Blood Safety (Variant Creutzfeldt-Jakob Disease)

Debate between Andrew Miller and Paul Beresford

Thursday 29th January 2015 Westminster Hall

[Andrew Miller (Ellesmere Port and Neston) (Lab)]

On behalf of the Select Committee, let me say that it is a pleasure to introduce our report “After the storm? UK blood safety and the risk of variant Creutzfeldt-Jakob Disease”, which was published last July. We considered the ongoing health risk posed by variant CJD and examined the steps taken by the Government to ensure that any further transmission of this deadly disease through blood transfusion or other medical procedures is brought to a halt.

This will probably be the last time before I leave Parliament that I will address one of our reports in Westminster Hall, so it would be wrong of me not to put on record my thanks to not only my Committee, but its staff. Dr Stephen McGinness and his team have supported the Committee extremely well during this Parliament. There is someone with a listening pair of ears next to you, Mr Weir, and although he never speaks in these debates, he knows that I have told him how important it is that we have scientifically qualified members of staff supporting Committees such as mine so that our considerations take an evidence-based approach.

I should point out that the report’s title includes an inconspicuous piece of punctuation—a question mark. Throughout our inquiry, the Government expressed optimism that the storm to which our title alluded had in fact gone away. Unfortunately, as our report demonstrates, that optimism might prove unfounded. Like the Government, we hope that the storm is over, but the scientific evidence demands the inclusion of that question mark.

It may not be immediately clear what variant CJD has to do with UK blood supply. In the initial wave of cases, which were related to meat infected with bovine spongiform encephalopathy, the media stories were exemplified by that famous picture of the then Agriculture Minister, John Gummer—now the noble Lord Deben—feeding a burger to his daughter. Although that is the image that people have, three of the nearly 200 deaths attributed to variant CJD are known to have been caused not by consumption, but by blood transfusion.

Transfusions always carry some risk of infection, although in most cases that can be well mitigated. Donations are tested for a variety of pathogens before anyone is cleared for transfusion, and processes are in place to remove or kill the majority of microbes that might be lurking. Donors who are considered to pose a particularly high risk of infection are prevented from donating altogether. The Committee saw those processes on a visit to a major centre in Bristol.

However, several unusual features of variant CJD make it essentially impervious to those risk-mitigation measures. The infective agent of variant CJD is not a virus or a bacterium, as is the case for most contagious diseases, but a prion, which is a type of abnormally folded protein. Proteins, of course, are endemic throughout the body, which makes prions extremely difficult to detect and almost impossible to destroy. If one is to avoid also destroying the useful proteins, one has to be particularly careful. Variant CJD also has an unusually long incubation period—the time between infection and the onset of symptoms—meaning that people could unknowingly carry the disease for many years and give blood many times before appearing to be sick.

It is thought that 67 patients received blood or blood products from donors who went on to develop variant CJD, and three of those patients went on to contract, and then die from, variant CJD themselves. In total, 50% of the exposed patients who were later tested for variant CJD post mortem were found to have been infected. Those are tragic statistics but, thankfully, the numbers are small. As the Government were keen to point out, there have been no recognised cases of transfusion-related transmission of variant CJD since 1999, so the storm, in their eyes, appears to be over. However, the evidence suggests that another may be brewing.

In October 2013, the British Medical Journal published the results of a large research study that inspected more than 32,000 samples of archived appendix tissue for signs of variant CJD infection. Prions were detected in 16 of the samples, suggesting that about one in 2,000 people in the UK—about 30,000 people in total—could be silent carriers of variant CJD. Many of those people are likely to be blood donors. The implications of those findings are, frankly, not clear. However, they are undeniably a cause for concern and, in our view, they warrant further investigation. That was why one of the major recommendations of our report was that the Government should lend their support to research intended to reduce uncertainty about the potential level of silent infection across the UK blood donor pool.

I will give some background about the proposed research. As I have explained, prions are notoriously difficult to detect. A test for variant CJD has remained elusive for many years, but in 2011, a team of researchers from the Medical Research Council prion unit at University college London announced that it had developed a prototype blood assay capable of detecting variant CJD at a dilution of one part to 10 billion. When the assay was tested on 21 blood samples from known variant CJD patients, it accurately identified 70% of them as positive. More importantly, the test returned no false positives from a much bigger group of samples known not to be affected by variant CJD.

It is widely agreed that the next stage of the test’s development would be to carry out a larger study using UK blood donations, which might provide further information about both the effectiveness of the test and the level of silent infection in the UK donor pool. However, the Government appear reluctant to support that study. In their response to our report, they alluded to unspecified “scientific and technical issues” that would need to be overcome and told us that they would seek the views of the relevant scientific advisory committee before making any promises.

[Sir David Amess in the Chair]

Welcome to the Chair, Sir David. That last point is important because the Government’s response failed to mention that the committee in question had already made it known that it was strongly in favour of such a study. It is tempting to conclude that the Government would rather not know the extent of the problem that they might face. To return to my previous analogy, there are clouds on the horizon and a weather forecast is available, but the Government are choosing not to look at it.

Bad weather, to use the same analogy, looms at some of our hospitals. I shall not rerun some of this week’s discussions, which have been adequately handled, but to focus on variant CJD, an unusual feature is that the prions that cause the disease stick avidly to metal surfaces—so avidly, in fact, that surgical-grade stainless steel is used in research laboratories as a tool for transmitting variant CJD. Contaminated surgical instruments therefore offer a very efficient route for person-to-person prion transmission.

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

As a slight variation on the hon. Gentleman’s theme, it is not metal, because actually the prion sticks to stainless steel—that is the real difficulty. That is also the basis of the test that Professor Collinge is using.

[Andrew Miller]

The hon. Gentleman follows this matter with great care. He is absolutely right, but I am trying to simplify what is an incredibly complicated subject. The underlying science is very hard to communicate, but I am grateful for his observation.

This issue is known, because there have been several cases of classical CJD being passed on through contaminated surgical instruments. Following two separate incidents in 2011, 59 patients had to be notified that they were at risk of developing the disease because they had been operated on with instruments that were also used on someone who was later found to have been suffering from CJD.

Guidance is in place to help to reduce that risk, but evidence suggests that compliance is poor. Worryingly, it seemed that the Government were not aware of that. They have since promised to work with the Care Quality Commission to ensure that best practice is followed in future, so I look forward to receiving an update from the Minister on that important work.

Ultimately, however, such guidance can be only partly effective, because prions are known to be impervious to standard decontamination processes. The Government told us that that they had spent nearly £10 million since 2001 on trying to solve that problem and they have come very close to doing so. A product initially developed using public funds, and later commercialised by DuPont, has been shown to reduce the risk of surgical transmission more than a million-fold. We were therefore astounded to discover that that product had not been put to use in the NHS, in large part because its use would add an additional step to the decontamination process. That seems to be an example of institutional inertia trumping common sense.

Unsurprisingly, DuPont has ceased development of that potentially valuable product. During our inquiry, we came across other examples of commercial developers withdrawing investment because of the Government’s failure to take up much-needed technologies. I hope that the recently announced innovative medicines and medical technologies review will go some way towards resolving that problem. In the meantime, I look forward to hearing from the Minister how she plans to ensure that those undergoing surgery in UK hospitals are not needlessly exposed to potentially deadly prions. I stress that I am not trying to be alarmist. I have been through medical procedures myself, and I would not want people to be put off in any way from having necessary medical procedures.

Decisions about whether the NHS should adopt particular technologies are currently spread among a number of bodies. The National Institute for Health and Care Excellence is, of course, the largest such body, and is recognised as a world leader in health technology appraisal. However, during our inquiry, we found that similar decisions are being made by a variety of other scientific advisory committees and panels using a range of techniques. We found that a little troubling. If the Government are serious about wanting to ensure value for money for the NHS, all health technology appraisals should be carried out to the same high standard and according to the same basic methodology, wherever they are performed. We therefore recommended that the Department of Health should work with NICE and the Government Office for Science to ensure that best practice is more consistently applied.

The Government have set up a working group to explore differences in appraisal methodology and to set out options for closer alignment. We welcome that move, but we were surprised to find that the group had been set up under the auspices of the Department’s chief economist, seemingly with no input from the Government Office for Science, the Department’s own chief scientific adviser or from the chief medical officer, Dame Sally Davies. When I pointed that out to the life sciences Minister, the hon. Member for Mid Norfolk (George Freeman), I think that he was equally surprised.

The Government explained their decision by stressing that the review would be about the methodological approach to a valuation, not the science itself, which seems nonsensical to me. Health technology appraisal tests rest on an evaluation of both cost and clinical effectiveness. The chief economist is, I am sure, well placed to comment on the former part of the equation, but Dame Sally is vastly more qualified to comment on the latter part. It is simply not possible to remove science from the process. I hope that the Minister has had time to reconsider the Government’s position on the matter. I also want to hear what progress the working group has made.

The Government’s claim that science is peripheral to the process of health technology appraisal is somewhat belied by the fact that it is often the Department’s scientific advisory committees that carry out the appraisals. Almost 70 such committees are dotted around Government, and they are governed by a common code of practice that sets out minimum requirements regarding communications and transparency. Few of those requirements were being met by the SACs that we came across during our inquiry.

The Rapid Review Panel, a SAC responsible for assessing innovative infection prevention and control products, had an extremely limited website at the time of our inquiry and did not seem to publish either an annual report or a statement of members’ interests. Not even the membership of the panel was clearly stated. The Government explained the failures by stating that the panel was not and never had been an SAC, meaning that it did not have to comply with the code of practice. That presumably came as news to the Government Office for Science, which included the panel in its list of SACs, and to the chief scientific adviser, who told us that he met all SAC chairs regularly.

We came across other issues when assessing the work of another Department of Health SAC, the Advisory Committee on Dangerous Pathogens. This time the Government gave us another excuse, claiming that sub-groups and working groups of SACs were technically not themselves SACs, and therefore were exempt from the code of practice. That might technically be true, but it flies in the face of the Government’s reported commitment to openness, which was absolutely reinforced in the document on science and innovation strategy published by the Government just before Christmas.

I began the debate by drawing attention to the question mark in our report’s title—“After the Storm?” We all hope that the storm created by variant CJD has now passed, but the reality is that uncertainties remain. In the six months or so since our report was published, we have seen little evidence of action by the Government to reduce our concerns. The Minister has told us that she is optimistic, but optimism is not a good basis for policy. I hope that she can reveal what the Government plan to do to make our question mark obsolete.

I reinforce a point that I made earlier: statistically, we are dealing with tiny numbers of people. However, at the end of the day, the families affected are real human beings and we should not simply brush aside action in the area because we are dealing with such a tiny group. I hope that the House will take the report as seriously as our Committee and the many brilliant scientists who gave evidence to us.

House of Commons Administration and Savings Programme

Debate between Andrew Miller and Paul Beresford

Thursday 8th November 2012 Commons Chamber

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

The two Chairs have covered the main points and, with the limit on time, I thought I might touch on some aspects of amendment (b)—not to oppose it, but to provide a tiny warning.

The package coming forward is a general public sector savings package that is in line with the target. The difference this time is that the report, and the thinking behind it, are being discussed in the Chamber. It has also been put together under a new attitude, which is to seek to provide better and more efficient services at less cost to meet the target. As has been mentioned, the officials putting the package together have worked very closely with staff and unions. In fact, many of the ideas for change have been derived from staff undertaking the service. That has enabled staff redeployment within the House of Commons service, rather than redundancies. Although hon. Members may not be aware of it, many services are already contracted out. Many services will come up for renewal, and, in the present atmosphere, they may well bring savings to themselves. In the event of franchising out, staff could of course move to the new provider with TUPE protection, or move within Chamber services themselves by redeployment.

The possibility of market testing has been extensively researched. The team undertaking it have had a free hand to assemble a business development plan. Outside private sector support and advice has been utilised. Market research to provide benchmark information has been undertaken, and that has given the Commission a forward-looking financial information system that it will be able to use to gauge whether it is worth market testing. Obviously, there has to be an in-house bid and the research will give such a bid a competitive edge.

While I understand the thinking behind amendment (b), I suggest caution. First, it seeks to tie the Commission and reduce its flexibility to choose the time of testing, if indeed that appears to be the choice to go for. Secondly, it may well delay savings. Some of the services projections indicate that the private sector could contribute to much lower costs in the latter half of a contract. That means that if tendering was chosen in some cases, the sooner this is undertaken the sooner we will get savings. Thirdly, from my own experience, outside advice on costs or savings always overestimates costs and if the service is tendered and, crucially, if the private sector bid, they have a benchmark that they know they can come in under. Finally, any outside bidder will know from the business improvement plans the bid level they must beat to win if we follow the amendment. I therefore hope there is some caution before we adopt amendment (b). Much credit must be given to the Administration Committee for looking at business improvement plans, efficiency savings and better use of our facilities. The House has already had a debate on this a few weeks ago.

I am concerned about amendment (c), tabled by my hon. Friend the Member for Harlow (Robert Halfon). He appears to have missed the opportunity, but is now asking us for a second time to present this before the House. Most of the areas in which he calls for commercialisation already happen in some way or other, although to a lesser degree, and therefore with less financial advantage to the House, but with no reduction of facilities to hon. Members. I hope he feels able to not press his amendment. The Administration Committee is suggesting careful extensions of our underused facilities to the UK public. Obviously, that would need to be done in a careful way, as indeed it is currently, so as not—if I may use the well-worn phrase—to bring the House into disrepute. I hope he realises that what he is proposing will result in further delay. It will be unsettling to staff. It will reduce the savings, because they would not be brought in earlier in the financial year, and that would mean further savings from other areas to meet the target.

The report comes as a package. That means that if there is any cherry-picking of specific items that reduce savings, they will need to be compensated by savings in other areas. I hope that when my hon. Friend stands up to speak, he thinks about that carefully before he puts his proposal. I hope that the House will approve the motion without amendment, so as to give the Commission a chance to consider points raised while retaining the flexibility to act appropriately on various aspects of the programme to the benefit of the House budgets and of Members’ services and staff.

[Andrew Miller]

Does the hon. Gentleman not realise that the amendment proposed by the hon. Member for Windsor (Adam Afriyie) has a positive cost benefit, not a negative one, in terms of available staff to the House?

[Sir Paul Beresford]

The hon. Gentleman has just beaten me to POST. The Commission will look at what was said. The Chair of the Finance and Services Committee, my hon. Friend the Member for Caithness, Sutherland and Easter Ross, has already made it clear that he will look closely at that with the Committee, so I will not comment on the details of that particular amendment. I am concerned about amendment (b); amendment (c) is destructive.