Unnamed: 0 int64 0 47k | index int64 0 357 | q_a stringlengths 22 51.4k ⌀ |
|---|---|---|
46,300 | 336 | QUESTION:
Yes. We will see how this -- how it plays out
in the documents that follow, I won't take you to a ll
of them, is that the DHSS arrange the central
contract. They do so to try to take advantage of
economies of scale, and that is a contract with the
providers of Hemofil and Kryobulin. However, that is... |
46,301 | 336 | QUESTION:
I think, at least I read this as what would
later be described as high purity, intermediate pur ity
and --
ANSWER:
It might, however, mean extra
concentrated.
|
46,302 | 336 | QUESTION:
It --
ANSWER:
Just as one buys a bottle -- to use
a home-spun analogy -- a bottle of squash and then you
can get a smaller bottle, which is supposed to be
three times as concentrated.
|
46,303 | 336 | QUESTION:
It could mean that, sir. My -- I can't take you
to any document which shows this, but my sense is t hat
it is probably referring to what later becomes term ed
"purity". But I cannot be sure about that.
ANSWER:
Yes. I mean, if there's no other
document that helps, well, that's just a mystery an d... |
46,304 | 336 | QUESTION:
We can look into it and see if we can find
anything. The terminology in this period is a litt le
looser than it becomes later.
75 ANSWER:
Well, they knew what they meant.
|
46,305 | 336 | QUESTION:
They knew what they meant, yes. Certainly, the
sense is that there should be two forms of product,
one which will be for general use, as it were, and one
which is for a more specialised use.
ANSWER:
Yes.
|
46,306 | 336 | QUESTION:
The next meeting of note is on 20 July 1973.
I won't take you to the document, but it was a meet ing
of the Regional Transfusion Directors, which discus sed
the issue of domestic production, and considered
a paper, which is referred to in the written
presentation at paragraph 60.
At that meeting, it w... |
46,307 | 336 | QUESTION:
Well, again, the terminology isn't absolutely
clear. And it could mean -- sometimes BPL is used as
a term to cover both Elstree and Liberton. From th e
previous documents, the discussion was very much th at
you would need -- to provide self-sufficiency acros s
the UK, you need both. Both plants. A... |
46,308 | 336 | QUESTION:
Yes.
ANSWER:
Is there any description anywhere as
to how quality was to be assessed?
|
46,309 | 336 | QUESTION:
There isn't a single document, I think, that
sets that out. There is discussion in some of the
other meetings which really echoes what is said the re:
that the domestically made product is as good to us e
as the commercial products. Now, I have inferred f rom
that discussion that that is a reference... |
46,310 | 336 | QUESTION:
-- "the Meeting supported and wholeheartedly
endorsed the Appendix B Document [that is the MRC
report]. Again it was stressed that the estimates in
Appendix B are just for present but in five years'
time there may be a need for more material.
"ACTION . The Chairman agreed to write to the
DHSS saying... |
46,311 | 336 | QUESTION:
Yes, and that is an argument which is made
repeatedly in the papers by various people, includi ng
Dr Waiter.
ANSWER:
But, as you say, it cuts against the
principle of regional payment.
|
46,312 | 336 | QUESTION:
It does, sir. What we will see in the papers
that follow is that, in order to expand plasma supp ly
requires significant upfront capital costs and,
indeed, revenue costs that occur. Those will be
incurred upfront, and you won't get your plasma --
increased plasma supply until sometime afterwards
bec... |
46,313 | 336 | QUESTION:
Just to pick up on three things from this
morning, sir. First, SAMO stands for Senior
Administrative Medical Officer. Apologies. There' s
so many acronyms. Sometimes they slip through the
net.
7 ANSWER:
Well, I'm sorry couldn't hel... |
46,314 | 336 | QUESTION:
The second point, this question of potency and
purity. If we could have on screen, please,
WITN3431001, page 32. This is the witness statemen t
of Dr Snape from whom we will hear at the tail end of
this block of hearings. We'll have paragraph 90 wh en
it comes up. Page 32, paragraph 90. The contex... |
46,315 | 336 | QUESTION:
-- which, in Dr Snape's usage, will therefore be
98 a reference to the concentration in units of
Factor VIII per millilitre.
ANSWER:
It's the degree of concentration.
It's the -- my example of the concentrated squash o r
the concentrated washing up liquid.
|
46,316 | 336 | QUESTION:
Exactly, sir. Exactly so. The wider context of
that discussion is that 90 per cent of what may be
referred to as standard Factor VIII was required an d
10 per cent of the higher potency --
ANSWER:
He makes the point here that the two
might be linked, possibly, in this sense: that if y ou
are usi... |
46,317 | 336 | QUESTION:
Yes.
ANSWER:
-- which may (unclear) , by the way,
but they're there. So it is also going to be more
equivalent to higher purity although -- because
it's -- high purity refers to the amount of excess
protein that you get, doesn't it?
|
46,318 | 336 | QUESTION:
That is my understanding, that the two will be
closely related. A higher potency Factor VIII prod uct
may be an increasingly pure Factor VIII product.
ANSWER:
Yes, on the other scale.
|
46,319 | 336 | QUESTION:
Dr Snape I hope will be able to take us through
99 this --
ANSWER:
Well, he can tell us if that's
right, but thank you for that. It looks as though
there was a proper distinction to be made.
|
46,320 | 336 | QUESTION:
Yes.
ANSWER:
Thank you.
|
46,321 | 336 | QUESTION:
Finally, a measure that I didn't introduce
earlier but will introduce now. We looked at the M RC
paper, Dr Biggs' paper that was later enthusiastica lly
endorsed by various meetings and was recommended as
the basis for planning. That expressed the amount of
blood donations required as the measure for... |
46,322 | 336 | QUESTION:
It's PRSE0002350. Electronic page 18, internal
page 17. Perhaps, actually, we will bring it up,
Paul.
PRSE0002350. Electronic page 18. We can see at
the top there the figure that we discussed earlier,
547,540 to 750,000 blood donations per annum. If w e
go down a few lines, it says:
"Expressed a... |
46,323 | 336 | QUESTION:
We will see increasingly, as the '70s goes on,
the measure of blood donations is dropped in favour of
weight or volume for the amount of plasma and
international units for the amount of Factor VIII t hat
is produced. This is a translation between the two
presented by Dr Biggs. There are various ways... |
46,324 | 336 | QUESTION:
The conversion that I have found, and I stress
this is a layman essentially looking online to try to
find the conversion, I think it's in the region of
1.024 kilograms.
ANSWER:
Thank you.
|
46,325 | 336 | QUESTION:
But there will be others who are far better
placed to be able to make that conversion.
ANSWER:
So it's very close to a kilogram
being equivalent to a litre.
|
46,326 | 336 | QUESTION:
You will see in appendix 1 and appendix 2 when
the Inquiry legal team have had to do that calculat ion
in order to be able to compare data points, the
conversion used is 1:1.
ANSWER:
Yes.
|
46,327 | 336 | QUESTION:
But it is stressed that that is a rough
approximation. And as we will hear when we come on to
look at those figures, they come with a lot of
caveats, the core of which is that they are helpful in
showing a general trend but they shouldn't be relie d
upon to be absolutely precise at all points as to... |
46,328 | 336 | QUESTION:
Yes. There are so many variables, it is never
going to be possible to say this figure is exactly
this figure in equivalence.
ANSWER:
You'd expect the donations to
approximate if there are enough of them in a pool, to
a hundred per cent activity, that being the average ,
but you don't know.
|
46,329 | 336 | QUESTION:
Exactly, sir.
ANSWER:
I see.
|
46,330 | 336 | QUESTION:
Returning, then, sir, to the chronology. The
tension that we were exploring before the break was
between the DHSS and the Regional Health Authoritie s
about who was going to fund the expansion of plasma
supply.
There was also a tension that was growing
between clinicians and the DHSS, and no doubt wit... |
46,331 | 336 | QUESTION:
From memory, and I stress it is from memory,
I think it was Factorate, Armour's Factorate, which
came on to the market third.
ANSWER:
Factorate. Because Profilate came
later?
|
46,332 | 336 | QUESTION:
Yes, I will check on that.
ANSWER:
Because I thought the date of that
was after '74 but, plainly, that's a mis-memory on my
part.
|
46,333 | 336 | QUESTION:
Well, the licence, I think, was after '74 but it
was provided off licence on a named-patient basis.
ANSWER:
Well, that would be so of any
product.
13 |
46,334 | 336 | QUESTION:
Yes, yes. My recollection, I will check it over
the break or overnight, is that Factorate is the th ird
product that enters the market, and rapidly --
ANSWER:
But it may not be the third she was
referring to, if she was talking about named-patien t
basis.
|
46,335 | 336 | QUESTION:
It may not be. But, again, my recollection from
last autumn is that Factorate pretty quickly
establishes a very strong market position, partly
because it's cheaper. So it may well be that
Factorate is the one that she is referring to.
Dr Owen, in his reply there doesn't seek to
rebuff the central c... |
46,336 | 336 | QUESTION:
I can look back, sir. I will look at the letter
and see if there is anything else that can tell us
which product she is referring to.
ANSWER:
Thank you.
|
46,337 | 336 | QUESTION:
Dr Owen, in his response then, not seeking to
deny the central charges that Dr Biggs had made in her
letter, and seeming to accept that the question of how
114 great a number of concentrates can be provided, is
tied heavily with how much domestic supply can be
increased, and that is the question for ... |
46,338 | 336 | QUESTION:
That is my understanding as well.
ANSWER:
So this is not setting up something
which is a contradiction.
|
46,339 | 336 | QUESTION:
No.
ANSWER:
It's basically saying we need more
plasma because it will serve these various differen t
needs.
|
46,340 | 336 | QUESTION:
That's right, and we will see later under
a group called the Working Party on Trends, they're
17 trying to work out how much plasma is needed to be
fractionated. The measure that they take is the
amount needed for albumin, and they say, "... |
46,341 | 336 | QUESTION:
That's right. And, indeed, for other blood
components as well. And you may remember Dr Walfor d,
when she was discussing the arguments about reverti ng
to cryoprecipitate, drew attention to Dr Lane's
statement, something that we will look at in due
course, where he said: if you are going to revert t... |
46,342 | 336 | QUESTION:
Returning to the document at point (c), and this
is the third of Dr Maycock's factors that are causi ng
118 difficulties for the NBTS, he says, and I quote:
"The need to depend, at least temporarily, upon
supplies of AHG concentrate and possibly PPF [that' s
protein plasma fraction] from commercial s... |
46,343 | 336 | QUESTION:
Sir, before turning to how the £500,000 was
spent, just a couple of points that we have checked
over the break.
The first refers to the point that you raised
from Dr Biggs' letter to The Lancet, where she said
that three commercial companies are now licensed to
sell good quality human Factor VIII in thi... |
46,344 | 336 | QUESTION:
Yes, sir.
ANSWER:
And it's a shame she's not available
to us to explain.
|
46,345 | 336 | QUESTION:
Yes. What I would say is from the documents
144 that we looked at in November, when Dr Walford come s
in the early '80s to try to tot up who was providin g
which products, those are the products that she ref ers
to. There is no other licensed product within the
United Kingdom that she is referring ... |
46,346 | 336 | QUESTION:
I'm afraid I can't assist more than that at the
moment.
ANSWER:
There will be perhaps some
indication given if we looked at the UKHCDO returns
and saw what was on their list, if they had a list at
that stage, for the different sorts of concentrates
because they did have pretty early on a list, didn'... |
46,347 | 336 | QUESTION:
I believe so. There is ongoing work trying to
put together all of the returns and interrogate the m
in order to provide some useful data for you. We w ill
feed this question into that.
ANSWER:
It doesn't -- this particular little
point, it's intriguing, but it doesn't actually aff ect
your presen... |
46,348 | 336 | QUESTION:
No, it doesn't. No.
A second point concerns Hansard references. The
Inquiry legal team, as I said, had identified the
question that was posed of Dr Owen following Dr Big gs'
45 letter as the first Hansard extract that we had fou nd
tha... |
46,349 | 336 | QUESTION:
It could do, sir. I'm afraid I cannot go any
further beyond that Hansard answer.
ANSWER:
Yes, but at least there is an
answer, and there is something about that, so I'm
grateful to Collins for having pointed that out.
|
46,350 | 336 | QUESTION:
Turning, then, to the £500,000. Appendix 3 to
the main presentation is a detailed analysis prepar ed
by the Inquiry legal team on how that money was spe nt.
And it is a centre-by-centre analysis at points.
I'm not going to take you to all of the
documents in that, or indeed take you to the
substanti... |
46,351 | 336 | QUESTION:
He's answering purely for England and Wales
because that is his departmental responsible for th e
DHSS. What is slightly unclear is whether or not
these answers cover Northern Ireland as well, but I 'm
afraid I can't assist on that.
The amount allocated to PFL and BPL in England
in 1978 to 1979 was ... |
46,352 | 337 | null |
46,353 | 338 | null |
46,354 | 339 | null |
46,355 | 340 | null |
46,356 | 341 | QUESTION:
Then between 1994 and 1996, you were a research
2registrar at the Public Health Laboratory Service,
which I'm going to call the PHLS, Communicable Dise ase
Surveillance Centre. Broadly, what did that
organisation do?
ANSWER:
Well, we were a public health protection service fo r
England, and I was wo... |
46,357 | 341 | QUESTION:
And in 1996 you received an MSc from the London Sch ool
of Hygiene and Tropical Medicine and took up a post as
senior registrar still at the PHLS.
ANSWER:
Yes. They have a training programme.
|
46,358 | 341 | QUESTION:
In 1999 you became a faculty of public health,
becoming a fellow in 2008. Is that the organisatio n
that sets the standards for training, examination a nd
specialist practice?
ANSWER:
That's our professional body.
3 |
46,359 | 341 | QUESTION:
Professional body for public health specialists.
Then in 1999 you were seconded from the PHLS to
take up a role at the Department of Health as Senio r
Medical Officer for the environmental transmission of
infection unit; is that right?
ANSWER:
Yes. So I think I was coming to the end of my
training, an... |
46,360 | 341 | QUESTION:
By November 2000 you had become the Senior Medical
Officer at the CJD policy unit at the Department of
Health, again seconded from the PHLS.
ANSWER:
That's correct.
|
46,361 | 341 | QUESTION:
What was your role as Senior Medical Officer in the
CJD policy unit?
ANSWER:
Supporting the team there involved in running vario us
committees that they ran and giving advice. To be
honest, I found it quite hard to remember exactly w hat
my role was now. It's about 20 years ago. But
looking at the do... |
46,362 | 341 | QUESTION:
So it looks again from the documentation as though you
were a member during that period. So November 2000 to
February 2002, you were a member of the Department of
4Health Medical Research Council Research Advisory
Group on TSEs?
ANSWER:
It's more likely that I was being an official rathe r
than a me... |
46,363 | 341 | QUESTION:
And an official -- what's the status of an official ?
ANSWER:
Attending meetings, writing minutes, making notes,
communicating the decisions to other members of the
policy team.
|
46,364 | 341 | QUESTION:
Then you are noted as being an observer on the
Advisory Committee on Dangerous Pathogens Working
Group on TSEs. Is that a similar role to an offici al?
ANSWER:
Yes.
|
46,365 | 341 | QUESTION:
And you are again recorded in minutes as being
a technical adviser to SEAC. Is that a different
role?
ANSWER:
Yes -- well, I'm just trying to think. I mean, aga in,
it's hard without seeing the paperwork to remember
exactly what I was doing, but it might have been
things like helping prepare papers fo... |
46,366 | 341 | QUESTION:
And then you are also described as an official in
minutes of the Chief Medical Officer's SEAC
epidemiology subgroup?
ANSWER:
Yes. I mean, it's all the same kind of supportive
role.
|
46,367 | 341 | QUESTION:
Supportive role. So not in a decision-making role but
in a supportive role. So either the secretariat or to
the groups themselves.
ANSWER:
Yes.
|
46,368 | 341 | QUESTION:
Then in March 2002 you took up your role as head of
the CJD team, presumably first at the PHLS, and the n
in 2003 when the HPA was formed -- the HPA being th e
Health Protection Agency -- you continued in that r ole
as head of the CJD team at the Health Protection
Agency.
ANSWER:
That's correct.
|
46,369 | 341 | QUESTION:
And you were, at that stage, a consultant
epidemiologist.
ANSWER:
That's correct.
|
46,370 | 341 | QUESTION:
And you remained in that role until May 2012.
ANSWER:
Yes.
|
46,371 | 341 | QUESTION:
So just pausing there in your CV to ask you some
questions about the Health Protection Agency.
You've told us that it then became Public Health
England, and then Public Health England has now bec ome
the UK Health Security Agency. So you have referre d
to those as PHE and UKHSANSWER:
|
46,372 | 341 | QUESTION:
So that's what that stands for, is it?
ANSWER:
Yes.
|
46,373 | 341 | QUESTION:
Was the -- geographically, in terms of the four
nations, what was the remit of the Health Protectio n
Agency?
ANSWER:
England.
|
46,374 | 341 | QUESTION:
And what were the equivalent organisations in
Scotland?
ANSWER:
We worked -- it was then -- we worked with SCIEH,
Scottish -- I can't remember exactly what it stands
for. But, again, infectious, epidemiology, health.
I can't remember what the actual acronym stood for.
Now it's, I think, Health Protection ... |
46,375 | 341 | QUESTION:
So they were equivalent to agencies in those --
ANSWER:
I was just trying to think whether our remit covere d
Wales at any time. I think we were always working
with Wales. It's hard for me to remember exact rem its
of the different organisations.
|
46,376 | 341 | QUESTION:
And the purpose of the Health Protection Agency?
ANSWER:
I'm trying to think how it changed. At which point
we -- I think it was still pretty much the same, an d
I think it was when we became PHE that it became
a much broader remit, including non-infectious
7diseases.
|
46,377 | 341 | QUESTION:
So the description you gave us in relation to PHLS
applies equally to the Health Protection Agency.
ANSWER:
From our perspective, yes.
|
46,378 | 341 | QUESTION:
And I understand that the Health Protection Agency was
what's called a non-departmental public body. So i s
this right: it wasn't actually part of the Departme nt
of Health, but it was funded by the Department of
Health?
ANSWER:
I don't want to give you incorrect information, so it
would have to be in... |
46,379 | 341 | QUESTION:
And so is it right to understand that you received
instructions from the Department of Health to carry
out some task? For example, a notification exercis e.
ANSWER:
Okay, so I think that you're talking about -- is th e
relationship between also the CJD Incidents Panel a nd
the Department of Health becau... |
46,380 | 341 | QUESTION:
So that would come through the Chief Medical Office r
or the Department of Health through -- accepting th e
recommendation or advice of the Panel. And then wh o
would instruct the Health Protection Agency? The
Panel or the Department of Health or if you don't
know --
ANSWER:
I think it may have been... |
46,381 | 341 | QUESTION:
It may become clearer as we look through some of th e
documents; it may not.
Returning then to look at what your team were
doing, the CJD team. What was the remit of your te am?
ANSWER:
Okay, there were different pieces of work going on, so
part of it, what I was doing, was we were providing ... |
46,382 | 341 | QUESTION:
We will come and we will be looking later this morn ing
at some of the documentation that relates to, for
example, following up those that were at risk in th e
community from CJD.
In terms of the prevalence work, is it right
that the Health Protection Agency set up the tonsil lar
and appendix tissue na... |
46,383 | 341 | QUESTION:
Was that headed up by your colleague Professor Gill ?
ANSWER:
Yes, so Noel Gill, and I think Kate Soldan was also
involved with those, as well as more junior members of
the team.
|
46,384 | 341 | QUESTION:
Can you give us an idea of the size of the team.
ANSWER:
Okay. So I think it might be a bit more confusing
than otherwise, just because I kept having -- it wa s
at the stage when I was doing maternity leave and
child care stuff, so people were covering for me, b ut
in essence there was myself and there... |
46,385 | 341 | QUESTION:
Then in May 2012 you took up a post as a consultant
epidemiologist at the HIV and STI (sexually
transmitted infection) division of the HPA?
ANSWER:
Well, yes, it's actually -- I had the same post. S o
11 I took the -- got the consultant post in CJD, and
I just moved responsibility. So the CJD team was... |
46,386 | 341 | QUESTION:
And that's a post you hold --
ANSWER:
That's the same post I'm in.
|
46,387 | 341 | QUESTION:
-- today.
So, I'm going to ask you some questions now
about the notification exercise, and we heard quite
a lot of evidence about that yesterday. I just wan t
to understand the division of responsibility, insof ar
as you understand it, between the Panel, the Health
Protection Agency and the Department o... |
46,388 | 341 | QUESTION:
Then it was for the Department of Health to accept or
not accept that advice?
ANSWER:
Yes.
|
46,389 | 341 | QUESTION:
We know that they did accept that advice?
ANSWER:
Yes.
|
46,390 | 341 | QUESTION:
Then it was for the Health Protection Agency to put
12 into effect that decision, that notification, to
effectively coordinate it and deliver it?
ANSWER:
Yes.
|
46,391 | 341 | QUESTION:
And in terms of authoring documentation, working ou t
how the process is actually going to work, the nuts
and bolts of it, was that led by the Health Protect ion
Agency or led by the Panel, can you recall?
ANSWER:
I think we would be -- we generally -- so are you
talking specifically about the haemophili... |
46,392 | 341 | QUESTION:
I'm talking generally now.
ANSWER:
Okay. We would have been the people coordinating w hat
should -- how to do it, but we would work very clos ely
with members of the Panel. So, I mean, I can comme nt
on yesterday if you -- if that helps, I don't know?
I mean, so, for example, in creating some of the
... |
46,393 | 341 | QUESTION:
Equally, you didn't have the -- you weren't sitting in
the full Panel, CJDIP meetings going through, line by
line, the toolkits, but you were going off and
doing -- getting advice and help from people outsid e
the Panel meetings and so on --
ANSWER:
I can't remember whether we sent drafts to the Pane ... |
46,394 | 341 | QUESTION:
Just in terms of trying to understand the time fram es
in which everything was taking place, we heard from
Professor Ironside that there was a period of
consultation in October 2001, and we know from the
papers, which we can go to if necessary, that the
framework document was provided to the Chief Medica... |
46,395 | 341 | QUESTION:
October --
ANSWER:
So the secretariat was still within the Department of
Health at that stage or had it moved over?
|
46,396 | 341 | QUESTION:
I don't know the answer to that actually.
ANSWER:
Given that the CMO set up the Panel, maybe that was
an expectation, that the Government would approve i t.
In a way you could -- I was thinking that in some w ays
it is a bit like the Covid response you can see now ,
that here is a recommendation to take... |
46,397 | 341 | QUESTION:
And we -- again, we can go to the documents if
necessary but the Inquiry -- I know you have looked at
some of the CJDIP annual reports which set out that
the four CMOs responded to the proposals in the
framework document in June 2003. Does that ring
a bell with you?
ANSWER:
I'm sure if it is in the a... |
46,398 | 341 | QUESTION:
Then, the framework document was published. And
I suggested to Professor Ironside that it was in
December 2003 but, having looked again at the annua l
reports from the Panel, it looks like it was
March 2004. Again, does that period of -- does tha t
sound right to you?
ANSWER:
I'm in the same boat as ... |
46,399 | 341 | QUESTION:
Yes. And certainly with Professor Ironside we look ed
at a version that was dated December 2003, but --
ANSWER:
Mm.
|
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