[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

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions


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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 
of Congress, Congressional staff, and other U.S. Government employees 
may obtain complimentary copies of any report by contacting the 
National Academies' Office of Congressional and Public Affairs at (202) 
334-1601 or [email protected]. For more information on publications by the 
National Academies, please visit the National Academies Press Web site 
at www.nap.edu or the homepage of the National Academies at 
www.nationalacademies.org.

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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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/.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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).
---------------------------------------------------------------------------
    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.]

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