SIR DAVID COOKSEY

24 JANUARY 2007

  Q40  Chairman: Were you disappointed?

  Sir David Cooksey: I was not disappointed because I was not expecting it. I think that whole—

  Q41  Chairman: Do you support the view that Dr Turner has just put forward, in terms of that?

  Sir David Cooksey: Absolutely. Just taking that a little further, it is very interesting that NIMR and the LMB at Cambridge are held up as two major examples of success in this area. LMB is embedded in Addenbrooke's Hospital and enables exactly the process we have just described to take place. I think that NIMR will benefit enormously from getting embedded into the campus where real patients are available right next door. From that point of view, I am all in favour of that type of move. Interestingly, the way in which the MRC funds those two bodies is on a quinquennial basis, without their going out to peer review on every single grant application. In other words, the researchers' teams that work in those institutions have a degree of freedom and a guarantee of funding which is much greater than your average investigator who has to rely on going to the MRC or to one of the medical research charities to get funding for his project or programme grant. As a result, the freedom to think across boundaries and to undertake more innovative research is actually much stronger in those institutions, and I think there is quite a lot to learn from that. You get the same sort of feel of what is going on at the Weatherall Institute, as I have just described, and I think that these biomedical research centres with quinquennial funding will find it much easier to make the right decisions in that area.

  Q42  Dr Turner: Clearly it allows them much more stability, allows them to take much more risk—

  Sir David Cooksey: Absolutely.

  Q43  Dr Turner: . . . and allows them to pursue longer-term objectives than the response-mode funding system allows. There is also the issue which you raise of the priority of different research areas. I do not have to tell you that there are fashionable areas that people can get into relatively easily and make a contribution, and others which are very much more difficult and virtually impossible to approach under the response mode, because there are just not enough handles to grip on. The obvious case is ME.

  Sir David Cooksey: Yes.

  Q44  Dr Turner: How do you view the relationship between funding or directing funding into unfashionable but necessary areas of research and areas which are fashionable, which are active, from which you do not want to withdraw resource either?

  Sir David Cooksey: This is why we proposed prioritisation. It is very easy to pile into popular areas, as you have just described, and sometimes one wants to give people the incentive to move into the areas which have a profound effect on human health or the economy. We need to ensure that we do devote sufficient resources to that area, to make as much progress as we can. I think we have to temper this with a real understanding that, whilst you might like to work solely on the highest priorities, one does not necessarily have the optimum resources available in this country in order to do that. You therefore have to look at this prioritisation against the capabilities that we have and also what is happening elsewhere in the world, so that one does not necessarily spend vast amounts of money in areas in which we can have a pretty good understanding that other people may get there first.

  Q45  Dr Turner: You also refer to the importance of small businesses in R&D initiatives. Technologies tend to be the most important here, I think, and also bioscience spin-outs, recognising of course that, as you have already said, the NHS is rather conservative in adopting new therapies or therapeutic technologies. What would you like to see put in place to ensure that (a) these R&D initiatives are better supported, and (b) the Health Service is much more proactive and effective in taking them up and applying them? Because more often than not these technologies are not only therapeutically effective, in the long term they also save money; so there is a double advantage in them.

  Sir David Cooksey: I could talk for an hour on this particular subject!

  Q46  Chairman: Please do not, Sir David!

  Sir David Cooksey: I would like to paint one or two bits of background in here. Clearly the theme running through this report is that this area—be it biotech companies, devices, or the delivery of all sorts of alternative therapies—is a prime knowledge-based industry and it is an area in which we can succeed if we get it right. However, we have to make it attractive for companies to set up and to develop new ideas in this country. What is very necessary to understand is that these companies can go anywhere they want to. It is clear that there is now only one major pharmaceutical company in the world that makes its decisions about where it carries out its clinical trials here in the UK. All of the others make those decisions elsewhere. That is very dangerous for us in terms of developing our industry because, unless we are prepared to make this a very attractive place to undertake clinical development of new therapies, the companies will go elsewhere. We look to the United States and see what is relatively a much more successful biotech industry over there. Yet the thing that came as quite a shock to me when we visited the National Institute of Health in the United States, and is mentioned in the report, is that the NIH is spending $4.2 billion a year on clinical trials. It is no wonder that their embryonic companies succeed over there, if they are having this huge input into the drug development process from the NIH. We do not have that advantage to anything like the same extent in this country. We really do have to create an environment that it is attractive. The things that will make it attractive are getting Connecting for Health right—this is absolutely vital—and making sure that there is good R&D access to it. That can enable us to get access to patients for clinical trials much more quickly than we do at the moment, and more successfully. Much more importantly, it will enable us to undertake the pharmacovigilance that is necessary during the evolution of a trial and in Phase IV, after the drug has been released, so that we can really understand the implications of that drug on a broader and broader patient base, and make sure that if there are problems they are identified earlier. This is why I rejected that remark about `skimping' earlier, because in fact what we are looking at is something which can make trials much safer, not less so.

  Dr Turner: We could pursue this all morning very happily—

  Chairman: But we are not going to!

  Q47  Dr Turner: One final quickie. Would you expect your Translational Medicine Funding Board to get involved and facilitate these processes?

  Sir David Cooksey: Absolutely, and that is fundamentally what it is for.

  Q48  Dr Spink: First, I apologise, because I should perhaps have declared an interest. My son is a neurosurgeon and therefore may be involved in these areas. Did you consider during your review, Sir David, the operation of NICE on translational research? Whether the operations of NICE can pull research through or make translational research less likely?

  Sir David Cooksey: The report has a considerable amount to say about NICE and about health technology assessment which is used in the NICE process, because we consider that this is a very important part about the development and evolution of new therapies. However, it does need to be involved in such a way that it improves the process rather than delays it, which is what it has done historically. In the proposals for a new drug development pathway, we suggest that NICE is brought in at the design of Phase III clinical trials, in order to make sure that we start to capture the information that they require as early in the process as we can. Obviously, the HTA will be involved in doing the assessment of that. We also suggest in the report that we can look at the prospects for conditional approval of drugs, so that they are released to defined cohorts of patients earlier in the process—if you like, part way through the Phase III trials—so that the patients that are most likely to benefit from them get early access to those drugs; but that, during that period of conditional approval, we also use the pharmacovigilance capability of Connecting for Health, or GPRD as an alternative in the short term, in order to identify any emerging problems. It also means that during the period of conditional approval, which I would anticipate to be 18 months to two years, you have got the drug out to an increasing number of patients; therefore, you get much better data from it and, by the time NICE has to make its decision, which will be at the end of that 18-month period, it has much more data, can make a much more positive decision, and has not inhibited the drug coming on to the market.

  Q49  Dr Spink: It appears to be eminently sensible thinking, Sir David. I want to address research careers. Do funding and career structures for clinical researchers need to change, in order to deliver the objectives that your review is seeking?

  Sir David Cooksey: If I might take you back a bit from there, the truth of the matter is that we have a number of holes in the training process, going back to first degree level. There are real shortages of clinical pharmacologists, biostatisticians and other, similar disciplines.

  Q50  Dr Spink: Could I just interrupt and say that in certain specialities there is an oversupply of people coming out at the consultant-qualified level compared to the number of consultancy vacancies they will be finding.

  Sir David Cooksey: Absolutely.

  Q51  Dr Spink: Will that push more people into research careers?

  Sir David Cooksey: The problem is you have got perverse incentives at the moment where people choosing a research career as opposed to a frontline clinical position take a penalty in terms of the financial rewards and also can easily—there is quite a lot of evidence of this—lose out in terms of the promotion prospects in their career advancement. It is no wonder with these perverse incentives that the number of people engaged in clinical research has dropped by a third in the last 10 years.

  Q52  Dr Spink: How do you think we should improve the incentives for people taking an academic research career rather than a clinical one?

  Sir David Cooksey: There are a number of initiatives which have emanated from UK Clinical Research Collaboration and from Dr Mark Walport's report on academic medical careers to try and improve that situation and put back the incentives in the system to make sure that this is an attractive option. That has got to be driven through. Also, we recommended—and this is one of these things we were talking about bringing into the ring-fence—that the monies which are available through the R&D function of the NHS to reinforce clinical academic careers are brought into the ring-fence so that funding is safe and is able to be applied for that purpose.

  Q53  Dr Spink: Were you happy with the involvement of the DfES in your review given that a number of universities are involved in medical research?

  Sir David Cooksey: The DfES had a fairly modest input into the review, but we did consult heavily with the universities' both at university body level and with individual universities. I think the review was characterised by a huge number of written responses, many of them from universities, but we also had a number of field visits to the universities concerned and discussed this at length.

  Q54  Dr Spink: Do you think there are any risks arising from transferring funding from clinical academic training into the NHS R&D budgets? Are there any risks in that?

  Sir David Cooksey: I think under the current leadership there is no risk, but it is always the concern that if you have a change in leadership there will be a change in priorities, and I think this is something one has got to keep a very close eye on.

  Q55  Dr Iddon: Sir David, we all know that the National Health Service is under financial difficulty at the moment, and your arguments put forward at the beginning of this evidence session for taking out the NHS R&D money into OSCHR resonate well in this Committee, but taking that money out at this critical time when we all know that budget has been raided all over the country, is that not going to destabilise the NHS even further, and how are we going to manage that process?

  Sir David Cooksey: I was not asked to investigate that per se, but let us look at it. The total spend is about 0.9% of NHS funding. The NHS funding has been increasing by seven and a ½% in real terms per annum over the last N years. It should be perfectly possible to find the 0.3 or 0.4% which needs to be shifted across out of one year's increased spending. It is a tiny proportion of the whole.

  Q56  Dr Iddon: Academics have got pretty big clout when it comes to claiming money for research to invest it in the institutes. The National Health Service clinicians do not have that clout, so by moving the NHS money into OSCHR are those doctors and consultants who are doing limited research within the National Health Service at the moment going to lose out?

  Sir David Cooksey: No. The money is bid for by OSCHR but it goes through exactly the same stream once it has been allocated as it does at the moment. As I said earlier, one of the reasons why we were insistent that NIHR is made into a real agency is in order that one can get a complete ring-fence around that and make sure that money is applied for that purpose and does not get siphoned off elsewhere.

  Q57  Dr Iddon: That is good to hear. The infrastructure for clinical research is not what we would want it to be, I am sure you would agree with that statement, do you think by creating OSCHR we are going to be able to improve our clinical research infrastructure?

  Sir David Cooksey: When you talk of infrastructure, could you be more specific?

  Q58  Dr Iddon: I am talking about buildings, obviously. NIMR are coming into central London, that is the proposal, so just improving the facilities in general for clinical research.

  Sir David Cooksey: I do think that particularly the university-based institutions have seen quite an improvement in their facilities. This is as a result of JIF and SRIF programmes and so on. I do not think it is buildings that are the main problem at the moment, it is actually in developing the research careers for the people who occupy those buildings and making sure they have got a secure base from which they can undertake this research which is the most important factor.

  Dr Iddon: There have been criticisms that your expectations of the Health Technology Assessment are over-optimistic. Would you like to answer those criticisms this morning?

  Q59  Dr Spink: Oh, no, they are not!

  Sir David Cooksey: Unless you are clear in what you want to achieve, I do not think you will ever achieve it. We have tried to raise the game as far as HTA is concerned. There is no doubt that there is a lot of value to be had from it, but what we have got to do in order to make sure that is delivered is to attract the right people into that process.