Oral evidence: Blood, tissue and organ screening, HC 990Wednesday 30 April 2014
Oral evidence, 30 April 2014.
Witnesses
Jane Ellison MP, Parliamentary Under-Secretary of State for Public Health, Department of Health, and Professor Dame Sally Davies, Chief Medical Officer, Department of Health, gave evidence.
Chair
Minister and Dame Sally, thank you very much for coming this morning. We realise that people are on a pretty tight timetable, so we will get straight in. I want to start the questioning simply by asking why the decision was made to dissolve the Spongiform Encephalopathy Advisory Committee—SEAC—in 2011. Did you support that decision?
Jane Ellison
Thank you very much for asking us here today. I say up front that this is a highly technical and scientific area, so there will be many occasions when I defer to the CMO. The decision you are referring to took place before I was a Minister. My understanding is that it was felt that the advice that committee supplied could equally well be supplied by other expert committees, but, as Sally was in post at the time, perhaps she could comment further.
Professor Davies
As you know, we have not had a new case of variant CJD since 2010.[2] There was an effort to rationalise all our scientific committees to make sure that we were not wasting scientists’ time but that for policy development we had the best advice. We rationalised them, and what we have here to share with you are the before and after charts of the committees. You may want those to look at. I did support the decision. The committee had done a very good job, but we remained with two major advisory committees: SaBTO—Safety of Blood, Tissues and Organs—and ACDP, the Advisory Committee on Dangerous Pathogens. There had always been a bit of an overlap, but now between them they deal with that.
Chair
I have not seen the before and after charts yet, but my understanding is that there are still multiple bodies advising on CJD.
Professor Davies
Yes.
Chair
Does that remain sensible, or would you want to rationalise it further?
Professor Davies
It is functioning well at the moment. I see no reason to alter it at this time, but of course I look forward to hearing your advice.
Chair
What role do you play in advising the Minister on matters related to blood safety?
Professor Davies
As CMO, I am the independent medical adviser on all medical things to the UK Government in England, and on public health, to the Department of Health. I review the advice in these areas, as in all public health areas, to ensure that it has been properly based on science, and looks rigorous and sensible. That is supported by the fact that I am also the chief scientific adviser to the Department, as you know. Meanwhile, I am also the head of the research division, so I am aware of, and sign off to a certain extent, the research that has been advised in this area.
Chair
How do you ensure that there is an integrated approach that covers Scotland, Northern Ireland and Wales as well?
Professor Davies
As UK CMOs, we meet three or four times a year to discuss issues of public health and policy, and if we had concerns in this area it would be on the agenda. We have not needed to since I have been CMO, but the committees have representation from across the UK and the policy teams talk regularly, as do the blood transfusion services. Ours are for England and Wales, but Public Health England is in regular communication on all these issues with the public health services of Scotland and Northern Ireland, so there is a lot of cross-talk in the interests of ensuring that our public and patients are well served.
David Tredinnick
The Government have acknowledged the potential value of a blood test capable of detecting variant CJD, but could they be doing more to support the development of such a test?
Jane Ellison
My understanding is that quite a lot is going on in this area. As a Minister, I am open-minded to receiving advice on this, but, like many other things, it will be based on it being evidence-based and cost-effective. Quite a lot of work is going on in this area. The Department are funding not only ongoing surveillance work but a number of studies, and other non-DH-funded studies are going on. I am pretty satisfied that, proportionate particularly to the number of cases and deaths over the last 10 years or so, there is a good body of work going on at the moment. I am open-minded; if evidence is presented to me that we can do something that is cost-effective and evidence-based, we would look at that.
David Tredinnick
In 2013, Professor Collinge submitted a proposal to the MRC worth approximately £750,000 to conduct further work to validate a test that he had developed and that was in use at the MRC, but it was turned down. Do either of you have any comment on this, and whether the Government propose to take it forward? What strikes me is that the amount of money is tiny in the scheme of things. We have a test that was working effectively on a small scale, and it seems very strange to me that nothing has been done to take it forward.
Professor Davies
Clearly, we have limited budgets for health care, public health and research. The MRC gives core funding to Professor Collinge’s unit—the MRC prion unit—every year, and they used some of that to develop the test. They also gave an additional £300,000 to help develop that blood test. There was an application last year that was turned down by peer review because of a number of issues, one being insufficient justification for its use for screening. He has not gone back to them with any further applications. Indeed, he has led them to believe that he is exploring other avenues of funding for the blood test project. The MRC and ourselves have given a lot of money to this area of prion research, particularly to Professor Collinge. We from the Department have given him about £14 million over the last 10 years from our policy research programme, which is more than any other individual gets from the policy research programme for any subject.[3] The MRC gives the prion unit £6 million each year, in addition to supplementary funding of a further £5 million since 2007, so he is in receipt of significant funds. Meanwhile, I understand from the NIHR biomedical research centre at University College that about £100,000 each year has been used, at the discretion of University College academics, to support his work; and he receives funding from the university because he is listed on the HEFCE QR submissions—the RAE submissions. They get significant funding.
David Tredinnick
I understand that. Thank you for explaining the amount of money that goes across. In this instance, I am interested to hear you say that Professor Collinge has apparently moved on. I understand this was turned down because of the issue about sensitivity, but he says that 71% “is perfectly adequate to do the study that we propose to do…it could be that only 70% of people with vCJD have prions in their blood,” and the test is therefore “picking up all of them.” Is this not something that perhaps should be reconsidered, and, if the MRC are not going to do it, it should fall within one of the funding schemes you described, Dame Sally?
Professor Davies
The integrity of research in this country is based on the peer review system. I would not want to second-guess the peer review of the Medical Research Council.
David Tredinnick
Minister, you referred to a number of studies in answer to my opening question. Could you be a bit more specific and tell us what studies have been undertaken?
Jane Ellison
I am going to ask the chief medical officer to look at that. I think Dame Sally referred to some of those going on in her previous answers. Some of them have been conducted by Professor Collinge. I believe that 20% of the funding that has been given to prion research has been given to projects led by him. I will ask Dame Sally to comment on some of the specific projects.
Professor Davies
Since 2002, he has had from us over £3 million for the national prion monitoring cohort. Starting in 2006—I was personally involved in ensuring this grant—he received over £7 million for the development of effective treatments for prion infection, working with GlaxoSmithKline looking at their library of compounds. I was the one who asked GSK to open up their library, and negotiated that. We gave him £2.75 million for the prion 1 clinical trial, and £1.6 million for some animal work involving transgenic mice. That is the last decade. Of course, we have funded a lot of other work. For instance, at the moment we have £49 million-worth of active research under way including on decontamination across the UK, so we continue. At the moment, we have a ring-fenced budget—it is the only ring-fenced budget in the Department of Health’s budget—of £5 million annually.
David Tredinnick
You are saying that overall there is a lot of research and a lot of money available for this area. Is that right?
Professor Davies
There is a fair amount of money, and we have to balance everything together.
David Tredinnick
I have a couple of further questions on a related but different subject. How many blood samples from known variant CJD patients are currently held in the UK? Related to that, how many of these are available to commercial test developers?
Professor Davies
I know it is one and a half tablespoons at NIBSC. I am looking for the actual numbers. We have seven individual cases held in citrate anticoagulant and nine individual cases held in pink bottles—EDTA anticoagulant. That is 16 patients. The National Prion Unit itself holds other ones. In the Lancet paper on Professor Collinge’s test showing the 70% sensitivity, I think he used 21 samples from patients. They, the NIBSC samples, are available, following a proper protocol, to all people.
David Tredinnick
Are you saying that the number of samples that he used was small? Is that what you are implying?
Professor Davies
It was large compared with what anyone else will be able to use, being 21. We only have 16 held at NIBSC.
David Tredinnick
Why was the Prionics test validated on the basis of only two samples when that could not possibly have given a statistically significant result?
Professor Davies
I do not have the details. We will send them to you, but it is not a test in routine use, as far as I am aware. We will send you the details.
Chair
Before we move off the issue of money, you talked about a ring-fenced budget. Minister, is it the intention that that ring fence remains after 2015?
Jane Ellison
No proposal has been put to me to remove it. I cannot commit to what would happen in the future and what any future Government might think, but it seems to me that we have established an approach to this particularly serious issue that is extremely precautionary, looking at the amount of money spent, the ring-fenced budget and the number of actual cases. I think it is right to take an extreme precautionary position. I have no intention to challenge that. Obviously, successive Governments might take a different view, but it seems to me that has been a consistent picture since the height of the whole crisis. Successive Governments have taken that precautionary principle.
Graham Stringer
NICE issued guidelines in 2006 to help stop the transmission of CJD during surgical operations. We have been told that that has not been universally implemented. What are the consequences of that, and what are you doing about it, if anything?
Professor Davies
I brought for you, if you needed it, all the official guidance, so the NICE guidance, which is significant, is in there. You will know that when NICE issues guidance the NHS is expected to implement it within three months. I was not aware—this is the first I have heard—that places are not using the guidance. We would have to ask the CQC, as our agency for inspection, whether they had picked that up, and probably talk to the Royal College of Surgeons. Because if that is the case, it is unacceptable, because we are concerned about the transmission of disease—not only prions but other diseases.
Graham Stringer
I cannot give you the reference, but our notes say that in 2011 a study found that the guidance had not been fully implemented in a number of trusts, partly because of resource issues. I am slightly surprised that you are not aware of that, but if you can give us a note on what you think about it that would be helpful. What do you think generally about the measures currently in place to prevent the transmission of prions? Do you consider them to be adequate?
Professor Davies
In the light of our present knowledge, our scientific advisory committees advise us that they are in the right place. We have implemented everything that the scientific advisory committees have said is effective, and cost-effective.
Graham Stringer
A Department of Health working group has acknowledged that the standard wash procedures do not clean surgical instruments; they do not get rid of the prions, yet there is technology available for doing that. Are you trying to solve that issue? To go back to the discussion with the previous panel, is it your understanding that autoclaving surgical instruments gets rid of prion contamination, or not?
Professor Davies
My understanding is that because they are hydrophobic they are difficult to get off surgical instruments.
Graham Stringer
They bond in a particular way.
Professor Davies
Yes, and autoclaving on its own does not remove them. If I am wrong, I will have to tell you.
Graham Stringer
That was my understanding.
Professor Davies
That is my understanding. We have clearly moved on a precautionary principle back in 2007 to single-use dental reamers and dental equipment for root canals, and it was a precautionary principle that took us there. We tried single use in tonsillectomy, and brought it in rather fast. There were patients who bled, and sadly a death, so we had to reverse that, but there is a lot of work to make sure that, where possible, there is single use and that decontamination is properly done. There is more to do. We have £46 million-worth of research ongoing, which started in 2011, including on decontamination, and most of that will be reporting later this year. Following that, clearly we may need to change what we are doing.
Graham Stringer
We are told that there is technology available for doing it. Do you accept that? Are you looking to put it into standard procedures?
Professor Davies
If you are talking about the DuPont decontamination product, I can tell you that the rapid review panel gave it a level 2 assessment.
Graham Stringer
Which means?
Professor Davies
It means that basic research and development has been completed and the product may have potential value. In-use evaluation trials are now needed in an NHS clinical setting. It is for the company to do that. We have been told that DuPont have not chosen to do that at this time. I should perhaps highlight to you that, even if effective, it would be quite a difficult product to introduce in the NHS, because it would involve changing the central sterile departments of every hospital, and their processes and some of their other machinery. Were it proved to be perfection, it would not be just the cost of it; it would have massive knock‑on costs elsewhere in the sterilisation department system.
Pamela Nash
Minister, we have been hearing this morning in the last session and this one about the new technologies that are being developed with the support of the Government and the MRC. We know that they have not been adopted more widely. What message is that giving to companies who are looking at developing products in this field? We have received some criticism about that. Do you think there is anything the Government can do to make it clearer to those companies exactly what technologies the Government would want them to invest in for the future?
Jane Ellison
Ms Nash, are you talking principally about the RelyOn surgical wash? Obviously, that is the one I am aware of. I have met Professor Collinge. I had a meeting with him shortly after I was appointed and discussed that. I am aware of the criticism. I am not a scientist; this is very technical for me, so as Minister I have to ask simple common-sense questions. Is someone presenting to me evidence that something can be very effective on the basis of evidence, and also cost-effective? Even if that was the case, it would not be my decision as Minister to say that is something everyone must use, because obviously there are other people producing products that the NHS might want to buy and use. But the first test that has to be met is whether something has passed an evidence test of effectiveness, and could it potentially be implemented in a cost-effective way? As far as I understand it, there is nothing to stop the company that developed this one taking matters further, going back to the rapid review panel and doing further development and further tests. Nothing has been put in the way of that. From my point of view as a Minister, it would be completely inappropriate to sit in my office and pick winners that have not gone through a proper process. I rely on the evidence presented to me of things having gone through a process. As far as I can see, no barriers have been put in the way of this product, but there is still some way to go for the people behind it to prove that it can be effective and cost-effective.
Pamela Nash
I appreciate that, and I understand where you are coming from, Minister. Just playing devil’s advocate, perhaps barriers might not be put up, but a company would want to know that a product might be used. You might not be picking winners in terms of the companies and the producers but, perhaps, giving an indication of what technologies are being looked for and would be invested in. Would the Government subsidise technologies if it became clear that they would be very helpful in protecting public health, but would not be profitable for the companies producing the products?
Jane Ellison
Our starting point is funding the research. We have given evidence that a lot of research is being funded. The issue would then come to me. It would be put to me that this is effective, but there are already processes in place for the NHS to consider the use of products. Do not forget that it would be for NICE, for example, to recommend the use of something that became a gold standard. We have existing processes that I think are pretty robust, and have to be; otherwise, you would never be able to make decisions in this area. It is so complex, and so much money is involved, that you have to have robust processes. I cannot see anything in the processes we already have that would stop an evidence-based effective product that could be used cost-effectively being recommended to the NHS.
Pamela Nash
My understanding is that the technologies that we have mentioned—the prion filter, the MRC projects as well, blood tests and the prion inactivator—were evaluated by different processes and different bodies at the time. Has that system now been rationalised as part of this diagram we have, or is it separate? My concern would be that a complex system of this sort would put off companies, and it might be costly both for them and the Government to have those different processes. Has that now been rationalised?
Professor Davies
It is a fairly smooth process. It is quite clear that the rapid review panel reviews technologies to reduce hospital-acquired infection. SaBTO reviews issues around blood safety. I do not think that any part of the industry worth their salt has problems with the system. If they do, they only have to ask us.
Chair
Is that advice available equally to companies, irrespective of size?
Professor Davies
Of course it is.
Chair
You are open to propositions from small companies.
Professor Davies
If they are asking how the system works and who will be assessing them and to what criteria, that is easily available to everyone.
Mr Heath
Minister, following on from that, does it not make a difference that in this particular area NHS England, or certainly the British NHS, would be one of the biggest markets—almost an exclusive market—for a product of this kind? Therefore, it is not quite the same as, say, a drug of general applicability where markets can be found anywhere and Britain can either buy in or buy out. Companies need that confidence to know there is a buyer for this.
Jane Ellison
I understand the point you are making.
Professor Davies
This is not just a British problem.
Mr Heath
It is not exclusively British but we are the biggest market.
Professor Davies
The market would take in other countries in Europe as well.
Mr Heath
But not if the British NHS does not buy; there won’t be a market without the British NHS.
Professor Davies
Unfortunately, there is a complaint from the medical devices industry that it is difficult to sell devices to the NHS even when they have been developed in the UK. They find it easier to sell abroad, and this may be no exception.
Mr Heath
I just think the normal market model does not necessarily apply when we have a centre of infection here. There is not a North American market, for instance.
Jane Ellison
Mr Heath, I understand the point you are making, but equally the conversation at the meeting in my office hinted at what you are saying, which is effectively should we almost say, “If you get this right, we will recommend”? If somebody developed a scientifically evidenced, cost-effective product that could, as Dame Sally said earlier, be incorporated without disproportionate cost to make our NHS safer, I see no reason why our NHS would not want to look at it. It would be irrational if they did not. The question then is, are we funding and supporting the development of some of this work? I think the answer to that is yes. I came at this very fresh. The meeting I had with Professor Collinge and others was very early on as a Minister, so I had no preconceptions. It seems to me that we have put investment and support in the way of developing these technologies, but there is a point at which either the company involved or the market has to do some of that work. Equally, there is an evidence level of effectiveness and cost‑effectiveness that has to be met.
Mr Heath
I do not dispute that. Let me talk about something completely different. The CJD incidents panel disappeared last year, I think. Are you confident that local management and local reporting structures are sufficiently robust for CJD?
Professor Davies
Yes. I think that in this country people have a very high index of suspicion about CJD. The number of referrals outnumbers the number of cases, so we have a high index of suspicion. We had an incident panel which set up the processes and advice, and we stood it down. The standard operating procedures should be good enough for anything that comes up, but if something new and different comes up we will seek advice from the ACDP and other experts. I think it is still a robust system.
Mr Heath
You think it should be, and there is evidence to suggest that it is.
Professor Davies
Yes.
Mr Heath
Dealing with the cohort of at-risk patients identified, are you satisfied that they are getting both the support they need and the continuing surveillance that gives us a clear picture of what is happening to them, if anything?
Professor Davies
As I understand it, there are two groups: those who have been labelled at public health risk because they received pooled products that may have had an infective load, but that, probably because it was pooled, is very low, and those where, through a look-back, we know that they received blood products where the donor subsequently developed disease. Both are very difficult for the recipient of that advice and how you follow them, but I believe that the clinicians are giving good support and following those at highest risk very carefully. The other public health at-risk group are mainly people with inherited bleeding disorders, and they get support through their routine management at haemophilia centres where they have counsellors and everyone there.
Mr Heath
One area of the surveillance system, as I suppose you could call it, which is clearly not desperately successful at the moment, is post-mortem examination of people within that at-risk group who subsequently die. First, is that a concern in terms of getting accurate figures for infection levels; and, secondly, if it is a concern, what have you done to improve it?
Professor Davies
There are two problems. One is that the rate of post-mortem examinations has gone down dramatically from being the norm to very low anyway, and that is a cultural issue. People do not want them, so not everyone consents. If an at-risk person’s family consents, the post-mortem is done to the standards we would expect. There is not a drop-off in quality of post-mortems, and we will know whether the spleens, tonsils and so on have relevant changes. There is then an issue of post-mortem studies to look at prevalence. There is some discussion at the moment with my research team as to whether we could and should fund an elderly cohort through post-mortems to look at prevalence, and we are looking at that to see whether it is doable and cost-effective.
Mr Heath
Without that, if an elderly person contracts dementia, distinguishing it from CJD prior to death is clearly quite difficult, so we do not really know the prevalence.
Professor Davies
We do not know the prevalence, but it is before the BSE problem arose. The assumption in our elderly people—it is an assumption and not proven by science—is that it will be low or negligible, but without doing such a study we do not know.
Jane Ellison
If I may comment on your previous question, my postbag from Members of Parliament is a very good indicator of whether we are getting things right on all sorts of issues. It is extremely wide-ranging, as is my portfolio. To the best of my knowledge—I think I would remember it—I have not had a letter from a Member of Parliament on behalf of a patient. You asked whether we were looking after people and supporting them well enough. There are a number of other areas where I get many letters from Members of Parliament on behalf of their constituents. To date, this is not one of them. Inasmuch as my post bag is quite a good early warning signal about where we are not getting things right, it has not alerted me to the fact we are not getting that support right in this area.
Mr Heath
That is very helpful.
Chair
But that is no reason to be complacent, because this is a very serious condition.
Jane Ellison
Believe me, Mr Miller, this is one area where, given the history of this disease, I do not think any Minister would ever be complacent.
Stephen Mosley
I have just a couple of questions on the National CJD Research and Surveillance Unit. You will probably be aware that current funding goes up to 2015. Are there any plans to continue funding beyond that?
Professor Davies
They would need to make an application, but I would be surprised if they did not receive funding. However, I cannot promise it because that is in a different Government and a different Comprehensive Spending Review, and they have not submitted an application.
Jane Ellison
I cannot speculate on a hypothetical, but I said in my earlier evidence that the view successive Governments have taken in this area has been a very precautionary one, but clearly that has not come to me as a Minister for a decision.
Professor Davies
I have a correction. They have a contract until 2017; we are funding them until at least then.
Stephen Mosley
The unit is currently based at the University of Edinburgh, which is of course in Scotland. Have any negotiations and discussions taken place as to what would happen if Scotland votes for independence in September?
Jane Ellison
No. I do not think any part of Government is making any sort of pre‑independence plan; that is not something we have had a discussion on.
Stephen Mosley
The unit has submitted to the Department a proposal for the investigation of atypical dementia in the elderly. Have you been able to look at that proposal? Have you given it any consideration at all?
Professor Davies
That is the proposal I just mentioned. The R and D team and policy team are going to discuss it with them.
Sarah Newton
Last but not least, may I move to the whole area of transplantation? Can you give us an update on the action that the Department of Health have taken to implement the “Taking Organ Transplantation to 2020” strategy?
Jane Ellison
Perhaps I can comment on one aspect of it as an example of where I am quite actively involved. I am very aware that one of the big challenges in this area is as much about consent as the number of people on the register. For the last year for which we have figures, about 100 families overrode the wishes of somebody who was on the organ donor register at that very difficult moment when the family was asked. Consent is a big issue. Consent rates vary widely between different communities. For example, the family refusal rate in BAME communities is about 80% compared with 25% as the national average. That is where we get our 40% figure, so they are very divergent figures. There are two actions that we are taking forward in that area. I am attending, I hope, diary permitting, the launch of the peer educator programme in Birmingham, where we are looking to create local champions within particular communities to champion both organ donation and the consent issue. We are planning some activities for transplant week in the second week of July in which I hope to involve parliamentarians, particularly those representing constituencies where raising the profile of these issues will be particularly helpful. Those are just a couple of examples of things directly within the Department of Health’s remit that we are trying to take forward from the strategy.
Sarah Newton
That is extremely helpful. Professor Neuberger, from whom we took evidence this morning, also highlighted the issue of consent. There is a very good target of 80% consent within the strategy, so it is encouraging to hear of the activities you plan, particularly around community champions. Where you have examples of people coming forward, it is a very powerful thing. An 80% target is very ambitious, so do the Government have any plans to review their position on presumed consent?
Jane Ellison
We are certainly going to watch what happens in Wales. We have no current plans to go down that road ourselves, but I will be watching with interest. Clearly, there are potential risks as well as potential benefits, so it is important to assess those. Because of what we know about the problems of consent, it is really important not to think that the only issue is about the number of organs. It would not alter the pool of suitable donors in any given year. What you would be looking to do is raise the proportion of them on the register, but if you did not tackle consent rates you would not have anything like the impact. At the same time, although we don’t know, there is quite a lot of research to suggest that it might have a negative impact on people being on the register. We will need to look at that. We will watch it with interest, but we have no current plans to go in that direction.
Sarah Newton
Professor Neuberger talked about issues around training health professionals. As you said, it is a very difficult moment to secure consent to enable organ donations when families are faced with the loss of a loved one. He was talking about this particular issue, which he felt was a barrier to hitting those targets. What plans have the Department got to work with professionals—nurses and doctors—in hospitals to drive up those consent rates?
Jane Ellison
Work is already going on. There is a group of highly trained professionals, in the case of nurses going by the somewhat unlikely acronym SNODs—specialist nurses in organ donation. They work embedded within intensive care units. They will start talking to families before death potentially, and look at how they can prepare to have that conversation. We already have those highly trained individuals. Where they are in place they can be very effective. It is really important to do that work. You cannot think of a more sensitive time to put a very difficult decision to people, so the more trained people are, the more likely we are to see consent rates rise. Some families consent to someone who is not on the register becoming an organ donor. That can happen. Many donations come from people not on the register. That specialist medical support is already there and is effective.
Sarah Newton
Professor Neuberger also talked about issues to do with some surgeons accepting particular organs for transplantation. He felt that was an area that needed more attention. The strategy commits the Government to a whole series of action plans. To what extent are the Department monitoring the delivery of the strategy and specifically getting the different pieces of the jigsaw signed up to their implementation plans?
Professor Davies
There is an accountability meeting every three months, and a big one annually between NHSBT and the Department sponsors, and this plan and the metrics in it are part of that, so an eye is kept on it.
Jane Ellison
When I became a Minister one of the first things I did was to ask to meet NHSBT. I asked them what I could do to support their work, and where I could bring particular focus. I was directed to some of the work on consent rates in particular communities, which led to the things that I have in my schedule. It is a strategy that so far has produced some really good results. There is a terrific increase in registering for donation and donations themselves, but we know we have more to do. We aspire to be extremely good at this, but we keep pretty close to it. It is an area that I am personally very interested in. I know that a number of parliamentary colleagues have done work in their own constituencies to try to address some of these particular issues. As a Health Minister I am also looking to see where I can involve parliamentary colleagues in spreading the word in those areas that require it.
Graham Stringer
Professor Davies, in the mid-1990s we were getting horrific projections about this disease. They have not come to fruition. Over that period of time what have we got right and what have we got wrong in dealing with this disease? Have we been lucky or very effective?
Professor Davies
I do not think it was luck; I think it was a planned cross-Government movement, first with animal feed and the progress made on slaughtering older animals and so on to reduce the infectivity pool, and then on primary infection, which had a dramatic impact. Then we were concerned about secondary infection person to person, and blood transfusion is the most obvious way that that comes through. If you look at the data, as I know you have, you can see that leucodepletion filters probably remove about 40% of the infectivity. With other changes we have had an impact to try to make sure we do not get into a vicious circle where, despite its no longer being in the food chain and infecting, we are continuing it. I think we have made very good progress. To date, all the probable and seriously likely cases have been MM genotype, though there is one possible case that was MV—a heterozygote. We remain open to the concerns that have yet to play out that there may be a longer incubation period in the heterozygotes, which is why we still are actively doing research. This is not something that we can ignore and get away from on the precautionary principle. Although that second epidemic has not hit us, it does not mean that we can sit back and say, “Problem solved, book closed.”
Chair
My final question stems from earlier comments. In this particular area is there a case for scientific advisory committees that exist under the new structure being responsible for, or at least reporting on, the cost-effectiveness of new technologies?
Professor Davies
They do give advice on cost-effectiveness, but that has to be based on health economic modelling.
Chair
That is their advice but it is not a decision-making process; it is advice to you, is it?
Professor Davies
I would have to go back and look at where the advice goes, but I would highlight to you as the Science and Technology Committee that you would be very unhappy if I overruled expert scientific advice.
Chair
Absolutely.
Professor Davies
I do not make a habit of it. I cannot think when I have.
Chair
We get upset, especially when Ministers do it.
Professor Davies
My role is to give advice to Ministers.
Chair
Thank you very much for a very helpful evidence session. Oral evidence: Blood, tissue and organ screening, HC 990 8 [1] Following this evidence session, SaBTO made the following clarification: “Leucodepletion filters are integral to blood collection bags and the value of leucodepletion is well accepted, not only as a vCJD risk reduction measure but also in other ways - for example in protecting against the transmission of cytomegalovirus. SaBTO reviewed the use of vCJD risk reduction measures in 2013 and agreed that has been no suggestion that it should be discontinued, and so no clinical and cost effectiveness analysis by SaBTO has been required.” [2] The witness later clarified that, there has been one new UK case since 2010. [3] The witness later clarified that, the Department had given £16,294,648.