Examination of Witnesses (Questions 80-99)
PROFESSOR COLIN
BLAKEMORE, DR
ALAN HAY,
PROFESSOR ANDREW
MCMICHAEL
AND PROFESSOR
ANNE JOHNSON
30 NOVEMBER 2005
Q80 Chairman: Is the answer yes or
no?
Professor Blakemore: I really
believe that the Government is doing all that it can reasonably
be expected to do at this stage and international comparisons
show that, if anywhere, we are at the top of the league. Interestingly,
you will have seen from the announcement by President Bush very
recently that America is catching up in terms of its strategy
for vaccine purchase, antiviral purchase and indeed investment
in research for the development of new technologies.
Q81 Dr Harris: If you were trying
to control a pandemic, would it not be sensible to give the human
influenza vaccine to people in Vietnam because that reduces the
likelihood and therefore it is projected to delay the onset of
re-combination occurring? Why are we spending such huge amounts
of money on stockpiling, which is arguably less effective and
likely to be resisted by the virus antivirals, instead of vaccinating
the Vietnamese and some of the Chinese against human flu to prevent
the re-combination? Have I missed something?
Professor Blakemore: The correct
approach to any innovative suggestion like that is to ask yourself
how you would defend such a decision if circumstances in the future
when a pandemic happened showed that you were wrong. For instance,
what if the essential mutation happens in Turkey or in Greece
and we have given all of our seasonal flu vaccine to Vietnam,
assuming that would be where it starts?
Q82 Dr Harris: I have already said
that we need to build up capacity and I think that was agreed
with. According to your Dr Farrar, it is far more likely to happen
in these places where humans are in very close contact with large
numbers of chickens and pigs. On the basis of a risk approach,
would that not be a sensible thing to do and would it not be the
ethical thing it do?
Professor Blakemore: We do have
limited resources and it is a matter of arriving at the most sensible
use of the resources that we have. There is a need now in this
country for seasonal flu vaccination. Thousands of people die
each year from regular seasonal flu. The present strategy is designed
to protect them. I would not like to see the limited resources
we have diverted on the basis of a very interesting scientific
epidemiological speculation.
Professor McMichael: I think the
other approach would be to try and do something about the infection
in the birds and/or in the chickens and ducks where it is transferring
into humans. In Hong Kong they killed all the chickens after the
original outbreak and that stopped it. In Thailand they culled
their chickens. In Vietnam they are trying to vaccinate all the
chicken. They have three vaccines, two from China and one from
the Netherlands. In China they have a ring culling and a ring
vaccination strategy developing. I do not know what they are doing
in Cambodia or Indonesia, Alan may know. This may be an alternative
way of approaching the problem out there.
Dr Harris: Is it an either or? Presumably,
Colin, people die of flu in Vietnam and China as well as in Britain
and indeed they may be more likely to die because perhaps their
health service is not as good at providing the access and the
treatments. Just looking at it globally on an ethical basis and
one life and the fact that it is more likely to be cost effective
in those countries, even on that basis would you not agree that
the WHO ought to be concentrating on human seasonal flu vaccination
in those areas as well as doing these other things as a priority,
to save lives from flu and to reduce the chance of re-combination
and a pandemic emerging in those high risk countries?
Bob Spink: And to increase capacity.
Q83 Dr Harris: It is a triple win.
Professor Blakemore: China has
probably the biggest vaccine production capacity in the world
and has a fantastic track record in the production of bird flu
vaccines. One of the interesting possibilities is that that huge
capacity for animal vaccine production might, in extremes, be
diverted to human vaccine production. The facility that Sir John
Skehel visited, I think I am right in saying, produces literally
millions of doses per day of bird flu vaccine. This is not a situation
where China needs that much help in terms of vaccine capacity
production from us; they might be able to help us.
Q84 Bob Spink: Could I ask what the
timescale would be in converting the animal to human flu vaccine
capacity given that there was the political will do it?
Professor Blakemore: I think it
is a matter of the facilities themselves and the regulatory framework,
the nature of the facilities where they are up to GMP standards
and so on; those would be the principal problems. Diverting production
to a different vaccine, whether human or a different animal strain
is relatively trivial. What matters is the nature of the facilities
and the regulatory framework for the transfer to human production
in animal facilities.
Q85 Bob Spink: Is any investigation
going on to check the preparedness of this if it did become extremely
necessary?
Professor Blakemore: This certainly
is an area of discussion amongst the WHO representatives in Beijing
that I spoke to and I understand they are in contact with the
Chinese authorities to discuss that possibility.
Q86 Dr Harris: I want to turn to
antivirals which we trickled into earlier. We have already heard
from Dr Hay that they are not enormously effective and we know
that there is a danger and indeed reports already of resistance,
of natural selection and evolution taking place with regard to
one. Is it sensible in your view that the UK Government and other
governments that have done this are putting all their eggs in
one basket in respect of buying Tamiflu and not looking for a
mixture of that and Relenza?
Dr Hay: I did not mean to imply
that the Tamiflu was not effective.
Q87 Dr Harris: We do not know.
Dr Hay: At the present time, as
I have already indicated, the actual characteristics of the infection
differ from a normal human infection in the case of the H5N1 and
we do not really know the best way to manage those infections
in terms of reducing the infection and saving lives, so there
is a lot of research needed to learn more about this. There is
evidence, for example, that whereas the current recommendation
is that the drug will only be effective if taken within 48 hours
of onset, with the longer infection and replication of the virus
in the case of H5N1 it has been shown that giving the drug at
a later time has reduced the virus infection and that people have
survived. We have to learn about that. The issue of resistance
is also of major concern and really what the characteristics are
leading to the emergence of resistance. The critical nature of
these people at the time when they are administered the drug can
seriously affect the potential effectiveness of the drug in different
cases. There is a lot we need to learn about that on the Tamiflu
side. We know, as you imply, that these resistant viruses are
still sensitive to the Relenza drug. Relenza has not been available
to any significant extent and has not been the drug of choice
because of the way in which it has to be administered. You can
pop a pill for Tamiflu but you have to use an inhaler for Relenza.
In these critical cases it is not clear that administration would
be very easy or very successful. There are suggestions that research
should be done on an injectable formulation of Relenza as one
way of making that drug more useful. The emphasis really is that
a lot of research has to be done. In terms of the combinations
of drugs that one might use, there has been essentially no work
done at the clinical level in the human, the studies to date have
all been done in animals.
Q88 Dr Harris: So you do not have
a problem with having just one antiviral stockpiled, which is
Tamiflu?
Dr Hay: Certainly there is more
need to consider the usefulness of having Relenza as well and
this would take the burden off the production of a single antiviral,
but this is a decision for countries to make in terms of which
drugs they want. Some countries have ordered a stockpile of Relenza
as well as Tamiflu.
Q89 Dr Harris: France, for example.
Given what you have said about the need to do more clinical research,
do you think there is a role for Government to instigate that
clinical research into the areas that you indicated in your last
answer but one?
Dr Hay: I think more support is
needed from the Government via the MRC, for example, to support
this research and I think that these would be items which the
delegation to South-East Asia have considered very seriously.
Q90 Dr Harris: Colin said that he
thought the pharmaceutical companies had behaved very well in
these areas. Sir John Sulston argues that we need to find a way
of decoupling R&D from manufacture to enable the manufacturer
of Tamiflu, for example, not to be limited by the decisions of
a company, however well behaved that company is in respect of
licensing out to large scale manufacturing facilities elsewhere.
Do you think there is a case for that or is Sir John hopelessly
idealistic?
Dr Hay: I do not think there is
a case for that and I think there have been appropriate discussions.
My understanding is that Roche have been in discussions with companies
in a number of countries about licensing the production of Tamiflu.
Q91 Dr Iddon: Is there not a major
bottleneck which is almost impossible to overcome with Tamiflu
in that one of the starting materials for the manufacture of Tamiflu
is shikimic acid, which is a natural product and you cannot force
the manufacture of that? That is the real bottleneck in Tamiflu
manufacture, is it not?
Dr Hay: You can make it from bacteria.
That is not the bottleneck, as I understand from Roche, that some
perceive.
Chairman: Our final line of questioning
is going to be on costs.
Q92 Mr Newmark: I am directing my
questioning to Professor Blakemore again. I am not talking about
the £10 million extra; this is an annual sum I am talking
about now. The MRC has been investing approximately £1.6
million per annum on flu research. Given the flu pandemic could
kill 50,000 or so, is this enough money on an annual basis?
Professor Blakemore: You have
to set that question in the context of all the other demands in
terms of health burden that the MRC has a responsibility to tackle.
You could quote similar figures for pulmonary disease, Alzheimer's,
HIV and so on. In all of those areas we have activity and we would
always like to do more. The important thing is to show that we
are responsive when the need increases and we have done exactly
that in the case of flu. At Mill Hill we maintain not only the
World Health Organisation centre but a very strong research division
working on flu and others that work on other infectious diseases;
that is part of the MRC's commitment to virology, infectious disease
and immunology.
Q93 Mr Newmark: Given limited resources,
you would love to spend more but is this enough to deal with on-going
flu challenges in the future?
Professor Blakemore: Within the
portfolio of MRC activities I think we are doing our best in the
area of flu. The question is whether there is more capacity out
there in the community of a very high quality that is worthy of
support. I am sure Professor McMichael, who is Chairman of the
Infections and Immunity Board, would be very happy to tell you
about all the wonderful work that he would love to fund if his
board had more money.
Chairman: That is for another occasion.
Mr Newmark: Let us deal with the bigger
number now. The MRC report that was written for us on Friday stated
that the MRC would be committing at least £2 million for
research on a potentially pandemic flu. Yesterday and today we
have been informed that the MRC is committing £10 million.
Where did you find the £8 million extra over the last weekend?
Q94 Chairman: Could it be from the
52 underspends?
Professor Blakemore: We have a
plan for using a fraction of our underspend this year. We prefer
to call it carry forward rather than underspend, but that would
be an issue for another of your hearings. The MRC maintains a
strategic fund which it deploys in response to more pressing need
than the plans that we can draw up at the beginning of each year.
We devolve most of our expenditure in the extra-mural programme
in research grants to our boards to administer directly and we
retain a strategic fund which we can deploy in special circumstances.
We have decided to recommend—this is only a recommendation
at the moment and the decision to make that recommendation was
made yesterday—to council not simply the £2 million
that we have already made a preliminary decision about but a total
of up to £10 million for work on flu.
Q95 Mr Newmark: Is this not really
a knee-jerk reaction that is going to end up depriving funding
elsewhere or is this extra money that is now coming in?
Professor Blakemore: As it is
money from a central pot being used for this purpose, it could
have been used for other purposes if we had not used it this way.
That is exactly what strategy and tactics are all about, making
sensible decisions about how to deploy limited resources.
Q96 Chairman: Was part of the tactics
that you were appearing here this morning and it was important
to have a good announcement on the Today programme?
Professor Blakemore: I would not
want to deflate the ego of the Committee, but it is not appearances
here which determine the strategy of the MRC.
Q97 Chairman: We are glad to hear
it.
Professor Blakemore: I tried to
unpack the background to the decisions that we have been making
over the past few days and will be making next week as a result
of the workshop and I hope I convinced you that they were not
a reflex reaction to present interesting circumstances but were
well conceived over the course of a year or more of thinking against
a background of a long-term investment in flu research in the
MRC.
Q98 Mr Newmark: Over what timescale
do you see this £10 million being spent?
Professor Blakemore: That is a
very interesting question. We have yet to work up the details
of the call which will be illuminated by the outcome of the meeting
next week. We envisage three forms of potential support. The first
is conventional research grants which might last anything from
three years to five years but with an emphasis on rapid delivery
in the present circumstances. We also want to consider applications
from researchers who have plans for work that could commence only
when a pandemic starts, in other words when viral samples are
available. I think this is a genuinely innovative move to agree
to fund research projects even in advance of there being the material
on which to base the subjects and we can snap into action as soon
as the virus emerges. Thirdly, we would like to give the potential
for existing MRC supported researchers, whether in our own units
or in the university sector, to divert their research effort into
issues of flu either before or after the beginning of a pandemic,
with a guarantee that they could have the additional money at
the end of that period to continue their original project. These
are all things that we are mulling over at the moment as part
of the call to give the maximum flexibility of response.
Q99 Adam Afriyie: Have you had any
representations at all that have caused you to make this decision
over the weekend? Has something changed out there or was this
always planned?
Professor Blakemore: I think the
crucial event was the meeting of our Strategy, Corporate Policy
and Evaluation committee over the last two days in which the results
of the visit to Vietnam and China and the deliberation within
Andrew McMichael's board and discussions elsewhere have influenced
the recommendations that have come out of the meeting of that
strategy committee.
| 
