Variant Creutzfeldt-Jakob Disease

Paul Beresford Excerpts

Thursday 28th April 2011 Commons Chamber

[Sir Paul Beresford (Mole Valley) (Con)]

I thank my hon. Friend the Minister for his attendance. I know that he has been looking forward to this Thursday afternoon with two and a half hours ahead of him in a warm Chamber. Looking at his smile, he is not taking that too seriously. I need to declare an interest in case there is any knock-on effect from the debate. If the Government were kind enough to go ahead with some of the suggestions I might make, there could be a negative financial effect on me personally, as I am a very part-time dentist.

I have been interested in this issue for a number of years, and I have raised it through questions and in an Adjournment debate. I am hoping that now we have a new Government and a fresh set of eyes on the issue, we might get some progression towards a little more prevention. Variant Creutzfeldt-Jakob disease—commonly known as variant CJD, and it will be from now on so that my tongue can get round it—is a fatal neuro-degenerative disease originating from exposure to bovine-spongiform-encephalopathy-like prions. Prions are small particles of protein. Prion infections are associated with long and clinically silent incubations and cause a spongy degeneration of the brain with a horrible and untimely death. There is no cure. The number of asymptomatic individuals with vCJD prion infection is unknown. It poses a risk to others via blood transfusion, blood products, organ or tissue grafts, and contaminated medical and dental instruments.

The emergence of vCJD and the confirmation that it originates from exposure to BSE raised a glut of public health concerns affecting endoscopy, surgery, dentistry, organ transplantation and blood transfusions. Exposure of the UK population to BSE was widespread, with over 181,000 cases in cattle and estimates of total infections of 1 million to 3 million cattle beasts. About 200 people, mostly from the UK, have been infected, although many more could be. Because of this, the UK is the largest reservoir of vCJD prions in the world. Much of the UK population born before 1996 has potentially been exposed to BSE-contaminated food, and the number of people who carry the infection but remain healthy is unknown.

The issue is particularly relevant in the light of recent deaths. For example, Jonathan Simms, who died aged 26 in Belfast, was given only months to live following his diagnosis in the summer of 2001. He had won a High Court battle which enabled him to receive controversial treatment with an experimental drug called pentosan polysulfate. He remained disabled, but his family and doctors said that his condition had not declined any further, and a slight improvement was recorded. However, he finally lost his battle in March.

From 1990 to February 2011, 170 people in Britain died from vCJD. Although the current wave of vCJD is apparently fizzling out, after peaking in 2000 with 28 cases, a big worry is whether there will be further waves a considerable time in the future.

I wish to touch on three topics in this short debate, and I assure the Minister that my speech will be short. The first is the development of a new blood test for vCJD; the second is the approval of a red blood cell filter that can catch vCJD, which we seem to be running around in circles about without coming to a conclusion; and the third is the use of cold sterilisation solutions on surgical and dental instruments, of which three are potentially available, including Rely+On. I would like to ask why those are not being used.

First, on the new blood test, the number of asymptomatic individuals with vCJD prion infection is unknown. Because of that, it poses a risk to others via blood transfusions, blood products, organ or tissue grafts, and contaminated medical instruments. A blood test for vCJD has been an important goal of medical research laboratories and companies around the world for many years. It has been very difficult to achieve because the infectious agent that causes vCJD has unique features that mean that the sensitive methods that doctors usually use to detect the presence of a germ, or other such agents, do not work.

Professor Collinge and others at the Medical Research Council’s prion unit have recently developed a blood test to detect vCJD, or at least the prions. It exploits the powerful attraction between abnormal prion proteins and some metals, in particular some stainless steels. The test was applied to a number of patients, including those with vCJD, sporadic CJD and a number of other neurological diseases that are easily confused with vCJD, and to a number of healthy blood donors. As vCJD is rare, only a relatively small number of samples were available for testing. When the new test was run on 21 samples from different vCJD patients, 15 of the 21 samples from people with clinical CJD tested positive. So far, all samples from other neurological diseases or healthy blood donors have tested negative. The test is quite dramatic. Although it is at an early stage, it is able to correctly identify the majority of patients with symptoms of vCJD and has not yet given any false results for patients with other brain diseases or for healthy individuals. That is important both for early diagnosis of the disease in patients and for the development of a screening test that may detect silent infection in healthy individuals.

The initial studies provide a prototype blood test for diagnosis of vCJD in symptomatic individuals, which could allow development of large-scale screening tests for asymptomatic vCJD prion infection. If a screening test can be developed, it will be possible to estimate the number of infected carriers in the UK population and potentially to reduce the risk of accidental transmission of infection through medical and surgical procedures such as blood transfusions, and through dental instruments, which I must mention.

Variant CJD has predominantly been diagnosed when the patient has had the disease for some time and has developed symptoms that are coupled with extensive damage to the brain. The early symptoms of the disease, such as anxiety, depression and tingling pains in the legs, are regularly mistaken for many more common causes. Understandably, doctors do not jump to the serious conclusion of vCJD until other symptoms show forth, such as difficulty with movement or balance and loss of mental abilities.

Due to the rapid and crippling nature of the disease and the length of time it takes to carry out the series of tests required to reach a diagnosis, more often than not the patient’s symptoms are well advanced before a definitive diagnosis is reached. A blood test will enable patients to establish a diagnosis early, or at least earlier. Although there is no cure yet, experimental drugs are being developed at the MRC’s prion unit and elsewhere, with a view to holding clinical trials in the next few years. The unit wants to try such treatments on patients at an early stage, before irreversible brain damage has occurred. Early diagnosis would also give the patient and their family a quick and definite answer, allowing them to use the time that they have left as best they can.

Although the blood test is a monumental step forward in the fight against vCJD, it is important to be mildly cautious about the news. The results so far are encouraging, but further research needs to be taken forward. The researchers need to examine blood samples from much larger numbers of healthy people and those with other brain diseases, to get a better idea of how specific the test is in practice. That is vital before a version of the test can be considered for the routine screening of healthy blood donors.

Two steps need to be taken now that the blood test has been tested successfully in the initial study. The first is the planned testing of 5,000 American blood donors, which I understand has been set up. That will enable Professor Collinge and his team to eliminate the possibility of false positives. However, there is a stumbling block—a lack of funding. As I understand it, the Government are not keen to fund the research. There is a possibility that the MRC will fund that stage of it, but then the researchers would need to move on to seek funding for the next step, which would be to test 50,000 UK donors. That would give the Government an indication of whether vCJD was as widespread as feared, which would make it possible to consider whether the costly procedures that are currently in place to offset its spread are really necessary, or whether their use should be increased.

From the answer to a recent question by the hon. Member for Colchester (Bob Russell), we know that the Government have taken a number of steps to offset the spread of vCJD, including the removal of white cells from donated blood; the massively expensive importation of plasma used to manufacture fractionated blood products; and disallowing recipients of blood transfusions from acting as blood donors. Those are all extremely expensive steps, and at a time of spending cuts it would make sense to spend a little bit of money to get the test that I have described moving, to discover once and for all whether vCJD is as widespread as feared, and in turn whether those expensive procedures are really necessary.

Whether the test on 50,000 UK donors shows a prevalence of vCJD prions or a lack of patients with them, it is a crucial step in the fight against vCJD and should, without doubt, be a priority for Government funding. At the moment, the test does not work on other forms of prion disease such as sporadic CJD, but there is some hope that with further work, it will be available for such conditions in future.

I move on to the issue of blood filtering. Following an anonymous study of archived tissue specimens, the Department of Health uses in its risk calculations the estimate that 1 in 4,000 individuals may be silently infected with vCJD prions. Professor Collinge and his team believe that there is considerable uncertainty about that figure, and that the true number could be significantly higher or lower. It is also unknown how many of those infected will actually go on to develop the disease, the problem being that the incubation period in humans can be as long as 50 years.

Those unknowingly infected individuals could be active blood donors, and they could pass on the infection to other people, including through medical and surgical instruments used on them. Although the National Blood Service has taken several actions to try to minimise that risk, such as removing white cells from blood, a process known as leucodepletion, and spending millions of pounds on importing blood serum from the US, it is uncertain how effective those methods are in reducing the risk, or indeed whether they will really be justified should the number of infected people turn out to be exceptionally small.

ProMetic and MacoPharma are two firms that strongly recommend that the Department of Health implement the CE-marked P-Capt prion reduction filter as a matter of urgency, to safeguard the UK blood supply. It is a tailor-made medical device that has been developed by the medical technology company MacoPharma. It is a blood filter that removes all infectious prion proteins that carry vCJD, thereby dramatically reducing or eliminating the risk of transmission through infectious prions and ensuring as far as possible that all blood is safe for transfusion. It has been proved safe and effective and is ready to use, with more than 350 patients having been transfused with P-Capt filtered blood with no adverse effects. The filter has been CE-marked since 2006, meaning that it has passed the EU safety and efficacy test required for it to be used in the UK. The filter has been designed to work with existing technologies and procedures used by the UK National Blood Service, and its introduction would be simple and probably cost-effective. The P-Capt filter could also be used to protect against other transmissible spongiform encephalopathies, including prion diseases that have not yet been identified and named. However, the previous Government appear to have stalled on introducing prion filtration, which is proven to protect people against vCJD transmission through blood transfusions.

Blood contamination is a disaster well known to thousands in this country. Many people with haemophilia were infected with HIV and hepatitis in the ’70s and ’80s because they received contaminated blood from the NHS that was not particularly well screened, or not screened at all, for those viruses. Not only were people infected, but they unknowingly passed the infections to their families. Nearly 2,000 individuals have died as result of that blood calamity, and the figure is increasing.

The vCJD situation is potentially a ticking time bomb—a similar blood disaster could be waiting to happen. Like those who were infected with HIV and hepatitis, those infected with vCJD could be unwittingly passing it on to others, including those who receive their donated blood. To date, at least five people have been confirmed as contracting vCJD after receiving contaminated blood and blood products.

A number of researchers in the department of haematology at Cork university hospital investigated the filter’s operational use and the quality of the filtered components, as well as whether the filtration resulted in any significant changes to blood group antigens. They found that 99% of “top-and-top” units, and 58% of “bottom-and-top” units, had a haemoglobin content of more than 40 grams. Haemolysis increased immediately after filtration, but units remained within UK specification throughout storage. Prion reduction resulted in the loss of 7 to 8 grams of haemoglobin, and reductions in haematocrit of 6% to 9%, due to the filter containing 40 ml of saline, adenine, glucose and mannitol. There is no evidence of any immunologic changes of clinical relevance to the red blood cells membrane after filtration.

The Cork university researchers concluded that prion filtration does not appear to have a detrimental effect on basic in-vitro measures of red blood cell quality or on blood group antigens as assessed by in-vitro methods. However, prion filtration using the P-Capt filter results in some loss of haemoglobin, as I noted. The researchers also found during their study that the filter provides encouraging data on the safety of filtration, which means that it could be used, as was planned and recommended, in adults and children, but particularly the latter.

The Health Protection Agency findings that up to 40,000 people in the UK may be incubating vCJD without knowing it highlights the ongoing threat of prion diseases and the need to filter transferred blood to ensure that donors who are carrying latent prions do not infect recipients. P-Capt has been extensively and independently tested for more than three years. It has been proven not only to work, but to be safe and effective, for a wide range of prion proteins, and its implementation has been recommended by an independent UK safety committee.

As I mentioned, deaths from vCJD continue, and I suspect that there will be more. Only last year, researchers from Case Western Reserve university in the US identified a new human prion brain disease—similar to vCJD—that is also associated with a fast-advancing form of dementia. It is now more than a year since the UK’s Advisory Committee on the Safety of Blood, Tissues and Organs—SaBTO—recommended that the Department of Health adopt the P-Capt filter. It is abundantly clear that those crucial safeguards against that vicious disease should be implemented without delay.

The SaBTO recommendation of the use of the P-Capt filter was subject to the completion of the prion-filtered versus standard red cells in surgical and multi-transfused patients study, which is known as the PRISM study. For those who are not aware, PRISM is the third safety study that has been performed on the filter. The two previous investigations, both of which demonstrated the clinical safety of P-Capt, showed absolutely no adverse events. The PRISM process was initially due to conclude in spring and summer of 2009, but it appears to have dragged on for much longer, which has caused considerable concern. The process should be progressed much more rapidly.

A recent parliamentary answer suggested that the tests would not be expected to conclude until mid-2012, although the original deadline was 2009. An interim report is due this summer and I hope that the Minister will confirm that. As the filter has been deemed safe for use since 2006, such a delay seems unnecessary and potentially dangerous for those currently receiving unfiltered, and therefore unprotected, blood.

Following the publication of SaBTO’s recommendations, the Department of Health informed MacoPharma that an impact assessment was being prepared for Ministers, to help make a quick decision on implementation. This was in October 2009, but the impact assessment appears never to have been published and it has been increasingly difficult to understand the decision-making process. Given the potential impact of failing to protect the blood supply from vCJD contamination, such a lack of transparency is deeply worrying.

In Ireland, P-Capt is being used routinely in one pilot hospital and is currently undergoing a health technology assessment in relation to national policy and adoption. Of all places, Macau has a blood transfusion service that has started to use P-Capt to remove vCJD from red blood cell concentrates donated by Caucasians thought to be at risk of carrying the prion. Globally, over 90 million blood units are collected annually and MacoPharma is committed to providing solutions that safeguard this blood supply. The present process of leucodepletion used on UK-donated red blood cell concentrates is not sufficient to prevent people from being infected with vCJD. It is shown to remove only 42% of the total transmissible spongiform encephalopathies infectivity.

In terms of the financial costs of the filter, full implementation to filter all donated blood would cost around £1 per person in England. I think—and I hope that the Minister agrees—that that is a small price to pay considering the consequences if the problem escalates. Despite the fact that some people’s genetic make-up may protect them from this disease, at least 89% of the population may be susceptible to vCJD if infected.

Lastly I would like to discuss briefly the situation relating to dental and surgical instruments. As we have seen recently in the news, there have been two separate incidents—one at Queen’s hospital in Essex and another in Wales—in which patients have been told they have been put at risk of contracting CJD through surgery. Details have not been released about the case in Wales. However in the Essex incident, the mother of a patient who had an operation in the same operating theatre as those who have been contacted had developed an inherited form of CJD. That patient has since been tested and found to be carrying a gene that meant that she too could go on to develop the disease. Although the risk of the individuals concerned actually developing the disease is probably very small, it is of course extremely distressing for them, and in the interest of public health safety they will not be allowed to donate blood, organs or tissue.

Professor Collinge and his team believe that such incidents are not uncommon and that although the risk to patients from contaminated surgical instruments is believed to be small, it has not yet been quantified. His research team, working with Dupont, has recently developed an effective prion deactivation soak called Rely+On. However, despite actually having a commercial partner, it is not being used in hospitals and in fact DuPont is no longer manufacturing Rely+On. This soak is one of three—another was developed at Edinburgh university and another was produced by the Government-sponsored Health Protection Agency. None has been used in a hospital setting. The reason for this is that the Government have not given hospitals or commercial partners the incentive to use and invest in these products. If the hospitals were under pressure and the cleaner was provided at a commercially viable cost, the cost would be lower because there would be a huge market to sell it to and production could recommence. The Government need to give commercial firms the green light to go ahead by explaining to the companies that they will have a commercial market. That will inspire them to carry out the final tests and make changes to make the product more viable for hospitals to use. I understand that a qualified clearance has been given to Rely+On. It is qualified only at the second level because it froths in washer disinfectors. If a commercial green light was given, I am sure that DuPont and others would produce a product that did not froth. A future requirement could be set through a change to health technical memorandum 01-05 or even through the dreaded Care Quality Commission.

I ask the Minister to act now on these issues and not to let this valuable research sink without trace or these products go to waste. We are lucky in that vCJD does not seem to have had an enormous effect on our generation. However, it is the next generation and the one after that we should be thinking of and trying to protect. They are the ones who could well feel the ghastly effects of this crippling disease and who will be pointing the finger at our generation—and perhaps specifically the Minister—and asking why we did not get stuck into the problem and introduce more prevention now.

[The Minister of State, Department of Health (Mr Simon Burns)]

I congratulate my hon. Friend the Member for Mole Valley (Sir Paul Beresford) on securing this important debate and on his thoughtful and well-informed comments on a matter of public concern and genuine importance. I also pay tribute to his ongoing commitment to keeping the issue of variant CJD in the public consciousness, not least through his various debates on the Floor of the House and his questioning of Ministers.

My hon. Friend asked about the Government’s response to vCJD, and I am happy to have this opportunity to update the House. Thankfully, the incidence of cases of clinical vCJD in the UK remains at a very low level, with a total of 175 cases recorded. Since a peak of 29 onsets in 1999 and 28 deaths—sadly—in 2000, the trend has fortunately been continuously downward. In 2010, there was only one new case. There have been no cases presumed to be associated with surgical or dental procedures and no known transmissions presumed to be associated with blood since 1999. The reality contrasts with some predictions that surrounded early discussion of vCJD in the late 1990s. Some people forecast large numbers of infections and deaths far in excess of what has come to pass. However, this is perhaps understandable given the uncertainties that still remain around the disease.

Although we can be pleased that the worst-case scenario has not materialised, we must remain vigilant and continue to do all we can to reduce risks to patients through potential transmissions via blood or surgical procedures. Many aspects of this condition remain unknown, and because of the unusual nature of the presumed infectious agent—the prion—are likely to remain so, as my hon. Friend alluded to. Existing measures have been put in place to reduce the risk of secondary vCJD infection passed from person to person, and it is vital that these are maintained unless evidence becomes available to indicate that they are no longer necessary or are otherwise ineffective.

Some measures put in place to protect against the transmission of vCJD also provide additional benefits to patients. One example is the continual improvement of decontamination practices across all of health care. This is vital to ensure that care is delivered safely with low levels of infection risk from all manner of infections, including vCJD, bacterial, protozoal and viral risks. The maintenance and improvement of existing, and the development of new, decontamination systems are essential for maintaining patient safety.

The Government take high-quality decontamination very seriously, and I can announce today that the Department of Health is commissioning a new programme of decontamination-related research. The Department will make available £2.4 million over the next four years to fund this research, which will include support for the development of cold plasma decontamination technologies, specifically for use in narrow channelled instruments such as endoscopes. Another study will aim to optimise the effectiveness of automated washer disinfectors used to wash and sterilise surgical instruments. Other projects will address new methods for detection of residual protein contamination on instruments following routine washing and disinfection.

In addition to decontamination, another vCJD risk-reduction measure that provides additional health benefits is the removal of white blood cells from all blood for transfusion. The removal of white blood cells not only reduces the risk of vCJD transmission, but reduces the risk of cytomegalovirus transmission, transfusion-associated lung injury and transfusion-related fever, and has other benefits. The provision of synthetic clotting factors for the treatment of all patients with bleeding disorders such as haemophilia is another measure associated with both reducing the risk of vCJD transmission and improved patient care.

[Sir Paul Beresford]

I thank my hon. Friend for his announcements and I note his repetition of some of the points that I have already made. Does he accept that there are already three commercially available materials that can be used for cold sterilisation—but which are not being used and to which the Government have given only semi-recognition—and could also be introduced extremely quickly? Secondly, I note his point about white cell depletion, but a filter has been available since 2006 that would take red blood cells out as well, greatly improving the restriction of the prion.

[Mr Burns]

I am grateful to my hon. Friend for that intervention. If he bears with me, I will come to both those points. I want to outline what the Government have been doing, but towards the end of my speech I have a number of comments to make in response to some of the valid points that he raised in his speech.

As I was saying, the provision of synthetic clotting factors for the treatment of all patients with bleeding disorders such as haemophilia is another measure associated with both reducing the risk of variant CJD transmission and improved patient care. Those products, although not suitable for all patients, eliminate all variant CJD and other blood-borne infection risks to those patients.

All the health care actions taken to reduce the risks of person-to-person transmission of variant CJD have costs. Estimates of the annual cost of blood-related protection measures alone amount to approximately £40 million. However, many costs that are badged as variant CJD risk-reduction measures would be incurred even without that specific risk. Without a variant CJD risk, many of the blood-related measures, including leucoreduction and the use of synthetic clotting factors, would continue because of the wider safety and other benefits that they confer. The Government also continue to support payments to those affected by clinical variant CJD through the Variant CJD Trust. The trust has paid out approximately £39 million to patients and their families over the last 10 years.

In the latter part of his speech my hon. Friend talked about the risk of contamination via dentistry, which I would like to address now. There have been no known, or indeed suspected, cases of variant CJD transmission arising from dental procedures. However, there are still considerable scientific uncertainties that prevent us from quantifying the specific potential risk. The Department of Health has focused on improving standards of dental decontamination over the last decade, as the risk from blood-borne viruses—especially hepatitis B and C, and HIV—is a recognised risk in dental practices. Approximately 500,000 people in this country are infected with those viruses, and there are more than 1.5 million patient contacts every week in NHS dental practices. It is essential that the quality of local decontamination in practices must be of the highest standard.

The available equipment for and knowledge about decontamination is constantly changing, as my hon. Friend is aware. We update our policies to keep pace with those technical and scientific developments. An essential feature of the British Dental Association guidance, published in 2004, was the importance of both the sterilization and pre-sterilization cleaning components of the decontamination process. Indeed, the essential quality requirements in the Department’s guidance, as set out in “Health Technical Memorandum 01-05”, were similar to those in the British Dental Association’s original A12 document.

Guidance from the Department of Health states that all dentists should use automated washer disinfectors as part of best practice. There are three reasons for this. First, they provide a consistent and reliable cleaning and disinfection process. Secondly, they contain the washing and disinfection process within a sealed unit, which helps to minimise the risk of spreading microbiological and chemical hazards. Thirdly, there is strong evidence that automated washer disinfectors are effective in removing the worst of the contamination from dental instruments and that they deliver a much greater degree of consistency in cleaning. This will reduce the worst-case risks to subsequent patients.

Also, following the recently commissioned research on optimising the efficacy of washer disinfectors, we expect their performance to improve significantly in the coming years. Initial research indicates that the use of automated washer disinfectors can reduce general protein contamination on instruments by a factor of up to 10,000. The reduction in hydrophobic proteins, similar to prion proteins, is roughly a factor of 100. Automated washer disinfectors are therefore very useful in improving the quality of instrument cleaning and reducing risk.

--- Later in debate ---

[Sir Paul Beresford]

I was not picking on dentistry specifically, because washer disinfectors are also used in hospitals. They are an excellent idea. They are very expensive, but we are going down the right road. The problem is, however, that the prion sticks to certain stainless steel instruments used in dentistry and elsewhere in hospital services, and the washer disinfector will not remove it. However, if the Rely+On, or one of the other two products, were utilised either in the soak beforehand or in the washer disinfector, that would make the process much more effective as far as the prion is concerned.

[Mr Burns]

Again, if my hon. Friend will bear with me, I will come to these points when I deal with a number of the issues that he raised in his speech.

The guidance encourages the purchase of automated washer disinfectors. However, no time frame has been stipulated and they were not part of the essential quality requirements that all practices had to meet by the end of 2010. A 2009-10 national survey on policy, equipment and procedures used by local dental practices in the decontamination of their instruments showed that more than 70% were at or above the standard required by Department of Health guidance. That figure is likely to improve further, as many other dental practices are close to the required performance level.

The British Dental Association was fully involved in the development of the guidance, and is supportive of the principles underpinning it. The guidance is also consistent with the BDA’s advice sheet A12, “Infection Control in Dentistry”, published in 2004, which states:

“CJD and related conditions raise new infection control questions because ‘prions’, the infectious agents that cause them, are much more difficult to destroy than conventional micro-organisms, so optimal decontamination standards need to be observed. As a universal precaution, all instruments should be thoroughly cleaned before autoclaving, in order to remove as much matter as possible.”

During 2006-07 and 2007-08, the Department of Health made £100 million of capital funding available through PCTs for use in primary dental care. One of the areas identified as suitable for that money was the improvement of standards of decontamination in primary dental care. Many PCTs have provided grants to practices to support the roll-out of automated washer disinfectors in primary dental care.

These and other variant CJD risk reduction measures will remain in place and we will continue to consider all other options where there is evidence of their overall efficacy, safety and cost benefit. For example, we closely follow the development by commercial and academic organisations of potential blood screening tests. While recent progress—as exemplified by the recent publication in The Lancet of the Government-funded prion unit’s development of a prototype diagnostic test—is promising, there remains no test suitable for screening blood donations.

Another possible technology is, as my hon. Friend mentioned, prion filtration, which aims to remove the presumed variant CJD infective agent from blood. In early 2012 on completion of a clinical trial, Ministers will consider the possible use of prion filtration in addition to leucoreduction to reduce further the potential risk of infection from red blood cells. I trust that that helps to answer one of my hon. Friend’s points.

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[Sir Paul Beresford]

I thank my right hon. Friend again for giving way, and for his tolerance. His statement is interesting, although under the previous Government there was a demand by the Department to provide an impact assessment on the P-Capt filter, which should have been ready for Ministers in October 2009. Will he inquire whether that is available, and if so have a look at it? It would speed up the decision making.

[Mr Burns]

I can answer my hon. Friend instantly on that. I said just before his intervention that we expect the trial results in 2012, and the impact assessment will be completed only when the trial is completed. The impact assessment, then, will not be available until 2012 when the trials have been completed. I hope that that explains it, and satisfies my hon. Friend.

I would like to enter a note of caution that, as with all new technologies, it is important to consider all the potential costs and benefits to ensure that, as far as possible, the benefits they offer and the costs they incur—both financial and clinical— are fully understood. One example was when single-use tonsillectomy instruments were introduced in 2001 to reduce the risk of variant CJD infection. The instruments were withdrawn within a year, after the death of a number of patients. This clearly shows that no matter how good the intentions, there can, sadly, sometimes be unintended consequences with the introduction of thoroughly assessed new technologies.

My hon. Friend raised a number of issues, which I would like to go through methodically. He talked knowledgeably about prion filtration and effectively asked what was the Government’s position on its use to reduce the risk of variant CJD. I can advise him that the independent Advisory Committee on the Safety of Blood, Tissues and Organs considers that there is evidence that a particular filter is able to reduce potential infectivity in a unit of red blood cells and has recommended—subject to satisfactory completion of the clinical trial—the introduction of filtered blood to those born since 1 January 1996. The Government are undertaking an evaluation of the costs, benefits and impacts to inform a decision on whether to implement that recommendation. As I said to my hon. Friend a few moments ago, that is expected to be completed in 2012, when we will also have an impact assessment, which could be studied.

My hon. Friend raised the issue of funding. The current funding by the Department is for studies led by Professor Collinge. Between 1996 and 2012 the Department of Health will have provided more than £18.2 million for studies led by Professor Collinge, which is in addition to his funding by the Medical Research Council. Through the RDD policy research programme, the Department currently funds two studies that underpin and are integrated with the MRC Neuropathogenesis Unit funding. The National Prion Monitoring Cohort funding is worth £3.04 million between 1 April 2008 and 31 March 2012. Secondly, the development of an effective treatment for prion infection by humans is funded to the value of £7.2 million from 1 February 2006 to 30 June 2012, in partnership with GlaxoSmithKline.

[Sir Paul Beresford]

First, I am astonished that the PRISM trials have taken so long. They were supposed to finish in 2009, and they have dragged on for a further three years. We really should be worried about the potential development of infection in the intervening period.

Secondly, the Minister has delighted us with the research figures, but they pale into insignificance in comparison with the volume of expenditure by the national health service on imports of blood products and blood serum from the United States in particular. Collinge’s team have produced the test and one of the three soaks, so he has achieved positive results. It would be a mistake to stop now, rather than investing a little more funding to support the next stages of the test so that the tree that was planted initially can bear fruit.

[Mr Burns]

I always welcome any justified lobbying for extra funding, especially if it is for research. I do not think it appropriate for me to promise my hon. Friend the earth from the Dispatch Box this afternoon, but I will promise him that I will ensure that his request and his justification for the provision of further funds are drawn to the attention of the Under-Secretary of State for Health, my hon. Friend the Member for Guildford (Anne Milton). No doubt she will consider what he has said and write to him in due course.

[Sir Paul Beresford]

rose—

[Mr Burns]

I feared that that might prompt another intervention.

[Sir Paul Beresford]

I thank the Minister sincerely, because it is unusual for Ministers to give way with such regularity. Perhaps it is also unusual for them to receive requests.

I understand that the Under-Secretary of State has considered the matter, and is looking to the private sector to fund the advances and further testing. The private sector is unlikely to do that because it has no incentive, but, as a Minister in the Department of Health looking after the nation’s health, my right hon. Friend has every incentive, as has the Under-Secretary of State.

[Mr Burns]

I admire my hon. Friend’s persistence and congratulate him on it, but I fear that it will not push me any further at this moment. I hear what he says about the meeting between my hon. Friend the Under-Secretary of State and Professor Collinge. I cannot comment on that, but I reiterate yet again that I will draw my hon. Friend’s comments to the attention of my hon. Friend the Under-Secretary of State so that she can reflect on them. No doubt she will be in touch with him once she has had time to do so.

My hon. Friend mentioned the three decontamination products. They have not yet been proven suitable for use in the standard decontamination cycle in health care, and we must therefore await the conclusion of the research. Once we have seen the results of that research and, in one case, the impact assessment, we shall be able to seek to make positive progress.

Let me reassure my hon. Friend that the Government take the risks of variant CJD very seriously indeed. Because of the uncertainty surrounding it, we cannot be satisfied that we can stop looking for ways of improving and enhancing the protection of members of the public, and minimising the development and spread of this particularly horrendous medical condition. Successive Governments have introduced a wide range of precautionary measures focused on reducing risk to protect public health. I assure my hon. Friend that we will maintain them and keep them under review as new evidence emerges, and that we will ensure that any new measures under consideration are effective, safe and appropriate.

Question put and agreed to.