Select Committee on Health Minutes of Evidence


Examination of Witnesses (Questions 659 - 679)

THURSDAY 13 JANUARY 2005

MR EDDIE GRAY, DR STUART DOLLOW, MR CHRIS BRINSMEAD AND DR JOHN PATTERSON

  Q659  Chairman: Good morning. Can I welcome our witnesses and express the Committee's appreciation for your co-operation with our inquiry and the written evidence which you have supplied. Can I ask you each briefly to introduce yourselves.

  Dr Dollow: I am Stuart Dollow, the Medical Director for GlaxoSmithKline in the UK.

  Mr Gray: I am Eddie Gray, the General Manager for GlaxoSmithKline in the UK.

  Mr Brinsmead: I am Chris Brinsmead and I am the General Manager of AstraZeneca in the UK.

  Dr Patterson: I am John Patterson and I am Executive Director of Development for AstraZeneca.

  Q660  Chairman: Can I begin by asking a question, which in a sense is at the heart of this inquiry, which is achieving the balance between the commercial imperatives that you people have to work to and the business issues that you have to address and the wider public health concerns that we have had put to us during the course of this inquiry. I am sure that you will probably have looked at some of the evidence that we have had so far and understand the kind of tensions that we are addressing: that, from a public health perspective, the concerns occasionally that the public health interest is not served well; concerns on the other side that obviously you are a major, a key player in the UK economy and a very important employer of very many people. How do we achieve this balance that kind of is at the heart of the issues we have addressed in this inquiry?

  Mr Gray: I think we would agree, Chairman, that it is a difficult challenge. My instinctive response would be to say that actually it is a focus upon the patient which should be the guidance for us all. I think absolutely the approach that I would hope would come out of an inquiry such as this and other aspects of health is a recognition that I think healthcare is a shared challenge. I think it is something in which everybody has a role to play; we do, not the most important role, but we do have an important role to play. I have to say that I have been pleased that there is a kind of acknowledgement throughout the inquiry you have held so far from many of the witnesses that even though they may not agree with us on every single point, they do recognise that there is an important role for the industry to play. I think clearly there are wider challenges in that issue of shared health and those which are perhaps most pertinent to the industry, I think, are to do with the issues of treatment, but also I think increasingly as society moves on and as we do, thankfully, conquer some diseases, the issue of preventative health and how we get that balance right going forward. I think for us as an organisation we, within that framework, would look at the whole issue of how do we approach that healthcare challenge where prescribing is an appropriate response to achieving the appropriate prescribing in each individual patient's case. I think if, as a collective in that shared challenge, we can target that and we can all agree that that is the target and we can build a system which I think incorporates many of the other threads which have emerged out of the inquiry, the kind of changing expectations, which I think we do sense quite strongly around things like public access, scrutiny, transparency, et cetera, and build that in a way that ensures that all the people who have a role to play can be, for want of a better phrase, adults in that environment, then I think we will be very successful. I think the danger is to think that if people have issues with the current situation, the conclusion, therefore, should be to exclude one player going forward in some way because I do not think that would benefit patients at all. I think certainly from a GSK point of view, and we have followed the inquiry very closely, we do have what we believe are some positive recommendations to add to those we have already submitted and hopefully at the end, Mr Chairman, you could give us an opportunity to contribute those.

  Q661  Chairman: I am sure you will want to make those points as we go on with some of the questioning?

  Mr Gray: We will try to do so, yes.

  Q662  Chairman: Does anybody from AstraZeneca want to add to that?

  Dr Patterson: I would like both to echo, Mr Chairman, what Eddie Gray has said, but also to add one or two things of my own. I am a physician by training. I joined this industry 30 years ago and the reason that I come to work every day along with my 60,000 colleagues in AstraZeneca is because we believe that many of the objectives of public health are shared by ourselves. In fact we are not working in the opposite direction in terms of treating disease and preventing disease wherever possible, so it is the desire actually to find new medicines and improve public health that makes most of us excited and interested in coming to work every day. Yes, we do it in a commercial environment, but that does not necessarily put us at odds with the Government and there are lots of good examples where the Government's priorities, the key areas, whether it is coronary heart disease, mental health, are exactly in line with our priorities for developing new medicines. Something like just under half of the new medicines introduced in this country in the last 10 years fit with those key priorities that the Government has expressed.

  Q663  Chairman: So with your medical background then and your past experience, do you feel that the balance that I referred to is struck about right at the present time or should it be shifted in one direction or the other from your own standpoint?

  Dr Patterson: I do not think there is a balance at the moment. I think in the last two or three years things seem to have gone completely out of balance in terms of public perceptions, in terms of people taking some seemingly very polarised stances in these areas, so I think it is useful to have a discussion about where the balance should stand. We are going through a period of dramatic change, a dramatic desire from patients and the public for more openness than there has been previously, a desire for perhaps the risk:benefit ratios to be different from how they have been perceived previously, and I think it is time to have an open dialogue about those kind of things and see how we can work together going forward.

  Mr Gray: I would just support that point. I was particularly struck in one of the previous hearings that you had when there was a phrase, I think, from Sir Ian Chalmers who was talking at the time about access to clinical trial information, which I think is what he was talking about at the time. He talked about the current situation not being consistent with 21st Century public values. I think within the industry I support John's comments and I think there is a feeling that actually the expectations have shifted quite quickly and quite significantly and to some degree trying to catch a train that is already moving is the kind of experience that most people would feel some commonality with.

  Q664  Mr Jones: I was going to raise this later, but, Dr Patterson, you just spoke about the balance having moved very rapidly in the last couple of years. Could you reflect on why there has been that change and why it is not a change which is peculiar to the attitudes that people have of the pharmaceutical industry in this country? I note from a poll conducted in America that confidence in the industry and the public perception that the industry is doing a good job has fallen from 79% of the public in 1997 to 44% of the public now, a huge change in a very short period of time and the conditions in the United States would seem to be very different from the conditions in this country, so why?

  Dr Patterson: I do not know that I have all the answers, but I can try and give you my own perception. I think health has become a much, much greater topic in the media than we have ever had previously. Every time you turn on the television or the radio, even the major news programmes are covering significant health issues, so it has become a much more public topic than ever previously. There is a tendency of course to polarise and things are either, certainly from our perspective, wonder cures or killer medicine and there is very little seemingly in the middle. Therefore, every time something happens in our world, a new medicine is introduced, there is a huge media outburst, shall I say, associated with it and, equally, when something happens with one of our medicines, that is also very much more public than it ever used to be. One of the issues that we face is that as we bring very effective, modern, potent new medicines to the marketplace, inevitably we are starting to see more evidence of issues of tolerability and side-effects. It is certainly true that as you innovate, you do not always know from either the laboratory work or from the clinical trials exactly what the profile of the medicine is and we have had a number of high-profile failures as an industry over the course of the last few years which have been very, very visible in the public domain, particularly as they got picked up often early in their life and perceived as being the next panacea, if you like. There is a more rapid rise and a more rapid fall going on than we have ever seen previously and these issues have been debated and people are not well versed, as we know, in many fields in talking about relative risk, so when there is an issue with tolerability of a product, to try and put it in the context of how many people are dying of that disease and what the current problems of that disease are does not always fit well with the 20-second soundbite on television.

  Q665  Chairman: What you are saying then, Dr Patterson, in a sense is that perhaps the increased media awareness of, and interest in, health has a bearing on your industry's image. I was going to move on to one or two comments that we have picked up on perceptions of the industry's standing. There was somebody from Mr Gray's company who was quoted in a conference recently who likened the industry's standing to that of big oil or big tobacco firms, and I think you may recall that reference. Richard Sykes said to our Committee when he gave evidence that the industry is getting, "a very bad name, possibly because of its competitive nature". Now, the impression that Dr Patterson is giving us is that perhaps this is an unfair image and these comments arise very much because of the media's focus on health, but is there some justification for this image and one of the reasons for the image that appears to be one that is fairly widespread?

  Mr Gray: I think John makes a valid point about the publicity and the impact that has and I think he does make an extremely good point around the concepts of risk and benefit. If I can simplistically put the position, society's attitude is, "This is a complex area. We'll let the scientists sort it out", and increasingly as society has found that to be unacceptable and started to want to peer in the box and scrutinise, then some of these issues have come to the fore and at the moment I think that the kind of science view of risk:benefit and the public view of risk:benefit is a very different one. I think there is a lack of understanding and I think it is natural human nature, when you do not understand, to be suspicious and, therefore, to mark things down.[14]

  Q666  Chairman: So to pick up that point and your point earlier on about engaging with the patients, what you are implying is that people need to understand more about the industry, but I would come back and say that perhaps the industry needs to be more transparent, so how could it become more transparent and more engaged with the people it serves?

  Mr Gray: I think in terms of what I was trying to say earlier about a kind of moving train and trying to catch that, I do not think I would argue about that as a direction. I think it is how we balance that movement against the fact that the situation is not any less complex than it was, so we are having to do that in an area that remains. It is still science and it is still the balance of risk and benefit that has to be assessed, but I do not think I would argue with that. I think a positive thing is that having realised that that train is on the move, we have started to respond, so I think the most obvious example of that would be the clinical trial registers, et cetera, and it is a little disappointing that that then gets reported as some kind of PR exercise when I actually think it is a genuine attempt to respond to this kind of new expectation and agenda. I think as a broad principle, how do we move forward, improving the kind of transparency and scrutiny, but doing it in a way where actually we can still arrive at good public health patient-centred risk:benefit balances absolutely is the broad challenge and doing it in a way which allows the industry to be an adult in that and play its role, not that the only way is to exclude it in some way or fence it off, I think that is the challenge, I would agree.

  Q667  Dr Taylor: Can we move on to information and the promotion side. The industry has got codes and standards that relate to the control of the quality of drug promotion. Are there any controls on the quantity of drug promotion? Witnesses have told us in other sessions that whereas research staff in companies are only increasing very slowly, marketing staff are increasing extremely rapidly. Have you any comments on that? Are there any controls on the actual quantity of promotional material you can use?

  Mr Brinsmead: I think the first thing to say is that if they are talking about the number of people employed in research and development and marketing, in our company, broadly speaking, those numbers have remained broadly consistent over the last sort of five to 10 years, so I am not sure that would be true for AstraZeneca. In answer to your question around the amount of promotion, the quantity as opposed to the quality, there are limits on that both in the code and in companies, so, for example, the number of times that we can visit a general practitioner in a year is prescribed by the code, so we do not have any limits, as far as I am aware, on the amount of material that we may provide, and the material provided would obviously be down to what material you need to provide to explain the disease and some of the ways that the product works.

  Q668  Dr Taylor: So the number of visits to a particular general practitioner is limited, is it?

  Mr Brinsmead: Yes, it is, by the code of practice.

  Q669  Dr Taylor: And the amount of money that the representative can spend on hospitality, is that limited too?

  Mr Brinsmead: I think, talking about the question of hospitality, we would only provide any hospitality if it was in association with a scientific or an educational meeting, so to give an example, it may be that a sales representative would have a meeting with some GPs at lunchtime and in the case of our own company, we would limit them to spending no more than £10 on the sandwiches and drinks that they would provide at that meeting for the GPs, so yes, there is a limit, but I would make the point that hospitality is really just secondary. The purpose of the meeting is to talk about the medicine and how it might be used.

  Q670  Dr Taylor: Any other comments?

  Dr Dollow: Maybe I could give a bit of context about the development process because I again would echo Mr Brinsmead's comments that the number of medicines in development in GSK has increased rather than decreased, so the R&D expenditure we expect to have increased, so although I do not have exact figures, I do have figures on the number of medicines in the pipeline which has increased since the time of the start of GSK. At the moment GSK spends 40% of its R&D in the UK, about £1 billion, and 6,000 employees are working in R&D in the UK. Additionally, we recognise that many of the products which are coming through in our pipeline actually have a very high attrition rate, so only one in 10,000 of the compounds that are synthesised will get to the marketplace to be medicine and only one in 10 that gets into man will be a medicine, and I think that is an important one to remember as well.

  Q671  Dr Taylor: So that is your firm—6,000 in R&D?

  Dr Dollow: That is correct, yes, in the UK.[15]


  Q672  Dr Taylor: How many in marketing?

  Mr Gray: In marketing, maybe about 120 or something like that, 120 or 130. There is one other point, if I may, or viewpoint of this which I think is worth thinking about and that is to kind of put the position of activity and promotion within the context of what actually seems to be happening within the UK as a health service and if I look across that big picture, then I see the rate of generic prescribing at 78% and a target of 85, and I see the uptake of new medicines generally being one of the slowest in western Europe, and acknowledged by everybody as being the case. The last time I appeared before this Committee it was about NICE and one of the recommendations was about implementation because NICE was making recommendations, so here it is effective and safe and it is cost-effective to the National Health Service and we still cannot get it taken up, so the broad picture would not suggest that the level of promotion is bracing things away in any one direction. The big picture tends to suggest that the checks and balances are working pretty well.

  Q673  Dr Taylor: Is it because we in this country are slightly more cautious than other places?

  Mr Gray: Well, I would take your advice, as a medic, on that!

  Q674  Dr Taylor: Witnesses in previous sessions have suggested that some drug firms are guilty of having a drug and actually looking for an illness, an extra illness for it to work on. Are there any comments on that?

  Dr Dollow: Maybe I could respond to that. For any medicine to be approved, it has to be treating a valid condition, so any condition that we seek to investigate has to be a condition that is recognised internationally, otherwise the regulators will not approve it. I do not recognise the fact that people are suggesting that we are inventing diseases. That is not something that we would do. Any medicine that we have which has an indication is certainly related to an indication which is well recognised by the medical community.

  Q675  Dr Taylor: We have got here two of the largest and, hopefully, most reputable firms. Do you think any of the other ones are trying to popularise an illness among people so that one of their drugs would be used more? That is the sort of thing people have suggested to us.

  Dr Patterson: Can I come in on top of what Stuart said. There is, first of all, a licence and anything that any company sells has to be within its licence, otherwise it is breaking the law, and those licences are given for specific diseases which are usually within what is called "ICD", the International Classification of Diseases, so they have to exist to get a licence. Now, it is certainly true that in order to make it more acceptable sometimes for patients to talk about their disease, we may give them a nicer name as an industry, and I will give you an example. No male around this table, I am sure, wants to say, "I've got impotence", but by calling it "erectile dysfunction", it has become a little bit more acceptable, but we did not invent erectile dysfunction; impotence has been there for centuries and is a considerable issue for many people. It is maybe part of the semantics of giving it a nicer name, but you cannot invent a disease against which you promote a medicine in this country because we have licences.

  Mr Gray: I think in watching all the tapes of the earlier hearings, this is perhaps the kind of thread of questions which has actually left me most confused, if I am honest, and I think that there has been a degree of confusion as to what are the kind of accusations, so to speak. I think this one about inventing diseases has been answered and I will not touch on that, but the other one has been this idea that it is the industry or certain members of the industry in some way trying to kind of expand the criteria by which patients gain inclusion. I think clearly there are separate conditions, if I look at the ones that we are involved in, where the symptomatology is clear and either you have this disease or you do not or there are well-established tests for asthma, et cetera, to test lung function, et cetera. I think the other thing which is changing a lot now which again is important is that the National Health Service itself, either through national service frameworks or through the GP contract, is actually setting the target and the standards which apply, so if I think about Type 2 diabetes, for example, within the GP contract they are targeted to have all Type 2 diabetes patients at 7.4%, so there is absolutely no credibility whatsoever in me going out and arguing that it should be 5%, so I think there is again in the way in which individual disease comes forward to a doctor, supported now by things like NICE guidelines, NSFs and GP contracts, et cetera, clearer definitions than there have ever been as to what constitutes an individual condition.

  Q676  Dr Taylor: Can you give us any idea of when a major drug is invented and discovered for one particular illness and quite legitimately it is discovered that it has actions on other things? I am thinking particularly of the hypotensives that were discovered to work well for prostatic hypertrophy. Have you got any idea of the sort of proportion of money your firms make from the big blockbuster discovery as opposed to the sort of creeping growth on to the other indications?

  Dr Patterson: Perhaps I can try and answer that, not quite in the terms you put it. Most medicines get into the marketplace for a licence in a single indication. We then continue to work with that product throughout its life cycle, often looking at new indications, new formulations, new ways in which it can be of value to patients. It is quite common for medicines to be used ultimately more in an indication that was developed later on. An example would be the angiotensin-converting enzyme, the ACE inhibitors, which started off as anti-hypertensives and then went into heart failure where they are used fairly uniquely and are successful. Our job is to continue to do that and, for instance, this year on a global basis AstraZeneca will spend about 40% of its total clinical development budget on actual life-cycle management of products that are in the marketplace, so it is very common for us then to look at the indications and we have to do that into special groups who are not indicated in the first licence. There were papers, I think, in The Lancet at the end of the 1990s which showed that something like half of the top 20 medicines in the world are actually being used more for indications that came after they had been put in the marketplace than their first indication, so it is an ongoing process. We live with these products for the whole of their life cycle to the point where they go off patent and disappear or are superseded.

  Q677  John Austin: I was tempted to ask Mr Gray if there is any empirical evidence that watching tapes of proceedings of this Committee might be a cure for insomnia! My real question is directed to Mr Brinsmead because in your marketing campaign for Crestor entitled "Right First Time", you mention the desire to exploit the emotions of prescribers. I wonder if you could explain that and perhaps describe other means of stimulating the use of your products.

  Mr Brinsmead: Perhaps I can just take a step back and say that heart disease and problems like that are a government priority and clearly having a high level of lipids is something that the Government and doctors and patients want to reduce because you can prevent heart attacks and strokes, so we are very proud that we have a statin called Rosuvastatin, which we brought to market a couple of years ago that does this more effectively than the statins that are already in the marketplace. Now, if you think about why people make a prescribing decision, well, they will make a decision on a rational basis and they will think about the data, they will think about the patient in front of them and what this patients needs to do. However, doctors are also human beings like anybody else and they have feelings and needs and what we find in the emotional sense is that it is important that we understand how people feel so that we can actually make sure that the messages we give them are appropriate. If I gave you an example, if someone was saying that they were feeling a bit cautious, a bit uncertain, and we talked earlier on about whether English doctors were perhaps more cautious than their counterparts in other countries, then it is important that we make sure we provide all the tolerability data and the safety data to try and address that feeling. I think the emotional aspect of the marketing is particularly important.

  Dr Patterson: I think there is an emotional reaction in this country against using new medicines. The Government's own figures show that in things like coronary heart disease, only a small percentage of the patients who should be receiving those kinds of medicines are doing so, so you have to look at what it is that is part of the decision-making of that doctor and appeal to the relevant senses.

  Q678  John Austin: I can understand the desire of companies to get new drugs on to the market fast, but I think from something Dr Patterson said earlier, should we not be concerned about the intensive promotion of new drugs which typically follow the launch of a new product when we are not really sure of the side-effects or long-term effects of the use of that drug?

  Dr Patterson: I think all new medicines carry potential risk because new medicines are effective and they hit pharmacological systems, some of which we do not fully understand. I think it is very important though that we, as an industry, who have spent the last 10 or 11 years developing those medicines, are the people who can carry that information in to the doctors and allow them to make an informed decision as to how that new medicine might fit into their therapeutic armamentarium compared with something they have been using previously. The issue that you raise is the intensity with which we do that and I am not sure on what basis we are saying that we are any more intense than we used to be in that activity. I think we often have more data, so if you take the medicine we are talking about here, whereas when I first started working in this industry at the most 1,000 patients would be treated prior to a licence, while with Crestor we had something like 30,000 patients treated in clinical trials before we came to the licence, so we knew a lot more about it than we did with medicines coming in 10 years ago, so there is a lot of data and a lot of information to be shared, all of which did not exist in the textbooks when those doctors were trained and none of which are pieces of information that they will have seen previously or the people whom they work with in hospitals will have seen previously, so we have to carry that information and that requires some kind of a process for getting that message across.

  Mr Brinsmead: Sadly, in this country only about half of the people who should be treated and achieved the levels that the Government's targets stated, only about half of the people treated reach those targets, so there is a positive outcome of intensely promoting a new medicine and that is if you can actually prevent more people having heart attacks and strokes, that must be a good thing. The other thing I would like to say is that there is the Black Triangle system in this country whereby all new medicines have a black triangle and that is an indication to the healthcare professionals that if they see any side-effects, they must be reported to the regulatory authorities, so there are ways with a new medicine where the safety of the patients and the safety of that particular medicine are picked up through that system.

  Dr Patterson: And the data show that Britain is still the slowest to take up new medicines in Europe. We take up new medicines at about the same rate as Croatia, so again we may be being intense in your eyes, but the reality is that the speed of uptake of new medicines in this country is slow.

  Q679  John Austin: Could I go back to the issue of Crestor. In July 2004 you developed a PR campaign to reinforce the positive risk:benefit profile of Crestor when a month earlier, in June, the MHRA had issued new prescribing advice for the 40mg dose and a revised pack insert had been introduced presumably because there was more awareness of risk. Why, a month after that was identified by the MHRA, did you have a positive PR campaign to reinforce the positive risk:benefit?

  Mr Brinsmead: Well, let me talk a little bit about that. I think the fact is that as we launched Crestor and as we got more experience in the marketplace, it became clear to us that the drug was not always being used appropriately at the correct start dose and we actually had a series of campaigns, not just the PR campaign that you refer to, but also we worked very closely with our sales team and very successfully to make sure that the drug was used at the correct start dose. I do not think that there is any negative implication of having a PR campaign aligned with a change to the prescribing information of the MHRA. I think it is important that we, as a company, when we get the information on the drug when there is a change, we make sure that we tell people about that very, very quickly.

  Dr Patterson: We are actually very proud of that campaign because the start dose for Crestor has always been 10mg in this country and quite a significant number of patients, who are often patients who are having side-effects from other statins or failing to get control, were being put on by doctors at higher doses than 10mg, so exactly in line with the agreement with the MHRA, we actually went out with that campaign and made sure that people started at 10mg and we have reduced the percentage of patients on the higher doses in this country by a significant number, and we can show you the data, as a result of that campaign. PR is not always bad, sell, sell, sell, but PR can actually be about the proper use of the product in the right circumstances for better patient safety.


14   Note by witness: "mark down" is used in this context to mean to view negatively, rather than simply to take note of. Back

15   Note by witness: The figure of 120-130 refers to GSK's UK Operations, ie those involved in marketing to the NHS. Back


 
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