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Daily transcripts
Hearing summary
20th October 1999
The Inquiry oral hearings will focus this week on the concerns raised
about paediatric cardiac surgery at the Bristol Royal Infirmary (BRI) between 1984 and
1995 and actions taken during the period to resolve those concerns. The Inquiry will also
hear evidence which will illustrate the national scene and address the subject of post
mortems and tissue retention.
Today the Inquiry heard evidence from Professor Sir Kenneth Calman,
Vice Chancellor and Warden at the University of Durham and former Chief Medical Officer
(CMO) for England 1991-1998. He began by discussing the evolution of audit and commented
on the medical profession’s concerns regarding confidentiality and the importance of
comparing data. Professor Calman stressed the importance of links between the CMO and the
professional medical bodies. He described the function of the Supra Regional Services
Advisory Group (SRSAG) and identified responsibilities for monitoring effectiveness of
Supra Regional Services. He commented on the proliferation of supra-regional services and
opportunities for limiting this. He then highlighted the option of de-designation of a
supra-regional service. He went on to talk about medical training and the report he
published (Calman Report 1990/91) outlining a competence based training programme for
junior doctors and the importance of communication skills. He then described
clinicians’ responsibilities regarding the introduction of new treatments and
techniques and gave examples of national interventions to prevent the establishment of
some procedures. He commented on his knowledge of the concerns raised about Bristol’s
cardiac unit and actions taken by the medical division of DOH in response.
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FULL TRANSCRIPT
1 Day 66, 20th October 1999
2 (10.10 am)
3 THE CHAIRMAN: Good morning, everyone. Good morning,
4 Mr Langstaff.
5 MR LANGSTAFF: Good morning, sir. Sir, this morning we have
6 Professor Sir Kenneth Calman. Professor, would you mind
7 standing to take the oath?
8 SIR KENNETH CALMAN (SWORN):
9 Examined by MR LANGSTAFF:
10 Q. Sir Kenneth, you are Professor Sir Kenneth Calman,
11 presently Vice Chancellor and Warden at the University
12 of Durham?
13 A. Correct.
14 Q. You were, as many will know, the Chief Medical Officer
15 for England between 1991 and 1998, despite, I think,
16 having originated from Scotland?
17 A. Correct.
18 Q. As a matter of interest, having come I think from the
19 same school as Sir Alan Langlands?
20 A. Yes.
21 Q. If we look at WIT 336/1, is that a statement which you
22 have prepared for the purposes of this Inquiry?
23 A. It is.
24 Q. If we turn to page 4, is that your signature at the
25 bottom?
0001
1 A. It is.
2 Q. And you stand by the contents of that statement?
3 A. I do, with one small thing I would like to add, if
4 I may. That is that I welcome the opportunity to be
5 here. I realise that much of the evidence will be
6 fairly technical and that does not hide, I think, the
7 human tragedies behind all of this, and my sympathies
8 have and will go out to the families who have been
9 involved in this particular Inquiry.
10 Q. Professor, in, I think it was 1948, the World Health
11 Organisation gave a definition of "health" as not simply
12 assisting in the absence of disease, but in a state of
13 complete physical, mental and social well-being.
14 What, in terms of that definition, do you see as
15 part of the role of the Chief Medical Officer of
16 England?
17 A. I think it is a very important part of the job, to think
18 about the health of the population, not in terms of
19 illness but in positive well-being and health and
20 happiness. Interestingly the WHO is just about to add
21 a further part to that, and that includes the spiritual
22 side of things as well so I have little doubt in both my
23 clinical experience in coming to the role of Chief
24 Medical Officer and in the role of Medical Officer, it
25 is about the holistic nature of individuals, but looking
0002
1 after them as people and looking after populations as
2 people, rather than thinking only about illness.
3 Q. So far as the Department of Health is concerned, many
4 may think of it as being largely the National Health
5 Service, but as we understand the position, you as Chief
6 Medical Officer were one of what has been described to
7 us as a "triumvirate", along with the Chief Executive
8 of the National Health Service Executive and the
9 Permanent Secretary.
10 So far as your role when you were Chief Medical
11 Officer was concerned, can we look, please, at
12 WIT 336/9? The role and functions which you were given
13 were, were they, what we see as 1, 2 and 3 on the
14 screen?
15 A. Indeed, yes.
16 Q. Just to bring it up to date, if we put that on split
17 screen, please, with 336/11, what we have on the
18 left-hand side, as the writing at the top indicates, is
19 what we have had supplied to us as what you might call
20 the "job description" of Professor Liam Donaldson, the
21 current Chief Medical Officer, and it seems that there
22 is an additional paragraph, really, which describes the
23 position within the system the Chief Medical Officer
24 occupies, although the role is described in the same
25 terms.
0003
1 Is that simply a matter of additional description,
2 or does it represent any change as between 1991 and
3 1998?
4 A. I am wondering which paragraph you are referring to.
5 Q. It is the top, the very first paragraph.
6 A. No, that is a correct description, and indeed, if the
7 one on the right-hand side had been developed further,
8 it would have been precisely the same. The point
9 I think is that the Chief Medical Officer is the
10 Government's Chief Medical Officer and was responsible
11 to a number of government departments and Ministers, not
12 just the Ministers within the Department of Health.
13 Q. So you would have, underneath you, I think, what may be
14 something of the last count, some 68 doctors within the
15 Department of Health whom you headed and you were able
16 when you were Chief Medical Officer to call on any of
17 those for medical input. Would that be about the right
18 number?
19 A. It really depends on your definitions and the timing.
20 My role and responsibilities changed around 1995.
21 Q. In what way?
22 A. Following the Banks Report, the medical staff, apart
23 from half a dozen or so of secretarial staff, reported
24 either to the Permanent Secretary or to the Chief
25 Executive of the NHS and the Chief Medical Officer
0004
1 therefore had no direct reporting medical staff.
2 Q. The first of the roles which is set out there, the roles
3 and functions, number 1, monitoring health and the
4 outcome of health care, we have heard from Sir Graham
5 Hart, whose evidence I think you have read and you
6 endorse -- you are nodding. Forgive me for saying that,
7 because a nod does not go down on the transcript.
8 A. I am sorry.
9 Q. He has told us that throughout the period of particular
10 concern to this Inquiry, there was no proper measurement
11 of the quality of care which was available within the
12 NHS, looking at the question of the delivery of care by
13 hospitals.
14 Is that broadly your view?
15 A. No, I do not think that would be my view, because for
16 really a very long time, the outcome of the health care
17 has been part of the responsibilities of individual
18 doctors and indeed Trusts and before that, hospital
19 boards. It would be impossible to manage a system
20 without knowing what the outcome was. That was done in
21 a variety of different ways over the years, but I think
22 in terms of the outcomes of health care, there are
23 difficulties in measuring sometimes the outcome of
24 health care. Mortality is a very relevant way to
25 measure, but once you move into other areas like quality
0005
1 of life, for example, it becomes more difficult to
2 measure, but in terms of the outcome of health care,
3 30-day mortality, wound infection rates have been
4 recorded and reported for a very long time.
5 Q. Can we have a look on the screen at HOME 9/7? What we
6 are looking at is the minute of evidence taken before
7 the Public Accounts Committee on 5th December 1988.
8 This was a committee which, as we see at the top, your
9 predecessor, Sir Donald Acheson, attended.
10 If we can please go to the right-hand side and
11 scroll down a bit, Mr Shersby, asking Mr Peach, says:
12 "Paragraph 2.4 states 'under present arrangements
13 the professions do not expressly require their members
14 to appraise the quality of their work or to compare
15 outcomes of treatments'. Is not part of the problem of
16 implementing a system of appraisal and assessment the
17 long-standing arrangements which have been entered into
18 by the professions and which have been perhaps largely
19 unquestioned for a very considerable period of time.
20 Is there not a difficulty from your point of view in
21 persuading the professions to adjust their attitude
22 slightly to meet what you are trying to do?"
23 Mr Peach answers:
24 "That certainly has been true in the past, but in
25 fact this movement which I have described has certainly
0006
1 borne fruit. May I report to you the result of the
2 CMOs' seminar on medical audit which took place on 9th
3 November, and the CMO may care to commit, as I fill in
4 the bare bones ..."
5 He sets out the attendance, the professional
6 representatives, the broad agreement that medical audit
7 was the responsibility of doctors although other
8 professions needed to be involved; that all doctors
9 should be involved and mechanisms should exist for
10 dealing with doctors where audit results are not
11 acceptable.
12 He ends up saying, with the agreement of the
13 committee, could he ask the Chief Medical Officer to
14 comment because he held the seminar.
15 What is being described is plainly a seminar
16 involving the person you have seen in the name in the
17 column in November 1988.
18 Sir Donald Acheson's first words:
19 "I do not think such an agreement consensus would
20 have been reached a year ago. It exemplifies the
21 extraordinary change one is seeing in professional
22 attitudes, which is being exemplified by the impact of
23 the Confidential Enquiry into Peri-operative Deaths."
24 Sir Donald is there describing what one might call
25 a sea change in attitude and approach towards it.
0007
1 Looking back on it, is that your perspective on
2 what happened?
3 A. I think it is a fair reflection, although I think my own
4 view would have been that it happened a little earlier
5 than 1998 in some places. Indeed, if you go to the top
6 of the screen you will see a comment about Lothian
7 pursuing elements such as happened in Lothian. One of
8 the most striking things that happened over the period
9 from about the late 1970s until the mid-1980s was
10 something called the Lothian surgical audit, which
11 radically changed clinical practice in Lothian in
12 a number of different areas.
13 So quite a lot was happening and there were some
14 very good models on which to work. The fact that all
15 the profession was not involved in audit was, I think,
16 a function of time. I was not at the CMO seminar;
17 I happened to be post-graduate dean in the West of
18 Scotland at the time and knew about this kind of work
19 going on, and indeed was pursuing it in the West of
20 Scotland in the same kind of way.
21 So there was a considerable change. I would have
22 put it slightly earlier, perhaps, 1983/84 rather than
23 1987/88.
24 Q. The change in attitude was one from what to what, as you
25 see it?
0008
1 A. I think the change in attitude was, as a professional,
2 as a doctor, the responsibility is to ensure that you
3 give the best treatment that is available to an
4 individual patient and to be sure that you know that
5 that is the best and to be able to measure that, and
6 compare it with others.
7 Good professional practice had always done that,
8 although not necessarily formally. If you look back
9 over the centuries, doctors have always recorded what
10 they have done and what the outcome was.
11 The change was to make that more formal and to say
12 that there was not only responsibility to do it
13 personally but to share that, and to ensure that in
14 sharing it, if there were any issues in clinical
15 practice, these could be picked up, developed, changed
16 and modified. It was that move, I think, that was
17 important.
18 Q. So in essence, it is taking a broader perspective of the
19 performance of one individual within the system?
20 A. And also, I think, in making it more open within
21 a professional group to be able to share that
22 information.
23 Q. The comment made to the Public Accounts Committee in
24 late 1988 suggests that certainly by the end of that
25 year, and for your part, you see it as happening rather
0009
1 earlier, the medical profession as a whole were behind
2 the idea of audit in the sense of measuring their
3 outcomes and measuring it rather more publicly, and
4 having a broader perspective, as we have discussed.
5 This was still medical rather than clinical?
6 A. Correct.
7 Q. What we have heard in the Inquiry from Kieran Walshe --
8 let me see if I can put it on the screen before you. It
9 is WIT 356/1. I am told it is not yet on the system, so
10 we shall have to come back to it. You will have to
11 forgive us for one of the very rare glitches we have had
12 with the technology. I will tell you what was said and
13 by all means we can put it on the screen later, but he
14 described the Department of Health's strategy as
15 a "softly-softly" approach, which was not directive and
16 did not mandate, but built up gradually on things that
17 were already there.
18 Is that again your perspective, or not?
19 A. I think you would have to remind me of the date of that
20 and what date he was referring to.
21 Q. I think he was talking about a gradual process
22 throughout the 1980s and 1990s.
23 A. I think that may well be correct, but I think you have
24 to also see it in the broader context of the NHS reforms
25 which began around 1989, if I remember, Working for
0010
1 Patients, a paper on medical audit, and there was
2 considerable controversy about these reforms, so the
3 issue of medical audit was caught up within that and as
4 part of that, and I think the process was therefore
5 taken in a way which allowed the majority of people to
6 take part and develop their skills in medical audit,
7 without making it so controversial that it took them
8 into the problems of changing the NHS which are going on
9 at the same time.
10 Q. Mr Walshe went on to say this: that there were concerns
11 in respect of audit about the possibility that it may
12 lead to or encourage civil litigation. Again, you are
13 nodding. He says this:
14 "That concern remained unresolved. There was some
15 discussion with the Department of Health at the time
16 about whether the data could have -- we now have it on
17 the screen. Can we go to page 2, please? Can we scroll
18 down to line 21? You can see what I am reading from:
19 "There was some discussion with the Department of
20 Health at the time about whether that data could have
21 some kind of privilege, some kind of immunity from
22 disclosure, as indeed information collected before the
23 Confidential Enquiry on Peri-operative Deaths and the
24 Confidential Enquiry on Maternal Deaths, which both had
25 PII certificates and the Department of Health was not
0011
1 enthusiastic about attempting to pursue that. It was
2 not pursued and it seemed to go away as an issue."
3 Do you recall there being any discussions with the
4 Department of Health, either in England or for that
5 matter in Scotland, where you may have been at the time,
6 about the need to protect information given in the
7 process of audit?
8 A. This was an issue which was discussed on a very regular
9 basis over the whole time that I was the Chief Medical
10 Officer.
11 Q. What were the particular concerns that the clinicians
12 had?
13 A. I think the particular concerns were that if the data
14 became very public in the sense of putting it into the
15 public domain, then it would encourage doctors to only
16 treat those patients in whom the outcome was likely to
17 be good and those doctors who treated patients in any
18 kind of high risk category, would have their results
19 scrutinised in a way which said that their results were
20 not as good as other people's.
21 If I simply give you an example of this, when
22 I became Professor of Cancer Medicine in 1974, 65 per
23 cent of my patients died in a month without treatment.
24 That is not a very good outcome, but most of the
25 patients who were sent to me were sent for palliative
0012
1 care. Comparative data would have shown me up as being
2 an extraordinarily bad clinician. I do not think
3 I particularly was. I think it is a function of the
4 kind of data.
5 One of the problems is ensuring that there is
6 appropriate comparability of the information between two
7 different clinicians. If you have a group of five
8 doctors who work in a surgical unit or a medical unit,
9 then no matter how you work it out, one of them will
10 always be at the bottom, maybe one month one will be at
11 the bottom and the other month the other will be at the
12 bottom. It is quite easy to get to the top if you do
13 not take difficult patients for the next few months, you
14 come up to the top again.
15 So there was real concern about the quality of the
16 data, how that data would be interpreted. I have
17 discussed this with a number of very senior members of
18 the profession over the years, and it was not about
19 withholding data from the public domain, it was ensuring
20 that any data that went into the public domain was in
21 fact comparable, could be looked at properly, and
22 actually helped you.
23 If you did happen to do a particular procedure and
24 your results were not as good as the other colleagues
25 that you worked with, then that was the opportunity to
0013
1 change that, to look at your practice, do it
2 differently, improve or indeed stop: a whole lot of
3 different options.
4 If that data went into the public domain before
5 that decision was taken, it might be very difficult.
6 I referred earlier to the Lothian surgical audit. This
7 was precisely the outcome of that. In looking at the
8 quality of outcome, particularly with vascular surgery
9 in Lothian, then a number of people stopped doing things
10 because they looked at the quality. Others continued
11 because they saw ways of improving the quality of the
12 data.
13 So it was a whole complex of issues, not that
14 doctors did not wish their results to be seen in public.
15 Q. Dealing with the question of stopping doing something,
16 that concern, if we can look back to the Home Office
17 document, HOME 9/13, if we can scroll down, please, this
18 is 254 on the left-hand side, talking about the problem
19 of the avoidable death. The suggestion being made, as
20 we see a reflection of here from the Public Accounts
21 Committee, was that one of the problems that there may
22 be with audit is the surgeon avoiding doing the
23 operation which may be, excuse the expression, the "last
24 chance" for the patient, simply because he, the
25 clinician, thinks "This patient is very much a last
0014
1 chance, there is a very small chance of survival, and
2 because of the impact of statistics, records about
3 treatment, if I treat him, I will be the bottom of the
4 pile, not the top", exactly as you have been describing.
5 How does one distinguish between a surgeon whose
6 approach is defensive in that way to the disadvantage of
7 patients generally, and the surgeon who looks at the
8 outcomes of his surgery and says, "Well, I am here, I am
9 down towards the bottom of the pile, I ought to stop
10 doing this surgery, not because I am going to deprive
11 people who are likely to die of my services, but because
12 it is to the public's advantage that they should be
13 treated by somebody better"?
14 A. There is another answer to the question, before I move
15 on, and that is patient choice in this. I reflect only
16 on my own experience in relation to cancer treatment.
17 Some people wish to have that treatment knowing there
18 are real dangers, major side-effects. Having that
19 explained, they say "Yes, please, I still want that".
20 Others will say "No". So I think part of this equation
21 is about patient choice too. Patients and/or their
22 families may not wish it.
23 How do you distinguish between the two? You
24 distinguish by being able to have the information that
25 stratifies things in terms of case difficulty. If you
0015
1 take many of our major teaching hospitals in the
2 country, they do have to deal and treat patients with
3 major complications much more difficult than you might
4 get in other places. You would not be surprised if
5 their outcome was less. But you can balance that up by
6 looking at the complicating factors. With a number of
7 conditions now it is possible to make that distinction,
8 so you could in fact differentiate between the surgeon
9 who just was not very good and the surgeon who was
10 taking on very difficult cases and therefore whose
11 mortality was lower than you would have expected.
12 So I think it is possible to do that if you have
13 the kind of condition that allows you to stratify in
14 terms of case difficulty, if you like, from quite easy
15 to very difficult.
16 Q. There is a further part to the problem, though, is there
17 not, which is that you may stratify within a unit, but
18 for the purposes of comparison, one has to have
19 a broadly agreed measure of stratification?
20 A. Indeed.
21 Q. If you like, for this process to work and for
22 comparisons to be made, there have to be standards
23 against which performance may be measured?
24 A. That is absolutely correct, and indeed, I think that was
25 the process that was beginning in the early 1980s.
0016
1 Instead of just looking at my data compared to what
2 I did, it was about trying to do this in a much more
3 national and indeed international way in terms of case
4 stratification, outcomes and outcome measurements, so
5 that you could do this, not just in your own little
6 patch but beyond.
7 Q. What role did the Chief Medical Officer have in
8 establishing the standards?
9 A. I think in terms of establishing the standards, my role
10 was establishing the systems by which the standards
11 would be developed. This seemed to me to be very much
12 a professional activity. I happen to have some interest
13 in cancer, but not in other areas, in terms of the
14 detailed clinical work. The real job of the CMO was to
15 stimulate activity in developing such standards, in
16 ensuring that such standards were tested, they were
17 reliable, and encouraging professional groups in all
18 specialties to be able to do that.
19 Q. In terms of laying down standards, who would do it? The
20 Royal Colleges? The Department of Health? Would it
21 depend on the area?
22 A. It would generally be the profession, and I say that
23 rather than the Royal Colleges, because there may be
24 a number of areas which do not neatly fall into
25 a particular Royal College. The Department and the
0017
1 Chief Medical Officer would normally have tried to
2 ensure that any professional group -- that is why
3 I think the Royal Colleges are not the only group; there
4 may be other subgroups within the Colleges, specialist
5 societies, for example, the British Dermatological
6 Association or the British Burns Association who do not
7 neatly fit into a College, would have that
8 responsibility to do that.
9 As the Chief Medical Officer, (a) I would
10 encourage that; and (b) if they had such information
11 available, I would ensure the dissemination of that, and
12 it supports that professional bit which I did on
13 a fairly regular basis.
14 Q. Would the support be formal or informal?
15 A. It would be a bit of both, as it happens: formal in the
16 sense that we developed latterly a Chief Medical
17 Officer's letter, a CMO's update which would formally
18 endorse that. Prior to that, in terms of CMO letters,
19 the profession's attention would be drawn to
20 a particular area, but the implementation of that would
21 be either through the professional body itself, or
22 indeed, latterly through the Trusts who would have that
23 information, who would be able to say, "Well, this is
24 the kind of standard, this is the kind of outcome that
25 we would expect".
0018
1 Q. The CMO letter system: when did that begin?
2 A. 1948, I suspect.
3 Q. So when did it become used for the purposes of setting
4 standards?
5 A. I think over the years it has always been used to say,
6 "Here is a particular procedure", or indeed, "Here is
7 a procedure you should not use" for whatever reason. So
8 it was a way of communicating widely public information,
9 as it happens, widely to the profession and to the
10 public that here was something which was important, and
11 I took the opportunity of raising a series of
12 non-medical issues as well as medical issues.
13 Q. I am going to come back to the question of audit in
14 a minute, but let me ask you this. Can I turn from
15 audit for the moment to the question of the
16 responsibility of doctors for care, or clinicians for
17 care.
18 We were told yesterday by Sir Alan Langlands that
19 there had been, in the process of developing Trusts and
20 the NHS reforms and the bedding-in process after 1991,
21 confusion over the roles and responsibilities that there
22 were for the delivery of care.
23 I am going to bring this discussion to a focus on
24 the supra-regional services in a moment. But talking
25 generally first, as between the patient and the
0019
1 immediate treating clinician, would I be right in
2 thinking that the immediate treating clinician would
3 have the responsibility for the delivery of care?
4 A. I think probably. I say that because it would be the
5 consultant who would have the overall responsibility,
6 rather than the doctor in training themselves. I am
7 certainly concerned about what the confusions meant.
8 I do not understand what the confusions are.
9 Q. In terms of roles and responsibilities.
10 A. Of whom?
11 Q. I think he had in mind the question of who in particular
12 would accept the responsibility for the successful
13 performance of, let us suppose, a supra-regional
14 service? Was it the hospital's responsibility, the
15 Region's responsibility, the Supra-regional Services
16 Group's responsibility, the Department of Health's
17 responsibility?
18 A. I understand the question.
19 Q. That is what was in mind.
20 A. So in terms of your question of who would have
21 responsibility for an individual patient, it would be
22 the consultant who was the named consultant in treating
23 that patient.
24 Q. And above the consultant, if there were a lack of
25 confidence in the clinician, that would be a matter
0020
1 for ... the Trust?
2 A. I think there are a whole series of different levels
3 that one could go through. Clearly one's own
4 professional colleagues are very much a part of that.
5 If you are working in a team or a group of individuals,
6 if there is a competence issue, then that might be
7 picked up and be dealt with at that level, for example.
8 Beyond that, it would be the Trust through the
9 Medical Director or in pre-1989 terms, Medical
10 Superintendent. Beyond that, it would be the governing
11 body or Trust Board, and beyond that, to the Regional
12 Director of Public Health.
13 Q. And beyond the Regional Director of Public Health?
14 A. It would depend on the issue, but if this was an issue
15 of competence, it would go to the General Medical
16 Council.
17 Q. So beyond the Regional Director of Public Health to the
18 General Medical Council and not to the Department of
19 Health itself?
20 A. No, not directly, unless there was an issue which
21 required a service to be stopped or closed, but that
22 whole circuit could, of course, be bypassed almost
23 directly from the first group I mentioned straight to
24 the GMC. It would not need to be up the line all the
25 way. If there was a service issue which needed to be
0021
1 dealt with, that could well be done through the
2 Department of Health. But it would not normally get to
3 that stage; it should be dealt with at Trust level
4 before it got as far up as the Department of Health.
5 Q. So far as the supra-regional services were concerned,
6 can we look for a moment at RCSE 2/24. To identify the
7 document, this is the interim report of the Working
8 Party on Neonatal and Infant Supra-regional Cardiac
9 Surgical Units in England and Wales, July 1989.
10 Can we go in that document to page 28, please?
11 What the Working Party report to the Supra Regional
12 Services Advisory Group: that they are not prepared to
13 calculate the basis of special funding; they talk about
14 financial support.
15 Then, seven lines down:
16 "Annual audit of work performed including hospital
17 survival in this age range should be continued to be
18 carried out by the Department of Health. The case mix
19 should be studied, with special reference to complex
20 cases. The interpretation of these findings should be
21 made in consultation with professional advisers,
22 paediatric surgeons, cardiologists who are actively
23 involved in this field of work and should be taken into
24 account when special funding is allocated for the next
25 year."
0022
1 So I get the reporting lines right, the Supra
2 Regional Services Advisory Group, we have been told,
3 reported through the Permanent Secretary to the
4 Minister. Did you, when you were Chief Medical Officer,
5 or to your knowledge Sir Donald before you, have any
6 input or involvement in the consideration of any
7 recommendation which they might make?
8 A. Not generally, as it happens. I clearly knew about it.
9 It was a very important part of the work of the
10 Department of Health. Indeed, in international terms,
11 it was very much a first and was looked on with great
12 envy in other parts of the world.
13 I did not attend meetings. I did not regularly
14 receive minutes, although I would, as I mentioned in my
15 written evidence, see the Chairman every now and then on
16 particular issues, but often by chance rather than
17 sitting down to discuss the work of the Supra Regional
18 Services Advisory Group.
19 Q. The audit which is being suggested here in the middle of
20 1989 plainly involves an annual process. It plainly
21 involves the case mix, "risk stratification" might be
22 another way of putting it, I think. Is that how you
23 would see that?
24 A. Yes, indeed.
25 Q. And looks to do what you have urged as important in
0023
1 evaluating the simple figures, which is professional
2 interpretation of the figures.
3 Where service was supra-regional (although
4 delivered locally) would responsibility for the service
5 be, as this might suggest, with the Department of Health
6 to look at and evaluate outcomes?
7 A. As I read that, and this is the first time I have seen
8 this particular document, it is an entirely appropriate
9 thing that on an annual basis, the work of the unit --
10 I think "audit" there may be seen slightly differently
11 than medical audit, although it is qualified beyond
12 that -- it would be an entirely appropriate thing for
13 the Supra Regional Services Advisory Group to look at,
14 and to take some advice on from specialists in the area,
15 and to ensure that the quality and outcome was
16 appropriate as the service was developed.
17 Q. Would the specialists, the professional advisers, come
18 from within the Department of Health?
19 A. I think unlikely, because although the Department of
20 Health does have a number of medical staff, they
21 certainly do not have the kind of specialists in some
22 areas that would have been required. My own view on
23 that, if I had been asked on this, would have been
24 somebody outside the department who has some particular
25 interest and expertise in the area.
0024
1 Q. So was it a matter of practice that the Department of
2 Health, if it needed inputting, would tend to go outside
3 for specialist input, rather than rely upon the doctors
4 within the Department of Health?
5 A. Yes. At the very specialist end, I think again in my
6 written evidence I have tried to answer that. There
7 were some people in the Department of Health whose
8 specialist expertise was of world quality. I give the
9 example of the immunisation and vaccination group.
10 Beyond that, particularly at the clinical end, once you
11 have been out of clinical work for a little while, it
12 really is quite important that things are reviewed by
13 those who are at the leading edge of that. I think
14 I would normally have gone outside to get that
15 specialist advice for this kind of purpose.
16 Q. Dr Halliday, who was the Medical Secretary of the Supra
17 Regional Services Advisory Group, was a doctor, as we
18 understand it, employed by the Department of Health in
19 that capacity.
20 As such, would he report to you at any stage
21 during your tenure of office?
22 A. I think I need to make the distinction again, perhaps
23 I was not clear about it, that there is a professional
24 reporting line and a line management line. In terms of
25 professional lines, he certainly would, yes.
0025
1 Q. Would it be any part of that professional reporting line
2 to report to you about the results of or the factors
3 bearing upon the results of audit of supra-regional
4 services, as described here?
5 A. It might well be, but because of the range of things
6 that go on within the Department of Health, I would
7 expect to do that only if there was a particular issue
8 which he wished to raise, not in a routine way.
9 Q. So it would be up to him, in essence, to see whether he
10 had concerns that he felt he needed to raise with you?
11 A. He and I, as it happens, used to meet fairly
12 frequently. We are both fellow Scots, as you have
13 gathered, and we both shared interests, particularly in
14 the business management area as it happened too, so we
15 used to see each other fairly frequently and discuss
16 a wide range of things. This might have been one that
17 he might have raised under these circumstances.
18 In terms of the formal reporting lines and the
19 appraisal system, he would be appraised by his immediate
20 line manager and not by myself, for example.
21 Q. Do you recollect him ever raising any issue with you
22 about the quality of outcome of the supra-regional
23 service so far as it related to paediatric cardiac
24 surgery?
25 A. I do not. I recollect him discussing one or two other
0026
1 issues about supra-regional services. I remember the
2 important one at the time was whether we developed it or
3 did not develop it, so I do recall a number of areas,
4 but I do not remember this area particularly and it
5 certainly does not stand out as an area which he
6 discussed with me.
7 Q. So if there had been a particular need to interpret
8 figures which he had in his capacity as Medical
9 Secretary of the Supra Regional Services Advisory Group,
10 would that be something for him to arrange in terms of
11 getting the necessary professional input, and not
12 necessarily something that you would know about?
13 A. Yes, that is correct. I mean, I would have expected, if
14 there had been a need for an alternative view, another
15 look at this, then he would have done that independently
16 to get advice. Perhaps the only thing I might mention
17 here is that of course the Chief Medical Officer did
18 have a series of specialist advisers, both of which
19 would have been covered by these areas and he may well
20 have gone to that individual, so it might have been my
21 specialist adviser he might have gone to for specialist
22 advice. I would not necessarily have known that, and
23 would not need to know that: that is what they were
24 there for.
25 Q. Let me turn away from this for a moment and look at the
0027
1 policy issues that lay behind the development of the
2 supra-regional services and the way in which the
3 Department of Health was involved, or might be involved,
4 in their development and continuation.
5 We have heard what has recently happened with the
6 Kasai procedure for biliary atresia, where we are given
7 to understand that the Department has secured as
8 a result of representations made to it that no more than
9 three centres in England should conduct this particular
10 form of procedure, the idea being, as we understand it,
11 that otherwise the numbers of such operations would not
12 be sufficient to ensure that any one team of clinicians
13 had the sufficient expertise, quite apart from the
14 necessary facilities.
15 Is there a general view that where operations are
16 comparatively rare, outcomes are likely to be better if
17 they are performed in one centre by one team, rather
18 than in a number of different centres by a number of
19 different teams who, by definition, would not have much
20 of a throughput?
21 A. I think there are several different ways of responding
22 to that. The first is that in general principles, that
23 is correct. The problem is, once you start looking for
24 the evidence, it becomes less clear. We recently,
25 before I left the Department, looked at this in
0028
1 particularly the cancer area. It is quite difficult to
2 find the evidence that that is correct, other than in
3 one or two instances. The instances where you cannot
4 find that evidence are often in the common tumours, not
5 in the least common tumours, so the principle was
6 correct but it was sometimes difficult to find the
7 evidence.
8 The second point is that the specialist expertise
9 is not necessarily of a medical or surgical nature; it
10 may be of a non-medical nature in terms of nursing,
11 dietetics and nursing. The whole concept of that
12 specialist team is important too, and it is the
13 availability of specialists outwith medical and surgical
14 specialists that may be just as important, which is why,
15 in rare instances, rare diseases, then it makes sense to
16 concentrate that expertise in a limited number of areas,
17 the number of areas depending on the incidence and kind
18 of expertise that is available.
19 Q. So the hypothesis is an accepted one: that where there
20 are only a few of patients suffering from a particular
21 condition, it is better to have them treated in a few
22 centres rather than many?
23 A. Again, it would depend --
24 Q. As a broad proposition?
25 A. As a proposition, although it depends on the level of
0029
1 expertise required. If something is rare but requires
2 something very simple to happen, then you could do that
3 in a much wider range of places than just a limited
4 number, although to build up the expertise, to build up
5 the numbers and to look at the outcome, then it makes
6 sense to put the data together.
7 Q. What we have been told in the Inquiry, so far as
8 paediatric cardiac surgery is concerned, is that surgery
9 for congenital heart disease was indeed one of the
10 procedures which was complex and that the view of the
11 profession throughout, from 1983 onwards, was that
12 patient care, in general terms, was best served by
13 limiting the number of centres who performed such an
14 operation.
15 The fact is, we have been told, that a number of
16 other centres began to perform such operations and the
17 consequence, we have been told, is that the decision was
18 taken by the Secretary of State on advice from the Supra
19 Regional Services Advisory Group in 1992 to de-designate
20 this particular service.
21 From your perspective, if it is thought desirable
22 on the best available medical advice that particular
23 operations should be restricted to a few centres rather
24 than proliferated to many, is it the case that nothing
25 in the early 1990s, or before, could actually
0030
1 effectively be done to prevent the proliferation?
2 A. If I return to the principle again, which is about
3 bringing together a team of clinical staff dealing with
4 a low incidence disease, whatever that disease is, it
5 makes sense for that to occur. Indeed, the real issue
6 the Supra Regional Services Advisory Group had of course
7 was money to actually fund it. If you did not have
8 funding, you could not do it. That in a sense was a way
9 of controlling that.
10 However, in a number of instances, and I give you
11 another one, with the coronary artery bypass surgery,
12 where it was quite clear at the beginning that that
13 should be restricted to a number of centres, although it
14 did not fall clearly within the Supra Regional Services
15 Advisory Group remit, as the expertise built up, as the
16 number of surgeons became trained to do it, it naturally
17 expanded and I think in many of these services, while
18 the numbers may be small, then it should be in a limited
19 number of places. But as skills develop, there is no
20 reason why that should not expand, if the outcomes are
21 as good.
22 Q. That depends upon the number of cases coming into the
23 hospital in the first place?
24 A. It does indeed, yes.
25 Q. If you have a condition unlikely to vary in terms of
0031
1 numbers, such as congenital defects of the heart, the
2 fact that people become more proficient at techniques is
3 no justification, in that case, is it, for expanding the
4 number of centres that can perform or do perform that
5 sort of operation?
6 A. Not a priori, but if you look at the data, there may
7 be. I return to a field I know slightly better and that
8 relates to the cancer area. If you look at bowel
9 cancer, for example, the most recent evidence I have
10 seen -- it may be out of date by now -- is that the
11 minimum number of patients to get the kind of good-ish
12 results you would want are probably between 15 and 20.
13 That is quite small. We have no good evidence that if
14 you do more than that, your results are much better. In
15 breast cancer, we do. In bowel cancer we do not. So
16 you have to look at the evidence on each occasion to see
17 whether expansion beyond a small number would or would
18 not be worthwhile.
19 Having said that, I return to the principle. The
20 principle is that if it is a low incidence problem, then
21 it should be dealt with in a limited number of places by
22 teams of people who are particularly skilled.
23 It is partly for the follow-through in terms of
24 the outcome, but also in terms of data collection,
25 analysis of the results and looking at quality of
0032
1 outcome.
2 THE CHAIRMAN: Sir Kenneth, I wonder whether I could come in
3 on that last answer. In the decision to concentrate
4 activity in a few centres, what role do you think the
5 need to accumulate reliable information so as to judge
6 performance played in that decision to concentrate,
7 rather than the other notion that with more experience,
8 so outcome will improve?
9 A. I think it is an important component of it. It is the
10 only way in the development of an entirely new service,
11 whatever that new service will be, that you can be sure
12 that the outcome is improving. Again, if you look at
13 the renal transplantation results from the beginning,
14 they were not very good and as experience built up they
15 became better. It expanded throughout a wider range of
16 places. So the data collection and analysis I think is
17 very important in providing the kind of positive results
18 which the public can then understand.
19 I think it is as much a public good as well as
20 a professional good. The problem is if you restrict it
21 to a limited number of services -- I talk now not of low
22 incidence disease but high incidence disease -- then you
23 restrict the number of people who will get treatment and
24 therefore there is a pressure to expand the service all
25 the time so more people can be treated.
0033
1 Q. May I follow that up by saying in a low incidence
2 disease, the continuation of a centre or a number of
3 centres which have a low number of cases going through:
4 does that mean that you will never be able properly to
5 judge the performance of that unit, and so for that
6 reason, if for no other reason, that unit perhaps ought
7 not to be doing that particular procedure?
8 A. Yes, I think that is an important, if you like,
9 consequence of having small units looking after small
10 numbers of patients. You cannot easily compare X with
11 Y, but again, that would depend on the outcome and how
12 easily that outcome could be measured. In a surgical
13 procedure, then you have wound infections and
14 mortality. In a non-surgical area, it might be more
15 difficult to do that kind of work.
16 MR LANGSTAFF: Apart from the issue of finance and making
17 available the supra-regional funding for a centre, was
18 there anything else which it occurs to you might have
19 been available to the Chief Medical Officer or the
20 Department of Health during the 1980s, from 1983 onwards
21 until 1995, to do to restrict particular operations to
22 particular centres?
23 A. I think there is a very strong professional issue here
24 about the profession itself saying "We should not be
25 doing one or two cases of X or Y". I can only again
0034
1 speak from personal experience, but certainly over the
2 last ten years, that has been quite a strong
3 professional thread: "We should not be doing things we
4 do a limited number of", partly for the reason as the
5 Chairman has mentioned, you cannot adequately compare
6 that with other people because it is such a small
7 number.
8 I think that is an important professional issue,
9 as opposed to a Department of Health issue.
10 Q. So it is a matter for professional self-regulation
11 rather than government influence?
12 A. Yes, but again, the Chief Medical Officer's role within
13 that is to discuss that kind of issue, which I did on
14 a fairly regular basis, with the Medical Royal Colleges
15 and the specialty associations, and made them ask that
16 question of their own service, whatever that particular
17 service was, whether it was a gynaecological service or
18 a gastrointestinal service or a paediatric cardiological
19 service. It is a fundamental question in terms of the
20 outcome and quality of care.
21 Q. You need a very firm consensus view to carry a whole
22 profession with a particular policy?
23 A. Yes.
24 Q. One of the features of medicine may be that for perhaps
25 very good reasons people may take different views on
0035
1 different issues.
2 To what extent in an area like this can one deal
3 with the exercise of clinical freedom so as to constrain
4 it in what is seen to be, on the best available advice,
5 the public interest?
6 A. I have always been slightly concerned about the concept
7 of clinical freedom. It suggests doctors can do
8 whatever they like. I do not think that is what
9 clinical freedom is. I am not sure if clinical freedom
10 exists. You can only practice medicine in the context
11 of existing knowledge, relating what you do in your own
12 practice to what happens elsewhere in the rest of the
13 world in terms of other people's practice.
14 I think that is the context in which clinical
15 freedom can operate and you can only deviate from what
16 is generally thought to be best practice if there is
17 a particular reason for that and you can justify that
18 change in professional practice.
19 Q. If one takes the example of, going back to paediatric
20 cardiac surgery, the general view we have been told, the
21 general consensus existed that it was best done in seven
22 centres. Nine centres began to be funded centrally and
23 that proliferated, against the better judgment of, we
24 are told, the consensus judgment of the profession, to
25 13 by the time that de-designation occurred.
0036
1 So here it might be said, is an example of the
2 profession recognising what was best practice but in
3 terms of restricting the number of centres, each centre,
4 no doubt, saying, "Well, the number of centres doing
5 this ought to be restricted in the public interest,
6 providing it is not us that is restricted, i.e. it is
7 somebody else".
8 How does one deal with that?
9 A. I think this is an issue which comes up on a fairly
10 regular basis, as to where a particular service should
11 be delivered and how it should be delivered. There are
12 undoubtedly geographical issues which need to be taken
13 into account. It is entirely possible for families to
14 move fairly large distances for treatment, but it is
15 much easier if they can get something closer to where
16 they live.
17 So there is continual pressure I think to deliver
18 services closer, in a geographical sense, to where
19 individuals live and where centres of population are.
20 So I am not surprised that move occurred. That
21 move occurred for several reasons, one of which would
22 be, I think that the number of people who had been
23 trained in the particular area had increased and
24 therefore there was no danger that they would be
25 inadequately treated.
0037
1 So it is a natural progression in terms of
2 clinical practice.
3 Q. Is not one of the problems of developing an expertise
4 which depends upon doing a certain number of operations,
5 one can lose it if one does not?
6 A. Absolutely. That is why the whole area of continuing
7 professional development is so important, and it is also
8 why areas of measuring your own performance against
9 somebody else's remains just as important.
10 Q. Can I come back to the question which I do not think you
11 have answered, although you have addressed it in the
12 answer before last, which is, given that you have
13 a profession which says, "This service needs to be
14 delivered in, let us suppose, seven centres ideally", it
15 is in fact being delivered in almost twice that number,
16 what can be done about the service delivery by Chief
17 Medical Officer, by government, when the profession
18 itself is not, for understandable reasons, delivering?
19 A. I think, if I can just expand it a little bit, it may
20 not be the profession itself, of course. It may be the
21 local area and the hospital, and the Trust, who say,
22 "Why can we not deliver that service, because we have
23 everything here that is able to do it?" and there is
24 pressure not only at the medical end but at the
25 non-medical end to be able to deliver a service.
0038
1 So the issue as to whether a particular hospital
2 as opposed to a doctor develops a service and is allowed
3 to deal with certain things is an area, I think, for the
4 Trust Board to think about, and they have to be able to
5 take on board the consequences of doing that if the
6 numbers are small and the outcomes not particularly
7 good.
8 So I think it is only partly a professional
9 decision. It is also related to whether that hospital
10 complex, whatever it is, wishes to see that as a service
11 that is developed. Again, if I move beyond paediatric
12 cardiology, then there is a very considerable wish in
13 some hospitals to do particular things because it would
14 be good for them to do it. They do not have that
15 service just now. It would be complementary to what
16 they already do. You can argue that they should not.
17 If I give you a totally different example, in
18 cleft palate, the review of cleft palate services some
19 time ago suggested that small numbers were being done in
20 places that probably should not be doing them. That
21 I think is the kind of intelligence that is required to
22 say they should stop doing them there and concentrate on
23 places able to provide the level of service. So you
24 need the intelligence first.
25 Q. Two questions arise. The original question I asked was
0039
1 what can be done to regulate the delivery of
2 a particular service through a restricted number of
3 centres. The answers you have given me so far are that
4 it is a matter for the professions. I say what if the
5 profession is not delivering? You say that it is also
6 a matter for the local Trust or the local health
7 authority, either the provider or the purchaser, to
8 determine.
9 Is it a matter for central government at all, do
10 you think?
11 A. I think, if you go to the next tier up, it is a matter
12 for the region to say, "How are our services
13 developing? What areas do we need to get into? What
14 areas are we not into that we need to provide for our
15 population within the region?"
16 Beyond that, it would be a matter for the
17 Department of Health to say, "We will not do the
18 following things", or "We might do the following
19 things". But I would have thought that that could and
20 should be resolved at a different level.
21 Q. If the government did say "This is not something we
22 should be doing in so many centres. We know that we
23 have 14 regions, let us suppose; each region wants to
24 give these services because, after all, they all have
25 their regional pride, their regional responsibilities,
0040
1 but it is in the interests of the public as a whole that
2 there should be only seven of them doing it", let us
3 suppose those are the facts: was there anything, prior
4 to your retirement, that central government would
5 actually be in a position to do about it?
6 A. Yes. Again, I have to return to concrete examples if
7 that is helpful to you. In the development of cancer
8 services across England -- I apologise for returning to
9 that, but a report was produced in about 1996 in the
10 particular area, which specifically addressed that issue
11 and said that "if individual clinicians are not dealing
12 with a sufficient number of cases, they should not be
13 doing that". That then became part of the professional
14 development plan, that in areas where small numbers of
15 patients were being treated, perhaps not with the best
16 outcomes of care, they would be sent elsewhere to ensure
17 that did not occur.
18 So there are mechanisms in place to shift the way
19 in which a particular service is delivered.
20 Q. If something such as the scenario that I have been
21 painting to you in respect of paediatric cardiac
22 services happened again, that is that it is thought
23 ideally seven centres, in fact 13 centres, were doing
24 it, would government, do you think, do something about
25 it?
0041
1 A. With one proviso: that the quality was not as good as it
2 should be in those centres. I think there are
3 mechanisms available now for that to happen much more
4 easily than there would have been in the early 1980s,
5 (a) through the professional lines which I think were
6 much stronger than they were; and (b) through the role
7 of the Trusts and the regional health authorities to
8 deal with that. I think it would be easier now to say
9 no to certain things than it would have been 20 years
10 ago.
11 Q. In an earlier answer, I put a word into your mouth which
12 you may not have meant to answer. You were talking to
13 me about Trusts developing services and regions, and
14 I came back to you and added in "purchasers". I do not
15 know if you have seen any role here for purchasers or
16 not?
17 A. I am sorry, my assumption was all of that would be part
18 of it and that the district health authorities and
19 increasingly I suspect through primary care groups, will
20 have a role in the development of individual services
21 and whether or not such services will or will not be
22 provided.
23 So that is the lever. That is the lever that was
24 developing from 1989 onwards in terms of the role of the
25 District Health Authority, in terms of purchasing.
0042
1 MR LANGSTAFF: I think the Chairman had a question.
2 THE CHAIRMAN: I did. I was just wanting to explore two
3 things which are related.
4 When you were talking about possible proliferation
5 of a service, you said that others might judge that it
6 would be unwise when the outcomes were seen to be poor.
7 Of course, the outcomes will not be seen to be
8 poor until some date in the future, and if the numbers
9 are small, they will probably never be amenable to such
10 judgment. That begs the question of whether there would
11 be prior control, more poignant and important.
12 Second of all, if one can tie another question to
13 that, when we are talking about supra-regional services,
14 the involvement of government cannot be devolved to the
15 Region because these are by definition supra-regional,
16 and come straight into somewhere in government.
17 Mr Langstaff I assume is asking what mechanism or lever
18 was available to central government, because central
19 government is then involved in controlling the situation
20 of proliferation.
21 Those are two questions, but they are not
22 unrelated.
23 A. The first question is about how you begin to develop
24 a new service and it can be in a low incidence area, it
25 can be in a disease which is in a high incidence area.
0043
1 Q. Assuming there is an existing service which is to be
2 concentrated so as to be optimal, should there be
3 another service elsewhere, outwith that plan, to which
4 you say, "Well, in time it will be seen, perhaps when
5 the results are bad, that that proliferation should not
6 take place".
7 My observation was: (a) you may never be able to
8 tell that; (b) there may be some damage already caused,
9 ergo the need for control, ergo the system of
10 supra-regional centres.
11 At that point, the control of that, because it is
12 supra-regional, vests with central government, it could
13 be thought?
14 A. I can respond to that then. If the issue is not
15 a Supra-regional Services issue, then I think that would
16 be at the District Health Authority purchasing level at
17 which that service, that new service, could very easily
18 be stopped and not allowed to develop.
19 At the supra-regional end, that is an issue which
20 is one for the Department of Health. I think that is an
21 issue particularly if there was a proliferation of
22 services which were inappropriate, then that would be an
23 issue that Ministers, I suspect, would wish to get
24 involved in, and through Ministers, and then through the
25 individual health authorities and Trusts to say that
0044
1 service should not be allowed to develop.
2 I still think there is an issue about developing
3 a new service, because that is always the case.
4 MR LANGSTAFF: One more question in this debate as between
5 division and proliferation, before we take a break. It
6 is this: you were suggesting that one of the ways that
7 proliferation is controlled is because the service which
8 is thought best provided in a few centres, but in fact
9 provided in many, when it is provided in the many the
10 results will demonstrate that the service is better
11 provided in the major centres rather than the outliers.
12 Is it perhaps one of the difficulties that if you
13 have a service which, let us suppose, is best (as
14 a matter of theory) provided in two or three centres but
15 in fact is provided, let us say, in 20 or 30, but if the
16 theory is right the 20 or 30 will all have less good
17 results than they might have, but if one compares one
18 against the other, the results seem to be perfectly
19 reasonable and there is, within the system, therefore,
20 a justification for continuing a proliferated service
21 rather than a concentrated one?
22 A. I think that statement makes several different
23 assumptions, some of which I do not think we can
24 justify. It assumes if there are 20 centres it will not
25 be as good as 3 centres and I do not think there is any
0045
1 evidence for that.
2 The possibility of comparing that internationally
3 would be where I think things would go. Again, if you
4 need 20 centres to deal with a larger group of
5 patients -- I am not talking about paediatric cardiology
6 now -- then the ability to deliver a service closer to
7 a patient's home may be important.
8 So I think there are several assumptions in your
9 statement which I do not necessarily agree with.
10 Theoretically, you are right, of course, but I do not
11 think the assumptions back up what you have just said.
12 Q. I was putting to you a very general proposition, and not
13 relating to any particular service, but in relation to
14 your answer, we need to look at the results. The
15 proposition was a simple one, which I think you are
16 accepting, subject to qualifications, which is that if
17 you do proliferate any service which is better
18 concentrated, let us assume, if you proliferate it to
19 a number of centres, the results from each of those
20 centres will bear comparison with each other, but not
21 against the gold standard there might otherwise have
22 been?
23 A. I am not sure I accept that without some specific
24 instance and some data.
25 Q. I accept it is entirely a general theoretical question.
0046
1 On that note, perhaps, we should have our first
2 break?
3 THE CHAIRMAN: Shall we take a break, then, for 15 minutes
4 and reconvene at 20 to 12?
5 (11.25 am)
6 (A short break)
7 (11.40 am)
8 MR LANGSTAFF: You have spoken about the number of links you
9 have with the profession, being yourself
10 a professional. Am I right in thinking that throughout
11 your tenure as Chief Medical Officer, you maintained the
12 best possible links you could with others in the medical
13 profession generally?
14 A. Indeed. I think it is one of the important functions of
15 the Chief Medical Officer to maintain and develop these
16 links.
17 Q. Because you obviously have to have a sense of how
18 doctors are likely to react to particular situations and
19 problems as they arise, in order the better to advise
20 the Secretary of State?
21 A. That is correct.
22 Q. When, in the evidence about an hour or so ago, we were
23 talking about Trusts, and you were saying if a Trust
24 wants to develop a particular area, they may do so, but
25 obviously they will have to have in mind the likely
0047
1 results because they may, in time, show that the Trust
2 has taken the wrong option -- words to that effect --
3 you were looking at it as a process of the provider
4 deciding to offer a new treatment or a new area of
5 surgery or expansion of an existing area, were you?
6 A. Yes. I am not sure if I quite agree with your summary
7 of what I actually said. So I disagree with what you
8 said. But I think what I was saying was that if a Trust
9 does want to develop a new service and why should it
10 not -- indeed, it might be very beneficial if it does
11 not have a service to develop it -- then the Trust and
12 the purchaser, and indeed the primary care groups
13 currently, would think about how best to do that, what
14 resources would be required, the numbers of patients and
15 the skills and expertise of the existing staff to
16 develop that new service.
17 Q. The initiative would come from whom, as you see it? You
18 seem to suggest the initiative comes from the Trust
19 itself, the provider?
20 A. No, not at all. I was using that as a particular
21 example. The initiative may come from the public saying
22 "Why do we not have a service in this area?" and the
23 primary care group or other organisations saying that
24 they would bring it to the attention of the Trust. It
25 could come from the Trust Board itself, who say "We are
0048
1 looking in a particular area, why can we not develop
2 it?" It could be that it is an individual clinician who
3 has developed a particular expertise who would like
4 a service to develop.
5 Q. Can I move to something very different, which is
6 I suspect a subject close to your heart, the training of
7 doctors? We have received, and scanned, and read with
8 interest what is known as the "Calman Report" which led
9 to a change in the way in which surgical and other
10 clinical staff were trained.
11 May I ask you some questions in relation to that?
12 First of all, as part of the consideration of training,
13 was any consideration given at that stage to retraining
14 and constant retraining throughout practice?
15 A. Very much so, and the consequence of introducing this
16 competency-based training programme, which is what it
17 is, means it is now possible to do the second part which
18 is the further retraining component, which the General
19 Medical Council are now considering and indeed there is
20 strong professional support for that.
21 Q. Before the reforms which the committee which you led
22 inspired, training was in essence a form of
23 apprenticeship in which those in the training grades
24 were supervised by their consultant?
25 A. No, I would not have put it that way at all. The
0049
1 training programme for most doctors in the hospital
2 specialties -- I now confine myself only to the hospital
3 specialties, if that is helpful to you -- would be
4 perhaps one or two years in a grade called Senior House
5 Officer grade, moving up into the Registrar grade and
6 then the Senior Registrar grade.
7 By the Senior Registrar grade the individual had
8 chosen a particular specialty within which they wished
9 to train. They would then be placed in a post and that
10 post would be supervised by one or two people including
11 Postgraduate Dean to ensure that the training was
12 appropriate. So in terms of the mechanism of training,
13 it was very much hands-on dealing with individual
14 patients, closely supervised by someone of some
15 seniority, and if you call that apprenticeship, it is
16 probably what I would call apprenticeship, but it has
17 pejorative overtones and I would like to make sure what
18 we mean by "apprenticeship".
19 Q. I certainly did not wish to convey the overtones to
20 which you refer.
21 The way in which the present system differs from
22 that is, is it, to provide a better structure or greater
23 structure to training, giving, for instance, curricula
24 which are developed?
25 A. The whole thrust of the report was that much of the
0050
1 training relied on an ad hoc approach and that a young
2 doctor would be moving from post to post, generally well
3 supervised but not always well supervised, into
4 a structure which provided proper supervision over
5 a period of time, five to seven years depending on the
6 specialty, with regular feedback on performance and at
7 the end of the day there would be an assessment of
8 competence. That is essentially the only difference.
9 The rest is mechanical difficulties in how it was
10 organised, but the real issue at the end was whether the
11 individual was competent to become an independent
12 practitioner in surgery, medicine, paediatrics or
13 whatever. That is the real change. It is the
14 competency-based approach which I think makes it
15 different.
16 Q. Does the clinician going through the present process get
17 as much hands-on experience now as he would have had
18 under the pre-Calman system?
19 A. I would hope he might get even better and more hands-on
20 experience, because it is now programmed over a five to
21 seven year period in a way which not only suits that
22 individual's previous expertise, but also picks up
23 problems they may have in that training and provides for
24 extra supervision if that is required.
25 So there is no reason at all that they should get
0051
1 less experience. In fact, as I mentioned, they might
2 get more. They often, particularly at Registrar grade,
3 got stuck for several years doing the same things in the
4 same place without any wide experience at all. This
5 should provide the opportunity to develop that: the
6 curriculum, developed by the specialties themselves, the
7 Colleges in particular, to ensure that wide breadth of
8 experience is in fact achieved.
9 Q. To what extent does the new system lend itself to what
10 one might describe as the "soft" side of medicine, what
11 perhaps used to be called "bedside manner", the dealing
12 with the patient or the patient's relatives in times of
13 stress and difficulty?
14 A. I am not terribly sure if I follow the question.
15 Q. Medical training now: to what extent is an emphasis
16 placed upon clinical ability and to what extent, by
17 contrast, if there is a contrast, is it placed on
18 interpersonal skills dealing with the patient or
19 relative?
20 A. My own view on this is fairly clear: I think the two
21 are the same. It would be very difficult to be an
22 appropriate clinical person doing a clinical job without
23 these interpersonal skills; it is relevant throughout
24 the whole of clinical practice; it should begin at the
25 medical school, not in specialty practice, and it is
0052
1 a process which I feel, and have always felt, pretty
2 strongly about in terms of the interpersonal part of it.
3 That is not dealt with, I do not think, by
4 a little course called "communication skills"; it is
5 much more about ensuring that throughout professional
6 practice, that individual, the young doctor, is able to
7 understand the sensitivities, the difficulties, the
8 feels and anxieties, concerns of individual patients and
9 their families. That is the strength of the feedback
10 system. That is what the supervisor should be doing,
11 saying "You are pretty good at doing the technical bit,
12 but you could do a little better that way, or the other
13 way round". That is the whole purpose of proper
14 supervision and feedback: to identify any problems.
15 So I see it as an integral part of clinical skill.
16 Q. And the same process applies, does it, to, for instance,
17 equipping doctors to deal with the harder parts of
18 medical practice, the grizzly sights that they may have
19 to deal with, the fact of bereavement and suchlike?
20 A. Yes. Again, my background does not come out terribly
21 well with what I have given you, but my particular
22 interest in the past 15 years has been palliative care.
23 It is an area which is difficult, it is not an easy
24 thing at all to do, but it is the kind of area where
25 doctors, and indeed our other clinical colleagues, need
0053
1 to have some exposure, some experience in doing it, and
2 actually being taken through the difficult bits so they
3 feel themselves what some of these problems are.
4 A lot of my tasks when I was Professor of Oncology
5 is to get medical students to meet patients, many of
6 whom were only too willing to raise difficult issues
7 with these young medical students, to get them to come
8 to terms with some of the difficulties they were going
9 to face in clinical practice.
10 Q. One of the added difficulties that there may be for
11 a young practitioner is the difficulty of coping not
12 only with the distress of those around him and the
13 distress of circumstances, but the possibility that he
14 or she may, themselves, be in error in something they
15 may have done, or failed to do.
16 To what extent are doctors now at any rate
17 equipped by training to deal with the handling, as it
18 were, of error?
19 A. I think there are several different components to that.
20 One, of course, is that the whole purpose of the new
21 training programmes is to provide sufficient supervision
22 and support so that there is someone to talk to about
23 the problems, if there are any problems; are there
24 problems about what I might have done or how did I deal
25 with that particular issue? In my own career I was
0054
1 fortunate in having people around me I was able to talk
2 to about difficult decisions.
3 I think it is a fact that all young doctors, at
4 some point, will feel concerned about a particular
5 decision that they have made in one way or another. It
6 does not necessarily have to be the wrong decision, it
7 is just a decision that they have made.
8 Again, the purpose of the process of talking to
9 your colleagues about it, either in a ward situation or
10 in an off-the-ward, sitting down talking to each other
11 situation, and many units do have the opportunity to sit
12 down and talk to somebody if you think you have made
13 a decision which you are uncomfortable with.
14 Again, a lot of it is providing that support and
15 providing the young doctor with if you like not only
16 a sense of support but a sense of humility, which is
17 a terribly important professional virtue, to be able to
18 talk to others and say "I am not sure about this, will
19 you help me?" and to have a system behind them that can
20 help. Then they learn with experience. But I would
21 also have to say that all doctors also have such
22 concerns, and they, too, are just as concerned about the
23 quality of their clinical practice. They also do need
24 a bit of help sometimes to talk to somebody about
25 difficult decisions that they have had to make.
0055
1 Q. Plainly, you are an enthusiast for developing in the
2 young doctor the necessarily interpersonal skills as
3 a necessary part of clinical practice, what you said.
4 Has the emphasis, do you think, in training and approach
5 changed at all in this area over the last 15/20 years?
6 A. Oh, significantly. I think the General Medical Council
7 have been very influential in this in the training of
8 medical students and new doctors. The reports I think
9 have been very important. If I look back in terms of my
10 own medical student training and to what is now
11 available, then it is significantly different and
12 emphasises what you call the "softer" side but I would
13 call much harder than that. It is the real part of
14 clinical practice, not the soft bit.
15 I think it is emphasised from teaching and
16 discussions in medical ethics to the social problems
17 that individual patients have, and I am fortunate in
18 Durham, by 2001, to have a whole group of preclinical
19 medical students coming to us. One of the things we
20 will be developing is what you call the "softer" things
21 as a very important part of medical education.
22 Q. Take us back to 1983/84: how, then, would the training
23 and approach have differed significantly from the way
24 that it is now delivered?
25 A. I think, if you want me to separate undergraduate and
0056
1 post-graduate: in terms of undergraduate, it was the
2 beginnings, I think, about that time, of very
3 significant change. As it happens I was the Regional
4 Post-graduate Dean in the West of Scotland between 1983
5 and 1994, and there was a very significant impetus
6 there, and indeed around the country, particularly the
7 Pre-registration House Officer level, the first time you
8 are actually on your own at times, in terms of
9 understanding the problems in how to support young
10 doctors.
11 Interestingly, the problems that came up in
12 a study that we did were not about, if you like, the
13 patient who might be very ill and dying, because there
14 is always an opportunity to spend time with a young
15 doctor then; it was the sudden death that was the
16 problem, in a ward they had never been in before and
17 suddenly had to face relatives they had never seen.
18 That is much more difficult than the patient whom you
19 know and can spend some time with.
20 So at the undergraduate end, a great deal was
21 beginning to develop there, and indeed just at that
22 particular point my own interest in literature in
23 medicine developed, reading poetry in terms of medical
24 education.
25 At the postgraduate end there was a much stronger
0057
1 emphasis at the beginning of 1984/85 on this kind of
2 structure of training that provided a range of
3 experience rather than just an ad hoc experience, to
4 provide at the end of the day somebody who was a rounded
5 practitioner, but had specialist skills and in a sense
6 that had developed and has developed quite significantly
7 over the last ten years or so. The Germans were there in
8 the late 1970s, early 1980s, and I think it is now
9 coming through quite strongly, and I think the GMC have
10 done a remarkable job at the undergraduate and now the
11 post-graduate end with continuing professional
12 development and the possibility of some kind of
13 refreshment programme to be taken on. That is a very
14 significant shift.
15 Q. The undergraduates of 1983/84 with the change in
16 emphasis about that time in the way you have described,
17 would go into clinical practice and then rub shoulders
18 with doctors who of course had been trained in what one
19 might describe as the "old school" ways.
20 Did that, as you see it, create a dilution of the
21 attempts that had been made to train them as
22 undergraduates in the subtler interpersonal skills that
23 you have been describing?
24 A. Again, if I may say so, you make an assumption. The
25 assumption is that these older doctors did not have
0058
1 these interpersonal skills, and I would reject that.
2 It did of course mean that the process of
3 socialisation, as you move through the professional
4 circles, is a very powerful and very important one.
5 I think that is always difficult and we have seen it in
6 other medical schools elsewhere: in Australia, for
7 example, I have seen this, where students taught in
8 a quite different kind of way suddenly find themselves
9 in conventional medical practice, and it is slightly
10 different.
11 So there are tensions there, but if you only
12 concentrated on medical students you had be missing the
13 point. In this process, the whole point is to encourage
14 senior colleagues to have thought through the kind of
15 things that were happening, and they would be teaching
16 them, remember, also they would be supervising them, so
17 you have to work on several different fronts to begin to
18 change the way in which the profession thinks about
19 individual people.
20 Q. You have queried the assumption that I made. Does not
21 the assumption follow from the acceptance of a need to
22 train doctors rather more in this sort of skill; the
23 need can only exist, can it not, if the perception is
24 that there is an absence or a significant lack of such
25 skills in those doctors who have previously been, if
0059
1 I use the word "produced", you know what I mean?
2 A. Yes. I do not accept that one either, but that is
3 another matter. Of course you are partly right. I just
4 would not like the impression to be given that all
5 doctors in 1984 over the age of 40 were not good at
6 talking to people. I think there was a recognition by
7 that group that they could do things better. There was
8 a much greater awareness of public involvement and
9 public requirements in terms of care and a lot of that
10 came through much greater professional wishes to look
11 after patients as people.
12 So it was part of the process, and of course you
13 are right, things will get better and things will need
14 to continue to get better, but it was the recognition
15 that maybe some things could change which I think began
16 the process.
17 Q. So going back to 1983/84, what you might agree with --
18 please say if you do not -- is that the medical
19 profession then contained a number of caring individuals
20 who could nonetheless benefit by training, which is why
21 it was given to the younger doctors, to improve the
22 caring skills which they displayed as part of their
23 clinical performance?
24 A. Yes. You have focused on 1983/84. That would go back
25 for a very long time because I think professional
0060
1 leaders over the last 200 years have asked the same
2 question: how can you make things better? You just need
3 to look at the medical education literature to see these
4 have been questions that have been raised for a long
5 time.
6 He focused on 1983/84 and I think here is
7 a recognition that, as a professional group, we could
8 respond more effectively to what patients and the public
9 need, and how could we do that better: a move through
10 the undergraduate and post-graduate training to begin to
11 change that.
12 Q. The reason I use 1984 is because it is the start of our
13 terms of reference, but moving from 1984, from the 1980s
14 into the 1990s, the perception is, is it, of an
15 improvement in the way in which doctors generally, young
16 and old, have approached the caring skills which they
17 have displayed as part of their clinical practice?
18 A. I could only give you an impression on this --
19 Q. That is all I am asking for.
20 A. My own feeling is that that has significantly shifted.
21 I used some of my own information in 1973/74 earlier
22 when I first became the Professor of Oncology and the
23 data there. The other bit of information, of course,
24 was that the majority of patients referred to me in 1974
25 as the first Professor of Cancer Medicine in Scotland
0061
1 did not know why they were being referred. That would
2 be impossible now. I think things have changed, so the
3 openness has changed. That is just a very nice example
4 of how I think things have changed very significantly.
5 I think you see patients now much more aware of
6 what is wrong, what we want to do. They see their
7 x-rays, they are part of the process. That did not
8 happen in the early 1960s when I was training in the way
9 that it now does. So I think there has been a very
10 significant shift. There is still a long way to go and
11 we do not get it right all the time.
12 Q. You mentioned the humility of doctors, humility being
13 a desirable characteristic for doctors to show. When
14 a doctor begins for the first time to practice
15 a surgical procedure -- and every surgeon must, by
16 definition, do an operation for the first time -- is
17 there a general perception that for whichever operation
18 it is, there is a learning curve?
19 A. The answer is yes, of course there must be, but having
20 said that, the whole purpose of a training programme is
21 that that individual is supervised throughout that
22 process with somebody senior. Indeed, that, I think, is
23 part of the strength of the new reforms, that that
24 should be happening. That is one of the tensions in
25 ensuring that that happens. As you develop your own
0062
1 particular skills, then you have somebody there who can
2 reassure, help, assist, develop, until you develop the
3 skills that are required to allow you to do things
4 independently.
5 Q. So the answer for the learning curve for the learning
6 surgeon, learning established skills, is that he does it
7 under the supervision of somebody who already has those
8 skills?
9 A. Yes.
10 Q. That must have been recognised, really, for many years.
11 You have described or accepted the description of the
12 system pre-Calman as having some of the features of
13 apprenticeship about it and that involves supervision,
14 does it not, by the established clinician of the junior
15 clinician?
16 A. Indeed.
17 Q. What about the consultant who is himself or herself
18 performing a new operation for the first time? They
19 have, by definition, surgical skills in the area, but
20 they may, by definition, have none in that particular
21 procedure?
22 A. I think that depends on what it is. I am sorry to
23 particularise, but let me give you some examples, if
24 I may.
25 I was involved surgically, for about eight years,
0063
1 mainly on transplantation and vascular surgery. During
2 that process, the senior consultant I worked with took
3 a year out to go and work in the United States on liver
4 transplantation. He would not have done a liver
5 transplant on his own in this country without a year's
6 experience with one of the most outstanding liver
7 transplant surgeons in the world. That would be the way
8 he would deal with an entirely new procedure: he would
9 normally go somewhere where they are doing it and learn
10 how it is done, come back with the skills and expertise
11 and build up a team.
12 If it is a modification of an existing procedure,
13 then, that might not need a great deal more because you
14 have already been familiar with it.
15 If it is an entirely new procedure you are going
16 to pioneer yourself, you are likely to have done some of
17 that in some kind of experimental way beforehand to
18 ensure the outcome is likely to be what you think it
19 will be, either on animals or some other way.
20 So there are a whole number of ways you would do
21 it, depending what the operation is at the consultant
22 level.
23 Another very good example relates to keyhole
24 surgery. It suddenly developed. Most people would have
25 gone to work with somebody for two or three weeks or
0064
1 three months or whatever it was, to find out how best to
2 do this and ensure they had all the right equipment and
3 knew where it was, and come back and build that up in
4 the unit. It is a matter of going to visit other
5 practitioners at the consultant level to see how best to
6 do it.
7 Q. If you take a consultant who is one of, let us say, or
8 two in a specialty in a particular unit, there are
9 pressures upon him, let us suppose, in terms of patient
10 demand, in terms of the Trust or the District Health
11 Authority wishing him to perform those particular
12 services with that particular population. If he is
13 going to take two or three or four weeks out in order to
14 be with somebody else performing an operation under
15 supervision in order to learn how to do it, how easy is
16 it, or was it, in the 1980s and 1990s, for that sort of
17 arrangement to be made within the National Health
18 Service?
19 A. It was certainly possible and happened pretty
20 regularly. Again, it depends a great deal on what the
21 new procedure is. If you take another example,
22 a gynaecologist using keyhole surgery, many of them were
23 already doing that for different purposes, but once you
24 started doing different things, then it did not take
25 very long to visit somebody, maybe even for a couple of
0065
1 days, to see exactly what the new procedure was, because
2 you were already up to speed with part of the
3 technology, if you like.
4 If it was an entirely new thing like developing
5 a liver transplant service, then you would have to go
6 and spend some time doing that.
7 Q. If it were an alteration of existing procedures, let us
8 suppose practising the arterial switch operation to
9 resolve congenital heart disease, rather than the
10 procedure such as the Mustard or the Sennings which the
11 doctor was familiar with, you might expect that to
12 involve the surgeon performing those operations for the
13 first time to carry out the sort of apprenticeship that
14 you have been describing?
15 A. Yes. I mean, I am not terribly familiar with the exact
16 techniques. It really depends on how close they are to
17 the existing ones, but it would seem to me that the
18 ability to discuss that with people who were doing it,
19 to watch them, to see them, and there were various
20 different ways of doing that, would be an important part
21 of that apprenticeship component, yes.
22 Q. It is your perspective that in the late 1980s, at any
23 rate, and early 1990s if a surgeon had wished to avail
24 himself of that facility, that it was easy to make
25 arrangements to do so?
0066
1 A. I think "easy" might not necessarily be the word I would
2 use, but it would be certainly possible.
3 If I give you another example, around that time
4 there were a lot of developments in endoscopy, putting
5 tubes down into the stomach. People were going too far
6 down. People were all right putting it in the top end,
7 but further down was more difficult. Routinely people
8 would go to centres for the further down ones, often for
9 a day to see half a dozen being done, check out
10 procedures, the kind of anaesthesia required and any
11 other preparation, and then come back and begin that
12 service. That was happening pretty regularly.
13 Q. You say "easy" is not a word you would necessarily
14 choose. What were the particular difficulties there
15 might be in arranging this --
16 A. There are service implications. You cannot say "I am
17 going away for a week" if there are patients to be seen,
18 so you do need to think how best to manage that and
19 ensure there is appropriate cover. That is the only
20 real problem.
21 You used the example of a two-man service.
22 It would be difficult to do on it a two-man service. If
23 it was a six-man -- there may be women in that service
24 too -- then it might be slightly easier to do that.
25 Q. So obviously a one-man service you could not do it,
0067
1 a two-man service it would be much more difficult?
2 A. One-man services do exist. For exactly that reason,
3 because they are a one-man service, they do need to
4 spend some time elsewhere honing their skills and they
5 get a locum in for that period of time. That is the
6 non-easy bit: making sure you have somebody who can do
7 it while you go away.
8 Q. The only other question on the introduction of new
9 procedures is this: if the procedure is, in truth, a new
10 procedure which a surgeon wishes to do, he may go to the
11 local Ethics Committee and ask for clearance or
12 discussion. Is there any central national
13 superintendence of decisions which are made by such
14 ethics committees?
15 A. I think if it was a new procedure -- you say he "may"
16 go. I think it is likely that he would go. The process
17 is quite devolved. There is both a local ethical
18 committee and a regional ethical committee to deal with
19 this; there would not be a central ethical committee who
20 would deal with that. If it was an entirely new
21 procedure which had not been introduced, it might
22 well come through a variety of different parts of
23 the department to see whether we should be doing this
24 procedure anyway, never mind the ethical side. Under
25 those circumstances, there would be very strong ethical
0068
1 components. One that the Chairman knows well is
2 xenotransplantation, which is technically
3 straightforward in one sense. There is an ethical
4 component and there is an infectious component to that.
5 The fact that we are not doing xenotransplantation is
6 not because it is technically impossible, it is for
7 other reasons. So here will be a new procedure to be
8 introduced, which could be introduced, but is not being
9 introduced nationally because of an interesting report
10 that the Chairman of this Inquiry chaired.
11 That is a very good example, as it happens, of the
12 non-introduction of a technique. That is perhaps the
13 best one: the non-introduction of a technique by central
14 government -- a technique which is technically not
15 a problem to do -- because of ethical and adult
16 implications.
17 So the government does have, through its expert
18 advisory committees, the opportunity to say "No, we will
19 not do xenotransplantation because there is a problem".
20 Once that problem is resolved, if it is resolved, then
21 it will be entirely possible to do that.
22 So the government at that level has a fairly
23 strong veto on the kind of things that can and cannot be
24 done.
25 Q. It has that strong veto, does it, in situations even,
0069
1 let us suppose, where a regional ethics committee says
2 "This is acceptable, we think on balance it should go
3 ahead"? Let us suppose the Department of Health,
4 someone in your position, takes a different view: what
5 happens?
6 A. I do not know if that has happened. I am trying to
7 think, there is something in the back of my mind about
8 a particular clinical trial which a group of clinicians
9 wished to do which the Department of Health felt was
10 inappropriate on ethical grounds and we had a very, very
11 long -- I mean, two to three-year, I think, discussion
12 on whether that trial should or should not go ahead. It
13 eventually went ahead, but in a limited category of
14 patients, which we felt was entirely appropriate and not
15 on another category of patients which the Department
16 felt was inappropriate. That was at ministerial level.
17 So there are ways in which that can be done and
18 that was in relation to Tamoxifen in patients who did
19 not have breast cancer and we felt in the high risk
20 group, you could do it, but in the low risk group,
21 because of the potential complications of long-term
22 Tamoxifen, you might run into difficulties. So that is
23 another quite good example where the government said,
24 "Actually, we do not think you should do this because
25 there are ethical implications".
0070
1 So that is two good examples where the Department
2 have said "No" to particular parts of a process.
3 Q. In each occasion, on ethical grounds?
4 A. Yes.
5 Q. Is there a distinction to be made, then, between the
6 central government applying its veto on ethical grounds,
7 and central government having a very strong clinical
8 view as to the desirability of a particular process,
9 rejecting an alternative process on clinical grounds?
10 A. Yes. If I move from the surgical procedures to the
11 medical procedures, then it has a very strong view on
12 which drugs should or should not be used and which drugs
13 will or will not be paid for by the National Health
14 Service.
15 Q. One control obviously is the financial control, and that
16 has a certain ring from a few weeks ago of publicity,
17 but looking at the question of provision in National
18 Health Services generally on particular procedures, does
19 the Department of Health exercise the same sort of
20 control on clinical grounds over the development of such
21 procedures as it would on ethical grounds? Is there
22 a distinction properly to be made between the two?
23 A. Yes. I think there is, through the Supra Regional
24 Services Advisory Group. In a sense, that is what that
25 group was set up to do. That is why it is the envy of
0071
1 many other countries that we do have a group that says
2 we restrict things to a certain number of centres who
3 have a special kind of expertise, or a new procedure
4 that comes in, and I would include diagnostic procedures
5 in that: how many MRI scanners should we have at the
6 beginning, new technique, quite expensive, needs to be
7 evaluated; certain centres could do that because you
8 need the data at the end of the day.
9 All these things could be done and have been done
10 without a major ministerial statement being made, they
11 have been done if you like through bureaucracy of the
12 Civil Service, because we do want to encourage new
13 procedures, but they have to be done in a way which
14 ensures both safety and efficacy, and quality. These
15 are the three things that are used in terms of the
16 introduction of new drugs.
17 THE CHAIRMAN: I wonder whether I could ask a question of
18 Sir Kenneth. You say -- if I may say so, quite
19 rightly -- that bureaucracy can get a grip on the
20 introduction of a number of things in relation to
21 medical treatment, not least the introduction or the use
22 of drugs.
23 Would it be your view, leaving aside for example
24 xenotransplantation which is sufficiently unusual to
25 warrant further consideration, would it be your view
0072
1 that that same capacity exists for the bureaucracy to
2 get hold of the introduction of surgical techniques, not
3 least variations in surgical techniques, because it is
4 as I understand it the history of such introduction that
5 they are not ordinarily submitted to ethics committees
6 or full review at whatever level?
7 A. I think that is a good point. I think that is a weaker
8 area in relation to the development of new things. For
9 example, some of the more recent developments in
10 vascular surgery required new bits of plastic to be put
11 in. That needs to be controlled in the same kind of way
12 to be sure that it is useful, it works, it is safe and
13 it makes a difference.
14 My understanding -- I am now out of the system,
15 but my understanding is that there is a surgical
16 committee to deal with this now in terms of new
17 procedures and/or variants on old procedures which are
18 just as relevant. I cannot confirm that, but I am sure
19 I could give you some supplementary information on that,
20 if you do not already have it.
21 Q. I think we would be grateful for that. I see the
22 Chairman is nodding. As you know, we invite witnesses
23 who have something to add to supplement their evidence
24 whenever they are able to do so.
25 May I change the topic and move to the question of
0073
1 the relationship which the Chief Medical Officer in
2 England had with the Chief Medical Officer in the
3 Scottish Office and the Chief Medical Officer from
4 Wales. You would have seen this from both sides of the
5 border and given your involvement in Scotland, am
6 I right?
7 A. Correct.
8 Q. The planning of services for Britain is done, is it, on
9 a national basis in terms of England being separately
10 considered from Scotland.
11 A. In most instances, yes, but not always.
12 Q. So if, for instance, one had a service in Edinburgh, one
13 would not necessarily expect those in Newcastle on Tyne
14 to take advantage of it?
15 A. You mean in terms of patients?
16 Q. In terms of patients.
17 A. That is different, I am sorry. There is no reason why
18 they should -- in fact it is the other way round. I was
19 going to use the example of cardiac transplantation.
20 Scotland did not have, for a while, and patients in fact
21 went south of the border for cardiac transplantation,
22 quite properly. Indeed, it was decided that Scotland
23 would not have a cardiac transplantation, or indeed
24 a liver transplantation centre, because it was felt they
25 were adequate in the UK, until the expertise built up,
0074
1 until the numbers built up, in which case it was
2 entirely appropriate that Scotland did have a cardiac
3 transplantation and a liver transplantation service.
4 So there is a UK dimension to this.
5 Q. Something like that is a matter for discussion, is it,
6 between the Chief Medical Officers of the individual
7 countries concerned, or is that a decision of the
8 Secretary of State?
9 A. It is essentially a Secretary of State decision.
10 I think it will be discussed at quite a number of
11 different levels. There was considerable pressure that
12 Scotland should have it: having the highest incidence of
13 cardiac problems in the UK, it needed to have some
14 service, but it was felt across the border, and I am
15 sure at Secretary of State level, that it was
16 inappropriate for Scotland to develop it until the other
17 units had built up and developed expertise from which
18 Scotland could develop further.
19 That is a very good example where the surgeons in
20 Glasgow, for example, had already spent some time in
21 other units learning the skills and techniques and were
22 ready to do it whenever it was available.
23 Q. How regularly did you, when you were Chief Medical
24 Officer, see your counterparts in Wales and Scotland?
25 A. On a sort of two-monthly basis, but we were often in
0075
1 daily contact. We had a very good link. We met very
2 regularly. We went round the four countries -- because
3 Northern Ireland would be very much a part of this,
4 too -- we would see each other very regularly and would
5 be very regularly in contact.
6 Q. Would that be the same when Sir Donald Acheson was the
7 CMO?
8 A. Certainly. I went down to see him when I was the CMO in
9 Scotland.
10 Q. We had evidence from Professor Crompton, the Chief
11 Medical Officer for Wales. I wonder if we can have,
12 please, WIT 70/12 on the screen and scroll down, please,
13 to page 28. Line 2:
14 "I have said in my evidence that at some time
15 around this time, either late 1986 or 1987, I made
16 a point of speaking to my colleague at the Department of
17 Health, the Chief Medical Officer and the Senior Medical
18 Adviser for Government, Professor Sir Donald Acheson, in
19 the margins of another meeting. The meeting was in
20 London. He properly referred me to speak with Dr Norman
21 Halliday, the Senior Principal Medical Officer of the
22 Department of Health, with responsibility, as
23 I understood it, for regional hospital services in
24 England, and was central to the processing of advice
25 coming from the Supra Regional Services Advisory Group."
0076
1 What Professor Crompton was expressing were
2 concerns that he had had expressed to him by
3 a cardiologist, Professor Henderson in Wales, about the
4 quality of services in Bristol. If what he says is
5 accurate that he spoke to Sir Donald Acheson, two
6 questions: first of all, is that something that you,
7 whilst you were CMO, knew had happened or not?
8 A. I did not know about this, no.
9 Q. Is it the sort of thing which, if you would been in
10 Sir Donald's shoes, you would yourself have made a note
11 of on some file, or would you have put it to the back of
12 your mind because you had passed it on to the
13 appropriate person?
14 A. On a number of occasions the Chief Medical Officers of
15 England, Scotland, Wales and Northern Ireland did raise
16 issues with me, and I would have been able to answer it
17 myself if it was an issue I was very familiar with, or
18 put them in touch with the appropriate person within the
19 Department who could answer the question.
20 Q. It appeared Sir Donald referred this particular matter
21 to the supra-regional service as it was to Dr Norman
22 Halliday. Again, perhaps you would just comment?
23 A. That would be, I think, an entirely appropriate thing,
24 and I think what I would have done, he had the
25 expertise, he had the information. He would know what
0077
1 the background to the problem was, and I would have made
2 that referral, I would have thought, entirely
3 appropriate.
4 Q. So far as Dr Halliday was concerned, you said earlier
5 you were not his line manager. Who was?
6 A. It is slightly difficult to remember this. I may have
7 been at the time -- things changed and I am not terribly
8 sure, I can never remember when they changed. I may
9 have been his line manager for the first two or three
10 years that I was there.
11 Q. And thereafter?
12 A. What I cannot remember -- you may be able to tell me
13 this -- is when Dr Halliday left the Department of
14 Health.
15 Q. I should be able to tell you that, but I cannot at the
16 moment.
17 A. If I can simplify it and help you with this, I was his
18 professional line manager at all times, if that makes it
19 easier.
20 Q. Suppose that Dr Halliday had, in response to the
21 concerns expressed to him through Professor Crompton,
22 sought the advice of one of the advisers. He might have
23 gone, you told us earlier, to any of the Chief Medical
24 Officer's advisers, or he may have gone to outside
25 experts?
0078
1 A. Yes.
2 Q. If he had gone to one of your advisers, would you have
3 expected some note on some file about that?
4 A. I might well have. It would depend how that was dealt
5 with, but I would have imagined if I had said to a Chief
6 Medical Officer from one of our other countries to
7 contact a doctor, then I would probably have expected
8 some note somewhere to say this is what happened.
9 But it may be that that individual could have
10 dealt with it very quickly just in conversation and
11 there would be no record.
12 Q. But suppose that Dr Halliday had gone to seek advice
13 because he could not answer it himself, he had gone to
14 speak to the professional medical adviser. You are
15 saying if the advice he, Dr Halliday, was given was
16 simple and quick, there would probably be no record of
17 it. If it required more detailed examination, there
18 would be?
19 A. Several things could have happened. Dr Halliday could
20 have answered the question immediately. If he could not
21 have answered the question immediately, he might have
22 had to go and find information and/or speak to somebody
23 else. That would most likely be done by telephone, and
24 in the days before e-mail he may simply have phoned
25 Professor Crompton and said "I have looked into this and
0079
1 this is the answer". That might well have been done
2 without any writing at all.
3 Q. If Dr Halliday had not gone to one of the advisers to
4 the CMOs as appointed an adviser but gone to an outside
5 expert, is that something you would have been told about
6 or not?
7 A. Not necessarily. It would have been entirely
8 appropriate for him to go to whomever he thought was
9 important. He could have gone to Professor Henderson
10 and said "What does this mean, do you have any further
11 information?" There are lots of different ways it could
12 have been done. If I had been Chief Medical Officer,
13 I would not necessarily have expected anything to follow
14 from that back to me. It could all have been done at
15 a different level.
16 Q. Dr Halliday left the Department of Health in March 1994?
17 A. Yes.
18 Q. But he retired in 1992 from the Medical Policy Division
19 with responsibility for the acute hospital sector. He
20 continued after 1992 as part-time Senior Medical
21 Officer, grade 5, as the Medical Secretary to the
22 Advisory Group?
23 A. Yes. That is why I think from the 1992 period, that is
24 why I was slightly struggling with it, I used to see him
25 regularly because he was part of the department. After
0080
1 1992 I did not see him as frequently because he was
2 part-time.
3 Q. In 1992, did you become aware of an article in Private
4 Eye?
5 A. It is difficult to answer that question, because I am
6 now aware of that article. I think all I can say is
7 that I used to see Private Eye on a very regular basis.
8 Q. You were a reader, were you?
9 A. Indeed.
10 Q. So probably, every issue you have taken and have a laugh
11 at, or read?
12 A. Yes. It depends a little bit on the weekends, but
13 I used to get it with The Economist at the weekend and
14 that gave me something to do on a Friday evening.
15 Q. So you read the column by "MD"?
16 A. Indeed.
17 Q. Can we have SLD 2/3 on the screen.
18 If we look at the left-hand column, "Doing the
19 rounds":
20 "Before the DoH bestows its mark of excellence on
21 the UBHT, it may wish to ponder the perilous state of
22 its paediatric cardiac surgery ..."
23 You can read on when the description is given of
24 the unit called "The Killing Fields", and so on.
25 Although you know the article now, do you have any
0081
1 recollection of having seen this in 1992?
2 A. It is honestly very difficult to say. There is another
3 one of these, particularly the most prominent outcome,
4 the second bullet point in the second column, that no
5 one wants to be a GP any more is certainly something
6 I noticed and these figures were of some interest to me
7 at the time, because it reflected a whole lot of
8 problems within general practice.
9 So I may well have seen this, but I cannot confirm
10 that I did see it.
11 Q. In that case, I will ask you on the hypothetical basis.
12 Assuming you say it, what sort of action would normally
13 be taken in respect of a report such as this?
14 A. A couple of points. I did not know that "MD" was Phil
15 Hammond until this weekend. I met Phil Hammond on
16 a number of occasions socially and did not know that, so
17 I did not know who MD was.
18 The second thing that is obvious, if you read more
19 than one issue of Private Eye, you will realise that
20 Bristol appears on a very regular basis, so my
21 assumption was -- and this is not hindsight, this is at
22 the time -- that there was somebody in the Bristol area
23 who was writing quite a lot about Bristol.
24 So it did not surprise me that Bristol came up,
25 because Bristol was there all the time. It was just one
0082
1 of these things I knew was the first one on the list.
2 So if I had seen it, I do not like things like
3 "slabs of meat" and I hope I have said enough to
4 encourage you to believe that I would not normally talk
5 about patients like that. The "Killing Fields" is the
6 kind of thing that disturbs you.
7 The most difficult bit, I think, is the last
8 sentence and the last sentence, of course, really does
9 not make any sense. It is two non sequiturs. It gives
10 Liverpool with 160 babies and no mortality rate, and it
11 gives Bristol with a mortality rate with no numbers. If
12 you know what the mortality rate for this procedure is