Examination of Witnesses (Questions 140
WEDNESDAY 23 JANUARY 2002
140. In general terms, looking at the way NICE
operates, can total independence ever be achieved in this kind
(Dr Crayford) Probably not. It is very difficult for
all members on both sides of the fence, both the evidence NICE
listens to and the members of NICE themselves, not to be wholly
unbiased. It is almost inevitable when you are dealing with experts
in a particular field some of whom will have been working in that
field and might hold a partial view; almost certainly not.
(Dr Walker) Whenever you are looking to appraise evidence,
the evidence can never tell you the answer completely, there is
always an element of interpretation. One thing the Appraisal Committees
do have is a breadth of experience and knowledge which would allow
all opinions to be expressed. I do not particularly have concerns.
141. Do you share Ms Marlow's views on the way
in which interests ought to be made much clearer than they are
at the present time. Is it an issue which concerns you as well?
(Dr Walker) It is not an issue which has particularly
concerned me. I have not seen any evidence that it has shaped
guidance, but it is consistent with the way things are going in
medicine generally, in corporate and clinical governance, so yes,
I would support the idea.
(Dr Crayford) It would certainly add weight to the
credibility of their guidance if they were to be more explicit
about these things.
142. How do you think this might be done?
(Dr Crayford) A simple declaration of interests of
each of the members, declaration of experience, declaration of
143. May I pick up what Dr Walker said that
this is an indication of the way things are going now in medicine
generally? What do you mean by that?
(Dr Walker) In medical journals now, for example,
if you publish a research study and you have a particular interest,
you have to declare that interest at the end of the article. That
is something which has just come in in the last few years. Corporate
governance and clinical governance have been raised in profile
over the last few years and that is a good thing and we should
144. Could it also be because there is much
more support than there used to be for what used to be called
independent research? Do you think that happens? What I mean is
that there was a lot more government sponsored research and university
research. Is there any evidence now that that has been taken over
by pharmaceutical company funded research or not?
(Dr Walker) I do not know.
(Dr Crayford) Quite a lot of concern has been expressed
about pharmaceutical funding of research, in particular research
being funded through contract research organisations which perhaps
are not as independent as university-based research which used
to be the home of most drug company funded research in the past.
145. Dr Crayford, at the end of paragraph 2.1
in your submission you say "NICE has appointed high-calibre
people who have in turn ensured that the membership of the NICE
committees is heavyweight and unbiased". Then on the next
page in paragraph 2.6 you put what I think you were referring
to just now, "There are widespread concerns about NICE's
impartiality and bias towards evidence it receives from the pharmaceutical
and health technology sector".
(Dr Crayford) Yes. Two sides of the fence: one about
the ears which listen to the advice, which to most of us would
seem to be impartial, heavyweight and unbiased; secondly the type
of advice which they listen to, which we could consider to be
often partial and biased, very industry-dominated and less what
we would prefer to see which is systematic reviews of evidence.
146. That is very interesting. I was approaching
it more from the fact that NICE might be influenced from the other
side, from the government side.
(Dr Crayford) That is very likely to be true but we
would see that as a political inevitability.
(Dr Cunningham) No, no; I do not think that is a political
inevitability. You asked how independent NICE is and the independence
which concerns us particularly, now that we have to fully fund
the NICE guidance, is independence from the Department of Health.
In a sense NICE was set up to give robust guidance on the basis
of evidence and it appears now to be almost being asked to do
resource allocation by the Department of Health. It seems sensible
to separate these two functions more clearly, particularly the
selection of the portfolio which NICE considers and the decisions
which are made when NICE has made its pronouncements.
147. There appears to be general consensus among
the witnesses on that point.
(Ms Marlow) Yes.
(Dr Crayford) Yes.
(Dr Walker) Yes.
148. I want to follow up on the announcement
by Alan Milburn last week when he said that he was going to remove
himself from the process so that NICE was more independent. Is
this a red herring? Do you think that in reality the Department
of Health will still have a strong hand on the tiller or be perceived
to do so? This was as a result of the Kennedy report; it was slipped
into the Government's response.
(Dr Cunningham) It is not possible to comment on what
the Secretary of State intends to do, but you mentioned the Kennedy
report. What we should welcome would be if one of the recommendations
in the Kennedy report were followed, namely that if the Secretary
of State wants all NICE guidance to be binding and health authorities
and funders to fund them three months after they are issued, we
want a portfolio of guidance relating to needs out in the population.
It would be very helpful if programmes were extended to cover
major areas of morbidity and mortality which more reflect the
priorities we are all facing locally. It would help us to be able
to deal more with the affordability issues because the NICE guidance
portfolio would be more relevant to the needs we are facing every
Sandra Gidley: That is a change since the submissions
were made so I thought it was a question worth asking.
149. May I move on to NICE "blight"?
I assume you are familiar with the termprobably very familiar
with the term in some respects. We have had this point mentioned
by a number of witnesses and we wonder from your perspective how
big a problem it is and whether health authorities should ignore
NICE evaluations until they are complete.
(Dr Cunningham) We cannot really ignore NICE guidance
completely: we have to make a decision locally when a drug or
an intervention is available for our use. Our examples for blight
would be beta-interferon and the blight still goes on. There we
had to make a decision. Also, our local trusts are very concerned
about Infliximab, which is a drug for rheumatoid arthritis which
we assume to be highly effective but cannot necessarily make financial
provision for until NICE has made a determination. The problem
is whether we should ignore NICE guidance until it is complete.
It is difficult. We have to appraise a drug ourselves first of
all and make up our mind. We cannot say never. We have sought
guidance from the lawyers on whether we can say no to a drug and
the answer is no, we cannot. We are putting clinicians and others
at risk if we say no. We have to provide some funding. We may
provide limited funding and these drugs may be quite expensive
so that beta-interferon may cost more than £10,000 per patient
per year. The patient we put on it may be on it for several years,
maybe up to a decade for some of these long-standing conditions.
If NICE guidance then comes out and says they do not recommend
the use of something like beta-interferon, it is then unethical
to take a patient who feels they are benefiting from a drug off
it. We also have a waiting list of people who have been waiting
for that drug. It is also unethical not to let the people on the
waiting list have that drug. It causes a lot of problems and we
end up again with a resource problem and an ethical problem.
150. What is the difference between saying no,
which you said you could not do if a clinician prescribed it,
and having only a limited number of patients treated? You are
saying no to quite a large number of people.
(Dr Cunningham) Exactly.
151. What is the difference?
(Dr Cunningham) It is a NICE way round a difficult
problem. We are unable to say no to any drug, except on the basis
of authoritative guidance that it does not work and we have had
legal advice on our position and the legal advisers have suggested
that we are unable to say no, particularly in the light of previous
Secretaries of State's guidance.
152. I am still genuinely puzzled about what
the difference is, because one patient comes along the next day
(Dr Cunningham) In effect we have to ration our resources
locally. We do not have enough resources to do everything we want.
We cannot give an unqualified yes on the basis of an unassessed
and unevaluated drug, so we say yes, but this is the amount of
money we are allocating to this drug on the basis of the evidence
we currently have.
153. Once that money is used up, then it is
(Dr Cunningham) Different authorities have different
ways of dealing with this.
(Ms Marlow) Legal advice says we cannot have blanket
bans, we cannot always say no. We always have to consider individual
patients, so even if we feel we do not have the money to fund
a particular treatment, if a particular patient or a clinician
feels a particular patient has a special case then we will hear
those cases under an "exceptional circumstances" policy.
We do not have blanket bans, we have general policies but we will
always have to consider an individual case.
154. To look at each case individually would
be a more sensible way.
(Dr Cunningham) It is not necessarily for health authorities
to do this. We expect every case to be looked at individually
by the clinicians.
155. What you are saying is that a clinician
could come along and say that even though there is no money left,
we must insist on this patient being treated.
(Ms Marlow) Yes, if it is a special reason.
(Dr Cunningham) Yes and the health authority would
be asked to provide special funding for that individual patient.
156. Do you feel that NICE's involvement so
far in beta-interferon has advanced the matter or clarified matters
(Dr Crayford) It has provided and summarised a lot
of evidence which probably every health authority in the country
has independently had to consider. As a national central evidence
collating body, that is undoubtedly very useful. Unfortunately
there has been a delay in production of the guidance, this drug
has been around for quite a long time anyway, so many health authorities
have precedents and policies which are already funding the drug.
The intermittent start/go that we have had from NICE, which you
may be aware of, has created what we would call NICE blight around
this. Now that evidence around beta-interferon has become a bit
clearer I suspect that the majority of health authorities probably
will not be funding this in most situations at the moment. Unfortunately,
because of the delay in NICE's guidance, we are unable to come
to that position.
(Dr Cunningham) We have had to review and reverse
our position. Beta-interferon is a special example because other
bodies, before the setting up of NICE, had actually considered
the evidence and made it available and produced interim guidance.
NICE has been asked to consider this particular drug quite a long
time after it received its product licence.
(Ms Marlow) The delay in final guidance coming out
is causing problems because the preliminary conclusions are available
publicly and there is a lot of patient demand on clinicians to
get them on beta-interferon before that becomes guidance. It is
a real problem for clinicians.
157. May I raise with you some evidence we have
had from some of the witnesses who will appear in the second session
today and that is CERT, Campaign for Effective and Rational Treatment,
whose work I am sure you will be familiar with? They talk about
what they allege to be inexplicable delays in the appraisals for
Herceptin, which they say has been responsible for the premature
deaths of women with breast cancer. Is this something you are
familiar with? Has it concerned you that delays have resulted
in specific problems?
(Ms Marlow) I am not aware that it has caused us specific
problems locally in terms of its delay.
(Dr Crayford) There is a general issue which we touched
on with interferon, about the timing of NICE advice generally
and that is that drugs are released at point A and at point B
there is some guidance about how to use them. Meanwhile you get
this thing called technology creep where in the absence of guidance
it works its way into the system and it becomes very difficult
to undo precedents which have been set about using drugs. That
is a general point which probably affects most of the things NICE
is considering. What would be best would be for drug approval
to come complete with NICE guidance. Then we would have a managed
way of introducing the drug across the NHS.
158. That would presumably take longer so you
would still get the arguments that people were dying because of
the lack of appropriate provision of drugs which could save their
(Dr Crayford) You would, but it would be consistently
longer and that would be the issue.
159. I am not sure if I were dying I would be
entirely happy about that.
(Dr Crayford) No.