Examination of Witnesses (Questions 500
- 515)
TUESDAY 7 DECEMBER 2004
DR ROBERTO
SOLARI, DR
MALCOLM BOYCE
AND MR
HARPAL KUMAR
Q500 Mrs Calton: Earlier you said
that Cancer Research UK would always publish the clinical results
of the studies.
Mr Kumar: We insist on publication.
Sometimes, where we fund academics in universities, given that
we do not employ those people it is not possible for us to absolutely
force them to do it ,if they have other priorities. We can put
pressure on them to do it but the terms and conditions are that
they must publish.
Q501 Mrs Calton: They must publish
all parts of all studies?
Mr Kumar: Everything, yes.
Dr Taylor: By making publication a condition
of approval, we remove the grey area and I hope that is a recommendation
we will come to.
Q502 Jim Dowd: Has anybody ever resisted
that?
Mr Kumar: If they do we do not
fund them, but I am not aware of anyone.
Q503 Chairman: Dr Boyce, on the issue
of patient involvement, we were interested in Australia to see
more patient involvement there in the research and approval process
than we have here. I wondered how could the conduct of medical
research be improved in terms of patient involvement and consent
to the publication of the data obtained from all clinical trials?
Have you any thoughts on this?
Dr Boyce: Yes. The problem with
the trials that we do is that the subjects are mostly healthy
volunteers. By the time we get the results, we have lost contact
with the subjects. Many of them do not want to know the results.
That may seem strange but they do not. There are requirements
within the European Clinical Trial Directive which encourage researchers
to give their results to the research subjects. There is already
the concept within the legislation—and as you well know
the Directive is law—to encourage subjects to have access
to research information. In the very early clinical trials, often
the results do not mean very much to a healthy subject unless
they are interested in the science or the medicine.
Dr Solari: The MRC has an active
policy called "Science in Society" which is to enhance
the public's engagement in medical research, in clinical trials
and health practice. We are very active and we commit a certain
amount of our funds to trying to engage the public in a greater
awareness of how medical research is performing.
Q504 Chairman: Have you looked at
examples from anywhere else in the world? We went to Australia
specifically but I am sure there are other countries who are engaging
with patients in a way that maybe we are not sufficiently.
Dr Solari: I would have to check
with the office.
Mr Kumar: For all of our late
phase trial work, that is carried out as part of a partnership
through the NCRN, for all cancer trials. There is a very specific
consumer liaison group that is involved in the design of all those
studies and the initiation of several of them.
Q505 Mr Bradley: Mr Kumar, you say
there is a lack of industry funded research into studies that
might identify the specific patient who might benefit from a treatment.
Can you explain what the problem is, how it has arisen and how
it can be solved?
Mr Kumar: The problem is that
the vast majority of drugs will typically benefit only a subset
of the population who receive them. Historically, we have not
had the technology to be able to distinguish between the patients
who would best benefit from a particular treatment. I believe
the technology is now there. It is still in its infancy but nevertheless
it is there. Within CRUK, for instance, we are now initiating
what we call translational studies on all of our clinical trials
to try to determine as much as we can during the course of the
trial about the specific subsets of populations that will specifically
benefit or not benefit, or who may have adverse reactions or not
have adverse reactions. You will see an acceleration of this over
the coming years. The problem with respect to pharmaceutical companies
is that the corollary of that is that it is a reduction of market
size. There is not necessarily the incentive for pharmaceutical
companies to do that, although it is not absolutely as black and
white as that. Sometimes, if you can absolutely pinpoint the patients
who will benefit, you have a greater chance of getting that drug
to market. We would advocate a partnership between the NHS, the
pharmaceutical industry and organisations like ourselves to carry
out these studies because, from the point of view of the Department
of Health or the NHS, there will be savings on the drug budget
if we target the treatment to the patient who will most benefit.
Q506 Mr Bradley: Presumably you have
had discussions on those lines. What sort of reaction have you
had to that proposal?
Mr Kumar: The pharmaceutical companies
we talk to are increasingly waking up to this as a necessity.
I think we are pushing against an open door.
Dr Solari: From my experience,
having worked in the pharmaceutical industry for about 12 years,
the right drug to the right patient is a concept coming out of
improved genomics and molecular biology. We are not there yet.
I think it is still a wish and we are still many years away from
that. I think the pharmaceutical industry is very aware of this
and is investing a great deal of money. The jury is still out
though on whether it will fracture markets and decrease their
profit margins or whether it will create new opportunities for
them. Until these technologies have really matured, I do not think
it is clear which way it is going to go.
Dr Boyce: A large proportion of
the early clinical research on potential new medicines is molecules
from outside the UK. Two thirds of our work comes from companies
outside the UK. When I am talking about pharmaceutical companies,
I am talking about the global industry. I am not just talking
about the UK. The examples I have given are not necessarily in
the UK. They may be in America or Japan.
Q507 Dr Naysmith: This is a question
again for the Medical Research Council. You have said in your
evidence that you need to avoid duplication of research. Personally,
I would not avoid duplication. I would certainly want to avoid
triplication and quadruplication but sometimes it is good to have
checks and at least one other group working. Why do you think
this is so important and what can be done to ensure that duplication
does not take place?
Dr Solari: Are you referring to
early, basic research or to more late stage, clinical type research?
Q508 Dr Naysmith: I think both apply.
You would have less control over the early, basic research, I
suspect.
Dr Solari: As an academic yourself,
you know that we do not read publications that are more than 10
years old generally. As scientists, we often repeat what has gone
before without reading the literature. We want to avoid wasting
the public's money repeating studies.
Q509 Dr Naysmith: You do not want
to rediscover the stuff that has already been discovered.
Dr Solari: You do not want to
rediscover it but it is an important part of the academic process
that a piece of research should be able to be replicated in another
lab. That adds to the validation that it is correct. That is all
part of the publication process. I think that is very important.
Sir Iain was making the point earlier that systematic reviews
on all the literature are very important for the whole progression
of medicines to man and I think the MRC would endorse that observation.
Q510 Dr Taylor: Mr Kumar, trials
of combination therapies are particularly important in cancer
and other diseases and I think you tell us that sometimes the
companies do not make their products available for these combination
trials? Is that a problem? Can you give a bit of detail?
Mr Kumar: I do not think I can
say that we have lots of evidence that companies do not make their
products available for combinations but I think this is again
an emerging area in cancer drug development. There is a wide expectation
that combination therapies are the way forward. It is for commercial
reasons difficult for pharmaceutical companies to test their drugs
in combinations with the drugs of their competitors. It is an
opportunity; it is a responsibility that organisations like Cancer
Research UK see for themselves, to undertake that kind of research
and what we would then seek is the cooperation of the pharmaceutical
companies in making those drugs available to us to test those
combinations.
Dr Solari: In the MRC I do not
believe we have had any experience of difficulties. Drug companies
are willing to provide their drugs for MRC trials. The breakthrough,
for example, in childhood leukaemia has come about because of
new combinations of drugs.
Q511 Dr Taylor: We do not need a
strong recommendation for that?
Dr Solari: I do not think so,
no.
Q512 Mrs Calton: Dr Boyce, does your
contract research organisation carry out any studies that you
think are for marketing purposes as opposed to understanding how
the drug works or how safe it is?
Dr Boyce: No.
Q513 Dr Naysmith: People have suggested
to us that it would be a good idea when a drug gets to its pre-market
stage that the regulatory checks that have to be carried out on
it are carried out by an independent unit that would do clinical
trials independently of the industry. Presumably the Medical Research
Council could do that sort of thing and if you do not think it
is a good idea tell us why not.
Dr Solari: I think the MRC could
do it. It has the infrastructure to do it along with the Department
of Health. I am sure it does not have the budget.
Q514 Dr Naysmith: Always assuming
that the budget will come. I know these promises are not always
acted on.
Dr Solari: It is an interesting
idea. I would need to think about it a little more rather than
giving an off the cuff reply.
Chairman: Write to us because obviously
that would be very helpful.
Q515 Siobhain McDonagh: Mr Kumar,
you are concerned about the influence that the industry has on
the topics chosen by NICE. Why are you concerned and what problems
might arise if there was excessive influence?
Mr Kumar: We were concerned that
there was a lack of transparency on the topics chosen by us. I
do not think we would say that there is an inherent problem but
that we do not know if there is a problem. What has happened over
the last several months is that my understanding is that NICE
now, at least as far as cancer appraisals go, relies on the NCRI,
which is a forum of all the major cancer research funders, to
determine or at least to take advice on the areas that should
be addressed. At least as far as cancer is concerned, I think
we have moved forward.
Chairman: Gentlemen, can I thank you
for what has been a very valuable session? It has been rather
short and somewhat constrained by time but we appreciate the help
you have given us. Thank you very much.
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