Examination of Witnesses (Questions 460
- 474)
WEDNESDAY 16 JULY 2008
Professor Sir John Bell and Professor Sir Alex Markham
Q460 Chairman:
We do not know why.
Professor Sir Alex Markham: We do not know why.
In a world where NIH funding of grants is currently running at,
I believe, 8 per cent of applications, I do wonder whether spending
$1 billion on what was proposed for that body in the United States
is going to materialise. They talk a good game but we have yet
to see the fruits of it. I think we are starting to see a few
cracks in it. I deal with quite a few of the American organisations
and organisations like the major suppliers, Kaiser Permanente
and so on, have very impressive data sets on their customers,
mostly of course driven by the need to send them a bill. You cannot
send somebody a bill unless you have pretty good records of what
you did to them. In the UK, because of some of the changes in
the way the NHS is funded, we have fantastic records about many
aspects of how we pay for care. We have superb data now about
waiting times for treatment in the NHS, which is very interesting.
I do not think we need another body for me to persuade about the
ethics of what I am trying to do. We can do these things with
the structures we already have quite effectively.
Professor Sir John Bell: You need to look at
where we are in this field. I have huge respect for Francis and
what he has done at the NIH but the reality is that, in terms
of delivery, our structures deliver considerably more. We had
an equal share of the sequencing of the genome, thanks to the
Wellcome Trust. The Wellcome case control consortium is a million
miles better than anything. If you look at the new genome sequencing
methodologies and technologies, one was invented in the UK and
the other was invented in Scandinavia. They were not invented
in America. I can tell you, because I have just met with them,
they would die to have a Biobank project. They do not have one
and they are not going to get one. I think we are doing pretty
well. I would be very concerned about upsetting the apple cart.
Q461 Lord Broers:
We have heard in evidence that the storage, transfer and interpretation
of genetic tests requires sophisticated IT systems and expertise
in bioinformatics. Will present IT systems and expertise need
to be expanded? If so, how should this be done? How should it
be funded and what are the priorities?
Professor Sir John Bell: I will first of all
refer to Alex's very positive comments about the Connecting for
Health programme which I think are going to take us into a new
era as it relates to research activities. Even research labs that
have a hold of the new sequencing technologies are finding it
almost impossible to manage the data. We have only just begun.
We have not really used it in earnest for epigenetic analysis
or across large populations. There are two problems. One is that
there is a hardware issue about having the kit to store the information
on. There is also a human capacity problem. Despite the fact that
we all sat around 15 years ago and said that the really crucial
thing to train in the UK will be bio-informaticians—people
who can handle data—the truth is we have now hit the wall
in terms of data handling and management. We do not have that
cadre of people. We are in real trouble and I am not quite sure
how we get from where we are now to where we need to be, but there
does need to be a much more concerted and systematic approach
to making sure that bright young people are brought into this
arena and trained up at a variety of different levels. That is
something that we will be discussing at OSCHR in relation to the
human capital programme because it is a really serious problem.
Q462 Lord Broers:
Have the key industrial players been talked to or involved? People
at Google or even small companies in this country like Autonomy
have people with phenomenal skills using absolutely vast volumes
of data and searching through them in a very sophisticated way.
Professor Sir John Bell: I have not directly
approached people but I know Google has been involved in discussions
at the Department of Health. That, it seemed to me, was a very
welcome interaction. You are absolutely right. Google does have
capabilities for dealing with that kind of data in a way that
many of the public sector participants probably do not. There
is expertise out there but I suspect that, taking some of the
technical aspects of churn through very large amounts of little
bitsy sequence data, getting it all to align and getting the information
you want out of it, I still think we are going to be overwhelmed
by a wave of data. I think that remains a big problem.
Q463 Lord Broers:
Do you think in the long run it is going to be possible to combine
personal health care records with genetic data?
Professor Sir Alex Markham: Yes. Right now,
in the first phase of the pilot studies for our NHS Research Capability
programme, we are working with Biobank to link the Biobank data
with data that currently they do not have. For example, at the
moment Biobank is not linked to the death records in the UK. That
is job one in our set of pilot studies. Biobank is not linked
to hospital episode statistics, HES data so-called, which is an
incredibly rich source of data from the hospital sector. Biobank
is not linked formally to GP research databases, so we are going
to be linking Biobank to GPRD and others. There are some interesting
challenges that we are going to take on in very short order there.
Can we combine that with the tidal wave of genetics information
that John and I have mentioned? Yes, I think we can, because in
the governance process of this programme, which is overseen by
an OSCHR committee, some of the key members of that are the likes
of the senior scientists at the Sanger Centre who are, I guess,
the world leaders in dealing with massive amounts of genomic information.
We have representatives from the European Bio-informatics Institute
in Cambridge, who are world leaders in pulling together bio-informatics
information of every kind including the sorts of things that you
get in the public literature. We have the British Library involved
in the process to bring their expertise to bear in how to align
published information to make sure that links into these databases.
All the time, how do you keep out wicked people who would want
to do something mischievous with people's confidential material?
How do we keep the firewalls up? Yes, it is a problem. Yes, through
OSCHR, we have right at the front of our minds the need in training
the so-called human capital programmes to make sure that this
agenda gets fed with the sort of workforce it is going to need.
Is the UK in a place where we are miles behind the rest of the
world and on the starting blocks without any planning in place?
No, I do not think we are. I think we are in reasonably good shape.
Q464 Lord Krebs:
Can I go back to your comments on bio-informatics? You said that
there had been a discussion about a decade ago to recruit more
people to this field. What went wrong with that?
Professor Sir John Bell: It was one of those
things that everybody said because everybody realised they would
look clever if they said it, but nobody did anything about it.
Everybody nodded wisely and then nothing happened. I cannot think
of any significant, single initiative that produced even a dozen.
People recruited a few of those interested in IT and computing
but I do not think there has been a systematic push to generate
a whole new generation of people who have those various sets of
skills. It has happened a bit but it certainly has not happened
in a systematic way. Nobody really grabbed it. OSCHR is very cognisant
of the fact that we do have a capacity programme and we will be
working together with the two big agencies to see how they propose
to deal with these problems.
Q465 Lord Warner:
Can I ask about the National Programme for IT? My scars have now
healed in this particular area. One of the intractable problems
of that which is very relevant to this inquiry is the electronic
patient record. That has been bedevilled by a couple of problems.
One is the issue of people giving consent to their records actually
going on the system in the first place. The other has been the
wish of many people in the National Health Service to have their
own version of the electronic patient record. This is largely
clinically led. The problem of standardisation, which helps the
kind of research that you enjoy that Alex and John have been talking
about, is under threat to some extent perversely from within the
health professions themselves. What is your advice on this issue
of consent and standardisation around the electronic patient record,
to make the best use of the emerging amount of genetic data?
Professor Sir Alex Markham: If you ever require
me to come and rub some salving balm on your wounds, I would be
willing to. The problems you highlight are very real ones. As
a complete newcomer to this whole world, I have been pleasantly
surprised by how effectively primary care has adopted e-health
records. To my utter amazement, effectively 100 per cent of NHS
patients in primary care have their records held electronically.
Those systems are supplied by three separate commercial suppliers.
One has 60 per cent of the market; one has 20 and the other has
20. Of those three data sources, the 60 per cent market leader
is available for research purposes because it will provide completely
anonymised data. That is done through a body called Q Research
within the University of Nottingham. One of the 20 per cent suppliers
supplies the GP research database, which is run by the MHRA, a
government body. That can provide pseudonymised data so that if
there is ever a need to go back to the patients that can be done
through GPs. The other supplier is involved in research activities
in a slightly more fragmented way. Primary care is in good shape.
The problem you allude to for the hospital sector is very severe,
but the first pilot studies for the care record are now ongoing.
I believe there is one into the Somerset/Avon region which is
going very well. The other one is the whole north Manchester,
Bolton, Blackburn, Burnley, Bury conurbation, which is running
an electronic hospital record. Again, that sounds as if it has
been very successful. There is a huge amount of work that has
gone on led by the Royal College of Physicians. Professor John
Williams from Wales has been at the heart of that, developing
the template for an electronic case patient recording. What does
a doctor have to tap into the computer for each patient and agreeing
the sorts of descriptors like snowmen that will be used for that.
It is at quite an advanced stage. Although the scars from NPFIT
and the people who have been close to it, I am sure, are still
there, I am now on the board of the National Programme for IT.
I went along to the first board meetings expecting to go to something
that was in a state of melt down and actually I found it an extremely
well managed programme. I have worked in some very well run organisations
in my time and I have not seen a better one than the National
Programme for IT right now, which astonished me. If there is one
lesson to learn, it is that the National Programme for IT and
the Department of Health have a lot to learn about telling the
British public just what a great job they do. I think we are missing
a huge trick nationally because that would provide people with
an enormous level of reassurance that what they are being asked
to participate in is not some disaster waiting to happen but is
really something that we can take an enormous amount of pride
in as a nation. I think we are on track to introduce the electronic
patient record. Yes, I am sure it is four years late. Yes, I am
sure there have been all sorts of problems along the way but we
are introducing one of the biggest IT schemes ever in the history
of the world. You only have to look at how quickly IT changes
and how ridiculous it makes you look when today's IT insoluble
problem is tomorrow's trivial issue. I think we can be very pleased
with where we are with the National Programme for IT and I would
be very optimistic about it. The roll out nationally I think should
go ahead in a measured way. There was a bit of a furore in the
press again a month ago when Fujitsu were ejected from the programme.
The immediate response to that was that the National Programme
had screwed up again and Fujitsu are walking away from it. The
truth of the matter was that the government body got rid of a
supplier that could not deliver and took a very serious line on
not wasting public money. NPFIT needs to hire a decent media team
frankly because we have a great story to tell.
Q466 Chairman:
That is a rare endorsement for national IT.
Professor Sir Alex Markham: Yes, but why does
not everybody say that?
Q467 Baroness Finlay of Llandaff:
Can I change the area a little towards education and training?
Given that it seems likely that there will be growth in medical
genetic tests and health care professionals maybe applying these,
do you think that medical genetics need to be expanded to meet
this need or do you think it should be training across other health
care professionals so that they have education in genetics? Linked
to that, if it was, would that be mainly confined to secondary
care or would it be general practitioners as well or would it
be beyond medicine?
Professor Sir John Bell: This is not a domain
for medical geneticists any more. Some of the examples we have
given you today show clearly how it is going to permeate all areas
of therapeutics and most specialties. As a result, I think it
has to be part of the core knowledge base that all doctors have,
none more so than general practitioners. The patient will come
to the general practitioner and it will all have to be explained
in that environment. The results will have to emanate down to
that level. They are going to have to start to understand this.
If you say to me, "How far are we along that road?"
we are not very far at all. In medical school curricula in some
of our most distinguished academic centres have precious little
of this. I think people have not realised quite how rapidly some
of this technology is now descending on us. It has important implications
but it has implications much wider than that within the NHS. For
example, we probably have 1,000, maybe 2,000, cyto-geneticists.
We have a variety of cyto-pathologists. There may be 3,000 or
4,000 people in the NHS who are doing jobs today that, within
a very few years, may be completely redundant. How do you take
those people and retrain that workforce? What you do not want
to do is run to the end and say, "Oh well, now we are going
to have to hire a lot of other people." You have to think
about how you can take that workforce and get them used to doing
something else. There is a real workforce training issue that
needs to be thought through aggressively now, because if you start
a process like that it is going to take a number of years to get
to the end. You want to embrace these people and move their skills
to where they need to be five years from now, it seems to me.
It covers not just the medical profession but a lot of these paramedical
areas as well.
Q468 Baroness Finlay of Llandaff:
We are talking about laboratory scientists. What about nurses,
because there is almost nothing in nursing at the moment.
Professor Sir John Bell: I agree. It probably
has to be across the piece. The medical school curriculum has
not done so well either.
Q469 Baroness Finlay of Llandaff:
You said earlier that we are world leaders at the moment in developing
this technology and so on. I just wonder how you think we would
be able to maintain the economic benefit from that knowledge capital
for the UK in the long term, because these developments are happening
here. What will happen in the future in a very much share led,
banking led, type of financial world environment?
Professor Sir John Bell: I am innately an optimist.
I think it would be okay. If you ask me to explain exactly how
it will be okay, it is difficult. As a crucial ingredient you
have to have smart people. You have to resource them to do innovative,
unconstrained science. Then you have to have a structure to take
the discoveries that emerge from that and put them into some translational
mode that allows you to turn something that is useful to people
out at the far end. If you look at where we have got to through
the OSCHR process in the last few years, I think we have had a
very significant impact on transforming that landscape with the
ability to take basic discovery and trying to establish decent
structures that will facilitate it going into something that is
useful. There is a whole set of issues that makes it complicated.
There is much less risk capital around. The venture capital sector
for biotechnology in the UK is not in robust shape. The availability
of resources for small companies is limited. There is a limited
number of big players in the diagnostics industry based in the
UK so that has some issues associated with it. We need to work
our way through how we deal with those things, but the fundamentals,
which are the people, the support for discovery science and the
support for the translational component of that discovery science,
are in place.
Q470 Chairman:
Do you want to comment on education and training, Alex?
Professor Sir Alex Markham: Yes. I think it
is going to have to become a core component of the medical and
the nursing curriculum. When you teach the students this stuff,
this is what really excites them. Properly and well taught, this
is the hottest story in medicine. The fact that what we used to
be shown in a book as a big mystery, disease X, now has all these
mechanistic bases to it is incredibly stimulating. We are going
to have to incorporate this in the great scheme of things. There
was an earlier question about the whole translational research
piece here and how do we build the UK capability and commercialisation,
particularly of the more diagnostic aspects of this. It is difficult.
The UK has never had an internationally competitive diagnostics
and devices industry. I was responsible for trying to start one
in the old ICI Pharmaceuticals. Now that is an industry which
is very consolidated with a small number of international players
that make it very difficult to break into the mainstream. If UK
plc is determined to go there, the way is going to be to take
very radical approaches. It will be paradigm shifts that allow
us to get in, not trying to do the same as the big battalions
but a little better. I would like to reassure your Lordships about
the translational elements of this. In the last 12 months we have
put some funding schemes in place that are there for people to
take inventions and knock them into things that will do something
for a patient. That never has existed very well at the interface
between MRC and the NHS and NIHR before. Those schemes are in
place. The question earlier said, "We are told that there
is no funding available to do this stuff." Rubbish. The money
is there. If people are coming to the system with ideas that are
good enough, the money is there redoubled in spades, both through
that development funding pathway, through the experimental medicines
and the evaluation pathway that runs in NIHR through the technology
assessment programme. That comment is not fair. There is money
available.
Q471 Baroness O'Neill of Bengarve:
The public, as we are told, has a suspicion of genetics because
of the potential for abuse of the data and because of poor publicity
and, I suppose also, because of the case history of what happened
with the attempted introduction of genetically modified crops
in 1999. Do you think this suspicion is in any cases well placed
and, if it is or even if it is not, what can be done to allay
public mistrust and to ensure that it does not impede progress
in health care and health care research?
Professor Sir John Bell: There may be public
mistrust, but I am not sure that public mistrust is of genetics.
A lot of public mistrust relates to what might be perceived to
be the bad outcomes of misusing genetic information. The public
are very anxious about the insurance industry because everybody
relies on it for their mortgage and all the rest of it, so they
are very anxious that their genetic susceptibility or data might
be used in a way to prevent them getting access to that. They
are also anxious because, in fairness, the government has not
been perfect in protecting their data held in other settings and
preventing it reaching the public domain. We should all accept
that. It has not been the finest hour of government departments
in keeping public data private, as it were. I think they have
concerns about those things but what is interesting is that almost
all patients innately understand that health is genetic. Although
we have all these complicated tests to tell you what you are going
to die from, the truth is when most patients walk in your office
for the first time they have a view of what they are going to
die from and it is largely related to what their parents died
from. They say, "My mum died of breast cancer. My sister
died of breast cancer. Am I going to get breast cancer?"
There is an innate understanding that health transmits in families
and that certain sorts of operations are more of a risk than others.
If you are providing people with a tool that allows you to dissect
that in a more precise way to their benefit, I do not think there
is going to be much anxiety about that at all. We have introduced
a whole set of things in health care over many years that have
often produced a flurry in the press. IVF was a pretty good example
of that, but the truth is that, when people realised that there
were considerable benefits to be had and that it was there without
any of the dangers that had been speculated about, people came
to accept it pretty readily. Biobank had recruited a very large
number of people by the time the disk from the Treasury with all
the data of the 22 million women on child support got lost in
the post or whatever happened. I immediately called and I said,
"Trouble coming. Let us watch the pace at which people pull
out of this study because they will say we just cannot trust you
guys." We did not have a single person withdraw. People treat
medicine differently than they treat the rest of this. That is
not to say I am complacent. We have to communicate better. We
certainly have to communicate better than the genetically modified
food gang who did not do such a good job, but I think you can
manage this by really open communication about what we are trying
to do.
Lord Taverne: I would like to put the
question rather differently. What can be done to stop the government
believing in what I regard largely as a myth, namely this public
suspicion of genetics, a point which you seem to agree with? Essentially,
as was shown for example over the concern with hybrid cells, the
government got off to the wrong start. There is no public worry
really about stem cell research. What the government seems consistently
to do is to listen to a very vocal minority and regard that as
the strength of public opinion. Again, there is this very widespread
concern that Sir Alex referred to about ethical issues. I almost
feel when people mention ethics I want to reach for my gun because
it is nearly always counterproductive. What can be done to make
sure that the government does not proliferate the ethical dogmas
and concerns and does not take public concerns very seriously
that do not exist? Sir Alex mentioned the concern about registration.
One out of 2,500 objected to their record being used.
Chairman: Perhaps Baroness O'Neill would
like to intervene at this point.
Q472 Baroness O'Neill of Bengarve:
I have to plead guilty. I do not think Lord Taverne will reach
for his gun, but it seems to me that there is a great tendency
to believe that self-appointed spokesmen for the public are indeed
representative of what the public thinks. One always has to go
behind the opinion polls to ask what do the public do. That is
the real evidence of what they think and whom they trust when
they go to their doctors, which is not to say one takes it lightly.
Professor Sir John Bell: That is correct. I
think this comes out of the hybrid embryo discussion. It is right
that government should enter these areas and consider them but
you have to get good evidence about what are the facts, what we
know and what we do not know. The hybrid embryo thing kicked off
with a lot of hearsay, again from vocal minorities, without a
substantial understanding even of what the definitions were of
what a hybrid embryo was; what have we done before? What does
it look like? Just to put a plug in here, the Academy of Medical
Science has spent a lot of time putting together a really authoritative
report which I hope informed the government as it got closer to
the stage of legislation. You have to use the independent bodies,
the British Academy, the Royal Society, Academy of Medical Science,
to put together people who can give you the best view about what
the science is telling you today, what is real and what is not.
That is really important because otherwise you end up on a wild
goose chase when you do not need to.
Q473 Lord Broers:
I am interested in large IT systems and their success or failure.
Sir Alex, you seem quite optimistic but what went wrong? Why was
an incompetent contractor appointed in the first place?
Professor Sir Alex Markham: Looking back as
an outsider, the problem was this: we were trying to develop in
Britain something bigger and more complicated than had ever been
done anywhere before. We were perhaps too optimistic. What we
have not done well is to say, "Let us build something that
works for this corner of Britain because if it works there it
will probably work almost everywhere else." We tried to implement
this big bang solution. When you do that and you are putting in
front of IT suppliers potentially the biggest contract that they
will ever see, they have to get them. There is not going to be
another one of these come along any time in the foreseeable future.
If they do not get the contract and their competitor does, they
are effectively out of existence. I suspect that the companies
were complicit because they said, "We will tell you we can
make you one of these even though we are pretty sure we cannot
because we cannot afford to admit that we are going to struggle."
I think there was a bit of an unholy interaction, the Department
of Health wanting to do something from a completely zero base
in IT terms and suppliers being desperately keen not to be excluded
from the party. One hears lots of anecdotes about the attempted
renegotiation of contracts when it becomes clear that the company
cannot deliver what they have contracted to do for the amounts
of money that they have contracted to do it for. Everybody is
in a blame culture then. There is not really someone to blame.
It is a failure to recognise that the challenge being taken on
was beyond both parties. We are just not very grown up about the
way we do those things, I do not think. You can make the commercial
world behave in really bizarre, unacceptable ways but I think
we are past that. The relationship that Connecting for Health
has with suppliers is pretty positive. I am optimistic. You are
perfectly right and at liberty to say, "I think your optimism
is misguided", but I do not think it is right now. The way
that the technology is developing will get us out of one or two
holes that we have dug for ourselves.
Lord Broers: In my experience of these
systems, success or failure depends almost solely on whether you
have defined the system properly in the first place. That generally
does not happen. When the supplier comes back and says, "That
is not a reasonable thing to do" then you start churning
and changing the specification for the system and then you have
chaos. That is very difficult. You are right; it is an interaction
that should take place before the contract is placed.
Q474 Chairman:
We have had longer than our normally planned session because both
of you were full of information that we needed. Before I finish,
if you have any other issues that you feel you would like to submit
further evidence to us about, please feel free to do so. It will
be regarded as the official evidence. I always ask this question
to all witnesses at the end and I will ask you the same question.
What two recommendations would you like to see in our report?
Professor Sir John Bell: I would like to see
you encourage this idea that the UK becomes the laboratory for
clinical utility testing and diagnostics because I think that
has all kinds of benefits, from the private sector to the public
sector, for patients and doctors. That would be interesting. The
other one relates to the question around what does the future
of a molecular pathology lab look like. I think this is really
pivotal. For cost effectiveness reasons, that really needs some
very careful deliberation. If you get that right, it will help
drive this agenda and get it much more used in the clinical arena.
Professor Sir Alex Markham: Sir David Cooksey's
recommendations about OSCHR and the integrated working of MRC
and NIHR have, possibly inadvertently, provided the nation with
a structure that ought to enable us to think strategically about
some of the new developments that we have discussed today in real
time. Rather than your Lordships having to convene every five
years with a sense of impending doom and disaster, OSCHR should
be charged to make sure that there is some strategic thinking
going on constantly about genetics and its place in the health
system. The structures that have been built over the last 12-18
months in and around OSCHR are well designed to do that. Of course,
I am conflicted because I have been part of that, but I think
we have an oversight capacity now that we have never had in this
country before to take the hot science into the clinic when appropriate.
All of that crystal ball gazing we have tried to do for you this
morning you cannot do and make a policy. You have to push that
into a body that is looking at that all of the time and making
changes as appropriate when the technology matures. I would, on
his behalf, put in a good word for him. Maybe you should give
him a bit more power.
Chairman: Thank you both very much indeed.
You have been very helpful.
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