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46,900 | 356 | QUESTION:
"... were of the opinion that it was better to make
a gradual change to NHS products that could be
sustained rather than a sudden switch in times of g lut
and then a sudden transfer back of all patients to
115 commercial material. This was the sort of thing th at
had been happening at that time."
Then you refer to there having been a meeting of
Haemophilia Centre Directors in which it was
considered advisable that patients remain on the
Factor VIII product they had been regularly using. So
that's the approach you were just describing,
Professor Franklin?
ANSWER:
Yes.
|
46,901 | 356 | QUESTION:
"Therefore it did not appear unreasonable at that t ime
to propose that patients who had been using Armour for
several years should continue to do so. There was
never at any time sufficient NHS Factor VIII availa ble
to treat all patients and the decision of Dr Hill a nd
myself was that patients should receive a regular
supply of a one or other product and not a mixture of
both."
So pausing there, the aim was if someone was
receiving Armour they'd carry on receiving Armour. If
someone was receiving NHS concentrate they would ca rry
on receiving NHS concentrate, as much as you could?
ANSWER:
Not only that they would stay on that same batch un til
that batch was exhausted, yes.
|
46,902 | 356 | QUESTION:
You referred there to limited supplies of NHS
material, and then times of glut, and having to
116 transfer patients between different products. What ,
if anything, can you recall about that?
ANSWER:
Well, I don't think we ever had a glut, actually, b ut
we did -- there was -- there were times when the
supply of NHS product increased, and so we -- I thi nk
there is some correspondence that you have between
myself and the director of BPL, which made the NHS
product. In light of that, I think we did transfer
some people from commercial onto NHS, in the hope t hat
that would be sustained. In the end, it turned out
not to be sustained and, I presume, though I don't
have any records, I presume we had to move them bac k.
I wasn't very happy about that at the time.
|
46,903 | 356 | QUESTION:
We might sense that from the tone of your letter to
Dr Lane, Professor Franklin. If we have a look at it,
BPLL0000853_002, please, Henry. So this is your
letter, 24 May 1984, so a couple of months after th e
letter that we don't have but we have seen describe d
in your letter to Dr Ala, and you are saying here:
"As co-director of the Haemophilia Centre at
this hospital, I have been most disturbed at the
sudden fall in supplies of NHS material for our
patients. It is only a month or so ago that I was
requested to change some patients to NHS from
commercial material because of a glut of the former at
the Regional Transfusion Centre."
So it appears there had been at least temporary
glut of NHS material?
ANSWER:
Yes.
|
46,904 | 356 | QUESTION:
"It appears that we will now be in the position of
having to treat patients with commercial material w ho
may never have been exposed to this in the past. T his
situation is particularly regrettable given the
current interest amongst haemophiliacs in the acqui red
immune deficiency syndrome."
Obviously, we will come on to that later,
Professor Franklin. You go on to say:
"Our efforts to reassure patients have included
maintaining them on a single product so as to limit
the pool of donors to which they are exposed as muc h
as possible. Not only will this sudden and unexpec ted
shortfall in NHS material mean that we will have to
change this policy but it will also make
epidemiological studies of hepatitis and AIDS
meaningless."
What did you mean by the reference to
epidemiological studies? Was that something you we re
involved with?
ANSWER:
Not particularly as a study. I imagine that was
just -- as we'll come on, you know, we knew -- we c ame
118 to know how many people had -- were HTLV-III positi ve
and I suppose it would have been perhaps helpful to
know whether any of those had been from people who' d
only ever had NHS material.
|
46,905 | 356 | QUESTION:
Then if we just --
ANSWER:
It wasn't a trial or formal --
|
46,906 | 356 | QUESTION:
Not as far as your involvement's concerned?
ANSWER:
No.
|
46,907 | 356 | QUESTION:
Then if we look at the next paragraph:
"Could you perhaps let me know of the likely
future supplies of NHS material so that I may plan the
treatment strategy for my patients."
You go on to say that you find:
"... the sudden swings in supplies with no due
notice to clinicians involved in the treatment of
patients to be unacceptable."
I think it's fair to say that Dr Lane's
response, which we have at BPLL0000853_001, suggest s
that this is an issue that you would need to take u p
with the Regional Transfusion Centre rather than BP L?
ANSWER:
Yes, it was a fairly robust rebuttal, I suppose.
|
46,908 | 356 | QUESTION:
We see that in his second paragraph:
"... Regional Transfusion Centres, and not the
Blood Products Laboratory, determine the issuing
policy within individual regions."
119 If we skip down to the fourth paragraph of the
letter he says, in relation to the sudden and
unexpected shortfall:
"Regional Transfusion Centres have monthly issue
reports and six-monthly updates at the time of
Pro-rata. Your RTC must have been aware of their
Pro-rata issue of Factor VIII as far as back as
December 1983 and known that this period would be
affected by the yield and plasma supply ..."
I mean, whatever the precise cause of the
fluctuation, was that a situation that persisted, a s
far as you can recall, in those first two or three
years that you were there? Was this a perennial
problem?
ANSWER:
To be quite honest, until I saw these I had rather
forgotten. I did know that I had some corresponden ce
with Dr Lane. This change in treatment obviously c ame
at a really critical period, sort of '84, and I thi nk
that was why I was concerned about it. I'm not sur e.
I think, thereafter -- after this, most of the majo r
changes came about when the issue around requiring
heat treatment came in and that sort of disrupted
a lot of the regular supply issues. So I think aft er
that, there was hardly any such thing as routine
supplies for a couple of years.
120 |
46,909 | 356 | QUESTION:
Okay. It would seem that you received your supply of
NHS Factor concentrate from the Regional Transfusio n
Centre?
ANSWER:
Yes, I think we got all the supplies from there but
I'm sure -- well, you were speaking this morning ab out
the contracts, and so on but -- I think it was all
stored over there, yes.
|
46,910 | 356 | QUESTION:
So the cryoprecipitate was from the Regional
Transfusion Centre?
ANSWER:
Yes, that would have been made locally.
|
46,911 | 356 | QUESTION:
The NHS Factor concentrate was made by BPL at Elstr ee
but supplied to the Regional Transfusion Centre and
then to you?
ANSWER:
Yes.
|
46,912 | 356 | QUESTION:
Then the commercial products, we'll look at the
contracting arrangements in a few minutes, but your
recollection is they were delivered to the RTC and
then hospitals would call them off --
ANSWER:
I think we called them off as we needed but it's
a long time ago. I'm not 100 per cent sure.
|
46,913 | 356 | QUESTION:
If it assists you, Professor Franklin, the
documentation suggests that for Queen Elizabeth,
although not the children's hospital, that that was
probably the case.
ANSWER:
Yes.
|
46,914 | 356 | QUESTION:
Just generally, in terms of the treatment policies,
what use was there in this period 1982, 1983, 1984, of
cryoprecipitate?
ANSWER:
Well, there was use. I remember doing it. I think
your previous chart suggested that we were using it
for von Willebrand's disease. I would have thought we
were using it for mild cases. It really depended o n
the severity of the problem that was required but w e
were definitely using it. In the absence of any mo re,
sort of, figures, I can't remember.
|
46,915 | 356 | QUESTION:
What about DDAVP?
ANSWER:
We certainly did use that. It was very useful, but it
was really good for things like dentistry in less
severe patients. As I'm sure you know -- I mean,
DDAVP works by releasing Factor VIII from the body
from the blood vessels. So if you are a very
severe -- a person with very severe haemophilia 0 t o
1 per cent, you don't have Factor VIII to be releas ed
from the blood vessels, but if your normal Factor V III
level is between 5 and 10 per cent, say, you actual ly
have quite a bit and the DDAVP would release that a nd
then you would be able to give it, perhaps, for
a couple of days to tide you over. But it was very
short-lived. So it was something we used -- I mean ,
I remember using it.
122 |
46,916 | 356 | QUESTION:
We saw reference this morning in the 1970s to
cryoprecipitate being used to provide cover for
surgery. Was that something which was still happen ing
when you joined QEH?
ANSWER:
Yes, I think it was, yes.
|
46,917 | 356 | QUESTION:
Then, in terms of NHS product, as opposed to
commercial, how were decisions taken as to which
patients would receive NHS product and which would
receive commercial; can you recall?
ANSWER:
Yes, difficult. To be quite honest, I can't rememb er.
I'm sure that if we had a young man transferring fr om
the children's unit who had only been on NHS we wou ld
have done everything possible we could to try and k eep
them on that. But, at times, we had very little NH S
and so, apart from that sort of more general commen t,
I don't remember specifics.
|
46,918 | 356 | QUESTION:
Presumably your product and batch policy would mean
the converse as well: if you had a patient transfer red
from the Children's Hospital who had been receiving
commercial concentrate, as we know many of the
children did, you would have been likely to keep th em
on that?
ANSWER:
Probably. It's unlikely it would have been the sam e
batch, perhaps, but yes.
|
46,919 | 356 | QUESTION:
Was there any specific policy or approach or practi ce
123 in relation to patients who were previously untreat ed
patients?
ANSWER:
Well, I don't remember ever treating -- well, other
than possibly some with DDAVP, who were very mild,
I don't remember treating any totally new patients.
|
46,920 | 356 | QUESTION:
The arrangements for obtaining the commercial produ ct,
we know that there was a regional contract in place ,
and it appears to have been with Armour at the time at
which we're talking when you arrived in 1982. As f ar
as you can recall, was all your commercial product at
QEH obtained pursuant to that contract or did you e ver
make any separate arrangements yourself for the
procurement of commercial concentrates?
ANSWER:
In normal times, it was always off that contract. The
period of time when the -- I think, maybe the BPL b ut
certainly the commercial unheated products were
recalled, we went through a period of having very
little and, although I have a vague memory of it, b ut
you have provided papers to show that I actually ma de
a personal plea to Armour for some extra supplies,
which they did provide us with, which was -- it was
commented by my colleagues was outside the spirit o f
the agreement but it was a difficult time.
|
46,921 | 356 | QUESTION:
The criteria for awarding the regional contract for
commercial product, before we look at any of the
124 documents, your statement refers to Professor Hill
suggesting that one might question suppliers of Fac tor
concentrates about their donor pools. If we just l ook
at your statement, I think it is your paragraph 11.
ANSWER:
Yes, I remember him doing that.
|
46,922 | 356 | QUESTION:
What you say is, you talk about -- in the early yea rs
of your time working at QEH you recall there being a
committee of doctors in the region which determined
which clotting factors were to be bought, and we wi ll
look at the documents in a moment.
What is it you can recall about Professor Hill
talking to you about donor pools and you asking for --
ANSWER:
He would ask about whether they were collecting blo od
from prisons, skid row locale -- I mean, this was
after the 1975 bad blood -- I can't remember the na me
of the programme now, but the World in Action
programme and there was, you know, great concern ab out
the quality of product. I know he had certain view s
about certain companies but -- and I think it was
really a combination, I think, of trying to reassur e
himself and myself that we were hopefully getting t he
best product, and also perhaps send a message back the
other way that this was an important issue that
companies should address.
|
46,923 | 356 | QUESTION:
You say he had certain views about certain companie s.
What can you recall about his views about particula r
companies?
ANSWER:
Well, there is a letter in the papers from a surgeo n
in Stanford University to the then head of BPL,
Dr Maycock, being really quite damning about
one company's product, and that company was one tha t
Dr Hill was never very keen on.
|
46,924 | 356 | QUESTION:
That's the letter from Dr Garrott Allen --
ANSWER:
It is.
|
46,925 | 356 | QUESTION:
-- to Dr Maycock, 1975?
ANSWER:
Yes.
|
46,926 | 356 | QUESTION:
Can you recall any other particular discussions you
had with Professor Hill about specific companies?
ANSWER:
No. None beyond that, no.
|
46,927 | 356 | QUESTION:
If we could just look at three meetings, one before
you arrived -- well, one whilst you were there but
before you took over as director, and then two afte r
you became director, just to get a sense of how
decisions were taken.
Could we please have? Henry, FHIN0000030.
This is a meeting of the West Midlands Regional
Health Authority's working party on the treatment o f
haemophiliacs. We looked at it this morning during
the presentation, Professor Franklin.
It's dated 27 June 1983. We can see Dr Hill was
126 there, and then representing QEH would have been
Professor Stuart.
So this is the time that you were a consultant
at the hospital but not yet director?
ANSWER:
Yes.
|
46,928 | 356 | QUESTION:
If we go to the second page, we can see under the
heading "Regional Contract":
"It was agreed that Mr Stanton should invite
tenders ..."
And then:
"Mr Shinton, Dr Hill and Mr Stanton would meet
to adjudicate when the tenders had been received."
So the process appears to have been, and we see
it later involving you, that Mr Stanton, from the
regional supplies department, would -- was that
something from the Regional Health Authority?
ANSWER:
I would have thought so, yes.
|
46,929 | 356 | QUESTION:
Would invite the tenders from a range of commercial
companies, and then there would be involvement of t wo
of the Haemophilia Centre Directors here, Dr Shinto n,
who was Coventry, Dr Hill, the Children's Hospital,
and Mr Stanton adjudicating.
Then we can see three criteria there set out, or
points to be taken into consideration:
"The amount of effort involved in changing
127 supplier."
What, if anything, can you tell us about why
that was regarded as important?
ANSWER:
Not really. It seems a strange thing to say, reall y.
I would have thought you would want the best produc t,
but -- I think, I mean, to be -- there were
differences, which I've only been reminded about in
the last week by reading a lot of the correspondenc e
and meeting papers, that the different companies
prepared different packs. Some of these were
perceived to be easier to use by patients at home t han
others. I can't see what other amount of effort wa s
relevant really.
|
46,930 | 356 | QUESTION:
Then the second point:
"Where firms have their donor facilities in the
United States."
So that goes back to the issue that you were
discussing a few moments ago.
ANSWER:
Well, I did think they all did. Maybe Immuno didn' t.
I know possibly Bayer didn't, but Bayer I think nev er
made a lot of product, and it was very expensive. But
as far as I knew they were all American products.
|
46,931 | 356 | QUESTION:
This appears to be looking at where in the
United States the donor facilities were.
ANSWER:
I see, I'm sorry. Different meaning of "where", I beg
128 your pardon.
Yes, where in the United States they had their
collection facilities, yes, which would be away fro m
major conurbations and places where ...
|
46,932 | 356 | QUESTION:
Then we see the third point that's
identified to be taken into consideration is:
"Any public pressure for a change of products
(eg to heat-treated Factor VIII) should be resisted
until another product had been proved to be more
satisfactory."
Do you know what the reference to
"public pressure" refers to?
ANSWER:
No.
|
46,933 | 356 | QUESTION:
We can see that as at June 1983 there's a reference to
heat-treated Factor VIII. We'll come on to how and
when QEH moved to using heat-treated products, whic h
was either at the very end of 1984 or the beginning of
1985 as far as we can tell. Do you recall any
consideration being given in the course of '83 or ' 84
to starting to use heat-treated products earlier?
ANSWER:
No. I think my only awareness of the heat-treated
product was the Bayer product, which was, as I say,
very expensive and beyond our budget. No.
|
46,934 | 356 | QUESTION:
If we go to the next page, please, Henry -- sorry,
actually we'll go back to the previous page. My
apologies, Henry.
If we just look at the bottom part of the page,
Professor Franklin, under "Supplies of Cryoprecipit ate
and Freeze-dried Factor VIII", we can see there
there's a discussion about the -- well, what is
described as "Receipts and Purchases", so presumabl y
who is using what in terms of Factor VIII.
There's a reference to a letter from Dr Shinton
about the risk of AIDS, and we'll come back on to t he
question of AIDS. But then there's a reference to
asking the working party to advise on the purchase of
heat-dried Factor VIII. So that appears to be
something that at least Dr Ala was raising in June of
130 1983. Was that something that you recall becoming
involved with advising?
ANSWER:
No. As you point out, I wasn't at this meeting. I t
was quite prescient of him. But I don't remember a ny
particular fall-out or progression of that idea.
|
46,935 | 356 | QUESTION:
Then the next page, please, Henry, if you go to the
heading "Funding of Commercial Factor VIII".
I don't know whether you can assist,
Professor Franklin, in understanding what's being
discussed here. In the second paragraph it's refer red
to -- or, there's an issue about deducting from
districts with haemophilia centres in order to
"top-slice", and the possibility of applying for RC CD
funds. Do you know what any of that refers to?
ANSWER:
RCCD is the revenue -- no, wait, revenue consequenc es
of ... I think it might mean revenue consequences o f
some sort of development -- capital development. T he
West Midlands Regional Health Authority had these s ort
of arcane phrases, I don't know whether they were
common across the NHS, but -- so we were often
applying for money to support the haemophilia patie nts
from something called the regional consequences of
services capital development, RCDRS. So they had - -
basically these are systems which the region divvie d
up the money that they presumably had from central
131 Government and -- probably in 1984 I would have bee n
able to work my way round this but I'm afraid I can 't
anymore.
|
46,936 | 356 | QUESTION:
Don't worry. We will move on then to the first of
these meetings that you did attend.
SHIN0000029, please, Henry.
So we can see this is a meeting on
5 December 1983. You had taken over as director by
this time, although Professor Stuart was there, you
were there, Dr Hill was there.
ANSWER:
Yes.
|
46,937 | 356 | QUESTION:
And a number of others. If we look down the page
towards the second half of the page, we can see und er
the heading "Regional Contract" that:
"Dr Ala informed the committee that the lowest
tender was forwarded by the present supplier - Armo ur
Pharmaceutical Corporation, and no change was
envisaged."
So it doesn't appear that there's any
discussion, at least here, of those points that we saw
referred to in the previous document. It just seem s
to be here the contract's been awarded on the basis of
price. Do you have any recollection or understandi ng
of that?
ANSWER:
I don't, but I would perhaps suggest that that migh t
132 still have been going on in the background.
Obviously, the tendering process was developed to
separate us as the users from the spending of the
money. I would have still thought that those
requirements, even if they were slightly strange, t he
three requirements, would have still been informing
the decision as to which companies to ask to tender .
But obviously that's a very brief limit so it's not
explicit, is it?
|
46,938 | 356 | QUESTION:
No. If we go to the next page, just two further
points to pick up, we can see that under "Any Other
Business", Professor Stuart informing the committee
that this would be his last attendance and in futur e
you would attend as sole representative. Just go d own
the page. So we see that under "Any Other Business ".
ANSWER:
Yes.
|
46,939 | 356 | QUESTION:
Then just going up from that, the paragraph headed
"AIDS" -- so this is now December 1983, there's
reference to there being a handout at donor session s
at the blood transfusion centre, and then it says
this:
"It was agreed that if any case of AIDS was
suspected, then the Regional Public Relations Offic e
should be informed in case their help was required. "
Are you able to cast any light on that because,
at first blush, it seems a bit odd to see the publi c
relations office being involved?
ANSWER:
Well, tragically we did ultimately have men who
developed AIDS, and I don't ever remember talking t o
the Regional Public Relations Office about it.
|
46,940 | 356 | QUESTION:
Then if we go on to the next meeting, which is
SHIN0000028, so we're now in May of 1984, you weren 't
in fact at that meeting. You sent your apologies.
But if we go over the page, we can see in the top
section of the minutes it says:
"From the annual statistics and supply of BPL
expected, there could be a shortfall of 3.5 million
units to be made up from Commercial sources. The
Working Party agreed that Mr Stanton ... should, in
due course, invite tenders and subsequently meet wi th
Drs I Franklin and RM Ibbotson to adjudicate."
Just pausing there, on this occasion it appears
that the assessment of tenders is going to be by
Mr Stanton, Dr Ibbotson -- where was Dr Ibbotson fr om?
ANSWER:
Stoke-on-Trent. I know him well.
|
46,941 | 356 | QUESTION:
And Dr Franklin, so yourself?
ANSWER:
Yes.
|
46,942 | 356 | QUESTION:
And then:
"It was agreed that the following points should
be taken into consideration ..."
134 And then we see the same three points there
articulated. So this is for the next round of the
contract?
ANSWER:
Yes.
|
46,943 | 356 | QUESTION:
Can you recall anything about that subsequent
adjudication process?
ANSWER:
I'm afraid I can't. I don't remember that at all.
|
46,944 | 356 | QUESTION:
So you don't know whether it would have been an
informal or formal process or records kept of it?
ANSWER:
Well, ideally they would have been kept but I don't
recollect any such meeting.
|
46,945 | 356 | QUESTION:
Do you know what, if any, steps were taken to get t he
information that would help you consider point 2, t he
point about donor facilities, what questions were
asked or when enquiries were undertaken?
ANSWER:
Well, the only enquiries I remember were those that
I think I also did ask in -- having been trained by
Dr Hill as to what questions to ask, I probably ask ed
myself, but I don't know whether the supplies
department asked those questions in a formal way an d
required anything in writing. I don't know.
|
46,946 | 356 | QUESTION:
Okay. I think we can see some evidence, when we ge t
to about 1986, of perhaps a more structured approac h,
but we don't have anything very clear in this stage .
Apart from the reference to donor facilities, we
135 can see that there is no express reference to any
other aspect of safety or risk. Can you recall
whether that factored into the decision-making proc ess
at all?
ANSWER:
Well, knowing what I know now, I suspect that it wa s
accepted that all these products had non-A,
non-B hepatitis in them, and that the issue of wher e
the plasma came from was our only lever, if you lik e,
of trying to manage that risk in any way?
|
46,947 | 356 | QUESTION:
In your witness statement at -- let me just find th e
paragraph -- yes, so two passages I wanted to ask y ou
about. Paragraph 13. Do you have a copy of your
statement?
ANSWER:
Yes, I do.
|
46,948 | 356 | QUESTION:
We can put it up on screen, Henry.
It's WITN4032001, please.
If we go to page 14. So paragraph 13, this is
now talking about the particular products for treat ing
patients. You say this:
"The particular products used for treating
patients at the Centre depended on availability -
which changed over time ..."
And we've touched on that.
"... previous treatment history ..."
Is that a reference to they have already been on
136 this product --
ANSWER:
Yes, whether they were always on NHS or commercial or
vice versa.
|
46,949 | 356 | QUESTION:
Then you say:
"... and also the specific reason for treatment
being needed."
What does that refer to?
ANSWER:
Well, I would think if you had someone who may have
been a less severe haemophiliac who you might try t o
use DDAVP for tooth extraction or possibly cryo for ,
I don't know, a hernia operation, and if they had
perhaps bowel cancer and needed a major resection, you
might feel you had to use concentrate.
|
46,950 | 356 | QUESTION:
Then if we go, please, to page 22, paragraph 18, yo u
say in the first sentence:
"Decisions were taken on the basis of an
assessment of risk and availability."
We have covered availability. What did you mean
by an assessment of risk?
ANSWER:
Sorry can you just run back up to the precise
question?
|
46,951 | 356 | QUESTION:
Yes, of course.
ANSWER:
Right, there we are.
Well, I think probably I've kind of explained
that. If the risk was relatively low, tooth
extraction something like that, then you might -- y ou
definitely try to use DDAVP if you could, and then so
on down to some sort of major cancer operation.
I think I mentioned somewhere else in my
statement one patient had a large bladder tumour th at
needed quite a big operation and that really had to be
done under concentrate cover.
I think they're the risks. That's the risk
strategy, isn't it, really?
|
46,952 | 356 | QUESTION:
What role did patients have in decisions about what
treatment to have at this time '83, '84, '85?
ANSWER:
Well, any patient is at liberty to refuse any
treatment at any time. I realise that might sound
a bit glib but it's true. Beyond that, probably no t
a lot. I mean, we would have recommended what we
thought was appropriate for the particular procedur e
they had.
|
46,953 | 356 | QUESTION:
Can you recall whether patients were ever offered a ny
kind of choice of treatment? So you correctly
observed there's obviously an entitlement and
principle to refuse?
ANSWER:
Yes.
|
46,954 | 356 | QUESTION:
Were they ever given a choice between, for example,
NHS concentrate and commercial concentrate?
ANSWER:
To be honest, I'm not sure I ever had that choice t o
138 offer them. The supply of the NHS product was
insufficient, so I think possibly not, really.
|
46,955 | 356 | QUESTION:
What about a choice between concentrates and
cryoprecipitate; was that a choice that was offered ?
ANSWER:
I don't remember offering that as a choice, no.
|
46,956 | 356 | QUESTION:
You talked about assessment of risk and much might
depend upon the circumstances of the patient and th e
risk of, for example, the bleed. Could we just loo k
at your evidence, your written evidence, to the
Archer Inquiry. There's just one point I wanted to
pick up with you. Henry, it's ARCH0000443. Could we
go, please, to page -- I'm sorry we've only got thi s
annotated version of your statement.
ANSWER:
Yes, I couldn't find a clean version for you.
|
46,957 | 356 | QUESTION:
Are these your annotations?
ANSWER:
I don't think so. It's not my writing, no.
|
46,958 | 356 | QUESTION:
We didn't think so either. If you could go to page 5,
please, it's the top paragraph. I'm going to come
back at a later stage in your evidence and ask you
about the precautionary principle, Professor Frankl in,
but you say this about six lines down:
"... the regular use of Factor VIII as a home
therapy was a quality of life, rather than a life
saving, approach. Most home therapy was for incipi ent
joint or soft tissue bleeds. These are not trivial ,
139 they are very unpleasant. But in the main they are
not life-threatening."
Do you see that? Because some of the evidence
the Inquiry's heard has posed this choice between
life-saving treatment to prevent, say, a cerebral
haemorrhage, on the one hand, and the risk of
treatments with concentrates. But, as I understand
the evidence you were giving there, you were making
the observation that most treatment for haemophilia cs
is of the life-enhancing, rather than life-saving,
nature.
ANSWER:
Well, I did think that and I'm not sure I've change d
my view. I mean, I'd have to preface that by sayin g
I was not one of the long-standing haemophilia doct ors
who had seen haemophilia care before decent treatme nt
was available and the long-term effect of even thes e
bleeds in some of the survivors that we did have wa s
pretty devastating in terms of arthritis, employmen t
prospects, personal relations, education. But I wa s
always slightly suspicious about the idea that if w e
didn't carry on using concentrate -- and I did carr y
on using concentrate -- that if that was stopped th en
suddenly many, many, many, many people with
haemophilia would have died.
I mean, if you develop cerebral haemorrhage when
140 you are at home, you need an ambulance. You don't
need someone to put cryo -- to get cryo out of the
freezer, I think that was my feeling. So I was alw ays
a bit sceptical about this but, I have to confess, you
know, I went with the -- I was at the meeting when
Professor Bloom said you should carry on with
concentrate and that's what I did, so --
|
46,959 | 356 | QUESTION:
Professor Franklin, I'm going to ask you to
consider now your knowledge of the risks of hepatit is
and, in due course, AIDS.
Before we look at any specific documents, what,
if anything, can you recall being taught in your
general medical training and then your haematology
training about the risks of viral transmission from
blood and blood products?
ANSWER:
Well, when I was in Leeds my main mentor, a chap
called Brian Roberts, Dr Roberts, did say that, you
know, blood transfusion was one of the more dangero us
treatments in a way. It sounds a bit dramatic, and
I think he was largely thinking of cross-match
mistakes, blood group errors, but I think it did
extend into concerns about hepatitis.
He did, however, sort of temper that by saying
it seemed to be mainly a problem in the USA rather
than in the UK. I mean, I think relatively speakin g
that may be true but I think we now know that there
was a lot of hepatitis risk in the UK. So that was
there.
As I say, when I was at the Blood Transfusion
Centre, most of the experience or the training was in
hepatitis B, and I think there was a sense of denia l
about non-A, non B in the UK. There was a meeting
in -- Medical Research Council meeting about non-A,
non-B hepatitis in 1979 when the then director of t he
Regional Transfusion Centre where I was training, i n
Edgware, Tom Cleghorn, said that he thought there w as
very little post-transfusion hepatitis in the UK at
the time and quoted the fact that they were
142 transplanting one and three quarters of a million
units of red cells at that time, which is a huge
amount.
His colleague Dr Maycock, from BPL, agreed with
that, that there wasn't much post-transfusion
hepatitis, and even Dame Sheila Sherlock agreed,
although she did caution about the use of commercia l
concentrates in that.
So I think there is a sort of sense that the UK
was protected by its non-remunerated volunteer dono r
population from this. So I didn't have a lot of
awareness of understanding about it other than that --
you know, what one got from textbooks or things lik e
that.
|
46,960 | 356 | QUESTION:
Just before we look at some of the materials that y ou
have referred to in your statement, what kind of
journals, medical journals or other sources of
information did you routinely have access to and wo uld
read?
ANSWER:
Well, it varied a little over time. I mean,
throughout my career that would be the British Medi cal
Journal, The Lancet and the New England Journal of
Medicine. During my research it would have been
papers about sickle cell disease, the journal Blood ,
which is probably the most prestigious haematology
143 journal. Various other journals over time. Online
papers now, really, in the last 15 years. You're m ore
likely to look for specific papers rather than open
a magazine.
|
46,961 | 356 | QUESTION:
In your evidence to the Archer Inquiry -- which we' ll
look at, ARCH0000008.
If we go to page 27, I think it should be --
next page, please -- you say this about non-A, non- B
hepatitis, picking it up four lines down:
"Certainly to my mind it was not taken that
seriously until a publication from the Sheffield gr oup
was published in 1985 with the lead author of Dr Ha y,
who showed quite clearly that quite a lot of patien ts
with these liver abnormalities actually had
significant liver damage."
Then you refer to a 1983 publication from
Manchester.
So your recollection at the time you were giving
your evidence to Archer was that it was this
publication in 1985 which was significant in your o wn
understanding of non-A, non-B; is that right?
ANSWER:
Well, yes. I think, though -- I don't know, you wi ll
be talking to both of the key workers on this paper ,
Charles Hay and Eric Preston, and I would be
interested to hear what they say. I think when you
144 look back now, I would say there's a high risk that
a lot of this was damage due to a combination of
hepatitis C and HIV.
Professor Lee's evidence last week suggested
that hepatitis C on its own, while certainly not be ing
benign, was certainly consistent with long-term
survival in most cases.
|
46,962 | 356 | QUESTION:
In your witness statement, if we go, please, to
WITN4032001, and we go to page 26, picking it up in
the last two paragraphs you talk about non-A, non-B
hepatitis being considered "mild and relatively
benign", and say that:
"Unfortunately this reflected a lack of
knowledge of the full long-term history of non-A,
non-B..."
Then you refer again to the Manchester paper and
then the Sheffield paper.
ANSWER:
Yes.
|
46,963 | 356 | QUESTION:
We'll just look at those briefly, and then the
textbook you refer to, as I think those are the
particular documents you suggest that you were
influenced by.
Before we do that, you say you would have learnt
more about non-A, non-B hepatitis from the reports by
Dr Craske at the UKHCDO. Would you have seen those
before becoming a director?
ANSWER:
No.
|
46,964 | 356 | QUESTION:
So only from 1983 onwards?
ANSWER:
Yes.
|
46,965 | 356 | QUESTION:
Then we'll just look at the other documents that yo u
refer to. So the Manchester paper is WITN4032009
I hope, Henry. No.
ANSWER:
That's the Manchester paper.
|
46,966 | 356 | QUESTION:
It's certainly not the report I've got.
Do you have PRSE0002564, Henry?
So this is a full copy of the Manchester paper?
ANSWER:
Yes.
|
46,967 | 356 | QUESTION:
This I think is the paper you're referring to, "Liv er
disease in haemophiliacs: an overstated problem?"
1983. We can see it refers to:
"... biopsy ... on 12 multi-transfused
haemophiliacs from the Manchester area with
persistently abnormal liver function tests."
If we go please, Henry, to -- it's page
number 654 of the report, Henry. I think it's
probably the sixth page of the electronic document.
That's it.
Go to the last paragraph on that page, we can
see it says in this study:
"Only one patient was found to have CAH ..."
146 That's chronic active hepatitis?
ANSWER:
Yes.
|
46,968 | 356 | QUESTION:
"... with progression to micronodular cirrhosis. F our
other patients had only mild chronic active hepatit is.
We suggest that the true incidence of it severe
histological liver abnormality in multi-transfused
haemophiliacs may be less than previously reported but
similar to the more recent results of 115 liver
biopsies carried out worldwide (Aledort ... 1981)
where the incidence of [chronic active hepatitis] a nd
cirrhosis was 16 per cent."
Then it goes on to say that liver biopsies may
not be indicated, perhaps for self-evident reasons.
Was this study which you recall reading at the
time?
ANSWER:
Yes.
|
46,969 | 356 | QUESTION:
Do you recall any discussions with Professor Hill
about non-A, non-B hepatitis or the risks of liver
disease?
ANSWER:
Well, I think we did. I mean, can I remember
a particular moment? I mean, no, I can't. I think my
knowledge of non-A, non-B hepatitis was quite limit ed
until I started looking after the men with
haemophilia, and that's interesting because I was
doing bone marrow transplants in patients with sick le
147 cell disease, some of those were multi-transfused a nd
yet it didn't seem to be something that was appeari ng
in them, and for that reason it wasn't something th at
was foremost in my concern until I began to look af ter
the haemophilia patients and it was obvious that al l
of them or virtually all of them had abnormal liver in
function tests.
So when this paper came along about that, about
the time I began -- either just about the time
I started or maybe it was a bit before but it was
certainly around that time, it seemed to be -- it's
not actually that reassuring when you read it again .
|
46,970 | 356 | QUESTION:
What I was going to ask you about, Professor Frankl in,
it's a study of 12 patients, I think.
ANSWER:
It is -- the only thing I would say, it's a very sm all
study we're looking at.
|
46,971 | 356 | QUESTION:
As indeed many of them are.
ANSWER:
Yes.
|
46,972 | 356 | QUESTION:
Then if we look at the reference to Aledort, which was
a slightly bigger study --
ANSWER:
Yes.
|
46,973 | 356 | QUESTION:
-- 16 per cent CAH and cirrhosis, it's not a small
figure, it's still a significant figure?
ANSWER:
Yes.
|
46,974 | 356 | QUESTION:
Do you recall whether either you or Dr Hill at the
148 time had any opportunity to discuss this issue with
liver specialists in Birmingham?
ANSWER:
Well, we did have liver specialists there. I don't
remember discussing this -- discussing that, sorry.
I do remember Frank Hill and myself talking
about whether we should be doing liver biopsies, an d
we decided against. I think -- to be quite honest,
I think by the time the Hay and Preston study came
out, the issue was largely resolved, and I think we
felt: what was the point? It's risky. You are wel l
aware that there was a death at the Royal Free
Hospital?
|
46,975 | 356 | QUESTION:
Yes.
ANSWER:
The -- not that money was the issue, but you need
a lot of Factor VIII to safely do this. So we deci ded
we wouldn't do that. 1983, the liver unit was only
just starting at the Queen Elizabeth Hospital. The re
was a liver expert there, a guy called Elias, very
good. He used to come and see my other haematology
patients. There's no reason why we wouldn't have
discussed these with him, but no, I don't think we had
any systematic approach with the liver unit, no.
|
46,976 | 356 | QUESTION:
Then the 1985 Hay and Preston paper -- Henry, I'm
hoping I've got the right reference here, PRSE00042 29.
Do you have that? Thank you.
So this is the 1985 study that you referred to
in The Lancet, and we can see there it refers to th ere
being:
"... an eight-year study of 79 unselected
patients with haemophilia ... [and] evidence of
chronic progressive liver disease in at least 17
(21 per cent). 8 patients had chronic active
hepatitis and 9 had cirrhosis ..."
What, if anything, can you recall your reaction
to this paper being?
ANSWER:
Well, concern. It's quite, you know, serious, seri ous
data. I mean, I think as a pure study in hepatitis ,
then I think the difficulty is that these were
probably taken from many patients who also had HIV; so
that affects its value as a pure study on non-A, no n-B
hepatitis. But in terms of the seriousness to peop le
with haemophilia, it's obviously pretty bad news.
The only problem is and was -- certainly was --
was there wasn't really any treatment. So in terms of
what we discussed, it was -- what we discussed with
individual people was that this may not be good and we
probably reinforced avoiding alcohol, not a lot els e
you can do. It also, of course, was published at t he
height of the worry about HIV. So I think a lot of
the discussions in my clinic were dominated by worr ies
150 about HIV and AIDS.
|
46,977 | 356 | QUESTION:
You've also referred in your statement to the
publication by Sheila Sherlock and, again, I think in
fairness to your evidence, we should probably look at
that because you say you did recall consulting this
textbook?
ANSWER:
Yes. I mean, I did. That was my source of knowled ge
about liver disease, really.
|
46,978 | 356 | QUESTION:
You have referred in your statement to two passages .
Sorry, you referred in your statement to one passag e
then more recently another?
ANSWER:
I've since realised there are two passages relevant to
non-A, non-B in this book, yes.
|
46,979 | 356 | QUESTION:
So we will look at the passage you refer to express ly
in your statement, first of all. Henry, it is
WITN4032021, please. So this is page 290 of the bo ok.
We can pick it up at the bottom of the page, "Chron ic
non-A, non-B hepatitis":
"Serial studies have shown that patients with
acute non-A, non-B hepatitis progress to chronic li ver
disease. This applies to the blood
transfusion-related, the blood factor-related and t he
sporadic disease. The incidence of chronicity seem s
to be about 30 to 40 per cent."
That would suggest a significant number of
151 patients, a very significant number of patients,
proceeding to a chronic liver disease.
ANSWER:
Well, it's probably actually an underestimate.
|
46,980 | 356 | QUESTION:
Then, if we just look at the next page, which was t he
second -- I'm sorry, Henry, it's a different
reference: WITN4032022.
Then we can see the clinical features set out:
"Chronic hepatitis can follow both the long and
short incubation types."
It says:
"Chronicity ... may develop insidiously and the
acute episode would not have been recognised if the
patient had not been under medical observation ...
"A characteristic feature is the marked
fluctuation in serum transaminase levels, extending
over many months."
Then:
"Liver histology shows the general features of
chronic hepatitis, usually of persistent or mild
chronic active type."
Then we see the next column "Prognosis and
course", it says:
"Clinical progress is toward improvement, but
cirrhosis has been reported."
Then "Treatment":
152 "Reassurance and regular supervision at
approximately three to six-month intervals."
So this is 1981, this publication?
ANSWER:
Yes.
|
46,981 | 356 | QUESTION:
I am just checking.
ANSWER:
Counsel has the volume but I think it is
a single-author text -- only her name on the --
|
46,982 | 356 | QUESTION:
It's certainly only her name. I can look in more
detail, sir, at the preface and acknowledgements bu t
there isn't another author whose name is given on t he
text.
You have also drawn the Inquiry's attention to
an earlier passage in the book pages 257 to 259.
Henry, those are at WITN4032023. Is there another
page? Keep going.
154 ANSWER:
I'm fairly sure it's only her that wrote the whole
book from that plate.
|
46,983 | 356 | QUESTION:
Yes, certainly the plate only contains her name, yo u
are right, Professor. So we see here, this is the
other passage that you have drawn attention to,
pages 257 onwards "Non-A, non-B hepatitis":
"The elimination of hepatitis A and hepatitis B
from transfused blood did not eliminate
post-transfusion hepatitis. Some of the cases were
due to cytomegala infection, but the majority were due
to another virus or viruses termed non-A, non-B. T his
infection now accounts for about 75 per cent of
post-transfusion hepatitis ..."
It goes on to say:
"Haemophiliacs receiving factor concentrates
obtained from commercial sources are particularly a t
risk. Non-A, non-B hepatitis is largely blood
spread."
Then if we go over the page, I can see it says:
"The agent has not been conclusively identified.
It has been transmitted to chimpanzees."
Then the clinical course is then described, an
incubation period:
"The acute episode is usually mild and often
anicteric ... Fulminant hepatitis is rare."
155 The end of that paragraph says "Cirrhosis can
develop."
Then it talks about liver biopsies if you go to
the next page. There's a description there of what
might be seen in liver biopsies.
Then it says:
"Non-A, non-B hepatitis often progresses to
a mild chronic hepatitis. The prognosis of this is ,
at the moment, uncertain but probably benign."
Unfortunately, there is no reference that is one
way or the other in relation to that last section.
ANSWER:
No. I mean, I think I wrote somewhere else in my
statement that when it became clear that a lot of t he
men that I was looking after had got HIV, that
I looked back at their notes from the period when
I wasn't there and I was quite shocked to discover
that virtually on the first injection of concentrat e,
regardless of type, they developed abnormal liver
function tests. I like to think that, had I been
there at that time, I might have been more concerne d
to not carry on but, I'm ashamed to say, I'm not su re
I would have had that strength of character to go
against the prevailing view.
I think this is sort of showing that -- to be
honest, I would interpret this as uncertainty from
156 someone who is the world expert not really knowing
what's going to happen, to be honest, and I think a lso
when we look back she hadn't -- even she hadn't got
a long enough longitudinal experience of a disease
that can take 15/20/30 years to destroy someone's
liver.
|
46,984 | 356 | QUESTION:
In terms of the materials that you recall seeing at
the time, bearing in mind that you were assuming
responsibility for people with bleeding disorders i n
1982/1983, other documents that we have looked at, you
recall looking at this book, you recall the Manches ter
report, you recall the Hay/Preston 1985 study?
ANSWER:
Yes.
|
46,985 | 356 | QUESTION:
The Inquiry sent you some earlier and other materia ls
from the second half of the 1970s through to 1980.
I am very happy to go through them with you if it
would assist, Professor Franklin, but they include
publications in The Lancet from Prince and then in
1978 an earlier study from Professor Preston which, if
I can put it this way, is not inconsistent with the
1985 study; would you agree with that?
ANSWER:
Yes, it's quite small but absolutely, yes.
|
46,986 | 356 | QUESTION:
We have sent you also some material from Dr Craske
from 1978 reporting some American information about
liver biopsies with 50 per cent showing changes
compatible with cirrhosis. I think we sent you
a letter, which we've looked at with a number of
witnesses, from Dr Kernoff to Dr Colvin, describing
non-A, non-B hepatitis as a serious disease with
long-term consequences.
You wouldn't, I imagine, have seen that letter
at the time. Do you recall whether, in the second
half of the 1970s, you came across any of the
materials that we've provided you with?
ANSWER:
Well, if I did they didn't impact that well. You
showed a number of papers from Harvey Alter and
colleagues. I don't remember those. It's quite
likely I read the Prince paper but it didn't impact on
me, I'm ashamed to say, no. I don't remember it.
|
46,987 | 356 | QUESTION:
As I say, I'm happy to go to each of those material s
if it would assist Professor Franklin but, in
an attempt to short-cut it, would you agree that,
looking at that material, which you may not have se en
at the time, that paints a rather different picture of
non-A, non-B. It doesn't suggest it is necessarily
going to be a mild or benign infection, it suggests it
may be something rather more serious?
ANSWER:
It does. I'd still stick to my statement that I fe lt
there was a bit of an atmosphere of denial in the U K
over the risks of non-A, non-B hepatitis from UK bl ood
158 transfusion and that was the area in which I had
experience at that time. I did not have experience of
treatment with concentrates, particularly not
concentrates from America until through towards the
end of '82 -- no, I started in '82. Towards the
middle and end of '83 probably.
|
46,988 | 356 | QUESTION:
I think one of our witnesses used a term that there
may have been a degree of wishful thinking on the p art
of haemophilia clinicians not wanting to think of
non-A, non-B hepatitis as something serious, becaus e
of what was seen as the very great benefits that
factor concentrates had brought. Do you feel able to
comment on that from your own experience and
perspective?
ANSWER:
I think there was definitely wishful thinking about
HIV AIDS in some of the papers I've seen. I think
there was in 1995, if you allow me to sort of -- th ere
was an Institute of Medicine book from the
United States that looked back at the disaster in
relation to hepatitis and HIV, and it came up with
a hypothesis that there wasn't enough effort made t o
introduce heat-treated safe products because there was
a feeling that hepatitis was -- if you let me look
at -- I scribbled this down.
Hepatitis was viewed as an acceptable risk --
159 this is not me saying this -- by governmental
regulatory advisory agencies responsible for the
safety of blood and blood products, by the plasma
fractionation industry and by the physicians lookin g
after haemophiliacs. It also says, and I don't agr ee
with this, by individuals with haemophilia. But I do
think that hepatitis at that time does appear to ha ve
been viewed as an acceptable risk.
I mean, it was -- surely it must have gone to
the Committee on Safety of Medicines, all these peo ple
getting hepatitis. I don't know.
|
46,989 | 356 | QUESTION:
Can I just see whether we're looking at the same
document. Is that the "HIV in the blood supply and
analysis of crisis decision-making"?
ANSWER:
Yes.
|
46,990 | 356 | QUESTION:
Sir, we've got that, I hope, at WITN4032024.
Is that the right document, Professor Franklin?
ANSWER:
Yes, I think so. Yes, it is.
|
46,991 | 356 | QUESTION:
What was the page you were referring to?
ANSWER:
That's a good question. If you could run down. It 's
not far from the front. It should be four bullet
points, I think. Two hypotheses. A bit further
please, next page.
|
46,992 | 356 | QUESTION:
Ah, yes. I think it is your second point.
ANSWER:
Here we are.
160 |
46,993 | 356 | QUESTION:
"Hepatitis was viewed as an acceptable risk by the
Government regulatory agencies responsible for the
safety of blood and blood products, the plasma
fractionation industry, the physicians who treated the
individuals with haemophilia ..."
Pausing there. That, I think, is the bit you
are associating yourself with --
ANSWER:
Well, I think it looks as if that was the case, yes .
In terms of wishful thinking, I suppose the hope wa s
it wasn't very serious.
|
46,994 | 356 | QUESTION:
In terms of the 1985 Hay/Preston research, would yo u
accept that that wasn't something which showed
something radically new or different, it was rather
perhaps confirmatory of earlier fears; would that b e
a fair way of putting it?
ANSWER:
Yes. Well, I think it was the final -- yes, the fi nal
sort of straw that, as it turned out, maybe it wasn 't
all hepatitis C, but what it definitely meant was t hat
we were going to see a lot of bad liver disease in
that group of men who were having those concentrate s
before effective heat treatment, yes.
|
46,995 | 356 | QUESTION:
Move on to HIV/AIDS.
I think I understand from your statement you
think you would have seen the MMWR report in 1982?
ANSWER:
I started looking at them. They weren't easy to fi nd
but yes, I did, because that was where -- I think
I mention in my report that the pre-internet era,
the -- actually knowledge was quite powerful, when
I think about it, because not everybody had it. No w
everybody has knowledge.
So we all knew that AIDS was happening in the
gay men in America. The journals were months out o f
date, so you really relied on things like MMWR,
because it was a weekly report, and also word of mo uth
by experts. Reading journals was -- you had to rea d
the journals but it was insufficient.
|
46,996 | 356 | QUESTION:
So the July 1982 report we know is the report about
PCP being observed in some haemophiliacs in the
States?
ANSWER:
Yes.
|
46,997 | 356 | QUESTION:
You also, I think, read the New England Journal of
Medicine January 1983 Desforges article, and you no ted
there the recommendation to switch back to
cryoprecipitate.
ANSWER:
Yes, I wasn't responsible -- I was looking after
people with haemophilia, that was on my rota, but
I wasn't responsible for it at that time.
Yes, that was quite a prescient article.
|
46,998 | 356 | QUESTION:
Then if we have up on screen, please, PRSE0002647.
This is the note of a meeting on
162 24 January 1983. It was with Immuno, to look at
hepatitis-reduced Factor VIII.
We know -- if we go to the last page please,
Henry -- from the list of attendees that
Professor Hill attended, Professor Stuart did not.
This is before you took over as director at
Queen Elizabeth. But there's what appears to be, f rom
the minutes, quite a lengthy discussion about AIDS.
There's a report about the San Francisco baby case
that had been reported in --
ANSWER:
Yes, that must have been very shortly before this.
|
46,999 | 356 | QUESTION:
Yes, that's absolutely --
ANSWER:
And it wasn't yet published. But that goes to show
the importance of bush telegraph-type communication s.
|
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