Unnamed: 0
int64 0
47k
| index
int64 0
357
| q_a
stringlengths 22
51.4k
⌀ |
|---|---|---|
46,300 | 336 | QUESTION:
Yes. We will see how this -- how it plays out
in the documents that follow, I won't take you to a ll
of them, is that the DHSS arrange the central
contract. They do so to try to take advantage of
economies of scale, and that is a contract with the
providers of Hemofil and Kryobulin. However, that is
arranged centrally but, for each of the regions who
wish to purchase the commercial product, they must
fund that out of their own budget.
There is a debate about whether or not this is
going to be centrally funded or regionally funded a nd
that is answered by the DHSS saying it has to be
regionally funded. So the regions will have to dec ide
how much concentrate they want, how much they can
afford, and then they will use the concentrates
obtained by the DHSS as their source of material, b ut
they will be the ones who are paying for it.
Just to finish that section off, sir, it's set
out in the written presentation from around about
paragraph [55], that the take-up by the Regional
Health Authorities of the commercial concentrates t hat
DHSS had arranged to purchase from the providers, t hat
take-up was well below the anticipated demand. I
won't take you to the document, but a memo from
71 July 1974 states this, and I quote:
"Because of a high cost [that's the high cost of
the concentrates] and authority's current financial
difficulties, the uptake of the material during the
first seven months of the contract has been far bel ow
the originally estimated level of demand: Travenol,
Hemofil, 1.35 million units, 47% of the estimate; a nd
serological products [that's Kryobulin], 244,000
units", which was about 8 per cent of the estimate.
So, although the commercial contract goes ahead,
it is of limited success in increasing the amount o f
commercial concentrate that is available to clinici ans
because Regional Health Authorities are reluctant t o
buy the concentrates because of their cost. If we
think back to October and November, when we were
looking at the pharmaceutical companies, we discuss ed,
briefly, the central contract there and the figures
that it gave rise to and the costs that it gave ris e
to.
That is all I will say on the central contract.
We turn then to the second strand, which is the wor k
that was done on increasing domestic production, an d
you'll have seen from the last meeting that the fir st
step is to set up a new body, the Joint Steering
Committee on Blood Products, and that met for the
72 first time in June 1973.
If we could go Paul, please, to PRSE0004359,
this is summarised at paragraph 59 of the written
presentation.
We can see from the heading that this is the
note of the first meeting and it was held on
20 June 1973. The list of those present, Dr Maycoc k
is in the chair, and then I won't go through all of
the names but there are various Regional Transfusio n
Directors, another representative of the Blood
Products Laboratory, representatives of the DHSS, a nd
representatives of the Scottish Home & Health
Department, including Dr Macdonald and Dr Bell. Fr om
the DHSS, we just note that Dr Waiter was one of th ose
who was present.
If we could turn -- I won't go through all of
this document, but if we could turn, please, to
electronic page 5, paragraph 19. There is
a discussion of Dr Biggs's paper and the previous
discussion that had been held about haemophilia
treatment. It says there that, and I quote:
"The main points that emerged from the
discussion were:
"a. It was decided that in principle to treat
the UK as a whole and that the first target should be
3 Dr Biggs' lower estimate of the plasma from 400,000
donations with 700,000 donations as the ultimate
target.
"b. The initial aim should be to provide
anti-haemophilic globulin concentrate from 250,000
donations by 1975.
"c. The UK should opt initially to meet most of
the requirement with an 'intermediate potency produ ct'
but about 10% of the total output should be a 'high
potency product'.
"d. DHSS was considering making 'call-off
contracts' for two commercially produced
anti-haemophilic globulin concentrates which would be
available through Haemophilia Centres. It was agre ed
that it would be of considerable interest to the Jo int
Steering Committee to have details of the rate of
purchase by the Centres.
"e. The UK should aim to be self-sufficient by
1975."
Again, sir, we see the different figures, the
initial aim of 250,000 donations, that is part of
a first target of 400,000 donations, which is part of
a way to an ultimate target of 700,000 donations.
ANSWER:
Is there any further detail as to
what the distinction, what distinction was seen
74 between intermediate potency and high potency? We' ve
had descriptions of intermediate purity and high
purity before, which is explained by removing
unnecessary proteins from the fraction. What's
potency? This is the amount of activity?
|
46,301 | 336 | QUESTION:
I think, at least I read this as what would
later be described as high purity, intermediate pur ity
and --
ANSWER:
It might, however, mean extra
concentrated.
|
46,302 | 336 | QUESTION:
It --
ANSWER:
Just as one buys a bottle -- to use
a home-spun analogy -- a bottle of squash and then you
can get a smaller bottle, which is supposed to be
three times as concentrated.
|
46,303 | 336 | QUESTION:
It could mean that, sir. My -- I can't take you
to any document which shows this, but my sense is t hat
it is probably referring to what later becomes term ed
"purity". But I cannot be sure about that.
ANSWER:
Yes. I mean, if there's no other
document that helps, well, that's just a mystery an d
we'll assume that it means one or the other.
|
46,304 | 336 | QUESTION:
We can look into it and see if we can find
anything. The terminology in this period is a litt le
looser than it becomes later.
75 ANSWER:
Well, they knew what they meant.
|
46,305 | 336 | QUESTION:
They knew what they meant, yes. Certainly, the
sense is that there should be two forms of product,
one which will be for general use, as it were, and one
which is for a more specialised use.
ANSWER:
Yes.
|
46,306 | 336 | QUESTION:
The next meeting of note is on 20 July 1973.
I won't take you to the document, but it was a meet ing
of the Regional Transfusion Directors, which discus sed
the issue of domestic production, and considered
a paper, which is referred to in the written
presentation at paragraph 60.
At that meeting, it was proposed that the figure
of 250,000 should actually be increased to 275,000,
and the basis for that was a recalculation of how m uch
plasma could be assumed to be obtainable from a sin gle
donation. As we saw earlier, there was an estimate
from Dr Biggs of 200 to 220 millilitres, and at thi s
meeting, the Regional Transfusion Directors thought
that 180 to 190 millilitres was a more realistic
target. Because you were obtaining less plasma fro m
each donation, you would therefore need more
donations, hence the figure of 275,000 donations.
The same meeting heard that there was an overall
deficiency of about 100,000 donations per annum, an d
76 that was by reference to the first goal of 400,000
donations. So there were about 300,000 donations a t
the time, and there should be about 400,000 to meet
overall need, and of those, 275,000 should go to
concentrates. That was the maths that was being do ne.
Now, interestingly, the meeting discusses how
that shortfall of 100,000 donations could be made u p
by the increased use of red cell concentrates. So as
we were discussing earlier, the separation of the
whole blood donation into red cell concentrates and
plasma. And appendix 7 of -- that is attached to t he
written presentation provides some further data on
this, and we will look at that in due course.
But the shift towards red cell concentrates as
a way of increasing domestic production is seen as one
of the things that can be done and can be done
relatively quickly at this time.
There was also discussion about how a donation
target should be distributed amongst the different
Regional Transfusion Centres in proportion to the
total number of donations that they collected. So the
idea there of setting each centre a target for the
number of donations that it should provide.
Now, the meeting was told, paragraph 4 of the
note, and I quote:
7 "It was expected that the necessary
fractionation capacity would be available at BPL."
And that goes back to the point, sir, that I
mentioned earlier about why there was no concerted
effort at this time to seek an expansion of the Blo od
Products Laboratory at Elstree.
ANSWER:
That meant BPL Elstree, did it?
|
46,307 | 336 | QUESTION:
Well, again, the terminology isn't absolutely
clear. And it could mean -- sometimes BPL is used as
a term to cover both Elstree and Liberton. From th e
previous documents, the discussion was very much th at
you would need -- to provide self-sufficiency acros s
the UK, you need both. Both plants. And my readin g
of this is that that is what was intended to be mea nt,
even if that's not necessarily expressly recorded.
There was a further meeting of the Regional
Transfusion Directors on 27 September 1973 where so me
of the practical issues and difficulties involved i n
increasing plasma supply were discussed.
That brings us to January 1974 at which point
a significant reconsideration of future demand took
place. And if we can go, please, Paul, to
PRSE0002350. We can see, sir, that this is a paper ,
but it's a report from the Medical Research Council 's
transfusion research committee working party on the
78 cryoprecipitate method of preparing AHF concentrate s.
So it is an MRC working party which has been put
together, and we can see who is on it from the fron t
page. Dr Biggs in the chair, and then other member s
include Dr Rizza, Professor Blackburn, Dr Delamore,
Dr Dormandy, Professor Ingram, and Dr Maycock among
others.
This working party produced a report, and it
drew very heavily on Dr Biggs' earlier work and
earlier paper, so I won't take you through all of i t.
But there is a slight -- a significant, sorry,
adjustment of the figures for the donations require d.
And if we could turn, please, Paul, to page 21 of t he
document, we will go to the conclusions.
Conclusion 1 is that:
"Calculations suggest that the amount of
material required for optimum treatment of all the
haemophilic patients in Great Britain would be deri ved
from 547,540 to 750,000 blood donations a year. Th is
material would be used for on-demand treatment of a ll
patients, including home treatment of the 1,000 or so
patients who might benefit from it. The present
supply is that derived from approximately 300,000
blood donations a year, of which most is in the for m
of cryoprecipitate."
79 Just pausing there, sir. I'll deal first with
that figure. So it has gone up from 400,000 to
750,000 to 547,540. The explanation for that is th at
there had been a recalculation of the minimum numbe r
of people with haemophilia in the UK. I'm going to
use the term "the UK" because I'm very confident th at
this refers to the UK, not just Great Britain.
Now, previously, Dr Biggs had said that that
figure was at least 1,754 and was almost certainly
more than that. In this paper, the lower figure is
2,434. That is taken from data which had been
obtained from Haemophilia Centres and certain other
assumptions which are explained in the paper. So t hat
explains why the lower figure has gone -- the lower
estimate for the number of blood donations required
has gone up from 400,000 to pretty much 550,000.
I would also note, sir, that this paper is later
published in the British Journal of Haematology,
and a slightly different figure is given there, whi ch
is between 511,000 and 720,000 donations. So not
quite as high as is covered in this paper, but
certainly closer to that than the original estimate of
400,000.
The first conclusion also addresses some of the
issues that we have been discussing earlier. There is
80 a reference to "all patients", so presumably meanin g
patients with severe, moderate, and mild haemophili a.
And included within that figure is, again, this 1,0 00
or so patients who would most benefit from home
treatment. The most severely affected. And very
clearly stated that this is about on-demand treatme nt,
so the same assumptions that had informed Dr Biggs'
earlier paper and the discussions of it. That
on-demand treatment was to include the home treatme nt
of the 1,000 or so most severely affected patients.
Returning to the conclusions. I won't take you
through all of them because they are echoes of
Dr Biggs' earlier work. There's a discussion at
conclusions 2 and 3 about comparisons between cryo and
concentrates.
At paragraph 4 on the next page, and I quote:
"For home treatment, it is our opinion that
a freeze-dried concentrate is the therapeutic mater ial
of choice. The gradual introduction to home treatm ent
of the most severely affected patients who have the
most frequent bleeding would reduce hospital
management of haemophilia by half. To give this
proportion of patients (approximately 1,000) home
treatment would involve the use of factor VIII
concentrate from about 250,000 blood donations a ye ar.
1 The present (1973) total of factor VIII concentrate is
derived from 40,000 to 45,000 donations a year."
Just pause there to note, sir, that we're back
to the 250,000 figure, rather than the 275,000 figu re
which the Regional Transfusion Directors had arrive d
at. And I also note that the figures of donations
devoted to concentrate had gone up by 1973 to 40 to
45,000 from the original 25,000.
And back to the document in paragraph 5:
"The number of donations contributing to pools
of plasma used to make concentrates does affect the
probability that a particular pool may contain
hepatitis virus. However, the incidence of jaundic e
in multi-transfused patients seems to be, to some
extent at least, dose related. In practice, the
incidence of jaundice in multi-transfused haemophil ic
patients does not rise very greatly with the use of
freeze-dried concentrates. In any case, with
universal screening of donors for hepatitis B antig en
now in operation, the danger of infection will
decrease to some extent in the future. The inciden ce
of anti-factor VIII antibodies is not affected by t he
type of human material used to treat the patient.
"6. We think that within the next few years
a great effort should be made to increase the amoun t
82 of plasma which is fractionated in the United Kingd om.
From the point of view of patients with haemophilia
and Christmas Disease, present estimations suggest
they need for 547,540 to 750,000 donations to be
fractionated annually to produce freeze-dried
factor VIII. On a national scale, this need for
factor VIII must be coordinated with other demands of
the Transfusion Service, for example the need for
albumin fraction. Clearly, a 20-fold increase in
fractionation cannot be achieved overnight, but it is
to be hoped that very substantial increase may occu r
without too much delay. The present estimate of th e
need for factor VIII is based on data now available ,
and as time passes and more concentrates become
available, the true amounts of factor VIII required
will be defined more certainly. Our present opinio n
is that the provision of freeze-dried material from
500,000 blood donations annually will do as much to
improve the lives of haemophilic patients as was
achieved several years ago by the provision of
cryoprecipitate.
"7. Freeze-dried factor VIII concentrate of
good quality is now available commercially. At
present, patient treatment at many of the Haemophil ia
Centres in this country involves a dangerous policy of
83 balancing the needs of one patient against those of
another and of delaying reconstructive orthopaedic
surgery which would greatly improve the lives of ma ny
patients. We believe it very important that the
material made in the United Kingdom, which is secon d
to none in quality, should be substantially increas ed
in amount. In the interim period before the
United Kingdom product is available in adequate
amounts, commercial factor VIII should be bought in
quantities sufficient to satisfy the needs of these
patients."
ANSWER:
Can you just help? The claim is
there made that the material made in the
United Kingdom is quote "second to none in quality" .
|
46,308 | 336 | QUESTION:
Yes.
ANSWER:
Is there any description anywhere as
to how quality was to be assessed?
|
46,309 | 336 | QUESTION:
There isn't a single document, I think, that
sets that out. There is discussion in some of the
other meetings which really echoes what is said the re:
that the domestically made product is as good to us e
as the commercial products. Now, I have inferred f rom
that discussion that that is a reference to things
such as the solubility of the product, the lack of
inhibitor reactions to it, the ease of storage, for
84 example, but that is not expressly stated. The
discussion on safety is that at paragraph 5 and ech oes
the discussions that were previously had.
I'm just going to go back over those numbers
again, sir, because I'm conscious that we have
a different set of numbers, and it's helpful, perha ps,
to just pause and take stock of what they are. So the
MRC are saying -- have presented three figures in
their conclusions. The first is that range from
547,540 to 750,000 donations, and that is stated to be
the overall need for donations for optimal treatmen t
for all people with haemophilia.
It is presented in conclusion 1 as a figure that
encompasses both Factor VIII and cryoprecipitate, a nd
it is compared with the current position of 300,000
donations. However, later, there is a discussion
about how there is a desire for all or most of that
figure to be made up in concentrates in the long ru n.
So that is 574,540 to 750,000, an increase, as
we've said, on the previous estimate of 400,000 to
750,000.
The second figure is that figure of 250,000
donations for home treatment for the 1,000 most
severely affected patients. That is consistent wit h
what Dr Biggs had said before and, as we've seen, t he
5 Regional Transfusion Directors have said, actually,
that figure should be about 275,000 to adjust for t he
amount of plasma that can be taken from a blood
donation.
The third figure that the MRC give is 500,000
donations, which, in their view, should be dedicate d
to concentrates in order to improve the life of peo ple
with haemophilia, as much as the introduction of
cryoprecipitate did.
The final recommendation is about how the UK
should both increase its own domestic supply and al so
buy commercial concentrates to cover the shortfall in
the interim.
This paper was presented by Dr Biggs, who I take
to be the lead author of it, to the directors of
Haemophilia Centres and Blood Transfusion Centres a t
a meeting that was held on 31 January 1974.
Paul, please could we go to CBLA0000187.
We can see from the top of that page that this
is a joint meeting and it is held to discuss
Dr Biggs's paper, among other matters. The Chair i s
Professor Blackburn. I won't go through the full l ist
of those who attended and sent apologies. There we re
41 representatives from Haemophilia Centres and
hospitals; five representatives from Regional
86 Transfusion Centres; Dr Maycock was present from BP L
and Dr Waiter was among those present from DHSS.
If we could go, please, Paul, to page 4 of the
paper, of the minutes, and we can see that item 3 i s
"The present and future supply of Factor VIII", and
Dr Biggs introduced the MRC Working Party report th at
we have just looked at.
If we go down just to the bottom of that
paragraph we can see that Dr Biggs said that the
report suggested a need for material derived from
500,000 to 750,000 donations annually. That is the
range that she is giving there.
There then followed discussion, if we look at
the next page. The first item was how many people
with haemophilia there were in the United Kingdom.
I won't go through that discussion but if I could j ust
ask Paul to go to point (iii), a point raised by
Dr Ingram, who:
"... spoke on the long term forecast of
factor VIII requirements ... and stressed that the
incidence of haemophilia is likely to rise as
treatment improved. Any assessment of the amount o f
[antihaemophilic globulin] required for therapy mus t
take this into account."
So Dr Ingram flagging the point that, as the
87 population increases, due to better treatment, it w ill
need more factor concentrate.
Then I will read the next part of the
discussion, which is "What kind of material was bes t
for treatment?" I quote:
"There was a wide ranging discussion about the
relative merits of cryoprecipitate and freeze dried
concentrates with regard to ease of manufacture,
recovery from the original plasma, ease of
administration and recovery of activity in the
patients. It was generally felt that larger suppli es
of concentrated preparations were required now and
urgently and some felt that it was rather meaningle ss
to ask doctors if they would prefer freeze dried
concentrate to cryoprecipitate when no freeze dried
concentrates were available to them. When the
discussion was completed the meeting was asked to
indicate whether anyone would in fact prefer to hav e
cryoprecipitate if freeze dried concentrate were
freely available. It was clear that none of those
present would prefer cryoprecipitate."
The next section of the meeting discusses how
much material was likely to be needed and we hear
a dissenting view from Dr Bowley, who was a Regiona l
Transfusion Director. I'm afraid, I -- Sheffield.
88 Sheffield Blood Transfusion Centre.
Dr Bowley, I won't go into this in detail, but
he criticised Dr Biggs's figures and thought that s he
was overestimating the amount of future need and he
suggested that it was lower. It's not a view which
gains much traction so I won't go into it in any
further detail.
But, if we go to the bottom of that page, it
says, and I quote:
"In view of all that had been said, the Chairman
concluded that with one exception [I take that to b e
Dr Bowley], the Meeting" --
ANSWER:
I think we need -- thank you.
|
46,310 | 336 | QUESTION:
-- "the Meeting supported and wholeheartedly
endorsed the Appendix B Document [that is the MRC
report]. Again it was stressed that the estimates in
Appendix B are just for present but in five years'
time there may be a need for more material.
"ACTION . The Chairman agreed to write to the
DHSS saying that the meeting of Haemophilia Centre
Directors and Transfusion Directors, approved the
contents of Appendix B and recommended that this
document be used as the basis for planning future
requirements for factor VIII in the United Kingdom.
"The meeting then went on to discuss problems
9 which would arise in trying to increase the supply of
factor VIII freeze dried concentrates.
"It was felt that once the new fractionation
laboratories in Edinburgh and at the Lister Institu te
[BPL and Elstree] were in full production, they sho uld
be able to meet the needs of the country provided
sufficient plasma was available.
"Some Blood Transfusion Centres felt that
plasmapheresis which was already being carried out on
a large scale in some Centres might be the answer t o
the problems of plasma applies. Dr Cleghorn descri bed
his procedure and said that his donors found it
acceptable and not distressing.
"There was no doubt that the 'processing' of
more blood to obtain plasma for manufacture of
factor VIII would require more staff, equipment,
mobile vans with cold storage facilities, etc, and
that this would add to the Blood Transfusion Centre s'
costs.
"Dr Waiter could give no statement as to how
this extra expense would be met but she said that i t
should in the first instance be referred to the DHS S.
She made the point that the purchase of commercial AHG
was already costing the DHSS a lot of money.
"The meeting digressed for a short time to
90 discuss the problems of genetic counselling ..."
I won't take you through that.
"Several directors said that they did not treat
all the patients at their Centres since this was to o
inconvenient for the patient and too difficult. On
the other hand, they were aware that the materials
might not be used properly. This raised the questi on
of home therapy. It was stressed that home therapy
was becoming more accepted and widespread and was
improving the quality of the patients' lives.
Cryoprecipitate was not ideal for home therapy from
many points of view. Some directors were buying
commercial AHG for use in home therapy."
If we could just go back to the previous page,
Paul, just to pick up a couple of points from that.
The joint meeting of the Haemophilia Centre Directo rs
and the Blood Transfusion Directors, therefore, gav e
a ringing endorsement of the MRC paper that we have
already looked at and of the estimates that it
contained, in particular, at least 500,000 to 750,0 00
donations per annum.
They recommended that the MRC report should be
used as the basis for future planning. We can see
about halfway down the page a statement again that,
once the new fractionation laboratories at PFC and BPL
91 were up and running in full production, then they
should be able to meet the needs of the country,
provided sufficient plasma was available.
Again, sir, I'll go back to that question of why
it is that BPL was not redeveloped at that time and
this may be the answer. That plays out in the way
that the £500,000 that Dr Owen makes available is
subsequently spent, something that we will come to
later.
Finally, just a couple of points on what
Dr Waiter is recorded as saying. She said that, in
the first instance, the costs of increasing plasma
production, which had been raised at the meeting,
should be referred to the DHSS. I take that to mea n
that there is a need to consider that centrally, in
Dr Waiter's view, rather than, in first instance, i n
the regions. This gives rise to significant debate in
the months that follow, about who should pay for th e
improvements that were needed in order to increase
plasma supply.
The second point that Dr Waiter made was that
the DHSS, looked at cumulatively, was already payin g
a lot of money for commercial concentrates, and tha t
could be offset against the cost of future producti on.
I don't think it is too far of a stretch to say tha t
92 one can see here that Dr Waiter is sympathetic to t his
argument but, of course, Dr Waiter is one individua l
within the DHSS, as --
ANSWER:
Well, what she seems to be saying is
the DHSS is paying centrally to buy a commercial
product, the production -- the greater production o f
which is capable, on the basis that the meeting
decide, capable of being fulfilled by BPL, Elstree and
PFC in Liberton, if they're given enough plasma. T hat
requires enough plasma, that'll cost a bit more mon ey,
but because it's going to save money with the DHSS
currently paying centrally, that's where you get yo ur
money from. It's the subtext.
|
46,311 | 336 | QUESTION:
Yes, and that is an argument which is made
repeatedly in the papers by various people, includi ng
Dr Waiter.
ANSWER:
But, as you say, it cuts against the
principle of regional payment.
|
46,312 | 336 | QUESTION:
It does, sir. What we will see in the papers
that follow is that, in order to expand plasma supp ly
requires significant upfront capital costs and,
indeed, revenue costs that occur. Those will be
incurred upfront, and you won't get your plasma --
increased plasma supply until sometime afterwards
because it takes a while to work through the system .
3 Buying concentrates commercially will cost less
in the short-term than your significant capital cos ts,
and you will get the concentrates immediately. So
there is a trade-off between a short-term and a lon g
term cost, both for the Regional Health Authorities
and, indeed, for the DHSS generally. That is perha ps
a dynamic which is important in the events that
follow.
The response of the DHSS to this meeting is
considered from paragraph 73 of the written
presentation. I won't take you to the documents
there. There was a minute from Mr Jackson of the
DHSS, dated 14 February 1974, in which he refers to
the fact that 8 out of 14 Regional Transfusion Cent res
had provided the DHSS with estimates as to how much
money would be required to increase plasma supply, and
he had extrapolated from those estimates that, acro ss
the country, about £160,000 would be needed for ext ra
accommodation, equipment, staff and transport, and
that BPL would also require about £45,000 for capit al
works.
That is, as Dr Jackson says, a calculation which
is a rough one, and is not based on data from all o f
the centres.
Now, Mr Jackson says, in that minute, and
94 I quote:
"The cost of increasing the production of plasma
is modest", when compared to the cost of production
products.
So the point that we have just been discussing.
Mr Jackson's minute triggers a debate amongst
DHSS officials about whether central funds should b e
provided or whether the regions should be left to f und
these improvements themselves. It's clear from the
relevant documents that there is an awareness, an
acute awareness, that this debate is taking place a t
a time of great pressure on public expenditure. To
quote from one document, I quote that public
expenditure reductions have, and I quote:
"... been so severe that Regional Health
Authorities will be unable to carry through all the
products that the department would like to see."
So there is a recognition that the regions are
very pushed for money. But, as of 19 April 1974, w e
have a minute from that date, the position of the D HSS
was that no central funds would be made available t o
the regions. By that time, the estimate for how mu ch
the improvements were going to cost had gone up to
being not less than £1 million, and the point made in
the documentation is that the savings on the cost o f
95 commercial concentrates would be savings that
benefited the regions, therefore it was for the
regions to put forward the capital costs to improve
the supply of plasma, in order to get the benefit o f
those savings.
Now, that lack of central funding coming at the
same time as the DHSS and others are pushing for an
increase in plasma supply caused tension, as one mi ght
expect. And just to give one example of that, if w e
could go, please, Paul, to DHSC0100005_094. This i s
a letter which is written from Mr Scott, who is the
regional medical officer of the Trent Regional Heal th
Authority, and it is written to Dr Maycock. It is
dated 16 May 1974, and it is entitled "Provision of
plasma for Factor VIII concentrate". And what
Dr Scott says is this, and I quote:
"I have recently received from Dr Wagstaff [the
director of the Regional Transfusion Centre] a requ est
for £17,000 capital and £29,000 recurrent revenue t o
meet the cost of providing fresh frozen plasma for the
manufacture of Factor VIII concentrate. It seems t hat
the DHSS was expected to meet these costs, but not
unexpectedly it has referred the matter to regions.
"I cannot comment on other regions' finances at
this time, but in the light of information currentl y
96 available to me, there is no hope whatsoever of the
Trent Regional Health Authority meeting these deman ds.
"I find this situation disturbing because
a national edict of this kind threatens to distort
other regional priorities. Equally, I am very unha ppy
at not being able to offer encouragement to the
Sheffield Centre which has always prided itself on
being to the fore in such developments.
"I would value your comments and advice."
That was sent, as I say, by Dr Scott. An
indication of the tension that had developed betwee n
the region and the DHSS in this area.
I note the time, sir, and wonder if that might
be a good point to stop for lunch.
ANSWER:
Yes. Well, we will take a break
now, shall we, until 2.00. 2.00.
(1.02 pm)
(The Luncheon Adjournment)
(2.01 pm)
|
46,313 | 336 | QUESTION:
Just to pick up on three things from this
morning, sir. First, SAMO stands for Senior
Administrative Medical Officer. Apologies. There' s
so many acronyms. Sometimes they slip through the
net.
7 ANSWER:
Well, I'm sorry couldn't help you.
I was trying to work out what the "A" meant.
|
46,314 | 336 | QUESTION:
The second point, this question of potency and
purity. If we could have on screen, please,
WITN3431001, page 32. This is the witness statemen t
of Dr Snape from whom we will hear at the tail end of
this block of hearings. We'll have paragraph 90 wh en
it comes up. Page 32, paragraph 90. The context i s
not relevant for today's purposes, but we can see h ere
what Dr Snape says about potency and purity. In th e
parenthesis he says:
"The term 'potency' refers to the concentration
of factor VIII in units/ml, whereas purity, or more
accurately 'specific activity', describes the ratio of
assayed factor VIII to measured protein content
expressed as units of factor VIII per mg of protein .
Specific activity is important in this context sinc e
it reminds the fractionator and the treating physic ian
how much non-factor VIII protein is going to be
infused."
We can see there the distinction that Dr Snape
draws in his statement. The reference earlier was to
the potency of the product --
ANSWER:
Yes.
|
46,315 | 336 | QUESTION:
-- which, in Dr Snape's usage, will therefore be
98 a reference to the concentration in units of
Factor VIII per millilitre.
ANSWER:
It's the degree of concentration.
It's the -- my example of the concentrated squash o r
the concentrated washing up liquid.
|
46,316 | 336 | QUESTION:
Exactly, sir. Exactly so. The wider context of
that discussion is that 90 per cent of what may be
referred to as standard Factor VIII was required an d
10 per cent of the higher potency --
ANSWER:
He makes the point here that the two
might be linked, possibly, in this sense: that if y ou
are using less volume to give you the necessary
Factor VIII, you are therefore providing less volum e
of other proteins --
|
46,317 | 336 | QUESTION:
Yes.
ANSWER:
-- which may (unclear) , by the way,
but they're there. So it is also going to be more
equivalent to higher purity although -- because
it's -- high purity refers to the amount of excess
protein that you get, doesn't it?
|
46,318 | 336 | QUESTION:
That is my understanding, that the two will be
closely related. A higher potency Factor VIII prod uct
may be an increasingly pure Factor VIII product.
ANSWER:
Yes, on the other scale.
|
46,319 | 336 | QUESTION:
Dr Snape I hope will be able to take us through
99 this --
ANSWER:
Well, he can tell us if that's
right, but thank you for that. It looks as though
there was a proper distinction to be made.
|
46,320 | 336 | QUESTION:
Yes.
ANSWER:
Thank you.
|
46,321 | 336 | QUESTION:
Finally, a measure that I didn't introduce
earlier but will introduce now. We looked at the M RC
paper, Dr Biggs' paper that was later enthusiastica lly
endorsed by various meetings and was recommended as
the basis for planning. That expressed the amount of
blood donations required as the measure for achievi ng
the requisite amount of blood products. The same
paper also expresses that amount in terms of
Factor VIII units. The figure that is given in the
paper, and it is page 18 of that document, is that --
ANSWER:
Is that PRSE0002553?
|
46,322 | 336 | QUESTION:
It's PRSE0002350. Electronic page 18, internal
page 17. Perhaps, actually, we will bring it up,
Paul.
PRSE0002350. Electronic page 18. We can see at
the top there the figure that we discussed earlier,
547,540 to 750,000 blood donations per annum. If w e
go down a few lines, it says:
"Expressed as factor VIII units, the range is
100 likely to lie between 38,327,800 and 53 million
factor VIII units."
So expressed in slightly more simplified terms,
it's between 38 million and 53 million Factor VIII
units. Now, I understand that to be a reference to
what later becomes referred to as international uni ts.
ANSWER:
Yes.
|
46,323 | 336 | QUESTION:
We will see increasingly, as the '70s goes on,
the measure of blood donations is dropped in favour of
weight or volume for the amount of plasma and
international units for the amount of Factor VIII t hat
is produced. This is a translation between the two
presented by Dr Biggs. There are various ways of
trying to calculate how many international units co me
from each donation, and it rests on a series of
assumptions. So it can't be seen to be an absolute
definitive figure, but in Dr Biggs' mind, what she is
thinking about is the need for between 38 and
53 million international units of Factor VIII
per annum.
ANSWER:
Yes. Just one other measure while
we're talking about measures. I understand there i s
a clear link between volume and weight if you're
looking and thinking of water, which I think is how
the MKS system of measurement works and converting
01 from kilograms to volume. Plasma plainly is not th e
same specific gravity as water, so it will be heavi er,
presumably, per volume. Do you know what the
conversion is?
|
46,324 | 336 | QUESTION:
The conversion that I have found, and I stress
this is a layman essentially looking online to try to
find the conversion, I think it's in the region of
1.024 kilograms.
ANSWER:
Thank you.
|
46,325 | 336 | QUESTION:
But there will be others who are far better
placed to be able to make that conversion.
ANSWER:
So it's very close to a kilogram
being equivalent to a litre.
|
46,326 | 336 | QUESTION:
You will see in appendix 1 and appendix 2 when
the Inquiry legal team have had to do that calculat ion
in order to be able to compare data points, the
conversion used is 1:1.
ANSWER:
Yes.
|
46,327 | 336 | QUESTION:
But it is stressed that that is a rough
approximation. And as we will hear when we come on to
look at those figures, they come with a lot of
caveats, the core of which is that they are helpful in
showing a general trend but they shouldn't be relie d
upon to be absolutely precise at all points as to
exactly how much is being either produced or suppli ed.
102 ANSWER:
I suppose it might be said that it
would give a degree of apparent accuracy, which isn 't
necessarily completely accurate, knowing that
different plasma donations will have different leve ls
of Factor VIII activity in them, depending upon how
much the donor had.
|
46,328 | 336 | QUESTION:
Yes. There are so many variables, it is never
going to be possible to say this figure is exactly
this figure in equivalence.
ANSWER:
You'd expect the donations to
approximate if there are enough of them in a pool, to
a hundred per cent activity, that being the average ,
but you don't know.
|
46,329 | 336 | QUESTION:
Exactly, sir.
ANSWER:
I see.
|
46,330 | 336 | QUESTION:
Returning, then, sir, to the chronology. The
tension that we were exploring before the break was
between the DHSS and the Regional Health Authoritie s
about who was going to fund the expansion of plasma
supply.
There was also a tension that was growing
between clinicians and the DHSS, and no doubt with
their regional administrators as well, about the
amount of concentrate that was being provided to th em.
Two examples of that come from Dr Biggs. The
103 first is a letter that she wrote to Dr Waiter at th e
DHSS on 23 May 1974. And, Paul, if we could have t hat
on screen please. CBLA0000206. What Dr Biggs wrot e
is this. It's in response to a letter sent by
Dr Waiter on 10 May 1974. Dr Biggs wrote, and
I quote:
"I wonder if there is some impression in the
Ministry of Health and Social Security that the
haemophilic patients in this country are now not
undergoing any real inconvenience? I cannot give y ou
figures about 'crippling' because it is hard to say
exactly what is meant by crippling. However, many of
our child patients arrive at hospital in ambulances on
crutches and with knees and ankles so painful that
they cannot put a foot to the ground. Elsewhere, I am
sure that patients with these bleeds are at home in
bed. In the long run, all of these patients will h ave
arthritis and deformity. In the bad old days, this
would occur before the age of ten. Now, hopefully,
most patients who attended Haemophilia Centres (abo ut
half the total) should at least reach adult life ab le
to walk. Our modest objective is to get enough
factor VIII delivered to the patient to delay the
onset of arthritis to middle age for all patients."
You can take that down.
104 Dr Waiter replied saying that her colleagues in
the department had been left in no doubt of the
requirements. And she also pointed out that if mon ey
were to be made available for more Factor VIII, the n
it would come at the expense of something else in t he
health budget.
I should add, sir, that although that letter was
addressed to Dr Waiter, I think that we can see fro m
the papers that Dr Waiter was sympathetic to the ca use
being made by Dr Biggs and others.
Dr Biggs, in the same letter, told Dr Waiter of
her intention to send a letter to The Lancet on thi s
matter, and that was published on 29 June 1974.
If we could go to that, please, Paul, it's
PRSE0002515. I'm going to read the entirety of the
letter, because it is significant in the effect tha t
it has on some Parliamentary opinion:
"Letters to the Editor
"Supply of Blood-Clotting Factor VIII for
Treatment of Haemophilia."
Dr Biggs wrote this:
"Sir -- The treatment of haemophilic patients
involves a replacement in their blood of an essenti al
substance which they lack. In this respect, the
disease resembles diabetes or pernicious anaemia.
05 Factor VIII to a haemophilic patient is literally h is
expectation of life. Haemophilia differs from
diabetes or pernicious anaemia in that the missing
factor VIII can only safely be provided from human
blood. The haemophilic patient is thus indebted to
society and in return is the responsibility of soci ety
in rather a special sense.
"Without treatment, before the middle of this
century, few patients reached adult life and those who
did were helpless cripples. Over the past 12 years ,
blood products containing factor VIII have graduall y
increased in amount. In the early part of this tim e,
medical attention was centred on the cure of
life-endangering bleeding and on the protection dur ing
essential major surgery. As more material became
available, patients were treated for particularly
dangerous muscle haematomas and haemarthoses in the
hope of reducing somewhat the severity of crippling
and delaying the age of onset of deformity. The
present, but still modest, objective is to treat al l
developing musculoskeletal bleeds as early as
possible, hopefully to prevent the occurrence of
severe deformity in all patients. This form of
therapy is called 'on demand' treatment. Very many of
the patients treated on demand arrive at the hospit al
106 on crutches, in ambulances, and with painful swolle n
joints. Most such episodes of musculoskeletal
haemorrhage resolve with treatment, but there can b e
no doubt at all that in the long term these patient s
will have arthritic joints long before those of the
normal population. An extension of on-demand hospi tal
therapy to the home (home therapy) so that treatmen t
is given by the patient to himself, by a relative o r
by a general practitioner would undoubtedly reduce the
damage and also the anxiety under which patients an d
their families now live. It should be noted that e ven
home therapy is a modest objective when comparison is
made with prophylaxis. In prophylaxis, treatment
would be given to prevent the occurrence of bleedin g
altogether. Prophylaxis is, of course, the rule fo r
patients with diabetes or pernicious anaemia; its
application to haemophilic patients would treble th e
present estimated requirements of factor VIII.
"Those who treat haemophilic patients in the
United Kingdom have in the past of necessity tolera ted
the chronic undertreatment of their patients and ha ve
put much time and effort into spreading the inadequ ate
amounts of therapeutic material thinly so that
deprivation should be least damaging. Essential bu t
non-urgent operations have been postponed and are
107 still being postponed. Economy has also been achie ved
by calculating the those for each lesion for every
patient to the absolute minimum dose. In addition,
patients have not been put onto home therapy who wo uld
greatly benefit by this treatment. Even with dire
economy, some centres have been hard pressed to mai n
minimum treatment. For example, the treatment of t he
boys at Lord Mayor Treloar College at Alton in rece nt
years has been maintained against a background of
begging and borrowing from other centres from one w eek
to the next. Were the school not supplemented in t his
way, it is calculated that there would be a deficit of
about 260,000 factor VIII units annually. There is ,
in fact, evidence that 90% of haemophilic patients in
the United Kingdom receive less (and in some cases
much less) than optimum treatment for their complai nt.
The consequences of this undertreatment include
subjecting the patients to unnecessary, painful, an d
destructive bleeding into joints and muscles.
Ancillary effects of undertreatment include loss of
educational time and inability to holding continuou s
employment.
"The question that arises is for how long should
this shortage of factor VIII be considered to be
a reasonable feature of haemophilia treatment? Two
108 things, in my view, make continued limitation both
unnecessary and unethical. The first of these is t he
fact that three commercial companies are now licens ed
to sell good-quality human factor VIII in this coun try
and they have between them amounts of material
adequate to supplement the present provisions of th e
National Health Service. In fact, at the time of
writing, one commercial firm has over 1,000,000 uni ts
of factor VIII awaiting use.
"The second consideration which renders adequate
provision of factor VIII both feasible and desirabl e
is the fact that blood can now be collected in plas tic
containers, which makes it possible to use the red
cells for patients who are anaemic and the plasma f or
patients who lack some plasma components. The bloo d
donated in the United Kingdom is freely given by
responsible citizens; the best use of this valuable
resource clearly lies in the best use of all parts of
the blood. With regard to the provision of
factor VIII by the NHS, we can say with certainty t hat
we have the skill, experience, and capacity in this
country to provide factor VIII of very high quality in
the amounts required.
"Why, then, is there still a chronic shortage of
factor VIII in the clinics where the patients are
09 treated? The reason is that factor VIII is expensi ve,
whether bought commercially or made by the NHS. Ov er
the country as a whole, a supply of commercial huma n
factor VIII sufficient adequately to supplement tha t
made at present by the NHS would cost an annual
£1-2 million. It is claimed that a sum of money of
this order cannot be found from current allocations to
the NHS without reducing money spent on other
necessities. To make increased amounts of factor V III
in the NHS is also likely to be expensive since it
would require substantial expenditure on organisati on
of blood supplies, on staff, apparatus, and buildin gs
for fractionation. Set against this financial
argument, it must be remembered that poorly treated
haemophiliacs also cost a lot of money in their rol e
as hospital inpatients and in receipt of
social-security benefits. But of course the financ ial
argument takes no account of the misery and anxiety
attached to frequent painful episodes of bleeding a nd
inability to hold a normal place in school and
society. In the long run it will probably be found
cheaper to pay for these patients' treatment rather
than to pay for the inevitable consequences of
undertreatment.
"When, as a director outcome of years of
110 research, lifesaving therapeutic materials suddenly
become available to a population of patients
previously chronically undertreated, there surely
should be some means of assimilating this welcome
advance, otherwise it is stupid to undertake the
research in the first place. How this should be
achieved is an administrative and political problem
rather than a medical one. Perhaps there should be
a special fund in the NHS set aside every year for the
practical implementation of research discoveries.
Perhaps an organisation should be set up to collect
money on a charitable basis to supplement the NHS
funds available for the introduction of new
treatments. Whatever solutions there may be for
problems of this sort in general, some immediate
solution should be found for the ridiculous impasse of
large available stocks of therapeutic materials loc ked
up in stores because no-one will buy them and, on t he
other hand, patients in dire need of this same
material."
That is Dr Biggs's letter to The Lancet on
29 June 1974. That letter, as I hinted, prompted
a number of Parliamentary questions about Factor VI II
supply and home treatment from Lewis Carter-Jones, the
Labour MP for Eccles. These are the first
111 Parliamentary questions that the Inquiry legal team
have been able to identify from Hansard on the topi c
of Factor VIII supply. They were addressed to the
then Secretary of State, Barbara Castle, but they w ere
answered by a minister, Dr Owen, on 9 July 1974.
If we could bring up on screen please, Paul,
LDOW0000032, I believe this is a document that Dr O wen
referred to in his evidence, certainly in his writt en
evidence. I think in his oral evidence as well. T his
is a written Parliamentary answer. Dr Owen wrote
this:
"The supply of Factor VIII produced within the
National Health Service is at present insufficient for
the optimum treatment of haemophilic patients. I h ope
that it will be possible to increase our supplies, and
meanwhile product licences were issued last year to
two firms to market imported Factor VIII in the
United Kingdom. Adequate stocks, I understand, are
held of this commercial material. It is not the
Department's normal practice to make central purcha ses
of health service supplies, but central contracts w ere
arranged to facilitate the purchase of this materia l
by Health Authorities.
"I recognise the desirability of enabling these
patients to receive treatment at home but progress in
112 this direction is likely to depend largely on the
extent to which production of Factor VIII within th e
National Health Service can be increased."
ANSWER:
Just as a matter of interest, it
doesn't directly affect self-sufficiency but it may
affect other points of accuracy, in her letter,
Dr Biggs speaks of three commercial firms, I think,
whereas Dr Owen speaks of two. When we had the
presentation in respect of the pharmaceutical
companies, I understood that Hemofil and Kryobulin
were the two which were authorised to be distribute d
in 1973, licensed. What was the third?
|
46,331 | 336 | QUESTION:
From memory, and I stress it is from memory,
I think it was Factorate, Armour's Factorate, which
came on to the market third.
ANSWER:
Factorate. Because Profilate came
later?
|
46,332 | 336 | QUESTION:
Yes, I will check on that.
ANSWER:
Because I thought the date of that
was after '74 but, plainly, that's a mis-memory on my
part.
|
46,333 | 336 | QUESTION:
Well, the licence, I think, was after '74 but it
was provided off licence on a named-patient basis.
ANSWER:
Well, that would be so of any
product.
13 |
46,334 | 336 | QUESTION:
Yes, yes. My recollection, I will check it over
the break or overnight, is that Factorate is the th ird
product that enters the market, and rapidly --
ANSWER:
But it may not be the third she was
referring to, if she was talking about named-patien t
basis.
|
46,335 | 336 | QUESTION:
It may not be. But, again, my recollection from
last autumn is that Factorate pretty quickly
establishes a very strong market position, partly
because it's cheaper. So it may well be that
Factorate is the one that she is referring to.
Dr Owen, in his reply there doesn't seek to
rebuff the central charges that Dr Biggs --
ANSWER:
My own note, actually, is that
Armour Factorate, was licensed on 25 March 1976, wh ich
would be a couple of years after this, and Abbott's
Profilate was earlier in '75, so I am just wonderin g
if there was something which we've missed.
|
46,336 | 336 | QUESTION:
I can look back, sir. I will look at the letter
and see if there is anything else that can tell us
which product she is referring to.
ANSWER:
Thank you.
|
46,337 | 336 | QUESTION:
Dr Owen, in his response then, not seeking to
deny the central charges that Dr Biggs had made in her
letter, and seeming to accept that the question of how
114 great a number of concentrates can be provided, is
tied heavily with how much domestic supply can be
increased, and that is the question for the wider
National Health Service, which is not inconsistent, in
any way, with what Dr Biggs said in her letter: tha t
it was essentially a question of politics and finan ces
as to why there wasn't a greater domestic supply.
Sir, we can see from this increasing tensions
and increasing public concern being raised about
Factor VIII supplies to patients. In this atmosphe re,
the Regional Transfusion Directors met on 3 July 19 74.
If we could go please, Paul, to NHBT0016495, we
can see from the document that Dr Maycock was in th e
chair and the list of Regional Transfusion Director s,
but also you can see Dr Waiter and Mr Jackson from the
DHSS attending.
If we could turn, please, to page 4, we can see
that the heading "Provision of Plasma for
Anti-Haemophilic Globulin Concentrate and Other Pla sma
Fractions Including Specific Immunoglobulins", what is
recorded in the minutes is this:
"The meeting considered Dr Maycock's letter of
12 June 1974 to Directors about the need to provide
more plasma for fractionation and [the paper] which
summarised information from Queensland, Western
115 Australia and New South Wales, Canada and Switzerla nd
about the number of donations collected and the use of
concentrated red cells."
Over to the next page:
"Dr Maycock said that as a result of a number of
factors that were operating or had operated, the NB TS
now found itself in a position of some difficulty a nd
facing a shortage of certain preparations of human
blood. These factors, not necessarily in the order of
importance, were:
"(a) The need to provide antihaemophilic
globulin concentrate equivalent to about 275,000
donations. This was the preferred preparation and was
essential for home treatment which was being
increasingly used. The department had been advised
that the NBTS should reach the position of being ab le
to supply this amount of concentrate by 1975, but t his
was clearly not possible.
"(b) An increase in demand throughout the world
for albumin fractions."
I won't go through the rest of that paragraph,
sir, but I do pause to note that we, of course, are
focusing on Factor VIII here, but the debate about
self-sufficiency is wider than that. Albumin forms
a particularly important part of that debate.
116 ANSWER:
What the fractionators say in their
report is that either a first step or a precursor t o
cold ethanol fractionation is the removal from the --
from what remains of Factor VIII and the proteins t hat
tend to come with it, the proteins such as fibrinog en.
It's later on in the same fractionation series that
you get albumin. So, presumably -- but this may ne ed
a specific question -- my assumption had been and i t
may still be that there is no conflict between (a) and
(b) in this sense: that if you get more plasma
supplied to BPL, they can make more, or get more
Factor VIII out of it, but they also have the
supernatant which remains in the process from which
you get more albumin. So the need to supply more
plasma is essential for both, and the same plasma
provides both --
|
46,338 | 336 | QUESTION:
That is my understanding as well.
ANSWER:
So this is not setting up something
which is a contradiction.
|
46,339 | 336 | QUESTION:
No.
ANSWER:
It's basically saying we need more
plasma because it will serve these various differen t
needs.
|
46,340 | 336 | QUESTION:
That's right, and we will see later under
a group called the Working Party on Trends, they're
17 trying to work out how much plasma is needed to be
fractionated. The measure that they take is the
amount needed for albumin, and they say, "If we get
this amount for albumin, then it's going to be enou gh
for Factor VIII as well." So, as you say, it's not
a contradistinction between the two. It's just
-- (overspeaking) -- you need to consider albumin a s
well in the wider picture, is what they're saying.
ANSWER:
If, however, one were to use the
plasma, I suppose, for cryoprecipitate production, you
wouldn't have it necessarily available for albumin.
|
46,341 | 336 | QUESTION:
That's right. And, indeed, for other blood
components as well. And you may remember Dr Walfor d,
when she was discussing the arguments about reverti ng
to cryoprecipitate, drew attention to Dr Lane's
statement, something that we will look at in due
course, where he said: if you are going to revert t o
cryo, you need to think of a way to make sure that we
at BPL have sufficient plasma supply in order to be
able to produce albumin ,Factor IX, Factor XIII, ot her
blood components which are not going to be covered by
cryoprecipitate.
ANSWER:
Yes.
|
46,342 | 336 | QUESTION:
Returning to the document at point (c), and this
is the third of Dr Maycock's factors that are causi ng
118 difficulties for the NBTS, he says, and I quote:
"The need to depend, at least temporarily, upon
supplies of AHG concentrate and possibly PPF [that' s
protein plasma fraction] from commercial sources po sed
a potential threat to the unpaid voluntary donor
system: (i) a permanent demand for commercial
preparations might arise; (ii) it had been suggeste d
that NBTS should provide plasma to commercial firms
for the preparation of coagulation factor concentra tes
which are needed by clinicians responsible for
treating disorders of coagulation."
I pause there, sir, to note that this is one of
the first references that we have been able to find
about the argument being raised that an inability t o
provide domestic Factor VIII and albumin may threat en
the very existence of the voluntary donor system in
the UK.
That is an argument that will be developed in
the papers that we'll go on to look at:
"(d) Dr Maycock reported that two meetings
between representatives of the DHSS and SHHD [Scott ish
Home & Health Department] had recently been held at
the request of the SHHD ..."
I skip a few sentences, and it says:
"As a result of these meetings, the following
119 principles have been reaffirmed:
"(1) The system of unpaid blood donation must
be preserved in the UK.
"(2) In order to preserve the system, the Blood
Transfusion Service services in UK must be
self-supportive."
Going on to the next page, and this is
a slightly different point, Dr Maycock says:
"There should be agreed UK targets for provision
of preparation of human blood."
There is then a discussion of Scottish targets
for PPF and a discussion about why those targets we re
higher than those in England and Wales.
Picking it back up again with the paragraph "In
the present circumstances", the minutes record:
"In the present circumstances, increasing the
number of donations used as concentrated red cells
seem to be the most practicable way of improving th e
amount of plasma for fractionation. In the Glasgow
region, 40% of donations were used as concentrated
cells.
"The present position in RTCs is ..."
And then a table is set out. I won't go through
all of those figures, but we can see that, in
comparison to Glasgow, 40 per cent of plasma going --
120 coming from -- sorry, 40 per cent of donations bein g
split between plasma and red cells. In comparison to
that, in England and Wales, the figures range from nil
in Tooting to -- the highest figure is 33 per cent in
Oxford. We can see just to pick a few others,
Cambridge is well below Oxford at 10 per cent; Leed s,
20 per cent; Sheffield, 6 to 7 per cent; Bristol, 2 5
per cent; Cardiff, 20 per cent.
In the right-hand side of that table, we can see
the needs listed in order to increase the proportio n
of red cell concentrates, and we can see that those
include staff. It says, "Plastic equipment" in
respect of Newcastle. And that I take to be
a reference to the fact that some of these centres
were still using glass bottles to collect blood
donations which weren't conducive to separation int o
red cell concentrates. You needed the plastic bags to
do that.
Other references are to space, to the need for
a centrifuge. Again, references to equipment and
staff, and also a reference to the need for
a haematologist and three technical staff.
So those are the reasons given by the RTCs as to
why they can't produce more in the form of red cell
concentrate at that time. It's a point that we wil l
21 come back to when we look how Dr Owen's money was
spent.
If we move then to the next page, page 7, the
paragraph underneath number 6:
"The meeting concluded that the immediate aim
should be to raise the use of concentrated red cell s
to 30 to 35 per cent but that in order to reach thi s
level, additional capital and revenue expenditure
would be necessary. The chairman asked RTDs to do
everything they could within the limitations of the ir
present budgets."
The key points that we take from this document
are as follows: firstly, there is a reference to th e
donation target of 275,000 donations, and we have s een
before lunch where that figure comes from. An
acceptance that that would not be reached by 1975.
The introduction of the new argument about the risk to
the domestic voluntary donor system. We will see
that is to prove an influential argument with Dr Ow en.
The emphasis that is being placed on red cell
concentrates as a way of increasing plasma supply.
And those final words from the minutes that it is f or
the Regional Transfusion Directors to try to do
everything that they can within their budgets to
increase the supply of red cell concentrates. So n o
122 central funding. This is going to have to come fro m
the regions.
That was a meeting of 3 July. The directors met
again, the Regional Transfusion Directors, on
9 October 1974. I'm not going to take you to those
minutes, but as is set out in the written presentat ion
at paragraph [85], there is a sense from them of
a very tense meeting and of a situation coming to a
head. The meeting reported that little progress ha d
been made on increasing red cell concentrates, and
that, and I quote:
"Progress was likely to continue to be slow
until money was provided by one means or another."
Mr Jackson from the DHSS was recorded as saying,
and I quote:
"The department was fully aware of the financial
difficulties of RHAs and centres regarding Factor V III
concentrate."
A tense meeting and little progress being made,
as of October 1974.
Also in the same month, the Expert Group on the
Treatment of Haemophilia met again. Reference to t hat
is made at paragraph [87] of the written presentati on.
I won't take you to those documents.
The position that was reached by October 1974 is
123 that we are now some 19 months after the initial
meeting of the Expert Group on the Treatment of
Haemophilia. The original goal of using 250,000
donations, later 275,000 donations, annually for
Factor VIII, fractionation, had not been met, and i t
was recognised that it was not going to be met in
1975.
There were also concerns over the domestic
production of albumin. The more ambitious proposal s
put forward by Dr Biggs and others for between 500, 000
and 750,000 donations being used for fractionation
were, of course, still more distant.
The central call-off contract had been arranged,
but Regional Health Authorities had been slow to
increase their expenditure on commercial concentrat es.
There had also been an unwillingness or an
inability to prioritise spending to increase plasma
supply to BPL.
Tensions had grown between the DHSS and the
regions about who should meet the additional costs,
and between clinicians and the administrators about
the shortfall of concentrates.
Concerns were now openly being expressed about
the threat to the voluntary donor system in the UK.
And running through all of this was an emphasis on the
124 lack of available funding.
And that, sir, is the context in which the
announcement made by Dr Owen of £500,000 of spendin g
took place. And it's to that that we will turn.
The origins of that policy announcement lie in
a letter that was ultimately sent by Mr Gidden of t he
DHSS, and we saw his name this morning, to regional
administrative officers, where there's a string of
correspondence within the DHSS when the letter is
drafted and redrafted, and thoughts are given on it .
I'm going to take you to the letter now. This
is what results from all of these discussions. It is
at CBLA0000239. I'm going to read all of this lett er,
sir, because this, ultimately, is the document that
Dr Owen approves, which amounts to the approval for
the spending of £500,000 of central funds from the
DHSS. The letter, addressed to "Regional
Administrators" and dated 24 December 1974, says th is:
"Blood Products Production
"1. The National Blood Transfusion Service is
currently unable to meet the demands of clinicians for
certain operations of human blood. There is
an immediate need to provide more AHG concentrate
(equivalent to about 275,000 blood donations
annually). AHG concentrate is now the preferred
25 therapeutic agent for the treat of haemophilia and
considerable benefit could be brought to these
patients if adequate supplies could be made availab le
for their treatment. There is also an increasing
demand for albumin fractions, mainly plasma protein
fraction (PPF) which is replacing dried plasma and
plasma substitutes. Over the next few years the ne ed
for PPF may rise to 200,000 bottles per annum.
"2. At present, part of the demand for these
blood products is being met by expensive imported
material which is now marketed in this country, and as
the demand increases commercial firms may consider it
worth their while to establish panels of paid donor s
in this country in order to obtain their supplies o f
human blood. Such a development would constitute
a most serious threat to the voluntary donor system
upon which the NBTS is founded. The Department
therefore regards it as of the greatest importance,
quite apart from the question of cost, that NHS sho uld
become self-sufficient as soon as practicable in th e
production of PPF and other blood products (the cos t
of purchasing AHG and PPF from commercial firms on the
scale envisaged in paragraph 1 would be around
£6 million a year).
"3. The current output from the Blood Products
126 Laboratory, Elstree is limited by the amount of pla sma
supplied by Regional Transfusion Centres (RTCs). T his
amount in turn depends upon (a) the number of blood
collected and the extent to which clinicians are
prepared to use blood in the form of concentrated r ed
cells, and (b) the facilities available at RTCs for
separating the whole blood into concentrated red ce lls
and plasma. At present, less than 10% of blood
donations in England and Wales are used in the form of
concentrated red cells compared with 30-40% in
Scotland. If this percentage could be raised to 40 %
in England and Wales it would be possible for the N HS
to meet the demand for AHG concentrate and to incre ase
the production of PPF from the current figure of
78,000 bottles to 136,000 bottles ... To reach the
medium target of 200,000 bottles of PPF per annum
mentioned in paragraph 1 would also require an
increase of 400,000 blood donations from the presen t
figure of 1.6 million per annum. It is intended th at
the production of blood products in Great Britain
should be co-ordinated and that some of the increas ed
output of plasma produced in RTCs in England and Wa les
should, by arrangement with the Scottish Home and
Health Department, be processed at the Plasma
Fractionation Centre, Liberton, Edinburgh.
127 "4. To achieve a 40% use of concentrated red
cells will require the full co-operation of
clinicians. Clearly no steps can be taken towards
this objective unless parallel action is taken to
ensure that RTCs have sufficient facilities to
separate more plasma from whole blood and thus to m eet
the increased usage of concentrated red cells. For
this purpose the cost of providing the necessary
facilities such as additional equipment and staff
might be up to £0.5 million in England and Wales, p art
of it recurring (the cost of collecting 400,000
additional donations annually might be of the order to
a further £1.0 to £1.5 million). The extent to whi ch
the capacity of RTCs to produce plasma can be
increased will vary from Centre to Centre.
"5. It would clearly be considerably cheaper to
produce these blood products within the NHS than to
buy them from commercial sources.
"6. If the normal procedure for financing of
health services were to be followed, authorities wo uld
need to agree, collectively, to accord blood
transfusion priority for additional resources over
a period of several years, within a co-ordinated
programme of expansion. However, additional
expenditure is bound to be some what disproportiona te
128 as between Regions if realistic targets are adopted
with the aim of making NHS production sufficient to
meet clinical needs. It has therefore been decided
that since the Department would in any case have to
co-ordinate a programme for the increased productio n
of blood products, earmarked finance of up to £0.5
millions should exceptionally be provided for this
purpose. The Department proposes to invite estimat es
of requirements in RTCs for the increased productio n
of plasma, with the primary aim of making the NHS
self-sufficient in AHG concentrate in 2 to 3 years.
"7. Additional copies of this letter are
enclosed for the Regional Medical Office, the Regio nal
Treasurer, and the Regional Transfusion Director."
It is signed by Mr Gidden.
The letter and the internal DHSS correspondence
that was circulated during the drafting of the lett er
indicate that this programme is something of a hybr id
between national and regional funding. The decisio n
is made, and it is stressed to be an exceptional
decision, to provide £500,000 of central DHSS fundi ng
in order to increase the production of blood produc ts,
with the aim of self-sufficiency in two to
three years.
The terms of the letter, the reference in the
29 letter to the immediate need to achieve 275,000
donations for concentrate, refer back to the immedi ate
target, as set out by the MRC, rather than the long er
term -- medium and longer term targets by the MRC,
which were of 500,000 to 750,000 donations per year .
The reference is to a sum of £500,000 coming
from Central Government. In order to expand plasma
production further, there would be a need for
continuing funding, and the hope within the DHSS wa s
that the £500,000 would meet initial costs and that
the Regional Health Authorities would then be
persuaded to invest further, in order to avoid the
costs for more expensive commercial concentrate in the
future.
To give a couple of pieces of correspondence
which evidence that, in June 1976, the DHSS officia l
then leading the initiative, Timothy Dutton, descri bed
the provision of central funds, the £500,000 in the
following terms -- for reference, I won't take you to
it, but the reference is DHSC0103283_102. Mr Dutto n
said that this was, and I quote:
"A pump priming operation to start the AHG
concentrate plasma production programme. Thereafte r,
it was expected that regions would continue the
programme from within their normal allocations, whi ch
130 include an element for the programme, revised in th e
usual way to take account of cost increases."
Back in 1974 Dr Waiter described the rationale
behind the £500,000 proposal in the following terms ,
and I quote:
"It is an initial injection of money by whatever
mechanism is now available to ensure such a program me
would get under way. At present, it shows little
likelihood of so doing."
The reference for that DHSC0003616_038. So both
Dr Waiter and Mr Dutton see this as, essentially,
a way of kickstarting production or increased
production of plasma for fractionation. The
exceptionality of this central funding, which
Mr Gidden was at pains to stress in the letter to t he
Regional Health Authorities, was also something tha t
was referred to by Dr Maycock in 1976 in a document
about -- in which he provides comments on a paper
about decision making structures in the NBTS.
Dr Maycock says this:
"While it is true that the Department [that's
the DHSS] can, if it wishes, provide additional mon ey
for Regional Health Authorities and direct how it
should be used, I think it is important that the
reader of a paper understand that the Department ha s
131 for some 20 years rarely, if ever, used this abilit y,
although there would have been occasions when to ha ve
done so would have enabled simultaneous and uniform
advances to be made. To the best of my knowledge, the
ability has been used only for AHG and then only af ter
prolonged and vigorous prodding."
That's Dr Maycock looking back in 1976. The
reference is DHSC0003738_047.
The reference to "prolonged and vigorous
prodding" is an interesting one and we have seen in
those RTD, Regional Transfusion Directors, meeting
minutes the tensions that were growing up in the
second part of 1974, that the policy is announced o nly
towards the end of that year when those tensions ha ve
built up.
The letter from Gidden goes out on
24 September 1974 and it does so after Dr Owen beco mes
involved in the debate and gives his authority to t his
policy. The earliest reference we can find to his
involvement is in a document, if we could go to thi s
please, Paul, DHSC0100005_189.
This is a minute to Mr Alexander, who
I understand to have been Dr Owen's private secreta ry,
and it comes from Mr Gidden. It's dated
9 December 1974. It says at paragraph 1:
132 "Since Dr Raison and I discussed with the
Minister of State last week the question of supplie s
of AHG concentrate, we have established within the
office that earmarked central finance to the extent of
£0.25 [million] capital and £0.25 [million] revenue
can be made available to Regional Authorities to
increase NHS production of this material. We have
asked to draw attention to the fact that a decision to
make this special allocation of resources to blood
products production inevitably means that less mone y
overall will be available for other high priority
Health Authority services eg mentally ill, mentally
handicapped, family planning, and certain centrally
sponsored projects, such as schemes to reduce waiti ng
times. But there is broad agreement that such
an allocation would be justifiable."
The minute then goes on to suggest a form of
words that could be used in answer to questions whi ch
have been raised by several MPs on this point, whic h
shows the political pressure that was building for
a policy development on this front as well. If we
could go over to paragraph 3, please:
"It will be necessary to inform Regional
Authorities of this decision, and I attach for
information a rather fuller draft of a Dear Sir let ter
33 which I suggest should issue at about the same time as
the Minister of State's letter to MPs."
I pause there to note that that was a draft of
the letter that was eventually sent out by Mr Gidde n:
"During our discussion last week mention was
made of a possible arranged PQ (which could be base d
on the last three paragraphs of the draft above).
I am somewhat doubtful about this since the main
pressure is for additional money to buy commercial
product now. However, you will no doubt take the
Minister of State's views on this."
Signed by Mr Gidden, 9 December 1974, so the
reference to the previous week means that Dr Owen w as
involved in discussing this policy in early
December 1974.
Also perhaps of note, the political pressures to
which Mr Gidden is alluding are to buy commercial
concentrates straight away, rather than to take
a longer term development of domestic production.
The response from Dr Owen comes in a minute from
Mr Alexander to Mr Gidden on 11 December 1974. Thi s
is DHSC0100005_191. Mr Alexander wrote this, and
I quote:
"Dr Owen has seen your minute of 9 December 1974
and has agreed the submission. He would like one
134 change made to the suggested new standard reply for
MPs. In place of the second paragraph you propose, he
would like inserted suitably amended versions of th e
first and second paragraphs of the draft letter to
regional administrators which you also submitted fo r
approval. He has commented that, and I quote, 'It is
time MPs knew the full arguments.' He would like t o
know if there is any objection to this.
"With reference to paragraph 4 of your minute,
Dr Owen has commented, 'I agree that we should not
court publicity'."
Picking up the last point first that is about
whether or not there should be a planted Parliament ary
question to make the announcement, Dr Owen says no.
The reference to the fuller draft, including the
second paragraph of the letters to regional
administrators, that is a reference to the risk to the
voluntary donor system which Dr Owen suggests shoul d
be put in the replies to MPs as well as being sent to
the regional administrators.
In response to that, Dr Gidden advises Dr Owen
not to do that. He says that the reason for that
advice is to avoid controversy and because he was
aware that there were some advocates within the UK, he
was suggesting that the voluntary donor system shou ld
135 be perhaps replaced or at least supplemented with p aid
donors. And Mr Gidden -- the tenor of Mr Gidden's
advice is "Let's not go there. Let's not raise thi s
issue."
Dr Owen accepts that advice, and we can see his
response at LDOW0000344, please, Paul. This is
17 December 1974 from Mr Alexander sent to Mr Brand es.
In it, it says:
"Dr Owen has seen Mr Gidden's minute of
13 December 1974 [that's the one I've just summaris ed]
about the standard draft letter to MPs on the
treatment of haemophilia. He has said that he will
accept this advice. Dr Owen has gone on to comment
more widely on related issues."
And this is a quotation from Lord Owen:
"I would like, however, the department to
consider a legislative ban on paid donor panels for
blood and semen and, indeed, any human biological
material."
And discusses a way in which such a ban could be
put into legislation:
"The philosophy and spirit of Richard Titmuss's
book The Gift Relationship is one to which I attach
immense importance. The concept of altruism is one
which Government should not be neutral over but
136 actively promote. I will never be party to the
National Blood Transfusion Service not being availa ble
to all."
Mr Alexander goes on to ask for a note on the
points raised by Dr Owen.
We know, sir, from Dr Owen's evidence that he
had reviewed The Gift Relationship back in 1971, and
Dr Owen stressed in his evidence the importance tha t
he attached to the idea of a voluntary donor system in
the United Kingdom.
Those were the internal discussions about the
policy. As we have seen, they led to the letter be ing
sent out to the regional administrators on
24 December 1974.
In terms of public announcements, the first that
we have been able to find is on 22 January 1975, an d
it is a written response to a Parliamentary questio n.
If we could go, please, Paul, to DHSC0000274. Towa rds
the bottom right of that page under the heading
"Haemophilia", the question has come from Mr George
Cunningham asking the Secretary of State for Social
Services:
"... what deficiencies exist in the supply of
Factor VIII (cryoprecipitate) for the treatment of
haemophilia; and what action she proposes to take t o
37 deal with the problem."
That is a reference to Barbara Castle. Dr Owen
provides the answer.
He wrote:
"The amount of Factor VIII materials, including
cryoprecipitate, produced within the National Healt h
Service is not sufficient and, in particular, there is
an immediate need to provide more human
antihaemophilic globulin concentrate -- AHG
concentrate -- which is now the preferred treatment
for haemophilic patients. There is also an increas ing
demand for certain other blood fractions.
"At present, part of the demand for AHG
concentrate is being met by imported material, but
this is very expensive and, for reasons which I wel l
understand, Health Authorities feel they cannot aff ord
to buy as much as they would wish to, given the
various claims on their resources.
"I believe it is vitally important that the
National Health Service should become self-sufficie nt
as soon as practicable in the production of
Factor VIII, including AHG concentrate. This will
stop us being dependent on imports and make the
best-known treatment more readily available to peop le
suffering from haemophilia. I have, therefore,
138 authorised the allocation of special finance to boo st
our own production with the objective of becoming
self-sufficient over the next few years."
That is, so far as we can tell, the first
announcement of the policy.
Dr Owen was asked about Factor VIII again in
oral questions on 25 February 1975, and he was push ed
to commit to central purchasing of what was describ ed
as "this drug" and to home treatment. And if we co uld
go, please, to HSOC0015202, we can see how he
responded to that. He says first:
"I have authorised the allocation of special
finance of up to £500,000, about half of which woul d
be recurring, to increase the existing production o f
Factor VIII, especially in the form of antihaemophi lic
globulin concentrate, AHG, within the National Heal th
Service. The first effects of this will, I hope, b e
felt by the end of the year."
Mr Watkinson, who was asking the questions,
welcomes the reply, and then goes on to talk about the
need for central purchasing. He also asks if Dr Ow en
will accept that this is far and away the best
treatment for haemophilia.
Dr Owen responds by saying this, and I quote:
"I confirm that in most cases I think it is the
139 most desirable form of treatment, but one cannot av oid
the fact that this is one of the many costly
treatments which are competing on priorities. The
present system whereby a doctor can persuade his lo cal
area health authority that his patient needs this f orm
of treatment most is the best way of proceeding, an d
not by central allocation. If we were to go to
all-commercial purchase of this factor, it would co st
an additional £1.5 million to £2 million annually."
If we could go back to the full screen, Paul.
Thank you.
A further question is asked by Mr Martin, with
particular reference to the under-treatment of
children, and he asks whether or not Dr Owen can go
a stage further and give more of a lead to Regional
Health Authorities. Dr Owen replies by saying this ,
and I quote:
"They are aware of our concern and have had
ample demonstration of it by the fact that we are
prepared to divert scarce resources to make the
National Health Service self-sufficient, but I conc ede
that it will take two or three years before we are at
full production. During that time, I am sure that
they will weigh very carefully the individual cases
and will be sympathetic to the sort of hardship whi ch
140 can arise."
Mr Shaw asks a further question where he
compares the position in the UK to that in Israel, and
Dr Owen says, and I quote:
"I know my [honourable] Friend's concern, but
honourable Members must face the fact that with
limited resources we have to choose, and these are
very difficult choices and priorities. When
confronted with an ill child, everyone wants to get
the best that is available, but there are many othe r
aspects of childcare which also have priority and w e
are not always able to meet all the demands."
That is 25 February 1975. I stress again, those
are oral answers to questions, whereas the previous
section of Hansard was a written answer.
On the following day, 26 February 1975, Dr Owen
published some further written answers to
Parliamentary questions. I won't take you to these ,
but they included -- the questions included concern s
over the provision of concentrates, and about domes tic
production. Dr Owen repeated his previous comments on
the £500,000 which had been made available, and
I quote:
"... to increase the existing production of
Factor VIII within the National Health Service."
41 He noted the expense of the commercial products
and the resultant reluctance of Regional Health
Authorities to buy them. He then stated, and I quo te:
"I believe that it is vitally important that the
National Health Service should become self-sufficie nt
as soon as practicable in the production of
Factor VIII, including AHG concentrate. This will
stop our being dependent on imports and make the
best-known treatment more readily available to peop le
suffering from haemophilia."
Those are the answers that he gave in January
and February 1975. There is no reference in those
answers or in Mr Gidden's letter to the regional
administrators to any perceived safety advantage of
domestically produced concentrates when compared to
commercial concentrates.
I'm about to move on to how that £500,000 was
spent and what was achieved by it, and what was sai d
about it.
I wonder if it would now be a good time to have
a break and come back to that.
ANSWER:
Yes, well we will take a break for
25 minutes and come back at 3.40.
3.40.
(3.16 pm)
142 (A short break)
(3.40 pm)
|
46,343 | 336 | QUESTION:
Sir, before turning to how the £500,000 was
spent, just a couple of points that we have checked
over the break.
The first refers to the point that you raised
from Dr Biggs' letter to The Lancet, where she said
that three commercial companies are now licensed to
sell good quality human Factor VIII in this country ,
and that is from a letter dated 29 June 1974. I'm
afraid we haven't got to the bottom of this because
Hemofil and Kryobulin were licensed in 1973, as we
know. The third licence, as you said, sir, is
Profilate, the product from Abbott, which was dated
May 1975, and then Koate and Factorate follow in 19 76.
Now, we know from the previous presentations that
several of these products were available on
a named-patient basis at an earlier stage. We also
know from a document that was referred to in the
earlier presentations that there are promotional
materials from Profilate in the Oxford haemophilia
centre archive from 1975. The reference for that i s
BPLL0008067. And we can a complements sheet signed by
Dr Bidwell there, and also evidence of Dr Rizza hav ing
143 seen it. Obviously, Dr Biggs worked in the same
centre, so it is possible that she saw these
promotional materials. We don't know if those were
promotional materials that were provided to the UK
market, or whether or not they were materials that
were obtained from the United States by somebody
connected to these clinicians and brought back to t he
UK.
But in any event, the licence is not granted
before Dr Biggs' letter of June 1974, so we are not
sure why she refers to three companies being licens ed.
Perhaps she is confusing a product which is provide d
on a named-patient basis with the licensed product, or
perhaps we have missed something. But we don't kno w.
ANSWER:
If you keep on looking, I'd be
grateful. It may simply be that she has seen a cha nge
of name from the producer which isn't a real change of
name. We know that happened. It may be something
like Speywood which she has in mind. I don't know.
But if we can work it out, we will. Otherwise, we' ll
have to rely upon what we know from other materials .
|
46,344 | 336 | QUESTION:
Yes, sir.
ANSWER:
And it's a shame she's not available
to us to explain.
|
46,345 | 336 | QUESTION:
Yes. What I would say is from the documents
144 that we looked at in November, when Dr Walford come s
in the early '80s to try to tot up who was providin g
which products, those are the products that she ref ers
to. There is no other licensed product within the
United Kingdom that she is referring to at that tim e.
ANSWER:
Yes.
|
46,346 | 336 | QUESTION:
I'm afraid I can't assist more than that at the
moment.
ANSWER:
There will be perhaps some
indication given if we looked at the UKHCDO returns
and saw what was on their list, if they had a list at
that stage, for the different sorts of concentrates
because they did have pretty early on a list, didn' t
they?
|
46,347 | 336 | QUESTION:
I believe so. There is ongoing work trying to
put together all of the returns and interrogate the m
in order to provide some useful data for you. We w ill
feed this question into that.
ANSWER:
It doesn't -- this particular little
point, it's intriguing, but it doesn't actually aff ect
your presentation on self-sufficiency does it, real ly?
|
46,348 | 336 | QUESTION:
No, it doesn't. No.
A second point concerns Hansard references. The
Inquiry legal team, as I said, had identified the
question that was posed of Dr Owen following Dr Big gs'
45 letter as the first Hansard extract that we had fou nd
that referred expressly to Factor VIII. We are
grateful to the Collins team who have pointed out
a question and answer in Hansard from 15 June 1966 in
which Mr Pavitt, MP, asked the Minister for Health
what information he has of advances recently made i n
the treatment of haemophilia and if he will make
a statement. And the answer given by Mr Robinson i s,
and I quote it in full:
"Concentrates of anti-haemophiliac factor have
been available for some years in this country on
a limited scale for the treatment of special cases,
and arrangements are now being made for preparation on
a wider scale. The method of preparation recently
reported from the United States is under investigat ion
in several centres here."
That is the answer that was given on
15 June 1966.
ANSWER:
Yes. Again, it's intriguing, isn't
it, because although I think that Kekwick and Wolf
developed a form of AHF concentrated in 1959, maybe
'57 but certainly in the mid-'50s, mid- to late '50 s,
I don't think there was any great production of it for
a while. And the reference to developments in the
United States may refer to the method which Dr Pool
146 had found of using the cryoprecipitate, which she
already knew existed, but using it for therapeutic
purposes by being able to have a system of closed b ags
and isolate it without losing its efficiency.
|
46,349 | 336 | QUESTION:
It could do, sir. I'm afraid I cannot go any
further beyond that Hansard answer.
ANSWER:
Yes, but at least there is an
answer, and there is something about that, so I'm
grateful to Collins for having pointed that out.
|
46,350 | 336 | QUESTION:
Turning, then, to the £500,000. Appendix 3 to
the main presentation is a detailed analysis prepar ed
by the Inquiry legal team on how that money was spe nt.
And it is a centre-by-centre analysis at points.
I'm not going to take you to all of the
documents in that, or indeed take you to the
substantive material that's contained there. It's
there for people to read both on the website and on
Relativity should they wish to do so.
What the appendix shows, if I may summarise it,
is that the announcement of the £500,000 was follow ed
by a dialogue between the DHSS and the regional
centres. The regions were given targets by the DHS S
for how many donations were expected of them, and t hey
in turn provided indications to the DHSS about the
amount of money that was going to be required for t hem
147 to be able to make those donations.
The discussions took into account local factors,
and as we saw in the documents before the break, th ere
was inevitably a degree of variation as to how much
would have to be spent on different centres in orde r
to increase production.
There were extensive negotiations that followed,
more extensive with some regions than with others.
The target of donations rose from 275,000 to around
340,000 per annum, which was about a 20 per cent
increase. The reasons for that rise and the differ ent
figures are contained in the appendix. I don't thi nk
that I need to explain those now, but it's to do wi th
different centres explaining how much they could
reasonably expect to produce.
The analysis of your team, which is supported by
a spreadsheet as well, which is referred to in the
appendix, is that just over £500,000 of special
allocation funds were spent in the year 1975 to 197 6.
That is if one includes the announcement on BPL. A nd
a further 433,000 was spent in the financial year 1 976
to 1977.
The money was spent on a wide variety of items.
As I mentioned earlier, some of the centres were st ill
collecting blood in glass bottles at that stage, an d
148 so some of the money was used to transfer to plasti c
bags. Equipment such as freezers and centrifuges w ere
purchased, as was laboratory kit. Several centres
required money to be spent on building works, often
referred to as "accommodation" within the budgeting
documents. Others incurred additional staff costs.
The position of Wales in this process isn't
entirely clear. There was some prior consultation
between the DHSS and the Welsh Office before the
announcement of the £500,000 funding, but it was fo r
the Welsh Office and not the DHSS to make the
necessary funds available to the Cardiff Transfusio n
Centre. That said, there was an awareness that
Cardiff was, and I quote one document which was
written by Mr Gidden:
"... unlikely to be able to do much in the way
of increasing its output of plasma."
Mr Gidden didn't explain the reason why that was
so.
The first set of regional targets that were sent
out by the DHSS did contain a target for the Welsh
Regional Transfusion Centre, but later documents
don't. And there were discussions between the Wels h
Office and the DHSS about what was being done in
respect of increasing plasma production.
49 The results of this programme were that the
target of about 340,000 additional donations for
fractionation was achieved by mid-1977. That's abo ut
two and a half years after the policy was announced .
BPL also received sums, and those are set out in
the appendix 3. Those sums seem to have been part of
BPL's annual budget, rather than part of the specia l
funding, and they were much smaller than the overal l
special funding.
Dr Lane, in his fifth draft proof of evidence
about which you'll hear much more later in the week ,
calculated that BPL received £58,000, and he says t his
was, and I quote:
"... for the purchase of additional equipment."
That sum allowed for a significant increase in
production at BPL on PFL. The figures, which are s et
out in paragraph [112] of the written presentation,
are that in 1973, production was estimated at
2.7 million international units per year. In 1975,
that had dropped to 2.19 million international unit s
per year. But it rose by 1976 to 6.1 million
international units per year, and in 1977, it's up to
11.5 million international units.
We will go into those figures and the sources
for those figures and their reliability a little mo re
150 probably on Wednesday or on Thursday this week. Bu t
the short point to take from it is that BPL's
production rose substantially in this period.
The documents demonstrate that Dr Owen asked for
and received various updates on the progress of the
scheme, that he was engaged in the policy and keen to
encourage more rapid progress where that was possib le.
The documents also show that officials were aware o f
the importance that ministers, and in particular
Dr Owen, attached to this scheme. I won't go throu gh
the references, but they're at paragraph [114] of t he
written presentation.
One document that I will take you to is at
DHSC0001774, please, Paul.
This was a minute sent by Mr Jackson on
11 July 1975 and it is sent to Mr Lillywhite, who
I understand to have been Dr Owen's private secreta ry.
It is a minute that is sent in response to
a Parliamentary answer, which has been given to
a question that was posed on 22 April. It is not a
question I took you to earlier, but Dr Owen, on tha t
occasion, said that:
"I hope that the NHS can become self-sufficient
in the production of all forms of Factor VIII withi n
two or three years."
151 You will see from the opening paragraph of this
minute that Dr Owen commented on that.
"Once again we are at a 2-3 year time-scale. I
have asked if we can improve on this. Can I have
a note?"
So that is Dr Owen chasing civil servants for
an update about this. This what Mr Jackson provide s
in response, if we pick it up from paragraph 2:
"Since then [which is since the Parliamentary
question], as a result of our discussions with
Regions, we have given them targets which will prod uce
plasma from 337,000 blood donations. This is some 20%
more than the total of 275,000 recommended by the
Expert Group on Haemophilia but that figure must be
regarded as the minimum ."
"Minimum" is underlined.
"All Regions, except two, have now indicated
when they expect to achieve their share of the targ et
of 337,000."
There is a summary of the table there showing
that by June 1977, 87 per cent of the target is
expected to have been achieved and the two other
regions make up the remaining 13 per cent.
Paragraph 4, Mr Jackson says:
"The main reason why the programme cannot be
152 completed earlier is that in four Regions extensive
alterations have to be made to the Transfusion Cent res
before they are in a position to provide more plasm a.
In one case the work will take six months, in two
cases one year, and in the fourth 21 months."
Paragraph 5:
"We are taking steps to clarify the position of
the two Regions whose ability to contribute to the
programme is at present uncertain."
Then at paragraph 6:
"It is difficult to be precise in estimating
a date for achieving self-sufficiency, not least
because not all are agreed as to what constitutes
self-sufficiency; some Haemophilia Centre Directors
envisage prophylactic treatment whereas the
Department's programme is based upon home treatment of
those patients for whom treatment at home can be
recommended. It remains to be seen whether RTDs wi ll
be successful in persuading clinicians to accept
a steadily increasing proportion of blood in the fo rm
of concentrated red cells; this may be a possible
limiting factor. AHG concentrate has not previousl y
been prepared in the NHS on the scale envisaged and
this in itself will almost certainly give rise to s ome
problems.
53 "However, accepting these qualifications, the
figures in paragraph 3 suggest we can improve on th e
previous estimate of achieving self-sufficiency wit hin
two to three years. We can now say that we expect to
be self-sufficient within two years or, alternative ly,
that within about a year we will be able to meet so me
2/3rds of present requirements and become
self-sufficient in 1977."
That was sent to Dr Maycock and to Dr Waiter,
and we know that it was seen by Dr Owen because on the
first page, the top right-hand corner --
Sorry, the top right-hand corner of the first
page, please, Paul. Could you just scan out on the
first page so we have the whole thing. It doesn't
seem to be coming up on my screen at least. Ah,
perfect, thank you.
We can see some handwriting in the top
right-hand corner which reads:
"This is excellent and I recognise that everyone
is doing everything possible. I believe we should
keep up the pressure. Can I be kept informed on th e
centrifuges and also the two regions? Why are ther e
difficulties and what can be done? I would not eas ily
accept that they should not contribute."
That is handwriting from Dr Owen.
154 We can see within that minute, Mr Jackson
discussing the different definitions of
self-sufficiency, before, at the end of that minute ,
saying that it can be stated that "we expect to be
self-sufficient within two years", which is from
July 1975.
Lord Owen returns to Parliament in July 1975,
7 July 1975, where he described the Government's
policy as being, and I quote:
"... to make the NHS self-sufficient in the
production of Factor VIII as soon as practicable."
In a letter to Andrew Bennett MP, dated
4 December 1975, he used similar terminology, and
I quote:
"I regard it as most important that the National
Health Service should become self-sufficient as soo n
as practicable in the production of AHG concentrate ."
He went on to explain that funding had been
provided by the DHSS and said, and I quote:
"I hope that in about a year we will be able to
meet some two thirds of the present requirements fo r
AHG concentrate and that within two years we may be
able to reach the target we have set ourselves."
The references for those documents are at
paragraph [116] of the written presentation.
155 On 29 April 1976, Dr Owen addressed the World
Federation of Haemophilia Congress. This is
a document that you have been taken to before, duri ng
Lord Owen's evidence. It is LDOW0000045. This is the
text of Lord Owen's speech to the Closing Ceremony of
the World Federation of Haemophilia, which was held at
the DHSS building in Elephant & Castle.
I won't read the whole thing but, if we pick it
up from the second paragraph, Dr Owen says this:
"This of course is the World Federation of
Haemophilia and I would like to state quite clearly to
you how strongly I believe all the nations of the
World should support the objectives and policies of
the World Health Organisation and none more so than in
the policy of the WHO that each country should be a ble
to supply its own blood and blood products to meet
clinical needs. The previous speaker,
Dr Rosemary Biggs, told you quite bluntly the facts
which are that the NHS was not at present able to
provide sufficient Factor VIII concentrate needed b y
haemophiliacs in this country for the management of
bleeding, and that Health Authorities are having to
buy expensive imported products. I think we ought to
have made ourselves self sufficient rather earlier
than we will now be able to do so. But we have mad e
156 the decision in principle to become self sufficient .
We have made a special allocation of half a million
pounds last year and substantial progress I am glad to
say is now being made in building up production
capacity in our country, and self sufficiency of ho me
produced Factor VIII we expect to be reached around
the middle of 1977. There is still some argument
about the overall level of supply that we should be
aiming at and I am not certain that we have
necessarily got it right at the moment. It might w ell
be that as it becomes more readily available the
products will be used more effectively, but I canno t
stress enough to you, as an International Congress,
that I think all nations, particularly the richer
nations of the World, ought to be able to be self
sufficient and not to drain the supplies which are
often much needed in other countries in the World."
You will see there, sir, that there is a degree
of nuance in what Dr Owen is saying about the debat e
about the level that should be aimed at. If we go to
the press release which accompanied that speech, wh ich
is at LDOW0000044, we can see in the third paragrap h,
I quote:
"Following a special allocation of £500,000 last
year, substantial progress was now being made in
57 building up production capacity in the NHS, and
self-sufficiency in home produced Factor VIII was
expected to be reached in mid-1977."
That is the press release and that doesn't have
a reference to the discussion about the overall
supply.
Dr Owen left the Department of Health in 1976
and so he wasn't in post when the targets set by th e
DHSS were achieved in 1977. The following year, Ma x
Madden MP tabled a series of written questions on
self-sufficiency which were answered by the then
Secretary of State Mr Roland Moyle. If we could go to
those, please, Paul it's DHSC0000291.
I will read through the entirety of this
exchange. These are written questions and written
answers:
"Mr Madden asked the Secretary of State for
Social Services, in view of ministerial statements,
made in 1976, indicating that Great Britain would b e
self-sufficient in Factor VIII, used in the treatme nt
of haemophilia, by the middle of 1977 if
self-sufficiency has been achieved; and, if it has
not, if he will explain the reasons."
I pause there, sir, just to say that the
reference to ministerial statements made in 1976 mi ght
158 be a reference to the press release and what Dr Owe n
said at the World Federation of Haemophilia. The
Inquiry legal team haven't been able to find
references in Parliament from 1976.
Mr Moyle's answer is this:
"The production target of Factor VIII set for
June 1977 was attained; however, new opportunities in
the treatment of haemophilia and associated
disabilities have been developed which have made
further clinical demands for Factor VIII.
"Mr Madden asked the Secretary of State for
Social Services how much of the authorised amount
referred to in ministerial statements, made in
February 1975, indicating ministerial authorisation
for the allocation of up to £500,000 to increase th e
existing production of Factor VIII, especially in t he
form of a new concentrate, within the National Heal th
Service had been allocated.
"Mr Moyle: The whole sum was used to increase
Factor VIII concentrate production within the Natio nal
Health Service.
"Mr Madden asked the Secretary of State for
Social Services how many units of Factor VIII
concentrate are being produced by each of the
fractionation centres at Elstree, Oxford, and Glasg ow.
159 "Mr Moyle: Production of Factor VIII concentrate
at Elstree and Oxford is currently at the rate of
approximately 15 million international units
per annum. The National Blood Transfusion Services ,
in addition, produces approximately the same amount of
Factor VIII in the form of cryoprecipitate. I have no
information about the production at Glasgow but I h ave
asked my right [honourable] Friend the Secretary of
State for Scotland to write to my [honourable] Frie nd
about the production at Liberton, Edinburgh.
"Mr Madden asked the Secretary of State for
Social Services what is the current shortfall betwe en
British National Health Service production of
Factor VIII and British demand for Factor VIII
concentrate; and, if there is a shortfall, what act ion
is being taken to remedy it.
"Mr Moyle: The current amount of Factor VIII
produced in England and Wales is approximately
30 million international units per annum; total usa ge
of Factor VIII in England and Wales is estimated to be
approximately 45 million international units
per annum. Regions are being asked to provide more
fresh frozen plasma to the central processing
laboratories where the National Health Service
concentrate is produced. In the meantime, quantiti es
160 of commercial Factor VIII continue to be purchased to
meet clinical demands."
If you go over to the next page, please, Paul:
"Mr Madden asked the Secretary of State for
Social Services what additional central funding has
been allocated to the Blood Transfusion Service to
improve blood fractionation.
"Mr Moyle: In 1978 to 1979, a total of £145,000
has been allocated to the central processing
laboratories in England to enable them to increase the
production of blood products, mainly of Factor VIII
concentrate.
"Mr Madden asked the Secretary of State for
Social Services if the three fractionation plants
supplying concentrate drugs for the treatment of
haemophilia are working at full capacity and where
supplies are allocated.
"Mr Moyle: The Blood Products Laboratory at
Elstree and the Protein Fractionation Laboratory at
Oxford are both working at present full capacity, b ut
this is being increased. Factor VIII concentrate i s
supplied by the central processing laboratories to the
regional blood transfusion centres who, in turn,
supply the haemophilia treatment centres.
"Mr Madden asked the Secretary of State for
61 Social Services what is the cost of producing one u nit
of National Health Service Factor VIII concentrate;
what is the cost of importing one unit of Factor VI II;
and if he will list comparable cost figures over ea ch
of the last five years.
"Mr Moyle: Detailed costing information in
regard to the production of Factor VIII is not
available in the form requested, but the department is
currently working on costing figures for blood
products which will include Factor VIII. It is not
the practice to disclose National Health Service
contract prices for purchased products.
"Mr Madden asked the Secretary of State for
Social Services what estimates have been made of
balance of payment savings and reduced public
expenditure if Great Britain were self-sufficient i n
the production of Factor VIII concentrate by reduci ng
dependence on expensive commercially produced suppl ies
of Factor VIII."
Go on to the next section please, Paul.
"Mr Moyle: In the year ending 1977 to 1978,
which is the latest year for which figures are
available, the amount of expenditure for the purcha se
of commercial Factor VIII for England and Wales was
approximately £1.18 million. Although the product is
162 imported by the suppliers, no information is availa ble
on the foreign exchange content of the purchase pri ce.
Because detailed costings of individual blood produ cts
produced within the National Health Service are not
readily available, no estimate of a potential
reduction in public expenditure has been made."
So those, sir, are the answers that were given.
The explanation given in response to the question
about whether self-sufficiency was achieved was tha t
the targets that were set were met but that because of
new opportunities in the treatment of haemophilia a nd
associated disabilities, further clinical demands w ere
made for Factor VIII.
Of interest from the other answers, the fact
that the collective output of BPL and PFL at that t ime
was 15 million international units per annum, and t hat
was said to be them operating at full capacity, but
the capacity was being increased, and that's someth ing
we'll look at tomorrow.
That's 15 million international units of
Factor VIII concentrate. A similar amount of
cryoprecipitate was being produced by the National
Blood Transfusion Service. That's 30 million
international units overall. 45 million internatio nal
units was the amount consumed, and so a shortfall o f
163 15 million international units was being made up by
commercial products. So on that analysis, it's abo ut
a third cryoprecipitate, a third domestic concentra te,
and a third commercial concentrate.
ANSWER:
It doesn't deal with the Edinburgh
contribution, does it?
|
46,351 | 336 | QUESTION:
He's answering purely for England and Wales
because that is his departmental responsible for th e
DHSS. What is slightly unclear is whether or not
these answers cover Northern Ireland as well, but I 'm
afraid I can't assist on that.
The amount allocated to PFL and BPL in England
in 1978 to 1979 was £145,000, and that was said to be
allocated to enable them to increase production of
blood products, mainly Factor VIII. The amount spe nt
on commercial concentrates in the year 1977 to 1978
was £1.18 million for England and Wales.
It can be seen, sir, from those answers that
although the £500,000 investment had achieved the
numerical targets that had been set for it, it had not
ended the use of imported concentrates in the
United Kingdom.
I'm going to move on to a separate topic, sir.
I wonder if that would be a good time to pause.
ANSWER:
Well, probably we'd be better coming
164 back to that tomorrow, I would think. So we'll tak e
a break now and come back at 10.00 tomorrow. 10.00 .
(4.17 pm)
(Adjourned until 10.00 am the following day)
65 I N D E X
1 Presentation by Counsel to the Inquiry ............ ...
about self-sufficiency and domestic
production of blood products in England and
Wales
|
46,352 | 337 | null |
46,353 | 338 | null |
46,354 | 339 | null |
46,355 | 340 | null |
46,356 | 341 | QUESTION:
Then between 1994 and 1996, you were a research
2registrar at the Public Health Laboratory Service,
which I'm going to call the PHLS, Communicable Dise ase
Surveillance Centre. Broadly, what did that
organisation do?
ANSWER:
Well, we were a public health protection service fo r
England, and I was working in the HIV and STI
department, so we ran the surveillance systems, so
that's how we know how much HIV and sexually
transmitted infections there are in the country. A nd
we -- more than that, the organisation as a whole
protects public health, looking at outbreaks. You can
see its role -- I mean, now -- PHLS then became HPA
became PHE became UK Health Security Agency, but
actually I have stayed in the same office in Colind ale
the whole time. It's the same function of protecti ng
public health.
|
46,357 | 341 | QUESTION:
And in 1996 you received an MSc from the London Sch ool
of Hygiene and Tropical Medicine and took up a post as
senior registrar still at the PHLS.
ANSWER:
Yes. They have a training programme.
|
46,358 | 341 | QUESTION:
In 1999 you became a faculty of public health,
becoming a fellow in 2008. Is that the organisatio n
that sets the standards for training, examination a nd
specialist practice?
ANSWER:
That's our professional body.
3 |
46,359 | 341 | QUESTION:
Professional body for public health specialists.
Then in 1999 you were seconded from the PHLS to
take up a role at the Department of Health as Senio r
Medical Officer for the environmental transmission of
infection unit; is that right?
ANSWER:
Yes. So I think I was coming to the end of my
training, and we were working on the communicable
disease strategy then, and the secondment opportuni ty
came up at the Department of Health, and that was
a good opportunity.
|
46,360 | 341 | QUESTION:
By November 2000 you had become the Senior Medical
Officer at the CJD policy unit at the Department of
Health, again seconded from the PHLS.
ANSWER:
That's correct.
|
46,361 | 341 | QUESTION:
What was your role as Senior Medical Officer in the
CJD policy unit?
ANSWER:
Supporting the team there involved in running vario us
committees that they ran and giving advice. To be
honest, I found it quite hard to remember exactly w hat
my role was now. It's about 20 years ago. But
looking at the documentation, that's what I think
I was doing.
|
46,362 | 341 | QUESTION:
So it looks again from the documentation as though you
were a member during that period. So November 2000 to
February 2002, you were a member of the Department of
4Health Medical Research Council Research Advisory
Group on TSEs?
ANSWER:
It's more likely that I was being an official rathe r
than a member.
|
46,363 | 341 | QUESTION:
And an official -- what's the status of an official ?
ANSWER:
Attending meetings, writing minutes, making notes,
communicating the decisions to other members of the
policy team.
|
46,364 | 341 | QUESTION:
Then you are noted as being an observer on the
Advisory Committee on Dangerous Pathogens Working
Group on TSEs. Is that a similar role to an offici al?
ANSWER:
Yes.
|
46,365 | 341 | QUESTION:
And you are again recorded in minutes as being
a technical adviser to SEAC. Is that a different
role?
ANSWER:
Yes -- well, I'm just trying to think. I mean, aga in,
it's hard without seeing the paperwork to remember
exactly what I was doing, but it might have been
things like helping prepare papers for them, that k ind
of role. Supporting the secretariat. Yes, it woul d
be helping, making sure that the Committee had the
information it needed to make its decisions.
|
46,366 | 341 | QUESTION:
And then you are also described as an official in
minutes of the Chief Medical Officer's SEAC
epidemiology subgroup?
ANSWER:
Yes. I mean, it's all the same kind of supportive
role.
|
46,367 | 341 | QUESTION:
Supportive role. So not in a decision-making role but
in a supportive role. So either the secretariat or to
the groups themselves.
ANSWER:
Yes.
|
46,368 | 341 | QUESTION:
Then in March 2002 you took up your role as head of
the CJD team, presumably first at the PHLS, and the n
in 2003 when the HPA was formed -- the HPA being th e
Health Protection Agency -- you continued in that r ole
as head of the CJD team at the Health Protection
Agency.
ANSWER:
That's correct.
|
46,369 | 341 | QUESTION:
And you were, at that stage, a consultant
epidemiologist.
ANSWER:
That's correct.
|
46,370 | 341 | QUESTION:
And you remained in that role until May 2012.
ANSWER:
Yes.
|
46,371 | 341 | QUESTION:
So just pausing there in your CV to ask you some
questions about the Health Protection Agency.
You've told us that it then became Public Health
England, and then Public Health England has now bec ome
the UK Health Security Agency. So you have referre d
to those as PHE and UKHSANSWER:
|
46,372 | 341 | QUESTION:
So that's what that stands for, is it?
ANSWER:
Yes.
|
46,373 | 341 | QUESTION:
Was the -- geographically, in terms of the four
nations, what was the remit of the Health Protectio n
Agency?
ANSWER:
England.
|
46,374 | 341 | QUESTION:
And what were the equivalent organisations in
Scotland?
ANSWER:
We worked -- it was then -- we worked with SCIEH,
Scottish -- I can't remember exactly what it stands
for. But, again, infectious, epidemiology, health.
I can't remember what the actual acronym stood for.
Now it's, I think, Health Protection Scotland, and we
work closely with our colleagues in Wales and North ern
Ireland.
|
46,375 | 341 | QUESTION:
So they were equivalent to agencies in those --
ANSWER:
I was just trying to think whether our remit covere d
Wales at any time. I think we were always working
with Wales. It's hard for me to remember exact rem its
of the different organisations.
|
46,376 | 341 | QUESTION:
And the purpose of the Health Protection Agency?
ANSWER:
I'm trying to think how it changed. At which point
we -- I think it was still pretty much the same, an d
I think it was when we became PHE that it became
a much broader remit, including non-infectious
7diseases.
|
46,377 | 341 | QUESTION:
So the description you gave us in relation to PHLS
applies equally to the Health Protection Agency.
ANSWER:
From our perspective, yes.
|
46,378 | 341 | QUESTION:
And I understand that the Health Protection Agency was
what's called a non-departmental public body. So i s
this right: it wasn't actually part of the Departme nt
of Health, but it was funded by the Department of
Health?
ANSWER:
I don't want to give you incorrect information, so it
would have to be in my understanding.
We weren't truly independent of the Department
of Health. It was more of an intertwined
relationship, and I think we were a non-departmenta l
body. We became an arm's length body at some stage ,
and then we became an executive agency, and actuall y
I don't really know the proper differences between
these different things, but I'm sure there will be
someone else who can explain it to you.
|
46,379 | 341 | QUESTION:
And so is it right to understand that you received
instructions from the Department of Health to carry
out some task? For example, a notification exercis e.
ANSWER:
Okay, so I think that you're talking about -- is th e
relationship between also the CJD Incidents Panel a nd
the Department of Health because the Chief Medical
8Officer set up the Incidents Panel, and the Departm ent
of Health used to run the secretariat for it before it
was moved over to what became then HP |
46,380 | 341 | QUESTION:
So that would come through the Chief Medical Office r
or the Department of Health through -- accepting th e
recommendation or advice of the Panel. And then wh o
would instruct the Health Protection Agency? The
Panel or the Department of Health or if you don't
know --
ANSWER:
I think it may have been the Department of Health, but
I don't know exactly. Yes, I'm not -- it was proba bly
the Department of Health. I can't -- it wouldn't h ave
been the Panel telling HPA what to do. It must hav e
been the Department of Health giving us that role.
|
46,381 | 341 | QUESTION:
It may become clearer as we look through some of th e
documents; it may not.
Returning then to look at what your team were
doing, the CJD team. What was the remit of your te am?
ANSWER:
Okay, there were different pieces of work going on, so
part of it, what I was doing, was we were providing
the secretariat to the CJD Incidents Panel, so it
could run smoothly. We responded, in sort of more of
a health protection way, to any incidents and
questions that came in from around the country. It
could be from our local public health teams or from
a hospital. It could be any -- generally not from
members of the public, this would be from the medic al
community generally, in dealing with some of the CJ D
health protection issues. And then we also had a t eam
sort of following up people who were in the at risk
group. So running that kind of data surveillance.
And then we had more of a sort of research team --
well, as I say, it's not really different teams, so rt
of within the team -- it makes it sound much larger
than it was -- running the prevalence studies, so
tonsils, appendices, to look at the prevalence of C JD
in the population. I think that probably covers ou r
scope of work.
|
46,382 | 341 | QUESTION:
We will come and we will be looking later this morn ing
at some of the documentation that relates to, for
example, following up those that were at risk in th e
community from CJD.
In terms of the prevalence work, is it right
that the Health Protection Agency set up the tonsil lar
and appendix tissue national archive?
10 ANSWER:
That is correct. So I wasn't working on those area s
but I was working with people who were running thos e
studies.
|
46,383 | 341 | QUESTION:
Was that headed up by your colleague Professor Gill ?
ANSWER:
Yes, so Noel Gill, and I think Kate Soldan was also
involved with those, as well as more junior members of
the team.
|
46,384 | 341 | QUESTION:
Can you give us an idea of the size of the team.
ANSWER:
Okay. So I think it might be a bit more confusing
than otherwise, just because I kept having -- it wa s
at the stage when I was doing maternity leave and
child care stuff, so people were covering for me, b ut
in essence there was myself and there would be Noel ,
and I think he would have had another consultant
supporting him on the prevalence work, and then the re
would be a couple of -- maybe three scientists. An d
then we had a senior administrator and junior
administrators helping with the Panel support. And we
had a nurse as well working with us, she did some o f
the qualitative work. That was the rough size. So
maybe six people. Something like that.
|
46,385 | 341 | QUESTION:
Then in May 2012 you took up a post as a consultant
epidemiologist at the HIV and STI (sexually
transmitted infection) division of the HPA?
ANSWER:
Well, yes, it's actually -- I had the same post. S o
11 I took the -- got the consultant post in CJD, and
I just moved responsibility. So the CJD team was
within the HIV and STI team. Noel Gill was the hea d
of the whole department, and I moved within his
department from CJD on to chlamydia and HIV.
|
46,386 | 341 | QUESTION:
And that's a post you hold --
ANSWER:
That's the same post I'm in.
|
46,387 | 341 | QUESTION:
-- today.
So, I'm going to ask you some questions now
about the notification exercise, and we heard quite
a lot of evidence about that yesterday. I just wan t
to understand the division of responsibility, insof ar
as you understand it, between the Panel, the Health
Protection Agency and the Department of Health.
Is this right, that it was for the Panel, the
CJDIP, to advise the Department of Health about
whether or not notification should take place and, if
so, who should be notified?
ANSWER:
Yes.
|
46,388 | 341 | QUESTION:
Then it was for the Department of Health to accept or
not accept that advice?
ANSWER:
Yes.
|
46,389 | 341 | QUESTION:
We know that they did accept that advice?
ANSWER:
Yes.
|
46,390 | 341 | QUESTION:
Then it was for the Health Protection Agency to put
12 into effect that decision, that notification, to
effectively coordinate it and deliver it?
ANSWER:
Yes.
|
46,391 | 341 | QUESTION:
And in terms of authoring documentation, working ou t
how the process is actually going to work, the nuts
and bolts of it, was that led by the Health Protect ion
Agency or led by the Panel, can you recall?
ANSWER:
I think we would be -- we generally -- so are you
talking specifically about the haemophilia -- the
plasma product notification in 2004 or ...?
|
46,392 | 341 | QUESTION:
I'm talking generally now.
ANSWER:
Okay. We would have been the people coordinating w hat
should -- how to do it, but we would work very clos ely
with members of the Panel. So, I mean, I can comme nt
on yesterday if you -- if that helps, I don't know?
I mean, so, for example, in creating some of the
information packages that we were putting out --
I heard Professor Ironside give his talk that he
wasn't particularly involved where he -- yeah, we
worked very closely with him on other things, from his
pathology point of view, but we worked with other
Panel members: so we had public health representati ves
on the Panel, we had lay people, we had
a psychologist, we had GPs, we had a range of peopl e
who we would work with, we had someone from the
3 CJD Support Network we had very good relationships
with, who would help us create the documentation. And
then we also, say particularly for the 2000 -- the
haemophilia notification work with the UKHCDO,
Frank Hill, Charles Hay and the Haemophilia -- I th ink
it was their Alliance? I'm just trying to think wh at
the name of the patient organisation was. So we --
and likewise, similarly with the immunodeficiency
groups, we had links with lots of -- that's how we
created the process. It wasn't -- we didn't sort o f
sit in a corner and go -- creating it was much of a
"How do we work with people? How do we get it" ...
|
46,393 | 341 | QUESTION:
Equally, you didn't have the -- you weren't sitting in
the full Panel, CJDIP meetings going through, line by
line, the toolkits, but you were going off and
doing -- getting advice and help from people outsid e
the Panel meetings and so on --
ANSWER:
I can't remember whether we sent drafts to the Pane l
as we developed it or whether -- but they certainly
would have -- I'm -- they definitely would have see n
the documentation. I can't remember at what stage
different members of the Panel saw the process they 'd
got involved in. It would -- as I've said, it
would -- depended what their area of special -- you
know, expertise. It was a multidisciplinary panel, so
14 we would have worked more closely with some than
others.
|
46,394 | 341 | QUESTION:
Just in terms of trying to understand the time fram es
in which everything was taking place, we heard from
Professor Ironside that there was a period of
consultation in October 2001, and we know from the
papers, which we can go to if necessary, that the
framework document was provided to the Chief Medica l
Officers in October 2002.
Do you know why the Chief Medical Officers were
asked to approve the framework document and the way
that the Panel was going to work?
ANSWER:
Well -- so that is in 2002?
|
46,395 | 341 | QUESTION:
October --
ANSWER:
So the secretariat was still within the Department of
Health at that stage or had it moved over?
|
46,396 | 341 | QUESTION:
I don't know the answer to that actually.
ANSWER:
Given that the CMO set up the Panel, maybe that was
an expectation, that the Government would approve i t.
In a way you could -- I was thinking that in some w ays
it is a bit like the Covid response you can see now ,
that here is a recommendation to take a public heal th
action that can be -- could be difficult or can
have -- because clearly it could protect public hea lth
if the risk is a bit uncertain, or very uncertain, and
15 there could be negative consequences to the public
health action, so it could be seen as a political
decision, so it ought to be taken by CMO, or
Government, as to whether it goes ahead.
|
46,397 | 341 | QUESTION:
And we -- again, we can go to the documents if
necessary but the Inquiry -- I know you have looked at
some of the CJDIP annual reports which set out that
the four CMOs responded to the proposals in the
framework document in June 2003. Does that ring
a bell with you?
ANSWER:
I'm sure if it is in the annual report it is correc t,
yes.
|
46,398 | 341 | QUESTION:
Then, the framework document was published. And
I suggested to Professor Ironside that it was in
December 2003 but, having looked again at the annua l
reports from the Panel, it looks like it was
March 2004. Again, does that period of -- does tha t
sound right to you?
ANSWER:
I'm in the same boat as you, that the only way I wo uld
know exactly what date it was published was by look ing
at all -- or looking through these records to look it
up. So I'm sure if you have seen it in the documen ts
that's recorded correctly.
I do remember that there were iterations of the
framework document because they were incredibly kee n
16 to get them out to get moving, but there was still
a delay what to do about some of these blood issues
and the plasma product, and it was all to do with
the risk assessments taking a long time and having to
get redone -- I think discussed on previous things --
so it was like, well, "Can we put it out and just h ave
some bits greyed out?", you know, so you could put out
at least part of it, as a way of getting past the s ort
of the blockage -- not really a blockage but, you
know, the fact that it was taking longer than we
wanted.
|
46,399 | 341 | QUESTION:
Yes. And certainly with Professor Ironside we look ed
at a version that was dated December 2003, but --
ANSWER:
Mm.
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.