Examination of Witnesses (Questions 1
WEDNESDAY 16 JANUARY 2002
1. Can I welcome you to this first session of
our inquiry into NICE and can I particularly welcome our first
group of witnesses? Can I thank you for your cooperation with
our inquiry and particularly for your very helpful written evidence?
Could you briefly introduce yourselves to the Committee?
(Clara MacKay) My name is Clara MacKay. I am the principal
policy adviser with responsibility for health at the Consumers'
Association. What I would like to do by way of introduction is
to say a few words about the Consumers' Association in general
and then turn over to my colleague to say a few words.
2. Most of my colleagues know about your organisation
and perhaps we can expand on that when we ask general questions.
(Dr Iheanacho) My name is Ike Iheanacho. I am deputy
editor of Drug and Therapeutics Bulletin, one of the Consumers'
3. Can I begin, Ms MacKay, by asking you about
the inquiry that your organisation undertook into NICE? What was
the background to that and what were the reasons for it?
(Clara MacKay) The Consumers' Association has followed
NICE very closely right from the point that it was established
through to the present and the Consumers' Association was one
of the first organisations to meet with the newly established
institute. We fully support and continue to support the principles
behind NICE and had not set out earlier this year to work some
campaign and research around it. It is not the case that the CA
had identified NICE as something that we would construct a formal
campaign around. Occasionally, DTB do some reviews themselves
that touch on guidance that NICE has done and we have crossed
paths with them. Part of our campaign that we have been running
is lobbying against the introduction of legislation to allow the
promotion of prescription drugs. We did take a keen interest in
the work of something called the Pharmaceutical Industry Competitiveness
Task Force and this is a government industry task force that was
set up in 1999 with a remit to look at ways to ensure that the
United Kingdom pharmaceutical industry retains its competitive
edge. This task force was chaired by Lord Hunt. When the task
force was first established, we wrote to Lord Hunt and we indicated
that we had some concerns about the lack of public and patient
input to the task force and we felt there were some issues they
would be considering that were very pertinent to the public interest.
When the task force reported in March 2001, it did deal with and
make recommendations about issues that greatly impact on the NHS
patients and the public. Some of those recommendations were very
closely linked to work that we were doing on direct consumer advertising
but we also noted that the report dealt quite extensively with
issues about NICE and about a scheduled review that would take
place around NICE. That was scheduled for last summer. It seemed
to us at that time, in reading the task force report and in talking
to some of the individuals involved, that there was a real need
to intervene to ensure that the patient and public interest was
considered in the actual review, even though the task force itself
was not going to conduct this review. When we had some informal
discussions with patient organisations that had an interest in
NICE, that reinforced our concern that there was not a lot of
knowledge about the review that was going to take place and we
all felt generally that, without some formal way of intervening
and raising patient concerns, the review would take place without
this important input and the patient perspective.
4. This was the background?
(Clara MacKay) Yes. Given the very tight time frame,
we felt that an inquiry type arrangement would be the best way
to flesh out and flag up the issues.
5. You proceeded to invite witnesses?
(Clara MacKay) Yes. Not unlike a health select committee,
we had a small panel chairing and we invited organisations, including
NICE, to provide written evidence as well as to come to an inquiry
day where questions would be put to them and issues pursued.
6. From the work you did in this inquiry, do
you feel there are particular areas that we especially need to
examine? What were the key concerns that came out of your own
(Clara MacKay) Two key issues struck me from the inquiry.
One is the enormous amount of effort and time that patient organisations
invest in the NICE process, an incredible drain on resources,
particularly for smaller organisations. Linked to that, a real
concern across the board of patient organisations not having a
sense of the impact that they make on the outcome of guidance
and that seems to be a crucial issue. One of our key recommendations
is we believe that resources need to be made available to support
patient organisations. Linked to that and equally important is
what emerged from the inquiry, which is a great deal of confusion
about the appraisal process and a lack of transparency and clarity
about how individual appraisals are undertaken. That was a very
strong theme from the organisations that gave evidence.
7. You have emphasised the role of patient organisations
and you said there needs to be more time for them to consult with
the members but you have also raised concerns about delays in
the NICE process. How do you square the two areas? How can you
have it both ways?
(Clara MacKay) You are quite right. A number of patient
organisations raised issues about very short, very tight time
frames that they were expected to respond to. I would repeat that
their biggest concern when they did respond was that they were
never sure what the real impact of their input was. I would go
back to the point I made earlier about the transparency issue.
It seemed to me, looking at the evidence, that as the process
was not explicit it was often difficult for patient organisations
to have a sense of when and what it was they needed to be able
to contribute and improving administrative processes could be
quite easily dealt with. A more explicit process would help to
resolve some of those problems. It is very important that although
we would call for any unnecessary delays in the appraisal process
to be eliminated patient organisations, in the same way as manufacturers,
should have an adequate opportunity to consider the information
that is being provided and have a chance to respond to that. It
is eliminating unnecessary delays, getting an appraisal through
as quickly as possible, but doing it appropriately and that is
about giving organisations sufficient time to be able to respond
to queries and to the process.
8. One of the issues about transparency and
one of the concerns expressed in some of the evidence is related
to commercial confidentiality. Was this an issue you looked at?
Do you feel it is possible to square transparency with dealing
with those concerns?
(Clara MacKay) We did not go into a lot of detail
in terms of the actual going back to NICE, confirming process
and pursuing the issues that were raised in our inquiry. The point
was to get these issues on the table and to make sure that the
formal review process and this process takes them into account.
Commercial confidentiality is important but where an element of
information is pivotal to a decision about whether to endorse
or not to endorse a treatment, on balance, the information available
should point to that conclusion. I think there has been some wide
concern that that is not always the case.
9. Dr Iheanacho, so far NICE has published 31
technology appraisals and you have highlighted six in your submission
which there were problems with. I thought the points you raised
were very good but could you comment on whether the other 25 were
without flaws or you just picked six as an example?
(Dr Iheanacho) The topics that we looked at were nine
in number. There were six major areas of interest, six treatment
areas, but in all NICE has issued nine pieces of guidance relating
to those areas. In total, we are talking about a third of the
31 technology appraisal guidance documents that you refer to.
We came to look at those because they are areas in which DTB had
published guidance by the time NICE issued its own, so we were
interested to see whether they came to the same conclusion or
different conclusions or we published guidance after NICE had
given its advice and therefore we wanted to take NICE advice into
account when reaching our own conclusions. All the areas which
we have reviewed fulfil those criteria. They are not things that
we have cherry picked because we are interested in either criticising
or praising NICE specifically on those areas. On the second part
of your question, if you consider the six areas in which we have
found flaws, the kind of flaws that we have found are far ranging,
we think. Although it would be comforting to think that the examples
that we have highlighted represent a minority, we think it is
hard to believe that the other 22 can be assumed to be perfect
in every respect. The kind of issues we are raising relate to
the scope which the guidance has taken, how narrow or wide the
brief for the guidance has been, how the evidence has been collated,
how it has been interpreted, how it has been presented, how it
has been used in offering guidance, how in some cases there seems
to be a lack of evidential basis for some of the recommendations
made and no alternative, convincing rationale for following that
line of advice. When you consider that scale of problems, it would
make us concerned that what we are looking at are fairly fundamental
problems, not things which are isolated incidents.
10. What have you done as a result of highlighting
the difficulties? Have you communicated those to NICE and, if
so, what has the feedback been?
(Dr Iheanacho) The first time we ran into this kind
of problem related to evidence and advice NICE offered on a drug
called Relenza. It is an anti-flu drug. When NICE issued its revised
guidance as it then was in November 2000, we looked at the evidential
basis. They had changed their minds. They were now recommending
Relenza having previously said that it should not be used in the
NHS. There were a large number of issues of concern which were
obvious to us, so much so that we felt that we really should communicate
this to NICE to see whether we were missing the point somewhere
or whether there were areas of genuine debate or whether there
were flaws in the advice. We compiled a fairly detailed report
listing all of our concerns and sent that to NICE. That was in
February last year, 11 months ago. To date, we have not received
an official response to that report. We have not received a rebuttal.
NICE has not formally accepted our invitation to debate the issues
we raised. Subsequently, perhaps slightly chastened by the experience,
we have not prepared anything like the same systematic reports
relating to the other areas of guidance, but we do not see that
as our role. It is not our role to criticise what NICE does. We
have submitted drafts of our advice in preparation for NICE to
comment. In the compilation of that advice, we have been very
careful to say that this is the conclusion NICE has reached and
to make it clear if we take a different view, so they have had
an opportunity to come back to us and say, "No, you have
got it wrong. You have misinterpreted the concerns" or, "You
are looking at the wrong piece of guidance or evidence",
or whatever. In general, we have received little or no response
to those submissions.
11. Is that from NICE?
(Dr Iheanacho) Yes.
12. What about the wider medical community?
Surely the specialists who prescribe any of these drugs will have
an opinion, I suspect. In highlighting those discrepancies, have
you had any feedback from health professionals?
(Dr Iheanacho) In giving our advice in terms of publication,
we have not majored differences between us and NICE. We do not
see that as our role. Our role is to come to an independent view
about a treatment or an intervention and to reflect that to our
readers. We have pointed out where there are differences between
us and NICE so that people can at least, if they want to, look
at the basis on which we have reached our judgments and also look
at the basis on which NICE has offered its advice. We have not
said, "We do not agree with them because of this, this and
this" and invited comments on those issues because in a way,
for us, that would be a slight distraction. We see our role as
offering an independent view based on the evidence as we read
it, and that is what we have done.
13. You have argued that the slimming drug,
Sibutramine, should not be given because of the safety risks associated
with its use. NICE have argued that it is wrong to reject a drug
on safety grounds as the risk benefit analysis had already been
done at the time of licensing. In the light of NICE's comments,
would you revise your position or would you like to comment on
what NICE are saying?
(Dr Iheanacho) Our reasons for coming to a negative
opinion about Sibutramine were not related specifically to safety
issues. Having reviewed not only the limited evidence of efficacy
but also the safety concerns about the drug and the practical
issues of using the drug in the NHS, which are as crucial sometimes
as safety and efficacy issuesfor instance, contra-indications
which are numberous with this particular drug; interactions with
other medication, again a potentially problematic thing for prescribers
and patients to deal withwe felt that in the round we could
not justify recommending this drug. I would like to take up the
point you mentioned about safety issues. I think you are reflecting
NICE's view that the drug should not not be recommended because
there are safety concerns about it, if it has a licence. I can
see where that argument comes from but I think it has to be tempered
slightly. If you have a drug which has expensive safety concerns
of any kind, it is inevitable that those concerns should feed
into any evaluation of the cost effectiveness of that drug because
if the safety issues necessitate special treatment, special monitoring,
or if a drug is prone to produce unwanted effects which consume
a lot of health resources, inevitably, if you are performing a
detailed cost effectiveness analysis of the benefits of that drug,
safety will be an issue. I would temper any view that says, because
a drug has a licence we can be reassured totally on safety issues
or that we can concentrate on this slightly nebulous term "cost
effectiveness" and completely ignore any safety concerns.
14. Would you go as far as to say that some
of NICE's advice has been bordering on the dangerous?
(Dr Iheanacho) I would not put it in those terms.
Sometimes, when you look at guidance, you do not see references
to safety concerns. Sometimes you do. Where it is missing, it
is not clear why it is missing. Sometimes it could have an influence
on prescribers or indeed a patient's wish to use that drug. It
is an unsettling feeling because you do not know whether the issue
has been taken into account and just not reflected in the guidance
or whether it has not been taken into account when assessing whether
the drug should be recommended or not. That is the difficulty.
It may well have been taken into account but if there is a serious
safety concern people should be able to share NICE's, or indeed
anyone else's, thinking as to why that does or does not lead to
a decision for or against use of a drug in the NHS.
15. The safety issue does concern me. It has
been highlighted somewhereI cannot remember where, unfortunatelythat
NICE have been enthusiastically endorsing products which are subject
to the black triangle and the medical reporting scheme. There
was a thought that that might be slightly irresponsible, that
they were actually advocating a greater use than was good while
that was still undergoing heavy surveillance. Could you comment
(Dr Iheanacho) I cannot think of a specific example.
16. The notes which I scribbled on I left behind
in my office.
(Dr Iheanacho) If you look at the interventions on
which NICE has issued guidance, a lot of them are new drugs and
therefore will be, by definition, black triangle drugsie,
drugs which are under intense monitoring because they are new,
so there would be nothing surprising about that. What would be
worrying would be if there were recommendations which go beyond
the licensed indication, the indications for which the drug has
been specifically licensed, without a clear explanation as to
why NICE, or indeed anyone else, feels there is a compelling reason
to go beyond licensed indications. If guidance recommends unlicensed
indications, if anything, the evidential basis for that recommendation
has to be at least as strong as for the licence indications.
17. Like the new anti-diabetic drugs you highlight
in your evidence?
(Dr Iheanacho) Yes. If that relates to your example,
the issue there is that in its recommendations NICE is suggesting
use of these new drugs outside the terms of the licence. Prescribing
outside the terms of the licence is part of medical practice.
There are certain circumstances in which doctors and other prescribers
will use drugs outside the licensed indications. That in itself
is not necessarily a problem. The problem comes when you do it
with new drugs, because there is not the experience necessary
to justify doing that; or you do it for drugs where there is no
evidence to back up that unlicensed indication. You could be leaping
in the dark because you do not have the solid, background knowledge
that you would have for a drug which has been licensed specifically
for that indication or for a drug which has been used for years
and years and where people are familiar with the way it behaves.
If guidance is going to say that "this is what the licensed
indication is but we feel that it can be used in this other way",
the rationale for using it in this other way has to be absolutely
clear because, if it is not, people are entitled to say, "There
is no evidence to back this up. There is no wealth of experience
that says this is a safe or useful thing to do. Why are we being
asked to do it?"
18. I would like to thank you for the submission
because to my mind this is one of the best submissions that we
have had and I think it is incredibly helpful and points the way
that the whole of this inquiry of ours can go. As far as the Drug
and Therapeutics Bulletin is concerned, as a relatively recently
practising doctor, I regarded that without doubt as one of the
two or three most essential bits of reading for practising doctors
so I am a bit biased in that I am very much in favour of you.
I would like to explore your views of the independence of NICE
because that is one thing that we will be looking at. Turning
to Relenza itself, have you any idea why they changed their mind?
Was it really the evidence? Was it pressure from the industry?
Was it pressure from the government?
(Dr Iheanacho) I cannot answer that question. I can
only go on the basis of their stated reasons, which was their
reading of the evidence. Fundamentally, that is where the Drug
and Therapeutics Bulletin and the Institute disagree.
19. You actually went back to them and had no
(Dr Iheanacho) We went back to them not just to say
that we were publishing an article; we went back with a 10 page
report listing everything that we thought was an issue of concern
and inviting them to debate those privately if they wished or
to come back to us and say, "No, you are wrong because you
have misinterpreted what we said or the data." We know, I
suppose, what their view of our recommendation is: that it is
different from theirs and therefore not sustainable, but we do
not know what they think of our detailed comments. That is unsettling
for us because we would like to know how they reached their decision;
do they think their decision is still justified in the light of
what we have said? If they think we are wrong, they should tell
us. We would very much like to know, but we do not have, the answers
to those questions.
Dr Taylor: This would strike me as being one
of the very obvious questions we have to ask. I was almost horrified
by the extent of criticism that you have in all these areas.
1 Note by Witness: While I cannot say for sure
that the 22 pieces of guidance we have not looked at in as much
detail have flaws, I would be hesitant in assuming otherwise. Back