[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''.
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\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.
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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.
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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.
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\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\
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\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.
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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\
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\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.
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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.
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\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.
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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\
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\5\ Pearson, G.W. The Children's Vaccine Initiative: Continuing
Activities. Washington, D.C.: National Academy Press, 1995.
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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\
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\6\ The complete Statement is attached to this testimony. It
includes the listing of specific functions appropriate for the NVA.
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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.