Examination of Witnesses (Questions 400
- 412)
THURSDAY 29 JUNE 2000
MR JAMES
COCHRANE AND
MR SAUL
WALKER
400. We will have to explore that further but
what I would now like to ask is whether you can direct us to any
work which is being done. We are talking in most cases about very
poor countries, very poor people and health systems. Has any kind
of cost benefit analysis been done to say, "You have X million
rand to spend on health care, what should you spend it on in terms
of coping with the general health needs of the country or the
HIV specific aspects of it"? For example, it might be suggested
that simply providing clean water for the whole population might
be more effective than a lot of expensive medical interventions.
Has that kind of analysis been done on what is the most effective
way of dealing with health care needs with a limited budget?
(Mr Cochrane) The WHO and the World Bank have addressed
exactly these issues and their conclusions are fairly broad indeed.
Obviously, prevention is the thing that should be done because
that is cost effective in the longer-term, but that does not help
you to deal with the problems you have today; that will help tomorrow's
problem. Their broad conclusion is that you cannot just spend
your money on one particular thing, you have to have a multi-faceted
approach which will deal with all of the various issues along
the line.
(Mr Walker) I think the phrase which is generally
used now is that we need to think about today, tomorrow and the
day after. In terms of where it is most cost effective to spend
limited resources, certainly boosting primary care infrastructure
in countries is important—access to clean water, as you
said, but also access to a whole continuum of care for people
with HIV—so access to drugs which are often much cheaper
and simpler to administer to prevent opportunistic infections
which are often the cause of death in people with HIV. That is
often a cheaper way and often adds several years to people's lives.
If you look at how the mortality rates in this country were affected,
we began to see a decline in the mortality rate before the full
availability of combination therapies in this country, partly
because we had better management of opportunistic infections and
things that generally were killing people with compromised immune
systems. So there are those opportunities. There are also opportunities
in areas like pain management and palliative care, so there is
a continuum of care. But a lot of those things are really just
going to buy you some time. One of the problems which was pointed
out earlier on is that you get an initial HIV curve, which is
then followed by an AIDS curve, and then if you want to think
ahead of that it is followed by the orphan curve. So there are
these huge surges in demand on health systems, education systems,
in countries which are spread out over a period of time with HIV.
So we do need to be thinking immediately about today, tomorrow
and the day after, about where we can fit things into that way
of thinking and that strategy of thinking, and looking at who
can provide what and what the roles are of different players,
whether that be state players or private sector or multilaterals,
in providing the components of that longer term strategy.
401. Perhaps this can be done in writing, but
can you draw our attention to where costings have been done? Even
given the preferential price for the retrovirals, what calculations
have been done about how much would have to be added to what levels
of care?
(Mr Walker) I can certainly investigate that for the
Committee and forward something.
Mr Robathan: We will come on as briefly
as possible to what is your specialist subject, Mr Walker, namely
vaccines. I think we would all agree that the best answer obviously
would be a vaccine in the long term.
Chairman: And the next answer is the
condom.
Mr Robathan
402. The long-term answer is to vaccinate everybody
but there are long-term problems with that. What is the current
state of research into the development of a vaccine and how long
do most people currently estimate it will take for a vaccine to
come to the market?
(Mr Walker) It is certainly better than it was. For
many years vaccine research was really only a poor cousin in this
area. The research which was done was generally focused on the
strains of vaccine which are most prevalent in the United States
and in Europe—Clade B. Only recently, again partly through
the activities of IAVI, there has been a recognition that we need
to start finding vaccine solutions and funding research which
is going to be useful for the majority world, so that is looking
at the types of virus which are prevalent in Asia and Africa.
IAVI's focus has been, as I said, to fund some of that basic research
itself but also to stimulate others to—
403. What is the current state of research?
(Mr Walker) In terms of IAVI, it has now announced
four vaccine development partnerships, and those partnerships,
as I have said, are built between institutions, the private sector
or academic institutions in the north, paired with institutions
in the south. So the most advanced one would be the partnership
between Oxford University and Nairobi University which is developing
a vaccine which will go to phase one trials in humans first in
Oxford in August and secondly a sister trial in Nairobi in December
or January of next year. Phase one is basically a safety test
which is undertaken in small numbers of human volunteers. This
is built on promising results in animals and promising results
in other tests which suggest that the Oxford model may be one
of the better candidates for a future vaccine. IAVI has also recently
announced three other partnerships, one with South Africa, one
with Uganda and also another partnership which uses the Oxford
technology but a different mode of delivery, an oral mode of delivery,
which will be with a country in East Africa. The whole point of
the IAVI process, I suppose, is to make sure that we do things
in parallel, not in series, that we do not try one idea, wait
for that to fail, try another idea, wait for that to fail, and
so extend the time in which it is going to get a solution.
404. So we have stage one tests to find out
if they are safe for one particular vaccine, but what is the timescale?
If this were to work, if this were not to kill anybody, what is
the timescale?
(Mr Walker) Realistically we are looking at a timescale
of at least seven to ten years. There is one phase three trial
in operation and phase three trials are the large scale efficacy
trials which take place to see the protective impact of a vaccine
at a population level, and that is taking place in Thailand at
the moment, which is run by VaxGen. Unfortunately, scientific
opinion seems to think that it is unlikely that that product is
going to be particularly protective. In terms of moving through
the new products which IAVI and other institutions are working
on, I mentioned the National Institute of Health's work which
they have just announced, what is really important is that we
can get those on line, but then we have an effective way of deciding
what moves on to the second and third phase trials, because those
are incredibly expensive, they are much, much more expensive.
As I have said, the phase one trial takes one to two years to
completely finish, phase two trials again the same period, but
a phase three trial of 4 to 5,000 people is probably going to
take three to four years to see what the results will be. But,
crucially, the preparation for that kind of trial has to happen
now. You have to work with the community to build its readiness
for that type of trial now.
405. Are Glaxo Wellcome involved in vaccine
research?
(Mr Cochrane) In a very small amount. SmithKline Beecham
are in a huge way.
406. So when you come together you will be very
much involved?
(Mr Cochrane) When we come together we will be very
much more involved, yes.
407. And your estimate of timescale?
(Mr Cochrane) Is the same. A minimum of five years,
and seven to ten more likely.
408. It might be ten years onwards?
(Mr Cochrane) Yes, ten years from now.
409. You mentioned earlier, Mr Walker—and
indeed in your written evidence—that a perceived lack of
market was one reason why there was not research into a vaccine.
I have to say I reckon the development of a vaccine by someone
will not only make them a fortune but also probably a Nobel prize
and knighthood and whatever else they might want—some people
might think these are just baubles—why do you perceive there
is a lack of a market for a vaccine?
(Mr Walker) If you look at the lack of private sector
interest in vaccine development over some time, it would suggest
they have not thought a vaccine was something from which they
would be able to recoup the kind of profits they would deem reasonable
for that kind of research. I think the problem is, if you produce
a vaccine which is going to be useful to the majority world, there
is going to be a huge demand for that vaccine, but obviously demand
is only a demand in the market sense if it can be paid for. At
the moment, even if you had vaccines which were very cheap, one
or two dollars as the actual cost, you would then have to have
the delivery and infrastructure to be able to provide that, which
means there is quite a large cost for developing countries to
deliver vaccines. If, in the calculations in the private sector,
that means they do not think people are going to be able to take
up and use those vaccines, that means they are not going to develop
a vaccine because they would be left with something which potentially
makes a loss. The way forward is not to then say that you cannot
develop a vaccine market, and one of the things IAVI has done
is to work on a pull mechanism which basically works with the
World Bank, the European Union and other multi-lateral funders,
to suggest that if a vaccine does become available they will consider
guaranteeing to purchase that vaccine. They will consider guaranteeing
that there will be a market for the private sector to be able
to provide that vaccine.[5]
410. Let us bring in the private sector because
I think they might disagree with you slightly.
(Mr Cochrane) I do. It is a hugely complex area. If
there was a simple solution to this, it would have been found;
it is not an easy business and it is technically and scientifically
extremely difficult to find a vaccine which will be effective
against HIV. There is certainly a market for a vaccine for HIV
in the first world—there are a million people in the United
States who are HIV-positive, there is a huge market if this product
were available, so I certainly would not say there was a lack
of market. There is a tremendous market and I am sure you are
right in saying there will be a tremendous incentive for companies
to be finding a vaccine for this difficult area. One of the joys
of HIV—"joys" is the wrong word to use—one
of the good things about HIV is that it affects America, Europe,
Australia as well as sub-Saharan Africa, in different degrees
I know. It is still a big, big issue in the United States, a million
people infected, over half a million people infected in Europe,
and it is a tremendous problem in those geographies.
411. Do you know whether or not the smallpox
vaccine produced royalties forever for whoever developed it, because
I suspect who developed it must have made a fortune although I
do not know.
(Mr Cochrane) I do not know.
(Mr Walker) If I could just reinforce the point about
the different clades of viruses across the world, the clade of
virus in Europe and America is the Clade B virus, in Africa it
is Clades C and A, and in Asia it is Clade E. We do not know at
the moment whether a vaccine which is effective against B is going
to be as effective against A, C and E. As I have said, the research
that has been done—and it is correct to say there would
be a market in the North—has been around Clade B.
(Mr Cochrane) But we still have not found it, so it
is not an easy area, in fact it is a really difficult area.
(Mr Walker) I would also like to emphasise that IAVI's
approach is not antagonistic to the private sector, it is just
that we need to find ways of working with the private sector to
ensure a market, to utilise the private sector's expertise. Certainly
when we move into manufacturing and producing a vaccine, large
companies such as Glaxo or Glaxo SmithKline or Merck or Aventis
Pasteur, are going to be absolutely necessary in bringing to bear
their expertise in producing vaccines.
Chairman
412. It obviously requires a combination, does
it not, of public sector money through the World Bank and other
government and intergovernmental agencies, together with the pharmaceutical
companies making available these drugs and vaccines at a lower
price, together with organisations of medical health provision
overseas and particularly in the developing countries themselves,
together with normal health provision which of course deals with
the opportunistic diseases to which HIV sufferers are prone? Are
there any other things you would like to mention, Mr Cochrane
and Mr Walker in conclusion because we really do have to conclude
now?
(Mr Cochrane) I appreciate that but there is one point
I would like to emphasise, and it fits in with what you have just
said, Mr Chairman, which is the huge importance of the British
Government and the support they can give as a partner in this
process of treating today's people who are infected with HIV.
It is very, very important that the British Government, either
directly through DFID or indirectly through the World Bank, through
the European Commission, plays its part in helping to be a very
active partner in ensuring we can now with private enterprise
from Glaxo Wellcome and the other companies, together with committed
governments in sub-Saharan Africa, play an equal part in ensuring
more is done than has been done to date.
Chairman: Yes, I am sure that is right.
I think that is a good note to end on. Thank you both very much
indeed, and particularly you, Mr Cochrane, who have done the whole
of the session with us.
5 Note by witness: AVI has worked with multi-lateral
funders-such as the World Bank and the European Union-to raise
the issue of `market failure'. IAVI has proposed the development
of purchase guarantees (`pull-mechanisms') for future vaccines.
These may take the form of credit lines for countries to purchase
vaccines or grants for vaccination programmes. The World Bank
and the EU have recognised such purchase guarantees as essential
to ensure future access to HIV vaccines and hence as critical
to stimulating HIV vaccine research and development by the private
sector today. The Global Alliance for Vaccines and Immunisation
(GAVI) has been awarded a $750m grant by the Bill and Melinda
Gates Foundation to increase access to vaccination for children
in the world's poorest countries. The Norwegian Government has
recently donated $125 to GAVI. Back
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