National Institute for Health and Clinical Excellence - Health Committee Contents


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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