Variant Creutzfeldt-Jakob Disease

Simon Burns Excerpts

Thursday 28th April 2011 Commons Chamber

[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.

[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.

[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.