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46,200 | 333 | QUESTION:
Carry on.
ANSWER:
It is -- thank you. It is possible that I wrote th is
letter as a follow-on to the first generation study
that we did and, as we got results back --
confirmatory testing results back, I drafted this s o
that Dr Collins could contact those. There is
something in that letter, if I recall, that mention s
two tests; is that correct?
|
46,201 | 333 | QUESTION:
Yes, the first paragraph says:
"When you donated blood recently, we included
two new tests for a form of Hepatitis or Jaundice
virus."
ANSWER:
Okay. So this letter does refer to the comparative
first generation study we did.
|
46,202 | 333 | QUESTION:
Thank you. That was what I --
ANSWER:
So this is as the results of that study -- yeah.
That's where it came from, then, because it says tw o
57 tests.
|
46,203 | 333 | QUESTION:
Then, just in terms of once testing was fully
operational across for the Northern Region, I think
there came a point in the course of 1992 when it
appears that you learnt that Dr Collins had not bee n
communicating to donors who had tested positive the
fact of their positive test and what steps they sho uld
take, for example, seeing a doctor, and so on.
ANSWER:
Yes.
|
46,204 | 333 | QUESTION:
The reference, just for the transcript, I don't
propose to go to it is NHBT0003991. How had that
happened and what steps were taken to rectify that
situation?
ANSWER:
Steps to rectify: as soon as we found out, we sort of
piled resources then to get the letters out, dedica ted
a secretary to help with it and we got on and got t he
letters out.
How it came about, obviously, as a consultant,
I can't -- I couldn't sort of go to Dr Collins and
sort of look over her shoulder and say, "What are y ou
doing?" She had a degree of autonomy and
responsibility for doing the work, and it is
regrettable that I didn't realise that she wasn't
doing this work. I mean, it was a pretty
straightforward piece of business to, you know -- s he
158 received the results. I think we had probably help ed
to draft -- you know, we'd got the drafts like this ,
letters like this, so we knew what we were going to
do, but, for some reason, she was unable to carry i t
out, and I don't really want to go into why she
couldn't carry it out, but she didn't.
|
46,205 | 333 | QUESTION:
Dr Lloyd, I'm going to move in a moment to three
further short topics of questioning I have for you,
but before I do so, on the question of the
introduction of hepatitis C screening, is there
anything further that you would want to say or that we
haven't covered or haven't covered in your statemen t?
ANSWER:
No, no, I don't -- nothing sort of springs to mind.
All I can say is it gave me some sleepless nights a t
the time. It wasn't easy -- an easy decision. I w as
certainly concerned for my position. But thankfull y,
you know, we got through it. But I don't think
there's anything else.
|
46,206 | 333 | QUESTION:
So I'm going to move now to an issue about the
introduction of hepatitis B core antibody testing.
Not as a surrogate measure for non-A, non-B hepatit is
but in relation to hepatitis B itself.
If we pick this up at WITN6935033.
This is a memo from you. I think it's an
internal memo from the names.
159 ANSWER:
It is.
|
46,207 | 333 | QUESTION:
18 May 1983. It refers to you having spoken to
Dr Gunson regarding hepatitis B core antibody testi ng.
"He says that the results of the trial have now
been completed and are being presented to the
appropriate Department of Health Committee on
Virological Safety."
Then the next paragraph discusses the test
results.
And then the third paragraph:
"With regard to the date of implementation of
the test in the [UK], Dr Gunson says he does not kn ow
when this will be but thinks it will be in the autu mn.
"As usual it looks as if the National
Directorate (now the NBA) and the Department of Hea lth
are being incredibly slow in their deliberations an d
of course should have introduced this test earlier
this year, given the information they had available
from the Liverpool study."
Is it right to understand from this, Dr Lloyd,
that your assumption and Dr Gunson's assumption was
that this test would be introduced, the only questi on,
really, was when rather than whether?
ANSWER:
Oh, absolutely. I mean, once again, in this case - -
referring to Sir Brian's comment -- we included
160 the increased cost in the supply of blood, but of
course we were doing that before the year's contrac ts
were negotiated.
So we had informed hospitals that we were going
to introduce the test. Our haematologists in the
region knew we were going to introduce the test. W e
were ready. I recall we had discussed it with our
supplier, Abbott, so that they were prepared to
deliver to us the suitable number of tests. So yes ,
we were ready to go. And as you say in that commen t,
I suggest that Dr Gunson also was expecting to star t.
|
46,208 | 333 | QUESTION:
And the reference to being "as usual ... incredibly
slow in their deliberations", is that harkening bac k
to the then not too distant past of the issue relat ing
to hepatitis C screening, do you think, or were the re
other issues that you had in mind?
ANSWER:
No, I think I was just referring to hepatitis C.
|
46,209 | 333 | QUESTION:
Is this right: that the Newcastle Centre or the
Northern Region, had been involved in the trial of the
anti-HBc test kits?
ANSWER:
Yes, I think we had. I think I've seen somewhere
a little -- a few sheets of paper sort of showing s ome
results, so yes, we did do some work on it. I can' t
remember the results we got in terms of incidence.
|
46,210 | 333 | QUESTION:
Just for the transcript --
61 ANSWER:
But I notice in that --
|
46,211 | 333 | QUESTION:
Carry on.
ANSWER:
Sorry.
I notice at the bottom of this that we're
talking about the information they had available fr om
the Liverpool study. I haven't seen -- I may have
seen it at the time, but obviously that was a study
that I thought at the time was of note.
|
46,212 | 333 | QUESTION:
And I won't go to it but there's a letter from
Dr Gunson to you in February of '93 which refers to
your participation in the trial of test kits from
Abbott and Pasteur, and the reference for the
transcript is NHBT0018413.
Can I then pick up this issue about anti-HBc
testing with a meeting in July of '93,
NHBT0016372_001.
So we can see it's a meeting of RTDs/chief
executives/general managers.
If we go to page 4 --
ANSWER:
Sorry, I -- you said it was a meeting of RTDs, and
I -- sorry, we lost the sound after that.
|
46,213 | 333 | QUESTION:
Yes, it was a meeting on 27 July '93 of
RTDs/chief executives/general managers, and you wer e
present along with a number of others who fell into
that category.
162 If we look at page 4, picking it up at
paragraph 6.1, under the headed in "UK Advisory
Committee on Transfusion Transmitted Diseases", you 'll
see there the reference to:
"Considerable concern was expressed about the
delay which had occurred by the Department of Healt h's
insistence on deciding whether and when routine
anti-HBc should be introduced."
There's a reference to events during the past
year in France.
"Dr Gunson confirmed that he had written to
Dr Metters ... stating that the UK Advisory Committ ee
on Transfusion Transmitted Disease had decided that
from a scientific point of view such routine screen ing
is warranted and that the latest series of tests ha d
shown that there are test kits which are satisfacto ry
although all give false positive results.
"It was recognised that the UK Advisory
Committee on Transfusion Transmitted Diseases is no t
in a position to decide that the test can be
introduced. However, it was agreed unanimously tha t
the NBA should have the authority to make this
decision. Dr Gunson and Mr Adey would ask the
Chairman of the Authority if he would speak to the
Minister of Health on this important transfer of
163 policy decisions from the DH to the NBANSWER:
"
So we can see what's set out there I think is
self-evident. Do you have any recollection of the
discussions at the meeting?
|
46,214 | 333 | QUESTION:
Then if we pick matters up towards the end of 1993,
at NHBT0005291_003.
This is a letter from you dated
8 November '93 to all consultant haematologists,
finance managers and blood transfusion contract
holders.
This particular letter is addressed to
Dr Hamilton.
"As you know, we included provision for
Hepatitis B Core Antibody testing in this year's [B TS]
164 Contracts. One Regional Transfusion Centre had
started testing and there were clear indications th at
the UK would introduce this test ..."
Then we see the purpose of it here described by
you:
"... to eliminate the small number of Hepatitis
B transmissions by blood transfusion that occur due to
a small group of individuals who are infectious but
negative for Hepatitis B Surface Antigen, for which we
currently test."
Just pausing there, the purpose of this testing
was to pick up this group who would not otherwise b e
picked up by the existing HBsAg testing, and meant
that cases of hepatitis B transmission by blood
transfusion did still occur. Is that right?
ANSWER:
Yes, yes. My understanding was that we were still --
there was still some infectious units, that the
surface antigen test was not picking them up. And
I wish I could see the Liverpool study to sort of
actually see the numbers, but obviously it was
sufficient to make people such as Dr Gunson realise
that this test should be introduced.
|
46,215 | 333 | QUESTION:
Then we can see next paragraph:
"At the beginning of this year we were asked not
to start this test and to wait until the whole coun try
65 started testing. We have now been informed that th is
test is not to be introduced, this instruction comi ng
from the Department of Health. I am told that the
decision was 'not taken lightly'."
Now, again, we'll obviously need to pick up
elsewhere the Department of Health's own
decision-making process. Do you recall any more ab out
how and when you learnt of the Department of Health 's
decision?
ANSWER:
No, no. As we know, the advisory committee at the
Department of Health minutes were not for circulati on
so we wouldn't have seen anything about how they ca me
to this decision, and not taking it lightly. I fin d
that difficult. I'm putting it in context. The
Department of Health, for both HIV testing and for
hepatitis C testing, made decisions not to fund the
testing directly but to just offload it onto the
Health Authorities and the hospital services to jus t
take up the cost. So how they came to this decisio n
not to introduce a test that increased safety, when
they were almost certainly never going to have to d eal
with the financial implications, I find difficult t o
understand.
|
46,216 | 333 | QUESTION:
It would appear that Dr Hamilton, to whom this was
addressed, was troubled by the decision. We can se e
166 that from NHBT000 --
ANSWER:
He would be.
|
46,217 | 333 | QUESTION:
-- 5291_002.
So Dr Hamilton, who was Dr Peter Hamilton,
a haematologist at the Royal Victoria Infirmary, wa s
here three days later seeking advice from solicitor s.
He referred to the letter he'd received from you, a nd
then said:
"As the Consultant in Administrative Charge of
Blood Bank at this hospital, I am charged with the
issue of 'safe blood' to patients. It would seem t hat
although there is a 'test' which could improve the
safety of the blood issued in my name it appears th at
for financial reasons in this country it has been
decided not to use it."
Then he refers to the criminal prosecutions in
France, and asks for reassurance as to his position .
ANSWER:
Mm-hm.
|
46,218 | 333 | QUESTION:
Just one further document, I think then, on this
issue, which is at NHBT0097150_007, please. This i s
a newspaper article in The Times, April 1995, so it 's
a year and a half, or so, later. If we just pick i t
up in the middle column, second paragraph down from
the top. I think we can leave the whole thing on t he
screen, Sully, at the moment. It says:
167 "Dr Huw Lloyd, a former director of the Northern
Regional Transfusion Centre in Newcastle upon Tyne,
said he had been 'strongly in favour' of introducin g
the hepatitis B test, known as anti-HBc screening.
'There was sufficient information to suggest that i t
would improve the safety of blood transfusions' ... "
So we're now in the top right-hand column:
"His centre made all the arrangements for the
test to be introduced last year, but was then
instructed not to go ahead. 'I think that was not the
right decision to make', said Dr Lloyd, who has lef t
the service."
Then if we go to the bottom half of the page,
left-hand side. We can see there's reference to ot her
countries using anti-HBc testing, there's reference to
people in the service being angry and then, picking it
up, it says:
"Dr Lloyd said that the test could have been
introduced relatively inexpensively. 'But if you a re
not very keen on it, you can make out that there ar e
a lot of additional costs'."
Then there's a reflection of the concern of
Dr Peter Hamilton and it would appear he wrote to t he
BMJ in January 1994 about it.
Is that article an accurate reflection of your
168 views as at 1995?
ANSWER:
I've lost it. Sorry, is that article an accurate?
|
46,219 | 333 | QUESTION:
An accurate reflection of your views, as at 1995?
ANSWER:
Yes, it is. Apart from a comment in the second
section right-hand column, right at the end:
"Dr Lloyd, however, agrees with the Health
Department's decision in this case."
I don't know how that comment came about because
it does not match anything I had said earlier.
|
46,220 | 333 | QUESTION:
I think that's a reference to testing for HTLV-I,
Dr Lloyd.
ANSWER:
Is it? Oh, I see.
|
46,221 | 333 | QUESTION:
Yes. That's how I read it.
ANSWER:
Yes, thank you for that. Yes, you're quite right.
|
46,222 | 333 | QUESTION:
As opposed to the anti-HBc.
ANSWER:
Okay. But anti-HBc, yes, I -- that was my feeling at
the time. I think that's a fairly accurate reflect ion
of what I was thinking and we see some -- you know,
Dr Peter Hamilton was good at coming forward and
stating the point clearly, and I have to agree with
him.
|
46,223 | 333 | QUESTION:
Then, whether by reference to those SHO years or th en
in the 1980s when you began to concentrate on
haematology and transfusion and you had some
experience with blood banking, and so on, do you
recall what the position was in terms of record
keeping? Were there -- how meticulous or rigorous an
approach were you instructed or advised to take fro m
the hospital's perspective about ensuring that ther e
were clear records of what was transfused and to wh om,
both in the blood bank and in the patient's records ?
ANSWER:
Oh, in the patient's records, it was certainly drum med
into me that we always recorded the information on
transfusions, the donation number and what was
73 transfused. So that went into the patient's record ,
and, you know, that was -- that was very much
an imperative that we did that.
Hospital blood banking, the way in which records
were kept was varied. When I worked at the Freeman
Hospital, there was the consultant -- one of the tw o
consultant haematologists, initially one, Dr Mansoo r
Qureshi, very, very interested and concerned about
record keeping, to the extent that he wrote compute r
programmes to help the Department keep accurate
records of what was happening.
The other two hospitals were -- would have been
more manual. I can't remember exactly how they did
it. But yes, keeping records was certainly
an important issue, level of importance, you know, as
I say, Dr Qureshi was certainly up there amongst th e
top, wanting to make sure we had everything correct ly
recorded.
|
46,224 | 333 | QUESTION:
Then if we could look at document you've exhibited to
your statement please WITN6935018. This is headed
"Transfusion -- Do We Have Any Choice?":
"The answer is Yes and No!
"In many instances there is no choice, but in
some cases there is a choice.
"The main choices can be summarised as follows:
174 "Reduce your threshold for Transfusing ...
"Make judgements on clinical state not just on
the value.
"Have a maximum blood order schedule and do not
transfusion blood just because it has been
crossmatched.
"Use volume expanders.
"Use Autologous Techniques."
Then you refer to the possible use of blood
substitutes.
First of all, what was this document, was this
notes for a lecture or talk you were giving?
ANSWER:
Yes, yes. This was notes for a talk I was giving.
I can't remember exactly who I was talking to but, you
know, one of the hospital -- perhaps, you know,
perhaps at one of the hospitals. So, you know, I d id
do -- invited to talk here and there. And that's w hat
this is. Just personal notes, notes to me that I
could use for talking. It was probably supported b y
some slides.
|
46,225 | 333 | QUESTION:
I just wanted to ask you a little more about the
second and third of those choices. The "Make
judgments on clinical state not just on the value",
what did you mean by that?
ANSWER:
Well, not just on the value of the haemoglobin. So
175 ...[frozen screen]... look at the clinical state of
the patient. Is this patient in distress or having
difficulties because the haemoglobin is low, or are
they actually coping with their current haemoglobin
level? Don't just top it up to a nominal value.
And of course, the next one, "Have a maximum
blood order schedule", which is sort of a more
organisational policy, particularly aimed at more
junior staff in a department. Junior staff are goi ng
to be more cautious and therefore over-order blood
because they don't want to get caught out and screa med
at for not having enough blood ready for a procedur e,
particularly in surgery. So if you provide them wi th
a maximum blood order schedule, you're not -- you'r e
allowing them to order less blood, and not put
themselves or perceive to put themselves in
a difficult position.
|
46,226 | 333 | QUESTION:
And do you know when that process of having -- this
idea of the maximum blood order schedule, when that
was introduced in the region?
ANSWER:
Oh, it wouldn't have been introduced across the reg ion
as a single process but, you know, you have to
remember in the Northern Region most of the
haematologists -- well, all the haematologists,
possibly bar one, met on a fairly regular schedule --
176 it's not a schedule, but there was a regular meetin g
every Friday at the Royal Victoria Infirmary and
haematologists would come in ...[frozen screen]... a
crossover of information between them, and
discussions. So things would tend to -- you know, to
permeate across the region perhaps faster than in a n
area in a region that didn't have this very good
little meeting.
|
46,227 | 333 | QUESTION:
And I think we can see a reference to --
ANSWER:
I can't remember --
|
46,228 | 333 | QUESTION:
We can see a reference to those meetings and to
hospital transfusion committees at NHBT0009710.
These are the notes of a November '91 visit to
the RTC by Dr Ala and Dr Hewitt. If we just go to
page 2, we pick it up at the bottom half of the
page first of all, paragraph 1.3, "Regional
Transfusion Committees", it says:
"There is no Regional Transfusion Committee.
The Northern Region Consultant Haematologists' Grou p
meets twice per year. There is also a weekly infor mal
meeting of the Regional Haematologists, which the R TD
attends."
Is that what you were referring to?
ANSWER:
That was -- yes, correct. That's what I was referr ing
to.
77 |
46,229 | 333 | QUESTION:
Do you know when that weekly practice started? Was it
already ongoing when you came back to the Centre in
86/87?
ANSWER:
It was -- that was going back -- that was operating
back in 1981. I recall going into it as a registra r
being in -- Dr Collins saying, "You know, you shoul d
get across to that meeting". So that meeting had b een
going for a long time. I suspect it was instituted by
Professor William Walker.
|
46,230 | 333 | QUESTION:
Then the next paragraph refers to three-monthly
haematology audits. It says there:
"... topic-orientated and have included
transfusion matters."
Is there a system with which you were -- or
a process with which you were involved at the
Transfusion Service, was that done with the region and
the hospitals themselves?
ANSWER:
I think that was a-- I think -- sorry. I think tha t
was the region and the hospital. It wasn't somethi ng
driven by us. We were perhaps not as intrusive int o
the hospital blood banking as we might have been.
And you will perhaps note from other things I've
said that we -- when I moved from being -- well, I say
moved -- when I became chief executive, we
introduced -- we were able to appoint a consultant to
178 become the head of our medical service, specificall y
to sort of recognise -- you know, recognising that I
didn't have enough time to devote to some of these
issues such as hospital transfusion committees. An d
of course, a bit like Anne Collins before me, for
a number of years I had very little in the way of
other sort of consultant-level support.
|
46,231 | 333 | QUESTION:
And if we look at the top of the page we can just p ick
up the reference to hospital transfusion committees .
It says:
"Twenty/twenty-one Hospital Transfusion
Departments are serviced by the RTC and of these,
three/four have set up Hospital Transfusion
Committees. These generally meet at three-monthly
intervals. The RTC is not actively involved, but t wo
of the RTCs invite an RTC Consultant as appropriate ."
It sounds as though the establishment of the
hospital transfusion committees by the three or fou r
hospitals was relatively recent at that point in ti me.
Does that accord with your recollection?
ANSWER:
I think so. I think so. You said this was 1991?
|
46,232 | 333 | QUESTION:
November 1991, the date of this.
ANSWER:
Dr Ala and Dr Hewitt, yes. When Dr Hewitt and Dr A la
visited. So I think there was a hospital transfusi on
committee at the Freeman Hospital before that, when
179 I was still perhaps a senior registrar. But they
would have been one of the sort of -- one of the
hospitals that tended to be at the forefront of tha t
sort of issue.
|
46,233 | 333 | QUESTION:
Looking back now, Dr Lloyd, do you think there is m ore
that could have been done, whether by the Regional
Transfusion Service or by the hospitals within the
region or, indeed, nationally perhaps, by the Chief
Medical Officer or the Department of Health, to
reinforce the message about using transfusion
appropriately and encouraging and educating doctors
and nurses about the better use of transfusion?
ANSWER:
Certainly you can always do better. I -- you know,
I could have spent more time, and sort of recognise d
that I wasn't spending as much time as I, you know,
perhaps should, in working at that level with the
hospitals. But we did have -- the Northern Region did
have a good group of consultant haematologists so - -
you know, they understood these issues. Prior to
the -- prior to a hospital getting a consultant
haematologist, you were left with a pathologist
looking after the issues, and at that time that wou ld
have, you know -- I'm sure there wouldn't have been
the same pressure on teaching people how to use
transfusion properly. But once you've got the
180 haematologists there, you know, that was changing.
And you saw that when we had meetings with
the haematologists from around the regions, only tw ice
a year, we were able to work with them to change
transfusion practice. And, you know, the reduction in
the use of whole blood was also -- you know, we als o
talked about single unit transfusions. So yes, cou ld
have done more, but I don't think the Northern Regi on
at that time, by the end of the 1990s, was doing to o
badly.
|
46,234 | 333 | QUESTION:
Then last on this topic, NHBT0072687_001.
This is a letter from you to a consultant
cardiothoracic surgeon at the Freeman Hospital,
Dr Hilton, 11 June 1990. It says:
"Following the recent episode in which you
phoned myself requiring that we provide blood bags for
you to collect blood from staff in theatre for the
provision of immediate blood transfusion. I feel t hat
I need to reply to you and make my position clear."
Then you go on to describe these procedures as
highly dangerous, both because of the lack of prope r
blood grouping, and the risks from that, and then, the
third paragraph, the fact that the blood would not
have been tested for hepatitis B or HIV antibodies.
Obviously this is before the introduction of the
81 hepatitis C testing.
And then you go on to talk about -- discuss
the practice of using fresh whole blood in cardiac or
cardiothoracic surgery.
Do you recall how, if at all, this issue was
resolved?
ANSWER:
Well, you'll also see in witness statements that on e
of the haematologists at the Freeman Hospital was
saying something very similar to myself, that this
wasn't a suitable procedure. I don't know -- I thi nk
that was probably a letter from Dr Patrick Kesteven
to -- to Mr Colin Hilton.
I would imagine that they worked it out between
them but I don't recall any sort of long term
follow-up. I did get a copy of -- it's a -- well,
it's in the state -- one of the documents in the
Inquiry -- another letter from Colin reminding me t hat
they were not the only people wanting to use fresh
whole blood in that clinical situation.
I have no problem with them using fresh whole
blood if that's -- was the best thing for the clini cal
care of the patient. I was concerned about it bein g
done safely. And I wasn't going to participate in an
unsafe procedure. But I don't know where it went
after that.
182 |
46,235 | 333 | QUESTION:
Then my final topic, Dr Lloyd, is in relation to
record keeping. We've covered already in your
statement, and the documents we've got refers to th e
record-keeping systems at the Centre and your
introduction of the various computerised systems, s o
I'm not proposing to ask you more about that, but y ou
were involved in the production of a report about
record storage, which is at NHBT0071590_001.
So "Record Storage Report for the [NBTS] in
England and Wales, Prepared on behalf of the Nation al
Directorate of the [NBTS] by Dr Lloyd, Dr Beal and
Mr Martina, April 1992.
Then if we go to page 4, we can just pick up the
"Introduction". So the report explains:
"Transfusion Centres store a wide range of
documents and records ..."
And then --
ANSWER:
Could we bring that up, could we bring that up on t he
screen, please?
|
46,236 | 333 | QUESTION:
Do you not have it on your screen?
ANSWER:
I don't, no. We've not moved on from Dr Hilton's
letter yet.
|
46,237 | 333 | QUESTION:
Ah, let's try again. Could you reload it, Sully,
because it was on my screen. Have you got it there ?
ANSWER:
Yes, I have 1.1, "Introduction". Thank you.
183 |
46,238 | 333 | QUESTION:
Yes, so it says:
"Transfusion Centres store a wide range of
documents and records ..."
Then if we skip down to the third paragraph:
"Each group of documents or records can be
viewed as having to be retained for certain minimum
periods to satisfy specific legal requirements ..."
Then you say:
"The need to retain documents and records for
use in future potential litigation is increasing as
the level of litigation increases and it is imperat ive
that major cases are not lost purely because the
relevant documents are not available."
Then if we -- I'll skip over the next paragraph
and then it says:
"To be of value, any records system needs to be
simple, robust and reliable."
Now, before I ask you a couple of questions
about the recommendations in the report, this
introduction seems to be very much focused upon the
fear of litigation. Was that the context in which
this report was commissioned, or -- how did it come
about that you and your colleagues were producing
this?
ANSWER:
I mean, obviously Dr Gunson asked for this report. He
184 must have been concerned about retaining records.
I know I've -- this little bit focuses on litigatio n
but I think you'll see elsewhere in the document th at
it actually focuses on -- it actually includes a wi de
range of sort of legal requirements to retain recor ds.
Obviously a lot of the -- these records are
retained because there is a potential to come back
and -- for litigation. Whether that was Dr Gunson' s
focus, I can't remember how it -- I don't -- I have n't
seen any letter from him sort of giving me and Dr B eal
and Tony Martina a remit, a formal remit for doing
this, for producing this. It's very much an
organisational-wide process that you might apply to
any sort of large organisation.
|
46,239 | 333 | QUESTION:
If we go to page 7, please, Sully, top half of the
page. We can see outline recommendations and you
identify there three categories: "Long Term", where
the recommendation is to keep the records for
30 years:
"This covers Donor and Donation records and
policy and management records as well as records
directly linked to Donor and Donation records such as
QA reports."
Then you have "Intermediate Term" for
a different category of documents, which was 10 yea rs,
85 and then a "Transient Term" storage period for
2 years.
There's more detail given about the categories
and, in particular, the inclusion of donor and
donation records, pages 10 to 11 of the report. I' m
not going to go through that, but if we turn to
page 14, we can pick up the recommendation at the
bottom of the page, in terms of a basic system:
"Transfusion Centres should institute a records
storage system which enables records of potential
significance for litigation to be retained for
30 years."
Then the next paragraph says:
"A record of the destruction of records should
be maintained, including the destruction of origina ls
after transfer of records to other storage media.
"A scheme such as the Annual Policy statement
records should be instituted."
Top of the next page:
"A formal written policy should be provided and
followed. The system used should be audited ..."
Then the next paragraph says:
"The system proposed in this report can be
adapted to each RTC's specific requirements ..."
Do you know when the recommendations in this
186 report were implemented, either in the Northern Reg ion
or more generally across England and Wales?
ANSWER:
I'll talk first about the Northern Region. Yes, we
implemented a policy, basically what was outlined i n
this document. We took a large room in the buildin g,
moved out what was in it, and created a record stor age
facility. We appointed -- we gave someone the
...[frozen screen]... the documents, and so we star ted
down this route. So the documents were in proper
cabinets the sort of things you see sometimes in
libraries, with big wheels that you move the cabine ts
up and down on tracks, allows you to have high dens ity
storage and, yet, you're able to access documents,
find them very easily, and we certainly implemented
the policy of keeping records of what we did.
It sounds silly: records of records. But,
I mean, if you're going to keep a record, you need to
know that you've kept it, what it's about, where it is
and if you decide to destroy it, you should -- you
identify why you destroyed it and when you destroye d
it, or when you destroyed it and why you destroyed it.
So then in the future, when someone comes along
and says why haven't you kept such and such a recor d,
you can go back to this long-term record that says,
yes, this is where we looked at this, we made
187 a decision, we destroyed it. This is why we did it .
It wasn't just a lackadaisical thing.
So in the centre, yes, we did start to follow
this. Of course, we didn't have any years to do it .
I believe, and this is very secondhand hearsay,
through a colleague of mine after I'd left the
service, who did say that the Transfusion Service w ere
using this document, didn't go into details, but he
sort of said that this document was still being use d
by the service after I'd left, and, you know, Tony and
Dr Beal, you know, helped produce a -- what I think
was a pretty sound document, and thanks to them.
|
46,240 | 333 | QUESTION:
I think the Inquiry has heard some evidence or
received some evidence that the Red Book guidelines
around this time were 15 years, in relation to the
kind of records you were here identifying should be
kept for 30 years.
ANSWER:
Yes.
|
46,241 | 333 | QUESTION:
Was that your understanding and was the intention,
therefore, to essentially depart from the Red Book
guidance and create a longer term storage system?
ANSWER:
Yes, definitely. I think the three of us recognise d
that you couldn't, sort of, rely on things, you kno w,
just saying, oh, well, you know, it's a certain num ber
of years. You actually had to look to the future, and
188 I do recall in this report I referred to litigation .
I can't remember the person's name but between
an individual and English electric company, I think it
is, in this report, someone who had pneumoconiosis.
And there you see that the litigation was allowed t o
proceed long after what at the time were considered to
be the sort of limits on bringing cases to court. So
we recognised that we couldn't rely on some of thes e
other documents.
And we also, I think, in this report, say, yes,
we've said 30 years but when you start getting towa rds
30 years, you have documents that have been stored for
30 years, you need to stop and review your policy a nd
decide whether you need to increase it again.
|
46,242 | 333 | QUESTION:
Don't worry, if you don't know, you don't know.
The next question is about donor exclusion on
the basis of previous transfusions. You'll recall we
looked yesterday at both the national guidance and
190 then the Northern Region zone guide or booklet on
donor selection, which looked at deferral of donors
who'd had a blood transfusion. What was your
understanding of the rationale for excluding donors or
deferring donors on the basis that they had had
a blood transfusion?
ANSWER:
Right. I think the issue was that we know that
there's potential for infection, and if someone is
infected, there is a period between infection and - -
the relevant tests becoming positive. So by
delaying -- by giving those months in between,
certainly if there was something transmitted then y ou
have a chance to pick it up on testing.
There's also a more general issue that people
who have been transfused presumably have had some
reasonably serious condition and therefore need tim e
to recuperate appropriately. So there's a little b it
of both. But I think the -- it was the first was
the -- sort of the issue there.
|
46,243 | 333 | QUESTION:
Then when donors were either excluded or deferred - -
and this next question is not limited to previous
blood transfusion -- what were the circumstances in
which a donor might be advised to go and see their GP
and have further testing?
ANSWER:
I mean, that usually -- that was sort of a rather
191 individual decision. It might start with a medical
officer -- in those days it was a medical officer a t
the session and not a clinical nurse specialist, bu t
you would have -- they might recognise, particularl y
being a general practitioner, they would recognise
that there was an issue that needed following up an d
would do so.
And the second was, when that wonderful illness
book, duplicate book, information came back from th e
session and the medical officer at the centre
looked at it, they might recognise that there was
a need to obtain additional information. Probably
more often, in that case, it was obtaining more
information rather than passing the -- asking the
donor to get further care and treatment. But I thi nk
at the sessions the medical officer was probably th e
one who was asking people to -- suggesting that the y
get followed up.
There is of course the case of those who were
found to be positive for infectious and transmissib le
disease.
|
46,244 | 333 | QUESTION:
Yes.
ANSWER:
Very different requirement to go and see somebody.
|
46,245 | 333 | QUESTION:
Then if you had a donor who was being deferred or s ent
away because they'd had a blood transfusion in the
192 past -- I appreciate the period of time might vary
depending upon the particular set of guidance in
operation at that time, but if you were doing that,
was there any practice of telling donors why it was
a transfusion might mean they shouldn't give blood at
that stage? Would they be told, for example, "Well ,
there is a risk of infection and you perhaps you mi ght
yourself want to go and get tested"?
ANSWER:
I don't recall that being certainly a written polic y.
I'm pretty sure it wasn't a written policy. Did th e
medical officer at the session do that? Certainly,
there was the option to discuss the issue. It depe nds
on the -- you know, it does depend on the individua l
doctor, and patient -- sorry, the donor. But, no,
I don't think we had a proper policy on saying you
must tell the person who has received the transfusi on
that they might be at risk.
|
46,246 | 333 | QUESTION:
Cases of possible transfusion-associated hepatitis, is
it right to understand that you did not report such
cases to the CDSC?
ANSWER:
Well, if a patient had a transfusion -- well, had
a transfusion and then developed hepatitis, that --
I don't think -- I don't think we were informing th e
CDSC ourselves. Whether the hospitals did, because
the person -- the individual was still a patient of
93 that hospital, becomes different once you start to get
into look-back and find issues there. But no, I th ink
the reporting in the case you referred -- in that
situation you referred to, would have been more lik ely
at the hospital and the transfusion centre level.
|
46,247 | 333 | QUESTION:
Do you think it would have been helpful to have som e
kind of reporting obligation and a body, whether it
was CDSC or another body, to whom all such cases of
transfusion-associated hepatitis should be reported ?
ANSWER:
Oh yes, definitely it would have -- it is the sort of
thing that, you know, you look at and think: well, we
should have taken -- there should have been a broad er
sort of picture of this, and therefore information
gathered -- should be gathered in one place, certai nly
something the National Directorate could have assis ted
with.
|
46,248 | 333 | QUESTION:
Then next can I ask you to look at your statement,
WITN6935001.
Page 108, please, Sully.
If we look at the bottom of the page,
paragraph 171, there's the reference there to "Maxi mum
benefit at minimal cost". And then I'm not asking you
about the first sentence in the context of the
question. I've just been asked to ask you more
generally to talk about the concept and explain wha t
194 it is when you talk about maximum benefit at minimu m
cost, and then the shift that you then talk about t he
move to whether risk of injury to patients becomes
more important.
Can you just flesh that out for us?
ANSWER:
Yes. Certainly if you read some of the documents t hat
have been supplied and a couple of journal articles ,
there were groups, certain people who were saying w e
shouldn't move to maximum -- we shouldn't move to
minimising risk, irrespective of cost. There was
certainly this feeling that -- more than feeling --
that, you know, you go for maximum benefit at minim um
cost, which means that you leave a number of people at
"risk of injury", as it's put here.
And certainly, you know, we've seen that that
sort of almost paternalistic approach to care is no t
what we see today. And I think that move was
occurring then. As I think I mentioned elsewhere i n
my statement, it wasn't a sort of a sudden change b y
the organisation, by the NBTS, but, you know, you
could feel that change coming. We were prepared to
introduce a test which was not going to, if you lik e,
save a large number of lives -- it was going to sav e a
lot of individual lives and distress, and so, you
know, we're moving from, "Oh, we don't need to worr y
195 about that, it's too expensive", to "We do need to
care about the patients and our donors."
So it's a move that was occurring, and I think
in some quarters of the Transfusion Service they we re
late in coming to that sort of conclusion.
|
46,249 | 333 | QUESTION:
Next --
ANSWER:
I hope that helps you.
|
46,250 | 333 | QUESTION:
Thank you. The next question relates to the delays in
the introduction of hepatitis C screening. One of the
concerns expressed in documentation at the time is
about false positives. What was your view on the
issue of false positives and how to deal with donor s
or the possible situation of donors being given
false-positive results?
ANSWER:
Right. Well, if you go back to HIV screening, we'd
already faced this issue. There were already cases of
donors who were marked as positive, and they weren' t
because they were not infectious. So we've had to
face that before. And so you try and -- you go dow n
to your roots. One is get you positive on initial
screening, you do repeat screening, you then do
confirmatory tests, and you still end up with some
where you're not quite sure.
So, in those cases, you are asking those people
to be seen and I think in one of the letters from t he
196 Centre, you know, we sort of expressed that. We do n't
think that you're infectious but you really need to
see someone who can really take you through more
detail, and get it sorted out. It's not going to b e
pleasant for the individual but that, I think, in m y
personal opinion, that's a more acceptable issue to
handle than not testing at all.
So we're going to test, we're going to have
positives, some of them will be false positives and
we're going to do additional testing, we're going t o
pass them on for others and well try and, you know,
support the individual during that initial phase wh en
they're suddenly faced with "Oh my goodness, I migh t
have something nasty".
The next question goes back to a completely
different topic. This is about the actual process of
donor screening.
|
46,251 | 333 | QUESTION:
In the Northern Region, could you just help us with
understanding who was undertaking the screening. I f
we leave aside at the moment the Teesside office an d
talk about the rest of the sessions, whether they w ere
general public sessions or industrial sessions in t he
Northern Region --
ANSWER:
Okay.
97 |
46,252 | 333 | QUESTION:
-- was it a donor session clerk with, then, referra l
to a medical officer in some instances?
ANSWER:
Yes, the donor -- actually it was the same for both
the Teesside office and the new -- sessions out of
Newcastle. At both sites we employed people who we re
specifically looking after donor issues. So they w ere
clerks, yes, but they were trained to carry out
certain tasks and they rotated between working with in
the Centre, where they might be fielding some
questions from donors by phone, out to the sessions
where they would be asking donors the questions, an d,
you know, recording information and making decision s.
And we did introduce training as ...[frozen
screen]... for the donor clerks to help them. And as
you said, then, if they couldn't resolve something,
they would pass it on.
And one thing we did try to do was to provide
them with better and more usable information. If y ou
look at some of those donor screening, donor care a nd
selection documents, one of which you presented to me,
from 1977 I think -- it was later, but anyway, thos e
documents are not that easy to use. You've got
different lists in different places, not easy -- it 's
very well laid out. So we did try to improve what we
were giving to the donor services clerks to make th ose
198 decisions.
|
46,253 | 333 | QUESTION:
When in May/June of 1991 there was a backlash in
relation to your decision to introduce hepatitis C
screening ahead of the common start date, what was the
response, if any, of your Regional Health Authority ?
Were they supportive of your position?
ANSWER:
Yes. I had absolutely no problem. I had no advers e
comment from the Regional Health Authority, any of its
senior officers ...[frozen screen]... actually it w as
probably the Regional General Manager at the time,
but, you know, no problem. There was -- I mean, th ey
didn't phone me up and slap me on the back and say,
"You're a jolly good fellow", but I had no complain ts,
no one is saying, "You shouldn't have done this". No
one saying, "Oh, you've put us in a difficult
position". So I certainly have no complaints about
how they acted.
|
46,254 | 333 | QUESTION:
And then the last question is this: did you get any
sense during the decision making in relation to
hepatitis C testing, whether from Dr Gunson and --
ANSWER:
Sorry, could you --
|
46,255 | 333 | QUESTION:
Yes, I'll start again.
ANSWER:
I'm sorry, I'm going to have to ask you to start th at
question again.
|
46,256 | 333 | QUESTION:
No problem.
199 During the introduction -- the decision making
about the introduction of hepatitis C testing, or
indeed after you'd introduced it, did you get any
sense that litigation, in particular the fact that
there had been the HIV Haemophilia Litigation again st
the Department of Health, and others, did you get a ny
sense that that was playing a role in the desire to
present a unified front?
ANSWER:
I mean, that was my impression. I don't think I ha ve
any documentary evidence to support it but my
impression was, you know, as long as we all start
together, no one can criticise us. And I think tha t
was probably the same with HIV, but certainly with
hepatitis C. As long as we all do it together, tha t's
a great defence because how could you -- how can yo u
go after one particular individual or one section o f
the organisation when they all did it together?
I've said before, that completely forgets the
issue of the patients.
|
46,257 | 334 | null |
46,258 | 335 | null |
46,259 | 336 | QUESTION:
Sir, we are turning to the issue of domestic
production of blood products and questions around t he
self-sufficiency. There will be a series of
presentations in the coming weeks and then some ora l
witnesses as well.
We are beginning with a presentation on
production of blood products in England and Wales. We
will follow that with some individual presentations on
Dr Lane and Dr Smith, two significant figures from
BPL, which will be done by Ms Richards towards the end
of this week. Next week, Mr Boukraa will present
a chronological account of blood product production in
Scotland. We will also look at pool sizes that wee k,
and then we will have the witnesses following up wh o
are Dr Snape, Dr Perry and Dr Foster.
ANSWER:
And will we be examining in the --
although we're separating England and Wales from
Scotland, and Northern Ireland is going to come in
there I think next week, isn't it?
2 |
46,260 | 336 | QUESTION:
Yes.
ANSWER:
We are going to bear in mind, are
we, that there may have been sources of production if
one viewed the whole as United Kingdom.
|
46,261 | 336 | QUESTION:
Yes. That is something that will be touched
upon today and examined in more detail next week by
Mr Boukraa.
Northern Ireland will be dealt with more with
Scotland because that is where product began to be
made in the 1980s for Northern Ireland. Again, it
will be touched upon today and some evidence as to why
that arrangement came to be.
ANSWER:
Will we in the course of the
presentations be looking at, or in the course of th e
next two or three weeks, be looking at the question of
whether Scotland could have supplied more in respec t
of the UK's consumption than it did?
|
46,262 | 336 | QUESTION:
Yes, we will be looking at that. In preparing
these presentations, we are very conscious of the f act
that you have heard oral evidence. These
presentations aren't an effort to try to surpass th at
oral evidence or even to try to analyse it. They a re
a piece of a jigsaw to go with the oral evidence
rather than replacing it.
ANSWER:
Those who read the opening words of
3the presentation will be left in no doubt this is n ot
the view of the Inquiry. These are relevant docume nts
and, to assist understanding, you put them in
chronological order and made observations about the m,
but they are as good as the person who is making th e
observations.
|
46,263 | 336 | QUESTION:
Exactly so, sir. These are not our submissions.
These are an account of what the documents seem to us
to show.
ANSWER:
And you will be open to others who
look at the documents to interpret them in a differ ent
way, if they think that is appropriate, and to
persuade me in their submissions that that's the wa y
I should look at them.
|
46,264 | 336 | QUESTION:
Absolutely, sir. Two people can look in good
faith at the same document and come to differing
conclusions, and that will be -- there will be an
opportunity for all Core Participants to make those
submissions in due course.
ANSWER:
Yes.
|
46,265 | 336 | QUESTION:
This presentation that I'm going to start today,
and I'm sure will go into tomorrow as well, doesn't
attempt to be comprehensive. It is inevitably base d
upon a selection of the documents, otherwise we wou ld
be here for many, many weeks.
4No special status is gained by a document being
included or excluded and, as you've just been sayin g,
sir, the Core Participants may well feel that there
are other documents which are equally or more
important, and they will have an opportunity to bri ng
those to your attention in due course.
All conclusions, sir, are for you, and your
counsel team do not seek to trespass on that territ ory
at all.
The Core Participants will also be aware that
a report has been provided from the expert
fractionators instructed by the Inquiry. It is als o
on the Inquiry's website. We are not currently
proposing to call the authors of the fractionation
report to give oral evidence, and we are not seekin g
to explore that report in the next three weeks. It 's
there as background. It will have the same status as
any other piece of evidence, expert or otherwise, a nd
you can accept or reject it in part or in whole and
give such weight to it as you feel is appropriate.
If Core Participants have any particular
observations on the report, then they can be provid ed
as part of their written closing submissions which the
Inquiry has asked to be filed in late October.
I mention that so that everybody is aware of it.
It is there, but it is not a resource that I will b e
referring to in the next few days.
ANSWER:
Well, it doesn't deal directly with
issues of self-sufficiency, though it does, I think ,
suggest that the first commercial anti-haemophilic
fraction was produced in Sweden and marketed as
AHF-Kabi or I-O, Kabi, and that was in 1956.
|
46,266 | 336 | QUESTION:
I think that's right, sir, yes. It brings me on
to where we are with this presentation which begins in
the 1970s. There are other places where one can
begin, as the fractionators have, back in the '50s.
You, sir, have looked at some documents in the
past from the 1960s, and in particular a letter fro m
1967, 22 August 1967. The reference is
DHSC0100025_062. I didn't ask for that to be broug ht
up, but that is a letter from Dr Rosemary Biggs to
Dr Godber, the Chief Medical Officer, which raises in
1967 the question of domestic production of
concentrates and suggests that 50,000 donors a year
could be used to produce such concentrates in order to
treat those who would most benefit from them at tha t
time.
There is this pre-history, but this presentation
is going to begin in the 1970s where the impact of
increasing commercial products and the product
6licences that we have seen were issued for Hemofil and
Kryobulin, the impact those have upon the spur towa rds
domestic production and a policy that was described as
self-sufficiency. I use that word somewhat cautiou sly
because it means different things to different peop le
at different times.
ANSWER:
Just going back for a moment to
Dr Biggs' letter to Dr Godber. That's a letter whi ch,
what, in April 1967 anticipates, does it, that ther e
would be a need for investment to make sure that th e
BPL and PFC in Scotland were able to produce more. It
envisages using red blood cells out of a donation o f
blood and harvesting the plasma, so it fits in very
neatly with some of the evidence that I've been
hearing over the past few weeks. And she does rais e
the question that if we don't get on with it, then we
may have to rely upon commercial concentrates from
elsewhere.
|
46,267 | 336 | QUESTION:
Exactly so, sir. Perhaps we can bring it up as
good a place to start as any.
ANSWER:
It might be a place to begin. It's
a contribution to the debate.
|
46,268 | 336 | QUESTION:
It is, and Dr Biggs is an important player in
that debate, as we will see in the 1970s as well.
It's DHSC0100025_62. We can see from the heading - -
7ANSWER:
I was wrong about the April. It's
August.
|
46,269 | 336 | QUESTION:
It's August. 22 August 1967. We can see from
the heading, should anybody need the reminder, that
Dr Biggs was from the Oxford haemophilia centre,
addressed to Dr Godber, Chief Medical Officer and w hat
the letter says is this. The first paragraph is ab out
thanking Dr Godber for an invitation to join the
committee. Paragraph 2:
"I should like to take this opportunity to
mention the question of preparations for the treatm ent
of haemophilia and Christmas disease. These are
mainly human blood products and do not, I suppose,
class as proprietary preparations. The preparation s
I have in mind are concentrates from human plasma o f
factors VIII and IX used for the treatment of patie nts
with haemophilia and Christmas Disease respectively .
"Both of these preparations are in very short
supply in England, and at present they're also scar ce
everywhere in the world. They are so important for
the treatment of these patients that their use make s
the difference between life and death in many cases ,
and the difference between quick recovery and long,
drawn, painful illness with residual crippling in m any
others. At present, many haemophilic patients are not
8aware of the great efficacy of this treatment and d o
not attend as they should for treatment. In the ne xt
year or two, I would expect that these patients wil l
attend for treatment.
"I have estimated on the basis of our practice
that a minimum quantity of these concentrates requi red
at present is the product from about 50,000 donors
a year."
I pause there, sir, to say that there are
various measures that are used about the quantity o f
plasma that is required to produce concentrates. I n
the period here and into the early 1970s, the metri c
tends to be donors or donations.
ANSWER:
Well, they didn't yet have an
International Standard for Factor VIII activity, di d
they?
|
46,270 | 336 | QUESTION:
That's right. That's right.
ANSWER:
When did that come in?
|
46,271 | 336 | QUESTION:
That comes in the mid-1970s when, firstly, there
is a reference to units and then it becomes
international units. That refers to the end produc t,
how much is actually made. The way that how much
plasma goes in to make that end product is describe d
in various ways, initially from donations, later it
comes to be referred to either by weight, by kilogr am,
or by volume, by litre. But in this early period i t
is donations.
It is quite hard sometimes to translate between
the different figures and must be done with a degre e
of caution. I'll come back to that on Thursday whe n
we look at some statistical analyses and graphs of
plasma supply and blood product production in Engla nd
and Wales.
But at this period, we're talking about donors
or, probably more accurately, donations. 50,000 is
the figure given here and that is a figure to keep in
mind as we go forward through the 1970s.
Returning to the document. I quote:
"When all of the patients come for treatment
more would be needed. The supply of plasma as
starting material for fractionation would, I think, be
no problem since the use of the red cells can be
organised. This shortage of material to treat thes e
patients is not new, but at the meeting I attended
recently, the plans made by the United States to de al
with the shortage were outlined. I have good reaso n
to believe that within the next year or two very la rge
amounts of these products will become available on
a Commercial basis in the United States. I estimat e
that the product from more than 1,000,000 donors
10 a year will be processed. When this material comes on
to the market we shall be obliged to buy it at a ve ry
high cost for our patients unless the English short age
can be remedied."
Going on to paragraph 5:
"In this country we have pioneered this
treatment, we have the personnel who know how to ma ke
the products, we could easily have enough plasma to
serve as starting material. It would seem to me
a great pity if we cannot make our own material in
this country for lack of the organisation, apparatu s
and buildings in which to work. The purchase of th e
finished products in the United States will
undoubtedly be very costly. A part of the
United States product will be made on contract by t he
American Red Cross and will presumably not be
available for sale aboard but a large amount will b e
made by commercial enterprises and on sale. On
present prices a course of anti-haemophilic treatme nt
for one emergency purchased from the United States
would cost $1,500 to $5,000. Surely it would be le ss
costly to us to do everything to expedite the
manufacture of these fractions in England and in
particular to accelerate as much as possible the ne w
fractionation buildings at Elstree and Edinburgh.
11 I feel that it is perhaps time to try to reassess t he
quantities of these products that might be needed a nd
to try to work out an emergency plan to try to meet
the need."
That's Dr Biggs, August 1967.
As you say, sir, some of the themes that come
out of that letter include the reference to red cel ls,
and that's the idea that one can separate red cell
concentrate from the plasma, thereby allowing more
plasma to be fractionated, the red cells to be used in
blood transfusions, a more efficient use of a blood
donation. There is also reference to the potential
cost of the imported products, and a plea, that is not
to put it too high, to start thinking about what ca n
be done in England and Scotland to produce more
products domestically, given that, as Dr Biggs said ,
the relevant expertise was available in the country .
But the reference to Elstree and Edinburgh:
Elstree is a reference to the Blood Products
Laboratory and Edinburgh to what becomes the Protei n
Fractionation Centre, the discussion of various
building works that were ongoing at that time.
ANSWER:
She refers also, in one word,
I think, to the necessary organisation to do it --
|
46,272 | 336 | QUESTION:
Yes.
12 ANSWER:
-- which we've heard, again perhaps,
a lot about just recently.
|
46,273 | 336 | QUESTION:
Yes, that will be something that comes up again
repeatedly in the '70s. Of notice, the fact that t he
letter was addressed to Dr Godber at the Department of
Health --
ANSWER:
Yes.
|
46,274 | 336 | QUESTION:
-- or, as it was then called, the Ministry of
Health, later becomes the Department of Health and
Social Security.
I will be coming on to the '70s shortly but,
just so there is a route map of where we are going to
go, the intention of a presentation is to trace the
rise in demand for Factor VIII concentrates in Engl and
and Wales and the associated calls for national
self-sufficiency, which pick up on what Dr Biggs sa id
in that earlier letter, and indeed are amplified by
Dr Biggs herself.
We will look then at how that fed into estimates
for future usage and planning on how to increase bo th
plasma supply and the production of blood products.
We will consider the response of the DHSS, and the
Regional Health Authorities, then a discussion of t he
announcements in late 1974 and early 1975, about wh ich
you've heard some evidence from Dr Owen and others,
3 the £500,000 of central DHSS funding to increase
plasma supply for fractionation.
We will look at how that money was spent, what
was said about it and what was achieved. We will t hen
turn into increases in demand for factor concentrat e
in the second half of the 1970s, and the revised
estimates that follow.
We will look at the related need to redevelop
BPL at that time, both through increased capacity a nd
in response to the Medicines Inspectorate report.
This led to what was called, originally, the Stop G ap
programme, which, as the name suggests, was an inte rim
measure for some redevelopment before a full
redevelopment of BPL. That programme was later
changed to be called the MARP01 programme, MARP
standing for Medicines Act Rehabilitation Programme ,
and again, as the name suggests, you can see how St op
Gap has been knocked off course by the Medicines
Inspectorate report, although there is a great deal of
overlap between those two programmes.
At that stage, sir, the presentation comes to
a point where Dr Walford's presentation to you bega n,
which is discussion about the full redevelopment of
BPL. To lapse into an analogy, the camera, at that
point, is going to pan out, both in the written
14 presentation and the oral presentation, to give
an overview of the events that led to the redevelop ed
of BPL but there is no intention to try to repeat t he
detailed evidence that was given by Dr Walford and by
reference to the documents about that period.
There is similarly going to be an overview of
the introduction of heat treatment at BPL and at it s
sister plant, the Plasma Fractionation Laboratory,
PFL, in Oxford. More detail is going to be provide d
on those matters when Ms Richards takes you through
the presentations on Dr Richard Lane and Dr Jim Smi th.
So I will touch very lightly, if at all, orally on
those, but there is an overview in the written
presentation, which may assist to provide some
background, some context for what is to follow.
Having gone through the events chronologically,
the intention is then to zoom in again with the cam era
on a couple of thematic points looking at the data the
Inquiry has identified on three issues. The plan i s
to do this looking across the 1970s and the '80s, s o
that we can see the patterns developing without the
chronology getting in the way.
The first is about the estimates that were made
for Factor VIII usage during the '70s and '80s. Th e
second issue was the level of plasma supply to BPL and
15 PFL, and the third issue is the amount of Factor VI II
concentrates that BPL and PFL could have produced a nd
did produce during that time.
By looking thematically at those matters, it is
hoped that this will help to identify the shortcomi ngs
that meant that clinicians in England and Wales
continued to use imported concentrates throughout t his
period.
The written presentation will be published on
the Inquiry's website; I'm not quite sure if it is up
there yet, but it will be there soon if not. It is
also available on Relativity. I understand, at the
moment, it is only available to the legal
representatives of the Core Participants but it wil l
be made more generally available on Relativity. It is
accompanied by seven appendices that will be publis hed
and disclosed in the same way and they provide more
detail on specific points, for example the detail o f
how the £500,000 was spent on a region-by-region
basis, and the documentary evidence about the role of
the SAG-M additive in the plasma supply.
Now, I won't seek to summarise all of those
appendices, they're intended to assist on more
technical and more granular details that are
important, and I would invite everybody who was
16 interested to read those, but, for reasons of time, we
will not be going through those in enormous detail.
The exceptions are Appendix 1 and Appendix 2, which
will form the mainstay of that thematic presentatio n
that I've just discussed.
The focus of this presentation is on
Factor VIII, the product that was more widely used in
England and Wales and posed more problems for
Government and fractionators in terms of providing
enough of it. England and Wales was largely
self-sufficient in Factor IX for much of this perio d.
There were imports, particularly following the
introduction of heat treatment, and that's somethin g
we will touch upon, but the focus will be on
Factor VIII. There will also be a presentation nex t
week on the specific question of the pool sizes tha t
were used in BPL and in PFC and indeed in Oxford as
well.
As you know, sir, it will be myself and
Ms Richards and Mr Boukraa who are giving these
presentations but we have been assisted enormously by
the hard work of the Inquiry legal team in preparin g
them, their names have been added to the appendices
and the main presentation as well. We are extremel y
grateful for everything they have done.
7 Before diving into the 1970s, it may be helpful
just to explore briefly a few themes that emerge in
this period on this topic. The first theme is real ly
to identify the three elements that determined how
much domestic Factor VIII concentrate could be
produced. Those three elements were the plasma
supply, the ability of BPL and PFC to fractionate t hat
plasma, and the planning assumptions that went into
both plasma supply and fractionation capacity, and
those assumptions were based on estimates of demand
for the products. Those are the three elements tha t
we will look at repeatedly.
The second theme, and something that you, sir,
have already touched upon, is the lack of a central
body with executive powers to direct and coordinate
those with the responsibility for those three
different elements.
Plasma supply fell within the remit of the
Regional Transfusion Centres and the Regional Healt h
Authorities that funded those Regional Transfusion
Centres. Fractionation fell within the remit of th e
Blood Products Laboratory and the Protein
Fractionation Centre. The DHSS, funded both of tho se
elements but it did so indirectly, in general, with
one exception that we will come to look at. The
18 clinicians were working within the NHS and, again, the
funding came ultimately from the DHSS, but there wa s
a strong value placed on clinical freedom and clini cal
independence.
Ministers and civil servants had little power or
inclination to dictate policies to doctors,
transfusion directors and fractionators, and they
equally may not have taken kindly to attempts to do
so.
These different groups were both interdependent
and independent.
The third theme associated with that lack of
a central executive body was the lack of a single
accepted definition of what self-sufficiency meant.
This a matter on which you have heard evidence befo re.
Did it include prophylactic treatment? Behind that
question lay the wider issue of the type of life th at
those with haemophilia should aspire to lead. We w ill
hear some of the debate that took place on that poi nt.
It is covered in particular in appendix 2.
Throughout that theme, there is an underlying
question of whether or not an assessment should be
made of clinical need rather than clinical demand.
Clinical demand reflected what patients and clinici ans
would like; clinical need reflected what those more
19 centrally thought should be supplied.
ANSWER:
At some stage, we may have to think
about, and I don't necessarily suggest in this week ,
how both of those, demand and need, reflect what th e
patient wanted.
|
46,275 | 336 | QUESTION:
Exactly, exactly. That is not something that we
will be looking at in detail this week, because the
focus is rather at the other end of the telescope
about how fractionators and civil servants and
regional administrators responded to what they
understood the demand to be. It is not a question of
how that demand was formed, in terms of how much
information patients had, and what their views were
compared to the views of the clinicians.
That is not something that I seek to discuss in
the next couple of days. It is a very important po int
and it is not one that -- I know, sir, that it is n ot
one that you will overlook but it is not the focus of
this presentation.
ANSWER:
It's just that it can be difficult
to talk about clinical need across a group, when on e
person's needs may be something for that person to
have an input into, as opposed to something which i s
determined by the body looking at what they need in
their opinion, and that was what I had in mind --
20 |
46,276 | 336 | QUESTION:
Yes, absolutely. It's the top-down and
bottom-up approach.
ANSWER:
-- how those two, personal autonomy
and clinical decision making or, for that matter,
strategic decision making, fit together.
|
46,277 | 336 | QUESTION:
Yes.
The fourth theme that we've identified is the
importance of the availability of commercial produc ts
in pushing forward both demands for self-sufficienc y
and pressures on clinicians, on politicians and civ il
servants, and on fractionators. Those commercial
products threatened, at least in some eyes, the ver y
existence of the UK's voluntary donor system. As w e
will see, in the early stages of the development of
the policy on self-sufficiency, the drive comes fro m
cost and the need to try to produce a domestic prod uct
that wasn't as expensive as the commercial imports and
to provide enough of it to ensure that the commerci al
imports didn't dominate the UK market.
Later, principles about safety and altruism also
developed within the argument. The protection of t he
voluntary donor system is something that weighed ve ry
heavily, particularly on Dr Owen.
Finally, sir, a theme which runs throughout the
earlier period is the financial pressure on all
1 involved, particularly in the 1970s and start of th e
1980s. It's a common theme across those different
bodies, the clinicians, the fractionators, the civi l
servants, the Regional Health Authorities, in that
period, in the 1970s. No attempt is made here to t ry
to describe the difficult economic environment in
which these decisions were taking place, but that i s,
of course, a factor which weighed very heavily upon
all of those involved.
With that production, sir, and mindful as well
of the letter that we've looked at from Dr Biggs,
we're going to turn to the early 1970s, and the imp act
of commercial blood products.
If we could bring up, please, Paul, OXUH0000673.
This is a letter dated 18 July 1972, and if we coul d
turn, please, to the second page, Paul, just at the
bottom we can see who it's from and to.
From Dr Rizza, of the Oxford Haemophilia Centre,
and it's sent to W Trillwood who is the director of
pharmaceutical services, the relevance of his role
there is -- will become obvious as we read through.
We can see that it is copied to Dr Biggs, Dr Bidwel l,
who worked at the Protein Fractionation Laboratory in
Oxford, and Dr Maycock, who was the director of BPL
and consultant adviser on blood transfusions to the
22 DHSS at that time.
What Dr Rizza says in the letter is this:
"Dear Mr Trillwood,
"During the past twelve months we have been
experiencing increasing difficulties in meeting the
needs for AHG for our haemophilic patients."
A pause there, sir, to say it is a reference to
antihaemophilic globulin. It is used, often
interchangeably, in this period with the word
"concentrate". I have used the word concentrate mo re
consistently in the report just so it is clear what he
is talking about, but here he is referring to
Factor VIII concentrates.
"At present we rely entirely upon human
cryoprecipitate supplied by Dr Grant of the Regiona l
Blood Transfusion Centre and freeze-dried human AHG
concentrate supplied by Dr Bidwell of the Plasma
Fractionation Laboratory, supplemented by a small
amount of human AHG from the Lister Institute of
Preventative Medicine, Elstree."
Pause there, sir, that's what becomes BPL.
"During 1971 we received and used concentrates
of human blood clotting factors derived from more t han
20,000 blood donors. This material was mainly from
donors in the Oxford Region and we are deeply indeb ted
23 to the Regional Blood Transfusion Service for the
co-operation over the years which has made it possi ble
for them to channel plasma from nearly a quarter of
the total donations of the Region into the
fractionation process.
"Despite this seemingly excellent supply, we are
chronically short of material to treat the ever
increasing number of patients that come to Oxford.
This shortage is not new and we have always had to
give priority for treatment to emergency cases and to
the treatment of children to prevent crippling
deformity. This restriction has meant that the
surgical waiting list for patients requiring
non-urgent operations has grown and at present 25
patients are on the list. About half of the patien ts
treated in Oxford during 1971 were from the Oxford
Region and half were from other parts of the
United Kingdom."
Go on to the next part of the letter. Thank
you.
"Until recently this shortage of therapeutic
material was unavoidable since no suitable commerci al
material derived from human blood was available.
There are now two sources of supply, one is from th e
Hyland Laboratories and the other is from Immuno AG of
24 Vienna."
Pause there to note that's a reference to
Hemofil and Kryobulin.
"Both are expensive and it would require
material to the value of £2,000 to treat one operat ion
case. Both of these preparations are clinically
effective and have been used extensively in other
countries. The Immuno concentrate has the advantag e
of being derived from blood which has been tested a nd
found to be free of Hepatitis Associated Antigen, t hus
diminishing the risk of hepatitis.
"At present we are often forced to balance the
needs of one patient against those of another in
allocating treatment. This potentially dangerous
practice was reasonable when there was no alternati ve
supply of therapeutic material. We feel now that g ood
material is available commercially our supply shoul d
be supplemented by the use of this commercially
available concentrate. It seems to us quite unethi cal
to continue to withhold treatment from patients whe n
material exists to supply their needs.
"We therefore ask that the Immuno AG Factor VIII
concentrate be bought at an estimated cost of about
£15,000 per annum for use at the Oxford Haemophilia
Centre. About half of the patients for whom this
5 material would be used would come from other region s
and most of the material would go to cover patients
requiring major surgery. This additional supply wo uld
much increase the safety margin for the treatment o f
urgent cases and would permit us over the years to
lessen the waiting list for non-urgent operations."
That is Dr Rizza, 18 July 1972.
A couple of things to pick up from that. First
is that many of the predictions that Dr Biggs had m ade
in 1967 were now coming to reality, albeit perhaps
a few years later than she had anticipated in her
earlier already. It's notable that Dr Rizza's requ est
for funds was based on a medical assessment of
clinical needs and was framed by reference to medic al
ethics. It is also notable that it's the recent
availability of commercial concentrates which have
prompted his concerns in that regard. We also
highlight the fact that Dr Rizza expressly
acknowledges the expense of those concentrates.
Finally, we note that the request that Dr Rizza
is making is about obtaining material to facilitate
surgery. No reference is made at the time, in 1972 ,
to either home treatment or wider prophylactic
treatment.
As is set out in the written presentation,
26 Dr Rizza's concerns were shared by others and refer to
the paragraph [14] of the written presentation.
I won't go to all of the documents that were in it.
We can see there that in October 1972, there was
a meeting that took place of Haemophilia Centre
Directors and, following that meeting, the Chair,
Professor Edward Blackburn of the Sheffield Centre,
wrote to Sir George Godber, the Chief Medical Offic er,
and requested that the DHSS establish an expert
committee. That committee, he said, should conside r
the supply of therapeutic materials in relation to the
treatment of haemophilia and allied disorders.
In the letter and at the meeting, Professor
Blackburn expressed that his colleagues had referre d
to a preference for concentrates over cryoprecipita te,
which is something we will pick up in some further
documents, and he also mentioned the desirability o f
home treatment.
In his letter, and I won't take you to it but
I will just quote the concluding section, he said:
"The directors feel there is an urgent need to
increase supplies of Factor VIII concentrates, in
particular those of freeze-dried concentrate. Many
feel that if a British preparation cannot be made
available very shortly, the commercial preparations
27 should be bought."
An interesting distinction there, perhaps, sir,
that the first sentence, the need to increase domes tic
supply, appears to enjoy the unanimous support of t he
directors. The second sentence about buying
commercial products in the interim, is expressed by
reference to "many" feeling that way, so not unanim ity
on that one.
Professor Blackburn's letter was copied to
Dr Richard Maycock, who I have said was the consult ant
adviser and also the director of BPL. He expressed
concern over the cost of commercial concentrates an d
supported the proposal of a working group being set up
to look at this matter.
In a memorandum dated 7 February 1973, which is
referred to at paragraph [19] of the written
presentation, Dr Maycock said that, in his view, an d
I quote:
"As far as possible, the UK should aim to be
self-sufficient in the supply of preparations of
antihaemophilic globulin and Factor IX."
He goes on to say that the preparations made in
the UK can be as good as any commercial preparation
and are available more cheaply. He also adds that
there is insufficient supply at the moment, and
28 pressure from those who are using the products,
because of the commercial material that is being ma de
available to them.
The interventions of Professor Blackburn and
Dr Maycock led to the DHSS establishing an expert
group. We can see that thought is being given to t his
at the most senior levels within the department
because in an internal minute dated 20 February 197 3,
at paragraph [20} of the written presentation,
Sir Philip Rogers, who was the Permanent Secretary and
so the most senior civil servant of the department,
was said to be, and I quote, "Concerned about the
possible financial consequences and is anxious that
these should be quantified as soon as possible,
bearing in mind the scope for meeting blood product
requirements from home sources."
So he is expressing concern about the cost of
commercial imports and the question of what can be
done domestically to meet the supply demands.
On 6 March 1973, Dr Godber, the CMO, sent
a circular to all senior administrative medical
officers, has copied it to Haemophilia Centres and
other regional health administrators, and informed
them that the expert group would be formed. That
circular is referred to at paragraph [21] of the
9 written presentation. We can see from it that
concerns about cost are, again, at the forefront of
Dr Godber's mind.
There is reference to the commercial products
which are being provided, and Dr Godber says, and I
quote:
"It has come to the notice of the Department
that one of the firms is already engaged in active
promotion of this expensive product. The firm has
indicated that they can supply a large quantity of
human AHG concentrate, and this could result in ver y
significant expenditure if amounts were bought in
excess of immediate needs."
I stress those last words, sir, because that is
again hinting at this debate about what these
concentrates should be used for. "Immediate needs"
may suggest -- is often referred to as on-demand
treatment; a response to a bleed, and possibly also
emergency surgery.
There is in this document the circular that was
sent by Dr Godber no reference to safety concerns
about imported commercial concentrates.
The expert group on the treatment of haemophilia
is the body that was set up to examine these
questions, at the prompting of Dr Maycock and
30 Professor Blackburn, and it met for the first time on
20 March 1973. At that meeting, it considered a pa per
that was presented by Dr Biggs. We will look at th at
paper first before we then look at a discussion tha t
followed.
If we could go, please, Paul, to PRSE0002553.
We can see that although the paper is marked "Draft ",
we think that this is the version that was seen. I t
is entitled "Factor VIII concentrates and the
treatment of haemophilia". We can see from the tit le
page that it is Dr Biggs who has written it.
If we could go on to the next page, please. I'm
not going to read all of the way through this
document. I'll point out how the document was
structured and some of the calculations within it
before turning to the conclusions and also highligh t
one or two passages as we go through.
What Dr Biggs is setting out to do is trying to
discuss the pros and cons of cryoprecipitate and
factor concentrate and to work out the needs of
patients with haemophilia in the UK. And she begin s,
as we can see halfway down the first page of the
report, by discussing the number of patients with
haemophilia per 100,000 of population.
And if we could turn to the second page, please,
31 Paul. The figures that she adopts, or the range th at
Dr Biggs adopts, is between 1,754 and 3,000 patient s.
And we can see that that is expressed to be for Gre at
Britain. I read that as meaning Great Britain and
Northern Ireland, but that's my interpretation, not
something which is expressed in the document.
Dr Biggs stresses that that is an estimate and it i s
not based on exact data. There was no central
database at that time.
On the figure for 1,754, she says that this is
the number of patients known to have attended
Haemophilia Centres. But she says that we know tha t
there are more than that number of patients because
cryoprecipitate is also sent elsewhere and has been
used in other hospitals as well. So she says the
lower limit for the number is 1,754; likely to be
more. The upper limit is not known for certain.
If we look at the next section, the Factor VIII
preparations at present used to treat haemophilic
patients, I'm just going to read a few paragraphs f rom
this because it's --
ANSWER:
That would be severely affected
patients, would it?
|
46,278 | 336 | QUESTION:
This is an attempt to calculate the total number
of patients. We will see later in the document tha t
32 there is an estimate of the number of most severely
affected.
ANSWER:
Well, the reason I say that is if we
look at the top of the page, she starts off talking
about the United States estimates, and she says:
"The estimate for the severely affected patients
in the USA indicates about 12,000 patients in
a population of 200 million. For Great Britain, th e
total would be between 1,754 to 3,000."
That looks as though that's for severely
affected. Presumably people who were severe
haemophiliacs is what she means by that, but that,
again, is an assumption which may be wrong.
|
46,279 | 336 | QUESTION:
I think so, sir. A problem with many of these
documents is that it's not entirely clear what it i s
that -- or what the numbers represent, whether or n ot
this is intended just to be people with severe
haemophilia or others as well.
As we will see in the debate that follows, there
is a number that is given. And tempted though I am to
try to pluck it out of my memory, I would undoubted ly
get it wrong if I do, so I will resist the temptati on,
but we will see that number given later for the amo unt
of people that are considered to be or -- who would
benefit most from the concentrates being provided a t
3 home. And that figure may correlate more closely t o
those with severe haemophilia. Certainly, the data on
which she draws is a US study about people with sev ere
haemophilia, and then she extrapolates that over to
the UK. And in fairness to Dr Biggs, she emphasise s
repeatedly this is not exact.
Turning, then, to the Factor VIII preparations
at present used to treat haemophilic patients. Thi s
is helpful just to gain an understanding of the bas e
level, where they were at that time, before
considering what they planned to do about it. If
we -- if I read from that, Dr Biggs said this, and
I quote:
"At present, the treatment of bleeding in
a haemophilic patient consists in giving a calculat ed
dose of an anti-haemophilic factor (Factor VIII)
preparation as soon as any symptoms of spontaneous
bleeding arise and of giving enough material during
and following operations to maintain normal
haemostasis.
"Each of the haemophilic patients treated at
Haemophilia Centres during 1971 had on average
received material from 122 donor units. This figur e
refers to the total amount of material that the
patient received. It does not refer to the number of
34 donors to whose blood patients have been exposed
through the use of pools of plasma.
"Most of this treatment was for on-demand
treatment which is given whenever a patient feels t hat
a haemorrhage is occurring and for major surgery an d
for dental extraction. At many Haemophilia Centres ,
the directors feel that they could use at least twi ce
as much material as they receive but that the prese nt
shortage of materials leads to a dangerous selectio n
between more or less urgent cases for treatment and
the accumulation of patients on long waiting lists for
non-urgent operations."
That last comment, sir, is one that echoes the
letter from Dr Rizza that we looked at earlier.
If we could turn to the next page, please, Paul.
Electronic page 5. We can see that Dr Biggs then g oes
into a comparison of concentrates and cryoprecipita te
and, in particular, compares four different aspects .
The first is the yield of Factor VIII activity. He re
it is -- the word "yield" is being used as a measur e
of the efficiency of both concentrates and
cryoprecipitate in using a blood donation and
providing the necessary treatment to the patient.
Elsewhere, "yield" is used in a more technical sens e.
The second criteria is the convenience of
35 a material in preparation and in use.
The third criteria is the reliability of
material from batch to batch.
The fourth criteria is the complications which
might attend treatment with the various preparation s.
I will summarise Dr Biggs' findings at paragraph
[28] of the written presentation. I won't take you
all the way through the document. If I summarise
briefly, on "yield", Dr Biggs' ultimate conclusion is
that the two products are equally efficient.
On convenience of manufacture, cryoprecipitate
was stated to be easy to manufacture in small doses ,
but, I quote:
"On a large scale and widely distributed over
centres with very different facilities, the method is
less satisfactory."
Concentrates, by contrast, required a higher
capital expenditure but were, in her assessment,
probably less expensive in the long run.
On convenience of use, Dr Biggs referred to the
need to thaw cryoprecipitate. The fact that the
process of making up cryoprecipitate was, in her
words, open to many abuses. She stressed the varie ty
in the activities of individual doses in cryo and t he
need for a deep freeze. She contrasted that with
36 concentrates which she said were, and I quote, were
"very convenient to use".
On reliability from batch to batch, Dr Biggs
referred to data from the study that had been
conducted and found that cryoprecipitate was very
variable, and concentrates in contrast could be
assayed to give a reliable estimate of dose activit y
per dose.
On the final criteria, the complications, I will
take you to the document. I will take you in
particular to electronic page 10. This is a sectio n
which I think has been put in evidence before, but
it's helpful to see it in the context in which it w as
written and the context of the debate which is to
follow. The heading is "Complications of treatment ",
and what Dr Biggs wrote is this:
"About 1 in 800 donors is a carrier of
hepatitis B antigen. The larger the number of dono rs
concerned in the preparation of concentrate, the
greater the risk of exposing the recipient to mater ial
containing hepatitis B antigen. The use of
freeze-dried concentrate, which is made of pools of
200 donors (or even higher numbers for commerce
material) must carry a higher risk than single
donations. But there is the possibility that the
7 development of jaundice may be dose related and tha t
single infected bottles may be more dangerous to th e
individual patient than pooled material in which th e
virus is diluted. Despite this, the frequency of
hepatitis in severely affected patients does not se em
to increase significantly with increased use of
freeze-dried concentrates. This is shown by a low
incidence of jaundice in patients treated in Oxford
(who have half of the material given to them as
freeze-dried concentrate) and in those treated at
other British centres. The conclusion is also
supported by data collected in the United States."
Reference is made to an article -- letter by
Kasper and Kipnis from 1972. The reference to that is
in the written presentation:
"An exception to this rule concerns the mildly
affected patients to whom very little treatment is
given. These patients do seem to have a higher
incidence of hepatitis if large pool fractions are
used. Kasper and Kipnis 1972 showed this, as did a lso
the British Survey where female carriers of
haemophilia treated with concentrate had a high
incidence of hepatitis.
"Since the majority of patients are in the
multi-transfused category, the increased risk of
38 exposure to hepatitis would not seem to be an
important disadvantage to the use of concentrates f rom
pooled material. Hepatitis is, in any case,
a complication which should decrease with universal
screening of donors for hepatitis antigen.
"The incidence of Factor VIII antibodies does
not seem to be related to the type of material used
..."
And a reference is made there to the British
Survey.
So this is a document which dates from 1973, and
so the discussion of hepatitis there is of
hepatitis B, rather than non-A, non-B hepatitis.
ANSWER:
And the comment about the incidence
of Factor VIII -- sorry, that complication should
decrease, I think universal screening of donors for
hepatitis-associated antigen, hepatitis B antigen,
have been introduced in 1972.
|
46,280 | 336 | QUESTION:
I think that's right, sir. The test gradually
improves in its sensitivity over the years as well.
ANSWER:
So what she is reporting on is
material which was -- some of which probably was
collected and manufactured into product, so far as it
was concentrate, before it was screened.
|
46,281 | 336 | QUESTION:
Yes.
39 Going back to the paper, we can see that the
next issue that Dr Biggs turns to is the amount of
Factor VIII concentrate required to treat
haemophiliacs in Great Britain. And we can see fro m
the paragraph that follows that she bases many of h er
calculations on work that was done at Treloar's, in
which observations were done of the students there of
the number of bleeds they had per year. And then f rom
that, Dr Biggs makes a number of assumptions --
necessary assumptions in order to do the calculatio ns
but assumptions nonetheless -- about the number of
bleeds per year, the amount of material that is
required per bleed, average patient weight.
If we go over to the next page, please. I won't
take you through all the calculations. We can see
there is also reference in the second paragraph to the
amount of plasma that can be taken from each donati on,
and the figure there is 200 to 220 millilitres of
plasma. And we'll see in later papers reference in
England and Wales at least is made to 180 millilitr es,
so this may be optimistic as to how much plasma can be
obtained per donation.
Dr Biggs goes through these various assumptions
and calculations to try to provide a figure for how
much Factor VIII will be required per year. It's
40 important to note that she is talking here about
on-demand treatment. And then in the next section, if
we go over to page 13, she then adds in major surge ry,
and then in the next section, page 14, dental
extractions. So these are the calculations that ar e
being done. And when she puts all of this together ,
page 15, we can see at the top of the page the
ultimate conclusion that Dr Biggs makes is this:
"Thus for all types of bleeding (spontaneous, at
operation and dentistry and after) the total materi al
required is likely to lie between 400,000 and 750,0 00
donor units per annum."
I pause there, sir, and contrast that with the
1967 figure of 50,000. Dr Biggs's assessment now i s
that it's between 400,000 and 750,000, and this
estimate included on-demand treatment.
ANSWER:
Just one question. She's talking
here, is she, about England and Wales as a whole?
|
46,282 | 336 | QUESTION:
She refers to Great Britain.
ANSWER:
Great Britain, so that's the UK?
|
46,283 | 336 | QUESTION:
I think that may be -- yes, a misonym For Great
Britain and Northern Ireland.
ANSWER:
When she spoke about the 50,000
earlier, she spoke about it on the basis of "our
practice", and her own reference in, I think, the
1 earlier letter of '67 was 20,000 units.
|
46,284 | 336 | QUESTION:
Yes.
ANSWER:
So this may not be comparing like
with like --
|
46,285 | 336 | QUESTION:
No, I was about to say, sir, it is not a direct
comparison. She does refer to "our practice" and - -
ANSWER:
Which may mean Oxford, and Oxford
was recognised as a centre, wasn't it?
|
46,286 | 336 | QUESTION:
It does and, from the context of her letter, she
refers not just to Oxford but to patients who were
coming into Oxford.
ANSWER:
Yes.
|
46,287 | 336 | QUESTION:
So it is a significant proportion of England,
but it is not the same figure here, which is betwee n
400,000 and 750,000. Of course, Dr Biggs, in her 1 967
letter, wasn't seeking to project into the future t he
demand that would be required in six or seven years '
time; she was talking about what, in her practice, at
that time, was needed then. That was the 50,000.
The figure here now is between 400,000 and
750,000 donor units.
Now that, she stresses, is for on-demand
treatment, so bleeds, major surgery, dental
extraction.
A little further down the page, she goes on to
42 talk about prophylactic treatment, and I read from
that section now:
"Prophylactic treatment to haemophilic patients
would require much more material since this treatme nt
envisages regular administration of factor VIII onc e
or twice a week to the patient regardless of whethe r
or not bleeding has occurred. The estimate of the
amount required for such treatment in the USA is
13 million donor units [reference to Stengle in 197 2].
So for Great Britain an estimate would be about
3 million donor units. Lazerson (1972) estimates 6 36
donor units per patient for prophylaxis which would
give a maximum figure for Great Britain of about
2 million donors units. It is not at present certa in
that this prophylaxis is desirable for even the mos t
severely affected patients. It is certainly at
present impracticable. In the USA about 4 per cent of
patients receive prophylaxis.
"Home Treatment should be distinguished from
prophylaxis. Home treatment involves the
administration of therapeutic material in the home by
a relative, by the patient to himself, or by the
General Practitioner. This form of treatment is
becoming accepted and should not involve the use of
more material than good Hospital care. In fact, th e
43 experience of Lazerson (1972) suggests that more
material is not used for home care. There is no do ubt
that the freeze dried concentrate is the best mater ial
to use for home care. Were the most severely affec ted
1,000 patients allocated to home treatment this wou ld
require about 250,000 donor units of freeze dried
concentrate but this would be instead of, not in
addition to, the doses given on demand in the
hospital."
We will come back to those figures in a second,
sir. I note that that 1,000 patients who are most
severely affected was the figure that I was trying to
recall earlier. I would have got it right. I shou ld
have guessed.
ANSWER:
But this may be no more than
a calculating figure, because "were the most severe ly
affected 1,000 patients", it isn't saying "of the
patients, 1,000 are most severely affected". It is
calculating how much would be needed for the worst
cases.
|
46,288 | 336 | QUESTION:
Yes. Yes. So it's not saying that is the total
number of people with severe haemophilia in the
country.
ANSWER:
Yes.
|
46,289 | 336 | QUESTION:
I'm just mentioning in parenthesis here, sir,
44 that the assumption that is made there about home
treatment, and that it shouldn't involve the use of
more concentrate than in hospital, is an important
assumption, which plays out in the estimates that
follow. It is one that is later challenged. There is
a suggestion that more concentrate is used,
particularly in the early stages of home treatment,
than would be used in hospital.
ANSWER:
Well, I think we saw some evidence
of that when we were looking at the haemophilia
centres and the use of concentrate, that home
treatment was thought to add something -- this is
a very broad recollection, I may be wrong -- but
something in the region of a third on top, to the
amount that might be needed compared to on demand.
|
46,290 | 336 | QUESTION:
There is a debate which emerges about this.
There is a sense that the higher use of home
treatment, initially, is making up the previous
under-treatment, which was done in hospital, and th e
reference to "good hospital care" by Dr Biggs may b e
hinting at that.
There is also a subsequent debate, which is not
quantified in the papers that I have seen, that the
earlier treatment of bleeds at home leads, ultimate ly,
to less concentrate being used than would be used i n
5 hospital because the bleed does not become as sever e.
ANSWER:
That certainly was the suggestion
early on and used to justify, in part, home treatme nt,
quite apart from the convenience for the individual ,
it might be thought, but I think the objective
evidence, so far seen -- as far as I remember it, i s
that it added to the consumption.
|
46,291 | 336 | QUESTION:
That would certainly fit with what we see in
terms of the demand curve, once home treatment beco mes
more widely used.
ANSWER:
Indeed, it was, I think, one of the
suggestions made at the time that people became awa re
of the risk that blood products might transmit
whatever it was that was causing AIDS, that
a suggestion was to reduce the amount of people on
home treatment or reduce home treatment, thereby
lessen the need for factor concentrate and thereby
lessen the need for reliance upon imported factor
concentrate.
|
46,292 | 336 | QUESTION:
I think, sir, we will see in some of the later
papers that there is an acceptance that the assumpt ion
made here by Dr Biggs is not one which is borne out in
practice.
Dr Biggs goes on in the paper to discuss the
economics of treatment. This is a short section in
46 which she points out that the cost of treating
patients with haemophilia is high but she doesn't t ry
to compute the figures. But she does make the poin t,
at the end of that paragraph, that proper treatment is
probably no more expensive than that of renal patie nts
requiring dialysis.
Then we come to the conclusions of Dr Biggs's
paper, page 17. I will read through these and then
I will come back to some of the numbers that are
contained within them.
Conclusion 1:
"Calculations suggest that the amount of
material required for optimum treatment of all the
haemophilic patients in Great Britain would be deri ved
from 400,000 to 700,000 blood donations a year. Th e
present supply is of the order of 300,000 per year of
which most is in the form of cryoprecipitate.
"2. Comparisons of cryoprecipitate and
freeze-dried concentrate made in Oxford suggest tha t
from the point of view of conservation of the
factor VIII activity of the donor plasma and of
recovery of infused activity in the patient the two
preparations are equally efficient.
"3. The cryoprecipitate is more difficult to
make up for administration and much factor VIII
47 activity may be lost when inexperienced staff handl e
the material prior to giving the infusion. Moreove r
the material varies in activity from one Centre to
another. There is evidence that the Oxford materia l
may be among the best.
"4. The pool size used in the preparation of
concentrate does not affect the incidence of
factor VIII antibodies nor of clinical jaundice in
multi-transfused patients.
"5. For home treatment it is our opinion that
only the freeze-dried concentrate is useful in most
cases. The gradual introduction of the most severe ly
affected patients who have the most frequent bleedi ng
to home treatment would reduce hospital management of
haemophilia by about half. To give this proportion of
patients home treatment would involve the use of
concentrate from about 250,000 donors a year. The
present total supply is of the order of 25,000
a year."
"6. We think that the subject should be set to
provide factor VIII concentrate from 250,000 donati ons
by 1975 and that, over ten years, an attempt should be
made to provide all of the necessary material in th is
form. By 1975 the magnitude of the problem should be
more exactly defined by surveys being made by the
48 Haemophilia Centre Directors.
"7. It may be noted that freeze-dried material
of good quality is now available commercially. At
present patient treatment at many of the Haemophili a
Centres in this Country involves a dangerous policy of
balancing the needs of one patient against another and
of denying patients reconstructive orthopaedic surg ery
which would greatly improve their lives. We feel i t
very important that the material made in the UK, wh ich
is second to none in quality, should be substantial ly
increased in amount. Otherwise we feel that materi al
should be bought from commercial sources which now
provide material of good quality both from the poin t
of view of factor VIII activity and from the point of
view of screening the donors for Hepatitis Associat ed
Antigen."
If we could just turn, please, to page 21,
Dr Biggs referred to Table II. That is a table whi ch
is appended to her report, and we can see there tha t
it is a representation of therapeutic materials for
the treatment of haemophilia.
We can see the four different types of material
in the first column, whole blood, plasma,
cryoprecipitate, and freeze dried concentrate, and
then the assessments for Dr Biggs made of Factor VI II
9 activities, and the post-infusion level of plasma
Factor VIII, as a percentage of normal. We can see
that, although I didn't take you to the sections on
whole blood and plasma, Dr Biggs's conclusion is, i n
essence, that they're not much use for treatment of
haemophilia.
Then we can see, in the final column, the
approximate donor units at present made. We can se e
that, at that time, about 25,000 units were dedicat ed
to concentrate, 220,000 to cryoprecipitate and 44,0 00
to plasma.
Just before the break, sir, I will go back to
some of those figures that are given in the report,
just so that we have in mind what they represent. I'm
afraid that this gets complicated and will become m ore
complicated as different estimates develop.
But the first figure is that figure of 400,000
and 750,000. That is the range of donor units
per annum that Dr Biggs calculates is required for
on-demand treatment. Now, expressed in its raw for m,
that could be treatment either of cryoprecipitate o r
of Factor VIII concentrate and, as they're equally
efficient, the question is simply how you divide th ose
two. So you could have 200,000 cryo, 200,000
concentrate, and that would be your 400,000.
50 Later in the conclusions section, Dr Biggs
refers to 400,000 to 700,000 donations per annum be ing
required for optimum treatment. So 700,000 rather
than 750,000, I'm not quite sure why that distincti on
is there. She says that the figure at the time is
300,000 donor units, so below even what she conside rs
to be the minimum.
ANSWER:
For optimum treatment?
|
46,293 | 336 | QUESTION:
Optimum treatment is 700,000 or 750,000.
ANSWER:
Yes.
|
46,294 | 336 | QUESTION:
The requirement for on-demand treatment, as she
puts it, is 400,000. So, in her analysis, there is ,
at that time, under-treatment, and that's consisten t
with what she has said in her letters and what
Dr Rizza has said in his. As mentioned earlier, th at
figure should be the same whether that treatment is
given in hospital or on home treatment, in Dr Biggs 's
analysis discussed there.
Prophylactic treatment, on Dr Biggs's analysis,
is going to require much more material, and she put a
range of estimates between 2 million and 3 million
donor units per annum, based upon the American
experience.
ANSWER:
She says it's impracticable.
|
46,295 | 336 | QUESTION:
Impracticable and, at that time it wasn't
51 necessarily clinically advised either. We will see --
I'm not going to go through the debate on prophylac tic
treatment in the 1970s but, every now and again, it
crops up in the papers and we can see that it is
something which has been considered at this early
stage, but it is not inevitable in the mind of
Dr Biggs, and indeed others, at this time, that
prophylactic treatment is going to come in but they
are aware that it is a possibility.
The final set of figures, or the final figure to
refer to, is this figure of 250,000 donor units,
a figure which is going to be important in the deba te
that follows. That figure, 250,000, is, as you sai d
sir, for the 1,000 patients who are most severely
affected and would most benefit from home treatment .
So Dr Biggs is plainly not saying 250,000 donor uni ts
per year will provide self-sufficiency. The figure
for on-demand self-sufficiency, as we've seen, is
between 400,000 and 750,000 units at that time, or
expressed as 400,000 to 700,000 for optimum treatme nt.
We will also see from the conclusions that there
is a sense that there should be a push, firstly, to
produce those 250,000 units of concentrate by 1975,
and that will be a tenfold increase from the 25,000
units then dedicated to factor concentrates, and th at,
52 over a longer period, given as 10 years, an attempt
should be made to provide all the necessary materia l
in the form of concentrates.
So that is all between 400,000 and 700,000 or
750,000 units. I pause there just to note that,
although it is expressed in that way, I'm not sure
that should be read literally as meaning that there
should be no cryoprecipitate produced anywhere.
Earlier in the report, Dr Biggs had referred to the
preference, at that time, for single donor units to be
given to people with mild haemophilia, based on the
evidence that she then had.
So this paper isn't necessarily making
an assessment about how treatment should be done
10 years down the line. So I'll just add that as
a slight caveat into perhaps reading too much into
that word. But, certainly, the thrust paper is tha t
more should be dedicated to concentrate, at the
expense of plasma, which was dedicated to cryo.
Sir, I note the time. I wonder if that's a good
place to stop for our break.
ANSWER:
Yes, well, let's take a break until
11.50, shall we? 11.50.
(11.21 pm)
(A short break)
3 (11.51 am)
|
46,296 | 336 | QUESTION:
Sir, a couple of points of housekeeping just at
the start. First of all, the presentation
I understand is now up on the website and so people
will be able to access it there. It should also ha ve
been provided on the CP work spaces.
The second point is that I earlier referred to
some paragraph numbers from the written presentatio n.
Due to my own error, these are out by five. So if
I said paragraph 9, it should be paragraph 14. I
won't bore you with the reasons for that, but I wil l
be careful about doing that in the future, and we w ill
arrange for the [draft] transcript to be corrected so
that the correct paragraph numbers are given.
ANSWER:
Thank you.
|
46,297 | 336 | QUESTION:
Turning back to where we left off, sir, which
was the expert group on the treatment of haemophili a
and its first meeting on 20 March 1973. We've
looked at Dr Biggs' paper which was considered by t he
group. Dr Maycock also provided two papers dealing
firstly with capacity figures for the production of
Factor VIII, and, secondly, dealing with the respon ses
to a survey that he had conducted of haemophilia
clinicians about their preferred use of product.
54 I won't take you to those documents. I will
just point out that paragraph 39 -- that is the
correct reference -- on the presentation, Dr Maycoc k
set out the different capacities of BPL, PFL and PF C.
His calculation was a total capacity to fractionate
1,145 litres per week once certain works had been
completed.
He also said that in order to meet the
preference of haemophilia clinicians, four-fifths o f
blood donation, so 80 per cent of blood donations,
should be assigned to concentrate production which he
put at a figure of about 330,000 donations per year .
He summarised the survey responses by saying
that 33 of 34 Haemophilia Centres had responded to
him. Of those, two were said to prefer using
cryoprecipitate, 14 were said to prefer using
concentrate, and 17 preferred to use both. We will
come on later to some other assessments made of
preferences between cryo and concentrate.
So those were Dr Maycock's papers. We will turn
now to the minutes of the meeting itself. If we co uld
go, please, to PRSE00047064. The first page, we ca n
see that this is the expert group on the treatment of
haemophilia meeting, held on 20 March 1973. In the
chair is Dr Reid. We can also see the other member s:
55 Dr Biggs, Professor Blackburn, Professor Douglas,
Dr Maycock, Dr Rizza, Dr John of the DHSS,
Dr Macdonald of the Scottish Home and Health
Department, Dr Thomas for the DHSS, Mr Walters for the
DHSS, Mr Gardiner of the DHSS and Dr Sheila Waiter of
the DHSS who was with Mr Gardiner, the secretary.
Dr Waiter is a significant figure in the months
to come. She was the predecessor of Dr Walford in the
role that Dr Walford would take from 1978 or 1979.
The terms of reference on the first page -- just
a little bit lower down, Paul. Those terms of
reference are:
"To advise the Department on trends in methods
of treatment of haemophilia and allied conditions, and
to consider possible future requirements for the
treatment of a condition and the consequences for t he
supply of therapeutic agents."
I pause to note that a different version of the
terms of reference refers to the departments, plura l,
which may reflect the presence on the committee of
Dr Macdonald of the Scottish Home & Health Departme nt.
I believe that Professor Douglas was from the
University of Aberdeen as well. Regardless of whet her
or not the department is given in the single or the
plural, there was certainly SHHD representation at
56 this committee, and so whether they were advised or
merely informed is perhaps a moot point.
If we could go over to the second page, please,
Paul. I'm not going to go through all of this pape r
because much of it repeats the analysis that Dr Big gs
has given in her paper. We can see that there is t he
comparison of therapeutic materials, and then
discussion of cryoprecipitate and freeze-dried
concentrate. If I pick it up from the final
paragraph, there is this said about the safety aspe ct
of concentrates, and I quote:
"A possible disadvantage arises from the fact
that AHG concentrate is prepared from a larger pool of
donations, and in theory, therefore, the risk of
hepatitis is greater. About 1 in 800 of the donors
who present to the Transfusion Service is a carrier of
hepatitis B antigen.
"The present policy of rejecting donations which
give a positive test for hepatitis B antigen will
reduce the incident of virus in the blood used to m ake
plasma pools. In practice, studies in several cent res
have shown that the incidence of hepatitis among
severely affected patients who have been treated wi th
freeze-dried preparation is not very much higher th an
that of the centres not using freeze-dried
7 concentrate, and this suggests that the development of
hepatitis in these multi-transfused patients may be
dose related. It was agreed that the theoretically
increased risk of acquiring hepatitis, which does n ot
seem to be borne out in practice, should not be
a deterrent to using the freeze-dried preparation, and
in any case this complication will decrease if
universal screening of donors for hepatitis antigen ."
That is what is said at the meeting, obviously
building on what is said in Dr Biggs' paper.
If we go down to section 4, "Future requirements
of therapeutic agents". If we just read from this
section until the end of the document, and I quote:
"During 1972, considerably more cryoprecipitate
from freeze-dried concentrate was issued in terms o f
donations of blood. It was generally agreed that
400,000 donations would be required to treat UK
sufferers from haemophilia of all degrees of severi ty,
and more if strenuous efforts were made to clear
surgical waiting lists and if home treatment, or
eventually prophylactic treatment, became accepted
ways of dealing with the problems of haemophiliacs.
Life-saving surgery has been undertaken for some ti me
using the therapeutic agents which are available, b ut
clinicians must now look to the possible improvemen t
58 in the quality of life of boys and men who suffer f rom
haemophilia.
"Since more freeze-dried AHG concentrate has
become available from two foreign sources, the
prospect of improved management of day-to-day bleed ing
episodes using this therapeutic agent has become
realistic. If the anticipated annual uptake of
20 million units of freeze-dried AHG concentrate is to
be met from foreign commercial sources, the cost wi ll
be of the order of £2 million per annum, (assuming the
cost to be 10p per unit).
"At present, UK production is considerably less
than the required amount of the freeze-dried
preparation. It was agreed that there was an
immediate need to discuss the advisability of centr al
purchase and distribution of the two commercially
produced preparations. There is also a pressing ne ed
to seek ways of increasing UK production with the
intention of reducing and, as soon as possible, end ing
purchase from foreign sources.
"Freeze-dried AHG concentrate is made at the
Blood Products Laboratory, Elstree, at the Plasma
Fractionation Laboratory, Oxford, and at the Blood
Products Laboratory, Edinburgh."
Note the phrasing there is slightly wrong, but
59 we will move on:
"It is essential the production and distribution
of the therapeutic agents concerned should be
considered as a UK exercise.
"In any consideration of increased UK production
of freeze-dried AHG concentrate, the immediate
problems are those of the organisation and cost of
increasing donations of either whole blood or plasm a
(by plasmapheresis) and the difficulties, including
cost, of increasing the capacity of the laboratorie s
at present engaged in production.
"Close cooperation between England (including
Wales and Northern Ireland) and Scotland will be
required in order to coordinate and optimise blood
collection and transport. The fractionation
processes, distribution of therapeutic agents and
utilisation of other blood fraction by-products.
"Recommendations by the expert group:
"1. DHSS should give early consideration to
central purchase of freeze-dried AHG concentrate fr om
the firms who have recently been granted product
licences.
"2. Distribution to other Haemophilia Centres
and hospitals should be through the regional centre s,
three of which are in Oxford, Manchester and Sheffi eld
60 in England, one in Scotland (Edinburgh or Glasgow),
and one in London (to be decided). The establishme nt
of such a distribution scheme would be a prerequisi te
of recommendation 1 in order to ensure the most
effective use of available material.
"3. At the same time, the UK should aim to
become self-sufficient as soon as possible by
increasing home production of freeze-dried AHG
concentrate.
"4. The Regional Transfusion Directors should
be consulted about the consequences of recommendati on
3 in terms of increased demands upon the Blood
Transfusion Services throughout the UK. Discussion
should take place between DHSS and the directors ab out
problems of decreasing productions of cryoprecipita te,
increasing production of fresh frozen plasma for
fractionation, and the possibly increased collectio n
of plasma by plasmapheresis.
"5. There should be further meetings of this
expert group at times to be arranged. Several
subjects need to be discussed further, including ho me
treatment and, in due course, prophylactic treatmen t.
"6. The expert group membership might be
expanded to include representatives of each of the
regional Haemophilia Centres, a representative of t he
1 Regional Transfusion Directors, and possibly a SAMO
[which is a Scientific Area Medical Officer]."
I will come back to SAMO, but a regional
scientific medical officer of some form:
"It was also suggested that the National Medical
Director of the Scottish National Blood Transfusion
Association and Mr Watt of the Edinburgh BPL should be
invited to join the group."
Edinburgh BPL is a reference to the PFC in
Edinburgh.
So we can see there, sir, support for the
position put forward by Dr Biggs. Reference to a n eed
for 400,000 donations to treat UK sufferers from
haemophilia of all degrees of severity, which is on e
of the questions you were asking earlier, and more if
strenuous efforts were made to clear surgical waiti ng
lists and if home treatment or eventually prophylac tic
treatment became accepted. So 400,000 as the minim um.
Reference as well to the costs of commercial
imports, £2 million a year.
And two strands of development proposed. One is
a central contract to buy commercial products, and the
other is efforts to increase domestic production. The
meeting referred both to the need to increase plasm a
supply and to consider the fractionation capacity o f
62 the different fractionation centres in the UK.
ANSWER:
If we just look at what is currently
on screen at the moment, just before we get to
"Recommendation", it sounds a bit like another
recommendation in the very last paragraph, "Close
co-operation".
|
46,298 | 336 | QUESTION:
"Close co-operation between England (including
Wales and Northern Ireland) and Scotland will be
required in order to co-ordinate and optimise blood
collection and transport, the fractionation process es,
distribution of the therapeutic agents, and
utilisation of other blood fraction by-products."
Yes, sir. A point which is, in fact -- that is
a repetition of the point which was made earlier in
the meeting as well, so something that the group
considered to be very important.
You'll note there, sir, that Northern Ireland is
grouped with England, at that stage, rather than
Scotland because, at that time, the blood products
were obtained from BPL. Later, of course, it would be
PFC.
On the point about cooperation, I referred back
to the discussion at the start of looking at this
document about the presence of Dr Macdonald of the
SHHD at this meeting.
63 ANSWER:
I think you said Dr Douglas as well.
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46,299 | 336 | QUESTION:
Dr Douglas from Aberdeen.
That was what the expert group said. The
response to that group within the DHSS can be seen in
a series of letters, which are summarised in the
written presentation. I won't take you to those.
I will, however, flag the fact that one of those
letters from Dr Reid to Dr Waiter, which is describ ed
at paragraph 47, ruled out spending £2 million per
year on blood products but suggested that if £250,0 00
to £500,000 could be found in the current financial
year so that is financial year from 1973 to 1974, t hen
it would provide time to explore the possibility of
the UK expanding production. Those figures, £250,0 00
to £500,000, will reoccur later on.
The working assumption within those internal
DHSS documents is that it would take around two yea rs
before domestic production could meet the total
demand. So it's talking about 1975 as a possible d ate
for self-sufficiency, as defined by the requirement s
set out in that document.
A meeting was held to discuss the expert group
recommendations in May 1973. If we could go to tha t,
please, Paul, it's DHSC0100005_022.
We can see that present at this meeting were
64 Mr Gidden of one of the divisions of the Health
Service division of the DHSS, so an administrative
civil servant and somebody who is important in the
development of the policy that comes; Dr Macdonald
again from the SHHD, Mr Taylor from DHSS; Dr Maycoc k
in his capacity as consultant adviser to the DHSS;
Dr Duncan Thomas; Dr Waiter; and then Mr Pearson an d
Mr Walters and Mr Fenner, all of different division s
within the DHSS.
Reading from the minutes, paragraph 1:
"Mr Gidden said that the meeting had been
arranged to consider the issues arising from the
recommendations of the Expert Group on Haemophilia,
including possible arrangements for central purchas e
and distribution of commercially produced AHG
concentrate, and for expansion of UK production.
"Mr Taylor referred to the anticipated UK annual
uptake of 20 million units and said that if it was
decided to purchase the material commercially, the
estimated cost of £2 million would almost certainly
have to be met from existing financial allocations.
It was most unlikely that the Treasury would make
additional funds available."
I pause there, sir, to say that is a prediction
which has proved accurate. So in the discussion wh ich
5 follows in the coming year, the references to budge ts
are always to the internal DHSS budget. If the mon ey
is going to come from somewhere, it has to come fro m
within the DHSS. There isn't additional Treasury
funding being made available for the increased
purchase of blood products or for the development o f
blood products domestically.
Back to the document, at paragraph 3:
"Dr Maycock said that professional opinion was
that the clinicians and the pressure group
representing patients felt strongly that the qualit y
of treatment would be greatly improved if there wer e
sufficient supplies of freeze dried AHG concentrate s
to replace a large proportion of the cryoprecipitat e
at present used. Dr Waiter and Dr Thomas supported
this view and stressed that the development of AHG
concentrate was a major advance in the treatment of
haemophilia. Clinicians prefer to treat episodes o f
bleeding by giving infusions of freeze-dried
concentrate as early as possible. Programmes of ho me
treatment and possibly in future prophylactic
treatment, which will be feasible when the
freeze-dried material becomes more widely available ,
would in the long-term reduce treatment costs and t he
demand on hospital facilities. Dr Maycock thought
66 that the cost of increasing production in the UK to
meet estimated requirements should be less than the
cost of importing material from commercial sources.
Dr Macdonald said that he had not looked at the
problem solely from the cost point of view. He fel t
that Departments should, wherever possible, avoid
involvement with commercial firms on all matters
concerning blood transfusion, including the product ion
of AHG concentrate. His view the Blood Transfusion
Service should be self-sufficient in all respects."
Pause there, sir, to pick up a couple of points
from that paragraph. The first is, again, we see
reference to the preference of clinicians for the u se
of concentrate over cryoprecipitate, expressed
forcefully by Dr Maycock and supported by Dr Waiter
and Dr Thomas.
Also reference to home treatment and possibly,
in the future, prophylactic treatment, stated -- th e
latter stated to be in the future.
Dr Maycock gave his view that, ultimately, there
would be a cost saving of domestic products because it
would mean you had to import less of the more
expensive commercial products, though it is importa nt
to note that is not quantified in this document, th e
calculation presented.
67 Interestingly, Dr Macdonald, from the Scottish
Home & Health Department, puts forward a more
principled view of the need for self-sufficiency. So
leaving cost aside, as a point of principle, he fee ls
that the domestic Blood Service should be
self-sufficient. When I say "principled", I mean
putting it forward as a point of principle, not
a judgement value if that is a more morally sound
position.
Paragraph 4 of the minutes of the meeting:
"Dr Maycock said that one estimate was that the
plasma from around 416,000 donations of blood would be
needed annually in order to prepare the materials
considered necessary to treat haemophiliacs in
accordance with present views of ideal treatment. At
present, about 228,000 donations in England and Wal es
were used annually for the preparation of these
materials. He thought that the BPLs at Elstree and
Liberton, when the latter was operational, would ha ve
the capacity to increase production of AHG concentr ate
to meet UK demand, but that some additional staff a nd
equipment would be required at both laboratories.
Dr Macdonald said that the new building at Liberton
should be open and functioning by the end of 1974; he
had some reservations about pursuing Mr Watt's
68 statement that the laboratory would be able to prep are
AHG concentrate from 2000 litres of plasma per week .
After discussion, it was agreed that the Blood
Transfusion Service should increase production of A HG
concentrate to meet all UK requirements, provided t hat
the necessary addition of funds could be made
available."
Pause there, sir, just for -- to refer to
a couple of matters from that paragraph. A questio n
which may be in your mind about what happens next f rom
1974 to 1975 period is why there was no decision
taken, at that stage, to redevelop BPL more
fundamentally than the incremental changes that wer e
made. Part of the answer to that question may lie in
Dr Maycock's analysis here, which is repeated in la ter
documents that we will come to, in which he says th at,
if you look at Elstree and Liberton together, then, as
long as there are some additional staff and equipme nt
made available, then they would have the capacity t o
increase production of AHG concentrate to meet UK
demand. The suggestion there is that the two
fractionation plants can cope with what is going to be
asked of them, subject to those pieces of equipment of
the staff being made available.
If we go to the end of the document, the
9 following action was agreed. Point 7, the first
action point is:
"Supply Division (that's a division within the
DHSS] should be asked to start negotiations with
a view to arranging a central call-off contract for
the purchase of freeze dried AHG concentrate on the
basis of a demand for 20 million units per annum fr om
about 40 haemophilia centres."
Then point (iv), as well, if we go on to the
next page, please:
"The question of UK production to be referred to
the proposed Joint Steering Committee on Blood
Products Production for consideration."
So again, sir, two strands. One is the central
contract to purchase commercial concentrates and th e
second is further work and a new body, the Joint
Steering Committee, to look at joint production.
Those were the action points suggested at that
meeting.
ANSWER:
So if we just go back to the
previous page, Supply Division starting negotiation
"on the basis of a demand for 20 million units".
Now, earlier in this meeting we said there was
no additional money for that. So what was being
proposed, presumably, was that this would come from
70 existing budgets?
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