[Senate Hearing 107-1028]
[From the U.S. Government Publishing Office]



                                                       S. Hrg. 107-1028
 
                 FIGHTING BIOTERRORISM: USING AMERICA'S


                      SCIENTISTS AND ENTREPRENEURS


                           TO FIND SOLUTIONS

=======================================================================

                                HEARING

                               BEFORE THE

             SUBCOMMITTEE ON SCIENCE, TECHNOLOGY, AND SPACE

                                 OF THE

                         COMMITTEE ON COMMERCE,
                      SCIENCE, AND TRANSPORTATION
                          UNITED STATES SENATE

                      ONE HUNDRED SEVENTH CONGRESS

                             SECOND SESSION

                               __________

                            FEBRUARY 5, 2002

                               __________

    Printed for the use of the Committee on Commerce, Science, and 
                             Transportation




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           COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION

                      ONE HUNDRED SEVENTH CONGRESS

                             SECOND SESSION

              ERNEST F. HOLLINGS, South Carolina, Chairman
DANIEL K. INOUYE, Hawaii             JOHN McCAIN, Arizona
JOHN D. ROCKEFELLER IV, West         TED STEVENS, Alaska
    Virginia                         CONRAD BURNS, Montana
JOHN F. KERRY, Massachusetts         TRENT LOTT, Mississippi
JOHN B. BREAUX, Louisiana            KAY BAILEY HUTCHISON, Texas
BYRON L. DORGAN, North Dakota        OLYMPIA J. SNOWE, Maine
RON WYDEN, Oregon                    SAM BROWNBACK, Kansas
MAX CLELAND, Georgia                 GORDON SMITH, Oregon
BARBARA BOXER, California            PETER G. FITZGERALD, Illinois
JOHN EDWARDS, North Carolina         JOHN ENSIGN, Nevada
JEAN CARNAHAN, Missouri              GEORGE ALLEN, Virginia
BILL NELSON, Florida

               Kevin D. Kayes, Democratic Staff Director
      Jeanne Bumpus, Republican Staff Director and General Counsel

                              ----------                              

             Subcommittee on Science, Technology, and Space

                      RON WYDEN, Oregon, Chairman
JOHN D. ROCKEFELLER IV, West         GEORGE ALLEN, Virginia
    Virginia                         TED STEVENS, Alaska
JOHN F. KERRY, Massachusetts         CONRAD BURNS, Montana
BYRON L. DORGAN, North Dakota        TRENT LOTT, Mississippi
MAX CLELAND, Georgia                 KAY BAILEY HUTCHISON, Texas
JOHN EDWARDS, North Carolina         SAM BROWNBACK, Kansas
JEAN CARNAHAN, Missouri              PETER G. FITZGERALD, Illinois
BILL NELSON, Florida




                            C O N T E N T S

                              ----------                              

                                                                   Page
Hearing held on February 5, 2002.................................     1
Statement of Senator Allen.......................................     5
Statement of Senator Cleland.....................................     1
Statement of Senator Rockefeller.................................     7
Statement of Senator Wyden.......................................     1
    Prepared statement...........................................     4

                               Witnesses

Benjamin, Hon. Georges C., M.D., FACP, President, Association of 
  State and Territorial Health Officers; Secretary, Department of 
  Health and Mental Hygiene, State of Maryland...................     7
    Prepared statement...........................................     9
Edwards, John. G., President and CEO, Photonic Sensor............    11
    Prepared statement...........................................    13
Hatchett, Richard J., M.D., Coordinator, the Civilian Medical 
  Reserve 
  Working Group, Clinical Assistant, Attending, Memorial 
  Hospital, Memorial Sloan-Kettering Cancer Center, New York 
  University Center for Advanced Technology......................    14
    Prepared statement...........................................    16
Johnson-Winegar, Anna, Ph.D., Deputy Assistant to the Secretary 
  of Defense for Chemical and Biological Defense.................    66
    Prepared statement...........................................    67
Klausner, Richard, M.D., Senior Fellow, Special Advisor for 
  Counter-Terrorism, National Academy of Sciences................    23
    Prepared statement...........................................    25
    Summary of Selected Counter-Terrorism Initiatives, by the 
      National Academies.........................................    29
Ryan, Una S., Ph.D., President and CEO of AVANT 
  Immunotherapeutics, Inc........................................    35
    Prepared statement...........................................    36
Simpson, Lisa A., M.B., B.Ch., M.P.H., Deputy Director, Agency 
  for Healthcare Research and Quality, Department of Health and 
  Human Services.................................................    71
    Prepared statement...........................................    72
Sobral, Bruno W.S., Ph.D., Director, Virginia Bioinformatics 
  Institute; 
  Professor, Plant Pathology, Physiology and Weed Science at 
  Virginia Tech..................................................    39
    Prepared statement...........................................    40

                                Appendix

College of American Pathologists, Division of Government and 
  Professional Affairs, statement for the record.................    79


                 FIGHTING BIOTERRORISM: USING AMERICA'S



                      SCIENTISTS AND ENTREPRENEURS



                           TO FIND SOLUTIONS

                              ----------                              


                       TUESDAY, FEBRUARY 5, 2002

                               U.S. Senate,
    Subcommittee on Science, Technology, and Space,
        Committee on Commerce, Science, and Transportation,
                                                    Washington, DC.
    The Subcommittee met, pursuant to notice, at 10:30 a.m., in 
Room SR-253, Russell Senate Office Building, Hon. Ron Wyden, 
Chairman of the Subcommittee, presiding.

             OPENING STATEMENT OF HON. RON WYDEN, 
                    U.S. SENATOR FROM OREGON

    Senator Wyden. The hearing will come to order. Today, the 
Subcommittee on Science, Technology, and Space convenes the 
second in a series of hearings on how America can rally its 
best scientists and technology experts to combat terrorism. I 
am going to have an opening statement, and I want to recognize 
all of my colleagues as well in a moment. But the Senator from 
Georgia is under time constraints this morning, and I would 
like to recognize him first.

                STATEMENT OF HON. MAX CLELAND, 
                   U.S. SENATOR FROM GEORGIA

    Senator Cleland. Thank you, Mr. Chairman. I do have two 
other committees that are wanting my attention. I did want to 
be here today to make a very special introduction. Mr. 
Chairman, I would like to thank each of the witnesses for their 
contribution to our understanding of the crucial role of 
scientists and entrepreneurs in fighting the war against 
bioterrorism, with the focus of today's hearing on how the 
Federal Government can better utilize private industry and its 
technical expertise in the continuing war against bioterrorist 
attacks.
    I am convinced we could more effectively pool our resources 
in order to form a fast, effective response to this threat. 
Such resources are available to us today in this country 
because of the knowledge, skills, and technical expertise of 
the American entrepreneur. However, the small business 
entrepreneur, and I am on the Small Business Committee here in 
the Senate, Mr. Chairman, cannot just go it alone. Small, high 
tech companies often need Federal assistance to fully develop 
new, cutting edge technology ideas and see those ideas come to 
fruition. The result of this collaborative effort between the 
Federal Government and private enterprise can often be a new 
product which improves the quality of lives for the citizens of 
this country.
    Today, I am pleased to introduce to the Subcommittee one 
such example of entrepreneurial success. Mr. John Edwards is 
President and CEO of Photonic Sensor, an Atlanta-based firm 
which produces a unique new product in the war against 
bioterrorism. In his testimony, Mr. Edwards will emphasize the 
story behind his company's product, how it was developed, how 
it was brought to mainstream use, and the role the Federal 
Government played in this process.
    The threat of terrorist attack is as real today as it was 
on September 11. We know all too well of the real danger of 
biological attack, having lost several American lives to 
anthrax. We as a Nation must be prepared for any such future 
attacks, and we simply cannot afford to overlook the promise of 
protection offered by America's scientists and entrepreneurs. 
Once again, we thank you, Mr. Chairman, for your leadership on 
this critical issue. I look forward to working with you in the 
ongoing war against bioterrorism, and I would like to thank our 
panelists, all of them, for coming today.
    Senator Wyden. I thank my colleague. I know my colleague 
has been very involved in the bioterrorism debate, and we look 
forward to his expertise as we move forward.
    Just as John F. Kennedy gave America's youth a forum for 
public service, I believe now is the moment that government 
should throw open its doors to the ideas, the creativity, and 
the energy of a generation raised on information technologies 
that is willing to fight the terrorist threat. This hearing is 
going to explore opportunities to respond to the threat of 
bioterrorism in particular.
    Our country has begun to mobilize its public sector, 
government, military, and law enforcement to fight terrorism. 
Analyzing the events of September 11, this Subcommittee found 
the private sector was ready and willing to contribute, but 
found too many obstacles. Some could not get proper credentials 
to get into the disaster site. Some simply could not find the 
right place to offer their people, their expertise, and their 
equipment.
    In the event of a bioterror attack, it appears many 
communities are going to face the same confusion. Right now, if 
a town is hit with a biological agent and looking for the 
closest medical authority, in most cases, there is no 
comprehensive list of certified experts available locally to 
assist. Where do those local leaders turn to find help nearby? 
Where can doctors, scientists, and technology experts go to 
offer their aid? Most do not know, and right now the Federal 
Government has few clear answers. At least 20 Federal agencies 
are charged with some part of fighting the bioterror threat.
    In the State of the Union address, the President said he 
would not wait on a fence while dangers gather around the 
public. I agree. America must marshall the efforts of 
technology experts and entrepreneurs, top scientists and 
medical minds before the next bioterror event. Among the 
objectives this Subcommittee should explore are: establishing a 
clear point of contact for those in the private sector offering 
help; putting the names of bioterror experts into the hands of 
local governments in every corner of this country; and creating 
a national testbed for private sector technologies that can 
help save American lives.
    After September 11, I proposed that the government launch 
the technology equivalent of the National Guard. I describe it 
as the National Emergency Technology Guard, or NET Guard, a 
cadre of volunteers from the private sector with the ability to 
help prevent these tragedies and to fix broken systems and 
create new networks wherever possible. In response, key Federal 
agencies must help establish a single point of contact of 
consistent policy for organizing the technology sector's help.
    Today I say that scientists, doctors, and entrepreneurs 
need an entry point with the government as well. This 
organization can help safeguard not just our technology 
infrastructure, but the very health of our citizens. A National 
Association of Counties study released just last week 
specifically calls for the development of up-to-date contact 
lists for local public health departments. It states that less 
than 10 percent of the counties surveyed feel ready to handle a 
bioterror attack.
    America's communities need a registry of the best 
scientists and doctors to deal with biological incidents as 
soon as they become apparent. Bioterror attacks are not always 
announced by a plume of spores from an opened letter, like the 
anthrax attack on the Senate. Too often, the agent spreads, as 
it did in postal facilities, undetected until victims become 
sick or die.
    A comprehensive database detailing experts' qualifications 
and locations could empower communities to get help as close to 
home as possible when the precious hours count. Once 
identified, specialists can be kept in the loop with ongoing 
training and information about new threats. Their advice will 
also be essential in developing a strategic reserve of 
supplies, a strategic technology reserve, as I would describe 
it, that would not just be medicines, but equipment and 
technologies to aid in the event.
    Since September 11, thousands of experts and entrepreneurs 
have contacted the Federal Government offering new 
technologies. I firmly believe the private sector can make a 
significant contribution to early detection of an effective 
bioterrorism response, but today two witnesses will testify 
that their efforts to offer a bioterrorism detection device and 
new vaccines were hampered by a confusing, lengthy maze of red 
tape.
    I am going to let them tell their own stories, but what 
concerns me about their testimony is that instead of being able 
to spring to the aid of their fellow citizens, they found 
themselves forced to run a bureaucratic marathon. Multiple 
agencies require separate, complicated, and slightly different 
applications. Companies can spend months waiting just to get 
their technologies to the top of someone's in-box. Who knows 
how many of these private entrepreneurs have simply run out of 
the time, financial and human resources demanded to navigate 
the current process. Companies should not have to hire 
lobbyists, as one California firm has, in order to figure out 
how to help their fellow Americans.
    I understand some agencies are making a special effort to 
accept private sector suggestions, and we will hear about that 
today, but more needs to be done. A central clearinghouse in 
particular should be created to accept and test private sector 
technologies that could detect and diminish the bioterrorist 
threat. Major General John S. Parker and others have made very 
thoughtful proposals in this area.
    With unanimous consent, I will put the rest of my prepared 
statement in the record.
    [The prepared statement of Senator Wyden follows:]
                 Prepared Statement of Hon. Ron Wyden, 
                        U.S. Senator from Oregon
    Today the Subcommittee on Science, Technology and Space convenes 
the second in a series of hearings on how America can rally its best 
scientists and technology experts to combat terrorism. Just as John F. 
Kennedy gave America's youth a forum for public service, I believe now 
is the moment the government should throw open its doors to the ideas, 
the creativity and the energy of a generation raised on information 
technologies, willing to fight the terrorist threat. This hearing will 
explore opportunities to respond to the threat of bioterrorism in 
particular.
    Our country has begun to mobilize its public sector--government, 
military and law enforcement--to fight terrorism. Analyzing the events 
of September 11, this Subcommittee found a private sector ready and 
willing to contribute, but facing too many obstacles. Some couldn't get 
proper credentials for disaster sites. Some simply couldn't find the 
right place to offer their people, expertise and equipment.
    In the event of a bioterror attack, it appears communities will 
face the same confusion. Right now, if a town is hit with a biological 
agent and looking for the closest medical authority, there is no 
comprehensive list of certified experts to help them. Where do local 
leaders turn to find help nearby? Where can doctors, scientists and 
technology experts go to offer their aid? Most don't know--and right 
now the Federal Government has few clear answers. At least 20 Federal 
agencies are charged with some part of fighting the bioterror threat.
    In his State of the Union address, President Bush said he would not 
wait on events while dangers gather around the American people. I 
agree. America must marshal the efforts of tech experts and 
entrepreneurs, top scientists and medical minds before the next 
bioterror event.
    Among the objectives this Subcommittee should explore are: 
establishing a clear point of contact for those offering help; putting 
the names of bioterror experts into the hands of local governments; and 
creating a national test bed for private sector technologies that could 
save American lives.
    After September 11, I proposed that the government launch a 
technology equivalent of the National Guard. I describe it as a 
National Emergency Technology Guard, or NET Guard: a cadre of 
volunteers with the expertise to fix broken systems, create new 
networks, and help prevent disasters wherever possible.
    In response, key Federal agencies agreed to establish a single 
point of contact and a consistent policy for organizing the tech 
sector's help. Today I say that scientists, doctors and entrepreneurs 
need an entry point with the government as well. This organization can 
help safeguard not just our technology infrastructure, but the very 
health of our citizens.
    A National Association of Counties study, released just last week, 
specifically calls for the development of up-to-date contact lists for 
local public health departments. It states that less than 10 percent of 
counties surveyed feel fully ready to handle a bioterror attack.
    American communities need a registry of the best scientists and 
doctors to deal with biological incidents as soon as they become 
apparent. Bioterror attacks are not always announced by a plume of 
spores from an opened letter, like the anthrax attack on the Senate 
last fall. Too often, the agent spreads as it did at postal facilities: 
undetected until victims become sick or die. A comprehensive database, 
detailing experts' qualifications and locations, could empower 
communities to get help as close to home as possible when precious 
hours count.
    Once identified, specialists can also be kept ``in the loop'' with 
ongoing training and information about new threats. Their advice will 
also be essential in developing a strategic reserve of supplies--not 
just medicines, but equipment and technology to aid in the event of a 
bioterrorist attack.
    Since September 11, thousands of experts and entrepreneurs have 
contacted the Federal Government offering new technologies. I firmly 
believe America's private sector holds the keys to early detection and 
an effective bioterrorism response. I also firmly believe government 
must do a better job of accepting and implementing their creative 
solutions.
    Today two witnesses will testify that their efforts to offer 
bioterrorism detection devices were hampered by a confusing, lengthy 
maze of red tape. I will let them tell their own stories, but I will 
tell you now what concerns me about their testimony. Instead of being 
able to sprint to the aid of their fellow citizens, they found 
themselves forced to run a bureaucratic marathon. Multiple agencies 
require separate, complicated, and slightly different applications. 
Companies can spend months waiting just to get their technologies to 
the top of someone's in-box.
    Who knows how many have simply run out of the time, financial and 
human resources demanded to navigate the current process? Companies 
should not have to hire lobbyists, as one California firm has, to 
figure out how to help their fellow Americans.
    A central clearinghouse should be created to accept and test 
private sector technologies that could detect and diminish the 
bioterrorist threat. Recently, Major General John S. Parker of the Army 
Medical Research and Materiel Command suggested a ``national test bed'' 
for new anti-terror inventions. Last fall, firefighters asked this 
Subcommittee for a test bed to evaluate bio-hazard technologies. A 
national test bed is part of my NET Guard legislation. Once verified, 
these innovations can be a crucial component of our Nation's response 
to terror.
    As I have said, I envision a modest role for the government in this 
endeavor. NET Guard is not intended to be a huge bureaucracy. Rather, 
it will be a gateway for the private sector to bring its resources to 
bear on the war against terrorism. There is no time to waste.
    The Subcommittee will hear testimony from two panels today: Dr. 
Georges Benjamin, President of the Association of State and Territorial 
Health Officers; Mr. John Edwards, President of Photonic Sensor; Dr. 
Richard Hatchett of the Civilian Medical Reserve Working Group; Dr. 
Richard Klausner of the National Academy of Sciences; Dr. Bruno Sobral 
of Virginia Tech University; and from the Federal Government, Ms. Anna 
Johnson-Winegar from the Department of Defense and Dr. Lisa Simpson of 
the Department of Health and Human Services.

    Senator Wyden. Even though there is a vote on the floor, I 
want to allow Senator Allen and Senator Rockefeller to make 
their full prepared statements. Why don't we see if we can get 
Senator Allen's in, and then we will come back and recognize 
Senator Rockefeller.

                STATEMENT OF HON. GEORGE ALLEN, 
                   U.S. SENATOR FROM VIRGINIA

    Senator Allen. Thank you, Mr. Chairman. I will try to be 
brief. First, I want to commend you, Mr. Chairman, for having 
this hearing on a very important aspect of our homeland 
security. Biology and biosecurity, bioterrorism are all 
involved in part of what is great about what is going forward, 
and that is a lot of advancements in biotechnology, but in all 
of those wonderful advancements we also see, obviously, some of 
the worry of using some of these advancements in the wrong way. 
I want to welcome and thank all of our experts who will be 
testifying here this morning, and I particularly want to thank 
Dr. Sobral for being here. He is with the Virginia 
Bioinformatics Institute at Virginia Tech, and very much a part 
of what will need to be the coordination and efforts here.
    We saw what effect this anthrax attack had here. We still 
do not get mail on time from our constituents, and let me 
apologize for all Senators when people say we are not getting 
our letters answered. Just understand, we are not getting your 
letters in a timely manner, so e-mail us or fax us, or send it 
to our home offices. But nevertheless, we saw the attack on 
major media outlets as well. We need to recognize, obviously, 
if there are future bioterrorist attacks, the impact, as bad as 
it was here, and we certainly mourn the loss of five lives, it 
is most likely to affect more people than what we have seen in 
this recent attack.
    These attacks emphasize why this Subcommittee hearing is so 
important. We need to have more innovative research to develop 
an early warning system for bioterrorist attacks; we need new 
vaccines and treatment for biological agents; and we need 
prompt, accurate, coordinated response methods to any future 
attacks.
    I think we will find here, with the help of the witnesses 
here today, we are going to find that we have many good, on-
going programs in the private sector, in our universities as 
well as with Federal Government agencies, trying to address 
these areas and advancing technologies to hopefully address--
prevent, if possible--but if there is an attack, make sure 
there is a rapid response to prevent as much harm as possible.
    I have been reading through the testimony. There is, for 
example, a hand-held device that uses biosensors to detect 
bioterrorist attacks. The study by Dr. Sobral, Virginia 
Bioinformatics Institute, is working to understand the spread 
of deadly diseases. The University of Virginia project is 
working to modify red blood cells to destroy deadly pathogens 
that are among the different private sector research 
initiatives.
    The Federal Government obviously should review this 
research, whether it is what I mentioned or others, to 
determine whether they can be applied in our preparations for 
future biological attacks. Many of the Members of this 
Subcommittee, including myself, are cosponsors of the Frist-
Kennedy Bioterrorism Response Act, which I believe shows the 
Senate taking a leadership role in this area of concern, and I 
commend the Bush Administration in at least their 
prioritization in the budget.
    Much of the research and prevention responses is going to 
require what I like to call a team effort, and it is going to 
be a large team that is going to involve the private sector; 
universities and research being done there; hospitals; the 
medical profession; civilian and military research at the 
Federal level; and obviously, working with State, local, 
regional, and Federal officials to assess the situation of the 
challenges and the assets that we have. We will then need to 
determine where improvement needs to be made in addressing this 
threat, and next will, of course, be the coordination of all of 
these resources and assets--and all of these are equally 
important. Finally is the communication, the easy and rapid 
communication among all these different team members so that we 
can respond promptly, efficiently, in the best way possible to 
protect the people of America.
    So I thank you, Mr. Chairman, and look forward to the 
testimony.
    Senator Wyden. I thank my colleague.
    We have a vote on the floor, then we are going to come back 
and recognize Senator Rockefeller.
    [Recess.]
    Senator Wyden. The hearing will come to order. We thank our 
witnesses. I do want to recognize Senator Rockefeller, because 
he has decades of experience in the public health field, and 
chairs the Finance Subcommittee on Health, and I am so pleased 
to recognize Senator Rockefeller.

           STATEMENT OF HON. JOHN D. ROCKEFELLER IV, 
                U.S. SENATOR FROM WEST VIRGINIA

    Senator Rockefeller. Senator Wyden, as part of that 
glorious introduction, it occurs to me our panelists have been 
waiting a long time, and what I have to say may be of somewhat 
less interest than what they have to say, at least from my 
perspective. I would encourage you to go to them, and I will 
just work my thoughts in as I go along.
    Senator Wyden. We are going to do that, and I am going to 
recognize you first for questions when they are done, and I 
thank you for your graciousness.
    Our first panel is Hon. Georges Benjamin, M.D.; Mr. John 
Edwards; Dr. Richard Hatchett; Dr. Richard Klausner; Dr. Una 
Ryan; and Dr. Bruno Sobral.
    Let us begin with you, Dr. Benjamin. We are going to make 
your prepared remarks a part of the record in their entirety, 
and please proceed.

    STATEMENT OF HON. GEORGES C. BENJAMIN, M.D., PRESIDENT, 
     ASSOCIATION OF STATE AND TERRITORIAL HEALTH OFFICERS; 
 SECRETARY, DEPARTMENT OF HEALTH AND MENTAL HYGIENE, STATE OF 
                            MARYLAND

    Dr. Benjamin. Thank you very much for allowing me to be 
here today. I am here wearing two hats. One is the Secretary of 
Health for the State of Maryland, but more importantly as the 
President of ASTHO, which is the Association of State and 
Territorial Health Officials. This is the organization which 
supports all of the State health officials in the country.
    You know, for the past 5 months we have been struggling 
with this whole issue of biological terrorism, but more 
importantly we have been struggling with how best to get 
information, how best to get access to the right people at the 
right time to give us the ideas that we need to make very, very 
sound public health decisions, and Mr. Chairman, let me tell 
you, that has been real tough.
    You know, I can take you back even prior to bioterrorism. 
Back in 1997, we had a little organism that showed up on the 
Eastern Shore of Maryland called pfiesteria pisscida. It is a 
fish disease, and some of us in North Carolina had been 
struggling with this for some time, and frankly, in Maryland we 
did not have a clue about that going on. But when it hit the 
waters in Maryland there was some concern that some of the 
people in Maryland were getting sick from that organism. We had 
to search and find some people that knew something about it, 
some people that knew about that class of organisms. What 
normally happens is you pick up the phone and call the CDC. The 
CDC gets you to an expert, that expert gives you good advice, 
and you do what you need to do. It turns out they did not have 
one in that particular area. It turns out we not only had one, 
but we had two of those folks, one at the University of 
Maryland and one at Johns Hopkins. The University of Maryland 
is down the street from my office. It is a little embarrassing 
that we would find these folks right in our own backyard. They 
were able to give us some expert advice, and we were able to 
solve that public health crisis.
    We move forward to September 11. This one was a 
communications issue. We had a great deal of difficulty talking 
back and forth. We needed secure communications. We needed to 
be able to share medical information not just within my 
department, not just within Maryland State government, but 
intrajurisdictional between Maryland, DC, and Virginia, and 
frankly, we did not have the technology to pull that off right 
away.
    We had put some things in place, standing conference calls, 
a few cell phones, but it was very, very difficult because of 
the needs of the public health system, but more interestingly, 
trying to find people to deal with anthrax who had actually 
seen it. Now as we begin to make our plans to look at smallpox, 
trying to find people who have actually seen smallpox has 
really been a challenge.
    One of the things we have done is, we have gone out to the 
medical society, we have gone out to the various teaching 
hospitals, and we have begun to put together a list of people 
who have actually seen it and done it. So we know they are out 
there, but we certainly think that is something that needs to 
be done nationally. All States need to do this. They need to 
find ways to identify experts to give them advice real-time. 
When a disaster happens that is not the time to be scrambling 
to try to find experts. We had the same issue around technology 
in terms of our cleanup.
    Some folks would say, ``well, most of this anthrax stuff 
occurred across the street in DC and at the Brentwood 
Station.'' But I got a call one day a few days after Brentwood 
from the president of a bank who said, ``I have a mailroom that 
looks just like Brentwood, big machines, sorting machines. It 
is downstream from Brentwood. And we need to have you come and 
test our facility.'' I mean, they got their mail directly 
downstream from Brentwood. 
    The Governor was prepared to do that. Maryland State 
government was able to step up and do that. But we needed to 
figure out how to do it, what were the testing protocols, are 
there some new technologies out there that we can utilize to do 
this quicker, more expediently? How do we bring our staff--and 
at that point it was another State agency, the Department of 
Environment--up to speed very quickly to be able to do that 
testing?
    Now, we did struggle through that. The good news is, we did 
not find any place, at least on our side, that was positive, 
but these were the kinds of things that happened to us in a 
very, very quick manner.
    I think that the most important thing that we saw during 
these anthrax outbreaks, at least nationally, was the speed in 
which information moved, the fact that we were practicing what 
I called ``a science of the day'' mentality. Today it was real, 
tomorrow it was not. We kept changing what we knew, what we did 
not know, and that was because information was moving so 
quickly, and we had a very, very difficult time validating what 
was real, what was not real, and where we needed to go.
    So that is your clarion call. For us to pull together the 
world's experts for us to have access to, I believe, is a 
crucial next logical step for the public health community.
    With that, Mr. Chairman, I will stop and take questions 
whenever you choose to take those questions.
    [The prepared statement of Dr. Benjamin follows:]
     Prepared Statement of Dr. Georges C. Benjamin, M.D., F.A.C.P. 
      Secretary, Maryland Department of Health and Mental Hygiene
    Good morning Mr. Chairman and Members of the Committee. I want to 
thank you for inviting me to speak to you today about the needs of the 
public health system and how we can improve our response to a 
bioterrorism attack. I am here today in my role as President of the 
Association of State and Territorial Health Officials (ASTHO). ASTHO is 
the national organization that represents public health agencies and 
the chief health officials in the country, the District of Columbia and 
the U.S. Territories. We are dedicated to formulating sound national 
public health policies and to assuring excellence in State-based public 
health practices.
    For the past 5 months, the clarion call of health officials has 
been the need to improve the public health infrastructure. Today, I 
want to talk with you about the role that America's entrepreneurs, 
scientists and expert clinicians can play in enhancing the public 
health infrastructure to protect our Nation.
    On October 2, a 63-year-old male presented to a Florida emergency 
department with fever and confusion. During the evaluation he was found 
to have a widened mediastinum and gram positive bacilli in his cerebral 
spinal fluid. Further testing revealed he had ``inhalation anthrax.'' 
He died 3 days later.
    This was the index case of an outbreak of anthrax caused by 
bioterrorism. At its conclusion, 18 people became ill and thousands 
were potentially exposed. Eventually, 11 cases of inhalation anthrax 
and seven cases of cutaneous anthrax were diagnosed. There were five 
deaths from inhalation anthrax. Over 33,000 people in several areas of 
the country required prophylactic antibiotics and a small subset 
elected to receive the anthrax vaccine as part of an investigational 
protocol for additional protection. Epidemiological and criminal legal 
investigations identified several letters filled with ``weaponized'' 
anthrax spores as the vectors of this attack.
    Prior to this attack the Nation had experienced several anthrax 
hoaxes delivered through the mail. Many of these threats contained 
powdery substances, which were not infectious or toxic. Based upon this 
experience and the limited clinical understanding of the 
pathophysiology of anthrax, bioterrorism planners reached several 
conclusions that subsequently proved to be incorrect. Some of these 
beliefs included:
 Anthrax was easy to grow but hard to weaponize. This placed 
    the emphasis on State-sponsored terrorism that then became the 
    focus of our training and preparations. State sponsored was 
    frequently interpreted as large-scale aerosolization.
 A letter had to be opened in order to expose people.
 Weaponized anthrax would stay put and exposure would be a 
    local event. Therefore re-aerosolization probably would not occur.
 Cross contamination would not be a significant problem.
 Inhalation anthrax is 90 percent fatal.
    These beliefs were challenged in our real world scenario and found 
to be untrue. In addition, the speed at which new knowledge was 
produced during this event was unparalleled and was utilized so quickly 
that keeping current was a major endeavor. This created a ``science of 
the day'' environment which was often confusing and suspect.
    I believe there is an important lesson that we must utilize in 
order to develop and enhance our capacity to rapidly access, exchange 
and disseminate new knowledge and information. These capacities fall 
into the following three areas: learning new information; building 
linkages to scientific experts; and the ability to identify and 
validate new or existing technologies.
    During the Anthrax investigations in October, State public health 
laboratories throughout the Nation tested thousands of samples of 
suspicious powder every day. In Maryland, for example, we tested over 
2,000 powders, nasal swabs and clinical specimens. Our scientists were 
performing these tests for the first time. We also learned how to 
properly perform environmental testing. For example, we learned that 
cotton swabs are not as reliable as nylon swabs in detecting Anthrax 
spores.
    Over the course of 3 weeks, the Maryland Department of Health and 
Mental Hygiene investigated eighty-five (85) suspected cases of 
Anthrax, including two deaths; tested thirty (30) private mailrooms for 
spores and opened clinics across the State to distribute antibiotics to 
individuals who were potentially exposed. At the conclusion of the 
event we had supplied Ciprofloxacin or Doxycycline to over three 
thousand (3,000) individuals as initial prophylaxis for potential 
anthrax exposure. Furthermore, we re-deployed staff from the 
tuberculosis program, the AIDS administration and the immunization 
clinics to handle more than one hundred (100) telephone calls a day to 
help with the surveillance investigation. The knowledge curve was steep 
and our resources were stretched to the limit. We shared this 
knowledge, as did others, with our public health partners across the 
country through a series of daily conference calls, e-mails and faxes.
    While some medical personnel in the Midwest and the Southwest are 
familiar with cutaneous anthrax., very few physicians and medical 
practitioners in the Eastern United States have ever seen it. The 
clinical symptoms of the other potential bioterrorist threat agents 
such as smallpox, plague and tularemia are also unknown to many of 
today's practicing physicians. If we are to be successful we need 
access to the clinicians and scientists who have actually seen these 
diseases. It is not just a matter of early recognition but we need 
their clinical ``pearls-of-wisdom'' about the treatment and management 
of these diseases. Hands-on experience is an essential key to making 
truly informed public health decisions. The modern technology at our 
disposal today makes it easier to access the knowledge, skills and 
information experts possess.
    The medical community responded during the Anthrax attacks with a 
thirst for new information. The public health system tried to quench 
that thirst by increasing our understanding of the diagnostic and 
therapeutic options and letting practitioners know where to call for 
administrative or clinical help. The goal was to raise the clinical 
index of suspicion across the Nation.
    New systems are needed for the rapid dissemination of this 
knowledge to the practicing healthcare community. Systems under 
development include rapid fax, e-mail and beeper systems. 
Teleconferencing and videoconferencing were frequently utilized to 
share important information on both anthrax and smallpox, but we need 
to develop more of these of educational services for the full range of 
biological threat agents (36 in all). Computer education through the 
Internet can be used in the future as an additional tool.
    On September 11, the Federal Centers for Disease Control and 
Prevention freely shared alerts and protocols with the public health 
community. For a variety of reasons, however, over time the information 
slowed to a trickle. The Health Alert Network--our nationwide 
communications information/training system--served as an essential tool 
in information sharing and even helped us clarify the appropriate role 
of the rapid screens used for environmental testing. This is an 
important example because at the height of the anthrax investigations, 
health department officials were being inundated with calls, e-mails, 
faxes and packages from vendors trying to sell ``quick-detection-
devices.''
    During the investigation, new linkages and relationships between a 
broad range of non-medical professionals such as environmentalist, 
disaster preparedness experts, fire and law enforcement officials and 
the medical professionals including emergency medical services 
personnel, occupational safety officials and ``bioweaponeers'' 
occurred. It is essential that these linkages are developed before a 
bioterrorist event occurs. Access to a core group of specialists in 
every State can be achieved by surveying the practicing community. 
There are a number of practitioners, scientists and researchers who 
have seen these threat agents in clinical settings. They should be 
identified now and asked to provide their expertise when an event 
occurs. In States like New York, New Jersey, Virginia and Maryland the 
medical and public health organizations are compiling databases of 
names, telephone numbers and e-mail addresses of experts for future 
reference.
    Access to cutting edge research is also important. This past 
summer, researchers in Canada performed an experiment to demonstrate 
the impact of opening an envelope filled with a biological agent in a 
sealed room. The results of this study served as an important tool in 
our understanding of how anthrax spores contaminate an enclosed space. 
The knowledge gleamed from this study was also important in the debate 
surrounding post-exposure vaccination.
    The need for new knowledge is not limited to the realm of 
bioterrorism. In the summer of 1997 in Maryland the public health 
community was challenged when fish with lesions began showing up in 
waters on Maryland's Eastern Shore. The need for information concerning 
a new and deadly fish disease became apparent immediately. In August of 
that year we not only faced the dilemma of fifty-thousand (50,000) dead 
and dying fish but we had to address the concerns of the watermen and 
fishermen who worked on those rivers. They were complaining about 
strange and unusual medical symptoms that defied explanation and were 
coupled with the belief that these symptoms were somehow related to the 
sick fish. We found ourselves in the midst of something completely 
new--pfiesteria pisscida.
    One of the most significant lessons learned during that time was 
how little information was known or available about the disease that up 
to that time had only been seen by a handful of people in North 
Carolina. The information was so scarce that the disease did not even 
have an official name. While we utilized our standard disease 
surveillance protocols to investigate and track reports of illness, our 
pool of information resources was limited to a small cadre of fish 
researchers in Florida and North Carolina who were not experts in human 
health. We discovered just how little information was available about 
pfiesteria.
    As we started our quest to identify if these watermen could have a 
medical condition, it became clear we would have to find an expert in 
dinoflagelates, the family of organisms that includes pfiesteria. These 
organisms were poorly understood or unknown by most public health or 
medical professionals. Like most public health agencies, we utilize the 
U.S. Centers for Disease Control and Prevention for expert advice. In 
most cases you simply pick up the telephone to talk to a disease 
expert. In this case we called and no expert was on staff who could 
answer our questions. They did refer us an expert who had previously 
worked for the CDC. He is currently the Chairman of the Department of 
Epidemiology and Preventive Medicine at the University of Maryland 
School of Medicine. He put a team together and was able to find another 
expert on the other side of town at the Johns Hopkins School of Public 
Health. In essence, the expertise we needed was in our own backyard and 
we did not know it.
    Related to the issue of accessibility of resources is assuring that 
the information, expert advice or technology is accurate and reliable. 
Every day I receive packets of brochures from companies, experts, 
inventors and vendors who want to demonstrate their products. They 
range from environmental testing equipment, gas masks and biohazard 
suits to gadgets that allegedly detect bioagents in the air. We must 
know if these products are legitimate and we must be able to verify 
that equipment is appropriate for use in the healthcare setting.
    In closing, I want to emphasize how well the public health system 
responded to the events of September 11th and the anthrax bioterrorism 
attacks. Our current system was stretched to the limit but we were able 
to mobilize quickly to address these public health threats. But these 
events were an eye-opener. We have discovered how much more we need to 
do to be effective and successful. We must increase the pools of 
resources so that credible information, reliable equipment and 
knowledgeable experts are available at a moment's notice.
    Thank you again for giving me this opportunity to speak to you 
today.

    Senator Wyden. Thank you.
    Mr. Edwards, welcome.

 STATEMENT OF MR. JOHN G. EDWARDS, PRESIDENT AND CEO, PHOTONIC 
                             SENSOR

    Mr. Edwards. Good morning, Mr. Chairman and Members of this 
Subcommittee. Thank you for inviting me to testify. I 
appreciate the opportunity to provide a perspective on how 
entrepreneurs and the government can work together in fighting 
against bioterrorism. I am President and Chief Executive 
Officer of Photonic Sensor. Photonic Sensor is a small, high 
tech company based in Atlanta, Georgia. We develop and 
manufacture biological and chemical sensing systems based on 
this tiny chip that I am holding in my hand.
    What I would like to share with you briefly this morning is 
the promise of this extraordinary chip as a part of the 
bioterrorism defense arsenal and how a combination of 
university scientists, entrepreneurial spirit, and government 
support led to its development. The creative spark came from 
Nile Hartman and his coworkers at the Georgia Institute of 
Technology almost a decade ago.
    The potential of their optical sensor that revolutionized 
biological and chemical sensing was immediately evident. Sadly, 
there is often a disconnect between what is exciting for 
science and what is exciting for business. Revolutionary 
technologies mean major changes in the way things are done. 
Major changes mean big risk, and big risks scare big companies. 
They have too much to lose. That is where entrepreneurs enter 
the picture.
    Photonic Sensor was formed in collaboration with, and 
eventually spun out of, Georgia Tech solely for the purpose of 
commercializing this optical sensor chip. Startup companies are 
very different from big companies. We like big risks. The 
bigger the risk, the better our chances of eventually growing 
into a risk-averse big company, which is, after all, what we 
want to do.
    Without early big company interest, small high tech 
companies must turn in other directions for support. The 
Department of Energy, the Department of Defense, and especially 
the National Institutes of Health have been major sources of 
support and guidance in bringing our optical sensorship from 
laboratory promise to commercial reality. The development path 
was long and winding, but the outcome was the successful 
emergence of a developed technology with a risk reduced to a 
level where big companies are now willing to get involved.
    It turns out that our optical chip has considerable 
advantages for detecting biowarfare agents such as anthrax, 
botulism, and smallpox. Current biodetection instruments, even 
the advanced instruments under development for the military, 
are very complex and costly. They are simply not practical for 
widespread domestic deployment. A place we see a particular 
chance to help is with so-called first responders--fire 
departments, police and medical alert teams in towns from 
Eugene, Oregon, to Albany, Georgia. Photonic Sensor can provide 
a simple, low-cost tool to meet the needs of these first 
responders.
    Photonic Sensor's work on bio agent detection began about a 
year-and-a-half ago, but the urgency has obviously accelerated 
since September 11. We are now responding to calls from the 
Department of Defense Technical Support Working Group and the 
National Institutes of Health for innovative antiterrorism 
tools. Our partners in these efforts are the Environmental 
Technologies Group of Baltimore, Maryland, a leading supplier 
of biological and chemical agent detection systems--and I 
should add, a very big company--and the Centers for Disease 
Control and Prevention, our neighbor and frequent collaborator. 
In addition, Photonic Sensor Environmental Technologies and 
D.A. Technologies of New York are exploring the development of 
a bio agent monitoring system for the New York City subway.
    Thanks to previous government supports, Photonic Sensor is 
in a position where it can contribute to the fight against 
bioterrorism. However, I know this Subcommittee is interested 
in how it can make the process easier for us and others like 
us.
    I would like to offer two observations about our 
experience. First, it is difficult for small companies like 
Photonic Sensor to get visibility within large agencies like 
the Department of Defense. Good contacts are just as important 
as good technology. However, a small marketing budget and no 
staff in Washington severely limits our ability to develop good 
government contacts. These Small Business Innovator Research, 
or SBIR program, addresses this problem to some extent, but 
even the SBIR process is something of a shot in the dark, and 
its multiphase solicitation proposal review and award cycle can 
easily outstretch the financial staying power of a small 
company.
    A second challenge is the many compliance and reporting 
requirements that come with government grants, especially with 
multiple agencies. Each imposing their own rules and 
regulations. Particularly frustrating for Photonic Sensor has 
been the seemingly redundant financial audits by each agency, 
and even being told in the course of these audits that a 
required financial practice of one agency is absolutely 
unallowed for another.
    Photonic Sensor's story is, of course, just one of many. 
Nevertheless, I hope it has been helpful. Thank you for your 
interest.
    [The prepared statement of Mr. Edwards follows:]
  Prepared Statement of John G. Edwards, President & Chief Executive 
                        Officer, Photonic Sensor
    Good morning Mr. Chairman and Members of the Subcommittee. Thank 
you for inviting me to testify today. I appreciate the opportunity to 
provide a perspective on how entrepreneurs and the government can work 
together in the fight against bioterrorism.
    My name is John Edwards, and I am President and Chief Executive 
Officer of Photonic Sensor. Photonic Sensor is a small, high tech 
company based in Atlanta, Georgia. We develop and manufacture 
biological and chemical sensing systems based on the tiny optical 
sensor chip I am holding in my hand. What I would like to share with 
you briefly this morning is the promise of this extraordinary optical 
chip as a tool in our bioterrorism defense arsenal, and how a 
combination of university scientists, entrepreneurial spirit and 
government support led to its development.
    The creative spark came from Nile Hartman and his coworkers at the 
Georgia Institute of Technology almost a decade ago. The potential of 
their optical sensor chip to revolutionize biological and chemical 
sensing was immediately evident. Sadly, there is often a disconnect 
between what is exciting for science and what is exciting for business. 
Revolutionary technologies mean major changes in the way things are 
done. But major changes mean big risks, and big risks scare big 
companies: they have too much to lose. That is where entrepreneurs 
enter the picture. Photonic Sensor was formed in collaboration with and 
eventually spun out of Georgia Tech solely for the purpose of 
commercializing this optical sensor chip. Startup companies are very 
different from big companies. We like big risks. The bigger the risk, 
the better our chances of eventually growing into a risk-averse big 
company, which is what we really want to be.
    Without early big company interest, small, high tech companies must 
turn in other directions for support. The Department of Energy, the 
Department of Defense and especially the National Institutes of Health 
have been major sources of support and guidance in bringing our optical 
sensor chip from laboratory promise to commercial reality. The 
development path was long and winding, but the outcome was the 
successful emergence of a developed technology, with the risk reduced 
to a level where big companies are now willing to get involved.
    It turns out that our optical sensor chip has considerable 
advantages for detecting biowarfare agents such as anthrax, botulism 
and smallpox. Current bioagent detection systems, and even the advanced 
instruments under development for the military are very complex and 
costly. They are simply not practical for widespread domestic 
deployment. A place we see a particular chance to help is with so 
called first responders--the fire departments, police and medical alert 
teams in towns from Eugene, Oregon to Albany, Georgia. Photonic Sensor 
can provide a simple, low cost tool to meet the needs of these first 
responders.
    Photonic Sensor's work on bioagent detection began about a year-
and-a-half ago, but the urgency has obviously accelerated since 
September 11. We are now responding to calls from the Department of 
Defense/Technical Support Working Group (BAA 02-Q-4655) and the 
National Institutes for Health (SB-STRR) for innovative anti-terrorism 
tools. Our partners in these efforts are Environmental Technologies 
Group of Baltimore, Maryland, a leading supplier of both biological and 
chemical agent detection systems (and, I should add, part of a very big 
company), and the Centers for Disease Control and Prevention, our 
neighbor and frequent collaborator in Atlanta, Georgia. In addition, 
Photonic Sensor, Environmental Technologies Group and E.A. Technologies 
of New York, New York, are exploring the development of a bioagent 
monitoring system for the New York City subway.
    Thanks to previous government support, Photonic Sensor is in a 
position where it can contribute to the fight against bioterrorism. 
However, I know this Subcommittee is interested in how it can make the 
process easier for us and others like us. I would like to offer two 
observations about our experience.
    First, it is difficult for small companies like Photonic Sensor to 
get visibility within large agencies like the Department of Defense. 
Good contacts are just as important as good technology. However, a 
small marketing budget and no staff in Washington, DC severely limits 
our ability to develop good government contacts. The Small Business 
Innovative Research (or SBIR) program addresses this problem to some 
extent. But even the SBIR process is something of a shot in the dark, 
and its multi-phase solicitation, proposal, review and award cycle can 
easily out-stretch the financial staying power of a small company.
    A second challenge is the many compliance and reporting 
requirements that come with government grants, especially with multiple 
agencies each imposing their own rules and regulations. Particularly 
frustrating for Photonic Sensor has been the seemingly redundant 
financial audits by each agency--and even being told in the course of 
these audits that a required financial practice of one agency is 
absolutely unallowable for another!
    Photonic Sensor's story is, of course, just one of many. 
Nevertheless, I hope it has been helpful. Thank you for your interest.

    Senator Wyden. Dr. Hatchett.

   STATEMENT OF DR. RICHARD J. HATCHETT, M.D., COORDINATOR, 
  CIVILIAN MEDICAL RESERVE WORKING GROUP, CLINICAL ASSISTANT 
 ATTENDING, MEMORIAL HOSPITAL, MEMORIAL SLOAN-KETTERING CANCER 
                             CENTER

    Dr. Hatchett. Good morning, Mr. Chairman. First, I would 
like to commend and fully support your efforts to establish a 
strategic technology reserve. It feeds very clearly into the 
sorts of things we have been working on. I would like to thank 
you for inviting me to appear before you to discuss the ways 
that the coordination of medical professionals can enhance the 
ability of our Nation's communities to respond to acts of 
bioterrorism.
    I served as one of the coordinators of the medical 
volunteers after the attacks on the World Trade Center, and I 
am currently coordinating the Civilian Medical Reserve Working 
Group, which is a citizens' initiative of medical professionals 
and public health professionals advocating the creation of a 
Medical Reserve Corps. Last week, President Bush endorsed the 
creation of Medical Reserve Corps as part of his USA Freedom 
Corps initiative. The Medical Reserve Corps is currently a 
division that will consist of retired or inactive doctors, 
nurses, and allied health professionals organized at the local 
level and integrated into local emergency response plans.
    Reservists will be trained as first responders, and capable 
of setting up field and triage sites to assist uniformed 
personnel and thereby decompress existing facilities in the 
event of mass casualties, but their key function will actually 
be as reserve personnel capable of being integrated into 
hospitals and clinics and public health systems during events 
that place stress on such systems. These events may be natural, 
such as severe epidemics or natural disasters, or they might 
develop after attacks with weapons of mass destruction.
    Local units of the reserve will be flexible and adaptable 
and the service will be as capable of manning field triage 
sites as staffing, vaccination, and antibiotic distribution 
points, and as ready to work in community hospitals as deliver 
care to patients in their homes if the need arises.
    I would like to say a few words on the subject of emergency 
preparedness. I think everyone in this room is aware we are not 
sufficiently prepared to respond to acts of bioterrorism or for 
attacks of weapons of mass destruction. Our hospitals are 
inelastic, our public health systems are not robust, our first 
responders need more training and more equipment. Article 3 of 
Frist-Kennedy, mobilizing over $1 billion to improve 
bioterrorism, is a positive step, as is the President's 
request, announced yesterday, to dedicate $5.9 billion in the 
next fiscal year to finance improvements in the Nation's public 
health system.
    The expansion of the national pharmaceutical stockpile, and 
the dedication of nearly $2 billion to the National Institutes 
of Health basically speak of the Administration's commitment to 
this endeavor, and we commend these efforts as well. We are 
definitely moving in the right direction.
    At the same time, one of the things we want to remind the 
Subcommittee is that we cannot neglect the resources we already 
have, the assets that are already available. Merely having 
assets do not make them useful. The value of assets are not 
fixed. Assets become useful and they become valuable when they 
are organized, with structures to fix them in relation to each 
other.
    Hernando de Soto, the Peruvian political economist, has 
pointed out the poor of the world's developing nations actually 
possess assets, but these assets, because they have not been 
included in formal property systems, have not been capitalized 
and thus cannot interact with each other. I think much the same 
can be said for our medical and public health assets.
    The mitigation of acts of bioterrorism can be viewed 
broadly as a problem of resource allocation under budget 
constraints. No community in America will ever develop the 
capacity to take care of 20,000 extra patients. I think that it 
is unrealistic to expect them to do so. Preparedness will not 
mean having beds waiting in reserve on empty wards, but it will 
mean being able to quickly reorganize the assets at hand and 
maximize their utility.
    This will mean, in the first place, knowing what assets 
exist. We have advocated actually the creation in every 
community of a medical registry, a census of the total 
available medical assets, including doctors and nurses and 
pharmacists, but also retired and otherwise inactive 
professionals, including hospital beds, but also decommissioned 
wards, potential auxiliary facilities, and including such 
things as quarantine facilities, staging areas, evacuation 
routes, and supply depots.
    Knowing what we have will improve our capacity to use it, 
and it will also let us make the hard choices that may need to 
be made with as much confidence as we can muster. President 
Bush's Freedom Corps initiative creates a Medical Reserve 
Corps, and it also mobilizes AmeriCorp's Senior Corps and Serve 
Study volunteers in the cause of homeland security. Many of 
these volunteers will be devoted to projects related to public 
health and bioterrorism preparedness. The number of such 
volunteers called to service will be substantial, perhaps as 
many as 100,000. In bringing such a large force to bear on the 
problems that now confront us, we should not let the 
opportunity to create a cohesive and organized force slip from 
our hands.
    I see little reason the Medical Reserve Corps and Community 
Emergency Response Teams and other volunteers should not be 
brought together under one overarching structure as a true 
Civilian Medical Reserve. Over time and training and drilling 
together and participating in team-building activities such a 
Civilian Medical Reserve would become a truly formidable force 
ready to serve our country in a crisis and be the backbone of a 
sustained response in more prolonged events.
    [The prepared statement of Dr. Hatchett follows:]
Prepared Statement of Richard J. Hatchett, M.D., Coordinator, Civilian 
 Medical Reserve Working Group, Clinical Assistant Attending, Memorial 
            Hospital, Memorial Sloan-Kettering Cancer Center
    Mr. Chairman, Distinguished Members of the Committee: Thank you for 
inviting me to appear before you to discuss the ways that medical 
professionals and voluntary organizations in the private sector can 
contribute to the war against bioterrorism. My name is Richard 
Hatchett. I am an Emergency Room physician at Memorial Hospital in New 
York City and coordinated the efforts of medical volunteers at the 
Stuyvesant Triage Center in the days after the attacks on the World 
Trade Center. In 1997 I served as Clinical Coordinator of the Yale 
University Ebola Project in Makokou, Gabon and I recently coauthored a 
privately circulated white paper on smallpox with Professor Jacob T. 
Schwartz of New York University. Over the last 4 months, I have served 
as the coordinator of the Civilian Medical Reserve Working Group, a 
citizens' initiative advocating the creation of a Medical Reserve Corps 
to enhance the capacity of local communities to respond effectively to 
epidemics, acts of terrorism, and natural catastrophes. Last Wednesday, 
in an Executive Order, President Bush endorsed our effort by calling 
for the creation of a Medical Reserve Corps as one component of his USA 
Freedom Corps initiative.
    I called the first meeting of what became the Civilian Medical 
Reserve Working Group within a couple of weeks of the attacks. The 
efforts of volunteers after the events of September 11 were 
characterized by intense camaraderie, and the dedication, endurance, 
and integrity of the volunteers was awe-inspiring. In terms of human 
capital, one could ask for nothing more: the doctors and nurses, 
medical students and residents who converged on Ground Zero were hard-
working, intelligent, independent, and used to taking responsibility 
for their actions. Where their efforts were well coordinated they 
performed almost miraculously. The problem was that because the 
response was spontaneous, in most cases the efforts of the volunteers 
were not well coordinated.
    From an operational point of view, the spontaneous flocking of 
medical volunteers to Ground Zero highlighted the problems associated 
with an uncoordinated response. Dr. Antonio Dajer, the Associate 
Medical Director of the Emergency Department at NYU Downtown Hospital, 
an institution located four blocks from Ground Zero, has written 
eloquently of his frustration at finding ``trauma triage areas'' run by 
volunteers set up on the street within a few blocks of his fully 
equipped emergency room. The triage areas that were set up operated 
independently, outside the New York City Office of Emergency 
Management's Incident Command Structure and with no overall system of 
coordination. The chains of command governing such sites were thus 
ambiguous or non-existent. Several operated in areas that had not been 
cleared by structural engineers. The lack of coordination also meant 
that there was no functional system of communication or supply, even 
for the ``approved'' triage facility at Stuyvesant High School, and no 
way to assure continuity of staffing. The credentials of volunteers 
could not be verified, and security was compromised by the continual 
flow of self-declared ``volunteers'' across the established police 
perimeter. Finally, hospitals throughout the city reported significant 
concerns that their own staffing would be compromised because their 
employees were ``helping out'' at Ground Zero.
    It was to explore ways to address these problems while harnessing 
the extraordinary talents of civilian medical professionals that we 
convened what became the Civilian Medical Reserve Working Group. As 
mentioned above, we gathered for the first time before the end of 
September--which is to say, before anthrax was distributed through the 
United States Mail. We had considered abstractly whether an 
organization such as we envisioned might prove useful in the event of 
biological or chemical attack; the anthrax episodes convinced us that 
it would. One of my colleagues, Eric David, participated as a volunteer 
in the distribution of antibiotics at the Morgan postal facility and 
witnessed firsthand the difficulty of educating and dispensing 
antibiotics to large numbers of anxious employees of varying 
educational backgrounds and degrees of sophistication. Ed Carubis of 
the New York City Department of Health notes that the evaluation of a 
single case of anthrax at Manhattan Eye, Ear, and Throat Hospital 
required setting up 12 registration stations to process worried 
patients and employees (personal communication). In more widespread 
outbreaks, the need to ramp up and create field stations for 
epidemiologic interviews, sample collection, and distribution of 
antibiotics or vaccines would rapidly overwhelm even the most robust 
Departments of Health.
    While causing only 23 infections and 5 deaths, the anthrax attacks 
did in fact place a severe strain on the American government and public 
health system. Activities of all branches of the Federal Government 
were disrupted, approximately 300 postal and other facilities were 
tested for the presence of anthrax spores, and approximately 32,000 
persons initiated antimicrobial prophylaxis following potential 
exposure to B. anthracis at workplaces in Florida, New Jersey, New 
York, and Washington, D.C. The November 9 Morbidity and Mortality 
Weekly Report, reported that ``For the week of October 21-27, Colorado, 
Connecticut, Louisiana, Maryland, Montana, North Dakota, Tennessee, 
Wisconsin, and Wyoming reported 2,817 bioterrorism-related calls (mean 
per State: 313; range: 23-800) and approximately 25 investigations of 
bioterrorism threats in each State. From eight to 30 full-time 
personnel are engaged in these responses in each State . . . For the 
same period, public health laboratories in 46 States participating in 
the Laboratory Response Network reported receiving approximately 7,500 
specimens and isolates for B. anthracis testing.'' The obvious lesson 
is that even limited attacks can cause major disruption.
    Biological weapons are agents of terror. In this regard, they 
succeed so well precisely because they are so insidious. They exert a 
profound multiplier effect, creating a vast number of ``worried well'' 
patients, many of whom will crowd medical facilities seeking treatment 
or reassurance. Because infections with anthrax share many clinical 
features with those of influenza, and the threat of anthrax emerged 
just as the flu season was getting under way, this effect was 
exacerbated, so that many patients who ordinarily would have been 
diagnosed with flu or an unspecified viral syndrome received Cipro or 
other antibiotics ``just in case.'' The anthrax episodes precipitated a 
public health crisis; what they did not do was precipitate a crisis in 
the Nation's hospitals. With a different mechanism of distribution and 
larger quantities of spores, the situation could have been quite 
different. The release of a few grams of highly refined spores in a 
crowded stadium or into a subway station at rush hour could conceivably 
produce hundreds or thousands of victims, many of whom would be 
critically ill, within a few days. These victims would present to local 
emergency rooms and be admitted to local hospitals; and it might be 
days before anthrax was identified as the causative agent.\1\ Very 
large cities, such as New York, might be able to handle the surge of 
patients; smaller cities would surely be swamped.
---------------------------------------------------------------------------
    \1\ Although this seems unlikely, given the currently heightened 
awareness among physicians about the disease and its manifestations.
---------------------------------------------------------------------------
    For a variety of reasons, it is difficult to estimate the true 
capacity of hospital systems. For one reason, the systems are seldom if 
ever tested. September 11 might be regarded as a full test of the New 
York City hospital system, which contains more than 100 hospitals. Most 
hospitals within the city cleared their emergency rooms, created extra 
emergency room capacity by adding beds, electively discharged or 
transferred patients to more distant facilities, and canceled elective 
operative procedures. Because of the violence of the collapses, 
however, most people who survived and were injured qualified as 
``walking wounded'' and did not require admission. The emergency 
departments of the four hospitals closest to the World Trade Center and 
another hospital serving as a burn referral center reported treating 
1103 survivors in the first 48 hours after the attack, but of this 
number only 181 (16 percent) required admission (data from Morbidity 
and Mortality Weekly Report, January 11, 2002). NYU Downtown Hospital 
treated in excess of 400 patients between 9 a.m. and 1 p.m. and cleared 
its emergency room by early afternoon (Antonio Dajer, personal 
communication). No formal assessment of the actual admitting capacity 
of New York City hospitals on September 11 has been performed, but 
based on information collected by the Greater New York Hospital 
Association from a number of hospitals it is possible to extrapolate 
that the system possibly could have absorbed about 3000 patients. How 
many critically injured patients requiring mechanical ventilation the 
system could have absorbed is unknown. By comparison, in testimony 
before the U.S. Senate Governmental Affairs Subcommittee on 
International Security, Proliferation and Federal Services on July 23 
of last year, Dr. Tara O'Toole reported that the State of Maryland, 
home to more than 60 hospitals and two academic medical centers, would 
be unable to handle an emergency that produced 100 patients needing 
ventilators.
    The United States health care system is fiercely competitive and 
notoriously inelastic. Hospitals are under tremendous financial 
pressure, with thin and falling margins forcing many to decommission 
beds and switch to ``just-in-time'' models of staffing and supply. An 
aging population and reduced lengths of stay mean that the beds that 
are available are filled by older and sicker patients, who require 
comparatively more attention. My hospital, for example, has reduced its 
bedspace by approximately 20 percent over the last few years and 
reconfigured several of the floors thus emptied. This means that only a 
portion of the decommissioned beds can be brought back into service in 
any reasonable timeframe. A slight surge in hospital admissions 2 weeks 
ago left 17 sick cancer patients requiring admission sleeping in the 
Urgent Care Center, which itself contains only 12 beds, overnight. It 
took until about 3 p.m. the following day for beds to be found for all 
of these patients. One can imagine, then, the crises that would develop 
should a real and sustained surge in patients occur.
    The dynamics of an attack with a contagious agent such as plague or 
smallpox would be quite different from even large-scale attacks with 
noncontagious agents such as anthrax or botulinum toxin. The effect of 
such an attack would not be an outbreak, as with the latter agents, but 
an epidemic. And epidemics, once they pass a certain critical 
threshold, are difficult to control, contain, or predict. The scope of 
the epidemic might accelerate for weeks and not peak for several 
months. Depending on the agent used, patients might require respiratory 
isolation and need to be admitted to specially vented rooms, which (it 
goes almost without saying) are in extremely short supply. Depending on 
the size of the epidemic, and to some extent on the virulence of the 
causative organism, it might be necessary to convert schools, 
gymnasiums, hotels, or armories into auxiliary facilities or quarantine 
stations. It might even be necessary, as was the case during the 
Spanish Influenza epidemic in the fall and winter of 1918, to switch 
over to a system of home care.
    And the issue of bedspace may, in fact, pale beside the issue of 
staffing. Tara O'Toole has argued that ``The big problem is not beds as 
everyone seems to suppose--it is staff. And there is no way to fix that 
in the short term.'' Staffing shortfalls may be exacerbated by the fear 
and flight of persons inadequately trained in the management of 
infectious diseases and other illnesses related to biological or 
chemical terrorism. Such staffing shortages would undoubtedly be 
particularly acute in the event of an outbreak sufficiently large to 
require the opening of auxiliary facilities or switching to a system of 
home care.
    This was the complex bundle of problems we set out to address. The 
model we have evolved for a Civilian Medical Reserve incorporates the 
Medical Reserve Corps as an essential element but also relies on the 
dedicated work of AmeriCorps and other volunteers. It requires the 
creation of a medical registry, the purpose of which is to enumerate 
and incorporate in community-wide planning what we have called 
``hidden'' human and institutional assets. It also requires tight 
integration and coordination of the Medical Reserve Corps into local 
emergency response planning and anticipates the development of certain 
information technology assets and capabilities. In the sections that 
follow I will attempt to lay out a blueprint of what we believe an 
adequately structured and sufficiently funded Civilian Medical Reserve 
can accomplish.
               the role of the medical reserve corps \2\
    The Medical Reserve Corps will consist of physicians, nurses, and 
supporting personnel who coordinate and work with the other elements of 
the Metropolitan Medical Response System. The Medical Reserve Corps 
will be led by doctors, nurses, and other medical professionals who 
receive special training in disaster medical response, the theory and 
practice of triage, biocontainment, and other relevant disciplines. As 
part of our proposed Civilian Medical Reserve, they would be assisted 
by a substantial group of civilian volunteers drawn from outside the 
medical profession and trained within the Medical Reserve itself. Local 
units of the Medical Reserve Corps will be pre-equipped and coordinated 
with existing municipal disaster plans, so that in the event of a major 
structural disaster they can be activated and establish field triage 
sites within three to 6 hours. They will also provide back-up in the 
event of major public health crises (particularly bioterrorist attacks) 
placing unusual demands on the medical system and be trained to detect 
and manage the agents of concern in such situations (e.g. anthrax, 
smallpox, plague, tularemia, viral hemorrhagic fevers, etc.).\3\ They 
will augment the efforts of public health authorities in administering 
vaccines and performing epidemiologic investigative work during 
outbreak situations or bioterrorism events, and they can assist with 
non-emergent, large-scale community medical projects during 
``peacetime''.
---------------------------------------------------------------------------
    \2\ In the sections that follow, ``Medical Reserve Corps'' refers 
specifically to the voluntary organization created within the USA 
Freedom Corps to recruit and train retired or otherwise inactive 
healthcare professionals as an emergency preparedness initiative. 
``Civilian Medical Reserve'' refers to a larger initiative in which the 
Medical Reserve Corps would work in conjunction with AmeriCorps, Senior 
Corps, and Federal Work Study Program volunteers and be charged with a 
wide range of tasks relating to biopreparedness.
    \3\ Advance training and drilling considerably reduces the anxiety 
associated with caring for patients with frightening infectious agents, 
and specially trained teams could deploy to hospitals caring for 
patients with diseases such as Marburg or Ebola fevers.
---------------------------------------------------------------------------
    Designing the Medical Reserve Corps so that it remains flexible and 
adaptable is essential. The Medical Reserve Corps must be capable of 
responding to both mass casualty incidents and evolving crises. With 
mass casualty incidents, local coordination is crucial. Studies of 
mortality patterns in earthquakes consistently demonstrate that 
response time is pivotal, that 25 to 50 percent of those who are 
injured and die slowly could have been saved if first aid had been 
rendered immediately, and that the greatest demand for patient care 
occurs during the first 24 to 48 hours after the disaster. Thus, the 
most critical needs of an affected population must be met by local 
providers. So must the needs of a community grappling with a severe 
epidemic or the consequences of a bioterrorist attack. We believe the 
development of locally coordinated and potentially mobile medical 
reserve units can play a role in enhancing the State's preparedness to 
deal with such situations.
    In the immediate aftermath of a disaster, the responsibilities of 
reservists might include triaging patients, providing essential medical 
care, and preparing patients for evacuation to local hospitals. In the 
twenty-four to seventy-two hours after a disaster, their role will 
likely shift to providing frontline support to search-and-rescue 
workers. In evolving crises triggered by bioterrorist attacks or severe 
epidemics their role in supporting overtaxed medical systems would be 
equally important. The establishment of mutual aid arrangements with 
Reserves in nearby cities will create a mechanism whereby care can be 
expanded into auxiliary facilities or provided in patients' homes as 
the need arises.
    Given recent events, we strongly believe that the general medical 
community will find the concept of the Medical Reserve Corps extremely 
attractive and that such an organization will have no difficulty 
attracting volunteers. The Medical Reserve Corps will provide for the 
special training and continuing education of its members and enable the 
State to identify and coordinate those physicians and other medical 
professionals with special experience and expertise. A properly trained 
and coordinated Medical Reserve Corps will be ready to meet the needs 
of our communities in acute crises and to provide the backbone of a 
sustained response in prolonged ones.
                       identifying hidden assets
    One of the major activities of local units of the Civilian Medical 
Reserve will be the creation and maintenance of comprehensive medical 
registries in the communities they serve. These registries will include 
but not be limited to practicing professionals and existing 
institutions. Perhaps the best reason to create such a registry, in 
fact, is to identify ``hidden'' human and institutional assets. By 
enumerating these assets, the registry will permit emergency planners 
to put together a census of the ``total available medical assets'' 
within a given community. The ways in which such information can then 
be used to facilitate planning and enhance preparedness are discussed 
at greater length below.
    The idea of accounting for hidden assets evolved from an event on 
September 11. Dr. Mark Robson, a breast oncologist at Memorial Hospital 
and a man who gives chemotherapy for a living, called me to see if he 
could assist in preparing the Urgent Care Center to receive patients. 
He explained that prior to joining the staff at Memorial he had served 
in the military and received training in triage and mass casualty 
response. Subsequently we realized that in any community there must be 
many physicians with special skills or relevant prior experience not 
reflected in their practice designations. Such experiences include but 
are not limited to military service, work in refugee camps or other 
austere environments, involvement with medical relief efforts in 
complex humanitarian emergencies, and prior employment in emergency 
rooms. This realization made us ponder other ways in which available 
but untapped medical expertise might be hidden or buried. Other hidden 
human assets we have identified include:
 Retired medical professionals.
 Persons with prior medical training and licensure who no 
    longer practice (because they are administrators, entrepreneurs, 
    scientists or consultants).
 Medical professionals who work outside of traditional hospital 
    settings (in community health centers, visiting nurse practices, 
    etc.)
 Medical and nursing students.
    Registration with the Civilian Medical Reserve will create a 
mechanism for calling such persons into the hospital system in the 
event of a severe crisis, and persons with special skills or prior 
experiences can be deployed where and as needed. We believe finding and 
registering such personnel represents a quick and exceedingly cheap way 
to enhance local response capacity.
    As there are hidden human assets, so also are there hidden 
institutional assets. The first step would be to assess a community's 
existing resources in terms of beds, isolation facilities, and critical 
care capacity. The Reserve would then assess the extra capacity 
provided by community health centers, post-anesthesia care units (which 
can provide intensive care), decommissioned but restorable clinics and 
wards, and potential auxiliary facilities such as schools, gymnasiums, 
and armories. This information would be useful in elaborating 
community-wide plans, assessing gaps in current levels of preparedness, 
and identifying thresholds at which mutual aid arrangements would need 
to be activated, auxiliary facilities opened, home care provided, and 
responsibilities devolved (from physicians to nurses, medical students, 
etc.).
    The administrative work of establishing and maintaining the medical 
registries would be performed by AmeriCorps or Federal Work Study 
Program volunteers under the supervision of the Medical Reserve Corps' 
full-time medical staff.
      the role of other usa freedom corps programs and volunteers
    The President, in his Call to Service, has recognized and called 
upon the industry, goodwill, and commitment of the American public in 
this time of national need. By creating the USA Freedom Corps Council 
and naming John Bridgeland to head the affiliated office within the 
White House, President Bush has signalled his faith in the capacity of 
normal citizens to contribute in areas related to national security and 
domestic defense and demonstrated his strong personal commitment to 
this endeavor. By calling for the expansion of AmeriCorps, Senior 
Corps, and Serve Study programs, he has dedicated his Administration to 
mobilizing a vast number of citizens in this effort. By establishing 
Citizen Corps and the Citizen Corps Councils, he has created a 
mechanism of coordinating these efforts in the interest of homeland 
security. And by asking Congress for more than $500 million in Fiscal 
Year 2003 to support these initiatives, he has called for the funds 
needed to transform this vision into reality.
    The Citizen Corps Councils have been tasked with developing 
community action plans that include assessments of infrastructure 
vulnerabilities and possible threats, available local resources, and 
the best ways to organize and expand local efforts. These plans will 
coordinate the community-based prevention and preparedness efforts of 
the programs falling under the mantle of the Citizen Corps (Medical 
Reserve Corps, Volunteers in Police Service, Neighborhood Watch, 
Community Emergency Response Teams, etc.). FEMA will provide $144 
million in matching funds in Fiscal Year 2003 to help create and 
maintain the efforts of the Councils. I would urge the local Councils 
to allocate a portion of this funding to censusing available medical 
assets in the manner described above, and to make performing such 
censuses a very high priority. The resulting registries could then be 
maintained by AmeriCorps or Federal Work Study Program volunteers 
working in conjunction with local emergency offices and Departments of 
Health and under the supervision of the Medical Reserve Corps' full-
time medical staff.
    Coordinating the response to and remediation of acts of 
bioterrorism poses considerable technical and logistical challenges. 
One of the biggest obstacles is that the groups whose activities must 
be coordinated (EMS and other first responder services, Departments of 
Health, hospitals) function autonomously in their day-to-day activities 
and historically have not forged strong links with each other. A 
Civilian Medical Reserve has the potential to become a nexus connecting 
these groups and promoting the formation of enduring institutional 
alliances. Municipalities implementing the Civilian Medical Reserve 
model would coordinate the Medical Reserve Corps and Community 
Emergency Response Teams with AmeriCorps, Senior Corps, and Serve Study 
volunteers engaged in public health and disaster preparedness and 
relief programs. Volunteers would interact on a regular basis, to 
foster team building and esprit de corps, and participate in drills and 
exercises together. These activities would lay the groundwork for a 
broad-based but coordinated civilian response in times of crisis.
    President Bush and Senators McCain and Bayh have called for an 
expansion of the AmeriCorps National Civilian Community Corps program 
to support homeland security, public health, and disaster preparedness 
and relief activities. I would urge that some of these new recruits be 
specifically assigned to Civilian Medical Reserve units to provide 
administrative and other support to members of the full-time medical 
staff. A large fraction of the AmeriCorps volunteers thus assigned 
would, when not otherwise engaged, be detailed to local hospitals to 
help implement hospital preparedness plans and foster the development 
of interhospital communication and coordination.
    A Civilian Medical Reserve unit would consist of a small full-time 
medical staff, the Medical Reserve Corps, and non-medical staff. The 
non-medical staff would engage in training and self-organization 
activities and have the following responsibilities when mobilized 
during disasters or other public health crises:
 Providing general assistance to physicians and nurses.
 Transporting patients and handling supplies.
 Tracking patients and maintaining medical records.
 Maintaining communication and supply networks.
 Providing security.
 Performing situational tasks appropriate to their level of 
    training.
    Under normal circumstances, the non-medical staff would have the 
following functions:
 Developing communication and database systems.
 Developing and distributing training materials.
 Contingency planning.
 Nurturing alliances with private voluntary organizations.
 Exchanging solutions with other Civilian Medical Reserve 
    units.
 Creating and maintaining the medical registry.
 Assisting local authorities in their efforts to foster 
    communication and coordination between hospitals and implement 
    hospital preparedness plans.
    The problems of designing and implementing Civilian Medical Reserve 
structures will vary from community to community, depending on what 
human and institutional assets are available and how these are 
organized and configured. A solution that works in Boston may not be 
relevant in Buffalo and almost certainly will not be applicable to 
Binghamton. Creating a central clearinghouse to which local Citizen 
Corps Councils can refer for guidance and inspiration would permit 
communities the freedom to develop solutions appropriate to their needs 
and resources while allowing them to profit from each other's 
experience.
               the role of other voluntary organizations
    Volunteers provided many critical services in the days after the 
attacks on the World Trade Center, from transporting workers and 
supplies from staging areas to Ground Zero to providing food and 
comfort to uniformed personnel and assisting in search and rescue 
efforts. Existing and spontaneously evolving voluntary organizations 
usefully channeled the outpouring of public support and provided their 
members with the ancillary, but by no means negligible, benefit of 
being able to do something. The emotional devastation of the attacks 
was compounded for many by the frustration of having no meaningful way 
to respond. The desire to respond and demonstrate solidarity with the 
survivors and rescue workers explains the long queues at blood donation 
centers across the country, the tremendous and immediate charitable 
giving, and the formation of numerous new voluntary organizations.
    One of the most interesting phenomena of the last few months has 
been the persistence of these spontanteously evolved organizations. 
Such organizations have emerged to meet specific local needs, from the 
provision of clothes and supplies to construction workers to the 
``staffing'' of cheering points along the West Side Highway and 
advocacy of victims' rights. Not surprisingly, many of these 
organizations are highly adapted to the functions that define their 
purpose. They were able to respond (and respond rapidly) to events 
because of their lack of rigid structure. Collectively, they 
demonstrate the ingenuity and initiative of affected populations and 
represent a wonderful, bottom-up mechanism for addressing new and 
previously unrecognized societal needs.
    Several of these new organizations address problems related to 
homeland security, and many of these are organized along disciplinary 
lines. Our Civilian Medical Reserve Working Group is but one of many 
examples. Andrew Rasiej, who has been involved with the effort to 
establish NET Guard, was instrumental in organizing Silicon Alley 
Cares, a consortium of about 1500 volunteers from New York City's 
information technology community. Sue Pinco, a social worker at 
Columbia, has put together a group called NYC-CAN that last week 
sponsored a weeklong ``Training Institute for First Responders'' with 
the goal of developing multidisciplinary crisis-response teams to 
address acute mental health care needs after future disasters. The 
needs that will arise after acts of bioterrorism will be complex and 
have consequences that extend beyond the domain of public health. 
Voluntary groups organized along disciplinary lines will give emergency 
management officials a way to mobilize otherwise widely distributed 
social assets.
    Such initiatives, to be useful, however, must be coordinated and 
publicized. Ed Carubis, the Chief Information Officer of the New York 
City Department of Health, speaks of the acute need of his office for 
additional manpower during the anthrax crisis but was unaware that 
Silicon Alley Cares existed, and Silicon Alley Cares is not affiliated 
with the New York City chapter of VOAD (Voluntary Organizations Active 
in Disaster) or New York Cares, both of which coordinate requests for 
volunteers. Coordinating private philanthropic efforts related to 
homeland security and disaster mitigation is a function that the new 
Citizen Corps Councils may want to consider assuming.
           information technology in community-wide planning
    Finally, I would like to say a few words about the information 
technology needs that are likely to arise during severe epidemics or 
after acts of bioterrorism. This is a vast topic, obviously, so I will 
limit my remarks to how information technology can address certain 
logistical concerns. Our experience demonstrates that epidemics and 
acts of bioterrorism can profoundly stress local hospital and public 
health systems and that such events are dynamic processes. To respond 
to and mitigate the consequences of such events, then, we will need to 
capitalize on every asset at our disposal. And to do this, to allocate 
our resources effectively, what we will need first and foremost is 
reliable data. We must be able to detect unusual spikes in emergency 
room visits. Then, as the event unfolds, we will need to know where 
patients are presenting, which hospitals and emergency rooms are 
already overloaded, which hospitals need which supplies, and how to 
distribute supplies arriving from Federal reserves such as the National 
Pharmaceutical Stockpile.
    We are making progress on the detection front. In part as a result 
of the West Nile Virus outbreak a few years ago, the New York City 
Department of Health has implemented a much lauded ``syndromic 
surveillance'' system. This system, which depends on cluster analysis 
and cluster modeling, produces spatial representations down to the 
census tract and ZIP code level of where events are happening. The data 
fed into the system has so far been based on EMS coding, with certain 
types of call (e.g., respiratory distress) being specially flagged. 
This system may soon expand to the hospitals, though. Thirty hospitals 
now participate in emergency room surveillance, submitting patients' 
chief complaints to the Department of Health within 12 hours of the 
patients' arrival (and often prior to their discharge). An additional 
benefit of this program is that it has opened up contact between the 
Department of Health and emergency rooms and hospitals and enhanced the 
information stream flowing between them. Syndromic surveillance has 
predicted the onset of the flu season well in advance of other 
techniques each of the last 3 years. In hospitals that depend on just-
in-time staffing and supply, this kind of advance notice allows for 
smoother ramping up of resources.
    There are also promising developments on the response and 
mitigation front. Dr. Eliot Lazar and colleagues working in the New 
York Presbyterian Hospital system (which contains about 30 hospitals), 
in conjunction with the New York State Department of Health, have 
tested a data acquisition system that allows for essentially real-time 
collection of information about the availability of hospital beds and 
inventory throughout the system. This system creates a common platform 
that theoretically could be used in all hospitals and that could 
interface with the vendor-managed inventory system employed by the 
National Pharmaceutical Stockpile. Such a system will greatly enhance 
the efficiency with which supplies collected at central staging points 
are distributed, and in an epidemic situation it could be used to route 
patients away from overtaxed facilities.
    Geographic Information Systems (GIS), which encode data spatially 
and generate updatable maps, show great promise as a tool for 
responding to and mitigating bioterrorism attacks. GIS has often been 
employed in epidemiologic investigations and thus used represents a 
technological enhancement of traditional medical detective work. 
Because GIS has fast response capabilities and permits fast access to 
integrated layers of information, the potential uses of GIS in 
bioterrorism events are numerous. The great strength of GIS is that it 
has strong analytic capabilities and permits the powerful visualization 
of spatial data. For example, by geocoding environmental samples (e.g., 
powders suspected of containing anthrax) and looking at the pattern of 
positives, GIS may permit the development of more rational prophylaxis 
and remediation strategies. Geocoding patients as they arrive at points 
of distribution (POD) of antibiotics and vaccinations will allow for 
more reliable and efficient follow-up (patients living next door to 
each other, but presenting to different PODS will appear next to each 
other on a computerized map and can be visited by a single public 
health worker). GIS can also be used to develop emergency response 
plans by identifying the location of schools, medical centers, staging 
areas, and evacuations routes. Just before September 11, New York 
City's Office of Emergency Management implemented an Emergency 
Management Online Locator System (EMOLS), a Web-based application that 
allows New York City residents to enter an address and see the location 
of the nearest emergency shelter.\4\ This application could 
theoretically be linked with the New York Presbyterian Hospital data 
acquisition system described above and allow EMS units (or even 
patients themselves) to avoid overcrowded hospitals and determine 
alternative routing. ESRI, the GIS industry leader, has developed 
wireless technology that allows uploading and downloading of data in 
the field and has great potential to enhance all of these capacities.
---------------------------------------------------------------------------
    \4\ Currently this application is dedicated to helping residents 
determine whether locations of interest fall within one of the city's 
Pedestrian and Vehicular Traffic Restriction Sectors. The EMOLS webpage 
is located at http://www.nyc.gov/htmVoeni/html/emols/emols wtc.html.
---------------------------------------------------------------------------
    Such technologies must continue to be developed and tested. Once 
implemented, they must be widely distributed and tightly integrated 
with existing emergency management operations. In terms of bioterrorism 
preparedness, this is one of the main challenges that we as a Nation 
will face in the coming decade.
                               conclusion
    We can anticipate that if a significant bioterrorist attack occurs 
on United States soil, it will cause massive disruption and panic and 
that it will severely affect the operational tempo of government. Given 
budgetary constraints it is highly unlikely that hospitals will build 
in new reserve capacity, that public health departments will massively 
expand their laboratories and personnel rosters, and that vaccines to 
the agents of concern will be developed any time in the near future. To 
meet the threat of bioterrorism, we will have to maximally leverage 
existing resources, identify untapped assets, and rely on the goodwill, 
industry, and intelligence of civilian volunteers. We have a unique 
opportunity to do so, and the USA Freedom Corps demonstrates great 
promise. Let us capitalize on both.

    Senator Wyden. Thank you.
    Dr. Klausner.

  STATEMENT OF DR. RICHARD KLAUSNER, M.D., SENIOR FELLOW AND 
  SPECIAL ADVISOR FOR COUNTER-TERRORISM, NATIONAL ACADEMY OF 
                            SCIENCES

    Dr. Klausner. Senator Wyden, Senator Rockefeller, it is 
good to be here for the first time in 7 years testifying in 
front of the Senate not as a Federal employee. I announced that 
I was stepping down from directing the National Cancer 
Institute on September 11, at about 9 a.m. Little did I know 
that within about 2 months I would agree to a request from the 
Executive Office of the President, particularly Jack Marburger 
and the National Academy of Sciences, to return to a type of 
public service, and that is to address some of the issues that 
are being raised at this table, and that is to report to the 
government, which I will tell you about as soon as possible, 
about ways to engage the multiple communities we call the 
science and technology communities in this country in order to 
best address, in this case, not just bioterrorism but, in fact, 
all aspects of terrorism. So my position now is Senior Fellow 
at the National Academy of Sciences and Liaison to the White 
House.
    It is interesting, the National Academy of Sciences was set 
up by President Lincoln in the middle of the Civil War in order 
to provide advice that would be independent advice, and 
hopefully, objective advice to the government and to the Nation 
about science and technology and, in fact, I was very moved and 
pleased that the leadership in the White House again recognized 
that we are not going to be able to address in the way we want 
to the current threats and future threats that we might be able 
to predict and things that we can predict without engaging the 
science and technology communities, who, I can tell you, are 
extremely committed to and enthusiastic for helping in what the 
Nation needs.
    The National Academy is engaged in many activities which I 
will submit to you, but let me tell you about two. The major 
activity is to provide to the Executive Office of the President 
by June a road map and overall strategic plan for the 
government and for the Nation about how to mobilize the science 
and technology communities in the government, in academia, and 
the private sector about all aspects of terrorism, from the 
fixed infrastructure to nuclear radiologic, to chemical, to 
bio, to the transportation system, et cetera, for indeed, these 
systems overlap and interact with each other.
    A bio attack in the context of disrupting communication or 
transportation, the fact that a bio attack can use a 
transportation system, the mail, in essence, demonstrates that 
one of the challenges is going to be to respond with science, 
with technology, with decisionmaking, with an intellectual base 
that does not and that cannot be constrained through the 
traditional silos of either our government agencies or either 
our traditional scientific disciplines, and I think that is 
abundantly clear in listening to the Photonics.
    And so we will be presenting this report by the beginning 
of June, and at that point I will be delighted to come back to 
the Hill and brief this Subcommittee and others about these 
recommendations, but they will be recommendations aimed at 
specifically how the government needs to either structure or 
restructure itself for better communication, for better access 
to the scientific community, how to evaluate the thousands of 
technologies, how to set standards, how to engage individuals, 
how to identify expertise.
    Along those lines, beginning in October we recognized that 
there was an immediate need, and so for the first time the 
academy set up basically an immediate response consultation 
service, where we have been linking Federal agencies to real-
time consultation about critical issues such as 
decontamination, bioforensic, how to deal with new analytic 
problems.
    We had a 1-day meeting with the U.S. Postal Service, out of 
which came the advice about different technologies that they 
may use. What we all saw in that was that in issues of homeland 
security the government is going to have to be able to avail 
itself of, evaluate and deal with science and technology 
advice, including the nonscience agencies that have never had 
experience with this. We are just beginning these experiments. 
We need to do more.
    I know the hour is running late. Let me just raise a few 
issues. As I said, the challenges for the public health system, 
which I will not comment on, other than that it needs an 
enormous amount of support and rebuilding. It is not just the 
public health system, but it is also the medical and clinical 
response system, but what they are going to respond with will 
depend upon new tools, reliable information, a process that 
allows beforehand modeling, decisionmaking, red-teaming, as we 
have done for other aspects of national security, but which has 
not been done in this context.
    I think those will be some of the issues we will be 
addressing in our report, but it is not just access to what is 
there now. We must recognize that we do not have all the 
knowledge now that we will need in the future. We do not have 
all the technological capacities and capabilities we would like 
to have, and that is why we need a sustained commitment to 
science and technology.
    Some of the challenges are, we have not been all that good, 
I can say this from running one of these science agencies, at 
connecting technology development, technology deployment with 
science. We need to address how we break down some of those 
silos, very important issues about how we connect the private 
sector, the academic sector, and the government sector, for a 
variety of reasons, not the least of which is that there may be 
many technologies, many approaches for the prevention and 
amelioration of bioterrorism that will not be driven by normal 
market forces.
    We will need to create products for which there may be not 
markets in the normal sense, but markets that must be driven, I 
suspect, by the government recognizing national needs or 
potential national needs, and those are going to take new ways 
to think about how we engage the biologic research community, 
public-private academic, with the government in ways that we 
have not done before.
    I will stop there, and I am pleased to answer any questions 
about what we are doing.
    [The prepared statement of Dr. Klausner follows:]
  Prepared Statement of Dr. Richard Klausner, M.D., Senior Fellow and 
  Special Advisor for Counter-Terrorism, National Academy of Sciences
    Good morning Mr. Chairman and Members of the Committee. I am Dr. 
Richard Klausner, Senior Fellow at the National Academy of Sciences and 
Special Advisor to the Presidents for Counterterrorism. I am also Chair 
of the National Academies' Committee for Science and Technology (S&T) 
Agenda for Countering Terrorism. The Academies include the National 
Academy of Sciences, the National Academy of Engineering, and the 
Institute of Medicine. The National Academy of Sciences was chartered 
by Congress in 1863 to advise the government on matters of science and 
technology. The National Research Council (NRC), the operating arm of 
the Academies, was established in 1916. The National Academy of 
Engineering was established in 1964. The Institute of Medicine was 
established in 1970. These institutions provide independent advice on 
science and technology and related policies for the Federal Government, 
including executive and legislative branches.
    The National Academies began mobilizing the S&T community to 
address the threats presented by terrorism immediately after the 
horrific events of September 11. It assembled a distinguished group of 
scientists, engineers, health care professionals, industrialists and 
former high level government officials on September 26 to develop a 
series of initiatives which the Presidents, themselves, could 
immediately initiate from their own resources while government was 
mobilizing its own activity. Among the suggestions emerging from that 
meeting which have all now been initiated, were the following:
    1. The development of an S&T agenda for addressing the 
comprehensive range of vulnerabilities our country faces extending over 
the next decade and how S&T can best respond to them; this work is 
being undertaken by a distinguished, eclectic committee which I co-
chair with Professor Lewis Branscomb of the Kennedy School at Harvard. 
This work is being closely coordinated with the Office of Science and 
Technology Policy (OSTP) and, through that office, with the Office of 
Home Land Security. I shall provide some details of the committee's 
work subsequently;
    2. Near-term technical assistance to the government through real 
time advice by scientific experts on topics panels chosen by the inter-
agency Technical Support Working Group (TSWG) and, separately, by the 
U.S. Postal Service.
    3. An intensification of international activities on both a 
bilateral and multi-lateral basis through a variety of institutional 
mechanisms. These include discussions with scientists in key countries 
on how to lessen the risk of proliferation of weapons of mass 
destruction under the auspices of the NAS Committee on International 
Safeguards and Arms Control. They also include multi-lateral academy-
academy discussions under the Inter Academy Panel and Council and 
bilateral activities of a wide variety of sorts, including discussions 
with national academies in Moslem countries.
    5. Technical and policy work on bioterrorism under the broader, on-
going activity on infectious diseases and vaccine policy, largely 
within the Institute of Medicine.
    5. Workshop and studies on issues affecting universities arising 
out of Terrorism Events. Issues include student visa and tracking 
policies and systems and the management of biological research security 
in university laboratories.
    In addition to the kinds of specific initiatives enumerated above, 
there have been a number of counter-terrorism activities related 
underway under the auspices of the more than 80 standing boards 
throughout the National Research Council. Some of these are activities 
and and studies were begun considerably before September 11, but they 
are even more timely because of the events of that day.\1\ Others have 
been initiated since September 11th in response to agency requests.
---------------------------------------------------------------------------
    \1\ Examples include the work by the IOM on anthrax vaccine policy 
for the military and the development of tools for evaluating the 
metropolitan medicine response system program. (See, Phase 1 Report, 
Frederick Manning, Lewis Goldfranks, Eds, Strategic Mechanisms for 
Improving OEP Analysis of Preparations for biological, Chemical, 
Radiological Terrorism, Washington, D.C.: National Academy Press, 
October 10, 2001.)
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    I have attached a document, entitled ``Summary of Selected Counter-
Terrorism Initiatives by the National Academies,'' dated December 18, 
2001, which summarizes the comprehensive scope of activities which have 
been initiated either by the Academy Presidents or by standing 
committees throughout the National Academies complex.
    I wish to offer several perspectives on the role of science and 
technology as related to bioterrorism, as an example of broader 
application, in the time remaining.
    It is clear to me that we cannot solve the comprehensive and 
daunting threat presented by bioterrorism without the active and 
sustained effort of the science and technology community. Indeed, the 
S&T community is ready and willing to respond. But how do we connect 
all the relevant S&T communities with the many requirements bio-
terrorism presents at both the national and local level?
    One part of the approach is embodied in the comprehensive S&T 
visioning project for combating terrorism I am co-chairing. This 
project is aimed at helping the Federal Government, and more 
specifically, the Executive Office of the President, to use effectively 
the Nation's and the world's scientific and technical community in a 
timely response to the threat of catastrophic terrorism. Under the 
sponsorship of the National Academies, a distinguished assembly of 
scientists and engineers will help the government develop a vision for 
how S&T can address the complex challenges presented by terrorism.
    The project will undertake the following tasks to be presented in a 
report in 6 months: prepare a carefully delineated framework for the 
application of science and technology for countering terrorism, (2) 
develop a comprehensive threat-based agenda by which S&T can address 
challenges presented by terrorism to our security; (3) characterize 
cross-cutting issues, and (4) address implementation hurdles with 
recommendations for overcoming them.
    The S&T vision and agenda will be developed in the following areas:
 Biological.
 Chemical.
 Nuclear and Radiological.
 Information technology.
 Transportation.
 Energy facilities, cities and fixed infrastructure.
 Behavioral, social and institutional issues.
 Systems cross-cutting issues.
    We believe the work of this committee will provide the an 
integrated science and technology vision and program plan, extending 
over a decade, for combating terrorism. We know of no similar activity 
underway anywhere else. We believe it will be quite useful in helping 
the executive and legislative branches in allocating resources against 
the comprehensive threats presented by terrorism. After completion of 
our report in May, I would be happy to return to present the report's 
key findings and recommendations.
    Parallel activities are underway to help connect the relevant S&T 
community with immediate technical requirements of Federal and local 
agencies. One is a project in which the Academies are inviting 
scientific experts to meet with government representatives in 1-day 
meetings to address how better to address near term requirements of 
Federal and local agencies. Although no written reports are produced 
and no formal Academy advice is provided, the dialog is beneficial to 
Federal agencies, including the 80 member, inter-agency Technical 
Support Working Group (TSWG) on counter-terrorism. In December, we 
invited scientific experts to engage in dialog with TSWG panels on bio/
chemical forensics and bio/chemical decontamination. Another meeting is 
planned next month on through-structure imaging. Earlier, we met with 
U.S. Postal Service personnel to assist the service in evaluating 
radiation technologies to sanitize contaminated mail.
    Within the Institute of Medicine (IOM), a number of public health 
strategies to address terrorist threats have been undertaken. The goal 
of this activity is to provide guidance on specific issues of national, 
local and individual concern, within the framework of a comprehensive 
strategy to assure the health of the public in the 21st Century. 
Projects include a comprehensive bioterrorism threat assessment. This 
assessment was initiated within the Forum on Emerging Infections. A 
November workshop, addressed ``Biological Threats and Terrorism: How 
Prepared Are We?''
    Other components of the IOM Strategy include communications, legal 
authorities, and vaccine policy components. The adequacy of 
surveillance systems and laboratory capacity are being addressed as 
well as the psychological consequences of terrorism and the long-term 
mental health consequences of asymmetric warfare. The IOM has already 
commenced the evaluation of the adequacy of local public health 
agencies and organizations to address the new bioterrorism threats with 
which they are confronted on top of the general spectrum of naturally 
occurring infectious diseases.
    Many agencies throughout the government work with scientists within 
their respective domains. But the task for the Office of Home Land 
Security is to cut across all these domains and mobilize scientists for 
the new challenges presented by terrorism and to connect scientists 
working in relevant disciplines with the requirements presented by 
counter-terrorism over the long term.
    We currently do not have adequate processes and structures in place 
to carry out the necessary connectivity not only among agencies but 
among the participants in the S&T enterprise: sponsoring agencies, 
users (both Federal and local), and the diffuse research community that 
must be mobilized to address terrorism.
    There are three over-arching issues relating to bioterrorism that I 
believe require focused attention.
    The first issue is to determine the ingredients necessary to 
mobilize all the relevant S&T communities to address the range of 
threats presented by bioterrorism. These threats include both the 
potential bio-terrorist weapons which exist today, e.g. smallpox, 
anthrax, botulism, as well as genetically modified organisms that can 
be made toxic and used as weapons. To engage the S&T communities fully 
will require effective communication of government needs and priorities 
as well as a sustained financial commitment by government to address 
these priorities.
    The second issue is how do we solve specific bio-challenges, 
solutions to which may span the ``silos'' of existing disciplines, 
agencies and sectors. We must develop the necessary linkages between 
S&T, the private sector (a necessary partner for technology 
development), and the government, which is the most significant sources 
of resources for scientific research and development. We need to find 
ways to make the necessary linkages across the ``silos'' that exist 
presently in agencies, disciplines and sectors. Are the agencies funded 
in such a way today that they have sufficient incentives to ensure that 
they do come together for the purposes we now must urgently address 
across many agencies? Do government agencies have the tools to 
encourage participation of and partnering with the private sector? Can 
agencies mobilize communication and management strategies that will 
engage creative solutions from needed disciplines or across existing 
disciplines?
    The third issue we must address is how the public and private 
sectors may more effectively partner to address bio threats at all 
stages of development: from research, through development, final 
product introduction and market penetration and wide use. The 
``products'' are varied. They include drugs, vaccines, detectors and 
other items across the complete spectrum of prevention, detection, 
response, recovery and attribution. We realize that we need very large 
dose numbers of vaccines, anti-bacterials, anti-virals and mocrobial 
agents to protect the public and limit the spread of disease. Yet the 
``market,'' alone will not produce these in sufficient numbers and at 
the quality needed. The government will have to ensure that promising 
projects in priority areas can be shepherded through to a productive 
end point and made available for use of the appropriate Federal, State, 
county, local and public levels. This will require a reassessment of 
management tools and traditions as well as new infrastructure.
    As the Council of the Institute of Medicine stated in its Statement 
on Vaccine Development, dated November 5, 2001:
    The events following the tragedies of September 11, 2001, have 
reemphasized a serious defect in America's capacity to deal with 
biological agents used in terrorist attacks. The capacity to develop, 
produce, and store vaccines to deal with these agents are inadequate to 
meet the Nation's needs. In 1993 the Institute of Medicine published 
The Children's Vaccine Initiative: Achieving the Vision. In assessing 
the national and international situation, the committee said, ``because 
the private sector alone cannot sustain the costs and risks associated 
with the development of most CVI vaccines, and because the successful 
development of vaccines requires an integrated process, the committee 
recommends that an entity, tentatively called the National Vaccine 
Authority (NVA), be organized to advance the development, production, 
and procurement of new and improved vaccines of limited commercial 
potential but of global public health need.'' \2\
---------------------------------------------------------------------------
    \2\ Mitchell, V.S., Philipose, N.M., and Sanford, J.P., eds. The 
Children's Vaccine Initiative: Achieving the Vision. Washington, D.C.: 
National Academy Press, 1993.
---------------------------------------------------------------------------
    In a 1992 report, Emerging Infections: Microbial threats to Health 
in the United States, another IOM committee recommended the development 
of an integrated management structure within the Federal Government for 
acquiring vaccines, as well as a facility for developing and producing 
vaccines with government support.\3\
---------------------------------------------------------------------------
    \3\ Lederberg, J., Shope, R.E., and Oaks, S.C., Jr., eds. Emerging 
Infections: Microbial Threats to Health in the United States. 
Washington, D.C.: National Academy Press, 1992.
---------------------------------------------------------------------------
    Evidence for the inability of the private sector to meet the 
country's needs for vaccines has accumulated substantially since the 
1993 report. Fewer private companies are manufacturing vaccines. 
Continually needed vaccines such as the tetanus and influenza vaccines 
are in increasingly short supply. The availability of influenza 
vaccines has been delayed over the past several years and in 2000, one 
company stopped production. Pneumonococcal conjugate vaccine is 
unavailable in several States because of the sole source manufacturer's 
inability to meet demands. Only one source is currently available for 
meningococcal varicella and measles-mumps-rubella vaccines.
    There are just four major vaccine manufacturers in the world today, 
and only two in the United States.\4\ There were four times that number 
only 20 years ago. There are many small new research and development 
companies backed by venture capital and devoted to vaccine development. 
Many are working on anticancer vaccines for which market forces may be 
enough to keep them in production. However, good products developed by 
these startups to combat infectious diseases often do not come to 
market because of the very large costs of testing in pilot studies and 
in manufacturing.
---------------------------------------------------------------------------
    \4\ Merck Vaccine Division (parent company is Merck 
Pharmaceuticals) and Wyeth-Lederle Vaccines (parent company is American 
Home Products Corporation) are U.S.-based companies. Aventis Pasteur 
and GlaxoSmithKline operate within the United States and have products 
licensed by the FDA for use in the United States, but they are 
companies based in other countries.
---------------------------------------------------------------------------
    Prior to the events of September 11, the delays and problems faced 
by both the Department of Health and Human Services and Department of 
Defense in developing and procuring a cell-culture smallpox vaccine 
provide convincing evidence that major changes are needed at the 
national level. With the government guaranteeing payment in this time 
of national need, several potential manufacturers have come forward. 
This is an ad hoc example of a larger national need for mechanisms to 
obtain other public-good vaccines on an ongoing basis, and not just 
under extenuating circumstances when there is a great deal of public 
awareness of the need for vaccines.
     . . . The Children's Vaccine Initiative committee listed the 
functions of a National Vaccine Authority . . . They now have a broader 
importance to America, as the potential need for vaccines required to 
meet biological threats increases. The IOM Council believes the 
Authority should focus its attention upon vaccines that will not be 
adequately produced by existing public or private entities.
    Recently, proposals have been made for the creation of a 
government-owned, contractor-operated national vaccine facility. The 
IOM Council believes this is one in a spectrum of public-private 
ventures by which a NVA could facilitate development and production of 
needed vaccines . . . While a major priority for this facility would be 
to develop vaccines necessary to protect American troops and for use 
against bioterrorism, the facility also should be charged with 
production of other vaccines that are in scarce supply and would not 
otherwise be provided in the public or private sectors. In some cases 
in which there are few private sector uses, the facility would become 
the principal source of such vaccines. In other cases, as variety of 
public and private partnerships could be undertaken to produce needed 
vaccines.\5\
---------------------------------------------------------------------------
    \5\ Pearson, G.W. The Children's Vaccine Initiative: Continuing 
Activities. Washington, D.C.: National Academy Press, 1995.
---------------------------------------------------------------------------
    The Council of the IOM believes that the development of a National 
Vaccine Authority is long overdue. It could be created within the 
Department of Health and Human Services, in collaboration with the 
Department of Defense or as a joint effort of the two departments. 
Moreover, the Council believes that establishment of a government-
owned, contractor-operated facility for research, development, and 
production of vaccines is essential to meeting the country's public 
health needs, particularly those related to bioterrorism and protection 
of our armed forces.\6\
---------------------------------------------------------------------------
    \6\ The complete Statement is attached to this testimony. It 
includes the listing of specific functions appropriate for the NVA.
---------------------------------------------------------------------------
    I believe there are three actions that should be initiated with the 
encouragement of Congress:
    First, the National Institutes of Health (NIH) needs to consider 
whether it needs to establish an Advanced Research Projects Agency--
perhaps modeled on the DARPA model--to more effectively engage and 
harness critical creativity and better link it to both local and 
Federal requirements and accelerate the rate of introduction of new 
technology into broad use.
    Secondly, the government should implement The Institute of Medicine 
recommendation to establish a National Vaccine Authority (NVA), charged 
with carrying out the functions spelled out in the November 5 IOM 
Statement.
    Thirdly, serious consideration should be given to the establishment 
of new funding and management tools that encourage and sustain public-
private partnership. Lessons should be captured from successful 
existing examples such as the efforts undertaken by MAID and expanded 
upon to meet current needs.
    We clearly need a better national approach for anti-toxin, anti-
microbial drugs development, production and storage. We are on the cusp 
of an explosion in genome development. In addition to the benefits of 
such an evolution are great risks: there will be the potential for many 
more drug ``weapons.'' Markets, alone, will not drive this development 
and production activity, yet partnership with the private sector is 
essential for realizing the goal.
    Underlying the effectiveness of all of the recommendations is the 
need for complete and effective communication and information exchange. 
This applies across Federal, State and local agencies; among the 
government, academia and industry; and across the silos of scientific, 
engineering, and health care disciplines. Critical to this effort is 
the need to develop ways to better access information and affect more 
rapid response capability for use at both the national and local 
levels. Part of this challenge is related to improved information 
management systems; another is to assuring the existence of accurate 
and authoritative information sources; yet another to addressing the 
need for better training, and better real-time linkages among those 
public and private-sector institutions which share responsibilities and 
capabilities to protect (and improve) the health of the public in the 
21st century.
    I have appreciated the opportunity to testify before the Senate 
Committee on Commerce, Science, and Transportation today on the 
important issues you have raised relating to Home Land Security against 
bioterrorism.
    I would be pleased now to answer any questions you may have and 
request my complete statement and attachment be included in the record.

                               __________

           Summary of Selected Counter-Terrorism Initiatives 
                       By the National Academies
                  s&t agenda for countering terrorism
    This project is aimed at helping the Federal Government, and more 
specifically the Director of the Office of Science and Technology 
Policy, Dr. Jack Marburger, to use effectively the Nation's and the 
world's scientific and technical community in a timely response to the 
threat of catastrophic terrorism. A committee of distinguished 
scientists and engineers with supporting panels will help to develop an 
integrated science and technology program plan and research strategy. 
Phase 1 of the project will in 6 months prepare a carefully delineated 
typology or taxonomy for the application of science and technology for 
combating terrorism and using additional experts serving on panels will 
prepare research agendas in seven key domains (biological; chemical; 
nuclear and radiological; information technology, computers, and 
telecommunications; transportation; energy facilities, buildings, and 
fixed infrastructure; and behavioral, social and institutional issues). 
The committee will also examine a series of cross-cutting and 
multidisciplinary issues, including interdependent vulnerabilities. 
Phase 2 will review key government research programs and provide 
recommendations for building improved interagency capabilities and 
coordination. A final report will be produced by September 11, 2002. 
($2 million--$1 million from the Academies and $1 million expected from 
Federal agencies and foundations)
              near-term assistance for the u.s. government
    On urgent topics where the government needs immediate assistance, 
the Academies are inviting scientific experts to meet with government 
representatives in 1-day meetings. Although no written reports are 
produced and no formal Academy advice is provided, the dialog is very 
beneficial to Federal agencies, including the inter-agency Technical 
Support Working Group (TSWG) on counter-terrorism. Recent examples 
include a meeting for the U.S. Postal Service on sanitizing the mail 
(11/14/01); a meeting for the Dept. of Justice on how to analyze the 
anthrax-infected letter to Senator Leahy (12/7/01); a meeting on human 
factors for the FAA's sky marshall program (12/5-6); a meeting on 
biological and chemical forensics for TSWG (12/11); and a meeting on 
biological and chemical decontamination for TSWG (12/14), 
(approximately $30 thousand per meeting; treated as project initiation 
activities)
         combating terrorism: prioritizing vulnerabilities and 
                    developing mitigation strategies
    The National Academy of Engineering will undertake a 12-month 
project to identify, assess, and prioritize vulnerabilities to the 
Nation's vital infrastructures posed by global terrorism, and outline 
strategies (technologies, policies) to mitigate priority 
vulnerabilities in a manner consistent with a free, open, and 
prosperous society. Using various fact-finding, forecasting, consensus-
building, and risk analysis techniques, the project committee will seek 
to integrate expert knowledge of the nature of modern terrorism 
(motives, capabilities, sociology, psychology), terrorist weapons and 
delivery systems, and the vulnerabilities of vital infrastructures to 
measure and rank order the myriad terrorist threats to the Nation 
(supported by the NAE).
  international collaborative activities with foreign counterparts to 
    reduce near-term threats and long-term root causes of terrorism
    Priority activities include:
 Cooperation on Preventing Terrorists from Obtaining Nuclear 
    Materials in Russia, which will include two projects. The first 
    will be a joint effort with the Russian Academy of Sciences to 
    produce a ``white paper'' assessing the steps that can be taken 
    immediately by the two governments to reduce the risks that nuclear 
    weapons or materials could fall into the hands of terrorists. 
    Working together, the two academies will also identify an agenda 
    for longer-term U.S.-Russian cooperation, including continuing 
    inter-academy attention to problems that may arise and how they 
    might be overcome. The second project will examine the problems 
    that will be faced by economically stressed Russian institutions in 
    maintaining and operating recently installed physical security and 
    accounting systems for protection of plutonium and highly enriched 
    uranium within the framework of cooperative projects when financial 
    support is no longer available from the United States and will 
    assess approaches to ensuring the long-term sustainability of the 
    systems. ($150,000 from the MacArthur Foundation and further 
    support expected from the Nuclear Threat Initiative foundation);
 Continuing of the U.S.-Russian InterAcademy Project on 
    conflicts in multiethnic societies (support sought from foundations 
    and partial support up to $200,000 from NRC funds if needed);
 InterAcademy meetings on both a bilateral basis with 
    scientists Pakistan, Iran, and other Moslem nations and on a multi-
    lateral basis through the InterAcademy Panel (support sought from 
    foundations and partial support of approximately $100,000 from NRC 
    funds if needed);
 Planning meeting for a study on building the capability of 
    foreign affairs and development agencies to help in reducing the 
    risk of terrorism, a study that would complement NRC report on 
    ``The Pervasive Role of Science, Technology, and Health in Foreign 
    Policy: Imperatives for the State Department'' ($35,000 in program 
    initiation funds);
 Continuation of the joint U.S.-Russian InterAcademy Project on 
    high-impact terrorism (supported by the Carnegie foundation).
 Cooperative Research in Russia on Dangerous Pathogens. This 
    project provides for two 2-week familiarization visits each year by 
    three or four American investigators (including young 
    investigators) to elected Russian research institutes that had 
    formerly participated in the Soviet biological warfare program. 
    Each year these visits are followed by individually tailored visits 
    of one to 3 months to the institutes by three or four of the 
    investigators who are interested in pursuing joint civilian 
    research activities in collaboration with Russian colleagues. These 
    projects provide a mechanism for gaining regular access to the 
    facilities and specialists and thereby promote transparency. They 
    also provide research opportunities for Russian scientists who 
    might otherwise look to countries with hostile intentions for 
    support. At the same time, cooperative research helps develop 
    technologies that will be useful in public health, agriculture, and 
    counterterrorism activities in Russia and the United States.
preliminary evaluation of u.s. industrial vulnerabilities and near-term 
                          protective measures
    Evaluations by the appropriate NRC boards in cooperation with 
volunteers to identify vulnerabilities in key industries, e.g. chemical 
and energy industries, and measures that might lessen this 
vulnerability or reduce the consequences of strikes to key 
infrastructure. The Board on Chemical Sciences and Technology met with 
chemical industry representatives on this topic on 12/9/01 and with 
Federal agencies on 12/10/01. The Board on Life Sciences and the Board 
on Agriculture and Natural Resources have held similar meetings. Other 
boards will meet with relevant industries in the weeks ahead. ($30,000 
in project initiation funds)
 an assessment of naval forces' defense capabilities against chemical 
                     and biological warfare threats
    At the request of the Chief of Naval Operations, the Naval Studies 
Board is conducting a study to: (1) examine existing and potential 
chemical and biological warfare threats to naval force operations in 
littoral regions and deep ocean regions of the world; (2) examine and 
project chemical and biological defense technologies, tactics, and 
procedures; (3) evaluate R&D and identify priorities for providing 
naval forces with needed capabilities; and (4) examine testing and 
evaluation procedures (in conjunction with training procedures) for 
ensuring adequate defensive capabilities. It is anticipated that a 
published report will be available by July 2002.
         improving cybersecurity research in the united states
    A study by the Computer Science and Telecommunications Board will 
be conducted to determine the extent and nature of current Federal 
research in cybersecurity and to identify areas of research that are 
not adequately supported. ($129,000 from NRC funds and a matching 
amount expected from the National Science Foundation).
  information and security: enhancing information management and data 
  mining capabilities for combating terrorism while protecting civil 
                               liberties
    A planning meeting for a study is being organized by the Computer 
Science and Technology Board (CSTB). The study will consider research 
opportunities in data mining as well as ways to minimize the privacy 
and civil liberties implications of anticipated increased collection 
and integration of personally identifiable information. ($40,000 in 
project initiation funds).
issues affecting universities arising out of terrorism events: workshop 
  on implications for research, scientific communication, and foreign 
                                students
    A workshop was held on December 13 and 14. Issues such as visa and 
foreign student tracking policies will be discussed by representatives 
of major research universities. Also discussed will be whether 
sufficient protections can be achieved to avoid the diversion of 
biological agents from research facilities. The implications of 
possible restrictions on biomedical research, scientific communication, 
and on graduate student participation will be examined. ($60,000 in 
project initiation funds).
    improving research standards and practices to prevent misuse of 
                         biotechnology research
    A study will review and assess the current rules, regulations, and 
institutional arrangements and processes in the United States that 
provide oversight of research on dangerous biological pathogens, 
including within government laboratories, universities and other 
research institutions, and industry. The review would focus on how 
choices are made about which research is and is not appropriate, and 
how information about relevant ongoing research is collected and 
shared. It will consider, but not be limited to, the ``biosafety'' 
practices that govern the conduct of research and the handling and 
transport of materials. The study will recommend changes to improve 
U.S. capacity to prevent the destructive application of dangerous 
biological pathogens while still enabling the conduct of legitimate 
research. (Supported by the Sloan Foundation and the Nuclear Threat 
Initiative Foundation).
     communicating to local governments and private citizens about 
                   preparedness for terrorism events
    A meeting requested by Dr. Marburger will be held in January to 
plan how better to link Federal and State governments on S&T policy, 
including for combating terrorism. Science representatives of each of 
the States will attend. ($30,000 in program initiation funds).
                       public health initiatives
    The Institute of Medicine will conduct new activities as well as 
capitalizing on work currently in progress to develop and communicate 
anti-terrorism strategies based on public health principles. The goal 
is to provide guidance on specific issues of national, local and 
individual concern within the framework of a comprehensive strategy to 
assure the health of the public in the 21st century. Priority (near 
term) activities include:
 A series of workshops under the Forum on Emerging Infections. 
    The first was held on November 27/28 and addressed Biological 
    Threats and Terrorism: Assessing Science and Response Capabilities. 
    The second will focus on antibiotic resistance and its implications 
    for counter-terrorism responses.
 A comprehensive study of the safety and efficacy of anthrax 
    vaccines will be released in February. Completion of this 
    Department of Defense funded study was accelerated in response to 
    the current need to make decisions regarding manufacture and use of 
    anthrax vaccine.
 On November 5th, the IOM Council issued a Statement on Vaccine 
    Development, assessing the country's capacity to develop, produce 
    and store vaccines. The recommendations include creation of a 
    National Vaccine Authority.
 The 1992 IOM report on Emerging Infectious Diseases is being 
    updated and expanded. The committee will include an extensive 
    discussion of issues related to bioterrorism. The report will be 
    issued in early 2003.
 A committee report providing a vision for assuring public 
    health in the 21st century will be issued in the Spring of 2002. It 
    will provide a framework for integrating investments and activities 
    related to counter-terrorism into the overall public and private 
    sector infrastructure to assure public health.
                       agricultural bioterrorism
    The Board on Agriculture and Natural Resources is conducting a 
study to evaluate the ability of the U.S., to deter, prevent, detect, 
thwart, respond to and recover from an intentional biological attack 
against the Nation's food and fiber supply. The report is expected in 
summer 2002 (supported by the USDA).
                         what terrorists value
    The Division of Behavioral, Social Sciences, and Education will 
conduct a study on what high profile terrorists groups value 
(especially the groups that caused the attack on September 11) with the 
goal of understanding how better to deter and defeat them. ($500,000 
funded by DOD).
    assessment of technologies deployed to improve aviation security
    This study by the National Materials Advisory Board (NMAB) 
sponsored by the Federal Aviation Administration, is assessing the 
operational performance of passenger screening, explosives detection 
systems and hardened cargo containers in airports and compare that 
performance to their performance in laboratory testing, with a focus on 
ways to deploy these systems more effectively to improve aviation 
security. The Committee plans a second status report in early 2001 and 
a third and final report in the fall of 2002 that will examine a 
technology development strategy for aviation security.
      assessment of practicality of pulsed fast neutron analysis 
                         for aviation security
    This National Materials Advisory Board study, sponsored by the 
Federal Aviation Administration, is assessing the practicality of 
pulsed fast neutron analysis (PFNA) for detecting explosives and other 
contraband in cargo and passenger baggage in an airport. The 
capabilities of PFNA are compared with the capabilities of explosives-
detection equipment currently available for deployment and with the 
expected future development of current equipment. The Committee plans 
publication of their findings early in 2002.
      advanced energetic materials and manufacturing technologies
    This study by the Board on Manufacturing and Engineering Design is 
investigating and assessing the manufacturing technologies required to 
scale up and produce bulk quantities of advanced energetics and suggest 
opportunities and strategies for government investment. Although these 
new materials are more difficult to manufacture when compared to 
standard explosives, they are equally difficult to detect using current 
systems. The study is sponsored by the Department of Defense.
       materials and manufacturing processes for advanced sensors
    This study by the Board on Manufacturing and Engineering Design is 
examining potential technologies for detect-to-warn systems for 
biological agents. Their charge is to review the DTRA-specified 
requirements for these systems and identify those requirements that 
will especially drive the detection concepts and architectures--e.g., 
less than 1 minute detection times, continuous operations with 
attendant implications for consumables and their costs--and understand 
to what extent, if any, these, or related, parameters (e.g. detection 
sensitivities), may be relaxed. The committee is also considering 
examples of representative operational scenarios or architectures (to 
be provided by the sponsor), which will be invaluable in putting these 
system requirements and tradeoffs in context.
           current additional specific board-based activities
Support for Transportation Security Research (TRB)
    The Transportation Research Board administers two cooperative 
research programs, one for State departments of transportation and one 
for the public transportation industry. $2 million allocated from the 
Transit Cooperative Research Program to provide flexible, ongoing rapid 
response research on transportation issues related to emergency 
incident prevention, preparedness, response, and recovery, paying 
particular attention to potential terrorist threats. Consultants have 
been selected and work is expected to get underway in early 2002. The 
National Cooperative Highway Research Program is currently supporting 
the development of manuals for vulnerability assessments and emergency 
response planning and is expected to program significant funding next 
year for security related research.
Standing Technical Committee on Critical Infrastructure Protection 
        (TRB)
    TRB maintains approximately 200 standing technical committee that 
support information dissemination activities in transportation. The 
Committee on Critical Infrastructure Protection, which was established 
2 years ago, facilitates the dissemination of state-of-the practice and 
state-of-the-art information on infrastructure security and protection 
and encourages research in this field. It sponsors TRB's website on 
security and has organized security sessions at TRB's Annual Meeting.
Survey on Vulnerability Assessment (TRB)
    TRB is conducting, in cooperation with the American Association of 
State Highway and Transportation Officials, a survey of States to 
determine whether and to what extent they have addressed infrastructure 
planning and security in their planning efforts.
TRB Annual Meeting (TRB)
    TRB's Annual Meeting is one of the largest gatherings of 
transportation professionals in the world. The January 2002 meeting 
will include over 30 security and recovery related sessions. An 
overview session will involve the DOT modal adminstrators and the 
Deputy Secretary and cover a dozen topics, from port and waterway 
security issues to aviation safety.
Transportation Associations--Information Sharing (TRB)
    TRB organized a meeting of a number of transportation associations 
to share information about the security issues they are confronting and 
the activities under way. The group will meet again in 3 months.
Redundancies in Transportation Systems (TRB)
    A planning meeting will be held to examine multi-modal 
transportation infrastructure redundancy to enhance defense against 
terrorist disruption. ($30,000 in program initiation funds).
Emergency Evacuation in Metropolitan Areas: Barriers and Opportunities 
        (TRB)
    A planning meeting will be held to discuss technical and 
institutional barriers to improved metropolitan-wide evacuation and 
emergency response. ($28,000 in program initiation funds).
Vulnerability of the Electric Power Transmission and Distribution 
        System to Terrorism (BEES)
    A planning meeting will be held to discuss reducing the impact of 
terrorist attacks on the electric transmission and distribution system. 
($40,000 in program initiation funds).
Safety of Our Nation's Water Supplies (WSTB)
    A series of activities will be held to discuss safety of the short 
term security and longer term research initiatives relevant to water 
supply safety from terrorist attacks. ($14,000 in NRC funds).
Forum on How Natural Disaster Research Can Inform the Response 
        to Terrorism (NDR)
    The Natural Disasters Roundtable (NDR) will conduct a 2-day 
workshop to develop thoughts on how responses to natural disasters 
might be applied to threats provided by terrorism. Topics to be 
considered include engineering design, promoting public awareness and 
understanding, evacuation planning, recovery planning, utilization of 
technology to detect and monitor public health risks, public health 
system needs, and mental health consequences. ($30,000 in NRC funds).
Interdependent Vulnerabilities for Critical Infrastructure Protection 
        (BICE)
    A 1-day workshop was held on October 31 to help develop 
methodologies to analyze interdependent vulnerabilities. The Board on 
Infrastructure and the Constructed Environment is developing a workshop 
series to address these problems.
Chemical Stockpile Activities (BAST)
    The Board on Army Science and Technology has conducted a fast-track 
review of proposed process changes for the expedited disposal of the 
chemical weapons stockpile inventory. Letter reports are being provided 
to the Army within the month (funded by the Army).
    A second BAST activity is an examination of the state of the 
stockpile as delivered to disposal facilities and the effects of 
stockpile condition on processing, handling, monitoring and stakeholder 
reaction. A third activity is an evaluation of process changes for 
alternative technology at the Aberdeen Bulk-Only Chemical Agent 
Disposal Facility (funded by the Army).
Forum on Terrorism (Committee on Law and Justice) (DBASSE)
    As part of the Academies' investment in ``root-cause'' analysis of 
terrorism, the Forum will discuss relevant social science tools to 
summarize the knowledge base on terrorism. The objective would be to 
improve understanding of the current situation, giving rise to 
terrorism both in the United States and in the Muslim world. A series 
of workshops and commissioned papers will examine such topics as:
 Understanding International Terrorism with emphasis upon 
    research from political science and sociology.
 A more specific contextual examination of terrorism in the 
    Middle East.
 Organizational analysis and terrorism.
 A profile of terrorists.
 Recent uses of profiling and their application to combating 
    terrorism.
 Money laundering.
 Collective behavior of populations under the threat of danger 
    ($30,000 in planning initiation funds).
General Education of the Media and Public on Terrorism Vulnerabilities 
        and Responses
    On 12/6/01, the Academies and the Foundation for American 
Communications (FACS) co-sponsored a Conference for News Executives 
[``Terror and Homeland Defense: Bringing the Stories Home''] at the 
Reserve Officers Association. Approximately 50 media representatives 
attended. (Supported by the NAE and FACS).
Cybersecurity and Authentication Technologies (CSTB)
    The Computer Science and Telecommunications Board has issued a 
letter report synthesizing a decade of work on cybersecurity, focusing 
on issue identification and practical guidance. CSTB's Committee to 
Study Authentication Technologies and Their Implications for Privacy 
has undertaken to develop a brief, interim report addressing issues 
associated with the concept of national identification systems. The 
resulting pamphlet will be ready in the winter.
Chemistry and National Security (BCST)
    The Board on Chemical Sciences and Technology is holding a workshop 
in January on ``chemistry and national security.''
Mathematics and Homeland Security (BMS)
    The Board on Mathematical Sciences is holding a workshop in April 
on mathematical topics relevant for homeland security, including 
pattern recognition and data mining, epidemiological modeling, voice 
and image recognition.

    Senator Wyden. Thank you. The country is lucky to still 
have you out there, and we will have some questions in a few 
moments.
    Dr. Ryan, welcome.

STATEMENT OF DR. UNA S. RYAN, Ph.D., PRESIDENT AND CEO OF AVANT 
                    IMMUNOTHERAPEUTICS, INC.

    Dr. Ryan. Thank you very much, Mr. Chairman, Senator 
Rockefeller. Thank you very much for inviting me to testify 
this morning. I would like to enter my written testimony into 
the record and just speak in summary extemporaneously for a 
moment.
    I am the President and CEO of AVANT Immunotherapeutics, a 
biotechnology company in Needham, Massachusetts, and I am also 
a member of the board of BIO, the Biotechnology Industry 
Organization, and it is in this capacity that I am here this 
morning to address some of the Subcommittee's concerns about 
how the Federal Government and the biotechnology industry can 
work together.
    We as an industry are unanimously against the use of 
biotechnology in any offensive sense, and we are united in 
wanting to help in the defense against bioterrorist attacks, so 
the question is, how can the government, and your Subcommittee 
in particular, help us in contributing?
    Let me tell you how I see it from my vantagepoint. As the 
CEO of a small, publicly traded biotech company, AVANT makes 
vaccines against both bacterial and viral diseases. That is our 
core peacetime business. We even have a vaccine that raises 
your good cholesterol, but that is not a bioterrorist threat at 
the moment.
    We have worked with the government, both the military and 
the civilian sector, for as long as I can remember, in 
particular in trying to develop vaccines against anthrax and 
plague. We have worked for 8 years with eight different 
branches of the government, culminating last October 10 in an 
announcement that we had licensed our technology for a 
protective antigen to Dynport as a part of the Department of 
Defense's efforts for a second generation anthrax vaccine, and 
we are very proud of having done that, and I think it shows 
that with an 8-year lead we can work with the government, but 
it is not all that we or my fellow biotech companies want to 
do.
    We as a collection of companies have devices, diagnostics, 
vaccines, drugs, for prevention, treatment, containment, and we 
want to help. Let me give you an example from my own company. 
We make travelers' vaccines, and travelers are picky people, 
and so we have made single dose oral vaccines that protect very 
rapidly. The idea is, you sip and go. You jump on the plane and 
you will be protected by the time you get there.
    Again, they are oral and they are single dose. These are 
against such diseases as cholera and typhoid fever, and the 
dysenteries, but we believe we can use this technology, use a 
cholera organism, for example, as a Trojan Horse, a bus into 
which you could vector or introduce what we call epitopes, but 
you can think of as soldiers to fight different bioterrorism 
threats, so you would get cheap, effective, safe, rapidly-
protecting oral and single dose, together with versatility.
    These are the kinds of things we would like to offer and 
find the right home in the government to protect, not only the 
military, but also the civilian American population, and it is 
very difficult to do, so I would like to come up with three 
questions, very close to some of your own suggestions, that I 
believe would help us as an industry interact with the 
government.
    The first is, I believe we must have a plan, a unified 
plan. So what are the government's unified requisitioning and 
development plans? As I said, we have worked with many 
different groups in the Department of Defense and in the NIH, 
and they were all productive sorties of their type, very 
interesting interactions. But I just have a sense that we were 
never in a part of any unified plan, and therefore we never 
really progressed. It was as if we were all busy and in Grand 
Central Station instead of in the Superbowl where everybody is 
working on one end. You have to forgive me. I am from New 
England.
    The next question I have is, again, to echo yours. We need 
a clearinghouse. We need a central source where we 
biotechnology companies can find out how these great 
appropriations that we hear about are going to be funneled out 
into the various agencies. My company is not naive about 
working with the government. We have done it before. We 
understand SBIRs, we understand CRADAs, but we cannot keep 
screening every agency to find out who is offering an RFP. We 
would like a clearinghouse for one-stop shopping.
    I think the third thing we would like to ask is if the 
biotechnology industry could have some input into the 
legislative process, and I say this because I think it would be 
helpful on both sides not only for the industry, but also for 
the government. I will give one example. I believe that we are 
sort of stuck in a time warp. I answered two sets of 
questionnaires recently by companies that were helping 
prioritize programs for the DOD, and HHS, and the first two 
questions were: ``How many injections for your vaccine?'' And 
the next, ``What is the adjuvant?'' That is something that 
improves the immunogenicity. That denies the government all of 
the advances we have made. No injections. It is oral. No 
adjuvant. It is very effective in a single dose.
    So in summary, we would like to hear the plan. We would 
like to hear it well-communicated and have a place where we can 
access information, and finally, we are united in wanting to 
contribute.
    Thank you very much.
    [The prepared statement of Dr. Ryan follows:]
       Prepared Statement of Dr. Una S. Ryan, President and CEO, 
                     AVANT Immunotherapeutics, Inc.
    Mr. Chairman and Members of the Subcommittee, thank you very much 
for inviting me to testify this morning. I appear before you this 
morning wearing two hats. I am the President and CEO of AVANT 
Immunotherapeutics, Inc., a biotechnology firm headquartered in 
Needham, Massachusetts. I am also a member of the Board of Directors of 
the Biotechnology Industry Organization (BIO). I appear representing 
BIO to address the Subcommittee's concerns about how the Federal 
Government and the biotechnology industry should work together to meet 
the newly evident threat of bioterrorism. My comments are based, of 
course, on my experience as the CEO of a company that develops and 
produces vaccines that support that effort.
    We sit this morning at ground zero of the new war against 
bioterrorism. Just yards from where we sit is where the anthrax-laden 
letter addressed to Senator Daschle was opened; just a mile away is the 
Brentwood facility where postal workers were lethally infected by the 
contents of that same letter. As awful as these events were, we all 
know that in some senses we were lucky in that a larger, coordinated, 
camouflaged anthrax attack could have been far deadlier.
    As the Federal Government embarks on a campaign to fight 
bioterrorism and biological warfare, let me assure you that the 
biotechnology industry stands ready to contribute and work toward its 
success. The Biotechnology Industry Association (BIO) is made up of 
companies that develop and supply a wide variety of products essential 
to biodefense. Many are already working on defense-specific 
technologies under contract with the Federal Government, while others 
are at work on products that can be used for both conventional health 
care and biological defense. These technologies and products include 
vaccines to inoculate citizens against infectious agents, devices to 
detect biological or chemical attacks, enzymes to decontaminate 
buildings and people, tools to diagnose victims of these attacks, and 
therapies to treat them.
    I think it is important to note that the entire biotechnology 
industry is absolutely opposed to the development of offensive 
biological weapons. This is BIO's longstanding policy, which is spelled 
out in the organization's Statement of Ethical Principles. The 
development and supply of biodefense products, however, is right in 
line with the central purpose of the industry, to save and improve the 
peoples' lives.
    The President and Congress have made it clear that biodefense is a 
top national priority. Be assured that my firm and its fellow 
biotechnology companies stand poised to offer solutions to bioterrorism 
threats, both known and envisioned. Those that did not focus on the 
bioterror threat before last fall have certainly begun to direct their 
attention toward this crucial challenge. The question we all now face 
is how will the government enable our industry to contribute?
    Let me speak briefly of how the biodefense effort looks from my 
vantage point. My company, AVANT, develops a variety of therapies that 
harness the body's immune system, including drugs to lower cholesterol 
levels, reduce the permanent damage inflicted by heart attacks and 
strokes, and prevent the rejection of transplanted organs and tissues. 
The area of AVANT's work most relevant to the national biodefense 
effort is our development of vaccines that fight both bacterial and 
viral diseases.
    Our vaccine business to date has focused on the market for 
travelers' vaccines-protecting against cholera, typhoid, and 
dysentery--and on anti-viral vaccines to combat herpes, diarrhea in 
babies. However, we have worked with the Department of Defense, in 
particular the Army, in the biodefense effort even before September. 
One result of that work is that last October AVANT licensed its 
recombinant protective antigen for anthrax to Dynport Vaccine Company, 
a Defense Department contractor developing a second generation anthrax 
vaccine. This protective antigen is the crucial ingredient of an 
anthrax vaccine, the protein that prompts the body to develop immunity 
to the disease so that if the person is infected, it already has 
protective antibodies in its arsenal.
    Although we are proud of this contribution to the biodefense 
effort, we stand ready to play a much more significant role. Our most 
advanced technology offers the prospect of biodefense vaccines that are 
far more effective, safer, less expensive, and faster acting than 
current generations of vaccines. For example, the current inventory 
anthrax vaccine provided to U.S. troops is administered through 
multiple injections, which are often painful because of the reactive 
side effects of the vaccine. Once the series of injections is begun, 
immunity develops gradually over several months.
    Compare this to the vaccine that we at AVANT, using our live 
attenuated vaccine vector technology, have successfully developed to 
fight cholera. This vaccine, called CholeraGarde, is administered in a 
single oral dose. It is safe and easily tolerated by the recipient. 
Immunity develops very quickly, in as little as 7 days. Manufacture of 
this vaccine is easy and inexpensive compared to current generation 
vaccines. While this particular vaccine fights cholera, our vector 
technology enables us to develop quickly an anthrax vaccine that is 
similarly effective, safe, and convenient. And we wouldn't have to stop 
there. Our technology enables us to adapt our vaccines to fight a wide 
range of bioterror agents.
    As a biotech CEO, let me tell you the questions I would like 
answered as I consider whether and how my firm can contribute to this 
national effort.
    1. What are the government's development and purchasing plans for 
biodefense products and systems? For vaccines, drugs, detection 
devices, and the entire array of biodefense materiel, what are the 
overarching goals and acquisition plans?
    Before I, or any biotech executive, can make a decision about 
whether and how to provide biodefense products, we have to know what 
the government needs--what is the national plan. Formulating a single 
unified plan is no simple task, as there is no obvious authority to 
create such a plan. Before September 11, the biodefense program 
consisted principally of the Department of Defense effort to develop 
vaccines and treatments for forces in the field. That's why my company 
has worked with the Army on development of an improved anthrax vaccine 
since before September, for the purpose of inoculating U.S. troops. The 
Department of Health and Human Services played a key role in supporting 
research and development of related vaccines and drugs, but it had 
little active role in the procurement, stockpiling, and distribution of 
vaccines and other therapies for biodefense. My company's work with HHS 
has focused principally on basic research and clinical trials.
    The new bioterrorism threat requires a capability to protect all 
Americans, military and civilian. Biodefense policymaking, previously 
split between two major agencies with divergent missions, must coalesce 
around a single national strategy. Acquisition authority and capability 
has been distributed widely among research labs and offices with varied 
program objectives. The Federal Government must coordinate these 
authorities and assets to ensure a rational use of resources in support 
a unified biodefense plan. Once that single plan is formulated and made 
available, I can determine how my company can contribute to the 
national effort.
    2. How will I access information about the national biodefense 
effort?
    Once the Federal Government puts a national biodefense plan in 
place, it is vital that my fellow biotech executives and I have ready 
access to its contents in a usable form. There needs to be a 
clearinghouse for information that lets me know exactly which 
government agencies, offices, and labs are responsible for research, 
development, procurement, and policy relevant to my products.
    Until such a resource is available, I will have to navigate a 
complex network of government entities, searching for the key contacts 
on vaccine development and biodefense procurement. Until there is a 
biodefense liaison office to industry and a well-maintained website 
providing the latest details on national biodefense policy, my 
colleagues and I will spend significant time and money searching for 
where the real authority lies, wondering if we are talking to the right 
people. Such a clearinghouse, will make the biodefense effort more 
efficient for both the government and its aspiring biotech contractors.
    3. Will the biotech community have input into the policymaking 
process?
    There will be two key players in making the national biodefense 
plan succeed: the Federal Government, which will determine goals, 
policy, and requirements and which will oversee the acquisition 
process; and industry, which will provide the goods and services the 
biodefense program requires. The national interest will best be served 
if the parties work together to formulate and implement the national 
program.
    This may seem like an obvious and generally accepted 
recommendation, but I believe the particular case before us demands 
extra attention to the matter of government-industry collaboration. 
Although the Federal Government has done some business with the 
biotechnology industry, it is a mere fraction of the biodefense 
acquisition effort about to be launched. This leap in activity will 
make government and industry much closer partners, requiring far closer 
cooperation and deeper understanding of each other's goals and 
motivations.
    From my perspective, I am most concerned that the government take 
into consideration the harsh economic realities of the modern biotech 
marketplace. Vaccine development, like development of any drug, is an 
extremely expensive and risky venture. Unlike the development of most 
drugs, vaccines have very limited sales potential, as the best vaccines 
eliminate their markets by eradicating the disease they target. 
Moreover, we have enormous liability issues as vaccines are generally 
administered to healthy individuals. All of these factors must be taken 
into account by the government as it considers the price and terms of 
contracts for the purchase of biodefense vaccines.
    In summary Mr. Chairman, the biotechnology industry stands ready to 
join the Federal Government in meeting the nation's biodefense needs. 
We ask that for its part the government formulate a coordinated, 
coherent biodefense plan, that all aspects of the plan and its 
implementation are readily accessible to industry participants, and 
that both partners open a continuous dialog about how to work together 
to meet the plan's vital goals.
    This plan should be accompanied by a clearinghouse of information 
on biodefense acquisition covering everything from policy to points of 
contact. If these steps are taken, we can look forward to a future 
where the best of our technical and management skills can protect all 
of us from some of the most terrifying threats of a new and dangerous 
era. Thank you very much.

    Senator Wyden. Dr. Ryan, excellent presentation. We will 
follow up on your suggestions.
    Senator Rockefeller was the author of the CRADA statute, so 
this comes at an ideal kind of time for your input.
    Let us hear from Dr. Sobral, then we will have questions.

STATEMENT OF DR. BRUNO W.S., SOBRAL, Ph.D., DIRECTOR, VIRGINIA 
     BIOINFORMATICS INSTITUTE; PROFESSOR, PLANT PATHOLOGY, 
          PHYSIOLOGY AND WEED SCIENCE AT VIRGINIA TECH

    Dr. Sobral. Good morning, Mr. Chairman and Members of the 
Subcommittee. I would like to thank you for this opportunity to 
appear before you and discuss the work of university research 
and the Virginia Bioinformatics Institute. Among other things, 
September 11 has made us acutely cognizant of our Nation's 
dependency on science and technology. We also know that science 
and technology will provide the best mechanisms to prevent, 
detect, and mediate bioterrorist attacks. Bioinformatics is at 
the forefront of disciplines that hold the greatest promise to 
achieve these goals. Early identification and intervention in 
any disease outbreak are pivotal to both control and abatement. 
This requires rapid diagnostic tools, a system to track 
diseases as they evolve, and epidemiological data to determine 
pathogen origin and inhibit dissemination.
    We must also consider indirect threats to our food and 
water supplies. Agriculture accounts for roughly one-sixth of 
the total U.S. GDP. A lone terrorist could introduce disease 
into livestock or crops, which would set off a chain reaction 
touching virtually every segment of this Nation's economy. An 
attack might also be used as a feint to divert critical 
response personnel from other primary terrorist targets.
    Currently, the fundamental science to support detection, 
identification, forensics, risk assessment, and mitigation is 
fragmented across many Federal and State agencies, academe, 
several non-profit organizations, and industry. In addition, 
that science is presently found in both varied contexts and 
diverse syntax. A critical need still to be addressed, 
according to the President's Science Advisor, John Marburger 
and others, is our seriously incomplete knowledge about 
pathogens, especially those that can be used as weapons. This 
cannot be emphasized enough. To handle bioterrorist attacks we 
need a global pathogen science portal where data and 
computational analysis tools come together and are made 
available to all stakeholders.
    VBI can create a single bioinformatics interface to access 
available information required for a comprehensive surveillance 
program. With access to such a system, researchers, public 
health workers, and security officials, could quickly access 
the threat and options for mitigation. Although VBI has 
comprehensive bioinformatics capabilities in-house, the 
completion of the information pipeline requires a strengthened 
partnership among government, academe, and industry.
    This partnership depends upon ractive inclusion. 
Partnerships with both IBM and Sun Microsystems ensure the 
necessary technology for information translating, routing, and 
accessibility are present. Partnerships with biomedical 
researchers, like Johns Hopkins Bloomberg School of Public 
Health, will provide field data on malaria, AIDS, measles, and 
tuberculosis for our information system.
    VBI is in a unique position to help defend against agro-
terrorism. We are located on the campus of Virginia Tech, which 
has strengths in agriculture, engineering, and information 
technologies. We have already worked with USDA and DOD to 
identify a list of high-priority pathogens. We can become an 
information nexus for pathogen identification, origin, and 
signature determination.
    With bioterrorist threats especially, the preferred 
solution is always prevention. Scenario-building is a technique 
to anticipate ``what-if'' situations and develop mechanisms for 
an event ``to not occur,'' or at a minimum, to have a carefully 
crafted response plan. Since we cannot prevent what we do not 
fully understand, all research must be available for access, 
and ongoing research must continue.
    Once a bioterrorist agent is released into the environment, 
the damage is extremely hard to combat and isolate. With 
advances in sensors, many researchers and entrepreneurs could 
collaborate in scenario-building sessions and in developing 
sensor-based alarm or warning systems. The VBI integrating hub 
can plan an important part in both the identification and 
remediation of bioterrorism as well as the anticipation and 
prevention of a bioterror fallout.
    Consensus will be essential to make decisions regarding 
access that will ensure both scientific progress and national 
security. At VBI, we are developing a flexible infrastructure 
applicable in times of peace and in times of national 
emergency, a new resource in this new century.
    Thank you. We look forward to working with you.
    [The prepared statement of Dr. Sobral follows:]
  Prepared Statement of Bruno W.S. Sobral, Ph.D., Director, Virginia 
 Bioinformatics Institute; Professor, Plant Pathology, Physiology and 
                     Weed Science at Virginia Tech
    Senator Wyden and distinguished Members of the Subcommittee:
    Good morning and thank you for this opportunity to appear before 
you and discuss the work of the Virginia Bioinformatics Institute 
(VBI). The resources of the Institute and university research in 
general, provide powerful tools and assets to combat bioterrorist 
threats.
                    the role of academe and research
    The Federal Government has a long, rich tradition of funding 
research in our Nation's colleges and universities. For the past 50 
years, Federal funding has provided continuous support to develop the 
fundamental science and technology that pushed disciplines, such as 
genomics and bioinformatics, to new frontiers. Federal support began, 
in large part, as a result of the significant role that scientists 
played in winning World War II. Our accrued knowledge from decades of 
research support already serves new objectives brought about by events 
that began on September 11.
    Since 9/11, the need for increased scientific and engineering 
knowledge has become abundantly clear. Every discussion--whether about 
airline safety, failure of communication links, contamination of food 
and water supplies, bioengineered weapons, and countless other 
concerns--depends on our Nation's scientific and engineering knowledge 
and expertise. In times such as these, we are acutely cognizant of 
living in a society defined by, and dependent on, science and 
technology.
    Once again, the experience, research, and measured debate conducted 
by academe can bring both historical context and analytical order to 
elucidate public discussion and public policy, and marshal technologies 
and tools needed to mitigate the threat of bioterrorism. As OSTP 
Director John Marburger III said in his keynote remarks before AAAS 
last December, ``Harnessing the Nation's collective S&T expertise is 
critical for long-term success in the war on terrorism.'' VBI's 
interdisciplinary approach--marrying bioinformatics, biology, 
information technologies, and mathematical modeling--is positioned to 
play a pivotal role.
          threats of infectious disease and biological weapons
    It is generally agreed that 21st century biotechnology and 
bioinformatics herald a new era for science and engineering, promising 
healthier and longer lives and further advances against infectious 
diseases. But like a double-edged sword, technologies with the 
potential to control disease might also be used to develop an arsenal 
of bioterrorist weapons.
    We are also aware that new antibiotic-resistant pathogen strains 
sometimes evolve faster than we develop new therapies. For instance, 
the resurgence of tuberculosis in the United States in the early 1990s 
was associated with the emergence of a multi-drug resistant 
tuberculosis strain. Many other diseases currently overwhelm our 
preventative and therapeutic measures--HIV, Ebola, West Nile virus, and 
malaria--just to name a few. Infectious disease concerns are global in 
scope. In today's world of rapid travel and large migrant populations--
diseases of humans, livestock, and crops, regardless of introduction 
mode (intentional or accidental)--pose a growing threat to our health, 
agriculture, and economy.
                        impacts on human health
    Even before the anthrax attacks that followed September 11, many 
public health and national security officials voiced their concern over 
the potential threat of biological weapons. In the March 25, 1999 
Senate Public Health and Safety Subcommittee meeting, the American 
Society for Microbiology warned that: ``National security measures 
against biological warfare must include building up the Nation's public 
health infrastructure to respond to bioterrorism.'' The Dark Winter 
scenario reinforced this position by illustrating the catastrophic 
potential of smallpox if used as a weapon. It underscored the need to 
inform the comprehensive medical and healthcare community about the 
symptoms, behavior, and virulence of known pathogens if millions are to 
have any chance of survival. Early identification and intervention are 
pivotal to both control and abatement.
    For each of the biological weapons considered by experts to be the 
most serious threats to America--anthrax, botulism, plague, smallpox, 
and tularemia--modern medicine has some effective means of responding, 
whether by vaccination, antibiotic, or antitoxin. To inhibit the spread 
of a biological attack or a ``normal'' disease outbreak in humans, 
livestock, or crops, we must have rapid diagnostic tools, a public 
health system to track disease as it evolves, and epidemiological data 
to determine the origin. Fundamental research and expertise provided by 
universities will be essential to complete these tasks. It will provide 
the foundation to deliver the tools with which we will prevent, detect, 
protect, and treat victims of biological terrorist attacks.
                  impacts on agricultural productivity
    We have already experienced direct threats to human life through 
bioterrorism using infectious disease, but what about indirect threats? 
Though we must certainly take precautions against human diseases, we 
must also consider indirect threats on our food and water supplies. We 
now know, for instance, that Al Qaeda plotted out landmarks and public 
water supplies of most major American cities. We also know that many 
countries considered to be epicenters of terrorist activity have 
experimented extensively with agro-terrorism. For example, Iraq was 
developing wheat cover smut as a weapon in the late 1980s, most likely 
to use against Iran.
    A single agricultural terrorist could launch a pathogen that, 
spread by wind, water, or soil, could cause an irremediable chain 
reaction. The food supply and industries involved directly in food 
production and distribution are especially vulnerable. The agriculture 
sector accounts for roughly one-sixth of the total U.S. Gross Domestic 
Product. A terrorist wishing to cause severe and reverberating 
financial consequences could simply introduce a foreign disease into 
American livestock or crops that would set off a chain reaction 
touching virtually every segment of this Nation's economy.
    Larry Madden of Ohio State University perhaps captured it best when 
he said, ``It would be a continuing, recurring problem, like a 
permanent bomb going off.'' The recent UK foot-and-mouth disease 
debacle is a case in point. Nearly four million (3,915,000) animals 
were slaughtered. The UK cattle industry was still reeling from the 
approximately $6 billion of lost agricultural revenue from the mad cow 
disease outbreak starting in 1996. This estimate does not include the 
billions in revenue lost by the tourism industry. Many farmers, their 
livelihoods destroyed by the disease, committed suicide. As in other 
parts of the world, we are ill-prepared to cope with an epidemic, 
whether a biological weapon, an accidentally introduced exotic 
pathogen, or a naturally mutated pathogen. In this country, we have 
little experience dealing with epidemics of any proportion.
    If an indirect agricultural bioterrorist strike does occur, we must 
also be cautious when deploying emergency personnel. An attack might be 
used as a feint to divert resources from critical command posts, 
leaving them vulnerable. For instance, a major livestock disease 
outbreak in Texas would shift our primary command and control emphasis 
there, as well as large numbers of military personnel. This would leave 
cities like New York, Washington D.C., and Fort Knox open to assault. 
We must be prepared to ensure that no potential targets are at risk.
         role of virginia bioinformatics institute and partners
    To handle such a scenario, a common place where molecular data 
about pathogens, their host's responses, and computational analysis 
tools come together and are made available to all stakeholders is 
paramount. At VBI, our recent efforts to create a comprehensive 
pathogen information system parallel national necessity. We 
recognized--prior to 9/11--the need for a common language to assess 
biological threats; avoid information, research, and analysis 
duplication; and facilitate interagency cooperation and coordination.
    At the numerous and diversified agencies playing a role in national 
biological security, the underlying scientific research to support 
detection, identification, forensic attribution, risk assessment, and 
mitigation is very similar. However, this fundamental science is 
conducted in a slightly different context or syntax in over 40 Federal 
and State agencies, at multiple colleges and universities, in several 
non-profit organizations, and throughout industry. Thus, an interface 
and infrastructure to connect and organize the molecular biological 
databases in these various sectors is critical. This ``science 
portal,'' or comprehensive pathogen information system, will be able to 
draw on already available resources to completely characterize known 
pathogens and their near relatives. This comprehensive and easily 
accessible system will serve as a fundamental knowledge and 
decisionmaking tool.
    VBI will provide genetic sequencing of pathogens as needed, but our 
primary mission is to create a single bioinformatics interface to 
access the already available information required for a comprehensive 
surveillance program. We integrate, and provide when necessary, 
molecular information regarding pathogens, their hosts, and their 
interactions within the environment. Our goal is to create a common 
language that can be understood by all accessors. To reiterate, we are 
not a comprehensive storehouse of information, but we are like a tour 
guide and translator who can also exchange currency.
    With access to such a system, researchers, public health workers, 
and security officials could quickly assess threats and options for 
mitigation. Platforms for detection and identification of pathogens are 
ultimately dependent upon distinctions between pathogenic and non-
pathogenic organisms and the distinctions of one pathogen from another. 
Therefore, bioinformatic interpretations of disease-host-environment 
interactions are crucial in finding solutions.
    Although we have comprehensive bioinformatics capabilities in-
house, the completion of the information pipeline--from basic research, 
to data interpretation, to useable information, to knowledge, to 
applications and technologies--requires a strengthened partnership 
between government, academe, and industry. We realize that connectivity 
is a critical first-link in our endeavor. Therefore, we are drawing 
upon diverse research expertise that is only available through 
partnerships. VBI will actively promote inclusion; there can be no 
prima donna in a system that will act as a common asset serving such a 
crucial national need.
    As a case in point, our biological resources are IT integrated and 
we rely on partnerships with both IBM and Sun Microsystems. We have 
already established partnerships with industry that will ensure the 
necessary technology for translating and routing information and making 
it accessible. In addition, since we are riot a medical research 
facility, we have recently established a partnership with Johns Hopkins 
Bloomberg School of Public Health to study many major infectious 
diseases, including AIDS, malaria, measles, and tuberculosis. In the 
malaria study, for example, Johns Hopkins researchers--working in 
collaboration with local health officials where malaria outbreaks 
occur--will provide the needed field data to integrate in our pathogen 
database.
    Along with our partnerships to fight human infectious diseases, VBI 
is in a unique position to help defend against agro-terrorism. As part 
of Virginia Tech, a land-grant university, we are among the top five 
agricultural research universities in the country. We have already 
identified a list of high-priority livestock and crop pathogens, which 
would form another contingent of our pathogen science portal.
    Using bioinformatics as a tool, we can integrate genomic and other 
databases with information on pathogens that will allow for rapid 
detection, attribution, and mitigation. VBI's primary role will be to 
integrate the molecular (genomic, metabolomic, proteomic) and 
toxicological signatures for pathogens and host responses. Overlaid 
field data records will be geospatially accurate to identify the origin 
of each strain, primarily through additional partnerships with users of 
Geographic Information Systems (GIS). At present, some molecular data 
exists but it is often incomplete, insufficient, or in formats that 
need to be translated. As these data are brought together, they will be 
translated, completed where necessary in-house, and integrated. This 
will enable work on threat assessment, pathogen detection, attribution, 
medications, vaccines, and disease prevention. We will create a common 
source of fundamental scientific information that has been fragmented 
to date. Integration on this new level will promote proaction rather 
than reaction.
                  science as prediction and protection
    VBI can serve as the ``integrating hub'' of knowledge among 
government, law enforcement, healthcare professionals, and local 
communities nationwide. We can become an information nexus for 
identification of pathogens, their origin, and their signatures. In 
addition, our outreach mission could be expanded to serve as an 
educational arm for first responders, i.e., law enforcement, doctors, 
community officials, to biological crises. Intensive 2-day sessions 
could be developed to familiarize first responders with identifying 
data. Knowing symptoms and the most effective antidotes in times of 
outbreak--including isolation, vaccination, and treatment--can help 
prevent panic and save lives. Preparation is paramount in these cases, 
as is reaction time. In the post-September 11 era, university 
researchers should not only teach and expand the frontiers of 
knowledge, but also serve the public by providing an understanding of 
the science and engineering that affects their lives. Director of the 
National Science Foundation, Dr. Rita Colwell, recently called this, 
``science as patriotism.'' It is time to further extend this capacity.
    Today, science is our common path to generate new knowledge or to 
solve an existing problem. With bioterrorist threats especially, the 
preferred solution is always prevention. However, it is impossible to 
prevent what we do not fully understand.
    In all research scenarios we are trained to ask questions and 
hypothesize. This ``scientific method'' is also an important tool for 
what many specialists call the prediction/prevention approach. Although 
scientific knowledge is the most powerful force for knowledge-based 
prediction, the research community needs to become increasingly 
proactive in that direction. With the advent of serious bioterrorist 
threats, prediction/prevention is critical.
    For many years, defense specialists have used a technique called 
scenario-building to anticipate and plan for even the most unlikely 
circumstances. The most successful results are achieved by bringing 
together thinkers and doers from diverse perspectives--everything from 
philosophers to practitioners. Anticipating ``what if'' situations 
leads to mechanisms for an event to ``not occur'' or, at a minimum, to 
have a carefully crafted response plan if it occurs.
    Once a pathogen is released into the environment--whether the 
postal service, a ventilation system, our water supply, or any number 
of other scenarios--it is extremely hard to combat and isolate. With 
advances in sensors, many researchers and entrepreneurs could 
collaborate in scenario-building sessions and in developing sensor-
based alarm or warning systems. No one need remind the Senators whose 
offices are in the Hart Senate Office Building of this need.
    The VBI integrating hub can play an important part in both the 
identification/remediation of bioterrorism as well as the anticipation/
prevention of a bioterror fall-out. We can pinpoint a pathogen and 
describe its known qualities so that remediation can be swift and 
pathogenspecific. We can be partners in scenario building to anticipate 
or forewarn about biological incidents and help in suggesting and 
developing mechanisms for prevention and protection.
               paradox of publicly available information
    I realize that as we discuss science and technology fixes, 
solutions, or preventions today, we are also talking about an issue of 
societal ideals and the public's will.
    Let me add at this time what I believe is an important overarching 
understanding on these issues. Alexander Hamilton expressed the opinion 
that ``to be more safe, [people] at length become willing to be less 
free.'' This is not an idle concern for the most democratic Nation in 
existence today.
    We must recognize that if information is publicly available, it is 
by definition available to wouldbe terrorists. If requests for 
proposals are publicly solicited, then the description of the project 
and the solution sought will give both well- and ill-intentioned 
applicants vital information. For terrorists, open information is like 
a window on someone else's thinking.
    For example, after the 1993 World Trade Center attacks took place, 
some hearings and investigations were open to the public. The 
informative descriptions of the Towers' structure provided key 
information for the September 11 terrorists.
    History provides other lessons. In the 1950s, physicists were 
pivotal. They possessed the primary knowledge to create new weapons of 
mass destruction. However, these experts needed sophisticated 
facilities to carry out their work. In contrast, biological weapons can 
be manufactured in relatively simple facilities by a single individual. 
To detect and destroy bioterrorist facilities, new tactics will be 
needed.
    We understand that public access to useful knowledge may arm a 
potential enemy. Limiting accessibility to scientific information may 
be the only blockade we possess. At the same time, science thrives on 
open discourse. Measures that inhibit dialog will impede progress. We 
cannot limit scientific interaction without limiting scientific 
progress. This presents a conundrum.
    It would be naive, however, to not anticipate problems with access 
and build in safeguards. Once again, collaboration among government, 
industry, and academe will be essential as we make access decisions 
regarding science and technology that will ensure both scientific 
progress and national security. We all agree the whole world has 
benefited from science, engineering, and technology conducted in our 
public institutions.
                                summary
    We have been gathered today to contemplate collaborations among the 
various sectors of our society and, in particular, the vital role 
university research can play. This pattern of integration will also be 
translated into a peacetime counterpart which will not merely 
familiarize our armed services with the progress made in science and 
industry, but also draw into our planning for national security all the 
civilian resources that can contribute to the defense of our country.
    At VBI, we are developing a flexible, collaborative infrastructure 
applicable in times of peace. Broad connectivity will allow access to a 
comprehensive knowledge source that will be key to tackling a host of 
complex problems: human, animal, and plant disease; environmental 
degradation; and economic recession.
    In summary, the Federal Government has provided continuous support 
to our Nation's universities. Academe has much to offer this 
partnership in terms of knowledge, research, and resources. University 
experts should be engaged in shaping public policy on the critical 
issues pertaining to biological weapons. Virginia Bioinformatics 
Institute, one such example, will provide a unique and centralized 
source for data compilation to help understand, mitigate, and control 
infectious disease pathogens, whether intentionally or accidentally 
introduced. This ``scientific portal'' will integrate underlying 
scientific research, genomic and other molecular data, and 
epidemiological information to support agencies addressing biological 
threats to humans, livestock, and crops. To accomplish this task, VBI 
has forged, and will continue to promote, crucial partnerships among 
universities, industry, and government agencies. Partnership among the 
three will be vital as we balance the access of scientific information 
to protect our country but not hinder the scientific engine. Access to 
information by the scientific community will be critical as we develop 
strategies to prevent biological attacks--the ideal solution.

    Senator Wyden. Doctor, thank you. All of you have been 
excellent.
    We will begin the questioning with Senator Rockefeller.
    Senator Rockefeller. Thank you, Mr. Chairman. I have a 
multilayered question which will come out in whatever free form 
it will come out in. A couple of thoughts. Cooperation is easy 
to talk about and very hard to do. Research tends to follow 
money. If you work for a Federal agency, you may not have to 
worry about that as much as you would if what you have been 
doing has only been funded by the Federal Government, and if it 
has not, you have an additional problem. There is also the 
constant problem of the slowness of large agencies, which 
includes the NIH.
    The Department of Veterans Affairs ought to be included, 
incidentally, in all of this talk of preparedness, because it 
does good work. We passed legislation 3 years ago requiring the 
VA to do long-term care, which is the veterans' basic need 
these days. That was under the Clinton Administration. We still 
have not seen the beginnings of any effort on their part.
    So why do I say that? Simply to say that because you are in 
health care, whether it is research or as a practitioner or as 
a government agency, it does not mean you are moving rapidly.
    You spoke of getting technology to the counties. I have 
been all over West Virginia in the past 4 or 5 months talking 
with law enforcement, with public health, with hospitals, with 
FBI, everybody in sight. The National Guard actually has been 
the most effective. They all have humongous needs which are not 
going to be met by the money which is now going to be available 
to us if the Congress votes that through, so they are doing it 
on their own.
    Now, that is good, except that 80 percent of them have been 
losing money for the last 4 or 5 years. If you need a hazmat 
facility which costs $300,000 because you are on an interstate 
with a lot of hazardous chemicals passing by, you are probably 
going to build one, but that is about it. That is about all you 
will be able to do.
    Universities do research, and they do basic research--and 
actually I have heard quite a lot of this recently. They do 
basic research to the extent sometimes that they come not to 
understand that there are people waiting for the results of 
that research who could be helped by that research, and this is 
something of a quandary. Companies do research for the purpose 
of being able to sell products, and that is not wrong. That is 
our system.
    If, let us say, smallpox is a very, very large potential 
problem but does not have a large commercial market--we will 
just say that hypothetically, because it has not happened--will 
industry do the research? You can count on industry, I think, 
to do the research to get it to market.
    So you have, on the one hand, the research for research's 
sake, and then sometimes that gets done under rather careful 
strictures. On the other hand, you have research done for the 
purpose of getting it to market, but it may not be that which 
is needed at the right time, because what happened was not what 
you expected.
    So my question is--I am going to end up with an odd thing. 
I serve on the Intelligence Committee. It is a very good 
Committee, and there are some very good groups who work in 
intelligence, but always our best hearings are when we have 
about six people who are from totally outside the purview of 
intelligence--in other words, they do not get paid by it. They 
work for companies that do unbelievable things, and they all 
think way out of the box, and they think about the future. They 
have been doing it for 10 years, and they do it because they 
love it, and because they want the Nation to be secure. They 
have all of these really interesting thoughts which our 
intelligence agencies decline to use.
    So we sit there as a committee, enthralled by what they are 
saying, probably knowing not much attention is going to get 
paid to it. You can do what you will with my mix in answering, 
but it is the whole question of the disconnect between the 
world of the university and the world of industry--and I will 
include counties, where there is a lot of talk about doing 
public health, but not a lot of talk about, for example, 
connecting public health up with law enforcement, or having the 
means to do that, via the Internet, for example.
    The West Virginia State Police is a wonderful organization, 
but only 7 of its 60 detachments have Internet capacity. Fifty 
percent of the police departments do not have any at all.
    It is a world of terrific statements, of strong will and 
determination, overlaid with an enormous amount of 
disconnection, it seems to me. Having probably already extended 
my time, I would be interested in what you think.
    Dr. Benjamin. I think, Senator, in summary you said that 
great ideas do not survive real-world analysis. I think, at 
least in my State, we started thinking about bioterrorism about 
4 years ago, and I went around the State talking about it for 
lots of reasons. But there was this huge blank stare and lots 
of vacant rooms, and people thought, ``nice guy, that Benjamin 
guy, but he is on another planet,'' because they could not 
visualize how this would help them in their daily lives.
    So I think one of the ways that you might try to make that 
technology transfer is figure out how to make that stuff 
relevant to what happens on a daily basis. Now, one of the 
arguments we have made on the public health infrastructure side 
of things is, this is great technology to have, but does it 
really help us? We think it should make the food safer to eat, 
and the water safer to drink on a daily basis. I think if that 
technology can be developed in that context, then it will 
certainly be there when we need it.
    And quite frankly, my experience in the emergency medicine 
world has been that people tend to do what they do every day, 
so that if you build that technology to function in the real 
world on a daily basis, it has utility, it has staying power in 
the marketplace. Those folks that look at me like I am crazy 
will think they will want to use it.
    Dr. Ryan. I think you are absolutely right that there is a 
disconnect, but I am not sure that there really needs to be a 
disconnect, and I think that there is a way to harness the cart 
to the horse. I gave you an example of some technology that was 
developed without any thought of providing it as part of the 
country's defense, so in a way the government can get all those 
years of research and improvement as a freebie. That is done.
    We also recognize that we have to go for large markets 
where there are large margins, and the government is not 
willing necessarily to pay those margins, but when you have 
technology that is so applicable to the defense effort, and one 
has seen this in previous wars where great inventions have come 
out of something for wartime, I think that it is relatively 
easy to take the advantages, take the need, the current need of 
the government, and couple them together without trying to get 
the returns that we would expect in a normal marketplace.
    I will give you one example. If the U.S. Government would 
help small biotechnology companies build plants that could be 
used to manufacture and stockpile vaccines that the country 
needs in down time, slow time, or when the stockpile is 
complete, that is an incredible advantage to us. The government 
would get the advantage of the technological know-how, a 
reasonable return for the product, and the company would have 
an ongoing benefit.
    I can think of lots of other examples. It does not have to 
be building plants, but I do think progress has taken place. I 
think the need is clear, and if the government will define a 
market, companies are nimble enough to find ways that they can 
fit into the profit margins that government will require and 
get something that is beneficial.
    Dr. Hatchett. I just want to amplify on Dr. Benjamin's 
remarks about doing what we normally do. A little anecdote to 
address Senator Rockefeller's concerns. I was at the Sloan 
Foundation about a month ago meeting with Jack Harrald and Joe 
Barbera from George Washington University here, who are working 
on a regional response plan, and with Tom Inglesby and Tara 
O'Toole from the Center for Civilian Defense at Hopkins. We 
were sitting around discussing issues relating to hospital 
preparedness and sort of speaking up in the ether about what we 
would do, and Ralph Gomory, the President of the Sloan 
Foundation, stopped us and asked: ``I am giving you 6 months to 
prepare. What would you do?''
    He said, ``I am not going to tell you what you are 
preparing for, but what would you actually do?'' And then we 
began to think, ``Well, what would we do in the first 6 weeks, 
in the first 12 weeks, what would we hope to have accomplished 
after 3 months?''
    I think in talking about the disconnect that you mentioned, 
I think one of the things we need to bear in mind is what might 
happen at the end of 6 months in Dr. Gomory's scenario is that 
the window of opportunity closes. There is a tremendous 
receptivity in all these communities to forge links, to 
establish connections. There is new interest in the public 
health community, in the hospital community, which 
traditionally, because they are competing with each other, have 
not been interested in sharing information. There is a new 
willingness to share information and to establish these links 
and to create the types of coordination that are going to be 
necessary to maximally utilize the assets we have.
    And then also, just to amplify on Dr. Benjamin's remarks, I 
think in terms of doing what we normally do as we move forward, 
if we can think about creating dual use, you mentioned the 
vaccine technologies that already exist. If our bioterrorism 
initiatives are created in a way that they will be useful no 
matter what happens, there will be a place for moving forward 
and establishing something that will be there. It has to be 
useful, even if there is never another bioterrorisn event. The 
initiatives we create have to have value in the marketplace, 
even without the actual event of bioterrorism.
    Obviously, there will be a risk of severe epidemics, 
another Spanish influenza that would approximate a bioterrorism 
event. I think as long as we keep in mind that we are trying to 
accomplish public health goals and hospital preparedness goals 
that do not depend on a successful bioterrorism event, I think 
we will have success.
    Senator Rockefeller. Mr. Chairman, can I ask one further 
question? I want all of this to be positive. I recognize the 
way I asked my question was not, but that was deliberate. The 
business of hospitals and public health and, let us say, CDC 
improving its website so that it is useful--not just to a 
scholar, but to a hospital administrator, or the head of 
nursing who really needs to get an answer right now because 
they are not quite sure what just walked in the emergency room, 
and nobody is trained really to figure out what that particular 
disease might be--I think the need is real. I agree with you, I 
think people are trying to connect.
    But I also think, and I suspect Dr. Benjamin ran into this, 
too, that the hospitals, the public health infrastructure is, 
as I indicated, going broke. They are trying to make it from 
week to week, and they cannot pay their bills, and they cannot 
pay their doctors, and they are losing all kinds of services. 
My question is, was September 11 enough of a stimulus to make 
what you are all saying, what those three of you that have 
replied have said, to make that come true? That is, the sense 
of connection, the willingness to adjust, to change behavioral 
patterns?
    Yes, we will find our way of making this little niche work 
even if we do not make a ton of money from it. Incidentally, I 
approve of your approach. I am for research that can be applied 
to making people better, to improve the welfare of mankind. I 
think that is what ultimately counts in life, and I think 
sometimes government agencies are slow to do that, and 
universities are slow to do that sometimes because of the 
demand for research and the Nobel that you get 20 years after 
you have done it, and that is not cynical.
    Now, the West Nile virus first broke out two years ago in 
New York. I think there was an interesting result from that 
that I would like your comments on. Beyond New York, throughout 
the Mid-Atlantic region, there has been kind of a wake-up call 
toward this business of ``pulling together.'' It did not get a 
lot of attention, but it has pulled together public health, it 
pulled together the medical community, it pulled together the 
veterinary community, and a lot more. It inspired public health 
to develop active surveillance software that collects data from 
pharmacies, emergency rooms, even school absence data.
    Now, it had a very interesting effect, and you could 
postulate that if this could go on, why could not this kind of 
software communication and syndrome surveillance be developed 
between regions, certainly within States, but really more 
regionally, even nationally?
    So was September 11, in fact, a wake-up call that is 
sufficient to the way your colleagues, let us say, have or are 
changing their behavior in your mind? I am trying to get an 
honest answer.
    Dr. Klausner. It is probably too early to tell. I think the 
current feeling is that an enormous amount changed on September 
11. What changed was our perception. The threats did not 
change, the weapons did not change. It was our perception. I 
think we all know it remains to be seen how sustained the 
interest, the concern, and that is going to require leadership.
    I think the government is going to be very important in 
maintaining a sustained interest in what has to be invested in, 
but there are several things, and of course we do not know what 
is going to happen when and whether and what sort of next event 
there will be. I think very few people do not think that at 
some point there will be other events. We are in an age of 
technology that gives people the capacity to produce terrorism.
    What has been said is that of the dual use, that so much of 
what we are talking about fixing needs to be fixed independent 
of bioterrorism or other forms of terrorism, hopefully is 
another part of sustaining our interest, but I think the level 
of interest is very real. I think it is very deep. I think 
September 11 was a profound and profoundly traumatizing event 
for the country and the world, and I suspect it will be 
sustained, but I think there is some uncertainty, and I must 
say that is one of the roles of government, is to provide that 
sustained leadership.
    There is a lot of worry about that in the scientific 
community, recognizing the things that have to be solved are 
not going to be solved today or over the next year or in the 
next fiscal cycle. But some of these things are going to 
require, as I said earlier, as a lot of people have said--
sustained investment in infrastructure, in communication and 
technology, and in fact, that curiosity-dependent science, that 
driven science that actually provides us with answers that we 
are going to need when they come up, that we actually can 
predict now. It is one of the problems with overdefining the 
direction of research.
    I think your question is a really important one, and what 
is really important probably is to continue to raise it. Will 
this be sustained? The more we remind ourselves it needs to be.
    Senator Rockefeller. You said quite apart from September 
11, these things should be going on, and I think that was kind 
of the heart of what you had to say, was it not?
    Dr. Klausner. Yes.
    Senator Rockefeller. That the changes are taking place 
anyway?
    Dr. Klausner. Right.
    Senator Rockefeller. Then you said we have to keep 
reminding you and pushing you. We will be doing that because of 
September 11, and because of what you mentioned. It is just 
interesting to me you would say that September 11 was important 
in the change of mind-set, the change of perception, it was 
interesting that you said that that had been going on anyway. I 
guess I had not noticed that, and I guess part of that will be 
defined in what NIH is going to spend this money on. How do 
they decide where they are going to spend their money? It will 
be different from what it was 2 or 3 years ago.
    Dr. Klausner. I suspect it will be, from what I see, but if 
I could just say one other thing, you did mention something, 
and that is the sort of fantasy of overall coordination. I 
think we have to be careful. Coordinating everything often 
sounds good and is often called for and it is probably 
impossible. What you need to instead is to have standards that 
are set about transparency, about quality of communication, 
about whether each entity, even if it is many different 
agencies, have a plan, it is clear, it is looked at, it is 
reported on, it is evaluated. I think that is a much more 
important goal than some sort of fantasy of complete 
coordination between such a complex organism as our society.
    Senator Rockefeller. Well, still admitting that the West 
Nile outbreak created some coordination that was useful, I am 
not talking about Soviet-style coordination.
    Dr. Benjamin. Senator, let me say two things. One that 
certainly in Maryland, West Nile virus got several of our State 
agencies working and playing well together. It was therefore 
very helpful when we had bioterrorism that the Department of 
Natural Resources and the State police and our Department of 
the Environment and Department of Agriculture all knew each 
other and had worked very closely together during West Nile 
virus. I do have two things, though.
    Obviously, the public health community in general is always 
skeptical around funding, because our history has been you get 
funding for tuberculosis, you get rid of tuberculosis, and the 
funding goes away. So we have a history, a long history, of 
skepticism. Then, of course, is when tuberculosis comes back, 
it comes back in a more virulent form, antibiotic-resistant.
    We obviously cannot afford to do that with the Nation's 
defense. We have to have an infrastructure in place. We have to 
recognize that infrastructure is here for the long haul. We 
have to understand what that infrastructure means. It means an 
adequate staff of epidemiologists and disease-control 
specialists. Without those disease detectives, we are nothing. 
We cannot track disease.
    Do not be fooled by anthrax. Anthrax was kind of an 
occupational health exposure. It was a terrible event, but it 
was contained. As epidemics go, smallpox is not going to go 
like that, as you know. West Nile virus, again, was a vector-
transmitted disease process. Many of us stood back in Maryland 
watching New York struggle with this when it first occurred, 
and it slowly crept down. Each season it came down the coast, 
and now it is going toward the Midwest and the Nation has been 
able to watch that and learn by that experience. We clearly 
would probably not have that opportunity in a purposely-
designed epidemiological outbreak with something like smallpox 
or plague. So that infrastructure is absolutely essential to 
have in place and to have it there for the long haul.
    Senator Wyden. Senator Allen.
    Senator Allen. Thank you, Mr. Chairman. I am sorry that I 
have only been able to read your statements because I was with 
the Secretary of Commerce and we were talking about broadband 
by the way--in the midst of all of this--and I know the 
Chairman and my colleague from West Virginia would be happy 
with that as well.
    Let me ask a few questions to Dr. Sobral. I have read your 
statement, your written testimony. I assume you stated it for 
everyone, and it fits in with Dr. Klausner, who was answering 
one of the questions.
    Senator Rockefeller, you were talking about the role, and 
recognizing various things that you recognized even prior to 
September 11 for the need of a common language to assess 
biological threats, avoid information research and analysis 
duplication, and facilitate interagency cooperation and 
coordination.
    Dr. Klausner said ``Well, maybe it is not so much that, but 
standards.'' I think you are all saying the same thing. It is a 
matter of phraseology, I suppose. People just need to 
communicate.
    I think he also referenced that VBI could serve as an 
integrating hub of knowledge among law enforcement, health care 
professionals, the government, and local communities 
nationwide.
    Now, how can you design this to ensure that there is fast 
and effective communication to all of these various 
stakeholders at different levels of government, some in the 
private sector, some in law enforcement as well, especially in 
the early stages of a biological attack? How can you assure all 
of that, that the hub is going to get the information?
    Dr. Sobral. Thank you very much, Senator Allen. Those 
comments are right on the money. The critical part of ensuring 
broad access, even though you are talking about a system, 
actually is its implementation. Information technology 
capabilities, by their very nature, are very decentralized. We 
have been, for example, recently in North Carolina talking to 
the supercomputer center about the building of a Biogrid to 
support these kinds of capabilities.
    Senator Allen. Building what?
    Dr. Sobral. A biological grid, basically an intelligent 
Internet that would handle pathogen data. I cannot emphasize 
how important collaboration and integration are, recognizing 
the structural problems in academia. We are a young institute. 
We are only 18 months old, but we were built outside of the 
traditional college structure. The reason was to integrate 
mathematicians, chemists, biologists, engineers, all under one 
place, working in teams and building together the capabilities 
and standards that need to be deployed. But, we are still yet 
only one component.
    I mentioned in my oral statement that Sun Microsystems, 
IBM, and others like them need to play a critical role. We are 
also reaching out to Johns Hopkins Bloomberg School of Public 
Health. Dr. Klausner made a very important point about the 
implementation of data standards. It is not so much ``where 
does all of the data reside?'' It is about creating a single, 
one-stop-shop where people can easily access data, distribute 
it. Then, the data communications standards are agreed upon 
across all agencies, groups, participants, whether they be in 
industry, academia, or elsewhere. We are a member of a 
consortium that is working on data communications standards for 
biological data. I think that is the enabling part of this 
system.
    Senator Allen. With this network--you obviously have not 
put this network into place. You are formulating this network. 
I assume in the midst of it there will be very secure ways so 
that you do not get viruses within your network, so to speak?
    Dr. Sobral. Certainly the network has to have appropriate 
access information and appropriate levels of access. Those 
things can be implemented.The technologies exist already. It is 
not so much about reinventing the wheel. It is taking what has 
been applied in other communities and applying it to the 
biological problem.
    Senator Allen. How far away are you, do you think, in 
working with all of this multitude of stakeholders--government, 
private, military and all the rest--to developing this standard 
for communications?
    Dr. Sobral. Those standards will be an ongoing effort. 
However, we have intermediate deliverables that are scheduled 
before October of this year, and we are working on 18-month 
deliverables right now as a team. This is going to be an 
ongoing sustained effort, as we have heard others say here. 
This needs to not go away when the worry about the next 
bioterrorism attack fades. It needs to continue and have its 
own sustained infrastructure. Most importantly, if I could also 
add, we are missing a lot of critical data about the pathogens.
    We must move from reactive, like when anthrax recently 
showed up. Our knowledge at that time about anthrax, despite 40 
years of research, was quite fragmented. In addition, we had 
very little capability to identify which strain or its origin. 
I suggest that before smallpox, plague, or any of these other 
organisms are here, let us make sure we fund the creation of 
those data and make it available through this kind of 
distributed, collaboratory, virtual portal available to all 
stakeholders.
    Senator Allen. Well, in light of the comments you just made 
in answer to a question, I think that gets to the point. As far 
as identifying the strains, would not the CDC or, in contract 
with, say, the ATCC, would they not be able to--you are 
familiar with the American Type Culture Collection. Would they 
not be able to assist in identifying that? Isn't that 
information already there in a variety of organizations? Most 
of them, of course, are not private organizations, but quasi-
governmental.
    Dr. Sobral. Yes. There are a number of different lists of 
high priority pathogens generated by a number of different 
agencies, and that is probably appropriate, because they have 
different needs and objectives.
    What we have been able to share with the Departments of 
Agriculture and Defense are critical lists, some of which came 
from defense work with ATCC and elsewhere, of high priority 
pathogens. But again, it is a matter of agreeing as a group 
which are the highest priority, which ones we should deal with 
today, which ones we should deal with tomorrow. I would also 
add that it is very important that these lists are not always 
just pathogens of humans because of the threat to our 
agricultural systems, and food and water supply. The list we 
have at this point in time, which has been shared through 
others, includes pathogens of humans, plants, and animals.
    Senator Allen. Thank you so much.
    Senator Wyden. If you need any extra time, go ahead.
    Senator Allen. One final question, and maybe you all can 
answer it, but I would just ask Dr. Sobral. One of the concerns 
is that there are all these different research efforts going 
on. There is research going on at UVA and at Virginia Tech, and 
West Virginia University, and Oregon State, and elsewhere. I 
want to know, are there existing mechanisms for all of these 
outstanding research institutions to discuss their research 
with Federal agencies, and how effective are any of these 
methods of communication?
    Dr. Sobral. I would like to just address this, because, of 
course, we need to be careful we do not duplicate. I think in 
the case of biological terrorism, which is the infectious 
disease problem, we are actually spread way too thin. There is 
not a big concern of duplication.
    What I do believe is that the communication across the 
groups needs to improve, and the implementation of these kinds 
of distributed systems, if nothing else, will help us know what 
it is that we do not know or what crucial data is missing. Just 
bringing the information together is critical. We have heard 
this in a number of different contexts today. But in terms of 
the actual data about pathogens, their genomes, identification, 
and epidemiological data, which we require to build response 
capabilities, just bringing that data together to know what is 
missing will be very helpful. I think we will find there is not 
a lot of duplication. We are actually missing a lot of parts.
    Senator Allen. Does anybody else want to comment?
    Dr. Ryan. I think your question relates very much to 
Senator Rockefeller's, too, which was, was September 11 enough 
to bring all of this cooperation and coordination together?
    I think the public, and I would include all of us as the 
public, can with goodwill and a lot of effort, probably come 
together, but I am not sure that is true for the government. 
Certainly, we cannot do it. Since September 11, the biotech 
industry has stepped up security at companies, stepped forward 
with ideas and products, has cross-agency products, and we do 
not know how to get in front of people. For example, we believe 
we would like to protect all Americans, military and civilian. 
I do not know how to put research ideas in front of the HHS and 
the DOD simultaneously, because the rules for applying and the 
rules for requisitioning are completely different. It may be 
that I just do not know how to do it, but I actually think that 
there are legislative barriers in the ways the agencies are set 
up that make it very, very difficult to cross the boundaries, 
and I think on that kind of cooperation we will need the 
government's help, not just our goodwill and patriotism.
    Senator Allen. That is a very good point. I think every 
Senator has run into this situation, where people at 
universities or private companies say, ``I want to help, I have 
a great idea, but I have no idea if it is a good idea.'' It may 
be very good, and they may be good salespeople.
    They may have a product that is worthwhile. Being a fairly 
new Senator, I have not yet figured the process out. But, when 
you hear that sort of a concern that somebody has an idea that 
they would like to get evaluated to determine whether it will 
it work, it is important that we allow those who have developed 
maybe some good ideas--some good products for that matter--to 
be able to get a quick analysis, or relatively quick. Some of 
these are too complicated to get a quick analysis--or at least 
a fair analysis of the value and usefulness to, say, a 
governmental function or to a military function.
    I do not see why you cannot have--and the procurement is 
enough of a nightmare as it is--dealing with the government. 
You might as well at least try to have it uniform within the 
Federal Government. As you go through each State they are 
naturally going to be slightly different from State to State, 
but that is the nature of the Federal system, so thank you for 
that point.
    Senator Rockefeller. Can I just add a point, not a 
question, but a point? I think it is a really important point. 
I cannot imagine anything more discouraging. If I am a 
researcher, my mind is in the lab, and yes, I have got to get 
funded and I have got to apply and all that kind of thing, but 
I have heard so many examples of what you call 16-page 
application forms that have been reduced upon pressure to 1- or 
2-page application forms coming out of the government. I think 
it ought to be the job of us as an oversight committee to 
figure out within the world of bioterrorism and applications 
how do something about it, with your help. That is, you can 
help us, giving us cases in point to haul some of these 
agencies before us.
    George, I still have not gotten over our experience with 
the Persian Gulf War Syndrome, where the Department of Defense 
threw up a shield of impenetrability that I have never seen. I 
mean, my wife does not pull that on me.
    [Laughter.]
    Senator Rockefeller. It was extraordinary. I think we can 
solve that, with a combination of you giving us examples, real-
time examples, so to speak, real-world examples, because this 
is basic to making progress on bioterrorism. We do not have to 
take on the whole world on this. Let us just start with 
bioterrorism research and the problems scientists have had. HHS 
does this, DOD does that, so you give up. Well, that is not in 
the national interest.
    I am finished.
    Dr. Hatchett. If I can make a comment on Senator Allen's 
point, which also touches on your point, Senator Rockefeller. 
The value of a lot of these initiatives and applications 
obviously will emerge as they are implemented, and this touches 
on the question of sustainability and whether September 11 was 
enough of a stimulus to really change the way things are done 
in America.
    The West Nile virus is actually an excellent example. New 
York City Department of Health, as I am sure you know, 
partially in response to the West Nile virus, introduced a 
system of syndromic surveillance into its surveillance system. 
The way syndromic surveillance works, or the way it initially 
worked was you responded to EMS calls--and EMS in New York City 
has something like 51 different calls that they lodge with the 
central unit. So for example, they flag several different types 
of calls as things that should initiate increased surveillance: 
respiratory distress. If there was a sudden flare in the number 
of patients with respiratory distress, that would have turned 
the Department of Health on to looking at what was going on, 
why is it happening. The system has been refined down to the 
zip code and census tract level now in New York City. The value 
of that system, especially related to the hospitals, is a lot 
of hospitals have gone to what is called ``just-in-time'' 
staffing, and ``just-in-time'' supply. It is almost like the 
Dell computer model of running a hospital. They determine the 
number of nurses they need for Friday based upon the number of 
patients in the hospital on Thursday, and the same goes for 
inventory and pharmaceutical supplies.
    The value of having syndromic surveillance is, it gives 
hospitals prior notice. It lets them ramp up their resources as 
events begin to happen, and the syndromic surveillance system 
in New York City has actually predicted the onset of the flu 
season well in advance of any other methods for the last 3 
years running.
    What is interesting in terms of the sustainability is that 
the hospitals now realize that syndromic surveillance is a 
valuable tool, and so they have got a pilot program in New York 
where the emergency rooms--it previously was the EMS units, 
ambulances bringing people in--now the emergency rooms are 
getting interested. So hospitals have developed a pilot program 
involving 30 hospitals in New York City where the emergency 
rooms are reporting to the Department of Health the complaints 
of the patients coming in within 12 hours of their arrival. 
That includes people coming in on ambulance, but also people 
walking in off the street.
    The value of that system is that it increases the 
information stream between the Department of Public Health and 
the hospitals, and it begins to create alliances which become 
useful, and will have that kind of dual use purpose. One, the 
emergency rooms will pick up bioterrorism events quickly, but 
it is also useful to the hospitals in their day-to-day 
operation. So it is a wonderful example of showing how that 
type of approach can create alliances which then become self-
sustaining because they are useful, and because they have a 
dual use. This type of thing is something that a lot of 
Departments of Health and Departments of Public Health are 
watching in New York City closely, because they are really 
ahead of the curve on this issue.
    Senator Allen. Well, thank you, Dr. Hatchett. That is 
something that I think CDC, for example, as a repository, would 
like to be able to see for the whole country, not just New York 
City. They would like to see the hospitals in the Shenandoah 
Valley, what symptoms are coming in versus the Piedmont, versus 
over the mountain, again, over to West Virginia, for example. 
So they can see a pattern, and while seeing that pattern, it 
may not mean anything to Harrisonburg or Rockingham Memorial 
Hospital, or it might not mean anything to Martha Jefferson 
Hospital in Charlottesville, but you would see a pattern. You 
see lots of the same, Martinsburg, West Virginia; Carlisle, 
Pennsylvania; and you say, ``Wait a second, there is something 
going on here.'' You are treating it as a flu-like symptom, but 
it may be something more. So that is why that is great. I would 
like to see that same sort of information quickly available for 
the whole country. Granted, it helps run the hospital and it 
has an economic value. All the better. All the more reason to 
do it.
    Thank you, Mr. Chairman.
    Senator Wyden. I thank my colleague. All of you have been a 
terrific panel. You can see my colleagues, Democrat and 
Republican are like-minded in terms of this challenge. Since 
late September, I have been trying to draft a piece of 
legislation to essentially incorporate the sensible ideas you 
have heard from Senator Rockefeller and Senator Allen, and the 
Administration has been exceptionally helpful. Joe Albaugh, 
Richard Clarke--across the board have been very helpful. I 
think there is an understanding now about what the job is.
    This is an organizational challenge as much as anything 
else. We have got to mobilize the scientists, the information 
technology specialists, and entrepreneurs, and properly done, 
this can make a huge difference in terms of both preventing 
problems and responding to problems. Suffice it to say there is 
a lot of history here that we have got to try to reverse.
    I am holding up here a book put out by the National Academy 
of Sciences a couple of years ago, ``Chemical and Biological 
Terrorism.'' It goes through, at some length, a variety of 
recommendations put out by NAS--the country's leaders like Dr. 
Benjamin on the panel. As far as I can tell, not a whole lot of 
those recommendations ever got implemented, and I gather that 
there are scores of other reports out there that are 
essentially gathering dust in exactly the same way.
    So what I would like to start with, I am going to draft 
this bill. I am going to have it out for comment very shortly 
in terms of mobilizing the scientists, information specialists, 
entrepreneurs, and I think probably central to turning this 
around is the fact that there are 20 Federal agencies and 
scores of people who would like to offer their ideas and 
suggestions to define how the President of the United States 
and the Congress can work together on this. Joe Albaugh has 
made the suggestion, and I think it is a very thoughtful one, 
that the Congress basically tell the Administration they want 
it done in a couple of years, give them a little freedom, and 
see how they have done in 2 years.
    My sense is there needs to be more direction than that, but 
I think you get the sense that there is an awareness both on 
this side of the dais and in the Bush Administration that this 
is an organizational kind of challenge, mobilizing the 
scientists and the experts. I was struck by reading something 
Condoleeza Rice said that really paralleled what I have been 
saying. She said, ``we are mobilizing everybody else. How is it 
we cannot mobilize this sector?''
    So I think what I would like to do before I get into some 
of the nuts and bolts of this bill is have Dr. Klausner and Dr. 
Benjamin talk to me, because you have been through similar 
debates about how you would see, as we draft this bill, the 
Executive Branch and the Congress working together to mobilize 
the scientists and the experts in this field.
    Why don't we start with you, Dr. Klausner?
    Dr. Klausner. I would be happy to look at any proposal. We 
have asked actually our committee to consider structural ways 
and organizational ways to do exactly the types of things you 
are asking for. I do not want to avoid--I am a little hesitant, 
since we have asked a committee that is now working hard on 
this----
    Senator Wyden. I understand. I am asking your opinion, 
because what we are likely to do is have this draft proposal 
out well before your committee is done, and to the extent we 
can get people's input and ideas, it is helpful.
    Understand also that this is going to be a thoroughly 
bipartisan kind of effort. This is not something that is going 
to get done unless you get the Executive Branch and the 
Congress to work together. That is why I think--and you saw it 
here today with Senator Allen and Senator Rockefeller--we are 
singing from the same hymnal here. What the job is, is to find 
that set of ideas that is going to advance as quickly as 
possible, so all I am doing is asking for your opinion today.
    Dr. Klausner. My feeling is we need to do the types of 
things to identify where expertise is and where capacity is. 
That is really very important. But once we do that, we really 
need an ongoing system that deals with how you move that 
information back and forth. How do you have a quality control 
system to know the information is correct, recognizing things 
you do not know? How do we make sure that, coupled with that 
sort of system, whether it is a corps, or whether instead of it 
being a corps, whether we are making sure that we actually have 
the systems that we have in place now. That is a part I am not 
sure about, to be honest. Whether it is that we are 
underfunding, underserving, undersupporting the structures that 
exist now versus need, a separate entity. That we have to 
figure out whether there was an unintended consequence of 
pulling people away from--people that are away from where they 
are because most of their time for all of this is going to be 
spent not in responding to bioterrorism, but in making sure 
that we have a constantly working public health system.
    So my major concern is that we have a bill, that there 
would be a bill that would address the functionality and 
dysfunctionality of our current linkages between those who 
generate information and resources and how they get 
distributed. How we create a communications system to know what 
is going on, to know how people rapidly get information, and 
where to turn for that information, and I am not sure exactly 
what the structure of that is, but I want to make sure that we 
do not actually create a new entity, which now the current 
entities have an added complexity of figuring out how they 
interface with.
    I do not know if that gets at what you are asking.
    Senator Wyden. Dr. Benjamin.
    Dr. Benjamin. Senator, there may be a model you want to 
build on. A few years ago, we took some of our tobacco 
settlement dollars, Governor Glendening made a strong 
commitment to both antitobacco and anticancer efforts, and we 
gave dollars to our two academic medical centers, both Johns 
Hopkins and the University of Maryland. Part of that deal, 
though, was when they came up with hopefully new and exciting 
discoveries, we wanted to make sure that we had a capacity to 
translate that research into action, so we actually have an 
office in the State of Maryland which does that. It works with 
private industry to take new discovery, so if someone wants to 
take it to the marketplace to translate that actually into the 
market it also has a way of working with other places, so that 
we can reinvest and research. I am not sure that is exactly the 
model, but it is along that line, and you may want to take that 
and look at that and maybe build on that. That may be one way 
to achieve the goal you are trying to accomplish.
    Senator Wyden. Well, thank you. That is what we are looking 
for.
    Dr. Ryan, if you want to comment further on it, central to 
this will be to have one set of rules as it relates to 
procurement and developing these products. I have spent a lot 
of time looking at this, and the irony of this situation with 
respect to procurement is that virtually everybody in these 
agencies means well.
    In other words, once in a while you will find somebody who 
does not, but that is not the rule. There is nobody at the 
Department of Defense or at the Department of Health and Human 
Services, as far as I can tell, who gets up in the morning and 
says, ``I want to be rotten to BIO and hold up innovative 
ideas.'' But what happens is, absent this kind of coordinated 
effort, everybody goes off on their own.
    In other words, we are going to hear from HHS in a little 
bit. Secretary Thompson is talking about this. This is a very 
good man who is committed to this. They started their own 
private initiatives effort, and it is going to be good. But 
they are going to have a set of rules, and then we are going to 
have the other 19 agencies involved in bioterrorism again with 
similar kinds of efforts, and so we are going to stay at it 
this time. I am committed to doing that so that we hit the kind 
of principles you are talking about, a unified plan, one set of 
procurement rules, the clearinghouse I talked about in the 
opening statement.
    The one thing you all did not mention, and then I have some 
more specific questions, is, I am absolutely committed to 
making this user-friendly for the first responders in local 
governments. We have got to do that, because there is a real 
danger out there, and I have been meeting with a lot of these 
first responders in recent months. There is a real danger out 
there that what will happen in Washington, DC is all of us in 
our suits give big speeches about fighting bioterrorism, and we 
pass bills, and off it goes to people at the local level, and 
they do not have the dollars to carry it out.
    It will not be called that, because I think people 
understand the way laws are written, but it would be sort of a 
terrorist version of an unfunded mandate, where somebody passes 
a law in Washington, DC and by the time it gets to Jackson 
County in my home State, where we have been working with the 
fire and rescue people, there are not the dollars. So we are 
going to get the uniform set of procurement rules, and we are 
going to make this user-friendly for the first responders and 
the local governments, because those are the people that are on 
the front lines.
    So let me now, because you all have been so patient, sort 
of get into some of the nuts and bolts of these kinds of 
issues, and let us start with first, and perhaps this is one 
that Mr. Edwards, Dr. Sobral, and Dr. Ryan might all want to 
take a crack at. Tell us all a little bit about getting 
products into the Federal system. I gather you, Dr. Ryan, you 
spent 8 years with respect to one of your particular products. 
That seems to set a land speed slowness record even for the 
Federal Government. Why don't you tell us a bit about what it 
took to get the attention of these Federal agencies, and then 
perhaps you, Mr. Edwards, and you, Dr. Sobral, could do that as 
well.
    Dr. Ryan. Well, I again want to emphasize all of these 
interactions were very, very pleasant. There was never any 
adversarial spirit here at all. In 1994, we began with a CRADA 
with Walter Reed. We worked with various agencies, including 
USAMRID on anthrax and plague vaccines using one of our 
adjuvants at the time. This progressed through various studies, 
using SBIRs and CRADAs, support from, as you can see, the NIH 
and the DOD. But I would say that it was not until January of 
2001, when we began to work with Dynport, a contractor of the 
DOD, that we began to get to language we could understand, like 
what was it we were going to license, what were the terms of 
the license.
    Senator Wyden. Between 1994 and 2001, you basically sort of 
shuttled back and forth between one agency or another, and it 
was impossible to really get the project zeroed in on?
    Dr. Ryan. Well, it was not that we were stopped at the 
front door. We did get into these agencies, but we would do one 
set of experiments with one group, another set of experiments 
to test another idea with another group, and I would say that 
most of it was the kind of thinking where, could we make an 
improvement on something that existed. There was no real 
attempt to get into new vaccine concepts of the 21st century.
    When we began to work with Dynport, I would say it went 
relatively fast from January until October, when we did a 
license. Then we realized that in working with the Department 
of Defense, we had made it virtually impossible to work with 
NIAID. We went in all starry-eyed and said, ``now we want to do 
this for the civilian population,'' and it is very difficult to 
do it. The material would have to be obtained from the DOD 
contractor, and it is a cumbersome process. Though we consider 
our second generation anthrax vaccine, the single dose oral, 
very versatile approach that I am talking about, we have not 
yet been able to find fertile ears. Everybody loves the idea 
and says, ``oh, this is much cheaper, it is much quicker, very 
innovative.'' But in the case of the NIH they said, ``well, we 
are working on a Continuing Resolution. We do not know how the 
money will come in.''
    Everything is believable, everything is real, but we want 
to compete. We do not mind at all having to go through even a 
6-page application. We would be very willing to do that. We 
just do not know how to go about it, and we do not want to 
forfeit working with the civilian population in order to work 
with the military.
    Senator Wyden. Let me make a pledge to you. As we work to 
come up to this plan for a uniform set of rules, we are going 
to ask BIO and a variety of public interest groups, not just 
industry groups but a variety of public interest groups, to 
sort of walk us through, step by step, how it would work for 
them to ensure that it is possible to actually get answers. So 
we are going to be asking for your input on that.
    Dr. Ryan. We appreciate that very much.
    Senator Wyden. Mr. Edwards, your experience, and let us get 
you that microphone.
    Mr. Edwards. The one word I would use to characterize our 
experience is perseverance. That is just the name of the game 
and a fact of life for small companies. There is kind of a 
catch-22. Big companies have connections, and you made a deal 
with a big company and boom, it was easy to get in. I am not 
saying easy, but it was easier, because of the connections they 
have, but in order to make a deal with a big company you have 
got to be somewhat established, so there is this catch-22 of, 
we are too innovative and risky for them to deal with us. On 
the other hand, they have got to make a buck, so the government 
does supply a very valuable, valid role in bridging the gap of 
still too risky to get us far enough along, but that makes for 
a very long cycle.
    So you start with the government to get the seed, then you 
go back to the big company once you have done the seed, and the 
big company you can really go in and do something productive 
either at the civilian or military level, it does not matter 
which, so perseverance is unfortunately the name of the game.
    Now, how you get around that, how you short-cut that, I 
leave that to our elected Senators to come up with the wisdom. 
I observe it is a problem. One cautionary note I would throw 
in, however, is, in coordinating things we do not want to 
overcoordinate to the point where we stifle innovation.
    The ability to go the Department of Justice which has a 
specific need for first responders versus the military, which 
has a true protection need, versus NIH, which has a more 
medical need, that gives you multiple opportunities to have 
multiple eyes perhaps recognize the value of your technology, 
and if it is all too well-coordinated then you have a uniform 
decision made and you cut off the option for innovations 
percolating up, but something to shorten the whole process is 
really valuable for a small company.
    Senator Wyden. In my mind, rather than see it as a 
coordination exercise, I see it more as a streamlining 
exercise. We have got all of these agencies; it is almost as if 
the Federal Government is muscle-bound here. It is so big, and 
so bulky, it is having trouble moving in order to get these 
decisions made, and that is a good point.
    Dr. Sobral.
    Dr. Sobral. Yes. I think one of the things that comes out 
in thinking about this is that agencies, as our colleague said, 
have a history. They were built in some cases for a specific 
motive that now is sort of transcended by a need, so we need to 
think across these, to use Dr. Klausner's word, silos. This is 
very critical, because the basic science and technology we need 
to deal with infectious diseases, bioterrorism, and pathogens 
is pretty much the same because of the underlying science of 
life on earth is actually very similar.
    In some instances, tools, applications, and software 
systems that could be used by Defense could be developed 
specifically to serve the needs of NIH or USDA, et cetera. We 
need to be very, very clear about trying to remove the 
obstacles of having technology move from one domain or agency 
to another.
    The other critical component is the real partnering that 
has to happen to take basic research ideas and concepts all the 
way to products. We have seen some examples here today of 
discoveries that have spun out of universities. It is extremely 
important that universities are optimized to do the big ``R,'' 
little ``d'' preparations, paired with industry, which is 
typically little ``r,'' big ``D.'' Together they form a very 
important network. Partnerships for innovation, rather than 
traditionally putting things in bins of agriculture, human 
health, or defense, should overcome that in a very important 
way. Some vaccine production, for example, may require 
technologies to be developed to express genes in plants, for 
example. We need to link to those technologies.
    Recently I heard Steve Briggs give a talk on this. 
Together, we were invited to Mitre Corporation to speak about 
the production of these things in a rapid experimental mode 
using, for example, corn plants. I think it is really about 
breaking down ``silos,'' as Dr. Klausner has used it. Any help 
that occurs from the government in doing that will help all of 
us.
    Senator Wyden. Dr. Benjamin, let me talk to you, if I 
might, about how you and your colleagues who are on the front 
lines are going about this task of evaluating new devices and 
products in this fight against bioterrorism.
    You mentioned in your testimony that during the anthrax 
crisis that the health department officials were inundated with 
offers of new, quick detection products from vendors. That is 
consistent with what Joe Albaugh was telling us in terms of 
FEMA. It is what I hear from fire officers at home in Oregon. 
How are your people dealing with the scores of products that 
come across their desks in terms of evaluating them? What ought 
to be done to try to assist them?
    Dr. Benjamin. It is very difficult. One of the things, I 
get two or three e-mails a week from somebody trying to share a 
new technology or a new idea with me. It has trickled off some, 
but it is still continuing.
    The biggest problem we have is one of validating whether 
that technology does what it says it is going to do, so we kind 
of use our old medical model. We look for things that are 
certified by the various Federal agencies. For example, if it 
is a clinical device, obviously the FDA plays a prominent role 
in that, but the biggest problem we have is that a lot of 
people walk in the door every day, particularly when you are in 
a State like Maryland, which has a phenomenal number of new 
biotechnology companies and research centers that are doing 
lots of good work.
    Frankly, we do not have the expertise to make that 
assessment, so frankly the way we do it is the way we do 
procurement. If it's an authorized device, you get it. If it's 
a new cutting edge device that has not quite gone through all 
the hoops, you do not, and you basically utilize what you get, 
and the problem with that is that you often do not get cutting 
edge stuff. Particularly when you are in very, very constrained 
fiscal times you do to get to buy twice, so once you get it, 
you have got it, and we are certainly doing a lot of that.
    The current debate on the table, of course, is all of the 
new surveillance systems. Maryland also has a much more 
rudimentary system than New York has, but we also have a 
surveillance system that as a part of our new bioterrorism 
efforts we are looking at putting together not only a 
surveillance system for Maryland, but one for the region, and 
we have lots of people coming to us with ideas on how best to 
do this, and again it is very, very difficult to evaluate those 
systems, because you tend not to have the experts around, and 
this, as I talk to my colleagues around the country, is going 
to be a very, very trying debate as to how to put those systems 
in place, how to make sure that they have the connectiveness so 
that no matter what we ultimately get, we have not wasted the 
dollars, and those dollars will be able to talk to one another. 
It is kind of like putting up the Internet in one fell swoop 
versus having that system grow up in an evolutionary nature.
    Senator Wyden. Dr. Benjamin, I am going to include in my 
legislation, the bill that we will have out for comment 
shortly, a national testbed, in effect, that would allow us to 
evaluate new homeland security devices, and we want to do 
everything we can to make sure that this is useful to States 
and localities that are trying to prepare themselves. Is it 
your sense that something like this would be well-received by 
people, by your colleagues at the State and local level?
    Dr. Benjamin. I think so. We all have the capacity to do 
some kind of early evaluation and research. The issue is 
access, procurement, and funding.
    Senator Wyden. Dr. Hatchett, a question for you. We have 
some real issues based upon our review around the country of 
trying to verify the credentials of people who would like to 
help, and it is especially important with respect to public 
health to get it right.
    For example, in our first hearings we looked at the 
communications side. I was told by Intel, which is a very large 
employer, of course, in my home State and others, that they 
were anxious to send their people and their equipment and 
basically nobody was there to essentially verify that they were 
from Intel, and they had this expertise in the health area.
    It is also very sensitive. If you call the Centers for 
Disease Control, you do not have to question the credentials of 
the person on the other end of the line, but we have got to 
make sure that in that registry that I would like to have in 
communities across this country, that if somebody, say, claims 
to treat smallpox, that they actually have that expertise.
    How would you go about trying, as a part of this 
legislative effort, to try to make sure that there is a 
registry of doctors and specialists available across the 
country in the case of a bioterrorist threat? How would you go 
about setting it up, and also how would you go about keeping it 
up-to-date, because you do not want to write something that 
suddenly is useless to everybody and not very far down the 
road.
    Dr. Hatchett. Just in referring back to the experience 
after September 11, briefly credentialing was a major issue and 
was actually one of the things that stimulated our group to get 
together to begin to think about coordinating health 
professionals.
    On September 12 and September 13, inside the perimeter 
around the World Trade Center credentialing amounted to 
flashing a hospital ID badge, and there was no way to 
credential volunteers beyond that, and you essentially had to 
take their word for it, and you had to somewhat keep an eye on 
them. There were unfortunately people who abused their hospital 
affiliations merely to get inside the perimeter to look at the 
site, and there were people who were actually working in some 
of the triage centers that we regarded as questionable, and we 
made sure they did not have access to narcotics or other 
controlled substances, and it was a major problem.
    Credentialing is a terrifically difficult issue. It is one 
thing to have volunteers sign up for the registry. The process 
of actually checking up on their references and checking their 
institutional affiliations is a large problem. I do not have 
the specific solution. In some of these issues the question may 
not be technology as much as manpower. Just literally 
generating people to follow up on issues of credentialing is 
one example. That might be a function for the AmeriCorps, or 
the Senior Corps, or the study volunteers, or mobilizing a 
large number of people and establishing the database. I do not 
think you will have any shortage of people signing up for it. 
Following up on their credentials, making sure the database is 
maintained, is something that will take a significant effort, a 
significant commitment of manpower, and probably a significant 
degree of funding.
    Andrew Rasiej, who I think you may know, in New York has 
put together a group called Silicon Alley Cares, which we have 
been working with, and they volunteered their services for the 
creation of databases that function efficiently and that can be 
queried in a way that maximizes their utility.
    I think there will have to be a combination of bringing 
people with information technology expertise into the system in 
terms of creating these databases at a local level. You will 
subsequently need to mobilize volunteers. I would think you 
would want to mobilize and organize volunteers such as 
AmeriCorps volunteers, rather than civilian volunteers, to 
maintain that database. I do not think there is a panacea or 
magic bullet to that issue. A lot of that is just going to 
involve sweat and effort, basically.
    Senator Wyden. Well, Mr. Rasiej has been very helpful to 
this Subcommittee, and a lot of the innovative thinking that 
has been done in this area has really come from him, so we will 
be calling on him. I am also told that we can get the 
professional societies at the local level to be involved in 
what you are talking about. Again, these are well-meaning 
people, and my sense is because they license and to some extent 
accredit their members already, it may be possible to get them 
with a modest amount of cost, for example, to be involved in 
it. So we are going to follow up with you, and we would welcome 
your ideas on that.
    One last question, if I might. It was triggered by 
something Dr. Sobral included in his written testimony, but 
something that when I saw it I would be interested in any of 
you making comments on it. As you know, as a big part of this 
exercise we want to make sure that we share information, that 
people have state-of-the-art information about these 
technologies, how to fight bioterrorism, and the issues that we 
are talking about. At the same time, we know there may be some 
who try to exploit that information-sharing, and who would do 
this country harm as a result of being able to access that 
information. In fact, it would turn these good deeds against 
us.
    I wonder if any of you have thought about the kinds of 
safeguards that the science and technology sector is going to 
need in order to make sure that as we share the information, 
and it gets out to all of these small communities that would 
not have it if it was not shared, that at the same time it is 
not turned on the goodness of the American people.
    Why don't we start with Dr. Klausner, and any of the others 
that would like to comment.
    Dr. Klausner. This is a really complicated and worrisome 
issue. There is a tradition from the nuclear experience with 
science and research of in some ways--and this evolved over 
time, that know-how was restricted much more than knowledge, 
that I think we have learned over time that restricting 
knowledge probably does not work, and it may just backfire. 
This becomes a much more difficult problem with bioterrorism, 
because one of the distinctions between bioterrorism and, say, 
nuclear weapons is the fact that the distance between knowledge 
and know-how is shrinking, knowledge about an organism and how 
you might misuse it.
    I think there are ways that we need to think about in our 
laboratories around the country where we have primarily thought 
about safety and environment to also think about security. I 
think that is part of it. I do not know the answer about the 
secrecy of biologic information, information about organisms, 
about genomes. However, what I do believe is that this has 
capacity to both limit research in ways we might not want.
    This may not be a great answer, but I really think we must 
convene, which we have begun to do, the scientific community to 
have a discussion about secrecy about information, about the 
control of these things. It is real, it is very complicated. We 
cannot have a reflex. There should be no discussion of it. I do 
not know how it will come out. I think there has already been 
efforts and legal efforts to determine who has access to 
clearly pathogenic organisms and how they can be traced and 
tracked.
    So I think there is a whole series of things, from control 
over materials to safety issues, to the most difficult thing 
being whether there should or should not be controls over 
information, as opposed to the application of information.
    Dr. Sobral. Information follows this hierarchy, beginning 
with data that later becomes usable knowledge. We have learned 
this is the whole Pandora's Box problem. Science thrives on 
openness, and there are a lot of great people in this country 
who need to have access to different levels of information so 
that we can come up with countermeasures, for example.
    At the same time, I do believe that in the interest of 
national security there are certain data products that become 
knowledge that should be done in specific areas with 
appropriate security. There are currently ways to implement 
levels of access in these kinds of systems that would guarantee 
that.
    Dr. Hatchett. I would like to just touch on that as well. I 
think we need to acknowledge the fact that it is inevitable 
that these technological developments will create opportunities 
for people with malevolent intentions. They will find ways to 
leverage what we create in ways against us in the same way they 
have discovered that airplanes could serve as flying missiles.
    Dick Garwin, who is at the Council for Foreign Relations 
now, I think it was a December 12 New York Review of Books did 
an article about red-teaming and vulnerabilities and actually 
received criticism for detailing ways we were still vulnerable.
    One example of the technology that is incredibly useful and 
that has been incredibly helpful in public health terms, Steve 
Morse, who is now at the Center for Public Health Preparedness 
at Columbia, and was really one of the people that created the 
concept of emerging diseases, was also the founder of an e-mail 
network called PROMED, which is the Program for the Monitoring 
of Emerging Diseases, and what PROMED is is an e-mail network.
    People can sign up for it, and then when they are on the 
list they receive e-mail updates, and that has been very useful 
in identifying outbreak situations in remote areas. Somebody 
who is in the Sudan and sees an outbreak of what looks like a 
Hemorrhagic Fever can e-mail PROMED and then the information is 
widely distributed. It moves information quickly. It is very 
helpful to WHO. It is helpful to CDC. It is helpful for 
improving and increasing the speed of response, but it also 
becomes something that a terrorist could mobilize, or could 
make use of.
    Aum Shinrikyo, the Japanese terrorist organization, is 
known to have sent people to Zaire during the mid-1990s to 
search for Ebola, and if somebody beams out an outbreak that 
there is Hemorrhagic Fever in northeast Gabon, the first person 
on the scene might be a terrorist. It might not be a public 
health worker.
    The question of restricting access to information is a very 
thorny one, and I think we may be shooting ourselves in the 
foot by doing that. No matter what we do terrorists will find 
ways to leverage that against us, and I think maintaining open 
access and maintaining the information flow and the information 
stream ultimately will serve us better than trying to restrict 
it in the interest of national security, within reasonable 
limitations, obviously.
    Senator Wyden. Well, I will tell you I go into this 
discussion having a very strong orientation in favor of getting 
out as much information as possible just for the reason you are 
talking about. Just with the Internet there are millions of 
content-creators worldwide. You are not going to be able to 
restrict that under any scenario, and at the same time, as you 
said, there have to be efforts to make sure that in every way 
possible, that the openness and the goodness of our free 
society is not turned against us. Trying to figure out how to 
do that is the challenge.
    I would probably ask a number of other questions of this 
group. We have not even gotten into matters like the 
compatibility of communications systems at the local level and 
the like, which was certainly a concern on September 11, but 
you have been terrific and very patient. The people who are 
behind me on the dais are going to be working over the next few 
weeks to try to put in place a draft for this proposal to 
mobilize the scientists and technology specialists. We are 
going to work very closely with the Administration, as I say. 
They have been very cooperative with all of our efforts.
    Dr. Klausner, that what you are doing will be available in 
June is extremely important, and as much as anything I think if 
Congress and the Executive Branch can work with people like 
yourselves, this time it can be different. You will not have 
committees coming back in 5 years holding up books that were 
written in the aftermath of September 11 and everybody saying, 
oh, my goodness, why weren't they acted on, and it is really 
going to sort of be our lodestar in all of this.
    If any of you would like to add anything further, we would 
welcome you. Otherwise, we will excuse you at this time. Any 
last comments any of you would like to make? We will excuse you 
at this time. Thank you for your cooperation.
    Our next panel will be Ms. Anna Johnson-Winegar, Ph.D., 
Deputy Assistant Secretary of Defense for Chemical and 
Biological Defense Programs; and Dr. Lisa A. Simpson, Deputy 
Director, Agency for Health Care Research and Quality. We 
welcome both of you, and let me at the outset say that both of 
your departments have been extremely cooperative with our 
efforts, and we are very appreciative, and your departments, as 
I mentioned, the entire Administration has been very 
constructive and helpful. We will make your prepared remarks a 
part of the record in their entirety.
    Dr. Johnson-Winegar, why don't you begin, and then we will 
hear from Dr. Simpson.

STATEMENT OF DR. ANNA JOHNSON-WINEGAR, Ph.D., DEPUTY ASSISTANT 
TO THE SECRETARY OF DEFENSE FOR CHEMICAL AND BIOLOGICAL DEFENSE

    Dr. Johnson-Winegar. Thank you very much for the 
opportunity to be here this morning. I certainly would like to 
take a few moments to summarize my remarks, which you have for 
the record, highlighting the fact that I think the tragic 
events of September 11 and the anthrax cases resulting from the 
letters sent to Members of Congress and to the media have 
heightened the public's awareness of the biological terrorism 
threat, but it has been one that has been high on the priority 
for the Department of Defense for quite some time.
    Today, I would just like to highlight for you some of the 
efforts ongoing in the Department of Defense to counter the 
threat of biological weapons, including some instances of how 
we are leveraging the capabilities of the private sector 
scientific community and, in addition, I will describe some 
ways in which I think the scientific community will continue to 
be integral to developing our response to address the 
biological threat.
    First of all, I would just like to summarize the process by 
which the Department of Defense defines our requirements and 
programs, second to outline some programs we have ongoing, 
including how we are using the scientific community and, third, 
some planned efforts and processes by which the Department 
coordinates with the scientific community to assure ourselves 
that cutting edge technology can be evaluated and incorporated.
    The Department of Defense has long had an established set 
of requirements for enabling us to complete military operations 
in a chemical and biological environment and, as such, our 
research and development and procurement efforts are, indeed, 
structured to support the framework of that mission, which is 
primarily one of contamination avoidance that includes such 
things as detection, identification, and warning; second, 
protection, which includes individual, collective, and medical 
protection, and third, decontamination.
    In order to address these concerns, we have been at war 
against biological agents for quite sometime, and since 
September 11 we have been more at war against terrorism, and I 
think it is clear to all that the Department of Defense 
community has been fully engaged in supporting both our combat 
operations overseas as well as our role in homeland defense.
    I think you are well aware, because of the Department's 
specialized expertise in both chemical and biological agents, 
and because of our many unique research facilities and 
capabilities, the DOD does, indeed, play a very strong role in 
addressing bioterrorism.
    As we all know, technology advances are being pursued 
across the board in research, development, and manufacturing of 
vaccines and pharmaceuticals, as we heard from our first panel, 
that will help prevent the lethal and incapacitating effects of 
biological warfare agents. Clearly, the Department of Defense 
has a major role to play in that and has indeed funded research 
and development to address a number of these products for many 
years now.
    I think that through the execution of our chemical and 
biological defense program the private sector, academia, and 
other Federal agencies are invited to apply their knowledge, 
skills, and ideas to help us solve our needs. We use, as you 
are well aware, a number of different mechanisms, including 
broad agency announcements, requests for proposals, request for 
quotations, the small business innovative research program and 
others. In addition, we publish all of our requests in the 
Federal Business Opportunities, known to the world, I am sure, 
as FedBizOpps, and in addition to that, shortly after the 
September 11 attacks the Department of Defense established a 
specific announcement to accept proposals from all sources on 
how to respond to terrorist threats. At latest count, over 
12,000 ideas had been submitted, and indeed, hundreds of these 
apply specifically to the biological terrorist threat.
    Finally, I would like to point out that there are numerous 
conferences in which the Department's programs in chemical and 
biological defense are presented to academia and industry 
organizations, providing other opportunities for the scientists 
in the private sector to become aware of how they can 
contribute to the program and addressing the biological and 
terrorist threats.
    I have personally participated as a speaker and panelists 
in a number of those conferences and symposia, as well as other 
people from my office. I think that, indeed, we are all well 
aware that the anthrax attacks of late last year pointed out to 
many in the public and to the Congress and the Administration 
the real dangers of biological weapons, and while these attacks 
have increased the priority of our efforts, the Department of 
Defense has long been drawing upon the Nation's scientific 
expertise to develop and field effective defensive capabilities 
to protect our military forces and now our Nation's citizens 
and others from the use of biological weapons by adversaries.
    We are fully aware of the fact that advances in genetic 
engineering, biotechnology, and other related scientific 
disciplines, require continued vigilance to be sure we are 
prepared for the threat, and that we are not caught by 
technological surprise.
    I would like to conclude by just saying I resonated very 
much with a number of the comments made by the first panel 
today, and I look forward to continuing opportunities for the 
Department of Defense to work with our sister Federal agencies, 
as well as the private sector and academia.
    [The prepared statement of Dr. Johnson-Winegar follows:]
Prepared Statement of Dr. Anna Johnson-Winegar, Deputy Assistant to the 
        Secretary of Defense for Chemical and Biological Defense
    Mr. Chairman and distinguished Subcommittee Members, I am Dr. Anna 
Johnson-Winegar, Deputy Assistant to the Secretary of Defense for 
Chemical and Biological Defense. My office is the single focal point 
within the Office of the Secretary of Defense responsible for 
oversight, coordination, and integration of the Department's Chemical 
and Biological Defense Program. The tragic events of September 11th and 
the anthrax cases resulting from the letters sent to Members of 
Congress and the media have heightened the public's awareness of the 
biological terrorism threat. I was invited to speak to the committee 
today about means by which to harness the potential of America's 
scientists and private sector to address bioterrorism. In order to 
address the committee's concerns, I will discuss the extensive efforts 
underway by the Department of Defense (DoD) to counter the biological 
weapons threat, including highlights of how we are leveraging the 
capabilities of the private sector scientific community. In addition, I 
will discuss some means by which the scientific community will continue 
to be integral to developing material responses to address the 
biological threat. My testimony today is in three parts:
    First, I will discuss the processes by which the Department defines 
requirements and programs to support the current and future needs of 
the warfighter;
    Second, I will outline current programs that address the biological 
threat, including how we are drawing upon the scientific community; and
    Third, I will outline some current and planned efforts and 
processes by which the Department coordinates with the scientific 
community to ensure that cutting edge technologies to counter 
bioterrorist threats are evaluated and incorporated into the 
Department's research, development, and acquisition (RDA) efforts.
    department of defense threat, requirements, and programs process
    Following Desert Storm, there was a need to coordinate chemical and 
biological defense efforts among the Armed Services in order to better 
address lessons learned from the Gulf War. In 1994, the Department 
established the Joint Service Chemical and Biological Defense Program. 
The vision of this program is to ensure U.S. military personnel are the 
best equipped and best prepared force in the world for operating in 
future battlespaces that may feature chemical or biological 
contamination. The events of the past few months have demonstrated that 
our concept of future battlespaces is changing from the battlefield to 
include greater emphasis on homeland security.
    The customer for the DoD's Chemical and Biological Defense Program 
is the warfighter. The customer, through the Joint Staff and the 
combatant commanders, identifies requirements that form the basis of 
programs for the RDA community. In order to identify capabilities 
needed in the far term, the Services prepare a document entitled 
``Joint Future Operational Capabilities,'' which provides direction to 
the science and technology community.
    In addition to warfighter requirements, identification of current 
and emerging threats by the Intelligence Community provides a principal 
means for the definition of program needs for biological defense. The 
Defense Intelligence Agency provides validated biological and chemical 
threat assessments. These reports assess the effects of weapons on how 
we fight, and in turn are used by the warfighter to generate the 
requirements to resolve materiel shortcomings. Together, assessments of 
operational needs, adversarial threats, and vulnerabilities form the 
basis of Mission Needs Statements and Operational Requirement 
Documents. The result is that our programs and technologies are driven 
by validated threat assessments and user mission requirements, not by 
technologies.
    The Department of Defense has established a set of requirements for 
the successful completion of military operations in chemical and 
biological environments. We submit an Annual Report to Congress 
documenting our progress in meeting these requirements. The Chemical 
and Biological Defense Program consists of all DoD RDA efforts that 
develop and procure systems designed to provide U.S. Forces with the 
ability to operate effectively in the presence of chemical and 
biological agents. Joint and Service unique RDA efforts are structured 
to support the framework of the three mission areas of chemical and 
biological defense: contamination avoidance (detection, identification, 
warning, reporting, reconnaissance, and battle management), protection 
(individual, collective and medical support), and decontamination. The 
programs affect all joint warfighting capabilities, while providing an 
integrated system of systems on the battlefield. It is essential to 
view all chemical and biological defense programs as an integrated 
system, with each mission area important to joint forces' survival. Our 
forces need the full spectrum of defensive equipment to survive, fight, 
and win in a contaminated environment. For example, protective clothing 
may be of little value if we don't provide the appropriate detection 
and warning systems.
      current dod research development and acquisition to address 
                              bioterrorism
    The process I described roughly outlines how the Department 
conducts business during peacetime. Since September 11th, we have been 
at war against terrorism of global reach, and the DoD RDA community has 
been fully engaged in supporting both combat operations overseas and 
homeland defense. I must point out to the committee that DoD is not 
charged with lead Federal agent responsibilities as described in the 
Federal Response Plan for response to incidents of domestic terrorism. 
However, because of the Department's specialized expertise in chemical 
and biological defense and many unique research facilities and 
capabilities, the Department plays a key role in addressing 
bioterrorism.

DoD Biological Defense Funding Summary

    In Fiscal Year 2002, the budget request for the Department of 
Defense Chemical and Biological Defense Program was approximately $856 
million, which includes approximately $507 million for research and 
development and $348 million for procurement. Science and technology 
efforts included approximately $86 million for the Medical Biological 
Defense Research Program and approximately $32 million for biological 
detection. Some of the remaining budget includes dual purpose projects 
(such as decontamination and masks) that provide protection against 
both chemical and biological threats. In addition, the Defense Advanced 
Research Projects Agency (DARPA) separately requested $140 million for 
exploratory research efforts for biological warfare defense.

DoD Biological Defense Selected Project Description Summary

    Following is a brief summary of key biological defense efforts.
Detection of Biological Agents
    The Department of Defense has fielded the following detection 
capabilities:
 Biological Integrated Detection System (BIDS) is a vehicle-
    mounted biological detection and identification capability. Until 
    recently, BIDS units were deployed around the Pentagon.
 Portal Shield is a network sensor system that provides 
    automated biological point detection capability to protect high 
    value fixed sites against BW attacks. This system was deployed at 
    the NATO 50th Anniversary, and Presidential Nomination Convention.
 Biological Weapons Agent Sampling Kit provides a low cost, 
    disposable assay ticket which can provide rapid detection using 
    environmental samples.
 Joint Biological Point Detection System which would provide 
    automated point and mobile biodetection, with reduced size, weight, 
    and power requirements compared to existing systems. The JBPDS is 
    currently fielded at high value military sites.
    Research activities include automation of biological sample 
preparation, methods for detection of biological agents in water, and 
modeling and simulation of agents to assist in hazard warning.
Medical Biological Defense
    Today, the medical treatment for individuals exposed to biological 
agents requires a response tailored to each specific threat. A critical 
capability for effective treatment includes training to diagnose and 
treat biological threats through such courses as ``Medical Management 
of Biological Casualties,'' which is available on the internet at 
www.biomedtraining.org.
    Technology advances are being pursued in the research, development 
and manufacturing of vaccines and pharmaceuticals that prevent the 
lethal or incapacitating effects of biological warfare agents. 
Therapies that improve survival and reduce the time for recovery have 
been developed by private industry and tested against specific 
biological warfare agent threats by the DoD. These include commercially 
available antibiotics such as ciprofloxacin, doxycycline, and 
tetracycline. Rapid portable diagnostics enabling quick medical 
response for exposed warfighters are being pursued. Currently fielded 
diagnostics rely on immunological response assays. The Joint Biological 
Agent Identification and Diagnosis System currently under development 
is based on the use of polymerase chain reaction (PCR) technology to 
provide more rapid and accurate diagnosis. DoD has been working with 
the Food and Drug Administration (FDA) to obtain approval for therapies 
and diagnostics that are not yet FDA approved. DoD is working with FDA 
and the National Institutes of Health to identify candidate therapies 
that could be tested in animal models for select biological agents. DoD 
is also working with the Centers for Disease Control and Prevention and 
the Department of Energy National Laboratories in the development of 
genetic primers.
Decontamination of Biological Agents
    Decontamination supports post-attack restoration of forces and 
operations to a near normal capability. Decontamination is organized 
into three categories that reflect operational urgency: immediate, 
operational, and thorough decontamination. Decontamination also entails 
special considerations for patients, sensitive equipment, aircraft, 
fixed sites, and the retrograde of equipment. DoD doctrine addresses 
consequence management decontamination operations, which uses civilian 
standard operating procedures, including hypochlorite solutions, and 
soap and water solutions. Some of the existing systems include the M291 
Skin Decontaminating Kit, the M295 Individual Equipment Decontaminating 
Kit, and the sorbent decontaminating system, which is replacing the 
existing decontaminant with a non-aqueous and less caustic 
decontaminant. Development efforts include the Joint Service Sensitive 
Equipment Decontamination, for items such as electronics, and the Joint 
Service Fixed Site Decontamination System, which will provide a family 
of decontaminants and applicators to provide the capability to 
decontaminate ports, airfield, and rear-area supply depots. Currently, 
military requirements support a combined decontaminant that is 
effective against chemical and biological agents.
Leveraging the Private Sector
    The efforts described above highlight key biological defense 
capabilities that are fielded or are planned to be fielded in the near-
term. This does not include the numerous research efforts to exploit 
cutting edge science and technology advances to ensure continuous 
improvement in our protection and response capabilities. Through the 
Department's science and technology efforts, the state-of-the-art in 
basic and applied research is being explored. An excellent example of 
the DoD leveraging cutting edge science and technology developed by 
America's scientists is the Biological Agent Warning System (BAWS) 
technology developed by MIT Lincoln Laboratory. The BAWS technology 
integrated into the JBPDS not only improved overall system performance 
for biological warfare agent detection, but also significantly reduced 
operation and support costs of the most advanced U.S. point biological 
detection capability.

Research and Development Opportunities

    Through the execution of the Chemical and Biological Defense 
Program, the private sector, academia, and other Federal Government 
agencies are invited to apply their knowledge and skills to solve 
warfighter materiel needs. Executing agencies post Broad Agency 
Announcements, Requests for Proposals, and Requests for Quotation in 
accordance with the Federal Acquisition Regulation to provide a 
structure for fair competition of concepts and ideas. Interested 
parties may submit their proposals for review and award of contract. 
These procedures can be shortened in time of need, but remain the 
preferred method for the government to leverage private sector 
innovation.
    The Chemical Biological Defense Small Business Innovative Research 
(SBIR) program is an effort by the Department to incorporate emerging 
scientific and technical capabilities of America's scientists and 
private sector. The overall objective of the SBIR program is to improve 
the transfer of innovative scientific and technical efforts that, in 
our case, will maximize a strong chemical and biological defense 
posture. Examples of innovative capabilities tapped by the SBIR program 
include biological detection technology, modeling and simulation, 
contamination avoidance, and individual protection.
    The Military Departments and Defense Agencies retain the 
responsibility to manage and execute the various individual projects. 
Frequent requests are made to review new technologies and concepts to 
incorporate into chemical and biological defense efforts. Solicited 
proposals may be submitted in response to requests for proposals (RFPs) 
or requests for quotations (RFQs) published in Federal Business 
Opportunities (known as ``FedBizOpps''), the government's designated 
point of entry on the Internet for providing public access to notices 
of procurement actions over $25,000. FedBizOpps may be found at http://
www.fedbizopps.gov.
    The appropriate addressee for submitting unsolicited proposals is 
with the Military Departments and Defense Agencies. There are several 
organizations participating in the DoD management of chemical and 
biological defense programs to whom unsolicited proposals might be 
submitted. Many of these organizations provide information on the 
processes for submitting proposals through Broad Agency Announcements 
(BAAs) or similar instructions. Following is a partial list of 
organizations, and internet addresses, with information on submitting 
unsolicited proposals. This information may be updated occasionally, 
and thus should be checked for updates.
 U.S. Army Soldier Biological and Chemical Command--http://
    www.sbccom.apgea.army.mil/RDA/baa0l.htm
 U.S. Army Medical Research and Materiel Command -- http: // 
    mrmc-www.army mil/
 Air Force Research Laboratories -- http://extra.afrl.afmil/
    bus-op shtm
 Naval Surface Warfare Center -- http: // www.nswe.nav.mil/
    dahl.htm
 Marine Corps Systems Command -- http: // 
    www.marcorsyscom.usmc.mil/BusOpps.htm
 Joint Program Office for Biological Defense -- http: // 
    www.jpobd.net/default.htm
 Defense Advanced Research Projects Agency -- http: // 
    www.darpa.mil
 Technical Support Working Group -- http: // www.tswg.gov
    In response to the September 11 attacks, the Department also 
established a BAA to accept proposals from all sources on how to 
respond to the terrorist threats. Thousands of proposals were 
submitted. Hundreds of these applied to the biological terrorist 
threat.
    Finally, there are numerous conferences annually in which the 
Department's chemical and biological defense science and technology 
needs are presented to academia and industry organizations, thereby 
providing yet further opportunities for scientists and the private 
sector to become aware of how they can contribute to America's chemical 
and biological defense posture.
                               conclusion
    The anthrax attacks late last year pointed out the real dangers of 
biological weapons. While these attacks have increased the priority of 
our efforts, the Department has been drawing upon our Nation's 
scientific expertise to develop and field an effective defense 
capability to protect our forces and Nation from adversaries at home 
and overseas. Continuing advances in genetic engineering, 
biotechnology, and related scientific areas will require our continued 
vigilance to ensure that we are prepared for the threat and not caught 
by technological surprise. My comments today highlight just some of the 
numerous scientific efforts the Department is supporting. I thank you 
for the opportunity to speak today and welcome any questions you may 
have.

    Senator Wyden. Thank you.
    Dr. Simpson.

 STATEMENT OF DR. LISA A. SIMPSON, M.B., B.Ch., M.P.H., DEPUTY 
    DIRECTOR, AGENCY FOR HEALTH CARE RESEARCH AND QUALITY, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Dr. Simpson. Good afternoon, Mr. Chairman. I am very 
pleased to be here today to discuss an exciting new effort at 
the Department of Health and Human Services that will give us 
an opportunity to learn how to respond to what the private 
sector is doing to improve the security, safety, and quality of 
our health care system.
    We, too, have been frustrated and have heard from the 
companies and the issues and concerns that the first panel 
detailed for us, because we have recognized that it is 
difficult sometimes for them to find the right place in 
government for their products and ideas to be considered.
    Alleviating this frustration and forging a strong 
collaboration between government and industry is especially 
important as the Nation comes together to improve the security 
in the face of the recent bioterrorist attacks.
    To that end, on December 6, 2001, Secretary Thompson 
established the Council on Private Sector Initiatives to 
improve the security, safety, and quality of health care. The 
council, as we call it, will help us to manage in a fair, 
systematic, and consistent manner the requests that the 
Department is receiving from individuals and firms seeking 
review of their innovative ideas and products. In essence, the 
council offered something we heard about this morning, the one-
stop shopping concept for companies seeking to present their 
ideas to the Department of Health and Human Services.
    I would now like to describe the council to you, focusing 
specifically on its charge, its composition, the process for 
submitting requests, and its current activities. Secretary 
Thompson laid out a clear mission for the council with five 
very specific charges.
    First, to triage the requests from individuals and firms 
seeking HHS review of their ideas to improve the security, 
safety, and quality of the health care delivery system.
    Second, to ensure that HHS responds systematically and 
consistently to these requests, providing constructive feedback 
as appropriate.
    Third, to ensure that our focus on public health 
preparedness is complemented by careful attention to the 
preparedness of our health care delivery system.
    Fourth, to provide the private sector with a single point 
of entry to the Department of Health and Human Services for 
these initiatives, and finally, to report to the Secretary 
periodically to ensure accountability for these efforts.
    Recognizing the breadth of expertise to properly evaluate 
the private sector requests and the need to foster interagency 
and even interdepartmental collaboration, as we have heard this 
morning, the Secretary has invited a wide array of HHS agencies 
and departments to serve on this council. As necessary, the 
council can also be expanded beyond these original members.
    The current members of the council are the heads or their 
designees of the following agencies of the Department of Health 
and Human Services, and I will use acronyms for the purposes of 
time, the CDC, the FDA, the NIH, CMS, ARC, the Assistant 
Secretary for Health, the Assistant Secretary for Planning and 
Evaluation, and the Director of the Office of Public Health 
Preparedness.
    In addition, the council also includes the heads or their 
designees from the Department of Defense, the Department of 
Veterans Affairs, and the Federal Bureau of Investigation. We 
have also extended invitations to the Environmental Protection 
Agency and the Department of Energy to ensure appropriate 
coordination across other relevant departments. Equitable 
access and consideration is a key principle for this council.
    The requests received to date by the Department of Health 
and Human Services represent a broad range of private sector 
entrepreneurs, ranging from a major pharmaceutical manufacturer 
to a recently disabled man whose company consists of him and 
his wife, and whose letter presented an idea for a compact 
respirator. The council will help level the playing field 
between these large and small companies and these innovations 
in the private sector.
    To help ensure that all of them are treated in a fair, 
systematic, and consistent manner, we have set out a clear 
process to triage the requests, refer them to the appropriate 
agency or department, and to follow up on their disposition.
    The council held its first meeting on January 23 of this 
year, and has already started its work. Since its formation, 
the council's staff has reviewed requests from 18 companies. 
Member agencies have already met with three of these companies, 
and the remaining requests are being currently reviewed.
    We have already established a website, the name of which, 
the URL is www.cpsi.ahrq.gov, for Council and Private Sector 
Initiatives. This website will give companies instructions on 
how to submit a request, as well as enable access to the 
contact persons within the council who can provide further 
information on their respective agencies.
    We hope that this council will provide opportunities for 
the Department of Health and Human Services, all of our 
agencies, and our fellow Federal departments to learn from this 
innovation and energy in the private sector. Further, we also 
hope that the council will reduce the frustration and burdens 
that private sector companies have so eloquently detailed for 
us, and have faced in bringing their ideas and products to us.
    This concludes my prepared remarks. I am happy to answer 
any questions from you.
    [The prepared statement of Dr. Simpson follows:]
  Prepared Statement of Lisa A. Simpson, M.B., B.Ch., M.P.H., Deputy 
  Director, Agency for Healthcare Research and Quality, Department of 
                       Health and Human Services
    Good morning, I am very pleased to be here today to discuss an 
exciting new effort at the Department of Health and Human Services 
which will give the Federal Government an opportunity to learn what the 
private sector is doing that could enhance the security, safety, and 
quality of the Nation's health care system.
    We have heard from private-sector companies that they are 
frustrated because it is difficult for them to find the right place in 
government for their products and ideas to be considered. Alleviating 
this frustration--and forging a strong collaboration between government 
and industry--is especially important as the Nation comes together to 
improve security in the face of recent bioterrorist attacks.
    To that end, on December 6, 2001, Secretary Thompson established 
the Council on Private Sector Initiatives to Improve Security, Safety, 
and Quality of Health Care. CPSI, or the Council as we call it, will 
help us to manage in a fair, systematic, and consistent manner the 
requests the Department has received from individuals and firms seeking 
review of their innovative ideas and products.
    In a memo creating the Council, Secretary Thompson noted, ``The 
Council will ensure that our focus on public health preparedness is 
complemented by careful attention to the preparedness of our health 
care delivery system. This Council will also enhance our responsiveness 
to innovation by providing the private sector with a single point of 
contact at the Department.''
    In essence, the Council offers ``one stop shopping'' for companies 
seeking to present their ideas to HHS. Requests will be reviewed and 
sent to the appropriate Federal Agency or Department for action in 
coordination with the department performing similar functions. However, 
we do recognize that not all requests can be met fully because they are 
outside the scope of what HHS and other government agencies can do. Our 
goal is to reduce the time and potential duplication of effort that 
companies may face in bringing their ideas to experts within Government 
who have the knowledge to evaluate them.
    I would now like to describe the CPSI to you, focusing specifically 
on its charge, its composition, the process for submitting request, and 
its current activities.
                                 charge
    Secretary Thompson laid out a mission for the Council with five 
very specific charges:
    1. Triage requests from individuals and firms seeking HHS review of 
their ideas for improving the security, safety, and quality of our 
health care delivery system.
    2. Ensure that HHS responds systematically and consistently to 
these requests, providing constructive feedback as appropriate.
    3. Ensure that our focus on public health preparedness is 
complemented by careful attention to the preparedness of our health 
care delivery system.
    4. Provide the private sector with a single point of contact at the 
Department of Health and Human Services for these initiatives.
    5. Report to the Secretary periodically on the nature of the 
requests received; the timeliness with which they are handled, their 
disposition, and the opportunities they present for supporting new and 
existing Secretarial initiatives.
    In addition to reporting to the Secretary, CPSI will provide 
feedback to the agencies and Departments so that they can see the 
progress of other requests, examine the reporting of their own 
activities, and avoid the processing of duplicate requests within their 
own organizations.
                              composition
    Recognizing the breadth of expertise required to evaluate the 
private-sector requests and the need to foster interagency and even 
interdepartmental collaboration, the Secretary invited a a wide array 
of Federal Agencies and Departments to serve on the Council. As 
necessary, the Council can be expanded beyond these original members.
    The current members of CPSI are heads, or their designees, of the 
following agencies of the Department of Health and Human Services:
 Centers for Disease Control and Prevention;
 Food and Drug Administration;
 National Institutes of Health;
 Centers for Medicare and Medicaid Services;
 Agency for Healthcare Research and Quality;
 Assistant Secretary for Health;
 Assistant Secretary for Planning and Evaluation; and
 Director of the Office of Public Health Preparedness.
    In addition, the Council also includes the heads or their 
designees, from the:
 Department of Defense;
 Department of Veterans Affairs; and
 Federal Bureau of Investigation.
    Invitations are being extended to the Environmental Protection 
Agency and the Department of Energy to ensure appropriate coordination 
across other relevant departments.
    The CPSI is being chaired by John M. Eisenberg, M.D., Director of 
the Agency for Healthcare Research and Quality.
                                process
    Equitable access and consideration is a key principle of the 
Council. The requests received to date by the Department of Health 
Human Services comprise a broad range of private sector entrepreneurs 
ranging from a major pharmaceutical manufacturer offering their 
production capabilities to a letter from a recently disabled man, whose 
company consists of only him and his wife, presenting an idea for a 
compact respirator.
    Many large companies have learned how to gain entry to the 
government; many small companies do not have the resources and the 
knowledge to even know where to begin. The HHS Council will help level 
this playing field. To help ensure that all are treated in a fair, 
systematic, and consistent manner, we have set out clear process to 
triage requests, refer them to the proper Agency or Department, and 
follow up on the disposition.
    Once received, requests are reviewed by Council staff to determine 
the purview of which Departments or Agencies the content falls. 
Requests that fall under a single Agency or Department are forwarded to 
a designated contact who will take whatever action is deemed 
appropriate. Requests that involve multiple Departments or Agencies may 
be invited to a meeting where representatives of those agencies are 
present. This fosters collaboration among the agencies and reduces the 
burden that private sector companies face in trying to gain access to 
multiple agencies or offices separately.
    After the referral and contact are completed, Agencies and Offices 
report their actions back to the Council for tracking and reporting 
purposes. Since the Council is newly formed, this process will be 
evaluated and refined as we gain more experience.
                           current activities
    Less than 2 weeks ago, on January 23, 2002, the Council held its 
first meeting at the Hubert H. Humphrey Building. The goal of this 
meeting was to ensure that the HHS agencies and our sister Federal 
Departments involved in the Council had an opportunity to provide input 
into the formation of the Council, its structure, and processes.
    To date, we have received requests from approximately 18 companies. 
Although, the Council is newly established, we have already started 
work. The Council already has met with 3 companies, and we have 
scheduled meetings with an additional 8. Another 5 are being referred 
to specific agencies. Two are in the process of consideration.
    Having attended some of the meetings myself, I found it exciting to 
learn about what is being done in the private sector which can extend 
and strengthen current public sector investments.
    We have also established a website -- www.cpsi.ahrq.gov -- that 
will give companies instructions on how to submit a request as well as 
provide access to the contact persons within the Council who can 
provide further information.
    We hope the Council will provide opportunities for the Department 
of Health and Human Services, our Agencies, and our fellow Federal 
Departments to learn from innovation in the private sector. Further, we 
also hope that the Council will reduce the frustration and burdens that 
private-sector companies have faced in bringing their ideas and 
products to us.
    This concludes my prepared statement. At this time, I would be 
happy to answer questions from you and other Members of the 
Subcommittee.

    Senator Wyden. Thank you very much, and again you both, and 
your departments, have been very cooperative, and we appreciate 
it.
    I think what I am concerned about at this point, and it 
sort of sparked out of a comment that you made, Dr. Simpson, 
because the department is going to have one-stop shopping in 
the Department of Health and Human Services, but it strikes me 
that for the entrepreneurs, that what that raises is the 
question of one stop out of 20 that Dr. Ryan may have to make 
as she and her colleagues work through the Federal Government. 
As I understand it, you all are going to try, if an 
entrepreneur is in touch with you, you are going to try and 
walk them all the way through the system in terms of other 
agencies and the like.
    Let us say, for example, that somebody brings you a product 
that might involve a communications focus, or even an energy or 
environmental kind of concern, are you going to walk them--the 
Health and Human Service staff--are you going to walk them 
through all the potential agencies so that the hypothetical Dr. 
Ryan does not have to say, ``Thank you, Dr. Simpson,'' and then 
start traipsing to all the other 19?
    Dr. Simpson. Well, within the Department of Health and 
Human Services, our goal is to appropriately and in a timely 
manner refer them to either the one agency, if their product or 
idea is clearly linked to just the one agency, or if there are 
multiple agencies, to do that at the same time in a coordinated 
fashion, and then built into this an accountability and 
feedback to the council staff, and hence to the Secretary. A 
clear charge from the Secretary is to find out how were those 
requests handled, and what was the final decision.
    Now, in the specific example you just gave us, if the idea 
or innovation really crosses departments and goes to the 
Department of Defense or Environmental Protection, we would 
then refer them to our contact through the council and rely on 
those departments to continue the coordination they have 
already established within their departments, and periodically 
to give feedback to us on how effective has our process been in 
getting the information they need to them, and vice versa. So 
we are trying to learn as we go, with this new council, to 
really improve the communication, both internal and external as 
well.
    As we see the process of our referrals, the process is that 
we send it to one agency, but all the other agencies will see 
who has been referred where, and they can say, ``hey, that is a 
product we may have a role in here, let us also do that.''
    Senator Wyden. I think that is certainly a step in the 
right direction. What I am concerned about is, I want the first 
person that an entrepreneur with a promising idea meets at the 
Federal level, I want that person to walk them all the way 
through the system, and I think that what you describe 
certainly is a constructive step, and as I say, I talked with 
the Secretary about it, and I know that he is committed to 
doing this. That is not what is in question.
    What I am concerned about is the possibility, even under 
the scenario that you describe, that someone spends a lot of 
time at the Department of Health and Human Services, and your 
people are plenty useful, but then they decide that it is 
something with the Department of Energy or Commerce, and then 
our entrepreneur starts all over again at that department, and 
they decide it is somebody else, and by that time everybody has 
started all over multiple times.
    We do not need to belabor this. I think that you all have 
clearly taken a step in the right direction. I think what my 
interest is, and I may ask your associate to touch on the same 
kind of question, I would like one set of rules for those 
entrepreneurs, one set of rules so that they understand what 
the kind of general parameters are, and then one advocate to 
sort of take them all the way through the system, and what we 
are talking about still today leaves us with the possibility of 
lots of different rules coming from lots of different agencies, 
and then having to start over.
    Please go back to your departments and let Secretary 
Thompson and Secretary Rumsfeld know that this is not some sort 
of an attack on them. They have been very helpful, and we are 
going to work with you, and I think those are the general 
parameters of what I am interested in.
    Ma'am, would you like to comment and pick up on the same 
sort of thing, because I think it really frames where we want 
to go with this. I think the case of the Department of Defense, 
it perhaps has been even more baffling to the entrepreneurs, 
again not because somebody is trying to be malicious or 
difficult. It is that the lines blur.
    I serve on the Senate Intelligence Committee, as Senator 
Rockefeller does, an intelligence area that I have sort of been 
very interested in, and sort of the lines are blurred between 
what you all are doing and DARPA. I have had entrepreneurs come 
to me and say, I read about this announcement, and I read about 
it 2 weeks after it closed, and then I read a story that there 
were 13,000 applications, and perhaps if you could take the 
same point that I touched on with Dr. Johnson and put it in 
connection particularly with the agencies that are most 
relevant for you, and I think it is particularly--not just DOD 
but the CIA. I think that would be helpful, to the extent you 
could in a public forum.
    Dr. Johnson-Winegar. Well, you are absolutely right that 
the Department of Defense is very, very complex, and probably 
bewildering to many folks. First of all, they are not sure 
whether they should talk to the Army, the Navy, the Air Force, 
or the Department of Defense or to DARPA, or to some other 
components of the Department of Defense, and they are not 
really sure that all of those individual components re talking 
to each other, much less to other agencies with which we have 
very similar efforts.
    As Dr. Simpson mentioned in her comments, between the 
Department of Defense and the Department of Health and Human 
Services we share a lot of ongoing work and initiatives on the 
medical countermeasures for bioterrorists, whether that be 
vaccines, or drugs, or therapy, or diagnostic devices, and so I 
would certainly characterize the relationship between our two 
departments as constantly improving and increasing interchange 
of ideas and thoughts between the two of us. Similarly, in 
other areas.
    For example, in the area of decontamination we are working 
very closely with EPA, who was given the lead role for 
decontaminating the Senate building here. They did not really 
have any hands-on expertise in working with anthrax, so who do 
they come to? The Department of Defense. Likewise, a number of 
other agencies. The Department of Energy has a number of other 
efforts for biological detection, as do we, and so I think that 
between the Federal agencies our coordination and communication 
has improved.
    However, I do admit and recognize that that is probably not 
clear enough to the small companies, the entrepreneurs and the 
private business, as to where to start. We get numerous 
requests on a daily basis. We try to identify the appropriate 
agency if we feel that is not appropriate for something that 
the Department of Defense wants to pursue. We do not have all 
of the information that we need to make that an easy road for 
those individuals to travel. I think we realize we have some 
improving to do in that area, but I am certainly willing to 
admit we are not there today.
    Senator Wyden. Well, extra points for candor, and I 
appreciate that. That has clearly got to be one of the 
priorities in all of this, both as it relates to what we are 
trying to do, and then as I put on my other hat on the defense 
intelligence side as well.
    Let me ask you one other question that has been of interest 
to me in my service in the Congress, and that is whether you 
have any suggestions on how we can improve the tech transfer 
effort in this area.
    As you know, there is a very significant statute, the Bayh-
Dole Act, which my sense is has again been a very useful law, 
but there have been a number of changes since it was originally 
conceived. Today, from essentially all of the parties, 
universities who are eager to participate in these joint 
efforts, certainly entrepreneurs who would like to tap into 
these technologies, and then taxpayers who want to see a rate 
of return on licensed products and the like, there may be areas 
where we could strengthen this law and improve it. Are there 
efforts underway in your departments to look at the Bayh-Dole 
law and, if so, what can you tell us about those?
    Dr. Simpson. Well, first, let me just state again, and I 
think it is something you alluded to, which is Secretary 
Thompson's commitment to this partnership with the private 
sector, and he has challenged each of us, each of our agencies, 
to come up with new and better ways to be open and to be 
responsive. To the extent that looking at this act in ways that 
it needs to be modified, I think he would be open. I personally 
would need to go back to the department--and I am now being 
told, Senator that the Office of the Inspector General has done 
work in this area, and we would actually be happy to provide 
that information, but I think at the heart of this is a real 
commitment on our part and the Secretary to be responsive, and 
be more efficient in our operations.
    Senator Wyden. I would like to see any work that is going 
on at the department. I am not sure if the Bayh-Dole work is 
primarily on pharmaceuticals which would be useful, taxpayer-
funded medicine, which is something the Secretary has been 
helpful to me on as well, but what I am talking about is basic 
research, particularly in the fight against bioterrorism.
    My sense is that the taxpayers put up billions and billions 
of dollars in various government-funded laboratories, and I 
think we ought to be looking at ways to transfer more of that 
federally-funded basic research to the private sector, and 
that, of course, was the purpose of Bayh-Dole, and why I have 
made an effort to see how it is being carried out, and I would 
hope we would look for ways, again on a bipartisan basis in 
conjunction with the Administration, to strengthen that.
    Doctor, did you want to add anything to that?
    Dr. Johnson-Winegar. I would just echo her comments and say 
I cannot give you any specifics today, but I certainly will 
take that for the record and get back to you with any 
information the department can provide.
    Senator Wyden. Let us do this. If both of you could give us 
a little report, say within 30 days, on how your agency is 
carrying out Bayh-Dole, particularly as it relates to terrorism 
and what, if any, ideas you have for strengthening it, and I 
would be particularly interested in ideas that could be 
achieved quickly through the administrative route, rather than 
through the need to pass a law.
    Well, you two have been very, very helpful, and 
exceptionally patient. Is there anything either of you two 
would like to add?
    Dr. Simpson. No. Just thank you for having us here, and we 
look forward to working with you and your Subcommittee in 
responding to this very important national priority.
    Dr. Johnson-Winegar. I would just like to add that, clearly 
from the Department of Defense point of view, we recognize the 
terrific contributions that both industry and academia can 
make. Having been a scientist once myself, even though it was 
quite sometime ago, I do realize that perhaps we do not often 
recognize and appreciate the contributions they make, and I 
think it is incumbent on all of us to do things to focus those 
energies and talents on this problem which is facing all of us 
today.
    Senator Wyden. We will be calling on you often, and 
certainly be soliciting your input as we go forward with this 
draft legislative proposal, and with that, the hearing is 
adjourned.
    [Whereupon, at 1:25 p.m., the hearing was adjourned.]
                            A P P E N D I X

     College of American Pathologists, Division of Government and 
             Professional Affairs, Statement for the Record
    The College of American Pathologists (CAP) appreciates the 
opportunity to comment on the critically important issue of ensuring 
that all needed technologies are available to the government to 
prepare, respond and prevent a biological weapons attack. The College 
represents more than 16,000 pathologists who serve as medical directors 
of the Nation's clinical laboratories. Combating and preparing for the 
threat of bioterorrism is important to the College from multiple 
perspectives: that of our pathologist membership, in our role as a 
private accreditation organization and, of particular interest to this 
hearing, as a leader in providing cutting-edge bioinformatics 
technology.
    The U.S. health care information system is challenged as never 
before by the need to link disparate pieces of data from numerous 
emergency rooms, pathology laboratories and physician offices into a 
network of ongoing bioterrorism disease surveillance. The College 
oversees the strategic direction and scientific maintenance of the 
Systematized Nomenclature of Medicine, better known as SNOMED. SNOMED's 
concept-based clinical language provides a validated technology to help 
health care workers and government officials quickly identify and 
respond to biological and chemical threats. With extensive content 
relating to such potential threats as anthrax and smallpox, SNOMED 
helps ensure that consistent, reliable information can be 
instantaneously shared and understood by clinicians, hospitals, the 
Centers for Disease Control and Prevention (CDC) and other Federal 
authorities that coordinate surveillance activities.
    SNOMED Reference Terminology provides the framework to encode and 
integrate clinical data, from symptoms to definitive diagnoses, and 
creates a common language essential to identifying and ensuring a rapid 
response to bioterrorism. College members played a key role in 
identifying the Nation's first case of anthrax in Florida and are 
concerned, because of the lack of an electronic surveillance network, 
with the potential for delays in the reporting of new cases. CAP 
believes that if all labs used a uniform terminology, such as SNOMED, 
the detection, diagnosis and response to bioterrorism agents would 
occur much more quickly and efficiently. Further, because SNOMED and 
other new technologies offer significant value to multiple government 
agencies and applications, the College believes the government would be 
well served to create a central point for information and evaluation to 
ensure all appropriate agencies know about and have access to valuable 
resources, tools and technologies. Similarly, the private sector would 
be well served by a central point of entry to the Federal Government 
for bioterrorism capabilities. With an ``information central,'' the 
private sector could more easily share its technological knowledge 
governmentwide--enhancing coordination at the Federal level.
    On another front, the College performs accreditation inspections 
for more than 6,000 clinical laboratories and provides quality 
assurance testing materials to more than 30,000 labs. Therefore, the 
College's Laboratory Accreditation Program network provides a 
significant conduit for communication with the private laboratory 
sector and an opportunity for education and awareness on this issue. On 
October 12, the College was pleased to respond to a CDC request to ask 
clinical labs to familiarize themselves with CDC anthrax protocols and 
procedures to follow should they suspect a case or isolate. Within 5 
hours of CDC's request, the College, using a combination of fax and e-
mail, sent the CDC alert to 30,000 clinical labs and to all its 16,000 
members, and placed the alert on the CAP Web page. We stand ready to 
assist the CDC, Congress and other public health and government 
entities in anyway we can. Such private sector resources, if better 
understood and known by the government, could help coordinate and 
improve the ability of our Nation's laboratories to respond to 
bioterrorism.
    Bills have been introduced in both the House and the Senate to 
better prepare for biological and chemical attacks by strengthening our 
public health and medical infrastructure and improving response efforts 
at the Federal, State and local levels. These bills highlight the need 
to boost funding for hospitals, laboratories, clinics, information 
networks and public health services in the event of a bioterrorism 
attack. Of particular interest, the final version of the ``Public 
Health Security and Bioterrorism Response Act'' (H.R. 3448) includes 
provisions that provide additional Federal grants and funding for the 
development of materials for the recognition and identification 
(including proficiency testing) of potential bioweapons and other 
agents that may create a public health emergency, and for the care of 
victims of such emergencies. The College urges support of this 
provision which seeks to utilize important private sector resources.
    Finally, the College has a four-point approach to enhance the 
understanding of laboratory pathologists in preparing their facilities 
and educating their colleagues about the eventuality of a bioterrorist 
attack. These include:
     Provide multimedia education to our member pathologists 
and laboratory technicians in the proper identification, handling and 
transport of bioterrorism agents. In that regard, the College has on 
its Web site, www.cap.org, instituted a current and updated information 
site on Bioterrorism Preparedness.
     Educate clinicians so they can effectively use laboratory 
techniques and procedures that will detect and combat suspect 
bioterrorist agents.
     Continue to work with the CDC to provide information to 
the private clinical sector about the laboratory response network and 
other government programs to ensure laboratory preparedness.
     Explore the need to expand the microbiological proficiency 
testing program to include regular challenges of strains of potential 
bioterrorism agents--in a form nontoxic to lab personnel.
    The College will continue to reach out to both government 
policymakers and professional groups as the Nation, and laboratories, 
respond to the growing threat of biological and chemical attacks. Thank 
you again for the opportunity to comment.
  

                                
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