Examination of witnesses
(Questions 1 - 19)
THURSDAY 4 FEBRUARY 1999
PROFESSOR SIR
MICHAEL RAWLINS,
DR GINA
RADFORD and DR
TIMOTHY RILEY
Chairman
1. Good morning, colleagues, and may I welcome
you to this meeting of the Select Committee. Can I begin by welcoming
our new Member, Ivan Lewis, who is replacing Ann Keen, so welcome
to the Committee. Can I welcome our witnesses and thank you for
coming to the Committee today. Perhaps, Professor Rawlins, you
could introduce yourself and your colleagues and briefly say a
bit about your background because it would be interesting to the
Committee.
(Professor Sir Michael Rawlins) I am Michael Rawlins
and I have been a Professor of Clinical Pharmacology in Newcastle
for 25 years, so I am an adopted Geordie, not a native Geordie.
I have recently been appointed Chairman of the National Institute
of Clinical Excellence. On my right is Dr Gina Radford who is
in charge of public health development within the NHS and on my
left is Dr Tim Riley who is the branch head within the same division.
2. Can I begin, on behalf of the Committee,
by expressing some concern that the discussion paper that was
issued yesterday was not sent to the Committee for some reason.
I suspect that this may be an error within the Department. It
has caused us some difficulties in that clearly we had did manage,
by a circuitous route, to obtain copies late last night, but it
has caused us the Members some difficulty in obviously preparing
ourselves for this session and so we may be asking questions which
are covered in fact in that document which we have not yet had
a chance to consider. Dr Radford, have you any comment on that
because obviously the Department did not send this to the Committee
which has caused difficulties?
(Dr Radford) All I can do is apologise on the Department's
behalf and clearly we will hope to give as full answers as we
can and cover the ground as well. Clearly we would be very happy
to give any written evidence or further follow-up if there are
any specific questions which are not able to be taken today as
a result of that delay.
3. But you do not know the reason why we were
not supplied with it?
(Dr Radford) No, I am afraid I do not.
Mr Walter
4. Chairman, could I just say, and this may
not be specifically your responsibility, that in the press release
which I received last night, it said, "Mr Dobson also today
laid before Parliament the Orders to set up the Special Health
Authority from 1st April 1999". Those Orders are not available
within the House of Commons. I do not know if you would have any
comments to make on that.
(Dr Radford) Can I refer that to my colleague, Dr
Riley?
(Dr Riley) As far as I understand it, they have been
sent to the House of Commons and I will follow through with officials
to see exactly what the situation is and we will be able to provide
you with written evidence afterwards of any circumstances as to
why they are not.
Chairman
5. I think it is important that you are aware
that we do take this seriously and obviously we raised it with
the Secretary of State because it makes it very difficult for
a Select Committee to undertake its functions without having information
that is in the public arena. We found yesterday that other organisations
had received this document, but not the Select Committee Clerk,
so it does cause us problems and I think you should probably bear
that in mind in the questions that we have this morning. Can I
begin by asking you, Professor Rawlins, for your thoughts on the
reasons behind the establishment of the new National Institute,
particularly in respect of the current problems with the existing
appraisal system. Could you give us some background information
as to the logic behind moving towards NICE, what are the problems
with the current system and what benefits do you expect the new
system to bring?
(Professor Sir Michael Rawlins) Over the past 20 or
30 years, I think it has been obvious to everybody that there
has been an explosion in medical knowledge and an explosion in
medical literature and the quantity is now so great that no doctor
or health professional can begin to be able to assimilate more
than a small fraction of the information and assessments that
he needs or she needs in daily clinical practice. There are even
now large numbers of journals which are devoted to reviews and
any single health professional really finds it quite impossible
to disembroil what is necessary and what is not necessary for
his or her practice. The problem of this huge information explosion
is not confined to the United Kingdom, but it is all over the
world; North America, the rest of Europe and so on are all struggling
to find solutions to how to resolve this. Now, over the past few
years with new technologies, new devices, new pharmaceuticals,
the sort of appraisal that has been undertaken has largely been
undertaken by district health authorities each acting independently
with little warning, no horizon-scanning, but suddenly presented
with a new technology, no agreed criteria on which to perform,
a huge replication of effort right across the country, and frankly
many of them not having the scope or the expertise to be able
to assimilate and assess and appraise all these individual technologies
and actually ultimately reaching different conclusions and that
is inevitable when you have this disparate, patchy arrangement
across the country. By contrast, in one or two areas there have
been national guidelines, national, if you like, appraisals, national
screening programmes, for example, or immunisation policies, which
have actually been very helpful to help professionals right across
the country in giving nationally agreed guidelines, targets and
so forth. The second area is that of clinical guidelines, and
this is not individual technologies, but individual ways of handling
and managing clinical conditions and diseases and there again
the guidelines that have been produced across not just Britain,
but across the world have been extraordinarily variable in quality
and if you read the guidelines, it is not very easy necessarily
to find out how robust and rugged they are and how well they have
been constructed. In some instances, there are large numbers of
guidelines covering a single area. I am told that there are 167
guidelines for treating asthma and if confronted with 167 guidelines,
the average doctor, and I would call myself an average clinician,
finds it very difficult to know where to begin and where to end.
Many of them have been indigestible, thick volumes rather than
short summaries. You need the thick volume to back it up, but
you do not necessarily need the thick volume at three o'clock
in the morning if you are the consultant on reception in a teaching
hospital. Finally, they are inaccessible and many of them are
very difficult to find; they are in what people often refer to
as the "grey literature". So these are the broad problems
and the background and I do not wish to ascribe blame to anybody,
any professional group, any Civil Service group or political parties,
but it is a problem that has arisen gradually over the years that
we have been struggling to find some sort of answer to which is
confronting healthcare systems right across the world.
6. So what are you going to do about it?
(Professor Sir Michael Rawlins) What we are planning
to do is to do three things. We are planning to set up a system
of appraisal of new technologies on a national basis, or at least
England and Wales. This form of appraisal will provide robust
assessment of the clinical and cost-effectiveness of new technologies
and should advise on whether they should be in routine use in
the NHS or whether for one or reason or another, clinical ineffectiveness
or lack of evidence, they should not be in routine use or whether
they should still be subject to further research. The second is
to produce and disseminate clinical guidelines, disease orientated
guidelines, which are robust based on clear scrutiny of the scientific
literature and which are disseminated in a form that is practical
and useful to health professionals. Thirdly, to develop and promote
clinical audit particularly in the areas in which the Institute
has produced appraisals and produced clinical guidelines for.
7. Could you possibly give what might be termed
an idiot's guide to the way NICE will encompass the range of other
organisations currently attempting to fulfil some of the functions
that you have described.
(Professor Sir Michael Rawlins) Yes. Some of the organisations
that are doing some of this work will be brought under the NICE
umbrella, for example the National Centre for Clinical Audit.
NICE, however, will maintain a sort of arm's length relationship
with many other organisations, particularly the Royal Colleges
and their audit functions and their confidential inquiries, and
will thereby in some senses be a virtual institute rather than
just in one large building in the middle of London. It will also
need to have very close relationships with the NHS R&D because
a lot of what NICE will be doing will be based on the work that
the NHS research and development programme has itself instituted.
In one sense one can envisage NICE as being a development of the
R&D initiative in having determined the best practices and
then disseminating them out to health professionals generally.
8. You are aware at the present time of the
vigorous debate on the issue of "rationing". I am sure
you are aware that NICE has been portrayed in some circles as
being all about a rationing process. How would you comment on
that point? How would you counter that point if you disagree with
that?
(Professor Sir Michael Rawlins) I would not want to
get into semantics too much but I am old enough to still have
my old ration book which I fondly keep as a memento of the post-war
years when I was allowed seven sweeties a week. The coupons are
still there and in those days rationing was concerned with a strict
allocation, not dependent on need, fat boys and thin boys got
exactly the same amount of sweets. My understanding of rationing
from those days from personal experience is exactly the same as
that in the Oxford Dictionary which points out that it is a fixed
allocation of resources. The health service has never done that,
it has never had a coupon book where once you have spent your
coupons on health care or the NHS has snipped them out of your
ration book you have no further health care. I have been practising
medicine for over 30 years and never at one moment has that sort
of rationing ever occurred. I do not think it has ever occurred
at all. What has happened from time immemorial, not just in the
health service but since the practice of medicine started with
Hippocrates in ancient Greece, is priorities. Doctors and nurses
and other health professionals have always had to prioritise-a
horrid word, I know, but it has now gained common currency-they
have had to prioritise the resources that they have available
usually on the basis of need and those who have the greatest need
have the first call on the resources. Doctors and nurses and other
health professionals have always varied, for example, the amount
of time that they spend with patients on the basis of need. Prioritisation
in health care is nothing new, it has been going on for centuries
and will continue with finite resources. What NICE hopes to be
able to do is where circumstances are such that prioritisation
is necessary to determine based partly on the scientific evidence
but also based on the judgment of clinicians who are involved
in these things as to where the needs are greatest and where they
are least, where cost-effectiveness, health gain is greatest and
where it is least.
9. If you reject the rationing argument, and
I have listened carefully to what you have said, how do you answer
the concerns of some doctors who I have spoken to who feel that
there are some threats to their clinical freedom in respect of
what is being proposed by NICE, that you will be looking over
their shoulders and possibly interfering in an area that has been
left to their discretion?
(Professor Sir Michael Rawlins) As a practising doctor
myself I have some sympathy with that, but at the same time when
you are confronted, as wise old George Godber said many years
ago, with the patient in front of you you also have to remember
the rest of the patients in the waiting room. You cannot allocate
resources to the one individual without taking into account those
others who are there also wishing to have a share of the resources.
We have finite resources in the health service, we always have
had. Every health care system has that sort of problem. However,
when it comes to guidelines clinical guidelines never can encompass
one hundred per cent of patients, people vary and some people,
some patients, do not fit into guidelines so there needs to be
a lot of professional judgment in determining which people are
appropriate to follow the guidelines and which patients are not.
Mr Walter
10. I am interested in what you say, whether
we are using the word "rationing" or whether we are
using the words "priority setting", and you referred
to a previous Chief Medical Officer, surely that is when you are
talking about financial rationing or financial priority setting?
What about a clinician who says "this is the treatment which
I think is right for my patient" whereas you might have said
as an Institute that in general terms you do not think this is
a clinically effective treatment?
(Professor Sir Michael Rawlins) I think there are
two areas there. One is we may believe it is not clinically effective
and I think most doctors would accept that judgment. Virtually
the entire medical profession commenting on NICE has accepted
that the professions as a whole would accept those sorts of judgments.
When it comes to cost-effectiveness there comes a limit. I have
told this story on many occasions. About three years ago I was
rung up by a general practitioner from another part of the north
east who said he had a patient who was receiving a particular
drug on the advice of a hospital some way away and it was costing
a million pounds a year. The patient had recently been for a review
and this rather distant hospital had recommended doubling the
dose. He asked me what he should do. Two million pounds a year
for one patient for a treatment of non-proven effectiveness, irrespective
of anyone's clinical judgment, clinical freedom, really does have
to be questioned. I know it is a stark example in the extreme.
11. You are using a rather stark example. Let
us say that there is a new therapy which has been developed in
the United States on which there is some evidence that it is effective
and it is one that you have not as an Institute actually looked
at but a particular clinician says "I believe this is right
for the rare condition of this patient that I am treating".
Are you going to say "No, I am sorry, it does not have our
charter mark"?
(Professor Sir Michael Rawlins) If we had not appraised
it then we would not be in a position to make any comments at
all. I hope that if it was that sort of episode we would have
been asked to appraise it by the Department of Health but if we
had not been asked to appraise it we would have no part to play
until asked to do so. We would not be in a position to be able
to opine on whether it was effective, ineffective, cost-effective
or what have you.
12. If his particular health authority said
"I am sorry, you cannot use that treatment because it does
not have the NICE seal of approval"
(Professor Sir Michael Rawlins) We are not going to
be appraising every single new incoming technology, the numbers
are so great that it would be impractical.
Julia Drown
13. I would just like to ask a bit more about
who will be involved in NICE and whose opinions should count.
Clearly you are looking at all the scientific evidence. Would
you take into account the views of healthcare workers, patients,
users and carers?
(Professor Sir Michael Rawlins) Very much so and it
is the intention that when appraisals are undertaken, the, as
it were, provisional conclusions, draft conclusions will be widely
circulated and discussed with health authorities, patients, consumer
groups and seek their views on the appropriateness or otherwise
of the draft advice. Of course it is the intention of the Institute
to involve patients and patient representative groups right the
way through the organisation and I think it would be my hope that
the Secretary of State would agree to appoint a non-executive
director who represented patient groups and patient interest groups
and it would be my hope that I could persuade the Secretary of
State to ensure that about a quarter of the partners' council
represented patients and patient groups because I think they have
a very important part to play.
14. You said you would like the results of your
investigations to be widely available to health professionals.
Would they be available to the general public as well and are
you likely to make that information available on the Internet,
for example?
(Professor Sir Michael Rawlins) Yes, absolutely. I
would also like to see us developing guidelines to help carers
and patients themselves. There are particular conditions where
great problems are posed to carers, and I am thinking of things
like schizophrenia and Alzheimer's disease and so on, where guidelines
for carers could be very helpful if we can devise a way of making
sure they reach the right people at the right time.
15. You talked earlier about how you would not
be able to appraise every medicine and every innovation. I would
be interested in knowing how you are going to select the different
areas of investigation. I am particularly aware that a similar
institution in America set out to do 30 to 50 appraisals a year
and did not even succeed in doing that, so how will you succeed
where they did not?
(Professor Sir Michael Rawlins) Well, we will be hoping
to do 30 to 50 once the Institute is mature, but our sights are
set a little lower for the first year or two while the organisation
is getting on stream. The, as it were, shopping list for what
NICE is to appraise will ultimately be determined by the Department
of Health and I think it might be more appropriate if either Dr
Riley or Dr Radford described that because they will, as it were,
be sending it on to NICE.
(Dr Radford) We have proposed a process within a consultation
document, so what I am going to describe is purely the thinking
behind that proposal; it is not fixed in tablets of stone, but
it is genuinely out for consultation and we welcome comments from
individuals on that. There are two components. First, the overall
process, because what we are trying to describe is a more comprehensive
process that recognises the need to be proactive, not just reactive,
but also the other thing is to recognise that we are dealing with
not only new technologies, but also existing technologies, so
slightly different in terms of that. When the process is fully
mature, we see that very early on in the life of a product we
will be undertaking what we call horizon-scanning, and we do have
a contract with the University of Birmingham to undertake that
at the moment, as to what are the most significant technologies
that might be coming over the horizon over the next few years
so that we have some advance intelligence. That will give us a
chance to do some provisional selections, have provisional discussions
with the industry about their new technologies and to identify
what is likely to be coming. We will be giving formal notification
about a year from the expected launch, licensing, whatever it
may be, within the NHS and then clearly from there on there will
be discussions with industry and others in terms of gathering
evidence and providing information for NICE to then consider.
So that is the overall process in terms of trying to select at
a very early stage and having much more advance warning and intelligence.
In terms of what we are proposing and asking for comments on in
terms of what may then come to NICE to be selected at that year
stage, the sorts of criteria we are looking at are those products,
technologies, techniques that have an intrinsic significance to
the NHS, whether it be measured by cost or potential health gain
and health benefit to patients or patient groups. There are a
number of other factors which we also consider, such as the other
resources or service implications from that technology because
it may not be so much the technology, but particularly around
a particular device or a surgical intervention what else is going
to be required to support that device or intervention which may
have quite a degree of significance for the service. We also recognise
that those treatments or interventions which are the first either
in a disease area and particularly in chronic conditions or life-threatening
conditions where there is no other apparent product or technology
we will need to take consideration of. Then there is where the
evidence for some reason we anticipate being quite hard to interpret,
in other words, there are not obvious clinical end points which
can be translated usefully at present and where it is going to
be difficult to understand what the evidence means and for practitioners
to make sense of that. There is also the issue of where we think
there may be ethical or scope issues where guidance of some sort
would be very beneficial to practitioners. Overarching all of
this is the basic question: can NICE and its appraisal mechanism
add value to health carers at practice within the NHS and to patients
and information to carers? So that really deals primarily with
new technologies, but some of those criteria will also apply to
existing technologies. The other way we will select existing technologies
will be where there is considerable variation in practice and
where guidance or guidelines would help in that process and also
where there has been research, for instance, on the health technology
assessment programme, around existing technologies which would
suggest that an appraisal of that technology is appropriate. So
the appraisal mechanism will not just be dealing with new technologies,
but will be dealing with significant existing ones as well to
make sure that there is a fairness and an equity applied to healthcare.
16. Would there be a different track for an
area where NICE has done an appraisal and dismissed something
as being ineffective and then new evidence comes through? Would
that be a different track or would that go through the same process?
(Dr Radford) That would go through the same basic
process. Clearly the horizon-scanning element would not be required,
but it may be that new research is done and either NICE becomes
aware of it because NICE itself has suggested that that research
might be useful, ie, when it has appraised the original evidence,
it said, "More research would be needed", so that research
might be forthcoming, or the industry itself may have undertaken
further research that would suggest that the original appraisal
should be revisited and then the NICE secretariat will take notice
of that and decide whether that is of such importance that the
appraisal should be reconsidered. Also NICE itself, when it produces
the guidance, may itself say, for whatever reason, "This
is a time-limited one which we would like to come back on at a
later stage because we are aware that there are some other issues
on the horizon which we will need to consider".
17. And what about the first priorities-are
you clear what NICE will start off looking at?
(Dr Radford) No, because we are consulting on the
selection criteria at the moment and it would be inappropriate
to preempt the results of that.
Audrey Wise
18. If I can just follow up a little bit on
some of Julia's thoughts, you made it clear that patient groups
would be involved in this process and there seems to be quite
a logic in the description that has been given to us of how the
selection of topics for appraisal would work. However, if I can
follow the thought through a little bit about patients, that is
patient groups involved in the process, but what about patients'
views about the end result, patients' views about the effectiveness?
This will of course go into what you will think of as meaning
that something is effective and there can be differences of view
between clinicians and patients as well as clinicians and clinicians.
My experience on this Committee is that patients, in dealing with
professionals, particularly medical professionals, seem to be
regarded as falling into one of two groups: either they are patients
and, therefore, they know nothing about it; or they are patients
who have taken a considerable interest and read up and, therefore,
they have become experts and, therefore, they are disqualified
as patients. I wonder how you see the fitting in of patient groups
and patients' opinions about effectiveness as well as about the
process? I feel happier about the process, I feel suspicious about
the views about effectiveness.
(Professor Sir Michael Rawlins) The point you make
is a very important one because doctors, and I am as guilty as
anyone, just because the x-rays and the blood tests are all right
that is it and if the patient is not feeling any better he or
she does not really mind about the x-rays and the blood tests.
I do appreciate that. There are a number of approaches to it.
The first approach, of course, is in the assessment of effectiveness.
Increasingly we are looking for improvements in the quality of
life, not the pathological changes or whatever it is but in a
quantitative manner how patients are feeling. Quality of life
assessment has now become a rather important part of deciding
the clinical effectiveness. Nevertheless, I think we do need to
engage patients and patient groups. I think one of the important
ways will be when we produce our provisional advice and guidelines
because we will be going to specific groups and we will be wanting
to know what they feel about the criteria of effectiveness that
we have used. Maybe we will evolve other approaches. I cannot
give a complete answer to you because I think we need to evolve
and do a bit of experimentation to find out how we can do that.
I do agree that the process being all right is one thing but people
have got to feel better as a result of a technology or a guideline
and not just be told that they ought to be feeling better.
19. Or the other way around, if they feel better
and they are told "we cannot see why you are feeling better",
does that mean they are not feeling better?
(Professor Sir Michael Rawlins) That is not very encouraging
either. No, I accept that. I fully agree.
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