely affecte d,
as a temporary option? Was supply the only reason?
ANSWER:
Same answers, I think, you know. No supply. I mea n,
you know, there was very little cryo around, as far as
I can recollect. At least the part of the world wh ere
I was working, it would have meant cessation of hom e
therapy, patient reluctance, less efficacious,
et cetera. I mean, safer. I'm not denying the
importance of that, but it just didn't seem an opti on
to it for all those reasons.
|
2,621 | 27 | QUESTION:
Do you recall whether you had or your colleagues at
Guy's at this time had any discussions with patient s
to offer them cryoprecipitate?
ANSWER:
No.
|
2,622 | 27 | QUESTION:
As in, no, you can't recall, or you didn't have --
ANSWER:
No, I can't recall.
|
2,623 | 27 | QUESTION:
I think you have already told us that no patient
positively asked you to go back on -- asked if they
99 could go back on cryoprecipitate?
ANSWER:
No.
|
2,624 | 27 | QUESTION:
If they had -- this is a hypothetical question, but if
they had, what would your response have been?
ANSWER:
Well, I would have talked it through with them.
I mean, if they were very, very concerned about goi ng
on with concentrate, if I could have got guaranteed
supplies of cryoprecipitate, if they understood the
implications of what that decision meant, in terms of
having to come into hospital each time they had
a bleed, which is quite a significant thing, then
I would certainly have had an open discussion with
them.
But our recommendation was, you know, as we've
been discussing, to introduce these restrictions to
these particular sort of subgroups of patients who we
could get away from concentrate to, you know, expre ss
our anxiety about the situation and the lack of
apparent progress towards self-sufficiency. I mean ,
of course, I am still a trainee at this time, so
I don't have any managerial authority or anything, and
that was really as far as we could go.
|
2,625 | 27 | QUESTION:
You may or may not know the answer to this, Dr Wint er,
but in terms of cost, and leave aside for one momen t
the practical question that there may have been sup ply
100 issues in relation to the Tooting centre -- in term s
of cost, do you know whether cryoprecipitate was, t o
the health authority, more expensive or cheaper tha n
factor concentrates?
ANSWER:
Oh, much cheaper.
|
2,626 | 27 | QUESTION:
May I just ask this: did any patient
later on, when you were a consultant -- did any of the
patients whom you treated who were young -- that is
children who were having cryoprecipitate in accorda nce
with the guidelines, or mild, early affected, and
having it in accordance with the guidelines, or fir st
just newly diagnosed -- did any of them say to you,
well, look, these other people we've come across, t hey
get this factor concentrate to keep in their fridge at
home. Can I have some of that?
ANSWER:
No. No, they didn't. I mean, as I stressed, this was
a very small centre with very small numbers of
children only, but none of the patients approached me
with that sort of conversation, and I can't recall at
this distance of time -- I mean, I can remember usi ng
cryoprecipitate in a child, but I can't remember -- my
recollection is that most of them we were able to
secure BPL concentrate, and that's the way we treat ed
them, and we advised them to only use it for times
when it was absolutely necessary. We didn't have
prophylaxis programmes going in children, so we
suspended prophylaxis, so it was only given for
episodes of significant bleeding.
|
2,627 | 27 | QUESTION:
Then the question of commercial versus
British concentrates. Your statement says, and you r
evidence has been clear, that in terms of
concentrates, BPL concentrate was your treatment of
choice. Was the reason for that your understanding
that it was, relatively speaking, safer than
commercial concentrates?
ANSWER:
Yes, because I'd been signed up for a long time --
well, really during all my time as a trainee -- to
a firm belief that if you had Factor VIII that was
derived from a pool of voluntary donors, it was --
wherever those donors lived, it was going to be muc h
safer than if the concentrate was derived from a po ol
of paid donors, for obvious reasons. Because the
voluntary donors were giving it through altruism, a nd
the paid donors were doing it because they needed t he
money and were, therefore, much likely to have alco hol
and drug problems and, therefore, much more likely to
be carriers of viruses.
|
2,628 | 27 | QUESTION:
Other than safety, were there any other advantages or
102 disadvantages of British product over commercial
product?
ANSWER:
No. I mean, we had obviously wished, as the situat ion
was in Scotland, to be entirely self-sufficient in
what would have been English Factor VIII. That's w hat
we wanted. But that was the only consideration -- and
we wanted that because it was safer.
|
2,629 | 27 | QUESTION:
Were you aware at this time that in the United King dom
there was still collection of blood from prisoners?
ANSWER:
In the US?
|
2,630 | 27 | QUESTION:
No, in the United Kingdom.
ANSWER:
No.
|
2,631 | 27 | QUESTION:
Can I ask you just to clarify one point in your
witness statement, Dr Winter, before I move to a ne xt
topic. It's paragraph 23(c) of your witness statem ent
if you just have the hard copy.
ANSWER:
Could I ask you to get the audio person back. I'm
still not picking you up.
|
2,632 | 27 | QUESTION:
Certainly. We will just pause there.
(Pause)
I just wanted to check one point in your witness
statement to see that I've correctly understood it.
It's paragraph 23 of your witness statement, and at
paragraph 23(c) you say:
"As I believed that all of the available
103 commercial concentrates were of equal clinical
efficacy and safety my main responsibility was then to
purchase coagulation factor concentrate at the most
advantageous price."
As I understand that, you are not saying that
commercial concentrates were of equal safety to
British concentrate, you are saying that, as betwee n
the various different commercial concentrates, you
weren't aware of anything to pick and choose betwee n
them. Is that right?
ANSWER:
That's correct in terms of both efficacy and safety .
|
2,633 | 27 | QUESTION:
Thank you.
Before we get to you being a consultant, which
I promise we will get to, I just wanted to ask you
a handful of questions about UKHCDO and its decisio ns
and actions during this period.
So if we go first, please, Henry, to
CBLA0001619.
We can see these are the minutes of a UKHCDO
meeting on 13 September 1982. If we go to the bott om
of the second page, please, Henry, we can see, towa rds
the very bottom, that you're there in place of
Dr Barkhan, and Dr Barkhan was represented by you a nd
apologies had been received by him.
This was, I think, the first UKHCDO directors'
104 meeting that you attended, and you attended at this
stage not as a director but still as a registrar?
ANSWER:
That's correct.
|
2,634 | 27 | QUESTION:
Then if we go, please, to page 10, Henry.
We can see that AIDS was discussed. It's the
bottom of page 10. It's said that:
"The Reference Centre Directors had asked
Dr Craske to look into the report from the
United States of this syndrome mainly in homosexual s
but including three haemophiliacs. It appeared tha t
there was a remote possibility that commercial bloo d
products had been involved. Dr Craske asked the
Directors to let him know if they had any cases of the
syndrome. The Working Party was considering the
implications of the reports of the USANSWER:
"
So that's the sum total of the discussion on
AIDS as recorded in those minutes.
First of all, what, if anything, do you recall
of that meeting?
|
2,635 | 27 | QUESTION:
So that's September '82 when you're there. Now I'm
going to go now to a meeting which I know you weren 't
at, Dr Winter. It's HCDO000003_008 please, Henry.
I will just get an alternative reference.
Forgive me. We'll see if we can find a difference
reference for that, Dr Winter. Let me tell you wha t
it was. It was a meeting of Reference Centre
Directors at St Thomas' on 13 May 1983 to discuss
AIDS.
Could I ask you whether you have any reflection
on the lapse of time between September 1982, the
meeting we have just looked at, and there not being a
special meeting to discuss this until May of 1983.
Do you think that can -- showed sufficient urgency on
the part of Reference Centre Directors?
ANSWER:
Well, of course this was an organisation that I did n't
belong to at that time. It seems to me that -- if my
memory's correct, it was the end of 1982 that we ha d
the San Francisco baby --
|
2,636 | 27 | QUESTION:
Yes.
ANSWER:
-- which was important sort of additional informati on,
in addition to the three original American cases. We
106 would have had a small number of further American
cases. We didn't get the first British case until
May '83 I think, in Cardiff.
|
2,637 | 27 | QUESTION:
It was publicly reported in May of '83. We've seen
evidence to suggest that the patient presented to
Professor Bloom in Cardiff in March of '83.
ANSWER:
Yes. I mean, you know, looking back I just don't k now
what drove them to schedule the meetings in that wa y.
I mean, the Haemophilia Directors, now known as
Comprehensive Care, is a pretty small community, an d
we -- you know, outside of the meetings, we are all in
touch with each other pretty closely, or most of ea ch
other. So for all I know there may have been quite
a lot of telephone dialogue going on about the
evolving situation, but I obviously don't know why
they didn't meet again until May, which -- here's t he
document now in front of me.
|
2,638 | 27 | QUESTION:
Yes. That's fair enough, Dr Winter.
Can we then look at the document that you did
become aware of, which was the recommendation sent out
after this meeting in June of 1983.
I'm hoping this is the right reference, Henry,
HCDO0000270_004.
So after that meeting in May, this letter was
sent by Professor Bloom and Dr Rizza. You will see
107 it's dated 24 June 1983. You can see, if we just
scroll down a little, "general recommendations":
"1. For mildly affected patients with
haemophilia A or von Willebrand's disease and minor
lesions, treatment with DDAVP should be considered.
Because of the increased risk of transmitting
hepatitis by means of large pool concentrates in su ch
patients, this is in any case the usual practice of
many Directors."
That reflected the practice at Guy's?
ANSWER:
It did.
|
2,639 | 27 | QUESTION:
Then:
"For treatment of children and mildly affected
patients or patients unexposed to imported
concentrates many Directors already reserve supplie s
of NHS concentrates (cryoprecipitate or freeze-drie d)
and it would be circumspect to continue this policy ."
So the recommendation is cryoprecipitate or NHS
factor concentrate for those categories?
ANSWER:
Which is what were already implemented.
|
2,640 | 27 | QUESTION:
At Guy's at this stage?
ANSWER:
Yes.
|
2,641 | 27 | QUESTION:
You may or may not have view on this, Dr Winter, bu t
this is voiced as "general recommendations", and wh at
we see in paragraphs 1 and 2 is, well, this is the
108 practice generally, "circumspect to continue" is th e
language of paragraph 2.
It falls short of being an instruction or firm
advice. It's to some extent leaving it to clinical
judgment; would you agree?
ANSWER:
Yes, it's interesting to reflect on this. Medicine
now is different to medicine then and there was
a great stall then, the famous phrase "clinical
freedom", the ability of a doctor to look at some
guidelines and say, "I'm going to do something tota lly
opposite to that because I have clinical freedom" - -
a very dangerous concept.
I think, therefore, for some doctors at that
time, these documents were seen as advisory but not
binding. I think now the word "protocol", which is
not mentioned here, we don't -- well, when I was
working we didn't have advisory documents, we had
protocols, and it was generally agreed that once th e
haemophilia directors had issued a protocol to the
haemophilia -- to the UKHCDO members, they were on
dangerous ground if they deviated from that and
something went wrong with the patient. So this was ,
you know, this moved from being a guidance, which i s
advisory, over the course of the next 30 years to
being essentially a strongly recommended protocol
which was produced by experts and you were expected to
follow it. If you didn't follow it, then that migh t
be a problem.
|
2,642 | 27 | QUESTION:
Then we'll move from June 1983 to October 1983.
Henry, could we have PRSE0004440, please.
So we can see this is a meeting of the directors
on 17 October 1983. If we go down we can see --
actually, if you leave it there, Henry, that's grea t.
I don't know whether you see, if you go down, in
alphabetical order, the list of attendees. We have ,
I believe, Dr Chisholm, Dr KGA Clark, Guy's Hospita l,
London. That's the other consultant?
ANSWER:
That is the case. He is not a haemophilia speciali st.
|
2,643 | 27 | QUESTION:
Then if we could go to page 10, please, Henry.
We can see under the heading "Any other
business", bottom half of the page:
"Dr Chisholm raising the problem of patients
refusing to take up commercial Factor VIII concentr ate
because of the AIDS scare. She wondered, in view o f
the worry of the patients whether the directors cou ld
revert to using cryoprecipitate for home therapy."
Then this is Professor Bloom's response:
"He felt that there was no need for patients to
stop using the commercial concentrates because, at
present, there was no proof that the commercial
110 concentrates were the cause of AIDS."
Would you agree with this, that to await proof
before taking action in circumstances where the lin k,
although not proven, is pretty clear, is the wrong
course to take?
ANSWER:
Well, we're only a few months away from the events of
April and May 1984, which we'll talk about in a few
minutes, where exactly that situation arose. And,
together with some other doctors, I did have to mak e
very radical changes to therapy on theoretical
considerations alone.
|
2,644 | 27 | QUESTION:
You have told us you were pretty satisfied, and as far
as you are concerned, most haemophilia clinicians w ere
pretty satisfied at the beginning of 1983 that bloo d,
blood products, were the cause of -- or were the
relevant transmissible agent. And yet here's
Professor Bloom saying, well, there's no need to st op
using concentrates, and the reason he gives is not
supply or anything else. The reason he gives is no
proof. Would you agree that's the wrong question f or
him to have been posing, or the wrong answer for hi m
to be giving at that time?
ANSWER:
When I've done these inquiries, one of the
difficulties is being asked to explain why other
doctors said and did something.
111 |
2,645 | 27 | QUESTION:
You are right. I think this is
a question, ultimately, for me to evaluate. What
counsel is doing, I think, is finding out what the
views were of different clinicians as to what the
answer should be, although ultimately it's one whic h
I will have to decide. So it's helpful. You have --
I think the background to this is you have just
described the word "remote" possibility. The word
"remote" used several months before this as being
misplaced and significant would be better. You hav e
indicated that you understood there is a real risk --
leave aside the question of certainty -- the questi on
might be put this way: is a significant or real ris k
a proper ground for action? You've said it was, fo r
yourself, a year later or a few months later when y ou
had to consider what action to take in advance of
there being definite proof of cause and effect.
ANSWER:
I mean, of course, if I may say so, I stress, you
know, this has been a very long conversation. You' re
talking now about what interactions I had with othe r
haemophilia doctors. I didn't have any. I wasn't
a consultant. I didn't -- I was not part of UKHCDO .
I was not having regular dialogues with other
haemophilia treaters around the country because I
didn't know them because I was a trainee. So all t his
112 will change in a minute when I eventually do get to be
appointed as a consultant. But if I've been rather
vague with my answers for this last couple of hours ,
it's because, you know, I was in a little bubble at
Guy's Hospital working as a senior registrar, and
I was not part of the UKHCDO network, and I can't t ell
what interactions they were having at their level,
which was presumably by telephone and informal
meetings.
|
2,646 | 27 | QUESTION:
I understand that. Now, we know that the
next document or set of recommendations issued by
UKHCDO was in December of 1984, and I know you have
got some observations you want to make about that
document. What I'll do is come back to that when
you've explained the decisions and actions you took in
the course of 1984, so we can look at it in that
context.
Can I just ask this, though: you talked about
the status of UKHCDO recommendations. If -- and th is
is hypothetical -- but if the Chief Medical Officer
had issued guidance (for example, guidance saying
clinicians should no longer use imported concentrat es,
or clinicians should revert to using cryoprecipitat e),
would you have expected to follow guidance from the
Chief Medical Officer?
ANSWER:
I think that that's -- it became a very significant
issue as we, over the next few years, dealing with all
these very spectacular problems, the lack of very w hat
you might call powerful, influential, centralised
advice. I think we're going to talk about this whe n
we talk about how to tell patients they've got HIV,
how to test them, and so on, and so on. There were
many of these issues. It was made a lot more
difficult to cope with at local level as a consulta nt
trying to respond to these spectacularly difficult
problems that there was no central body that had
published very clear, firm guidance or protocol, or
call it what you will, to haemophilia doctors sayin g,
this is what we think you should do in this situati on.
You know, this is why one of the key things for me in
the whole academic is the variability word, and all
these things we've already been speaking about of e ach
doctor having the freedom to do what he wanted.
That was just one of the very, very major
difficulties that emanated out of a very clear
diktat -- let's use a proper word -- from somewhere
powerful and central saying this is what you should
do, and we really lacked that. Particularly when H IV
broke, we were blood specialists, haemophilia docto rs,
not virologists dealing [on a] day-to-day basis wit h
114 the problems caused by a virus of which we were not
specialists.
So I think that point you are raising is
a really core one. We very much lacked firm, centr al
guidance from whatever body; you know, a body set u p
for national virological advice, or the Chief Medic al
Officer or whatever.
|
2,647 | 27 | QUESTION:
And you -- I infer from your answers -- would have
welcomed such guidance, whether it was from the CMO or
others?
ANSWER:
Yes.
|
2,648 | 27 | QUESTION:
Because what you have described is a situation in
which you as a registrar with your fellow registrar s
in a centre in which the two consultants are not
specialists in this field are having to take your o wn
decisions?
ANSWER:
Well, yes. We had the UKHCDO guideline, which we'd
followed, about how to minimise concentrate usage.
But apart from that, yes.
|
2,649 | 27 | QUESTION:
Can I ask you one further question about UKHCDO, no t
at any one point in time, but in the knowledge that
you are about to become a member, in the end of 198 3,
when you become a director in Kent.
Professor Savidge, who you obviously dealt with
quite extensively over the following months and yea rs,
115 in his evidence to the Archer Inquiry was very
critical of UKHCDO. He said it was run pretty much as
a club by the ten or so main players, and there was
something of an information vacuum for directors in
particular of smaller centres.
Would you agree with that, based upon your own
experience once you became a director?
ANSWER:
I don't agree with that. I think we should state
UKHCDO was generally regarded by the other haemophi lia
societies and doctors and other countries as actual ly
being a model of its kind. There isn't really any
other country where haemophilia doctors came togeth er
and collaborated to such an extent that every patie nt
with an inherited blood disease in the country was
registered, we knew the number of patients with the
condition, we knew the severity of the condition, w e
knew whether they had an inhibitor, we knew whether
they were on home treatment, we knew whether they w ere
alive or dead. No other country had information li ke
this and every time you went to a World Federation
meeting, people would say, you know, your system yo u
have in the UK is light years of what we have in ou r
country. We have nothing like it.
Then, in addition to that, as we've seen
already, it was a very active organisation, in
116 addition to all the day-to-day work we were doing. At
any one time, there would be six, seven, eight work ing
parties in specialist areas. So I thought the UKHC DO
was a very good thing. Of course, there were
personalities involved, of which Professor Savidge was
a large one.
|
2,650 | 27 | QUESTION:
So we've finally, Dr Winter, reached December 1983
when you took up your appointment in Kent as the
centre director and consultant haematologist.
Could you just describe what the services were
when you arrived in Margate at the haemophilia cent re.
ANSWER:
Well, very unsatisfactory really. There were very --
although it was a centre and covering a very wide
geographical area and with quite a good number of
patients, there was no proper centre as such. It w as
just a haematology department.
There was a particularly unsatisfactory state of
affairs in that the patients got Factor VIII on
prescription from the general practitioner, and it
wasn't clear to me how this completely inappropriat e
system had come about. But what that meant was whe n
the patient needed Factor VIII, they went off to a GP
who wrote a prescription -- please issue ten bottle s
of Factor VIII, and they went to a local pharmacy w ho
had never heard of Factor VIII but looked it up and
found somebody who would sell it at an inflated pri ce,
doubtless. And the particular and very, very
unsatisfactory aspect to all this was that, of cour se,
no batch numbers were taken.
So when I took over, I had no information
whatsoever as to what people had been receiving ove r
the years and that became critical when, over the
months to come as HIV broke, UKHCDO would start
circulating to all haemophilia treaters details of
contaminated batches. You would get a letter sayin g,
"We now know that the following batches, a patient' s
got HIV. Please let us know if your patients have
received that batch" and I couldn't tell them becau se
I had absolutely no records at all.
So that was one of my top priorities, was to get
rid of that completely inappropriate system.
|
2,651 | 27 | QUESTION:
We'll just look at a couple of documents in relatio n
to that, if we may, Dr Winter, just to illuminate
that. HCDO0000174_009, please. We can see this is
7 February 1984, and it's a letter that you wrote t o
Miss Spooner at the Oxford Haemophilia Centre. You
say that you recently replaced Dr Harold Sterndale as
director. You enclose the annual returns and then you
say this. You note:
"I have not been able to give you any
118 information about material used in the home treatme nt
of our haemophiliac patients. I understand that th ere
was a serious lack of local funding a few years ago ,
and for these reasons an arrangement was made where by
all haemophiliacs on home treatment received
Factor VIII concentrate from their general
practitioners on prescription."
Then you explain that you are extremely unhappy
about that and taking every step you can to abolish it
and issue Factor VIII directly. Then you are afrai d
you have no data on the type or amount of Factor VI II
that was used by our haemophiliacs on home treatmen t.
If we just look at the returns.
ANSWER:
Can we just point out that she is the secretary of
UKHCDO which, at that time, was based in Oxford and
subsequently moved to Manchester.
|
2,652 | 27 | QUESTION:
Yes. We've seen that from other documents. Thank
you.
Then if we could have, please, Henry,
HCDO0000174_003. So we can see this is the annual
return for 1983 for Margate. Your name is there.
This is in relation to haemophilia B. Total number of
patients treated during the year, three. Then we c an
see that you have been able to give a figure for th e
total used at hospital, whether in-patient or
119 out-patient, and that it's NHS Factor IX concentrat e.
No commercial Factor IX concentrate has been used a t
the hospital, but you are not able to give any figu res
for home treatment. It's nil because you don't hav e
the data.
ANSWER:
It's useful to see this because it gives everybody an
idea of the way in which the Oxford returns -- ever y
January or February, all haemophilia doctors would sit
down and submit information about the previous year 's
treatment. These are patients with haemophilia B, not
|
2,653 | 27 | QUESTION:
Yes, we will look at --
ANSWER:
The haemophilia A would look very similar to that.
|
2,654 | 27 | QUESTION:
Yes, and we've got that. Henry it is the same, but
004 at the end.
ANSWER:
Then, in addition to this, each patient is register ed
with Oxford, has a unique identification code, so
there would be a separate piece of paperwork to do
where for every registered patient you would provid e
agreed information along the lines of had they had
treatment, are they still alive, have they develope d
an inhibitor, et cetera.
|
2,655 | 27 | QUESTION:
Yes. Then we can see again -- if we look at the
column, we've got -- at the top, we've got total
number of haemophilia A patients treated during the
120 year, 25, and then we can see for the haemophilia A
patients, for in-patient or out-patient treatment, so
treatment at the hospital, there's 48,750 units the re
of NHS Factor VIII. Then we can see the figure for
commercial Factor VIII at 16,320 of Kryobulin. But in
terms of home treatment you've put nil, and then
you've put amount unknown, for the reason you've gi ven
because the home treatment system was being done
through the GP and local pharmacies.
ANSWER:
These are tiny amounts; less than 5 per cent of the
usage, I would think. So nearly everything has gon e
through a general practitioner.
|
2,656 | 27 | QUESTION:
So that system -- and I appreciate entirely it's no t
a system for which you were responsible, and it's
a system which you were horrified by, but that mean t
that either a GP -- not a specialist -- or
a pharmacist -- not a clinician -- was determining
what actual product the haemophiliac patient had fo r
their home treatment?
ANSWER:
It was not the GP at all who had also not heard of
Factor VIII. He wouldn't have known anything about
Factor VIII or even if it came in different types. It
was all down to the pharmacist who also had not hea rd
of Factor VIII who went and looked it up in a book and
found there were suppliers and, for whatever reason ,
chose one of the suppliers and rang them up and sai d,
how much is a bottle of Factor VIII? Whereas most
haemophilia centres would have been ordering severa l
hundred bottles at a go, they must have been highly
amused at a commercial company to have a local
pharmacist ring up and ask to buy ten bottles of
Factor VIII. But that's what happened.
|
2,657 | 27 | QUESTION:
Is this a correct inference to draw, that the patie nts
who would have been receiving their Factor VIII in
this way would have been receiving exclusively
commercial concentrates because the pharmacist
wouldn't have access to the regional transfusion
centre supply?
ANSWER:
That's correct. This is a reflection of what we've
been talking about earlier; the great shortage of
Elstree BPL in the south-west Thames and south-east
Thames regions, and therefore the need to buy
commercial.
|
2,658 | 27 | QUESTION:
It's probably clear from the letter you wrote to
Miss Spooner, but would you agree that this was
a completely inappropriate way to manage the care o f
the patients at the centre?
ANSWER:
Well, it wasn't any form of management at all. It was
anti-management.
|
2,659 | 27 | QUESTION:
You then arrived in December of 1983, and at that
122 point, as consultant, the decision as to which form of
treatment to use or which particular product to use
was yours. Your witness statement says that it's t he
ultimate responsibility of the local trust. Can
I just ask what you mean by that; do you mean you a re
an employee of the health authority and, in that
sense, it's the trust's responsibility?
ANSWER:
Yes, I mean, the ultimate responsibility laid with me,
really, as the clinician. It was solely my decisio n
as to which type of concentrate a patient received.
And that, for the first three or four months of my
consultancy, until we move on in a minute to talk
about heat treatment, was basically a situation whe re
there was very little Elstree available. So I was
also, of course, continuing to follow the same
recommendations that we had been implementing at Gu y's
about moderating concentrate usage for this first
three or four months in early 1984. Then for the
other regular severely affected patients I was havi ng
to purchase commercial Factor VIII.
|
2,660 | 27 | QUESTION:
The source of NHS concentrate for you in Margate,
would it still have been Tooting?
ANSWER:
Mmm.
|
2,661 | 27 | QUESTION:
It was. You were now a consultant and therefore ha d
a status you hadn't had at Guy's, and indeed
123 a responsibility that you perhaps hadn't had at Guy 's.
Did you raise the question of the shortfall or
inadequate supply of NHS concentrate with anyone at
the Tooting regional transfusion centre or in the
Blood Transfusion Service?
ANSWER:
I think something very influential happened.
Dr Savidge, as he was then, rang me up very, very
early in my consultancy and he said, "I think we ne ed
to meet and to talk", which was extremely helpful.
I remember going to meet him at St Thomas' very, ve ry
shortly after I started, and we actually, rather th an
talking about shortage of BPL, what we spoke about at
that meeting were the double problems, what we were
going to do about the new disease, which seemed to be
in the blood supply, what were we going to do about
chronic liver disease and we actually immediately - -
most our conversation was could we get heat treatme nt.
I know we're just about to come on to talk about
that but he was extremely helpful and influential i n
persuading me as to the right way forward over the
next few months and -- because, if you like, we wer e
very hopeful of -- we'd accepted that Tooting was
never going to be able to come up with any
improvement. This had been a very long-running sag a
and, as I say, at really all aspects of their
124 operation.
You know, we'd have situations in the hospital
where we would ring up Tooting at night for emergen cy
supplies and be told, "Oh, we're very short". Ther e
was a chronic shortage of all blood and blood produ cts
from Tooting because of this situation where they w ere
covering the two health authorities. So we didn't
think there was any mileage in trying to get more
supplies of Elstree. By January there was so much of
concern that we were already at that stage talking,
the two of us, asking ourselves: can we get
inactivated Factor VIII? Because that's going to b e
the way forward.
|
2,662 | 27 | QUESTION:
Now, in the period from December 1983 until May 198 4,
when you started to use the heat-treated product, a re
you able to give us any idea, on a very rough basis ,
what the percentage was of NHS versus commercial th at
you were using for your patients?
ANSWER:
Well, as you've seen from the previous year, there was
hardly any Elstree reaching Margate. The supplies
were so limited. There was a feeling, of course, i n
the provinces, that it all went into central London
and that we were an afterthought, but this -- I can
only reflect that we had very, very little BPL, as the
previous year's returns show.
|
2,663 | 27 | QUESTION:
So is it fair to say that probably the majority of the
treatment was commercial concentrates?
ANSWER:
Yes -- nearly all of it.
|
2,664 | 27 | QUESTION:
Where you were using factor concentrates --
ANSWER:
For that three or four months when I was in post.
|
2,665 | 27 | QUESTION:
You told the Penrose Inquiry that -- I can take you to
it if need be but I will just summarise and if you
don't remember and want to look at it, we will.
You told the Penrose Inquiry the patients didn't
want to have American concentrate or some patients
didn't want to, and you say it took quite a bit of
work to persuade patients in some cases to continue to
receive commercial concentrate. Do you want to loo k
at the passage?
ANSWER:
No. So this is really, now, one of the next of
a number of absolute key points in the epidemic.
|
2,666 | 27 | QUESTION:
I wanted to ask, that process you talk of, persuadi ng
patients to continue to receive commercial
concentrate, are you talking there about the
heat-treated concentrate?
ANSWER:
Well, that's -- I wasn't sure whether you were talk ing
about -- are you talking about -- before we switche d
to heat treatment, about carrying on with commercia l?
|
2,667 | 27 | QUESTION:
Yes, I really just wanted to know that that
description of persuading patients in some cases to
126 continue to receive commercial concentrate, what ti me
period does that relate to?
ANSWER:
Well, in my experience, the whole history was,
haemophilia patients, from the moment of their
diagnosis and growing up and going to meetings, lea rnt
that one of the sort of key things to follow was th at
you -- you know, people used to say to them in the
Sunday morning meeting in a Haemophilia Society
seminar in wherever, "You know, when you get back t o
your centre, you want to make sure that you get
British Factor VIII. Don't ever get American
Factor VIII". Very early on in the haemophilia
experience the patient would have that message from
somebody. It's a family illness; other people,
a cousin or somebody, an auntie, might have said, " You
make sure". All the patients knew.
You know, in my experience, whether it's this
period, January '84 or at a time a few months later ,
when we're trying to persuade people to switch, peo ple
were very, very reluctant -- completely
understandably, they were right -- to have Factor V III
from commercial donors.
|
2,668 | 27 | QUESTION:
The reason -- I'm really just interested in your us e
of the verb "persuade". What was the reason you we re
trying to persuade patients to do so?
127 ANSWER:
Well, before the switch, because it was the only
Factor VIII I had, because I didn't have any Elstre e,
and as we've discussed I didn't want to go back to
cryoprecipitate.
|
2,669 | 27 | QUESTION:
Then for this first few months of your consultancy,
was it the case that you were still trying to treat in
accordance with the UKHCDO recommendation from the
June of the previous year?
ANSWER:
Yes.
|
2,670 | 27 | QUESTION:
So for children, for newly diagnosed, for mildly
affected patients, would you be trying to use NHS
concentrate?
ANSWER:
Try to use NHS, use DDAVP where appropriate, try an d
postpone surgery if it wasn't necessary, use BPL fo r
children, maybe cryo for an older child if it was
possible. Do all you can to restrict concentrate
usage for children and mildly affected patients.
|
2,671 | 27 | QUESTION:
Was there any prophylactic programme during these
first few months --
ANSWER:
No, not at that time.
|
2,672 | 27 | QUESTION:
So just given that there had been this previous rat her
unsatisfactory situation of the GP and the pharmaci st,
could you just talk us briefly through what you the n
did. This is, again, before heat treatment. Did y ou
call every patient in or invite every paint for an
128 appointment and explain that the situation was goin g
to now be different?
ANSWER:
Yes. I mean, when patients come in to a haemophili a
centre and they get supplies, they get enough for
a couple of months, say. On this very inappropriat e
system, the ten bottles they were given might only
last them a week or something, so the patients were
having to get prescriptions very regularly, so they
ran out very quickly. So it was actually pretty ea sy
to send for them to say, "I need to talk to you abo ut
what's going to happen in the future, I've got
a better system, we're going to give you the
Factor VIII from the hospital and you don't need to go
to the GP anymore."
|
2,673 | 27 | QUESTION:
Given that the time-frame we're talking about is en d
of 1983/early 1984, in the course of that conversat ion
that you're having with your patients because you'r e
changing the way in which they receive their
treatment, did you tell your patients anything abou t
the risks from commercial concentrates in terms of
either AIDS or non-A, non-B hepatitis?
ANSWER:
Well, I certainly, in a very major way, did, as we' re
coming on to talk about, in April and May. These
patients had not been particularly well informed ab out
haemophilia, really, let alone its treatment. I th ink
because I was already in a discussion with Dr Savid ge,
my priority -- I had a highly inappropriate, danger ous
system. My priority was to get a proper haemophili a
treatment programme going with dispensation -- that 's
the wrong word -- dispensing being done from the
hospital rather than GP and a pharmacy.
So my priority was to get the patients onto, you
know, a system where they collected from us, and
I thought: let me do that first of all and then I c an
talk to the patient about a range of things.
There was hardly any home therapy I wanted to
do, there was no prophylaxis I wanted to do. The
major thing bubbling under was: are we about to swi tch
to heat treatment?
|
2,674 | 27 | QUESTION:
So in those first few months is it right to underst and
from your answer that you wouldn't have necessarily
have been telling your patients as a matter of rout ine
about the risks of AIDS and non-A, non-B hepatitis?
ANSWER:
I didn't start until 12 December, so by the time --
you know, Christmas, and then most of these patient s
I'd never met and they were coming in for reviews o nce
every couple of months or so, by which time I was w ell
on the way to trying to switch.
|
2,675 | 27 | QUESTION:
Then you've told us I think of some of the initiati ves
of trying to implement the UKHCDO recommendations, and
130 you mentioned possibly delaying surgery, not having
prophylactic treatment until you can sort the
situation out. Was the giving of advice about how to
manage the condition, through lifestyle changes,
through rest, was that ever part of the conversatio n
at that point in time?
ANSWER:
To be honest, it was -- I was starting from scratch
there. I did not have a haemophilia nurse, I didn' t
have a physio, I didn't have a centre, I didn't hav e
a finance manager, I didn't have a secretary, I did n't
have a centre. All my patients were getting
Factor VIII from a GP. I mean, you couldn't have
started from a lower position.
So I started -- you know -- and also, as if that
wasn't enough, I was immediately into a situation
where I knew there were two really serious issues
which was really also at the core of my thinking. So
I had a whole range of really important priorities
about, firstly, establishing, in effect, for quite
a lot of patients, coming in from all over Kent, fo r
the first time a proper centre. So -- and there we re
just me. So there were a whole range of priorities
I had to do first. By then it's spring time, by th en
we're into heat treatment.
|
2,676 | 27 | QUESTION:
Just in terms of the numbers of patients that we're
131 talking about, I think we saw a number on the retur n,
your statement had estimated about 20 or so severe
haemophiliacs, with haemophilia A?
ANSWER:
I think that's right. We had a sort of hub and
spokes. So I did also look after patients in adjac ent
centres. They would go for day-to-day treatment to
Medway or Maidstone or places like that, and then t hey
would come to me for reviews, as a haemophilia
specialist. So, in all, I'm thinking about
35 patients with significant haemophilia and I say
that because those were the patients who were comin g
on later in the year to get HIV tested.
|
2,677 | 27 | QUESTION:
Then, if we just look at your witness statement aga in
please, Dr Winter, at paragraph 35.4 you say this:
"At this highly critical time there were
therefore only three options for haemophilia
clinicians:
"... suspend treatment ..."
I'm sorry, I'll wait -- do you have that?
ANSWER:
Yes.
|
2,678 | 27 | QUESTION:
My apologies.
So your option 1 was "suspend treatment"
completely?
ANSWER:
Yes.
|
2,679 | 27 | QUESTION:
Your option 2 was to "continue with BPL concentrate
132 only". Your option 3 was to "switch to heat-treate d
Factor VIII and IX".
Now, we know you opted for option 3, and we'll
talk about that in a moment. I just wanted to ask
whether the position was truly as stark as you ther e
set out. Because presumably you wouldn't have to
suspend all treatment; you could reduce the amount of
treatment, suggest "try and use a little bit more
cryoprecipitate", give advice about management and bed
rest, on a temporary basis at least. Was it
a more nuanced set of options than this perhaps
suggests?
ANSWER:
No. Nobody ever gave bed rest to a person with
haemophilia. They're bleeding and they need to hav e
the bleeding stopped.
With hepatitis C we know you almost certainly
got hepatitis C the first time you had a treatment, so
the viral risk from one treatment might have been t he
same as from 30 treatments. So where was the logic in
trying to reduce treatment? You know, you were sti ll
going to give the treatment that had the virus, so
there was no logic there.
So it really did seem, as a matter of sort of
strategic principle, those were the three core choi ces
that lay in front of us.
|
2,680 | 27 | QUESTION:
So could you then talk us through your reasoning fo r
taking what was -- I think, could fairly be
characterised as a bold decision, in the spring of
1984, to use heat-treated products?
ANSWER:
Yes. This is one of the absolute key moments in th e
history of the epidemic. We'll have heard on the
documentary and other things there was a certain vi ew
retrospectively from some people with haemophilia: why
did I have to continue to have Factor VIII, couldn' t
I have stopped? Haemophilia clinicians like me wer e
very unhappy about that suggestion. Cerebral bleed ing
has always been the most common cause of death in
haemophilia. I think in that year there had alread y
been ten deaths from cerebral bleeding in haemophil ia.
These are things, of course, the patients don't see
unless it happens to their family relative. It's t he
sort of thing that the doctors see.
If you look at the Birch report of the early
1930s, an American doctor I think, she looked at li fe
expectancy of patients with severe haemophilia. Of
course there was no treatment. Nearly all the
patients were dead by the age of 21/22. The World
Federation of Haemophilia have a twinning system an d
every two years at the World Federation a centre li ke
ours, from the developed world, would get twinned w ith
134 a developing centre, and we became twinned with
Islamabad, in Pakistan, who we went to see. They a re
a nuclear power but they had no Factor VIII at all,
nothing. On the first day we did a clinic for abou t
50 children, all of whom got carried in by their
fathers, unable to walk, and at the end of the day
I said to the centre director from Islamabad, "Well ,
tomorrow presumably we can go and do a clinic at th e
adult centre", and he just looked at me and said,
"There isn't one. We don't need one. All of these
children will die of bleeding."
So the natural history of haemophilia,
untreated, is to die of bleeding. So you'd never g et
a clinical doctor like me to sign up to a situation
where I said to a patient, "Why don't you stop havi ng
Factor VIII for a bit?" Bleeding is a very, very
serious issue. As I keep on saying, it's the most
potent bleeding disorder known to man.
So that was the easiest of the three options.
It was absolutely not an option not to treat. So t hat
was the easy bit.
Now we come to the really hard bit. For years,
I reflected on this very difficult time and thought it
was the hardest decision I ever had to make as
a doctor. So let me just try and walk you through
135 what the issues were.
Firstly, we have the patients', "British, good,
American, bad". So the choice is: you can stay on
British Factor VIII. It's from voluntary donated
plasma: good. It's got a full product licence: goo d.
It's cheap: good. The patients like it: good. But
there's no inactivation step. Surely you have to
believe that this new virus, which hadn't -- well, it
had been identified by then, and we had better make
the point. In mid-1983, the French and then the
American groups had identified the virus that we no w
know as HIV. So we knew that we were dealing with
a virus, we just didn't have a test for it.
So that was the big "but": did you believe, with
increasing numbers of cases -- still not very many --
did you believe that the new virus would only be
present in American Factor VIII or could it be
possibly there also in British Factor VIII?
So that was the British choice.
Or did you say to yourself, "People with
haemophilia are so vulnerable, the batches are from
20,000 donors, if one of those donors has a virus, the
patient's likely to get it, they are incredibly
vulnerable to any virus, therefore if I go for
American, not liked by the patients, 50 per cent mo re
136 expensive, no licence, but it's heated"?
Now there was experimental evidence. The
companies had started to bring in heat-treated
Factor VIII to try and see if it inactivated
hepatitis, before anything was known about AIDS. S o
the companies in the US had started to work on heat
inactivation. In 1983 the Germans had a heat-treat ed
product, Bering, but we were not able to get that.
But -- so that was the choice.
You know, and I sat down with the patients and
said, "I'm not happy about no treatment. This is
a really, really difficult call, but ..."
Again, I stress, I owe a debt of gratitude to
Dr Savidge, who was very, very clear and strong tha t
he thought we ought to switch -- everybody -- to bo th
Factor VIII and Factor IX.
By February 1984, one of the companies, Alpha,
who had a plant in Norfolk, they are an American
company, they had a licence in the US for the
heat-treated product. That was a major step forwar d.
Dr Savidge and I approached them together with the two
other doctors in Britain and said: we're aware of t his
licence in the US, do you think you would be able t o
get supplies for us? Which we would have to give o n
a named patient basis. So, you understand, if a dr ug
doesn't have a licence, doctors in this country sti ll
have the ability to use a drug on a named patient
basis. The answer was, "Yes, we can. It's going t o
be 50 per cent more expensive".
So we decided that was the route we really ought
to go down, because we were so very concerned, for all
the reasons we've discussed this morning, that HIV --
we now had a virus. We couldn't convince ourselves
that it wasn't going to be in British Factor VIII a s
well as American because of the intrinsic
vulnerability of the system.
There was very widespread disagreement with
those views, and I'm never critical -- you can ask the
other doctors who are coming who didn't go down tha t
pathway. The arguments against were: some people
believed, including Professor Bloom the Chairman, t hat
this was a problem to do with commercial Factor VII I.
The whole virus story, non-A, non-B, HIV, it was
commercial. Terrible donor practices. It was not
going to happen to Britain with altruistic voluntar y
donors. This was an American problem. That was vi ew
number one.
Secondly, the Germans always used huge amounts
of Factor VIII, much higher than Britain, from Germ an
donors. They had -- apparently, they had had littl e
138 or no HIV. That was quoted.
Then, thirdly, there was a very understandable
concern -- we've spoken about inhibitors. About
10 per cent of patients develop inhibitors which ma kes
the future treatment with Factor VIII effectively
impossible. Some doctors very reasonably said, I'm
really worried about this because the heat treatmen t
might alter the antigenic nature of Factor VIII in the
bottle so that when it's injected into the patient,
the antibodies, the patient's immune system might
recognise the injection as being foreign for the fi rst
time and make an inhibitor. This was a very
serious -- you know, it would have been a very seri ous
development, and it was a perfectly -- it was
perfectly reasonable to put up that as an argument.
Having said all that and had this incredibly --
I can't stress to you enough -- the difficulties an d
the -- plus all the implementation of it, I had to
persuade the patients who were anti-American. I ha d
to, in the middle of a financial year, increase the
budget by 50 per cent. At some stage in the next d ay
and a half, I would like to talk to you about the w ay
finances were arranged in haemophilia and prioritie s
and things because that's a particularly important
thing. We had all the logistics of getting
139 un-heat-treated supplies in, getting heat-treated
supplies out. So it was -- just in terms of
logistics, once you'd done that, it was complicated ,
and you had other doctors saying to us at meetings,
I don't know why you're doing this.
Anyway, finally, very poignantly, although for a
long time I thought this was just the most
unimaginably difficult decision, I now realise -- a nd
this is quite a powerful thing to say -- actually, it
was all probably irrelevant because I now realise t hat
nearly all of the patients had already been infecte d.
And at some stage, I'd like to talk to you about th at
data.
|
2,681 | 27 | QUESTION:
Absolutely. We will come to that.
ANSWER:
Anyway, that was the heat treatment dialogue.
|
2,682 | 27 | QUESTION:
Can I just ask -- sorry. You mentioned two other
doctors along with you and Professor Savidge. I th ink
you've named Middlesex and Sheffield as the areas.
Could you just let us know who the doctors were?
ANSWER:
Yes. There was a Professor Eric Preston, who you a re
due to be seeing, and Professor Sam Machin from the
Middlesex. They were -- his is quite a smaller
centre.
|
2,683 | 27 | QUESTION:
Did you consider heat-treated products other than
Alpha? Were there other options available to you t hat
140 time?
ANSWER:
No, that was the only one available, and we were ve ry,
very keen to get on with it as soon as possible. W e
were -- we made the decision. It seemed absolutely
right but difficult, and we absolutely wanted to ge t
it done, so we started May 1984. There were then s ome
supply problems, but from June '84, all of those fo ur
centres were using only heat-treated Factor VIII an d
Factor IX, and they did not get any more viral
infections in those centres after those dates, whil st
other centres, as we will discuss, were going on us ing
un-heat-treated material all the way through till
September the following year, a period of about
15 months or so.
|
2,684 | 27 | QUESTION:
Can I just ask before we break again, Dr Winter, in
terms of the categories of patient who switched to
heat-treated product in May of 1984, was that all o f
your patients, so those who had been on some form o f
NHS or cryoprecipitate? Presumably it wasn't those
for whom DDAVP was the most appropriate treatment?
ANSWER:
No, DDAVP is fine. For everybody else, we were mak ing
a core statement. Any concentrate is unsafe becaus e
of the nature of concentrate manufacture. You know ,
the vulnerability of a haemophiliac patient to get
a virus is so strong with 20,000 whatever it is
donors, be it donor from voluntary donor or commerc ial
donor. We'd convinced ourselves all -- at that mom ent
in time, you were very, very unwise to continue to
treat any patient with a concentrate that had not h ad
a step to inactive a virus.
|
2,685 | 27 | QUESTION:
If we leave aside von Willebrand's and mild
haemophiliacs, for whom DDAVP was appropriate, all the
rest of the patients, haemophilia A and haemophilia
B --
ANSWER:
And haemophilia B as well. Even though there were no
patients with AIDS, we felt, as a principle, if it was
in Factor VIII concentrate, why shouldn't it be in
Factor IX as well? We wanted everybody to switch.
|
2,686 | 27 | QUESTION:
Well, it will be after I have asked
one further question, if I may.
You have described how difficult a decision it
was. You've given credit to the arguments against
that decision. Was there one factor in particular
which made you decide the way you did or not? And if
so, what was it?
ANSWER:
Well, I think the combination of these particular
factors -- I was totally sold up, and had been sinc e
142 1982, to the idea that AIDS was due to a transmissi ble
agent. I then knew, by the middle of '83, that tha t
was the case because the virus had been identified.
I knew then that that virus had been causing illnes s
in a small number of American haemophiliacs and, by
that stage, a British haemophiliac and I knew that the
patients were incredibly vulnerable because they we re
receiving concentrate from thousands of donors. So if
you added in all those little things, you had a pre tty
clear view. You had just lost confidence, if you e ver
had confidence, that concentrates were safe.
When historians in 50 years will write histories
of haemophilia, they'll say concentrates brought
unimaginable benefits to people with haemophilia fo r
the first time: home therapy, schools, work, exerci se,
et cetera, a normal life with a huge but -- a huge
but. The Achilles heel: it came from thousands of
blood donors. If there was a virus in town in bloo d,
the haemophiliacs would get it.
|
2,687 | 27 | QUESTION:
Dr Winter, are you able to hear me okay?
ANSWER:
I can.
|
2,688 | 27 | QUESTION:
So you had been describing the switch of your patie nts
to heat-treated product in May of 1984. You'd said
that that was essentially for all your patients, ot her
than those who could be treated as mild patients or
von Willebrand's patients with DDAVP.
Was there any space left, as it were, for the
treatment of cryoprecipitate? Did that continue at
all for any category of patient, or was it, other t han
DDAVP, all now heat-treated concentrates?
ANSWER:
No. As you'll gather from my remarks, cryo was rea lly
regarded as obsolete, and we didn't want to use it
unless we absolutely had to. After an initial hicc up,
we were able to get all the supplies of the
heat-treated material that we needed from Alpha so we
could get all the patients across, as I say, by the
end of June '84.
|
2,689 | 27 | QUESTION:
So the switch took place, I think, between May and
June, or in the course of May and June 1984.
Can you just describe for us, please, the
process in terms of your meetings with patients and
the information that was provided to patients.
ANSWER:
So I sat down -- we're probably talking about a swi tch
of about -- you know, this is initially with the
144 regularly treated patients who were going to be
switched as a priority, and there were probably abo ut
30 of those, I suppose. So some of those had upcom ing
appointments. If they didn't, I sent for them.
I don't know about other centres, but my
patients were well-read and knew of the issues and had
obviously been talking about the possibility of
getting treatment that had been virally inactivated .
So I sat down with them, usually with their wife or
partner, and said, "I really need to have a very
significant discussion with you because we've got
a big decision to make because I can now" --
I explained all about heat treatment. I explained all
about why I was very worried about carrying on with
any form of concentrate that hadn't been virally
inactivated. And I said, you know, we've now got
a choice, but I can get supplies of heat-treated
Factor VIII, or Factor IX if they were a haemophili a B
patient.
I mean, I wouldn't say I pushed them, but
I said, you know, this is my recommendation.
I really -- we thought about this very hard. I sai d
St Thomas' are going to do the same thing, and
I really think we should -- it's the best way forwa rd
for you. You know, as I'm the centre director look ing
after you, this is going to be your choice, but my
recommendation would be that we did change you over on
to this different treatment.
|
2,690 | 27 | QUESTION:
Did all the patients that you spoke to accept that
recommendation?
ANSWER:
Yes. I mean, the issue was the word "American", an d
we spoke through all that, about -- I said even if
I could get them British unheated Factor VIII -- wh ich
I couldn't -- but if I could, you know, I still had
significant concerns that although the virus load
might be less than in American un-heat-treated, it was
still significant. So for that reason -- this was the
total reversal of everything they always wanted to
hear, but I was saying, controversially, American
heat-treated was safer than British unheated, even
though the latter came from voluntary donors.
So it was a very dramatic switch, and for some
of them, you know, they sort of needed an intake of a
few moments to really think about what I was saying ,
and -- but, you know, this wasn't a surprise to the m.
It had been in the air. I may have been speaking
about them in February, you know, earlier when -- f or
the first time I was thinking about trying to switc h.
That's what happened, and they -- I mean, some
were more enthusiastic than others, but nobody
146 disagreed, which made it easier because that would
have been very messy logistically to have some
patients on heat-treated and some on un-heat-treate d.
But we managed to get everybody to agree to switch,
and that's what happened.
|
2,691 | 27 | QUESTION:
What was the mechanism for the named patient basis?
Was there any particular procedure that you had to go
through?
ANSWER:
Yes. That was another area. I can't remember the
exact way it's done now, but it's all very formal, and
you have forms to fill in for each patient that you
might treat, not only the regular ones. So I had t o
do it for every patient in the centre who was likel y
to need clotting factor concentrate. So there was
a lot of administration to be done. This would hav e
been a national form for doctors to treat patients on
a named patient basis. That must have been sent of f
to some national committee somewhere to be register ed.
So all that had to be done and approved. Doubtless ,
there was work with my Trust to get them to agree t hat
I should start treating patients on a named patient
basis. I would have had to go to the ethical
committee, and then there was the finance. You kno w,
this is what may -- I'm buying it -- well, the new
financial year's just started in April, and NHS
147 budgets are not easy at the best of times. But to
go -- you know, when the budgets have all been set
early in the year and to go and see the finance peo ple
and say, I really want to change to using a differe nt
type of Factor VIII. It's 50 per cent more expensi ve.
The reason I want to do this is theoretical. And
they've got people coming in, the neurologists comi ng
in saying there's a new drug for multiple sclerosis .
The oncologists are coming in and saying there's a new
drug for breast cancer. Haemophilia is low priorit y
in the Health Service because it's a chronic
disability. You've heard this. Priorities in the
Health Service are: accident and emergency, cancer
waiting times, surgery waiting times. Chronic
disability is low, and haemophilia is especially
unpopular. What finance people like are low cost,
high volume, totally predictable. They want to go to
a Trust and say, we're going to commission 20,000 h ip
replacements from you. Haemophilia was a complete
nightmare because it was everything they hated: low
volume, high cost, and totally unpredictable.
Every March, I used to sit down with them, and
they used to say to me, "Dr Winter, how much are yo u
going to spend on Factor VIII this year"? And I sa id,
"You're asking me how often my patients are going t o
148 bleed, and I don't know the answer to that". So
haemophilia was a nightmare for finance.
Sorry, you've rather started me off on
a long-winded theme, but I'm not quite sure how we
manage to get the finance, given all those things, but
I think there must have been a bit of press activit y.
In fact, I'm sure there was. I think there was
a Sunday Times campaign or something. My local MP was
Jonathan Aitken, and I got him to ask a question in
the House of Commons. He was the first MP to ask
a question about AIDS. So I think there was a bit of
political activity going on which must have helped.
Anyway, we somehow did manage to get the money.
|
2,692 | 27 | QUESTION:
You may not know the answer to this, given what you 've
said a few moments ago, but the named patient forms ,
I've been going to ask you who you sent them to. Y ou
thought it was potentially some national committee or
organisation?
ANSWER:
Yes.
|
2,693 | 27 | QUESTION:
But you don't at this stage recall that?
ANSWER:
I cannot remember who it was, but there was definit ely
a mandatory process for each patient. You know, wh at
was the name of the patient, the name of the drug, why
you were doing it.
|
2,694 | 27 | QUESTION:
Then how did you manage asking your patients to ret urn
to you any stocks they had of unheated product?
ANSWER:
So I think -- because we knew it was going to be
a rolling period over a few weeks, most of the
patients had upcoming appointments, so by that stag e
I had one or two haemophilia nurses appointed. The y
were responsible for home therapy administration. So
they would have rung up the patients and said, you
know, Dr Winter was talking to you about this switc h.
We're now in a position to do the switch, so the ne xt
time you come to the centre, we're going to give yo u
the new supplies of the new treatment and show you how
to draw it up and how it works. Please will you br ing
with your any unused bottles of the old concentrate .
That was pretty straightforward.
|
2,695 | 27 | QUESTION:
Now, that was May/June. The exclusive product, in
terms of concentrate used from then onwards in the
centre, was the heat-treated Alpha concentrate.
Did you -- and presumably that was used both in
the hospital and for home therapy?
ANSWER:
For all treatment.
|
2,696 | 27 | QUESTION:
Did you initiate a prophylactic programme at that
stage?
ANSWER:
I did.
|
2,697 | 27 | QUESTION:
For children or adults?
ANSWER:
Just for children.
150 |
2,698 | 27 | QUESTION:
You then -- in the summer of '84, testing for HIV
started to become available.
Can you talk us through the process whereby you
sent off or collected blood samples and sent them o ff
for testing.
ANSWER:
Yes. It was actually a bit later. It was
October 1984. A viral test then known as HTLV-III --
it was an antibody test. Not for the virus but for
antibody -- was available through the laboratory of
Dr Richard Tedder who was a virologist at the
Middlesex Hospital and it was not being advertised to
any of the hospitals because everybody suddenly wan ted
this test. But the UKHCDO came to an arrangement w ith
Dr Tedder that haemophilia centres could send him
blood samples on their patients for that test to be
done.
A range of things then happened, apparently,
from centre to centre. In my centre -- I hadn't be en
there all that long -- there were no stored blood
samples. So I had to speak to each patient by writ ing
and say, you know about this new virus. I can now get
you the blood test. Please will you come and see m e
on such and such a date so we can have this test do ne.
That was the process that happened in my centre.
|
2,699 | 27 | QUESTION:
So every patient who -- in respect of whom you sent
151 off a test was a patient who you had told why you w ere
asking them for a blood sample?
ANSWER:
Because they had to come to the hospital to have a
blood test. But there was a whole diversity of
practice, as you will gather, and it appears that i n
some centres blood tests were done on these patient s
without them being informed. I think that's clear.
It seems that in some centres they had blood stored
down which they sent off to Dr Tedder and it seems
that in some centres they maybe, at that stage, did n't
test at all but tested a bit later. So there was
a whole range of things that happened in response t o
this announcement that the test was available. But
anyway, that's what happened in our centre.
|
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