Examination of Witness (Questions 60-79)
ANDY BURNHAM
MP
26 OCTOBER 2006
Q60 Chairman: Anyway, I will let
you look at that. In general terms—and I think you alluded
to this yourself a few minutes ago—trusts have been pressurised
to improve financial forecasting as a result of recent deficits.
Does the unpredictability of the financial impact of NICE guidelines
not make accurate forecasting very difficult? You mentioned earlier
the new cancer drug. We believe there are probably half a dozen
trusts waiting now for licensing to be brought into the market
place, as it were, which has major financial implications for
the National Health Service in providing them on prescription.
Andy Burnham: It is obviously
a difficult thing to anticipate the costs that may be coming in
terms of drugs coming on to the market. You could never make that
a precise science, could you? It is obviously dictated by the
pace of science and the activities in which companies are involved.
Provision is made within PCT allocations for the funding of new
technology that NICE will have approved and that will then come
on to the market, because, obviously, as I was saying before,
that is not a negotiable issue, it has to be complied with. Provision
is made in terms of the PCT allocations for that cost pressure
but it is obviously very difficult to do it treatment by treatment
or technology by technology. The anticipated impact of NICE guidance
is factored into financial planning within the Department, as
you would probably guess, and work goes on within the Department
about the size of the drugs bill, obviously, and efforts to keep
it under control, but also to anticipate what it will be.
Q61 Anne Milton: I would like to
make a plea, following on from the Chairman's last comments. If
there is a general acceptance that the work of NICE is important
and critical, trust in it is absolutely paramount. I think that
the public trust is waning at the moment. I appreciate the comments
you have made about poor press reporting, and on the other side
of this big debate is drugs companies with huge amounts of money
to throw at the marketing, but I think reassurance from you that
things like the implementation of guidelines, taking into account
the total cost of health but all social care, and also taking
into account the opportunities that exist—the one that is
coming up is the vaccine for cervical cancer—are going to
be really important in order to readdress the loss of trust in
the NICE decisions.
Andy Burnham: I understand the
point you are making and I think the issue of trust is crucially
important. As politicians, I think we have a job of leadership
to do in terms of the public debating on these issues. I would
also say—and this is depressing in relation to the reporting
of the Health Service—that, of the 26 cancer drugs that
NICE has looked at, it has approved 25. There is not a great deal
of coverage about the 25 but there is obviously a lot about the
one or two that do not get approved. That is why I suppose I was
making a plea for balance. If all the public reads are difficult
headlines about the one that does not get approved, it is not
surprising that there is a jaundiced view that develops about
bureaucrats who are denying us treatments. This is not just an
attack saying that everyone misunderstands NICE; there is a responsibility
on me too to explain their job better. In response to Sandra Gidley's
point and Doug Naysmith's point, if we can put more information
before the public, we should do. That is a duty on us. I think
we all have a responsibility in this but my plea to everybody
is that inherently there is a balance that NICE are making, a
balancing test: clinical benefit versus cost effectiveness, and
often the portrayal of it is: "There is clinical benefit
but they will not pay." People take away the balancing test
from the coverage and it just becomes a very black and white issue
and it is disappointing, particularly given the NHS budget is
obviously under particular pressure from new technology.
Q62 Dr Naysmith: Minister, could
we move to a more positive note for a few minutes. You will recall,
when you were a member of this Committee, that on more than one
occasion we came across treatments and so on that were not very
much used. Everybody recognised they were not very much used but
they lingered on for historical reasons in the National Health
Service—and not just in the National Health Service but
elsewhere as well. It was really pleasing, therefore, to see that
you have recently introduced a new programme of work for NICE,
the aim of which is to identify and stop ineffective interventions.
It is clear that this Committee is occasionally useful and it
is nice that you remembered that, now that you are a minister.
That arises directly from the Pharmaceutical Industry and National
Health Service inquiry. There was a lot of evidence of things
that were a waste of money: Why did we not get rid of them? Would
you tell us how this is going to work?
Andy Burnham: Maybe I can put
a stunning revelation before the Committee this morning and flatter
you all. Being a poacher turned gamekeeper I can assure you that
you are all well and truly listened to inside the Department.
A considerable amount of work goes on on each committee report.
Q63 Dr Naysmith: How are you going
to get this programme running? How are you going to identify the
treatments at which NICE should be looking?
Andy Burnham: With the NHS, it
seems to me, we are constantly saying, "Do everything you
have done before and then this little bit more." We are constantly
loading things on the pile but not taking stuff off the bottom.
When I was saying to Sandra about how we move NICE forward, that
it should not be a static organisation but it should be a changing
organisation, that is precisely what we should do. I personally
would like to see some growth in that area. We have funded NICE
to do this work. Originally they will look at treatments that
cost the NHS £1 million or more. Obviously there are examples
of those kinds of treatments that people could think about, but
I think it is important. Again, there may be the potential of
the negative coverage of some of this: here they are again, denying
things. I think this is an issue that the public will understand.
As technology changes some things become outdated and you do need
to help the NHS disinvest from some of the things it has been
doing for a long period of time. But yes, absolutely, that is
being taken forward.
Q64 Dr Naysmith: How much money do
you expect to save as a result of this programme in, say, the
first year or couple of years?
Andy Burnham: I think it would
be too early to give that figure. There may have been an indicative
figure that we published when we announced that NICE was doing
this work, but obviously we are going for the bigger end, where
savings could be reasonably big. But perhaps I could come back
to you on that.
Q65 Dr Naysmith: That was a trick
question really. I wanted you to say the money is not important;
it is about stopping people having ineffective interventions and
being made ill rather than better.
Andy Burnham: Obviously I am just
thinking about money, which may say something about my current
state of mind. There is obviously direct patient benefit of not
having treatments which they do not necessarily need to have.
Linked to this work, we issued productivity indicators for the
NHS—I think published for the first time this week—which
list a grade of information that the system has never really had
before. One of the things was levels or procedures for the 15
most common conditions. This kind of information is an attempt
to help people understand where they may be carrying out procedures
that are not strictly necessary.
Q66 Dr Taylor: I am sure you are
aware of the very helpful leader in the Guardian on Monday,
followed by Polly Toynbee's article on Tuesday. In the leader
on Monday it said that NICE embodies the least-bad way of tackling
an impossible job. I would like to try to get you to focus on
what we ought to be doing to make this job more possible and take
you back to our report. I do not expect you to remember it, I
have had the chance to look at it—the last two recommendations
in our report in 2001-02 were about prioritisation of healthcare
extending over the whole NHS. We said: "Prioritisation of
healthcare spending is an issue of overwhelming importance and
during the course of this inquiry it has become clear to us that
a more open debate on healthcare prioritisation needs to take
place." The Government's response to this, in a nutshell,
was that it was going to be terribly complicated to do. The last
two sentences say: "Achieving a comprehensive empirically-based
framework could therefore only be achieved in the long term. The
establishment of NICE could, however, be seen as an important
first step in that direction." What steps do you think you
could take as the Minister responsible—and this was written
four years ago—to widen the debate on healthcare rationing,
so that some of the things that a lot of us would admit the NHS
should not provide could be got rid of? That would get more money
to go into the pot, so that NICE's QALY level, whatever it is,
could come down, and we then could have more of the drugs coming
through. You also said that you are seeing new drugs coming almost
every week, so the demands are relentlessly increasing. NICE is
about to look at the treatment for age-related macular degeneration.
Unfortunately the result is not going to be out until next August,
by which time several people will have probably gone blind, which
is terribly difficult. It is really your views on healthcare rationing—and
I hate to use the word "rationing"—as a whole,
as releasing money, as well as your drive for efficiency to release
money, to make NICE's job slightly more possible.
Andy Burnham: An excellent question.
In many ways, I think you have answered it yourself. I think that
is the role NICE will have. I think it is important to society
as a whole and to the NHS as a whole that it just cannot be underestimated,
given the pressures that it is trying to reconcile. It is obviously
trying to reconcile the pressures and the costs of new technologies
with the need for an aging population to have access to the very
best. It always must be the case that the NHS makes the very best
available to those who need it. You are right, it is a relentless
pressure that NICE is under. I remember that report very well.
I probably enjoyed that report more than any other. It was a very
interesting experience. I do not know how you feel and how Sandra
feels, because she too took a huge interest in it, but the extent
to which NICE is established now as an authoritative organisation
is considerably enhanced and some way down the line from where
it was. I think it is an organisation that is growing in stature,
in confidence, and it knows the job it is doing. It knows it is
a difficult job, but it is confident in the way it handles its
communications, in terms of the advice it is giving to the system.
Obviously it is at a point, increasingly, where it has caught
up with a lot of the technology appraisals and that does open
up the scope to move into the work that Doug Naysmith was asking
me about.
Dr Taylor: I am pushing for a much wider
debate on healthcare rationing than NICE alone can do.
Chairman: Maybe we could have a discussion
on whether we want to do an inquiry on that.
Q67 Dr Taylor: You do not want me
to go on.
Andy Burnham: I will try to answer
the question very quickly. People talk about that a lot, that
the NHS has to shrink back and become more of an emergency system
that provides life-saving or life-threatening treatments.
Q68 Dr Taylor: Core services.
Andy Burnham: Core services, and
then you retreat from a whole sphere of treatment. I am still
passionately of the view that the NHS should be a comprehensive
service in terms of the population, comprehensive in terms of
the care needs that it is meeting, but, within that, it will always
have to make judgments about which treatments are best to meet
those needs. That is the job that NICE is doing. I think you are
hinting at something slightly broader.
Q69 Dr Taylor: I am.
Andy Burnham: Which personally
and politically I do not believe is justified. If you look at
the job the NHS does—in terms of the percentage of GDP that
it spends compared to other European countries but the service
it provides to everyone regardless of the condition they have—it
is phenomenal in my view. Personally, I do not think there is
an absolute complete necessity today to open up an honest debate
about rationing.
Q70 Dr Taylor: One example: should
the NHS be paying for tattoo removal?
Andy Burnham: Some of these things
should be, properly, a clinical judgment. You would defend clinical
discretion, surely. There are some treatments that I would say
are on the edge of whether or not they should be provided—and
clearly we all know what those kinds of things are—but that
is different from issuing ministerial edicts against any NHS activity
in those areas. I would agree with you, life-threatening and life-saving
are significantly different from tattoo removal.
Q71 Chairman: Could we move on to
the National Patient Safety Agency (NPSA). I would like to ask
you whether you agree with the Public Accounts Committee's conclusion
that the National Patient Safety Agency "has yet to demonstrate
value for money." I wonder if you could tell us when and
how it will demonstrate value for money.
Andy Burnham: I think that was
a harsh criticism of a new organisation, an organisation which
is beginning to establish itself and I would argue beginning to
have real benefit across the NHS. Obviously the NAO is there to
provide challenge within the system but I could point to the establishment
of the National Reporting and Learning System, which the National
Patient Safety Agency is in charge of, which is a major undertaking
and a major step forward, and these things take time to become
embedded in the culture.
Q72 Chairman: There was a two-year
delay in relation to that. It should have come out in 2002 but
it was not completed until the end of 2004. I am pleased that
it now is. The other issue is that we have been told that both
the NPSA's joint chief executives were sent on extended leave
in August of this year. What are the current arrangements for
running the NPSA under those circumstances if that is true?
Andy Burnham: It is true. There
is an acting chief executive of the NPSA, a gentleman called Bill
Murray, a retired experienced trust chief executive, who is in
charge at the moment of the agency. The issues to which you refer
are subject to internal disciplinary proceedings, so it would
not be—
Q73 Dr Taylor: I understand that,
but you are reasonably happy, under current circumstances, that
the NSPA is doing its work.
Andy Burnham: I have taken a close
interest, as you would expect, of the agency during this particular
period. The Chair, to whom I speak regularly, is a member of the
House of Lords and I have regular contact with him. Clearly, there
have been some internal difficulties. You mentioned that the reporting
and learning system had taken time to become established, which
is correct, but it is now receiving in the order of 60,000 to
70,000 safety reports every month and, as I was saying in my answer,
I would not underestimate the improvement that could bring in
terms of transforming the patient safety culture. Obviously we
want to get the agency on to a solid footing as soon as possible.
Q74 Dr Naysmith: One of your other
responsibilities, Minister, as you know, is the Medicines and
Health Care Regulatory Authority, and it has recently had on its
books probably the biggest disaster it has ever had to deal with,
the clinical testing at Northwick Park of the new monoclonal TGN1412
and there is the expert scientific group that was set up and its
interim conclusion is that the pre-clinical testing of TGN1412
did not predict a safe dose in humans. The drug was tried and
all the pre-clinical stuff had failed to show that it was going
to be really dangerous when it was put into humans for the first
time. How concerned are you by the fact that this is now the case
or may be the case for quite a significant number of new pharmaceuticals...
I was going to say, coming onto the market, but we will have to
wait and see—coming forward for testing.
Andy Burnham: As everybody, I
guess, I was very concerned when that incident happened. The fact
that such an incident is and has been so rare I would argue does
demonstrate that we have extremely high standards within our domestic
arrangements for clinical trials and in terms of the strength
of our pharmaceutical industry. I should also say that before
coming to this job I within the Home Office was responsible for
the Animal Procedures Committee and the inspection of animal testing
People have made the argument that that in some way disproves
the efficacy of the use of animals in the research and development
of new medicines. I am led to believe in this particular instance
that the dosage used in the testing of the product in animals
was significantly larger, and a very large safety margin was left
between the dosage given to those participating in the trial,
but clearly it does give cause for concern. I think the nub of
the matter, as pharmacological or pharmaceutical science develops,
is that it is obviously moving to the field of novel molecules
which can be very active and can produce change and can be a significant
breakthrough. You can obviously tell there is an English student
speaking here, but there is an issue. The point in this particular
incident was the unexpected reaction that this particular molecule
caused in the individuals concerned.
Q75 Dr Naysmith: That is the point
really, you have to find out why the MHRA's investigation did
not reach the same conclusion as the interim conclusion of your
expert scientific group. Are you having discussions with people
from the MHRA or people in your department to try to make sure
this does not happen again?
Andy Burnham: Of course. This
is of the utmost importance. Public confidence in clinical trials
is crucial, of course. We clearly do need people to participate
in clinical trials and it is a matter of the utmost seriousness
that we maintain public confidence in the regime around clinical
trials. The MRHA did go through a thorough process before approving
the stage 1 trial. A similar process carried out by the counterpart
body in Germany came to the same conclusion that the product was
safe to allow it to proceed to a stage 1 trial; so it is not that
experts here came to a different view, it obviously was a view
shared by counterparts in Germany.
Q76 Dr Naysmith: I know it is easy
after the event but there are quite a few experts in this country
who will say you could have predicted that this kind of drug would
have a different effect from previous pharmaceuticals and that
the MHRA was not then and still is not set up to undertake much
more detailed studies and recommend studies on this kind of agent.
Most of that will come out eventually, when we get the expert
scientific group's final report. When is that going to be published?
Andy Burnham: Obviously we had
interim findings from the group in the summer. In November we
are expecting to publish the final report. The MHRA has already
taken some action on the interim findings. Clearly you are right,
Doug, there is a learning process to be gone through and that
is why the Secretary of State has set up the expert scientific
group. Obviously some of the interim recommendations that the
group has already made call for earlier dialogue between the drug
developer and perhaps those organising the clinical trials with
the agency, so there was a sharing of data and information at
a much earlier stage in the process. There are also issues around
whether one person rather than a group of people should have been
trialled.
Q77 Dr Naysmith: Individuals on scientific
training have phoned up to say that this was a stupid thing to
do, to give this dose at the same time to six people. One of the
simple recommendations in the interim report is that the trials
should have been staged.
Andy Burnham: Yes.
Q78 Dr Naysmith: That seems sensible.
If a body like the MHRA does not have the power to make recommendations
of that sort, then it needs to have.
Andy Burnham: Typically, stage
1 trials have typically involved a range of anywhere between 10
and 100 people. That would be a normal range. Obviously in this
case it was six people. When we received the Committee's interim
recommendations, that was one which leapt out because it makes
practical commonsense, but I suppose you do also have to consider
what message that would send to the public. Who would be the one
person who came forward for the trial? You do have to balance
these things because it might in itself discourage people from
taking part and these things need to be balanced. The Committee,
as far as I can see, are doing an excellent job, a thorough job.
It is going to become increasingly important that we give detailed
consideration to their work because of the changing nature of
products coming on to the market and I think it is very important
that we make the appropriate changes.
Q79 Dr Naysmith: Could I just clarify
that you intend to publish the report in November. That is when
you anticipate it will be published.
Andy Burnham: Yes, and it will
be published.
Chairman: Could we move on now to the
home oxygen service.
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