Examination of Witnesses (Questions 576
- 579)
THURSDAY 18 OCTOBER 2007
DR BEVERLEY
HUNE, PROFESSOR
ROGER ATKINS
AND DR
ANITA THOMAS
Q576 Chairman: I welcome you to the
fifth evidence session of the Committee's inquiry into NICE. Perhaps
for the record you would introduce yourselves and the positions
that you currently hold.
Dr Hunt: I am Dr Beverley Hunt,
Medical Director of Lifeblood: The Thrombosis Charity which I
co-founded in 2002. Our aim is to increase awareness of venous
thrombosis and improve the amount of research funds that go into
it. Am I allowed to continue by explaining a little about the
work of the previous Health Committee?
Q577 Chairman: I believe that will
arise as we develop this particular session.
Dr Thomas: I am Dr Anita Thomas,
a consultant physician in acute medicine in Plymouth Hospitals
NHS Trust. I currently chair the Chief Medical Officer's VTE (venous
thromboembolism) implementation working group. I was chair of
the independent expert group on venous thromboembolism. I apologise
for something that I am not. Your leaflet says that I am on a
NICE appraisal committee. I am not.
Q578 Chairman: And never have been?
Dr Thomas: No.
Professor Atkins: I am Professor
Roger Atkins, a consultant orthopaedic surgeon from Bristol. I
am here as the British Orthopaedic Association lead for NICE.
I represent the British Orthopaedic Association and specialist
societies such as the Hip Society, Knee Society and British Trauma
Society.
Q579 Chairman: I know that some of
us have met Dr Hunt in her lobbying of Parliament in relation
to this subject-matter. Most commentators praise the clinical
guidance of NICE. Why did not its normal processes work for the
VTE guidelines?
Dr Hunt: I am a member of a NICE
guidelines development group which is for the next set of guidelines
on thromboprophylaxis. I very much appreciate NICE. We have to
have NICE. It is an excellent institution, but I think we need
to change the process. The process is not without flaws. If we
consider the process of producing clinical guidelines, some of
the problems have been exposed by the recent guidelines on the
prevention of pulmonary embolism in hospitalised surgical patients.
From the perspective of experts in venous thromboembolism the
problem is that the process does not use experts well. If we consider
what happens to the clinical guidelines, they go out to scoping
and at that time there is a consultation with experts and interest
groups. They decide what they will do and that then goes to the
guidelines development group. That group uses information scientists
and statisticians who analyse the evidence available and then
present it to the clinicians on the committee. The problem is
that on that committee there are no experts. There are clinicians
who are very well meaning and intelligent; they are all good eggs,
but they do not have expertise in the area. Therefore, they will
review what the statisticians have said and come out with an answer
which is usually there or thereabout, but they do not have an
understanding of the nuances of the scientific papers in the area.
I believe that the recent guidelines on the prevention of venous
thromboembolism in surgical patients highlights that. They analysed
the same data set as all the other international guidelines in
the area and also the independent expert group set up by the Chief
Medical Officer and came out with a different answer. Everybody
else in the international community would recommend pharmacological
thromboprophylaxis if somebody was going to hospital and needed
some form of prevention against DVT. That would be the first choice.
The NICE guidelines recommend mechanical methods as first choice,
that is, perhaps just a pair of stockings. How it emerges is that
in this country if you are a patient between the ages of 40 and
60 and you have a major operation but are otherwise well—you
may be a woman having a hysterectomy or a man having a gall bladder
removed—under the NICE guidelines you get a pair of stockings
but anywhere else in the world for five, six or seven days blood
thinners are injected. What does this mean? It means that if you
use pharmacological methods the statistics show that the death
rate due to pulmonary embolism is reduced. There are no studies
to show that you reduce the death rate with a pair of stockings.
This has a good deal of impact on patients. The suggestion in
my written evidence was that NICE should consider the use of an
expert from the area as a member of its guidelines development
group. I think that it chooses not to use experts because it is
concerned about a conflict of interest, for example it may have
funding from pharmaceutical companies. I recommend that if somebody
is earning perhaps more than 10% of gross salary or has grants
totalling more than £100,000 he should be excluded from the
panel, but NICE certainly ought to have an expert on board so
it can understand all the nuances of the papers.
Dr Thomas: In order to shine some
light on this area we need to go back to the beginning and follow
how we got to this position. It began with this Committee's work
and the seminal report that it produced about the prevention of
venous thromboembolism. The Committee drew attention to the 60
potentially avoidable deaths every day and the estimated £640
million a year this condition costs the NHS. The Government responded
very rapidly to that report and set up the independent expert
group having consulted NICE about the production of guidance and
the timeframes over which guidance might be produced for different
groups of patients. It was clear that the independent group convened
by the Chief Medical Officer had a broad remit, including measures
to do with implementation of guidance as well as "to review
existing guidance", in totality and in the main. It was agreed
at an early stage that NICE would deal with a particular group
of patients in hospital, those being high risk surgical and orthopaedic
patients. The independent group produced its report which was
published in April 2007 and at the same time the Chief Medical
Officer wrote to all doctors with a summary of the guidance and
the recommendations produced by the group. Both the independent
group's report and the CMO's letter referred to the fact that
NICE would be producing guidance on high risk surgical and orthopaedic
patients. We are now at April 2007. Looking back, I presented
the report to the Chief Medical Officer in 2006. At that time
NICE was consulting and thinking about the process for its broad
and wide-ranging consultation on venous thromboembolism. I believe
that was published in November 2006. The result of that consultation
was a broad set of replies, many of them detailed. One of the
replies was from the Department of Health itself. It is important
to note that the title of the document that went out for consultation
was "High Risk Surgical and Orthopaedic Patients". It
is perhaps also important to note that the Department of Health's
response to that included a concern that NICE should stick to
its remit of high risk surgical and orthopaedic patients in order
to avoid any potential confusion for clinicians and patients in
due course. In the event, in April 2007 the Chief Medical Officer
published the report on venous thromboembolism prepared by the
independent group. The earliest time that I learnt that there
had been a change in the title was during a teleconference in
April with NICE and Department of Health/NICE liaison officials.
It became clear that the title of NICE guidance had been changed
after the period of consultation to "Patients Undergoing
Surgery", ie all in-patients undergoing surgery. This was
also news to Department of Health/NICE liaison officials and I
do not believe that it was possible for those officials to see
NICE's guidance or recommendations before they were published.
However, there is always tomorrow. I believe that the focus now
both nationally and internationally is not on guidance because,
as NICE has itself said, guidance is just guidance, and any member
of this Committee would expect his or her doctor to make an informed
decision in his or her best interests. In its own press release
NICE has indicated that now we are turning to the implementation
phase it will work closely with the implementation working group
announced by the Chief Medical Officer on behalf of Ministers
in the independent group's launch of its report. We know that
even in moderate to high risk patients less than one in 10 receive
thromboprophylaxis, so the focus now of both NICE and the implementation
working group is on measures for prevention and risk assessment.
This disease is silent. Very few cases are diagnosed before death;
80% to 90% are diagnosed after death, yet it is easy to predict.
The issue is about identifying who is at risk. As a patient you
have the right to ask what will be the risk and what will be done
about it. There are effective methods and whether they are pharmacological
or mechanical or other depends on the precise clinical situation
at the time. The focus now is on implementation of risk assessment
strategies across every hospital. Certainly in England, the question
is: what is the risk of a particular patient developing VTE and
what is to be done about it?
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