Examination of Witnesses (Questions 1220
- 1232)
WEDNESDAY 8 DECEMBER 2004
DR RICHARD
KENNEDY, PROFESSOR
ALLAN TEMPLETON
AND PROFESSOR
LESLEY REGAN
Q1220 Dr Harris: You are not answering
my question. My question was: do you think there was evidential
development in the safety of PGD for the embryo produced between
the first decision on the Whittakers and the decision on the Northern
Ireland family where they changed their mind? Or are you not qualified
to answer?
Professor Templeton: I think I
am not qualified to answer. I perfectly understand the question.
Q1221 Dr Harris: Can I ask you a
general question, then? Should the precautionary principle be
that these things should not be allowed until someone else in
the world shows they are safe, or should things be allowed—if
there is good reason to do them, obviously—unless there
is evidence that it is unsafe? How would you like to see us approach
that?
Professor Templeton: You cannot
generalise about it. If we are talking about safety in relation
to the welfare of the child, the fact that that child may have
to live with something for the rest of its life, then that is
a different dimension of decision making.
Q1222 Chairman: What good would guidelines
be, then, if you are making an individual basis?
Professor Templeton: That is what
I was saying previously. I think within the legislative framework
you have to allow the policy-making body to dissect out and try
and discuss these things, reflect what the view of society is,
what the need is within society for this particular advance and
then to weigh up safety and efficacy.
Q1223 Dr Harris: There are two different
approaches and they do not merge together; PGD is a good example,
particularly when, as in the Whittaker case and the Ashby case,
there is another child whose welfare might be considered. Should
the precautionary principle operate, in your view, to say that
we should not go ahead for the good reason of therapy for the
other child until we are more certain that something is safe,
or if there is no evidence that it is unsafe should we allow proceeding
cautiously, collecting the evidence, database, follow-up and all
of that? I think that is two options.
Professor Templeton: Yes.
Q1224 Dr Harris: The public say they
want a precautionary approach, but I say which one? What do you
think?
Professor Templeton: There are
two options but you are talking about two different approaches
and I do not think life is like that. You take each case as it
comes along and you weigh up the relative risks. For example—again
coming back to cytoplasmic donation—there is no evidence
that that is unsafe, but there is a lot of circumstantial evidence
that it could be unsafe, and if it is unsafe it might have disastrous
effects on your children. For that reason, certainly, I took the
view—and still do—that it would inappropriate to allow
this to happen while there is evidence that it might be unsafe,
and certainly there is evidence that it would not do a lot of
good. It is the safety issue.
Q1225 Dr Harris: So you do more animal
work, but at some point someone has got to start.
Professor Templeton: Indeed, and
it is exactly the same issue with egg freezing; that has been
part of the issue: low success rates and safety and trying to
weigh up when you think it is reasonable to promote that in clinical
practice. I do not think guidelines and legislation in this particular
area of ethical decisions about the appropriateness of treatment
in individual family circumstances is going to be helpful.
Q1226 Dr Harris: Has anyone got a
different view on the question I asked, Dr Kennedy, Professor
Regan?
Dr Kennedy: No.
Q1227 Dr Harris: Can I ask you finally,
Dr Kennedy, you are an inspector and there are inspectors who
are involved in running clinics in competition with other clinics.
I am sure you are full of integrity but there is perception among
the inspected, and perhaps among those looking on, that you have
a vested interest in knocking out the competition, particularly
in respect of some techniques that might put them above you in
a league table, regardless of whether you are NHS or private yourself—presumably
private clinics also provide inspectors Do you think that is an
appropriate way forward and would you like to see that changed
to a more seen-to-be independent inspection approach?
Dr Kennedy: The general observation
would be that the inspection process is rather too soft. There
is a process to allow declaration of interest, but in answer to
your question I think there should be a professional inspectorate
which does not necessarily take from those involved in current
clinical practice, so there is an independent professional inspectorate
which inspects clinics and can do so completely objectively, and
has the teeth to say this is right, this is wrong, this is what
you have to put right.
Professor Regan: Although you
could add at that point that if you have individuals who are independent
of clinical practice at the present time, are they the best individuals
to be inspecting clinics?
Dr Kennedy: If you have a professional
inspectorate I think you overcome that because you appoint professional
inspectors.
Q1228 Chairman: The last question—just
briefly, because then we have to go to Prime Minister's Questions—is
on clinical trials. Are you happy with the state of them in this
country, that they are well-funded or what? You have put a lot
on evidence and without clinical trials there is no evidence.
Are we playing at it or is there a real investment and concern
about developing clinical trials?
Professor Templeton: It is difficult,
but the opportunities are there. I know, perhaps, of three that
have gone to the MRC and have been turned down. I know that the
NPU recently have put in a proposal to the MRC to set up a clinical
trials centre, if you like, which has been turned down, and it
is always difficult to know if the reason is the quality of the
science or if there is a genuine bias against doing such trials.
I am involved in two multi-centre trials that are appropriately
funded; they are multi-centred, they do show good collaboration
among the various centres in this country and that is a way forward.
Perhaps we need to encourage the MRC to look again at some of
the proposals that have come forward.
Q1229 Chairman: Professor Regan,
have you a point to make?
Professor Regan: Yes, we do need
more trials, particularly on the points I was making earlier,
not just on the IVF treatment cycle but on the adjunctive therapies
that are being offered. I think it is important to emphasise as
well that unless we get more funding of the trials it is going
to be progressively more difficult to recruit these patients and
their clinicians to encourage those patients to go into trials.
Many of them will say "I want to try this treatment anyway,
I am prepared to take the risk because it might help me."
It is very different when you are wishing to avail yourself of
a treatment that may possibly help you achieve your live take-home
baby from discussing the TNF alpha drug which may or may not be
prescribed for your rheumatism.
Q1230 Dr Harris: Why not a levy on
private clinics that they could pass on to the patient that could
contribute to NHS patient research? Should the private sector
contribute?
Professor Regan: Yes.
Professor Templeton: Do you mean
financially or by contributing patients?
Q1231 Dr Harris: They can pass it
on, obviously, to patients.
Professor Templeton: The costs
of the research?
Dr Kennedy: The licence fee that
currently is applied to patients throughout the UK for licensed
treatments, you could divert that into research. That would be
a very useful use of a licence fee.
Dr Harris: Good idea.
Q1232 Chairman: Thank you very much
for coming and giving us your views and professional judgments
and so on, it has been very helpful. Our report will finish some
time early next year after we have seen the Minister and the Human
Fertilisation and Embryology Authority, for both of whom we will
have many questions to ask; you have helped us with that, thank
you very much indeed.
Professor Templeton: Thank you.
| 
