Unnamed: 0 int64 0 47k | index int64 0 357 | q_a stringlengths 22 51.4k ⌀ |
|---|---|---|
45,700 | 320 | QUESTION:
Yes.
ANSWER:
Um ... maybe in some -- I don't -- I don't know how to
answer that question.
|
45,701 | 320 | QUESTION:
No smoke and mirrors here, that's the --
ANSWER:
That's the question.
|
45,702 | 320 | QUESTION:
If you're in the circumstances where it is unlikely
that this will ever be made into a --
ANSWER:
Well, it was made at the bio products laboratory, t hat
product. So they must have thought something posit ive
about it at that stage, in spite of the difficultie s
that we had with it. So maybe they thou... |
45,703 | 320 | QUESTION:
Do I take it from your answer that you were trying now
to help us by looking back and thinking what the
thinking might have been, but you weren't actually --
you're not able to say what you yourself thought at
the time?
ANSWER:
Yes.
|
45,704 | 320 | QUESTION:
I should say, out of fairness, that we looked at th e
1983-1985 business plan and, as we discussed during
the presentation, the door was not being closed
absolutely on Factor VIII through polyelectrolyte
fractionation, although there were concerns about h ow
feasible it was going to be.
ANSWER:
Mm.
|
45,705 | 320 | QUESTION:
We know that the initial application was turned dow n,
and I referred to a meeting that you attended on
2 June 1983. If we could have that on screen, plea se,
Soumik. It's IPS --
ANSWER:
That wasn't the same product.
|
45,706 | 320 | QUESTION:
Ah. If we bring it up on screen, perhaps you can
assist us with it. IPSN0000165_109, please.
ANSWER:
Yeah.
171 |
45,707 | 320 | QUESTION:
So this is a meeting on 2 June 1983.
ANSWER:
Yeah.
|
45,708 | 320 | QUESTION:
Then "source of cryoprecipitate"?
ANSWER:
Which was this Alpha cryoprecipitate, which was bei ng
bought in 100-kilo lots -- was it 100-kilo lots -- in
large lots, as a frozen cryoprecipitate, to make -- to
try to make Mono Factor |
45,709 | 320 | QUESTION:
Yes, I think we're at slightly cross purposes.
ANSWER:
Oh right, okay.
|
45,710 | 320 | QUESTION:
So the paper I referred you to earlier, which you
co-wrote with Dr Lane, et cetera, et cetera, and
Dr Tuddenham, that was a product that was made in
Elstree --
ANSWER:
In Elstree, yes.
|
45,711 | 320 | QUESTION:
-- and that was used, as you said, on three
patients --
ANSWER:
And one von Willebrand's.
|
45,712 | 320 | QUESTION:
-- with haemophilia A and one von Willebrand's
patient.
ANSWER:
Yes.
172 |
45,713 | 320 | QUESTION:
This is different. This is the application for the
clinical trial --
ANSWER:
Yes.
|
45,714 | 320 | QUESTION:
-- which was made at some point in 1982?
ANSWER:
Yes.
|
45,715 | 320 | QUESTION:
That was what I was discussing with you a moment ag o?
ANSWER:
Yes, yes.
|
45,716 | 320 | QUESTION:
Why it was that there was an attempt to have
a clinical trial at that stage.
ANSWER:
Oh, from this -- yes.
|
45,717 | 320 | QUESTION:
The idea was that the material -- the
cryoprecipitate would come up in from Alpha, and th en
you would fractionate it --
73 ANSWER:
It was a frozen paste that you re-suspended. We
did -- I did do some work with it. It was a frozen
past... |
45,718 | 320 | QUESTION:
I'd like to just look at what was to said at this
meeting. There was you and Anne Walton from Speywo od?
ANSWER:
Yes.
|
45,719 | 320 | QUESTION:
The note is by -- the initials are EAW. Is that An ne
Walton?
ANSWER:
Yes.
|
45,720 | 320 | QUESTION:
Who was Anne Walton?
ANSWER:
She was -- she did some marketing but she also focu sed
in on regulatory affairs.
|
45,721 | 320 | QUESTION:
Was she a scientist?
ANSWER:
Yes.
|
45,722 | 320 | QUESTION:
The participants from the DHSS, a Dr Fowler and
Dr Purves.
ANSWER:
Yes.
|
45,723 | 320 | QUESTION:
And if we could just look at the note and I'll read it
through to you.
"1. Dr Fowler was of the opinion that, despite
the controversy surrounding US imports as a result of
AIDS, our application will not be judged prejudicia lly
by the CSM if we pursue it with Alpha cryo cited as
source material. Ther... |
45,724 | 320 | QUESTION:
Would you or Anne Walton have been in a position to
make that observation? Do you think it's more like ly
to have come from the DHSS officials?
ANSWER:
I think it's more likely to have come from the DHSS
officials.
|
45,725 | 320 | QUESTION:
But the references to the source material choice be ing
"based on commercial and scientific grounds", as
opposed to what other grounds?
ANSWER:
Um ... as opposed, presumably, to citing the source of
the raw material. So in other words, it's coming f rom
the US. I don't know what else.
|
45,726 | 320 | QUESTION:
Are you able to assist us any further now about the
contents of that meeting and what was discussed at it?
Can you remember it at all?
ANSWER:
I can't remember it. I can't remember it very well at
all, no.
|
45,727 | 320 | QUESTION:
Do you know why it was that you were asked to go fr om
Speywood?
ANSWER:
Well, Anne would have set it up, and I would have g one
176 along because of being -- whenever that meeting was ,
still being chief scientist of Speywood. The most
experienced for the human Factor VIII.
|
45,728 | 320 | QUESTION:
Can you help us with whether or not a further
application was made for a clinical trial certifica te
on that product?
ANSWER:
I don't think it was.
|
45,729 | 320 | QUESTION:
Do you know why it wasn't pursued?
ANSWER:
No -- well, yes, I probably do, because I don't thi nk
there was anywhere to make it.
|
45,730 | 320 | QUESTION:
The facility that had been planned wasn't built?
ANSWER:
No. And I think at one stage it might even have be en
thought you could share the facility with porcine, but
that became a no-goer when -- because of virus
concerns, and it had to be separate.
|
45,731 | 320 | QUESTION:
That is something we saw with the business plan abo ut
the DHSS no longer allowing a multi-purpose site.
ANSWER:
Yes.
|
45,732 | 320 | QUESTION:
Looking back on human Factor VIII and polyelectroly te
fractionation, was this always a project that was
ultimately bound to fail, given the knowledge and
equipment and availability of material in the early
1980s, or were there any missed opportunities to ha ve
developed it further?
ANSWER:
Sorry, do yo... |
45,733 | 320 | QUESTION:
Yes.
ANSWER:
I don't think it was going to fly. It worked very
nicely for porcine Factor VIII.
|
45,734 | 320 | QUESTION:
But not for human?
ANSWER:
But not for human.
|
45,735 | 320 | QUESTION:
On recombinants -- I'm going to take this very
briefly, if I may -- your role was important but
limited in helping to provide the purified -- the
first step of the purification process?
ANSWER:
Yes.
|
45,736 | 320 | QUESTION:
And then passing that on to Dr Tuddenham and his te am
to work on thereafter?
ANSWER:
Yes.
|
45,737 | 320 | QUESTION:
Mr Heath's view that we heard earlier was that this
was something of a tragic failure by the UK to
capitalise upon the work that was done, because the --
ultimately the work was taken forward by Genentech,
an American company, and subsequently by other
American pharmaceutical companies as well?
ANSWER:
... |
45,738 | 320 | QUESTION:
Could I ask for your opinion on that view from
Mr Heath, and in particular upon the question of
whether, if other steps had been taken, it would ha ve
led to a quicker development of recombinant product s
or just a development by a British firm as opposed to
178 an American firm?
ANSWER:
I think what ... |
45,739 | 320 | QUESTION:
Ms Middleton, a few questions from some of the
Core Participants that I've been invited to ask you .
This means we're going to jump rather from one topi c
to another.
ANSWER:
Yes, okay.
|
45,740 | 320 | QUESTION:
Starting with your time still in Scotland, and the
reference that you made to a colleague sadly dying of
hepatitis B, were any changes made to the way you
operated in response to that death?
ANSWER:
Um ... immediately, yes, we did become much more
aware, I think, of the potential problems with the
plas... |
45,741 | 320 | QUESTION:
Do I understand from that answer that the colleague
was somebody who worked within the Edinburgh Royal
Infirmary rather than within the PFC?
ANSWER:
Yes, she wasn't in the PFC, she was in the Royal
Infirmary. But in the same sort of department, blo od
transfusion.
|
45,742 | 320 | QUESTION:
Do you know if the accident and the death was notif ied
to any public health body?
ANSWER:
I'm sure it was. It was a prick. It was an
accidental prick with a needle, which was, you know ,
tiny, but yeah, that's what happened.
|
45,743 | 320 | QUESTION:
Staying with your time in Scotland, and moving to
Glasgow, do you recall if the blood that you were
dealing with, which was taken from patients with
haemophilia, was marked as being high risk?
ANSWER:
I don't think it was.
|
45,744 | 320 | QUESTION:
Do you remember if any particular procedures were i n
place for how you dealt with and handled that blood ?
ANSWER:
No, I don't think so.
183 |
45,745 | 320 | QUESTION:
I am going to -- this is a document that you haven' t
seen and I don't think is on our system, so I'm jus t
going to read a short passage to you. It comes fro m
a meeting in May 1985, a meeting in Scotland of the
Scottish National Blood Transfusion Service. And i t
refers to a request that has come fro... |
45,746 | 320 | QUESTION:
First of all, do you have any recollection of makin g
such a request?
ANSWER:
I don't, but I do remember the project, so ...
|
45,747 | 320 | QUESTION:
Could you explain what that project was?
ANSWER:
The project was to use monoclonal antibodies, the o nes
developed at the Royal Free, to make
a Factor VIII-deficient plasma. Factor VIII-defici ent
184 plasmas from haemophiliacs were used as reagents to
test for the potency of a Factor VIII concentrate.... |
45,748 | 320 | QUESTION:
In order to create assays?
ANSWER:
To use for assays.
|
45,749 | 320 | QUESTION:
So everybody has the reference, it's PRSE0004075, a nd
the minutes record that it was considered not
appropriate to provide the material because there w as
no surplus at the time.
ANSWER:
Right.
|
45,750 | 320 | QUESTION:
Do you know if you were able to obtain an equivalen t
material from elsewhere?
ANSWER:
I did get some from somewhere. I bought some from
somewhere. But it wasn't the United States. I'm n ot
quite sure. It can't have been English, British --
I don't know where it -- (overspeaking) --
|
45,751 | 320 | QUESTION:
Because it was commercial?
ANSWER:
It must have been commercial.
|
45,752 | 320 | QUESTION:
And your desire was to avoid the material coming fr om
the United States because of perceived risk of
HTLV-III?
85 ANSWER:
Well, it was to come from -- there was no point in
doing it unless it came from a clean source. And
I can't recall ... |
45,753 | 320 | QUESTION:
Moving on to a different topic, was there any
discussion about proposed research concerning AIDS,
HIV, HTLV-III, at Speywood during your time there?
ANSWER:
Not AIDS, no. I think AIDS and HIV were only reall y
identified -- started to be identified in '82, '83.
|
45,754 | 320 | QUESTION:
But Speywood wasn't involved in any --
ANSWER:
No.
|
45,755 | 320 | QUESTION:
Specific projects that tried to address the risk of --
ANSWER:
No.
|
45,756 | 320 | QUESTION:
-- HIV, HTLV-III, et cetera?
ANSWER:
No.
|
45,757 | 320 | QUESTION:
Further question. How much of your work, either at
the PFC or at Speywood, informed by a knowledge of the
different severities of haemophilia in patients, mi ld,
moderate and severe haemophilia?
ANSWER:
Um, I'm not sure I understand the question. We wer e
making concentrates to treat haemophilia, what... |
45,758 | 320 | QUESTION:
But were you aware of the distinctions between --
ANSWER:
Yes.
|
45,759 | 320 | QUESTION:
-- mild, moderate and severe?
ANSWER:
Yes.
|
45,760 | 320 | QUESTION:
Does it come back to the fact that your role as
a scientist was to seek to make the product --
ANSWER:
Yes.
|
45,761 | 320 | QUESTION:
-- and not to decide how it should be used by the
clinician --
ANSWER:
Yes.
|
45,762 | 320 | QUESTION:
-- and the patient?
ANSWER:
Yes, yes. Although in discussions with the
clinicians -- because we were very close to the
clinical use, particularly in the UK -- we did get to
learn about what people were doing, what clinicians
were doing for treatment, et cetera.
|
45,763 | 320 | QUESTION:
Ms Middleton, with all of our witnesses, we ask
at the end if there is anything else that you wish to
say in your evidence.
ANSWER:
Um, no, I don't think so. Thank you.
|
45,764 | 321 | null |
45,765 | 322 | null |
45,766 | 323 | null |
45,767 | 324 | null |
45,768 | 325 | null |
45,769 | 326 | QUESTION:
MS SCOTT:ANSWER:
MS SCOTT: |
45,770 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,771 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,772 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,773 | 326 | QUESTION:
SIR BRIAN LANGSTAFF:ANSWER:
MS SCOTT: |
45,774 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,775 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,776 | 326 | QUESTION:
SIR BRIAN LANGSTAFF:ANSWER:
MS SCOTT: |
45,777 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,778 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,779 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,780 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,781 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,782 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,783 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,784 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,785 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,786 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,787 | 326 | QUESTION:
MS SCOTT:ANSWER:
SIR BRIAN LANGSTAFF: |
45,788 | 326 | QUESTION:
MS SCOTT:ANSWER:
CSA: |
45,789 | 326 | QUESTION:
"The Management Committee does not have within,
83
or available to
,
it, such
independent specialist and
other advice as was available within its predecessor
,
the Executive Committee of SNBTANSWER:
This lack of
professional expertise and clinical user involvement
is
considered by the Transfusion Dir... |
45,790 | 326 | QUESTION:
A.ANSWER:
A. |
45,791 | 326 | QUESTION:
This lack of
professional expertise and clinical user involvement
is
considered by the Transfusion Directors
to
be
a
retrograde step in the management of the service.
"5.
For some years before 1974
it
had been
planned that
a
small B
T
S Headquarters should take over
the duties of the
part-time
... |
45,792 | 326 | QUESTION:
A.ANSWER:
A. |
45,793 | 326 | QUESTION:
"
Then the proposal that's made for the future is
set out at paragraph 7:
"
It
is suggested that the service should
transfer to
a
Management Committee responsible to the
Secretary of State and having the following
membership
:
"
Chairman, appointed by Secretary of State
...
"
Transfusion Service National ... |
45,794 | 326 | QUESTION:
A.ANSWER:
SIR BRIAN LANGSTAFF: |
45,795 | 326 | QUESTION:
MS FRASER BUTLIN:ANSWER:
SIR BRIAN LANGSTAFF: |
45,796 | 326 | QUESTION:
SIR BRIAN LANGSTAFF:ANSWER:
MS FRASER BUTLIN: |
45,797 | 326 | QUESTION:
MS FRASER BUTLIN:ANSWER:
SIR BRIAN LANGSTAFF: |
45,798 | 326 | QUESTION:
SIR BRIAN LANGSTAFF:ANSWER:
MS FRASER BUTLIN: |
45,799 | 326 | QUESTION:
MS FRASER BUTLIN:ANSWER:
SIR BRIAN LANGSTAFF: |
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