Blood Safety (Variant Creutzfeldt-Jakob Disease)

Luciana Berger Excerpts

Thursday 29th January 2015 Westminster Hall

[Luciana Berger (Liverpool, Wavertree) (Lab/Co-op)]

It is a pleasure, as always, to serve under your chairmanship, Sir David. I thank the Chair of the Select Committee on Science and Technology, my hon. Friend the Member for Ellesmere Port and Neston (Andrew Miller), and the other Committee members for their extremely thorough and valuable report, and for ensuring that we have the opportunity to debate this important issue.

I think that we all agree that variant Creutzfeldt-Jakob disease is a deadly illness around which many uncertainties remain. The report “After the Storm?”, the Government’s response and this debate are welcome contributions to parliamentary and public understanding of vCJD, transfusion and prion diseases, and the Government’s action in response to those risks.

The history of blood transfusion in this country is impressive and important. The principle of freely given, unremunerated blood donation operating within the NHS, free of commercial considerations, has served this country well. It was Richard Titmuss who famously described that arrangement as “the gift relationship” and blood as

“a bond that links all men and women in the world so closely and intimately that every difference of colour, religious belief and cultural heritage is insignificant beside it.”

We have come a long way since the UK’s first voluntary blood service was founded by the British Red Cross to help the treatment of servicemen in 1921. Today, approximately 2.2 million whole blood product donations are made in the UK each year and screened for a variety of different pathogens. Those donations are tested, processed and distributed by one of the country’s four blood services. The success of the system hinges on an assurance of the very highest level of safety and risk avoidance. Sometimes, an element of honesty is important on the part of the potential donor, but even more important are procedures to protect recipients of blood and blood products from risk. We should be proud that our UK blood supply has been proven to be extremely safe. In the vast majority of cases, the benefits of receiving a transfusion far outweigh the risk of acquiring a transfusion-transmitted infection.

Sadly, however, we have reached that point only after significant tragedy. Last week, the House debated a report by the all-party group on haemophilia and contaminated blood that looked at support for the thousands of haemophiliacs who were treated with blood that carried the hepatitis C virus in the 1970s and ’80s. In the ’80s and early ‘90s, contamination of the UK blood supply with HIV led to a further 1,200 infections. Since those tragedies, all UK blood donations have been tested for HIV and hepatitis C. Those experiences are relevant to this debate, because the safety measures were implemented only after those mass infection events.

The report “After the storm?” makes a helpful distinction between the known risks that can be well mitigated and the known risks that cannot. Our existing blood safety measures are largely focused on the known risks that we can easily mitigate through measures such as testing and screening. Unfortunately, as we have heard, prions, which are responsible for variant CJD, are invulnerable to those methods, so we need to develop new ways to mitigate those risks. The key question that we have debated today is how far the Government should prioritise such research and development.

It is extremely difficult to draw conclusions, because so many uncertainties remain. However, there are several things that we know. Although it is extremely rare, variant CJD is invariably fatal, and most people die within a year of first experiencing symptoms. Recent studies indicate that tens of thousands of people in the UK could be silent carriers of the prions responsible for the disease, and they may transmit those prions to others. Cases of transfusion-transmitted variant CJD are known to have occurred although, as has been pointed out, that happened 15 years ago. The Government have acknowledged that risk.

Currently we do not use a test to detect the presence of prions, but there are emerging technologies that could mitigate the risk, such as prion filtration and the prototype variant CJD blood test. It is natural to hope that the Government will adopt a precautionary approach and support the development and introduction of technologies that have the potential to mitigate those risks. The report “After the storm?” makes concerning reading in that regard. I take on board the Government’s response that they have not reduced any of the significant steps taken since the late 1990s to reduce the potential for secondary transmission. It is also welcome that the Department continues to allocate its only ring-fenced research budget to research related to prion disease, but the question is whether that is sufficient. In her covering letter to the Government’s response to the report, the Minister wrote:

“There are competing research priorities for our limited funding”.

That must be true, but surely there can be no greater priority than assuring the safety of patients receiving blood transfusions.

The Science and Technology Committee examined several possible technologies that might be developed to militate against the transfusion of variant CJD, and I will discuss some of them briefly. The Chair of the Science and Technology Committee, like the hon. Member for Mole Valley (Sir Paul Beresford) and my right hon. Friend the Member for Holborn and St Pancras (Frank Dobson), spoke about those technologies, but I have further questions about them for the Minister. The development of a test for the presence of the prion is of enormous importance, given that data suggest that the prevalence of sub-clinical disease and infection may be as high as one in 2,000 people. Although this is disappointing, I appreciate that the Government may not be in a position to commit to a prevalence test yet. It is welcome that they have committed to seeking the views of the transmissible spongiform encephalopathy sub-group of the Advisory Committee on Dangerous Pathogens on the scientific and technical issues involved in developing such a test and on the potential value of a blood prevalence study. I would welcome an update from the Minister on how that work is progressing and when the Government will be in a position to make a decision about the value of a prevalence study.

The report examined ways to mitigate the risk of transmission of prions by surgical instruments and the Committee expressed concern about the implementation of guidance on the decontamination of surgical instruments. It is indeed alarming that such concerns exist. As we have heard from the Committee Chair and the hon. Member for Mole Valley, it should be part of local clinical governance arrangements that such a fundamental patient issue should dealt with, reviewed routinely and reported to the board of the trust.

The Government stated in their response to the very reasonable recommendation of the Science and Technology Committee:

“Accordingly, the Department will discuss with the CQC the need for the implementation of decontamination guidance to be addressed in its regulatory activity”.

I find that use of the word “discuss” a matter for concern. Decontamination should be mandated, inspected and assured. Patients might find it worrying that all the Department of Health is prepared to do is to “discuss” with the CQC the need for action on the matter. I would be grateful for the Minister’s assurance that the proper sterilisation of medical instruments will be dealt with as a matter of urgency.

[Sir Paul Beresford]

To be fair, I think that the hon. Lady should recognise that the RelyOn is not in a state in which it can be simply used. It is a wash, but if the opportunity were there, it might well be developed for the market so that it could be put into washer-disinfectors. I think that that is perhaps what the discussion is about.

[Luciana Berger]

I thank the hon. Gentleman and hope that the Minister will deal with that point. She could perhaps directly task the newly appointed regional public health directors of Public Health England to review instrument sterilisation in all trusts and report directly to her on the matter.

Prion filtration is another possible method of mitigating the risk of transmission of variant CJD. That is the process through which prions are physically removed from blood through the use of highly specific resin ligands. After recommending the use of the technique in 2009, the Advisory Committee on the Safety of Blood, Tissues and Organs decided in 2012 to rescind its initial recommendation, so prion filtration has not been adopted in the UK. The scientific decision making of the committee must of course be respected, so I do not seek to challenge its decision, but the Select Committee’s report raises important questions about the process that is followed through such reviews, and makes some important recommendations.

The report recommends, for example, that the health technology appraisals conducted by the advisory committee should use the same methodology and meet the same high standards as those undertaken by NICE, the UK’s centre of excellence for that activity. The Government have said that work to explore the differences in appraisal methodology between NICE and other health-related bodies, including the Advisory Committee on the Safety of Blood, Tissues and Organs, is being carried out through an appraisal alignment working group. I reiterate the question asked by my hon. Friend the Member for Ellesmere Port and Neston: will the Minister please give us an update on how the work is progressing and when the group will report?

The “After the storm?” report raised concerns that the scientific advisory committees are not currently independent of the bodies to which they provide advice. In response, the Government also said that they would review the terms of reference of the Advisory Committee on the Safety of Blood, Tissues and Organs and ensure that they are clarified appropriately. They said that the advisory committee is planning to amend its code of practice so that future working groups and sub-groups will not be chaired by someone who holds a senior policy-making position in an organisation if the topic under consideration relates directly to that organisation’s interests or activities. Has that work now been completed?

We should all agree that protecting the public from potential harm by transmission of the prion that causes variant CJD—or, indeed, from the transmission of any serious threat to health via our blood service—should be given the highest priority. The Science and Technology Committee has raised valid concerns that some recent Government decisions signal a change from the precautionary approach to variant CJD risk reduction of the late 1990s to a more relaxed approach today. As we have heard, significant questions remain, so I look forward to the Minister’s response.