Examination of Witnesses (Questions 260
WEDNESDAY 23 JANUARY 2002
260. So you are not criticising NICE per
se in terms of the Appraisal Committee. You are saying that
some of the contracts they give out to various other institutions
or people are not of high enough standard. Is that it?
(Mr Gray) Certainly where we touch the process we
see a high level of factual error and we are aware from a recruitment
point of view that NICE recognise the problem themselves.
261. Would you be prepared to name any of the
recent appraisals which have fallen into that category?
(Mr Gray) Pretty much factual errors of varying degree
have occurred in all of the individual appraisals which we have
been involved in. An example would be in a diabetes treatment
where the original assessment included commentary about use of
the product on its own with patients, not in combination with
any other products. That is actually outside of the licence indication.
We were able to point that out and it was changed. That would
be one example.
262. Do you think this whole business has seriously
affected NICE's judgements? What proportion of the reports would
you say this applied to, or is it just one or two?
(Mr Gray) Clearly as the process has developed, and
we should say that the degree of openness of the process has improved
over time, therefore our ability to assist the assessment groups
in identifying these kinds of errors has improved over time. As
I also said at the beginning of my answer, we do not have a question
about the quality of the individual on the Appraisal Committee
itself, but it is very difficult to follow through and give you
a percentage of occasions on which it comes up with a poor answer
in that case. In terms of our own experience, we do have areas
such as the example I gave, where even though we caught that particular
issue with the indication, once we got to the end of the process,
in our view we would still feel that the guidance was unclear
by the time it was finished. That is about as much as I could
263. The other thing you suggest is that the
industry itself should be involved in the selection of treatments
and procedures and drugs which are looked at by NICE. Do you think
that is important?
(Mr Gray) I think it is important that all stakeholders
264. How would it help?
(Mr Gray) We had an eloquent answer to that from the
last set of witnesses about how really the identification of NICE's
workload needs to be better allied to the challenges which the
National Health Service faces. If that is the case, then the process
of setting NICE's workload really should have the input of all
groups who can make a contribution. I did notice that NICE itself
have put their own submission to this Committee on their website
and I notice that they are calling for that themselves. They have
identified, as did the last group of witnesses, that people who
work in the National Health Service should be involved. Similarly
we would feel ourselves and patient groups and expert groups,
Royal College of General Practitioners, whatever, are all valuable
people who can help understand the balance of challenges that
the NHS face and particularly if there is a focus on guidance
and not appraisal which areas are likely to bring the greatest
265. Is that something which is shared with
the industry as a whole?
(Dr Jones) Very much so.
266. Would they like to be able to be involved
in what is submitted?
(Dr Jones) All the stakeholders involved ought to
be part of a transparent process there.
267. Of selection?
(Dr Jones) Yes, of selection of the priorities which
need to be identified.
268. Would ABPI do that?
(Dr Jones) We could offer an individual or individuals
who could represent the wider view of the industry to do that.
That said, over the years some of us have sat in areas and represented
industry although we wear a particular company tag. For 12 years
I was a member of the Medicines Commission. I do not think in
any way that gave me a bias because of where I was at the time.
We can do that in an objective way with all the declarations of
interest on the table.
(Mr Gray) I have not actually seen it in full myself
but I understand that the Department did announce yesterday that
they were going to issue a consultation document on this very
point which GlaxoSmithKline would certainly welcome and would
look forward to making a constructive contribution to that.
269. I note that the ABPI's evidence does actually
say that you have been involved in discussions with the Department
and NICE about the process for the selection of topics. Are we
right to conclude that it is already happening?
(Dr Jones) We have had very constructive discussions
on that following the endorsement of the Prime Minister about
working together generally. We have made submissions to them.
We understand from the statements recently that there will be
some consultation now by NICE on this issue. We look forward to
seeing that consultation. Hopefully it will reflect many of the
discussions we have had very openly with them in the last six
or nine months.
270. Do you feel the direction is going that
(Dr Jones) Indeed. For example, we welcome the statements
the Secretary of State made last week on the response to the Kennedy
issues; the point made about independence earlier. It is pragmatically
necessary to have this link somehow to the Department of Health
and the National Health Service. NICE became some isolated body,
it is just not going to be tied into the overall system. The idea
that the Secretary of State has mooted, that it has more independence
and direction in its own activities, is very welcome. Yes, this
dialogue has been very productive. We have put our proposals and
we look forward to seeing the consultation document which I believe
will come out shortly.
271. Would you welcome patients being as involved
in that process as others?
(Dr Jones) There is a group called Patients Involved
in NICE (PIN) who also have regular dialogue.
(Dr Patterson) Patients, health providers, primary
care physicians should all have input.
(Dr Patterson) The point we want to make is about
the selection of technologies (for assessment) rather than guidelines.
You cannot simply take a technology at launch, (ie a new medicine),
and always be able to do the work which gives you the definitive
answer. If it is a medicine which is in a well trodden area of
medicine like diabetes or asthma, you might well have the kind
of information you need to make cost effectiveness measures. However,
if you have a brand new treatment for Alzheimer's for instance
where there is nothing else that works and it is a difficult area
to measure, it is going to take some while of usage in real life
to establish cost effectiveness which takes availability in the
health system to achieve. We are in danger of a Catch 22. If all
the medicines are assessed at launch, a large number of them,
or interesting ones, may well not get through. You have heard
already that if they do not get through, they will not be prescribed,
they will not get onto formularies, so we will lose some really
273. How do you balance the tensions within
your own organisation about which technologies get put forward?
Is that difficult? Can you always give an impartial view? Obviously
there are competing pressures there, are there not?
(Dr Patterson) We all have competing pressures in
our own organisations and we make priority decisions.
274. There are competing pressures in this place,
I can tell you.
(Mr Campbell-Morrison) I should like to go to some
points raised by Mr Gray and the public health doctors about the
issue of funding and priority, for instance we are very involved
with cancer drugs at the moment. The Government has been very
generous in the present financial year, in the region of £258
million allocated for new treatments in cancer and we really do
not think that is being fed through. It is very difficult with
the financial systems to see what that is actually being spent
on. Talking to oncologists, it appears that has not reached the
oncology unit, it has been used for pressures in other parts of
the system. A partial answer to the public health doctors is that
the money allocated by the Government for cancer treatments should
be used for cancer treatment as far as possible.
Chairman: Mr Burns has noted that you have said
the Government has been very generous.
275. It has more or less been covered but back
to Mr Gray. You have been arguing in your submission for full
disclosure of the membership of the Technical Advisory Group and
there have been many submissions around transparency, also for
disclosure of level of industry representation. Who else should
be involved in decisions about NICE's agenda?
(Mr Gray) Clearly we would agree with the submission
that patient groups and patient representatives will be involved.
Local health care areas, be it PCTs or whatever, would seem again
to have a strong contribution to make, as indeed may some of the
professional bodies: Royal College of General Practitioners, other
276. Let me play Devil's Advocate for a moment.
We all say yes, this is nice and fluffy and consultation is the
thing to do. I agree, but it takes time.
(Mr Gray) It does.
277. The longer you take over a consultation,
the longer people are waiting for medicine. Where is that balance?
(Mr Gray) That is one of the reasons why we feel that
the emphasis on medicine or technology appraisal is letting down
NICE's track record. Actually a concentration on the provision
of guidelines and best practice within which PCOs, PCTs, individual
clinicians, could start to work with the available medicines and
technologies to achieve those goals, is much more likely to produce
the outcome that NICE and everybody else is looking for. Obviously
once one starts to look at different therapeutic areas and different
diseases, there are far fewer of them than there are individual
medicines and individual technologies. That in itself should help
the issue of workload and how much success NICE is likely to have.
The other benefit is indeed that local primary care organisations
or local clinicians are then less likely to perceive an either/or
in areas where clear guidance is provided by NICE about what is
best practice. They can work with their individual patients to
try to achieve those goals. In areas where there is not yet NICE
guidance, there is not really a situation where clinicians or
primary care organisations would say they are not doing that until
there is a NICE recommendation. Clearly if there is no NICE recommendation
for psoriasis, the GP is not going to tell the patient to wait
and come back when NICE have decided on psoriasis. They will use
their clinical judgement experience to deal with that patient
in much the same way they do now. Our submission would be that
that move in concentration towards the guidelines and away from
the appraisal process helps NICE in many ways.
278. Then the other things will automatically
come on board, such as the patient's input.
(Mr Gray) Exactly.
279. May I just go back a step, because we have
missed something out on breast cancer? If the evidence is so incontrovertible
particular drug, why are the oncologists not all
jumping up and down, or are they?
(Mr Campbell-Morrison) They are.
(Mr McKinney) They are.