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From: TSS (216-119-136-52.ipset16.wt.net)
Subject: Re: CJD/TSEs/MADCOW BLOOD -- PRICE OF POKER GOES UP (they have gambled too long)
Date: December 18, 2003 at 6:15 am PST

In Reply to: Re: CJD/TSEs/MADCOW BLOOD -- PRICE OF POKER GOES UP (they have gambled too long) posted by TSS on December 17, 2003 at 6:44 pm:

vCJD: Blood Transfusion Incident

3.58 p.m.

Lord Warner: My Lords, with permission, I wish to repeat a Statement made by my right honourable friend the Secretary of State for Health in another place. The Statement is as follows:

"With permission, Mr Speaker, I wish to make a Statement about a
blood transfusion incident involving variant Creutzfeldt-Jakob
Disease (vCJD). It may assist the House if I begin by setting out
the basic facts before discussing the implications.

"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

17 Dec 2003 : Column 1170

continuing my description of the events to the House, I will from
now on refer to those individuals as the 'donor' and the
'recipient' of the blood.

"The donor showed no signs of variant CJD at the time the blood
was given, but developed the disease three years later—that is, in
1999—and 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 House—even if only on a precautionary basis.

"This incident was discovered by good surveillance. In 1997 the
Department of Health funded a research study 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.

17 Dec 2003 : Column 1171

"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.

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"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.

17 Dec 2003 : Column 1173

"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".

My Lords, that concludes the Statement.

4.12 p.m.

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.

In the light of that, will the Government seek to commission some computer modelling on the scale of any enhanced risk posed by these findings? On that

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issue, the Minister mentioned that all probable cases of CJD are subject to a search of the National Blood Service blood donor records to establish whether the person was ever a donor. For every such case, will the question of whether the individual was ever a recipient of blood also be investigated? That is important in advancing our knowledge of the epidemiology. Will the Minister confirm that there is full traceability for all blood donated in the NHS?

The Statement reminded us that all blood plasma used in the NHS is now sourced in the USA. Will the Minister confirm that no cases of variant CJD have been recorded in the United States?

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.

4.16 p.m.

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?

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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 contingencies—the 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.

4.22 p.m.

Lord Warner: My Lords, I am grateful to both Front-Bench spokesmen for their thoughtful responses on this particularly difficult issue.

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 incidence 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

17 Dec 2003 : Column 1176

Government's medical and scientific advice is that pooling reduces by dilution the risks to recipients. The highest risk applies to direct blood transfusion rather than use of plasma products.

The CJD incidence 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 incidence 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 proposed—an 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 died—a 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.

I am not sufficiently expert to know the pros and cons of people storing their own blood, but I will be happy to look into the matter and to write to the noble Lord, Lord Clement-Jones.

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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 incidence 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.

4.29 p.m.

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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http://www.publications.parliament.uk/pa/ld199697/ldhansrd/pdvn/lds03/text/31217-08.htm#31217-08_head1

Lord Warner: My Lords, before I respond to that point, I forgot to answer a question asked by the noble Earl, Lord Howe, to which I have the answer. No cases of variant CJD have been found in the USA. I hope that that reassures him.

On the measures that the Government have taken to ensure blood safety, I can tell the noble Lord, Lord Chan, that we have taken a number of precautionary measures. All cases of CJD are reported to the CJD Surveillance Unit. If the patient has been given blood, blood stocks are destroyed. I have already mentioned the £70 million programme to remove white cells from blood for transfusion and the steps taken in 1998 to phase out the use of UK-sourced plasma and all blood products made using US-sourced plasma from October 1999.

The advice that I have been given is that the arrangements for monitoring blood safety are rigorous and, in the Government's view, adequate. However, one is always looking for new precautionary measures that might make matters safer. As I said in my Statement, that is a matter on which the Government will be seeking further expert advice.

Lord Williamson of Horton: My Lords, I thank the Minister for the information about a case which may involve transmission from a blood transfusion. Will he ensure that we have regular information not only on the number of suspected and actual cases of new variant CJD, but on the trends in the number of cases of BSE in the cattle herd, with appropriate commentary? That is important. As we gradually reduce BSE cases in cattle to zero, which is certainly possible, we regain control of the human risks of new

17 Dec 2003 : Column 1178

variant CJD, including the possible risks to which the Statement refers. The whole picture should always include the state of BSE in cattle as well as the risks of new variant CJD.

Lord Warner: My Lords, I am sure that that is right and that my noble friends in Defra will consider the point. The noble Lord is certainly right that, as we take BSE out of the herd, the risk to humans is reduced.

Baroness Masham of Ilton: My Lords, as blood products which infected haemophiliacs with HIV came from the USA, is the Minister confident that something else nasty may not come again from imported blood from the USA? Is he aware that there are ways of cleaning blood to make it safer? I know that that is done in Vienna, in Austria. Will the Minister look into that? Following the question asked by the noble Lord, Lord Clement-Jones, about people using their own blood, I am sure that, when this Statement goes out into the wider community, people will want to know that information.

Lord Warner: My Lords, I take note of the point made by the noble Baroness about people storing and having access to their own blood. As I said, I will look into the matter and write to the noble Lord, Lord Clement-Jones, and make sure that other noble Lords have copies of that letter. There are controls over blood sourced from the USA. Plasma for fractionation—for albumin and factor 8—is taken from volunteer donors. Although it has occasionally been suggested, the donor population does not include any jail inmates. Additional testing over and above that carried out on UK plasma is applied in this case.

Fresh frozen plasma for children born after January 1996 is taken from volunteer donors. Donations are subject to additional testing over and above that carried out on UK donations and are then treated with methylene blue which inactivates most viruses that are transfusion transmissible such as HIV and hepatitis B and C.

Baroness Hayman: My Lords, I am sure that everyone is grateful to my noble friend and his department for coming forward with this Statement so early. Obviously, however, there is great uncertainty, and that uncertainty is likely to remain when there are so many questions about transmission routes for variant CJD and the course of the disease itself. However, what is not uncertain is that, every day of the year, blood transfusions save lives in the health service. What is being done to reassure potential donors and those receiving blood products about the security of the service and the effects of the decision on leucodepletion, for example, in order to minimise the risks which we all recognise cannot be totally eliminated?

On a separate point, I recognise that variant CJD is a very different disease from sporadic CJD or other variants. However, if I heard the beginning of the Statement correctly, there are long periods before symptoms become apparent in either the possible

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donor or donee. Has that sparked a concern that we need to examine the donation records of those suffering from CJD rather than variant CJD?

Lord Warner: My Lords, I do not have a direct answer to the last point. However, when I write to the noble Baroness, I shall certainly ensure that that issue is being examined through the CJD Incidents Panel.

On the security of blood donations, as I have been trying to say, we have to be open while at the same time maintaining some balance in the information and interpretation of the information provided. We do not want to do anything to drive down the numbers of people donating blood. We need, give or take, about 9,000 donations a day. The donor base is decreasing, so it is very important that we reassure people in this area. We want people to give blood and for donations to continue. That is why I also said in my Statement that the Government are concerned and will be working with the Royal Colleges and others to see whether we can ensure that blood is used only when absolutely medically necessary. That is a matter of clinical practice that must be taken forward with the profession.

The Countess of Mar: My Lords, following on from the question asked by my noble friend Lord Williamson of Horton, is it not the case that the causal link between BSE and CJD is still an hypothesis? If my assumption is correct, what research is still being conducted in order to establish any causal link, or a cause of BSE and CJD that may be similar in both creatures but is not a direct link?

Secondly, the Minister made much of the risk analysis, and the noble Lord, Lord Clement-Jones, said a great deal about the precautionary principle on which I support him entirely. However, does not the Minister agree that the precautionary principle should also be exercised with a view to cost-benefit analysis? If we compare the millions and millions of pounds that have been poured into research into a disease which has caused 143 deaths to date, compared with the 5,000 deaths a year from hospital-acquired infections, should we not look at the proportionate application of the precautionary principle?

Lord Warner: My Lords, I had hoped that what I said in my Statement and my subsequent answers would suggest that we are being proportionate in our response. We rely on expert analysis and advice. We look to the CJD Incidents Panel to interpret extremely complicated information and to give expert scientific advice on which we can act. I have no reason to think that it does not also act proportionately in its risk analysis. As I said, I will write more widely to noble Lords about the detail of that risk analysis.

I am not sure that I can give the noble Countess a detailed explanation on the subject of BSE in the way that she asked for. However, I am happy to look into the matter and write to her with, I hope, some reassurance.

Lord McColl of Dulwich: My Lords, the Minister assured us that he would ask the medical profession to

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be sure that it did not use blood unnecessarily. I must point out that the medical profession has always had that policy. We never use blood unless it is absolutely necessary. Many of the medical professionals in England are Scots, and I assure the Minister that we never waste anything.

Lord Warner: My Lords, to avoid doubt, I must stress the point that I made in the Statement, without making any adverse remarks about Scots or others. In the Statement, I said that my right honourable friend would ask the National Blood Service to have urgent discussions with the medical Royal Colleges and NHS hospitals to address clinical practice with regard to the unnecessary use of blood. That is an important issue, and concerns have been expressed about it. We have listened to the advice of the Chief Medical Officer on the matter.

http://www.publications.parliament.uk/pa/ld199697/ldhansrd/pdvn/lds03/text/31217-09.htm

TSS

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