Examination of Witnesses (Questions 1180
- 1199)
WEDNESDAY 8 DECEMBER 2004
DR RICHARD
KENNEDY, PROFESSOR
ALLAN TEMPLETON
AND PROFESSOR
LESLEY REGAN
Q1180 Chairman: Lesley, what is your
view, as a clinical director?
Professor Regan: In response to
Dr Iddon's comment about why the UK is halfway down that list,
I think it is very important to emphasise that this is inherently
linked to the way the data is presented and collected. I have
not seen the table but to base assessment of a clinic's, if you
like, achievements on embryo transplant rates I think is not helpful
at all; it should be on live baby rates. As Allan was pointing
out, there are concerns regarding multiple embryo transfers and
multiple pregnancies; there is enormous attrition in terms of
miscarriage and very early, pre-term delivery and serious neurological
consequences in triplet pregnancies.
Q1181 Chairman: If we had a table
of live baby rates, where would the UK be?
Professor Regan: I would have
to look at the figures, but I think significantly higher. If you
talk to colleagues in the United States where embryo transfers
can be three and upwards, there are enormous problems in ante-natal
pregnancy care and enormous attrition of pregnancies that have
been conceived as a result of assisted reproductive technologies
with enormous consequences for the health care resources that
are needed to look after those babies even if they survive, as
they very often suffer from significant neurological disabilities,
and that is even before we have got to the point of the trauma
of the very vulnerable couples who undergo treatment.
Q1182 Dr Turner: Previous witnesses
have suggested to us that "the regulatory framework needs
to move forward to deal with the unexpected frontiers"—to
come back to this discussion we were having earlier, Dr Kennedy.
Who do you think should make the decision on what is a standard
treatment or a treatment that is pushing at the frontiers?
Dr Kennedy: In-vitro fertilisation,
for the vast majority of patients in the United Kingdom is a very
standardised treatment now; 1 to 2% of all children born have
resulted from this treatment. The recently published NICE (National
Institute for Clinical Excellence) guidelines did allude to the
sorts of areas for which there is no evidence for efficacy, and
a number of areas of practice—for example, assisted hatching
would be one—for which there is no published evidence but
yet is practised fairly widely and would be one area that research
should look at and prove conclusively, once and for all, whether
it is useful or not. There is clearly the mechanism and the framework
within the United Kingdom to establish research studies for unproven
technologies or new technologies, and that should be the framework
that should apply to new developments in this area.
Q1183 Dr Turner: At the moment, the
HFEA has to rule on proposals for new treatments for research.
Do you think this is satisfactory? Do you think it should be done
by a separate body from the day-to-day regulatory body and, if
so, how would you like to see it set up?
Professor Templeton: The approval
of research, I think, has been a reasonably satisfactory process
and has permitted embryo research within this country. I think
the rate-limiting factors, to a great extent, have been just the
nature of the treatment, the lack of embryos to research on and
the funding to do it. Within the HFEA framework the capacity to
do the research has not been inhibited by the legislation, in
my view. Where there is a problem has been where research moves
into clinical practice and where clinical practice then is still
in the realm of research. A good example is cytoplasmic transfer,
which means taking a bit from a healthy egg and putting it into
a so-called unhealthy egg. That was actually carried out quite
extensively in several clinics, although not many, in the US without
any form of regulation, without evidence of safety and without
any evidence of efficacy and, in my view, was something that should
have been regulated at that stage prior to being offered to patients
who, by and large, were paying for treatment that was both unsafe
and inefficacious. However, that is the nature of medicine and
the way it is delivered in the United States, to a great extent.
I think there needs to be, alongside the research processes, processes
for clinical trials and here they should really be not on the
inhibitory side but encouraging clinical trials. Last week, of
course, the MRC/HFEA report very much suggested that we do need
to get going with multi-centred clinical trials in this country.
So I think that the mechanism can be set up in the same way as
for research but more encouraging for clinical trials.
Q1184 Dr Turner: Do you think it
would be useful to use local research ethics committees for the
purpose of judging embryo research proposals, provided they were
suitably beefed up, or do you think the public would distrust
that?
Professor Templeton: My own view
is that provided the ethics committee knows what is permitted
within the legislation it is perfectly appropriate for the local
ethics committee to proceed in the same way they would for any
other clinical trial, or research.
Q1185 Paul Farrelly: I just wanted
to move on to the issue of the welfare of the child. This is really,
given the evidence, a question for the two professors but, please,
Dr Kennedy, if you want to come in. The Royal College says that
the current welfare of the child provisions should be replaced
by guidance to ensure that the child is not born into a family
where there are reasons to believe it will be at risk. How do
you envisage that working in practice?
Professor Templeton: It is good
medical practice. I am talking here about a patient who needs
IVF or donor insemination, or whatever, within the law—therefore
it is the welfare of the child—but I may well be seeing
another patient who is requesting some other form of fertility
treatment, and it is good medical practice to ensure that the
treatment we are offering is appropriate to those patients' conditions.
I do not actually see that there is a need for specific welfare
of the child issues within any act; it is good medical practice.
The welfare of the child recommendations came about because of
concerns, at that time, of single women having children through
assisted reproduction. We actually agreed it is without brackets
"the need for a father". That became hugely distorted
into an attempt to try and pick and choose which patients were
appropriate to be treated on the basis of the welfare of the child,
and the outcome of the treatment, and it has been one of the major
distractions. I said there were one or two rough edges and irritations,
and that has been one of them. It has been a distortion of clinical
practice; it has been absolutely beyond any effect at all in terms
of trying to enhance the welfare of the child. All the time it
was going on, of course, we were having multiple births—triplet
births and so on—around the country, and if you want to
talk about the welfare of the child start talking about 28-weekers
being born in triplet births. So it was a complete distortion
of HFEA priorities.
Q1186 Paul Farrelly: That is the
first part of the question. The second part is how do you see
guidance working?
Professor Templeton: It is good
medical practice. I do not think you need guidance. Why would
you need guidance to try and make a decision? It is the same issue
as whether you treat an HIV-positive patient or you have two patients
who happen to be heroin addicts and whether you should treat those
within your clinic. That is the discussion you have. You cannot
generalise; it is good medical practice to take a decision about
the appropriateness of treatment in any given circumstance.
Q1187 Paul Farrelly: So someone,
for example, who was on the Home Office register of (let us put
sexual offenders to one side) violent offenders would be a relevant
consideration?
Professor Templeton: It certainly
would be a relevant consideration, in my view. Of course, the
responsibility is to try and find out if, indeed, that history
exists in a particular circumstance.
Q1188 Dr Harris: I would like to
explore this good medical practice. I understand what you say
about the welfare of the child, and thank you for being so clear,
but I would like to explore the difference (I was not here earlier
but I read your evidence) in approach between infertile and fertile
couples in respect of allowing them to breed, from an ethical
point of view. What you are saying is it is good medical practice
for a doctor to come along and say, "We are not going to
let you have a child, though we are not going to sterilise you
if you happen not to be infertile, but we are going to use our
subjective judgment" (and it may not be someone as progressive
and liberal-minded as you; it might be some old, crusty gynaecology
professor—I understand some still exist—
Professor Templeton: There are
a few!
Q1189 Dr Harris: Is that good medical
practice or is that just the application of prejudice in a sort
of paternalistic way, not even to the patient in front of you
but to some future person?
Professor Templeton: The application
of prejudice in a paternalistic way is not good medical practice.
Chairman: Did you miss that in your training?
Q1190 Dr Harris: You have just said
there are HIV-positive issues, for example, or heroin addicts.
Let us take a doctor who is a heroin addict, and there are many
around. What you are saying is that there are two options: to
say, "We are going to treat you as a patient; we are going
to give you education, information and offer you treatment, and
urge you to take that treatment. You have these questions about
your fertility, we are not going to stop you from trying to conceive
naturally", but instead of taking the approach "I am
going to inform social services because there are issues for the
child" you are going to make the decision to deny treatment
to that person. That is the example you used. I would like to
ask Dr Kennedy as well for his view.
Professor Templeton: I might.
Having discussed that, a good medical practice view, with everybody
who could possibly be involved in such a decision you would, particularly,
obviously, want to discuss it with the patients. It may be that,
from time to time, your view would be that it would be inappropriate
from the point of view of the child to treat that couple. It may
be. It obviously is a difficult area, and I do not think it is
going to be helped by guidelines or legislation, because they
cannot legislate or produce guidelines for every clinical situation;
there are principles which are laid down in good medical practice,
which I would follow in reaching such a decision. Because this
patient is infertile and seeking assisted reproduction treatment
does not make the approach any different from, perhaps, seeing
an ante-natal patient who happens to be a heroin addict and alerting
the services and discussing her management with those who can
best support that management. It is exactly the same decision,
exactly the same process.
Dr Kennedy: Yes, I agree with
that. I do not think you need to regulate for it specifically.
As a doctor, when you discuss with the patient, in the consultation
process, the wider implications of whatever it is you are advising
or about to undertake for that patient, those wider implications
will include the consequences of the treatment, the child that
may be born and the background of the person who is seeking treatment.
This is part of the normal consultation process. If that involves
accessing information from social services or asking the patient
if we can access information then so be it, you do so. If it requires
additional help to make that decision, then you invoke that additional
help, but it does not need regulation to ensure that you conduct
that practice. The other issue here is the bureaucratic process
which is currently applied in the implementation of the welfare
of the child assessment.
Q1191 Dr Harris: We have heard plenty
of evidence on that. So what you are saying is that you would
be happy for some of your colleagues to deny treatment to a man
who is a heroin addict where the mother was not, and for some
of your colleagues not to (because they might think that) but
to notify social services around an at-risk assessment, and you
would be happy with two different approaches being taken by different
people with a different background and different medical perspective,
because you do not support guidelines, and you think as long as
they are acting in the interests of society—
Dr Kennedy: I did not say we did
not support guidelines. There have to be guidelines to undertake
good medical practice—of course there have to be guidelines.
That would require you to take account of certain issues and certain
considerations before you make your decision about offering treatment.[1]
Professor Templeton: You make
the assumption, if I may, that the guidelines would actually prevent
what you have just said, and there is no evidence to suggest that
you might not treat appropriately one patient quite differently
from another patient in that patient's circumstances—something
the guidelines could not even begin to help you with.
Q1192 Dr Harris: If there was a human
rights claim, for example, by a lesbian couple, then guidelines,
I would imagine, would swiftly follow to say it is unlawful, if
there had been a successful claim, as people think there would
be if there was a claim. So some of your colleagues to whom we
have spoken who refuse on their own moral grounds to treat lesbian
couples would be out-with their terms—
Professor Templeton: It is just
the same as some doctors refusing to do abortions.
Q1193 Dr Harris: I am not convinced
that there would be a conscience option when there is a human
rights claim that you are suffering discrimination and the NHS
says, "We will not discriminate—"
Professor Templeton: You have
a human rights issue; if you are doing something against your
conscience then the proper way of dealing with that is to pass
it to another doctor. That, again, is good medical practice. That
is enshrined in that code.
Q1194 Dr Harris: One more point here.
Is an alternative to this welfare of the child provision and,
indeed, some guidelines about good medical practice to say that
we are not going to discriminate against the infertile, as we
do in practice, effectively, by denying them reproductive freedom,
for whatever reason, but we are going to say that—
Professor Templeton: Or, more
particularly, denying them funded treatment.
Q1195 Dr Harris: So denying the poor
infertile from access to reproductive freedom (which I think adds
to the strength of my argument because there is an equity issue
as well as a human rights issue) and, instead, say "Look,
at least we now know what is going on and we have the option of
ensuring that social services are there at the birth so they can
make a risk assessment and, if necessary, intervene, but we are
not going to do it in a prior way." Do you think that is
a reasonable approach in cases where there is a history of domestic
violence, for example, or there is a drug addiction issue? Is
that an alternative approach? Do you see merits in that?
Professor Templeton: Do you mean
that the guidelines would say that, or do you mean—?
Q1196 Dr Harris: The system would
be that there would be a presumption of non-discrimination against
the infertile, because if they are fertile and there is domestic
violence or heroin addiction they can breed, and you do not know
there is the risk, whereas here, at least, you know there is the
risk and you can bring in social services at the birth.
Professor Templeton: I would be
very happy if that steer, which is all that we are saying here,
was enshrined in the legislation, yes.
Q1197 Dr Harris: Finally, if the
welfare of the child issue around multiple embryo transfer is
so obvious why did it take so long?
Professor Templeton: Do not ask
me. I have been writing about it since 1995. The RCOG guideline
in 1998 recommended two embryos, and the BFS guidelines at that
time. It has taken until two years ago for the HFEA to catch up
with what was recommended clinical practice. In Scandinavia now,
in many clinics, 60% of the embryos are put back one at a time,
with no apparent reduction, as that table that has just been passed
round shows, in the overall pregnancy rates. So I think it is
a big issue and I think we have to ask ourselves why it did not
happen more quickly. Certainly the HTA could have made it happen
more quickly but I think they were very concerned about legal
challenges; they were very concerned that there was a society
view out there that patients were willing to take the risk. That
was quite erroneous, in my view but, nonetheless, is part of the
reason for this slowness in their eventually making their pregnancy—
Q1198 Dr Harris: I see Dr Kennedy
nodding, for the record.
Dr Kennedy: For the record.
Q1199 Paul Farrelly: Has Professor
Regan been nodding as well?
Professor Regan: Yes, she has.
I think it might be useful to add as well that one of the delays
in introducing this legislation is that there has been an enormous
drive from the private funding sector in the sense of what they
have wanted. Whether that is in the remit of this Committee or
not, I think it is important to look at this issue and keep that
context in mind.
1 Note by the witness: My views about the legislation
governing the Welfare of the Child and of the British Fertility
Society are very similar to those of Allan Templeton in that we
believe its assessment is enshrined in good medical practice.
It is helpful for guidelines to draw attention to its need and
how clinics might construct protocols for its assessment, however
it does not require legislation. Our major concern is to eliminate
the bureaucracy that this element of the legislation gives rise
to. Back
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