TUESDAY 16 MARCH 1999

MR BRIAN DICKINSON, MR JIM SCUDAMORE, DR CHRIS CHEESEMAN and DR GLYN HEWINSON

  640. Would it help if the Government, and I know the Government have put more money recently into this area, but if they said "Right, instead of spending all the money on the Krebs trials, why don't we just shove it all into getting a vaccine"; would that assist it? Is there a workable candidate at present that actually just needs a whole load of funding to help it along?
  (Dr Hewinson) There is no candidate that is better than BCG at the moment, so that you would not help to boost the money at the moment; you might monitor the progress and see when there may be appropriate times to put more money in. What I would say, at the moment, a blueprint for TB vaccines has been produced in the United States, that has gone to the White House, and there they estimate $800 million will be required for a human vaccine; so I think that the cost-effective way to develop a vaccine for cattle is to focus on what is different between bovis and TB and to piggy-back on the advances that are going to happen in the human TB field. And that is why I am a member of the Animal Models Task Force, to try to produce a network in which we can have access to those vaccines and test them in the M. bovis models.

  641. And do you have any concerns about, if we do now, because we seem to be on a bit of a spring-board and we can maybe take forward, do you have any concerns about the commercial viability of a cattle vaccine; in your memorandum you did sort of have concerns about the marketing of a vaccine?
  (Dr Hewinson) We are in conversation with industry, and they are at the moment taking a watching brief, and their decision will depend on what will happen with EU legislation, in terms of vaccination and tuberculin testing.

  642. And going back to a point that you made, why do we not give badgers the BCG then, why do we not just pellet, then, what we have got?
  (Dr Hewinson) There is a pilot trial going on in the Republic of Ireland, which we are involved with, to look at BCG in badgers.

  643. So we are doing that pilot?
  (Dr Hewinson) That is being done in the Republic of Ireland, yes, and we have transferred our expertise in badger immunology to allow them to do that, yes.

  644. Are there any difficulties about trying to vaccinate a wildlife population, I think they have done it a bit in Europe, have they not; is it very easy, you just scatter a whole load of pellets of nice little worms that badgers like with the BCG in it? It is not like getting 14-year-olds to roll up at school and show their left thighs, a badger is not going to do that?
  (Dr Hewinson) I think there are technical difficulties in oral delivery and in protecting the vaccine against the stomach contents for badgers, so you would have to develop oral delivery routes. A pilot trial in the Republic of Ireland, using marked bait, showed that if you use chocolate peanuts with tetracycline in, as a marker, you get about 80 per cent uptake, so you would get quite a good, high uptake. But what you cannot guarantee is the dose, so you would not know how much each badger is getting and you might have to ...

  Chairman: Do badgers have peanut allergies, do we know? Please do not answer that question

  645. Are you saying then that we are nearer than we were to a cattle vaccine, but, in your estimate, how far off are we actually going to have what we would hope to be a really sustainable control situation?
  (Dr Hewinson) So vaccination, I think, the Krebs recommendation, there is an international consensus that 15 years is a reasonable time frame, but, as Einstein said, if we had the answer it would not be research, we cannot actually guarantee that, so you would not want to put all your eggs in one basket.

  Chairman: We will have to move on, because we have got six minutes left before we have the Minister.

  646. The Road Traffic Accident Survey, how were the seven counties chosen to be included in that survey?
  (Mr Scudamore) They were chosen by the Independent Scientific Group. They were chosen in relation to where the trials are, because the intention, with the Road Traffic Accident Survey, as suggested, is that if you are doing a trial area you are getting a lot of information on badgers and on prevalence of disease in badgers. If you then pick up road traffic accidents in those areas you might be able to work out a system for relating what you have found in the badgers you have killed to what you find in the road traffic accident; in other words, you could then use the road traffic accident to give you some indication of infection in badgers. So that was one reason. And the second reason, I think, possibly, underlying it, was also you could use it as a method for finding out what the TB incidence might be in the `no cull' areas. So that was the reason for the proposed Road Traffic Accident, by the Independent Scientific Group.

  647. So what would your views be then of actually extending that survey to all areas so that you could monitor areas with new outbreaks?
  (Mr Scudamore) There are a number of issues there, in fact. The first one is that we would like to know what the TB situation in badgers is outside those seven counties; the question is how we find out, and the question is whether the Road Traffic Accident Survey would give us the answers we want. Because, I think, as it stands at the moment, looking at road traffic accident badgers would not give you an indication of the prevalence or level of disease in badgers in that county. In other words, if they were all negative, it might just be they were all negative; if there was one positive, it could tell you that you have got TB in badgers in that county but it would not tell you how much or where. So the question with extending the Road Traffic Accident to the whole country is it could be very resource-intensive, it costs quite a lot of money to do, we would use up laboratory facilities, because, again, we would have to look at them in the same laboratories we will be looking at the trial area badgers, and it might not give us a lot of useful information. Having said that, targeted road traffic accident surveys might be valuable, and I think what we would want to look at is all the options for doing road traffic accidents, and I think the crucial thing is, will they provide useful information, and if the answer is yes then we would have to look at it with the Independent Scientific Group to see if it is worth extending to other areas.

  648. So you are saying that the premise is that it is not a good idea, it is totally random, it does not actually provide you with what you need, but then you are saying, well, it might, so you are going to hold fire, "We'll consider it in due course"?
  (Mr Scudamore) No, we want to look at it to see whether taking road traffic accident surveys throughout the whole country will give us any valuable information. In some areas, it might give us information, but it will not give us statistical information, it will just tell us that that road traffic accident badger had TB. And we already have a view of the large number of counties where we have had road traffic accidents positive in the previous survey.

  649. When will the survey start though?
  (Mr Scudamore) I think the question of road traffic accidents is being looked at, and I do not think we actually have a start date at the moment. I think the question is, which counties, how extensive, how do we collect them, is it extended to other areas, are all under debate, so I cannot give you a date on that.

  650. Are we talking weeks, months, years?
  (Mr Scudamore) I would think, probably, weeks or months, but I cannot give you a specific time on that.

  651. I think, on the back of this sense of urgency, again, that we have talked about before, that it is just a bit disconcerting, if you are saying that "It could be soon but we're not quite sure when"; again, if it is going to provide more information that will quickly get onto the real issues, obviously, it will help?
  (Mr Scudamore) But the question is, what information it is going to provide; for example, we know a lot of counties have TB in badgers, therefore the Road Traffic Accident, if it comes up with positive badgers, will only confirm what we already know. So the question is, in those counties where we do not know whether we have TB in badgers, it suggests it is probably at a very low level anyway, and will putting a lot of resource into road traffic accidents in those counties tell us anything we do not know.

  652. You keep talking about resources, so what do you actually mean by that; are you going to be actively encouraging the public, including farmers, then to participate, and badger groups who assist in this survey: how will it work?
  (Mr Scudamore) I am talking about physical resources, not financial resources. I think part of the problem is the laboratories that are able to look at these animals and to take the material culture from them, so I think it is a physical resource as much as anything.

  653. And should we be asking the Minister to provide more resources for those laboratories, is that the real bottle-neck in all this; is that a problem?
  (Mr Scudamore) No, I do not think so. We have a set of laboratories around the country that can do this work.

  654. But you say you are limited by the availability of laboratory time; you are now telling us it is not a problem?
  (Mr Scudamore) We are limited by the availability of laboratory facilities, because of Health and Safety constraints and the numbers of badgers that can be put through; but I am also saying, what is the benefit of looking at all these road traffic accident surveys from other parts of the country.

  655. So you do not think there is an important constraint on your work because of the bottle-neck in laboratories?
  (Mr Scudamore) No. I do not think so, no.

  656. I want to ask just two very brief questions which arise from a number of those which have been asked by colleagues already. There seems a consensus that much of the work that has been done so far on this problem is pretty miserable; is that because of inadequate resources, or an inappropriate process?
  (Mr Dickinson) I think that, in saying it has been pretty miserable,—

  657. We do not seem to know anything?
  (Mr Dickinson) No, I do not think we do know nothing; that is, if I may say so, going too far. We did have, from the Krebs, a conclusion that the evidence, although indirect, was compelling, and that suggested that there has been a certain amount of work done already which has led to some conclusions. So we should not just discard what has gone on in the past, there has been work done, it has produced results; it does not give us all we want, actually, which is why we are going further. So I think that is the main answer I would make to your question.

  658. Let me put the question more clearly then. I perhaps caricatured the work, but let me put it more clearly. Given the problems which clearly you have expressed, time and time again, in answer to questions this morning, with what we know so far, and yet there has been considerable work done over a period of many years, has the problem in the past been inadequate resource allocated to those efforts, or has it been an imperfect process?
  (Mr Dickinson) I think, almost certainly, there have been elements of both, is the simple answer. There are some ways which we can see that we have not done things rigorously enough in the past, and Krebs identified in particular the fact that the work done on culling, for example, was not subject to any controls, and, as we have said, we have not used the TB49 form in a way which it could be used to identify epidemiology and to produce information for that purpose. So we can see ways in which we have not gone about it as well as we could. However, there have also been, obviously, questions of public acceptability in what we do, which is a further element in it, and there is the question of resources, which is always with us, and I am sure always will be with us.

  659. Finally, Chairman, having got to where we are, and we might say we would not want to start from here in an ideal world, but having got to where we are, how can we be assured of the objectivity of this work, it is a point that Mr Todd made, but which, frankly, I did not feel was answered entirely completely; how can we be assured of the objectivity of this, when vets are going to be involved in it? I have nothing against vets, but recent evidence suggests that anecdotal views on these things seem to predominate; last week we had some evidence that their view was not based on scientific method, it was based on a feel, an anecdotal impression of the problem. What are the checking mechanisms to assure us that this work will not be imperfect and subjective?
  (Mr Dickinson) The main checking mechanisms are, firstly, that we are trying to design in more rigorously at the start necessary procedures, and we referred earlier to having standard operating procedures agreed by the Independent Scientific Group, that is a very important part of it. In addition, we have heard this morning that training is an important part of what we want to do, in terms of getting our staff geared up for the job. And, thirdly, we are putting in external auditors, and I think we just had an announcement on that yesterday, about the appointment of Cresswell Associates as external auditors for the trial.