Examination of Witnesses (Questions 912
- 919)
TUESDAY 6 MAY 2008
Professor Harvey Rubin
Q912 Chairman:
First of all, can I welcome you to the Intergovernmental Organisations
Select Committee on Communicable Diseases. The architecture of
the intergovernmental organisations is the issue which we are
fundamentally interested in rather than the diseases themselves,
although they are underpinning the discussions. These events are
being recorded this afternoon and a transcript will be sent to
you and you can correct any factual matters that you feel need
correcting. I also want to invite you to send in any further comments
that maybe, when you have read it, you feel you have left out;
or, if you want to add things, do not hesitate to do that through
the Clerk here. Again, can I thank you very much for your very
generous offer of coming over to see us at your own expense and
in your own time; clearly you do have a very great interest in
this area and in the the Global Compact which you are putting
forward. You are the Director of the Institute for Strategic Threat
Analysis and Response in the United States. So, picking up your
wording from your written evidence—which, incidentally,
I found very helpful and very detailed—you say there "the
only way I see to overcome [the obstacles to achieving progress
in the prevention and control of the four diseases] will be to
completely develop a Global Compact for Infectious Diseases".
Could I invite you, first and foremost, to summarise the content
of that Compact, particularly placing emphasis on whether you
see it as being a treaty or an organisation. How would you see
it being set up and how would you describe it?
Professor Rubin: Thank you, and thank you for
inviting me. I greatly appreciate the opportunity to come and
share some of our thoughts on this really important issue and
I congratulate the Committee for taking this on as a major enterprise.
The Compact is comprised of four interlocked, interdependent,
linked missions that will enable, produce and regulate the problem
of communicable diseases. That is a mouthful, so what do I actually
mean by that? And how will we do that? The key to that statement
is that these four missions, these four enterprises, are linked;
involvement in one implies involvement in the others. So what
are the four issues? The four issues are to develop a knowledge
base, a fully integrated, interdependent, interoperable knowledge
base of infectious diseases. The second mission is to create major
basic research centres that focus on specific areas of infectious
diseases, in particular helminths, protozoa, viruses and bacteria—so
a knowledge base plus basic science research centres. The third
component is the development of best practices, both best regulatory
practices and best laboratory practices. And, finally, the fourth
component is to use all of that to increase the accessibility,
the manufacturing and the distribution capacity and capabilities
to distribute new agents and even current agents that are useful
as vaccines or drugs. The key here is to start building the knowledge
base, this is something that can get done relatively quickly;
it does not require a lot of money, it requires a lot of knowledge
and intelligence though. The surveillance that we are talking
about is more than figuring out what disease is current now in
Zimbabwe or what disease is current now in Philadelphia. The knowledge
base is an entire integrated knowledge system. There was a wonderful
paper published by a woman named Kate Jones (first author), who
is right here at the Zoological Society in Regent's Park, in which
she and her colleagues described, 335 new infectious diseases
that have emerged over the past several decades since 1940. Within
the past decade there has been a significant increase in vector-borne
diseases, within the past decade there has been a significant
increase in antibiotic resistance in terms of bacterial diseases.
These are new events, and she was able to map these events. In
fact the authors says that we can now start correlating the emergence
of these diseases with new environmental issues and new human
demographic issues. We have not been able to do that before in
such detail so linking the kinds of knowledge that one can gather
by tracing disease and linking that to other data sets is really
important. The data sets have to be interoperable, the data sets
have to work in a multi-language environment, and the data sets
themselves are vastly different: they could be lists of numbers,
they could be images, they could be chemical structures. All these
data sets now exist in different places and very few are actually
linked together. Without having integrated data there are a couple
of things that happen: we get behind the eight ball in terms of
tracking new diseases for which there have been no descriptions,
like SARS;, we also get behind the eight ball in creating new
drugs. Without that kind of integrated data set we do not know
how to actually fill the pipeline. So surveillance in our definition
is more than just tracking diseases, it is tracking and integrating
enormous sets of data functions and data algorithms. We include
surveillance of disease outbreaks, but it should also include
clinical data from ongoing clinical trials, failed clinical trials;
we can always learn from our mistakes—those are buried away
for the most part but it would be very nice to have access to
that kind of data. We need to generate access between the community
of scientists and doctors working on these problems. Right now
we can call our friends, we can look on Google and see who is
working on things, but it would be great to have and build a community
of scholars, a community of epidemiologists, a community of private
sector, involvement a community of government officials and committees
like this that actually are working on the problem. That does
not exist either. Then there are suites of services that exist
in the private sector for example what is the best way to design
a clinical trial, where clinical trials could be focused these
data sets exist out there in various ways that are not totally
linked. The basic science part, the second component of the Global
Compact for Infectious Diseases, is based on the old Rockefeller
Foundation, Ford Foundation and eventually the World Bank endeavours
in plant research; understanding that the world lives mostly on
cereals and grains and rice, these agencies decided that we had
better start figuring out what the basic science of these natural
resources are and can we use basic science to increase the viability
of grains and seeds, can we develop grains and seeds that are
resistant to blight, can we increase grains and seeds that would
exist under very wet circumstances or very dry circumstances?
That early infusion of money was the basis of the green revolution.
We need to have similar kinds of basic research centres, overseen
by an integrating organisation. We must study these diseases and
these organisms and we will fill the drug development pipeline?
The drug development pipeline is basically empty. The Global Compact
for Infectious Diseases will link the basic research centres to
the surveillance/knowledge centres; if you want to be part of
the basic research centre, you must be part of the surveillance
group. The third component of the Compact is to harmonise intergovernmental,
inter-state regulations. Right now there is a vast array or a
hotchpotch of regulatory issues, a hotchpotch of best laboratory
practices that have to be standardised. This will not happen under
the current kinds of agreements that exist between States. Finally,
put all the components of the Compact together, populate the knowledge
base fill the pipeline, have harmonised regulations, and understand
how we will direct antimicrobial agents to the individuals who
need them and build the capacity to make new vaccines and new
drugs. Big pharmaceutical companies, in this country, in my country,
in France, in Switzerland, and around the world are effectively
out of the game of making new antibiotics, there is no business
model that makes that an effective business enterprise for the
largest companies. The goal of the Compact is to link all these
missions together and, in linking them together, we will be able
to begin to address the communicable diseases problem. There are
lots of organisations that are doing one or the other and are
doing them relatively well, but there is no overall incentive.
The incentive is the linkage between the four missions of the
Compact and the ultimate improvement of the quality of life and
economic development.
Q913 Chairman:
Before I go on to the next bit, you thought this would be an international
treaty. What should be the formal structure for it? Or are you
suggesting that it is an informal structure?
Professor Rubin: We have given great thought
to that issue and we are not so confident that a treaty in this
day and age is the right way to start. What we believe is to start
with NGOs, academics, the private sector, to agree that this is
an important enterprise to study and to solve, and then, as that
grows, to start engaging governments, built very much on the Ottawa
Landmine Convention. I was privileged to hear four questions discussed
earlier in the day in the House of Lords and we heard about cluster
bombs and the treaty that is going to be debated in Dublin, I
understand. Like the cluster bomb issue, the issue of communicable
diseases really revolves around that same fundamental process,
of engaging the worldwide community. It will start with small
groups, and the Noble Lord actually mentioned the Landmine Convention:
this is the same idea. The difference between our Compact and
the Landmine Convention—and we are deliberately calling
it a Compact, not a Treaty—is that infectious diseases is
a symmetric issue, it is not "over there". There may
not be an landmines out on Pall Mall, there are no landmines on
Broad Street, we hope, there are no cluster bombs in Broadway
in New York. But there sure as heck are infectious diseases there;
90,000 die of antibiotic-resistant bacterial infections in my
own country; 30,000 will die of influenza in my own country; this
is happening here, in your country as well. You pick up the newspaper—when
I was here last August, MRSA was all over the newspapers, the
same thing in my country. Unlike cluster bombs, unlike landmines,
this is a totally symmetric issue. We should start with NGOs,
start with academics—all of whom by the way who have been
given this talk have agreed that there is a need for a new approach
to communicable diseases—and then engage governments. I
would be delighted if governments would be engaged even sooner,
and that is why—you said thanks for coming over here—I
would have not missed this opportunity.
Q914 Chairman:
Thank you for being so clear about that. What you have described
is bringing together these non-governmental organisations and
so on. I suppose I would first of all like to know what the feedback
from them to you has been like but I would also ask you to address
the question of why is it that you would not just end up with
another intergovernmental organisation, which to some considerable
extent would squeeze out, if you like, some of the things the
World Health Organisation does.
Professor Rubin: That is a great question and,
I must tell you, one that I have been used to answering; this
is not the first time I have heard that question. The answer is
that yes, we are need to set up a new intergovernmental organisation,
absolutely, to fill a vast gap and a yawning abyss, to fill a
need which is the need for an integrator. My secondary appointment
at Penn is in the Computer Science Department; this problem of
communicable diseases is one that we call part of complex system,
it involves everything from a sick and dying patient to synthetic
biology, and everything in-between. It is a complex process and
in any complex system you have to have an integrator. You build
an Airbus and there are thousands of embedded computers in an
Airbus; you must have a systems integrator. As good as the World
Health Organization is, as good as the Bill and Melinda Gates
Foundation is, there is no systems integrator and without a systems
integrator the plane will not land safely.
Q915 Chairman:
Why should it not be the WHO?
Professor Rubin: The WHO has a limited scope,
a limited vision. They have limited funding and they have a very
narrow but nevertheless very important mission in this world;
it does not extend to the kinds of things that we just laid out
in the parts of the Compact.
Q916 Chairman:
Following the logic of this, if the WHO had more funding, then
people like you could work within that?
Professor Rubin: If the World Health Organization
were able to expand in some sense its mission and its goals, then
it might be a viable alternative; it has not been able to do that
in the past, its constraints are legal, political, social, geographic;
for example the World Health Organization has very little to say
about MRSA in my hospital.
Q917 Chairman:
Before I bring some of my colleagues in, is not the fundamental
issue here that you, as the proposer of this organisation, can
either create a new organisation, which you are suggesting would
act as a body that drew people together, or you could say we should
build on what has already been built, do things step by step almost,
rather than the grand new venture. How do you respond to that?
Professor Rubin: We would certainly not exclude
the existing organisations. Those existing organisations have
to be included, but as I said it is just like building a very
complex aeroplane. There has to be a systems integrator. The World
Health Organization does one thing in a great way, the Bill and
Melinda Gates Foundation does another thing in a great way, Merck
and Pfizer and Sandoz do things in a great way; but nobody is
integrating them, it just does not exist and it has not existed
ever. The situation in the written testimony you asked me to write
is actually getting worse and so the system is not working. The
only way that I can see, and I could be wrong, is to create an
integrated system.
Q918 Baroness Eccles of Moulton:
Leading on, Professor Rubin, from what you have just been saying,
but looking at it slightly from the other end of the telescope,
under your four aims is there not in each category—maybe
not so much in research but in the other three—already a
fund of knowledge in the World Health Organization—I quite
take the point about the systems integrator. Have you got any
sort of policy yet? Or have you talked to them or whatever about
actually drawing on this quite considerable knowledge base that
already exists within the objectives that you are going to achieve?
Professor Rubin: A great observation! We were
part of the OECD's Noordwijk Medicines Agenda. I was talking to
my friend Ian Gillespie at OECD—and I understand you will
be speaking to Ian as well, and as far as I understand the World
Health Organization is an intrinsic and important part of the
solution but not the full solution. The reason for that is because
there are no linkages; this goes back to the very fundamental
idea that we need to have an organisation that will enforce linkages
between these issues. Yes, one could be part of a research endeavour,
but that as currently configured has nothing to do with the part
of receiving antibiotics and vaccines. One could be required,
as the World Health Organisation is now beginning to do with IHRs,
to do reporting and surveillance. Part of the problem of this
whole Indonesia H5N1 issue, I believe, never would have come to
the table if we had linked the idea of receiving vaccines and
drugs as part of contributing surveillance data. If we had understood
that fundamental idea from the very beginning, the Indonesians'
resistance to sharing sequence data, I believe, it never would
have become a problem. Yes, WHO have a fantastic fund of knowledge
and we need to use that knowledge and we need to use some of the
normative ideas behind IHRs, but we need to go further than that
and a lot of the problems then will be avoided if this linkage
is recognised initially.
Q919 Baroness Eccles of Moulton:
If you get off the ground and this happens, do you see it working
more and more closely with the World Health Organization as time
goes on. Or would you say that they could be an encumbrance on
your progress?
Professor Rubin: I do not believe they will
be an encumbrance. If you read the language of the Noordwijk Agenda,
it sounds very much like part of our Compact, and that is because
we deliberately put it in there. I see the World Health Organization
welcoming this kind of structure, allowing them to do what they
do very well but also involving countries and States well in advance
and trying to get around some of the issues of this whole notion
of how do you get a federal government to mandate to its localities
and its regional enterprises. The WHO has not solved that problem
and they also have not solved the technical problems; the World
Health Organization is great at what it does but it does not have
some of the actual technical abilities to solve this problem.
We would see us working very closely with them.
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