After the storm? UK blood safety and the risk of variant Creutzfeldt-Jakob Disease - Science and Technology Committee Contents

Conclusions and recommendations

Risks to the UK blood supply

1.  Blood transfusions save lives and we should be proud, as a nation, of our long tradition of altruistic donation. In recent years, the UK blood supply has proved to be extremely safe and, in the vast majority of cases, the benefits of receiving a transfusion will far outweigh the risk of acquiring a transfusion-transmitted infection. However, we urge against complacency and stress the need for UK Blood Services to remain vigilant to the threat posed by blood-borne pathogens. (Paragraph 9)

2.  The evidence that we have heard suggests that we cannot be confident that prions are not present in the blood supply. There remains considerable uncertainty about the potential implications of such contamination. We consider it imperative that a precautionary approach to this risk be maintained until further evidence becomes available. (Paragraph 17)

3.  We echo concerns that population-level risk assessment could lead to inaccurate and potentially discriminatory judgements being made about the risk posed by individuals, particularly men who have sex with men. We recommend that the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) reconsider the feasibility of a move to more individualised risk assessment as part of its 2015 work programme, following completion of the current UK blood donor survey. (Paragraph 22)

4.  Pathogens are constantly emerging and evolving; novel pathogens will therefore always pose a threat to the blood supply. In the past, it has often taken multiple cases of transfusion-transmitted infection before these threats have been recognised and mitigated. This will remain the case as long as risk mitigation measures remain pathogen-specific. We urge the Government to take steps to support the development of broader spectrum technologies with the potential to mitigate the risk of both known and unknown pathogens. (Paragraph 26)

Surgical transmission of prions

5.  The Government has acknowledged that contaminated surgical instruments are a potential source of prion transmission and states that it has taken a precautionary approach in its response to this risk. However, this response appears to rest heavily on guidance which, based on the available evidence, may not have been fully implemented. We recommend that the Government work with the National Institute of Health and Care Excellence (NICE) and the Advisory Committee on Dangerous Pathogens to better understand the extent to which the precautions recommended by these bodies have been implemented across the NHS. We ask the Government to provide us with an update on this work well before the dissolution of Parliament, together with an indication of the steps it will take if preliminary findings suggest that implementation has been incomplete. (Paragraph 29)

Case study 1: decontamination of surgical instruments

6.  Given the NHS's resistance to change and the well-documented challenges associated with initiating a UK clinical trial, the Minister's assessment that "no barriers" were put in the way of DuPont's prion inactivation product does not reflect the reality of the situation. Where technologies are developed in direct response to Government need—and on the back of Government funding—the Government must be prepared to take steps to help companies overcome barriers to adoption. We ask the Government to set out how, in future, it will ensure that the directed research that it funds is better supported through the technology readiness pathway. In particular, we ask the Government to set out how it will ensure that promising clinical technologies are promptly trialled in an NHS setting, so that potential adoption challenges can be quickly identified and resolved. (Paragraph 37)

7.  We also question the value of a scientific review panel which has no mandate or power to ensure that the products that it recommends can be tested in, and eventually adopted by, the NHS. We see this as further evidence of the Government's passive approach to technology uptake. We propose that the Rapid Review Panel (RRP) be given stronger powers to ensure that its recommendations open the door to in-use evaluation and stimulate NHS uptake. (Paragraph 38)

8.  In our view, all Scientific Advisory Committees should adhere to both the 2010 'Principles of Scientific Advice to Government' and the 2011 'Code of Practice for Scientific Advisory Committees'. We were disappointed to find that the Rapid Review Panel (RRP) failed to do so. We recommend that the Chief Medical Officer takes action to rectify current weaknesses. We request a progress report be sent to us well before the dissolution of Parliament. (Paragraph 40)

Case study 2: prion filtration

9.  We do not wish to question the scientific decision-making of the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) and we respect its decision not to recommend adoption of prion filtration at present. However, we feel that the time taken to reach this decision was excessive and that the process, particularly in its latter stages, entailed an unnecessary level of uncertainty for the commercial developer. We have some sympathy for SaBTO's desire to wait until more evidence was available before making a decision; however, if industry is to continue to develop innovative blood safety products for the UK market, SaBTO must introduce greater speed and predictability into its evaluation process. We recommend that, in future, when assessing a new technology, SaBTO agree with stakeholders at the outset what the evaluation will consist of, together with key dates, milestones and decision-points. This 'evaluation roadmap', and any subsequent amendments, should be made publicly available to ensure maximum transparency and accountability. (Paragraph 45)

10.  We also consider it important that the health technology appraisals conducted by SaBTO—and all other SACs—use the same methodology and meet the same high standards as those undertaken by the UK's centre of excellence for this activity: NICE. We therefore recommend that the Government Office for Science work with NICE over the next 12 months to develop and publish a standard methodology for all SACs tasked with conducting health technology appraisal. Until this guidance is published, we recommend that a NICE representative review and, where necessary, provide input to all such appraisals undertaken by, and on behalf of, SACs. (Paragraph 46)

11.  Scientific Advisory Committees should be—and be seen to be—independent of the bodies to which they are providing advice. At present, the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) comprises members who are both contributing to, and acting on, the advice that it formulates. We consider that this could be damaging to its perceived independence and a source of potential conflicts of interest. We recommend that SaBTO's terms of reference be amended to reflect the fact that it does, in effect, provide advice to UK Blood Services as well as the Government. We suggest that SaBTO's current membership be reviewed and potentially revised in light of this change. (Paragraph 50)

Case study 3: vCJD blood testing

12.  We understand the need to carefully control access to rare vCJD samples and commend the National Institute of Biological Standards and Controls (NIBSC) for putting in place a standard protocol for test validation. However, we are disappointed that so few samples are currently held by the NIBSC and consider its process to be undermined by the fact that the two major centres of UK prion research—the National CJD Research and Surveillance Unit and the MRC Prion Unit—can each use and distribute samples independent of NIBSC evaluation. All test developers should be given equal opportunity to gain access to the available samples and these should be distributed on the basis of merit alone. We recommend that access to all vCJD patient samples—including those currently held elsewhere in the UK—be managed through the NIBSC, according to a consistent set of test validation protocols. (Paragraph 59)

13.  We were also concerned by the apparent statistical weakness of past NIBSC evaluations. We recommend that the CJD Resource Centre Oversight Committee add to its membership an individual with expertise in biostatistics, who can provide it with expert advice on this matter during future deliberations. (Paragraph 60)

14.  The incubation period of prion diseases such as vCJD can extend to several decades and it is therefore possible that individuals infected in the 1990s might not yet have developed symptoms. We do not follow the Minister's logic that there should be a link between the number of cases seen in the last ten years and the level of resource dedicated to prion research. We simply do not know, at present, how many people have been exposed to prions and what the implications of this might be for the blood donor pool. There is an urgent need to reduce this uncertainty. (Paragraph 65)

15.  Based on the testimony that we have heard, we consider that a vCJD blood prevalence study utilising a version of the prototype test developed by the MRC Prion Unit would be of considerable value, both for test development and research purposes. We recognise that significant public funds have already been directed towards the development of this test; we view this as even more reason to ensure that a return on this investment is realised. To cut off support now would be a false economy. We recommend that the Government ensures that a large-scale vCJD blood prevalence study be initiated in the UK within the next 12 months. (Paragraph 66)

CJD risk management

16.  People who are notified that they may have been exposed to CJD will inevitably be alarmed by this information and will likely have questions that cannot be answered in the leaflets currently provided by Public Health England. We consider it totally inappropriate for this news to be communicated solely in writing. We recommend that the Government put robust measures in place to ensure that all individuals assigned this designation receive the news verbally, either from a healthcare provider or from a CJD specialist with experience in patient communication. (Paragraph 70)

17.  It is clear that the prototype vCJD blood test developed by the MRC Prion Unit cannot yet be relied upon for universal screening purposes. However, it could be of significant value to those people who have been notified that they are at increased risk of carrying the disease. Until the implications of a negative test result can be more firmly established, current precautions must remain in place for those considered to be 'at risk' of vCJD. However, the results of an imperfect test may provide comfort to some. We therefore recommend that 'at risk' individuals be given the opportunity to participate in the blood prevalence study recommended in paragraph 66. (Paragraph 73)

CJD surveillance

18.  The Government claims to be undertaking close surveillance of those it considers to be 'at risk' of CJD. Yet it cannot provide reliable data either on the total number of people designated 'at risk' or the number who have been notified of this fact. This is unacceptable. We recommend that the Government conduct an immediate audit of the entire 'at risk' cohort to establish whether any notifications remain outstanding and to ensure that appropriate support and follow-up is in place for all those affected. We also propose that the Government commission an independent review of the transfusion data pathway to ensure that, in the event of any future blood contamination incident, it can promptly trace, notify and provide support to affected recipients. (Paragraph 77)

19.  We were disappointed by the evident lack of support provided to those designated 'at risk' of CJD. We consider it inappropriate for the Government to have effectively delegated responsibility for the care and surveillance of a large proportion of these individuals to external bodies such as the UK Haemophilia Centre Doctors' Organisation—a charitable organisation with no formal relationship with the Executive. We recommend that the Government, through its public health agencies, assume direct responsibility for the surveillance and support of all those considered to be 'at risk' of CJD, with input from other specialist organisations as required. (Paragraph 78)

20.  In our view, the decision to participate in research should always rest with the individual or, in exceptional circumstances, their loved ones. Nevertheless, samples contributed by those potentially exposed to CJD are of immense scientific value and we are disappointed that more has not been done to obtain consent from those willing to participate in research. We recommend that the Government consider ways to increase the number of 'at risk' individuals giving consent for research participation, particularly post-mortem. We ask that the Government summarise its plans for achieving this in its response to this Report. (Paragraph 81)

21.  We are confident in the integrity of the National CJD Research and Surveillance Unit and have not seen any evidence to corroborate claims of deliberate under-reporting or misclassification. However, we share our witnesses' concerns that cases could be missed due to misdiagnosis, particularly in the elderly. We recommend that the Government lend its support to research intended to give greater clarity over the causes of atypical dementia in the elderly and, through this, the potential rate of undiagnosed CJD. (Paragraph 87)


22.  SaBTO's decision not to recommend the adoption of prion filtration, taken alongside the other evidence that we have gathered during this inquiry, in our view signals a change from what was a genuinely precautionary approach to vCJD risk reduction in the late 1990s to a far more relaxed approach today. Much of the uncertainty surrounding prions, their potential modes of transmission and the possible rate of undetected infection and disease remains: recent evidence that subclinical prevalence could be as high as one in 2,000 people would suggest that a precautionary approach is now more warranted than ever. (Paragraph 94)

23.  Our fear is that the Government's current attitude is driven less by the available scientific evidence than it is by optimism: a hope that the storm has now passed and that vCJD is no longer the threat to public health that it once was. In the current economic environment, this attitude is not surprising. However, it is not justified. For all we know, the storm may well be ongoing. We conclude this report by recommending that the Government take a more precautionary approach to both vCJD risk mitigation and blood safety more generally, in order to safeguard against future infections. We suggest that it begin by assessing the key risks, known and unknown, that the UK blood supply currently faces and might face in the future, so that it can identify and fill relevant knowledge gaps and support the development of appropriate risk reduction measures and technologies. The Government should initiate this work immediately and we ask that it provide us with an update on its progress well before the dissolution of Parliament. (Paragraph 95)

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Prepared 24 July 2014