Examination of Witnesses (Questions 160
- 179)
WEDNESDAY 23 JANUARY 2002
DR TIM
CRAYFORD, HELEN
MARLOW, DR
DEIRDRE CUNNINGHAM
AND DR
DAVID WALKER
Mr Amess
160. Helen, in your written evidence you made
that damning statement that you feel that the credibility of NICE
has been damaged. This is big stuff. Could you explain to the
Committee why you feel it has been damaged? Given that you have
this—some might say; I am not saying it—jaundiced
view, how then when they give their guidance do you and your colleagues
react to it?
(Ms Marlow) The first thing to say is that I am not
saying NICE is an organisation without credibility. I do think
credibility is a perception and the perception around NICE's credibility
has been damaged for a number of reasons because some things have
happened which have made us lose some confidence in their decision
making. Probably the best example is the guidance on Zanamivir.
The timing of that was very unfortunate because it was very early
on in NICE's life when they were trying to develop a track record.
A lot of people thought that decision to recommend Zanamivir seemed
rather strange based on the information available in terms of
the health technology assessment. That raised a lot of question
marks about how on earth they could possibly come to that decision
and whether there were other factors at work or other pressure
being put on them to come to that decision. That was the first
issue around credibility.
161. You said "other pressure". What
might this other pressure be?
(Ms Marlow) It could be the Department of Health,
it could be the pharmaceutical industry, it could be patient groups.
I do not know, but it seems a strange decision and it does make
you wonder why they made that decision, that is all. I have no
material evidence to suggest what that might be, but it just seemed
quite strange at the time.
Mr Burns
162. Do a lot of people in the medical world
share your concerns and suspicions on that issue?
(Ms Marlow) Certainly about Zanamivir, yes.
Mr Amess: There is nodding going on everywhere.
163. The Department of Health or the pharmaceutical
industry put pressure on NICE.
(Ms Marlow) I do not know.
164. I am not saying you know, but that is what
is perceived within the health profession.
(Ms Marlow) Yes.
Mr Amess
165. So it was a bad start really.
(Ms Marlow) Yes, and other things have happened since.
It is detail really, but issues around quality of some of the
health technology assessments which NICE have used. People who
look at them in detail feel that the quality of some of them could
be better. There are other issues around other authoritative and
respected sources, for example the Drug and Therapeutics Bulletin
has drawn conclusions about treatments which are different to
NICE and one has to ask why there is that conflict. There are
other issues around NICE being able to use unpublished data which
is not in the public domain and open to scrutiny which the NHS
and others have no access to. There are issues around the conflict
within the Department of Health to whom NICE are responsible,
because of trying to manage the tension between being responsible
for the NHS and the pharmaceutical industry. That is a potential
conflict. There is the issue of them not being as open as they
might be about declarations of interest.
Mr Burns
166. Briefly on this question of credibility,
do you think the saga and delays over-beta-interferon have adversely
affected NICE?
(Ms Marlow) Yes, I think that has added to it; definitely.
167. Do you think that the pilot scheme of people
being able to test it before we get a final decision from NICE
has seriously undermined their credibility? It looks as though,
for whatever reasons, whether political or whatever, politicians
have stepped in. In a way one assumed when NICE was set up that
they would be given the task to look into a specific drug and
everyone then waited until the report came from NICE on that.
For some odd reason we have the situation where not only has there
been constant postponement and missing of deadlines on getting
NICE's final decision, but we also now have what I think is unique
in NICE's history so far: Ministers stepping in with this half-way
house to try to relieve the political pressure of a pilot scheme
for testing the drug on a cohort of patients.
(Ms Marlow) That certainly raises the question of
whether NICE is being undermined.
Jim Dowd
168. I should like to revisit the Relenza issue
for a moment because there seems to be broad agreement amongst
all of you that this was not well handled, for whatever motives.
How did that translate for good or ill in terms of patient care?
What effect did it actually have on the treatment which was given?
(Ms Marlow) One of the issues that winter was that
we did not have very much flu circulating so there was not a great
need for the drug anyway. If you look at the national figures—and
certainly in all our health authorities—very little was
used.
(Dr Cunningham) We had a policy of not implementing
it the first time the guidance came out on Relenza.
169. So the effect on patient care of this hiatus
in the progress of NICE was zero.
(Ms Marlow) Very little. One of the issues around
Relenza is that there are many practical issues about it having
to be started within a certain timing, patients seeing doctors
and being able to use the inhaler device. There were many practical
barriers to using it as well which meant in reality that it did
not get implemented particularly because there were so many other
barriers to using it.
(Dr Crayford) Until very recently, NICE guidance had
not been mandatory. We were left to make local decisions and make
those according to how Relenza fitted in with our local priority
setting process.
(Dr Walker) We had problems with a number of issues
locally. The first one was selection, the prioritisation of Relenza.
In our particular population it was much more important to consider
non-time-dependent interventions, particularly vaccination with
the flu vaccine. We felt we could have spent the time which was
used on setting up patient group directions for Relenza on promoting
the vaccine. We felt it was inappropriate use of resources, although
we did follow the guidance. Secondly, we thought that the recommendations
did not appear to be supported by the evidence which was published
at the time. Whether there was other evidence which was not published
at the time is another matter but that created a lot of difficulty
in the medical press, amongst general practitioners locally who
felt they were being asked to do something for which there was
not a sound evidence base. Finally, there were the practical problems
to do with not just the distribution, which was difficult in 36
hours from the onset of symptoms. In a rural population very few
people are going to present to their general practitioner with
flu within 36 hours of getting symptoms, so this was not going
to be available to them. There was the broader issue of whether
the evidence was relating to our population.
The Committee suspended from 4.38 pm to 4.48
pm for a division in the House.
There were practical difficulties in implementing
the guidance in those authorities which did. Some authorities
chose either not to implement the guidance or not to publicise
that the drug was available and therefore not to have to put measures
into place. Although we had very little flu, GPs did report to
us that they had had a lot of consultations, people asking for
the drug. In a larger outbreak of flu, if there were a similar
increase in the number of consultations, that would have a knock-on
effect of other work in primary care. For that reason, we should
like that view, the primary care view, to be reflected in NICE
decision making.
Mr Amess
170. Another question to Helen Marlow. You certainly
seemed very keen on the Scottish guideline group SIGN. Could you
explain, given that we have already heard how you feel about NICE,
why you think that it does work better? In particular do you think
that there are things that NICE could perhaps learn from the way
the Scottish group works?
(Ms Marlow) The first point to make is that SIGN,
which is the Scottish Intercollegiate Guidelines Network, essentially
produces guidelines and does not do technology appraisals of individual
therapeutic things. NICE does produce guidelines but it is only
part of the work of NICE. There are some key points about SIGN
which are interesting to look at: it was developed by health care
professionals themselves not government and is based on an academic
institution which enhances its credibility and perceived independence;
it was started in 1993, so they have an advantage over NICE, in
that they have had time to establish themselves and have not had
the same spotlight put on them as NICE has had; particularly the
robustness of the way they develop their guidelines, the presentation
in terms of the clarity of the language—quite often NICE
uses quite passive language such as "may consider";
SIGN is very clear and gives very clear practical advice to clinicians,
very clear diagrams, summaries of the guidance, they write in
a more practical, user-friendly way; they appear to have slightly
better involvement from interested parties when developing the
guideline as well as the membership of the guideline development
group, which is even broader than the NICE membership; they have
a national open meeting to which anybody can turn up to discuss
the draft guidelines. At the moment NICE only send their guidelines,
although they are published on the web, to their consultees, their
stakeholders, which is a fairly limited list of people. Their
guidelines are also independently reviewed by specialist referees.
Just to follow the process through, they have guideline co-ordinators
in each trust and health board in Scotland to disseminate and
support implementation, which is an example of good practice.
171. You mentioned that it is really inspired
by the professionals rather than the Government. Do you not think
it in any sense smacks of self-regulation?
(Ms Marlow) I do not think so. The ethos of SIGN is
very much about improving quality of care and they put a great
emphasis on patient involvement. They have strong patient representation,
they even have special training programmes and support programmes
to allow patients and patient representatives to take an active
involvement in the guideline development. That is a very positive
thing.
Mr Amess: Thank you for that. The Committee
has heard your evidence. There is a strong Scottish influence
within the Government, so perhaps they may act on what you have
said.
Dr Naysmith
172. I must say I am very pleased to hear something
good being said about Scotland too, although I represent an English
constituency I should quickly say. I should like to pick up something
Helen Marlow was saying. You were talking about beta-interferon
and you were talking about the debacle—you did not
use that word but you were certainly not very happy about what
had happened over beta-interferon. You were suggesting that it
had destroyed the credibility. We have heard already that quite
a lot was known about beta-interferon before we started and that
it was going to be a problem even before it went in to the NICE
system. What would you do about beta-interferon, given that there
are people who want to prescribe the drug and we have questions
about its efficacy in a large number of cases. How would you find
out whether it is a good thing or not, or would you just prescribe
it ad lib?
(Ms Marlow) We have been looking at it over time already
in our health authority and have had a look at the evidence and
have agreed how we would use it locally with our local clinicians,
which is basically in accordance with the national guidance which
came out at the time that beta-interferon was licensed. Our local
clinician has a very sensible approach and gives a very balanced
view to patients about the pros and cons of Beta-interferon. We
do have some patients on it.
173. Yes, but you have some patients who are
not on it. I am quite sure that they are asking why they are not
on it. How do you deal with that?
(Ms Marlow) It is out local clinicians' decision.
174. I am very much familiar with that, but
it is what happens once the clinician has made that decision.
(Ms Marlow) About not being on it?
175. Yes.
(Ms Marlow) Because it may not be the best treatment
for them.
(Dr Cunningham) Beta-interferon is an example where
a lot of health authorities have taken a decision, based on the
evidence as they assessed it and the previous interim guidance
which had come out, not to fund it very much. We put in our evidence
that we did a study involving about 40 people with multiple sclerosis
and the Multiple Sclerosis Society and professionals in our health
authority at the time. We asked them where the gaps in the service
were, what they wanted us to invest in, whether it was beta-interferon.
They said no, that beta-interferon was not their top priority.
We shared the evidence with them. They actually wanted other things
which we could do, which would make more difference to their lives,
such as the only way they could access specialist multiple sclerosis
nurses at that time was through the nurses who were funded by
the pharmaceutical companies which provided the beta-interferon.
What they wanted us to do was fund the nurses so they did not
necessarily have to have beta-interferon, but they could have
nursing. They wanted better information and a lot of other interventions
which we put in our evidence. If you consider the whole package
of care, the care pathway that the patient needs, the drug is
not necessarily always the most important aspect of that. Unfortunately
the way we are told to fund the drug at the moment, the drug is
what we are told to fund and sometimes in some of the national
priorities at the moment, like coronary heart disease, cancer
and mental health, if we really fully funded the drug and fully
implemented the guidance, we would use up almost all of the growth
money that we have to fund that complete area. That is the problem.
(Dr Crayford) I would support that entirely. The problem
is that NICE is often looking at just a bit of the picture. As
health authorities we have all sorts of other pressures on us
for things which we have to fund and NICE does not take those
things into account by virtue of the way in which it is set up,
whereas we have to. It does not seem rational to prioritise health
care unless you can consider all of your priorities at once, which
by virtue of its design NICE cannot do.
(Dr Walker) I would agree with the last two comments.
That is absolutely right. Also, there is another effect which
this delay has and that is to create a conflict and to lose support
in all of the different groups which are contributing to this
process. Instead of everybody working together for a total package
of care which is most appropriate, it becomes a big issue which
divides people and that is really unhelpful.
176. So to go back to my initial question, would
you not have recommended that-Beta-interferon be looked at by
NICE? I wrote two years ago to my local Avon Health Authority
urging them to institute proper nursing facilities for MS patients
aside of the Beta-interferon. What you are saying is that you
can treat most MS patients perfectly well without widespread prescription
of Beta-interferon, but some who are told they need it by consultants
get it and this is not what NICE was asked to look at it, was
it? It was asked to look at the effectiveness of beta-interferon
in that disease. It was not asked about the other things which
can make a huge difference to most patients.
(Ms Marlow) That is one of the problems of looking
at an individual drug, individual intervention: you are not looking
at the bigger picture and taking the whole context. A drug can
distort the whole picture.
177. Was there anything which should have been
referred to NICE as far as treatment of MS was concerned?
(Dr Cunningham) The problem with Beta-interferon is
that so many people have looked at it before. It was very long
after it had received its product licence. At the time NICE appeared
to have been set up to look at new products coming onto the market,
but this was almost an old chestnut. If NICE is looking at new
products, this was not new enough and the practice had diffused
into the system really. If NICE is now asked to have a slightly
wider remit, to look at main causes of morbidity and mortality,
it will have to look at existing treatments as well as new treatments.
(Dr Crayford) That is a really important point because
until NICE has looked at things such as the additional half dozen
nurses which we really ought to have in our accident and emergency
department at Mayday in Croydon, it is very difficult for us to
see the sense of giving priority to one of the new technologies
that NICE has evaluated when we have pressures like these that
we really have to fund. There are national directives through
all sorts of other areas of policy which dictate that we should
be spending our money on these things and this is one of the real
tensions that we face.
Sandra Gidley
178. A broad consensus appears to be emerging
about looking at the broader picture but I want to come back to
an area where there seems to be a bit of disagreement among the
people I have in front of me and that is the credibility of NICE
guidance. Last week we heard from the Drug and Therapeutics Bulletin
who were quite scathing and highlighted half a dozen instances
where they did not think NICE guidance was very credible. I notice
that Dr Cunningham really excused herself from this question but
she can answer it if she likes. Helen Marlow questioned the credibility
of NICE guidance. Dr Crayford and Mr Walker seemed to think that
the guidance was credible. I have to say—and I do not mean
this to be disrespectful—I notice you are both public health
doctors who have a huge range of skills but would not necessarily
be best placed to comment critically on each of the pharmaceutical
appraisals. Bearing that in mind, is that not a concern that people
in your position are taking the NICE guidance, it sounds plausible,
it is fine, but people whose day job is examining pharmaceuticals
in detail seem to be questioning some of it.
(Dr Crayford) Taking those two points about our professional
expertise, I am sure you are quite right. Speaking personally
I am not an expert in everything that NICE has adjudicated on
but I have looked at a few pieces of evidence which NICE has prepared,
in particular in relation to implantable cardiac defibrillators,
which is why I came to the conclusion in my evidence that NICE
was listening to a biased view. Yes, I would agree. We struggle
with a broad range of issues. What we would hope for from NICE
would be that it could act as an honest broker and appraise evidence
equally and do essentially what we have attempted to do, often
re-inventing the wheel many times over in each health authority
by appraising the body of evidence systematically ourselves. Yes,
you are right, we do need to take NICE's evidence on trust and
it does need to be credible. We have also read the concerns in
the literature about NICE's impartiality and it has to a degree
dented its credibility with us in public health.
179. So you would say from that that more openness
about the process and more consistency in the appraisal teams
is a must.
(Dr Crayford) Yes; essential.
(Dr Walker) I would agree with some of that. Although
we are not experts in all the things NICE will look at, we are
involved in a lot of areas like commissioning and development
of services, where we work with a wide range of specialists. For
example, when a cancer drug is being introduced or is proposed,
a whole cancer network in my area will get together and discuss
this guidance and will critically view the evidence which is presented
and it will not just be one individual, it will be many people
looking at it from different perspectives. We get the information
back and we are part of that group and we can represent that information
without necessarily being expert in it.
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