Examination of Witnesses (Questions 407
- 419)
TUESDAY 7 DECEMBER 2004
SIR RICHARD
SYKES, PROFESSOR
PATRICK VALLANCE
AND SIR
IAIN CHALMERS
Q407 Chairman: Colleagues, I welcome
our witnesses to this morning's session. We are most grateful
for your co-operation with our inquiry. I think you are aware
that we have two separate sessions this morning, and we will try
to keep each session to an hour each. We will keep our questions
sharp and ask you for reasonably concise answers. Would you each
like to introduce yourselves to the Committee?
Sir Richard Sykes: I am Director
of Imperial College.
Professor Vallance: Patrick Vallance,
Professor of Clinical Pharmacology and Head of the Department
of Medicine at University College.
Sir Iain Chalmers: I am Editor
of James Lind Library and one of the co-conveners of the James
Lind Alliance, which is a coalition of patients and clinicians
trying to influence the research agenda.
Q408 Chairman: Professor Vallance,
I gather you have just got off a plane from America. We do appreciate
you coming here in those circumstances. Sir Iain, you suggest
in your evidence that the pharmaceutical industry has a perverse
influence on the clinical research agenda, and you also criticise
publication bias by industry. Could you expand on these observations
and perhaps give us some examples of how you feel patient well-being
is being affected by these concerns?
Sir Iain Chalmers: If I could
start with an example to make a general point: some researchers
in Bristol a couple of years ago asked patients with osteoarthritis
of the knee and the people caring for them—physiotherapists,
rheumatologists and general practitioners—what unanswered
questions they would like to see addressed in research, and the
answers that they came up with were things like better evaluations
of surgical options, better evaluation of physiotherapy, and better
evaluation of ways of coping with a chronic, painful condition.
When the researchers compared the questions which these patients
and professionals had indicated as important with what had been
studied in osteoarthritis they found that very few of those questions
had been addressed. Rather, yet more placebo-controlled trials
of non-steroidal anti-inflammatory drugs were being done. All
of the focus groups of patients and clinicians said, "we
do not want any more studies of drugs, of pain-relieving drugs."
That is just one example of the way in which research agendas
can be distorted by the interests of industry. In fact, in this
week's BMJ there is a report of acupuncture for osteoarthritis
of the knee, which is an example of the sort of thing that industry
has no interest in at all. So, there are inappropriate questions
being addressed in research, or inappropriate from the point of
view of patients and clinicians. In addition inappropriate comparators
are sometimes being used. For example placebos are being used
as comparators when there are already effective treatments, and
sometimes inappropriate outcome measures are being used. From
a commercial point of view there may be reasons for doing these
studies, but they are not necessarily serving the interests of
patients and clinicians, rather than shareholders. There is also
the problem of the academic influences on the research agenda,
some of which I regard as perverse. In this country, one of these
is the Research Assessment Exercise, which is done to decide how
much of the science budget should go to support particular universities.
Within that system there is no encouragement to review systematically
what is already known from existing research, before ploughing
ahead and doing new additional studies. There is discouragement
of collaborative research, which is often necessary to obtain
robust evidence about the effects of treatments. People in particular
institutions competing for resources see collaborative research
as a threat because it submerges the identity of the institutions,
and does not give individuals in institutions the prominence which
they think they require. This encourages academics to do small-scale,
often poorly-designed, studies. The other, often perverse influence
there has been growing encouragement of academia to attract for
income-generating research. Take a trial funded by the NHS R&D
programme or the Medical Research Council. There may be a certain
sum of money to support the recruitment of every patient in the
trial, but industry sometimes can offer a bounty for each patient
recruited of thousands of pounds. Clearly, people who are wanting
to make income for their academic institutions, or indeed their
hospitals, may find it difficult to support a study that is addressing
an important question (of no interest to industry) that is funded
by the MRC or the NHS R&D programme. Those are the perverse
incentives that I believe exist. You asked me about the problem
of publication bias. This is a very serious problem, and one that
I have been wittering on about for well over a decade. I am very
glad that Sir Richard Sykes is here at this session, because I
want to give credit to those people in industry who, way back
in the mid nineties, said that this was unacceptable behaviour.
Richard Sykes and his colleagues within GlaxoWellcome did that,
so also did Mike Wallace, the Chief Executive of Schering Healthcare.
It is quite unacceptable that people should be invited to participate
in clinical trials, and then, when the investigators or the sponsors
do not like the results, their contribution is not made public.
It is a very, very serious problem.
Q409 Chairman: Can I ask the other
two witnesses whether they feel their institutions or research
groups are influenced in similar ways by the industry in some
respects; and, if so, how?
Professor Vallance: I can answer
from my own institution. We get a small percentage of our total
research income from industry, and it is about 2% in total of
research income.
Q410 Chairman: Where does the rest
come from?
Professor Vallance: From the Medical
Research Council and major charities like the British Heart Foundation.
Currently 2% comes from industry. We are probably unusual in that
in terms of having a very high percentage of peer-reviewed grant
funding. But there is no question that what Iain Chalmers says
is correct; that industry will of course pursue drug-related research
over and above other kinds of research. The question is, to what
extent that distorts the ability to undertake other types of research.
One of the problems is that a rather small percentage of patients
are involved in clinical trials and there is huge uncertainty
in healthcare. There is capacity in the system, but it is not
used. I remain concerned that we have not got the capacity issues
right, or the infrastructure right to undertake more studies.
It does not surprise me that industry will want to pursue studies
of interest to itself.
Sir Richard Sykes: Our research
budget is £200 million a year; and £20 million of that
will come from industry. That is the biggest industrial funding
of any university in the UK. Most of that, of course, is in the
physical sciences and engineering, not in medicine. However, we
live in a knowledge-based economy. The knowledge base is university-based,
and we want industry to work alongside universities. If we are
going to be competitive in this country, then we have to use our
knowledge, our creativity and innovative skills. Therefore, the
universities have to play a very important role in that, and we
have to have translation of research in healthcare or other areas
because that is the fundamental basis now of being competitive.
We have to use our knowledge base.
Q411 Chairman: You do not feel that
that relationship with industry has a bearing on the objectivity
of the work that you do?
Sir Richard Sykes: I think it
has to some extent, but again—
Q412 Chairman: In what way?
Sir Richard Sykes: In the way
that we have heard already, that industry will want to come in
at the front end, doing clinical trials; they will also want to
invest in certain types of research. Of course, the academics
themselves will not get involved in that research if they do not
believe it will benefit them at the end of the day, so how it
manipulates is difficult to tell. Certainly, big clinical trials
in patients related to the hospitals are certainly being done
to generate money. We are being driven to generate money, otherwise
we would not be competitive in the world.
Q413 Dr Naysmith: This is really
a question to Sir Richard. I agree with what Sir Iain said, and
we are really pleased to have someone who has been at the top
of scientific research and one of the country's major companies.
We suspect that you will be able to give us quite an insight into
what goes on if we can discover the right questions to ask. One
of the most important questions facing this Committee in producing
the report is to try and find the right balance, if there is one,
between business and trading and health priorities and between
marketing and evidence-based clinical practice. I am sure you
would agree that that is something we all want to do. As I have
just said, you have experienced both sides. What do you think
of this conflict? How do we get the right balance? You have partly
touched on it, but as a more global thing?
Sir Richard Sykes: I think we
have carried a lot of baggage from the past, and somehow we have
to recognise that those days have gone, or at least they are going
away. We have to look forward. If we are going to deal with some
of the big problems in healthcare today, it has to be a partnership
between the academic face, the research base, the industry, the
NHS. We have to work together to solve some of these big problems.
I believe that this has got to be a collaboration today, not a
group here, a group here and a group here, and it is all "them
and us". That method will not work.
Q414 Dr Naysmith: How do you get
rid of this conflict between trade and health, and how do you
make sure that they work together?
Sir Richard Sykes: I think you
need a lot of transparency. As Iain said, you need to be transparent,
and you need to make sure what everybody is doing, and that the
information is there so that we can all share with it and deal
with it, rather than having things hidden—"if we do
not like the result we put it away and do not tell anybody",
which is totally inappropriate. Transparency is particularly important.
Q415 Chairman: Do you see there is
any way of squaring up that transparency with a market system
where there is this obvious emphasis on the need to create profits
and business incentives; and on the other side the health policy?
Do you see that can in any way actually be balanced out so that
you can have transparency and also a commercial market operating,
which is what the companies clearly want?
Sir Richard Sykes: I do not think
there is any conflict at all. If you produce good medicines, whether
they are diagnostics, whether they are treatments, whether they
are palliatives, curatives, preventatives, whatever they are—if
they benefit somebody in society, we should all be very happy.
That is the objective at the end of the day.
Q416 Dr Taylor: The phrase "commercial
confidentiality" is thrown at us all the time. How do you
square that with transparency?
Sir Richard Sykes: There are certain
areas where, at the beginning of the research process, there has
got to be a degree of confidentiality in terms of intellectual
property. Once that intellectual property has been achieved the
whole point about intellectual property is to make it available
to everybody so that everybody can see what you are doing.
Q417 Dr Taylor: How early in the
process should that be done?
Sir Richard Sykes: As soon as
you have got the intellectual property filed.
Q418 Dr Naysmith: How do you resolve
the conflict that Sir Iain referred to, where you have the situation
where people who are suffering from an arthritic condition would
much more benefit from physiotherapy or something like that than
from another painkiller and another anti-inflammatory, and the
companies just put the money into that?
Sir Richard Sykes: If the doctors
continue to prescribe analgesics for treating these diseases,
so that the market—I do not know what it is today, but it
must be billions of dollars for these kinds of drugs—then
what do you expect the market to do? They respond to it. That
is what I am saying: people have to work together. If you are
talking about osteoarthritis, the first thing you need is a diagnostic,
because it is a nightmare to decide whether somebody has osteoarthritis
or not.
Q419 Dr Naysmith: Where does the
transparency come in, then, because you were just following down
that because it is the job of companies to generate profits as
well as to generate—
Sir Richard Sykes: They cannot
generate profits if nobody sells the drug. The companies do not
sell the drug to the patient; it is the doctor—the gatekeeper.
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