Variant CJD
Good morning. The first item of business is a statement by Malcolm Chisholm on the development in variant Creutzfeldt-Jakob disease. The minister will take questions at the end of his statement. There should therefore be no interventions.
I am grateful for the opportunity to inform the Parliament of the circumstances surrounding a blood transfusion incident involving variant Creutzfeldt-Jakob disease and of the action that is now being taken.
The background is that, 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 in England and Wales. Shortly after that, the donated blood was transfused into a patient who underwent surgery for a serious illness. Three years later, in 1999, the donor developed variant CJD and died from it. The recipient of the blood died in the autumn of 2003.
Initial post-mortem examination of the recipient of the blood showed changes in the brain indicative of CJD. Further examinations and tests confirmed the diagnosis of variant CJD. The link between the donor and the recipient was first reported to officials in the Department of Health in England on 9 December 2003, at which time the diagnosis of variant CJD in the recipient was still being confirmed.
I was first alerted to the incident on Friday 12 December. In the light of the statement delivered yesterday in the House of Commons by the Secretary of State for Health, I thought it right that the Scottish Parliament should be similarly informed and made aware of the action that has been taken in Scotland and in the rest of the United Kingdom.
In the light of the facts that I have outlined, it is possible that the disease was transmitted from donor to recipient by blood transfusion. I wish to emphasise, however, that that is a possibility and not a proven causal connection. 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 thus impossible to be sure what the route of infection was. However, I am advised that the possibility of transmission being transfusion related cannot be discounted, albeit that this is the first report from anywhere in the world of the possibility of transmission of variant CJD from person to person via blood.
As yet, there is no blood test for variant CJD. There is therefore no way of screening blood donations for the presence of the CJD group of diseases. In recognition of that, since 1997, a range of precautionary measures—based on expert advice—has been put in place. It might be useful if I briefly rehearse them. In 1997 a research study, the transfusion medicine epidemiology review, was funded to examine links between all variant CJD cases and any form of blood transfusion. It is through that study that the association between the two patients was identified. Since 1997, all cases of variant CJD that are reported to the national CJD surveillance unit and which are diagnosed as having "probable" variant CJD result in a search of blood donor records. If the patient has given blood, any stocks of that blood are immediately destroyed.
On 17 July 1998, a £70 million programme was introduced to remove most of the white cells from blood that is destined for transfusion. That process of leucodepletion was progressively implemented by the Scottish National Blood Transfusion Service and completed by the end of August 1999. On 12 November 1998, a further £30 million programme was announced to phase out the use of UK-sourced plasma in the manufacture of blood products. From the end of September 1999, all blood products in Scotland have been made using plasma that is sourced from the United States of America and Germany. On 17 December 2002, to ensure continuity of supply, the Department of Health purchased the largest remaining independent US plasma collector, Life Resources Incorporated.
As indicated yesterday by the Secretary of State for Health, the National Blood Service informed the Department of Health that 15 people in England and Wales had received donations of blood from donors who subsequently developed variant CJD. In Scotland, two similar cases are known to us. Of those individuals, we have been informed that some received blood after leucodepletion had been implemented and others before that happened. The earliest such transfusion was in 1993 and the latest in 2001. All will be told about the circumstances of their case and will be given the opportunity to discuss the risks with an expert counsellor. The Scottish centre for infection and environmental health, supported by the Health Protection Agency, is in the process of contacting the affected patients in Scotland.
Of course, other patients, including haemophiliacs, will have received plasma products before plasma was sourced from the USA and Germany. They will have received products that, because they are derived from the large pools of plasma that are donated from many thousands of people, are heavily diluted. The UK-wide CJD incidents panel considers the risks for this group to be even lower than it is for those who received whole blood.
It is very difficult to trace all individual recipients of products that were made from those plasma pools, but the incidents panel will be advising on a case-by-case basis which recipients will need to be contacted as the necessary information becomes available. Those people will also have the opportunity for a discussion with an expert on an individual basis.
These are very significant arrangements that are designed to counter the possibility of transmission from blood. The need for continuing vigilance remains, however, and the relevant expert groups have been considering whether further measures are required in relation to variant CJD and blood.
In October 2003, our expert advisory 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 giving blood, was not necessary. However, in the light of the present case, the committee was asked to look comprehensively at whether further precautionary measures could be taken that would not adversely impact on the safety or availability of blood. Meanwhile, in Scotland, we have asked the Scottish National Blood Transfusion Service to begin to assess the implications of deferring the taking of blood from those who have received transfusions.
In conjunction with the other health departments, we are also initiating action to consider whether the use of blood and blood products can be confined to situations in which, medically, that is absolutely needed. Although that has been an on-going activity for some time, it will now be given added impetus. We have been concerned to ensure that people who may be worried about the implications of this incident are given appropriate advice. The NHS helpline has therefore been briefed with relevant information and the chief medical officer has written to health professionals updating them on the present situation. We will take any further appropriate steps to inform and reassure people who remain concerned.
Finally, I emphasise that this tragic case must be seen against a background in which, since 1996, some 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. A wide range of measures is routinely used to reduce the risk of transfusion by screening for HIV/AIDS, hepatitis B and C and other infections. Indeed, we are generally regarded internationally as having a very safe blood service, especially because of our precautionary approach. That said, we will continue to strive for yet further improvement.
The minister will now take questions on the issues that were raised in his statement. I will allow about 20 minutes for the process.
I thank the minister for the advance copy of the statement. His prompt decision to make a statement this morning is to be welcomed
Given that scientists have warned that people living in Scotland are twice as likely to develop variant CJD and that there is, as yet, no blood test for CJD and therefore no way of screening blood donations for the presence of CJD, what further precautionary steps will be taken to safeguard our blood supplies to ensure that they are not a means of spreading variant CJD?
Furthermore, the minister said in his statement that the expert advisory committee on the microbiological safety of blood and tissues for transplantation advised that it was not necessary to stop people who have received blood transfusions giving blood, but that that is now under review. What are the implications of excluding that group of people from giving blood and when will the SNBTS complete its assessment of the issue? Given the fears that will be raised about the issue in the public domain, how can the public be reassured that our blood supply is safe? What action will the Executive take to reassure the public?
I thank Shona Robison for those important questions—they go to the heart of the matter.
The simple answer to Shona Robison's questions on the advisory committee on the microbiological safety of blood and tissues for transplantation is that it will act soon and quickly. The committee has been asked to come up quickly with its view on this important matter. All members will accept and agree that the correct approach is to ask the United Kingdom experts to examine the matter and it is important that the committee comes up with a view very quickly, in the light of the new knowledge. I discussed that point yesterday with Melanie Johnson, the Parliamentary Under-Secretary of State for Public Health in England, and we agree that that must and will happen quickly.
On potentially excluding people who have received blood transfusions from donating blood, we have—as I indicated in my statement—asked the SNBTS to begin to assess the implications of that. Again, that will be done promptly and urgently.
On reassuring the public, we must be honest about the fact that, owing to the lack of tests for variant CJD, we cannot be at all confident about the extent of the problem. In relation to blood, the figure that I quoted at the end of my speech puts the matter in context. Twenty four million units of blood or blood components have been given to patients since 1996, and out of those 24 million units this is the only such incident—I remind members that a causal connection is only a possibility. We should explain the context to the public, while following the precautionary principle. That is why we have asked for urgent pieces of work to be done by the SNBTS and the advisory committee on the microbiological safety of blood and tissues for transplantation.
I congratulate the minister on giving the Parliament such a clear statement of the current situation. It is important that we use the opportunity this morning to reassure the people of Scotland that our blood transfusion systems provide an excellent service. We must take the measures that are necessary to maintain that confidence.
In the light of recent shortages in supplies of blood, will the SNBTS seek—on an emergency basis—to identify people volunteering to give blood who may have had a transfusion in the past so that, on a precautionary basis, blood can be held and processed separately at an early stage? Would not that allow a decision to be made about how any risks will be dealt with when the advisory committee on the microbiological safety of blood and tissues for transplantation has done its work?
The minister talked about the sources of plasma being countries with low risks of variant CJD contamination, such as the USA and Germany. In the light of the possible shortfall in supply, can the minister tell us whether other countries would be in a position to assist us in maintaining the volume of safe blood products? What measures are being taken to ensure the safety of that supply?
I thank David Davidson for his questions. As I indicated, the SNBTS has begun its work on assessing the implications. I am sure that part of that assessment will relate to the second point that David Davidson raised. If the assessment shows that it may be difficult to secure enough blood from this country, the SNBTS would have to consider the implications of that, as would the Executive. We must let the SNBTS do that work, and David Davidson's point must be considered within that broader context.
That leads back to David Davidson's first point, which is that it becomes even more important that blood is donated in this country. We all support that and we welcome the publicity that has been given, particularly at this time of the year, to blood donation. I am sure that we would like to thank all the people who generously give blood.
On David Davidson's other point about identifying those who have had a transfusion, I am confident that the SNBTS will do that in its current work.
I thank the minister for coming to the chamber to make a statement as soon as practically possible after the statement that was made yesterday in the House of Commons. However, when issues of such importance affect the people of the United Kingdom in future, could we bear it in mind that there should be more co-ordination between statements made in the House of Commons and statements made in this Parliament? It is important that we get the co-ordination right.
The fact that there has been a gap of a few hours between the two statements is not a major issue. It was more important that we should do all the necessary preparation in Scotland. Obviously, we plan to do that. The fact of the matter is that the statement was made in the House of Commons slightly more quickly than we anticipated. I do not think that that is a major issue.
I thank the minister for his statement, which reminds us of the need to maintain our awareness of this most devastating of conditions and not to be complacent about variant CJD. He will know of my own interest in the subject and that two of my constituents have lost a loved one through variant CJD. Is he aware of the Human BSE Foundation, which is the leading charity representing families affected by the disease throughout the UK? Is he aware that Strathclyde has the highest incidence of variant CJD in the whole of the UK?
Although the Human BSE Foundation receives a modest grant of about £30,000 from the Department of Health, it will be funded only for a further two years and will have to rely on charitable donations after that. Graham Steel, the vice-chair of the Human BSE Foundation, has recently written to me and to the minister. In the light of today's development, I ask the minister to look favourably on the possibility of providing direct support for the Human BSE Foundation here in Scotland.
I thank Ken Macintosh for drawing the information about Strathclyde to the attention of the Parliament and for speaking about the Human BSE Foundation. I shall look closely at the correspondence that he mentions, now that he has drawn it to my attention. I certainly applaud all the work that the Human BSE Foundation does on this important matter.
The minister has correctly emphasised the importance of the safety of our blood supply. He will recognise that at this time of the year in particular there are problems with the quantity of blood that is donated in Scotland. We currently have dangerously low supplies and the publicity that may be generated by this case could undermine blood donation even more. In the light of that, will he consider launching an urgent, high-profile, nationwide campaign to encourage even more blood donation in every part of Scotland, because people's lives depend on it?
Although Tommy Sheridan expresses the concern that this case might undermine blood donation, we all hope that it might have the opposite effect. Issues have been raised about people who have had transfusions, but it is clear that the vast majority of people have not, so there is no question mark over their donation of blood. As I have indicated, I praise the campaigns that have been conducted by the SNBTS and I support and encourage further publicity on this important issue.
I welcome the minister's timely statement. He says that we will no longer provide blood products except where medically absolutely necessary. Previously, blood products have been provided prophylactically to a range of people, including people who receive gamma globulin boosts prior to travelling to medically dangerous parts of the world. What steps are being taken to identify people who may have had blood products that have not been provided through the normal medical service to ensure that they are aware of any risks to which they may have been exposed?
The first point that I made on that matter related mainly to blood transfusions given during operations, and I understand that that is an area in which Scotland has been making more active progress than other parts of the United Kingdom have. The principle that is now followed is that blood transfusions are, of course, given where necessary, but perhaps not quite so readily as in the past, because the medical view in Scotland now is that they used to be given more often than was necessary. Further action will be taken to ensure that blood transfusions are given only when they are necessary, not when other procedures and processes that modern surgeons can carry out can be used. That was my main point on that matter.
I do not know whether I took in the whole of Stewart Stevenson's second point on blood products. I referred in my statement to blood products in the pre-1999 situation, but I will look into any other issues on the sourcing of blood products and try to give him a fuller reply in writing.
The minister and several other members have referred to the current shortage of blood supplies. Given the fact that any further limitations on who is allowed to give blood might have undesirable implications, will he look into whether those who are not allowed to give blood because of their age, such as the Presiding Officer and I, could supplement the supply of blood?
I will be in that category soon as well, but it is not for me to give a view on that matter: it is for the clinicians to decide on it. However, I will communicate Phil Gallie's point to the chief medical officer. The best way in which I can reply to Phil Gallie will be to send him a letter with the medical view of his suggestion.
We should obviously start by extending our sympathies to the two people in Scotland who are about to be given the news that they may have received contaminated blood, and we should be especially concerned about that at this time of year. What discussions have taken place, and with whom, about the ethical dilemma that arises from vCJD not yet being curable? What resources will be allocated to those patients and to addressing the ethical questions? What resources are being devoted to research into developing a screening mechanism for vCJD in blood?
I am sure that we all join Carolyn Leckie in extending our sympathies to the two individuals who are involved and, indeed, to all the other individuals and families who are affected by vCJD.
On her next point—if I understand it correctly—there is a CJD incidence panel, which has met for some time and comprises not only clinicians but ethicists and others. It has been considering what to do about informing people about such situations, particularly as there is no cure for the illness. Therefore, the difficult question of when we inform people has been considered.
Research into a screening tool continues. The fact of the matter is that no such screening is available at present. It is being investigated, but I am afraid that I have no good news to report on the matter at present.
What information is given to a potential recipient of a blood transfusion, or to someone who is authorised to consent to one on their behalf, so that consent can be fully informed?
Consent is central, perhaps far more than it was in the past, but I will have to write to Christine Grahame about the precise information that is given.
If we were to stop taking blood for transfusions from those who have received one, how quickly could that be implemented and what implications would it have for the availability of blood for transfusion? What percentage of the population has had a transfusion—is it, for instance, 1 per cent, 10 per cent or 20 per cent?
That, too, is a central question, and the SNBTS has already started to work on it. The SNBTS is considering the implications of such a change, which will include the time scale in which it could be implemented. The conclusions of the deliberations of the advisory committee on the microbiological safety of blood and tissues for transplantation and of the SNBTS's work will be communicated to the Parliament at the earliest possible opportunity.