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46,100 | 333 | QUESTION:
Don't worry.
ANSWER:
So, yes, we have this, sort of -- what I thought wa s
that the ALT test was probably the more effective.
Yes, you get a better coverage if you put the two
together, but, you know, at the time, there seemed to
be a fairly strong view that we shouldn't introduce
it. I should have stood up add said we should.
|
46,101 | 333 | QUESTION:
Well, we'll move next to the topic where you did st and
up and say that you should, and that's the question of
hepatitis C screening, Dr Lloyd.
Now, there's quite a number of documents I want
to look at with you on this issue. We'll go throug h
them in a largely chronological order. I'm going t o
ask you some questions about the various documents and
your statement, and then some general questions wov en
in about this issue of screening for hepatitis C.
So I'm going to start with WITN6935032. So this
is headed:
"The Chiron Corporation Test for Non-A, Non-B
Hepatitis
"Lecture by Dr Michael Houghton of the Chiron
Corporation
83 "Sheffield Medical School -- Thursday
6th July 1989."
We don't need to go to the last page but your
name is at the bottom of that document with that da te
of 6 July. So do we understand this is a lecture y ou
attended and took notes of and this is your typed u p
copy of your notes?
ANSWER:
Yes, yes. It's my writing in the top right-hand
corner showing that I wanted to file it and, yes,
these are the notes that I made.
|
46,102 | 333 | QUESTION:
If we go over the page, we can see that there's
a heading "Correlation with the Surrogate Markers f or
[non-A, non-B hepatitis]". I'm not proposing to go to
that, but just note that that's there.
Then if we go to the third page, bottom of the
page, there's a section on costs.
ANSWER:
Mm-hm.
|
46,103 | 333 | QUESTION:
You refer to the costs per sample for the kit and s ay:
"It looks likely that this test will soon be
required in the UK. The cost of testing will be in
the order of £200,000 -- £230,000 [per annum]. We
will lose about 600 donors from our present panel a nd
will have to destroy at least 600 donations in the
first year. The cost of this will be around
£4,000-£5,000 to replace the lost donors and
84 £15,000-£20,000 for the destroyed donations, togeth er
with the additional clerical costs and medical cost s
of dealing with these 600 extremely anxious donors.
An additional Medical Session may be required durin g
the first year or two to deal with these donors.
These donors will need to be referred to Specialist s
in the liver disease, which in turn will have
considerable cost implications. The total cost to the
BTS in the first year will be between £219,000 and
£255,000 on a very crude costing."
Pausing there, that presumably is not part of
the lecture. These are your own thoughts about wha t
it's going to cost --
ANSWER:
Yes, yes.
|
46,104 | 333 | QUESTION:
-- and these are costs to the --
ANSWER:
Yes, in Newcastle.
|
46,105 | 333 | QUESTION:
-- northern Region --
ANSWER:
Yes, this is -- this was me looking at what I'd see n
and heard at the meeting and trying to translate it
into what it was going to mean for our Centre.
|
46,106 | 333 | QUESTION:
Were there other Regional Transfusion Directors at
this lecture or meeting, as far as you can recall?
You may have no memory at all of it.
ANSWER:
I can't, no, I can't. I can't recall, no, I'm sorr y.
|
46,107 | 333 | QUESTION:
If we go over the page, we've got the "Summary":
5 "A non-A, non-B Hepatitis ... has been
characterised and termed Hepatitis C virus."
Then I don't propose to read out the rest of
that paragraph.
If we go to the third paragraph, you say this:
"The impact on our donor base will be moderate
but not catastrophic, assuming that the 0.5%
positivity level is confirmed. We will lose and ha ve
to replace 600 donors. There will be costs and
operational problems associated with identifying th em
as HCV positive and they will have to be referred t o
Consultants specialising in liver work."
Then the last sentence has your cost -- your
estimated cost to the Northern Region of the BTS --
ANSWER:
Mm-hm.
|
46,108 | 333 | QUESTION:
-- for the first year. So it looks from this as
though, as at July 1989, you were effectively plann ing
ahead, both in terms of what kind of funding might
need to be put in place, and what might need to be
done to ensure that there wasn't a significant loss of
donors without them being replaced; is that fair?
ANSWER:
Yes, I think that's fair. I mean, I think the fact
that I could -- you know, it's going to be difficul t
but it was certainly no way impossible, 600 donor
loss, and I think I mentioned it yesterday, that's not
86 a lot of donors lost, compared to some of the probl ems
we had when a lot of our industry closed down.
|
46,109 | 333 | QUESTION:
Then if we look at NHBT0000188_008. This is a lett er
from you, 20 July 1989, so a couple of weeks after
you've attended --
ANSWER:
Yes.
|
46,110 | 333 | QUESTION:
-- that meeting, to the director of management
services at the Northern Regional Health Authority,
headed "Non-A Non-B Hepatitis". You say this in th e
first paragraph:
"The problem of Non-A Non-B Hepatitis has been
with us for many years. This disease is transmissi ble
by blood but no test has been available to screen o ut
infected blood donors. Most people who have Non-A
Non-B Hepatitis, and continue to carry the virus, a re
asymptomatic although a very small proportion of
people go on to get cirrhosis of the liver. The
effects of transfusion transmitted Non-A Non-B
Hepatitis vary from nil through a minor illness wit h
no jaundice to a moderately severe illness with
jaundice, with a small proportion of people going o n
to become long-term carriers of the virus. It is
these people who get long-term carriage of the viru s
who run the risk of getting cirrhosis of the liver,
and possibly even hepatic carcinoma."
87 Then you go on, having introduced non-A, non-B
hepatitis to Mr Garland, to refer to the test. If we
look at the fourth paragraph, you say:
"Now that this test is available I suspect that
pressure will mount fairly rapidly for this test to be
introduced in this country. Previously, I had
expected that something as major as this which woul d
have to be introduced in all Transfusion Services i n
the UK would be funded by the Department. However,
Dr Gunson has suggested to me that this will not be
the case and that Regions will be expected to fund
this new development themselves."
Now, that would indicate that you had had some
discussion with Dr Gunson on the issue of introduci ng
the tests and how they might be funded. Do you hav e
any further recollection of the discussions at that
point in time?
ANSWER:
There is a letter that -- I think from a perhaps
a month later, in which Dr Gunson refers to the
Department not funding -- or that regions would hav e
to fund themselves. So there is some documentation ,
it comes after this letter. So I don't recall the
exact discussions I had with Dr Gunson, whether tha t
was at a meeting or whether it was by phone.
Given the short interval between the meeting
88 I attended in Sheffield and writing this, it was
probably something that was a phone call but, no,
I can't recall the details of it.
|
46,111 | 333 | QUESTION:
Then if we go over the page, we can see you set out in
the first paragraph costs and some of the implicati ons
in terms of loss of donors and loss of donations an d
what would need to be done, and then the next
paragraph you give not a detailed estimate but
an estimate of the total figure in the first year a nd
then it would fall after the first year. Then you
say:
"At the moment there is nothing to be done about
this but I felt it was worth highlighting this
situation, as we do not know at what stage we might be
instructed to introduce this new test. At the pres ent
time the virus detected by this test has been
designated as Hepatitis C virus."
ANSWER:
Mm-hm.
|
46,112 | 333 | QUESTION:
So what was it that prompted you to make this
relatively early contact with your Regional Health
Authority, and what then happened in terms of your
dialogue with the Health Authority?
ANSWER:
Well, the fact that we -- this was quite a big, you
know, step to undertake. In the overall terms of t he
NHS, you know, £250,000 seems nothing but, within o ur
9 budget, it was significant. So I needed the RHA to be
aware that -- you know, people don't like being
surprised. You don't want someone to phone you up and
say, "Oh, we're starting the test tomorrow, by the
way, and we need £250,000". So you want to start t he
dialogue as early as possible and then they have ti me
to ask questions and they have time to adjust their
funding model for the next year.
So, you know, you asked me about my relationship
with the RHA before. It was a reasonable
relationship. And, you know, there was backwards a nd
forwards and I didn't want to cause them a problem and
this was just part of the process of getting this
whole thing rolling so that they weren't blindsided by
it.
|
46,113 | 333 | QUESTION:
And we don't, I think, have the details of your
further discussions with the Health Authority in
documentary form, but you tell us in your statement
you kept the Regional Health Authority informed as
time went on, and the result, as I understand it, w as
that when we get to 1991, and we'll look at what
happened in between in a moment but when you got to
1991, you had the agreement of the Regional Health
Authority for funds to be used to introduce testing ;
in broad terms, that's correct?
90 ANSWER:
Yes, that's correct. Yes.
|
46,114 | 333 | QUESTION:
Now if we just then, however, go back to 1989, I ju st
want to pick matters up in November 1989, with
NHBT0005043.
Now, these are the minutes of a meeting of the
Advisory Committee on the Virological Safety of Blo od,
6 November 1989. You weren't, of course, on this
committee, and I think we see obviously that it was
chaired by Dr Metters, who was Deputy Chief Medical
Officer, and in terms of representing the Transfusi on
Service, it had Dr Gunson amongst its members.
We know from other material, Dr Lloyd, that
the minutes of the Advisory Committee on the
Virological Safety of Blood were intended to be
confidential.
ANSWER:
Yes.
|
46,115 | 333 | QUESTION:
And as I understand it, your and your colleagues in
the regional Transfusion Service did not at the tim e
see these documents; is that correct?
ANSWER:
Oh yes, absolutely. I think I said in my witness
statement, if I had seen some of this or known some of
this, I might have taken a somewhat stronger line.
I didn't know that -- what was being discussed,
particularly this early -- relatively early,
November 1989.
91 |
46,116 | 333 | QUESTION:
And of course --
ANSWER:
And it wasn't transmitted by -- sorry, I was going to
say, as far as I recall, Dr Gunson wasn't relaying the
detail. And I think in a conversation with John Ca sh,
I think, you know, he intimates that he can't actua lly
pass some of this information on, it's not for
publication and therefore presumably not for other
distribution.
|
46,117 | 333 | QUESTION:
And even though you wouldn't have seen it at the ti me,
just to complete looking at this document,
the discussion of the testing starts on page 4.
Yes, NHBT0005043. And if we go now to page 4.
I won't read it all out but we see paragraph 23
is Dr Gunson talking about a paper that had been
prepared and referring to a meeting that had taken
place in Rome.
ANSWER:
Yes.
|
46,118 | 333 | QUESTION:
There's then, at paragraph 25, Dr Tedder giving the
committee a summary of the history of the test.
26:
"Dr Metters explained that although the
Department must bear in mind the possible litigatio n
that could rise from a prolonged delay in the
introduction of general screening, the NHS Manageme nt
Executive would want to know more facts and figures
92 before backing such a move."
Dr Gunson then provides some more information
based upon the North London Transfusion Centre's
experience.
Then if we go to the next page, paragraph 28:
"The feeling of the Committee, as summed up by
the Chairman, was that the test represented a major
step forward, but that the Committee need to know
a great deal more about it and acknowledge the need
for a confirmatory test. It was agreed that while the
UK would not want to go on in advance of an FDA
decision, it could prove difficult if the FDA do no t
decide in favour of the test."
So that's the position as at November of 1989.
Now --
ANSWER:
Yes.
|
46,119 | 333 | QUESTION:
I don't know whether, from your subsequent involvem ent
in this issue, you have any particular observations or
comments upon the stance being taken by the ACVSB a s
at November 1989?
ANSWER:
It's the sort of -- a little bit of the beginning
of -- of the almost a dance around the issue of the
test. There's no confirmatory test we hear -- we s ee
in this -- being put forward. Well, the FDA, you
know, are they, are they not going to approve it?
3 It's -- at this stage, this particular document see ms
a little bit unclear. Although they're saying, "Ye s,
we should test", then they're saying, "Well, maybe
there's issues, and maybe we don't want to do it ju st
yet, or at all."
|
46,120 | 333 | QUESTION:
Now that's November 1989, and we'll be exploring,
Dr Lloyd, with other witnesses or through other
witnesses I hope some of the events, particularly f rom
a Department perspective, through into 1990.
I want to pick things up in the middle of 1990.
July of 1990 -- I don't, I'm afraid, have the
document to display but I'll read the reference for
the benefit of those listening, PRSE0000976 -- is
a further meeting of the Advisory Committee on the
Virological Safety of Blood, in which they recommen d
that there should be an evaluation of the two
commercial kits that were then available, Ortho and
Abbott, to be done in three centres: Glasgow, North
London and Newcastle.
So if we then pick things up with a letter
copied to you in August 1990, NHBT0000061_180. We can
see 30 August 1990, if we just look at the whole
letter please, it's from Dr Gunson to Dr Rejman and we
can see at the bottom it says, "Same letter to" and
94 then it's listed Dr Mitchell, Dr Lloyd (yourself),
Dr Barbara and others.
ANSWER:
Yes.
|
46,121 | 333 | QUESTION:
Then we can see Dr Gunson says he hopes this is:
"... the final draft of the proposals for the
proposed study comparing anti-HCV testing using Ort ho
and Abbott test systems."
Now, there had been some other studies and
evaluations going on in the intervening period in
which, I think, Newcastle was not involved, but can
you recall how you came to be involved in this
proposed comparison of the two tests?
ANSWER:
I'm not quite sure why we were. It may well have b een
that they wanted couple of centres or they wanted
a centre that was comfortable using the Abbott test
and the Abbott test equipment. We were certainly i n
a position to do it. And I think Ruthven Mitchell and
I think the Glasgow Centre -- I'm not sure if they
were using it as well, but certainly we were using the
Abbott system, quite happy to participate. But
I don't recall why we were approached, specifically .
|
46,122 | 333 | QUESTION:
If we look at NHBT0000042_045. So this is now
a couple of months later, and Dr Gunson is sending
a report on Phase I of this trial, which I think is
how this particular evaluation was characterised, t o
95 Dr Rejman. We've got the report itself at
NHBT0000190_030, if we just look briefly at that.
Yes, NHBT0000190_030. So "Comparison of
Anti-HCV Tests using Abbott and Ortho Test Kits
(A Multi-Centre Trial) Summary are Results of Phase I
of the Trial", and this is authored by Dr Gunson,
29 October.
I'm not going to go through the detail of it.
If we look over the page, however, we can see this is
the study comparing the results of using the two
different kits, the Abbott and the Ortho kits,
involving Glasgow, yourself and north London.
ANSWER:
Yes.
|
46,123 | 333 | QUESTION:
We can see, if we go to page 3, paragraph 1.7:
"All three RTCs reported that the tests were
easy to perform and that the manufacturer's
instructions were 'user-friendly'."
There are then some specific comments made by
yourself and the various -- and the other two centr es
but I'm not going to take up time looking at those
specific comments.
What did you understand the purpose of this
comparative evaluation to be and for whose benefit it
was being carried out?
ANSWER:
This seem to be to me to be a way of ensuring that
96 both tests were suitable for use. It didn't -- we
know that different centres in the UK used differen t
test methods, different, you know, kits from differ ent
companies, and were used to using things in differe nt
ways. So you need to know that -- (a) that both te sts
are usable, that they're not completely terrible to
use.
I think we saw in some later tests that one of
the test kits presented for comparison -- actually, it
might have been for HIV -- you know, one of the tes t
kits was actually quite difficult to use and diffic ult
to get consistent results. So here we have a trial .
It shows that both test kits are usable, within the
transfusion centre setting, and they give comparabl e
results. As one would expect, they're not perfectl y
the same but substantially the same.
So it gave me quite a lot of confidence that,
you know, we had something we could do, we could us e
this ...[frozen screen]...
|
46,124 | 333 | QUESTION:
Now, we know -- sorry, you froze for a moment then,
Dr Lloyd, which is why I paused.
ANSWER:
Yeah.
|
46,125 | 333 | QUESTION:
We know that by this time -- this is August 1990, w hen
the study protocol, as it were, is being drawn up, and
then October 1990, when it's being concluded -- we
7 know that there were a number of other countries wh ich
had already introduced hepatitis C screening by thi s
point in time, I think Japan in November 1989 and t hen
a number of other countries throughout 1990.
ANSWER:
Mm-hm.
|
46,126 | 333 | QUESTION:
Do you recall whether you were aware of that at the
time or whether there was any discussion amongst
Regional Transfusion Directors about the fact that the
UK was arguably lagging behind other developed
nations?
ANSWER:
I don't recall specific discussions. You know, one of
the problems we've seen and discussed with the
National Directorate splitting up the transfusion
centre directors into these divisional groups, we
didn't have a single forum where everyone could get
together. So whereas quite a lot of work on
virological matters was done from the North London
Centre, there wasn't that emphasis from the centres
that happen to be in the northern division. So we
were divorced from a lot of this discussion. So --
and of course we didn't have anyone from the
Department who might have brought perspective to be ar.
So no, we didn't have a lot of discussion.
Certainly aware that this test is being used. I me an,
you know, I knew that at the time. There's no doub t
98 about that. That: here's a test, it's being used,
we've done a test, shown it works. So, you know, n ext
step is to use it. It's sort of a logical
progression.
|
46,127 | 333 | QUESTION:
If we then look at another meeting of the Advisory
Committee on the Virological Safety of Blood, from
November 1990.
NHBT0000073_018.
So we can see the date of the meeting,
21 November 1990. If we go over the page we've got
the heading "Hepatitis C testing":
"The Chairman recalled the summing up of the
last meeting and said that a note had gone to
Ministers telling them that the ACVSB was in favour of
introducing routine HCV testing in the UK. A furth er
submission was awaiting the decision of this meetin g
as to which test would be the most suitable. The
Chairman reiterated the recommendation that all pla sma
should be tested for HCV."
There's then a discussion of various papers and
studies which I'm not going to go through. If we g o
to the top of the next page, paragraph 10 says:
"The Committee agreed that it was important to
start screening as soon as practicable as a measure
which would further enhance the safety of the blood
99 supply."
Now, I think one of the observations you've made
in your witness statement, Dr Lloyd, as I understan d
it, is that had you known this, that this was the v iew
of the committee at this point in time, it might ha ve
made you want to start testing earlier than you did ,
recognising that you were still earlier than everyo ne
else.
ANSWER:
Absolutely.
|
46,128 | 333 | QUESTION:
But this message was never conveyed to you --
ANSWER:
-- absolutely.
|
46,129 | 333 | QUESTION:
-- is that right?
ANSWER:
I never saw this, never heard this.
And looking back now, I'm rather -- I'm somewhat
annoyed that this sort of information wasn't provid ed,
I'm left in the dark, and I'm sorry about that.
|
46,130 | 333 | QUESTION:
Then if we go over the page, there's two further
paragraphs I want to read with you and then I want to
look at some of the observations you make on it in
your statement. So paragraph 18:
"The Chairman summed up the discussion by saying
there was agreement that the UK should introduce
hepatitis C testing as soon as practicable. RTCs
would decide individually whether to use Ortho or
Abbott test. The blood from any repeat positives
100 would be set aside."
Then there's a discussion of the arrangements.
Then there's a reference in the penultimate
sentence there to the reference centres determining
a protocol for supplementary costing:
"A submission would go to Ministers regarding
this significant policy decision and the Management
Executive would consider the funding aspect."
Then if we go to the paragraph 21, further down
the page, last sentence:
"The Chairman stressed the importance of
a common date of introduction throughout the UK."
In fact I think I should read the sentences
above that.
"He reported [this is Dr Gunson] that some
centres had asked for a 6 month period in which to set
up testing. Dr Gunson himself thought this to be
excessive, but he said he would need to consult wit h
other Directors first. It was agreed that he would
hold off consultation until the submission had been
put to Ministers."
Then we had the sentence:
"The Chairman stressed the importance of
a common date of introduction throughout the UK."
What I wanted to do, Dr Lloyd, because you deal
01 with this in your statement, is just look at a page
from your statement where you comment upon these
minutes.
WITN6935001, please, Sully, page 86.
You say this:
"In the minutes of the November 1990 meeting of
the ACVSB ... the statement:
"'The Chairman stressed the importance of
a common date of introduction throughout the UK'
[which is what we were just looking at]
"is presented without any background
information. There is nothing in the document that
indicates why the Chairman ... came to this
conclusion."
Then you say this:
"I note these statements in the document ..."
Then paragraph 10 from the minutes:
"The Committee agreed that it was important to
start screening as soon as practicable ..."
Paragraph 18:
"The Chairman summed up the discussion by saying
that there was agreement that the UK should introdu ce
hepatitis C testing as soon as practicable."
Then paragraph 21:
"... some centres had asked for a 6 month period
102 in which to set up testing."
And your observation there is:
"This suggests some disconnect in the thinking
... as soon as practicable ... but only if all
together."
ANSWER:
Mm-hm.
|
46,131 | 333 | QUESTION:
Is there anything further you would wish to add on
that issue and on the basis of what we see in those
minutes, Dr Lloyd?
ANSWER:
No, I think that pretty much sums it up. You get t he
feeling through these minutes that, yes, we're goin g
to do it but there always seems to be a little "if" ,
a "but" behind it, instead of just getting on with it.
I mean, they've already decided this is a test
that needs to be done and yet we're flip flopping
about. As to the "all together", I've seen that in
documents that Dr Gunson produced before, so my
feeling, and that's purely a personal thing, don't --
can't say substantively, but it seems that it was
Dr Gunson who had this view that "All together" was
the necessary -- was the imperative. I'd seen it i n
other documents he'd prepared, so I feel that's whe re
that came from.
As is noted, there is no actual discussion
recorded in the minutes as to how they came to deci de
103 that that was an important issue.
If I may go back to the minutes, paragraph 11.
|
46,132 | 333 | QUESTION:
Yes, so NHBT0000073_018, please, Sully, page 3.
ANSWER:
I hope I've got this right. I saw it briefly then and
it reminded me.
|
46,133 | 333 | QUESTION:
So paragraph 11 should be on your screen, Dr Lloyd.
ANSWER:
Okay, yes. In that highlighted section in the midd le,
we see:
"Both Dr Gunson and Dr Mitchell felt that if the
results of the pilot study giving 6 true positives out
of 10,000 donors were borne out in practice then
counselling would be manageable."
I think if you're saying that counselling would
be manageable, you're obviously saying that the tes t,
introducing the test would be manageable. So, you
know, here we are with the first -- referring to th e
first generation test, saying that the number of
positives is manageable. And I think that's import ant
to remember as we go through this. Thank you.
|
46,134 | 333 | QUESTION:
Then going through this chronologically, I'm going to
ask you to look next at a document from early
January 1991, not a document you would have seen at
the time. It's PRSE0002858, these are headed "JDC
Notes of NBTS/SNBTS Management Meeting
(7th January 1991)". So these are Dr Cash's own no tes
104 of his meeting.
ANSWER:
Yes.
|
46,135 | 333 | QUESTION:
If we go to the second page and pick it up at
paragraph 5, "HCV Donation Testing", Dr Cash has
recorded here:
"HG [that's Dr Gunson] conveyed his concern that
DOH has still not decided on a start date. It now
seemed probable that May/June 1991 would be the
earliest possible.
"2. HG advised that he believed that the major
problem for DOH was mechanisms for finding the mone y
for NBTS RTCs and for E/W [which I assume is
'England/Wales'] confirmation testing."
ANSWER:
England/Wales, yes.
|
46,136 | 333 | QUESTION:
"The issue is one of DOH's disinclination to fund
centrally and insist on cross charging -- ie
increasing the unit cost of blood supplied to
hospitals."
Now, two questions arising out of that,
Dr Lloyd. The first is, as I understand your
evidence, you had not been working on any assumptio n
that the Department of Health would be funding this .
You'd been working since 1989 on the assumption tha t
the region would be funding it; is that right?
ANSWER:
That's correct.
05 |
46,137 | 333 | QUESTION:
Secondly, did Dr Gunson ever communicate to you the
belief that is recorded here by Dr Cash that this w as
an issue relating to the Department of Health tryin g
to find the mechanism for finding the money? Was t hat
something ever communicated to you at the time as
a potential cause of the hold-up?
ANSWER:
No, no, I wasn't -- I don't recall ever being told
"We're on hold because they can't find the money".
That message never -- I can't recall it coming my w ay.
|
46,138 | 333 | QUESTION:
Then, if we, still in --
ANSWER:
I do note, if I may just interject there?
|
46,139 | 333 | QUESTION:
Yes.
ANSWER:
Under the same section 5, item 3:
"...[frozen screen]... requested a more
definitive operational description for a 'start dat e'
..."
It gives the impression that John Cash and the
Scottish Transfusion Service are unhappy about this
vague issue of a start date, that they're not happy
with a May/June earliest possible. So again, that' s
just an observation. Thank you.
|
46,140 | 333 | QUESTION:
So if we then move a little further on in January 1 991
to NHBT0000076_006, so this is a memo from Dr Gunso n,
22 January '91 to the Regional Transfusion Director s
England and Wales so you would have received this,
106 Dr Lloyd.
ANSWER:
Yes.
|
46,141 | 333 | QUESTION:
Paragraph 1:
"The Department of Health have agreed that
routine testing of all blood donations for anti-HCV
can be put into operation.
"2. I have been asked to try and ensure that
testing starts simultaneously in RTCs in England an d
Wales and that it is co-ordinated with commencement of
testing in Scotland.
"3. Will you please advise me what you consider
to be the earliest date that you could commence
testing.
"4. Financial arrangements to cover routine
screening and supplementary tests have later still to
be concluded and I will advise of these at a later
date."
Then there's a reference to a protocol being
considered by the Advisory Committee on Transfusion
Transmitted Diseases, and 6, he says:
"[He] will inform Ortho and Abbott that routine
screening ... has been approved and ... will inform
them of the starting date in due course."
Now, you responded to the invitation in
paragraph 3 in a letter of 7 February.
107 NHBT0000073_044.
This is you on 7 February writing to Dr Gunson,
saying:
"The Northern Region Blood Transfusion Service
would be able to start HCV testing from approximate ly
1st April 1991. The Company (Abbott Plc) would be
able to supply the first generation test by that da te
without any problems. I understand that you have b een
in touch with the Manufacturers with a view to
ascertaining when the second generation test would be
available."
Then there's a reference to a concern about the
relatively low incidence of positive confirmations and
saying it would be advantageous if there was a seco nd
generation test with improved specificity.
As I read this letter, but please correct me if
I'm wrong, Dr Lloyd, you're saying it would be good to
have an improved second generation test but it's no t
essential in order to get started, and you can star t
with the first generation test; is that right?
ANSWER:
Absolutely. Yes. We were ready to go with that fi rst
generation test. We -- when we set things up, we
didn't know that a second generation test was sort of
just around the corner. You obviously know that
improved tests are going to come, that's the way it
108 happens, but yes, we were ready to go with the firs t
generation test.
|
46,142 | 333 | QUESTION:
And then we know that other Regional Transfusion
Directors also responded to Dr Gunson's request wit h
a range of different potential commencement dates.
The next, I think, global, communication from
Dr Gunson to RTDs is NHBT0000191_077.
Again, we can see this is a round-robin letter
from Dr Gunson, 15 February, to all RTDs.
If we go further down the page, he refers to
minutes of the management committee -- we know that 's
the management committee of the National
Directorate -- and some papers.
If we go over the page, he refers there to
enclosing reports on the comparison of the Abbott a nd
Ortho tests, which of course was the work you'd bee n
involved with the previous autumn.
Then the second paragraph under paragraph 10:
"I have now been able to speak to all RTCs and
an agreed date for commencement for anti-HCV screen ing
of 1st July 1991 has emerged. This, of course, wil l
be dependent upon a reasonably normal blood collect ion
pattern at that time since if the later is still
disrupted by affairs in the Gulf [I think that shou ld
be "latter"] we may have to reconsider the date."
09 ANSWER:
Yeah.
|
46,143 | 333 | QUESTION:
Do you ever any recollection of what your reaction or
feelings were, bearing in mind you were ready to st art
at this point in time, on 1 April, being told it wa s
going to be 1 July?
ANSWER:
I was upset. I thought this was unnecessary. And
it's -- there's nothing there that tells you why
it's 1 July. And it's this sort of this comment th at
an "agreed date ... has emerged". You know, where did
it come from? Certainly not from me. And several
other centres were ready and able to start earlier
than this. So the agreed date is -- you know, I wa s
unhappy with that. I was definitely unhappy with
that. So that was setting me on the course for wha t
happened afterwards.
|
46,144 | 333 | QUESTION:
"... had not yet been finalised. Members agreed it
was important for proper evaluation of the Ortho an d
Abbott 1&2 tests to be carried out before RTCs deci ded
which test they would adopt."
So this is the decision or recommendation of
the ACVSB that before testing is introduced, there
should now be a further evaluation comparing the fi rst
and second generation tests, or looking at the seco nd
generation tests.
Now you obviously didn't see this --
ANSWER:
Sorry --
|
46,145 | 333 | QUESTION:
-- but that information --
ANSWER:
-- no.
|
46,146 | 333 | QUESTION:
-- came to your attention. We'll look at how in du e
111 course. But in broad terms, what was -- what's you r
view of the suggestion that there should now be thi s
further evaluation involving the second general
election tests?
ANSWER:
Sorry, can you remind me the date, was this Februar y
1991?
|
46,147 | 333 | QUESTION:
We'll do that.
ANSWER:
Yeah. It's a confusing statement:
"... likely availability of second generation
tests ..."
Saying we're not sure when, it's only the
"likely availability". Then:
"... Operational factors ... might influence
decision [of] RTCs as to which screening test to
choose."
That's very strange. Why would you choose
between a first generation test and a second
112 generation test? You might choose between two or
three different manufacturers of a second generatio n
test, but why would we be deciding whether to do
a first or second generation test? That really doe s
not make sense to me.
"Members agreed it was important for proper
evaluation of the Ortho and Abbott 1&2 tests to be
carried out before RTCs decided which test they wou ld
adopt."
So again, we're saying you might decide to go
with some centres -- and this is interesting --
evaluation -- centres decide which tests they would
adopt. Would they adopt first generation or the
second? So now we're suggesting that you might hav e
a situation, once the second generation test
eventually becomes available, that some centres wil l
choose to use first generation tests ...[frozen
screen]... doesn't make any sense.
|
46,148 | 333 | QUESTION:
Dr Lloyd, we lost you there for a --
ANSWER:
Either the minutes or -- okay. I was repeating
myself.
|
46,149 | 333 | QUESTION:
No, no, we lost you for a couple of seconds, so I j ust
wanted to check we didn't miss anything significant .
ANSWER:
Yes.
|
46,150 | 333 | QUESTION:
You said this:
13 "So now we're suggesting that you might have
a situation, once the second generation test
eventually becomes available, that some centres wil l
choose to use first generation tests ..."
And then we missed possibly just a few seconds.
ANSWER:
Okay.
|
46,151 | 333 | QUESTION:
And then you said, "doesn't make any sense".
ANSWER:
Okay.
|
46,152 | 333 | QUESTION:
So could you just repeat that point?
ANSWER:
Certainly.
This minute suggests that the situation might be
after this testing that some transfusion centres wo uld
choose to use the first generation test, and some
centres would choose to use the second generation
test. And that makes no sense.
Either this minute is wrong and is -- does not
correctly reflect what was being said, or there was
a big problem over what they were talking about and
what they were suggesting. Very strange.
|
46,153 | 333 | QUESTION:
And it may be that we will, with other witnesses, n eed
to explore the whole minutes, but I'll just flag up
that in paragraph 7 it says:
"The Chairman summed up the view of the
Committee following discussion ..."
And then if we go over the page, there's three
114 bullet points there, and then over the page, the to p
of the page, the next point is:
"Ortho and Abbott 1 and 2 should in principle be
available among others from 1 July for RTCs to
choose ..."
So that is, I think, consistent with how you
were reading that earlier paragraph.
ANSWER:
Mm-hm, right.
|
46,154 | 333 | QUESTION:
"The start date for HCV testing set by the National
Directorate is currently 1st July. However two
Centres in particular are unhappy about this. One of
them is Cambridge."
Now, that would suggest you'd had some
discussions or communications with some other centr es.
Do you recall what the unhappiness was?
ANSWER:
No, I don't. I mean, when you read that, I would s ay
the only -- you know, if someone is unhappy about t hat
date, that -- I don't know whether they were unhapp y
because it was too early or because it was too late .
But I think, if you look at some of the other
documentation, Cambridge was one of the centres tha t
was looking for a later date, but I -- that is pure ly
from my memory --
|
46,155 | 333 | QUESTION:
No, you're absolutely right.
ANSWER:
-- I don't have documentation about that.
|
46,156 | 333 | QUESTION:
I think Cambridge had indicated it would be ready b y
October so that might suggest the unhappiness --
17 ANSWER:
Yes.
|
46,157 | 333 | QUESTION:
-- from their perspective.
You then refer to the Procurement Directorate
"looking at FOUR potential suppliers of HCV kits".
That, I think, is a reference not to a Northern Reg ion
Procurement Directorate but to the NHS Procurement
Directorate or DoH Procurement Directorate.
ANSWER:
Yes. That's correct.
|
46,158 | 333 | QUESTION:
You say there:
"... want ... several firms involved to enable
them to obtain lower prices for the kits."
Do you recall what the source of your
information was in relation to that?
ANSWER:
No, I don't. I don't know how I came by that.
I would imagine -- I mean, that's the sort of thing
that ...[frozen screen]...
|
46,159 | 333 | QUESTION:
Sorry, we lost you again, Dr Lloyd.
ANSWER:
Okay. No, I'll wait for a moment. Okay.
I don't know where I got that information from,
I'm sorry. I think I was waffling a bit then.
I don't know where it came from.
|
46,160 | 333 | QUESTION:
Then you say:
"I suggest we proceed as intended, as soon as
a second generation kit is available."
So that's 14 March. If we then just still in
118 March go to NHBT0000062_039. Now, this is an inter nal
Department of Health memo, 8 March 1991, referring to
the ACVSB decision to extend HCV screening evaluati on.
We can see paragraph 2 sets out what's said to be t he
additional costs, and so on, in relation to this
further evaluation.
Paragraph 3 then records:
"I gather that Dr Gunson, who was not present at
ACVSB on 25 February, has telephoned Mr Fuller to s ay
that he doubts whether the Newcastle and Glasgow
Centres have the laboratory capability to carry out
the additional work now proposed. I understand als o
that Dr Rejman is unsympathetic to Dr Gunson's view on
this. However, I think you should be aware that
Dr Gunson has raised this point as it seems to
underline the need to look very carefully at what
ACVSB has advised to be sure that an evaluation on
this scale is both necessary and practicable."
ANSWER:
Mm-hm.
|
46,161 | 333 | QUESTION:
Do you have any recollection of Dr Gunson exploring
with you Newcastle's capability to carry out the
additional work? Because, as I understand it, it w as
anticipated that Newcastle would be one of the cent res
evaluating the second generation kits.
ANSWER:
No, I don't recall him discussing it with us. Ther e
119 was absolutely no reason why we couldn't have done it.
And when I read this minute, I was really quite
surprised, politely, that this point had been made.
Certainly, there's no reason why we shouldn't
have evaluated. I also note in the previous minute s
of the ACVSB that you showed that original proposal
for comparing the first and second generation tests
was purely on the 10,000 samples. It wasn't a sort of
a full-blown new study and maybe this letter allude s
to a change in proposal from just testing stored
samples to actually running, sort of, almost a live
testing scenario, which would have been much more
expensive and time consuming.
|
46,162 | 333 | QUESTION:
I'm not going to go to the next document, which is
a letter from the Procurement Directorate, to
Dr Gunson, on 21 March 1991, which sets out how it was
proposed this second round comparative evaluation
should be undertaken at Newcastle, North London and
Glasgow, but the reference for the transcript is
NHBT0000191_115.
The document I want to display before we take
a break, Dr Lloyd, is then Dr Gunson's letter of
3 April to all RTDs, NHBT000073_065. This is the
letter in which he communicates the delay from July to
September for testing. So if we go to the bottom h alf
120 of the page --
ANSWER:
Yes.
|
46,163 | 333 | QUESTION:
-- you'll see:
"You will recall that in my letter to you in
15th February I suggested that 1st July 1991 might be
an appropriate date to commence anti-HCV screening of
blood donations."
Then he refers to the availability of the second
generation test kits, and also to the possibility o f
other companies supplying tests, which I think is w hat
your internal memo, Dr Lloyd, had alluded to. It t hen
says:
"The Department of Health has agreed that there
should be a 'second-round' comparative evaluation o f
anti-HCV test kits at the Newcastle, North London a nd
Glasgow RTCs, together with appropriate confirmator y
testing."
Next paragraph:
"It is undoubtedly in our interest that this
evaluation takes place. However, to complete this
study and become operational by 1st July 1991 is to o
tight a schedule. It is difficult to state precise ly
a revised date, but I think we should aim to commen ce
routine screening for anti-HCV by 1st September 199 1."
Now, after the break I'll ask you about the
21 decision that you then took. But can you just assi st
with this: Dr Gunson sets out in that fourth paragr aph
his view of "our interest", and then the proposal t o
move the date for testing back from July to
September --
ANSWER:
Mm-hm.
|
46,164 | 333 | QUESTION:
-- or forward from July to September, however you w ant
to characterise it. Had there been, as far as you' re
aware, any discussion between Dr Gunson or anyone e lse
from the National Directorate and Regional Transfus ion
Directors, such as yourself, or did this come out o f
the blue?
ANSWER:
This came out of the blue. This came completely ou t
of the blue. I had no idea this was being consider ed.
July was already too late and, as perhaps we'll
discuss later, this was, as they say, the straw tha t
broke the camel's break, from my perspective.
So it is -- it was -- yes, it was completely
a surprise when this arrived.
|
46,165 | 333 | QUESTION:
In a nutshell, Dr Lloyd, what was your reasoning fo r
going ahead in the way described here?
ANSWER:
Well, obviously I'd written it in my witness
statement. We had the wherewithal to do the test. We
had the -- funding was in place, we had the tests
available. We had the equipment available. We had
the staff who were more than competent to carry it
out. Our own internal IT department had made sure
that we could communicate the test results into our
existing system, and so we were sitting on the star t
line ready to go. Then we're told to wait for -- i f
you look at the last letter from Dr Gunson, it didn 't
say, "We will start on 1 September" it was a "may
start on 1 September".
So we -- I felt that I could not delay testing.
I mean, we had the wherewithal to remove infectious
donations out of our system and therefore reduce th e
risk to patients receiving the blood. We really ha d
no -- there was no alternative. I mean, there was --
you can't not go ahead when everything is in place,
just to meet some mythical common start date.
|
46,166 | 333 | QUESTION:
We can see you anticipated in that last sentence th at
there might be some problems with the
124 National Directorate. Let's pick that up with
a letter Dr Gunson wrote to you.
NHBT0000062_054, please. And we go to page 3.
So 29 April, Dr Gunson wrote to you. First
paragraph refers to a telephone conversation. Seco nd
paragraph:
"I was sorry to learn that you had taken this
unilateral decision to proceed with testing without
first discussing the issue, not only with me, but w ith
other colleagues in RTCs given you must have been
aware of the implications for them of your decision ."
Then he refers back to the ACVSB meeting and to
a letter he wrote, which we've already looked at, i n
January --
ANSWER:
-- (overspeaking) -- problems.
|
46,167 | 333 | QUESTION:
And then over the page, we see, the top of the page ,
he refers to the 'second-round' evaluation. Then t he
next paragraph:
"Unfortunately the timing stated in this letter
slipped ..."
And he explains that was the reason for his
letter deferring the date to be aimed for as
1 September 1991.
Then the last paragraph he says:
"I have written these details in some length to
25 demonstrate that I had kept you fully informed of t he
national policy with respect to anti-HCV testing.
There are still other matters which have not yet be en
concluded."
Then he sets out what some of those are.
Can you recall what your thoughts were on
receiving this letter and do you have any particula r
comments on what we see set out in it?
ANSWER:
First of all, this letter follows the telephone
conversation which was somewhat harder to listen to
than this was to read. Dr Gunson was, how shall I put
it, beside himself over what we had done, and I sor t
of realised that there would be issues.
Then here we have a series of odds and ends as
to why they can't do it. Certainly the second roun d
evaluation is referred to, and this comes up
elsewhere. We do now know from correspondence betw een
Dr Gunson and, I think it was, Simon Pearl, the law yer
with the firm representing the NBA, probably, in
litigation, in which Dr Gunson says the second-roun d
evaluation was effectively a sham. It wasn't
a serious thing. And that it was not actually
necessary.
So we now know that he thought it wasn't
necessary, and yet here he is saying we've got to d o
126 a second-round evaluation and we've got to, you
know -- the procurement people have got to do this and
that.
None of it mattered. None of it mattered. Even
if the second generation test had not been availabl e
for months, we would have gone ahead with the first
generation test. So all of this is just some sort of
way, to me, for Dr Gunson to sort of say, "I've got
all these great reasons for delaying it, and you
shouldn't have broken ranks". It was an unpleasant
letter.
|
46,168 | 333 | QUESTION:
We can see your response at NHBT0000074_010.
You say there:
"When a common date of 1st July was circulated
sometime ago, I made a decision to start testing
in April 1991 so that we could be assured that not
only were all issues of blood and blood components
negative for the antibody but that all units
transfused from that date were negative.
"I set up the internal arrangements and made it
clear that testing would start in the Region in the
early part of the year. The decision to start test ing
was based on a test that was not perfect, but
nevertheless, it was available and it did detect
a group of people who appeared to be positive for t he
127 Antibody. The comparative study of the Abbott and
Ortho kits (first generation), was not going to
influence my decision as to whether or not to start
testing."
"The next round of comparative trials which
encompasses other manufacturers kits as well as sec ond
generation kits from Abbott and Ortho when started was
not going to be completed in time to allow this Cen tre
to meet the July deadline, even on the original
schedule. The change in date based on a further delay
in completion of the next round of evaluations would
have delayed the introduction of testing (all
transfused units negative) by several months, possi bly
taking us to November of this year.
"If during that period anyone becomes infected
and subsequently takes action, in my opinion, I wou ld
have had no defence. We that the wherewithal to te st,
including kits, equipment and staff and we had agre ed
to start previously. The delay is thus administrat ive
and that not only forms no basis for a defence or
a mitigation but also I think aggravates the
situation.
"I have therefore proceeded on the basis that
all units available for transfusion from 1st July w ill
have been tested."
128 Just in terms of the mechanics of it, first of
all, Dr Lloyd, is this right -- is it right to
understand that the routine testing of donations
started with effect from 24th April but then there
was, as it were, a catch-up in terms of stored
products --
ANSWER:
I lost you then. Could you start again?
|
46,169 | 333 | QUESTION:
Yes.
ANSWER:
Is it right for me to?
|
46,170 | 333 | QUESTION:
It's, in terms of the mechanics of putting screenin g
into operation, is this correct: routine testing of
donations began on 24 April but there'd also be
a period of needing to test what was held in stock and
so on, and is that what feeds, then, into this last
sentence, all units will have been tested from 1 Ju ly?
How do we understand the reference to 1 July?
ANSWER:
I've re-read this letter. I think part of this
letter, to be honest, was me trying to protect my o wn
back, using this 1 July as a date when all units wo uld
be tested when, really, that wasn't the issue.
I think I was trying to say: look, I thought we wer e
going to have things all done by 1 July so I had to
start in April. The dates don't really quite add u p.
But we started on 24 April. There would be
a period, and one can be criticised for this, but
29 there would be a period when units of blood and
platelets and so on that were in stock were issued
untested. I don't think we went back and tried to
re-test samples, you know, from recently collected
blood. I don't think we did that, and I'm sorry fo r
that.
But we -- so 1 July really is -- it's a little
bit of a smokescreen. Not a big issue. The big th ing
is we started on a certain date. Everything we
collected from that date was -- that we put into is sue
was HCV negative. And it would take a little while
for things to clear through the system before
everything -- everything -- that was issued was HCV
negative.
|
46,171 | 333 | QUESTION:
And then the way you've put it in your statement, a nd
I don't think I need display it, it's just two
sentences I wanted to read out:
"A delay until July displayed me, and a proposed
July until about 1st September was unacceptable. W e
all knew that there were infectious donations in th e
system that were being transfused to patients and w e
had the means to stop that."
Again is that, in a nutshell, the essence of
your thinking?
ANSWER:
Absolutely. Yes.
130 |
46,172 | 333 | QUESTION:
You also wrote to your Regional Health Authority an d
you wrote a letter to your Regional Transfusion
Director colleagues. I'm not going to go through
those, I'll just read the references out so that
others have a record of them. The letter to the
Regional Health Authority, 30 April 1991, was
NHBT0000191_162, and your 2 May 1991 letter to RTDs is
NHBT0000074_014.
What I want to do, however, is now pick up some
of the letters that you got in response, or some of
what was being written about your decision, and the n
ask you about that.
Dr Lloyd, we've already looked in earlier
hearings at Dr Cash's initial letter to you and you r
reply to him; we've looked at the letters that
Dr Entwistle and Dr Martlew sent you; we've looked at
the letter that Dr Boulton sent you, and I don't kn ow
if you've followed any of the Inquiry's evidence
Dr Lloyd, but he told the Inquiry last week this,
"I now feel quite strongly that Huw was right"; and
we've looked at the letter that Dr Contreras sent y ou,
and she said in her oral evidence to the Inquiry, " I'm
really sorry to have written this letter".
So what I'm now going to do is just show you
some of the letters that we haven't looked at in ot her
131 hearings and then invite your comment.
So if we start with a letter from Dr Fraser,
NHBT0000074_018.
Do we have that, Sully? It's not come up on my
screen. NHBT0000074 -- thank you.
So 7 May '91, from Dr Fraser, picking it up in
the third line:
"I feel you are making an error of judgment here
and seem to be flouting the advice given by Dr Guns on,
who I thought had made it fairly clear, that
transfusion centres should not start testing until
September 1st at the earliest. Obviously, we need to
have some experience with regard to the newer
generation tests. The Transfusion Service normally
acts in unison when introducing new tests for
transfusion transmitted diseases. This certainly
happened for HIV I and HIV II. I think it would be
far better for you to wait to introduce this test
until a date has been agreed for all transfusion
centres to commence testing."
Is there anything in that letter that led you to
doubt your decision?
ANSWER:
Oh, no, no. I mean, there was no -- there was noth ing
in that letter that makes you think: oh my goodness ,
we should have delayed. No, certainly not.
132 |
46,173 | 333 | QUESTION:
Then Dr Ala wrote to you on 8 May, NHBT0000074_020.
He says:
"I am afraid your decision to commence testing
before everyone else has come at a very inopportune
moment, for it will seriously undermine the whole
concept of establishing a National Service precisel y
at the time when this proposal is being submitted f or
reconsideration by the Department of Health. The
importance of supporting this concept goes far beyo nd
parochial interests, and the issue is an urgent one .
"Your view that to defer screening is
'indefensible' in the light of product liability
legislation cannot be taken seriously, nor is there
any evidence of HCV prevalence sufficient to justif y
your precipitate decision on epidemiological and
scientific grounds.
"If we cannot work together, we shall decline
separately."
You've commented on this letter in your
statement, Dr Lloyd --
ANSWER:
I did, yes.
|
46,174 | 333 | QUESTION:
-- WITN6935001, page 95. You described this, at th e
top of the page, as:
"... a strange criticism to throw at Newcastle's
decision ... given that Dr Ala had stated in respon se
33 to Dr Gunson's earlier request that they [in
Birmingham] would be able to start testing by April
..."
Again, any further comment or observation on
Dr Ala's letter?
ANSWER:
Yes. Fereydoun Ala's letter was very strange when he
talks about there being no scientific evidence
...[frozen screen]... not being evidence of there
being sufficient infectivity in the supply, words t o
that effect.
|
46,175 | 333 | QUESTION:
Yes.
ANSWER:
But those were things that had already been discuss ed
extensively that we knew that we had a problem, and
Dr Ala wasn't raising any complaints about starting
testing. So that argument -- I think, in the heat of
the moment, you know, people were throwing in
arguments just because they felt they had to say
something, they had to come up with something. So
I didn't take it seriously.
|
46,176 | 333 | QUESTION:
Then the third letter I wanted to discuss briefly w ith
you was NHBT0000074_033. This was from Colonel Tho mas
of the Army Blood Supply Depot, 17 May, third
paragraph:
"I must say that I was personally dismayed to
learn that you were going to break ranks over the
134 agreed policy on the introduction of Hepatitis C
testing. As someone who might be considered an
outsider and therefore not bound by the collective
decision, I believe, and this is the policy of my
Director General, that it is vital that we maintain
a common front. Only in this manner are we going t o
navigate the difficult waters ahead engendered by t he
introduction of product liability and our requireme nt
to be licensed by the Medicines Control Agency".
Any observations, Dr Lloyd, on what Colonel
Thomas was saying there about maintaining a common
front and not breaking ranks?
ANSWER:
Well, again, you see that at the end there, "going to
navigate difficult waters ahead engendered by the
production of product liability and our requirement to
be licensed": irrelevant, irrelevant stuff. I thin k,
again, as with Fereydoun Ala's letter, something
thrown it just to try to make the point: not releva nt.
If you don't -- if you decide to delay testing, you 're
deciding to issue infected units, and these sort of
arguments really don't -- didn't hold any sway with
me, that's for sure.
|
46,177 | 333 | QUESTION:
Then I want to ask you now to look at you letter th at
you wouldn't have seen at the time, it was from
Dr Cash to Dr Gunson, NHBT0000074_024, headed "The
135 Newcastle Saga: HCV Donation Testing".
ANSWER:
Yes.
|
46,178 | 333 | QUESTION:
I just want to --
ANSWER:
May I?
|
46,179 | 333 | QUESTION:
Yes.
ANSWER:
May I just -- I'm sorry, I -- rather than come back to
this after this document, may I just say something
about the previous letters that I received?
|
46,180 | 333 | QUESTION:
Of course.
ANSWER:
Obviously, I was, you know, fairly upset by the ton e
of the letters but I think there were two letters t hat
I received that and I'd like to point out were in
a much more reasonable tone, and I think it's fair
that I should say that the letters from Dr Martlew and
Dr Mitchell in Scotland were both, you know,
reasonable letters to send in the circumstances and
were not peppered with the sort of stuff that we sa w
in some of the other letters. So I just would like to
make that point.
|
46,181 | 333 | QUESTION:
Thank you, Dr Lloyd.
So I just really wanted to invite your attention
here and any observation you have on the last sente nce
of the first paragraph, where Dr Cash puts it in th ese
terms:
"... we should make every effort to maximise
136 this disaster to our corporate advantage."
I wondered whether you have any observations,
either about the concept of characterising this as
a disaster, or the concept of maximising corporate
advantage?
ANSWER:
Yes. When I saw this -- I mean, it doesn't surpris e
me, in some ways, that, you know, Professor Cash wr ote
something like this. But, yes, "corporate advantag e"
is really pretty gross. But I don't know exactly w hat
corporate advantage he was trying to make. I don't
know.
|
46,182 | 333 | QUESTION:
Then just in relation to a response of the Departme nt
of Health -- or, sorry, I should say a response of
someone within the Department of Health, more
accurately, NHBT0000062_054.
This is a memo from Dr Rejman to Dr Metters,
30 April 1991. He says he encloses "a copy of
a letter sent by Dr Gunson ... to Mr Canavan".
I should just, if we go to the second page, we
can see what that is.
So Dr Gunson wrote to Mr Canavan enclosing
a copy of his letter to you, which we've already
looked at, Dr Lloyd, and referring to a call he'd h ad
from Ortho and then saying, "I fear the worst."
ANSWER:
Mm-hm.
37 |
46,183 | 333 | QUESTION:
That's what Dr Rejman is referring to.
If we go back to the first page, please, in
Dr Rejman's memo.
Point 2, he says:
"This gives details of routine anti-HCV
screening at Newcastle RTC which commenced last wee k.
"3. This action was taken despite the agreed
policy by the ACVSB that screening should start
simultaneously in all the RTCs in the UK.
"4. This had also been agreed by the RTC
Directors with the National Director of the NBTS."
Just pausing there, that appears to suggest that
a policy of simultaneous screening was the consensu s
view agreed by RTC directors. Was that your
understanding, that this had been agreed by
RTC directors?
ANSWER:
...[frozen screen]... correspondence I received and
phone calls I received, it was quite clear that all
the other directors believed that we were going to
start on the same day. So yes, I have to say it wa s
agreed. I do not recall actually being in a meetin g
where I said, "I agree to start on the same day".
I might have done. Possible. Particularly when we
thought the test was being introduced fairly prompt ly.
So yes, it's -- I think it's fair to say RTC direct ors
138 agreed with the national director that it should st art
simultaneously, yes.
|
46,184 | 333 | QUESTION:
Then Dr Rejman's observation in paragraph 5, and
obviously we can ask him about this, but it says:
"This action has caused problems in that the
other major competitor company feels disadvantaged,
and has also caused problems in Scotland.
"6. We are waiting for written reasons as to
why this action was taken."
Then he says he is:
"... copying it to members of the Management
Executive to determine whether action is required
where an individual Region decides to oppose a
universal agreement."
Do you have any observations, Dr Lloyd, on
paragraph 5, whether the problems it's said that ha d
been caused are disadvantage to the other competito r
company, and unspecified problems in Scotland?
ANSWER:
I have absolutely no sympathy for a large commercia l
company that happens to feel disadvantaged over
something that happens. They're in the business of
making money and I'm quite sure many companies, and
you see it in the newspapers occasionally, companie s
come up and complain that they feel they've been
disadvantaged by something that has happened, by so me
139 government decision or whatever. Of course they're
going to come up and say that. They don't want to be
left behind. They don't want to make less money. So
I certainly feel no sympathy, if that's the right
word. You know, tough. They're a big business.
They're a multinational corporation and they can lo ok
after themselves.
As for Scotland, I'm not quite sure what was
being suggested here. Whether it means that Scotti sh
NBTS was now put in the same position as some of
the -- as the other transfusion centres in England,
although somewhere along the line I have a feeling
that the Scottish centres were also prepared to sta rt
earlier. I do note that with the exception of the
letter from Dr Ruthven Mitchell, which as I said wa s
a moderate, reasonable letter, none of the other
Centre Directors from Scotland actually wrote and
complained about my decision to start testing. So
maybe the Scottish Blood Transfusion Services were not
as comfortable with the delay, apart from, obviousl y,
John Cash.
|
46,185 | 333 | QUESTION:
Were you surprised that the introduction by you of
a measure designed to improve patient safety trigge red
such a response from others?
ANSWER:
When I decided to introduce the test, I knew there was
140 going to be a backlash. Or I was pretty sure. And
what I -- when I re-read those letters, what I note is
that nobody mentions the patients. The ...[frozen
screen]... jolly good show, we're all -- no one is
going to break ranks. And I sort of felt that was --
there's something wrong with that. Wrong focus.
|
46,186 | 333 | QUESTION:
Just a handful of further questions about the
correspondence and so on at this time.
First of all, NHBT0000074_026.
You wrote to Dr Gunson on 9 May 1991. You
referred to Dr Contreras's letter and said your
impression was "that there was a concerted attempt to
obtain funding from the Department of Health", was
this is an agreed strategy? And then you posed the
question:
"Would you be good enough to let me know whether
there was in fact a strategy which involved delayin g
the introduction of the tests while awaiting centra l
funding for this test. As far as I am aware, no
previous communication has indicated that the start
date for the test depended on funding direct from t he
Department of Health."
Now do you recall if you had an answer from
Dr Gunson to that question: was there a deliberate
strategy here?
41 ANSWER:
I certainly don't recall any response. But obvious ly
...[frozen screen]... well, obviously -- but no,
I don't ever recall receiving an answer to that.
|
46,187 | 333 | QUESTION:
Now, one of the things that happened next, and we c an
pick this up at NHBT0000192_024, was the suggestion
that your action would be regarded as a trial and n ot
the commencement of routine testing. So we can see
this is a letter from Dr Gunson to all RTDs,
9 May 1991. We can pick it up, I think, bottom of the
page:
"Dr Lloyd's premature introduction of the test,
however, can be used to extend the scope of the
evaluation if it is developed as part of a national
policy. To this end DH have agreed that two other
RTCs in England, namely Leeds and Liverpool, will t ake
part in an extended trial using the Ortho 2nd
generation kit. This will still be regarded as
a trial and not the commencement of routine testing ."
There's further communication in relation to
that suggestion. You've characterised it in your
statement as a face-saving exercise and a charade, and
I just wondered if you would care to elaborate upon
that?
ANSWER:
Yeah, certainly. At the time when this came out, w hen
Dr Gunson started talking about an extended trial, you
142 know, I -- my immediate reaction was that this was
just Dr Gunson trying to save face. He'd told the
Department, or the ACVSB, you know, "We're doing it
all together, no problem here", and then this guy g oes
and does this differently, upsets everybody, and no w,
somehow, Dr Gunson has got to save face, either
amongst his -- amongst the directors or the Departm ent
of Health.
So I saw this as nothing more than a face-saving
exercise and I think you do have, again, some of th at
correspondence between Dr Gunson and Simon Pearl th at
that's exactly what this was, and I think there was
also a letter that he wrote to Dr Contreras, in whi ch
he suggests that this was not a genuine trial that he
was proposing.
|
46,188 | 333 | QUESTION:
If we just go to the third page of this document,
please, Sully. This a brief to answer press querie s,
"Line to Take" being set out by Dr Gunson.
I'm not going to go through all of it but if we
can just go towards the bottom of the page, just ab ove
paragraph 6 "Legal Liability", there's a heading
"Importance of Testing" and the suggested line to t ake
is this:
"The new test will improve the safety of the
blood supply but it should be noted that Hepatitis C
143 is normally only a mild infection (not like AIDS)."
Now, you have some observations from that in
your statement, Dr Lloyd, but I just wondered if yo u
could tell us orally what your response is to that.
ANSWER:
I mean, that's really a quite outrageous statement to
be putting out and suggesting that people should pa ss
it on to the general public. Dr Gunson knew that
wasn't true. People who, unfortunately, you know,
were HIV infected, developed AIDS and died, and the re
are people who contracted hepatitis C and developed
severe disease cirrhosis and died: normally only
a mild infection? No, sorry, that's wrong.
|
46,189 | 333 | QUESTION:
Then if we look at the penultimate paragraph on thi s
page, beginning "The second of these valid
criticisms", so this is about not giving other cent res
adequate warning, you say:
"The second of these valid criticisms resulted
from my view that had I informed everyone earlier,
pressure would have been brought to bear to stop me
instituting testing, a course that I believe was ri ght
and am now even more convinced was right."
I think you say in your statement, Dr Lloyd,
that your real concern was that, somehow,
an instruction might be issued from the Department of
Health to instruct you not to go ahead; is that rig ht?
ANSWER:
Yes, that was my line of thinking. I didn't think
I was going to be stopped from doing it just by sor t
of peer pressure. I thought if I was going to have be
stopped, it would have to come through the Departme nt
of Health, because Dr Gunson had no -- I had no lin e
accountability to Dr Gunson. He couldn't stop me
directly ...[frozen screen]... he was the advisor o n
the advisory ...[frozen screen]... to happen, and t hen
through the Department of Health, back through to
the Regional Health Authority, and then my boss wou ld
have said, "Don't do it."
146 So that was what I was worried about happening.
|
46,190 | 333 | QUESTION:
I think we lost a few seconds of your --
ANSWER:
Fortunately the -- yes. Yes, that's what I thought
was would happen, would be that there would -- that
the route would be from the Department of Health
through to the Regional Health Authority, where the
person I reported to would then tell me not to star t
testing.
But of course I was fortunate also in having
discussed this in advance with senior people at the
Regional Health Authority, and I have to thank,
I think it was, at the time, Professor Liam Donalds on
who supported me, and certainly understood the issu es.
A very savvy individual.
|
46,191 | 333 | QUESTION:
And then if we can look at a memo you wrote in
June of 1991 setting out your reflections.
NHBT0000192_092.
18 June 1991. It's not to anyone. It reads as
though this may be as it were a note to yourself,
almost, for the record.
ANSWER:
It was, yes. It was a note to myself. I occasiona lly
did that. Helped me remember things.
|
46,192 | 333 | QUESTION:
I'm not going to read through the detail of it. Yo u
refer to a meeting held in York. I think that was the
Northern Region that had met.
147 If we look down at the --
ANSWER:
I think it was on the -- 14 June, I think.
|
46,193 | 333 | QUESTION:
Then if we look down the bottom of the page, just w ant
to look at the last paragraph. You say this:
"At the end of this meeting I felt confident
that as a Centre we had made the right decision to
proceed with Hepatitis C testing when we did. My o nly
regret is that we didn't introduce it earlier. The
coordinating activity of the National Directorate
appears to have provided us with a lowest common
denominator approach rather than a best possible
approach."
As I understand your statement, Dr Lloyd, this
remains your position. Your only regret now still is
that it wasn't -- that you didn't do it earlier tha n
you did?
ANSWER:
Absolutely, yes. And I am sorry for that.
|
46,194 | 333 | QUESTION:
Do you have a sense of how much earlier you could h ave
introduced it on a local basis in Newcastle, given the
other constraints about the way in which the ACVSB was
taking its decisions and so on?
ANSWER:
There's a number of issues there. If you take the
purely logistical issue, we had the wherewithal to
introduce the first generation test earlier because we
had been the -- we had run the trial. So technical ly
148 we could have continued to test when the trial ende d.
So that's a sort of a technical issue.
The second issue is if, as we mentioned before,
the ACVSB had noted in November that we should test ,
should start testing as soon as practicable, I thin k
the word was, we could then perhaps at that stage h ave
gone to the Regional Health Authority and said, "Do
you have some remaining sort of emergency funds whi ch
you would be prepared to use so that we can purchas e
this test kit for the first couple of months of 199 1
before the new financial year starts?" You know, i f
we'd gone to them in November, perhaps they could h ave
found funding for sort of January, February, March.
What I -- I say I didn't know, I probably --
perhaps I did know, but I hadn't thought about it i n
that way, was that we couldn't start testing withou t
the Department of Health approval and the minister' s
approval.
So there was a real -- there would have been
a real problem with starting testing before that
approval, which I think was given on 22 January 199 1.
But even then, we could possibly have started
testing in January if the Regional Health Authority
had had some residual funding to fund the test.
|
46,195 | 333 | QUESTION:
Then we see Dr Gunson explains:
"[He is] thinking of responding to Simon Pearl
in terms roughly as set out above. I think it is
important that our efforts [that's his and
Dr Barbara's] correspond reasonably well."
Then if we go to the report from Dr Gunson and
Dr Barbara, or the statement, I should say, it's th en
produced at NHBT0088813_002. NHBT0088813_002.
So we can see it's a joint statement by
Dr Barbara and Dr Gunson, entitled "Unilateral
Introduction of Anti-HCV Testing at Newcastle RTC i n
April 1991". I know you've had an opportunity to l ook
at this, so there are only two passages I'm going t o
ask you about, Dr Lloyd, second page, bottom half o f
the page, it says:
"Dr Lloyd ... did not raise any objections to
53 the agreed starting date of 1 July ... However, we can
only conclude that he intended to begin testing in
April 1991, since he used the specious argument for
taking this premature action that he wished to ensu re
that all products for issue had been tested by
1 July ..."
Then that refers, I think, to the letter that
we've already looked at, or one of them.
ANSWER:
Yes, yes.
|
46,196 | 333 | QUESTION:
Do you have any observations about what's set out
there?
ANSWER:
Yes, as I said, the letter I sent to Dr Gunson
referring to 1 July, I think I, as I said before, I
was tying to protect my own back, a little bit, by
sort of making out that I wasn't quite as forthrigh t
in starting this testing when I did. I was -- so
1 July, when we say here it's a specious argument,
there is some truth in that. It actually wasn't th e
reason I started testing, but when Barbara and Guns on
saw that, they could use that information in this w ay,
so perhaps not unreasonable, given what I had writt en.
|
46,197 | 333 | QUESTION:
Then the last part I wanted to ask you about in thi s
document is on the last page. Last paragraph:
"There is no doubt that Dr Lloyd's decision was
not in the interest of the Service as a whole and w as
154 taken in the knowledge that he was flaunting the
decisions of the Department of Health who had made it
clear through the ACVSB that they were the responsi ble
body to determine when routine anti-HCV testing sho uld
start and the steps which should be taken prior to its
introduction."
Any observations, Dr Lloyd, on that and, in
particular, on the suggestion that this was not in the
interest of the Service as a whole?
ANSWER:
Yes, yes, certainly some observations. I mean, fir st
of all, I'll come back to your question about in th e
interests of the Service as a whole. "Flaunting th e
decisions of the Department of Health", well, I was n't
part to the minutes of the ACVSB and so I only had
limited knowledge of what their position was, as
provided through Dr Gunson.
Secondly, by the time I started testing, the
ACVSB, they had already said, "You will start
testing". So this argument that they were the
responsible body to determine when testing should
start doesn't hold water in this case. They'd alre ady
said, "Go ahead". They had handed it over to
Dr Gunson to arrange starting.
So then we come back to "the interests of the
service as a whole". Well, what is missing in that
155 statement is what about the patients, you know, it' s
corporate speak, you know: "interests of the servic e",
never mind about the safety of the blood we're
issuing. I think that's it.
|
46,198 | 333 | QUESTION:
Then can I ask you -- and this is now just really o n
a point of detail, rather than the issues of princi ple
which we've been discussing, can I ask you to look at
WITN6935035. This is a letter from Dr Collins,
3 January 1991, and it says -- it's a letter for
donors who have been tested and whose test results
suggests hepatitis C positivity. I just wondered i f
you can assist us in understanding the significance of
this in terms of the date. Was this a draft in
anticipation of the later introduction of testing, do
you know?
ANSWER:
No, I think if you scroll up to the top of the
document, if you would, please, you'll see at the t op
that, although it's under Dr Collins's name, the --
our reference shows that it was myself who drafted
this, and 3 January '91, this was after we had done
the first generation test.
So, yes, this must have been preparing ourselves
for the introduction of testing. I'm just looking at
the date ...[frozen screen]... Yes, it was written on
the 3 January, the reference number confirms that i t
156 was actually written -- typed up on 3 January. So it
was -- it has to have been in anticipation of
starting.
I can't think why else I would have prepared
that document at that stage ...[frozen screen]...
|
46,199 | 333 | QUESTION:
An alternative explanation could be -- sorry, you'r e
frozen, Dr Lloyd, so I'll just wait until --
ANSWER:
-- following on -- sorry.
|
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