Examination of Witnesses (Questions 60
- 79)
WEDNESDAY 16 JANUARY 2002
DR MARTIN
DUERDEN, MR
CHRIS NEWDICK,
PROFESSOR TOM
WALLEY, PROFESSOR
MARTIN KENDALL,
MR DINESH
MEHTA AND
MR ANDREW
MOORE
60. Surely, NICE would have taken the views
of cardiologists into account in formulating their advice?
(Mr Mehta) Indeed. We imagine they should have and
would have.
61. We might have two or three different consultant
cardiologists giving different advice?
(Mr Mehta) Yes. That is perfectly possible.
62. Why would your advice be preferred to NICE's
advice?
(Mr Mehta) Everybody, whether the BNF, NICE or any
other organisation that provides guidance, has to work from the
evidence. On the major points of evidence, there was really no
huge discrepancy. It was the details where we had some concerns.
For example, we know that there are certain drugs which, given
after a heart attack, prevent further problems. The BNF advisers
have taken the view that those drugs really ought to be started
while the patient is still in the hospital, being treated for
their heart attack, rather than to suggest that if it is not possible
to do it in hospital the GP perhaps might do it. Our advisers
took the view that, on this particular point, it was much better
to get the patient established on the correct medication before
the patient was discharged.
Dr Taylor
63. We have had some pretty severe criticisms
from the Drug and Therapeutics Bulletin about several of the works
NICE has done that they have looked into, particularly the use
of Relenza, obesity drugs, motor neurone disease drugs and the
Alzheimer's drugs. Are you aware of those criticisms that have
come from them and do you support those? What are your reactions
to those?
(Dr Taylor) I must say I gave the drug and therapeutics
bulletin a plug. The British National Formulary is the second
thing junior doctors carry in their pocket after their stethoscope.
Mr Burns
64. Perhaps you should have declared an interest.
(Mr Mehta) Going back to Relenza, yes indeed, there
were difficulties. We and our advisers saw practical difficulties
in implementing NICE advice and therefore the BNF reflected the
NICE advice but (in square brackets—it is an editorial comment
here) it said, "But see notes above". In the notes above
it actually says, "Hang on. There are one or two groups of
patients you are recommending this intervention for but it is
not actually appropriate because the drug cannot properly be used
in these patients, for example, people with respiratory problems".
The product literature for the medicine says that you need to
take precautions when you are using this drug for people with
respiratory problems. However, NICE guidance suggests that it
is these very people that should be given Relenza if they have
an attack of the `flu.
Dr Taylor
65. So a pretty significant disagreement?
(Mr Mehta) Yes.
(Professor Kendall) The other thing to say is that
we do not give the whole lot. We summarise the key points. There
are one or two occasions like that where we have chosen to draw
attention to the fact that we are concerned and therefore we have
given a note saying, for example, that you should not give it
to people with asthma.
Dr Naysmith
66. My final question is to the BNF representatives.
Let me make it quite clear that this is asked in a spirit of inquiry
and carries no connotations other than that. In this area people
are very anxious to attribute bias to people who are getting money
from drug companies and being influenced in that situation. The
BNF as I understand it, the Editorial Committee, is made up of
representatives of the Royal Pharmaceutical Society and the British
Medical Association, with representatives from the Department
of Health. Both of the first two organisations are a cross between
a trade union and a trade association. Is there any suggestion
of bias in that? Do you come across lobbying from within your
professions to try and make sure that treatments which are felt
to be well worthwhile, even though there is no scientific evidence
for them, are included?
(Professor Kendall) I would say firmly and categorically
no. The editorial team is one of the most monastic (if I can put
it that way) in their views about the pharmaceutical industry.
My colleague here would be reticent about saying this but if he
found that one of his editorial staff had a biro with a drug name
in he would break it in two. He feels lquite strongly about this.
I think that we go out of our way to be independent. Our whole
reputation depends upon being independent. If doctors felt and
pharmacists felt that we were doing anything that showed any kind
of bias then our reputation would be lost. I would make the point
that all doctors, all pharmacists, all medical students, all pharmacy
students have this (the BNF). We come in for quite a lot of close
scrutiny.
67. Thank you for that robust defence. What
I really meant to ask was, in this conflict of advice which Richard
was eliciting from you between NICE and your publication how is
it that you expect your readers to differentiate between the two
sets of advice when the Formulary says something and NICE says
something else? How would you recommend that practising doctors
decide?
(Professor Kendall) We go out of our way to make it
quite clear. I think we have submitted this as a document in evidence
(the BNF). What we have done is to pick out all the pages where
we have printed NICE advice.
68. I have it here.
(Professor Kendall) And so we go out of our way to
make it quite clear what we think they should do and if it is
not what NICE says we are quite robust about that. I do not think
there would be any doubt about it.
69. How do they choose, is the question.
(Professor Kendall) The good example is Relenza and
asthma. The advice about Relenza is that although NICE recommends
that this drug might be used for people with bronchitis and asthma,
it is recommended that the drug should not be used in these patients
and certainly not without care. We make it quite clear what the
doctor should do.
70. And you expect them to take your advice
rather than that of NICE?
(Professor Kendall) Absolutely.
Jim Dowd
71. In the notes it says that on rare occasions
the Formulary Committee, because of concerns about quality of
advice, omits the NICE guidance.
(Professor Kendall) Yes.
72. Is it not more objective for you to publish
that and give your reasons why you find it to be defective rather
than pretending it does not exist?
(Mr Mehta) The BNF is very much a manual for use while
the patient is in front of you. It is meant to give you answers
very quickly and without sitting on the fence. It does not really
often have the room to discuss the pros and cons of particular
arguments and for that reason it would be difficult to say, "NICE
has given this particular piece of advice; however, the BNF does
not agree with this advice, you should do something else and these
are the reasons". Instead of that the BNF says, "This
is what should be done" which is much clearer and for the
busy practitioner it is much easier to follow that advice.
(Professor Kendall) We have offered to read the NICE
guidelines before they come out and come up with these little
points before they go public and so far they have not taken up
the offer although it still stands. We would like to be able to
have the guidelines take notice of our views. We obviously do
not want to change those views but the more people who read it
the more you pick up things that might go wrong.
73. You do want to change their views if you
think their conclusions are incorrect.
(Professor Kendall) Absolutely, we do want to change
their views. What I mean to say is that I do not want us to be
seen as a lobby group. I think they are people who are coming
up with their own ideas but sometimes when you have written down
your ideas you omit to notice that you have actually recommended
something which is not sensible. It does not fit in with the type
of patient your are treating or whatever. The BNF has been checking
guidelines for the last umpteen years and we still note errors
and improve clarity. We have very careful editorial staff and
I am sure we can be quite constructive to NICE.
Dr Naysmith
74. I want to move on to Professor Walley. You
indicate in your evidence that NICE can never be entirely independent
of Government since "the Government must consider resources
to the National Health Service and a possible alternative use
of those resources". Does that mean that you believe that
NICE is not independent of government as it is set up now and
operates now?
(Professor Walley) I think we need to distinguish
which part of NICE's formal activities we are talking about. There
are two areas to my mind where NICE cannot be independent of government.
The first is in setting which technologies it will embrace, and
the second is in deciding what resources will be available to
meet the appraisals at the end. At the start and at the end I
do not believe NICE can be independent of government. The bit
in between where the appraisals are being taken, as far as I know
that is independent of government. I know of no government influence
during the appraisal or review process.
75. So you do not believe that NICE should be
independent of government? You do not think it can be independent?
Not the appraisal part but the referral and the resources.
(Professor Walley) I think in an ideal world NICE
would be independent of government and would be seen as a body
giving advice to government. My concern at the moment is that
NICE is seen to determine what NHS priorities are and this really
should be the minister. NICE should be advising the minister and
be seen to be advising the minister. The minister should be seen
to either accept or reject NICE advice. I would go along with
the argument that NICE can undertake an appraisal of the evidence.
Issues of affordability are political issues and not for NICE
to decide.
76. So should there be ring fenced funding for
NICE and the part of their series of projects that could be government
recommended and they could decide, "This needs looking at
and we will do it"? But if they had enough ring fenced money
they could do that, could they not?
(Professor Walley) I would hesitate to dedicate a
clear budget for NICE activities only, at least in advance. I
think, however, once the Minister has accepted an appraisal from
NICE the funding to meet that appraisal should be considered centrally.
It is not appropriate in every case that it should be administered
centrally. For instance, we might consider in the high volume,
medium cost products that would fall into the remit of the average
GP that it would be inappropriate that that should be considered
for central funding, but areas where NICE appraisals recommend
therapies which are really only for use by highly trained specialists
in very well defined patient groups, I think it is appropriate
that those should be considered for central funding. That has
several advantages. One of the current problems when NICE approves
a very high cost technology is the effect it has on a health authority
in a year. A health authority will have difficulty delivering
that technology from its already overstretched budget. As has
been said already, the only option for a health authority is that
it will divert funding from other areas of its overall care into
that technology. The other areas of care are perhaps less visible
and not well appraised, but sometimes the postcode rationing is
shifted away from the technology under appraisal into the unappraised
less visible areas. A clear acknowledgement of central funding
for specific areas of administration centrally would avoid that.
There are other advantages as well for central funding. It would
mean that we could administer the drug according to very fixed
protocols in very well defined patients. We could collect data
about who had actually received the drug and what the outcomes
of that were which at the moment we are very poor at doing in
the NHS. There are several advantages of selective central funding
to meet NICE appraisals but I would not advise it for all NICE
appraisals.
77. I was talking about the funding of the research
process and the whole process of NICE at a national level, but
you have answered some other questions. Maybe it was my fault
for not making it clearer. The question was really the question
of resources for the whole NICE process in terms of producing
valid results that people really have confidence in and that the
Government can have confidence in. Do you think that needs more
resources?
(Professor Walley) I think it does need more resource.
Evidence is very expensive. As one of the units trying to do this
work we are conscious that we are constantly working against deadlines,
we are working within limited resources, we cannot do everything
we would like to do in the time available. However, that is the
reality of the National Health Service across the board.
78. Does that mean you think that just occasionally
NICE advice is, if not flawed, not as good as it should be?
(Professor Walley) There have been occasions when
it could have been more robust.
Mr Burns
79. Can I ask what the occasions were when it
could have been more robust?
(Professor Walley) There are several examples. For
instance, I would point to Zanamivir advice which you have already
considered this afternoon. I have some hesitations about the advice
around anti-obesity agents. My particular point there would be
tht they considered the technologies in isolation of the condition.
For instance, we have two appraisals on two separate technologies
rather than the consideration of how we should manage obesity
in the whole of the NHS. It is being driven by the existence of
the technology, not the priority of the NHS in managing the condition.
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