Examination of Witnesses (Questions 1111
- 1119)
WEDNESDAY 24 NOVEMBER 2004
PROFESSOR ROGER
PEDERSEN, PROFESSOR
ALISON MURDOCH
AND DR
ROBIN LOVELL-BADGE
Q1111 Chairman: Can I welcome you
all. You have been sitting through the first part and enjoying
the attempt to define some arenas of the activity which quite
clearly did not bother the last group too much but we will be
asking you questions about other issues as well and I am very
pleased that you have found time to come and talk to us. You know
how important this inquiry is and how organisations are getting
to grips with these problems now. I am going to start off with
the first question. Roger Pederson, I want to get you on line
really because we have talked about this in the past. As the man
who came from California to undertake stem cell research, you
missed Arnie Schwarzenegger and his amazing success over there
in the votes and so on in the Presidential Election and his undertaking
to conduct stem cells research. Do you regret that now? Would
you go back to San Francisco and engage there with them with the
multi-million dollars that they are going to throw at this or
do you think you are doing the right thing and are we doing enough,
are we doing the right thing, or are we just playing at it in
this country? I want to get you on record.
Professor Pedersen: It is an honour
to be here and a privilege and I feel very special being a Californian
Yankee in Queen Elizabeth's Court. Thank you for that opportunity.
What I would say is that I came here for a very specific reason
which was to accelerate research on stem cells to reach the patient
community at the earliest possible date. I came here because it
was clear to me at that juncture that the UK was the best place
in the world to accomplish this. I have been asked numerous times
why I reached that decision and it is very clear in my mind that
the primary reason for the UK's past success and the potential
future success rests on the foundation of public policy developments
that have been made as a result of hard work on the part of many
people including people in this room. That public policy was of
course inspired by the success in in vitro fertilisation
in Professor Edwards's hands some 25 years ago. So, there is a
tradition really of successful public policy development in the
UK that is unparalleled anywhere else including California. So,
the simple answer is that I would not hear of going back to California
where there is a mismatch between the initiative in California
and the countrywide hostility towards stem cell research.
Q1112 Chairman: The second part,
Roger and Alison, and Robin can join in this too, is, what more
do we need to do in this country to stay ahead of the game, as
it were, to be upfront, to have that attractive value, to bring
more Roger Pedersens over, not just from the States but from elsewhere
in the world of course?
Professor Pedersen: Thank you
for that compliment. What I would say, if I may use vernacular
with which I am familiar, is, if it ain't broke, don't fix it.
I think that the HFEA works and that it is a huge part of the
engine that drives forward stem cell research obviously insofar
as it is related to embryo research in this kingdom. I think the
important thing to do is to not dismantle or not provide a target
for diminishing the effectiveness of the HFEA by opening up the
doors to changes that might diminish its effectiveness. I think
on the whole, at least in the timeframe that I have observed it
closely, it has been incredibly effective. Obviously there are
other things that need to be done. The HFEA in itself is not a
sufficient cause for success in the stem cell field and I think
that further public policy developments need to be undertaken,
for which I compliment you and your Committee. I think this is
an extraordinarily important role because what needs to be done
is to look forward at the ethical, legal and social issues that
are going to be brought out on to the table as a result of the
progress of the technology and not stay mired in the issue of
moral status of early human embryo. That is not the only issue
and we will be blindsided by other issues that will come as a
result of the progress in technology. I think there are other
issues that need to be addressed such as long-term funding and
the commitment to that, but that is a separate issue from regulatory
issues.
Q1113 Chairman: When will we move
into the clinic, as it were, in your opinion? When will we be
treating Parkinson's, Alzheimer's or whatever because those were
basically the hard-line reasons that it got through Parliament
and are we moving into that position? Are we up for that? Are
we organised enough to do that?
Professor Pedersen: I think that,
in terms of your responsibilities for the public trust and the
public welfare, you should be prepared for the risk, if I might
state it that way, that the field will be ready to go to first
inpatient work within five years which means that a lot of work
needs to be done starting right now to consider the impact of
that clinical undertaking in terms of distributive justice of
the technologies—is it really going to be for everybody
or is it just going to be available for the wealthy few?—in
terms of the safety of the technique and in terms of the equitability
of the choice of the diseases on which we focus, and I would focus
on Parkinson's probably and have a treatment within five years.
Professor Murdoch: I think the
first obvious answer to your question about where we go now is
money and I think that is probably not the remit of this Committee,
so I will stick to the issues that relate to regulation. Despite
any negative things that I might have to say about the authority,
I think the fact that we have an act that regulates IVF treatment
and research in embryos in the UK is the single most important
reason why we have taken a lead worldwide in terms of stem cell
particularly and, if you look at the situation in America, it
is not just stem cell regulation, it is the fact that the IVF
clinics are not regulated in the same way that we are regulated
and do not have that structure of control that has slowed things
down and still slows things down in America. Just putting money
into California is not going to get them necessarily the answers
that they need. So, the need for strong regulation in terms of
the use of the embryos to generate stem cells is important and
has to continue. I think there is an important issue in terms
of perhaps slowing down what might regulate the progress in terms
of embryonic stem cells work which is if the current IVF regulation
then goes on into regulating stem cells. Once you have an embryonic
stem cell line, the whole process of then what goes on in the
laboratory in terms of developing it, differentiating it and using
it. We have to be very careful that we do not tie down that research
into a regulatory process. If you put that part of the regulation
into the hands of the HFEA, into the hands of requiring ethics
committees for each individual study that is done in the lab,
then I think we will slow things down in the UK in a big way.
So, we have to find some way of identifying that an embryo has
a certain specific identity that has to be given certain respect
but, once it becomes a stem cell line, even though it is called
an embryonic stem cell line, it has actually changed, it is not
the same thing and does not require the same strict regulatory
processes that we have now. There are other ethical committees
that can look at regulating that in a way that is more appropriate.
Dr Lovell-Badge: I have very little
to add. I think the attraction of the amount of money in California
is certainly going to bring some people there. They are actively
trying to recruit people and the amount of money is actually enormous.
Q1114 Chairman: Do you think we could
lose out to them?
Dr Lovell-Badge: We could well
lose some people to them simply because of the attraction of the
money. That is an issue. Otherwise, I agree, I think it is far
better to do this sort of research in an environment where you
have backing from all sides and good regulation and I absolutely
agree with Alison, I think it would be a big mistake to have work
done in vitro in embryonic stem cells subject to any regulation
apart from perhaps a local one.
Q1115 Mr Key: Could we look at the
awarding of research licences. In the 2001 regulations that Parliament
has produced, it extended the purposes of research to include
knowledge about the development of embryos, knowledge about serious
disease and to enable such knowledge to be applied. Do you think
that those regulations are adequate or should they be extended
in some way?
Professor Murdoch: I think they
are adequate at the moment but they are in the process of being
tested through the courts and I am not sure that it is the time
now that we should be thinking about going back and looking at
them.
Q1116 Mr Key: We are going back and
looking at them whether we like it or not. That is why we are
here.
Professor Murdoch: I have a particular
difficulty in that the particular licence we have is now going
to judicial review which rather limits what I can say to the Committee
here.
Q1117 Mr Key: We understand that.
Would anyone else like to add to that?
Dr Lovell-Badge: I think as always
it comes to where you draw the boundaries as to what is clear.
You were having this debate earlier about whether being infertile
is sufficient justification to, for example, use embryonic stem
cells to make germ cells.
Q1118 Mr Key: Professor Pederson
has given a five-year timeframe for some of this work. How should
we regulate clinical trials in the future because we are only
going to get an opportunity for an act like this maybe once every
15 years? We have to look ahead. How do we need to regulate clinical
trials?
Professor Murdoch: Clinical trials
are already regulated. There are already considerable procedures
that we have to go through. If I wanted to introduce a new drug
into my clinical practice, there are various processes that I
go through. If it is a drug that has been tried and tested, I
would go to my Trust, I would go to the Drugs and Therapeutics
Committee; I would give them the evidence to show that it was
better than the existing and was cost effective and would be introduced
into clinical practice. If it were a new drug, I would go through
phase one, phase two and phase three so as to do it; it would
go to Ethics Committee and patients would be informed and it would
be appropriately funded. In terms of introducing clinical trials,
I do not see any need to introduce any different model.
Q1119 Mr Key: Are we all agreed?
Does anyone have any concerns about the EU Tissue Directive and
do you think that will have an effect on human stem cell research?
Professor Murdoch: I have lots
of views about the EU Tissue Directive. I think overall it is
going to require an improvement in the quality system in terms
of IVF laboratories and how they are run and, in that respect,
the professional societies are supportive of anything that would
improve quality. I think it is still going through the discussion
process to make absolutely sure that the processes that are going
to be required under the Directive are not so rigorous that actually
it effectively stops the practice because theoretically it could
do that. Overall, I think it is going to be an improvement on
clinical service because, if you are talking about generating
new embryos, the better quality embryos you have, the better the
treatment will be and, the more effective it will be, the more
likely it will be to be able to have patients coming through for
treatment, the better embryos we will have that will be donated
to research and the better stem cell research we will have. So,
it will follow on. A good IVF unit is the one that is going to
be working for the stem cell generation, not the bad IVF unit.
Dr Lovell-Badge: I agree with
that and I think it is very important. I am looking into some
of this. I do not work directly on human material at all but,
looking into some things that go on in different places, you see
in IVF widely different rates of success, different rates of success
of growing embryos, to blastocyst stages, and I think anything
that can be done to improve the overall success rates of all the
methods being used . . .
| 
