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UNCORRECTED TRANSCRIPT OF ORAL EVIDENCE To be published as HC 1030-iii House of COMMONS MINUTES OF EVIDENCE TAKEN BEFORE HEALTH COMMITTEE
THE INFLUENCE OF THE PHARMACEUTICAL INDUSTRY
Thursday 11 November 2004 DR I HEATH, DR T KENDALL, MR M GRIFFITHS, MR J D'ARCY, MR R DARRACOTT and DR R NICHOLSON Evidence heard in Public Questions 203-315
USE OF THE TRANSCRIPT
Oral Evidence Taken before the Health Committee on Thursday 11 November 2004 Members present Mr David Hinchliffe, in the Chair Mr David Amess John Austin Mrs Patsy Calton Mr Jon Owen Jones Siobhain McDonagh Dr Doug Naysmith ________________ Memoranda submitted by Royal College of General Practitioners, Royal College of Psychiatrists, Royal College of Nursing, Royal Pharmaceutical Society of Great Britain and Bulletin of Medical Ethics
Examination of Witnesses
Witnesses: Dr Iona Heath, Past Chair, Committee on Medical Ethics, Royal College of General Practitioners (RCGP), Dr Tim Kendall, Deputy Director, Royal College of Psychiatrists Research Unit, Mr Matt Griffiths, Senior Charge Nurse and Joint Prescribing Adviser, Royal College of Nursing (RCN), Mr John D'Arcy, Chief Executive, National Pharmaceutical Association (NPA), Mr Rob Darracott, Director of Corporate and Strategic Development, Royal Pharmaceutical Society of Great Britain and Dr Richard Nicholson, Editor, Bulletin of Medical Ethics, examined. Q203 Chairman: Can we make a start? I will begin by welcoming our witnesses and thanking you for your co-operation with this inquiry. Could I begin by asking each of the witnesses briefly to introduce themselves to the Committee, starting with you, Mr Darracott? Mr Darracott: Good Morning. My name is Robert Darracott, I am the director of corporate and strategic development at the Royal Pharmaceutical Society and my responsibilities include support for policy developments across the organisation and the Society's research and development programme. Q204 Chairman: Was there any particular reason why you did not submit any evidence to the Committee other than some old papers? Was a particular decision taken not to submit evidence? All the other witnesses have actually submitted fairly detailed evidence upon which we can ask questions this morning. Was there a reason for that? Mr Darracott: No, there was no particular reason. Mr Griffiths: Hello. I am Mike Griffiths and I am the joint prescribing and medicines management adviser at the Royal College of Nursing. We support our members; we have 370,000 members and support them on anything to do with prescribing or medicines management. Dr Heath: I am Iona Heath. I have been a GP in Kentish Town since 1976 and I am a member of the Council of the Royal College of GPs. Currently, until tomorrow, I chair their ethics committee; my six-year term finishes tomorrow. Mr D'Arcy: Good Morning. I am John D'Arcy. I am chief executive of the National Pharmaceutical Association. We represent community pharmacy owners and we have a membership of about 4,300 owners who collectively own 11,000 pharmacies in the UK. To put it into perspective, that is just about everybody except Boots. We provide a range of services to support members, act as a voice for members, provide services and also provide professional indemnity. Dr Kendall: I am Dr Tim Kendall, I am a consultant psychiatrist and medical director at Sheffield Care Trust, but I am also deputy director of the Royal College of Psychiatry's research unit and co-director of the National Collaborating Centre for Mental Health, within which we do most of NICE's mental health guidelines. Dr Nicholson: I am Dr Richard Nicholson. I trained as a physician, but for the last 20 years I have been working in medical ethics, editing the Bulletin of Medical Ethics and specialising in research ethics. I also set up the Association of Research Ethics Committees seven years ago. Q205 Chairman: May I begin by asking a general point about the mechanisms the organisation you represent have to deal with what might be regarded by some as undesirable influence from the pharmaceutical industry on the work that your members do and any conflicts of interest that there may be? How are these declared, how do you actually take account of the possible difficulties which might arise where such a conflict could occur? Obviously all of you represent different areas of work and I should be interested, briefly, in how you fully address some of the concerns that you will be aware we have picked up as a Committee so far in this inquiry. Who wants to begin? Dr Heath: We face a problem in that every major national and international conference for general practice is financially dependent upon pharmaceutical company sponsorship, which is a deeply regrettable situation and it is one in which a lot of people have colluded really to create unrealistic expectations of how much post-graduate education will cost. That is a whole area. Q206 Chairman: One of the questions I asked at our last session was on continuing education and the answer I received, I cannot remember which witness it was, was that 90 per cent of the sourcing of continuing education for people such as you is funded by the industry. Would that accord with your own views? Dr Heath: No, that would not accord with my idea. Q207 Chairman: What would your view be? Dr Heath: I think it is very individually variable. A minute proportion of my own post-graduate education is pharmaceutically sponsored and the whole range is there. The only time in which I personally am in that situation is when I attend major national/international conferences. I cannot not do that. Q208 Chairman: Yes, but are you unusual? Dr Heath: No, I am not unusual. Q209 Chairman: I am trying to get a picture overall of your members. Dr Heath: There is still a lot of sponsorship of small educational meetings, but the changes in the way general practice post-graduate education is organised, now much more based on the appraisal system and on personal development plans, means that you can structure your own learning and you can do study from the internet, you can do study from books and it counts in a way that it did not before. You used to have to collect a whole load of events, the vast majority of which were sponsored, but I do think that the situation has changed with this new way of looking at post-graduate education. I do think that it has improved at the level of day-to-day continuing education. There is still a real, big problem about major meetings and about a minority of the profession whose entire education comes from attending meetings that are pharmaceutically sponsored. Q210 Chairman: You would challenge the evidence of 90 per cent that was given to the Committee but another witness. Dr Heath: That would certainly not accord with my experience. Q211 Chairman: You would also perhaps challenge the suggestion that new GPs are dining out every lunchtime with the drug reps, which was one point that came over from one witness. What is the extent to which GPs, your members, might accept hospitality with a drug rep? Is it common practice when they are marketing at a local level? Dr Heath: It is very difficult for me to have a grasp of exactly how much my colleagues ... I should be amazed if my colleagues had the time to dine out every lunchtime. It is very hard to find the time to grab a sandwich, let alone accept extensive hospitality. Again, there is undoubtedly a minority which makes the most of the offers available. For that sort of caricature picture, it is a very small minority. It is like the GPs spending all their time on the golf course; that was the previous caricature. I think that caricature is in that league. Just to go back to answer the question, the College has created a series of ethical guidelines about the sponsorship of their own meetings, so that we try to make sure that there is no direct linkage between the educational content and the sponsorship. You have to try to do that and I think to an extent, we succeed. We also have a register of interest for all our council members and try to make things explicit in that way and expect people to declare conflicts of interests, if they have them, when we are debating issues. Q212 Chairman: So you feel that system works reasonably well. Dr Heath: Up to a point. I still think, and the College's view is that it is regrettable that we are dependent on this financial support for the highest status meetings. It is regrettable. Q213 Mr Jones: You say that the College tries to ensure there is not a conflict of interest in the sponsor and the type of event. What is the point for the sponsor then, if there is no influence? Dr Heath: Precisely. It has to be said that since we have been taking a firmer ethical stance and trying very hard to make sure that there is no linkage and making very clear, if there are sessions within, that those are directly sponsored sessions, it has been more difficult for us to get sponsorship. It is also extremely difficult to get sponsorship for topics such as learning disabilities, just to grab one out of the air, for obvious reasons. That is just one of a whole range. Mr Griffiths: There is sponsorship in major conferences that the RCN are involved with from pharmaceutical companies, particularly as far as exhibitions go, and that does obviously help generate income to make educational conferences accessible. There are 370,000 members of the RCN and about half million nurses in the UK and a lot of nurses, including myself, pay for continuing professional development (CPD) out of their money and do it in their own time. Now, obviously an awful lot of commitment comes with nursing and making sure that you get the best education, so that you can deliver the best care to your patients, but there is a need for continuing professional development to be helped out. Now as far as continuing professional development and the split of what is paid for is concerned, I do not know, but higher education institutions do develop some continuing professional development which is paid for the workforce development confederations and the strategic health authorities. We do work in conjunction with some pharmaceutical companies and the reason that we work in conjunction with them is to ensure that when they are putting education out to our members it is validated, it is non-promotional, there is a certain quality element to the education and to make sure obviously that our members are getting decent information across at the same time. Q214 Chairman: Obviously nurse prescribing is a relatively recent development. Has the relationship between your organisation and the industry changed as a consequence in recent times and if so, how? Mr Griffiths: We have probably had more interest in the nursing profession since we have become prescribers and since the formulary has been opened up. Nurses can now prescribe as supplementary prescribers from virtually the entire British national formulary. There has been an increase in interest. There has also been an increase in the debates within the nursing press and within several publications which I edit we have had several articles written on the influence of the pharmaceutical industry to make sure that we are not going down the line of influencing our clinical practice. There is some evidence that yes, we may be influenced as well by marketing, by a whole host of different tactics, but we try to ensure that our patient care is not compromised and we are discussing and debating the issues with the profession. Q215 Chairman: Do any other witnesses want to come in on this general point? Dr Kendall: The Royal College of Psychiatrists has taken an increasingly tough stance about the influence of drug companies and less than five per cent of the income of the College is from drug companies now, so it is not dependent on them. The membership, on the other hand, is rather divided. There are people who are very adamantly opposed to the use of drug company money because of the influence that it inevitably brings, but there are others who seem to exploit it quite openly. Q216 Chairman: And the resolution of conflict of interest within your Royal College? You have a register along the lines of Dr Heath's organisation. Dr Kendall: I think there is a registry, but I am not that familiar with it. Q217 Mrs Calton: What is the influence of personal contact, repeated personal contact, the development of relationships as opposed to individual pieces of information? Is there some tendency for strong personal relationships to develop which, over a period of months or years, might well lead to some influencing of prescribing? Dr Heath: I am sure there is and for that reason our practice has not seen a drug rep in 40 years and will never see them, for just that reason. I think more and more GPs take that sort of stand, but not all by any means. Dr Kendall: I personally, as a psychiatrist, have never seen, maybe once or twice in my youth, a drug rep, but I am very aware that there are physiatrists whose prescribing is obviously influenced by those relationships. Q218 Mrs Calton: I do not mean anything untoward in those relationships. Dr Kendall: No, the problem in an area like psychiatry is that it is full of me-too drugs, so that when prescribing an anti-depressant you have a choice of a whole range of them, but all doing much the same type of thing. I believe whichever drug rep becomes your closest friend does have an influence on you. Dr Nicholson: Just to come back to your original general point, members of research ethics committees have to declare their interests in a register of members' interests before they join the committee. At every meeting, we have a declaration of interests at the beginning of the meeting, so that anybody who has any link with any of the proposals we are reviewing withdraws from the discussion. The association of research ethics committees has never taken any drug company money and would not, as a matter of policy, and the bulletin I edit has never had any advertising from drug companies. Q219 Chairman: You and I have talked before about your work. In terms of local level, the ethics committees that would operate within our NHS trusts, is that the same procedure that you described there that if there are any conflicts of interests, they are recorded and there are clear principles at work. Dr Nicholson: Yes, it is a general principle. Mr Darracott: In response to your general question, Chairman, I would make a number of points in respect of pharmacists. First of all, just to clear up the point, we have a register of interests for council members and a register of interests for staff working at the Society and I would expect people to declare interests in discussions. Q220 Chairman: What might those interests be, just out of interest, from your point of view? Where could there be conflicts potentially? Mr Darracott: It would not be unusual, but it is not common, for pharmacists to act as consultants to pharmaceutical companies from time to time. We do not see a lot of it, but it does happen. The other thing, which again relates back to a point that you raised earlier with respect to nursing, is that we are seeing increasing numbers of pharmacists involved in prescribing activities and we have certainly acknowledged that, like nurses I guess, pharmacists can be expected to be approached in greater numbers by representative of the industry. Q221 Chairman: Is that already happening? Mr Darracott: Pharmacists have always been approached by representatives of the industry. Q222 Chairman: Has the change in terms of prescribing arrangements meant, as it has with the RCN, that you have more contact with the industry than previously? Mr Darracott: I think it is beginning. The nurses are a few more years down the tracks than we are and we are only now really getting a few hundred pharmacists through the accreditation process for being in a position to begin to prescribe and then local arrangements will need to be made for that actually to begin to happen in reality. I am sure it is starting, but these are early days with respect to that in particular. As an organisation we have produced some guidance for pharmacists on working with the pharmaceutical industry and that covers everything and reminds pharmacists of the sorts of skills that they might have to do in their preparation for initial practice, things like critical appraisal and evaluation; it covers things like hospitality. We are very much mirrors, sorts of industry codes, in terms of what is acceptable and what is not acceptable. It also covers commercial sponsorship and, again, I guess like a number of other organisations, we do have protocols for sponsorship of things like the British Pharmaceutical Conference where we will have industry involvement in an exhibition at the time. The other thing I should perhaps also mention is that, as an organisation, we publish both Martindale which is an enormous reference book to help professionals and, jointly with the BMA, we publish the British National Formulary which is purchased by health departments for all doctors and pharmacists. It is generally regarded as independent advice for all prescribers. Q223 Chairman: In relation to the way your role in prescribing is changing, where a pharmacist will have a particular relationship with a GP and a local practice, how aware would you be, where the initial prescription was from the GP in that practice, of any influences that there might be on that GP on the initial prescription that you probably would follow on? Mr Darracott: I am not sure that we would be aware that a prescription was particularly influenced. Q224 Chairman: In terms of how a practice relates to the drug reps who will visit GPs, would you be aware of those influences which might have a bearing on the prescribing practices of a particular doctor, who would link in with your practice? Mr Darracott: That very much depends on the relationship, as you said at the beginning, between the pharmacist and the local practice and obviously we have encouraged pharmacists as part of a wider health care team to have good relationships with local prescribers. If that relationship develops and they then fundamentally become part of the team, then I guess the pharmacist would be more likely to know whether the doctor is seeing representatives or not, because they may well be invited along to the team meeting in which that sort of thing takes place. That is the level at which a pharmacist would be aware of the influence, particularly of a representative of the industry, on a particular practice. Q225 Chairman: Have any of your members given examples of where perhaps they have raised a concern about prescribing which has maybe been influenced in a way that they were concerned about? This is anecdotal stuff which has come to one or two of us on the Committee, but is that anything that has come up through your members? Mr Darracott: Not to my knowledge, no. Mr D'Arcy: To add on that from a pharmacy committee perspective, taking your original point where you said other mechanisms were dealing with undesirable activity, pharmacists are slightly at arm's length from that prescription pharmaceutical industry in that, although prescribing is coming on stream, traditionally the main prescribers have been GPs. Where we do have a problem with industry, where an issue occurs, and to be honest it occurs very rarely, then what we would do would be to take it up directly with the company, or to take it up with the ABPI, or, if it was a very extreme example, perhaps refer a matter to the code of practice committee. In my time at the MPA, I am aware of us doing that once on a leaflet some time ago, something said in a leaflet, but issues like that are very, very rare. Just to give a little bit of background about changing pharmacy, because I think prescribing fits into that, a pharmacist's role, and it is an important role in modern health care, is to ensure that patients get the right medicine at the right time and with the information necessary to ensure that they take that medicine safely and appropriately. Whilst this is the principal role of pharmacists and in delivering that role medicines are clearly a principal tool of the trade, the role is changing and pharmacists are taking on a much wider public health role. This is on the back of government policy which is aimed at making better use of the skills of pharmacists and increasing access to pharmacy services. Indeed we have just negotiated a new contract between the negotiating body for pharmacy, the Department of Health and the NHS Confederation. The other thing is that as the role of pharmacists is changing we are looking more at the pharmacy team these days: there is the pharmacist but there will also be behind the pharmacist a range of qualified staff, medicine counter assistants, who have to do accredited training, dispensary assistants who will have to do a Level 2 NVQ or equivalent, dispensing technicians who do a Level 3. As far as pharmacists are concerned, they are bound by a code of ethics as health care professionals and one of the key responsibilities of a pharmacist, and this is enshrined in the code of ethics, is to act at all times in the best interests of patients. Pharmacists do need to ensure that patients receive sufficient information and advice to enable them to use their medicine safely and appropriately. The point was made about CPD and, similar I think to my colleague from the nursing profession, pharmacists do their own CPD and are responsible for their own CPD and will undertake CPD, support their CPD with a range of materials. As part of that they will from time to time use materials produced by the industry and I think that is a reasonable thing to do because a manufacturer who researches and produces the drugs will be a natural source of that material. However, they are not influenced in terms of CPD in that it is up to pharmacists individually to decide how to do that CPD. As far as hospitality is concerned, there is not a great deal of it in pharmacy, but we do get sponsorship for meetings. I spoke, for example, at a meeting last night in Southampton that had industry sponsorship to extent of providing money to put on a buffet supper. They will have a display and will tell people about what they are doing, but from a pharmacy perspective, it is more, I would say, general marketing, to create awareness about the company and what it is doing, rather than what you could refer to as straightforward promotion. Finally, just to say a little bit about pharmacists prescribing, it is still early days with pharmacy prescribing. No doubt that will alter and affect the relationship between pharmacy and industry, but, given that pharmacists are bound by a code of ethics, we would expect pharmacists to adhere to their code of ethics and to realise that in any relationship they have with industry, they do have to keep an arm's-length relationship, professional relationship and at all times think about what is in the best interests of patients. Q226 Mr Jones: I want to come in on prescribed medicines first and Mr Darracott. You described in answer to the Chairman the safeguards that your organisation tries to use to ensure that patients get balanced advice and so on. Have there ever been any occasions where you, as an organisation, had to warn one of your members, or perhaps even withdraw the licence from one of your members where you believed that medicines were being inappropriately prescribed or a pharmacist had been inappropriately influenced? Mr Darracott: Inappropriately influenced? Not to my knowledge. In a sense the supply of prescription medicines through a pharmacist is also dependent on one having receipt of a prescription by another practitioner, so the pharmacist is acting on the instructions of another health professional. What we do have instances of, and indeed there are a few cases which come before our statutory committee, are pharmacists who have inappropriately supplied quantities of over-the-counter medicines. We would see one or two cases of those per year. Now whether that is as a result of an undue influence from the pharmaceutical industry or the pharmacist getting into a position where they are faced with the pressure to supply the sort of products which might be misused, is a moot point. The instances of supplies of large quantities tend to be around narcotic medicines, rather than other types. Q227 Mr Jones: But in prescription medicines, is it just because it is early days, or is it because the ethical system and code are perfect and there is never any need for any regulatory mechanism or sanction? Mr Darracott: We would never say it was perfect, but I think it is early days and it is something that we will certainly be looking out for as we go on. Q228 Mr Jones: It is early days, but Mr D'Arcy in his evidence was saying that of course if there are no examples of anyone ever having anything withdrawn, then the conclusions are either that the system is perfect, or that the regulatory system is inadequate. In terms of the over-the-counter medicines, Mr D'Arcy, increasing numbers of medicines are available over the counter. Where do the pharmacists get information about the new products? Do you think that information is fair and balanced? The Committee suspended for a two-minute silence Mr D'Arcy: Pharmacists will get the information they need from a variety of sources and the first thing to say is that by the time the medicine goes over the counter, it has been used on prescription for quite a while before so pharmacists will already be familiar with that product. So there will be information from a variety of sources. We may produce information, the Pharmaceutical Society may produce information, there will be other information from other academic, I suppose you could say, sources, the industry will produce information, the manufacturer of that product will produce information and it varies. It varies from being credible robust objective information about the product and its use at one extreme, to in some cases something which may be no more than company propaganda. What will happen is that pharmacists will make their own judgment on materials. The experience we have is that because they are clinicians with expertise in the actual use of medicines pharmacists can very readily see what is credible, objective information and differentiate that from what you might call company propaganda. The message we give to industry is that if they are producing training materials, and indeed we would expect them to produce training materials, if they are not objective, if they are not balanced and they are not meeting the needs of pharmacists in their capacity as a clinician with an expertise in medicine, they will go in the bin. Pharmacists will do that. In fact one of the areas in which we work with manufacturers is to help them with their materials, to try to produce what we believe to be objective materials. Q229 Mr Jones: May I take you back to the code of ethics? You quoted some of the code of ethics to me. What I can remember is that you would wish to ensure that you do no harm to your patient. Does the code of ethics cover whether you do any good? Mr D'Arcy: By implication it does. It might not specifically say you must do the public good. Q230 Mr Jones: You exist in order to sell medicines and it should be the priority to ensure that the medicines you sell do not do any harm, I can understand that. But if the medicines you sell do not do any good, you still exist in order to sell the medicines. Mr D'Arcy: It is a bit more than that you just exist to sell medicines. If we look at the way the regulatory process works, and this applies to prescription medicines and over-the-counter medicines, medicines are assessed, and there are regulatory controls for this, against quality, safety and efficacy. It does not just stop at that point: it is not just that once you have a product licence that is it, that is the end of the game. Pharmacists are an important part of the supply chain and in fact the last link in the supply chain before patients. So pharmacists are critical evaluators of medicines and their skill base is about evaluating the safety and efficacy of medicines. I would expect pharmacists as professionals, and this would be underpinned by the code of ethics, to assess, as part of the supply of a medicine, whether it is on a prescription or whether it is over the counter, whether or not that medicine was appropriate and actually not put themselves in such a position. In fact the code of ethics does say you should not supply a medicine where you doubt its efficacy - I cannot think of the exact wording, but I am paraphrasing - and we would not expect pharmacists to do that. In fact in something like 25 per cent of cases pharmacists do not recommend any product at all. My view would be that we can rely upon pharmacists and indeed it would be part of their professional duty, if they do provide a medicine, to provide only those medicines that work. Q231 Mr Jones: Since you do not represent Boots, I can use them as an example. Next time I walk round Boots, I can be assured that all the medicines I see are efficacious, can I? Mr D'Arcy: If it is a medicine, then yes, I think you can. If it is a medicine, it will have a product licence and in order to get that product licence it has passed a regulatory test which satisfies the regulators, in this case the MHRA, that that product is of sufficient quality, is sufficiently safe and is efficacious. Yes, you can in the case of a medicine. Dr Kendall: Pharmacists like doctors are absolutely dependent upon a regulatory body which actually does not look at efficacy in the way that has been described. They are primarily concerned with safety and the same is true in the United States with the FDA. You only have to have two trials that show efficacy for a drug to be regulated. I also wanted to say that all of us are dependent on what is published and drug companies do not always publish their trials. So when we say that something is efficacious, we can only say it is efficacious according to what we have seen. Chairman: We might get onto that point a bit later on. Q232 Dr Naysmith: I want to ask Mr D'Arcy a question really. If, as has just been pointed out by Dr Kendall, what the regulatory bodies look at is safety rather than efficacy, and that is almost certainly true, do you have any mechanism for feeding back problems you might observe or your members might observe in terms of safety? There is the yellow card scheme for GPs. What is there for pharmacists? Mr D'Arcy: Pharmacists now are included in the adverse drug reporting scheme, that is the yellow card scheme and pharmacists can and indeed do report instances where they experience problems with drugs; they report that back on the mechanism. There is proportionately less reporting from pharmacists than GPs, and I think that is probably in part due to the fact that pharmacists do not carry out the diagnosis, but where they do see a problem with medicines - and indeed identifying problems with medicines is part of their core role - then they can and do report through the yellow card scheme. Q233 Dr Naysmith: Is it working? As you say, it did not always apply to pharmacists but it does now. Mr D'Arcy: As far as I am aware it is working and it is working well. Mr Darracott: The latest figures I saw about the yellow card scheme, and yes of course, there could always be more reports, was that around a quarter of all reports are now submitted by pharmacists, in particular by hospital pharmacists. I think 24 per cent of reports are submitted by hospital pharmacists and there is a small proportion submitted by community pharmacists. I would agree with John that one of the issues around that is about access to the information required to provide a full report within the yellow card scheme. What we would certainly argue very strongly for as we go forward is that pharmacists have access to more information, the sort of information that is going to be put on the national care record, and allowing us to see that information means that we are going to have more of the information that is needed for a yellow card report. It is working reasonably well, but I am sure we could always have more reports. Q234 John Austin: We put this to other witnesses before. The yellow card scheme is voluntary rather than mandatory. Do you think it is right that it should be? Mr D'Arcy: I have no problem with it being voluntary. Perhaps the question to be asked in terms of a mandatory scheme is: how would you mandate that, how would you prioritise what needs to be reported on? In the case of pharmacy, and I can only speak for pharmacy, it is relatively early days and we are still seeing it bed down. Certainly our view initially would be that we would like to see a voluntary scheme to see how it works and learn lessons. I do not have a particularly strong view one way or the other on that. Dr Heath: The people with the most interest in reporting are of course patients themselves and I do not know why we do not have a system of allowing patients to feed back their experience directly. I think that would be much more effective than trying to mandate people around something which is actually a continuum, from the most minor side effect to a very serious side effect and the way you draw the line in that range. I would really like to see a system that invited feedback from patients about their own experience of using medicines. Q235 Chairman: May I turn to a slightly different area? In one of our earlier sessions we had a GP who came to the Committee and was arguing very strongly on the issue of so-called disease-mongering about some of the concerns he had, and I quote. He said "One of the issues that I feel very strongly about as a day-to-day general practitioner is the amount of health anxiety and health neurosis that has been generated, often through things like disease awareness campaigns. We certainly feel that is undermining people's sense of health and wellbeing. To put it bluntly, the reasons for that is because it is in the commercial interests of the pharmaceutical industry to promote new conditions and different conditions". I notice in your organisation's evidence Dr Heath, you refer to certain disease conditions and say it is very much in the interests of the industry to draw a line which includes as large a proportion as possible within the range of abnormality. Could you expand on that and your comments about the over-consumption of pharmaceuticals being a serious and growing health problem? Are we taking too many drugs and if we are, are you people not in a prime position to do something about it? I do not often go to the doctors, I do not know how many years it has been since I saw a doctor, but certainly going back to my experience, and the experience of most people as patients, it is interesting that when you go in front of the doctor you will see that the prescription pad has your name and address written on it before you have even said what is wrong with you. So there is an assumption that there is going to be something on that prescription pad before you even sit down. Dr Heath: There is not. There certainly is not a system like that. Q236 Chairman: Perhaps there are different procedures, but I have certainly seen many doctors and talked to people who have made the same point, that you go in front of a GP and the receptionist will have already ensured that your name and details are on that prescription pad so the doctor only has to write the actual prescription to give to you at the end of the consultation. The assumption I have from that is that automatically we are straight into me coming out with a piece of paper, which may not necessarily be the best thing from my point of view. Dr Heath: Oh, absolutely not. That is not my experience. Obviously computers are changing all that; the vast majority of prescriptions are now computer generated and there would be no point putting your name on it beforehand. I do not have the data about how many consultations end with a prescription, but it is nowhere near 100 per cent. General practitioners regard part of their role as defending patients against the healthcare system in general and the pharmaceutical industry in particular, because medicines are as dangerous as they are beneficial. According to the government's own medicines partnership - what is it called? -the one working on concordance and compliance, 70 per cent of the UK population are taking medications regularly every day, either over-the-counter ones or other. We are healthier than we have ever been before in history and is it appropriate that 70 per cent of the population are taking medications? I think the data from Norway, which is an even healthier population, which we put in our report, is about the new guidance putting 90 per cent of over-50-year olds in a sort of disease category. The problem I really wanted to emphasise today is the difference between treatment and preventive technologies. When you are treating someone with a condition, you have some chance to assess whether the treatment you are giving is having an impact, is efficacious, is more beneficial than harmful, you have a framework within which to work. However, the pharmaceutical industry is now investing much more in developing preventive technologies than treatment technologies because humanity seems to have this constant illusion that you can prevent all ill health. It has been a very costly struggle to realise the limits of that approach. Q237 Chairman: Can you get up to the point which was the key point in my question in a sense that? Are people presenting to you and your colleagues assuming there is something wrong with them as a consequence of what has been termed disease-mongering by certain people in the industry which is the argument which has been put to us by other witnesses? Dr Heath: Absolutely. I see women worrying about osteoporosis every day of my working life. I see people inappropriately worried about cholesterol every day of my working life. We are including an ever greater proportion of the population within a group who considers themselves to have some sort of health problem and that has huge psychological and social implications for them and it has huge financial implications for society. Q238 Chairman: What can we do about the issue you have just described? Dr Heath: We need a huge public debate. We have to have a really adult conversation within society about the limits of medicine, about the limits of pharmaceuticals, about how much gain. I am sure you have been informed about numbers needed to treat. Some of these preventive technologies have huge numbers needed to treat. There are people who will take drugs for years with no tangible benefit whatsoever and others who gain a very, very small amount. The cost per gain is becoming increasingly huge and it is a sort of collision of different strands: the fact that we now have preventive technologies, but we now also have this kind of computer surveillance of the population where we know where everybody is and we can target everybody. Those two working together seem to me to be increasingly malign. I am supposed to be able to make people feel better and I spend my life working in a situation which seems hell-bent on making everybody feel worse. Q239 Chairman: Do you find yourself as a GP in a situation where patients come with a particular expectation of an outcome from a consultation with you and go away disappointed if the outcome is not a prescription of some sort which can offer them some sort of instant cure, when you might say that there are other means of dealing with their condition, or you might say that they do not have a condition? Is that increasingly a problem? Dr Heath: It is certainly a problem. I hope people do not go away disappointed. I have to work very hard to make sure they do not go away disappointed. I think what has happened about antibiotic prescribing over recent years shows that GPs have been successful in having that sort of conversation about treatment therapeutics. It is much more difficult in preventive therapeutics because of the global fear about early death. It is very hard. Q240 Chairman: You obviously think very deeply about these issues. With the greatest respect, and it is human nature, not all your colleagues who are GPs will think as deeply. Is it not the easiest thing for a GP, who has a patient with certain expectations of the outcome of that consultation, to write a piece of paper and send them on their way? In view of the pressure that you and your colleagues are under, is that not probably the easiest way out for many of them? Does that not happen in many instances? Dr Heath: Not necessarily, because, particularly in older people, we are in a situation with older people where we now have guidance for every single condition. Most older people have got a minimum of four and with the number of different medications that people are on you add another one at your peril. It just gets more and more of a mess, but you are not meeting the sort of audit guideline for the single condition. I am not sure I should say this in this setting, but I sometimes say to my patients that they can have ten medications, they must choose, but they cannot have 20 because of the risks to them of these things compounding with each other. Of course there are no studies about the sort of combinations of drugs that we are now using every single day; there are only studies around single or at most double prescriptions. All general practitioners have a large number of people taking at least ten, pharmacologically active products, let alone what they are buying over the counter as well. This is going nowhere good. Q241 Dr Naysmith: I just wanted to pick up on what you said about people who are inappropriately worried about cholesterol levels. One of the ways of dealing with it now is to prescribe statins and there is evidence of course that statins do reduce, on a population level; we do not know yet how to prescribe the ones at an individual level who are going to benefit from them. However, it is becoming so costly, that the answer seems to be that we are going to allow people to buy them over the counter. What do you think about that? That ties in exactly with what you have just been talking about, but it is a specific example that faces us with the costs and not really knowing whether it works for individuals or not, so we are prescribing on a population level. Why did you say inappropriately worried about the cholesterol level? Dr Heath: Because, as always, it is the old inverse care law: it is the fittest, wealthiest people who seem to spend most time worrying about cholesterol. The people from poorer situations who are facing much greater surviving-from-day-to-day sorts of problems actually do not have time, or the energy, to concern themselves about their cholesterol. Of course, because they are on poorer diets, that group is the one which could benefit much more statistically. Q242 Dr Naysmith: From other measures. Dr Heath: If you put it onto over-the-counter, all you are going to do is exacerbate that health inequality, because poorer people cannot afford to buy Paracetamol for their children, let alone to buy a statin over the counter. It is a question of how we target these interventions and really to have a realistic estimate of the amount of input and how little, I think this government is doing more, but how little we put into non-therapeutic, non-pharmaceutical interventions, into exercise, into giving people opportunity. Things like hope keep you alive. There is definite data that having a positive view that your life is worth living makes you live longer. When patients ask me about their cholesterol, be happy, be rich, it is not always easy but those are by far the best determinants, far above your cholesterol level. Q243 Dr Naysmith: I just wanted to pick up one other thing you said directly on this. You were saying look at antibiotics and GPs. Actually, although their have been some successes in educating patients not to ask and demand antibiotics, it has not been hugely successful. There are still a lot of patients who do still pop in and say right, I have a snuffle, I have a cold, give me an antibiotic and the easiest way to get them out of the surgery is to give them what they ask for. There have been some successes but it has not been hugely successful. Dr Heath: I think there is a definite downward trend and I think it does show the benefit of having a campaign aimed at the prescribers, but also having a campaign aimed at citizens themselves. That same sort of thing needs to happen around these preventive technologies because statins are only just the beginning. The pharmaceutical industry will come up with any number. I would say we are going to have ten over-the-counter preventive technologies by 2050; I should be amazed if we do not. Dr Nicholson: I just want to make the point that it is important to remember that the supposed efficacy of all these new drugs that have come on-line is shown in very tightly controlled clinical trials, where the circumstances of the individual subjects of the trials are rigidly controlled. They do not relate to real life at all, they do not relate to the way that people actually take drugs in real life and I think we vastly overestimate the value of most of these drugs. If one just looks at an overall picture of life expectancy in this country, it went up by 32 years in the twentieth century. Now only the most optimistic commentator suggests that maybe three and a half years of that is down to having a health service and a year and a half of that is down to having childhood immunisation, so the rest of the 99.9 per cent of what we spent on the NHS gives us perhaps two years added life expectancy. OK, we say it produces vast improvements in quality of life, but actually when you start measuring morbidity, you find that the main activity of the NHS is to keep chronically ill elderly people alive a bit longer, so actually we are probably adding to the burden of morbidity as well in society. Chairman: Thank you for cheering us up. Q244 John Austin: I want to go back to Dr Heath, because whilst I would accept that we should be concerned about inappropriate prescribing and we should be concerned about unnecessary self-medication, I was somewhat concerned that when the Chairman used the term disease-mongering he mentioned osteoporosis, since this is a condition which is easily preventable and treatable, affects far more women than it does men, affects far more women than does breast cancer or cardiac disease and if we are going to live longer, it is going increasingly to affect more and more people. Dr Heath: You speak like someone how has been speaking to a drug rep. Osteoporosis, thinning of the bones, happens naturally with ageing. Everybody at my age has thinner bones than somebody at 20. When I am in my eighties I will have even thinner bones. Some people's bones get thinner earlier than others. It is absolutely a continuum. There is no cut-off where people have good bones and people have bad osteoporotic bones. I would not dispute that at one end of that continuum, there are people whose thinness of their bones causes them very serious problems. Q245 John Austin: And serious problems for the NHS. Dr Heath: Yes and that those people would benefit from being identified and treated. But the whole drift of the osteoporosis public discussion has been to widen that, to make people worried about their bones. It is very interesting that the measurement for osteoporosis is to compare the current bone density with a young woman's bone density, so there is a whole thing about it. The other important thing, and we do not understand why, is that actually fracture rates do not correlate with your bone density measurement. You would expect, and the whole drift of the publicity is, that the thinner your bones, the more likely you are to sustain a fracture. It is not actually true when you look and it remains an idiosyncratic thing. There are all sorts of non-pharmacological things that you can do to improve your bone density. Q246 John Austin: I was not suggesting that one should instantly put everybody on HRT. Dr Heath: Least of all HRT. Q247 John Austin: That is what I would have been saying to if I had been listening to the drug companies. However, there are things people can do in terms of dietary supplement, in terms of exercise. Dr Heath: Stamping. I recommend stamping for all women in their fifties, it is extremely good. Impact exercise. You should stamp regularly. Q248 John Austin: That is not to suggest it is disease-mongering, but that people should be concerned. Dr Heath: No, but it is disease-mongering to look to extend that range across the continuum. That is disease-mongering and exactly the same process is happening in blood pressure. Of course if you treat across a wider range, you will get an incremental benefit, you will, but it is an exponentially declining benefit. The more you treat, the less benefit you will get. So the pharmaceutical industry clearly wants the cut-off point at the broadest point. I suspect society would benefit very considerably from having it drawn somewhere else. The last point I want to make it that we are only just beginning to understand the health effects of making people worried about their health. We are only beginning to see that and I predict that is also going to be a huge health problem for the future where people more and more feel that their body is in some way sabotaging them. We know that once you diagnose somebody as having raised blood pressure, they think about their blood pressure a minimum of seven times a day. That is not a definition of health and if they are not only worrying about their blood pressure but their cholesterol and their bone density, there becomes a sort of introspective health surveillance attitude that is the very antithesis of health. Q249 Chairman: Do you have any appointments available? Can I actually ask our pharmacy colleagues about the general point about disease-mongering and whether you concur with Dr Heath's organisation's views on this and if so, what is your role in countering this kind of situation? Mr D'Arcy: From a political standpoint, we do not really have a view on the disease-mongering, so there is not a NPA position on it, but I would accept what Dr Heath said, that there does need to be a debate about this and I think it is debate that requires all stakeholders to take part. So in responding to that it is probably more personal comments, partly as a pharmacist and partly as a patient I suppose, but I will feed them in. The debate is whether we tell patients, whether we do not tell patients, whether we disease-monger, or not disease-monger. We need to recognise that we live in an information world and people will get information from a variety of sources. They will get it from the internet, they will get it from friends, they will get it from healthcare professionals, they will get it from the media and health sells. If you put a health column in your magazine or whatever, people want to know about it, people are interested in it. The question is whether patients have a right to know. In other words, if we tell patients more then they get alarmed. I think that is for patients to decide and as an individual it should be my decision. I was interested in the comment on the blood pressure. Speaking as me, as a male, I had my blood pressure measured the other day and I was pleased and surprised and I have to say mightily surprised, relieved as well, to find that it was normal. But had it not been normal, there is no doubt my mindset would be adjusted by that. I would think differently, I would feel differently and I would start worrying about it an awful lot and it would leak into other area. So do you want to know, do you not want to know? On the other hand, if I had high blood pressure and it was indicative of an underlying condition, I would probably on the one hand not want to know that because I should just like to live in ignorant bliss, but on the other hand, I might need to know as a father with children and do what I can to prevent that. It is down to me to decide on that and I think the debate needs to centre around whether patients do have a right to know about this and to make their own decisions. The big issue then is, if patients do have a right to know and as time goes on we know more and more about conditions and we have a debate about whether or not it is disease-mongering or whether it is a real level of concern, what is affordable. Of course that is the ultimate policy decision that has to be taken. We talked earlier about quality safety and efficacy: the so-called fourth hurdle, of course, was and is NICE which was to look at cost-effectiveness of medicines. So there can be a range of opinions on what is right or what is wrong; from a pharmacy perspective, we have not got involved in the debate and listening to it I think we must and I think we must need a wider debate. Ultimately, I do think it is going to come down to a political decision about what is affordable. Statins have been talked about and actually statins are an example of that. NICE guidelines say that below a certain level, you do not treat and that is where the gap comes for statins. It is down to individuals to decide whether or not they want to take a statin, whether or not they are sufficiently worried about cholesterol and to get back to the decision about whether to be sufficiently worried they need sources of advice and they will choose a source of advice themselves, but what they need to be assured about in the whole healthcare system is getting access to objective advice somewhere down the line, and they need to be able to rely upon honest brokers in the healthcare system. Q250 Chairman: No disrespect to you personally, but are your people honest brokers in the context of where some of us are, to pick up Dr Heath's concerns, convinced that we have all sorts of things wrong with us that might be absolute nonsense and I come along to you as a middle-aged man with all sorts of fears about my health, convinced, because of marketing techniques, that if I acquire a certain product, that will help me. I do not go through Dr Heath for that product; I can probably buy it over the counter. Ethically, would you say frankly I do not need it, or it is a waste of time, or really this has built up to an issue it is not and I am just wasting my money by buying it? Or would you members think well, sell it and off you go and make the money on the product? Mr D'Arcy: You are going to get a variety, but I would say in the main pharmacists would do that: they would look at it, they would look at you, they would talk to you and they would consider whether it is in your best interests. If they believed that it was not in your best interests, or they believed, taking the earlier point, that it actually was not a therapeutically effective product, whatever it was, that is the advice they would give you and that is actually what pharmacists do on a day-to-day basis. In terms of a pharmacist taking commercial decisions, thinking they will just sell it to you, actually pharmacists do not operate particularly commercially in that respect. They tend to favour more giving impartial advice to patients, because they believe in giving objective advice, and they believe in providing a service to patients which is based around that objective advice because that is the way they operate and, going back to it, the code of ethics underpins that. You will, however, get some patients who will come into a pharmacy, sticking with statins again, who will say - and it may be another medicine -"I am aware there is a product to deal with X, Y and Z, give it to me". Sometimes a pharmacist will have difficulty saying "Well, actually hang on a minute, is this right for you? Is this appropriate for you? Are you taking any other medicines?" asking a variety of questions. Sometimes that discussion is difficult because a patient has such a mindset that they want a particular product or a customer has a mindset that they want a product and they will try to get it. Where pharmacists are given an opportunity to engage in giving advice, they are duty bound to and will give objective advice about that and will act for what they perceive to be in the best interest of the patient. Mr Darracott: I should like to add a couple of things to that. We have expressed particular concern about disease awareness campaigns where they relate to a new product, approaching a new area where there is effectively no direct competition. So the disease awareness campaign is really a straight link to a single product, not just because there are no direct competitors, but also with a new product on the market, there is only a provisional risk benefit profile and one of the approaches that the BNF takes in dealing with new medicines is that it will note the launch of a new product and the product will only really be considered in terms of its place within the armamentarium after two or three years of use. So the new product will appear and say such and such a product has been launched in a column under the drug class and after a couple of years there will be some more information as the product gets used. We also have a particular concern, looking at the American experience, that disease awareness campaigns really were the precursors to direct-to-consumer advertising and we have great concerns about direct-to-consumer advertising. I just observe that the five products advertised across the Super Bowl weekend in the USA tend to be three prescription drugs and two alcohol products, which is an interesting combination. We have some serious concerns about that. One thing we have taken the opportunity to do, and it relates back to an earlier point, is that with prescription switches to pharmacy from prescription-only controlled pharmacy medicine status the Society does has a policy of producing our own guidance to pharmacists on the major products. We did include in the guidance on the switch of the statin product recently, that questions from customers on a statin was an opportunity to discuss other things like smoking and weight reduction. The other I would say, anecdotally is that I think there is a healthy debate within pharmacy about some of the new products which are available for sale over the counter and I recently had an opportunity talk to a pharmacist from Liverpool who said that this had cropped up at a local meeting that he was at with colleagues and they had managed to find two pharmacists in Liverpool who were stocking statins on the grounds that actually they really could not imagine anybody coming in and asking for them. On the other hand, I also spoke to a pharmacist recently who said that he had been approached about a product which had been read about, saying could they have statins, and when the pharmacist began to ask some questions about what they wanted it for they said "Well if you're going to ask me all these questions, I'll go to somebody who will sell it to me". We do have to face the fact that where consumers want a particular product, they want a product. Q251 John Austin: Could I come on to the issue of drug research and drug use, especially to Dr Heath. In your evidence, you said the relationship between the health service and the pharmaceutical industry must mature. In what way is the relationship immature at the present time? How would you see it in the future? Dr Heath: One would not want to understate the very real therapeutic advances there have been. Just during my career as a doctor, for example, the complete disappearance of surgery for peptic-ulceration, except on the rare occasions now where people still perforate, is an astonishing turnaround. So the challenge is to find some sort of regulatory framework which encourages genuine innovation, which actively discourages the whole me-too culture and somehow discourages this whole area of disease-mongering and risk factor creep, as we could perhaps call it. I think that is in an immensely difficult task and the regulatory framework at the moment certainly does not seem to distinguish adequately between genuine innovation and me-toos and does not seem to have any grasp on risk factor creep. I am not speaking for my organisation now. Personally I am always much better at seeing what is wrong with the situation, than what can be done to right it. Q252 John Austin: I was going to ask you about the me-too culture as well. Certainly it was suggested in one of our visits as well that where a specific drug was reaching the end of its patent period, then it was likely that the pharmaceutical company would develop a new improved drug with a new patent. Dr Heath: Absolutely and the whole research base of me-toos, where you read the research and you are just amazed why they are not using the commonest drug to compare it with. They are comparing it with something that you are not using anyway, so how the hell are you supposed to make a decision; so the range of comparisons. The other thing, particularly again with preventive technologies, there was the issue that has already been made about the multiple morbidity of real people as opposed to research subjects, but also the length of follow-up and the way that people are allowed to extrapolate over a relatively short follow up into a huge follow-up. Do you see what I mean? That is what happened with HRT, the rapid reversal of the HRT situation, and as a doctor the HRT chaos, even though it has been very distressing for patients, has been enormously beneficial because here we have a whole group of women who have been confronted with the uncertainty and the mobility of the evidence base and have begun to understand, as a very useful group of citizens, the lack of absolutes in this game. It is an opportunity to build on that understanding which a whole group of women now has and actually a degree of very healthy scepticism about initial reporting. Q253 John Austin: I know that Dr Nicholson wanted to come in and perhaps I could widen it as well and bring in the suggestion we have had from the King's Fund that the areas of research and the development of research do not go into priority areas as far as the health service is concerned and go into a very narrow base and whether there is a possibility that the health service could, by some mechanism, influence the direction and development of drug research. Dr Nicholson: May I just carry on from what Dr Heath was saying, that she was not certain why she was presented with some comparisons between a new drug and an old drug. I am sure that is usually for marketing purposes. Take as an example, Vioxx, which has been removed from the market recently. A clinical trial was proposed to my ethics committee some years ago of Vioxx versus Naproxen and we wondered to ourselves why on earth Merck want to compare this with Naproxen. They did not give us the details initially and then when we asked and asked, we finally found out that they had already carried out major trials against the two major anti-inflammatory drugs, Ibuprofen and Indomethocyn and found absolutely no advantage of their drug. They were hoping that by comparing it to Naproxen, which had just five per cent of the market, they would be able to show an advantage. Now that presents us, as an ethics committee, with a real problem. It might be that a few patients, one in a thousand patients, eventually might benefit from having this drug. We would be really delighted to be empowered to say, "Look, this is just a straight marketing exercise. This is not a proper clinical trial" we would like to be able to reject that. But, sure enough, we do not have the power, so it seemed like a moderately safe clinical trial and we allowed it to go ahead and all the advertising in this country for Vioxx was that it was better than Naproxen with no mention of the fact that it was no better than Indomethocyn and Ibuprofen which are the market leaders. There is a sense in which ethics committees, if they were to be somewhat empowered, would have some function in trying to prevent the disease-mongering element. Of course these drugs, if you are going to extend their use to new conditions, have to be tested, they have to be tried out. If we are presented with a clinical trial to approve one of the SSRI anti-depressants because people think it might be useful in social phobia or for people who are a bit shy when they go into a party and maybe if they take their Seroxat, they will do better, we would love to be able to say no, this is a ridiculous use of a drug. Q254 John Austin: Do you not have the power to say you are not comparing like with like and you should be comparing with something else? Dr Nicholson: If it is unscientific, if the design of the trial is bad, then obviously we can reject it. However, there is a real sort of issue that we could be a better control of what sort of uses are made of drugs and at present the system would not permit that. I would take your point about the research not being appropriate, because what I might have followed on with from my earlier gloomy predictions of how valuable medicine is, would have been to point out that the WHO rule is that 90 per cent of all medical research worldwide is done on only 10 per cent of the global disease burden because the research is done on the chronic diseases of rich elderly people and does not affect the main disease burden throughout the rest of the developing world. Q255 John Austin: Do you think it is possible for the NHS to develop a national drug policy which might influence the direction of research? Dr Nicholson: It would require research itself to be less dominated by drug company money and the proportion of medical research that is funded by drug company money at the moment is really much too high. Curiously, I suspect one would be in a better position to do that if one where in the United States where well over half of all medical research funds come from the federal government. In this country it is well under a quarter. Q256 Chairman: Why is that? I find that the point you have just made very interesting about the distinction between the two countries. What is the background to that being the case in the States? Dr Nicholson: I think there is a very long history of the national institutes of health being extremely well funded by the federal government, setting up a whole series of major research institutes which have always run to a very high quality, attracted very good scientists, produced good results and successive governments continue to fund it well. Chairman: We have a socialised healthcare system in the UK but do not have the kind of regime you are describing in the States. I find that interesting. Q257 John Austin: One of the suggestions the King's Fund put forward is "New forms of public/private partnership are required in which the public interest would be given greater weight ... the Department of Health should aim to create a level playing field, by appropriate research commissioning policies, between drugs and other forms of treatment". Is that a view that you would share? Dr Nicholson: I suspect I would be sceptical, knowing our failures in other public/private arrangements, to think that this was going to be a good way of dealing with research. Q258 Dr Naysmith: Just picking up on what Dr Nicholson was saying about drug trials, one question related specifically to what you were saying. In testing a drug, whether you have an ethics committee looking at it or any kind of research committee looking at it, do you have any control of what the drug is tested against? You mentioned that the one you were talking about was tested against a not very effective, probably slightly old-fashioned drug. Can you insist that the placebo is not enough nowadays? If you have an effective treatment, or semi-effective treatment, can you say that it is no good just showing that it is better than a placebo, it has to be better than that? Dr Nicholson: We cannot positively require researchers to use a different comparator from the one they have chosen, but in cases where a placebo is being used and there is already effective treatment, then we can just decline to approve that study. Another example from one of the major drug companies a couple of years ago to my committee was that they wished to try out a new drug for Type 2 diabetes, a glitazone-type drug and they wished to compare it against placebo but the inclusion criterion for that trial was that the person with diabetes had failed to achieve control using diet and exercise and their physician believed that they needed pharmaceutical treatment. That trial would have, if we had allowed it to go ahead, consigned half the people in the trial to receive the new drug, half of them to receive a placebo for nine months, during which period the side effects to their diabetes could have got a great deal worse in terms of visual deterioration, deterioration of kidney function and so forth. So we rejected that one but now the problem we have is that that is the sort of trial that the FDA in the States still wishes to do and we would have had a good argument against it had the Department of Health, in the clinical trials regulations which came into force on 1 May, said that we were allowed to insist on clinical trials being done according to the most up-to-date ethical guidelines. However, in the clinical trials guidelines, it says that all clinical trials in this country must be conducted according to an out-of-date version of the declaration of Helsinki which is the internationally accepted agreement. The version according to which they have to be done was effectively written in 1975, with one or two minor changes since then, because the Department of Health believes that this makes it easier to make placebo control trials, where we would, as ethics committees, insist that there will not be placebo control trials. If we were allowed to use the 2000 version of the declaration of Helsinki, there would also be other advantages as well. Q259 Dr Naysmith: Is that something that you reckon we should look at and possibly make recommendations about? Dr Nicholson: I think you have to. The 2000 version declaration of Helsinki requires that any clinical trials results be made publicly available or published. We could, if we were allowed to work to that version of the declaration of Helsinki, insist that unless you made the results of your trial public at the end of it, you had never had effective ethical approval, but the Department of Health has removed that power from us. Q260 Mr Jones: Another way of potentially addressing this issue of the effectiveness of me-too drugs might be, rather than specifying what sort of trial should be required, that the Department of Health should agree prices for drugs, dependent upon the evidence of its therapeutic value. Where a drug has not been able to demonstrate its effective therapeutic value, as compared to a well-known market leader, the Department of Health would agree only to pay a much more modest price for this drug. Dr Nicholson: Whether the drug companies would be willing to sell at a much lower price is something the Department of Health could explore. Q261 Mr Jones: I ask the question, because something similar apparently applies in Australia. Dr Nicholson: I do not know the Australian scene, but it is certainly something that would be well worth exploring and if countries around the world could adopt such a policy, then the emphasis on pharmaceutical companies trying to produce me-too drugs rather than looking for really innovative drugs would be much reduced. It is worth remembering that the proportion of new drugs which have been licensed over the last two or three years which really are a new principle rather than just a me-too drug is well under 10 per cent. Q262 Dr Naysmith: Moving to the question of the protection of patients who are involved in clinical trials and we actually just touched on it a moment ago, are you satisfied that the ethics committee system is working well in terms of protecting patients? I know you have had a look at the evidence that we got from the Department of Health about ethical audit a couple of weeks ago. Dr Nicholson: I think the Department of Health was extremely optimistic in the picture that it painted in the evidence it sent to you. The ethics committees have had two overriding needs for well over 20 years: firstly, support for their administration; secondly, support for training of the members. The need for support for administration is shown in that even in the last three years I have come across committees where there is a lay chairman and the only support that he has is 10 hours of a temp per month. That is absolutely no way to run a serious committee. These committees are made up volunteers who put in on average 150 hours of completely unpaid time and unsupported time and they are not even sent a publication on a regular basis. They do need some support. Likewise, if they are to work together effectively and come to reasonably common decisions - there is no reason why they should always come to the same conclusion because very often protocols are so riddled with ethical problems that one committee will pick up one set of ethical problems, another committee will pick up a different set, so there is no absolute reason why they should all come to the same decision - were they to have much more training, then you probably would get better uniformity. Q263 Dr Naysmith: So you are suggesting more training, more resources. Any other recommendations? Dr Nicholson: The resources have gone into the Central Office for Research Ethics Committees (COREC), but they have not come out the other side. Each has decided to build itself an empire and the Central Office for Research Ethics Committees is now made up of nearly 40 staff. In 1997 the Department of Health thought that 250 ethics committees could be supervised by half the time of a higher executive officer. Now, when there are only about 180 committees, we have an office of about 40 staff. Interestingly, the American equivalent, the Office for Human Research Protections in Washington, also has about 40 staff, but it has oversight of 10,000 research ethics committees and is a great deal more effective. So the real problem is that there is a variety of ways in which the work of COREC completely lacks coherence. For instance, at the moment, we have the clinical trials regulations which were approved in April this year, and came into force on 1 May, which have one approach to getting consent to the involvement of an adult who lacks capacity who is to be in a clinical trial in that sort of research. The latest version of the Human Tissue Bill which has come out of the House of Lords has another version of how consent is to be obtained from adults who lack capacity, if their tissue is to be involved in research. The mental capacity bill which is going to be before parliament next session has a third set of regulations proposed for how to obtain consent when you are dealing with an adult who lacks capacity. Q264 Dr Naysmith: We are struggling with that at the moment. Dr Nicholson: Already we are likely, with the Human Tissue Bill - it is likely to go through, is it not? - to have some proposals and what it has to say about consent is contrary to what the clinical trials regulations say. Many clinical trials involve human tissue nowadays because people take blood samples to do DNA analysis at a later stage and so that research comes under the Human Tissue Bill. We are having real problems with coherence and the other problem with coherence is that, unlike America where one has institutions trying to develop a proper system throughout the institution for protecting the subjects of research which involves the researchers having to have training in research ethics, it involves those who assess the science as well as those how assess the ethics working together, we do not have that here. The R&D departments have to approve research before it goes ahead and they are working totally differently to the ethics committees and sometimes on totally different timescales. Recently, a clinical trial was proposed in East Anglia to be done at four centres. All four research ethics committees approved it within a month, three out of the four R&D departments approved it within the month, the fourth R&D department took five months to approve it, by which time the trial had been up and running in Poland for three months because this is a competitive field and if you do not get on and do things quickly, the research will go elsewhere. Q265 Dr Naysmith: What you have just said brings me on to the second major question I wanted to ask. What evidence do you have that patients are well enough informed before consenting to take part in drug trials? I am going to bring in Dr Kendall in a moment as he has been sitting there very quietly for the last half an hour not saying very much but I am sure this is an area that you will have views on also. Dr Nicholson: Essentially very little evidence because the empirical studies on informed consent show that, as with any form of education, patients are best informed if you give them the information in a variety of different ways on a variety of different occasions. The problem is that we are stuck in a routine of giving an information sheet and having one conversation with a researcher and that is really inadequate. Q266 Dr Naysmith: Bearing in mind that we are looking at the pharmaceutical industry and its effect on the National Health Service. Dr Nicholson: The pharmaceutical industry is as bad as any because the patient information sheets which they submit have on average a reading age of about 19 years, when they should be aiming at a reading age of about 11 years. They do not include on average about 20 of the items which the various international regulations say should be in a patient information sheet. Normally they are called Version 1 and they have been written a few days before the application to the ethics committee. Absolutely no effort has been put into providing information in a way that patients are likely to understand. That means that every time their research proposal is delayed for a month because the ethics committee rejects it and says "Go away and rewrite this patient information sheet" they have wasted a month. Yet this happens on 90 per cent of the information sheets sent to us. Q267 Dr Naysmith: What about the relationship with the pharmaceutical industry? Do they have influences on patients and patient selection and that sort of thing? Dr Nicholson: Not directly, because of course it is going to be the researcher who should be approaching the patient and we would regard it as highly unethical for there to be any direct approach from the pharmaceutical company sponsoring the trial to the patients. Normally it is the researcher who makes the approaches. In some situations, if the researcher has written one of these patient information sheets, one has to wonder what language he would use when he talks to the patient and whether he is capable of communicating. Q268 Dr Naysmith: Dr Kendall, what do you think about all this area of conducting clinical trials and making sure that the patients understand what they are doing it for and that kind of thing? Dr Kendall: Unfortunately an awful lot of the clinical trials done by drug companies are done probably not to find out whether or not the drug is efficacious or safe or whatever, although those are concerns. They are largely done to support advertising campaigns so that the results which come out of trials are very selectively used for that. There are also problems with things like recruitment. For a lot of the trials which drug companies recruit to, they recruit from populations which are completely inappropriate. For example, in some of the work on treatment of depressed children, some of the trials have recruited depressed children by advert. They are not people who in this country would have been treated with any anti-depressant, but it is on the basis of those studies. Q269 Dr Naysmith: We will be talking about that a little later on, but at the moment we are just talking about clinical trials. You are saying that the real reason for some of the clinical trials being carried out is to back up advertising. Dr Kendall: Yes, it does seem to be and certainly that is reflected in the publication bias I suppose. What appear in print are generally only things which are favourable to the drug. Q270 Mrs Calton: Dr Heath, can we turn to post-marketing research? You say in your submission that post-marketing research should be independent of the pharmaceutical industry. Who do you think should conduct such research? Should this independent body, if there is one, have legal rights of access to all company data in order to compare post-market data with pre-market results? Dr Heath: I am absolutely certain that any data should be publicly available for any product which is going to be used by the National Health Service. Selective publication is dreadful, because half the information is missing and everybody at every level is making decisions on the basis of half the data and therefore is being misled. The huge problem of unravelling post-marketing research from marketing is something which is crying out to be solved in some way; the fact that a large number of campaigns which involve financial inducements seem really designed just to get the product prescribed and somebody into the habit of prescribing it rather than to do a serious evaluation. It has to be some sort of arm's-length ... On the problem of who should fund it, it is not for us to say, but if it continues to be funded by the pharmaceutical industry it has to be in some way at arm's-length so that the actual regulation of the research and the publication of the research is not in any way controlled by the industry. I also think that patients need to be very much more fully informed about what exactly they are involved in. Our College definitely has debated this issue and made a statement about full information being available to patients involved and this thing about inducements offered to the prescribing doctor, for example. Q271 Mrs Calton: We have heard in previous evidence that actually not that much post-marketing research goes on, but most of the research is pre-marketing. The very little which goes on is not in the hands of independent people. Do you believe that it is possible for an independent body to be set up which could look at post-marketing research? Dr Heath: I am wondering whether the same organisation that looks at the adverse drug reactions in that first crucial interval with a new drug, when adverse drug reaction surveillance is so much more important than in any other stage in the life of the drug, could in some way be tied into post-marketing research. Q272 Mrs Calton: In some senses the fact that people are being prescribed a drug is a whole new, big trial, is it not? Dr Heath: Exactly and there is an opportunity there to put a research framework round it and to get real prospective data which is lost at the moment. Q273 Mrs Calton: Do you think it could be linked to the yellow card system? Dr Heath: I do and also systematically getting feedback from patients who take new drugs, rather than waiting for the patient to come to tell their doctor or their pharmacist who then may or may not do a yellow card depending on what sort of morning they have had. Q274 Mrs Calton: How much do you think it would cost to do that? Mr Griffiths: I do not have the first idea. Q275 Mrs Calton: May I turn now to Dr Nicholson? In our last evidence session, Dr Andrew Herxheimer suggested that ethics committees might have a key role to play in relation to disclosure of clinical trial results by insisting that trials be registered at inception on an appropriate registry before people are recruited to it. Do you see merit in this proposal? Dr Nicholson: Certainly I see merit in that proposal. However, as I explained earlier, we are stymied by the Department of Health saying that clinical trials are to be conducted according to out-of-date ethical guidelines, so we do not have any way of enforcing such a requirement. Personally I have been arguing that all research should be registered for over 20 years now. I am absolutely in favour of giving ethics committees the power to insist on registration of any trial they approve. Q276 Mrs Calton: And the parts of the trial, so that all the different parts of the research are all fully reported at a later date. Dr Nicholson: Yes; not necessarily published, because one cannot insist on journals taking material, but they must be publicly available and put on the website. Indeed the most recent version of the Declaration of Helsinki says that the design of all the studies should be publicly available. I see absolutely no reason why the protocols of these trials should not be required to be put on the internet or made publicly available in some way before you even start the trial. The drug companies will shout and scream about commercial confidentiality, but if their competitors have not already done their industrial espionage at least five years earlier I would be amazed. Their competitors will know very well what is going on by the time something gets to clinical trials. The idea of commercial confidentiality is meaningless in that situation. Q277 Mrs Calton: Thank you; that is helpful. You think the main way of doing this would be to insist on publication on the website rather than depending on the journals such as The Lancet requiring that sort of publication. Dr Nicholson: Obviously you have to leave the journals to choose what they are going to publish; they are independent bodies in that sense. I do think that there are ways in which one could ensure that the material is publicly available via the internet. May I just make one point about the post-marketing studies? It should be remembered that every study of the yellow card system has shown that something between one fifth and one quarter of adverse events are actually reported, that one does need to have some active surveillance to pick up the true level of side effects and adverse events. So, if one were doing post-marketing, one would have to insist that there was some sort of active system, rather than relying on some further use just of yellow cards. Q278 Mrs Calton: Dr Heath mentioned earlier that there should be much more patient reporting. Do you think that would make up the gap between what we are seeing at the moment with the yellow card system and what there could be? Dr Heath: It is hard to predict the future, but it would be well worth a pilot to see the quality of the information which was coming back and how it compared with the yellow card system. I should be surprised if it was not more useful. Q279 Mrs Calton: You, Dr Nicholson, are thinking more in terms of a compulsory system rather than the voluntary system. Dr Nicholson: We have had a lot of examples of drugs being thought to be the latest wonder drug and then turning out to have some fairly nasty side effects a year or two down the road which end up with the drug being withdrawn. We do need some sort of active surveillance system in order to pick up those instances earlier. However, it may well be that in most of those cases, had we had access to the results of all the clinical trials which have been carried out and had there not been in some a disclosure failure by the pharmaceutical industry, we might have got to the point of not licensing those drugs to begin with. Mr Griffiths: I believe yellow card reporting is actually open to the general public now. It was made available about a year ago, at the same time as they opened it up to the nursing profession, to members of the general public to yellow card report via NHS Direct. I do think it does need publicising. Mrs Calton: Are you aware whether that has made a difference? Chairman: That is news to us. Q280 Mrs Calton: I did not know that before. Has it made any difference at all? Mr Griffiths: I am not aware of any difference, but it was publicised at the same time as they opened it up to the nursing profession and obviously with 500,000 nurses there is an incentive to get nurses doing it as well. Very often nurses are administering the drugs and they are writing out critical incident forms if someone has an adverse drug reaction. It makes it very sensible to utilise them and utilise their skills to report these incidents as well. Mr Darracott: May I add a comment on the availability of information? When I discussed this particular issue with the editor of Martindale, which has 100,000 references to thousands and thousands of drugs, one thing he did say was that in his view there is a rather worrying trend where products are new to the market and the team then tries to find evidence - because obviously the material which has gone into the regulators is confidential - that in trying to find any evidence at all about the use of the drug available in the published literature we are getting down to the stage of finding abstracts of proceedings, which are papers about some of these being presented somewhere at a conference. He is saying that happens far too often in his view. I am sure he would agree that registration of trials would be very beneficial, because they would certainly want to follow those things through. If there were a register, that would be one way for them to bring this information together much faster. Q281 Mrs Calton: May we turn now to information for patients? It may be appropriate for Mr Darracott and Mr D'Arcy to answer my question, although I think Dr Nicholson has already talked about information for patients in trials. I was interested, as an ex teacher, to hear that the reading age is about 19 and that would certainly go with what I have seen so far of the material which is put in front of people. In its evidence the Royal College of General Practitioners suggests that "... it would be preferable for Patient Information Leaflets to be written by sources independent of the pharmaceutical industry and should emphasise the place of the particular drug in the overall scheme of disease management". How could this be done? Mr D'Arcy: There is probably some merit in it. I agree with the age of 19. We see patient information leaflets as being a legal defence document rather than actually being a patient information leaflet. I have an example here. I shall not talk about the actual product, because that is probably unfair, but just give you an idea of it. This is the patient information leaflet and it says "Are you suffering from untreated widespread systemic infection? Are you suffering from herpes infection of the eye? Have you taken this product before? Do you suffer any heart condition or high blood pressure? Do you suffer from kidney problems? Do you suffer from liver problems? Do you suffer from stomach ulcers? Do you suffer from glaucoma or does glaucoma run in your family? Do you suffer from diabetes or does diabetes run in your family? Do you suffer from thyroid problems?". I am going on. "Do you suffer from epilepsy? Are you suffering from or have you had tuberculosis? Are you past the menopause - the change of life? Are you past the menopause and suffering from osteoporosis - thinning of the bones?" It goes on. "Do you have Cushing's disease? Are you pregnant or trying to become pregnant?" To be honest, anybody reading this would want their bolts tightening if they then took the medicine. That is the legal defence point: you have to put this stuff down otherwise you are not giving everybody full information. Q282 Chairman: It would be very helpful if you could leave that with the Committee to have a look at. Mr D'Arcy: Yes, I can send that through. The point is that that is what it is. It is not particularly helpful. At one level what that will do is prompt a load of other questions and you will then clog up the GP service or clog up a pharmacy asking all these questions. The first thing to say is that whilst that information has to be out there, because you have to put it there, how do you grade that and what does it actually mean to you in terms of taking that? There does need to be some kind of additional information just to explain in layman's terms what this medicine is. I would agree with the objectivity then, because then you can say this has been looked at separately. It is right for the patient information leaflet to come from the industry because they have researched the product and they should be the people who put the information in. Getting the patient information leaflet approved is part of the regulatory process. The other thing about it is that whatever information you put out, it will raise more questions. Somebody will say either "What does this mean? Actually I don't understand a word or don't understand the way it is put" or "What does it mean to me as an individual?" They need help with that and whatever leaflets you put with products, one of the things about information leaflets is that they request more information. Certainly from our members' perspectives, one of the things they are doing increasingly is helping patients try to understand that information and put a perspective on it. One of the roles of pharmacists is to take an objective view on it in providing that information. Dr Nicholson: May I just mention that there is one company in this country which has made a serious effort to produce patient information sheets for their clinical trials which are understandable. Novartis realised that they were wasting an awful lot of time by having their projects rejected just because they could not write patient information sheets. They got together various writers, worked with focus groups of potential participants in their trials and ended up with extremely long information sheets, but ones which people were happy to read. They had narrow columns of text like a newspaper, they did not have enormously long lines which were totally unreadable and they had plenty of white space, short words, short sentences, short paragraphs, diagrams, flow charts wherever possible. The commonest response of people in focus groups after reading 15 pages of this was "That's fine. I think I understand that. What else do I need to know about the trial?". They were obviously having the right effect. They were taking people forward and not just turning them off. Mr D'Arcy: Something I meant to say as well was that pharmacists are obliged to give a patient a patient information leaflet. However, one problem we have in pharmacies is an inability to do that in all cases because in dispensing a medicine we are required in many cases to give the exact quantity written on the prescription and if that does not coincide with the patient pack which has the leaflet in it, you are left without a leaflet. This is still an unresolved issue. Some pharmacists try to photocopy leaflets if they can, but that is difficult and it is a breach of copyright. Trying to download them from the internet has also been put forward as a solution. Some of the patient information leaflets are booklets. The contraceptive pill leaflet tends to come as a booklet and it is impossible to download that in any kind of sensible format. I shall send you a copy of that as well. That is an example of how difficult it can be. It means that in some cases pharmacies are forced to dispense a prescription and have the inability to provide the leaflet. Notwithstanding the limitations of the leaflet in terms of its content, in some cases patients do not actually get it because they cannot get it. That is actually a breach of a European obligation. Mr Darracott: One thing I want to bring to the Committee's attention is that one of the elements of the work which is funded through the task force on medicines partnership is called the medicines' information project. I cannot give you any reassurance that it is not a wide stakeholder group, so it does have the industry as one of the stakeholders in this project, but what this particular group is attempting to do is to develop information for patients of the sort we should all like to see. It is early days yet, it is in its second year, but it is linked to NHS Direct Online. The material about individual products, whether by brand or by generic name, can be accessed through and is linked to the section of NHS Direct Online which is related to the condition that somebody might be suffering from. The areas they have explored so far are epilepsy, influenza and during Ask About Medicines Week, last week, they released a new area looking at hypercholesterolemia. It is a developing area, but it is small scale, though the work is funded through the medicines partnership by the Department of Health. If you have not had anything on that, it is perhaps something you would like to look at as well. Q283 Mrs Calton: It would be useful, but it is dependent obviously for individual patients on being able to access the internet which not everybody can. Mr Darracott: Indeed. Dr Heath: A definite problem is that people are frightened by these things and the fact is that huge list of potential side effects is written to defend the company legally with no indication of prevalence. I had one particular patient who came back the day after I had given her a prescription and brought the tablets back and said she did not want them. She had read this and very sweetly thought effects, side effects; dish, side dish. She thought she was going to get all these things and she had read about them all and no thank you, she did not actually want them and I could have my tablets back. That is a different reading age. It is the lists themselves; those lists of the potential adverse effects are very frightening to some people. They are not contextualised in any sort of way about how likely that is to happen to you and that information is available. In the actual way it is presented, nothing is done to mitigate the fear which comes with information. Q284 Mrs Calton: May I throw out a challenge to those of you who feel this could be done better? We have already had offers of existing patient information leaflets which could be sent to us and we shall be very pleased to receive those. Would it be possible for those of you who feel you could have a go at this, or that you have access to people who could perhaps do this, to modify an existing patient information leaflet and send it to the Committee to illustrate exactly what you have in mind as to what it ought to be; not just what is bad about what is there already, but how it could be done so it could be better. Can we throw that out as a challenge? Dr Heath, your Royal College put this forward. Dr Nicholson has some very clear views on the reading age and those sorts of issues. We should be very pleased to see an example of what you think it could be for one particular one. Dr Heath: The treatment notes from the Drug and Therapeutic Bulletin set a standard of patient communication. Q285 Mrs Calton: If you could send us some examples, that would be very useful. Mr Griffiths, in your submission you state that the distinction between product information provided by industry, which may be useful to healthcare professionals, and promotional material should not be blurred. How should this distinction be sharpened? Mr Griffiths: Particularly when it comes to educational material we recommend that it should be validated to make sure that the quality is there, but also that there is a distinction between what is promotional and what is educational; generic names used wherever possible. Nurses are being taught to research critique, to look at research, rip it to bits and try to take out what is of value and what is not of value. Obviously there are experts in this and we could utilise those experts - not everybody is good at critiques - as part of the validation process, to break down what the good information is here, the dubious information here and what can be utilised in that. Q286 Mrs Calton: Could we ask for examples of that to be sent? If you have examples that you could send us, not masses and masses but one or two examples that you could send us, to give us an indication of the sort of thing you need so that we can see the difference between straightforward promotional material and educational material, it would be helpful. Thank you. Mr Griffiths: Okay. Chairman: I am conscious that we have been going for two hours. We ought to conclude before one o'clock as we have a health debate and I know that some colleagues will want to participate. I know we are going to get some snappy questions from Doug. Can we have some snappy answers as well, so we can get through what we have to cover? Q287 Dr Naysmith: This is one of the areas where there was a bit of blurring I am sure. I gave an indication earlier on that I was going to talk about the selective serotonin reuptake inhibitors (SSRIs) and anti-depression. I just want to ask in a very snappy way whether the Royal College now regrets accepting pharmaceutical company sponsorship for its Defeat Depression campaign which was largely supported by the College. Dr Kendall: I am not convinced that they did actually receive support from the pharmaceutical industry. I can certainly find out and let the Committee know. Chairman: We understood you did. Q288 Dr Naysmith: Our information is that you did. Dr Kendall: I did notice that in looking at a previous select committee hearing. It struck me when I saw it that I was not aware that they did receive pharmaceutical company money. Q289 Chairman: Would you get back in touch with us? Dr Kendall: Yes. Q290 Dr Naysmith: Would you think it a bad thing if you had? Dr Kendall: Yes, because money usually brings with it some sort of influence and in having a campaign to raise awareness about depression, we need to be really careful that is not to try to increase the use of anti-depressants just to increase profits. Q291 Dr Naysmith: That maps into the whole question of disease awareness campaigns and the disease-mongering and the distinction between the two. It certainly happens with depression. Dr Kendall: It is very difficult with mental health, because you do want people to see mental health problems in a less stigmatising way. That does mean we need to talk about the fact that people get depressed quite often and people have schizophrenia, manic depressive illnesses and so on, rather than hide it away, but there is an inherent danger, as soon as you try to raise awareness, that drug companies will capitalise on it. Q292 Dr Naysmith: It is possibly also related to the fact that it is quite difficult clinically sometimes to distinguish between clinical depression and ordinary fed-up-with-life in a serious way. Dr Kendall: Yes. Q293 Dr Naysmith: That is really a professional job for you to do, to make it very clear, if you can, what qualifies and what does not. Most mental problems are dealt with by GPs anyway these days and it must be at your level, Dr Heath, that these things are dealt with and you have to make this distinction. We have your views from earlier on, but if there is anything else you want to add here, it would be useful. Dr Heath: Depression is a classic example. GPs are always being told that they fail to diagnose depression adequately, but if you actually follow up patients with so-called depression whom GPs missed, they are actually a group who do very well. Maybe it was appropriate not to label people with that sort of a diagnosis. It is definitely an area of disease creep, if not risk factor creep. The other one I was talking about, treating depression in children, is the nightmare of hyperactivity disorder and the increasing prescription of amphetamines for children when the problems they face are not pharmacological in the vast majority of cases. There is always going to be a small core where there is benefit, but in the hinterland of negative prescribing which just labels a child as having an illness, there are real, real issues around these sorts of huge diagnostic baskets. Depression is a huge diagnostic basket, as is behaviour disorder in children. Q294 Dr Naysmith: I am sorry to embarrass Dr Kendall, but I have here a copy of a letter from the President of the Royal College of Psychiatrists to the Social Audit, published Volume 28, which says that the campaign's total income amounted to £449,800, of which only £129,530, that is 28.8 per cent, came from pharmaceutical companies. Dr Kendall: That is terrible; I did not know that. Q295 Dr Naysmith: I am sure you did not, or you would not have said what you said. Dr Kendall: Which I have to say is embarrassing. I do know that our current president is very unhappy about this type of relationship. Q296 Dr Naysmith: That brings us into another area where there is a lot of pharmaceutical industry involvement with patients' organisations nowadays and we touched on that earlier too. This also brings pressures and I just wondered what you think about that. I am sure it operates in psychiatric illness. It is often a single disease and pharmaceutical companies provide funds to help them lobby. Dr Kendall: Increasingly so. It presents a real difficulty. Say, for example, I was an observer to the health technology appraisal for atypicals at the National Institute for Clinical Excellence and in that process they bring in representatives from patient organisations as well as experts as witnesses. The professionals declare their interests and the patient organisations declare their individual interests but I am not aware that they declare the funding they get for their organisations. I am aware that there are some, as far as I know, like Depression Alliance, which have very substantial funding at times from drug companies. They do lobby for an increased accessibility to drugs which the drug companies are selling to these patient organisations. They are persuading them that these are the drugs they must have, with very little evidence to support it. Q297 Mr Jones: Dr Kendall, in your submission you call for "... a review of the role and regulation of medical practitioners in pharmaceutical companies by the General Medical Council". Could you explain why you feel such a review is needed? Dr Kendall: Because you cannot conduct clinical trials without having doctors and since we know that there are trials which go unpublished because they are negative, we have to look at the role doctors have in that process. For us to recruit patients into a trial, that is patients with real illnesses whom we are taking into a trial and are putting them through treatments or placebos or whatever and then not publishing those results, strikes me as unethical from a doctor's point of view. I do think that the medical profession has to look at their part in this. Q298 Mr Jones: Mr Griffiths, you state that nurses should not use their professional status to promote individual products. What are your views on the use of nurses to conduct prescribing audits in general practice, with the presumed intent of increasing prescribing of a particular product? Mr Griffiths: At the end of the day we have members who are both working in the NHS and in the independent sector, whether that is in industry or in the independent health sector. At the end of the day we do expect that they will enhance patient care. We have to stick within the Nursing and Midwifery Council's (NMC) code of conduct and nurses treat their NMC code of conduct as the ultimate. Q299 Mr Jones: I noticed that answer from all professional organisations I have ever dealt with, that they have a professional code of conduct. Mr Griffiths: At the end of the day, if you get disciplined, if you go against the NMC code of conduct and you get disciplined, you get struck off and you lose your livelihood. Q300 Mr Jones: Are there any examples of nurses being struck off for inappropriately advising the use of a particular pharmaceutical? Mr Griffiths: I could not tell you whether any have been struck off recently; that is for the Nursing and Midwifery Council. Nurses do get struck off. Q301 Mr Jones: I know that. I have asked a similar question of several professional bodies in this inquiry so far and so far nobody has come up with a single example of any of their professional organisations being deregulated, unlicensed, struck off or whatever for inappropriate prescription or advice on prescriptions. Either it does not happen and there is no problem with a big chunk of what this inquiry is about, or the regulatory system organised by the professionals is inadequate. Mr Griffiths: I do not think it is inadequate. I think that nurses are going up in front of disciplinary councils and they are being called to answer for what they are actually doing. A recent case was a nurse who gave a prescription-only medicine without it being prescribed and I believe they were struck off by the Nursing and Midwifery Council. Q302 Mr Jones: That is a different sort of thing. Since the nurses are employed by the pharmaceutical company, there is an inherent conflict of interest if they are conducting an audit within the practice. Mr Griffiths: I do not believe so. I believe that at the end of the day you need to have people there with some clinical skills. Q303 Mr Jones: You do not think that he who pays the piper calls the tune. Mr Griffiths: At the end of the day if you are auditing, you are auditing. If you are changing a prescription, that is a different, but even then under supplementary prescribing by nurses, for example, the supplementary prescribing takes place in a partnership. It has to be backed up with an evidence base which is basically supporting your prescribing decision. It is not as though people are just going in and changing people's scripts, it has to be evidence based. If it is not evidence based, they would have to answer why it was not evidence based. Mr Jones: You are satisfied. Thank you. Q304 Siobhain McDonagh: GSK told us that it funded the diplomas in respiratory disease management of 235 nurses and 199 nurses in diabetic management in 2003. How did the deal come about? Could funding mean that training in some areas is done at the expense of training in others and thereby distort the overall output of specially trained nurses? Mr Griffiths: I do not know how the deal came about, because I have never had any dealings with GSK to tell you the honest truth. As far as the amount of training which has gone on is concerned, it is actually worthwhile and thank you very much to GSK for actually providing that sponsorship. If they had not provided the sponsorship, then the nurses probably would not have got the actual training. As long as there is some sort of quality indicator in there and somebody actually making sure it was independent and not biased only towards their drugs, but giving them education around the disease process, I do not see a problem with that as long as it is the case. I am sorry, what was your last question? Q305 Siobhain McDonagh: Could funding mean that training in some areas is done at the expense of training in others and thereby distort the overall output of specially trained nurses? Mr Griffiths: Not necessarily. Obviously they were picking up diabetes and asthma and there are national service frameworks around diabetes and asthma. The new GMC contract which pays GPs on quality has diabetes and asthma in it as quality indicators. So they are not only targeting areas which are of interest to them as a company commercially, but also areas which are important to clinicians in ensuring that quality care is delivered and making sure that national service frameworks are also delivered. Dr Heath: May I come in because I am astonished by that figure and it makes a lot of sense of my local experience. We now all have local respiratory nurses and local diabetic nurses and it is very interesting how much of their recommendation is proprietary rather than generic and how often they suggest changing to a different glucose measurer, how often they suggest a different pen system. I think it is having more of an influence and it is very worrying for a practice like ours which tries very hard not to have a direct ... We were all rather uncomfortable after one of our sessions with the respiratory nurse which was all around different gadgets. That just throws light on that experience, which is interesting. Mr Griffiths: Most diabetic nurses I have come across have actually not come through with any pharmaceutical company qualification, they have come through with a higher education institute qualification; they are coming through with the Warwick diabetic diploma or the Warwick asthma diploma. It is usually a higher education institution which has validated a course and it is a degree or master's level course, as opposed to the pharmaceutical company. Q306 Siobhain McDonagh: This is not picking on nurses in any sense but the next question is about the whole area which we have dealt with in other inquiries, not just in the pharmaceutical industry but in terms of work done on obesity and the relationship of sponsorship from good companies and stuff. Has the RCN any real concerns about safeguarding its own independence as its relationship with the pharmaceutical industry develops? Has the RCN developed any formal policy, defining how that relationship should and should not be pursued? Mr Griffiths: We do and any sponsorship which comes in, anything commercial which comes into the Royal College of Nursing - and there are things which do come in, we do work in partnership where possible - goes through a sponsorship manager, it goes through committees within the Royal College of Nursing which is a member-led organisation and at the end of the day we will represent our members, but our members are involved in the running of the organisation. We are looking out for them and obviously to make sure that patient care is kept to a high quality. Our independence is important to us and I know we cannot be truly independent if they are validating something on behalf of a pharmaceutical company, but we do have to look at working partnerships to make sure that we can get the education out of our nurses. Q307 Chairman: Do you know overall how much you are receiving directly from the industry? Mr Griffiths: I could not tell you. Q308 Chairman: Is there any way of getting back to us? Mr Griffiths: We could get back to you. Q309 Chairman: Could I put that question to the other organisations here today who have some relationship? Is it possible for you to give us some feedback on the full financial support which is received and the various ways in which it is received? That would be very, very helpful. Dr Kendall: The drug industry's relationship throughout all of medical education is a constant presence, even down to the Wednesday morning case conference. You will have a pharmaceutical company stand there and it is all around you. Q310 Dr Naysmith: We had some evidence a couple of weeks ago about clinical trials and the publication of the results of clinical trials and we have dealt with quite a lot of that already today. One of the things which was suggested was that there existed something called ghost writing in terms of pulling together the results of a number of clinical trials in various areas and that prominent academics would then put their names to a paper summarising this result and publish it. That struck me as most amazing. Have any of you ever come across that sort of thing happening: having clinical academics, usually in medical schools, who have not actually participated in the trials but only given their name to something done by somebody else, then putting their names on a scientific paper and publishing it as though they had been one of the main contributors to it? Mr Griffiths: I edit five publications and I know that all of the work we commission from authors comes from those authors. I am sure that ghost writing does happen. Q311 Dr Naysmith: Why are you sure that it does happen? Mr Griffiths: I am sure that it happens because at the end of the day academics are obviously judged on the amount of research they get out, the quality of the research. Q312 Dr Naysmith: That is the driving force behind it. Mr Griffiths: And there is a funding issue behind it. I do not think it happens to any extent in the nursing profession or at least not very widely. For most of the publications I edit I know the authors personally and I know that it comes in from them. Dr Nicholson: I do not have personal experience, but I know that two years ago there was a paper in the journal called Pharmaceutical Physician, which goes round to physicians working in the pharmaceutical industry, on the importance of choosing your ghost writer early and getting them well briefed on what the trials was supposed to be showing and how to make sure that your ghost writer handles the academics whose names are going to go onto the paper in a proper manner to keep them on side. Q313 Dr Naysmith: Did you say this was a published article? Dr Nicholson: Yes. Q314 Dr Naysmith: It would be nice to have a look at that. Dr Nicholson: Yes. Q315 Chairman: May I conclude with one question? All of you have made some critical comments about the industry in a variety of ways. I think we are all conscious that the industry plays a very important role in our economy and we are also conscious of concerns about increasing movement of the industry out of the UK, for a variety of reasons which I do not want to go into, but you will be aware of some of them. Do you have any fears that if we cannot act or recommend action on some of the issues you have pinpointed as concerns from your organisations, we may add to that process even further of losing the industry within the UK? Could a balance be struck without us losing the industry, addressing some of the areas you have raised? Dr Kendall: I suspect that you would need to have at least a Europe-wide approach to it. At the moment the different regulatory agencies are not properly synchronised, but they do all talk and they do share some regulations. Unless you did it Europe-wide there might be a risk. If a new regulatory framework could be agreed throughout Europe, it is an industry which is in need of pressures on what amount to massive profits. I am sure they could sustain better regulation and still make profit. Mr D'Arcy: We are the end of the supply chain and I made the point earlier that a key part of the tools of our trade are medicines which come from the industry. So a relationship with the industry is very, very important to us and critical to us. You are quite right that the industry on the one hand does do a lot of good. It provides medicines and Dr Heath gave the example of a peptic ulcer, which is a good example of how medicine has contributed to healthcare, made patients' lives better and reduced healthcare expenditure in secondary care. There are issues which face industry: no doubt tax regimes, animal rights issues are a big one which is a growing concern, the regulatory burden is there. The regulatory burden has to be there and we have to work within that. It is a difficult job balancing the commercial role and a healthcare contribution role and a balance does have to be struck. It is possible to draft this and make recommendations where the two can co-exist, to say that we do need the industry and we do need to recognise the good that the industry brings and certainly from a pharmacy perspective we need to work with industry, but we need to work with industry in a way which is credible, in a way which is objective. I think therefore that within the regulatory burden, or within ethical codes or code of practice, controls over there, we need to make sure that they are there to deal with these issues of probity. It would be a great shame if we took all of these issues. It is easy to go through a session like this and be very, very negative about everything and ignore the positive. It is about getting a balance and it would be a great shame indeed if we came to a conclusion and said that because there are loads of problems we need to diss the industry or rubbish the industry. What we need to do is to find a balance and one that works and deals with that effectively through controls. Dr Heath: The relative proportions that companies spend on PR and promotion and that they spend on original research seem to have got out of kilter. That must be something to do with the incentives which we are offering the industry and that seems to me where there is room for shift. Dr Nicholson: Two quick points. One is that the Department of Health has failed to help the pharmaceutical industry in terms of running clinical trials in this country. In particular the Central Office for Research Ethics Committees and what it has been doing and its failure to get hold of the R&D departments has meant that a lot of research is now going to other parts of Europe, which is why the Europe-wide approach may not work well because it is much cheaper to do the research in Poland or Hungary or even Croatia, countries like that, than it is in this country. The second point is that I wonder whether there is any way that one can produce some sort of moral pressure on the pharmaceutical industry to spend some of its time looking towards long-term interests rather than short-term profits. I suspect the pharmaceutical industry would look a great deal more pleasant in many people's eyes if they started making serious efforts to address that 90 per cent of the global disease burden which they do not address at the moment. Mr Darracott: You have had the King's Fund paper which I think is called Getting the Right Medicines. This is a personal view but there is a positive contribution in there for what might be done. It seemed to me that what the King's Fund was suggesting was that there was an opportunity for a grouping within the Department of Health or within government to look systematically at the whole disease burden. We recognise that at the moment there is investment in specific areas and that there are some neglected areas which are not being looked at which from society's point of view might be more appropriate to be looked at and we might want to look at them. The other thing the King's Fund did point out in that paper was that that sort of group could be a place where the public voice could be a serious part of what needs to be done as well. That paper does have some merits and could certainly be looked at. Chairman: On behalf of the Committee may I thank you for what has been an excellent session. We have learned a great deal and a number of you indicated that you would come back to us with further information on certain issues. I should like to thank you all for your co-operation with this inquiry. Thank you very much. |