Examination of Witnesses (Questions 28
WEDNESDAY 16 JANUARY 2002
28. Can I welcome our second group of witnesses
and express my appreciation to you for your cooperation with the
Committee in this inquiry and for your written evidence. Could
you each initially introduce yourselves to the Committee? Could
you, in doing so, indicate any involvement you have had to date
with any funding that your organisation or you have received from
drug companies? Obviously it is of some relevance to our inquiry.
(Mr Moore) My name is Andrew Moore. I am a biochemist
and the executive editor of Bandolier, which is an evidence
based news letter in the NHS that has a very large website which
has the best part of 200,000 visitors per week. I am also a researcher
in pain research, particularly in areas around evidence based
medicine. I have had very little contact with NICE apart from
on the basis of an expert witness, looking at the evidence on
one product base, the coccyx, for a pharmaceutical company. For
25 years, I have worked in various aspects of research, much of
which has been funded by government, some of which has been funded
by pharmaceutical companies and some of which has been funded
by charities. We work to one rule only and that is that any work
we do should be published and we have the absolute right to publish
which I believe gives us a degree of independence which is quite
important in this area.
(Professor Walley) I am Professor Walley.
I am Professor of Clinical Pharmacology at the University of Liverpool.
I am also a consultant physician in the NHS and chairman of the
Drugs and Therapeutics Committee at the Royal University Hospital.
I have been involved in studying prescribing as research for the
past ten years. Currently, I have had no funding from the pharmaceutical
industry but I do hold funding as one of the units responsible
for producing technology assessment reviews on which NICE would
base its appraisals.
(Mr Newdick) I am Chris Newdick. I am the reader in
health law at the University of Reading. I am also a member of
the Priorities Committee on Berkshire Health Authority. I have
no other connection with NICE.
(Dr Duerden) I am Martin Duerden. I am a part time
GP. I have had a long interest in matters relating to medicines
policy, evidence based medicine and prescribing advice. I have
worked for the National Prescribing Centre which receives funding
from NICE and I am currently working for Prodigy, which also receives
funding from NICE. I have been involved with a pharmaceutical
company in terms of helping to prepare a submission to NICE.
(Professor Kendall) I am Martin Kendall and I am the
chairman of the Joint Formulary Committee which produces the BNF,
which I think is why I am here today. I am also a member of the
Committee on the Safety of Medicine. I am a Professor of Clinical
Pharmacology in Birmingham and my day job is as a consultant physician
in Birmingham. I have no links with NICE at all and I have no
direct financial links with any member of the pharmaceutical industry.
(Mr Mehta) My name is Dinesh Mehta. I am the executive
editor of The British National Formulary. We have no direct
links with NICE; nor do we have any links at all with the pharmaceutical
industry or any direct links with the Department of Health.
29. Dr Duerden, you argue in your evidence for
separating decisions about clinical effectiveness from affordability.
What should NICE do?
(Dr Duerden) That is a very tricky question and I
wish I had a very clear answer to it. It is something that needs
to be thought through very carefully because at the moment it
is in a very difficult position in terms of giving a view on cost
effectiveness and expecting people to be able to afford to provide
that alongside a lot of conflicting other priorities. One way
round that is to maybe suggest that some of the work of NICE could
be a National Institute of Clinical Evidence. It could do a pure,
evidence based medicine report that would take into account all
the advice and information that it provided for and, at that point,
also look at the potential impact of using the therapies within
clinical practice, what the particular costs may be, what the
resource implications may be and maybe at that stage hand that
package across to another body that decides on how affordable
that is, whether it fits within the NHS priorities or alongside
things like national service frameworks.
30. Last week I went to see the chief executive
of a hospital trust close to my constituency who expressed concern
about the timing of NICE guidance and you make reference to that
in your evidence. Could you explain what you mean when you refer
to NICE flight?
(Dr Duerden) It is a slightly pejorative term. Maybe
I should not have used it but it has been used by quite a lot
of other commentators on this subject. It is a situation that
has arisen and I do not put the blame on NICE. It is just the
situation where it has been expected to prepare a lot of guidance
almost immediately, as soon as it comes into being, and there
is a backlog of things that need handling. There are many issues
within clinical practice where you really want decisions made
very clearly. Unfortunately what has happened is that the providers,
the people responsible for making decisions about whether a therapy
will be provided, have been placed in an invidious position. They
cannot give a positive proposal in case NICE comes along and contradicts
that. They cannot give a negative proposal because the Department
of Health says that it is not appropriate not to make a decision
on this matter. At the moment, that has created major problems
for many health care organisations. They really are trying to
just hold back until they get their various determinations through
so that they can make proper planning and strategic decisions.
It has made a considerable difficulty, in many respects, worse
than it was before. Hopefully, that will get resolved as time
31. I wondered if it went a stage further than
that. You do not know what NICE is going to appraise. It is a
fairly obscure process and I cannot quite see the logic or the
continuation of thought behind it, but is there sometimes the
thought that this is a new drug? It is likely that NICE might
look at it and people are waiting on that decision before they
make their own and it goes back a stage beyond that which you
have just identified.
(Dr Duerden) It would be difficult to cite evidence,
particularly around things like cancer therapies. You can see
new therapies coming along there beginning to emerge as possible
useful interventions, but at the same time you are aware that
there is a prioritisation list for NICE and you are not quite
clear whether that particular procedure would be on the NICE list
and therefore you hang fire. It is a lot of resource to do this
type of evaluation. It needs a lot of expertise. You might not
want to use that expertise locally when you have other things
to get on with and therefore you hang back and you wait.
32. The whole thing is a delay to the patient?
(Dr Duerden) Yes.
33. You also suggest that NICE should have greater
independence from the political processes. What evidence do you
have that it is not independent?
(Dr Duerden) I do not. It is a perception and that
perception needs to be dispelled.
34. How do you dispel perceptions?
(Dr Duerden) We talked earlier on about the issues
in relation to Relenza and the reversal of the decision. That
created a perception that maybe NICE had been got at, that it
had made a change in response to major political pressure, pressure
from the media and the drug industry.
35. Do you think it was got at?
(Dr Duerden) I do not know but it gave that impression.
I think we need to try to dispel that impression.
36. Could you also argue that it was being receptive
to all sorts of people's views and in another world, if we want
patients' groups and everything else to have influence, perhaps
decisions or ideas do get changed because
(Dr Duerden) I can see that. That is the problem.
That is a real dilemma in terms of getting that balance right.
We want a body that will take account of many different issues
such as evidence based medicine, which I personally think should
be the driving force, but also things like patient requirements,
patient needs, the things that they think are most important and
that can meet political expediency as well. Therefore, getting
that balance can be very difficult.
37. How do you stay independent?
(Dr Duerden) One of the ways would be what I have
suggested which is that you have an evidence based body which
makes very specific appraisals of the evidence and the implications
of using those therapies and maybe leave another body to respond
to all those political and other pressures to make a decision.
We have a problem at the moment in that we are expecting a single
body to deal with everything. I am not sure how practical that
38. On affordability, given that there will
always be a finite limit on the funds available for the health
service generally, let alone the pharmaceutical budget, and given
the advances in pharmacological technology in recent years, surely
any assessment that is just purely technical and is not informed
by affordability is going to be of diminishing value because money
spent on one thing is clearly money not spent on the other.
(Dr Duerden) There are quite a few different components
to that argument. You end up having a philosophical discussion.
I think that needs to be sorted out, but you could spend a long
time discussing that. One element is removing interventions which
are ineffective, where there is clear evidence they are ineffective.
I do not think we have been very good at doing that. That is one
element to make sure you use resources wisely. There are other
elements in terms of affordability, in terms of making sure that
when you look at a particular treatment you look at it in the
total management package that is involved in that treatment. One
of the concerns I would have about the NICE appraisal system is
it is looking at very specifically focusing on an individual drug
rather than looking at the overall care of a patient. If you are
going to deal with affordability, you really do need to get into
that area. NICE does have a remit to get into guidelines and that
is beginning to develop. I see the real future in the strength
of NICE as being around having good clinical guidelines to make
sure that we maximise intervention appropriately.
39. That implies a broader, more comprehensive
approach to affordability rather than ignoring it altogether.
(Dr Duerden) Yes, I agree. There is a dilemma there
again because I am saying let us step back and take a very narrow
focus in terms of evidence based medicine but then you need to
put that in the context of the overall care of the patient. That
can be done but I am not sure that the process is correct at this
point in time.