Examination of Witnesses (Questions 611
- 619)
WEDNESDAY 8 SEPTEMBER 2004
DR SIMON
FISHEL, PROFESSOR
PETER BRAUDE
AND PROFESSOR
TOM BALDWIN
Q611 Chairman: I think you were sitting
in the previous section, so you know what we are looking at today,
PGD and so on. Do you think that the 1990 Act anticipated PGD
in any adequate way at all? It used to be talked about years ago,
but did they discuss it at the time the Act was being drawn together?
Professor Baldwin: If one looks
at the judgment in the most recent Court of Appeal dealing with
the Quintaville case against the HFEA for licensing the Hashmi
application, the Justice goes through the parliamentary debates
in great detail in order to make the case that, when the Act was
being processed through Parliament, PGD was very clearly a topic
for discussion and he cites Kenneth Clarke, who was then the Minister
of Health, very explicitly bringing that into consideration.
Q612 Chairman: But did it get incorporated
into the thinking in the Act and the action of the Act in your
opinion?
Professor Braude: You were around
at the time, Dr Gibson, and you will remember that certainly there
were two cases actually going through treatment at the time of
the 1990 Act and I think it was very influential for MPs that
they could actually see it was a reality. I do not think what
they could anticipate was where it was going to go because the
technology for actually doing the kind of things that are being
done now was not around at the time. I think the one thing that
was not appreciated then, and I do worry when I hear what has
been discussed previously about PGD, is seeing the way it is going
currently, in that the kind of patients we have seen here do not
represent the majority of PGD cycles in the way it was classified
in the States, and that is the number of PGD cycles, for example,
that are done in this country ever since the Act probably does
not exceed 500. If you put that against the 25,000 IVF cycles
per year, it is a trivial amount but it does have public import.
I think the public are concerned about what is being done. Where
there is a large amount being done, increasingly with—and
there is plenty to quote you—some debate about whether the
evidence is substantiated, is using PGD to improve infertility
treatment. Although no difference is made, for example, in the
United States between those two and the volumes are huge, the
big difference in this country is to do with funding and the three
people who spoke here all mentioned money, they all mentioned
expense, and I think one of the things that has to be looked at
is how these sort of people who were here before are going to
get a fair deal. I think they get a fair deal if they are dealt
with through genetics. The other patients who are having some
kind of testing done to improve their chance of IVF clearly fall
within the fertility budget and if this is taking place in the
NHS—and indeed very little does—then we actually have
to decide how the funding is going to take place. So that distinction,
I think, needs to be made and was not made at all in the previous
session.
Q613 Chairman: You are emphasising
the commercial situation but what about the safety factors, the
clinical risk and so on, that must be in people's minds too? Are
they well informed?
Professor Braude: I think you
are absolutely right. I think this is one of the areas where we
have very, very little information. Yes, certainly, we can talk
about success in terms of child produced, we can talk about some
of the experiments that have been done that show that probably
the embryos can continue with a cell being removed because of
what we know from freezing, for example, where you will often
lose a cell and yet we know that pregnancies are occurring there.
What has not been established and could not be established other
than by long-term follow-up is, has this any impact later in life?
We hope not, we very much hope not, but the data is not there.
Q614 Chairman: So, what do you say
to me if I come to you and say, "Come on, doctor, tell me
about the risks that are involved here"? What do you say?
Professor Braude: We tell them
that the risks are not defined but these kind of people who have
been to see you here—
Q615 Chairman: There is no answer
to the questioning?
Professor Braude: No. The people
who have been to see you here have to balance the risk. They balance
the risk of having an unaffected child or the child they have
now versus the small as yet unquantified risk—and it must
be small because—
Q616 Chairman: Can you think of any
other areas of clinical practice where you can say what the risk
is?
Professor Braude: I do not think
there is another area of medical practice that is like assisted
conception. There is no other area I know other than drugs in
pregnancy where, in satisfying the client—and let us call
the patients that for the moment—who come along to you and
say, "We desperately want some children", to solve that
problem is a child. It actually does not take into account that
what you are doing to the embryo is eventually going to be another
person, and that person's health may be compromised by what you
are doing by what the first patient wanted. There is no other
area that does that and it really is a heavy weight.
Q617 Chairman: Do you think there
are safety risks?
Professor Braude: I suspect there
aren't from all the data that we have and the part that persuades
me is the 20 years of frozen embryo replacements for infertility
patients. You lose cells in that. I mean, you might lose half
the embryo. They will come out seemingly normal but that is 20
years' work. So, in answer to your question, we feel comfortable
but that does not abrogate our responsibility to be following
up those children and there is not a mechanism because of the
Act for doing that.
Q618 Bob Spink: When you said that
you do not think there are significant risks to health, you were
talking about physical health but would you extend that also to
include psychological health as far as PGD is concerned for the
life to the new child that is created?
Professor Braude: I think rather
in the same way as the HFEA has had to address this in some cases,
this is speculative because what you would be saying is, is this
child different? Is it going to be treated differently because
the term, for example, "designer baby" may be in there?
That would be completely speculative but, from all the evidence
we have from assisted reproduction children and even in new relationships,
ie two females, single parents, is that those children seem very
well adjusted because they are wanted.
Q619 Chairman: Do you think that
assisted conception is so different from other clinical practices
in terms of regulation that the HFEA do not have it right or wrong
in terms of the regulation? If it is slightly different, then
it demands different types of regulation.
Professor Braude: I would like
to quote something to you because we have some models of no regulations
as in the States. In the United States, there is no regulation,
there are guidelines and recommendation, and, as you know, one
of the biggest problems that we have in assisted reproduction
is multiple pregnancy. Triplets have gone up by 400%, half of
which are from assisted reproduction. There, despite the fact
we know we should not be putting back too many embryos and the
fact of course that we know of multiple pregnancy—and I
dug these figures out from the American figures—in 66% of
cycles, there were more than three embryos replaced, in 32%, there
were more than four embryos replaced and, in 11%, there were more
than five embryos replaced. That is in the presence of professional
guidelines. That is why I think some of these issues have an impact
on our health service because we pick up the tab for looking after
the babies. I got into a lot of hot water in the States by suggesting
that perhaps the centres that create the babies should pay the
neonatal costs and you can imagine what the response was to that,
but there is a responsibility for us.
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