Examination of Witnesses (Questions 80
WEDNESDAY 16 JANUARY 2002
80. If we could just return to that question
on who should decide what is examined by NICE, do you think there
should be some sort of independent mechanism other than the Minister
deciding what should be taken up and what should be examined?
I know there are all sorts of things proposed. At the end of the
day it tends to be a political decision of Government.
(Professor Walley) I think it is probably appropriate
that it should be. At the end of the day the Minister has to decide
what are NHS priorities, so any decision has to be made by the
Minister taking advice from his experts, of course. To some extent
that has led to an unfortunate appearance that NICE has been firefighting
all the time, that its agenda has been thrown around by new technologies
that have come up rather than defining what the NHS priorities
should be and sorting that out.
81. My question has almost been asked but you
might like to elaborate on it. I want to pick up on the point
of the anti-obesity drugs. You suggested that the focus is too
narrow, that we look at the drug in isolation and not at the wider
issues around this. Would you like to elaborate a bit more on
the problems with this approach and perhaps guide us in the way
(Professor Walley) I do not know if I can guide you
in the way forward but I can certainly elaborate on the problems.
The anti-obesity drug is a very good example. Again, my reading
of the situation was that NICE was driven into appraising these
products by the fact that they were coming onto the market and
the NHS were screaming for advice, "What do we do with these
products?" Given a longer time run-in the approach should
have been that one would develop a guideline which included or
did not include the use of these drugs and to look at the condition
rather than being forced by what seems sometimes the manufacturer's
agenda rather than the NHS agenda. It would be appropriate I think
to put more effort into guideline development. It is early days
for NICE. Guidelines require a much wider view than a simple technology
review and therefore take longer to produce. I think NICE has
been firefighting at times. It needs to be able to sit back and
take a wider view of managing conditions. It is starting to do
that. Its programme of guidelines will start to roll out over
the next few years.
Dr Taylor: I am really rather thinking aloud
here. Devolution is the flavour of the year. Certainly, as an
Independent, I can say this. It appears to me that the Secretary
of State is devolving decision-making to take the heat off himself,
certainly with NHS appointments, with re-configurations. Is there
any sense in which NICE is being made to carry the can for those
sorts of decisions?
82. Yes or no?
(Professor Walley) Thank you for the poisoned chalice.
Yes, I think there is, in that when a NICE appraisal approves
a product the funding seems to follow automatically, whereas to
my mind the decision should be made by the Minister as to whether
or not funding will appear for that product. Because it is not
apparent when the Minister has made a decision that the funding
will be available there is a perception, which I do not think
is actually true, that at some point the Minister has influenced
the process before it has got to the final stage. That leads to
problems which cause NICE difficulties with credibility. I think
there needs to be a clear distinction between executive roles
and the evidence weighing appraisal process. The final decision
to my mind should rest with the Minister.
83. Do any of you gentlemen feel that there
is any truth in the claim that since we have had NICE companies
have been put off developing their products in this country and
have increasingly gone abroad?
(Professor Walley) I am not aware of any evidence
but then it would take quite a long time to shift one's development
programme one way or the other.
(Dr Duerden) One of the things it may have done is
improve the research that is done into drugs in terms of providing
better evidence in terms of clinical effectiveness, whereas previously
we have been getting evidence of the fact that it worked against
a placebo and was relatively safe. We are getting better evidence
in terms of how it fits in alongside other drugs.
84. Mr Moore, we have not forgotten your presence.
If you want to respond to that please do.
(Mr Moore) If I may. I have no evidence that research
or the profession or anything is moving off shore. I think that
pharmaceutical companies are jolly slow beasts. You think the
NHS is slow. Inside the pharmaceutical companies it is really
slow. I had a director of a pharmaceutical company seeing me two
and a half years ago saying that they were desperate to get a
systematic review done on a product because they thought they
might have a NICE appraisal and it would not be a problem if they
came to us, which was a very nice compliment, and two and a half
years later I am still waiting for the data. Part of the difficulty
here is that although the British arms of the companies might
see the necessity for doing this, the American or German arms
of the companies, where often the major decisions are made, do
not. I think it is going to be a little time before the pharmaceutical
companies really appreciate the benefits that companies will get
out of this process as well as the NHS. Certainly one of the things
that I would like to see out of NICE is getting together with
the pharmaceutical companies maybe to do more in helping to determine
who benefits from drugs and not just that drugs are beneficial
85. You want independence from the political
agenda and Professor Walley has made it clear that as long as
resources are involved it is virtually impossible to have that
independence. Do you agree with Professor Walley's view or do
you think there is some way to achieve independence?
(Mr Moore) I think this is less of a problem now than
perhaps it has been in the past. When NICE came along first of
all there was a general fear, and perhaps a genuine fear, that
NICE was a mechanism in some way to establish rationing on the
NHS. What we have had are a number of decisions which have been
broadly positive. They broadly come along and say yes, these interventions
work, and that should not surprise us because we are looking at
interventions that have gone through a very lengthy process. At
the same time as that is happening, there is this general feeling
that NICE is a little more benign than people were worried about
two or three years ago and the resource is coming into the NHS
now. The lack of pressure on prescribing budgets in particular,
and perhaps the provision that prescribing budgets may go up in
years to come to at least accommodate some of the provisions of
NICE has actually changed that perception that NICE is controlled
directly from Whitehall. I am less concerned about that than I
have been in the past.
86. What about the saga of beta interferon?
(Mr Moore) In a funny sort of way I think they may
have come up with a reasonable answer. The beta interferon problem
was not something that was a surprise to anybody who had looked
at it. In fact, you could have said a couple of years previously
that this was a difficult one, that on balance this looked like
interventions which were effective, but we did not know if it
was effective. That made it expensive, combined with the cost
of the drug. On balance it would have been difficult for anybody
to have looked at the evidence and say unequivocally that this
was something that should be done. I think it would be equally
difficult for anybody to look at the evidence and say, "This
should not be done". It seems to me that by coming up with
that answer and finding a way out of it, that is, that you should
perhaps go down the route of treating some of the patients as
deemed appropriate, but making sure that they go on to some sort
of treatment register so that we can look at this, is a sensible
87. You do not think that having this kind of
trial that has been introduced was bypassing NICE and basically
seeking to get the Government off a very difficult political hook?
(Mr Moore) No, I really do not. It may have been done
for that reason. I have no idea what the reason for making that
88. That is why I was asking.
(Mr Moore) I think it is a very sensible thing to
89. But does that not rather invalidate the
whole raison d'être of NICE?
(Mr Moore) No.
90. Correct me if I am wrong, and I may well
be, but I understood that the whole purpose of NICE was to take
away from ministers the decision-making process of what drugs
would be supplied and paid for by the National Health Service
and theGovernment and that in effect you would have this independent
organisation that would scientifically evaluate new drugs and
whether they were effective for treating patients as their manufacturers
claimed. As I understand it, what we now have is that we do not
have a final decision yet by NICE on beta interferon but the Government
decided to have a trial use of the drug. To my mind what is the
point of NICE if the Government are going to step in and bypass
it by having this trial, a trial that I think you have half admitted
is probably due to political pressure. Surely if you are going
to have an independent scientifically based body that is going
to evaluate the effectiveness and the usefulness of drugs you
wait until NICE has issued its considered opinion before you take
a decision. You do not jump the gun by having a trial.
(Mr Moore) I think that is a reasonable point of view.
If you are happy that we know (a) how to evaluate the evidence
and (b) you think you know what the evidence is. I am much less
certain and certainly much less confident that we know what the
basic rules are here. What could NICE have done? On the basis
of the trials as done I cannot see a way in which it could have
come up with a definitive answer either on efficacy or cost effectiveness.
Therefore a trial in the way that has been proposed is a reasonable
way forward. What could NICE have done? It is interesting. There
are a couple of things. For instance, one of the issues is outcomes
in trials. We have been sitting here using the word "evidence"
and we are making assumptions here about the statistics and the
outcomes. Some of the statistical things that we do are not right.
Certainly when we look at outcomes of trials, what the actual
result is, very often we do not really appreciate how useful that
outcome is. Okay, this is tricky territory. In this particular
case what they could have done was to go to all the companies
with similar products, ask, for instance, for the individual patient
information, and perhaps be able to do a better analysis on that
basis for which patients particularly would benefit, especially
if you have got blood samples available at the start of the trials.
These days with the rapid advances in genetic testing we are getting
to the stage where we might be able to say not just that that
drug works for everybody but that it works particularly well in
some patients and not so well in others.
91. Thank you. Can I now ask Professor Walley,
who has listened to all of that, what he thinks of that answer.
(Professor Walley) I have not seen the protocols for
this trial yet.
92. On the general principle.
(Professor Walley) As Chairman of the Health Technology
Assessment Panel for Pharmaceuticals in the past, we tried to
set up a pragmatic study of this kind and we were unsuccessful
because we could not get the neurologists to agree what the protocols
for the outcomes were. I am not at all clear that it will be any
more successful this time and I wonder what the purpose of the
93. I just find it an unusual decision in that
it seems to me that it is completely undermining the raison
d'être of NICE in that I thought that the whole point
of that organisation was in effect to take difficult research
and scientific decisions on medicines in particular out of the
political arena and left in the hands of the experts, the scientists,
etc, to carry out their research and reach a decision. Does it
not seem rather pointless to short circuit that by having political
interference to set up a trial process two-thirds of the way through?
(Professor Walley) I think it would be very nice to
have the evidence from a properly designed trial but in the short
term this may damage the credibility of NICE.
94. The position that Simon sketches there about
the role of NICE, and I am not sure if he was saying that that
was his preference, as I understood your initial comments some
time ago would be the very reverse of what you would like to see.
Ultimately all these things are political decisions for ministers
and others to make, with guidance, rather than just handing everything
over to research.
(Professor Walley) I agree that the decision should
be made by the Minister but I think I would really like to see
what the protocol of the trial would be. Is it going to resolve
the difficulties we faced four or five years ago when we considered
95. So you are simply saying to Mr Moore, "Andrew,
we will be no further forward"?
(Professor Walley) It may be so.
96. Is it not true that the very last disease
or condition that you would use to design something that is NICE
would be MS? It is so unusual in that there is a small proportion
of patients who are assisted by beta interferon and the great
majority are not. How are you going to sort that out? Simon is
suggesting a model that it is irrelevant really to give beta interferon
treatment of MS.
(Professor Walley) I think it is exceedingly difficult
to untangle this one. The disease itself is so variable in its
progress, it is difficult in its diagnosis sometimes and there
is a very variable response to drugs. It would be exceedingly
difficult and a properly designed trial is going to be very expensive
(Mr Moore) And we are uncertain what the outcome of
any trial would be. I think that is exactly the point Tom is making
and one that I would go along with, which makes it almost impossible
for NICE to appraise it if you do not know the benefit of the
outcome. Perhaps that is one of the things that we are arguing
too much about the difficulties and at this stage that is one
of the things that we might like to see NICE doing, turning around
and looking at this as a whole issue because there are outcomes
of benefit to the patient, outcomes of benefit to professionals
and health care systems, and outcomes of benefit to society as
a whole. Maybe some agreement on those would allow us to revisit
the trials that have been done and also get a greater appreciation
of any pragmatic trial that might be ongoing.
97. What would you do about the situation in
MS because you said it is a political decision? If you were a
politician what would you do?
(Professor Walley) I would accept what seems to be
NICE advice in this particular case and I would consider asking
the companies to reconsider their trials. In an ideal world we
would actually have had that input into the trial development
of the drugs long before it ever got to launch, so that it is
actually looking at outcomes that were irrelevant to the NHS.
98. Mr Moore, you provided us with a completely
new model for the working of NICE. We have not really got time
to go into it but it did strike me as quite expensive and bureaucratic.
Does the fact that you have come up with that new model mean that
you think that the present arrangements are beyond help?
(Mr Moore) No, not at all. NICE is essential; if we
did not have it we would just invent it. I come from the basis
that I spend a lot of time either doing evidence based reviews
or reading evidence based reviews and some of them are very difficult
indeed. In fact, all of them are quite difficult and some of them
are incredibly difficult. There is an assumption that we understand
what the rules are to do this. That assumption is often incorrect.
What I would be looking for is something which would develop over
time to do several things: first of all, yes, provide better evidence
from the trials that have been done, but also to input into the
trials that are going to be done in the future. The outcomes of
trials are not decided by the pharmaceutical companies working
alone. They are decided by the pharmaceutical companies working
in conjunction with regulatory authorities and the only regulatory
authority that really counts is the FDA. We have got to talk to
them about getting better in the sense that most of the pharamaceutical
companies are in America it is the biggest market for drugs int
he world. Almost every other country in the world, apart from
Europe and Autralasia and Japan, almost take what the FDA says
as gospel. The FDA in a sense is driving part of the agenda. I
think we have to get in there and begin to say that there are
other issues involved and try and help the companies and the regulatory
authorities to think the other way round. There are issues about
the evidence, there are issues about cost. There is an assumption
that cost effectiveness is a relatively straightforward thing
to do. I think it is enormously complicated. Again, whose cost
and when? How are we going to fund it, not just in terms of this
particular intervention in this particular patient, but in the
Health Service as a whole? The one thing that is almost always
ignored in all this is how to do it. There is an assumption that
anybody anywhere can issue an edict and suddenly it gets done.
Actually management issues in the NHS, as the Minister was saying
recently, are very complex. He was saying that it is so big, it
has a million people in it. A lot of those people are making dozens
of management decisions every day and we need to help them in
terms of getting good cost effective evidence. That is a big job.
Therefore, if you are going to say, "What is clinical excellence",
is it just about whether the treatment works or not or about the
whole spectrum, then you probably need a reasonably good NICE
to do it, and it has got to be excellent. There is no point in
being half-hearted about it. It has got to be excellent. That
is an incredible name to give any organisation. I would not like
to run it with that name. You think about it in parliamentary
terms, the Health Committee on Excellence. You immediately start
worrying about almost everything you are doing. If one were saying,
"Is NICE okay?", no, it is not. No organisation is going
to be after three years. Are the people in there doing a reasonable
job? Probably, although I think we would all agree with them in
some sort of detail. Could they be doing better? Sure they could.
Sometimes you have to sit back and not do the British thing and
quibble, but look at the vision. We are spending tens of billions
of pounds in the NHS. It is a superb treasure. It needs a little
bit more help in terms of trying to do a better job with the resources
99. Assuming my colleagues have finished their
questions can I throw in one which if any of you want to have
a stab at answering I would be very interested. It is back in
a sense, Professor Walley, to your comments about affordability
being a political question, and the exchange that there was with
Richard who was talking about devolution. I have always been very
interested in how one devolves these decisions to pleople who
are affected by them. Have any of you given any thoughts to how
we may devolve the issue of prioritisation to our own localities,
the people who the NHS serves? I was very interested some years
ago to see the Oregon list system in the States where people have
been asked to rank health interventions in the order in which
they felt they should be funded. Have any of you ever given any
thought at a local level to how this might be addressed?
(Mr Newdick) Can I start by saying we have done it.
Since 1948 we have done it. All these local decisions are delegated
to local health authorities.
100. But they are not made by local people.
The point I was really making is that we have a democratic deficit
in the Health Service that nobody has addressed. It is not made
by the patients. It is made by bureaucrats. Is often is not accountable
to the local people. It is accountable to the Secretary of State,
not to the people that their decision affects. That is the point
I am making. If any of you have any great ways forward in the
pursuit of excellence, we are looking at this issue.
(Mr Moore) One of the things I am interested in is
the patient perception of what is a valid outcome. This is an
area which we have been pursuing research on, albeit sporadically,
because it is not terribly well funded, but if you go and ask
patients independent of their doctors in fairly structured circumstances
what they think of their treatment, what they think of the adverse
events, what their attitude is to risk, what their knowledge is
about their treatments and so on, your eyes open very wide very
quickly. If we want to go down that sort of route, which is one
I strongly advocate doing more of, then the whole way in which
you might balance the various components of your health service
might change quite dramatically.
Chairman: This is a bit beyond the terms of
reference of our inquiry; I accept that, but if you have any thoughts
when you leave the Committee and would care to drop us a line,
I would be very interested in them. On behalf of my colleagues
thank you for a very helpful session. We are most grateful.