Select Committee on Science and Technology Minutes of Evidence


Examination of Witnesses (Questions 80-87)

TUESDAY 29 OCTOBER 2002

PROFESSOR SIR PETER LACHMANN, PROFESSOR JONATHAN COHEN AND PROFESSOR HUGH PENNINGTON

Lord Haskel
      80. You have told us quite a lot about the importance of collaboration. Perhaps you could describe the relationship between the academic institutions, service providers and industry in relation to vaccine research and perhaps you could comment on whether this relationship could be improved so that the United Kingdom could become more competitive.
      (Professor Sir Peter Lachmann) That is a complicated and difficult question. The common prophylactic vaccines that are given to healthy babies have an extraordinary high safety requirement. For this reason they are extremely expensive to develop and take a very long time to come to the market. Few companies work in this area and they are large and have deep pockets. Academic institutions provide much of the original work research in vaccinology. This is a tremendously active field at present reflecting advances in immunology and there are many innovative ideas for improving vaccines. Nevertheless most of the vaccines currently in use for children are quite traditional because none of the more innovative vaccines (with the exception of hepatitis B) have yet come to market in part because of the huge expense involved. Some years ago the development and manufacturing of vaccines in the United States (where much of this would be done—almost came to a total stop because the Companies felt that the risk of litigation was such that they were not going to carry on with this work. The Federal Government then introduced an indemnity for companies which develop vaccines for children - although not for adults—against any successful actions for vaccine damage. The service providers really provide facilities to do clinical trials of vaccines, a very important activity. They do not, themselves, as far as any of us know, engage in vaccine research. Much of the basic research comes out of academic institutions, and we are very active in this area in the UK. There is some very excellent vaccine research coming out of the University of Oxford and other places as well (I used to work with this also). To bring these vaccines to market has always been in the hands of industry. A new dimension has been introduced into vaccine development by the Gates Foundation, who have provided funds on a scale that most governments could not contemplate for the development and bringing to market of new vaccines for children. Really extraordinary sums of money are distributed by them to a number of international bodies. The vaccines that are needed on a world scale—against HIV, TB and malaria—are being developed rather faster than would otherwise be possible because of the support from the Gates Foundation. What can we do to make vaccine development go better? We might produce an indemnity for companies in this country as well. I think the MRC has been very good at stimulating this. Innovative vaccines are under trial in Kenya and elsewhere for HIV and malaria using techniques that have been developed in this country. There are numerous new approaches being developed by bio-technology companies for example by incorporating or complement fragments to increase immungenreity for example. There is a drive to develop plasmid vaccines where your own vaccine inside you just by being given a plasmic vaccine that is transcribed and translated; these are sometimes called DNA vaccines—but that is actually an unfortunate term and causes public resistance—and they should really be called plasmic vaccines. Those are only just coming to market in spite of the fact that they have been developed for a considerable number of years. They will have the advantage of being cheaper and not requiring a cold chain, in other words you can just keep them at room temperature and travel around the world with them. There is a great deal going on, but for these vaccines for children it will be difficult. What are called therapeutic vaccines for treating cancer or rather focussed vaccines such as giving travellers a vaccine against malaria, that is quite different and is being developed by much smaller companies because there the requirements are much less and it is much easier to bring them to market. This is also a very active field. It is a field in which we are very good in this country; there is a lot of vaccinology going on. But bringing major vaccines to market is a horrendous enterprise and can be a road to ruin.

  81. You seem to be implying that the standards of entry, particularly for children, are unnecessarily high; you said it was very high. Do you think it is unnecessarily high?
  (Professor Sir Peter Lachmann) I will now give you my personal view. My personal view is that it probably is. The cost of the last 10 lives saved is so enormous that if spent in other ways—such as bringing the vaccine on stream earlier—it would probably save a thousand lives. In fact, in a real cost benefit analysis the final testing, the final attempt to save the very last small number of lives, is actually costing more lives than it is saving. This sort of statistical argument does not have the emotional compulsion of a child who has been damaged by a vaccine and who appears on television. It would be very difficult to get the regulatory authorities to agree to it, but if you ask me for my personal opinion it is exactly that, yes.

Chairman: Any other points on that?

Baroness Walmsley

  82. The idea of indemnifying companies against potential damages pre-supposes that enormous damages would be given if there was any harm done or that could be attributed to a new vaccine. Is there any other solution?
  (Professor Sir Peter Lachmann) Damages in this country are assessed by what the care of the cost of the person is. If you damage a child and it is claimed against you and life expectancy is several many decades, then you may have to supply care if that child is left mentally damaged for all their time, then damages even in this country would be very high, let alone the sort of damages juries would give in the United States. I believe that the government is looking at a no fault compensation system as I think exists in New Zealand. I have no idea how they are getting along with that. It has been talked about for many years. One problem is that the amounts given—this is not just for vaccines, it is medical in general—are much smaller but they are given to far more people. In a way it is crazy where somebody is held at fault compensation is given; if it is held that the thing was genuinely an accident and no one is at fault, then nothing is given. You may say that this is actually not equity. On the other hand if you go to a no fault system then the payouts to everybody are rather smaller. I would be interested to see how the government gets along with this study. We have not yet seen anything emerge from it. That is an alternative that is used in some countries.

Lord Haskel

  83. On the matter of this indemnity, of course in practice what would happen is that the company would try to get insurance cover. Is it possible to get some sort of insurance cover for this?
  (Professor Sir Peter Lachmann) If you really want an answer to that you would have to have it in writing. We would have to ask some of our industrial colleagues. The Academy, as you know, is very keen to include industry among our consultations. This particular question of whether any insurance company is prepared to give this indemnity and at what price I cannot give you an answer to. I doubt if either of my colleagues can but we can certainly get you an answer to that if you would like it. In the States it was certainly done by the federal government.

Chairman: If there are no more points, can we move on to the last question. Lord McColl?

Lord McColl of Dulwich

  84. Could you deal with the impact of some of the advances in diagnostic technology and IT, please?
  (Professor Pennington) I think there are two aspects which are very important. One is near- patient testing which might supplant the need, for example, to culture an organism in a laboratory. That could have quite serious implications if that became very wide spread in terms of tracking the spread of organisms through the community where essentially you need either the organism or its nucleic acid or at least some definite serological evidence of infection. Personally I am reasonably relaxed about that. The applications of that kind of testing have not resulted in serious deficits to my knowledge in terms of surveillance. For example, there are rapid tests for Legionnaire's Disease and so on, but that has not got in the way of tracking outbreaks because traditional methods are being used as well. That is something that has always to be kept in view, I think that we do not move into a system where a litmus paper test or a black box type of test supplants traditional methods to the detriment of surveillance. An entirely different aspect of new developments in diagnostic technology are basically molecular methods for diagnosis. PCR is now very well established, for example in diagnosing meningitis. That has not resulted in any problems in terms of surveillance because the product of your PCR on the one hand tells you what you have in your cerebrospinal fluid and it can also be used to type the organism. So you are getting a double bonus. In fact, it has speeded up surveillance rather than having the opposite impact. One would hope we would go down that particular route of that sort of development. The problem with that is that it is not a technique that is open to every district general hospital. It involves sending a sample off to a reference laboratory, so you have to have a good network of contacts and transport and so on. On the broader sense of surveillance, there are developments (and I alluded to some, for example, tuberculosis) where one can have an international typing system which is all connected by IT (and there are systems like that in Europe). There is a system based on IT for the typing of organisms that cause food poisoning. That has been a European initiative although it has been largely led by people from the PHLS. There is a similar system in the United States which they were driven to develop essentially by the failure of their federal system to get to grips with problems across the country. Some states were good at it; some were less good. It is a centrally driven electronic system for looking, for example, at their E coli isolates across the country. A laboratory in Washington State can compare its isolate with a database in Atlanta, Georgia and see whether it is a strain that is similar to the one that caused problems down the road or whether it is a new strain. That is coming along extremely well. I think it links up to our infection centres, in fact, because some of the technology is still quite expensive. For example, to do some of the more sophisticated typing you need DNA sequencing capability. Again, in the foreseeable future, that is not going to be available in the large district hospitals; it is only going to be available in regional centres, for example. But it makes typing of an organism as powerful a technique, as the forensic DNA system. We are well down the road in developing that for a number of organisms; there is a universally applicable system which was developed in Oxford called multi locus sequence typing which is universally applicable with the proviso that you do need DNA sequencing capabilities, so there will have to be some kind of national network to provide that until, maybe, DNA sequencing will become a black box thing that everyone can have in their kitchen. It is certainly not on the horizon yet.

Chairman

  85. Does teleconferencing have a role here in getting information or helping people in other countries where they may not have this black box available?
  (Professor Pennington) I think the face to face meeting still holds sway, but I am slightly surprised, personally, that teleconferencing is not used more because it is a relatively cheap and powerful way of having eye contact with experts as far away as you like. It is now pretty easy to set it up in academic centres. I am slightly surprised it has not caught on more.

  86. One question which is not on the list here but Professor Pennington is from Scotland (although we are largely concentrating on England and Wales). Have you any advice for us that you may bring from Scotland to England and Wales?
  (Professor Pennington) I think many of the problems, My Lord Chairman, that you have been discussing are English problems in the sense that we do not have the PHLS and have never had the PHLS north of the border. Having said that, we have been heavily dependent on the PHLS in terms of providing reference functions. We have obviously a very strong vested interest in seeing that whatever developments take place do not lead to any diminution of the kind of service that we have had in terms, for example, of my own particular area, food-borne pathogens. We have had very close relationships with laboratories in Colindale and throughout England. We have a slightly different problem with infection specialists in Scotland. There is a number of centres in England with excellent infectious diseases physicians that are academically based; we have fewer of them in Scotland. We have a particular problem there in that we need to come up to English standards on that. We have already heard that we have about the same number of specialists in England as in New York, so you can see that there is a UK problem in that particular area. I think Scotland really just mirrors England in many ways - although our structures are somewhat different—and we have exactly the same problems that occur south of the border. We certainly have the same pathogens and we need to have the same relationships with our veterinarian colleagues as south of the border. We have devolved structures which are slightly different so they have to be taken account of, but the basic problems are the same.

Lord Turnberg

  87. Returning to this business about IT and the need for more and better IT, the functions of a surveillance system are very dependent on good IT between laboratories and epidemiologists, the epidemiologists and practitioners, and so on. How good or bad are we and what more do we need to do?
  (Professor Cohen) My personal view is that we are not very good at the moment. I think we allude elsewhere in the report that we need to have some joined-up relationships between the various different agencies who are involved. There are many, many examples where they are not as good as they could be, and it is absolutely dependent on IT, not just good IT but IT which operates in all these different areas in a way which will talk to each other, as it were. My personal view is that that is an area which needs substantial investment.
  (Professor Pennington) Could I just echo that. For example, HIV IT transfer—the transfer of information—certainly in Scotland is very good. A lot of money was pumped into it. In my area we have a very small HIV problem, but we have very good IT. We can send our data to central bodies and so on. Of course there are confidentiality issues. That has been solved because enough resource has been put into it. In other areas it is dismal because we do not put enough resource into it. If I can just remind you that the first piece of food that had a bar code label on it—which was a piece of Wrigley's chewing gum—went across a check point in the United States in 1974 but we still do not have a bar coding system for our samples in laboratories up and running that we can rely on yet. It is not that it cannot be done; the technology is there; it is really a question purely of resource, in my view.

Chairman: Thank you very much indeed. Are there any other points that you wish to put before the Committee that we have not dealt with? Or alternatively, if, when you leave this room, you think you should have mentioned something, if there is anything like that and you wish to submit additional evidence, we would be glad to receive it. If not, may I thank you all very much for coming. We have had a thorough discussion on a wide range of issues and we have taken note of many things you have said. Thank you.






 
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