Examination of Witnesses (Questions 240
- 254)
THURSDAY 21 FEBRUARY 2008
Dr Anthony Warrens and Mr Keith Rigg
Q240 Baroness Neuberger: Sure.
It is not the ethical problem?
Dr Warrens: In my view, it is not. There are
ethical issues but, in my view, the dominant factor is organisational.
The reason we probably have not hit our heads on the ethical ceiling
yet is because quantitatively it is a much smaller practice than
donation after brain stem death. There were something like 150
donations after cardiac deaths in the UK in 2006 compared with
over 600 after brain stem death, so quantitatively it is much
less. The ethical issues may become more prominent if and when
we do more. The problem with donation after cardiac death is that
you need to have a team that is available who can preserve the
organs very rapidly. Clearly, if you know it is likely to happen,
then it is easier to plan than if you do not, but it is still
not nearly as easy as a situation where somebody is maintained
on cardio-respiratory support but is dead because their brain
stem is dead. That clearly is a more elective procedure. So there
is a major organisational issue. There are also areas of doubt
as to what the legislative framework is for donation after cardiac
death in the UK, and it will be very helpful, I think, for people
who are practitioners in that area to have clarification about
this. The Human Tissue Act moved that forward greatly when it
came into force in 2006, but there are some areas that have left
practitioners still without guidance, and it would be very helpful
if Parliament and government were able to give guidance to my
colleagues who are involved in that.
Q241 Chairman: Would you be
prepared to write to us and say what they are?
Dr Warrens: I will speak to some of my colleagues
within the Society about this and write to you. I am sure it would
be useful to have your support in clarifying these issues.
Mr Rigg: Perhaps if I can just add, the Academy
of Medical Royal Colleges have been working, as you know, on the
code of practice for the diagnosis of death, and I am not sure
what stage it has reached. There is the promise that it will be
published very soon but there is no date yet set for this. There
are going to be, hopefully, some clarifications within that. I
know that there are people within particularly the intensive care
community in the UK who have concerns. It is really the time after
the heart stops beating: how long you should leave it until it
is safe to go ahead with removal of the organs. Again, this is
very different across Europe. Some people say that two minutes
is adequate, some people say five minutes, some people say ten
minutes, and there is that level of concern there. I should also
say that the EU document talks about increasing the number of
living donors and extended donors, or extended organ criteria
donors. I think we would probably say that donation after cardiac
death is not part of the extended criteria donor; it is something
separate. It may be that the European Union intended it to be
included within that, but I think it does need to be specified
because they are two different types of donor. Just to clarify,
the extended criteria donor is somebody who has brain stem death
but, because of other medical conditions they have, the organ
may not be perhaps of as good quality as another one. Let us say,
for example, if somebody who was 25 was unfortunate enough to
have a head injury and died, then you would expect the organs
of a 25-year old to be of good quality and to last for a long
time in the recipient. If, however, the donor was 70, had a previous
history of heart disease and then died of a stroke, then they
would have an underlying disease that might mean that that organ
may not last as long in the recipient. That is what we mean by
the two types of donation after brain death, there is the extended
criteria and then the normal one. Then there is donation after
cardiac death, and to confuse things further, there are two categories:
there is the controlled category, which is where the patient will
usually die in an intensive care unit from cardiac death and there
is the uncontrolled category, which is where somebody may be brought
into accident and emergency having had a heart attack and the
organs can be used. That happens very infrequently in the UK,
and there is conflict between the Human Tissue Act and the Coroners
Act about that which has not yet been resolved. It was certainly
one of the issues that came out of the taskforce that coroners
do have different perspectives in different in parts of the country,
their own interpretation of the legislation is different, and
that does cause issues for transplant co-ordinators and others.
Dr Warrens: I was just going to come back to
the ethical and religious issues that you raised, which I think
are important. I am sure you are right that there are some traditions
that find it unpalatable to proceed with donation after cardiac
death. My own view here would be that it is our responsibility
to find out what people's traditions are, to make sure that they
are in a position to make an informed decision, without any coercion
whatsoever and full respect given to whichever decision they take,
and as long as that framework is in place, I think the pressure
then is removed and those for whom it is culturally, ethically
acceptable would then be in a position to proceed. I think the
whole system, as it were, would benefit from basically opening
up discussion, understanding what people's views are, and it is
not just the Catholic position. You said you are a Rabbi and I
remember having a discussion with a Rabbi myself whose concerns
were how long after the cessation of cardiac function does one
have to wait before that defines death?
Q242 Baroness Neuberger: It
should be eight minutes.
Dr Warrens: There are issues in many cultures,
and I think what we need to do to get round some of the problems
we were alluding to earlier of a lack of trust is make it abundantly
clear to everybody that we wish to know what people's views are,
we wish to respect them, and in that context we can move forward
and those who feel comfortable with participating in this will
be able to do and I am sure the number of organs would increase.
The last comment to make, because you asked me also about European
dimensions, is that we have a lot to learn from Europe here because
probably the leading centre in Europe for donation after cardiac
death is Maastricht in southern Holland, which has led the way.
Professor Kooststra there has done an enormous amount of work,
so I am sure we have a lot to learn.
Chairman: Lord Eames, you wanted to ask
a question.
Lord Eames: No, I was nodding in agreement.
Baroness Neuberger: Shall I follow up
with living donors? They have given me these nice neat ethical
issues that are so easy to answer, and I know that Lord Eames
and I have been nodding to each other all the way along. You make
the case very strongly for the expansion of living organ donation
in the UK and throughout the EU. Could you, first of all—this
for the record—describe what the advantages of living organ
donation are and then could you also explain exactly for us what
is meant by the terms "paired" and "pooled"
donations and non-directed donation. I think we really do need
to know why you feel so strongly that these should be encouraged.
Chairman: We mentioned this earlier.
Q243 Baroness Neuberger: We
need to get it on the record.
Dr Warrens: It bears repetition anyway, does
it not? Living donation is very successful. The outcome following
living donation is better than the outcome following cadaveric
donation, even if the living donor is not particularly well-matched.
By definition, if you are performing a deceased donation, the
donor was ill prior to donation: by contrast you only take a kidney
from somebody who is well, and so you are using a very good quality
organ and so the outcome from the recipient is extremely good.
The risks for the donor are extremely small. There are data that
demonstrate that the life-expectancy of kidney donors is actually
better than the life-expectancy of age-matched individuals from
the general population. That is because you only get to be a kidney
donor if you have been screened and, therefore, all patients found
to have medical problems are not considered further as donors.
The reason I say this to patients is because it tells them the
magnitude of the risk they are taking, which is extremely small.
The risk of death we quote as 0.03%, which is approximately the
risk of being run down in the street in a 12-month period as a
pedestrian. But, while the risk is very small, it is not zero.
There is also additional advantage for donors, because in the
vast majority of cases they have an ongoing relationship with
the recipient, and renal disease is not something you experience
alone. The majority of donors probably are partners, and living
with somebody who is on dialysis has an impact on your own quality
of life and so there is an additional benefit for the donor in
improving the quality of the life of their recipient. Retrospective
studies of people who have been donors suggest that the vast majority
of them are very pleased that they did it and, quite rightly,
they feel good about themselves. As a physician, I find it a very
humbling experience to see people who are prepared to put themselves
through this sort of discomfort, and it is often no more than
that, but altruistically. That was the first question about the
advantages of donation. I have talked long enough. Shall I leave
Keith to talk about "pooled" and "paired"
again?
Q244 Baroness Neuberger: Yes,
please.
Mr Rigg: Do you want the definition of paired
donation again at this stage?
Q245 Baroness Neuberger: Yes,
very briefly, so we have absolutely got it.
Mr Rigg: We have a pair who would like to be
able to donate to each other, let us say pair A, but they are
incompatible, and then pair B, who are in a similar position,
would like to be able to donate to each other but, again, are
incompatible. It is, therefore, possible through a matching system
whereby the donor in pair A can donate to the recipient in pair
B and for the donor in pair B to donate to the recipient in pair
A. The modelling data would suggest that you probably need at
least 30 to 50 pairs within a pool of patients, and that will
mean that about 30% of those will actually get a successful transplant.
Therefore, there is a minimum number within the pool. So it will
not be the answer for everybody. I think we have calculated in
the UK that if you look at all the people who are incompatible,
either because of them being the wrong blood group or because
of, going back to the HLA or the antibodies whereby people cannot
donate, then we could probably increase the number of living kidney
donors by between 50 and 100 (but, again, that does mean that
everyone who is seen has to go into the scheme), and it has to
be recognized that not every living donor pairing want to do this,
because some really want to have a kidney from their loved one
and do not necessarily want theirs to go to someone else and to
receive one back from someone unknown. So it is not going to be
the answer for everyone, but it is an option for a number of people
who are currently difficult to transplant. Again, they have a
successful scheme in the Netherlands. Certainly, in the introduction
of the scheme in this country, we took on board some of what they
were doing. Again, there is the opportunity to learn from other
people within Europe and also for other countries within Europe
to learn from those who are doing it. Alongside of that, the Human
Tissue Act also allows for altruistic or stranger donation, which
is where an individual decides that they have two kidneys, they
only need one and they would very much like one of their kidneys
to go to someone else. That is not something that many people
would choose to do and, at the risk of stereotyping, I think we
have found that those people who are most likely to do this tend
to be middle-aged women whose children have grown up, and I think
that perhaps shows the generous nature of that group, or maybe
they are fitter, I do not know, but that tends to be what has
happened. Again, it is not a large number and probably less than
five or six people have done that, but it does increase the number
of organs that are available.
Q246 Baroness Neuberger: You
have mentioned the Netherlands for the paired donation, the absolutely
altruistic. Is that more common in other European countries?
Mr Rigg: I am not sure exactly. I know in Germany
it was permitted, but I think they may have stopped it. I think
it is one of these things that, ethically, people do have some
concerns about, because one of the things that has to be ensured
in the work-up process is that there is no evidence of coercion
or inducement, and one could argue that who in their right mind
would give up an organ? It is different giving up blood or bone
marrow but giving an organ that is not going to grow again, why
would anyone choose to do that? One has to be sure that the reasons
are right.
Q247 Chairman: Can I just
clarify one further point. If pooling is so useful, why would
it not be useful for the EU to have this wider pool and, if so,
how would you see the EU carrying that out without increasing
the paperwork (because I cannot say that word this morning!)
Mr Rigg: Again, part of it is around the transport
times and that is one of the issues because one of the other advantages
of live donation is that the organ is not out of the body for
very long. In a traditional living donation it comes out of the
donor and goes into the recipient more or less straight way or
within a couple of hours. Within the paired donation scheme in
the UK again you are putting that up to perhaps four to six hours.
It you then start to expand that across Europe that time is potentially
going higher.
Q248 Chairman: Presumably
people could travel?
Mr Rigg: They can do. One of the other things
is that there is a requirement for anonymity between both pairs
beforehand. Let me explain that because there are some horrified
faces! I think the concern is that if people know who they are
donating to in terms of the other pair, they may say because of
their colour or because of their age or whatever that they do
not want to go ahead, so I think the reasoning is that before
the donation goes ahead it is recommended there should be anonymity
so there is no condition attached. That is part of the problem
with logistics because, yes, potentially everyone could travel
and go into the same hospital, but people do not necessarily want
to travel to another unit and then it is very difficult to maintain
that anonymity within one hospital where you have a defined number
of wards where those patients are and a defined number of theatres
so logistically it would be difficult but not impossible.
Q249 Baroness Morgan of Huyton:
You have submitted evidence to us on donor cards and my understanding
of what you said is that you are pretty hesitant about the notion
of a European donor card and you are more interested, if anything,
in going even more local than a national donor card. Then you
raised the possibility of a local or community-based donor card
with some sort of EU stamp of approval as a possibility. For the
record, could you expand on those points.
Dr Warrens: I think it is all a matter of buy-in.
We were talking earlier about people identifying with the services
that they were going to be interacting with and I think people
do that more naturally with something that is familiar. Therefore
if you can introduce some sort of familiarity by virtue of it
having recognisable authority or displaying features that are
important to them, then it is something they are going to feel
more comfortable about. That is why I feel we are going to get
greater buy-in to a UK donor card than we would to something that
was EU-wide. It may be that within local communities there are
alternative ways of "kite-marking", as it were, a local
system of donor cards. There is very little research on this,
but I think there is the potential for doing it, if a local community
has respect for a particular set of individuals whose authority
they believe is something that is important to them before proceeding.
If that individual were to participate in the local scheme, then
I think it is more likely to win the affections and buy-in of
the local populace than something that is imposed from a structure
with which they do not identify.
Q250 Baroness Morgan of Huyton:
Is that a presentational point or is that a reality in the sense
of are you saying that you are against the notion of organisationally
having a European-wide donor card or are you saying presentationally
that it should be a locally presented card but that nevertheless
could be organised on a EU basis?
Dr Warrens: I do not think it is just presentation
because there may be local requirements for adaptation to different
approaches. For example, there are communities who have problems
with the definition of death on the basis of brain stem death
criteria, and it may be that they would be prepared to sign a
donor card that stipulated they would be donors, but only in the
context of the cardiac death and not following brain stem death.
If we were able to develop a system with enough flexibility to
accommodate their wishes—and I think to a certain extent
we could—then (i) we could communicate to that community
that we have an interest in taking their concerns to heart and
(ii) I think we would increase the number of donors, so that is
what was behind the idea.
Q251 Chairman: It would be
a pity if we did not ask for your views on opt-in and opt-out
because, having heard what you have got to say, I think it would
be very useful to know what your views are about that topic.
Dr Warrens: We thought you might ask that!
Mr Rigg: We did do a survey within the British
Transplantation Society recently and we have done it a number
of times. There was a small response and two-thirds of the membership
were in favour and one-third were against, which is not that disparate
from the views of the general population. I think we would have
to say that as individuals we both have some concerns about it
because we now have a Human Tissue Act which is based on consent
and if you introduce presumed consent, there is concern that people
may not have the knowledge. I think it is fair enough if there
is extensive public information so that everyone knows but how
you do that so that everyone in the population is aware, I do
not know.
Q252 Chairman: The work with
the relatives will still have to be done?
Mr Rigg: It would do and is that any different
to what we have currently have?
Dr Warrens: In the situation of being faced
with the implacable opposition of the relatives of somebody who
has just died in your coronary care unit or intensive care unit,
it is very difficult to disregard that, and those are the practical
issues that the professionals who are involved in this have to
face on a day-by-day basis.
Q253 Chairman: I think we
have found that people say yes until they think about it! We have
got one more question but I think we need not spend a long time
because you have answered it and that is: do you want to say anything
else about the organising of services or is there anything you
particularly wish to pick out in relation to the Task Force report
and particularly what you want to send us away thinking about
in relation to organisation in Europe?
Dr Warrens: Just for the record, to reiterate,
I think it is a first-class document and I think the idea of having
a unified organ donor service within this country will represent
a very great step forward. UK Transplant is a very good organisation
and I am sure is the right place to house that. I suppose I would
look to your good offices to push forward the implementation of
that because I appreciate that there is many a slip twixt report
and lip.
Q254 Chairman: Can you add
anything to that? Spain and Belgium certainly have given it consideration.
Mr Rigg: I think the report takes on board what
is happening in Spain and some of the recommendations are based
on those reports, so it important to be able to learn from each
other and to learn from good practice, and I think there are aspects
around quality and safety, as we have already said, where we can
learn from each other. We would just emphasise that we would not
want the extra bureaucracy. I think there are minimum standards
for quality and safety and we all need to be able to maximise
knowledge about organ donation so that people can make a choice
and hopefully we can then meet the needs of the many people who
are waiting for organs.
Chairman: Gentlemen, we are immensely
grateful to you. We have not only learnt from you but enjoyed
your presence and we would say thank you very much.
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