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46,400 | 341 | QUESTION:
Yes.
I'm going to take you to a meeting of a minute
from March 2001 to try to understand your evidence
about what happened in that interim period between the
Panel being set up and the framework agreement bein g
published in, looks like, March 2004.
So it is DHSC0020723_087.
Now, this is a "DRAFT Minute of Meeting to
Discuss Incident Number PI37 (Incident Involving Bl ood
and Blood Products)" from 26 March 2001, and we can
see that you are, at the bottom there, listed as th e
7 Panel Secretariat.
Now, it is not entirely clear from this whether
or not this is a CJD Incident Panel meeting, but is it
right that that is a -- the PI37 is a Panel referen ce
and those people attending, certainly the chair and so
on, were members of the Panel, or some of them were
members of the Panel?
ANSWER:
Yes, it looks like a subgroup or something, althoug h
it is only a draft minute, I see, so it is not a fi nal
minute.
|
46,401 | 341 | QUESTION:
If we look at paragraph 2 we can see why the meetin g
has been called and what the incident is. It is:
"The incident [involving] blood products derived
from pooled plasma, which ... [was] donated in 1996
and 1997 by a person who later developed vCJD. The
possible size of the cohort could be up to
40,000 patients."
And a query about whether or not the donor's
blood may have been used in labile blood components ,
but that hadn't yet been confirmed.
Then if we go, please, to paragraph 5 over the
page.
We can see that the current NBA policy is set
out, NBA being the National Blood Agency (sic). Th ey
consider it "ethically unacceptable to take a donat ion
18 knowing that it will be discarded". So if someone
presents to donate blood, not accepted as a donor,
they'd have to be told why. And it says:
"At present, pending guidance from the Panel,
the NBA has a list of names of individuals who have
been identified as recipients of blood components
originating from donors who have later developed vC JD.
These individuals have not been informed of the
situation, but it was considered wise to ensure tha t,
if any of these individuals presented as donors, th eir
donation would not be issued for use."
Dr Hewitt gave the Inquiry evidence in relation
to that issue.
Then this meeting seems to be -- although it is
not entirely clear from the minutes -- discussing t he
interim guidance from the Deputy Chief Medical
Officer, and we can see at the bottom of this page:
"Conclusions to be taken into the draft
guidance.
"10. It was explained that, based on
epidemiological evidence, fractionated blood
(ie plasma products) would have only a low risk/lev el
of infectivity. It could also be hard to identify all
recipients of fractionated blood, as tracking was n ot
necessarily in place for this product.
19 "11. Whole blood and blood components were not
considered to be of a low level of risk."
Then if we go over the page we can see, at the
bottom there, there is a heading "Comments on the
draft letter from the Deputy Chief Medical Officer" ,
and a range of comments are made in relation to tha t.
Then "Summary of Action Points" at the bottom,
the second one down:
"Charles Lister to re-draft letter from
Dr Pat Troop."
Now, it is not entirely clear what's going on in
this minute but what I wanted to ask you arising fr om
this is two -- on two issues.
First of all, it looks like in this meeting
there is a discussion about interim guidance being
drafted by the Deputy Chief Medical Officer, and yo u,
I understand, heard the evidence of Professor Irons ide
yesterday when we looked at that document.
He wasn't -- he couldn't recall discussions
about that document. Can you recall whether or not
such interim guidance was issued?
ANSWER:
I mean, it's so hard, I mean, because -- I mean, so
much of the way I was able to answer all of the
questions you've given me is because I've still got
access to all my documents because I still work in the
20 HIV and STI department, so I can see. But I don't
know because I don't have access to all the DH
documentation, so I -- you would have to ask someon e
within the DH what was done.
|
46,402 | 341 | QUESTION:
So you don't -- you have no recollection of that?
ANSWER:
No.
|
46,403 | 341 | QUESTION:
And then the second issue that I wanted to ask you
about was in relation to the conclusions that we
looked at on the previous page about the risk from
blood and blood components, so paragraph 11 there.
Paragraph 10, conclusions were that it was:
"... fractionated blood, (ie plasma products)
would only have a low risk/level of infectivity."
And then:
"Whole blood and blood components were not
considered to be of a low level of risk."
I wanted to ask you -- I wanted to take you to
another document and then ask you a question in
relation to that point. Could we look, please, at
SCGV0001019_073.
Now, this is a document we looked at with
Professor Collinge. It appears to be an informatio n
sheet for patients exposed to variant CJD through
blood components from the Health Protection Agency,
December 2003. It says:
1 "Why are you contacting me?
"A patient has been diagnosed with vCJD ...
probably caused by a blood transfusion. This patie nt
received blood donated by a person who later develo ped
vCJD. This is the first time that this has happene d.
"Some other people also donated blood before
they became ill with vCJD. You have received blood
donated by one of them."
So this appears to be the patient information
sent as part of that December 2003 notification to
those who had received implicated blood components.
And then what I wanted to ask you about was the
paragraph "Do I need to know about this?" It says
there:
"The risk appears to be very small, but it is
important that you know, even though this may
regrettably cause you anxiety."
Then a little bit later on down the page, it
says:
"Am I a risk to other people?
"There is a small possibility that vCJD could
have been passed on to you. If this has happened,
then likewise you could pass vCJD onto others in
certain circumstances."
Then it sets out the public health precautions
22 that should be taken.
In light of the meeting minute that we've just
looked at, do you know why the messaging in this
leaflet was as it was, that there was a low -- a sm all
risk it's identified as?
ANSWER:
Okay. So I became aware that you were interested i n
this issue when I saw Professor Collinge on Friday
doing his thing because that wasn't in my kind of
Rule 9 set of questions. But what I did after that
was I was trying to look at these -- what
information -- what records I could find about the
information that we'd sent out over the years to
patients or people who had been -- were being told
that they were at risk of CJD. And what I could se e
was from the 2003 notification, when there was one
possible transmission, the language used then was
very -- was changing as we -- as the evidence for
transmission grew and the second, third, fourth
transmissions came to light.
So, I mean, it would have been gone over
unbelievably carefully, the wording about how to do
this. It hadn't been done before, and people -- it 's
interesting because if you look at the framework
document, it does show the thinking of the Panel an d
not wanting to scare people witless and yet wanting to
23 get them to take a public health precaution. It wa s
a very difficult message to put across because peop le
were very -- the Panel was very aware, and we are a ll
very aware that this is very scary thing to tell
people. And so how do you put this in a -- how do you
actually write -- what words do you use was very
difficult, and people thought long and hard about i t.
And, you know -- so I was looking at that
thinking, "Okay. That's what we said at the time."
And you think, well, I can see by 2005, actually, t he
language had changed and, you know, then people wer e
saying -- so I think that was the balance that was
struck then, and it was felt right at the time, and as
evidence grew and what we know -- we changed the
message. That's all I can really say.
|
46,404 | 341 | QUESTION:
We'll come on to look at some of those later docume nts
in a moment.
But is it -- it's right to understand then that
the focus here was to ensure that those that were
being contacted would take public health
precautions -- don't donate blood, don't donate org ans
or tissues, and tell clinicians if you need surgery .
ANSWER:
Mm.
|
46,405 | 341 | QUESTION:
But the focus wasn't -- and I think this is what
Professor Collinge's concern was, was that the focu s
24 wasn't on ensuring that the patients understood tha t
they actually should probably go and have specialis t
referral, have -- and be under the clinical care of
somebody that knew about vCJD.
ANSWER:
Well, what was felt quite strongly was that it was
kind of: how do you support -- what's the best
mechanism of working really with this small group o f
patients? And many of them were very elderly, so
we've got people in their 70s, 80s, 90s, so -- and
some people -- you know, because we were liaising w ith
their GPs, we knew that some people were more
vulnerable than others, you know. So we agreed tha t
actually the GP should be the kind of holding
gatekeeper, as it were, so that we knew that some
patients -- or some of these -- they're not -- you
know, some people just wouldn't want to know and wo uld
have the right. In a way, that was kind of the
ethical discussions within the Panel to say: thank you
very much; I don't want to get referred.
So I think the discussions were very much going
to be via the GP, and those -- so we -- that was th e
kind of liaison, and that was the process that we
developed. So then we gave people contact details of
the Prion Unit and the Surveillance Unit, and the G Ps
were aware of it, but we didn't -- it was felt righ t
5 that patients could very much choose what they want ed
to do with this.
|
46,406 | 341 | QUESTION:
And so key to that strategy is that the GPs underst and
what the risk is and understand what vCJD is so the y
can give proper information and advice to their
patients; is that right?
ANSWER:
Yes. So we set up -- I mean, again, this came out --
it was something from -- that I think you were talk ing
about with -- I can't remember whether it was John
Collinge or James Ironside, but this: how do we
support people? So, obviously, the public health
members of the Panel were there. We have
a relationship. The way the organisation, HPA, is set
up is that we have a relationship with our local
public health teams, so they are local public healt h
consultants covering each area, and they will often
work with GPs on health protection issues and outbr eak
or whatever, so there's a -- that's the way we rela te.
And in addition to that, we set up this -- what
we called a cadre of experts. But, basically, I th ink
I sent it out to -- I think you've got the document
which was, basically, we had -- we developed this s ort
of virtual -- well, it wasn't virtual then. It was
a team of people from -- counsellors or nurses or
doctors from the Prion Unit, the Surveillance Unit.
26 We also worked with the Institute of Child Health
because they had experience through human growth
hormone, and we had GP -- we had a range of people who
were there also to support local teams.
|
46,407 | 341 | QUESTION:
And the document reference -- we don't need to look at
it -- which sets out the list of those people in th at
cadre of experts is PHEN0002466_003.
How was it anticipated that these experts would
be accessed by the GPs?
ANSWER:
They would come through us at Colindale, so -- beca use
we didn't want to sort of issue -- so -- well, ther e
are two ways, actually. If anyone -- any GP wanted to
directly contact the Prion Clinic or the Surveillan ce
Unit or us in Colindale, they could do so, and if t hey
wanted some sort of advice over the sort of
counselling or whatever particular questions that
a patient had or something, then we could put them in
the direction of this list of people that we had
access to.
|
46,408 | 341 | QUESTION:
And were the GPs informed that this list existed, t hat
this was a --
ANSWER:
I can't remember if that was established by the -- at
2003. I'm trying to think because the document
I found was, I think, from 2005, so I'm not sure. It
may have been something that we had more informally or
27 we just directed people to the units, but I'm not
sure -- I suspect it was a slightly later date just
because that's the date of the document that I saw.
|
46,409 | 341 | QUESTION:
Just for the transcript, the date of the document t hat
I read the URN out for is 22 July 2005.
Can I take you to a document from December 2003,
NCRU0000180_010. Now, this is an inter-office
memorandum, and it appears to be an inter-office
memorandum for the National CJD Research and
Surveillance Unit. So I know the Inquiry sent it t o
you, but presumably you hadn't seen this document
before the Inquiry sent it to you?
ANSWER:
Yes.
|
46,410 | 341 | QUESTION:
And it sets out -- it's from Richard Knight from th e
Surveillance Unit, and it sets out a record of the
details of a conversation that he had on
29 December from somebody who phoned to speak to
someone in the unit because she'd been informed --
she'd been notified that she was a recipient of vCJ D
blood and wanted to discuss the implications. And in
that first big paragraph there, she says:
"She told me that she had been asked to contact
her GP as a matter of some importance and eventuall y
had an appointment with a doctor that she had not s een
for seven years on Christmas Eve. This doctor told
28 her that she had received a blood transfusion from
somebody who had had variant CJD. She said that sh e
was informed that they did not know whether the don or
had had the disease when he donated and were not ab le
to give her a lot of information, although they
obviously tried quite hard to deal with the matter
sympathetically. When she asked what would happen
next, she was told that she would obviously ... hav e
to wait and see whether she developed the disease.
She obtained information as to the symptoms of vari ant
CJD and was a little bit concerned as she herself h ad
suffered from depression and also [had] some painfu l
symptoms in her legs. Following this, she said tha t
her legs became more painful, but she thought that
this was probably because she was worried. The new s
obviously cast a very bad shadow over the Christmas
period."
Then she goes on to say:
"She received a leaflet which was apparently
from the HPA, and the leaflet was dated December 20 03.
At the end of the leaflet, she stated that it simpl y
said if she wanted information, she could contact o ne
of four numbers. There was then a list, with the
National CJD Surveillance Unit at the top, the
Department of Health second, the CJD Support Networ k
9 third, and the MRC Prion Unit fourth. She decided to
contact ourselves because our unit was at the head of
the list."
Then he goes on to say that he spoke to her at
some length, and he raises a number of issues:
"If recipients are to be told about their
previous transfusion risk, I think they should have
some organised method of follow-up discussion.
"I would have thought that the National Blood
Authority would have provided some form of organise d
access to information and discussion."
Over the page:
"In my view, such further discussion is best
undertaken face to face and not over the phone.
"... is ... best undertaken when ... some
background information about the individual concern ed,
including of course the reason why they had blood
transfusion and any other relevant past medical or
personal history.
"If we indeed are to be one of the principal
sources of help to such individuals, this has been
arranged as far as I'm aware without any consultati on
with us, and certainly I personally was not notifie d
of this in advance.
"Again, if we are to be involved, it would be
30 very helpful to have a copy of the leaflet that is
actually being given to these individuals so we cou ld
at least see what is being said in this. I persona lly
have never received such a document or seen it."
The next point is: it is all rather
unsatisfactory. Then at the bottom, he says:
"You will know that when the discussions about
notification first took place, I personally was in
favour of the policy not notifying individuals. Th is
was primarily on certain grounds of principle.
However, I did make a number of practical points, a nd
one of these was a concern as to whether or not pro per
follow-up discussions would be organised with
individuals who were notified. This recent contact
rather suggests that my concern was a reasonable on e."
Were you aware in December 2003 that this was
the position of the Research and Surveillance Unit,
that they hadn't been effectively -- weren't really on
board with how the notification process was going t o
operate and their part in it?
ANSWER:
I'm trying to think. So Bob Will and James Ironsid e
were members of the Panel I believe at that stage.
Richard Knight did become a member of the Panel, bu t
that may have been later on. I'm not sure. So it may
have been that some of them knew but not everyone
31 knew, and -- I mean, it's really bad, actually,
reading about that. I feel very sorry for the lady .
So I think -- yeah, obviously, you look at that and
you think, "Oh, gosh, we wanted to have done that
better," is actually my reaction to you hearing you
read all that out.
So Richard -- he didn't -- he wasn't in favour
of notifying individuals. Yeah, I mean -- so --
I don't know. I mean -- sorry, what's the question ?
|
46,411 | 341 | QUESTION:
The question I asked was whether you understood tha t
this was the position taken by the Research and
Surveillance Unit, and I think what you've told me is,
well, actually, there were two members of the Resea rch
and Surveillance Unit on the Panel, so -- and they
would have known what the position was.
ANSWER:
It's hard to believe. I mean, Hester Ward, Bob Wil l,
I mean, you know, it's hard to believe that they
didn't all know what was going on. I mean, I -- so --
I mean, the thing about that notification -- I thin k
it was driven by the fact that that's when Secretar y
of State made the announcement and that case was
identified shortly before Christmas. I mean, it's
always terribly -- you never want to do anything li ke
this over a Christmas period. It's not ideal in an y
way, and that would have been the reason, is that i t
32 was going to come out in the press and you had to t ell
people first.
In a way -- may I diverge to what you were
talking to James Ironside about yesterday, which wa s
the plasma product notification, which -- this idea
that you could sort of do it in a staggered way, bu t
it doesn't work like that because once things are o ut
in the press, people get terribly worried and terri bly
upset that they haven't been told by their doctor. So
you have to -- however difficult it is, you have to
make sure that you've had that contact with people
before things get into the media, otherwise it beco mes
even worse, and then people get worried that they
haven't been told and why weren't they told.
|
46,412 | 341 | QUESTION:
I'm going to now look at the further communications
with this patient group, so sticking with the group of
patients who were notified in December 2003 as
a result of having blood and blood components.
PHEN0002406.
So this is a letter from the Health Protection
Agency dated 6 February 2006 to a -- what looks lik e
a GP. And it's in relation to a patient, and it sa ys
this:
"It is now just over two years since this
patient was informed of their potential exposure to
3 vCJD via their blood transfusion in 1998 and of
certain precautions they are asked to take for publ ic
health purposes."
Then sets out what the purpose of the letter is:
"To give you fresh news on the risk that your
patient may develop variant CJD;
"Ask you for an update on the clinical status of
your patient;
"Advise you, and through your patient, of
an invitation for evaluation at the National Prion
Clinic (sent under separate cover), and other optio ns
for specialist evaluation, and to
"Inform you of proposals for research that your
patient may be asked to volunteer for.
"We have written to you previously about this
patient. If your practice is no longer responsible
for this patient, please would you let me know."
So just pausing there. Is it right to
understand from that last paragraph I've just read out
that there would have been communications between t he
December 2003 notification and this February 2006
correspondence with the GP surgeries of those that
were notified. Is that your understanding?
ANSWER:
I believe so because, yes, we would have contacted
them at least when -- that was in 2006 and 2004 --
34 yes -- I mean, I haven't got the chronology here.
I can see that was Kate Soldan's letter, so, yes, w e
would have been getting updates and --
|
46,413 | 341 | QUESTION:
Certainly, you carried out a -- you got some feedba ck
from the GPs following the notification, didn't you ?
ANSWER:
Yes. We wanted to ask them how it went.
|
46,414 | 341 | QUESTION:
And so we can see here that the multiple purposes o f
this letter, more news about the risk, and then 3 a nd
4, the issues that Professor Collinge had been
raising, is this right, that -- Professor Collinge
told us that he had been raising these issues with the
Department of Health and with the Health Protection
Agency, that he wanted to ensure that the patients
really understood what was available to them, and s o
was that a driver for this letter?
ANSWER:
Yes. We wanted -- and I think some ethics approval
had come through for other studies, so I'm sure the y
would have been in collaboration. We worked with J ohn
Collinge, but also within -- there was another
neurologist, Simon Mead, and his unit who we worked
quite closely. And we always had this issue of --
again, this balance of wanting to respect people's
autonomy and using -- therefore going through the G P,
and yet recognising that it was super important to
encourage people to have post-mortems and give samp les
35 and do everything else, but yet respecting their
wishes that they may just not want to; it's too sca ry
to go there kind of thing.
|
46,415 | 341 | QUESTION:
Then we see at the bottom of the page that informat ion
is given about the third case of vCJD infection, an d
right at the bottom that last sentence, it's messag ing
about the risk:
"This case further increases the level of
concern about the risk that variant CJD may have be en
transmitted to patients exposed to implicated blood ."
Then if we can go over the page, and we see
halfway down the page where it says:
"We believe it is now appropriate to ask you to
consider referring your patient for specialist
evaluation."
And sets out details of the National Prion
Clinic and makes it clear that the referral decisio n
form should be sent via you.
So the idea was if there was to be a specialist
referral to the National Prion Clinic, it would go
through the Health Protection Agency; is that right ?
ANSWER:
I think -- no. It was more that we wanted to know
what they were doing, and while we couldn't tell
them -- we weren't telling them to refer but that, in
our language, would be quite a strong recommendatio n,
36 and please let us know if you haven't and why not k ind
of thing.
|
46,416 | 341 | QUESTION:
Then a leaflet was sent with that, which we -- can we
look at, which is PHEN0002415_002.
So "Information for patients, February 2006",
and it sets out information for those patients who
have been informed by their doctor that they are at
risk from having blood transfusions.
Then if we go over the page, please, we can see
under "Why am I being contacted?", the second
paragraph there:
"Medical records show that you have received
a blood transfusion from a donor who later develope d
vCJD. It is therefore possible that vCJD could hav e
been passed on to you through your blood transfusio n."
If we go down to paragraph 4:
"Does this mean I'm going to suffer from vCJD?
"You have been identified as being 'at-risk' of
vCJD. This does not mean you will definitely devel op
vCJD. The risk of this happening is unknown.
"It is impossible to put an exact figure on the
chances of getting vCJD, either from BSE-infected b eef
and beef products, or the possible additional risk
from receiving a blood transfusion from a patient w ho
later develops vCJD. To date, three patients out o f
7 a relatively small group of patients who have been
transfused with blood from donors who later develop ed
vCJD have been found to have evidence of vCJD
'infection'. Two of these patients have developed
vCJD disease ..."
And go on to give the details in relation to
that.
So it is right to understand, is it, that the
messaging is changed by February 2006 from a small
risk to -- well, we don't know what the risk is but
these are the facts, that out of a small group so m any
have been infected.
ANSWER:
Yes.
|
46,417 | 341 | QUESTION:
Then there are other documents sent, and I'm not go ing
to go to them, I will just read them for the
transcript.
Another example of a document being sent by the
Health Protection Agency in January 2007, PHEN00024 65.
Correspondence sent in February 2011 about
Professor Collinge's direct detection assay, his
DDA test, PHEN0002385.
So the Health Protection Agency is keeping in
touch with these patients through their GPs, is tha t
how it worked?
I'm going to move, then, on to the
38 September 2004 notification, so the notification of
those with bleeding disorders and other patients wh o
had received plasma products.
Again, just to try to understand how that -- how
the process worked to begin with.
Can we look at DHSC6710801.
We heard a bit about this from
Professor Ironside. I don't want to go over that w ith
you but I want to ask you about the input from the
Department of Health, and so I want to show you at the
bottom half of this page we can see that this is
an email from Nathan Moore dated 23 July 2004 to
Professor Gill.
I'm not sure whether you have been copied in or
whether it is to you, it is a bit unclear, but I th ink
it is actually to you, rather than you being cc'd i n.
But it says this:
"We have received a response from Minister on
the plasma products submission.
"Minister has agreed ..."
Then it sets out the detail, so agreed:
"- to an 'umbrella' approach ..."
Then if we go over the page we can deal with
this quite quickly:
"- to informing clinicians treating people with
39 haemophilia ...
"- to informing people with haemophilia and
other bleeding disorders ...
"- to ensuring NHS traces implicated
products ...
"... communications strategy ..."
Then the minister makes a point then about there
not needing to be -- that the notification exercise
doesn't need to be put in the public domain by way of
a press release, and then "now ... [ensuring] that the
notification exercise moves forward as planned".
I just wanted to ask you about the fact that the
minister appears to be getting involved in the deta il
of how the notification exercise was undertaken. I s
that how you recall it?
ANSWER:
I actually don't remember this email. So, the only
thing that they are saying, really, is, "It is all
fine except for don't do a press release"; is that
right?
|
46,418 | 341 | QUESTION:
Yes, I think that's right.
ANSWER:
That would be -- I wouldn't -- that would be a sort
of -- yeah, the DH might well have that kind of thi ng.
Our press office and their press office would often
have discussions about lots of things, about who di d
a press release, what -- you know, how that -- the
40 sort of comms side of things worked --
|
46,419 | 341 | QUESTION:
So there's nothing -- (overspeaking) -- surprising
there to you?
ANSWER:
It sounds like a general -- what I can imagine is t hat
the official sort of said to them, "These are the
plans", and they are saying, "Yes, fine but just th is
little bit we don't want."
|
46,420 | 341 | QUESTION:
Can we then look at how -- the sort of mechanics of
the notification process by looking at the report t hat
the Health Protection Agency gave to the Panel abou t
the notification.
That's at WITN7091004.
Now we can see this is the report from the
Health Protection Agency, and it is not authored by
you, it is by Anna Molesworth and Angie Bone, and i t
is dated 19 January 2005, "Final report".
ANSWER:
So, Angie Bone, she's another public health doctor in
the team, and Anna Molesworth is a senior scientist
who has actually, I think, gone to the Surveillance
Unit. So, yeah.
|
46,421 | 341 | QUESTION:
Can we turn, please, to page 6, where the process i s
set out. If we can just run through the process.
So, this is how the HPA identified the process.
First of all:
"4.1. Identify vCJD cases who were blood
1 donors ..."
That was for the Surveillance Unit and the blood
services. Then:
"4.2. Trace blood donations and use of
components. Inform fractionators of implicated pla sma
sent to them ..."
That was for the blood services:
"4.3. Trace batches of plasma product made from
implicated plasma. Collate batch specific
manufacturing details (UK plasma fractionators).
"4.4. Estimate the potential infectivity of
each batch of implicated product and dose equivalen t
to 1% risk of vCJD infection ..."
And that's for the Health Protection Agency.
Then you set out there -- or you don't, but the HPA
sets out there how they have undertaken that exerci se.
Then the next action is:
"4.5. Identify patient groups likely to have
received sufficient product to be considered
'at-risk' ..."
Again, that's an action for the Health
Protection Agency, and it says there:
"Following the precautionary principle, the
entire period of possible exposure to vCJD through
plasma products was taken as 1980 (when BSE is thou ght
42 to have entered the human food chain in the UK) to
2001 (the last possible expiry date of any plasma
product manufactured using plasma that was sourced
from UK donors until 1998)."
Then, if we miss out the next paragraph we can
see that:
"By comparing the threshold doses of the
implicated batches equivalent to a potential 1% ris k
of vCJD infection with the range of doses recipient s
were likely to have received in clinical practice, the
patient groups likely to be affected were identifie d."
So that's identifying the patient groups, and
that was undertaken by the Health Protection Agency ,
is that right?
ANSWER:
Yes.
|
46,422 | 341 | QUESTION:
Then, if we carry on down the document we can see 4 .6:
"Stratify risk of implicated batches according
to the likelihood of a recipient crossing the
'at-risk' threshold."
So there the Panel -- the Panel's
recommendation -- and we went over this briefly wit h
Professor Ironside yesterday -- that implicated
products should be divided into: high-risk products ,
so those batches that should be traced and the
individual recipients considered at risk of vCJD fo r
43 public health purposes; medium-risk, where efforts
should be made to trace those batches and assess th e
potential additional risk to individual recipients to
determine if special precautions should be taken fo r
public health purposes; and low-risk product, where
those batches do not need to be traced and the
recipients do not need to be informed.
And then some detail is added in relation to
that.
Then the next action is at 4.7:
"Develop a strategy for the management of each
patient group ..."
And that's the Health Protection Agency and
SCIEH. What's --
ANSWER:
That is the Scottish equivalent of us.
|
46,423 | 341 | QUESTION:
So what's set out there is that:
"Patient group management strategies were
developed through negotiation with professional and
patient group representatives, with the aid of expe rt
opinion of condition-specific professional
representatives, the UK national blood services, an d
NHS Trust medical directors and pharmacists contact ed
through the HPA/CJD Incidents Panel network.
"Arrangements were made for each patient group
on the basis of:
44 "... likelihood of surpassing the 'at-risk'
threshold;
"- estimated numbers of patients possibly
affected ...
"- the feasibility of identifying which
batches ..."
The main patient groups are then identified and
from -- and they are: patients with bleeding
disorders; patients with primary immunodeficiencies ;
and other patients.
Then it sets out the arrangements for patients
with bleeding disorders. And we looked at this wit h
Professor Ironside, so I don't need to go into this in
any detail, but -- and you have already told us tha t
the UKHCDO and The Haemophilia Society were involve d
in the decision to have an umbrella notification fo r
all those patients with bleeding disorders who had
been treated with UK-sourced pooled factor
concentrates or antithrombin between 1980 and 2001,
because they should all be considered at risk and
asked to take public health precautions.
Then if we go over the page we can see the other
two groups, and I wanted to ask you about the third
group:
"4.7.3. Patients with other conditions."
5 "The remaining patients were cared for by
different specialities and without
a condition-specific professional organisation, whe re
treatment with plasma products may have been
'off-licence' and batch information may not have be en
as rigorously recorded as for the groups above.
"An estimate of the expected numbers who may be
considered 'at-risk' was not possible. The only wa y
for these individuals to be traced and their potent ial
exposure assessed was through the NHS hospital trus ts.
Informal feasibility studies by representatives of the
UK national blood services and SCIEH, and discussio ns
with medical directors and pharmacists suggested th at
there would be great variability in the ability of
Trusts to trace implicated batches to individual
patients and assess potential exposure.
"Despite the potential difficulties, it was
considered important that such efforts be made,
although only where batches were traceable and
recipients could be easily identified as having
received implicated batches would the trace-back
effort be considered proportionate to any possible
public health benefit."
So this is the way that it was done, is this
right:
46 "Clinicians would be asked to forward individual
batch exposure details to the HPA for assessment of
whether the patient should be considered 'at-risk'. "
So hospitals would know which batches were
implicated, they would search through their records ,
they would say: yes, we have had these batches and we
gave them to these patients, this is the amount thi s
patient has had. And then you carry out a calculat ion
to see whether it crosses the threshold?
ANSWER:
That was the plan and, as it sort of says there, th e
problem was, back in the '80s, hospital computer
records were not great so -- and variable, so lots of
them couldn't trace. But we did what we could.
|
46,424 | 341 | QUESTION:
Then if we just pick that up, please, on page 14, w e
can see at 4.10:
"Trace recipients potentially 'at-risk' and
assess 'at-risk' status according to the patient gr oup
strategy. Inform 'at-risk' recipients of possible
exposure and the public health precautions they are
asked to take ...
"The assessment of potential additional 'risk'
and notification of 'at-risk' individuals, amongst
patients with bleeding disorders and primary
immunodeficiency, is being managed by the clinician s
providing their care, under the separate arrangemen ts
47 in place for these patient groups.
"For other patients clinicians were asked to
forward patient exposure details to the HPA CJD
Section for assessment ...
"The total estimated potential risk for
individual recipients was calculated by multiplying
the batch specific potential infectivity per unit d ose
by the total cumulative dose of that batch received ,
and summing the results potential infectivity doses
for all batches received."
That was presumably for those patients that had
received what had been termed medium risk product?
ANSWER:
Yes.
|
46,425 | 341 | QUESTION:
Ie if you had enough of it you would reach the
1 per cent threshold?
ANSWER:
That is correct.
|
46,426 | 341 | QUESTION:
So that's why the individual calculation for the
individual patient had to be undertaken?
ANSWER:
Yes.
|
46,427 | 341 | QUESTION:
But if you were somebody who had taken what's calle d
a high risk product, so Factor VIII or Factor IX,
where one dose was enough to get you over the one p er
cent threshold, that individual calculation was not
undertaken for you?
ANSWER:
No, I think they were just able to find out if they
48 had received an implicated batch. I'm not sure the re
was a -- I don't know if there was a sort of, "You' ve
received X number of batches". I'm not -- can't
remember the level of detail that was provided to
patients if they asked.
|
46,428 | 341 | QUESTION:
Then we can see the outcomes on page 15:
"By the end of December 2004, a total of 9 UK
plasma donors are known to have developed vCJD.
Collectively they have made 23 blood donations wher e
the plasma has been used to make plasma products.
"The donated plasma has been used to manufacture
a total of 187 batches of plasma products, comprisi ng
factor VIII, factor IX, antithrombin, intravenous
immunoglobulin G, albumin, intramuscular human norm al
immunoglobulin, anti-D and 13 batches of plasma
fraction intermediate."
Then it sets out that those products had been
supplied to the UK and to 12 countries overseas.
Then, if we go over the page -- in fact, sorry,
can we go back to "Patients with bleeding disorders ":
"Within the UK, an estimated 4,000 patients with
haemophilia A and B and Von Willebrand's Disease in
the UK would have received UK sourced plasma derive d
Factor VIII and Factor IX during the period 1980-20 01,
and therefore be considered 'at-risk'. It was
9 considered that few patients with congenital
antithrombin deficiency would have required treatme nt
with plasma derived antithrombin.
"It is understood that all these patients have
now been notified (via their haemophilia doctor) of
their 'at-risk' status. Individual exposure
assessments are being collected and managed by UKHC DO
in collaboration with the HPANSWER:
"
Just on that last paragraph there. What do we
understand to be the individual exposure assessment s?
|
46,429 | 341 | QUESTION:
So certainly the information that that group of
patients with bleeding disorders received was: you are
at risk of vCJD, you must take these health
precautions; if you want to know whether or not you
have received an implicated batch, you can find out .
So they would presumably be told, "Yes, you have
received one" or "You haven't".
50 This here is suggesting that there are -- is
this suggesting that some other kind of assessment is
being collected?
ANSWER:
I think -- I mean, again, I would have to look at t he
whole document -- other documents -- I think what t hat
is, is just the same sort of thing: it's this perso n
has received six batches, this person has received two
batches.
The other point that is worth making -- I think
you covered this with James Ironside yesterday, abo ut
why the umbrella approach was taken, I think -- als o
it is thinking back. I mean, now we can say, "Okay ,
relatively few cases of variant CJD", whatever, but --
compared to what people were worried about, but at the
time a big argument was they thought there might be
a lot more notifications coming through the pipelin e.
We thought there might be many more blood donors be ing
identified. And so it was the idea of not having t o
go back again to people to constantly enlarge the
group.
And also I think I remember conversations where
it was actually -- I think "community" might be too
strong a word but the fact is if the information yo u
are giving -- you know, there would be a shared
understanding between different families with
51 haemophilia patients, that you want to make sure th at
you have got a clear message that avoids confusion and
different messages to different people.
|
46,430 | 341 | QUESTION:
Then if we go over the page, please, to see the
outcomes for the "Patients with other conditions", at
5.4:
"By the end of December 2004 a total of
73 traceability questionnaires had been received fr om
NHS Trusts, of which 53 reported having received
implicated plasma products. Of these 16 reported
being unable to trace the recipients of these
products."
Does that mean that -- were traceability
questionnaires sent out to every single NHS trust a nd
you had 73 responses?
ANSWER:
I would have to go back through these things. If t hey
were able to identify which hospitals had received the
plasma products, they would have sent them to those
hospitals. I would have to check the documentation to
see if that is what actually happened.
|
46,431 | 341 | QUESTION:
I think we will come on to see that that's what
happened in later notifications.
ANSWER:
Right.
|
46,432 | 341 | QUESTION:
But I'm not aware of any -- I haven't seen anything --
ANSWER:
This would be the report that would explain it, and if
52 it doesn't ...
|
46,433 | 341 | QUESTION:
Then it says:
"By the end of December 2004, the HPA CJD
Section had undertaken a total of 1826 individual
exposure assessments for patients suffering from ot her
conditions, of which 0.7% (n=12) had had sufficient
potential exposure to vCJD implicated plasma produc ts
for patients to be considered 'at-risk' for public
health purposes."
So, in that September 2004 notification you have
a very large group of people with bleeding disorder s
being notified, you have the group of people with
primary immunodeficiencies, which we haven't looked
at, and then 12 from this third other group of --
ANSWER:
Correct.
|
46,434 | 341 | QUESTION:
And was consideration given to giving different
messages to different -- to patients who had had
60 perhaps more plasma than others -- plasma products?
ANSWER:
Within the -- okay. There are lots of different
groups of at risk patients that the CJD Incidents
Panel created really or developed through its risk
management processes, and they might be patients
who've received plasma products, or had surgery whe n
the instruments had been used on someone else with
CJD, or blood donations. There are lots of
different -- I mean, I think there were some flow
diagrams which showed the various different groups and
how they related. And the only group that I think
that they could say there was clearly a difference
were the people who had received blood components f rom
a donor who had had CJD, and that was the only grou p
that they really felt comfortable saying, "This is
a different kind of risk," and they called them -- in
the public health -- not in the communication to
patients but in our way of managing it, it was kind of
almost presumed infected. We managed this group
differently, and that's why they're accessing the
various research and other -- you know, other sort of
research and public health interventions. But ther e
was not enough evidence really to clearly demarcate
risk within the other groups.
|
46,435 | 341 | QUESTION:
So whichever clinician was responsible for notifyin g
the patient would have had to make a decision about
whether or not there was any counselling available,
presumably?
ANSWER:
Yes. I mean -- yeah, there -- and the idea of it
being through the clinician who knew the patient be st
would be that they would be aware if they were alre ady
having medical -- other psychological medical conce rns
that maybe would make this a more difficult
notification than for other patients.
|
46,436 | 341 | QUESTION:
And do you recall any discussions or consideration
being given to the fact that for quite a large numb er
of these patients who have been notified, they had
63 already had this devastating history of infections,
sometimes multiple infection as a result of their
treatment with blood and blood products, and this w as
going to be another very difficult message to recei ve,
and that perhaps there should be some provision to
deal with that?
ANSWER:
I'm -- okay. So that's why we worked so closely wi th
the haemophilia doctors and patient organisations.
They said they wanted the umbrella -- it was kind o f
like -- I think that's probably why the risk
management was done the way it was because that's w hat
they thought would be best for their patients.
I think I saw in all these documents there was
a sort of question from UKHCDO for money for their
database. I'm not sure that I've seen anything
saying, "Can we have money for counselling services ?"
And I don't -- I certainly wasn't aware of any
conversations about that.
|
46,437 | 341 | QUESTION:
Can I take you to the House of Commons Science and
Technology Committee report from 2014. TSTC0000052 .
Before I ask you a question on this, is this
a document that you think you have received from th e
Inquiry?
ANSWER:
Yes.
|
46,438 | 341 | QUESTION:
Can we just -- just so we understand what this is, if
64 we just look at -- we can see it's dated July --
published on July 2014. We can see it's the House of
Commons Science and Technology Committee. It is
called "After the storm? UK blood safety and the r isk
of vCJD". If we look very briefly at page 8, we ca n
see at paragraph 4:
"In December 2013, we issued a call for written
evidence addressing the following points."
And a number of points are set out there:
"Are UK policies governing who can donate blood
and blood products, tissues and organs sufficiently
evidence-based?
"Is the government and its scientific advisory
structure sufficiently responsive to the threat pos ed
by emerging diseases being transmitted through bloo d
and blood products, tissues and organs?
"Has the threat of ongoing transmission of vCJD
through ... blood and blood product supply been
adequately mitigated?"
And so on. And we can see that they received 55
written submissions and took oral evidence from 27
witnesses.
That is right, isn't it: you weren't in post at
this stage, so you didn't give evidence?
ANSWER:
I don't think I gave evidence. I certainly don't
5 remember it.
|
46,439 | 341 | QUESTION:
If we can just turn to page 40, please. We can see
this is in the section where they're setting out th eir
reasoning and conclusion, and it's the bold at 70, and
I just want to get your response to this:
"People who are notified that they may have been
exposed to CJD will inevitably be alarmed by this
information and will likely have questions that can not
be answered in the leaflets currently provided by
Public Health England. We consider it totally
inappropriate for this news to be communicated sole ly
in writing. We recommend that the government put
robust measures in place to ensure that all
individuals assigned this designation receive the n ews
verbally, either from a healthcare provider or from
a CJD specialist with experience in patient
communication."
I just wanted to get your response to the --
what's set out there, that the Committee thought it
was totally inappropriate for the news to be
communicated solely in writing. Was that something
that the HPA understood may very well happen as
a result of the way the notification process was
designed and rolled out?
ANSWER:
No. The intention was always that people would be
66 seen by their clinician. Whether they would get th eir
clinician appointment -- for the haemophilia thing,
because of the large numbers involved, they might - -
people might have received -- I can't remember whet her
the -- I'm trying to think now. Would the haemophi lia
doctors have had to send out a letter before they s aw
the patient? But the expectation was that everyone
would be seen or have a chance to communicate.
I would totally agree with that.
And even for the blood donor notification that
I think was managed by the national blood services,
again, they provided -- even though they may have m ade
a contact in writing, it was supported by some --
an individual, a clinician, talking to people.
So -- and I think because of the numbers of
people who were informed from the haemophilia
notification, it may have been difficult for them t o
get appointments in their clinic all at the same da y
kind of thing. So they might have received the
letter -- and I can't remember the actual process, if
they would have received the letter first, or if
they -- but then it should have been followed up. So
I would have expected there to be some support.
|
46,440 | 341 | QUESTION:
Now, you've indicated that the group of transfusion
blood component recipients was treated differently to
67 the other groups that were notified.
In terms of keeping in contact with the group
that was notified in September 2004, so the plasma
product recipient group, was it a different strateg y?
ANSWER:
So we at the HPA didn't have any direct contact wit h
the haemophilia and the bleeding disorder patients.
That was managed by the UKHCDO who would give us
feedback on the numbers of patients that they had i n
their at risk group. Then they also set up,
I believe, a research study with the National
Surveillance Unit, the CJD Surveillance Unit, and
there would have been -- I can't remember the exact
details of it, but our normal practice would be for
our at risk patients a flagging -- you can flag
individuals with the office of national statistics to
pick up death certificates. So there are various
flags you can do, in surveillance terms, to see wha t
a clinical outcome would be. So I think -- I know
that they had a research programme with the
Surveillance Unit.
|
46,441 | 341 | QUESTION:
And so any communication in respect of changes in
risk, developments in testing and so on would have
been done from the HPA to the UK Haemophilia Centre
Director Organisation, with the expectation that th at
would then be passed on to their patients if
68 appropriate.
ANSWER:
With an agreed plan of communication.
|
46,442 | 341 | QUESTION:
And we've certainly got one you've exhibited to you r,
statement I think -- I think it's your statement. One
example of that which we don't need to go to, but f or
the transcript, it's in February 2009 when haemophi lia
centre doctors were told about the finding of the
person with haemophilia being -- testing positive f or
vCJD. That's WITN3289130.
I'm going to come on now to ask you about other
notification exercises. There was a notification
exercise in 2005. Is it right to understand that t hat
was led by the blood services supported by the Heal th
Protection Agency to trace the recipients of donati ons
from 110 donors whose donations had been given to
patients who had gone on to develop vCJD. It had c ome
out of the reverse TMER, and so the evidence we hea rd
from Dr Hewitt was that the blood services felt tha t
that was their responsibility to lead on that
notification.
ANSWER:
Yes. I mean, there certainly -- it's hard now with out
having the document in front of me for the differen t
notifications, but certainly there was -- I mean,
I worked very closely with Dr Hewitt, and they had
a duty of care and responsibility to their blood
9 donors, and that was their -- they had a role in
communicating and tracing and supporting their bloo d
donors, but we would have worked closely with them on
anything.
|
46,443 | 341 | QUESTION:
I don't intend to ask you anything more about that.
For those that are interested, there's been a paper
published by Dr Hewitt and others about that
notification exercise, and that can be found at
RLIT0000156.
I'm going to come then onto ask you about
notifications that took place in 2006. If we could
look, please, at PHEN0000528. This is, as
I understand it, the summary of the notification
exercise commenced in November 2006 by the HPANSWER:
An d
if we go to the last page of this, we can see it is
dated 8 May 2007. Again, I think it's by -- right at
the bottom there ... I think it's by the same peopl e
we saw in the 2004 --
|
46,444 | 341 | QUESTION:
Yes, I think you might be right there. I don't thi nk
we know who authored it. I think you must be right .
Again, I ask you the same question: is this
a document you've received from the Inquiry?
ANSWER:
I can't remember whether I gave it to the Inquiry o r
70 received it from the Inquiry, but I've certainly se en
the document.
|
46,445 | 341 | QUESTION:
Yes, okay. I just want to read the summary which i s
on the first page, please:
"The English and Welsh blood services, supported
by the HPA, carried out a further plasma product
notification exercise in November 2006 to inform 13 1
hospitals of four batches of plasma product which h ad
been manufactured using plasma from donors who had
developed vCJD. Hospitals were asked to trace the
implicated batches, link them to patients, and
determine whether any additional patients had recei ved
a sufficient dose to put them 'at risk' for public
health purposes. Hospitals were asked to return
a traceability questionnaire and complete an exposu re
assessment form for each at risk patient. By
13 April 2007, 64 hospitals had returned traceabili ty
questionnaires. No additional patients to date hav e
been identified as having received sufficient quant ity
of implicated batches to put them at risk for publi c
health purposes."
So is it right to understand that these four
batches hadn't been identified in time for the
September 2004 notification?
ANSWER:
That's correct.
71 |
46,446 | 341 | QUESTION:
It took place just over a couple of years later --
ANSWER:
They thought -- I think -- I was looking through so me
of the documentation for 2004, and it said --
somewhere or other it said there were four untracea ble
batches, and then obviously someone then did trace
them.
|
46,447 | 341 | QUESTION:
We can see there that the same process is undergone as
we looked at in that report of the 2004 notificatio n;
is that right?
ANSWER:
Yes.
|
46,448 | 341 | QUESTION:
It's the same process.
Then in your witness statement, which -- can we
turn up, please. It's WITN7091001 at page 21. You
have identified a further blood notification exerci se
that took place, and I understand that has come fro m
one of the CJDIP annual reports.
If we look -- I think it starts, in fact, at 70.
It's a little bit difficult -- if we look at
paragraph 70, you say:
"I am unaware ..."
I think you were being asked about blood
notification exercises in 2006. You say:
"I am aware of another blood notification
exercise that took place in 2006, and I quote from the
6th annual report of the CJDIP ..."
72 Then you set out the reference to that.
Then the quote from the annual report starts at
paragraph 71 of your statement. You say this:
"Following the first two reported cases of
probable vCJD transmission via blood transfusion [. ..]
[The European School of Radiology] ESOR carried out
a 'reverse risk assessment' to investigate the
likelihood that a patient's vCJD infection could be
the result of a blood transfusion [...]. As descri bed
in the previous annual report, the Panel had
recommended that people who have donated blood to
patients who later developed vCJD, should be
considered at risk of vCJD for public health purpos es,
unless their estimated risk is clearly below 1%. T he
UK CMOs requested, and then accepted, advice on
managing other individuals who had received blood f rom
these donors. The next step was for the Panel to
consider additional analyses of the 'reverse' risk
assessment to estimate the risks to other recipient s
of blood donated by people who had also given blood to
vCJD cases. The UK CMOs accepted the following Pan el
recommendations concerning this group of
blood recipients:
"72. For cases where blood recipients had only
received blood from a low number of donors, and
3 therefore the implied risk for each other recipient is
well above 1%, the Panel in general would advise th at
other recipients should be traced, informed of thei r
potential exposure to vCJD and considered as at ris k
of vCJD for public health purposes.
"73. For cases where blood recipients have
received blood from a high number of donors, (say,
more than 90), and therefore the implied risk for e ach
other recipient falls close to or below 1%, the Pan el
would examine each case individually."
Then you set out what actually happened in this
notification.
"74. The UK Health Protection Scotland and the
HPA implemented these recommendations following the
public announcement in November 2005. Patients wer e
traced and notified in 2006. In Scotland, 156 unit s
of implicated blood components were traced to 90
recipients of whom 22 were living. Of the 20 other
recipients traced in England, only three were livin g
and definitely confirmed to have received blood
components from the 'at risk' donors. These 25
individuals were notified and asked to take public
health precautions."
First of all, it is right to understand that the
25 individuals is made up, is it, of the 22 living
74 recipients in Scotland and the three living recipie nts
in England?
ANSWER:
Yes.
|
46,449 | 341 | QUESTION:
So those were the subject matter of the notificatio n.
Do you know or do you have any -- can you give
us any help on how it is that in Scotland they were
able to trace 90 recipients, a smaller country,
whereas in England only 20. Is there a reason for
that?
ANSWER:
It looks to me that they just had a lot more of the
implicated units in Scotland, they have 156 units - -
blood components in Scotland were traced. I mean, it
may just have been a distribution of how the -- I
mean, it may just be that's what happened. I mean,
I don't have any reason -- I don't know if they wer e
better or worse in tracing blood things.
Can I make one correction to this?
|
46,450 | 341 | QUESTION:
Yes.
ANSWER:
If you go back to paragraph 71.
|
46,451 | 341 | QUESTION:
Yes. Which starts on the earlier page.
ANSWER:
Right. The ESOR was actually -- that's a team with in
the Department of Health. I can't remember what it
actually stands for, it is their modelling analytic al
team, it is not the European School of Radiology.
|
46,452 | 341 | QUESTION:
Ah, so that is where the error is. I have got that
75 written down --
ANSWER:
I can't remember what it actually stands for.
|
46,453 | 341 | QUESTION:
I can't either.
Then I just want to ask you one question then
about the 2010 -- a notification in 2010.
We get this from an annual report of the
CJD Incidents Panel. WITN7091016.
This is an exhibit to your witness statement.
Here we go. 1 January to 31 December 2010 annual
report.
If we could just go, please, to page 17 of this.
Under 4.3, "Notification delays", it says this:
"In 2003 an incident was reported to the Panel
that involved an index patient who had received a v CJD
implicated blood transfusion. In 2010 the patient
notification exercise for this incident was complet ed
in which 21 patients were informed of their risk
status."
Then it says:
"As a result of the delays in implementing this
patient notification exercise the Secretariat
developed an internal protocol to ensure timely act ion
in the event of future delays in implementing Panel
advice."
Do you recall this incident?
76 ANSWER:
Let me just read this.
Ah, yes. I think -- I think -- this is talking
about -- this patient may have undergone surgery an d
that the 21 patients -- okay, without seeing the
actual incident details it is hard to be completely
sure, but reading this, it is not that this patient
wasn't told about their blood transfusion. It is t he
fact that they then -- the index patient, so that i s
the starter patient, who is the -- who is at risk
because they have received blood from someone with
vCJD, that patient then had surgery, and that surge ry
was obviously deemed to be high enough risk that ot her
patients ought to be notified, which are the 21
people. Yes?
So that was delayed. And I'm pretty sure that
I know exactly which this incident is, because ther e
was a report into it. I mean, I can go into that i f
you want me to. So it is a particular incident whe re
the trust didn't want to notify. There were lots o f
things about this notification that were difficult.
And I think -- I think that's what this is about.
|
46,454 | 341 | QUESTION:
So it is not -- looking at that, it looks like ther e
might be a seven-year delay between the 2003 incide nt
and then the notification, but you are saying that' s
not the case?
7 ANSWER:
No, if you look at this, it is patient notification ,
it is a local incident team about surgical instrume nt
used on the at-risk patient who then had surgery --
I think at some point this patient, who had receive d
implicated blood, at some point they had surgery,
and -- well, 2003 it has been reported -- well, it may
have that when they were -- it may be, because that 's
2003, that actually the act of notifying them that
they are at risk because they have received blood w as
also the look-back to see what surgery they have ha d,
and they said, "Oh, you have had surgery, there are
other patients who need to be notified now."
But, yeah, I mean, it's -- we haven't talked
about surgical instruments. That is a whole other
ball game that we were involved with.
|
46,455 | 341 | QUESTION:
The point being made here is that there was a delay in
implementing Panel advice?
ANSWER:
Yes.
|
46,456 | 341 | QUESTION:
Was that -- I asked Professor Ironside whether or n ot
there was an obligation on trusts -- NHS trusts to
implement Panel advice and he wasn't entirely sure of
the --
ANSWER:
No, but I think with this particular -- I think
what -- in normal practice you would expect a hospi tal
to do what the HPA recommended them to -- or PHE -- if
78 we were recommending something, you would expect
people to take the recommendations. For this -- wh en
that doesn't happen -- I think what happened is we
would have gone, probably here, through the Departm ent
of Health colleagues to somewhere -- I can't think of
now what was then the NHS hierarchy of who it was w ho
told hospitals what to do. Whether that was
a strategic health authority. I can't now think wh ich
bit of the chain we would have gone to, to say, "He y,
this hospital isn't doing what we want it -- what i t
ought to be doing", but there would have been that
kind of conversation.
But perhaps it wasn't -- it's hard without --
there was a report into this particular incident
because things took so long. Yeah.
|
46,457 | 341 | QUESTION:
So is this right, to draw from that, that the Panel
gave advice to NHS bodies in relation to notificati on,
and then the Panel was kept up to date as to whethe r
or not those had been implemented?
ANSWER:
Yes. So we kept a tally of what -- you know, who h ad
traced -- who had taken instruments out of
circulation, who had notified patients. You know,
what the recommendations were from the Panel and wh at
had been done, but that -- what we were getting at
was, did the Panel have authority to tell a hospita l
79 what to do? And I think the answer is no, it was
giving advice. But then we could -- while we didn' t
have authority over them either, we could then talk to
someone who did have authority over them.
|
46,458 | 341 | QUESTION:
You could escalate it, effectively --
ANSWER:
Yes.
|
46,459 | 341 | QUESTION:
-- up the chain, and then steps could be taken?
ANSWER:
Yes. So that was basically the route. But it was not
a straight -- it wasn't an obvious route. It didn' t
generally happen, it was just that was a particular
issue.
|
46,460 | 341 | QUESTION:
So that was the next question, is, was it common th at
NHS bodies were unwilling to implement panel
recommendations?
ANSWER:
No, I remember there were two difficult -- this one
and there was -- well, this was one where
an individual -- someone disagreed with Panel advic e
in the hospital. You know, there was an argument
going on kind of thing. And then there was another
incident which springs to mind which wasn't a delay
but was a problem because the press got hold of thi ngs
and people got very upset and -- about it.
But generally things went through very
smoothly -- you know, not very smoothly, but things
happened and, you know, the Panel's advice was take n.
80 |
46,461 | 341 | QUESTION:
Then you left, as we discussed this morning, the CJ D
unit in May 2012. So it is right, is it, that you
didn't take part in the 2013 denotification process ?
ANSWER:
No.
|
46,462 | 341 | QUESTION:
That was led by Dr Katy Sinka, is that correct?
ANSWER:
If that's on the documents. I mean, everyone did
different roles at different times, so ...
|
46,463 | 341 | QUESTION:
And the Inquiry has a witness statement from her.
I just have one last area of questioning for
you.
Can we look, please, at HSOC0016641.
This is an article published in Haemophilia
co-written by you, "Risk reduction strategies for
[vCJD] disease transmission by UK plasma products a nd
their impact on patients with inherited bleeding
disorders".
Just to understand what this article is
addressing, if we could just look, please, at that
summary, just above where it says "Keywords" on the
right-hand side. The last sentence, it says:
"We evaluate vCJD surveillance and risk
management measures taken for UK inherited bleeding
disorder patients, report current data and discuss
resultant challenges and future directions."
Then if we could just go, please, to page 7.
1 I just want to ask you some questions about
endoscopies.
So we can see there that heading "Endoscopy":
"A significant challenge that has arisen from
the public health notification exercises surrounds
endoscopic biopsy. The possible contamination of t he
biopsy forceps and the endoscope channel as a resul t
of the vCJD infectivity in the gut mucosa of
subclinically infected individuals led to the 2003
recommendation to quarantine endoscopes and retain
their use only for the specified patient should
invasive procedures such as biopsy or diathermy be
required in an 'at-risk' patient. For several year s,
the cost implications that resulted from the
individualisation of endoscopes in 'at-risk' patien ts
requiring biopsy were borne by the hospital trust
concerned. This resulted in variation between trus ts
in the threshold at which biopsies have been perfor med
in these patients, thus raising the possibility tha t
patient care may have been compromised in some case s.
In 2008, the DH provided central funding for the
refurbishment of suitably quarantined endoscopes us ed
on patients at risk of vCJD. Sufficient resources
will similarly be required to ensure the continued
implementation of appropriate public health measure s
82 in aging 'at-risk' bleeding disorder patient
population while maintaining high standards of
clinical care."
I just want to ask you a handful of questions in
relation to that.
You may be aware that the Inquiry has received
information from some patients care was compromised as
a result of this, as has been set out there, in two
ways. Firstly, as set out there, because some
hospitals had been unwilling to have to quarantine
their instruments, so haven't wanted to carry out t he
procedures.
But also that some patients have been unhappy
about the procedures in place at the hospitals, and
have been concerned that if they go forward for the ir
surgery, that they may be putting other people at
risk, because they are not sufficiently -- the
procedures that they -- that they have been told th at
the instruments won't be quarantined.
So that is the sort of the background to asking
these questions.
What role, first of all, did the Health
Protection Agency have in promulgating the
2003 recommendation to quarantine endoscopes?
ANSWER:
When we were putting advice out to clinicians, I th ink
83 it probably -- again, I don't have the documents in
front of me -- it -- I thought it would have includ ed
information about how to manage surgical instrument s.
So talking about the Panel advice here.
So when there was a -- so ... okay, I will have
to go back and look at those documents, but I'm --
anything that we put out would be in the letters th at
we sent to clinicians and information for clinician s,
which I would have thought would include informatio n
about endoscopies -- and actually, as I'm talking t o
you, I can think, hang on a second, we were asking
people to do look-backs and to see what procedures
patients had undergone, so we would have certainly
been relaying the Panel advice. So we would have b een
a conduit for whatever the Panel had recommended. We
weren't making our own decisions, we are saying: th is
is how you deal with your endoscopes, this is what you
do when a patient requires endoscopy, because this is
what the Panel has recommended.
|
46,464 | 341 | QUESTION:
In fact the 2003 recommendation has a footnote 58, and
in fact it makes it clear in the footnotes that --
that it's a -- that the recommendation comes from t he
ACDP "Transmissible Spongiform Encephalopathy
Agents: safe working and the prevention of infectio n".
So in terms of promulgating those kinds of
84 recommendations, that kind of guidance, would the
Health Protection Agency have a role in ensuring th at
that had been distributed widely?
ANSWER:
We would have -- if it was something relevant to th e
management of patients who were at risk with CJD,
I would have thought we would have communicated it.
There was quite a close relationship between the
Panel and that ACDP TSE joint working group. We we re
a subgroup of that. Don Jeffries, who I think was
chair of that ACDP group at some point, was deputy
chair of the Panel, so there was lots of dialogue
between the groups, and they were very concerned wi th
endoscopes.
|
46,465 | 341 | QUESTION:
In your discussions with and your communications wi th
NHS trusts as a result of Panel recommendations, wh at
was the impression that you got as to how successfu l
that 2003 -- how successfully that had been
distributed, that 2003 message?
ANSWER:
I wasn't -- I mean, we -- I'm trying to think. Sor ry,
I'm a bit hesitant.
There were different types -- okay. There were
different types of surgical management messages.
There were some things that were generic for all
hospitals to deal with. There was stuff about how you
ought to decontaminate surgical instruments, and st uff
5 that NICE put out. There was generic guidance that
everyone needed to know. And then there were speci fic
things of: oh, you've got an incident. You've got a
patient. This is what you do. And so we would hav e
been involved with the latter not the former.
And I can't remember discussions where
I thought, "Hang on a second. They ought to know
this." You know, I don't remember that being
a particular issue. It was more like: how do we
implement it?
|
46,466 | 341 | QUESTION:
And then we see from the extract from the article t hat
we have just looked at that in 2008, Department of
Health "provided central funding for the refurbishm ent
of suitably quarantined endoscopes used on patients at
risk of vCJD".
Did you have any -- did the HPA have any role in
implementing that scheme? Do you know how it worke d?
ANSWER:
No. I don't think that was our role. There was
a separate -- there were two things. There was tha t,
which was this concept of refurbishment. Who did
that? I don't know how that was done.
There was another concept of: would you one
day -- all these instruments that had been taken ou t
of action, could you do some research into them at
some stage, so there was like a storage thing, but
86 I wasn't directly involved with these projects. I was
aware of them, though.
(Pause)
|
46,467 | 341 | QUESTION:
When we looked at the report from the Health
Protection Agency to the CJDIP giving a summary of
what had happened and so on, and we were looking at
the outcome, and it said in there that the haemophi lia
people had been thought to have been notified. Was
that an assumption by the Health Protection Agency, or
had they actually had -- do you recall whether you
actually got feedback from particular haemophilia
88 centres to say that they had actually engaged in th e
notification process?
ANSWER:
Okay. I would have thought that this was a summary
response from the UKHCDO either to HPA or to the Pa nel
directly. I don't remember if UKHCDO made a sort o f
breakdown in their information. I don't recall any
sort of presentation from them saying that these
centres are doing it; these centres aren't doing it .
I don't remember that. I don't know whether
Frank Hill or Charles Hay have been witnesses, but
that would be their kind of -- for them to answer.
|
46,468 | 341 | QUESTION:
Again sticking with the 2004 plasma product
notification, in terms of the decision to have
an umbrella notification, can you recall what weigh t
was given to the individual patients' well-being, a s
opposed to the question of public health protection
when the decision was made to have an umbrella
notification?
ANSWER:
I think that was decision was taken primarily for t he
patients' well-being. That was -- it was the
clinicians, the haemophilia doctors, the directors'
association and the patient group who were both
thinking: the last thing patients want is for us to
keep going back to them and changing the at risk
message. So that was the motivation for the umbrel la
9 group.
|
46,469 | 341 | QUESTION:
Again sticking with plasma product notification in
2004. Is it right to understand your evidence that
the notification for those patients with bleeding
disorders was managed by, in the case of people wit h
haemophilia, their haemophilia clinicians?
ANSWER:
Yes.
|
46,470 | 341 | QUESTION:
And that it was a matter between the haemophilia
clinician and the patient as to whether there would be
a follow-up appointment. The Health Protection Age ncy
would expect one to be offered, but whether it was
taken would be a question between -- a choice for t he
patient? Is that what the HPA understood?
ANSWER:
I think we understood that the haemophilia clinicia ns
were going to manage this and offer appointments.
Yeah, that they were doing it. We didn't know what
the individual centres were offering to their patie nts
or what the patients were accepting or asking for.
|
46,471 | 341 | QUESTION:
So the question of whether or not an appointment wa s
going to be offered was a matter that was left to t he
decision of the haemophilia clinicians themselves?
ANSWER:
I believe so.
|
46,472 | 341 | QUESTION:
And does it follow from that as well that the Healt h
Protection Agency didn't have any communication wit h
those patients with bleeding disorders' GPs? All t he
90 communication on the notification went through the
clinician that dealt with their bleeding disorder,
rather than communicating with their GP as well?
ANSWER:
Okay. So for that, I know we provided all the repo rt,
and it would say within the report and the tool
kits -- I don't recollect that there was
a communication directly to their GPs. I think it was
all through the UKHCDO, but I'd have to look at the
documentation that we've discussed to sort of verif y
that. Yeah, I believe it was all through the
haemophilia centres.
|
46,473 | 341 | QUESTION:
Again sticking with the --
ANSWER:
Sorry. It would definitely have been because we
didn't have these patient IDs. We didn't have thei r
details to contact the GPs.
|
46,474 | 341 | QUESTION:
Sticking again with the 2004 plasma product
notification. With the benefit of hindsight, shoul d
there have been a list sent out to GPs of specialis t
counsellors with information about the risks in the
2004 notification so that patients could have
contacted them, or should a set of specialist
counsellors have been made available to patients?
ANSWER:
So we -- okay, so -- so the assessments that we did
about how the notifications were received, there is
one where we did a review with GPs and another wher e
91 we did a small qualitative interview study based wi th
patients. Those were not the haemophilia cohort. So,
therefore, I am not aware of any studies or audits
that have looked into how the haemophiliacs receive d
this information and to what degree -- you know, to
actually quantify the -- how much it went well or
otherwise, and the response, therefore, what was
the -- and also what provision there was around the
country within the different haemophilia units. I
mean, this would be -- you asked a question. It ma kes
me think these are the questions I would then ask, so,
therefore, I find it hard to say to you that there was
this unmet need, you know, and we should have provi ded
or it should have been provided, whatever, because
what I imagine is there would be some reports of --
some individuals would say, "I didn't get enough
support," but I can't quantify that among those 4,0 00.
So it may well be that there wasn't sufficient
psychological support within the Trusts, but
I can't -- and then how would that best be answered on
a Trust basis of a Trust employing a counsellor?
I thought some Trusts did employ counsellors,
actually. Or whether was, you know -- I don't -- w e
have this central core of sort of specialist suppor t,
and I don't recall them saying they were getting
92 overwhelmed in any way. They certainly were being
involved, but they weren't saying, "Hey, we're gett ing
60 calls this week." They weren't saying that. So
I think it's hard to quantify, but it's not saying --
I'm not saying one way or the other kind of thing.
|
46,475 | 341 | QUESTION:
I may have misunderstood your evidence. I understo od
that this group of specialist experts was there to
support the clinicians rather than the patients?
ANSWER:
Well, sometimes, or sometimes the clinicians might
have referred. Because we had nurses -- some of th em
were nurses, some were counsellors, and some were
doctors. You know, whatever the need was, they cou ld
have been there. They were certainly able to suppo rt
patients, should they be required.
|
46,476 | 341 | QUESTION:
Again still on the 2004 plasma product notification .
Should everyone have been offered and/or written to by
the Prion Centre to be able to have a specialist
evaluation, instead of leaving the communication of
that up to the GP during -- at the time they were
notified? So we looked at the February 2006 materi al,
but at the time they were notified, should that kin d
of material have been sent to the patient?
ANSWER:
Are you saying from the point of view of entering
their research studies, or are you talking about fr om
the point of view of getting extra support?
3 |
46,477 | 341 | QUESTION:
So effectively for a specialist evaluation is what the
question is, so that they could go and have
a discussion with, an assessment if necessary, or
whatever would be suggested by the Prion Unit.
ANSWER:
I mean, the Prion Unit were most -- as John Colling e
was explaining -- were most keen to work with the
patients who had received blood components, where t hey
were more concerned that this is a higher risk grou p.
Would they have been able to offer more help?
I mean, I think -- again, I think the haemophilia
doctors would have been able to refer their patient s
or help their patients access their Prion Clinic fr om
2004. I'm not sure whether -- you know, so I don't
know whether any actually did. I know they receive d
some help from -- I know that they were approached and
supported some at risk patients. I'm not sure if i t's
specifically haemophilia at risk patients.
|
46,478 | 341 | QUESTION:
Were there instances, to your knowledge, of the wro ng
people being notified that were at risk for public
health purposes? For example, were you aware in 20 04
that the Royal Free hospital notified recipients, o r
do you know whether the Royal Free hospital notifie d
recipients of all blood products they were at risk,
rather than those BPL products manufactured from UK
plasma?
94 ANSWER:
I was not aware of that. I don't recall being awar e
of that.
|
46,479 | 341 | QUESTION:
And were you aware of any other instances of the wr ong
people being notified and then having to be contact ed
and de-notified, other than in that 2013 --
ANSWER:
Well, there were other de-notifications as the risk
assessments changed. Not just the -- there were ot her
issues. But I wasn't aware of any people being
incorrectly notified.
|
46,480 | 341 | QUESTION:
Was any support given to people that were de-notifi ed?
And was any consideration given to that?
ANSWER:
I -- it would have -- there would have been the sam e
contact list available through the GP. You know, t hey
would have had the same list of, you know, these ar e
the national centres and these are the -- they woul d
have come to us if they wanted help, but there was no
specific thing given, other than a carefully worded
information to support the clinician who was talkin g
to a patient.
|
46,481 | 341 | QUESTION:
I'm now asking you a question about some of the
evidence that Professor Collinge gave. He gave som e
evidence last week about the product that he was
involved in developing, the pre-soak in order for
instruments he used on those at risk of vCJD could be
decontaminated and sterilised. I'm asked to ask yo u
95 whether the HPA ever investigated the introduction of
that product into the NHS and whether that was part of
the HPA role?
ANSWER:
Not that I'm aware of.
|
46,482 | 341 | QUESTION:
Another question in relation to surgical instrument s,
and I think this might arise from the passage we
looked at in the article co-authored by you about
this.
Were quarantined endoscopes reserved for
particular individual patients, or could they be us ed
on any patient considered to be at risk?
ANSWER:
I think -- I mean, I'd have to go back to the
documents, but I think they were reserved for that
individual patient ... I think. In the best of my
knowledge talking about it now. I would have to go
back to the documentation.
|
46,483 | 341 | QUESTION:
Then, lastly, you gave some evidence in relation to
questions about those who had been highly transfuse d
group, and the question is this: as for the ethical
issues about notifying those with multiple blood
transfusions about the possible risk to them, what
consideration was given to their right to be notifi ed,
and was it too difficult to even find out who these
people were?
ANSWER:
Sorry, could you just repeat that again.
96 |
46,484 | 341 | QUESTION:
Yes. What consideration was given to their right t o
be notified?
ANSWER:
The people who received many blood transfusions?
|
46,485 | 341 | QUESTION:
Yes.
ANSWER:
Well, everything was -- well, I think the decision --
first of all, I'm not sure what actually was resolv ed,
because that was after I'd left CJD, and these
discussions were going on and the risk assessments
were going on. And there was a big discussion, one
about what the actual risk was, which was basically
based on modeled estimates. And then whether it wa s
a sufficient risk to actually take any action. And
I think there was a lot of concern about the fact t hat
people would -- could move into a risk group, and y ou
could see that this was going to happen, so at what
stage did you start telling people. And then they
were thinking, well, all the doctors might tell the ir
patients who've had -- at what level they are going to
start telling people because they just want -- you
know, so it was very difficult to work out -- to se e
how it was going to work.
As far as people's right for the information,
I think, yes, I mean, it is considered -- the Panel
sort of had that fundamental -- I mean, in the
framework document it sets out all their principles
7 about the right for people to know what has happene d
to them. But I think it was just one of the many
difficulties in that particular piece of work.
And then, interestingly, as that was going on,
then the blood risk assessments changed. I think t hey
re-did it in 2012/2013, you know, after I had left,
and then the whole levels at what we considered to be
highly transfused changed as well. So you could se e
how difficult it was as the information was coming in.
And also there was another uncertainty, and
no one really knew how many people this was going t o
be, and that, again, made the Department of Health --
I mean, that, again, slows it down because you have
got not just what is the uncertain risk and how do you
manage it, but how many people are you talking abou t?
So there is a lot of complications with that
particular ...
|
46,486 | 341 | QUESTION:
And the second part of the question was: was it too
difficult to even find out who these people were?
So what was the difficulty in finding out who
they were?
ANSWER:
As we discussed with the chasing of batches, I thin k
when you are trying to figure out who has received how
many doses of blood -- I mean, we were -- I think w e
found this out with the pre-surgical risk assessmen t.
98 It is not really recorded in any uniform way. And
each hospital would sort of look through their
haematology lab data and it might be variable, and
then could they find out what someone had received
when they were living in a different part of the
country. It was a difficult process. I mean, ther e
has been lots in the press about NHS IT systems and
stuff, and this was back in the '80s, so ...
|
46,487 | 342 | null |
46,488 | 343 | null |
46,489 | 344 | QUESTION:
-- starting as a medical reporter?
ANSWER:
Indeed. Yes.
2 |
46,490 | 344 | QUESTION:
You were the medical correspondent for The Mail on
Sunday in 1983?
ANSWER:
I was and I'd just started at that point on that pa per
and the newspaper was fairly new, at that stage.
|
46,491 | 344 | QUESTION:
Then in 1988 you moved to the Daily Mail as Assista nt
Editor in charge of features coverage.
ANSWER:
That's correct.
|
46,492 | 344 | QUESTION:
Then you were Deputy Editor of The Sunday Times fro m
1991 --
ANSWER:
Yes.
|
46,493 | 344 | QUESTION:
-- and Editor of the Sunday Express from 1995?
ANSWER:
Yes.
|
46,494 | 344 | QUESTION:
Subsequently, you've had executive roles with Conde Nast
and Trinity Mirror Group?
ANSWER:
Correct.
|
46,495 | 344 | QUESTION:
The role this Inquiry is particularly interested in is
of course your role as medical correspondent. Can you
tell us, first of all, how you came to be appointed as
medical correspondent at The Mail on Sunday?
ANSWER:
I was working purely on shifts at the Daily Mail.
That's how many people -- it's almost like
an apprenticeship, you are just tried and tested wi th
your ability as a reporter on a casual basis on the
Daily Mail. And then The Mail on Sunday had just
started up as a new sister paper for the Daily Mail with
3a rather different political agenda as a Sunday ver sion,
but not a complete sibling of, and they were lookin g for
staff, and particularly first special correspondent s
that underpinned the DNA of what the newspaper was going
to be. So it would be crime, politics, medicine,
science. And it was discovered that, actually, I h ad
a background in medicine in as much as I'd got a de gree
in physiology and biochemistry and that I'd worked
originally, way back when I first started in journa lism,
for Haymarket Publishing on a medical magazine.
So, at that point, I was offered the possibility,
because I'd been tried and tested upstairs on the m ain
paper, the Daily Mail, with a job as medical
correspondent, and that had happened just before th e
point of this Inquiry, the stories that I was able to
give them about contaminated blood.
|
46,496 | 344 | QUESTION:
Before we come to the particular articles that you
wrote, I'd like to just explore with you the proces s of
a story then reaching the front page of the paper.
ANSWER:
Sure.
|
46,497 | 344 | QUESTION:
What can you tell us of the process that's followed
before something is published?
ANSWER:
So it's different for each faction of the paper but for
a specialist, which is slightly different from a ro ving
reporter, the specialist is -- your brief is to loo k at
4your subject, tunnel vision, inside out, and look f or
great stories that were basically stories that you hoped
would be worthy of public attention. And the whole
reason why I'd ever wanted to become a journalist w as
all really about telling people what was going on i n the
world. And this is, don't forget, in an era when t hey
couldn't just Google what was going on in the world or
look on YouTube.
So they were very dependent, the public, on what
discerning journalism could tell them and, obviousl y,
that was underpinned by, one hopes, the truth. And
that's underpinning the society we live in where we have
a free press, notionally, and we do, and that was r eally
important, and to me, one of the reasons why I want ed to
be a journalist, that your job is to go around ferr eting
for stories that actually people wanted to keep cov ered
up and you would say, "Oi, people should know about
this". And that was one's role, whether you were a t the
Financial Times or The Sun. And it didn't matter a nd
a lot of journalists would quite capably and happil y
move between any of them.
So I think at that stage my job was really to find
great medical stories and there's always a great
appetite, because it affects all of us, for obvious
reasons, about medicine, and that whole world, and that
was my brief.
|
46,498 | 344 | QUESTION:
You might have a story that you want to be publishe d but
what checks are in place before that story is publi shed?
ANSWER:
First and foremost, you have to have some kind of
intuitive sixth sense about what's interesting and what
isn't quite the story and what people don't really know
about and, frankly, that they care, because it's al l
very well to find out a story that you think "Oh, t his
is really good", and no one cares.
So again, the point is this is really important
because of the juxtaposition of all sorts of other
factors, politically in society, where we are,
et cetera.
So your judgement is important. So you have
a degree of responsibility. So you would collect
stories and quite often you'd put them in your bott om
drawer and you'd be thinking, "Right, the timing fo r
this story is perfect", because this or that happen ed or
the Government was looking at it, or there'd been
another case. So, in the context of the particular
story, though I know we're going to come on, it's
a story that I was aware of that was sort of bubbli ng,
and we'll come on to how I knew about that in a min ute.
|
46,499 | 344 | QUESTION:
Just to go back to the general point of you might h ave
a story, you might have a story bubbling, but what
6checks are in place by the paper before it's publis hed?
ANSWER:
Right. So the very first thing you do as -- this i s
a good story, before you go off and investigate and
spend time and money, you say to the News Editor, w ho is
your immediate boss "What do you think? I think I could
get something quite good on this". The News Editor
would then take counsel amongst the executives and say,
"What do you think? Yes/no?" So that's another le vel.
Then that will be presented in conference where
everybody would be, which I then later discovered,
obviously as my career progressed, and you'd be
surrounded by people checking and, frankly, there's
a degree of peer jealousy, as well, so you've got t o
have it really copper bottomed and it's got to be a good
story. And then there would be an interest. And t he
Editor, whose decision was always final, would say,
"Yeah, I think we should do that" and for a Sunday
paper, "Yeah, I think we should do that, hopefully, for
this Sunday" or it might be way off because you've got
to go somewhere or do all sorts of research, and so you
would embark on that story.
When you'd got as many of the facts as possible,
you would keep reporting in to your newsdesk to the News
Editor, and they would say "Oh, have you spoken to
this?" or "Don't you think you should go and find o ut
7about that?" So all the time you're being checked and
almost like an examination process, you know, when
you're a student at school or something, "Have you done
your homework?" which absolutely is the thing that you
needed to be doing.
And then finally, when you're tapping away at the
story and you think "Right, this is it", that's aga in
your judgement, your discernment about how you fram e the
story and you tell the story. And then it's submit ted
to what's called the backbench and that's another f ilter
of discernment where the backbench is checking, "Wh y
didn't she say that? Is that the right name? Is t hat
the right person?" So you'd be summoned as the rep orter
to say, "Have you done that? Have you done that?" And
then there's another tier of lawyers.
So before the story can actually be published,
which is the Editor's final decision when and if an d
where in the paper, what prominence is it given, yo u've
got the legal team actually looking at it and sayin g,
"You can't do that" or calling you and saying, "Why did
you not speak to that person?" And the counterbala nce
to that begs that question.
So there are all those layers which, of course,
now are compromised, they're very expensive. That' s
a labour intensive process of that story being the
8truth.
|
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