Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 820 - 839)



  Q820  Mr Bradley: Can I take from that that to date you do not think that your information has been as good as that put out by the industry and the public are more likely to take that information and promotion rather than yours, accepting the point you are making that you will try and do better in the future?

  Professor Sir Alasdair Breckenridge: Well, we have suffered as an agency for not being professional enough in our communications. That is the bottom line and we are determined, as I have said once or twice already, to change that. It seems strange that a regulatory organisation did not think that communication was important, but since 2003 it is quite clear, the importance that it has, and we are acting very greatly on it. I do not know, Kent, whether you want to add something to that.

  Professor Woods: I would just add a word because it is a very important area of our business. We had an independent external review of our communications activities which reported some months ago earlier last year and, as a consequence of that, we are forming within the Agency the Communications Division. That will bring together some 26-27 people, many of whom are already in the organisation, but we are drawing this together as a focus of activity. We have appointed a Director of Communications, who will take up post in about 10 days' time and we are also investing about £1 million in our website over the next six months, so this is a very substantial investment, as an organisation, in our ability to communicate information not only to the general public, but also to health professionals. We have quite a complex external environment who require communications from us and I think that one of the difficulties we have had in the past has been that because we did not make an explicit task of communicating in that way, others have done it perhaps with less disinterest and, therefore, I feel that we do, as regulators, have an important function in ensuring that we are a source of authoritative, independent and trusted advice on matters of drug safety, efficacy and quality.

  Q821  Mr Bradley: In that review, did they comment on the fact that your independent review panel on advertising and on breaches of advertising did not meet at all in 2002 and has it met since?

  Professor Woods: I cannot answer that specific question. Dr Raine may be able to shed some light on that.

  Dr Raine: You are absolutely right, it has not met and, for that reason, and it is an appeal mechanism which industry may choose to follow, we are adopting different strategies and the main one has been to publish the complaints that we have. I think you will find on our website that there are 17 correct statements out there now. It is adopting one of the successful strategies which the FDA has used which is naming and shaming. If we cannot get the appeal forum used as a way to get a rigorous result, then we will adopt other measures and, as I have said, we are consulting on how we interpret the law at the moment.

  Q822  Chairman: When I opened up, talking about the changes you are bringing about, one of the issues which was mentioned was openness and, in particular, your view that the public should be much more engaged and more aware of some of the difficulties and some of the implications of the work you do. I think a theme which has come through our discussions in this inquiry and, in particular, with the companies themselves has been their understanding of the need to be much more open and transparent, but of course at the end of the day in an area of quite vigorous competition you have got commercial confidentiality and I wonder whether you feel you can go further on openness and engagement where you have inevitably at the end of the day got the problem of this commercial confidentiality. Would you, for example, like to publish some of the data that you have referred to which you receive and which currently you cannot? Could we reach a situation where we could at some point achieve that possibility which will even more engage with the public and inform the public possibly?

  Professor Sir Alasdair Breckenridge: Yes, I think, Mr Chairman, there are two changes which are taking place. Firstly, although we are bound, as you say, by the laws of commercial confidentiality, if an issue does come up of public health importance, we will publish that data irrespective of the commercial confidentiality and we have done this on several occasions. The second thing which is happening, and I know that you have discussed this as well, is that there are these proposals which are going ahead incredibly quickly now about the registration and the making public of clinical trials, so however these are worked out, and we are a party to these discussions obviously, once the public know that a trial has been registered and they will be able to access the results at some time, it will be impossible for companies who are starting bits of work to hide that away. We welcomed this move both to register and to publish clinical trials and that will make our job much easier, although we still recognise that there are issues of commercial confidentiality with which we will have to deal.

  Q823  Dr Taylor: Can I go back to Dr Raine and the problem with the particular drug that I think Mr Austin raised. Is there a likelihood when patients are used in market research that this can indirectly sort of turn into a promotional campaign? Certainly with this particular drug, we have had evidence that their campaign was actually to target consumers and patients. Now, are you aware of that? Could you expand on what you said to Mr Austin before? What methods would you have of controlling that sort of activity?

  Dr Raine: Would you like to name the medicine?

  Q824  Dr Taylor: It is AstraZeneca and Crestor.

  Dr Raine: Yes, of course. No, our controls on promotion do not extend to the activities and these would fall under the general controls on clinical trials and the nature of the consent that needs to be obtained and full explanation. It would not be within my domain in advertising to look to see the information that is provided to subjects in trials of this nature.

  Q825  Dr Taylor: So would anybody be aware of promotional campaigns taken on, which could target the consumers directly?

  Dr Raine: The issue of direct-to-consumer promotion of a prescription medicine is prohibited very clearly. The grey area which Professor Breckenridge referred to where we do have obviously a policeman role is what is called "disease awareness". Now, the law prevents us from getting involved so long as specific medicines, specific licensed products are not mentioned, but clearly, by implication, if there is a new medicine in a particular area, one can construe that a campaign might be referring, by implication, to Viagra, for example, if that is the only medicine in that area. Certainly we would take very careful advice, including legal advice, if we thought a disease awareness campaign was effectively promoting a medicine.

  Q826  Dr Taylor: Promoting a particular drug?

  Dr Raine: Yes.

  Q827  Dr Taylor: So you would be able to do that?

  Dr Raine: Yes.

  Professor Sir Alasdair Breckenridge: Yes.

  Q828  Dr Naysmith: Perhaps we can turn to an area really which you have mentioned already two or three times, which is this question of balance between safety and efficacy, and of course we have spent quite a lot of time talking about safety so far. Could I ask you if it concerns you that there are pretty reliable figures suggesting that under 50% of new drugs which get on to the market offer any significant advance?

  Professor Sir Alasdair Breckenridge: Thank you for asking that question. It is a very interesting question because when you see a drug being developed, it will be 10 or 12 years before it comes to the market. It is based on a pharmacological idea and many companies will light on this idea and start to develop the medicines. Now, the precise route which they go down differs and the drugs may well come to the market 10 or12 years later at about the same time and there are several very interesting examples of where the company, which was first in the field, in fact did not finish up the best and it was the second in the field which had a better efficacy profile or fewer dangers. The other thing which does happen of course is that as drugs are developed, they very often develop indications for efficacy in areas for which they were not intended, so whilst the drugs which are developed down the line from the leaders may not have obvious advantages in one area, they may well be incredibly important in other areas. There are many examples of that going back to the 1960s with beta-blockers and more recently with angiotensin-converting enzyme inhibitors where it was the second and third drugs in the line where people began to notice an effect in heart failure and not in hypertension and these are the mainstays of heart failure treatment now, so it is a very interesting debate as to what a me-to drug really means.

  Q829  Dr Naysmith: What I am really interested in is finding out what you can do to encourage less concentration on need-to drugs. For instance, the FDA in the States categorise new molecular entity drug applications according to significant therapeutic advance and what they do with them then is prioritise them for peer review and moving into the system. Now, do you operate anything similar to that?

  Professor Sir Alasdair Breckenridge: No, we do not.

  Q830  Dr Naysmith: Why not?

  Professor Sir Alasdair Breckenridge: Well, the law says that we will consider a drug for safety, quality and efficacy. That is the law under which we operate. There are certain other countries which do, I am aware, operate policies which you describe, but the European law, as far as I am aware, under which we operate cannot categorise medicines in that way.

  Q831  Dr Naysmith: Are you saying that it would prohibit you from doing it in that way?

  Professor Sir Alasdair Breckenridge: I think it would. I think that if a submission came to us for a new chemical entity and its safety, efficacy and quality were sufficient, we would license it.

  Q832  Dr Naysmith: But there is a backlog, is there not? There is a queue to get things through.

  Professor Sir Alasdair Breckenridge: Well, the queue is much less than it was. You may care to ask Sir Michael Rawlins in the next session that question because that is very relevant to his role.

  Q833  Dr Naysmith: I realise that, but it is also relevant to your role.

  Professor Sir Alasdair Breckenridge: Well, with all respect, it is not because we are regulators. We do not say how people should use drugs and whether the National Health Service—

  Q834  Dr Naysmith: So you are criticising the FDA's policy?

  Professor Sir Alasdair Breckenridge: I am not criticising it. Who am I to criticise the FDA? I am just saying that they operate under a different legal system than we do.

  Q835  Dr Naysmith: But maybe if we thought it was a good idea here, we could start beginning to change the legal system here, if people thought it was a good idea. I am trying to find out what your views are on it and whether your Agency, in doing what you do, could be helpful in this.

  Professor Sir Alasdair Breckenridge: For all the reasons I have just discussed with you about looking into the future as to what the role of an individual agency may be, I think it would be a very brave thing for an agency to say, "Look, this is just a me-to drug. We are not going to license it". I think that is not how I see the role of the Agency.

  Q836  Dr Naysmith: I do not think people are saying that they are not going to license it, but they are saying that if there is competition for resources, they will maybe try to go for something which offers more advance potentially. Professor Woods looks as if he wants to have a go at this one.

  Professor Woods: A couple of thoughts might be helpful. Firstly, the assessment times for new products have been very substantially shortened over the years and I do not think there is a queue such that one would need to prioritise in the way you suggest. The second thing is that although it would be nice if each innovative drug broke into a new therapeutic territory, in reality we do not actually fully understand what the utility of a drug will be at the point it reaches the market. We know about its safety, its efficacy and its quality to a degree sufficient to grant the product licence, but its actual utility and use will become clear. I think the distinction between safety and efficacy on the one hand and practical utility on the other is an important one. Speaking as a prescriber, and I spent 30 years prescribing drugs as a physician, it is certainly valuable to the prescriber to have a range of options available to suit the needs of the individual patient. Although you can say that drug A is not as good as drug B in large trials, when it comes to the individual patient if drug A does not work, you may want to try drug B and, therefore, there is that, if you like, redundancy in the system, but in reality it is the flexibility which allows patients to be better treated. The other point I would make is that if you were to consider legislating in a way which inhibited the development of what seemed like need-to drugs, there is a risk that we would lose things. For instance, if you take the antibiotic area, there is a multitude of antibiotics which might treat a particular infection, but we need all of them because patterns of resistance change and the likelihood that we might actually discard or obstruct the development of a drug which five years down the line is actually the antibiotic that we need because the first four antibiotics are no longer working, I think that is the kind of practical implication one would have to think through before considering new legislation.

  Q837  Dr Naysmith: Some of the things you have said are really very interesting because we have had views expressed here, and I know from my own experience and background in various aspects of medicine and so on, that we need more, better, more efficacious new drugs and whilst I accept what you say about altering the odd molecule here and there can make quite a difference, there is a concentration, and I am sure many people agree with this, on diseases which are sort of easy to crack, easy to treat rather than looking at some of the very difficult ones. For instance, on a worldwide scale, it is ridiculous that malaria still kills so many people, but it has been suggested that because there is not a particularly good market for it in developing countries, maybe there is not nearly enough concentration. That is a very extreme example, but the same applies to lots of other drugs, I think.

  Professor Woods: I think that is absolutely right.

  Q838  Dr Naysmith: Witnesses have told us this.

  Professor Woods: Indeed.

  Q839  Dr Naysmith: All I am asking is if there is anything you can do as an agency to sort of encourage firms to do the right thing. Of course if you are saying you cannot do it because of legal constraints, then maybe we need to look at that.

  Professor Woods: Well, I think there are limited things which regulators can do to ameliorate this situation. It is a problem, I do not dispute that and I think you are absolutely right, but the drivers which encourage or inhibit useful innovation in the pharmaceutical area are quite complex and regulation is only one of them. It can act negatively. If one creates a climate where innovation generally is made more risky, more expensive, if one over-regulates, if you like, it means that the available investment will go towards the safer products, safer in the commercial sense. To produce another beta-blocker is not going to be quite as much of a blockbuster as to produce a completely new treatment for something untreatable, but, on the other hand, it has a degree of commercial sense about it and, therefore, it is important to recognise that although regulators cannot do a great deal to stimulate innovation, and there are some things we can do which I will come back to, we can certainly do things to inhibit innovation and we must be careful that we do not inadvertently do that The ways in which we can simulate innovation are actually to engage with innovating companies at an early stage of product development to provide scientific and regulatory advice, that is to say to help the company understand the hurdles that will have to be cleared, perhaps a different mechanism of action, perhaps breaking new ground, to satisfy us as regulators that it is worthy of a product licence. I think that scientific advice is something which we have really only been doing over the last year or two and the number of scientific advice meetings we hold is going up really quite steeply. I think that is something very positive that we can do and the only constraining factors on us really is firstly industry's uptake of that option which they are very keen to do and the second thing is our resources, our scientific resources within the Agency, to provide that degree of assistance. The FDA, to whom you referred, I think have taken this even further and they have produced a very thought-provoking document recently called Innovation or Stagnation? which asks the question and delves more deeply into the matter of, what can regulators do to foster innovation? The areas they see as a difficulty are the growth of regulatory science, if you like. Are there better ways of predicting clinical hazards at an early stage of development in order that companies do not waste money on drugs which ultimately are going to fall down? Are there other surrogate markers which will detect potential hazards at an early stage and, if so, can the regulators introduce those into the assessment process? Are there therapeutic markers that we can pick up earlier in order that the process of development can be more accurately targeted on those things which are going to work and have an acceptable safety profile than those things which are doomed to fail at a late stage of development? Regulators around the world are thinking about this and both the FDA and ourselves have discussed it internally at length.

  Professor Sir Alasdair Breckenridge: The other thing is that the picture for malaria, which is an area in which I am closely involved, may not be as gloomy as you are saying. There are some very interesting things happening in that area now, thank goodness.

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