Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 480 - 499)



  Q480  Dr Naysmith: Do you think there are any adverse effects of this not terribly close but close-ish relationship between the MRC and the drug companies, or some drug companies?

  Dr Solari: Potentially. We have to be aware that they are businesses and they are run along business lines. We are here to serve the public good. We have to make sure that our partnership does not stray into areas where they are driving our agenda. We need the pharmaceutical industry and they need us to deliver improved health care. We have checks and balances. We make sure that there is no undue pressure by the pharmaceutical industry on the activities of the MRC but it is potentially a concern and we watch for it very carefully.

  Mr Kumar: For Cancer Research UK, I would answer the question in a very similar way to the way that Roberto did. We tend to do two types of clinical trials. We develop new drugs that arise out of the research that Cancer Research UK funds, whether in its own institutes or universities around the country. Sometimes those give rise to new drug possibilities and we will carry out internally the early phase studies on those drugs prior to partnering them with a biotech or a pharmaceutical company. In those cases, all of our studies are entirely controlled by us with no influence from pharmaceutical companies at all. We also do a number of later phase studies and those span every possible type of study you might think of, from the types of things that Roberto was talking about to does broccoli help you avoid bowel cancer, to new studies on drugs either prior to or post registration. In the cases where we are looking at those types of trials, we will always insist that we control the protocol and the study design. To the extent that a pharmaceutical company is involved at all, it would only be to give a sum of money in the form of an educational grant which would simply be for funding data monitors or the supply of a drug. It would not be to have any control over the trial at all.

  Dr Boyce: We contract a lot of trials for the industry but I cannot name a single instance where they have tried to influence the procedures and the results. They might argue about the interpretation but that is not unusual even amongst academics. If there is a breakdown of trust between the pharmaceutical industry and society, that surely must stem from the breakdown of trust about science rather than the industry alone. I do not think the industry has a patent on lack of trust. That largely stems from the lack of grasp of understanding of the general public. At least that is the way I see it. We can produce evidence that something is not useful but it does not prevent people going on doing it. I wonder how many people in this room took their vitamins this morning. All the evidence is that they are not useful but if you believe published data there will be several people in this room who have taken vitamins. A well informed public is not taking any notice of scientific facts. The trust surely has to start with education rather than the pharmaceutical industry. I think it is a bit unfair to blame the pharmaceutical industry for lack of trust over science.

  Q481  Dr Naysmith: Sir Richard Sykes was giving the answer to your vitamin thing. There may be a tiny proportion of the population who will benefit but Sir Richard Sykes was saying that very shortly you will be able to identify the relatively small number who want a particular vitamin and make sure they have it. That will be the end of the vitamin industry.

  Dr Boyce: That is a lovely concept but I fear that Sir Richard is incorrect.

  Q482  Dr Naysmith: Have you come across ghost writing of papers?

  Dr Boyce: I have in the pharmaceutical industry, yes. Once or twice I have been asked to do it but they have been multicentre studies throughout the world that I have organised and set up.

  Q483  Dr Naysmith: You must have lots of people who—

  Dr Boyce: The problem with academics is, despite the fact that they need publication for their success within academia, they are not always good at writing up the publications and they do not always write well.

  Q484  Dr Naysmith: Do you write for them?

  Dr Boyce: No, I have never done it, but I have known individuals within a pharmaceutical company write up a publication in which the company was involved. Always, the clinicians who do the study are involved and they have a say in interpretation. If they do not like the conclusions, that is because they have not spoken up.

  Q485  Mr Burns: When they have been ghost written, from your experience, does it say anywhere in the document it has been ghost written?

  Dr Boyce: We have to define what you mean by "ghost written". Many professors put their name on the end of a paper written within their own department and they may have very little input into that study.

  Q486  Dr Naysmith: In my experience they always say, "The original idea was mine."

  Dr Boyce: Yes. You could argue that the paper has been ghost written for the professor. The difficult bit is getting a blank sheet of paper into a first draft. Lots of people can do that but the honing and shaping requires input from everybody. Providing the clinicians, the sponsors and everybody has two pennyworth, I do not have any strong feelings about who writes the first draft but I do not call that ghost writing. Some people are better motivated than others at writing up papers.

  Q487  Mr Burns: I recognise that people are very busy but in the non-academic world if a politician, for example, writes his memoirs and they are ghost written it usually says, "Fred Bloggs with Joe Smith." People understand that it is not Fred Bloggs who has written from word one to the last word at the end of the book. If there is a professor who is an acknowledged expert in a particular field of research and his name is put on the document, it will be put on the document for one particular purpose, which is it will seek to give credence to the content of that document because that individual has a reputation for expertise in that field. If that individual has done no work on writing the document and it is the work of others, is that not somewhat misleading and very disingenuous?

  Dr Boyce: Yes, I agree entirely. There are rules about publication and authorship. In that instance you have just cited, it would be quite wrong of that opinion leader, which is the term people in the industry use for someone that is well known and influences prescribing habits, to allow his name to go onto the paper.

  Q488  Dr Taylor: Mr Kumar, I was pleased to hear you say that if Cancer Research UK are taking part in a combined study with industry you control the study and the design. You insist on publication?

  Mr Kumar: We do, of every trial we fund.

  Q489  Dr Taylor: And the MRC?

  Dr Solari: I believe it is the case for the MRC as well.

  Q490  Dr Taylor: I was very intrigued with Dr Boyce's suggestion that a condition of ethical approval should be that results are published. Is that a feasible condition to put on? Is it practicable?

  Dr Boyce: I believe it is, yes. It is also a requirement of the Declaration of Helsinki, the 2000 version, which has not been recognised under the EU Directive but I think it could be. It is in many protocols. It is also a requirement of good clinical practice that there be within the protocol a statement about publication. If I write the protocol, I always put "if the results merit." Sometimes, despite the fact that they are negative, if you are just doing a single dose rising study to assess tolerability, there is nothing of any scientific value in the study and nobody is really interested in publishing it. It is not hiding it; it just does not merit publication. Maybe when you start to get a randomised trial, which was mentioned by one of the speakers this morning, then obviously I agree it should be published.

  Q491  Dr Taylor: That sort of very early study probably would not have ethical approval.

  Dr Boyce: It would. Every clinical trial has to have ethical approval.

  Q492  Dr Taylor: I thought those were before you got on to the stage of clinical trials.

  Dr Boyce: Under the EU Directive, since 1 May this year, every clinical trial and investigation of a medicinal product, of a potential new medicine, must now have approval of the MHRA and the Research Ethics Committee.

  Q493  Dr Taylor: It would seem to me to be a very simple, straightforward recommendation for us.

  Dr Boyce: Yes. There should be a statement in every protocol. That is good clinical practice. Several years ago I wrote a publication policy for our own company along those lines. Sometimes the pharmaceutical companies are a bit naughty. We do the work but they go off and publish it. They do not tell us. Sometimes they give us recognition but they do not include us amongst the authors. Under the new rules of authorship, that is probably okay but it is very discourteous to publish something that somebody else has done and not tell them. Usually when we publish there is good collaboration. We discuss the paper. We have different interpretations. We come to an agreement about the wording. In the early stages, it is researched. It is in nobody's interests to distort the results in early studies. Everybody wants to know: is this a useful medicine? Does it need to go into late development? If not, it needs to be put in the bin and another one tried.

  Q494  Dr Naysmith: When I talk about negative results, it is when you do three or four trials and most of them are negative but one shows up as positive. You then suppress the four or five and use the one that shows that your drug is accurate.

  Dr Boyce: That is quite wrong.

  Q495  Mrs Calton: It seems to me that there is room here for a grey area around the decision not to publish trial results or parts of them. Who makes the decision?

  Dr Boyce: For the research that I do, we make it as a group. Often I say, "This is a very interesting result. It adds to the literature. We should publish it." Nowadays, somebody else writes the first draft. I never allow my name to go on a publication unless I have had a substantial input into it. Until recent years, I always seemed to be the fall guy who wrote the first draft and took it through because I enjoy doing that. There is nothing better than doing a study with a brand new molecule and getting a very interesting result that is going to set the development in process. The decision is usually made amongst the group, as in academia.

  Q496  Mrs Calton: Can you tell me who the members of that group would be?

  Dr Boyce: It would be the clinical pharmacologist doing the trial and representatives within the pharmaceutical company.

  Q497  Mrs Calton: Would they ever say, "We do not think this should go forward"?

  Dr Boyce: They may, yes. I have cited examples where it has happened to me, where I have said, "I would like to publish this. It is in the protocol. It says, `if the results merit'" which is usually my phrase. Then either the sponsor or us, the investigators, will write the first draft and send it to all the other individuals involved in carrying out the trial to comment in order to hone and polish the final paper. It is a group of people but occasionally when I have initiated that process the pharmaceutical industry says no. That has happened to me and I have always battled against it. I could give you examples. Once, when I worked in a pharmaceutical company—this is going back 20 years—when I wanted to publish something, I had agreement with academics. They said, "Will we be able to publish this?" I said, "Yes" and I put that in the protocol. It went through a protocol review process so the people in the company had seen it. I was not doing things on my own. When we wanted to publish it, we wrote the first draft and I submitted it to the company for comments. They said, "No, you cannot publish it." I said, "But you said earlier on I could" and I was threatened with a High Court injunction if I went ahead to do it. Unfortunately the academics backed off, not me. I was in the company. I was left very vulnerable for a period. It was published a year later. A lot of the time it is a storm in a teacup. There is not the need for secrecy in the early clinical development. Once a new molecule goes into studies in humans, it does not go into humans until it is patented and protected. Then you have to produce an information leaflet for the subject. Aunt Mabel would know about it and the man in the street might be a volunteer. Why should it not be published? There seems little point in holding back.

  Q498  Mrs Calton: Effectively, from what you are saying, the sponsoring company that clearly has an interest might well block publication?

  Dr Boyce: Yes, often for the wrong reasons.

  Q499  Mrs Calton: Whatever the reasons, the point is the public and those who are buying the drug subsequently—

  Dr Boyce: This may be 10 years away from becoming a product that is sold to the public. The attrition rate is very high.

  Mr Kumar: I think there is a relatively simple way of overcoming the greyness that you describe which is if that drug ever does make it to market, regardless of what the reasons were for not publishing when the early phase studies were done, whether it did not merit or commercially in confidence, as and when a drug hits the market all data should be published. That way you overcome any greyness that there might have been through the process.

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