Examination of Witnesses (Questions 1080
- 1099)
WEDNESDAY 24 NOVEMBER 2004
PROFESSOR ROBERT
EDWARDS, PROFESSOR
CATHERINE PECKHAM
AND PROFESSOR
HENRY LEESE
Q1080 Mr McWalter: On ethical oversight,
Professor Peckham, your report mentions the development of a "balanced
ethics and governance framework" to regulate data collection
and follow-up studies. Who should do this?
Professor Peckham: I think it
has to be independent. I think we have many examples in other
areas in science now, whether it is the newborn screening or whether
it is Biobank where an independent approach has been shown to
be very successful, particularly if it is done with public consultation.
When we are talking about issues like monitoring children and
following up children who have been conceived by different methods
in order to ensure safety, and I think that is a good procedure,
I think that is vigilant and something we are doing in other areas,
you have to think about the public concerns. You have to think
around the issues of confidentiality, the issues of consent, the
issues of what you are doing and you have to bring on the public.
You have to have the public behind you or these things cannot
work, and I think it needs an independent body to look at what
is going on, and that can be very successful.
Q1081 Mr McWalter: This Committee
has just come back from talking at Vatican City to some of the
people there, and one of the things they were very interested
in was whether using techniques like PGD you might get over the
long-term a contraction in the gene pool so that removing something
that looks as if it has highly negative, like, say, a gene for
Alzheimers or whatever, may in the end give you a gene pool whose
members who participate in that then have other vulnerabilities
that were not previously identified. Would you think that is a
danger? Do you think that is something that should be part of
the consideration for such an ethics committee?
Professor Peckham: I think one
should always be looking at the effects which may be immediate
or even more long term; that is appropriate for many different
areas of medicine. We know that the intrauterine environment is
very important and that it has implications for the child and
implications much further than the child—for the adult—and
I think we have to be very aware of the long-term effects as well
as the immediate effects of what we are doing, and that is a precautionary
approach and something we need to do, and we have to balance the
concerns of the individual and confidentiality with the benefits
to society as a whole, and I think that debate is something that
we have not addressed sufficiently and we need to address, because
we have to think of the public good versus the benefit to the
individual, particularly when you are not harming an individual,
you are just merely wanting individuals to work together to produce
something so that you can monitor what you are doing. So I think
it is quite complex; it is not easy; it is not something you can
just set up; you have to think it through and you have to do it
properly, particularly with the ability that there will be soon,
and this is certainly something Biobank is addressing, which is
the linking with other data sets and linking with other health
information within the NHS. That can tell you a lot. It can tell
you if something is going seriously wrong. It might not be subtle
things but if you can link databases and relate the information
back to the individual technologies you are applying, it can alert
you if there is anything you need to investigate further. So I
think there is huge progress in data linkage that we are just
beginning to apply in other areas that would be appropriate for
the assisted reproductive technologies.
Professor Edwards: Answering that
question from the point of view of a geneticist, if we use PGD—and
we are talking about five years—for disease, I should be
delighted if we get a decline in the frequency of genetic disorders.
I think that would be wonderful for the human race. That is our
target, so I am not the slightest worried on that point. I cannot
understand what the questioner was saying to you. But if we can
go later, you have to think that down the line already we are
starting to look at multiple gene situations—not single
gene but multiple genes—and when you enter that area you
are talking about the more human characteristics of the embryo,
if I can put it that way. Even though you may be putting new genes
in, I would have thought the chance of risking any change in gene
frequencies in a population of 60 million people would be incredibly
minute. I would strongly recommend you consult a population geneticist,
but I think his answer would be "Not a chance", that
the effect would be very minor.
Q1082 Mr McWalter: Are you suggesting
we cannot eliminate Huntington's Chorea?
Professor Edwards: We can probably
eliminate any of these genes if we are prepared to pay for the
screening. When people say PGD is expensive, I always say what
is the price of a disabled baby who is born. What is the cost
for anyone to bear? That is a terrible price for anybody to bear,
and the financial cost is immense. A PGD by comparison is a very
small sum of money. On PGD, I fully agree, we have to do it responsibly,
but if done responsibly then I think it is a very new and challenging
thing for us to accept.
Q1083 Mr McWalter: Professor Leese,
do you have any observations about the performance of ethics committees
in the private sector?
Professor Leese: I do not quite
understand your question. They are always properly constituted
as far as I know, and I used to be an HFEA inspector. They would
have strong lay representation and we would always check on that
to make sure the person responsible was not a member or left for
items concerning his clinic. No, I do not have a view on that.
I am going really back to when I used to chair inspections and
all the paperwork and the ethics dimension. I always felt they
were of course immensely valuable for difficult cases. If the
clinic had a difficult case we would put it to the ethics committee,
but I cannot recall anything that would distinguish ethics committees
and private clinics from NHS Committees really.
Q1084 Mr McWalter: So people do not
just appoint their pals? "So-and-so is worthy", or "I
met Jo Bloggs down the lodge", that kind of thing?
Professor Leese: There is always
an element of the great and the good, as it were, but how you
resolve that one I just do not know. That is one I would put back
to you in every walk of life. The expert versus the lay, and how
you balance the two.
Q1085 Mr McWalter: So they might
have a collective blindness?
Professor Leese: I think they
are doing their best, really.
Q1086 Chairman: Do you think we can
regulate private clinics at all, or do they just tell us to run
away? What about the regulation of them? How do you feel about
that in comparison with the regulations that you feel are strongly
enacted through the system we have in the public sector.
Professor Leese: In the private
clinics?
Q1087 Chairman: Yes.
Professor Leese: I am struggling
to find a problem here, I really am. There is obviously something
in your mind but I would have—
Q1088 Chairman: We are cynical, suspicious
people. We read the newspapers and we see things going wrong and
we find that people who are privatised tend to—
Professor Leese: Perhaps they
were not the clinics I inspected but we would always look at the
constitution of the ethics committee. It was one of the questions.
"Do you have a properly formulated ethics committee?"
We would always look at it and see who was on it. I cannot recall
the problem, anyway.
Q1089 Mr Key: I think the evidence
so far is that the HFEA should not become a research organisation,
if I understand you correctly, but this does bring us back to
the question of clinical data bases. Under the Act, Section 31,
the HFEA has to log information under certain circumstances and
the recent MRC HFEA working group has suggested that there should
be a new monitoring framework in place to collect and collate
more comprehensive information than is currently done. Would that
be a good idea, if there is to be no research function? What is
the point? Why do we not just ask the HFEA to record very basic
information like recording gametes and embryo donations?
Professor Edwards: I would find
no problem in people following up our research at regular intervals,
coming and checking, making sure it was safe rather than it was
ethical, if you see the difference, which I think is what you
are saying. I would have no problem with that at all. In fact,
such a body would be welcome. First of all, they may find things
we had not thought of which is always wonderful to us but it would
give us the chance to show what we are doing, and this body would
show that we are doing it properly. That is what we want—to
make sure that people see what we are doing is being done perfectly
correctly. And, by the way, I think IVF is being practised correctly.
There are one or two renegades, I am sorry to say, but on the
whole it is practised correctly. Does that answer your question,
sir?
Q1090 Mr Key: Partly, but I wonder
if our other witnesses have a view particularly on this question
of clinical databases and whether there is duplication here, and
what would be the point of the HFEA enlarging a database if it
was not for research?
Professor Edwards: When Louise
Brown was born, and we opened the Oldham General Hospital we started
getting a lot of data, we sent it to the Medical Research Council
and they wanted to follow up all the babies for us. After a short
time they wrote back saying "It is too expensive; we will
do chromosomes only". After three months they said "We
do not want to do chromosomes either", so our first database
which could have been established in the United Kingdom in 1982
was never established, so I think the MRC must get its act right
on this. If it is going to come in it must be seen as a duty of
the MRC. At the moment it is a place for research applications.
I have not applied for ten years, by the way, and it might have
changed in ten years, but when I was around it was a place for
research applications and not for checking research. I do not
know if it is the right body.
Professor Peckham: I think the
information database that the HFEA has is a unique information
base but it has been set up to address different questions. It
has a lot of information on treatment cycles, conceptions, and
minimal information on outcome. What was suggested in the MRC
report was that you might want to look at certain questions as
demanding more details of the technology that was used in trying
to tease out that in relation to the effect on the health of the
child, so I do not think you would want more information; you
might want selected but fairly discrete information. So you are
not suggesting two databases; you are suggesting there needs to
be very close collaboration to ensure that the information you
would require for that purpose, which is different, is available
on the database, so it is complementary. You do not want to duplicate
things; you want to work together, and I think one can think of
many examples where that has taken place. I think the monitoring
falls in a way between good clinical audit and research but there
is no doubt that such information provides a very valuable database
from which to do more in-depth research using more detailed approaches
which would be more appropriate for bodies like the MRC, but at
least you have a sampling frame and you know who you are investigating
and you can look at issues about bias. It is difficult to follow
up and we know at the moment we have not got that in place; it
is not easy. So it falls between two, that monitoring process.
It is good clinical practice, and it is audit.
Q1091 Mr Key: That is helpful. Can
I move on to something really fundamental. I want to ask you how
you define an embryo and a gamete. When Parliament decided all
those years ago in the Act to define an embryo and a gamete, they
used terminology which now appears to be inadequate, and the HFEA
in its evidence has suggested that we need a redefinition of embryos
and gametes, and the Canadians, of course, have recently done
that in their Act which in March 2004 received Royal Assent, so
who would like to start by advising us how you would define an
embryo?
Professor Edwards: I think it
matters for whom you are defining it.
Q1092 Mr Key: For us for the time
being
Professor Edwards: For lawyers,
you probably have to watch every step you take
Q1093 Mr Key: Forgive me for interrupting,
professor. I am asking you to advise us as representatives of
our constituents wrestling with day-to-day problems on the one
hand listening to you and on the other hand reading the Daily
Mail. How would you define an embryo to us?
Professor Edwards: Let me give
you one example where there is a problem. You do not need fertilisation
to establish an embryo; it can set off by itself and we call that
parthenogenesis and we call that a parthenogenetic embryo. We
do not have a problem with that. If somebody clones it, instead
of fertilising it, they put a nucleus in it, we call that a nuclear
transfer embryo, NT for short, and you will hear more about that
in your next meeting I would think. That is how we see it. I would
say that most scientists I know would be very unwilling to define
too hard because we understand what we are doing and I can understand
what all my colleagues are doing in the advance of research. I
am not trying to be unhelpful.
Q1094 Mr Key: Do any of our other
witnesses disagree with what the Professor has just said?
Professor Leese: It is very difficult
to come up with a definition on the spot. It really is. It is
the product of a union of two gametes for a start, an egg and
a sperm. The whole thing is a continuum of course and, with any
developmental process, it is where you begin and where you end
but, for starters, it is the union of two gametes.
Q1095 Mr Key: How do you define a
gamete?
Professor Leese: In operational
terms, it is an egg and a sperm.
Q1096 Mr McWalter: It is not though,
is it, because you have artificial gametes?
Professor Edwards: One of my ambitions
is to take a sample of blood and take a white cell in place of
a gamete for patients who do not have their own gametes. That
would be wonderful and, by the way, that would involve cloning
and that is why I do not agree with abandoning cloning either.
I think you have to leave your mind open on all these questions.
You never know where you are going to be next week! We may find
that cloning helps infertile patients. I think the answer is to
make your own definition. This is a very hard question off the
cuff, you know.
Q1097 Mr Key: Good! That means we
are doing our job!
Professor Edwards: Let us bring
a group of scientists in, let them argue for a couple of weeks
and then see what they say.
Q1098 Chairman: No chance!
Professor Leese: I see where you
are coming from now. I would say that physiologically it is normally
the union of two gametes. However, it may also be formed in the
following ways and you could have somatic cell nuclear transfer
and you could list them if you wish. I am not sure how useful
that would be.
Q1099 Chairman: Do we need a new
word? Do we need new language?
Professor Leese: No, I do not
think so.
Chairman: You understand what an embryo
is.
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