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)
Conclusion
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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