Blood Safety (Variant Creutzfeldt-Jakob Disease)

Andrew Miller Excerpts

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.

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[Jane Ellison]

I will come on to talk about the assay in some detail.

[Andrew Miller]

I find the Minister’s remarks somewhat surprising. As I said in my opening remarks, the Government response alluded to unspecified “technical issues” that they would refer to the relevant advisory committee, but that committee had already recommended that the study should go ahead.

[Jane Ellison]

I will update the Select Committee further. We have already committed to submit an additional piece of work before the end of the Session.

I will say a few words about the work undertaken so far. The chief medical officer and I gave evidence to the Committee last April. The report was published in the summer and the Government response in October. In that response, the Government committed to responding with a further update report to the Committee. I subsequently received a letter from the Committee with more than 20 further questions, to which I responded in November. The Select Committee then held a legacy hearing on 3 December at which Professor David Walker, the deputy chief medical officer, and I gave further evidence.

I am extremely grateful to all members of the Committee who have put the issue on Parliament’s agenda and maintained a close interest in it, something that has been clear to me in the relatively short time I have been in post. I will write to members of the Committee, as we have undertaken to do, before the end of March with further updates on some work. That will include an update on the CQC issues that have been raised, which I will not give an update on today.

Let me focus on the potential use of the vCJD blood test. In the response, we made a commitment on that, so I can focus largely on it today. There is the potential to use a prototype variant CJD blood assay, developed by Professor Collinge and his team. He leads the relevant unit, and as hon. Members might know, the MRC is concluding its latest quinquennial review of that unit.

I am pleased to report that—along with two of my Public Health England officials, Professor Noel Gill and Dr Katy Sinka—Professor Marc Turner and Dr Lorna Williamson, the medical directors of, respectively, the Scottish and the English national blood services, met Professor Collinge and his team in October 2014 to discuss the potential use of the prototype assay. At the meeting on 13 November 2014 of the transmissible spongiform encephalopathy sub-group of the Advisory Committee on Dangerous Pathogens, Professors Turner and Gill presented a paper on the possibility of using the assay to carry out an anonymised blood prevalence survey for asymptomatic vCJD, as recommended by the Select Committee.

Members might recall that the ACDP is the independent scientific advisory committee that provides the Government with authoritative advice on all forms of TSE, including all forms of CJD. During the presentation to the sub-group, the professors asked three specific questions. I will update Members on those questions and the ACDP’s responses.

First, with a view to the ability of the assay to detect sub-clinical vCJD infection in otherwise healthy individuals, the ACDP was asked if it had confidence in three qualities of the assay. The first was sensitivity, which is the ability of the assay to give true positive results; in this case, that is the true number of asymptomatic cases that the test could identify in any population. The second was specificity, which is the ability of the assay to give true negative results; in this case, that is the true number of unaffected individuals that the test would identify in any population. The third was reproducibility, which is the ability of the assay to be reliably and repeatedly reproduced outside the centre in which it was developed.

Basically, that process would be to find out whether the assay could be used to identify people with asymptomatic infection, and those who showed no clinical signs of vCJD but who would be presumed at some stage to be potentially infective and/or go on to develop clinical symptoms. My hon. Friend the Member for Mole Valley (Sir Paul Beresford) said that symptoms could develop over a very long period.

The ACDP’s sub-group discussed the issue and agreed that the answer to the first question had to be no, because it has seen no published data on the assay when used in any human or animal samples from individuals without clinically diagnosed disease. Members might recall the February 2011 paper in The Lancet that first gave detailed information on this assay. That paper provided evidence that the assay can give, in seven out of 10 cases, a positive result in blood samples taken from patients with known and clinically diagnosed vCJD. Unfortunately, however, that is not what we need if we are looking for evidence of vCJD in those with no clinical signs. There is no published evidence that provides assurance that the assay, if used in the general population, would give true positive results in those who might be carrying the infection but are asymptomatic.

If a test for this very rare disease—it has been noted that we have had only 14 new cases in the UK since 2005, and only one was after 2010—is used in presumed healthy individuals, it is essential that it is accurate. We have no evidence that the MRC assay can identify vCJD infection in an asymptomatic individual. Those in Westminster Hall with a keen interest in science will understand that undertaking a test of large numbers of individuals when we do not know what a test result means—either for those individuals or, as in this case, for the development of effective public health measures—is not the best use of limited resources.

The second question that the ACDP was asked—

--- Later in debate ---

[Andrew Miller]

I thank right hon. and hon. Members for participating in the debate, which has been about a hugely important subject.

I respect the integrity of the Minister on this matter. She needs to be probing some very serious questions. I hope that she insists that her officials get those responses to the Committee and to Members participating in the debate as quickly as possible; it would be unfortunate to leave such an important issue simply hanging because we had the small matter of a general election campaign coming up.

Any chemical assay evolves. I developed some techniques in the world of geology years ago. When I was in Imperial college earlier on, in the school of mines—admittedly speaking to the Labour club—I was reminded of some of the work that I did when I did a proper job a long time ago. Some of the analytical techniques that we were developing then, from a theoretical basis and given the knowledge available to us at the time, have been refined to a very high degree since then because of the development of techniques and technology. Brushing aside issues around the assay on the three questions that the Minister posed is not a satisfactory way forward.

I have heard the story told by my right hon. Friend the Member for Holborn and St Pancras (Frank Dobson) before—of how he told Prime Minister Blair as he left the room about spending £100 million, and the language expressed at that point. However, it takes courage in a Minister and necessary leadership to get things to happen. The hon. Member for Mole Valley (Sir Paul Beresford), too, has been absolutely consistent and persistent in his views and I congratulate him on that.

Given the short time available, it might be sensible if I used the Minister’s good offices to set up a meeting between me, and perhaps other Members participating in the debate, and the life sciences Minister, because some of the issues are worth pursuing.

I remind the Chamber of the conclusions and recommendations of the report. We start:

“Blood transfusions save lives and we should be proud, as a nation, of our long tradition of altruistic donation”—

a point made by my hon. Friend the Member for Liverpool, Wavertree (Luciana Berger), the shadow Minister.

The report is intended not as a scare story, but to increase enthusiasm in participating in this altruism, so that the next generation of people requiring blood products can be confident that they are safe. There is no politics in that. It is a question of driving the science forward, which should not be done simply on the basis of a cost-benefit analysis in the Department of Health. We ought to look at the costs at a societal level.

We have met people in tragic circumstances who have suffered diseases—not only vCJD, but others—as a result of contaminated blood products. The tragedies that they represent, although small in number, carry an enormous cumulative cost to society. We have a moral responsibility to those people to address such very challenging issues. I thank the Minister for her contribution, but ask her to go much further in this hugely important debate.

Question put and agreed to.