Examination of Witnesses (Questions 360
WEDNESDAY 30 JANUARY 2002
360. Finally, how would you assess and what
weighting would you give to patients' experiences of particular
treatments, particularly when their experience of a treatment
conflicted directly with the results of RCTs?
(Professor Barnett) With great difficulty. This is
not easy. I would say, however, that we rarely, if ever, hear
from patients who have been harmed by a treatment. What we get
is a lot of very positive testimonials to the quality of their
experience. I can think of one exampleand I will not quote
the appraisal itselfin which we got 70 or 80 separate letters
attesting to the quality of this particular intervention, one
of which actually said, "It did me no good." Only one.
So I am a bit concerned about who represents whom and what the
balance of that judgment is there. I think also that we do take
on board that there are differences of opinion. You raised the
example about cancer and we are very concerned and have been concerned
in the appraisals we have done on cancer topics, which were very
complex, very difficult, about issues of quality of life, about
how much life is worth having depending upon the quality in which
you endure it. We have had representations from some patients
and care organisations who say, "We don't want doctors to
tell us what the quality of our life should be. We want extension
of life irrespective of the pain and suffering that the drug may
cause." Alternatively, we have heard that patients and carers
do wish to be fully informed and make the decision that they are
not prepared to put up with adverse effects. So we take all that
into consideration. Balancing it up and getting the correct approach
to it is not easy but it is the only process of its kind which
is done in this way internationally.
361. I would certainly like to come in on cancer,
but, before I do, you chaps seem pretty pleased with yourselves,
if you do not mind me saying. Your evidence here seems to be a
little bit complacent and self-congratulatory. You are shaking
your head, but that is the way it comes across to me. You were
budgeted for £12 million; that is rising. You have dealt
with over 30 appraisals; you have given the green light to six
and the rest you have given some restriction in. But, before coming
on to cancer, the thing I want to ask you is: Do you think that
the National Institute for Clinical Excellence is actually working
(Professor Sir Michael Rawlins) Yes, I do. I think
it has already enabled thousands of patients to have access to
treatments that they would not otherwise have had. When we started
off there was this ugly phenomenon of post-code prescribing, which
was accidental, not deliberate, nobody's particular fault, but
it was a scar on the health service. It was loathed by the public,
it was loathed by patients and it was loathed by health professionals.
The prospect of having two patients side by side in a hospital
ward, one having one treatment and one another because one health
authority would not pay for that particular form of treatment
was just impossible. To stand on the Tyne Bridge and have access
to Alzheimer's drugs north and no access south is not tolerable
in a national health service. If we have done something to eradicate
that very unfortunate practice, I actually do feel quite pleased
and quite proudand I think rightly so. As the time goes
on, we hope that NICE will not only make sure that there is access
to treatments but also that the quality of care that we can give
as health professionals for patients is improved. This is not
a weakness of the health service. I do not want to go away with
this as another health service problem. Every health care system
in the world is struggling with the problem of trying to improve
the quality of care using known effective forms of treatment for
their patients. We have a lot of discussions with the United States,
who have three times as much money to spend per person on health
care and who actually in very many respects have just as poor
quality for their patients as we do, and there is a global initiative
going on to try to improve the quality of care. We are part of
that. We will not get there quickly but we very much hope to shift
the whole median of quality of care. I am sorry if we sound arrogant.
We have goals. We have not begun to meet many of them, but we
have goals and aspirations and a vision for which we are quite
362. Thank you. That is a very clear answer.
You think that patients are better off with your organisation.
Let us deal with cancer specifically and I will come on to Professor
Barnett's point about quality of life. Can you explain, Professor
Rawlins, how your organisation reconciles the NHS cancer plan's
commitment to the publication of your service guidelines on palliative
and supportive care for people living with cancer in 2001 with
the fact that these are now not expected for another two years,
2003? Can you explain that?
(Professor Sir Michael Rawlins) Mr Dillon, would you
like to explain?
363. You cannot explain it?
(Professor Sir Michael Rawlins) I can, but
perhaps you were not here when I explained at the beginning that
I do not take part in the appraisals and I do not take part in
the detail of the guidelines because I have to stand back and
wait for appeals. I therefore, on legal advice, have to stick
way back until such time as those processes are completed so it
would be more appropriate for Mr Dillon to answer this.
364. I just thought you would know something
about the time delay, but never mind. Mr Dillon?
(Mr Dillon) The whole of our guidelines programme
started later than we wanted it to. The fact is, as I mentioned
earlier, that when we were formed in 1999 the first staff were
appointed by the Institute in July 1999. The priority as it was
given to us by the Department and the Assembly was to establish
the appraisal programme and that is what we did. In establishing
it, it took all the resources that the Institute was able to bring
together at such short notice. The guidelines programme therefore
had to start later and commitments that might have been made previously
about anticipated time lines were not delivered on because inevitably
it took time for the Institute to be established, to get in place
enough people to design the programmes which enable us to produce
365. And you do not think it is pretty bad,
this two-year delay?
(Professor Sir Michael Rawlins) All guidelines take
round about two years to construct. The guideline construction
and development, whether it is done by us or whether it is done
by the Agency for Health Care in Washington, or whether it is
done by the Rand Institute in Los Angeles, Santa Monica, takes
about two years to produce a full clinical guideline on a particular
366. Can you give us any date in 2003 when we
will have the guidelines?
(Mr Dillon) The palliative care cancer service guideline,
the actual date in 2003
367. It would just be very helpful to the huge
number of people who are interested in this subject if you could
specify somewhere within the 12 months when we could expect the
(Mr Dillon) The information that I have just been
given shows that there are two parts to the guidelines. We plan
to deliver the first of those in November 2002 and the second
part in July 2003.
368. Thank you for that. Professor Barnett,
you were talking about the quality of life with cancer patients.
What do you think your organisation will be doing to ensure that?
(Professor Barnett) First of all can I say that it
is not my organisation. I chair the Independent Advisory Committee.
369. I just hate using the word "NICE".
(Professor Barnett) Fine.
370. The National Institute for Clinical Excellence
that you are associated with. Presumably you are here to support
your two colleagues.
(Professor Barnett) I am here to give evidence on
what I feel we do, yes. The question again?
371. You want me to repeat the question?
(Professor Barnett) Please.
372. What is this organisation actually going
to do to ensure that cancer patients do enjoy some sort of quality
(Professor Barnett) What we are going to do is that
the Appraisal Committee will look at what evidence there is for
the way in which anti-cancer drugs do influence quality of life.
What is obvious is that for the vast majority of anti-cancer drugs
which are presently licensed measuring the quality of life improvement
these drugs produce is not part of the licensing procedure. Many
of the trials do not include quality of life estimates. Most of
the patient information we get is from patients and relates to
their personal experience and is a very important part of the
appraisal process which enables us to try and assess the quality
of life. Listening to those values and judging the balance of
risks and benefits for the patients is a very important part of
this process. The evidence base for that, however, is very poor
and I think that the appraisal process in the way it functions
at present will encourage future trials to take on this point
of view and therefore produce better evidence in the future. What
we have to do at present is to deal with what we have, and therefore
listening to patients and assessing their quality of life interest
is a very important part of our process. The Appraisal Committee,
the individual members of it, take this very seriously.
373. Finally, gentlemen, could you confirm that
the National Institute for Clinical Excellence back in July 2000
published guidance about hearing aids including digital hearing
aidsand you are very familiar with this because there has
been an exchange already about this in the House of Commonsbefore
an NHS bulk purchasing contract of digital hearing aids had been
completed which revealed that the NHS can buy digital hearing
aids for just £150. How could this august organisation provide
guidance on the cost effectiveness of digital hearing aids before
the price of digital hearing aids was known to the NHS? How is
(Mr Dillon) First of all the NICE guidance was not
specifically about digital hearing aids. The guidance was on advances
in hearing aid technology. What we were doing was looking at the
current range of hearing aids available to the NHS, for example,
including programmable analogue aids. We base our calculations
of cost effectiveness on the information that is available to
us at the time. The information that we used in relation to any
of the hearing aids was the price paid by the NHS for those aids
at the time we were conducting our appraisal. We are not involved
in, nor would we wish to be, any negotiations that the Department
of Health has with manufacturers to supply any technology to the
374. Can I come back to postcode rationing because
this is something that is close to all our hearts? I absolutely
welcome your aim to get rid of it but, as you know, you have not
got rid of it anywhere near yet. One of the problems that has
been raised goes under the phrase of "NICE blight",
as I am sure you are aware. If we turn to some anti-cancer drugs
we had an example of this over the weekend on a programme on Midlands
television, which I am sure you did not see, but an eminent oncologist
in Birmingham was saying absolutely clearly that for certain anti-cancer
drugs which are under study by you at the moment but have not
been passed he is prepared to jump up and down and make sure his
health authority provides them, but people in South Staffordshire
and Worcestershireand he actually mentioned those twodo
not get those drugs. We are talking about drugs that are of crucial
benefit because unfortunately your study, quite understandably,
takes a long time. Is there any way that you could, perhaps in
partnership with the BNF, perhaps in partnership with the Drug
and Therapeutic Bulletin, which are both intensely well read (even
though I have retired I have got my up to date BNF because I need
it), provide interim advice that would avoid this? We cannot have
people in Worcestershire and South Staffordshire not getting what
is of patent benefit that people in Birmingham are getting?
(Mr Dillon) Apart from anything this underscores the
advantages of early referral of technologies to the Institute.
One of the things that we have been doing is to press the Department
and the Assembly to refer technologies, including pharmaceuticals,
to us to enable us to issue guidance to the NHS as close as possible
to their point of launch into the Service, and we have been able
to do that with a number, including the glitazones used for people
with diabetes. That worked very well. The Service got the guidance
very quickly after the drugs became available. When NICE was established
the Department of Health issued guidance to NHS organisations
that said that they had to use their local arrangements to make
decisions about the way in which technologies that are being appraised
by NICE should be used whilst the guidance is being prepared.
We recently had an approach from a Director of Public Health who
said that, given that they had to do this, it would be very helpful
if they were to be able to get access to evidence that is being
used by the Institute to undertake appraisals whilst we were doing
it as it were. We have thought about this and we think it is a
good idea, so again, as part of our new process, we will be publishing
on our web site what we are going to call an appraisal consultation
document. It is in affect the results of the Appraisal Committee's
first consideration of any individual technology. Everyone will
be able to see the direction and travel of the Institute's thinking.
One advantage of that will be that anybody can comment on it,
so we are being even more inclusive and transparent in terms of
how we engage with those who have an interest in what we do than
we were in the old process. We have also decided that we will
be putting on our web site the assessment report that we were
discussing earlier which has been prepared by the independent
academic body. That will enable the NHS organisations that are
attempting to get this interim fix sorted out to have access to
good quality information so that they will be able to put in place
an interim policy, of whatever kind they think is appropriate,
whilst they are waiting for the Institute's guidance to be published.
(Professor Sir Michael Rawlins) Can I add one other
point to that? We have been playing a lot of catch-up at NICE.
We have been looking at anti-cancer drugs that were first launched
in 1994. This is not a tolerable situation. What we do need to
do, as I said earlier, is to be proactive. We need to be starting
the appraisal process a year before a drug is licensed. It is
perfectly feasible to do it. The pharmaceutical industry thought
we would find it very difficult but we have actually done it on
a number of occasions now12. In 10 out of the 12 there
was no appeal against the decisions we reached, it worked pretty
well, and in fact in at least six of them the companies have used
NICE's good housekeeping seal of approval on their advertising.
Whether I am happy about that I am not sure but that is another
matter. We have to do it in advance; otherwise we will be getting
into this wretched situation for years and years to come.
375. A comment that other people have made is
that they have welcomed some of your negative advice very much.
Are there not treatments, techniques, which are still used that
do not work that you could get rid of fairly quickly?
(Professor Sir Michael Rawlins) Not all that quickly.
We would have to go through the due process; otherwise we would
find ourselves down at the Royal Courts of Justice in the Strand.
We would have to do it very carefully but it is indeed one of
the things that all of us want to do, to get rid of useless treatments
or inferior treatments. That is one of the reasons again why we
are so anxious to engage the Health Service in the agenda setting
of NICE's programmes.
376. You have said that you want to engage other
people. The impression we got from the British National Formulary
was that you did not work particularly closely with them. Is that
(Professor Sir Michael Rawlins) The British National
Formulary have received many of our forms of guidance in draft
form, have they, Mr Dillon?
(Mr Dillon) No. The BNF is not a formal consultee.
The definition of "consultees" is representative patient
and professional organisations that have a direct interest in
the work that we do, and manufacturers. Having said that, the
Royal Pharmaceutical Society is a consultee in our process.
377. Should you not consider having the BNF
because of its importance? It is what almost everyone carries.
(Mr Dillon) It is whether it is better to go to the
BNF or whether consulting with the representative professional
bodies and the Royal Pharmaceutical Society is better targeting
our requests for advice.
378. What I think you are trying to get at are
the prescribing doctors and that is what they carry, is it not?
(Mr Dillon) They carry it but do not the professional
organisations represent clinicians, and, indeed, the specialist
societies that we identify as consultees?
(Professor Barnett) I agree with you entirely, Dr
Taylor. Senior clinicians carry the BNF. The BNF is an important
listing of drugs that are licensed, drugs that can be prescribed,
their dosage schedules, their contra indications, and it contains
within it a degree of advice about when appropriately to use this
medication. But they do not identify themselves and should not
be acted upon or even be accepted as guidance in practice for
a particular clinical situation. The guidance that the Appraisal
Committee is intended to provide is a very different sort of guidance.
It should be read in conjunction with the BNF, not instead of
or in any other way. I feel that way myself because I carry it
too. I think it is important.
379. You have said "in conjunction".
I am not convinced you are working in conjunction with them.
(Professor Sir Michael Rawlins) I think I am right
in saying that when the Royal Pharmaceutical Society respond it
is often with comments from the BNF. Is that right or not?
(Mr Dillon) Honestly I do not know whether I have
seen comments that are specifically attributed to anyone within
the BNF. It would be the Joint Formulary Committee I think that
we would have to go to, so we would have to decide that it was
appropriate that the Joint Formulary Committee of the BNF, and
specifically its editor, was an appropriate consulted and represented
clinicians' views. Clearly you feel strongly as a practitioner
that it should be and that is obviously something that we would
now have to consider.