Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 500 - 515)



  Q500  Mrs Calton: Earlier you said that Cancer Research UK would always publish the clinical results of the studies.

  Mr Kumar: We insist on publication. Sometimes, where we fund academics in universities, given that we do not employ those people it is not possible for us to absolutely force them to do it ,if they have other priorities. We can put pressure on them to do it but the terms and conditions are that they must publish.

  Q501  Mrs Calton: They must publish all parts of all studies?

  Mr Kumar: Everything, yes.

  Dr Taylor: By making publication a condition of approval, we remove the grey area and I hope that is a recommendation we will come to.

  Q502  Jim Dowd: Has anybody ever resisted that?

  Mr Kumar: If they do we do not fund them, but I am not aware of anyone.

  Q503  Chairman: Dr Boyce, on the issue of patient involvement, we were interested in Australia to see more patient involvement there in the research and approval process than we have here. I wondered how could the conduct of medical research be improved in terms of patient involvement and consent to the publication of the data obtained from all clinical trials? Have you any thoughts on this?

  Dr Boyce: Yes. The problem with the trials that we do is that the subjects are mostly healthy volunteers. By the time we get the results, we have lost contact with the subjects. Many of them do not want to know the results. That may seem strange but they do not. There are requirements within the European Clinical Trial Directive which encourage researchers to give their results to the research subjects. There is already the concept within the legislation—and as you well know the Directive is law—to encourage subjects to have access to research information. In the very early clinical trials, often the results do not mean very much to a healthy subject unless they are interested in the science or the medicine.

  Dr Solari: The MRC has an active policy called "Science in Society" which is to enhance the public's engagement in medical research, in clinical trials and health practice. We are very active and we commit a certain amount of our funds to trying to engage the public in a greater awareness of how medical research is performing.

  Q504  Chairman: Have you looked at examples from anywhere else in the world? We went to Australia specifically but I am sure there are other countries who are engaging with patients in a way that maybe we are not sufficiently.

  Dr Solari: I would have to check with the office.

  Mr Kumar: For all of our late phase trial work, that is carried out as part of a partnership through the NCRN, for all cancer trials. There is a very specific consumer liaison group that is involved in the design of all those studies and the initiation of several of them.

  Q505  Mr Bradley: Mr Kumar, you say there is a lack of industry funded research into studies that might identify the specific patient who might benefit from a treatment. Can you explain what the problem is, how it has arisen and how it can be solved?

  Mr Kumar: The problem is that the vast majority of drugs will typically benefit only a subset of the population who receive them. Historically, we have not had the technology to be able to distinguish between the patients who would best benefit from a particular treatment. I believe the technology is now there. It is still in its infancy but nevertheless it is there. Within CRUK, for instance, we are now initiating what we call translational studies on all of our clinical trials to try to determine as much as we can during the course of the trial about the specific subsets of populations that will specifically benefit or not benefit, or who may have adverse reactions or not have adverse reactions. You will see an acceleration of this over the coming years. The problem with respect to pharmaceutical companies is that the corollary of that is that it is a reduction of market size. There is not necessarily the incentive for pharmaceutical companies to do that, although it is not absolutely as black and white as that. Sometimes, if you can absolutely pinpoint the patients who will benefit, you have a greater chance of getting that drug to market. We would advocate a partnership between the NHS, the pharmaceutical industry and organisations like ourselves to carry out these studies because, from the point of view of the Department of Health or the NHS, there will be savings on the drug budget if we target the treatment to the patient who will most benefit.

  Q506  Mr Bradley: Presumably you have had discussions on those lines. What sort of reaction have you had to that proposal?

  Mr Kumar: The pharmaceutical companies we talk to are increasingly waking up to this as a necessity. I think we are pushing against an open door.

  Dr Solari: From my experience, having worked in the pharmaceutical industry for about 12 years, the right drug to the right patient is a concept coming out of improved genomics and molecular biology. We are not there yet. I think it is still a wish and we are still many years away from that. I think the pharmaceutical industry is very aware of this and is investing a great deal of money. The jury is still out though on whether it will fracture markets and decrease their profit margins or whether it will create new opportunities for them. Until these technologies have really matured, I do not think it is clear which way it is going to go.

  Dr Boyce: A large proportion of the early clinical research on potential new medicines is molecules from outside the UK. Two thirds of our work comes from companies outside the UK. When I am talking about pharmaceutical companies, I am talking about the global industry. I am not just talking about the UK. The examples I have given are not necessarily in the UK. They may be in America or Japan.

  Q507  Dr Naysmith: This is a question again for the Medical Research Council. You have said in your evidence that you need to avoid duplication of research. Personally, I would not avoid duplication. I would certainly want to avoid triplication and quadruplication but sometimes it is good to have checks and at least one other group working. Why do you think this is so important and what can be done to ensure that duplication does not take place?

  Dr Solari: Are you referring to early, basic research or to more late stage, clinical type research?

  Q508  Dr Naysmith: I think both apply. You would have less control over the early, basic research, I suspect.

  Dr Solari: As an academic yourself, you know that we do not read publications that are more than 10 years old generally. As scientists, we often repeat what has gone before without reading the literature. We want to avoid wasting the public's money repeating studies.

  Q509  Dr Naysmith: You do not want to rediscover the stuff that has already been discovered.

  Dr Solari: You do not want to rediscover it but it is an important part of the academic process that a piece of research should be able to be replicated in another lab. That adds to the validation that it is correct. That is all part of the publication process. I think that is very important. Sir Iain was making the point earlier that systematic reviews on all the literature are very important for the whole progression of medicines to man and I think the MRC would endorse that observation.

  Q510  Dr Taylor: Mr Kumar, trials of combination therapies are particularly important in cancer and other diseases and I think you tell us that sometimes the companies do not make their products available for these combination trials? Is that a problem? Can you give a bit of detail?

  Mr Kumar: I do not think I can say that we have lots of evidence that companies do not make their products available for combinations but I think this is again an emerging area in cancer drug development. There is a wide expectation that combination therapies are the way forward. It is for commercial reasons difficult for pharmaceutical companies to test their drugs in combinations with the drugs of their competitors. It is an opportunity; it is a responsibility that organisations like Cancer Research UK see for themselves, to undertake that kind of research and what we would then seek is the cooperation of the pharmaceutical companies in making those drugs available to us to test those combinations.

  Dr Solari: In the MRC I do not believe we have had any experience of difficulties. Drug companies are willing to provide their drugs for MRC trials. The breakthrough, for example, in childhood leukaemia has come about because of new combinations of drugs.

  Q511  Dr Taylor: We do not need a strong recommendation for that?

  Dr Solari: I do not think so, no.

  Q512  Mrs Calton: Dr Boyce, does your contract research organisation carry out any studies that you think are for marketing purposes as opposed to understanding how the drug works or how safe it is?

  Dr Boyce: No.

  Q513  Dr Naysmith: People have suggested to us that it would be a good idea when a drug gets to its pre-market stage that the regulatory checks that have to be carried out on it are carried out by an independent unit that would do clinical trials independently of the industry. Presumably the Medical Research Council could do that sort of thing and if you do not think it is a good idea tell us why not.

  Dr Solari: I think the MRC could do it. It has the infrastructure to do it along with the Department of Health. I am sure it does not have the budget.

  Q514  Dr Naysmith: Always assuming that the budget will come. I know these promises are not always acted on.

  Dr Solari: It is an interesting idea. I would need to think about it a little more rather than giving an off the cuff reply.

  Chairman: Write to us because obviously that would be very helpful.

  Q515  Siobhain McDonagh: Mr Kumar, you are concerned about the influence that the industry has on the topics chosen by NICE. Why are you concerned and what problems might arise if there was excessive influence?

  Mr Kumar: We were concerned that there was a lack of transparency on the topics chosen by us. I do not think we would say that there is an inherent problem but that we do not know if there is a problem. What has happened over the last several months is that my understanding is that NICE now, at least as far as cancer appraisals go, relies on the NCRI, which is a forum of all the major cancer research funders, to determine or at least to take advice on the areas that should be addressed. At least as far as cancer is concerned, I think we have moved forward.

  Chairman: Gentlemen, can I thank you for what has been a very valuable session? It has been rather short and somewhat constrained by time but we appreciate the help you have given us. Thank you very much.

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