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Lord Grocott: My Lords, perhaps I may say a word about timings on the two timed debates, which, I regret, were omitted from the note that noble Lords will have seen. However, none of this will come as any surprise to anyone.
The first debate on maritime policy is time limited to two and a half hours. That means that, with the exception of the winding-up speech, which can last up to 20 minutes, all speeches should be limited to a maximum of 15 minutes. In the debate on road deaths and casualties, which is again time limited to two and a half hours, with the exception of the opening speech by the noble Baroness, Lady Scott of Needham Market, which may last 15 minutes, and the winding-up speech of my noble friend Lord Davies, which may last 20 minutes, all speeches should be limited to 12 minutes.
"In March 1996, a blood donor, who was at the time free of the signs of variant CJD, donated blood to the National Blood Service. Shortly after that, the donated blood was transfused into a patient who underwent surgery for a serious illness. In
"The donor showed no signs of variant CJD at the time the blood was given, but developed the disease three years laterthat is, in 1999and died from it. The recipient of the blood died in the autumn of this year.
Initial post-mortem examination of the recipient of the blood showed changes in the brain indicative of CJD. Further examinations and tests of this patient's brain confirmed the diagnosis of variant CJD. The link between the donor and the recipient was first reported to officials in my department on 9th December 2003 at which time the diagnosis of variant CJD in the recipient was still being confirmed.
"I was first alerted to the developments on Friday 12th December and was briefed by the Chief Medical Officer on Monday and Tuesday this week. Today I am bringing this information to the House at the earliest opportunity. I have given and will give the minimal clinical details of the recipient, because the family has indicated that it wishes to have its privacy respected.
"In the light of the facts I have outlined, it is therefore possible that the disease was transmitted from donor to recipient by blood transfusion in circumstances where the blood of the donor was infectious three years before the donor developed variant CJD and where the recipient developed variant CJD after a six-and-a-half-year incubation period. This is a possibility, not a proven causal connection, because it is also possible that both individuals separately acquired variant CJD by eating BSE-infected meat or meat products.
"This is a single incident, and it is possible that both individuals acquired variant CJD by eating infected meat products, but it is impossible to be sure which was the route of infection. However, the possibility of this being transfusion-related cannot be discounted. That is the conclusion of the Chief Medical Officer and experts who report to me.
"It is because this is the first report from anywhere in the world of the possible transmission of variant CJD from person to person via blood that I thought it right to come to the Dispatch Box to inform the Houseeven if only on a precautionary basis.
"This incident was discovered by good surveillance. In 1997 the Department of Health funded the Transfusion Medicine Epidemiology Review study to examine links between all variant CJD cases and any form of blood transfusion. It is through this research study that the association between these two patients was identified. I should also point out that this emphasises the importance of post-mortem examination. Without it we would never have known about these matters. I would like to thank our NHS pathologists for their expertise and constant vigilance.
"I can inform the House about matters which some will already know. There is as yet no blood test for variant CJD, or for that matter BSE, let alone one that could detect the disease years before symptoms develop. So there is no way yet of screening blood donations for the presence of the CJD group of diseases.
"Fortunately, however, a range of precautionary measures have been put in place by the Government since 1997, even though there was at that time no evidence of the risk of person-to-person transmission of the disease via blood. For the benefit and reassurance of the House, it is right briefly to set out the action that has been taken to date and the further action that we now propose.
"First, since 1997 all cases of variant CJD that are reported to the National CJD Surveillance Unit and diagnosed as having "probable" variant CJD result in a search of the National Blood Service blood donor records. If the patient has given blood, subsequently any stocks of that blood are immediately destroyed.
"Secondly, on 17th July 1998, acting on expert advice, the Government announced a £70 million programme to remove most of the white cells from blood destined for transfusion. White cells were considered by experts at the time to be a potential source of infection. This process of so-called leuco-depletion was then a highly precautionary measure to reduce what was then a hypothetical source of infectivity. The process of leuco-depletion, that is removal of white blood cells, was implemented by the National Blood Service over time and completed by October 1999.
"Thirdly, on 12th November 1998, again acting on expert committee advice, the Government announced a £30 million programme to phase out the use of United Kingdom-sourced plasma in the manufacture of blood products. This was at the time, in the absence of any defined risk, another highly precautionary measure. Therefore, from the end of 1999 all blood products have been made using plasma sourced from the United States of America. To ensure continuity of supply the Department of Health purchased on 17th December 2002 the largest remaining independent US plasma collector, Life Resources Incorporated, as part of our attempt to ensure plasma-related resources were derived from outside the UK.
"Fourthly, the National Blood Service has informed us that 15 people received donations of blood from donors who subsequently developed variant CJD. Of the 15 individuals, we have been informed that five received blood after leuco-depletion had been implemented, the remainder before. The earliest such transfusion was in 1993 and the latest in 2001. Working with the National Blood Service, the Health Protection Agency is in the process of contacting these individuals. All will be told about the circumstances of their case and have the opportunity to discuss the risks with an expert counsellor.
"Many more patients of course, including haemophiliacs, will have received plasma products before plasma was sourced from the USA. They will have received products derived from large pools of plasma donated from many thousands of people and thus heavily diluted. The UK-wide CJD Incidents Panel considers the risks for this group to be even lower than for those who received whole blood. It is very difficult to trace all individual recipients of products made from these plasma pools. However, the CJD Incidents Panel will be advising on a case-by-case basis which recipients will need to be contacted as the necessary information becomes available. This group of patients will also have the opportunity for a discussion with an expert on an individual basis. Any person with concerns may ring NHS Direct on 0845 4647.
"Fifthly, before these events expert groups were already deliberating on whether further measures were required in relation to variant CJD and blood. In October of 2003 our expert committee on the Microbiological Safety of Blood and Tissues for Transplantation advised, on the basis of a risk assessment, that further action, such as stopping people who have received a blood transfusion from giving blood, was not necessary.
"However, in the light of today's statement, we have asked this committee to look comprehensively at whether further precautionary measures could be taken which would not adversely impact on the safety or availability of blood.
"Sixthly, it is apparent that much more blood and blood products are used clinically than need to be. There have been many past attempts to reduce the use of blood to situations where it is absolutely needed medically, but these have been only partially successful. I will be asking the National Blood Service to have urgent discussions with the medical Royal Colleges and NHS hospitals to address this area of clinical practice. More appropriate blood usage will reduce all the risks associated with blood and will make more effective use of our precious blood supplies.
"A finding of this kind, albeit one whose full medical significance is still far from clear, inevitably will give rise to concern. It is therefore important that this House and the wider public take account of the wider context in two respects.
"First, since the events in 1996 approximately 24 million units of blood or blood components have been given to patients in the United Kingdom. Blood transfusion can be a life-saving treatment, but no medical treatment is free of all risks. Indeed, it is an unfortunate fact that already each year approximately 12 people die as a complication of blood transfusion. Many people receiving blood transfusion are already very ill, some in life and death situations.
"A wide range of measures are routinely used to reduce the risks of transfusion by screening for HIV/AIDS, hepatitis B and hepatitis C and other infections. For specific high-risk patients, even more detailed screening takes place.
"These wider measures should be seen in the context of the precautionary action also being taken on variant CJD and a recognition that so far we have only one single report of a possible link between a single donor and a single recipient.
"We are generally regarded internationally as having a very safe blood service, especially because of our precautionary approach to screening for infection, careful donor selection and the tradition of volunteering in this country, which means that our donors generally have a lower incidence of many viral diseases compared to those in other countries who are paid for their donations.
"Secondly and finally, as for the wider situation for variant CJD, thankfully we have not so far seen the thousands of cases of variant CJD that some projections suggested. As of 1st December 2003, there have been a cumulative total of 143 cases of variant CJD in the United Kingdom. Over the past three years, the annual number of new cases has fallen each year. However, there should be no complacency. It remains premature to conclude that the epidemic has peaked and any single case of variant CJD is tragic for the patients and families concerned.
"I hope that my Statement has given the House a clear and accurate account of this finding in the full context in which it needs to be seen. I have asked the Chief Medical Officer to oversee the further work and investigation that is required and to keep me closely informed, and the House may be assured that I will of course keep it informed of any major developments in this area".
Earl Howe: My Lords, I thank the Minister for repeating the Statement, which is both significant and disturbing. While it was helpful in explaining the facts surrounding the transfusion and the possible transmission of CJD by the donor to the recipient, and in explaining the actions that the Government are taking, one or two questions inevitably arise.
My first question relates to risk. The Minister sensibly thought to put the scale of the risk from contaminated blood into context and mentioned a number of safeguards already in place. Clearly, we all welcome those. As yet, we are dealing with one possible case of transmission of variant CJD by blood. So far, transmission by this route is only a hypothesis, but there may be a genuine causal link and the Government must act as though there is.
On the incidence of variant CJD in this country, I welcome the fact that the statistics do not show an increase over the past few years but show a slight fall. Notwithstanding that, is there a geographic bias or pattern to variant CJD cases recorded in the UK?
I note that the Health Protection Agency is in the process of contacting the 15 individuals who received blood donations from donors who subsequently went on to develop variant CJD. To inform them of the possible risk of their developing variant CJD does not seem to me to be an ethically straightforward decision. Some might argue that it would be better for those people not to know because it will only give rise to psychological and emotional pressure over a long time. Clearly those individuals must be prevented from donating blood, but I would have thought that to be a separate issue. Will the Minister comment on that point?
Finally, the Minister mentioned that the expert committee has been tasked with considering what further safeguards can be put in place. Can that matter conveniently be reported to your Lordships' House by means of an inspired Written Answer in Hansard? It would be helpful if the Minister could take that suggestion away with him.
Lord Clement-Jones: My Lords, I, too, thank the Minister for repeating the Statement and the Secretary of State for bringing these facts and findings to both Houses so speedily. I, too, welcome many aspects of the Statement, in particular the fact that we are not faced with an epidemic of vCJD. However, the Minister having said that the Government are acting in accordance with the precautionary principle, I feel bound to ask questions which probe whether it does in fact constitute a full precautionary principle.
The Minister will be aware that during the past year I have asked many questions on blood safety and I feel that many questions arise out of today's Statement. First, some factual questions arise in following up the incident. Have other people who have received blood from the same donor been followed up? The Minister said that 15 people who had received blood, which I presume was from another set of donors, have subsequently developed vCJD. Is there an automatic record-keeping process to monitor follow-up whenever a case of vCJD is identified, indicating whether the person has donated blood?
Many of us welcome the Government's commitment to imported fresh frozen plasma for young babies born after 1996. However, it appears that that is not universally available and administered across the UK, despite the announcement made some considerable time ago. It will be useful to have the Minister's clarification on that.
It would also be useful if the Minister could expand on the availability of a vCJD blood test. Not only is such availability of great importance, as is research and government funding, but also the contingencies the Government are making. If such a test becomes available, what will happen as regards public perception? Will blood donors be reluctant to submit themselves to such tests? What precedents can we rely on, and what contingency plans is the National Blood Authority making in the circumstances?
It is peculiar that we are dealing with a panel report that is more than two years old. I have not had time to probe the matter since the Statement was announced, but it seems peculiar that it has taken two years for the report to come to light.
Increasingly, in many countries, people are entitled to store their own blood in blood banks against the contingency that they may need it in future. That is an eminently sensible procedure that gives people the satisfaction of knowing that their own blood is being transfused to them. It would be useful if the Minister expressed a view on that.
My final point is the key thrust of my comments today. Virtually every question that I have raised since last September has been on viral inactivation of fresh frozen plasma. I have asked around 30 questions. On each occasion the Minister, his predecessors, and indeed the Minister's surrogate, the noble Baroness, Lady Andrews, responded that viral inactivation was not necessary. The implicit reply has been that it is not proportionate to inactivate fresh frozen plasma virally. We have seen contingenciesthe use of US blood and other ways of dealing with the issue. Taking out white blood cells is another such solution. I recognise that there are two infections that one cannot get rid of by viral inactivation, but the thrust of my questions has been that viral inactivation is almost foolproof and is an absolute necessity. That is where I differ from the Government in regard to the precautionary principle. A true precautionary operation would be to ensure that we virally inactivated our fresh frozen plasma.
In response partly to the noble Earl's question about computer modelling and other questions from both noble Lords, I should say that the CJD Incidents Panel has gathered information and tried to make a complicated risk analysis of people who have been transfused and a much larger pool of plasma recipients. Plasma is a pooled product; it comes from a much wider pool of people who have given blood. The
The CJD Incidents Panel has used the information that it has on people who may have had a transfusion of blood or blood plasma from someone subsequently found to have variant CJD in order to look at the risks for that patient. That risk is changing after leuco-depletion. We have two groups of people in the risk analysis: those who preceded the 1999 changes of leuco-depletion and the removal of white cells, and those who did not. This is an extraordinarily complicated risk analysis to set out in detail to noble Lords in the circumstances, but I will be happy to write to noble Lords to outline in more detail the basis of the analysis.
I cannot give the number of recipients who were also donors, but I will look into the matter and, if the figure is known from this kind of risk analysis, I shall include it in my response. There is full traceability. The fact that we can make a Statement about the 15 people demonstrates our capacity to track people in those circumstances. It is a trickier job in relation to the much larger numbers of plasma recipients, but the CJD Incidents Panel is working on that.
The noble Earl asked about the ethically difficult decision whether to tell the 15 people involved. It is a difficult issue, but if the risk analysis suggests that an individual is highly unlikely to be at risk, it may be decided not to make the information known. However, at present, the starting premise is that people probably ought to be told and will want to know about the risks to which they may be vulnerable. Work to track down the individuals is going on with that intention.
As I said, we have put a lot of work into working with expert committees and seeking expert advice. It will be up to those committees to advise the Government on some of the extra safeguards that the noble Lord, Lord Clement-Jones, mentioned. I am certainly willing to assure noble Lords that, as more information in this area becomes available to us, we wish to put it into the public arena by such means as the noble Earl proposedan arranged Written Answer. The Government certainly wish, as I hope the Statement indicates, to disclose fully any new information about safeguards that can be taken.
I must respond to several issues that the noble Lord, Lord Clement-Jones, raised. As I understand it, one other person received blood from that same donor, but that person subsequently dieda long time ago, before we knew that that person was at risk and before the donor died. We have no additional knowledge other than that there was another case.
Virally inactivating plasma is one of the precautionary issues that the Government will study, and on which we are seeking expert opinion. When we have that expert opinion, we will make the information available.
In the time available, I have tried to respond to as many questions as possible. I was asked why it has taken two years to publish the report. The matter was referred to the CJD Incidents Panel, which has conducted a very complicated risk analysis. The panel returned with the results only recently, and we put that information in the public arena as quickly as possible when we knew about the episode.
Lord Chan: My Lords, I thank the Minister for that report. I wish to ask him about how the Health Protection Agency works with the National Blood Service. As the Minister said, it is important that we have a broader review on the use of blood. What steps are being taken to ensure that the clinical guidelines for the use of blood and blood products are implemented? Is there any monitoring? Will there be an overall review of other types of infection and reactions from blood products that can take place through transfusion?
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