Blood Safety (Variant Creutzfeldt-Jakob Disease)

(Limited Text - Ministerial Extracts only)

Thursday 29th January 2015 Westminster Hall

[The Parliamentary Under-Secretary of State for Health (Jane Ellison)]

It is a pleasure to serve under your chairmanship, Sir David. Sadly, I have been left with less time than any of the other hon. Members who have spoken in the debate to respond to the questions put to me, but I will do my best.

[Sir David Amess (in the Chair)]

Order. The debate goes on until 4.30 pm.

[Jane Ellison]

Marvellous. My mistake. In that case, I have plenty of time.

In case there is anything I cannot cover in my remarks, I should point out that we have already committed to write to the Committee with a further update before the end of the Session. There are issues where we will have more to report, and I will focus on a couple of specifics today.

Let me start by thanking the Committee for the opportunity to look at the issue again. May I also apologise for the fact that I am holding my notes so far away from me? I have left my glasses at home.

[Frank Dobson]

Would you like to try mine?

[Jane Ellison]

Let’s see how I get on, although I thank the right hon. Gentleman for that kind offer.

First, let me reiterate—I said this in the evidence sessions, but perhaps we did not stress it enough in responding to the Committee—that there is no hint of complacency over the issue on the part of the Government, the Department of Health, me, the chief medical officer or anyone else, although I understand why that question mark is in the title. I would hate for my optimism about our perhaps being in a better place than we were to be characterised in any sense as complacency or as not wanting to keep this area under careful review.

In that respect, I want, like other contributors to the debate, to mention the number of cases. We have had one UK case of vCJD since 2010. The UK’s annual mortality rate per million for all forms of CJD from 1993 to 2012 was 1.1, which, I am pleased to say, is lower than that in France, Spain, Germany and Italy. On secondary transmissions, there is no evidence of any person-to-person transmissions via blood since 1999, as was said in the debate. There is also no evidence of any person-to-person transmissions via surgery or dentistry. However, I accept that the fact that there is no evidence does not mean there is no challenge.

On Government funding, the shadow Minister, the hon. Member for Liverpool, Wavertree (Luciana Berger), referred to the ring-fenced budget. The Department of Health has provided more than £95 million for CJD studies since 2001. It is funding 18 CJD-related research projects with total investment of about £45.5 million. In 2011, it was estimated that about £500 million had been spent on prion-related research.

Professor Collinge has been mentioned. His advocates are here in the form of hon. and right hon. Members who are familiar with the work done by him and his unit. The Department of Health has provided more than £16 million of research funding to the National Prion Clinic, led by Professor Collinge, since 1996. The Medical Research Council continues to provide £6 million annually to fund the MRC prion unit, which is led, again, by Professor Collinge. Members have said that that has been said before, but it is important to stress that it is the context in which the Committee’s report was written.

There was perhaps a slight lack of generosity in the way some contributions to the debate characterised the attitude of the Department and the Government, and I want, therefore, to make two general points about science. I rather disagree with the point made by the right hon. Member for Holborn and St Pancras (Frank Dobson) that if we have spent an awful lot on theoretical research, it follows that we must always seek to apply it. It would be slightly dangerous always to adopt that principle, because that would make the funders of research far more risk-averse. If there was an obligation to put into practice every piece of research one had backed, there would be an inclination to back away from the more risky pieces of research and to back only the winners. That is just a comment on the principle; it does not necessarily relate to this issue.

The second point I hope colleagues would concede is that there is surely a difference between having one set of scientists look at something and then another set of scientists look at it and reach different conclusions and recommendations, and being in any sense complacent. A lot of different people with great scientific knowledge have advised Ministers over the years and have sometimes come to different conclusions or made different recommendations. It is important to stress that in all the ways in which we have responded to the report we have been guided by some very senior scientists. I want to put that on the record.

[Frank Dobson]

Will the Minister confirm that none of the scientific advisers has advised her or any other Minister that the John Collinge treatment proposals would not work or ought not to be tested?

[Jane Ellison]

I will say a few words about some aspects of the Collinge work later, but I want to focus on giving an update on some of the work on the assays.

[Sir Paul Beresford]

In the early days of research, a number of different tests were brought forward. To my knowledge, all have fallen by the wayside bar one. Have any of the 18 research projects come up with tests that look fruitful?

[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—

[Sir Paul Beresford]

Of course, the results would be anonymised, so the effect on individuals would not be apparent.

[Jane Ellison]

Let me move through the second question; I will be very happy to pick up on any further things in my additional response to the Committee.

The second question that the ACDP was asked was whether it would replace its current UK prevalence estimate of 1:2,000, which is based on data generated by a blood study using the MRC Prion Unit assay. In response to that second question, the ACDP also agreed that the answer to the question—whether to replace the current prevalence estimate—was no. It gave that answer because it is uncertain as to what the blood assay would measure in a general population. Even in the event that a prevalence result lower than the current 1:2,000 figure were found, the precautionary principle, which the Select Committee rightly emphasised in its report, would still apply and the 1:2,000 figure would continue to be used.

Thirdly, given its negative answers to the first two questions, the ACDP was asked what further data it would need to develop confidence in the outcome of any study using the assay. In summary, it suggested that in the first instance the assay developers work with the National Institute for Biological Standards and Control, and with others, to show that the assay can be used to identify asymptomatic infection, and with the blood services to develop the throughput of the assay. If that work progresses successfully, the ACDP will, of course, look again at the issue and we will take its advice on any potential use of the assay.

I turn briefly to the RelyOn issue, as it has been raised. RelyOn is the protein removal soak developed by DuPont, which Members have discussed. Members will recall that this technology has been fully considered by the Rapid Review Panel, which assesses new products that may be of value to the NHS in improving infection control, on two occasions.

Although the RRP raised specific points on the application of the product in practice—my hon. Friend the Member for Mole Valley well described the challenges around it being a soak—it considered that it would be a

“useful addition to available decontamination products”

if it could be correctly formulated. Obviously, it is for the developers to make a commercial decision to market the product, although I have noted what has been said about where DuPont is with that. It is not within the remit of the RRP to influence procurement and the uptake of products in the NHS, but we would always be willing to discuss with manufacturers the potential for adoption of all effective technologies.

The Minister for life sciences, my hon. Friend the Member for Mid Norfolk (George Freeman), takes seriously the ensuring of rapid access to innovative therapies. It is a large part of his portfolio, and that is why he launched the major review of the pathways for the development, assessment and adoption of innovative medicines and medical technology. That very much goes to the point made on whether the process can be speeded up to make it more easily usable.

The review will consider how to speed up access for NHS patients to cost-effective new diagnostics, medicines and devices. It will set out short and long-term options for action by the Government and relevant bodies, including the National Institute for Health and Care Excellence, the Medicines and Healthcare products Regulatory Agency and NHS England. That will make a major contribution to the policy debate and may well answer some of the points made on this piece of technology.

[Sir Paul Beresford]

I thank the Minister and apologise for being persistent. DuPont undertook the work because it thought there was a market. When the Department backed away from the market and it became apparent that, if developed, the product was not going to be put through as a requirement, perhaps through the Care Quality Commission, DuPont stopped. There was no market and no interest, so it stopped the project.

[Jane Ellison]

I understand the point. We have debated it before, and it was explored in the meeting with him and Professor Collinge. As I said, the Department was happy to discuss the potential for adoption with manufacturers, but the hurdle was the Rapid Review Panel’s rating. That work is ongoing and has moved on in the past year or so. The new Minister for life sciences acknowledged that there are sometimes challenges around the adoption and the speed with which large organisations can adopt these things, and I am happy to keep Members updated on that work.

There is a well established process whereby the Rapid Review Panel assesses potentially useful products. Those achieving a level 1 rating are suggested as suitable for NHS use. It was acknowledged by the DuPont representative on 5 March that RelyOn had reached only the level 2 rating and more work was needed. It would be unfair on the manufacturers of other level 2-rated products to change unilaterally the RRP processes for one product. As it stands, it is not formulated in a way that could be used in standard NHS decontamination processes.

In my remarks, I have offered a potential route forward and an assurance that the area is being carefully looked at by my colleague the Minister for life sciences. He is looking not only at soaks, but devices, other diagnostics and other medicines. I am happy to draw to his attention the view of the Committee and other Members that this product might be an example of where adoption has been delayed or held up.

We have undertaken to give the Committee a detailed update before the end of March on the other points that have been raised. I thank the Committee again for bringing this subject for debate. I am glad I have had another chance to put before Members some of the recent and ongoing developments and to commit to continuing to use our extensive research strategies. I stress, particularly to the Chair of the Committee, how seriously this Government and successive Governments have taken the subject. It was interesting to hear some of the history from the right hon. Member for Holborn and St Pancras. We will update Members shortly.

Thank you, Sir David, for giving me the opportunity and reminding me that I had time available to respond in a little more detail than I thought I could. I thank you, the Committee and Members who have attended the debate.