Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 407 - 419)



  Q407  Chairman: Colleagues, I welcome our witnesses to this morning's session. We are most grateful for your co-operation with our inquiry. I think you are aware that we have two separate sessions this morning, and we will try to keep each session to an hour each. We will keep our questions sharp and ask you for reasonably concise answers. Would you each like to introduce yourselves to the Committee?

  Sir Richard Sykes: I am Director of Imperial College.

  Professor Vallance: Patrick Vallance, Professor of Clinical Pharmacology and Head of the Department of Medicine at University College.

  Sir Iain Chalmers: I am Editor of James Lind Library and one of the co-conveners of the James Lind Alliance, which is a coalition of patients and clinicians trying to influence the research agenda.

  Q408  Chairman: Professor Vallance, I gather you have just got off a plane from America. We do appreciate you coming here in those circumstances. Sir Iain, you suggest in your evidence that the pharmaceutical industry has a perverse influence on the clinical research agenda, and you also criticise publication bias by industry. Could you expand on these observations and perhaps give us some examples of how you feel patient well-being is being affected by these concerns?

  Sir Iain Chalmers: If I could start with an example to make a general point: some researchers in Bristol a couple of years ago asked patients with osteoarthritis of the knee and the people caring for them—physiotherapists, rheumatologists and general practitioners—what unanswered questions they would like to see addressed in research, and the answers that they came up with were things like better evaluations of surgical options, better evaluation of physiotherapy, and better evaluation of ways of coping with a chronic, painful condition. When the researchers compared the questions which these patients and professionals had indicated as important with what had been studied in osteoarthritis they found that very few of those questions had been addressed. Rather, yet more placebo-controlled trials of non-steroidal anti-inflammatory drugs were being done. All of the focus groups of patients and clinicians said, "we do not want any more studies of drugs, of pain-relieving drugs." That is just one example of the way in which research agendas can be distorted by the interests of industry. In fact, in this week's BMJ there is a report of acupuncture for osteoarthritis of the knee, which is an example of the sort of thing that industry has no interest in at all. So, there are inappropriate questions being addressed in research, or inappropriate from the point of view of patients and clinicians. In addition inappropriate comparators are sometimes being used. For example placebos are being used as comparators when there are already effective treatments, and sometimes inappropriate outcome measures are being used. From a commercial point of view there may be reasons for doing these studies, but they are not necessarily serving the interests of patients and clinicians, rather than shareholders. There is also the problem of the academic influences on the research agenda, some of which I regard as perverse. In this country, one of these is the Research Assessment Exercise, which is done to decide how much of the science budget should go to support particular universities. Within that system there is no encouragement to review systematically what is already known from existing research, before ploughing ahead and doing new additional studies. There is discouragement of collaborative research, which is often necessary to obtain robust evidence about the effects of treatments. People in particular institutions competing for resources see collaborative research as a threat because it submerges the identity of the institutions, and does not give individuals in institutions the prominence which they think they require. This encourages academics to do small-scale, often poorly-designed, studies. The other, often perverse influence there has been growing encouragement of academia to attract for income-generating research. Take a trial funded by the NHS R&D programme or the Medical Research Council. There may be a certain sum of money to support the recruitment of every patient in the trial, but industry sometimes can offer a bounty for each patient recruited of thousands of pounds. Clearly, people who are wanting to make income for their academic institutions, or indeed their hospitals, may find it difficult to support a study that is addressing an important question (of no interest to industry) that is funded by the MRC or the NHS R&D programme. Those are the perverse incentives that I believe exist. You asked me about the problem of publication bias. This is a very serious problem, and one that I have been wittering on about for well over a decade. I am very glad that Sir Richard Sykes is here at this session, because I want to give credit to those people in industry who, way back in the mid nineties, said that this was unacceptable behaviour. Richard Sykes and his colleagues within GlaxoWellcome did that, so also did Mike Wallace, the Chief Executive of Schering Healthcare. It is quite unacceptable that people should be invited to participate in clinical trials, and then, when the investigators or the sponsors do not like the results, their contribution is not made public. It is a very, very serious problem.

  Q409  Chairman: Can I ask the other two witnesses whether they feel their institutions or research groups are influenced in similar ways by the industry in some respects; and, if so, how?

  Professor Vallance: I can answer from my own institution. We get a small percentage of our total research income from industry, and it is about 2% in total of research income.

  Q410  Chairman: Where does the rest come from?

  Professor Vallance: From the Medical Research Council and major charities like the British Heart Foundation. Currently 2% comes from industry. We are probably unusual in that in terms of having a very high percentage of peer-reviewed grant funding. But there is no question that what Iain Chalmers says is correct; that industry will of course pursue drug-related research over and above other kinds of research. The question is, to what extent that distorts the ability to undertake other types of research. One of the problems is that a rather small percentage of patients are involved in clinical trials and there is huge uncertainty in healthcare. There is capacity in the system, but it is not used. I remain concerned that we have not got the capacity issues right, or the infrastructure right to undertake more studies. It does not surprise me that industry will want to pursue studies of interest to itself.

  Sir Richard Sykes: Our research budget is £200 million a year; and £20 million of that will come from industry. That is the biggest industrial funding of any university in the UK. Most of that, of course, is in the physical sciences and engineering, not in medicine. However, we live in a knowledge-based economy. The knowledge base is university-based, and we want industry to work alongside universities. If we are going to be competitive in this country, then we have to use our knowledge, our creativity and innovative skills. Therefore, the universities have to play a very important role in that, and we have to have translation of research in healthcare or other areas because that is the fundamental basis now of being competitive. We have to use our knowledge base.

  Q411  Chairman: You do not feel that that relationship with industry has a bearing on the objectivity of the work that you do?

  Sir Richard Sykes: I think it has to some extent, but again—

  Q412  Chairman: In what way?

  Sir Richard Sykes: In the way that we have heard already, that industry will want to come in at the front end, doing clinical trials; they will also want to invest in certain types of research. Of course, the academics themselves will not get involved in that research if they do not believe it will benefit them at the end of the day, so how it manipulates is difficult to tell. Certainly, big clinical trials in patients related to the hospitals are certainly being done to generate money. We are being driven to generate money, otherwise we would not be competitive in the world.

  Q413  Dr Naysmith: This is really a question to Sir Richard. I agree with what Sir Iain said, and we are really pleased to have someone who has been at the top of scientific research and one of the country's major companies. We suspect that you will be able to give us quite an insight into what goes on if we can discover the right questions to ask. One of the most important questions facing this Committee in producing the report is to try and find the right balance, if there is one, between business and trading and health priorities and between marketing and evidence-based clinical practice. I am sure you would agree that that is something we all want to do. As I have just said, you have experienced both sides. What do you think of this conflict? How do we get the right balance? You have partly touched on it, but as a more global thing?

  Sir Richard Sykes: I think we have carried a lot of baggage from the past, and somehow we have to recognise that those days have gone, or at least they are going away. We have to look forward. If we are going to deal with some of the big problems in healthcare today, it has to be a partnership between the academic face, the research base, the industry, the NHS. We have to work together to solve some of these big problems. I believe that this has got to be a collaboration today, not a group here, a group here and a group here, and it is all "them and us". That method will not work.

  Q414  Dr Naysmith: How do you get rid of this conflict between trade and health, and how do you make sure that they work together?

  Sir Richard Sykes: I think you need a lot of transparency. As Iain said, you need to be transparent, and you need to make sure what everybody is doing, and that the information is there so that we can all share with it and deal with it, rather than having things hidden—"if we do not like the result we put it away and do not tell anybody", which is totally inappropriate. Transparency is particularly important.

  Q415  Chairman: Do you see there is any way of squaring up that transparency with a market system where there is this obvious emphasis on the need to create profits and business incentives; and on the other side the health policy? Do you see that can in any way actually be balanced out so that you can have transparency and also a commercial market operating, which is what the companies clearly want?

  Sir Richard Sykes: I do not think there is any conflict at all. If you produce good medicines, whether they are diagnostics, whether they are treatments, whether they are palliatives, curatives, preventatives, whatever they are—if they benefit somebody in society, we should all be very happy. That is the objective at the end of the day.

  Q416  Dr Taylor: The phrase "commercial confidentiality" is thrown at us all the time. How do you square that with transparency?

  Sir Richard Sykes: There are certain areas where, at the beginning of the research process, there has got to be a degree of confidentiality in terms of intellectual property. Once that intellectual property has been achieved the whole point about intellectual property is to make it available to everybody so that everybody can see what you are doing.

  Q417  Dr Taylor: How early in the process should that be done?

  Sir Richard Sykes: As soon as you have got the intellectual property filed.

  Q418  Dr Naysmith: How do you resolve the conflict that Sir Iain referred to, where you have the situation where people who are suffering from an arthritic condition would much more benefit from physiotherapy or something like that than from another painkiller and another anti-inflammatory, and the companies just put the money into that?

  Sir Richard Sykes: If the doctors continue to prescribe analgesics for treating these diseases, so that the market—I do not know what it is today, but it must be billions of dollars for these kinds of drugs—then what do you expect the market to do? They respond to it. That is what I am saying: people have to work together. If you are talking about osteoarthritis, the first thing you need is a diagnostic, because it is a nightmare to decide whether somebody has osteoarthritis or not.

  Q419  Dr Naysmith: Where does the transparency come in, then, because you were just following down that because it is the job of companies to generate profits as well as to generate—

  Sir Richard Sykes: They cannot generate profits if nobody sells the drug. The companies do not sell the drug to the patient; it is the doctor—the gatekeeper.

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