Research opportunities
7.18. While an influenza pandemic would be a
destructive and costly event, it would also be a unique opportunity
for research. As Professor Menon, of the Intensive Care Society,
noted, one of the reasons the world is so poorly prepared for
a potential pandemic is that "previous pandemics have not
been subjected to the rigorous research that modern research techniques
allow". (Q 178)
7.19. Some of this researchfor instance,
into the impact of different combinations of antiviral drugs on
patient outcomes and into the incidence and type of secondary
infections such as pneumoniawould feed directly back into
the health service response to the pandemic. In Professor Menon's
words, "If we are going to use antivirals, we need to know:
does it make a difference
whether the antiviral was given
on day one or day four? If, on day four, it was making no difference
to the severity of the illness, then that makes a difference to
how we treat people at the end of the pandemic."
(Q 178)
7.20. Other research would have longer term significance.
For instance, we have already drawn attention to the high mortality
among young adults in 1918-19, and to the theory that they were
killed by their own immune response. In the event of a new pandemic
it would be possible to show definitively "whether what is
killing [patients] is the disease or whether it is the host response."
Professor Menon noted that such extreme immune responses may be
"genetically-driven
There is a case to be made for
trying to understand the genetics underlying how badly people
do or how well they do". This would in turn "inform
our understanding of a lot of major illnesses both infectious
and non-infectious"; undertaking such research would be "not
only a duty but also an opportunity". (Q 178)
7.21. Once a pandemic starts, however, there
will be formidable practical, ethical review and regulatory barriers
to getting research underway. Professor Troop of the HPA noted
that there needed to be "rapid access to research funds",
which had proved "very difficult to achieve in SARS"
(Q 125). Nor will there be time to go through the normal system
of regulatory approval for such research. Professor Menon pointed
out some of the potentially time-consuming regulatory requirements:
- Assessments of drug efficacy would probably be
construed as clinical trials, falling with the ambit of the Clinical
Trials Directive.
- With regard to children or those too sick to
give informed consent, such consent would have to sought in accordance
with the terms of the Mental Capacity Act 2005.
- The storage of blood and DNA samples would have
to be conducted in compliance with the Human Tissue Act 2004.
(Q 181)
7.22. Professor Menon supported the suggestion
that in the event of a pandemic normal legal requirements should
be suspended in order to facilitate research. Professor Zambon,
of the HPA, recommended "planning ahead" in order "to
engage the research councils and ensure that there are rapidly
responsive mechanisms for funding research proposals and ethics
approvals". (Q 125)
7.23. The Minister refused to be drawn on these
points in her oral evidence, repeatedly assuring us that "these
are all issues which are being looked at very closely at the moment",
but offering no clear guarantees. In a follow-up letter she drew
a distinction between "collection and analysis of data for
public health and health protection surveillance purposes"
and "research projects". The former (which we assume
could include collection of data on patient responses to antiviral
treatment) would not require "the formal approval of a Research
Ethics Committee". However, by implication the latter, which
would include many of the projects described by Professor Menon,
would require approval. In practice research projects would probably
never get off the ground in time. (Q 291, p. 104)
CONCLUSIONS
7.24. In the event of a pandemic the speed
with which a vaccine can be prepared, manufactured and distributed
will be crucial. We therefore make the following recommendations:
- The Government should follow the example of
the United States in making a major investment in developing new
vaccine production techniques. The industry has been too conservative
in relying on tried and tested methods; it is time for the Government
to show leadership;
- The Government should explore mechanisms to
encourage the free exchange of proprietary technology between
vaccine manufacturers;
- With a view to promoting public health, the
Government should continue to encourage take-up of the annual
"flu jab" by at-risk groups. However, we do not believe
that the corresponding increase in manufacturing capacity will
be sufficient to meet the challenges of a pandemic. The Government
should explore other incentives to the industry to develop surge
capacity;
- In the event of a global pandemic, inequitable
distribution of limited vaccine stocks could have serious implications
for international relations. We therefore urge the Government,
in conjunction with United Nations agencies, to examine ways to
develop vaccine manufacturing capacity globally;
- We welcome the initiative of the European
Medicines Evaluation Agency in developing a "mock-up"
dossier for a pandemic vaccine. We recommend that the Government
invest in one or more "mock-up" dossiers with a view
to removing the regulatory barriers to a new vaccine.
7.25. We recommend that the Government fund
further research on alternative treatments for pandemic influenza.
This should include a full assessment of the risks and benefits
of fractionation. If such risk analysis is left until a pandemic
outbreak it will be too late.
7.26. We agree with Professor Menon that a
pandemic would present a unique opportunity for detailed research
into the effectiveness of treatments, immune responses, the causes
of mortality, and related issues, which could offer enormous long-term
health benefits. The Government have a duty to facilitate such
research, which will not be possible without advance ethical clearance,
rapid access to funding, and the suspension of various legal and
regulatory requirements.
7.27. We therefore recommend that the Government
initiate a public dialogue on the regulatory barriers to research
in the event of a pandemic. We believe the public would support
this research if its benefits were properly explained.
12 White House press release: http://www.whitehouse.gov/news/releases/2005/11/20051101-1.html.
Back
13
See HL Deb., 22 November 2005, cols. 1534-39. Back
14
Take-up in 2005 was higher, with the result that the Government
announced on 22 November that the 14.5 million doses ordered by
GPs had been exhausted. Back