§ 8.36 p.m.
§ Lord Lucasrose to ask Her Majesty's Government what preventive measures they are taking and what preparations they are making to deal with the possibility of a sizeable epidemic of new-variant CJD.
The noble Lord said: My Lords, I seek to persuade the Government to prepare for the worst. I can do no better than refer the Minister to the paper published by Professor Collinge in July 1999 setting out his views on the likely course of new-variant CJD in Britain. The conclusions he reached were that in all likelihood what we are seeing at present are not individuals who caught the disease at the time we knew that BSE existed but those who had caught the disease before that; and, taking a line from other TSEs in humans, we were likely to see the peak of this epidemic in 15 or 20 years' time. Therefore, considering the level of cases occurring now, we may be looking at a disease which will kill hundreds of thousands or even millions of us.
Should we ever reach that horrific moment when we have to admit that an epidemic will kill enormous numbers, I want the Government to be able to look back at what they did with pride and to say, "We did the best we could. We took all the measures we reasonably could take at the time". I want the rest of us to be able to agree with the Government on that.
I was a fly on the wall, as a very junior member of the Government in the Ministry of Agriculture, Fisheries and Food, when the BSE crisis boiled over. I look back at that period as a time of panic and a lack of preparedness. I look back at 1,001 things that we could have done better in the years running up to that point. But I also look back at a government composed of people who had the best of motives, took the best of advice, and did what they thought was best at the time.
There are two main reasons why the road to hell was paved with our good intentions. First, we were optimistic. Of course we were. Before knowing to the contrary, who would not wish that BSE could not transmit to humans? However, we allowed that optimism to cloud the need for pessimism. We concentrated on giving the public a reassuring message and we believed that doing so precluded us from taking precautions, openly and in public, to deal with the situation should our optimism turn out to be unjustified.
The second reason for getting things wrong was that we were secretive. There is, and always has been, a strong culture of secrecy in MAFF, but we allowed it to take over. All the research data, conclusions and direction were confined within MAFF. There was little 1176 public knowledge outside of what was happening. All the decisions were taken internally. Such a closed attitude leads to bad, slow, misdirected research.
The other aspect of secrecy was that we took our decisions in private. We did not publicly share them or the reasons for taking them. That meant that if later the decision turned out to be wrong or questionable, it was hard to go back on it. As it had not been accepted by the public when it was taken, to go back on it (having asked them to believe in it) risked precipitating a crisis which might not be justified. Sadly, that was not borne out by experience.
Optimism and secrecy meant that we could not obtain proper funding from the Treasury for preventive measures and for research. The Treasury was not told the full extent of the fears about what might be going wrong. We could not prepare our European and other colleagues for the worst and we could not prepare our citizens for what might happen. Therefore, when the crisis broke, it was devastating.
The reason I have asked for tonight's debate is that when I look at what the Government are doing about new-variant CJD I recognise the same symptoms in what we did during the run-up to the BSE crisis. I see the same optimism and secrecy.
If we were making preparations for the worst, we would expect to see a large, open, public research programme. We would expect to see scientists all over the world swapping information openly and freely. In the best and most open scientific areas there is real work to be done at the fundamentals of science. That is certainly true in respect of new-variant CJD when we do not even know the basic disease mechanism.
The best examples publish their laboratory workbooks daily on the Internet. We have to wait a year, or a year and a half, for results on new-variant CJD to be published in a review paper. Asking the Government for information can be like drawing teeth. I asked the Minister a Question about the ages of people who have died of new-variant CJD and was told to the nearest 10 years. How can one use such data to draw a graph and see what is happening, given the number of people who have died of the disease? Even the basic, most simple, least important data is being held back and delayed by the Government. That is entirely familiar to me as we did exactly the same thing.
We ought to be looking at a research programme which will clearly and to everyone's knowledge provide a good picture of what is happening. The foundation of that must be prospective studies. It must be gathering data on a large group of us, testing us, seeing what is happening to us and then waiting to see how many of us die of the disease. Unless that is done, we shall lack the basic predictive data which enables us to work on the disease if and when it becomes relevant.
There is only one sizeable prospective study. It is a tonsil test covering 1,000 people, but it has been delayed for more than a year by a hospital ethics committee. The sense of urgency does not exist. I ask the Minister what progress has been made in evaluating the capillary electrophoresis test developed by Mary Jo Schmerr. He may remember that the 1177 Answer he gave was that the test had undergone some preliminary evaluation and that an application for full evaluation is being considered.
However, The Times of 3rd October—six months ago—reported a MAFF spokesman as saying that a team had been set up to evaluate the test and then begin a screening programme. In six months we have gone backwards We are not looking at a government with a sense of commitment or urgency to analyse what is going on with the disease.
If we arrive at a point of crisis, we must have diagnostics, cures and prospective studies well under way and co-ordinated; and we, the public, must know what is going ort. If not, we shall risk a catastrophe of confidence in the institutions of this country and in our future as individuals.
Another symptom of optimism and secrecy is things left undone. The noble Lord will have seen the article in the Sunday Times picking up the fact that we in this country are still feeding calves with blood, gelatin and tallow. We now know—we might not have known at the time the regulations were promulgated by the EU—that all those substances carry infection when the original animal is carrying BSE. How can we be feeding such substances to calves, which is the most vulnerable stage of a cow's life? How can we continue to do so when we have taken expensive precautions to try to reduce the risk of humans transmitting new-variant CJD in their blood, a course which has not been proven? We have ignored the certainty and alighted on the great uncertainty.
When dealing with BSE and new-variant CJD, we have always had a problem as regards the lack of coordination between MAFF and the Department of Health. Having responsibility for the one disease sited in two ministries was always a questionable decision, but this Government have gone further and sited it in three departments. The Food Standards Agency is to have its own axe to grind on the subject. The possibilities of co-ordination have been immensely reduced.
One of the basic things we need to know about TSEs is the strain of disease we are facing. The strain of TSE makes an enormous difference to the symptoms and to the progress of the disease. Presuming that the disease has come from cattle, which is almost certain, we need data about the strains of BSE in cattle. We have always been told that there is only one, but that assertion has been based on strain-typing nine cows—nine out of the hundreds of thousands which have died of the disease. There could be a significant level of infection from a different strain attacking the human population. We would not know about it because we have not done the basic research into the strains which exist in cattle.
One of the key actions to take at this stage in the BSE epidemic is to examine what is happening to the tail in order to make sure that there are no transmission mechanisms in cattle that we should be dealing with, thereby ensuring that the original source is gone for ever. But MAFF will no longer make predictions for the BSE epidemic beyond 2001; it is not even looking at the question of what will happen 1178 beyond that. When the Sunday Times asked it about those cattle born in 1996 which had contracted the disease—that is supposed to be at the end of the epidemic—MAFF refused to say in which month those cattle had been born.
That is symptomatic of a determination not to pick up the details in the hope and pervading optimism that we shall not need to know them because everything will turn out all right. We are not properly testing cattle at slaughter to discover whether they are carrying BSE. We are not running trials in sheep to discover whether they can catch BSE, what the symptoms are, and how we can pick them up in the national herd.
We are not looking at the brains of other species of food animals to see whether they, too, have TSEs or have been exposed to TSEs or whether, through our practice of feeding cows to them, they have picked up BSE in their turn. All those little things are being left undone because there is no stream of pessimism in the Government's thinking, any more than there was in ours.
Another symptom is evasive answers. I asked about blood donations. The noble Lord replied that there is strong epidemiological evidence that classic CJD is not transmitted through blood. That is not true. There is no evidence one way or the other, but there is certainly no evidence that it is transmitted through blood. However, even a combination of all available studies is not statistically significant. In many of them there are severe problems with the selection of controls, and some studies show that receiving blood from a person who has CJD protects that person against CJD. The selection of controls has been bad enough to allow that result through. The answer given by the noble Lord—in the best of faith, I am sure—does not accord with the evidence. It is a distortion of the evidence. We got away from that for a year or two after the break of the BSE crisis when there was a pathological attachment to openness and honesty. That seems to have gone, but it needs to be recreated.
Again, I asked about transmission from mother to child in utero of new-variant CJD in humans. The noble Lord replied that no confirmed or probable ca se had been reported. I read the newspapers. I know about this child, who appeared to have neurological symptoms after his mother had been diagnosed with new-variant CJD. I know that their symptoms are different from classic new-variant CJD. However, perhaps the noble Lord can tell me—I am sure that the Box could tell him—whether that child is met/met at codon 129 or whether that child is met/val? If that child is met/val, one would expect different symptoms and a different disease. Those data, which I am sure the Government have, have not been released.
What do I want the Government to do? I want the Government to be open. I want to make sure that all the Government's data are available to all and any researchers. I want people who research with government money to be open on a daily basis about what they are doing. I want the Government to take their decisions in public so that their errors may be 1179 exposed quickly and so that what, at the time, are reasonable decisions gain public support at the time so that they are not blamed if those decisions turn out to have been wrong. I want the Government to prepare for the worst. I want them to think through what it would be like if we had a major epidemic of new-variant CJD in this country.
Then I want the Government to talk that through with the Treasury so that proper funding is in place for preventive measures; with the European Union so that we do not have the "kick Britain" attitude that we had at the time that the BSE crisis broke; with the United States, whose attitude to trade and passage of peoples between the UK and America will be enormously important; and with life insurers, who will have a great deal to say if people start dying in large numbers from this disease.
I want the Government to be able to look back and say that everything that they have done is all that it should have been. I believe that if they follow the route of openness and preparedness, they will be able to do that and that we shall have a research programme that we all believe to be right and adequate and of which we can be proud. I believe that we would then have good decisions in place of the frightened and bad decisions that we seem to get at the moment. Above all, I believe that if the crisis breaks with this Government in charge, rightly or wrongly they will be able to blame us for BSE and get away with it. If this Government, with our example in front of them and in the clear knowledge of all that we did wrong, make the same mistakes, we shall suffer enormously as a country and this Government will be damned and doubly damned in the eyes of their people for ever.
§ 8.54 p.m.
§ Lord Clement-JonesMy Lords, I begin by congratulating the noble Lord, Lord Lucas, on securing this debate tonight. I pay tribute to him in his tenacious pursuit of the truth and proper action regarding new-variant CJD. He has raised a number of very important questions. Clearly, the noble Lord, Lord Lucas, has engraved on his heart the experience of the former government. However, I do not intend to go over some of that rather well-trodden ground and I do not believe that I wish to anticipate the results of the BSE inquiry, which we all await eagerly. I am sure that we shall debate it in this House in due course, and that will no doubt take us back to 1986 and probably beyond.
I believe that the real story started in 1996 when new-variant CJD was first recognised and described, whatever the rights and wrongs of the background to it. We now see that new-variant CJD is a disease that has terrible consequences. Slowly and surely, it destroys a patient's mental and physical control and leads to an early death. The recent Sunday Times article on 5th March, which I believe the noble Lord, Lord Lucas, referred to in his speech, described harrowingly how Janet and her child, Amanda, also with new-variant CJD, were slowly dying before the eyes of Sarah, who was both mother and grandmother 1180 in those circumstances. I must admit that that article made a considerable impact on me and I have no doubt that it did on many thousands of others.
Already, some 52 people have died from new-variant CJD. Tragically, those people were predominantly in their twenties and thirties. There is no doubt that the risks are taken seriously by this country and other countries. Indeed, the US Food and Drugs Administration has banned blood products from those who have merely visited the UK for more than six months after 1980. Certainly, that can be described as the "ultra-precautionary" approach.
However, the debate this evening mainly provides an opportunity to question this Government's approach to prevention and treatment of new-variant CJD. On these Benches we welcome a number of the steps already taken by the Government, such as the setting up of the BSE inquiry in the first place. However, I believe that the results of the inquiry are now nine months overdue. Can the Minister indicate when it will report?
Another matter that we welcome is the guidance issued in June 1999 on the danger of cross-infection from contact lenses. We also welcome the announcement of improvements to the care of new-variant CJD patients announced in December by the Minister of State responsible for Health, John Denham. However, will he follow up those February 1999 recommendations on the care and information needs of new-variant CJD patients? The Minister will recall that there is a strong recommendation for a key worker to be appointed at a very early stage as soon as new-variant CJD is diagnosed. I believe that those care and information recommendations should be a strong part of the new procedures that the Minister announced in December.
We also welcome the reissuing of guidance to coroners and others regarding the treatment of those who have died from new-variant CJD in the face of evidence of distress caused to families by inappropriate restrictions placed on funeral arrangements. That was a matter raised recently in the other place by my honourable friend Nick Harvey. We also welcome the agreement of the CMOs reached last December to monitor closely the incidence of new-variant CJD, as we do the new system of reporting by SEAC announced this March which will track the incidence of possible new-variant CJD among living patients, not only the deaths arising from CJD. I welcome the fact that the research appears to show that the tracking system is watertight.
Finally, we welcome the setting up of the Food Standards Agency today. I take the opportunity to welcome Sir John Krebs and his colleagues to their important task. I believe that they will play a very important role in relation to the food safety aspects of BSE/CJD.
However, there is still much uncertainty surrounding new-variant CJD. We are still at the foothills of knowledge in relation to CJD. I very much support the call by the noble Lord, Lord Lucas, for the 1181 maximum amount of openness in this respect. New research will no doubt end some of it, but there are still major questions to be asked of the Government.
What are the Government's most recent thoughts on the nature of the CJD infection? Does Professor Donaldson still stick by his view expressed last July and published last September that millions could still be at risk? Can we read anything into the fact that deaths from CJD went down from 17 in 1998 to 11 in 1999? Have we actually reached the peak? What is the best estimate from the Government and their advisors of the incubation period? Are the Government now convinced that the key cause of new-variant CJD was exposure to BSE? Do they consider that the research by the University of California and the Edinburgh Western General Hospital is conclusive on this matter? Is there a risk of vaccines causing new-variant CJD? That is tipped as something which the BSE inquiry may wish to discuss.
Furthermore, what about blood products, mentioned by the noble Lord, Lord Lucas? Not just blood products of animals but the general ban on the use of UK plasma in 1997 for haemophiliacs was welcomed. But what of fresh frozen plasma which is used? What other risks are there in relation to other blood products? Is the process of leucodepletion safe?
We need to answer all those questions. The noble Lord, Lord Lucas, raised a further question which needs to be answered. Is it now accepted that new-variant CJD can be transmitted from mother to child? If so, what preventive steps can be taken? I mentioned the case written up in the Sunday Times of 5th March. That did seem to indicate transmission of new-variant CJD from mother to child. It certainly behoves the Government to be taking active steps to ensure that prevention is strongly on the agenda.
What tests are available for use in the NHS? The noble Lord, Lord Lucas, also asked what tests are available to detect CJD. Is the tonsil test generally available in the NHS? Is there urgent evaluation of any other tests? How is the research which is being carried on by Imperial College and St Mary's Hospital proceeding on the matter of testing? How watertight is the current system of tracking cattle and their offspring? Is it really correct that some 90,000 cattle have simply "gone missing"? Are reports elicited by the noble Lord, Lord Lucas, that cattle are still being fed cattle products made of tallow, blood and gelatine actually correct? Does the Minister agree with Professor Collinge, who wrote in The Lancet last July:
that the risks of blood and blood products cannot be quantified".If so, how can the Government claim that they are taking a precautionary approach? What guarantee do we have that the events of the past few years will not happen again?There are many unknown aspects of BSE and CJD and there have been for many years. The public need to have a considerable degree of trust in politicians and scientists that the right course of action is actually being taken. To date, to be quite frank, that trust has not always been justified. I look forward to hearing what the Minister has to say.
§ 9.3 p.m.
§ Earl HoweMy Lords, the whole House should be indebted to my noble friend Lord Lucas for having secured a debate today on the subject which he has made it his business to research in depth. It is a deeply troubling subject, and if there is a single message that my noble friend would wish distilled from his admirable opening speech, it is—at the risk of misrepresenting him—that if ever there was an issue on which there is absolutely no room for complacency whatever, this is it. I hope and believe that the Minister's speech will reassure us that no such complacency exists, politically, scientifically or medically. But the issue of new-variant CJD does not stand still. As my noble friend has emphasised, we must constantly examine all new data and constantly look ahead.
The Question on the Order Paper urges us to look ahead to the possibility of a major epidemic of new-variant CJD at some point in the future. Our difficulty is getting our bearings on the likely scale of such an epidemic or indeed on whether any sort of epidemic will occur at all. At this stage we simply do not know what will happen. It is not even possible to make an educated guess, despite the theory of a causal link between BSE and CJD being now a virtual certainty. Shortly after the last election I attended a presentation given by senior statisticians from City University. Their research indicated that the total number of variant CJD cases was likely to be fewer than 100. That conclusion was based on an analysis of new-variant CJD cases to date and on a number of assumptions, the most significant being that the incubation period for new-variant CJD was relatively short.
However, that conclusion is by no means universally accepted. It is clear from published data that we cannot be at all certain that the incubation period for the disease is a short one. On an analogy with kuru, it may extend over a period of 20 or 30 years. While we can estimate the number of BSE-infected cattle that may have entered the human food chain in the early to mid-1980s, we do not know how much infected meat was consumed, nor the extent to which the species barrier between cattle and people has inhibited such infection. Similarly, there is some evidence that genetic susceptibility plays a part in the onset of CJD, but that does not mean that people with a different genetic make-up may not be infected with the disease and incubate it for longer. The fact that there have to date been only 52 deaths positively attributable to new-variant CJD is no indication at all that the optimists are right and the pessimists wrong. The Chief Medical Officer has warned that we could still be facing a large number of cases over several decades.
Therefore, predicting the course of the disease must be a priority. Currently there are programmes in train to devise a non-invasive test for BSE infection in live cattle and for pre-clinical new-variant CJD in the human population. I hope that the Minister can tell us something about these. We can also look forward to the results of biopsies of tonsils and appendices. Some 18,000 such samples taken from patients in the south west of England and the Lothian regions are being 1183 examined for the presence of abnormal prion protein. I was pleased to see a few days ago that ethical approval had been given to begin a further study of 2,000 tonsils. Will the Minister tell us about the timescale of this work and when the results are likely to be published?
Meanwhile, the paramount duty of government is to protect human health from the risk of infection. There are perhaps two principal spheres of action. The first is to ensure that food is safe. The measures that are in place relating to cattle are well known: the ban on animal protein in ruminant feed; the rule that cattle over 30 months cannot enter the human food chain; the cull of offspring of BSE-affected cows; the removal of specified risk material from all cattle at slaughter. Those measures are only as good as the rigour with which they are enforced.
I understand that the Meat Hygiene Service is confident that procedures at slaughter to ensure that banned meat and offal does not slip through the net are being observed conscientiously. However, will the Minister confirm that the checks on cattle at slaughter still include an inspection of teeth? Irrespective of the ear-tag and the date on the cattle passport, there is a need for a belt-and-braces approach to prevent overage animals from entering the food chain. What level of error or deliberate non-compliance on the part of farmers has been uncovered by the Meat Hygiene Service in recent months? What procedures are in force to check the safety of imported meat?
However, there are some worrying areas of uncertainty. It is still possible that BSE may have been transmitted to other agricultural species; notably, sheep. The symptoms of scrapie and BSE are indistinguishable. If BSE were to be found in the sheep population, the consequences would be extremely serious, not least because, unlike its occurrence in cattle, BSE infects almost the whole animal and not just certain organs. Is the Minister in a position to say whether large-scale tests are now under way; whether there are any plans to tag sheep; and whether, if BSE were to be found in sheep, consideration would be given to a cull? If he cannot comment in any detail now, will the Minister undertake to keep the House closely informed of developments under that heading?
I mentioned action in two spheres. The second sphere is to eliminate, as far as possible, the risk of transmitting new-variant CJD from person to person by medical means. Much has been done to forestall what is still only a hypothetical possibility. Procedures are in place to remove white cells from blood intended for transfusions and to source blood plasma from abroad. There are strict rules to prevent blood entering the blood supply from donors who themselves received blood from people who later developed new-variant CJD.
On a less theoretical level, there are strict precautions for the sterilisation or disposal of surgical instruments and for dealing with waste, spillages and accidents involving potentially infectious material in hospitals and other clinical settings.
1184 None of those precautions is failsafe but they are important safeguards nevertheless. Can the Minister say whether the guidance on safe working practices published in April 1998 is due to be updated and if so, when?
My noble friend laid great stress on the need for openness by government. I endorse that view without hesitation. His opinion of the culture within MAFF as one which inhibits such openness is perhaps, with all deference to him, somewhat jaundiced. I should not go that far. I believe that in MAFF there exists a desire to ensure that whatever information reaches the public domain is both robust and fully considered. MAFF has had a lot of experience of trying to rebut inaccurate scare stories and it has not always been successful in that. While it may not have appeared that way to some, I can say from my own experience that Ministers in the last government were insistent on the need for full disclosure of all findings on BSE as they emerged, whether good or bad news. Despite the worrying examples of evasiveness quoted by my noble friend, I hope that the present Government work to the same principle.
On a small but significant level, it is reassuring to see that the monthly statistics published by the Department of Health now include probable as well as confirmed CJD cases.
The real difficulty about disclosure is one which my noble friend tended to gloss over somewhat. It is extremely difficult to give the public a balanced picture of what the risk is when it is innately suspicious of government and fearful of what they think may happen. Presentation of statistics is the easy bit. But what we have not always got right is the language which accompanies such statistics to ensure that people have a proper understanding of what the figures are saying. Scientists are not necessarily the best people to articulate such language, even if the public tends to trust them more than it does politicians.
If I have a criticism of the last government, it is that they were not as aware as they should have been that their attempts to communicate the extent of the risk to human health posed by BSE were largely unsuccessful. The announcement in March 1996 that there was a prima facie link between BSE and new-variant CJD should not have come as such a shock when, for the previous 10 years, the precautionary measures put in place by government had been designed to anticipate that very finding.
That argues for the more effective dissemination of the results of government research, as my noble friend emphasised. I hope that the Minister will be able to tell us how that task is being tackled.
It is perhaps a tall order to ask government to prepare in detail for a set of events whose likelihood no one can predict. But my noble friend has made some very powerful points. One of the things that Ministers can do is to reassure us that should a sizeable epidemic of new variant CJD occur, resources will be found in both money and people for the proper care of patients.
1185 A paper by Dr Margaret Douglas and others published just over a year ago makes salutary reading. They found that the needs of CJD patients and their carers are usually not clearly defined; that there was poor co-ordination between professionals and a lack of essential information for families. One recommendation was that every patient with suspected CJD should have a key worker allocated to co-ordinate his or her care and especially to reassess the patient's needs as his condition develops, as it often does so extremely rapidly. It was suggested that the key worker should be a professional, such as a nurse or social worker with a good knowledge of local health and social services. I ask the Government whether those conclusions have been taken on board and whether they share my view that the availability of good palliative and hospice care for such patients should not be overlooked.
I do not doubt that much more could be said on this important topic. It is one to which we should return at appropriate intervals. For now, I hope that the Minister can provide us with a clear exposition of government policy.
§ 9.14 p.m.
§ The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath)My Lords, I thank the noble Lord, Lord Lucas, for having raised the issue of new variant CJD. He has spoken in a sense from experience, as well as from a great deal of knowledge. The friendly warning which he has given to the Government in relation to the dangers of complacency, optimism and secrecy is one which I well take. I hope that I shall be able to indicate to noble Lords that the Government take those matters with a great deal of seriousness. We are ever mindful of the need for rigour in terms of monitoring what is happening and planning for the future.
The noble Earl, Lord Howe, put his finger on the matter; that, in discussing these issues, we must bear in mind public confidence in all that we do, enabling us to give the public a balanced picture of risk in these important areas. I certainly hope that the approach we are taking and the openness that we are adopting to public debate in those areas, alongside the introduction just three days ago of the Food Standards Agency will enable an informed public debate about many of those difficult issues. None of us can be complacent in assuming that it is easy to enable an informed public debate on areas about which there is both understandable concern and, in some cases, susceptibility to rumours and to allegations which are often not proven but which nevertheless give rise to a great deal of public concern. That serves only to indicate the difficult balance in deciding on a sensible way of approaching the issues.
The noble Lord, Lord Clement-Jones, reminded us that it was in March 1996—only four years ago—that the first cases were confirmed. Since then, we understand that 53 people are known to have died of the disease. We are aware of a further 12 people still alive who are probably suffering from the disease. There are also two other probable cases where the 1186 sufferers have since died but pathological confirmation is still awaited. That adds up to a total of 67 known cases to date. But statistics alone can in no way describe a disease which is always fatal and which has caused and causes untold suffering both for the patients and for their families.
One of the particularly distressing features of variant CJD is the number of young people who have suffered terribly. Since May 1997 the British Paediatric Surveillance Unit of the Royal College of Paediatrics and Child Health has been working with the CJD Surveillance Unit and Addenbrookes Hospital, Cambridge to try to identify any possible variant CJD cases at the first possible moment. Each month, a survey is carried out of all 2,000 consultant paediatricians, to ask if they have come across any cases of progressive intellectual or neurological deterioration in under 16 year-olds. There is currently a 90 per cent response rate, including some nil returns.
Of the 602 cases investigated to date, only three definite or probable cases of variant CJD have been found. Results are published in the annual report of the British Paediatric Surveillance Unit. I should not pretend from that that we know the whole story. In helping to address our knowledge gap, I pay particular tribute to the work carried out by the government-funded National CJD Surveillance Unit in Edinburgh—the scientists who first discovered variant CJD. We work closely with them as they undertake their work of monitoring the incidence of the disease and looking for any trends which may be emerging.
The unit maintains close links with neurologists across the UK in their tracking of cases and reports findings regularly to the Government. In 1998, 17 confirmed deaths were reported from the disease. My understanding is that 1999 is likely to show a drop, with only 12 cases having been confirmed so far, although there may be one or two more in the pipeline. We can only cautiously welcome the news about last year's decline. However, in using the word "cautious", I take the point made by the noble Lord, Lord Lucas, because the disease can have a long incubation period of 20 years or even more, so we certainly cannot relax. The statistical modellers tell us that it may be at least a year or two yet before we shall be able to rule out significant numbers of people eventually succumbing to the disease.
There is the related question of diagnostic tests. There has been recent scientific progress in this area, in particular with the use of magnetic resonance imaging of the brain, and with tonsil biopsy performed at St Mary's, London. Those developments have enabled clinicians to be able to examine those clinically ill but still alive and provide a "probable" diagnosis of variant CJD. The CJD Surveillance Unit is then able to pass on statistics of such cases to the Government to enable figures to be published. We did that for the first time on 16th March, and we shall incorporate such information within our regular monthly press statements, the first of which is published today. That 1187 information provides a more current picture than hitherto, and helps us to get a better handle on what is happening with this disease.
I was asked about those who may be incubating the disease but have yet to show any clinical symptoms. How many are there and who are they? With variant CJD we are much hampered by the lack of a simple diagnostic test. Last September the Spongiform Encephalopathy Advisory Committee, or SEAC, identified the development of such a test as a priority. Although no imminent results are in prospect, studies are under way as part of the £26 million-worth of government-funded research to look into CJD and BSE issues during the coming year.
Meanwhile, and in answer to the comments made by the noble Earl, Lord Howe, analyses are taking place retrospectively of some 18,000 tonsil and appendix samples taken from routine surgical operations in the South West and Scotland. In that study, scientists are looking for the presence of abnormal prion protein, as there is some evidence that that may be detectable at the pre-clinical stage, although we do not know when. Results from the first 2,000 samples will be presented to a meeting of medical and scientific experts under the auspices of the Medical Research Council and the Department of Health later this month. An announcement about the findings will be made shortly thereafter.
Turning to the preventive measures that the Government are taking, we have to rely on the scientific advice that we are given, even when, in some instances, that has to be taken on a precautionary basis. Of course, the Government rely on SEAC in its provision of independent scientific advice. Given the theoretical possibility of some pre-clinical infection being present in the population, the possibility of person to person transmission of that infection cannot be ruled out. We have taken action on a precautionary basis to deal with that. All blood destined for transfusion from 1st November 1999 has had its white cells removed and all blood products are now sourced from non-UK plasma. SEAC has endorsed those measures. The Government have also taken steps with the optical profession to implement SEAC advice that, among other things, the single patient use of trial contact lenses should be adopted.
In addition, SEAC has recommended rigorous implementation of washing, decontamination and general hygiene procedures to be key preventive measures when dealing with surgical instruments. Again, we have issued a comprehensive package of guidance to the healthcare sector to underscore this message. I can tell noble Lords that we regard this as forming a part of infection control procedures within hospitals which we are determined to performance manage rigorously.
SEAC has highlighted that the theoretical risk of person-to-person transmission could be greatest from operations involving central nervous system and ophthalmic tissue, followed by lymphoid tissue. SEAC has also advised that, wherever practical, the use of disposable surgical instruments for such surgery is to 1188 be encouraged. We have met with surgeons and others to look at the practicalities of developing and implementing a single-use policy wherever this is seen as being realistic and we are taking this forward.
The noble Lord, Lord Lucas, asked what progress had been made on evaluating the test developed by Mary Jo Schmerr of the National Animal Disease Center of the US Department of Agriculture. I regret that I am not in a position to provide any further information beyond that I gave in my Written Answer. It is clear that before such a diagnostic test is put into use, we must be sure that it provides accurate and reliable results without giving what might be described as false positives. I am not able to predict when any of the blood tests currently being developed will be completed, although I am happy to ensure that the noble Lord is provided with as much information on progress as possible.
The noble Lord asked about information relating to the ages of new-variant CJD cases. I have to tell the noble Lord that one of the issues in relation to this information is that because of clinical confidentiality such information cannot be released in a form which could be linked to particular individuals. Furthermore, in response to the noble Lord's comments on the secrecy surrounding research in this area, I have to tell the noble Lord that, while I fully accept the need for openness, it is important to note that all TSE research projects currently completed and funded by public moneys are already listed on the MRC website. The site provides a breakdown of areas of research being covered, including those identified with the issues before us tonight, as well as issues concerning the annual costs of such research projects.
The noble Lord also raised the question of whether research ethics committees were inhibiting the development of such research. He mentioned in particular the research proposed by Professor Collinge. In this area it is important to ensure that all ethical considerations are taken into account with the utmost care. I believe that it would be wrong to ride roughshod over the normal processes of establishing a science-based ethical opinion on how such matters should be addressed. If, for instance, inappropriate short cuts were taken, the fall-out could be considerable, in particular if—as I have already suggested—an unreliable test produced false positives and thus caused unnecessary alarm.
However, I agree that we need constantly to review the performance of research ethics committees. Only two weeks ago I attended the annual conference of the Association of Research and Ethics Committees. The department provides some resources to support the work of those committees. I can assure the noble Lord that I shall continue to keep under review their work and progress because I accept the point about striking a balance between the need to ensure that necessary research is undertaken as quickly as possible and the need to ensure that a proper review of the ethics takes place.
1189 The noble Lord asked about a case reported about the possibility that TSE had been transmitted by a mother to a child in utero. I cannot report on individual cases. The case in question is a confidential matter between clinicians, patients and families. However, my understanding is that no child under the age of 13 has been reported as a probable or definite case of new-variant CJD.
I was asked by the noble Lord, Lord Lucas, about the feeding of gelatin and blood products to calves. I understand that United Kingdom rules on feeding stuffs are much tighter than those elsewhere in the EU. We ban the feeding of mammalian meat and bonemeal to all farm animals whereas the EU rules only prevent the feeding of MBM to a selected area. Certainly in accordance with EU rules, we allow the feeding of milk, allow, gelatin and blood products to ruminants and we believe that is in line with SEAC's advice.
I have dealt with the issue of blood transmissions. The noble Lord asked me about genetic testing. All probable and definite cases of new-variant CJD so far have been found to have been from methionine/methionine homozygous genotype and of the same genetic sub-type as the population. However, I cannot divulge the details of individual cases.
The noble Lord, Lord Lucas, also asked me about the testing of other animals for BSE. Of course, extensive research has been undertaken into the issue of sheep and BSE. My understanding is that BSE has not been confirmed as occurring in animals from the national flock. The possibility of BSE occurring in sheep has been recognised for some time, and for that reason precautionary controls on a number of specified risk materials from sheep carcasses have been recommended by SEAC and introduced over the past few years; SEAC keeps under review the research that could distinguish between BSE and scrapie infection in sheep. However, that work will take several years, and preliminary and interim findings will be coming along, as they do now, at intervals.
I was asked a number of questions about the issue of service provision. We are talking about a rare disease and our hope is that it will remain a rare disease, although we cannot be complacent, as the noble Lord said. We also know that this disease can be extremely 1190 distressing. We would all feel enormous sympathy for all the people who have suffered from the disease and for the families who have been affected. It is very important that we ensure that the National Health Service in particular is able to provide appropriate care and support.
The CJD Support Network, with government funding, provides support to families affected by CJD. The network issued guidance in 1998 to help to inform social service professionals. The need constantly to reappraise care needs in the light of families' wishes is one key message. The St. Mary's Prion Unit in London offers information, advice and support for patients, families and professionals. The Human BSE Foundation, with a grant from the Government, plays an active role in providing emotional and practical support to the families of patients. The CJD Surveillance Unit works very closely with the voluntary CJD Support Network. Earlier this year the unit appointed a care co-ordinator to provide a central source of advice for professionals and carers. This will help the unit further in carrying out its important role in providing expert advice on healthcare for all CJD victims.
The Government will very shortly be publishing some new guidelines, which are expressly intended for those healthcare professionals who are caring for CJD victims. I can say to your Lordships that it will mention the importance of having a named key worker in place as soon as possible.
I think it follows from all that I have said that this terrible disease is by no means an easy one to deal with. I believe that the noble Lord, Lord Lucas, has done a considerable service to the House in bringing to our attention many of the factors that need to be considered. His overwhelming message is to avoid complacency and over-optimism. I hope he will accept from me that I understand that we need to be careful in monitoring what is happening and in ensuring that we have the mechanisms in place to deal with problems that may arise.
I hope I have reassured the noble Lord. I am happy to engage in further discussions with him and thank the House for its tolerance in listening to my creaky voice for 20 minutes.
House adjourned at twenty-five minutes before ten o'clock.