[Senate Hearing 109-131]
[From the U.S. Government Publishing Office]
S. Hrg. 109-131
TWENTY-FIRST CENTURY BIOLOGICAL THREATS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON BIOTERRORISM AND PUBLIC HEALTH PREPAREDNESS
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
ON
EXAMINING TWENTY-FIRST CENTURY BIOLOGICAL THREATS, FOCUSING ON DUAL-
PURPOSE PREPAREDNESS AGAINST NATURAL AND DELIBERATE MICROBIAL THREATS
__________
MAY 11, 2005
__________
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
MICHAEL B. ENZI, Wyoming, Chairman
JUDD GREGG, New Hampshire EDWARD M. KENNEDY, Massachusetts
BILL FRIST, Tennessee CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee TOM HARKIN, Iowa
RICHARD BURR, North Carolina BARBARA A. MIKULSKI, Maryland
JOHNNY ISAKSON, Georgia JAMES M. JEFFORDS (I), Vermont
MIKE DeWINE, Ohio JEFF BINGAMAN, New Mexico
JOHN ENSIGN, Nevada PATTY MURRAY, Washington
ORRIN G. HATCH, Utah JACK REED, Rhode Island
JEFF SESSIONS, Alabama HILLARY RODHAM CLINTON, New York
PAT ROBERTS, Kansas
Katherine Brunett McGuire, Staff Director
J. Michael Myers, Minority Staff Director and Chief Counsel
______
Subcommittee on Bioterrorism and Public Health Preparedness
RICHARD BURR, North Carolina, Chairman
JUDD GREGG, New Hampshire EDWARD M. KENNEDY, Massachusetts
BILL FRIST, Tennessee CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee TOM HARKIN, Iowa
MIKE DeWine, Ohio BARBARA A. MIKULSKI, Maryland
JOHN ENSIGN, Nevada JEFF BINGAMAN, New Mexico
ORRIN G. HATCH, Utah PATTY MURRAY, Washington
PAT ROBERTS, Kansas JACK REED, Rhode Island
MICHAEL B. ENZI, Wyoming (ex
officio)
Robert Kadlec, Staff Director
David C. Bowen, Minority Staff Director
(ii)
C O N T E N T S
__________
STATEMENTS
WEDNESDAY, MAY 11, 2005
Page
Burr, Hon. Richard, Chairman, Subcommittee on Bioterrorism and
Public Health Preparedness, opening statement.................. 1
Enzi, Hon. Michael B., Chairman, Committee on Health, Education,
Labor, and Pensions, opening statement......................... 3
Prepared statement........................................... 4
Deutch, John, Institute Professor, Massachusetts Institute of
Technology; Former Director of Intelligence; and Former Deputy
Secretary of Defense........................................... 5
Prepared statement........................................... 8
Fineberg, M.D., Harvey V., President, Institute of Medicine, The
National Academies; Guenael R. Rodier, M.D., Director,
Department of Communicable Diseases Surveillance and Response,
World Health Organization; J. Craig Venter, President, J. Craig
Venter Institute; and Shelley Hearne, Executive Director, Trust
for America's Health........................................... 13
Prepared statements of:
Dr. Fineberg............................................. 14
Dr. Rodier............................................... 30
Mr. Venter............................................... 37
Ms. Hearne............................................... 47
(iii)
TWENTY-FIRST CENTURY BIOLOGICAL THREATS
----------
WEDNESDAY, MAY 11, 2005
U.S. Senate,
Subcommittee on Bioterrorism and Public Health
Preparedness, Committee on Health, Education, Labor, and
Pensions,
Washington, DC.
The subcommittee met, pursuant to notice, at 2:03 p.m., in
Room 430, Dirksen Senate Office Building, Hon. Richard Burr,
chairman of the subcommittee, presiding.
Present: Senators Burr, Hatch, and Enzi.
Opening Statement of Senator Burr
Senator Burr. We are going to call the hearing to order. I
know that some Senators are scattered around trying to
reconstruct, I think, today's earlier schedule. I think for
those that may not be accustomed to being on the Hill that
might be with us today, this is one of the unfortunate things
that we react to post-9/11. It is a reminder to us, really, as
to why we are here and we take very seriously the work of not
just the subcommittee, but the full committee.
I want to take this opportunity to thank those for
attending the second hearing of the HELP Subcommittee on
Bioterrorism and Public Health Preparedness. I certainly have
enjoyed working with the chair of the full committee, Senator
Enzi, and the ranking member, Senator Kennedy, and all the
members of the subcommittee. I believe those that follow the
work of the subcommittee, you will be busy trying to keep up
with the subcommittee as this year goes on.
Since our last meeting, there has been much legislative
activity in the area of bioterrorism. Senators Hatch and
Lieberman have introduced their bill, S. 975. I want to thank
them and their staffs for the substantive contribution and
simply say that we will be considering it along with S. 3,
Senator Gregg's bioterrorism legislation, as we evaluate
additional measures that are needed to ensure our Nation has
the kind and quantities of safe and effective medical
countermeasures to meet the challenges of the future.
The future is really the subject of the hearing today. As
we prepare to look at what additional legislative measures
might be needed to develop countermeasures as well as
reauthorize the Bioterrorism Act of 2002, I thought it would be
useful to step back a bit and to look over the horizon to
understand the nature of the future biological threat and how
that helps us consider what kinds of countermeasures we may
need in the future.
This hearing today represents the first of several events
we have designed to look down the road and appreciate where
technology, information, Mother Nature, and other current and
future adversities may be heading.
We have invited Porter Goss of the CIA to brief this
subcommittee later this month and give us his assessment of the
current and emerging bioterrorism threats.
For the record, the Bioshield Act of 2004 has already
yielded a number of important countermeasures that are being
added to our strategic national stockpile. HHS has announced
purchases of the next generation of smallpox and anthrax
vaccines using the Bioshield authorities. Bioshield is enabling
the purchase of therapeutic treatments for anthrax and botulism
toxins, as well. I commend HHS and DHS for moving out smartly
to implement Bioshield.
As evidenced by the two draft bills I have mentioned, there
is a sense that more incentives and other provisions may be
needed to mobilize the pharmaceutical and biologics industry to
work on countermeasures. I look forward to working with my
colleagues in this subcommittee, the full committee, and other
interested members to ensure that we enable the private and
public sectors and the Federal Government to meet the
challenges confronting our Nation.
Today, we will hear from our panel of experts about the
diversity and challenges and opportunities we face. Besides
terrorists, we are frequently reminded that Mother Nature can
be counted on to serve up some challenges. Infectious diseases
happen. And if that isn't enough, human error occasionally does
occur, also. Witness the recent shipment of the H2N2 influenza
around the world. Situations like this bring to mind the old
Pogo cartoon strip, ``We have met the enemy and he is us.''
These realities reaffirm for me that our Nation needs a
strong biodefense to address deliberate, accidental, and
natural biologic threats. It also highlights that unlike the
old adage, ``All politics are local,'' infectious diseases are
global and we must understand there is no border between the
domestic and international when it comes to contagious
infectious disease.
I want to thank our panelists today. We are honored to have
such an excellent group of experts that span the disciplines of
national security, medicine, science, and public health. As a
freshman Senator, I recognize that many Senators before me have
worked very hard strengthening our country's defenses against
bioterrorist attacks. I am humbled to have the opportunity to
work with them, many of whom are members of this committee and
subcommittee.
On our first panel today, we have Dr. John Deutch, now
Institute Professor of Chemistry at MIT, but significantly the
former Director of the Central Intelligence Agency and former
Deputy Secretary of Defense. We will hear this former national
security practitioner's views on biological threats our Nation
faces. We greatly appreciate your appearance today.
Our second panel will have Dr. Harvey Fineberg, President
of the Institute of Medicine of the National Academies of
Science. He is also the former Provost of Harvard and former
Dean of the School of Public Health. The Institute of Medicine
has played a vital role in helping the Nation understand the
complex nature of infectious disease as it relates to both
emerging and reemerging events, as well as deliberate acts of
bioterrorism.
Joining Dr. Fineberg is Dr. Craig Venter, President and
founder of the Venter Institute. Dr. Venter has played a
central role in decoding the human genome. We will hear his
perspectives on the potential peril and promise of advanced
biological techniques.
Joining us via video teleconference from Geneva, we have
Dr. Guenael Rodier, Director of Communicable Disease
Surveillance and Response from the World Health Organization.
Dr. Rodier will give us an international perspective of today's
infectious disease challenges.
And last but not least, we have Dr. Shelley Hearne from the
Trust for America's Health who will give us a vision of what
our public health infrastructure should look like in the 21st
century. I would like to note that her recent report, ``Ready
or Not: Protecting the Public's Health in the Age of
Bioterrorism, 2004'' was a valuable, comprehensive assessment
of the preparedness of the States to deal with bioterrorism. It
is a matter of personal and professional pride to note North
Carolina was cited in this report as one of two States scoring
the highest in their assessment.
Again to our panelists, I thank you for your time and thank
you for your input.
Mr. Chairman, do you have any remarks you would like to
make?
Opening Statement of Chairman Enzi
The Chairman. Mr. Chairman, I do have a full statement that
I would like to be part of the record.
Senator Burr. Without objection, so ordered.
The Chairman. I do want to congratulate you for holding
this hearing and the other hearing that you held and the forums
that you have held and the personal meetings that you have held
in your office with different people that can provide a
perspective on this. You have really taken a vigorous role at
making sure that we are safe.
You mentioned in your opening statement that you are a
freshman here. Well, one of the great things about you coming
over to the Senate was you already had a tremendous
institutional memory from the House. You probably know more
about this area than any other Senator, so we really appreciate
having that. I am more than willing to defer to you on all of
these things so that we can get the best possible bill. I liked
your comments about the consideration that you are giving to
the two draft bills that have been put in there.
I know from talking to you before that there are some
things you are very definite on, and one thing we don't mention
a lot around here is staff. Excellent staff play a superb role
in anything that we do, and I want to congratulate you on the
people that you put together to be on your staff. A little
experience goes a long way around here, and you have got people
who have a lot of experience, so I have a lot of confidence
that we will come up with some really good things as a result
of your work and as a result of the testimony that we will have
today, and yes, there will be a real disruption in the work
because of the disruption this morning, besides a lot of other
things going on.
I do appreciate everybody turning in their testimony. I
think that one indication of people not being here, again, is
the confidence in the chairman and his staff on being able to
cover this. It is a very bipartisan issue. It is something we
are all concerned about and something we all want to solve.
Thank you for your efforts and your tremendous diligence on
the committee and the subcommittee.
Senator Burr. Thank you, Mr. Chairman, and by unanimous
consent, all members who want to enter into the record opening
statements, that will be made available.
[The prepared statement of Chairman Enzi follows:]
Prepared Statement of Senator Enzi
I commend Senator Burr as Chairman of this subcommittee for
holding today's hearing so we can better understand the
biological threats presented by both man and animal today and
in the years to come. I look forward to working with him to
lead the HELP Committee in developing the legislation we need
to respond to the ever-present danger of a biological outbreak
or a bioterror attack.
Very soon, we will be outlining our principles and our
process for crafting legislation that we will bring before the
HELP Committee this summer. This hearing is critically
important to alert us all about the nature of the threats we
face, and to remind us of the potential consequences if
Congress fails to act.
Over the years, time and technology have both conspired to
change the nature of the forces that can be used against us to
challenge the security of our Nation and the strength of our
economy. Unlike the old weapons of war, ``bioterrorism'' and
``pandemic'' are issues that we now must be concerned with for
the sake of this Nation's health and our economy. The military
threats of the last century came from countries that could
easily be identified. Attacks of bioterrorism and pandemic,
however, can come from any part of the world and appear in
forms that have never been seen before.
Though we've made remarkable strides to identify our
Nation's weaknesses with regard to biological threats, the fact
remains that our defenses on these fronts are far from perfect.
Despite the best efforts of Congress and the Administration,
there still are holes in our biological defense that must be
filled to ensure the safety of public health as well as
national security.
Clearly, we have the scientific knowledge, the technology,
and the resources, including access to the World Health
Organization, to face this challenge. What's missing though, is
a comprehensive plan to rally and coordinate these resources to
strengthen our overall defense against biological threats and
bioterror attacks. Senator Burr and I are committed to making
this mission the number one priority of this subcommittee.
Since the beginning of the 21st Century the threat that we
face from infectious disease has become clear. In the recent
past we have seen the U.S. Capitol attacked with anthrax by
terrorists, the emergence of a never before seen disease, SARS,
which infected thousands and rapidly spread across the globe,
and more recently, the emergence of a horrifically deadly
Marburg Hemorrhagic (hem-or-adg-ick) Fever. In addition, the
news regularly contains stories about the emergence of a deadly
strain of avian flu. Taken together, these incidents have
changed the way we view disease surveillance and they compel us
to take a new look at the way in which we view our national
health preparedness. It is clear that infectious disease can be
a weapon and protecting our Nation's health necessarily
involves worldwide disease surveillance.
To help us consider these issues I appreciate Professor
Deutch's appearance here today to help with our discussion of
the threats of the 21st Century so we may better understand how
we might best be prepared for any eventuality. As Professor
Deutch is a professor of Chemistry at the Massachusetts
Institute of Technology and a former Director of the Central
Intelligence Agency, I look forward to hearing about his
assessment of the threat we face and what needs to be done to
mitigate that threat.
I also look forward to hearing from the witnesses on our
second panel. Dr. Rodier of the World Heath Organization will
share his view on the role that organizations like the World
Health Organization play in detecting outbreaks as they occur
and marshalling the resources that are needed to meet these
challenges around the world. His perspective will be
interesting to hear and vital for us to consider. I also look
forward to the testimony of Dr. Venter, Dr. Hearne, and Dr.
Fineberg who will further describe the nature of the threat
that we can expect to face and what our response should be.
Whether the threat is made by man or occurs naturally, we
need to be prepared. That's why I look forward to working with
Subcommittee Chairman Burr, Ranking Member Kennedy, and my
fellow subcommittee and committee members to develop
legislation this year to create a viable and innovative
industry to supply us with the countermeasures, antidotes, and
detection tools we must have if we are to ensure the safety of
the people of our Nation and the world.
Again, I thank Chairman Burr and the other members for
coming here today to engage in this discussion of the threat
that lies before us. I look forward to working with this
subcommittee to do what is needed to build a strong national
biodefense.
Senator Burr. Again, I apologize for members in advance
that they will be coming in and probably leaving as they try to
reconstruct today's schedule, but with that, let me welcome and
recognize Dr. Deutch.
STATEMENT OF JOHN DEUTCH, INSTITUTE PROFESSOR, MASSACHUSETTS
INSTITUTE OF TECHNOLOGY; FORMER DIRECTOR OF INTELLIGENCE; AND
FORMER DEPUTY SECRETARY OF DEFENSE
Mr. Deutch. Thank you very much, Mr. Chairman. Mr.
Chairman, thank you for the invitation to appear in front of
you.
Bioterrorism is one of the dangerous threats facing this
Nation and this committee is to be commended for devoting the
attention and the energy to helping solve this problem. I hope
today to briefly give you my assessment about the nature of the
bioterrorist threat and some recommendations on measures that
should urgently be taken to prepare our Nation to defend
itself.
My views are based on my experience on following subjects
and weapons of mass destruction, including biological weapons
of mass destruction, chemical, and nuclear since the mid-1970s
in a variety of positions. My views on the severity of the
nature of this threat, I think align closely with others who
have studied it, and I may mention that this January, I
appeared on a panel at the World Economic Conference with
Senator Frist and I found that our views on this subject were
very closely similar.
Let me begin with my assessment of the threat. First,
terrorist groups with international reach, such as al Qaeda,
have shown an interest in biological agents and biological
weapons. The technology for producing biological agents and
dispersal mechanisms is well known and easily within the
capacity of terrorist organizations. Thus, the threat is real.
Moreover, several states around the world have biological
weapons, programs, or capabilities and there is always the
possibility that these technologies will be clandestinely or
through theft transferred to terrorist groups.
In my judgment, we are fortunate that the United States,
that our allies, that our deployed military forces have yet
been subject to a large-scale biological attack. The likelihood
of an attack, our vulnerability to an attack, the need to
prevent catastrophic consequences means that biodefense should
be a top national priority here.
Despite many warnings and some progress by the many
government agencies involved, including Health and Human
Services, the Centers for Disease Control and Prevention, the
National Institutes of Health, the newly formed Department of
Homeland Security, our territory, citizens, agriculture,
livestock remain unacceptably vulnerable to catastrophic
biological agent attack. State and local governments cannot
possibly deal with such an event without significant and
financial help from the Federal Government.
In the near term, in my judgment, the agents of greatest
concern are anthrax and smallpox. In the long-term, it is
entirely possible, and indeed, I should say likely, that new
classes of pathogens will be developed based on modern
molecular biology and biotechnology techniques. They will be
much more virulent and much more difficult to detect and to
treat.
Finally, to my knowledge, no comprehensive, multiyear plan
exists that integrates the efforts of the various agencies of
this government to improve our Nation's biodefense posture. So
that is my assessment of the circumstances in which we find
ourselves today.
Let me now mention several recommended actions that I
believe need to be taken or pursued more aggressively in
combating this bioterrorist threat.
First and foremost is improved intelligence on
bioterrorism. It is a vital way of protecting our country
because it offers the prospects of disrupting development
efforts in terrorist groups or countries around the world,
intercepting equipment or materials intended for hostile
recipients, interdicting an attack before it occurs.
However, bioterrorism intelligence is a demanding
intelligence task because so much of the technology and
activity is dual-use in character, possessing both legitimate
and illegitimate purposes. This committee should urge the
Director of National Intelligence, John Negroponte, to
undertake periodic, thorough, all-source reviews of our
capacity for collection, analysis, and dissemination of
intelligence on the biological interests and activities of
terrorist groups and nations of concern.
Second, I believe this Nation should reinstitute the
practice of smallpox vaccination for the entire population. I
recognize that smallpox inoculation carries a small but
definite risk, so there are important issues of indemnification
for drug manufacturers and health professionals and the issue
of fair compensation for those injured need to be addressed.
But smallpox vaccination is the single step that will best
protect the American people from the catastrophic consequences
of the most likely infectious agent that a terrorist might use
today.
Third, the Nation needs a plan that aligns resources
against the prioritized needs to address all aspects of
biodefense. This includes efforts to improve the capacity of
first responders to cope with an attack. This means providing
adequate equipment, facilities, medicines, and importantly,
training to local first responders. Emergency policies and
procedures for controlling epidemics and establishing
quarantines in the case of attack need to be set forth. An
aggressive research and development effort to improve
biological agent detection and treatment is necessary. In the
absence of an integrated plan which covers all these activities
of the several agencies involved, the President, Congress, and
the American people are not able to measure the progress we are
making in improving our biodefense preparedness.
Finally, the Nation urgently needs a robust research and
development program to develop vaccines and drugs to combat
both known biotoxins and to provide protection against virulent
new genetically engineered organisms. The 2004 Bioshield Act is
an important step in this direction.
These last two recommendations, the call for an integrated
plan that covers the various agencies involved and the need for
a robust research and development program, points to an
important linkage that deserves mention. As the Nation
strengthens its capacity for the public health system to deal
with the extreme situation of a biological attack from an
infectious agent and to develop the means of combating the most
virulent agents imaginable, these capacities should also serve
to improve the day-to-day functioning of our health system for
our citizens.
I do not suggest that biodefense funding should be used to
support unrelated but perhaps worthy public health
improvements, but I do believe that those enhancements should
compete on their own merits. But I do suggest that an
intelligent design and execution of a biodefense program can
and will improve the capacity of our Nation's health care
system to operate under normal circumstance. This committee is
in an ideal position to encourage this dual benefit.
I find that the accounts of horrendous consequences of
biological attack, whether in fiction or whether in the media,
often leads to the opinion that it is impossible to protect the
country and its citizens against this kind of a catastrophic
event. I do not believe that this is true. While perfect
protection cannot be guaranteed, a measured government
biodefense program can reduce the possibility of such an attack
and vastly reduce the consequences and casualties of suffering
should it occur.
I thank you very much for your attention. I am pleased to
address any questions the committee may have, and let me just
summarize by saying this threat is real and our country should
be doing more about it.
Thank you very much, Mr. Chairman.
Senator Burr. Doctor, thank you very much.
[The prepared statement of Mr. Deutch follows:]
Prepared Statement of John Deutch
Mr. Chairman, Senator Kennedy, members of the committee. Thank you
for the opportunity to appear before the committee. Bioterrorism is one
of the most dangerous threats facing this Nation, and you are to be
commended for devoting attention to this problem. I will give you my
assessment of the bioterrorist threat and my recommendations on the
measure that should urgently be taken to prepare our Nation to meet
this threat.
I base my views on my experience as Director of Central
Intelligence and Deputy Secretary of Defense in the first Clinton
administration, as a member of President George H.W. Bush's Foreign
Intelligence Advisory Board, as chairman of the Commission on the
Organization of the Government to Combat Weapons of Mass Destruction,
and from the mid-seventies, my service on many Defense Science Board
and other government advisory committees, that addressed various
aspects of the weapons of mass destruction threat.
My views align closely with most who have studied the threat of
bioterrorist and our biodefense preparedness. At the World Economic
Conference this January I served on a panel with Majority Leader Frist,
a member of this subcommittee, that addressed bioterrorism and I
believe our views on this important subject are quite similar.
My assessment of the threat is as follows:
Terrorist groups with international reach, such as al
Qaeda, have shown interest in biological weapons. The technology for
producing biological agents and dispersal mechanisms is well known and
easily within the capacity of terrorist organizations. Thus the threat
is real.
We are fortunate that the United States, our allies, and
our deployed military forces have not yet been subject to a large-scale
biological attack. The likelihood of an attack, our vulnerability to an
attack, and the need to prevent catastrophic consequences, means that
biodefense deserves to be a national priority.
Despite the many warnings, and some progress by the
various involved government agencies, including Health and Human
Services (HHS) and its Centers for Disease Control and Prevention (CDC)
and National Institutes of Health, (NIH), and the new Department of
Homeland Security (DHS), our territory, citizens, agriculture and
livestock remain unacceptably vulnerable to a catastrophic biological
agent attack. State and local government cannot possibly deal with
these events without significant technical and financial help from the
Federal Government.
In the near term, the agents of greatest concern are
anthrax and smallpox. In the longer term, it is entirely possible that
new classes of pathogens will be developed based on modern molecular
biology and biotechnology techniques that will be more virulent and
more difficult to detect and to treat.
To my knowledge, no comprehensive multiyear program plan
exists that integrates the efforts of the various agencies required to
improve our Nation's biodefense posture.
Here are some recommended actions I believe need to be taken or
pursued more aggressively in combating the bioterrorist threat.
Improved intelligence on bioterroism is a vital part of
protecting our country, because it offers the prospect of disrupting a
development effort, intercepting equipment or materials intended for a
hostile recipient, or interdicting an attack before it occurs.
Bioterrorism is a demanding intelligence task, because so much of the
technology and activity is ``dual-use'' in character, possessing both
legitimate and illegitimate purposes. Director of National Intelligence
Negroponte should be encouraged to undertake periodic thorough all-
source review of our capacity for collection, analysis, and
dissemination of intelligence on the biological interests and
activities of terrorist groups and nations of concern.
I believe that this Nation should reinstitute the practice
of smallpox vaccination for the entire population. I recognize that
smallpox inoculation carries a small, but definite risk, so the issue
of indemnification for drug manufacturers and health professionals and
the issue of fair compensation for those injured, need to be addressed.
But smallpox vaccination is the single step that would best protect the
American people from the catastrophic consequences of the most likely
infectious agent that a terrorist might use.
The Nation needs a plan that aligns resources against
prioritized needs to address all aspects of biodefense. The plan should
include: (1) efforts to improve the capacity of first responders to
cope with an attack. This means providing adequate equipment,
facilities, medicines, and training; (2) emergency policies and
procedures for controlling epidemics and establishing quarantines in
the case of an attack; and (3) an aggressive R&D effort to improve
biological agent detection and treatment. In the absence of an
integrated plan, the President, Congress, and the American people are
not able to measure the progress we are making at improving our
biodefense preparedness.
The Nation urgently needs a robust research and
development program to develop vaccines and drugs to combat both known
biotoxins and to provide protection against virulent new genetically
engineered organisms. The 2004 Bioshield Act is an important step in
this direction.
These last two recommendations hint at an important linkage that
deserves special mention. As the Nation strengthens the capacity of the
public health system to deal with the extreme situation of a major
biological attack and to develop means of combating the most virulent
and infectious agents imaginable, it is possible that these
capabilities will also improve the day-to-day capacity of the public
health system to serve our citizens. I do not suggest biodefense
funding should be used to support unrelated, but perhaps worthy, public
health improvements. Such enhancements should compete on their own
merits. But, I do suggest that intelligent design and execution of a
biodefense capability can and should improve the capacity of the
country's health care system to operate under normal circumstances.
This committee is in an ideal position to encourage this dual benefit.
Superficial accounts of the horrendous consequences of a biological
attack too often lead to the opinion that it is impossible to protect
this country and its citizens against a biological attack. I do not
believe this to be true. While perfect protection cannot be guaranteed,
a measured government biodefense program can both reduce the
possibility of such an attack and vastly reduce the causalities and
suffering that would accompany it.
Thank you for your attention and I will be pleased to address any
question the committee members may have.
Senator Burr. If I could, let me ask you to expand as much
as you are anxious to as it relates to the comments on smallpox
vaccinations. Clearly, that was a difficult measure that we
undertook here. We clearly learned a lot about the process in
that one issue. Why so strongly do you feel that smallpox is
something that we should focus on?
Mr. Deutch. I believe that smallpox is the single
infectious agent which is most easily and reliably obtained by
terrorist groups or by hostile nations, that its infectivity is
enormous, especially against populations such as ours, which
has not had any inoculation for a generation. I believe that it
is the single greatest likelihood of really creating tens of
thousands, if not hundreds of thousands, of casualties, and we
should get about protecting our American people from that
single greatest threat.
There will never be a way of understanding or apologizing
if we get hit with a smallpox epidemic and have not taken
measures that could have been put in place throughout our
Nation. I know that we had a small outbreak of smallpox, I
guess, in 1947 in New York City and it was contained. But
should it not be contained, we will see tens of thousands of
Americans die, maybe hundreds of thousands. All the exercises
that have been taken show what a smallpox attack might do.
Now, there is an argument which says we shouldn't--we
should wait until a better vaccine is developed, or we should
wait until the full spectrum vaccine is developed, which might
protect us against smallpox and maybe other things, as well.
But my view is you should take the measures today we can know
will protect us against catastrophic consequences of a
biological attack.
Senator Burr. I think many Members of Congress were shocked
in the days, weeks, and months after 9/11 when we began to look
at our health infrastructure and we found that clearly over a
third of our public health entities across the country were not
electronically connected to the CDC, that the notification of
an outbreak, the notification of an attack, were it needed to
be disseminated in that third was made by the telephone or by
the fax.
Do you envision any successful response program that we can
come up with that does not address a clear, engaged, robust
public health infrastructure?
Mr. Deutch. No. I think you are quite right in pointing to
a public health infrastructure where pharmacists, where
emergency rooms, where police, all know what should be done if
an outbreak occurs. That means you have to have the capacity
for response in this country throughout our public health
system, and it is a major challenge, but that capacity will
also serve us in normal times to improve the health care which
is provided to our citizens.
Senator Burr. In your testimony, you highlighted the need
for improving intelligence collection and analysis for the
biologic threat. Is this an issue that deserves special
attention with the creation of maybe a bio-issues manager to be
assigned under Ambassador Negroponte's staff and possibly the
creation of a BW National Intelligence Officer or National
Intelligence Council?
Mr. Deutch. Well, I believe that the--currently, there is a
single person responsible for all of the weapons of mass
destruction categories and that national intelligence officer
should be seen, in my judgment, as being an issues manager for
all different parts of these weapons of mass destruction
threats. It is possible to put, in my view, either a separate
National Intelligence Officer for Bioterrorism or to assure
that the current responsibilities for all weapons of mass
destruction is organized under that individual to give adequate
attention to bioterrorism.
So I don't think that the identification of a single
individual is important. It is just to make sure that the
current National Intelligence Officer devotes the attention to
it that is needed and that the community responds as a
community.
Senator Burr. Dr. Deutch, I certainly agree with your major
recommendation that we must align our public health efforts to
address the bioterrorism threat and that will improve our
overall ability to handle the routine issues. Given your
background in the Defense Department, what lessons or
observations do you have that might be relevant to the public
health community?
Mr. Deutch. My first year in the Clinton administration,
the first Clinton administration, I served as Under Secretary
of Defense for Acquisition and Technology, so I tend to look at
these issues, the one you have addressed, as an acquisition
problem, as a full-spectrum attack from research all the way
through procurement and making sure that you have an industry
able to produce, develop, and deploy the capacities that are
needed to improve our biodefense.
Today, I do not see that acquisition ability in any of the
agencies that are addressing this problem. The Health and Human
Services or DNS, I don't think have that acquisition capacity
that is needed to do the full spectrum attention, from first
responders to an R&D program, that are needed to meet this
threat over time.
Senator Burr. A last question and then I want to turn it
over to Senator Enzi. Any time you undertake something new,
like the creation of the Department of Homeland Security and
all of the different funding streams that we have out there
trying to address things, you get some things right, you get
some things wrong. You find even if you did everything right,
you would still have criticism on some things. I think you
probably agree with that.
There has been some national debate on whether there was a
need to spread this first responder money around the country or
whether it should be targeted in just those high target areas.
I remind people when we have the debate that when a community
is decimated on their ability to respond to their own incident,
it is, in fact, those that are trained from the surrounding
State and States that, in fact, provide them the law
enforcement and the first responder capabilities.
Do you have any observations, regrets, on how we have tried
to upgrade the entire country's ability to respond and to train
those first responders?
Mr. Deutch. Well, I think that the Department of Homeland
Security is still getting its bearings. I should tell you, sir,
that I was at the Department of Energy when it was formed in
1978, and so I could tell you it takes some time. But I do not
think that these early programs have maybe been as effective as
they might have been.
Now, on the balance between local and national programs,
that I leave to your judgment, to Congress's judgment. As of
now, I think there is a lot left to be done.
Senator Burr. I thank you for your observation and assure
you that we are still trying to fix some of those things at the
Department of Energy.
[Laughter.]
Mr. Chairman?
The Chairman. Thank you. This may be one of the most high-
tech hearings that I have been at. I have never seen a Harry
Potter-type thing where your picture, your moving picture is
hanging on a wall halfway across the world and coming back to
you.
[Laughter.]
So I want to congratulate you on that part, too.
Dr. Deutch, in your testimony, you mention that terrorist
groups such as al Qaeda have shown interest in biological
weapons and that the technology for producing the biological
agents and dispersal mechanisms is easily within their
capacity. Could you give us a better feel for the
sophistication of facilities and personnel that are required to
make this interest a reality? Are we talking about a kitchen
meth lab or a Level 4 containment facility or something in
between?
Mr. Deutch. There will be individuals on the panel
following me who could address this much more authoritatively
than I can, but let me just say that surely a fairly good
undergraduate training at any leading U.S. university in
microbiology would permit you to undertake the manufacture, the
growth of these kinds of bugs. I might say that how much safety
you have for your workers depends a little bit upon the
attitude of the group. You may lose a few workers. But the
answer is it is well in hand, sir, well in hand and quite easy
to do.
The Chairman. To do this work, where do you think their
technical experts would come from? Would they be ideologues or
mercenaries or where----
Mr. Deutch. I mean, here again, the understanding about how
to do the microbiology involved here is so widespread that you
could probably do it with people in the related communities
that these terrorist groups live in. It is unlike the nuclear
situation where there is a key element of finding enriched
uranium or plutonium. In this case, the biological agent, the
biological material that you need and the know how is
completely out there. So I think it could come from any one of
the communities, any one of the communities in which these--
and, you know, al Qaeda operates worldwide, so they operate in
many parts of the world where they have access to good
education.
The Chairman. Since your testimony says that, and I really
believe that, the threat is real and we have been fortunate
that there hasn't been a large-scale biological attack, given
that the technology is relatively simple and the knowledge is
pretty widespread and the terror benefit is so great, what do
you think accounts for our good fortune to date?
Mr. Deutch. This would be a longer discussion, but I do
believe that these highly organized international terrorist
groups, as al Qaeda was, it may not be quite that formed today,
also have very serious political objectives and they have to
always balance whether they are accomplishing their political
objectives with the level of terrorism that they want to
inflict.
So it is a delicate balance with terrorist groups about how
big an act do they really want to undertake. One of the
greatest, in my view, limitations on why we haven't had an
attack is because terrorist groups still have political
objectives. Their only intent is not to kill Americans. Their
intent is to achieve things in their own communities and
countrysides and they balance the risks and threats to us by
that. But it may happen, sir. It may happen.
The Chairman. My time is almost expired here, so----
Senator Burr. Mr. Chairman, I thank you----
The Chairman. [continuing]. And we have a vote going on----
Senator Burr. We do have a vote going on, and Dr. Deutch, I
hope you will be available for any written questions that
Senator Kennedy or others might have.
Mr. Deutch. Certainly. Certainly, Mr. Chairman.
Senator Burr. Thank you for that. Thank you for your
willingness to come in.
The chair would announce at this time that we will adjourn
for the purposes of this vote. It is my full intention to be
back here in about 10 minutes, if I can expedite my travel
over. Our next panel, Dr. Fineberg has a 3:00 need to leave for
flight purposes and I assure all that he will have an
opportunity to give his opening statement before that 3:00
magical time comes.
Once again, Dr. Deutch, thank you.
Mr. Deutch. My pleasure. Thank you.
Senator Burr. The committee stands in recess.
[Recess.]
Senator Burr. I would like to call the hearing back to
order.
At this time, the chair would recognize and welcome Dr.
Fineberg. I came close. I gave you 9 minutes. How about that?
STATEMENTS OF HARVEY V. FINEBERG, M.D., PRESIDENT, INSTITUTE OF
MEDICINE, THE NATIONAL ACADEMIES; GUENAEL R. RODIER, M.D.,
DIRECTOR, DEPARTMENT OF COMMUNICABLE DISEASES SURVEILLANCE AND
RESPONSE, WORLD HEALTH ORGANIZATION; J. CRAIG VENTER,
PRESIDENT, J. CRAIG VENTER INSTITUTE; AND SHELLEY HEARNE,
EXECUTIVE DIRECTOR, TRUST FOR AMERICA'S HEALTH
Dr. Fineberg. That is perfect. Thank you very much, Mr.
Chairman.
Senator Burr. Your microphone, please.
Dr. Fineberg. Good morning, Mr. Chairman, and thank you
very much. I do appreciate your consideration and, most
importantly, this opportunity to testify before you today.
The main idea that I wanted to put before your
consideration is that when it comes to bio threats, biological
hazards and biological threats, a dual-purpose strategy in
responding to those threats makes a great deal of sense, and by
dual purpose, I mean a response that is comprehensive,
strategic, and simultaneously deals with the hazards which come
from acts of terrorism intentionally and which come from acts
of nature.
I believe that you will find as you go forward that many of
the elements that ought to make up a protective strategy for
our Nation simultaneously will serve both purposes, and I would
go further. I would say that it is by undertaking actions that
do both, we actually do each better than we could do if we do
not have this dual-purpose idea in mind.
I want to just hit briefly on five basic ideas. The first
of these is that the emergence of new diseases and new
biological hazards from infection is not a transient phenomena.
It is not an aberration. It is not a temporary condition. It is
an enduring and continuing part of the way we live our lives
today.
Second, I want to point out that our vulnerability to
infectious agents, whether by nature or by deliberate intent,
is exacerbated today by a number of factors, the growth in
resistance to antimicrobials, the declining availability of
vaccine manufacturers, and the very few genuinely new agents to
treat infection which are, in fact, in the pipeline.
Third, I want to point out that many of the means that
protect the public, preventing these conditions or responding
when they occur, are steps that need to be taken regardless of
whether we are preparing for a threat from terrorism or a
threat from nature.
Fourth, I do want to emphasize the point that was brought
up earlier today that the weaknesses of our public health
infrastructure are a fundamental problem and an inhibition to
our ability to respond. If you had a rickety bridge in town
over a stream, if nobody ever drove on the bridge, you might
not know that it couldn't sustain the weight of a vehicle. It
is only when you have the need to use it that you discover its
inadequacy, and that is what we are discovering and what we
have learned about our current public health infrastructure.
And finally, I just wanted to make an observation that
whether we are talking about many of these natural hazards or
the terrorist hazards, we are dealing with a family of problems
that are what I describe often as low likelihood/high
consequence. They are not very likely in any given year to
occur, but if they did happen, they would have terrible
consequences. And when you are facing a situation like that,
the problem you have as a policymaker is that no matter what
you do, you are going to be subject to criticism. If you take
action because it is low likelihood and it probably didn't
occur, you will be subject to criticism of doing too much. But
if the event does transpire, you are going to find that you
never will have done quite enough to prepare for such a
devastating possibility.
The only approach to dealing sensibly, strategically with
those conditions first require detailed planning and capacity
building. Second, what I think of as contingent authority, that
is the ability to act quickly but contingently on conditions as
they develop. And finally, without the means, the financial and
technical and human capacities to deal with these low-
likelihood but high-consequence events, you cannot have any
legitimate accountability for dealing with them.
So with that background, sir, I would be very happy to
respond to any questions that you may have and appreciate this
opportunity to put before you and the committee the testimony.
Senator Burr. Thank you, Dr. Fineberg.
In an effort to keep everything from a standpoint of the
time frame that we have allotted on time, I want to ask you if
you would also open yourself to written questions from not just
me, but from other committee members, and with that, at your
leisure, you can depart based upon--your flight today will
probably be a little chaotic regardless of where you are flying
out of.
[Laughter.]
I would imagine things are backed up a little bit. But we
do want to make sure that you hit your time frame.
I want to thank you for your testimony and for the insight
that you have been able to provide for this subcommittee.
Dr. Fineberg. Thank you very much, Mr. Chairman.
[The prepared statement of Dr. Fineberg follows:]
Prepared Statement of Harvey V. Fineberg, M.D., Ph.D.
Mr. Chairman, and members of the committee: I speak to you today as
president of the Institute of Medicine of the National Academies. (The
National Academies are a congressionally chartered, independent adviser
to the Nation on matters of science, technology, and health. The
National Academy of Sciences, the National Academy of Engineering, the
Institute of Medicine, and the National Research Council comprise the
National Academies.) Before taking up my current position in July,
2002, I served as provost of Harvard University for 4 years, following
13 years as dean of the Harvard School of Public Health. Earlier, with
the late professor Richard E. Neustadt, I co-authored a report on
lessons learned from the ill-fated swine-flu immunization program of
1976 (R.E. Neustadt and H.V. Fineberg. The Swine Flu Affair: Decision-
Making on a Slippery Disease, Department of HEW, 1978. Subsequently re-
published with additional material as The Epidemic That Never Was,
Vintage Books, 1983.) A couple of years ago, I served on the Expert
Committee charged with reviewing experience in coping with the SARS
outbreak in Hong Kong. In recent years, the Institute of Medicine and
the National Research Council have produced a number of consensus
studies and hosted a variety of workshops that bear on the subjects of
microbial threats, bioterrorism, and public health. For your
convenience, I have listed a number of these reports in an attachment
to this testimony. Their findings, conclusions, and recommendations
cover many areas that I hope will prove useful in your deliberations.
The main message in my testimony today is the value of a
comprehensive preparedness strategy that simultaneously protects the
American people against microbial threats that are natural, accidental,
or deliberate in origin. Experts in terrorism refer to dual-use
technologies, meaning ones that can be used for legitimate scientific
research and commerce, or turned to the nefarious purposes of
terrorism. When it comes to bioterrorism, the soundest national
response is a dual-purpose defense that would deter, detect, and
respond effectively to microbial threats from either natural or
intentional sources.
In briefly elaborating on the case for a comprehensive, dual
purpose strategy to protect against both naturally occurring and
deliberately inflicted microbial threats, I will touch upon five
points:
1. We can expect and should prepare for continuing changes in
the appearance, severity and incidence of microbial threats.
2. Our vulnerability to microbial threats has been exacerbated
by the rise in drug-resistant organisms, the decline in the
number of vaccine manufacturers, and a shortage of new
antimicrobials.
3. Many of the same means of prevention, detection, response,
and management apply to both natural and intentional microbial
threats.
4. Deficiencies and variability in the public health
infrastructure across different national, State and local
jurisdictions represent a particularly severe gap in our
Nation's capacity to respond.
5. Microbial threats from any source that are relatively
unlikely, but very severe if they occur, pose a particularly
demanding challenge to decisionmakers.
New and Newly Emerging Microbial Threats
Species survive not because they are stronger or more intelligent,
but because they are better suited to their environment. Micro-
organisms have been adapting and surviving successfully for hundreds of
millions of years longer than plant or animal populations on the
planet. In terms of sheer number, range of habitat, and total bio-mass,
micro-organisms are the most abundant and versatile species on the
planet. In fact, life as we know it on earth would be impossible
without the positive contributions of innumerable microbial species to
plants and animals. The gut of each human adult, for example, contains
about two pounds of bacteria--more than 15,000 times as many individual
bacteria as there are humans on earth! These internal co-habitants aid
in digestion and absorption of essential nutrients, and play an
important role in the development of our immune systems. Only a tiny
fraction of the world's microbes constitute a threat to plant, animal,
or human life, but some of these threats are truly fearsome.
Recent decades have witnessed the appearance of dozens of
infectious diseases that were previously unrecognized or that attained
new geographic reach, incidence or severity. These encompass newly
resistant conditions such as some forms of bacterial pneumonia,
malaria, and tuberculosis; threats such as West Nile virus that have
spread across the United States; and new global catastrophes such as
AIDS. The conditions favoring emergence of new diseases are neither
transient nor aberrant; they are intrinsic to modern technology and
ways of life.
Among the forces promoting new microbial threats or increasing
human vulnerability:
Increasing population size and density. Population growth
is most rapid in low latitude countries. Large and growing cities in
tropical or subtropical developing countries are frequently surrounded
by peri-urban slums that lack clean water, sanitary disposal of waste,
and access to medical care. Growing populations drive the need for more
food, including animal protein, and closer proximity of human and
animal populations, often with both occupying the same, limited space.
More rapid and frequent travel. Almost 2 million people
cross international borders daily. In the year 2000, an estimated 400
million international travelers entered the United States by land,
ship, or air. Every human traveler is a potential conveyer of
infectious organisms.
Increased number of vulnerable individuals. Older
individuals tend to mount less vigorous immune responses to infection,
and the aging of the population increases the proportion that is
susceptible to infectious diseases. Growing numbers of
immunocompromised individuals--due to HIV infection, radiation and
chemotherapy treatment for cancer, or immunosuppressive therapy in
conjunction with organ transplant--also contribute to a population that
is more vulnerable to infections.
Growing global commerce. Trade involves living and dead
animals and animal parts shipped for food, pets, research, and by-
products. Mosquitoes that are competent to transmit human infections
have been introduced into new geographic areas via trade (breeding, for
example, in tires on ships). Food imports have been associated with
outbreaks of unfamiliar infections (such as cyclospora in the United
States and Canada from raspberries imported from Guatemala). Non-food
imports into the United States in 2002 included 47,000 mammals
(including 28 species of rodents), 379,000 birds, 2 million reptiles,
49 million amphibians, and 223 million fish. Most of these animals are
wild caught, not screened before shipment, suffer high mortality in
transit, and gain exposure to the public. Monkeypox was imported into
the United States in a shipment of African rodents to be sold as pets
in the United States.
Mass production in agriculture. Large concentrations of
genetically similar plants and animals render agriculture vulnerable to
large scale outbreaks of infection. Large, high-density populations of
poultry, hogs, and other animals are similarly susceptible to
infectious diseases.
Widespread antimicrobial use and misuse. Antimicrobials
exert selective pressure on bacteria, viruses, fungi, and protozoa,
leaving resistant strains able to survive, replicate, and, in some
instances, be transmitted and become more prevalent. Approximately 40
percent of antimicrobials in the United States are used in sub-
therapeutic doses to promote growth in farm animals, in aquaculture and
in cultivation of fruit trees. Such chronic use of low-dose
antimicrobials is especially favorable to development of resistant
strains. A substantial fraction of prescribed anti-microbials are
unnecessary or misused. Incomplete treatment of tuberculosis
facilitated emergence of multi-drug resistant strains of the infection.
Changes in land use and human habitats. Construction,
agricultural projects, drainage, dam construction, and other
alterations in land use can change the ecology for disease vectors and
for reservoir and intermediate animal hosts. Human development breaches
traditional biophysical barriers, such as rivers and mountains. Logging
roads in Africa facilitate bushmeat trade, a source of human exposure
to novel pathogens. Urban habitats can facilitate the spread of
infections, as occurred with air conditioned buildings and
legionnaire's disease in the United States, and with SARS and the high-
rise Amoy Gardens in Hong Kong.
Many newly acquired infectious diseases in humans derive from an
animal source. This includes HIV (from primates), SARS (from civet cats
or other animals), avian influenza (from birds), variant Creutzfeldt-
Jacob disease (from cows infected with bovine spongiform
encephalopathy), and Nipah virus (from fruit bats). When the ancestor
virus to HIV adapted to spread from person to person, the results were
devastating. Globally, to date, 20 million persons have died of AIDS,
and approximately 40 million are living with HIV infection.
The greatest natural catastrophe of the 20th Century was the
influenza pandemic of 1918-19. In the space of less than 12 months,
more than a half million Americans, many young and vigorous, lost their
lives to the flu, and this was at a time when the total U.S. population
was around 100 million. Worldwide, the great influenza pandemic killed
at least 20 million; some estimates are as much as five times higher.
The specific viral culprit was later identified as a form of influenza
A that probably originated in birds. Even in an average flu season,
influenza accounts for an estimated 30,000 to 40,000 deaths in the
United States. Because of its ability to undergo rapid genetic change
and to move across species (such as birds, pigs, and humans) the
influenza virus is a formidable pathogen. The shadow of the great
pandemic of 1918-19 darkens every discussion of the threat of
influenza, including the pandemic potential of avian flu.
The natural reservoir for influenza A is aquatic birds that carry
and excrete the virus, but do not experience disease. The virus
periodically infects other hosts, including other kinds of poultry and
mammals, which may suffer disease or death from infection. A highly
pathogenic form of avian influenza is now endemic in bird populations
in parts of Asia where 30 percent of the world's human population live
and where contact with poultry is common among rural residents.
Sporadic human cases have proven fatal in more than half the clinically
evident cases, although the number of sub-clinical human infections is
unknown. The major concern is that mutation or genetic re-assortment
may produce a viral variant that is efficiently transmitted from person
to person, sowing the seed for a global pandemic.
The currently prevalent form of avian flu has shown increased
severity of illness in poultry, an expanded mammalian range, and
excretion of highly pathogenic virus by apparently healthy ducks. One
worrisome development is the appearance of clusters of human cases,
suggesting the possibility of human to human transmission, as appears
likely in at least one reported instance. Efforts in some areas to
monitor infection in animals and to track changes are hampered by local
conditions, limited capacities, and concerns about commerce and
tourism.
Early vaccine trials are underway as is research on more efficient
ways to produce influenza vaccine and on the potential transmissibility
of avian flu variants. In addition to this current research, a
concerted strategy to cope with avian flu would incorporate intensified
bilateral and multi-lateral international efforts to monitor and cull
infected animal populations, accumulation of larger reserves of anti-
viral drugs that may reduce the severity of a disease outbreak, and
detailed plans for international sharing and domestic deployment of
drugs and vaccine if and when they are needed.
Drug Resistance, Vaccine Manufacturers, and New Drugs
Drug-resistant microbes are a serious public health threat. The CDC
estimates that approximately 2 million people acquire bacterial
infections in the hospital each year, more than 70 percent of which are
resistant to at least one antimicrobial commonly used to treat them.
Hospital-acquired infections claim approximately 90,000 lives each
year. Drug-resistant infections typically require more costly drugs and
are difficult to treat, estimated to impose an economic burden of at
least $5 billion annually. While the number of resistant organisms has
burgeoned, the number of newly approved antibacterial agents has
declined steadily over the past 20 years, dropping from 16 between 1983
and 1987 to 7 between 1998 and 2002, and to just 3 in 2003-04. In its
2003 report on Microbial Threats, the IOM pointed out that every
antibacterial drug then in clinical development belonged to an already
existing class of drugs, i.e., that not one new class of drugs was then
in late-stage development.
As drug resistance spreads and vaccine-preventable threats loom,
the declines in vaccine manufacturers and in new antimicrobials
represent a dangerous, combined trend. Vulnerability to the reduced
number of vaccine production facilities was revealed in last year's
shortage of flu vaccine. Vulnerability to drug-resistant micro-
organisms plays out every day in U.S. hospitals and in clinics treating
infectious diseases around the globe.
Strategies to Cope With Microbial Threats
Many of the same capacities, approaches, and tools to contend with
naturally occurring infections apply equally to deliberately deployed
infectious agents. Scientific research to create more effective anti-
viral agents applies to influenza as it does to smallpox, and inter-
disciplinary collaboration can reveal novel approaches to potential
drug targets on any dangerous infectious agent. More vaccine
manufacturers are needed to avert the kind of shortages seen in last
year's flu season and to provide preventives against potential agents
of bioterror. Incentives for investment in new vaccines and drugs can
provide more effective preventives and care for a range of natural or
intentional infections. Alert physicians, surveillance systems,
epidemiologic investigation, and well-equipped laboratories will be
necessary in identifying the cause of any new infection, from whatever
source. A strategy of prevention and containment will be needed for
infectious diseases, either natural or deliberate in origin, including
vaccination programs; public education; appropriate use of isolation
and quarantine; utilization of drugs, devices, and treatment
facilities; clear and authoritative communication; professional
collaboration among health care providers, public health officials, and
veterinary experts; and coordination across departmental jurisdictions
and among Federal, State, and local health authorities, as well as
international agencies.
Of course, there are differences in preparing for the possibility
of bioterror and of natural biological threats in terms of the specific
agents of interest, the risks and scope of research, the means of
deterrence, and the salience for special populations, such as the armed
forces. An important step is being taken through the implementation of
a National Science Advisory Board for Biosecurity to reduce the
likelihood that legitimate research will inadvertently increase the
risk of bioterrorism. A human adversary can take account of
preparations and attempt to exploit a perceived, remaining weakness.
This is what risk managers and military planners call the N+1 problem:
prepare for N contingencies, and the enemy will try to exploit one you
have not yet considered. By contrast, Nature, to paraphrase Einstein,
may be subtle, but is not devious. The microbial world, however, is
huge, diverse, and resilient, and a microbe's rapid generation time and
multiple means of adaptation may render its lack of intent a
distinction without much of a difference when it comes to the risk to
human health. Microbes, in their natural course of survival and
replication, may produce consequences as terrible and terrifying as any
bioterrorist. Most of what needs to be done to prepare against either
will serve against both.
The Public Health Infrastructure
Public health departments in communities and States across the
Nation are highly variable in their capacity to respond to natural or
intentional outbreaks of infection. The majority of personnel working
in health departments in the United States today are not trained in
relevant public health disciplines. Information technology and health
information systems are often seriously deficient. Many public health
laboratories are antiquated, and only about 60 percent of local health
departments have any laboratory capacity whatsoever. Almost all
departments lack a real-time surveillance system, and many lack a basic
capacity for epidemiologic investigation. Communication networks are
often ineffective and fragmented, and emergency response capabilities
are severely limited. While national guidelines for reform of public
health law have been proposed, many State public health statutes remain
outdated and internally inconsistent. These and other shortcomings, and
a comprehensive set of recommendations to overcome them, are enumerated
in the IOM report on The Future of the Public's Health (2003).
Systematic improvement in the Nation's public health infrastructure
would go a long way toward strengthening the Nation's ability to
respond to natural or intentional infection and provide many other
benefits to protect the public's health.
Low-Likelihood, High-Consequence Events
An especially challenging dilemma for decision makers is how to
respond to events that are relatively unlikely, but carry severe
consequences if they materialize. Such low-likelihood, high-consequence
risks include infectious diseases that may be natural (such as a new
SARS, or the appearance of pandemic influenza in any given year) or
intentional (such as smallpox or anthrax). In such cases, preparedness
and selected measures may be prudent and wise, yet cynics and armchair
critics will most often be correct if they claim the preparations were
for naught. That is the nature of a low-likelihood event. If the low-
likelihood, high-consequence event does eventuate, the preparations
will nearly always be seen in retrospect to have been less than was
optimal. The prospective dilemma intensifies when preparations are
expensive, intrusive, complex, and laden with risk. These conditions
make policymakers politically vulnerable, even when they are making the
right decision. Acknowledging this dilemma does not excuse flawed
decision making; indeed, the only hope for improvement is to learn the
strategic lessons from past errors of over-reaction and under-reaction.
Recognizing the dilemma, however, does place a premium on establishing
clear lines of authority and the necessary resources in advance.
Without such authority and means, there can be no legitimate
accountability.
__________
If there are ways that I or my colleagues at the Institute of
Medicine or the National Academies can be helpful as you proceed with
your deliberations, please do not hesitate to call upon us.
SELECTED REPORTS FROM THE INSTITUTE OF MEDICINE AND THE NATIONAL
RESEARCH COUNCIL
All reports are published by the National Academies Press. Members
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I. Infectious Diseases
The Threat of Pandemic Influenza: Are We Ready? Workshop Summary
(2005). Stacey Knobler, Alison Mack, Adel Mahmoud, and Stanley Lemon,
editors.
Public health officials and organizations around the world
remain on high alert because of increasing concerns about the
prospect of an influenza pandemic, which many experts believe
to be inevitable. Moreover, recent problems with the
availability and strain-specificity of vaccine for annual flu
epidemics in some countries and the rise of pandemic strains of
avian flu in disparate geographic regions have alarmed experts
about the world's ability to prevent or contain a human
pandemic. This workshop summary on The Threat of Pandemic
Influenza: Are We Ready? addresses these urgent concerns. The
report describes what steps the United States and other
countries have taken thus far to prepare for the next outbreak
of ``killer flu.'' It also looks at gaps in readiness,
including hospitals' inability to absorb a surge of patients
and many nations' incapacity to monitor and detect flu
outbreaks. The report points to the need for international
agreements to share flu vaccine and antiviral stockpiles to
ensure that the 88 percent of nations that cannot manufacture
or stockpile these products have access to them. It chronicles
the toll of the H5N1 strain of avian flu currently circulating
among poultry in many parts of Asia, which now accounts for the
culling of millions of birds and the death of at least 50
persons. It also compares the costs of preparations with the
costs of illness and death that could arise during an outbreak.
Learning from SARS: Preparing for the Next Disease Outbreak--Workshop
Summary (2004). Stacey Knobler, Adel Mahmoud, Stanley Lemon, Alison
Mack, Laura Sivitz, and Katherine Oberholtzer, editors.
The emergence of severe acute respiratory syndrome (SARS) in
late 2002 and 2003 challenged the global public health
community to confront a novel epidemic that spread rapidly from
its origins in southern China until it had reached more than 25
other countries within a matter of months. In addition to the
number of patients infected with the SARS virus, the disease
had profound economic and political repercussions in many of
the affected regions. Recent reports of isolated new SARS cases
and a fear that the disease could reemerge and spread have put
public health officials on high alert for any indications of
possible new outbreaks. This report examines the response to
SARS by public health systems in individual countries, the
biology of the SARS coronavirus and related coronaviruses in
animals, the economic and political fallout of the SARS
epidemic, quarantine law and other public health measures that
apply to combating infectious diseases, and the role of
international organizations and scientific cooperation in
halting the spread of SARS. The report provides an illuminating
survey of findings from the epidemic, along with an assessment
of what might be needed in order to contain any future
outbreaks of SARS or other emerging infections.
Microbial Threats to Health: Emergence, Detection, and Response (2003).
Mark Smolinski, Margaret Hamburg, and Joshua Lederberg, editors.
Infectious diseases are a global hazard that puts every nation
and every person at risk. The recent SARS outbreak is a prime
example. Knowing neither geographic nor political borders,
often arriving silently and lethally, microbial pathogens
constitute a grave threat to the health of humans. Indeed, a
majority of countries recently identified the spread of
infectious disease as the greatest global problem they
confront. Throughout history, humans have struggled to control
both the causes and consequences of infectious diseases and we
will continue to do so into the foreseeable future. Following
up on a high-profile 1992 report from the Institute of
Medicine, Microbial Threats to Health examines the current
state of knowledge and policy pertaining to emerging and re-
emerging infectious diseases from around the globe. It examines
the spectrum of microbial threats, factors in disease
emergence, and the ultimate capacity of the United States to
meet the challenges posed by microbial threats to human health.
From the impact of war or technology on disease emergence to
the development of enhanced disease surveillance and vaccine
strategies, Microbial Threats to Health contains valuable
information for researchers, students, health care providers,
policymakers, public health officials. and the interested
public.
The Resistance Phenomenon in Microbes and Infectious Disease Vectors:
Implications for Human Health and Strategies for Containment--Workshop
Summary (2003). Stacey Knobler, Stanley Lemon, Marian Najafi, and Tom
Burroughs, editors.
The emergence of new diseases such as SARS and the looming
threat of bioterrorist attacks remind us of how vulnerable we
can be to infectious agents. With advances in medical
technologies, we have tamed many former microbial foes, yet
with few new antimicrobial agents and vaccines in the pipeline
and drug resistance increasing rapidly among infectious
microbes, we teeter on the brink of losing the upper hand in
our ongoing struggle against these foes, old and new. The
Resistance Phenomenon in Microbes and Infectious Disease
Vectors examines our understanding of the relationships among
microbes, disease vectors, and human hosts, and explores
possible new strategies for meeting the challenge of
resistance.
The Emergence of Zoonotic Diseases: Understanding the Impact on Animal
and Human Health--Workshop Summary (2002). Tom Burroughs, Stacey
Knobler, and Joshua Lederberg, editors.
Zoonotic diseases represent one of the leading causes of
illness and death from infectious disease. As defined by the
World Health Organization, zoonoses are those diseases and
infections that are naturally transmitted between vertebrate
animals and man with or without an arthropod intermediate.
Worldwide, zoonotic diseases have a negative impact on
commerce, travel, and economies. In most developing countries,
zoonotic diseases are among those diseases that contribute
significantly to an already overly burdened public health
system. In industrialized nations, zoonotic diseases are of
particular concern for at-risk groups such as the elderly,
children, childbearing women, and immunocompromised
individuals. The Emergence of Zoonotic Diseases: Understanding
the Impact on Animal and Human Health covers a range of topics,
which include: an evaluation of the relative importance of
zoonotic diseases against the overall backdrop of emerging
infections; research findings related to the current state of
our understanding of zoonotic diseases; surveillance and
response strategies to detect, prevent, and mitigate the impact
of zoonotic diseases on human health; and information about
ongoing programs and actions being taken to identify the most
important needs in this vital area.
Considerations for Viral Disease Eradication: Lessons Learned and
Future Strategies--Workshop Summary (2002). Stacey Knobler, Joshua
Lederberg, and Leslie Pray, editors.
Since smallpox eradication, the science of eradication has
changed and with it, our definitions of what diseases it is
possible to eradicate. However, eradication must not beget
complacency. As has been learned from past control or
eradication attempts with a variety of viral diseases from
yellow fever to influenza, accidental or intentional
reintroduction is a real threat--one that could strike anywhere
and for which we need to be fully prepared. The criteria for
assessing eradicability of polio, measles, and other viral
infections have been debated extensively. With the elimination
and eradication of several viral diseases on the horizon,
issues surrounding the cessation of immunization activities
become exceedingly important. In an effort to better understand
the dynamics of disease eradication and post-immunization
policies, the Institute of Medicine's Forum on Emerging
Infections hosted a 2-day workshop on ``The Consequences of
Viral Disease Eradication.'' This summary of the workshop
explores the principles underlying the biological challenges,
medical interventions, the continuing research agenda, and
operational considerations for post-immunization strategies for
vaccine-preventable viral diseases, and highlights important
efforts that may facilitate wise decisionmaking.
Emerging Infectious Diseases from the Global to the Local Perspective--
Workshop Summary (2001). Jonathan Davis and Joshua Lederberg, editors.
In October 1999, the Institute of Medicine's Forum on Emerging
Infections convened a 2-day workshop entitled ``International
Aspects of Emerging Infections.'' Key representatives from the
international community explored the forces that drive emerging
infectious diseases to prominence. Emerging Infectious Diseases
from the Global to the Local Perspective includes summaries of
the presentations from this workshop and suggests an agenda for
future action. The topics addressed cover a wide range of
issues, including trends in the incidence of infectious
diseases around the world, descriptions of the wide variety of
factors that contribute to the emergence and reemergence of
these diseases, efforts to coordinate surveillance activities
and responses within and across borders, and the resource,
research, and international needs that remain to be addressed.
Perspectives on the Department of Defense Global Emerging Infections
Surveillance and Response System: A Program Review (2001). Philip S.
Brachman, Heather C. O'Maonaigh, and Richard N. Miller, editors.
This report describes the capacity, quality, and effectiveness
of the international and domestic facilities and programs that
are a part of the Defense Department's system to monitor and
address emerging infectious diseases globally. The committee
concludes that the goals of the system are in U.S. military,
U.S. civilian, and global public health interests and that
substantial progress has been made toward achieving system
goals.
Orphans and Incentives: Developing Technology to Address Emerging
Infections--Workshop Summary (1997). Polly Harrison and Joshua
Lederberg, editors.
Infectious diseases remain a leading cause of prolonged
illness, premature mortality, and soaring health costs. In the
United States in 1995, infectious diseases were the third
leading cause of death, right behind heart disease and cancer.
Mortality is mounting over time, owing to HIV/AIDS, pneumonia,
and septicemia, with drug resistance playing an ever-increasing
role in each of these disease categories. This summary from a
Forum on Emerging Infections workshop focuses on product areas
where returns from the market might be perceived as being too
small or too complicated by other factors to compete in
industrial portfolios with other demands for investment.
Vaccines are quintessential examples of such products. The
lessons learned fall into four areas, including what makes
intersectoral collaboration a reality, the notion of a product
life cycle, the implications of divergent sectoral mandates and
concepts of risk, and the roles of advocacy and public
education. The summary contains an examination of the
Children's Vaccine Initiative and other models, an industry
perspective on the emerging infections agenda, and legal and
regulatory issues.
Infectious Diseases in an Age of Change: The Impact of Human Ecology
and Behavior on Disease Transmission (1995). Bernard Roizman, editor.
Twenty-first century progress against infectious diseases is
threatened by urbanization, population growth, war refugees,
changing sexual standards, and a host of other factors that
open doors to the transmission of deadly pathogens. Infectious
Diseases in an Age of Change reports on major infectious
diseases that are on the rise today because of changing
conditions and identifies urgently needed public health
measures. This volume looks at the range of factors that shape
the epidemiology of infectious diseases--from government
policies to economic trends to family practices. Describing
clinical characteristics, transmission, and other aspects, the
book addresses major infectious threats--sexually transmitted
diseases, Lyme disease, human cytomegalovirus, diarrheal
diseases, dengue fever, hepatitis viruses, HIV, and malaria.
The authors also look at the rising threat of drug-resistant
strains of tuberculosis, rapid exhaustion of the weapons to
fight bacterial infections, and prospects for vaccinations and
eradication of pathogens.
II. THE PUBLIC HEALTH SYSTEM
Human Resources at U.S. Ports of Entry to Protect the Public's Health--
Interim Letter Report (2005). Committee on Measures to Enhance the
Effectiveness of CDC Quarantine Station Expansion Plan for U.S. Ports
of Entry, Institute of Medicine.
Nearly 40 newly emerging or reemerging infectious diseases have
appeared and spread to multiple continents since 1970--from
HIV/AIDS and SARS to West Nile virus and poliovirus. A
significant vehicle for the spread of disease today is the
speed and volume of international and transcontinental travel,
commerce, and human migration. These trends and the risk of
bioterrorism have prompted the U.S. Government to expand
efforts to prevent communicable diseases of public health
significance from being imported into the United States. As
part of this endeavor, Congress and the Bush Administration
have given CDC's Division of Global Migration and Quarantine
(DGMQ) a mandate to more than triple the size of its system of
quarantine stations at U.S. ports of entry and to play an
active, anticipatory role in nationwide biosurveillance. DGMQ
has asked the IOM to examine the proposed quarantine station
expansion plans and recommend how the system should evolve to
meet public health needs of the 21st century. This interim
letter report, Human Resources at U.S. Ports of Entry to
Protect the Public's Health, is the first of two reports
responding to DGMQ's request. In this report, the IOM's
Committee on Measures to Enhance the Effectiveness of CDC
Quarantine Station Expansion Plan for U.S. Ports of Entry
offers preliminary suggestions for the priority functions of a
modern quarantine station, the competencies necessary to carry
out those functions, and the types of health professionals who
have the requisite competencies. The committee's final report,
to be released in early summer 2005, will comprehensively
assess the current role of quarantine stations and articulate a
vision of their future role as a public health intervention.
Vaccine Safety Research, Data Access, and Public Trust (2005).
Committee on the Review of the National Immunization Program's Research
Procedures and Data Sharing Program, Institute of Medicine.
The Vaccine Safety Datalink (VSD) is a large, linked database
of patient information that was developed jointly by CDC and
several private managed care organizations in 1991. It includes
data on vaccination histories, health outcomes, and
characteristics of more than 7 million patients of eight
participating health organizations. Researchers from CDC and
these managed care groups have used VSD information to study
whether health problems are associated with vaccinations. A
subsequent VSD data sharing program was launched in 2002 to
allow independent, external researchers access to information
in the database. In this report, the committee that was asked
to review aspects of this program recommends two new oversight
groups to ensure that the policies and procedures of the VSD
and its data sharing program are implemented as fairly and
openly as possible. The Centers for Disease Control and
Prevention, which oversees the VSD and the data sharing
program, should create a new, independent committee to review
researchers' proposals to use VSD data, monitor adherence to
protocols, and advise the agency and its partners on when and
how to release preliminary findings based on the data, the
report says. In addition, CDC should create a new subcommittee
of the National Vaccine Advisory Committee (NVAC), or tap an
existing one, to enable stakeholders to review and provide
input on the VSD research plan every year. The committee makes
additional recommendations on specific aspects of the VSD data
sharing program and on conditions governing whether, when, and
how preliminary findings should be shared with others.
The Smallpox Vaccination Program: Public Health in an Age of Terrorism
(2005). Alina Baciu, Andrea Pernack Anason, Kathleen Stratton, and
Brian Strom, editors.
This report constitutes an archival compendium of the
committee's smallpox reports to the Centers for Disease Control
and Prevention, summarizing milestones in the smallpox
vaccination program and the committee's assessment of what has
been accomplished in the course of the program. The report
discusses lessons learned from the vaccination program,
concluding that there is a need to balance scientific
communication with national security imperatives in the context
of bioterrorism and similar programs in a way that preserves
the authoritative voice of the CDC (or other appropriate
agency, depending on the type of emergency). The report also
recommends that smallpox preparedness should be defined,
preparedness goals should be set based on the best available
scientific and public health reasoning, preparedness should be
comprehensively assessed, and the status of preparedness
efforts should be communicated to the public.
``Discovery of Antivirals Against Smallpox'' (2004). Stephen Harrison,
et al., Proceedings of the National Academy of Sciences vol. 101, no.
31, pp. 11178-11192.
This PNAS article summarizes the findings and recommendations
from a workshop hosted by the National Academies on scientific
priorities in smallpox research and policies that are needed
for promoting the development of effective countermeasures
against any possible reintroduction of smallpox into the public
community.
The Future of the Public's Health in the 21st Century (2003). Committee
on Assuring the Health of the Public in the 21st Century, Institute of
Medicine.
The anthrax incidents following the 9/11 terrorist attacks put
the spotlight on the Nation's public health agencies, placing
them under an unprecedented scrutiny that added new dimensions
to the complex issues considered in this report. The Future of
the Public's Health in the 21st Century reaffirms the vision of
Healthy People 2010 and outlines a systems approach to assuring
the Nation's health in practice, research, and policy. This
approach focuses on joining the unique resources and
perspectives of different sectors and challenges these groups
to work in a concerted, strategic way to promote and protect
the public's health. Focusing on diverse partnerships as the
framework for public health, the book discusses (i.) the need
for a shift from an individual to a population-based approach
in practice, research, policy, and community engagement; (ii.)
the status of the governmental public health infrastructure and
what needs to be improved, including its interface with the
health care delivery system; and (iii.) the roles that non-
government actors, such as academia, business, local
communities and the media, can play in creating a healthy
nation.
Who Will Keep the Public Healthy? Educating Public Health Professionals
for the 21st Century (2003). Kristine Gebbie, Linda Rosenstock, and
Lyla M. Hernandez, editors.
Bioterrorism, drug-resistant disease, transmission of disease
by global travel--there is no shortage of challenges facing
America's public health officials. Men and women preparing to
enter this field require state-of-the-art training to meet
these increasing threats to the public health. But are the
programs they rely on providing the high caliber professional
training they require? Who Will Keep the Public Healthy?
provides an overview of the past, present, and future of public
health education, assessing its readiness to provide the
training and education needed to prepare men and women to face
21st-century challenges. Advocating an ecological approach to
public health, the Institute of Medicine examines the role of
public health schools and degree-granting programs, medical
schools, nursing schools, and government agencies, as well as
other institutions that foster public health education and
leadership. Specific recommendations address the content of
public health education, qualifications for faculty,
availability of supervised practice, opportunities for cross-
disciplinary research and education, cooperation with
government agencies, and government funding for education.
Eight areas of critical importance to public health education
in the 21st century are examined in depth: informatics,
genomics, communication, cultural competence, community-based
participatory research, global health, policy and law, and
public health ethics. The report also includes a discussion of
the policy implications of its ecological framework.
Financing Vaccines in the 21st Century: Assuring Access and
Availability (2003). Committee on the Evaluation of Vaccine Purchase
Financing in the United States, Institute of Medicine.
The national immunization system has achieved high levels of
immunization, particularly for children. However, this system
faces difficult challenges for the future. Significant
disparities remain in assuring access to recommended vaccines
across geographic and demographic populations. These
disparities result in part from fragmented public-private
financing in which a large number of children and adults face
limited access to immunization services. Access for adults lags
well behind that of children, and rates of immunizations for
those who are especially vulnerable because of chronic health
conditions, such as diabetes or heart and lung disease, remain
low. Financing Vaccines in the 21st Century: Assuring Access
and Availability addresses these challenges by proposing new
strategies for assuring access to vaccines and sustaining the
supply of current and future vaccines. The report recommends
changes to the Advisory Committee on Immunization Practices
(ACIP)--the entity that currently recommends vaccines--and
calls for a series of public meetings, a post-implementation
evaluation study, and development of a research agenda to
facilitate implementation of the plan.
Protecting Our Forces: Improving Vaccine Acquisition and Availability
in the U.S. Military (2002). Stanley Lemon, Susan Thaul, Salem Fisseha,
and Heather O'Maonaigh, editors.
Infectious diseases continue to pose a substantial threat to
the operational capacity of military forces. Protecting Our
Forces reviews the process by which the U.S. military acquires
vaccines to protect its warfighters from natural infectious
disease threats. The committee found that poorly aligned
acquisition processes and an inadequate commitment of financial
resources within the Department of Defense vaccine acquisition
process rather than uncleared scientific or technological
hurdles contribute to the unavailability of some vaccines that
could protect military personnel and, implicitly, the welfare
and security of the Nation. Protecting Our Forces outlines ways
in which DOD might strengthen its acquisition process and
improve vaccine availability. Recommendations, which include
combining all DOD vaccine acquisition responsibilities under a
single DOD authority, cover four broad aspects of the
acquisition process: (i.) organization, authority, and
responsibility; (ii.) program and budget; (iii.) manufacturing;
and (iv.) the regulatory status of special-use vaccines.
The Anthrax Vaccine: Is It Safe? Does It Work? (2002). Lois M.
Joellenbeck, Lee L. Zwanziger, Jane S. Durch, and Brian L. Strom,
editors.
The vaccine used to protect humans against the anthrax disease,
called Anthrax Vaccine Adsorbed (AVA), was licensed in 1970. It
was initially used to protect people who might be exposed to
anthrax where they worked, such as veterinarians and textile
plant workers who process animal hair. When the U.S. military
began to administer the vaccine, then extended a plan for the
mandatory vaccination of all U.S. service members, some raised
concerns about the safety and efficacy of AVA and the
manufacture of the vaccine. In response to these and other
concerns, Congress directed the Department of Defense to
support an independent examination of AVA. The Anthrax Vaccine:
Is It Safe? Does It Work? reports the study's conclusion that
the vaccine is acceptably safe and effective in protecting
humans against anthrax. The report also includes a description
of advances needed in main areas: improving the way the vaccine
is now used, expanding surveillance efforts to detect side
effects from its use, and developing a better vaccine.
An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research
Program (2002). Committee to Review the CDC Anthrax Vaccine Safety and
Efficacy Research Program, Institute of Medicine.
In 1998, the Department of Defense (DOD) began a program of
mandatory immunization against anthrax for all military
personnel. As the program proceeded, however, some military
personnel and their families raised concerns about the safety
and efficacy of the anthrax vaccine. Acknowledging both the
need to protect military personnel and the concerns about the
anthrax vaccine, Congress directed the Centers for Disease
Control and Prevention (CDC) to carry out a research program on
its safety and efficacy. To assist in the development of this
program, CDC requested the Institute of Medicine to convene a
committee to review the completeness and appropriateness of the
research program. In An Assessment of the CDC Anthrax Vaccine
Safety and Efficacy Research Program, the committee makes an
overall assessment of the CDC research plan and reviews the
specific studies proposed by CDC in the three areas of
efficacy, safety and acceptability. The committee also notes
additional research needs that became evident following the
bioterrorist events of 2001 and makes recommendations about the
leadership of the research program.
Vaccines for the 21st Century: A Tool for Decisionmaking (2000).
Kathleen R. Stratton, Jane S. Durch, and Robert S. Lawrence, editors.
Vaccines have made it possible to eradicate the scourge of
smallpox, promise to do the same for polio, and have profoundly
reduced the threat posed by other diseases such as whooping
cough, measles, and meningitis. What is next? There are many
pathogens, autoimmune diseases, and cancers that may be
promising targets for vaccine research and development. This
volume provides an analytic framework and quantitative model
for evaluating disease conditions that can be applied by those
setting priorities for vaccine development over the coming
decades. The committee describes an approach for comparing
potential new vaccines based on their impact on morbidity and
mortality and on the costs of both health care and vaccine
development. The report examines: (i.) lessons to be learned
from the polio experience; (ii.) scientific advances that set
the stage for new vaccines; (iii.) factors that affect how
vaccines are used in the population; and (iv.) value judgments
and ethical questions raised by comparison of health needs and
benefits. The committee provides a way to compare different
forms of illness and set vaccine priorities without assigning a
monetary value to lives, and its recommendations will be
important to anyone involved in science policy and public
health planning: policymakers, regulators, health care
providers, vaccine manufacturers, and researchers.
Managed Care Systems and Emerging Infections: Challenges and
Opportunities for Strengthening Surveillance, Research, and
Prevention--Workshop Summary (2000). Jonathan Davis, editor.
This workshop summary examines how the managed care revolution
has created both problems and opportunities in the fight
against infectious diseases. It highlights ways in which
managed care systems can aid research, develop clinical
guidelines, manage the use of antibiotics, support public
education efforts, and monitor the spread of emerging
infections and microbial resistance.
Public Health Systems and Emerging Infections: Assessing the
Capabilities of the Public and Private Sectors--Workshop Summary
(2000). Jonathan Davis and Joshua Lederberg, editors.
With a focus on our knowledge and understanding of the role of
private and public health sectors in emerging infectious
disease surveillance and response, this workshop summary
explores the effects of the privatization of public health
laboratories and the modernization of public health care. The
issues discussed included epidemiological investigation,
surveillance, communication, coordination, resource
allocations, and economic support.
Assessment of Future Scientific Needs for Live Variola Virus (1999).
Committee on the Assessment of Future Scientific Needs for Variola
Virus, Institute of Medicine.
In 1980, the World Health Organization (WHO) officially declared
that smallpox had been eradicated. In 1986, WHO's international Ad Hoc
Committee on Orthopox Virus Infections unanimously recommended
destruction of the two remaining official stocks of variola virus, one
at the Centers for Disease Control and Prevention and the other at the
VECTOR laboratory in Siberia. In June 1999, WHO decided to delay the
destruction of these stocks. Informing that decision was Assessment of
Future Scientific Needs for Variola Virus, which examines (i.) whether
the sequenced variola genome, vaccinia, and monkey pox virus are
adequate for future research or whether the live variola virus itself
is needed to assist in the development of antiviral therapies; (ii.)
what further benefits, if any, would likely be gained through the use
of variola in research and development efforts related to agent
detection, diagnosis, prevention, and treatment; and (iii.) what unique
potential benefits, if any, the study of variola would have in
increasing our fundamental understanding of the biology, host-agent
interactions, pathogenesis, and immune mechanisms of viral diseases.
America's Vital Interest in Global Health: Protecting Our People,
Enhancing Our Economy, and Advancing Our International Interests
(1997). Board on International Health, Institute of Medicine.
This report focuses on the interest of the United States in
global health developments, arguing that this country has a
vital and direct stake in the health of people around the globe
and that this interest derives from both America's long and
enduring tradition of humanitarian concern and compelling
reasons of enlightened self-interest. For the United States to
engage successfully in global health, coordination among the
multiple U.S. agencies with statutory responsibilities in the
area is needed, as well as the formation of partnerships with
the U.S. industrial and academic sectors and nongovernmental
organizations, other nations, and international organizations.
This report stresses those areas of U.S. global health
engagement that are most likely to benefit the health of the
U.S. population and recommends changes in policy and
implementation that can enhance the health of Americans and
other peoples of the world, provide economic benefit, and
advance U.S. global leadership.
III. BIOTERRORISM AND SECURITY
Biotechnology Research in an Age of Terrorism (2004). Committee on
Research Standards and Practices to Prevent the Destructive Application
of Biotechnology, Development, Security, and Cooperation, National
Research Council.
In recent years much has happened to justify an examination of
biological research in light of national security concerns. The
destructive application of biotechnology research includes
activities such as spreading common pathogens or transforming
them into even more lethal forms. This new book by the National
Research Council recommends that the government expand existing
regulations and rely on self-governance by scientists rather
than adopt intrusive new policies. One key recommendation of
the report is that the government should not attempt to
regulate scientific publishing but should trust scientists and
journals to screen their papers for security risks, a task some
journals have already taken up. With biological information and
tools widely distributed, regulating only U.S. researchers
would have little effect. A new International Forum on
Biosecurity should encourage the adoption of similar measures
around the world. Seven types of risky studies would require
approval by the Institutional Biosafety Committees that already
oversee recombinant DNA research at some 400 U.S. institutions.
These experiments of concern include making an infectious agent
more lethal and rendering vaccines powerless.
Seeking Security: Pathogens, Open Access, and Genome Databases (2004).
Committee on Genomics Databases for Bioterrorism Threat Agents,
National Research Council.
Within the last 30 years, the genomes of thousands of organisms,
from viruses, to bacteria, to humans, have been sequenced or partially
sequenced and deposited in databases freely accessible to scientists
around the world. This information is accelerating scientists' ability
to fight disease and make other medical advances, but policymakers must
consider the possibility that the information could also be used for
destructive purposes in acts of bioterrorism or war. Based in part on
views from working biological scientists, the report concludes that
current policies that allow scientists and the public unrestricted
access to genome data on microbial pathogens should not be changed.
Because access improves our ability to fight both bioterrorism and
naturally occurring infectious diseases, security against bioterrorism
is better served by policies that facilitate, not limit, the free flow
of this information.
Giving Full Measure to Countermeasures: Addressing Problems in the DOD
Program to Develop Medical Countermeasures Against Biological Warfare
Agents (2004). Lois M. Joellenbeck, Jane S. Durch, and Leslie Z. Benet,
editors.
In recent years, substantial efforts have been initiated to
develop new drugs, vaccines, and other medical interventions
against biological agents that could be used in bioterrorist
attacks against civilian populations. According to this
Congressionally mandated report from the National Academies, to
successfully develop these drugs, vaccines, and other medical
interventions against biowarfare agents, Congress should
authorize the creation of a new agency within the Office of the
Secretary of the U.S. Department of Defense. The report
recommends that Congress should improve liability protections
for those who develop and manufacture these products in order
to stimulate willingness to invest in new research and
development for biowarfare protection. Giving Full Measure to
Countermeasures also identifies other challenges such as the
need for appropriate animal models and laboratories equipped
with high-level biosafety protections that will require
attention if DOD efforts to develop new medical countermeasures
are to be successful.
Biological Threats and Terrorism: Assessing the Science and Response
Capabilities--Workshop Summary (2002). Stacey Knobler, Adel Mahmoud,
and Leslie Pray, editors.
In the wake of the September 11th and anthrax events, our
Nation's bioterrorism response capability has become an
imminent priority for policymakers, researchers, public health
officials, academia, and the private sector. In a 3-day
workshop, convened by the Institute of Medicine's Forum on
Emerging Infections, experts from each of these communities
came together to identify, clarify, and prioritize the next
steps that need to be taken in order to prepare and strengthen
bioterrorism response capabilities. From the discussions, it
became clear that of utmost urgency is the need to cast the
issue of a response in an appropriate framework in order to
attract the attention of Congress and the public in order to
garner sufficient and sustainable support for such initiatives.
No matter how the issue is cast, numerous workshop participants
agreed that there are many gaps in the public health
infrastructure and countermeasure capabilities that must be
prioritized and addressed in order to assure a rapid and
effective response to another bioterrorist attack.
Countering Agricultural Bioterrorism (2002). Committee on Biological
Threats to Agricultural Plants and Animals, National Research Council.
Public confidence in the security of the U.S. food and fiber
system has been sustained by the quality, variety, abundance,
and affordability of agricultural products in the United
States. Although the system in place to defend against
unintentional threats to agriculture has weaknesses and needs,
the demonstrated ability of the system to resolve, accommodate,
or manage critical food safety problems, temporary shortages of
some commodities, plant and animal infestations and diseases,
and natural disasters indicates that, in general, such
confidence has been warranted. However, over the last several
years, there has been recognition of the possibility and
consequences of intentional threats directed at U.S.
agriculture. Such attacks could come from foreign or domestic
terrorists and use biological, chemical, or radiological
agents. They could be directed at the pre-harvest (live plant
and live animal) or post-harvest (processing and distribution)
stages of food and fiber production. Countering Agricultural
Bioterrorism assesses the vulnerability of U.S. agriculture to
intentional threats and provides recommendations needed to
strengthen and adapt the U.S. system for defense against
biological threats to agriculture.
Making the Nation Safer: The Role of Science and Technology in
Countering Terrorism (2002). Committee on Science and Technology for
Countering Terrorism, National Research Council.
Vulnerabilities abound in U.S. society. The openness and
efficiency of our key infrastructures transportation,
information and telecommunications systems, health systems, the
electric power grid, emergency response units, food and water
supplies, and others make them susceptible to terrorist
attacks. Making the Nation Safer discusses technical approaches
to mitigating these vulnerabilities. A broad range of topics
are covered in this report, including: (i.) nuclear and
radiological threats, such as improvised nuclear devices and
dirty bombs; (ii.) bioterrorism, medical research, agricultural
systems and public health; (iii.) toxic chemicals and explosive
materials; (iv.) information technology, such as communications
systems, data management, cyber attacks, and identification and
authentication systems; (v.) energy systems, such as the
electrical power grid and oil and natural gas systems; (vi.)
transportation systems; (vii.) cities and fixed
infrastructures, such as buildings, emergency operations
centers, and tunnels; (viii.) the response of people to
terrorism, such as how quality of life and morale of the
population can be a target of terrorists and how people respond
to terrorist attacks; and (ix.) linked infrastructures, i.e.,
the vulnerabilities that result from the interdependencies of
key systems. In each of these areas, there are recommendations
on how to immediately apply existing knowledge and technology
to make the Nation safer and on starting research and
development programs that could produce innovations that will
strengthen key systems and protect us against future threats.
The report also discusses issues affecting the government's
ability to carry out the necessary science and engineering
programs and the important role of industry, universities, and
States, counties, and cities in homeland security efforts. A
long-term commitment to homeland security is necessary to make
the Nation safer, and this book lays out a roadmap of how
science and engineering can assist in countering terrorism.
Countering Bioterrorism: The Role of Science and Technology (2002).
Committee on Science and Technology for Countering Terrorism, National
Research Council.
This publication reprints material from the above report,
Making the Nation Safer: The Role of Science and Technology in
Countering Terrorism (2002), that dealt specifically with
issues relating to bioterrorism.
Preparing for Terrorism: Tools for Evaluating the Metropolitan Medical
Response System Program (2002). Frederick J. Manning and Lewis
Goldfrank, editors.
The Metropolitan Medical Response System (MMRS) program of the
U.S. Department of Health and Human Services (DHHS) provides
funds to major U.S. cities to help them develop plans for
coping with the health and medical consequences of a terrorist
attack with chemical, biological, or radiological (CBR) agents.
DHHS asked the Institute of Medicine to assist in assessing the
effectiveness of the MMRS program by developing appropriate
evaluation methods, tools, and processes to assess both its own
management of the program and local preparedness in the cities
that have participated in the program. This report provides the
managers of the MMRS program and others concerned about local
capabilities to cope with CBR terrorism with three evaluation
tools and a three-part assessment method.
Chemical and Biological Terrorism: Research and Development to Improve
Civilian Medical Response (1999). Committee on R&D Needs for Improving
Civilian Medical Response to Chemical and Biological Terrorism
Incidents, Institute of Medicine.
What do we need to know to help emergency and medical personnel
prepare for terrorist attacks? Chemical and Biological
Terrorism identifies the R&D efforts needed to implement
recommendations in key areas: pre-incident intelligence,
detection and identification of chemical and biological agents,
protective clothing and equipment, early recognition that a
population has been covertly exposed to a pathogen, mass
casualty decontamination and triage, use of vaccines and
pharmaceuticals, and the psychological effects of terror.
Specific objectives for computer software development are also
identified. The report addresses the differences between a
biological and chemical attack, the distinct challenges to the
military and civilian medical communities, and other broader
issues.
Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian
Cooperation, A Report to the Cooperative Threat Reduction Program of
the U.S. Department of Defense (1997). U.S.-Russian Collaborative
Program for Research and Monitoring of Pathogens of Global Importance
Committee, National Research Council.
After extensive consultations with key Russian officials and
scientific leaders, and drawing on the experience gained
through the initiation of six pilot projects at two Russian
facilities to investigate the practical aspects of cooperation,
the National Academy of Sciences Committee on U.S.-Russian
Cooperation on Dangerous Pathogens has recommended a 5-year
Pathogens Initiative, followed by a second phase of sustained
joint U.S.-Russian research and related efforts. The program
would support collaboration on the epidemiology, prevention,
diagnosis, and therapy of diseases associated with dangerous
pathogens that pose serious public health threats, as well as
related fundamental research. The Pathogens Initiative would
engage a substantial number of highly qualified specialists
from the former Soviet biological weapons complex and would
serve important U.S. national security and public health goals.
Senator Burr. And as a successful way of transitioning, I
would like to turn to an area of the world that has many of the
same challenges. We talked earlier about the borderless nature
of infectious disease, and I would like to welcome Dr. Guenael
Rodier and apologize to the Doctor for butchering his name to
begin with at the start of this hearing. He is the Director of
the Department of Communicable Disease Surveillance and
Response at the World Health Organization, truly an
organization that is a partner of ours as we address the threat
that is presented with biologics in the future.
Dr. Rodier, welcome.
Dr. Rodier. Thank you very much, Mr. Chairman, and you will
have to suffer my English, actually. I hope it will go fine.
Good afternoon. I just want to thank the committee for this
opportunity to speak today on a topic which is central to the
work of the World Health Organization.
I have been working to control outbreaks of infectious
diseases my entire career, including 4 years with a U.S. Navy
research laboratory. Most of my career was spent in the field
with a focus on the control of hemorrhagic fevers in Africa and
in the Middle East. With this field experience, I was brought
into the WHO headquarters in 1995 to help develop WHO's new
response program on epidemics and emerging infections. As
Director of the Department of Communicable Disease Surveillance
and Response, I played a central role in the coordination of
WHO's global response to the SARS outbreak in 2003 and today
against the continuing threat from highly pathogenic avian
influenza.
I am speaking to you today from WHO's Strategic Health
Operations Center. We coordinate all our outbreak and emergency
responses through this room. It is a state-of-the-art
communications and command center which provides direct and
secure links to all WHO 148 country and regional offices and to
Ministries of Health and essential laboratories worldwide,
including the Department of Health and Human Services and the
U.S. Centers for Disease Prevention and Control.
This global interconnectedness is not a luxury. It is
essential. By their very nature, infectious diseases have the
potential to spread internationally, and WHO needs to be
connected to the front lines of outbreaks, to assess the risks,
to provide expert advice, and, if needed, to launch
international assistance to affected countries rapidly.
Each morning in this room, about two dozen WHO outbreak
disease control specialists gather, and this morning, for
example, we were tracing 18 outbreaks using this list. These
included the tracking of the polio virus which has spread from
Nigeria across Africa, into the Middle East, and is now trying
to establish itself in Indonesia. We also received updates from
our teams on the effort to control the largest Marburg fever
outbreak in Angola, the largest meningitis outbreak in India in
a decade, and the continuing reports of avian influenza from
North Korea to Vietnam and Cambodia.
In the last 5 years, the outbreak response group has
detected, verified, and often helped control more than 960
events in 147 countries.
These outbreaks threaten every country. We live in a world
more interconnected than ever. As this daily outbreak list
shows, the world now finds itself in a situation where
epidemics have the potential for spreading around the globe
unchecked at unprecedented speed. And mankind is increasingly
vulnerable to infectious diseases as the human population is
increasingly larger, older, urban, mobile, and, for most, has
limited access to safe drinking water and food and modern
health care.
New or newly recognized infectious agents that cause human
disease are being reported at the rate of approximately one per
year.
Microbes can incubate in apparently healthy travelers, hide
in food, animals, or cargo, or be carried by insects stowed
away in the cabin and luggage holds of jets or in the pots of
exotic plants.
As an international health agency with over 50 years of
experience in infectious disease control, the World Health
Organization is uniquely positioned to gather global disease
intelligence, assess public health risk, trigger and coordinate
the rapid, multifaceted response needed to contain outbreaks
quickly, and prevent their international spread.
The WHO staff, consultants, and expert advisers have
privileged access to all countries from Afghanistan to
Zimbabwe.
WHO has unique and permanently positioned geographical
resources. These include six regional offices and an additional
141 country offices, located within or in close proximity to
ministries of health.
WHO's disease control activities are supported by a network
of over 250 laboratories and institutions formally designated
as WHO Collaborating Centers. These centers provide the
expertise and facilities needed to conduct field
investigations, handle dangerous pathogens, test samples,
identify unknown agents, and confirm diagnosis.
Very, very few countries have all the experts needed to
fight all the dangerous and emerging diseases. But these
experts exist, working in universities and hospitals and for
departments of health. What has been needed is an effective way
to organize them so that they can be called on short notice to
join an outbreak response team. So WHO created a model similar
to the American volunteer fire department.
This ``volunteer fire department'' model works. This year,
thousands of deaths were prevented following the tsunami thanks
to this coordinated effort. Last year, meningitis outbreaks
which swept across northern Africa were controlled with massive
vaccination campaigns. And right now teams from North and South
America, from Europe, and from Africa are fighting to keep the
Marburg outbreak contained in Angola.
The U.S. Government is a precious partner for WHO in
building up global alert and response capabilities for
combating the threat posed by infectious diseases. Various U.S.
Government agencies have contributed to this effort in line
with the multifaceted nature of the threat. Most extensive is
WHO's long tradition of reliance on the practical experience,
technical expertise, and staff resources of the CDC to conduct
a range of fundamental activities needed to contain the
international spread of epidemics. This collaboration has
become even closer and more vital as the number of outbreaks
requiring an international response continues to escalate.
In addition to targeting known risks such as influenza and
responding to the unexpected like the emergence of SARS, a
third strategic direction focuses on improving preparedness by
strengthening national surveillance and response systems. WHO
conducts a number of activities aimed at helping countries
expand their laboratories and epidemiological capacity and take
advantage of new tools such as Web-based communications,
mapping software, and remote sensing data from NASA and other
satellites.
In a world that is now closely interrelated in matters of
health as well as in economics and trade, defense against the
threats posed by infectious diseases requires a collaborative,
multifaceted, global response. WHO wishes to express its
gratitude for the support provided on so many fronts by the
United States and its agencies as part of this global response.
Outbreaks can be most effectively controlled at their
origin, preemptively, when they are small and contained. If
they break out, we will be fighting them in the hospitals of
London, Paris, and Wichita.
We need to significantly strengthen countries' early
warning and response systems--to build labs, train
epidemiologists, improve communications. We need to continue to
effectively assist countries and further develop global and
regional operational platforms. This step will benefit the
global public health, as well as enhance security and provide
business with stability rather than the chaos which often
accompanies an outbreak and leads to large economic losses. It
was estimated that SARS took (U.S.) $30 billion out of the
global economy.
What will future investments in global health security buy?
Even a profound shift in resources will not stop the emergence
of new diseases. But we can guarantee, with confidence, that if
we have the tools to identify outbreaks early and the resources
to respond quickly, we can limit the impact of these epidemics.
That means fewer lives lost and less harm to economies. This is
the spirit of the proposal for the revised International Health
Regulations which should provide the global community with
collectively agreed ground rules to prevent and respond to
public health emergencies of international concern.
I am happy to take your questions. Thank you very much.
Senator Burr. Dr. Rodier, thank you very much, and I
realize that it is probably after 9:00 p.m. at night where you
are. I can't thank you enough for your willingness to
participate in this, and if you can stay with us for the next
20 to 30 minutes as we finish the rest of the testimony, I hope
you will make yourself available for some questions from
members of the Senate.
[The prepared statement of Dr. Rodier follows:]
Prepared Statement of Guenael R. Rodier, M.D.
Introduction
Good afternoon, I want to thank the members of the committee for
this opportunity to speak today on a topic which is central to the work
of the World Health Organization.
I have been working to control outbreaks of infectious diseases my
entire career, including 4 years with a U.S. Navy research laboratory.
Most of my career was spent in the field with a focus on the control of
hemorrhagic fevers in Africa and the Middle East. With this field
experience, I was brought into WHO headquarters in 1995 to help develop
WHO's new response programme on epidemics and emerging infections. As
Director of the Department of Communicable Disease Surveillance and
Response, I played a central role in the coordination of WHO's global
response to the SARS outbreak in 2003 and today against the continuing
threat from highly pathogenic avian influenza.
Strategic Health Operation Center
I am speaking to you today from WHO's Strategic Health Operations
Center. We coordinate all our outbreak and emergency responses through
this room. It is a state-of-the-art communications and command center
which provides direct and secure links to all WHO 148 country and
regional offices, and to Ministries of Health and essential
laboratories worldwide, including the Department of Health and Human
Services, and the U.S. Centers for Disease Prevention and Control.
This global interconnectedness is not a luxury. It is essential. By
their very nature, infectious diseases have the potential to spread
internationally and WHO needs to be connected to the front lines of
outbreaks, to assess the risks, to provide expert advice and, if
needed, to launch international assistance to affected countries
rapidly.
Trends in emerging and re-emerging infectious disease raise the
spectre of highly virulent and communicable pathogens, some of them
resistant to existing medical countermeasures, arriving anywhere in the
world in 24 hours. The risk of deliberate introduction of infectious
diseases such as the anthrax attacks in the United States in 2001--or
as has happened recently, the accidental wide laboratory distribution
of a potentially dangerous flu strain--adds a new dimension to the
challenge of naturally occurring outbreaks and demonstrates the
potential for very serious global health implications of natural,
accidental and deliberate events.
Each morning in this room, about two dozen WHO outbreak disease
control specialists gather for a daily update on global health threats.
This morning, for example, we were tracing 18 outbreaks. These included
the tracking of the polio virus [SLIDE 1 spread of polio virus] which
has spread from Nigeria, across Africa, into the Middle East, and is
now trying to establish itself in Indonesia. We also received updates
from our teams on the effort to control the Marburg hemorrhagic fever
outbreak in Angola; the largest meningitis outbreak in India in a
decade, and the continuing reports of avian influenza from North Korea
to Viet Nam and Cambodia.
In the last 5 years, the outbreak response group has detected,
verified, and often helped control more than 960 events, in 147
countries.
As you can see, the microbial world is complex, dynamic, and
constantly evolving. Microbes proliferate rapidly, mutate frequently,
and adapt with relative ease to new environments and hosts. They will
also eventually develop resistance to the drugs used to treat them.
Numerous factors, including those linked to human activities, can
accelerate and amplify these natural phenomena, as has happened in
recent years. Complacency towards public health practices has proven to
only hasten opportunities for microbes to spread, adapt, and resist.
This was well highlighted by the 1992 and 2003 reports on emerging
infections and microbial threats to health of the Institute of
Medicine.
The combination of natural, accidental or deliberate occurrence of
infectious diseases demands the establishment or strengthening of
national and local capacities to contain these incidents.
Vulnerability
These outbreaks threaten every country. We live in a world more
interconnected than ever. As this daily outbreak list shows, the world
now finds itself in a situation where epidemics have the potential for
spreading around the globe unchecked at unprecedented speed. And
mankind is increasingly vulnerable to infectious diseases as the human
population is increasingly larger, older, urban, mobile and, for
billions, particularly in developing countries, has limited access to
safe drinking water and food, sanitation, and modern health care.
New or newly recognized infectious agents that cause human disease
are being reported at the rate of approximately one per year. AIDS
emerged as an important infectious disease in the early 1980s and is
now entrenched on a scale that threatens global security. Other
emerging diseases, such as Marburg virus and Severe Adult Respiratory
(SARs) disease, illustrate the severe damage caused by lethal new
agents that cannot currently be curbed by vaccines or drugs. The
continued occurrence of human cases of avian influenza in Asia
highlights the potential for the emergence of a new pandemic of a
highly virulent virus that could meet or exceed the estimated 20
million deaths during the deadly Spanish Flu of 1918. Altogether, over
30 new infectious diseases have emerged over the past 25 years.
Microbes can incubate in apparently healthy travellers, hide in
food, animals, or cargo, or be carried by insects stowed away in the
cabin and luggage holds of jets or in the pots of exotic plants. In the
UK alone, 1,128 cases of malaria were imported into the country by
travellers in 2000. Cases of ``airport malaria,'' in persons who live
or work near international airports yet have not travelled, are
detected regularly in cities such as London, Paris, Brussels, Geneva,
and Oslo as well as in the United States and Canada. In just the past 2
years, unexpected outbreaks of relatively new or previously rare
diseases have taken populations on every continent by surprise.
Legionellosis and leptospirosis in Australia, Lassa fever, yellow
fever, hantavirus, listeriosis, and new variant CJD (human cases of
``mad cow'' disease'') in Europe, and yellow fever, West Nile fever,
monkeypox, cryptococcosis, and E. coli O157 in the United States are
just some examples. In the face of such highly mobile, microscopic, and
easily disguised threats, national borders are porous. An outbreak
anywhere in the world must now be considered a threat everywhere else.
Global Health Security
As an international health agency with over 50 years of experience
in infectious disease control, the World Health Organization is
uniquely positioned to gather global disease intelligence, assess
public health risk, trigger and coordinate the rapid, multifaceted
response needed to contain outbreaks quickly, and prevent their
international spread.
During the course of 2004, the WHO's system for verification of
public health emergencies of international concern identified 385
events with potential importance for international public health
concern. Of the 385 events, 293 were verified, 24 were unverifiable, 42
were defined as ``no outbreak verified'' and 26 were tracked by WHO for
information only.
WHO staff, consultants, and expert advisers have privileged access
to all 192 of its member States, which include countries from
Afghanistan to Zimbabwe. WHO's technical expertise and long standing
relationship with countries allows the Organization, in the interest of
safeguarding international health, to transcend the prevailing
political sensitivities in which access to critical expertise might be
denied because of one country's political relationship with others. On
many occasions, the Organization's ability to secure laissez-passer
visas has proved decisive in getting the best experts quickly and
smoothly into countries. This ability to obtain privileged status is
extended to all of the many security-cleared partners who may be needed
to mount an effective international response.
WHO has unique and permanently positioned geographical resources.
These include six regional offices and an additional 141 country
offices, located within or in close proximity to ministries of health.
All WHO offices are staffed with medical experts and often with
epidemiologists, and all have the essential logistic equipment,
including vehicles and local communications, needed for the prompt on-
the-scene initial investigation of a suspected outbreak.
WHO's disease control activities are supported by a network of over
250 laboratories and institutions formally designated as WHO
Collaborating Centres. These centers provide the expertise and
facilities needed to conduct field investigations, handle dangerous
pathogens, test samples, identify unknown agents, and confirm
diagnosis.
WHO coordinates a large number of electronic surveillance systems
and databases for keeping experts alert to changes in the volatile
infectious disease situation. These networks, most of which now operate
in real time, keep watch over disease-related events ranging from new
strains of influenza virus, through outbreaks of salmonellosis and
dengue, to the emergence of drug-resistant pathogens. Most of these
networks also include quality assurance and training components to
ensure that data submitted from all parts of the world are comparable
and conform to established standards. The oldest of these, FluNet, was
established over 50 years ago and has served as the prototype for the
design and implementation of subsequent systems.
WHO has decades of experience in coordinating the field operations
needed to control infectious diseases. Current campaigns build on the
epidemiological approaches and logistic infrastructure that contributed
to the successful global eradication of smallpox. These mechanisms,
which have been refined over time, have proven to be robust and
effective even under difficult conditions. The successful containment
of the largest recorded outbreak of Ebola, which began in Uganda in
October 2000, was coordinated by WHO and involved over 500 local staff
and volunteers, supported by some 120 international staff from 22
institutions and agencies, including CDC. WHO coordinated the
considerable efforts and logistics needed for the identification and
confirmation of 425 cases and the surveillance of approximately 5,600
contacts in an area in which 70 percent of the population was
internally displaced because of civil disturbances.
Very, very few countries have all the experts needed to fight all
the dangerous and emerging diseases. But these experts exist all over
the world, working in universities and hospitals and for Departments of
Health. What has been needed is an effective way to organize them, so
that they can be called on short notice to join an outbreak response
team. So WHO created a model similar to the American volunteer fire
department. This model is known as GOARN, the Global Outbreak Alert and
Response Network [SLIDE 2: GOARN institutions]. GOARN coordinates
outbreak assistance found in 120 international technical institutions,
NGOs and networks for global alert and response operations. Within 24
hours, GOARN teams can be assembled and launched to any outbreak site
in the world.
The annual budget for operating this WHO-run global volunteer fire
department is only $8 million. This is about half the money spent on
the fire departments of Wake County, North Carolina.
This ``volunteer fire department'' model works. This year,
thousands of deaths were prevented following the tsunami thanks to this
coordinated effort. Last year, meningitis outbreaks which swept across
northern Africa were controlled with massive vaccination campaigns. And
right now, [SLIDE 3: Marburg outbreak in Angola] teams from North and
South America, from Europe and from Africa are fighting to keep the
Marburg hemorrhagic fever outbreak contained in Angola.
WHO country offices, Regional Offices and headquarters have been
directly involved in responding to outbreaks. International epidemic
control and field operations have been coordinated with GOARN. During
2004, WHO and technical partners in GOARN responded to outbreaks in
Bangladesh, Burkina Faso, Cambodia, Chad, Central African Republic
(CAR), People's Republic of China, Democratic Republic of Congo (DRC),
Indonesia, Laos, Liberia, Sudan, Sierra Leone, Thailand, and Viet Nam.
This represents the major communicable disease outbreak responses but
does not reflect all of the response operations of WHO country offices
to many other events and emergencies.
The work of coordinating large-scale international assistance,
which can involve many agencies from many nations, is facilitated by
operational protocols, developed by WHO, which set out standardized
procedures for the alert and verification process, communications,
coordination of the response, emergency evacuation, research,
evaluation, monitoring, and relations with the media. WHO has also
issued guidelines for the behavior of foreign nationals during and
after field operations in the host country. By setting out a chain of
command, and imposing order on the containment response, such protocols
help protect against the very real risk that samples of a lethal
pathogen might be collected for later provision to a terrorist group.
SARS has disappeared thanks to this coordinated volunteer
firefighting approach combined with increasing capacity for real-time
telecommunications. I might point out that one of the most unusual
accomplishments of that outbreak included the building of a virtual lab
in response to the health emergency--a lab which was composed of a
dozen labs knitted together from around the world. Working around the
clock, and sharing information without restriction, this lab group was
able to identify the cause of SARS within 5 weeks. It took 3 years to
identify the virus which caused AIDS.
U.S. Involvement
The U.S. Government is a precious partner for WHO in building up
global alert and response capabilities for combating the threat posed
by infectious diseases. Various U.S. government agencies have
contributed to this effort, in line with the multifaceted nature of the
threat. Most extensive is WHO's long tradition of reliance on the
practical experience, technical expertise, and staff resources of the
CDC to conduct a range of fundamental activities needed to contain the
international spread of epidemics. This collaboration has become even
closer and more vital as the number of outbreaks requiring an
international response continues to escalate. At times, such as during
the simultaneous outbreaks of Ebola and Rift Valley fever in 2000, the
resources of both agencies have been stretched to the limit. As with
the strengthening of national capacities and infrastructure elsewhere,
any U.S. decision to strengthen CDC benefits WHO as well as a large
number of countries where populations and governments have been
weakened by repeated outbreaks and epidemics. Any decision to
strengthen CDC would likewise count as a sure, sustainable, and cost-
effective measure for defending world security against the mounting
threat of infectious diseases. The United States has been a critical
partner in controlling outbreaks around the world. Representations from
the U.S. Centers for Disease Prevention and Control have worked with
WHO on all continents fighting a long list of diseases. In addition to
the CDC, WHO has drawn on the expertise of the National Institutes of
health and the DOD Global Emerging Infection Surveillance and Response
System (GEIS). These experts have worked shoulder to shoulder with
experts from Japan, Australia, the EU, South Africa, China and
elsewhere. U.S. support made possible the creation of the Strategic
Health Operations Center at WHO headquarters.
Strategy
In addition to addressing known risks such as influenza and
responding to the unexpected like the emergence of SARS through the
volunteer fire department approach, a third strategic focus for WHO is
improving preparedness by strengthening national surveillance and
response systems. Global health security depends on strengthening
capacities everywhere for early local alert and response, but
especially in resource-poor settings where current capacities are poor
or non-existent. Such poverty often is associated with increased risk
for disease outbreaks and, conversely, improving local capabilities in
such places contributes to making the whole world safer. WHO conducts a
number of activities aimed at helping countries expand their laboratory
and epidemiological capacity and take advantage of new tools such as
Web-based communications, mapping software and remote sensing data from
NASA and other satellites. In collaboration with CDC, WHO formed the
Training Programmes in Epidemiology and Public Health Interventions
network (TEPHINET), another global network utilized by the Global
Outbreak Alert and Response Network, which seeks, through shared
resources and expertise, to enhance the effectiveness of national
training programs. In 2001, WHO opened a new office in Lyon, France, to
provide specific assistance to countries in developing national plans
for strengthening their alert and response systems and improving
biosafety and biosecurity, including training of senior managers and
implementing quality assurance programs.
Within the context of its outbreak alert and response activities,
WHO has developed protocols for containing outbreaks of diseases, such
as anthrax and viral haemorrhagic fevers, which could result from the
intentional use of biological agents. As part of its official mandate
for dealing with smallpox-related issues in the post-eradication era,
WHO is also responsible for ensuring the security of the remaining
stocks of smallpox virus and overseeing their final fate.
What is Needed?
The resurgence of infectious diseases, and the emergence and spread
of antimicrobial resistance, have unleashed threats whose magnitude is
almost certain to grow. Epidemics are again sweeping across continents.
The tools needed to control emerging diseases are, in many cases, non-
existent. The control of re-emerging and epidemic-prone diseases
likewise suffers from the spread of resistance to inexpensive first-
choice drugs. Nonetheless, today's information society is better
equipped to protect itself, through effective networking, early
detection and proactive preventive measures, than in the past, when
isolation and quarantine comprised the sole measures for control. Aided
by powerful electronic communication tools and rapid access to modern
biotechnology, key defense strategies now include early alert, through
sensitive global networks for real-time outbreak detection and
verification, and rapid national and international responses once
outbreaks are confirmed. The strengthening of infrastructure in
epidemic-prone countries is vital to the successful and cost-effective
implementation of both strategies.
In a world that is now closely interrelated in matters of health as
well as in economics and trade, defense against the threats posed by
infectious diseases requires a collaborative, multifaceted, global
response. WHO wishes to express its gratitude for the support provided
on so many fronts by the United States and its agencies as part of this
global response. WHO also wishes to express its strong desire to stay
in close dialogue with the United States as we continue to track the
evolving infectious disease situation, sound the alarm when needed,
share expertise, and mount the kind of tailored responses needed to
protect us all from the health consequences of epidemics, whatever and
wherever their origin might be.
Outbreaks can be most effectively controlled at their origin,
preemptively, when they are small and contained [SLIDE 4: Verified
outbreaks, 2003-04]. While not all outbreaks can be anticipated and
prevented, our goal in WHO is to keep outbreaks from turning into
epidemics, and to keep epidemics from becoming pandemics, through
preparedness, rapid alert and coordinated global response. If outbreaks
can be contained locally, we will not have to fight them in the
hospitals of London, Boston and Raleigh.
We need to significantly strengthen countries' early warning and
response systems--to build labs, train epidemiologists, improve
communications. We need to continue to effectively assist countries and
further develop global and regional operational platforms. This step
will benefit the health of citizens of all countries, as well as
enhance timely public health response to security threats. More
economic security and stability for business is also a benefit of
avoiding the chaos which often accompanies an epidemic and can lead to
large economic losses. It was estimated that SARS took (U.S.) $30
billion out of the global economy.
What will future investments in global health security buy? Even a
profound shift in resources will not stop the emergence of new
diseases. But we can guarantee, with confidence--that if we have the
tools to identify outbreaks early and the resources to respond
quickly--that we can limit the impact of these epidemics. That means
fewer lives lost and less harm to economies. This is the spirit of the
proposal for the revised International Health Regulations which should
provide the global community with collectively agreed ground rules to
prevent and respond to public health emergencies of international
concern.
Thank you. I am happy to take your questions.
Senator Burr. At this time, let me recognize Dr. Craig
Venter. Craig, welcome, and please take the floor.
Mr. Venter. Thank you, Mr. Chairman, Senator Hatch. I
appreciate very much the opportunity to be here today to
testify before your subcommittee. This is a very key area that
affects all of us going forward.
I am here as a scientist, a basic research scientist that
works in the field of genomics. My teams over the last decade
have decoded many of the key pathogen genomes, starting with
smallpox 10 years ago during the first genome for a free-living
organism. I have been going on to do tuberculosis, malaria,
anthrax, and many other organisms that are commonly discussed
in this field. This cumulated with the human genome in the year
2000.
It is clear from the previous testimony that the threat of
emerging infections and the threat of deliberately introduced
agents is real, and like the previous speakers, I do not make a
distinction between them because we need the same
countermeasures for either one.
We have two major areas of problem. One is detection. Right
now, we use the human population as our canaries. That is how
we know there is a new infection, a new outbreak somewhere. We
are not using the modern tools of science where we can now,
instead of taking a decade to sequence a genome, we can do it
in two hours. So instead of tracking emerging viruses in the
field, which we are trying to train groups in Southeast Asia to
do at the current time, where we could try and predict things
in advance, we are waiting until they occur. That needs to
change and we need new support for the science to drive that
area. If we are trying to predict what the outbreaks are going
to be, it is virtually impossible.
We have seen from some of the materials included with this
hearing, the interview with Mr. Popov, that as early as 1976 in
the former Soviet Union, they tried to use synthetic genes as a
means of producing new biological warfare agents. The field of
synthetic biology and synthetic genomics is now rapidly
maturing and this has been viewed as the new latest risk in
this area. The technology now exists in multiple laboratories,
including several commercial companies, to synthesize genes in
virtually any existing viral genome.
But the threat does not exist to design new organisms from
scratch. We understand so few of the basic principles of
biology. We don't know, for example, why the 1918 pandemic
influenza virus is so lethal. We can't tell that from looking
at the sequence. So we do not have the knowledge in this field
yet, nor is it a threat for somebody to go make a new
hypothetical organism that we don't know the consequences of.
That will be possible in coming decades.
The only solution is for the counter-events having
vaccines, having broad-spectrum antibiotics and broad-spectrum
antivirals that work against a whole set of organisms. That
looks like it is possible. It looks like it is possible in
cancer. It looks like it is possible in antivirals, in
antibacterials. The pharmaceutical and biotech industries
aren't currently incented to work in this area. Major
pharmaceutical companies are shutting down their programs and
not increasing their research in this area. I think this
committee, this Congress, can have a major role in providing
the proper incentives for moving forward.
With that, I would be happy to take further questions.
Thank you.
Senator Burr. Thank you, Dr. Venter.
[The prepared statement of Mr. Venter follows:]
Prepared Statement of J. Craig Venter, Ph.D.
Mr. Chairman and subcommittee members, I welcome the opportunity to
testify today before you. I would like to present my observations about
the nature of the threat of bioterrorism over the coming decades and to
present my views and recommendations regarding the state of the science
in biotechnology, particularly genomics, which could be ``dual use.''
As with many new technologies, these areas of science can be useful in
preventing or alleviating the threat of bioterrorism or can contribute
to increasing the risk. I will also address the need for improvements
in the system of detection and treatment of emerging infectious
disease, which in my opinion is a much greater threat than is a
bioterrorist attack. It is my firm belief that investment in basic
science research is one of the most effective ways to ensure that our
country is adequately protected against the potential threat of either
an emerging infectious disease or a bioterrorism agent.
My name is J. Craig Venter, and I am the Founder and President of
the Venter Institute and Founder and Chairman of The Institute for
Genomic Research (TIGR), both affiliated nonprofit basic research
institutes located in Rockville, Maryland, that are devoted to pursuing
and supporting genomic research and its impact on society. They are
described in the Appendix to my testimony. The genomics research
underway at both of these Institutes is helping us better understand
the potential of biothreats that we face today, and more importantly,
improve tomorrow's biodefenses. In fact, our DNA sequencing center is a
designated Federal emergency response center to aid in dealing with a
bioterrorism event.
Our Nation needs to prepare for two kinds of bioterrorism threats:
those that we know are within the technological capabilities of
bioterrorists today and the new but largely unknown threats that will
be added a decade or two in the future. Add to this the greater threat
from emerging infectious diseases and you can see the importance of
ensuring that our current defense needs do not distract us from
adequately preparing for what may become an even greater challenge in
the future.
It is virtually impossible for anyone to accurately predict the
nature, or precise disease agents, of an infectious outbreak next year
or decades away. Thus, I am among those who firmly believe that the
best way to protect ourselves from both the manmade and natural disease
agents is to advance cutting edge fields of basic biological research.
The Landscape of the Science of Genomics
In the last decade, since my team sequenced and published the first
complete genome of a living organism, the field of genomics has changed
dramatically. The basic science advances in genomics have begun to
shape and change the overall landscape of science and medicine. To date
about 260 organisms' genomes, including most major human pathogens and
the human genome \1\ have been sequenced. Innovations in the enabling
technologies of genomics--high-throughput DNA sequencing, high-
performance computing, DNA microarray technology, and bioinformatics--
are allowing this science to grow exponentially. Our ability to
sequence and analyze all the genetic components of an organism helps us
to better understand how an organism functions at its most basic level.
This provides a platform from which to launch solutions to a plethora
of problems such as better healthcare, improved treatments for disease,
improved agricultural yields, cleaner and more efficient energy
production, and environmental monitoring and remediation.
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\1\ Venter JC, Adams MD, Myers EW, Li PW, Mural RJ, Sutton GG,
Smith HO et al., 2001. The Sequence of the Human Genome. Science 291:
1304-1351.
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The output of genomics has been vast stores of biological data.
Most pharmaceutical and biotechnology companies are utilizing these
data to design new therapeutics to treat many of our most feared
diseases such as infectious disease and cancer, as well as developing
more advanced and sensitive diagnostics.
The National Institute for Allergy and Infectious Disease (NIAID),
an institute of the National Institutes of Health (NIH), is a world
leader in the use of genomics approaches to understand and treat
infectious disease. The Department of Energy, Office of Science, has
long valued genomics for its potential for bioremediation and energy
production. Both have been embracing this area of science and are
driving more research both in academia and in the commercial sector
through funding of important grants and contracts.
Yet, we have much to learn. We are just beginning to be able to
interpret the genetic code. We do not have a clear understanding at the
genetic level of what makes most pathogens dangerous and why. Though
technology exists for duplicating some existing pathogens, the ability
to ``design'' a wholly new pathogen is likely decades away.
We clearly need to learn how to harness the potential of basic
science of genomics to help ensure that our Nation and the world is
protected against new infectious agent threats.
Venter Institute and TIGR
In 1992, the year I founded TIGR, the Secretary of Health asked us
to sequence the smallpox genome, in collaboration with the CDC, as part
of a bilateral treaty agreement with the Soviet Union. This was
supposed to be done as a prelude to destruction of all stocks of the
virus.\2\ In 1995 my team at TIGR decoded the first genome of a living
organism, the bacterium pathogen, Haemophilus influenzae.\3\ The novel
technique that we developed to sequence this genome, called ``whole
genome shotgun sequencing,'' opened the door to rapid, accurate, and
cost-effective genome sequencing and is now the technique used by all
major centers to sequence genomes. TIGR has now sequenced more than 40
genomes including many of the major human pathogens that are of concern
as potential use as agents of terror. These include smallpox, anthrax,
tuberculosis, cholera, listeria, two strains of malaria, syphilis, and
various respiratory infectious agents.
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\2\ Massung RF, Liu LI, Qi J, Knight JC, Yuran TE, Kerlavage AR,
Parsons JM, Venter JC, Esposito JJ. 1994. Analysis of the Complete
Genome of Smallpox Variola Major Virus Strain Bangladesh-1975. Virology
201: 215-240.
\3\ Fleischmann RD, Adams MD, White O, Clayton RA, Kirkness EF,
Kerlavage AR, Bult CJ, Tomb J-F, Dougherty BA, Merrick JM, McKenney K,
Sutton G, FitzHugh W, Fields C, Gocyne JD, Scott J, Shirley R, Liu L-I,
Glodek A, Kelley JM, Weidman JF, Phillips CA, Spriggs T, Hedblom E,
Cotton MD, Utterback TR, Hanna MC, Nguyen DT, Saudek DM, Brandon RC,
Fine LD, Fritchman JL, Fuhrmann JL, Geoghagen NSM, Gnehm CL, McDonald
LA, Small KV, Fraser CM, Smith HO, Venter JC. 1995. Whole-Genome Random
Sequencing and Assembly of Haemophilus Influenzae Rd. Science 269: 496-
498; 507-512.
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NIAID has been a key supporter of genomics research at TIGR for
more than a decade. NIAID, working with the FBI and other agencies, has
funded TIGR to sequence multiple strains of the anthrax bacterium, with
the goal being the development of a microbial forensics database that
will hopefully provide new insights into the source of the anthrax
mailings that occurred in the fall 2001. NIAID has also funded, through
monies appropriated by Congress as part of NIAID's Biodefense Research
Agenda, a multi-million dollar Pathogen Functional Genomics Resource
Center at TIGR that is providing genomic reagents, laboratory services,
and training to the Nation's infectious disease researchers. As part of
this grant, TIGR has developed a database called Pathema that will
house functional genome data pertaining to pathogenicity of organisms
that are listed on the NIAID category A-C system. This is the kind of
important research that the government, through its agencies like
NIAID, has been wise to fund and needs to continue to allocate monies
to do more.
At the Venter Institute, I lead a team of about 185 scientists and
staff who are undertaking research into several aspects of genomics--
synthetic genomics, biological energy, environmental genomics, and
human genomic medicine. As well, we operate one of the world's largest
DNA sequencing centers. We also have a policy group that is focused on
exploring the ethical and social implications of the research that we,
and others in this dynamic field, are conducting. I will discuss
further those aspects of our work that have direct implications for
potential use in the detection and prevention of a bioterrorist event.
Synthetic Genomics
Synthetic genomics comprises a constellation of emerging
technologies that allow for the construction, from chemical precursors,
of any specified sequence of DNA. It offers the potential of
spectacular benefits (vaccines, drugs, efficient manufacture of
biobased compounds); at the same time one must also be aware of the
possibility of a bioterrorist using this technology to synthesize a
pathogen. The number of pathogens that can be synthesized today is
small and limited to those with sequenced genomes. And for many of
these the DNA is not infective on its own and poses little actual
threat. Our concern is what the technology might enable decades from
now. I will talk about how we are addressing this concern later in my
testimony.
Synthetic genomics is part of a larger set of approaches commonly
referred to as ``synthetic biology,'' itself a part of the overarching
field of biotechnology. Synthetic biology encompasses the design and
construction of both systems that already exist in nature, and those
that do not. While a new field, it is rapidly growing and already a
large meeting of its practitioners has been held.\4\ Several
universities have synthetic biology departments and/or major efforts in
synthetic genomics in other divisions. The Massachusetts Institute of
Technology offers a course for undergraduates in which students use
standard synthetic biology techniques to fabricate a variety of
engineered biological systems.
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\4\ Synthetic Biology 1.0: The First International Meeting on
Synthetic Biology. June 10-12 2004, Massachusetts Institute of
Technology. http://web.mit.edu/synbio/release/conference/.
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Coupled with this increasing interest in the ideas and techniques
of synthetic biology, a number of academic laboratories and companies
have been working on improving specific aspects of synthetic biology
approaches, including synthetic genomics. Dr. George Church's group at
Harvard is perfecting a chip-based approach that could rapidly speed
DNA synthesis and lower the cost of gene synthesis to about a penny per
base pair of DNA.\5\ Further developments are coming rapidly from
companies. Kosan Biosciences in Hayward, California, recently reported
the full-length, accurate synthesis of a multi-gene cluster about
32,000 base pairs in length.\6\ Blue Heron Technologies of Bothell,
Washington, for example can quickly provide its clients with DNA of
thousands of base-pairs in length for around $2 per base-pair.
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\5\ Tian J, Gong H, Sheng N, Zhou X, Gulari E, Gao X, Church G.
2004. Accurate Multiplex Gene Synthesis From Programmable DNA
Microchips. Nature 432: 1050-1054.
\6\ Kodumal SJ, Patel KG, Reid R, Menzella HG, Welch M, Santi DV.
2004. Total Synthesis of Long DNA Sequences: Synthesis of a Contiguous
32-kb Polyketide Synthase Gene Cluster. Proc Natl Acad Sci USA 101:
15573-15578.
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Our synthetic genomics group was founded based on work conducted at
TIGR several years ago called ``the minimal genome project.'' We
sequenced the organism Mycoplasma genitalium, which at the time was the
smallest living organism to be sequenced. Our data showed that
Mycoplasma's essential gene set was between 265-350 genes.\7\ Because
of these characteristics M. genitalium is often used as a model of a
minimal cell. Through this work we began to imagine that we could
uncover much information about the basic functions of life, and that we
could contemplate construction of a synthetic genome based on first
principles of biology. To demonstrate that one fully understands the
properties of a chemical or biochemical entity, one must be able to
synthesize it.
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\7\ Hutchison CA, Peterson SN, Gill SR, Cline RT, White O, Fraser
CM, Smith HO, Venter JC. 1999. Global Transposon Mutagenesis and a
Minimal Mycoplasma Genome. Science 286: 2165-2169.
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Synthetic genomics work in my institute began in 2003 under the
direct guidance of Hamilton Smith, M.D., a Nobel laureate who has
unique expertise in DNA research. Our team set out to synthesize a
bacteriophage (a virus that attacks bacteria) called PhiX 174. With
funding from the Department of Energy, Office of Science, and using
newly devised methods, the group improved the speed and accuracy of
genomic synthesis by assembling the 5,386 base pair PhiX 174. DOE was
interested in this research because if we could construct an entire
genome synthetically, we could contemplate valuable applications of
such work including more efficient and cleaner energy sources like
biologically produced hydrogen and ethanol, and better ways to produce
textiles, chemicals and pharmaceuticals.
The PhiX synthesis was done from short, single strands of
synthetically produced, commercially available DNA (known as
oligonucleotides or ``oligos'') using an adaptation of polymerase chain
reaction (PCR), known as polymerase cycle assembly (PCA), to build the
PhiX 174 genome. Our team produced the synthetic PhiX in just 14 days
and published these results in the Proceedings of the National Academy
of Sciences (PNAS).\8\ We are continuing to make advances on this work
in the following areas: faster and more efficient means of synthesizing
DNA, joining together longer pieces of DNA, and correcting errors in
the synthetic DNA pieces to enable larger molecules to be synthesized.
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\8\ Smith HO, Hutchison CA, Pfannkoch C, Venter JC. 2003.
Generating a Synthetic Genome by Whole Genome Assembly: phiX174
Bacteriophage from Synthetic Oligonucleotides. Proc Natl Acad Sci USA
100: 15440-15445.
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Building on this work, we envision a day when we could build
``cassettes'' of desired genetic components with their associated
function that could then be programmed to execute the particular
industrial processes needed. A specific rationale for building and
using a minimal genome versus genetic modification of existing species
is to control the cells from continued self-evolution and to prevent
cell survival outside of the laboratory or industrial setting. One
application for synthetic genomics that we are pursuing is in the area
of renewable energy. For example, some organisms produce hydrogen as
part of photosynthesis. If these biochemical pathways could be
harnessed and these hydrogen-producing functions optimized, I can
envision bioreactors that could generate clean hydrogen fuel from
sunlight and water.
Environmental Genomics
Another area of research at my institute pertains to using genomics
for understanding the environment. The high-quality mathematical
algorithms that my teams have developed to assemble genomes makes it
possible to ascertain what organisms are represented by the random
sequence samples taken from various environments. Using our algorithms
and high-performance computing, we are able to classify organisms by
their unique DNA and gene structures.\9\ We are characterizing ocean
and soil environments as part of our Sorcerer II Ocean Research
Expedition, which is funded through the DOE, Office of Science; Gordon
and Betty Moore Foundation; and the Venter Foundation. We are just
beginning to characterize air samples in a newly announced project we
are conducting with funding from the Alfred P. Sloan Foundation. Since
we know so little about these environments at the microscopic level,
this research is allowing us to take a baseline measurement of the
organisms in each environment and then going forward to monitor the
changes occurring and what that means for the ecological balance of
life. With the air genome project we are sampling air inside and
outside a building in midtown Manhattan in New York City. We have
modified the protocols we developed to filter seawater as part of the
Sorcerer II Expedition to capture the bacteria, viruses, and fungi
suspended in air. We then ship our samples back to our high-throughput
DNA sequencing center and sequence the DNA from the organisms we have
captured. The sophistication of our bioinformatics programs and the
expertise of our scientists who analyze these data allow us to organize
the seemingly random DNA into various classes of organisms. This work
has broad implications for science, and for helping to design monitors
to detect the release of any deadly organisms. It is very difficult to
figure out how to find a needle in a haystack if you do not know of
what the haystack is made.
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\9\ Venter JC, Remington K, Heidelberg JF, Halpern AL, Rusch D,
Eisen JA, Wu D, Paulsen I, Nelson KE, Nelson W, Fouts DE, Levy S, Knap
AH, Lomas MW, Nealson K, White O, Peterson J, Hoffman J, Parsons R,
Baden-Tillson H, Pfannkoch C, Rogers Y-H, Smith HO. 2004. Environmental
Genome Shotgun Sequencing of the Sargasso Sea. Science 304: 66-74.
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Human Genomic Medicine
As I stated earlier, I believe that we face a greater threat from
emerging infectious disease than from a bioterrorist attack. Genomics
is a key part of the solution. We are talking with countries in
Southeast Asia about sequencing strains of avian influenza (bird flu)
isolated from poultry and wildlife. The concern is that these strains
may spread from birds to animals and then to humans, possibly resulting
in a pandemic. Genomics offers the ability to track how these strains
are changing through time in nature, from the random genome
recombination events that shuffle viral genomes to create new versions.
Some of these new versions can be highly lethal to humans, such as the
1918 flu pandemic virus. The techniques of synthetic genomics may
eventually help us rapidly construct new vaccines to counter such
threats.
Moving Forward With Synthetic Genomics: Ethical Considerations
Synthetic genomics is an area of science that holds both great
promise for advances and improvement of human life, as well as
presenting areas for debate and potential concern. I have always firmly
believed that as scientists we have an obligation not only to
passionately pursue the research, but also to pursue and contemplate
with equal zeal the ethical and societal implications of our work. This
self-policing nature of scientific research has with few exceptions
worked well in maintaining the highest ethical standards. It is for
this reason that I insisted on an ethical review of our idea to
synthesize a minimal genome prior to its inception in the laboratory.
We commissioned a team of bioethicists from the University of
Pennsylvania Center for Bioethics who then convened various religious
and scientific leaders to review our proposed work. They published
their review and recommendations about the work in the same issue of
the scientific journal where we published background results on, and
proposed the concept of synthesizing, a minimal genome. The committee
recommended that our work proceed, but with caution and with an eye to
societal implications, particularly the bioterrorism implications,
along the road toward progress.\10\
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\10\ Cho MK, Magnus D, Caplan AL, McGee D, and the Ethics of
Genomics Group. 1999. Ethical Considerations in Synthesizing a Minimal
Genome. Science 286: 2087-2090.
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We have continued to pay particular attention to the societal
implications as our work has progressed. For example, we took great
care in selecting which organisms we would use in our synthetic
genomics work. Rather than selecting a human pathogen, as other
scientists have done in work with poliovirus,\11\ we chose to work with
PhiX, a bacteriophage that is harmless to humans. In our synthetic
genome efforts we are working to ensure that any synthetic organism
cannot live outside the confines of the laboratory environment. This is
relatively easy to ensure through genomics and has been employed in
many cases, including with the basic workhorse of molecular biology,
E.coli, for decades.
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\11\ Cello J, Paul AV, Wimmer E. 2002. Chemical Synthesis of
Poliovirus cDNA: Generation of Infectious Virus in the Absence of
Natural Template. Science 297: 1016-1018.
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Prior to the publication of the synthesis of PhiX genome we
contacted our funding agency, DOE, who in turn notified the highest
levels of government about our achievements. The work was vetted by the
Administration who gave the go ahead for scientific publication. About
the same time our work was being published, the National Academy of
Sciences (NAS) released a report titled, ``Biotechnology Research in an
Age of Terrorism.'' \12\ This report, chaired by Gerald Fink of the
Whitehead Institute at MIT, and known as the ``Fink Report,'' outlined
a series of recommendations for the scientific community to ensure the
safe undertaking of any research having the potential for misuse. We
were pleased to note that we had already adhered to the recommendations
of this committee. Having adequate review of research that has the
potential for misuse, setting up additional committees specifically
designed to review such research both during the work phase as well as
prior to publication, and coordinating efforts with the international
community on such research are all important recommendations to come
out of the Fink Report. We would encourage these kinds of careful and
serious reviews by respected scientific organizations.
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\12\ Committee on Research Standards and Practices to Prevent the
Destructive Application of Biotechnology, National Research Council of
the National Academies (USA). 2004. Biotechnology Research in an Age of
Terrorism. The National Academies Press (Washington, DC).
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To this end a team at the Venter Institute and a group of
collaborators from other institutions is planning a series of several
workshops on the societal implications of synthetic genomics. With
funding from the Alfred P. Sloan Foundation, a team of scientists and
policy analysts from the Venter Institute, the Synthetic Biology Group
at MIT and the Center for Strategic & International Studies (CSIS),
this project will explore the risks and benefits of synthetic genomics.
Our goal is to construct and evaluate potential guidelines and
regulation for policy makers to consider that will address both the
risk of the technology being used for purposeful, nefarious ends, and
other risks such as laboratory accidents. We want to engage multiple
viewpoints through this series of expert workshops to discuss
technological and societal issues; by producing a series of research
papers; and by organizing an invitational, inclusive meeting of
policymakers, scientists, press, and other interested parties. We plan
to widely disseminate the output from these workshops by the means of
articles, books, Web sites, and through the lay press. It is our hope
that this project will serve as a model for how individual scientists
and society can address other areas of potentially sensitive biological
research in this heightened era of bioterorrism.
Recommendations and Concluding Remarks
As a young man I decided to become a scientist rather than a
physician because I felt that science had the potential to positively
affect more lives at an earlier intervention point than medicine. I
have derived no greater joy than through making basic scientific
discoveries--finding a new gene, understanding how adrenalin works in
the body, sequencing the first genome and the human genome. I have
always believed that scientific pursuit is the ultimate pursuit of
truth. It always seemed like such a simple and honorable endeavor to
me.
However, the pursuit of science is not simple and it cannot be
conducted in a vacuum. We have made incredible advances that have the
potential to profoundly and positively change our lives. We read
everyday about breakthroughs in stem cell research, genomics, and other
areas of science and medicine. Against this backdrop of rapid and
promising advancement, looms the ever present reminder that the world
post September 11th is a very different and in many ways, very
uncertain place. To help harness the power of this new science to help
us deal with our new world, I would like to recommend to you the
following:
1. Continued support of basic science research.
A key way to advance such cutting edge sciences as genomics and all
its exciting applications is through continued support through
competitive grants and contracts. Increased knowledge is our best
weapon in biodefense. Understanding common mechanisms of action
associated with viral infectivity is absolutely crucial for moving
forward. We need to develop drugs effective against a wide range of
viral pathogens, much as we have developed broad-spectrum antibiotics
that work against a wide range of bacterial pathogens. Future
treatments will not be single drugs for single organisms but new agents
that attack common mechanisms of viral and bacterial infectivity.
2. Increased support for better and more rapid detection of and
treatment of new emerging infectious disease.
Everyday the potential for new infectious agents to emerge looms
before us. We have experienced this recently with the emergence of the
SARS virus in 2003 and we are experiencing it today with the outbreaks
and spread of avian and other flu virus strains that could potentially
kill hundreds of millions and wreak havoc with our global health
system. Genomic tools were rapidly employed with SARS and thus
scientists were able to accurately identify and mobilize to prevent the
spread of the virus. A global monitoring system and enhanced global
collaboration on genomic tools as well as collective intellectual
capital could help prevent such potential catastrophes.
3. Incentives for pharmaceutical and biotechnology companies to
increase development of improved broad spectrum antibiotics and better
vaccines.
Over the last several years there has been a troubling trend in the
decreased dedication to research on, and production of, antibiotics and
vaccines. In this age of emerging infectious diseases and with a
continual threat of bioterrorism, we need an increasing--not
decreasing--commitment to research and infrastructure for antibiotic
and vaccine development. Government directed funding in a DARPA like
approach could provide the needed capital and incentives for an eager
biotech industry. Direct leadership in setting research and specific
drug development goals, e.g., broad spectrum antivirals with subsequent
production contracts could help drive industry in the right direction.
Congress needs to find new incentives for industry to build up these
important areas of research.
I have held a privileged seat at the scientific research table for
more than 30 years. I know first hand the power of science and most
especially the power of understanding that my area of expertise,
genomics can wield. Scientific advance can sometimes outpace societal
understanding and comfort. Research can sometimes unleash unintended
and harmful consequences. These are the facts of life in our
technologically, intellectually and scientifically advanced society. We
are at a crossroads now of how best to deal with the tantalizing
science available to the world, to ensure that it is used for the best
purposes to enhance society rather than be the vehicle for our demise.
I thank you for the opportunity to testify before you and welcome
any questions.
APPENDIX
The Venter Science Foundation's Affiliated Nonprofit Organizations
The Venter Foundation includes two affiliated nonprofit entities,
which conduct basic, scientific research: The J. Craig Venter Institute
(Venter Institute) and the Institute for Genomic Research (TIGR).
The Institute for Genomic Research was founded in 1992 with venture
capital funding and an initial goal to identify as many human genes as
possible using Expressed Sequence Tags (ESTs)--a controversial, but
rapid, cost-effective method that I developed while doing research in
the intramural program at NIH. I left NIH to create TIGR in part
because, at the time, NIH was not in a position to conduct a large-
scale human gene discovery study within the intramural program. In our
first 2 years, we at TIGR used the EST strategy to identify more than
half of the genes in the human genome. Then, using many of the
laboratory and computational methods that we developed for the human
gene discovery program, we pioneered the whole-genome shotgun
sequencing of the first complete genome of a free-living organisms,
Haemophilus influenzae, a bacterium that causes ear infections in
children.
In its first decade, TIGR has become one of the leading genomics
institutions in the world, developing research critical to the fields
of medicine, energy and environmental science.
With financial support from the National Institute of Allergy and
Infectious Diseases (NIAID), the Institute has determined the complete
genome sequence for forty microbial species, including important human
pathogens that cause tuberculosis, cholera, syphilis, stomach ulcers,
anthrax, and malaria.
In addition, TIGR has also sequenced a wide range of important
environmental microbes--some of which live in extreme environments but
may be critically important to the health of the planet--and that carry
out a variety of interesting metabolic reactions, including degradation
of cellulose and other organic matter, precipitation of heavy metals
such as uranium from solution, and production of methane and hydrogen
as potential new sources of fuel. These are areas relevant to the field
of bioremediation and are of great interest to DOE.
TIGR has also played a leading role in the sequencing and analysis
of many important plant species, including Arabidopsis thaliana, a
small weed that serves as a model for understanding approximately
250,000 other more complex plants--rice, soybean, potato, and tomato
among them. Together, these efforts are helping in the search for genes
that control the rate of plant growth, yield, and resistance to
diseases and drought.
The J. Craig Venter Institute is a not-for-profit research
institute dedicated to the advancement of the science of genomics; the
understanding of its implications for society; and the communication of
those results to the scientific community, the public, and
policymakers. Founded by J. Craig Venter, Ph.D., the institute is home
to approximately 185 staff and scientists with expertise in human and
evolutionary biology, genetics, bioinformatics/informatics, high-
throughput DNA sequencing, information technology, and genomic and
environmental policy research.
The Institute's areas of scientific focus include: genomic medicine
with an emphasis on cancer genomics and human genome resequencing and
analysis; environmental genomic analysis with an emphasis on microbial
biodiversity, ecology, and evolution; use of molecular and genomic
methods to develop biological sources of clean energy; synthetic genome
development; and policy research on the ethical, legal, and economic
issues associated with genomic science and technology.
A key component of the Venter Institute is the Joint Technology
Center, which provides rapid, accurate, and low-cost DNA sequencing for
both the Venter Institute and TIGR. The JTC, which functions as both a
resource and technology development center, will work collaboratively
with a wide variety of technology leaders in the private sector, as
well as with academic and Federal scientists, in our work to advance
the efficiency and lower the cost of genomic sequencing.
The JTC uses the latest in automated DNA sequencing,
supercomputing, networking, and high performance storage technologies
to rapidly and accurately sequence and analyze genomes in a more cost-
effective manner. The JTC currently has a sequencing capacity of 45
million ``reads'' per year and an ultimate capacity in excess of 100
million ``reads'' per year. A goal of the JTC is to substantially
reduce the cost of genomic sequencing so that everyone can benefit from
the great promise that genomics holds.
The J. Craig Venter Science Foundation provides administrative and
legal support for, and coordinates policy and research activities
between TIGR and the Venter Institute. In addition, the Foundation
explores new ways to foster science education and scientific
innovation.
Senator Burr. At this time, I would recognize Dr. Hearne
for her statement. I would also say to her that I am not sure
how I would have introduced her had North Carolina not passed
her test, but I am delighted that that evaluation went on and I
am delighted that North Carolina did well.
Ms. Hearne. Trust me, I am delighted, too.
[Laughter.]
On behalf of Trust for America's Health, which is a
national nonprofit health organization, I would like to thank
Chairman Burr and Senator Hatch for holding these hearings. I
know he is getting whispered to in his ear, but I would
actually, on behalf of my board's President--I am sorry to
interrupt, but I was actually going to say on behalf of my
board's President, who is the Honorable Lowell Weicher, I knew
I would be remiss if I didn't personally thank you for being
part of this. He talks with great pride about his time of
advancing with you many health initiatives when he was in the
Senate and just wanted to say thank you for being part of this.
Senator Hatch. Please give him my love and affection, too,
because he was a powerful member of this committee, let me tell
you, and I sure enjoyed working with him, so I will look
forward to working with you, as well.
Ms. Hearne. Good. Part of why I have been asked to be here
is to--it is fully described in my written testimony and I will
also ask that it be submitted into full testimony--our report
that we conducted in December of 2004--we have conducted it in
the past, too, on an annual basis--called ``Ready or Not:
Protecting the Public's Health in the Age of Bioterrorism.'' In
the time that I have allotted here, I will go through some of
those key details, but it is going to be emphasizing what we
clearly here have heard amplified by many of the previous
witnesses.
Unfortunately, we hear over and over again that public
health can be our weakest link in an effective and rapid
response in a bioterrorism event. We got alerted to this
shortly after 9/11 when the anthrax attacks hit. This Congress
made a very smart and strategic decision when it passed the
Frist and Kennedy Public Health Security and Bioterrorism
Preparedness Act of 2002. It has provided nearly $3 billion
over the past 3 years to States and localities to fortify our
Nation's defenses against these various health threats.
We have also heard that a series of independent analysis
has looked at the Nation's public health readiness and has
found that while significant progress has occurred in several
key areas, we know that to better protect Americans, there are
still several serious vulnerabilities that we must do a better
job in addressing.
The bottom line here is we are not ready for a bioterrorism
event. There are still many basic questions that remain about
what even constitutes preparedness and what protections
Americans should expect.
That small Cessna plane that caused Congress and the White
House to evacuate today could have been a modified crop duster.
It could have been carrying biological, chemical, or radiologic
agents, and thank God, it didn't. But as Professor Deutch had
pointed out, and he is right on target, that had it been a
catastrophic event, a ready-to-go public health system could
have quickly responded and saved thousands upon thousands of
lives.
Unfortunately, just 2 months ago, we had a false alarm here
in D.C. where there was a possible anthrax attack over at the
Pentagon. That gave us a glimpse to the fact that many gaps
still exist. Rather than demonstrating that we are combat ready
for biological agents, it was a little bit more of a Keystone
Cop type of scenario. State and local health officials were not
notified in a timely fashion, nor were their labs used to test
the biosensors, nor was it even clear who was in charge at that
time. Had it been a real attack, it could have resulted in an
unnecessary loss of lives and dollars.
So whether we are facing an anthrax attack, or as has been
noted earlier, a global epidemic of a deadly strain of
influenza, our best defense is a full-range, modern day, 21st
century public health system. So where are we?
Well, to fill the void in what the assessments are out
there and the baseline comparisons of what is happening from
State to State is why we conducted that report, ``Ready or
Not.'' We had the input of key public health experts to develop
10 indicators to take a look at a snapshot picture of how each
State is doing as it has been getting these critical
investments of Federal dollars.
Let me give you the top findings here, what we found in
this report. We found that over two-thirds of the States had
achieved a score of six or less on a scale of a possible ten
points. North Carolina did receive a nine, Florida also. It is
actually believed that a lot of the everyday experiences or
challenges from threat of a natural disaster is part why those
States have taken public health so seriously.
We also found, though, that nearly a third of the States in
the fiscal year 2003-04 cut their public health budgets, and
two-thirds of the States the year before had done so. So just
at a time when the Federal Government was making smart
strategic investments, the money from the State was not being
matched and it left public health in the challenge of having to
do more with actually less resources.
We found that six States had achieved the green status to
receive the Strategic National Stockpile. Those are the
emergency medical materials that can be brought into any
location within 12 hours. Only six States are fully ready to go
should that stockpile arrive.
Only five public health labs believed that they could
adequately respond to a full-blown chemical terrorism threat,
and only a third of the States report that they have sufficient
capabilities to respond to a major bioterrorism event.
In the critical areas of disease tracking, which has been
mentioned several times here today, we actually found that two-
thirds of the States, including North Carolina and
Massachusetts, do not electronically track outbreak information
using national standards. This causes serious delays in
reporting and could render the rapid and early warning response
to a public health threat very difficult.
I do also want to point out, though, and here we go again,
North Carolina getting some applause, but they were just
yesterday recognized for their best practices by the Rand
Corporation and specifically looking at taking the everyday
public health practitioner and making sure that the ability to
find a surveillance disease outbreak at the local level could
be done with teams of people on the ground.
What that does, though, is rely on key public health
practitioners. Perhaps one of the biggest challenges public
health is facing right now is a brain drain of its best and
brightest. We do not have the next generation of public health
experts ready to go. We also have an enormous number of them
about to retire within the next 5 years. It offers a critical
challenge that these front-line responders will not be there if
an emergency should happen.
Given all of these concerns, the Trust for America's Health
recommends that we have the increased and sustained commitment
to modernizing this public health preparedness, which includes
the continuation and extension of Federal, State, and local
bioterrorism funds. We are going to recommend the following
here, which is in much more detail in my written testimony, but
just to give the overview.
One is to build a better bio game plan and get back to
basics. We need to have basic measurable standards in every
State. They require a demonstration of how the funds were used,
if we are meeting the measures that we need, and are we ready
to go. A lot of the programs that have been coming out in
recent years, and important ones--Biosense, Bioshield, Bio
Watch--are very important, but we are concerned that there is
not an overarching bio game plan. This was mentioned before by
Dr. Deutch, that the bigger picture of how all these pieces are
out there and how they connect are missing.
It is important to practice, practice, practice. We have
got to have the States working together in regional
assessments, doing those drills to make sure that we get it
right and do that over and over again.
We also urge that we take immediate action to build a
strong and fast track U.S. pandemic flu plan out there so that
we really are, should either this recent avian flu or other
potential novel strains evolve, that we are ready in this
country.
And last, let me point out that we need to restore the
proposed $130 million cut that is being made to the State and
local preparedness funds. The job is long from done here. There
are many gaps, many vulnerabilities. What we need to do is
again step back and take a look, as this subcommittee is doing,
and look at what is that bio game plan that we need.
We would actually recommend convening a national summit,
bringing in leaders from key arenas such as the security side,
such as the hospitals, the insurance industry, the
pharmaceutical, public health community. Get those leaders
together to really put together an actionable game plan. A lot
of this isn't rocket science. It is about taking the best and
brightest from a number of fields, getting the community to be
working together, and get the commitment that over the next 5
years, here is what we need to do. Here is how we can get the
job done, and let us move on it today.
So thank you very much for this time. I appreciate the
thoroughness and I know many hearings that you will be having
on this and that public health is part of that discussion.
Senator Burr. Dr. Hearne, thank you so much. I think that
clearly from the title of the subcommittee, you understand that
Chairman Enzi gets it, that it is bioterrorism and public
health, that the two are connected, and I think that many times
we separate those two.
Thank you for your comments on North Carolina. I think that
North Carolina, as you well know, generates out of academia the
public health experts of the future in some fine institutions
that we have.
[The prepared statement of Ms. Hearne follows:]
Prepared Statement of Shelley Hearne, DrPH
Mr. Chairman, and members of the subcommittee, my name is Dr.
Shelley Hearne and I am the Executive Director of Trust for America's
Health (TFAH), a national non-profit, non-partisan organization
dedicated to saving lives by protecting the health of every community
and working to make disease prevention a national priority. I would
like to thank Chairman Burr, Ranking Member Kennedy, and members of the
subcommittee for holding this important hearing, and appreciate the
opportunity to present our thoughts about protecting the Nation's
public health from bioterrorism.
The attacks of September 11, 2001, and subsequent anthrax tragedies
alerted the Nation to the dangers we face from terrorists armed with
biological, chemical, or radiological weapons. The U.S. Congress acted
wisely and quickly by passing the Public Health Security and
Bioterrorism Preparedness Act of 2002, which provided nearly $3 billion
over the past 3 years to States and localities to fortify our national
defenses against health threats. A series of independent analyses
examining the Nation's public health readiness to respond to
emergencies post-September 11 have found that these funds have resulted
in significant progress toward better protecting the American people.
However, serious vulnerabilities remain that must be addressed.
Unfortunately, 3 years after September 11, many basic questions still
remain about what constitutes preparedness and what protections
Americans should expect.
Preventing and combating threats to our Nation's health is the
unique responsibility of the public health system. These threats range
from a potential global epidemic of a deadly strain of influenza to
preventing the spread of disease in the wake of natural disaster. Our
best defense against all of these threats is a modern, strong public
health system.
Trust for America's Health ``Ready or Not'' Report Findings
In 2003 and 2004, Trust for America's Health studied the Nation's
preparedness to respond to bioterrorism and other health emergencies.
The results were issued in reports entitled, Ready or Not? Protecting
the Public's Health in the Age of Bioterrorism. The reports found that
while incremental improvements have been achieved, States were only
modestly better prepared to respond to health threats than they were
before the 2001 tragedies. We concluded that States have been left to
manage shifting and competing priorities for limited public health
resources, without enough support to focus on fixing the fundamental,
tried-and-true basics that are the backbone of a well functioning
public health system.
With input from public health experts, we developed 10 key
indicators to assess a snapshot review of each State's public health
preparedness. Together, the indicators provide a composite view of
preparedness capabilities and trends. Each State was assigned a score
on a 0 to 10 point scale, depending on the number of indicators met.
Some key findings from our 2004 report include:
Over two-thirds of States and the District of Columbia
achieved a score of six or less. Florida and North Carolina scored the
highest, achieving nine out of a possible 10 indicators, and Alaska and
Massachusetts scored the lowest, at three out of 10. These scores
demonstrate that preparedness efforts are lagging behind goals and
expectations. With most States still in the middle range of the scale,
and with no States meeting all of the indicators, there are still areas
of vulnerability that leave Americans at risk.
Many basic bioterrorism detection, diagnosis, and response
capabilities still are not in place. Bioterrorism preparedness policy
is ill-defined and inconsistent. Bioterrorism preparedness planning
still lacks strategic direction, well-defined priorities, and
appropriate levels of resources to match needs. There is no clear
definition for what the public should expect as protection in the event
of bioterrorist attack or public health emergency, and there are no
real performance standards in place to assess how well the public would
be protected in the event of such tragedies.
Nearly one-third of States cut their public health budgets
between fiscal year 2003-04 and Federal bioterrorism funding decreased
by over $1 million per State in 2004; States still do not have adequate
resources to address their preparedness gaps.
Only six States have achieved ``green'' status for the
Strategic National Stockpile, which means being recognized as
adequately prepared to administer and distribute vaccines and antidotes
in the event of an emergency.
Only five public health labs report capabilities
(facilities, technology, equipment, and/or staffing) to adequately
respond to a chemical terrorism threat, and only one third of States
report that they have sufficient bioterrorism lab response capabilities
(facilities, technology, and/or equipment).
Nearly 60 percent of States report that they do not have
adequate numbers of laboratory scientists to manage tests for anthrax
or the plague if there were to be a suspected outbreak.
In the crucial area of disease tracking, two-thirds of the
States, including North Carolina, do not electronically track outbreak
information using the national standards. This causes serious delays in
reporting and rendering rapid or early warning of disease threats
difficult. At the same time, North Carolina was recently highlighted in
a new report by the RAND Corporation for other disease tracking
efforts. They were featured as a ``best practice'' example for using
Federal bioterrorism preparedness funds to support North Carolina
Public Health Regional Surveillance Teams. This effort includes seven
teams of public health practitioners to assist local health departments
with disease outbreak preparedness and response.
Coordination among Federal, State, and local health
agencies is still strained, often due to competition for limited
resources.
The public health workforce is on the brink of an urgent
``brain drain'' as baby boomers retire and next-generation recruitment
efforts suffer. State and local health agencies face shortages of
epidemiologists, laboratory scientists, medical professionals, and
other trained experts.
Concerns remain that States are unprepared to implement
quarantine, although every State except Alaska has adequate statutory
authority to quarantine in response to a hypothetical bioterrorism
attack.
TFAH Recommendations: A Sustained Bio-Game Plan is Needed
While Federal funds for bioterrorism preparedness have resulted in
rapid and substantial improvements, many critical gaps remain. To
address these concerns, TFAH recommends for an increased, sustained,
and ongoing commitment to modernizing public health preparedness, which
include the continuation and extension of Federal, State, and local
bioterrorism funds. We recommend the following:
Building a better bio-game plan, with consistent,
measurable standards for improvement that require demonstration of how
funds were used to achieve progress. While such programs as Bio-Sense,
BioShield and BioWatch have been established in recent years, TFAH
remains concerned that there is no overarching Federal bio-game plan.
Congress should identify a lead agency to develop and oversee a
comprehensive plan. In anticipation of the reauthorization of the
Public Health Security and Bioterrorism Response Act of 2002, a
systematic review of preparedness gaps should be conducted;
Getting back-to-basics, by building on fundamental
components of a comprehensive public health system that is fully
prepared to meet both emergency and ongoing challenges from threats of
terrorism to the flu and cancer. This includes addressing workforce
shortages, modernizing disease surveillance, expanding laboratory
capabilities, and communications planning. For instance, the proposed
Public Health Workforce Act (S. 506) would help alleviate the dangerous
shortage of public health emergency responders;
Conducting practice drills to assess capabilities and
vulnerabilities, to help identify gaps and improve coordination of
roles and responsibilities;
Limiting liability to encourage vaccine development and
protect health care workers. Liability protection and additional
incentives are needed to encourage private industry to invest in
crucial research and development of vaccines and to provide protection
for both public and private health care workers who could be putting
themselves in harm's way or exposing themselves to disease;
Taking immediate action must be taken to build a strong,
cohesive, fast-tracked U.S. pandemic flu strategy. Although planning
for a flu pandemic (often viewed as requiring a similar response to a
bioterrorism attack) has improved, TFAH has more recently found that
only between 25-30 States have made their plans publicly available. All
of the plans have yet to be evaluated for quality and feasibility; and
Convening a national summit on the future of public health
to develop a robust, integrated approach to public health protection.
It is clear that the United States needs to revitalize our public
health system. A national summit of experts from a range of sectors
should be convened to address all aspects of public health preparedness
and what it would take to achieve a system designed to effectively face
this century's current and emerging health threats.
The bottom line is we've only made baby steps toward better
bioterrorism preparedness, rather than the giant leaps required to
adequately protect the American people.
In order to examine the States' use of the Federal bioterrorism
preparedness funds in States, Senator Lieberman, Ranking Member on the
Senate Homeland Security and Government Affairs (HSGAC) Committee and
Senator Kennedy, Ranking Member on the Senate Health, Education, Labor,
and Pensions (HELP) Committee, and this subcommittee, recently
requested and received a report from the Government Accountability
Office (GAO). The report found that the funds were being adequately
obligated and expended. The February 2005 GAO report found that
``jurisdictions have expended a substantial amount of Bioterrorism
program funds.'' As of August 30th of last year, ``over four-fifths of
the fiscal year 2002 funds awarded through the HHS P accounts during
the third budget period [had been expended].'' Further, the report
stated that ``it is useful to consider that the responsible use of
public funds requires careful and often time-consuming planning before
funds are obligated and expended. In addition, it is important to
recognize that some expenditure take place over a period of time, which
also can affect the speed at which jurisdictions expend funds.''
Unfortunately, the President's fiscal year 2006 budget currently
recommends a $130 million cut to CDC's State and local bioterrorism
preparedness program.
The new GAO report demonstrates that States have been responsible
in the allocating and spending of the bioterrorism funds, and our study
and others show that additional funds are critical to help States and
localities achieve adequate preparedness capabilities to protect
Americans in the event of a bioterrorist attack or public health
emergency.
The Congress should restore the President's proposed $130 million
cut in State and local preparedness funds; otherwise further readiness
progress is in peril of being derailed. In addition, further efforts to
reprogram funds away from this vital program should be halted. While
programs including the Cities Readiness Initiative and the Strategic
National Stockpile are extremely important, the resources to support
these efforts should not come at the expense of support to build basic
State and local emergency preparedness capabilities.
Additionally, to protect Americans from the spread of disease,
whether it is caused by Mother Nature or a bioterrorist, there is a
need to bolster the CDC's Global Disease Detection Program. This
initiative is aimed at identifying, verifying and responding to global
infectious disease outbreaks more quickly and efficiently.
Finally, it is critical that you continue to enhance capabilities
to respond to chemical and radiologic threats as well as biologic ones.
Developing responses to these hazards were not prioritized as highly in
the first awards of bioterrorism preparedness funds, and, resultingly,
these efforts are lagging. For instance, increased support is needed to
give public health laboratories the ``biomonitoring'' capabilities they
need to screen for human exposure to toxics and chemicals. This is an
essential capability needed to assist with diagnosis and treatment
responses to either a chemical terrorism or accidental threat. For
example, the CDC participated in an exposure investigation of New York
City firefighters involved in rescue operations after the terrorist
attacks on the World Trade Center. Bolstering this essential component
of chemical terrorism preparedness is reliant on additional support to
the CDC's National Center for Environmental Health, which includes
providing extramural funds to enhance States public health
laboratories.
Evaluating the country's vulnerabilities and gaps are necessary to
ensure the public's safety and preparedness, and I appreciate the
subcommittee's work to ensure we get the job done to meet the urgent
need of protecting our Nation's public health from bioterrorism. An
effective public health defense requires us to be prepared for the
epidemics we already know and those we have yet to imagine. We are
counting on you to make prudent decisions that will save countless
lives and protect our communities and Nation.
I respectfully submit for the record this testimony as well as a
copy of our December 2004 report, entitled Ready or Not?--Protecting
the Public's Health in the Age of Bioterrorism.
Senator Burr. At this time, I would like to recognize
Senator Hatch for questions.
Senator Hatch. Thank you, Senator Burr. I want to commend
you for holding this important hearing today.
As some of you know, Senator Lieberman and I recently
introduced our biodefense bill known as Bioshield II, which
does provide a comprehensive approach to engaging private
enterprise in the area of biodefense prevention and
countermeasures. Now, to accomplish this important goal, our
bill includes tax incentives, intellectual property
protections, contracting and liability protections, and
improved technology transfer arrangements. It also expands
covered research to include naturally occurring infectious
diseases and pandemic threats.
So I would urge all of my committee colleagues to study
this bill very carefully, because we need both your support and
your constructive suggestions on how to improve it.
Senator Lieberman and I went to work with members of the
HELP Committee on this important matter in the past and we want
all the help we can get in the current system.
Again, I want to extend my appreciation to you, Chairman
Burr, for taking the first step by holding today's hearing and
raising the important issue of bioterrorism.
Dr. Rodier, if I could ask a question of you, we appreciate
you waiting around and we know it is late over there, but you
have stressed the international nature of the problem of
disease outbreaks. Now, what do you consider to be each
country's responsibilities in this area? What should be
America's role? Should our goals differ from other nations? I
think these are questions I think everybody would be interested
in learning from you.
Dr. Rodier. Thank you very much Senator. A quick answer
would be that we are all in the same boat, all being
vulnerable. I think that between the rich and the poor, the G7,
G8 countries, does not only have a key role to play in terms of
solidarity, and also I think a right-made investment, which is
good for solidarity, but also for national security purposes.
Here we also touch on this dual-purpose strategy that was
mentioned before by Dr. Fineberg. I think if the rich countries
can really help the poor countries or less rich simply to have
effective alert and response system, this we believe would be a
good investment from a solidarity standpoint and also from the
national security standpoint.
Senator Hatch. That is right. Dr. Rodier, let me just go a
little bit further here. As a member of the Senate Select
Committee on Intelligence, I followed with interest the
recommendations that we strengthen the ties between the
intelligence and medical communities to improve our Nation's
biopreparedness. Now, do you have any concerns that closer
connections between the CDC and intelligence community could
cause problems with the World Health Organization's ability to
work with other nations on disease outbreaks?
Dr. Rodier. I cannot comment really for the CDC, but I can
certainly comment about this overlap between security and
intelligence and public health. It is an area where we both
have to be present--I would simply take the analogy of--you
need a policeman and a physician. I think that both have to be
very well defined and not confused, and I think the challenge
for the public health sector is to work with these new
partners, which is the security groups. We do not necessarily
know them very well and we need to learn about different
cultures and different [unintelligible] we will have to deal
with [unintelligible], but from the public health standpoints
will be [unintelligible]. If that was the case we may well lose
some kind of privileged access that public health has today
because we are only technical [unintelligible] and not
[unintelligible] as playing with intelligence or sharing
systematic information with intelligence community. So it is
very important we work together, intelligence, security and
public health, but we do not confuse the roles.
Senator Hatch. Well, we appreciate workers and scientists
like you at WHO and the work that you do and we surely want to
be helpful in every way we possibly can.
Dr. Venter, welcome back. It is good to see you again. You
recommend that we use incentives for pharmaceutical and
biotechnology companies to increase development of improved
broad-spectrum antibiotics and better vaccines. Could you tell
us why, or if you do, it appears to me, do you limit yourself
with regard to antibiotics and vaccines, and might I add to
that, what other new technologies--what about other new
technologies, from devices to IT decision support to other
forms of drugs? I would like you to cover that, if you could.
And then should we not encourage as broad a field as possible
so that the items are of use against biological threats?
Mr. Venter. Thank you, Senator. That is clearly a compound
question.
Senator Hatch. It sure was. I will be happy to repeat parts
of it if you need it.
Mr. Venter. Well, let me pick the parts that I might be
able to answer.
Senator Hatch. OK.
Mr. Venter. I think it is critical to provide new
incentives because the research that is taking place in the
pharmaceutical industry has really been falling off in this
area. Some major companies have laid off their entire
antimicrobial-antiviral groups because they don't see the same
profit margins in those drugs as they do in some of their
chronic treatments. So we can't leave it up to the
pharmaceutical industry. I think we need a directed government-
driven research in a DARPA-like fashion that will provide the
key incentives for what I consider a very hungry biotech
industry with a lot of talent to make broad-spectrum
antibiotics, broad-spectrum antivirals that could work against
a whole variety of threats.
The industry has been driven that way in terms of new
treatments for cancer and it looks like there may be new
mechanisms to interfere with, for example, Tyrosine kinase
receptors that may work against a whole variety of cancers.
Many in the community think that will be possible with viruses
interfering with common mechanisms for their replication, for
example.
So the incentives need to be there. I don't know enough
about the industry, whether the incentives in your bill are the
key ones, and I can't really speak to those.
We have to drive the basic research. It is not a matter of
just making more drugs because we don't know the answers yet to
most of these questions.
Senator Hatch. Thank you. Dr. Hearne, let me just ask one
question of you. Would you be kind enough to get us, if you
will, more details about your communications plan that you have
recommended, or that you recommend.
Ms. Hearne. Well, there are a number of pieces that we
recommend.
Senator Burr. Your microphone.
Ms. Hearne. Speaking of communications, it helps to turn on
the microphone.
[Laughter.]
There are a number of pieces here that fit together, and I
think it is important that as we talk about countermeasures
that we do look carefully at the public health side, because as
we make those smart investments into developing
countermeasures, we need to make sure we also have the ability
to deliver them in a time of need, which is the public health
side.
There are several basic pieces that need to be fixed, and
it is actually not, as I had mentioned before, rocket science.
It is really about getting the State capacity along with the
local health departments and the Federal oversight to be
matching up, and that is basic things like communications, of
making sure each of those entities, along with the hospitals,
along with law enforcement, along with every first responder,
can communicate when an event occurs. That has been some of the
big progress that has happened with the first round of the
bioterrorism grants, but we still have a long ways to go in
being able to make sure that we are doing that early detection,
that word is getting out to those who need to have the rapid
response, and that we do have the right materials to get it out
into the field.
So one of the examples in--we talk about the need to put a
bio game plan together. It is critical that the evaluations
that are going on for what are the right countermeasures, such
as antidotes, vaccines, antibiotics that you would need, are
also matching up to what you can go out there and deliver in an
emergency response. And as we have been making investments in
the Strategic National Stockpile in this country, there are
concerns that some of those pieces aren't matching up.
For instance, there is a great concern about a global
pandemic. We are now purchasing Tamiflu as part of the
Strategic National Stockpile in vast enough numbers to protect
the population. That then connects back to what would those
different health agencies do in an emergency to take care and
prioritize and communicate to all the different groups.
So I have put a lot into this answer for you, Senator
Hatch, but part of it is, it is about getting our hands around,
and think that is part of what this subcommittee will deal
with, is making sure all those different dots are connecting.
Senator Hatch. Thank you very much.
Thanks, Mr. Chairman, for letting me have a little
additional time.
Senator Burr. Senator Hatch, thank you so much for your
contribution, not just today but your continual contribution to
this effort. I said in my opening statement that we were
benefited in the fact that you and Senator Lieberman had
produced legislation, that Senator Gregg had legislation, and
it was surely the intent of this subcommittee, and I have the
assurance from the full committee chair, that we will include
everybody in this process as we try to reach consensus on a
piece of legislation.
Senator Hatch. Thank you so much. I appreciate it.
Senator Burr. Let me once again thank all of our panelists
today.
I want to pick up on where Dr. Hearne left off, and you
talked about the pandemic avian influenza. I am going to shift
and go to Dr. Rodier, because Dr. Hearne said that around the
world, individual countries have prepared by bringing in doses
of Tamiflu in preparation for a potential outbreak.
Dr. Rodier, if there were an outbreak later this year, how
would the World Health Organization approach containment,
particularly if it extended outside of one country and into
another country or several other countries, and do we have a
possibility that one country might have the doses of Tamiflu
and those that are also affected might not?
Dr. Rodier. Thank you very much. It is a tough question in
a way because we know well that Tamiflu [unintelligible] that
seems to work on this particular virus, will not be available
in any case to the whole world. The only choice, looking at
what could be done, and it is clear that shown by modeling,
that there is something to do, including with Tamiflu early on
before we start to really have a large-scale pandemic. But if
we do detect early and before we reach [unintelligible] human
cases of new [unintelligible] strains, there is an intervention
which is using Tamiflu, pouring Tamiflu in this particular
affected area that could really maybe not stop completely the
pandemic, but help us to buy time to develop the main tool,
which means the vaccine. Vaccine development takes about 6
months, 8 months to have that in large quantities, plus all the
logistics on distributing the vaccine. So it is very important
we detect early, respond early with Tamiflu and buy time for
vaccine development.
Senator Burr. Thank you very much. We appreciate your
comments concerning the United States' vital role in supporting
the World Health Organization, its efforts around the world.
If you had to cite one area that the U.S. contribution has
been the most crucial, what would that area be?
Dr. Rodier. I think our partnership with CDC has been
through technical assistance and technical input to the work of
the organization.
Senator Burr. Well, I certainly anticipated that that would
be your answer and it is important that members here in
Washington understand just how valuable the CDC is because it
continually has the needs of the technological upgrades that
the marketplace is providing and that will do nothing but get
faster as time goes on.
Dr. Hearne, let me come back to you, if I may. You
highlighted in your testimony that the public health workforce
is on the brink of brain drain. In your opinion, how do we
reverse this trend?
Ms. Hearne. It is reversible by making public health a go-
to place. I think there are many features that we could do
today, but one piece is there is actually a Public Health
Workforce Act that has been introduced to the Congress, that is
about trying to replenish those dwindling numbers, about
creating incentives so that students will want to go into
public health. They will see this as the front line. They will
have the incentives financially, academically, career-wise to
know that this is a place where they want to go to and can go
forward. So Congress is actually putting those pieces together.
It would be wonderful to see that legislation go forward.
Senator Burr. Thank you for that.
You made a passing remark earlier that I want to stop and
highlight on because I think it is probably one of the most
important questions raised and one of the most important
answers needed. You described a potential scenario and you said
one of the problems is not knowing who is in charge. Can you
expand on that?
I happen to believe that that is one of the questions that
we have yet to answer in the big scope of--we understand here.
We saw today who was in charge. There was somebody in charge.
There was an evacuation. There was aircraft that was sent. All
of the pieces of what was designed worked. My concern is when
you take a locality somewhere in this country or you take a
location somewhere in the world, who is in charge?
Ms. Hearne. It is an excellent question and it is part
where we have asked as part of our recommendations, really
clarifying some of those roles, because let us continue with
that example today. Had it been a more serious event, such as
the example I had created of it the plane was carrying CBMs,
the Congress has a very well practiced and structured response
mechanism. But go a few blocks outside and you start to wander
into, well, who really would be in charge in a biological
event? How many times has that been practiced? And would the
citizens have the same levels of rapid response and public
health capabilities as, say, the Hill would?
Those are the kinds of questions that we do have to take
some serious looks at and may, in fact, be a beautiful tabletop
exercise that this committee could do to give a little open-
ended insight into some of these challenges.
We do need much better and clearer leadership. You asked
the tough question to Dr. Deutch about the Homeland Security,
Department of Homeland Security. From the public health world,
it may be a bit heresy, but I actually think that the role that
the Department of Homeland Security has played in public health
preparedness has been absolutely critical and healthy to
getting us better along the road. And I say that because they
have taken many of these natural, biologic, chemical,
radiologic threats quite serious.
They understand that public health has been one of the
weakest links in our security capabilities. And they also have
started to really push the system and the concept of
accountability, which is not what public health has done well
in the past, and that is exactly what we need to be doing here,
is asking those very tough questions, going through and
structuring, here is what we need to be doing, here are our
expectations, and testing if we are making the mark on a
routine basis.
Senator Burr. As you pointed out very well, the area of
jurisdiction for the Congress extends several blocks outside of
the Capitol. It is apparent when you see a decontamination tent
two blocks from the Capitol. The reason it is not three or four
or five is that we have no jurisdiction there. And the question
is, when you go past that tent, who is in charge?
And I think that is one of the challenges that we are going
to have, to begin to try to sort out what that answer is, to
begin internationally to work with our colleagues at the World
Health Organization to understand better how we bring that
coordinated response capability, and clearly we have got some
models that currently work. But public health is going to have
to play an absolutely integral role in how we design it for the
future.
Dr. Venter, of all the panelists here today, you are both a
scientist and a CEO of a biotech company. From your
perspective, what kinds of incentives would attract you and
others like you to work on issues of biodefense, meaning both
natural and deliberative biologic agent threats?
Mr. Venter. Well, I am only currently head of a large
research organization. I spent 3 years of my career as head of
a biotech company to sequence the human genome. It was clear
during that brief period of time and in-depth exposure to the
biotech and pharmaceutical communities, they are ultimately
businesses and driven by profit motives more than any other
events. So they have to have products that they can see a
market for. Beyond that, I don't think I am the right person to
speak for that industry.
Senator Burr. Well, I think you will find Senator Hatch,
myself, others taking every opportunity to get everybody's
comment, because I think we are all stumped to some degree why
the participation in this effort has not been more robust, and
it is not limited to the United States, it is around the world.
Clearly, we understand the profit needs of companies, but we
are trying to understand as we begin to revise legislation,
what can we do that achieves a different result in the level of
participation from not just biotech, but big pharma, as well.
Your testimony today, and I read it, was both reassuring
and unsettling. It was reassuring because you noted that the
likelihood of a terrorist event or even a State biologic
weapons program would be one or more decades away from
synthesizing new pathogens, unsettling because it takes upwards
of 10 or more years to create a new vaccine or a drug to
counter an existing pathogen.
I am intrigued by the suggestion that government, I assume
NIH, should take a DARPA-like approach. Can I ask you to expand
on that DARPA-like approach?
Mr. Venter. I don't think NIH is the right organization to
do that. I think the infrastructure at NIH doesn't allow it to
do things in a proactive fashion. It is a response to grant
applications. DARPA has been an organization that has
effectively, when the mission is known, with a large pool of
money can go out and actually initiate new research and new
construction efforts in industry and in academic organizations.
So it is a small group of people, not a large infrastructure,
and they have been able to really push the envelope of what
gets done in research. That won't happen probably through the
existing organizations. The culture there does not exist to do
that.
I was on Dr. Zerhouni's committee to award high-risk
research awards to researchers at NIH. The committee and the
infrastructure just did not have it within their bandwidth to
do things in a high-risk fashion. Organizations like DARPA are
designed to work in a much higher-risk environment where you
are not guaranteed results, but you are trying to incent
researchers and organizations to move in a new direction. I
think DARPA has been very effective with that. We are trying to
get new detection methods going.
Senator Burr. Dr. Venter, thank you. I was trying to get my
facts straight. I think some suggested that you couldn't do the
human genome mapping in the time frame that you did, and I am
not exactly sure what they claimed it would take and you
certainly shortened that by a lot, but thank you for the
reminder that there are some things that we can't redo or some
existing things that we just can't use and you have to go to
people with proven track records that know how to do things in
expeditious ways.
I want to thank all of you for your testimony. I hope even
Dr. Rodier will make himself available to potentially written
questions that might come from other members. As we go through
this process, it is going to be absolutely vital that we get
the input from many.
Dr. Rodier, I have noticed several staff members there with
you tonight. Let me take this opportunity to thank them, as
well, and to offer the collaboration of this committee in our
joint efforts to move forward on this issue in a very positive
way.
Again, I thank you for joining us long distance. I thank
all of our panelists for their willingness to be here and the
expertise that they have shared with us. We certainly look
forward to this committee's work as we move forward.
This hearing is now adjourned.
[Whereupon, at 3:46 p.m., the subcommittee was adjourned.]