Examination of Witnesses (Questions 880
- 899)
THURSDAY 20 JANUARY 2005
PROFESSOR SIR
MICHAEL RAWLINS
AND MR
ANDREW DILLON
CBE
Q880 Chairman: We have actually had
that point made by patients.
Professor Sir Michael Rawlins:
I think they are absolutely right.
Q881 Chairman: Do you have anything
to add to that, Mr Dillon?
Mr Dillon: Just a thought that
those who produce and those who use our technologies have some
strong common interests, that ultimately the benefits of what
is produced have to go through to patients, but they also have
some different interests too. They help to produce health technologies
and have a need to make a return on their investment and to keep
the businesses that they are responsible for viable in order that
they can produce good things in the future for example, and those
who, like NICE to some extent, value those products have a different
set of responsibilities. Because of that, I think it is really
important that when those different interests engage, there is
actually a structured and open and transparent process that recognises
the reality of those different drivers and makes sure that they
can be reconciled in a way that enables those who look at how
decisions are taken to understand how they are taken and to be
satisfied that they are taken objectively.
Q882 John Austin: In your submission,
you acknowledge that there is a potential conflict of interest
with the pharmaceutical industry's involvement in NICE's processes
given their key responsibility to their shareholders to secure
markets for their products and you have given a detailed description
of the processes you follow to minimise this risk. The industry
is also involved in selecting the topics that NICE addresses in
its advisory programme.
Professor Sir Michael Rawlins:
It is ministers who fall responsible. The industry can comment
on it. No companies have refused to take part in an appraisal
or a guideline but it is not them who decide whether their product
will go forward, it is actually ultimately ministers.
Q883 John Austin: So, they do not
have an independent involvement in determining?
Professor Sir Michael Rawlins:
They are present in ACTS, the Advisory Committee on Technology
Selection.
Mr Dillon: There is an advisory
committee within the Department of Health and the industry has
seats on that quite large committee, but ultimately decisions
are taken by ministers.
Q884 John Austin: Do you see any
benefits or disbenefits of the industry being involved at that
stage?
Mr Dillon: For us, the really
important thing is that we pick up emerging technologies as early
as possible in order that we can start work on evaluating them
so that we can provide advice to the NHS as quickly as possible
after they introduce them to the UK market. The people who know
earliest and most about those emerging technologies are those
who manufacture them. So, an understanding of how products are
developed and the ways in which information can be obtained about
developing products properly through publicly available data is
quite important and I think one of the benefits of industry participation
in that selection process is to provide that sort of perspective.
Q885 John Austin: You will be aware
from our previous inquiry that we know your position and how you
share our view on the importance of involving patients with patient
organisations. It has been suggested now that some patient organisations
might be very closely in bed with the pharmaceutical companies
and many of them are funded by them. Do you think there are risks
there and what is your view towards patient involvement where
there is a clear link with the pharmaceutical industry?
Professor Sir Michael Rawlins:
We do not exclude patient organisations or professional organisations
because they have some relationship with a pharmaceutical company
but we do formally ask them when they come to give evidence at
the present committee meetings if they know what those interests
are and we record them and they are placed in our minutes and
the minutes of the meetings are placed on the website and I have
a copy here of the guide which indicates the approach that is
taken. We do not exclude them because they have an interest, I
think that would be wrong, but we make sure that we know about
the interest and we make sure that the members of the committee
know about the interest and take that into account as part of
the judgment.
Q886 John Austin: Can I ask an unrelated
question arising out of the exchange between myself and Sir Alasdair
in the earlier session when we were talking about SSRIs. I put
a question to Sir Alasdair following the report of the Expert
Working Group when the MHRA put out a statement following the
report saying that SSRIs are effective medicines in the treatment
of depression and anxiety conditions and I asked Sir Alasdair
if that should have had some qualification to it. Could I ascertain
the position of NICE because I asked specifically about the use
of antidepressants in the treatment of mild depression. Could
you confirm that NICE does not recommend the use of drug treatment
in mild depression.
Professor Sir Michael Rawlins:
I think it depends on the circumstances. We have recently produced
a guideline on the management of depressive illness and that guideline
indicates that, in mild depression, it may not be appropriate
to go for pharmacological treatments but other sorts of therapy
too. It is a very difficult decision if you are a general practitioner
or psychiatrist as to the circumstances when you think that drug
therapy is appropriate and circumstances when it is not. It is
not all that easy to tell in the real world. We did want to shift
a little bit away from automatically prescribing and availability
of other forms of treatment. We were also very conscious that
clinical psychologists are in short supply in the Health Service
and those sorts of techniques, what someone would pejoratively
call talking therapies, are important and that is one of the reasons
why we have actually done an appraisal of computer behavioural
therapy and they are at an early stage but they are another alternative
route to that sort of form of treatment. Andrew, do you want to
come in there?
Mr Dillon: No, that is a good
summary.
Q887 John Austin: Would you acknowledge
that there appears to be a difference of view between NICE and
what the MHRA were saying?
Professor Sir Michael Rawlins:
I do not think so really. Having been Chairman of the Committee
on Safety of Medicines for six years and Vice-Chairman for six
years, I am well versed in the archaic rites of it all although
it is six years since I was involved but it is slightly different.
The regulatory authority is primarily there to regulate the industry,
that is what the Medicines Act is set up to do, and previous chairmen
used to shout at me when I was a raw young youth on the committee
with Alasdair, they used to shout at both of us, that we were
the Committee on Safety of Medicines and not Medicine and our
role was regulating the industry and not regulating the profession.
It is a difficult thing to balance and do; it was difficult when
I was chairing the CSM and I am not sure it is not easier now.
I think there has been a shift over the years to being more engaged
with the professions, more helping them to prescribe appropriately
and so on, which was not the original intention but I think that
is the right direction to go in.
Q888 Dr Taylor: Could you remind
the Committee about the selection of drugs for evaluation, how
you do it or who does it.
Professor Sir Michael Rawlins:
The topic selection is formally made by ministers. There is a
somewhat complicated process which Andrew is much more well versed
in because he goes to the committee meetings.
Q889 Dr Taylor: So, you do have some
influence in guiding the minister on what to select?
Professor Sir Michael Rawlins:
Yes.
Mr Dillon: Very briefly, there
is a whole series of sources of information about the kind of
pharmaceuticals that NICE might look at and bear in mind that
we only ever look at a small proportion of the total of new drugs
introduced into the UK market at any one period of time. All that
is looked at by a group called the Advisory Committee on Topic
Selection, which is a Department of Health Committee with a whole
range of membership from inside and outside the NHS. That creates
a shortlist which is reviewed by a joint planning group that has
NICE and Department of Health membership on it and that group
makes final recommendations through civil servants to the minister.
Q890 Dr Taylor: Would you tend to
try and concentrate on drugs that offer a real advantage but fill
a real gap?
Mr Dillon: Yes. There are actually
published criteria for selecting pharmaceuticals, those where
there is the potential for real therapeutic gain, and another
criteria might be where there is potential for very substantial
resource impact on the NHS, and another would be where there is
already considerable uncertainty in the Health Service about the
therapeutic value of the drug and therefore NICE can add value
by perhaps reducing some of that uncertainty.
Q891 Dr Taylor: How are you getting
on weeding out some of the things that do not provide particular
advantages or particularly good value?
Mr Dillon: Not well enough because
we have not done enough on that, we have not had enough topics
fed through to us and it is something that we, the ministers and
the NHS think should change. In fact, the Department of Health
is about to launch a series of workshops or seminars with the
NHS to identify those topics in order that they can be fed through
to the Institute.
Q892 Dr Taylor: Can you not feed
them in yourselves and say, "This needs looking at. We want
to get rid of it"?
Professor Sir Michael Rawlins:
We could do but actually the Formulary does not have many totally
inactive things in, I would be ashamed if it did since I was on
the CSM for so long, and some of the very old things that you
and I used to have to learn about in our youth are in the Formulary
but are hardly ever used and to go through the whole . . .
Q893 Dr Taylor: So, it is not much
of a problem?
Professor Sir Michael Rawlins:
I think it is but I think it is more subtle. I think it is much
more in areas like diagnostics. The pathologists have made proposals
about the sorts of things which should not be done any more. The
radiologists displaying films of the skull say this should not
be done any more. I think it is those sorts of areas that offer
opportunities that we really need to explore to a greater extent,
even complementary and alternative therapy.
Q894 Dr Naysmith: I want to explore
this concept of substantial therapeutic advance just a little
further and ask if there are any other implications for NICE in
this. Some of the witnesses have suggested that it would be good
if NICE could set criteria about what does and what does not constitute
a therapeutic advance. Would that be something you would be interested
in doing or is it so bound about by circumstances and depends
on this, that and the other that it is not worth trying?
Professor Sir Michael Rawlins:
There have been discussions across the world about, what is innovation?
I think the first group is where there is a substantial health
gain in areas that have been previously untreated and those, I
think, are the ones that we, as a society, would like to encourage.
There is a very interesting report from the WHO commissioned by
the Dutch Government on priority medicines making some really
fundamental points about areas of great need, not just the sort
of diseases of the third world like malaria but many other conditions
which are common both in developing countries and in developed
countries for which there is virtually no really effective form
of treatment and for which there is great, great medical need.
Somehow, we need to encourage those areas of researches and I
think there are a number of moves in that direction. Professor
Woods was just talking a few minutes ago about the regulatory
part of that. One of the very interesting things and I think a
very important thing is that there is much more pluralism in drug
discovery nowadays. University departments and so on are much
more actively involved. The National Institute of Health is setting
up its own chemical library for academics in the United StatesI
do not know if others will have access to itto be exploring
drugs. I do not think that is regarded as a failure of the pharmaceutical
industry, I think it is a good thing that others are involved
in an area which for 50 years pharmacologists have not been in
universities.
Q895 Dr Naysmith: But it is not an
area in which you see much role for NICE?
Mr Dillon: In a way, NICE has
done because all the decisions that we make together act as a
kind of case law. Those who want to understand in a sense what
it takes to obtain support for innovative interventions or want
to identify what it takes in a sense to get NICE's support and
endorsement for real therapeutic value, just take a look at the
decisions and indeed how the decisions have been taken. You can
look at the standard methodology that we have published on evaluating
the clinical and cost effectiveness of interventions and look
at how that methodology has been translated into specific decisions
and there is a story really over the last five years or so which
is, as I say, a kind of case law which could be used by those
who want to understand how innovation is interpreted, at least
in the UK.
Professor Sir Michael Rawlins:
Just to finally follow on from that, I have often used this example
but Riluzole for Motor Neurone Disease which prolongs life by
up to a year, we felt that was an important innovation for a disease
that had previously never had anything at all specific. It was
expensive at £38,000 per QALY. Relenza for influenza which
you give to everybody also comes in at £38,000 per QALY and
reduces your symptoms by a day and we said no to Relenza for everybody
and yes to Riluzole. So, I think that demonstrates how we interpret
it anyway.
Q896 Dr Naysmith: Can we move on
to something different. What, in your view, are the factors that
contribute to the time lag between the launch for a new drug and
the publication of NICE guidance on new technologies?
Professor Sir Michael Rawlins:
The processesand Andrew will go into some of the detailinvolve
a very careful scrutiny of the relevant literature, full systematic
review. That takes quite a considerable amount of time. Many hundreds,
sometimes thousands, of references have to be looked at. We also
have a very liberal, I believe liberal in the best sense of the
word, approach to engaging our stakeholders and they have opportunity
to comment and even to appeal against decisions. All that takes
time. If we curtail it in any way we will do either a less robust
job or we will end up disenfranchising some of our stakeholders.
I believe the route we should be taking is to start with the appraisals
around the same time as the licensing process and then complete
the appraisal once we know the outcome of the licensing process.
We have been doing this for the last couple of years. One of the
difficulties, which happened, is that halfway through the licensing
process and halfway through our appraisal the gentleman behind
me finds there is a problem in the licensing, so it gets held
up for a perfectly good reason I am sure, which means then we
get held up in our appraisal process and have to stick that on
hold.
Q897 Dr Naysmith: You are trying
to get to the stage where the appraisal will be published about
the same time as the drug's launch?
Mr Dillon: We have to wait about
three months, I think, but we need to know the precise indications
the MHRA are granting.
Q898 Dr Naysmith: Are there any lessons
to be learned from the drug licensing process for you in this
in speeding things up? It used to take far longer 20 years ago
than it does now for licensing.
Professor Sir Michael Rawlins:
I think we are fortunate, unlike the licensing process where they
have to react to demand and the problems of surges and so on.
I remember it from years back, it was always happening. For example,
when they introduced a fee in 1988, there were huge surges the
week before it came into force, which might have been predicted.
We do not have that problem, we can control the rate at which
things come in, which is an advantage to us.
Q899 Dr Taylor: Are you working more
closely with the MHRA than we got the impression you were when
we did the short inquiry in 2002, I think?
Professor Sir Michael Rawlins:
I think we are and we have developed very good relationships.
When we launched our depression guideline, we did it, as it were,
as a joint enterprise with the MHRA because of the licensing issues
which came up at the same time. I think that is a way we would
wish to work, but nevertheless, we have separate functions.
|