<DOC>
[107th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:76304.wais]
A REVIEW OF FEDERAL BIOTERRORISM PREPAREDNESS PROGRAMS: BUILDING AN
EARLY WARNING PUBLIC HEALTH SURVEILLANCE SYSTEM
=======================================================================
HEARING
before the
SUBCOMMITTEE ON
OVERSIGHT AND INVESTIGATIONS
of the
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
__________
NOVEMBER 1, 2001
__________
Serial No. 107-71
__________
Printed for the use of the Committee on Energy and Commerce
Available via the World Wide Web: http://www.access.gpo.gov/congress/
house
__________
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COMMITTEE ON ENERGY AND COMMERCE
W.J. ``BILLY'' TAUZIN, Louisiana, Chairman
MICHAEL BILIRAKIS, Florida JOHN D. DINGELL, Michigan
JOE BARTON, Texas HENRY A. WAXMAN, California
FRED UPTON, Michigan EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida RALPH M. HALL, Texas
PAUL E. GILLMOR, Ohio RICK BOUCHER, Virginia
JAMES C. GREENWOOD, Pennsylvania EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia SHERROD BROWN, Ohio
STEVE LARGENT, Oklahoma BART GORDON, Tennessee
RICHARD BURR, North Carolina PETER DEUTSCH, Florida
ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois
GREG GANSKE, Iowa ANNA G. ESHOO, California
CHARLIE NORWOOD, Georgia BART STUPAK, Michigan
BARBARA CUBIN, Wyoming ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois TOM SAWYER, Ohio
HEATHER WILSON, New Mexico ALBERT R. WYNN, Maryland
JOHN B. SHADEGG, Arizona GENE GREEN, Texas
CHARLES ``CHIP'' PICKERING, KAREN McCARTHY, Missouri
Mississippi TED STRICKLAND, Ohio
VITO FOSSELLA, New York DIANA DeGETTE, Colorado
ROY BLUNT, Missouri THOMAS M. BARRETT, Wisconsin
TOM DAVIS, Virginia BILL LUTHER, Minnesota
ED BRYANT, Tennessee LOIS CAPPS, California
ROBERT L. EHRLICH, Jr., Maryland MICHAEL F. DOYLE, Pennsylvania
STEVE BUYER, Indiana CHRISTOPHER JOHN, Louisiana
GEORGE RADANOVICH, California JANE HARMAN, California
CHARLES F. BASS, New Hampshire
JOSEPH R. PITTS, Pennsylvania
MARY BONO, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska
David V. Marventano, Staff Director
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Oversight and Investigations
JAMES C. GREENWOOD, Pennsylvania, Chairman
MICHAEL BILIRAKIS, Florida PETER DEUTSCH, Florida
CLIFF STEARNS, Florida BART STUPAK, Michigan
PAUL E. GILLMOR, Ohio TED STRICKLAND, Ohio
STEVE LARGENT, Oklahoma DIANA DeGETTE, Colorado
RICHARD BURR, North Carolina CHRISTOPHER JOHN, Louisiana
ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois
Vice Chairman JOHN D. DINGELL, Michigan,
CHARLES F. BASS, New Hampshire (Ex Officio)
W.J. ``BILLY'' TAUZIN, Louisiana
(Ex Officio)
(ii)
C O N T E N T S
__________
Page
Testimony of:
Barry, Anita, Director, Communicable Disease Control, Boston
Public Health Service...................................... 18
Broome, Claire, Senior Advisor, Integrated Health Information
Systems, Office of the Director, Centers for Disease
Control and Prevention..................................... 12
Davidson, Arthur J., Director, Public Health Informatics,
Denver Public Health Department............................ 23
Russell, John S., Executive Vice President and General
Counsel, Quintiles Transnational........................... 60
Wagner, Michael M., Director, RODS Laboratory, Center for
Biomedical Informatics, University of Pittsburgh........... 48
Zelicoff, Alan P., Senior Scientist, Center for National
Security and Arms Control, Sandia National Laboratories.... 54
(iii)
A REVIEW OF FEDERAL BIOTERRORISM PREPAREDNESS PROGRAMS: BUILDING AN
EARLY WARNING PUBLIC HEALTH SURVEILLANCE SYSTEM
----------
THURSDAY, NOVEMBER 1, 2001
House of Representatives,
Committee on Energy and Commerce,
Subcommittee on Oversight and Investigations,
Washington, DC.
The subcommittee met, pursuant to notice, at 9:40 a.m., in
room 2322, Rayburn House Office Building, Hon. James C.
Greenwood (chairman) presiding.
Members present: Representatives Greenwood, Stearns, Burr,
Whitfield, Bass, Tauzin (ex officio), Deutsch, Stupak,
Strickland, DeGette, Rush, and Dingell (ex officio).
Also present: Representative Harman.
Staff present: Tom Dilenge, majority counsel; and Edith
Holleman, minority counsel.
Mr. Greenwood. Good morning. This hearing of the Oversight
and Investigations Subcommittee of the House Energy and
Commerce Committee will come to order, and the Chair recognizes
himself for 5 minutes for an opening statement.
Three weeks ago, this subcommittee held a hearing to
evaluate the effectiveness of Federal programs designed to
bolster the preparedness of States and local communities to
deal with bioterrorist attacks. At that time the second and
third cases of anthrax infection in Florida had just been
discovered.
Several hundred people who worked with those individuals
were being tested and put on Cipro as a precautionary measure.
It was still unclear at that time whether the Florida situation
was an isolated incident or part of some broader criminal or
terrorist enterprise.
Since that hearing the anthrax scare has spread and the
death toll has increased. The numbers infected seem to increase
daily, as do the number of locations with anthrax detected in
them.
An anxious Nation is left to wonder if in Emerson's words,
``Things are in the saddle and ride mankind.'' People are
afraid and some with good reason. Unlike the 1930's, we have
more to fear than fear itself. An unscrupulous enemy, with
access to the most insidious means of human destruction, and a
demonstrated willingness to use them, is in fact a fearful
thing.
But what is truly worrying about the recent outbreak is the
possibility that this is a prelude to a worse attack, and that
this effort was designed more to test our capabilities and
probe our weaknesses than to cause sustained damage.
Surely there can be little doubt that this mail borne
anthrax attack was well coordinated and is in fact this
Nation's first real example of bioterrorism at work. All the
more reason that this Nation must promptly improve its public
health surveillance activities, which is the focus of today's
hearing.
Sadly for thousands of Americans, the 1993 attack on the
World Trade Center did not serve as a wakeup call on the need
to better protect our critical physical infrastructure. We
cannot afford to let this happen to our critical public health
system.
In this new kind of war where terror is the enemy's chief
aim, the most potent weapons may very well be biological
agents, and increasingly the battlefront will not be in some
far off land, but here at home. The anthrax outbreak is our
fire bell in the night, and we may not get another warning.
And a very real fear we now confront is the one H.G. Wells
wrote of in 1920 when he observed that human history becomes
more and more a race between education and catastrophe.
This is a race that we cannot afford to lose, nor will we.
America has always risen to meet the challenge, and our public
health system, while in need of repair, has more than an
adequate foundation to begin to wage a successful war at home
against our enemies, and the diseases that they may seek to
inflict on us.
But to do that more of our Nation's leadership, and the
President, and Congress, must be galvanized by the dangers we
face and must commit themselves to leading the effort to fight
this new kind of war in a new kind of way.
This is about much more than appropriating new money,
though money is needed. To be successful, we must harness the
creative genius of the American people in the public sector,
and in the private sector, and in academia.
Our traditional public health surveillance system, which in
many parts of this country still relies on doctors mailing in
post cards to their local public health departments is too
limited with regard to what is reported, and too slow to be
effective, to late in the patient evaluation process, and too
incomplete to meet our country's emerging needs in this area.
It is the equivalent of relying on the pony express in the
age of the worldwide web. Some bioterrorist attacks, like
sending anthrax powder in the mail, tend to be readily
apparent, at least to those who open the laced mail.
Other attacks, such as pumping bacteria or viruses through
ventilation systems, are more covert, and may not be detected
until exposed individuals get sick and go to their doctors or
local hospitals.
The goal must be to detect these covert releases as soon as
practicable. The successful early detection regime will enable
us to identify the exposed population sooner, and get those
individuals treatment faster.
Early detection will also allow us to contain the spread of
disease, which while less important with non-contagious
diseases, such as anthrax, will prove critical if a terrorist's
agents were a highly contagious disease, such as smallpox.
And even after initial detection, a good surveillance
system will enable our public health officials to more
effectively manage such outbreaks and quickly intervene with
appropriate care and guidance.
While astute and well-trained clinicians will always be the
bedrock of our health care surveillance system, we need to
ensure that recent advances in medical infomatics and improved
health care technology supplement our human intelligence
system.
As we will learn in today's hearing, our public
institutions and our private sector have already begun to make
substantial progress in developing early warning systems to
detect outbreaks of bioterrorism, and in developing rapid
responses to outbreaks.
This is essential if we are going to protect our Nation and
our people. We will also hear today about the Federal
Government's promising, but so far quite limited, efforts to
improve both the traditional surveillance system and to fund
pilot projects at the State and local levels to develop and
test more advanced, more proactive, and decidedly more
unconventional surveillance systems.
I have been concerned, however, that our Federal health
officials have done little to oversee and to better direct such
activities. In particular, it seems like we lack a national
strategic plan to test and evaluate these advanced systems, and
are presently unable to provide clear guidance to State and
local public health officials as to what we believe a good
surveillance system would look like.
The Director of the Federal Centers for Disease Control and
Prevention recently initiated a working group to review the
potential of some of the new surveillance techniques that are
being or already have been developed, and I welcome that
initiative.
I look forward to the testimony of all of our witnesses
today, and I will now recognize the ranking member, Mr.
Deutsch, for 5 minutes for his opening statement.
Mr. Deutsch. Thank you, Mr. Chairman. Thank you for having
this hearing. As I recall this was a hearing that was
interestingly scheduled before the events of September 11, and
the work of this subcommittee on this issue has been something
within our jurisdiction literally from the creation of the CDC.
I think though since September 11, not has just the work of
this committee changed, but obviously the work of the Congress,
and obviously the work of the country has changed.
And my hope is that as we have talked outside of the
hearing room, my hope is that we really broaden what we are
doing, because I think that our jurisdiction is as critical as
any jurisdiction in the Congress right now.
I mean, we have the legal responsibility to work on public
health issues, and work on our jurisdiction regarding the CDC,
and HHS has responsibility for public health, and I think we
need to take that job very seriously as we are.
But I think some of the focus needs to be ongoing in real
time, and the real time issues that I would focus on as we have
discussed is right now the HHS is working on trying to develop
250 million additional smallpox vaccines.
That is an issue which I don't believe there is a more
critical issue that the Federal Government is working on today.
And I know that everyone involved at HHS is incredibly sincere
and incredibly bright, and incredibly hardworking in the
efforts to successfully complete that endeavor.
But I think it is critical that we engage our resources
working with them toward the same goal of trying to acquire
those vaccines in as quick a real time basis as possible. And
we can talk, and we will have some testimony about the ability
of preparing the systems, in terms of what they can do down the
road, and what they might be able to more.
But I think there are some potentially cataclysmic events
that I will work and help prevent, and I think that is really
the focus, not just of the subcommittee, but I see the chairman
of our full committee here as well, and I know that next week
we have a briefing that both of our staffs are working on
together toward that goal.
So I welcome the testimony that we are expecting to have
today, but I urge us, and I am going to focus even some of
those questions regarding some of the more immediate
potentially relevant issues, and again not just smallpox, which
I think is in fact the more relevant, but as they also relate
to real time issues on anthrax, and real time potential issues
on the plague. So I look forward to your testimony. Thank you.
Mr. Greenwood. The Chair thanks the gentlemen from Florida,
and looks forward to his specific recommendations in those
regards. The Chair recognizes the chairman of the full
committee, Mr. Tauzin, for an opening statement.
Chairman Tauzin. Thank you, Mr. Chairman, not only for
today's hearing, but for having the foresight even before
September 11 to schedule this hearing, and to continue the work
of our committee in this important area of bioterrorism.
And I want to particularly thank you because today's
hearing, as Mr. Deutsch points out, is just the beginning of a
process, in which our full committee has been now recently
charged by the leadership to produce a major terrorism/
bioterrorism package for the U.S. Congress to consider before
we leave here this November, perhaps December.
The Health Department has already sent to us a food safety
package that we are now working with Mr. Dingell and his own
version of food safety, to see if we can come up with a common
ground document that will enhance dramatically the inspection
of food at America's borders as part of our oncoming efforts,
but nevertheless now an emergency need of this Congress and of
this Nation.
It is contemplated that now with the events of this anthrax
attack on American citizens, and we have just seen the fourth
victim in New York die, that while human toll so far has been
limited, the havoc brought by these attacks has been rather
broad.
And the damage done to public confidence in the mail, and
to the capacity of the CDC, and our health response systems to
deal with these, is seriously in question. The bioterrorism
package that we will design will hopefully answer those
questions, and begin to move the CDC and the health
department--and by the way, the EPA, which is now in charge of
the cleanup of these buildings here in the Nation's capital--
into a position where all of those agencies working in
conjunction with State and local government agencies, including
the National Guard, the Veterans Hospitals, and other great
institutions of that nature, will be more thoroughly
coordinated.
Today we will focus on how technology can help us identify
and react quickly to the evidence of an epidemic or
bioterrorism attack, and in the process this committee will
engage in next week, we will look at the CDC more precisely and
at the Health Department's capacity to respond more precisely.
We will be looking at such questions as how much and how
extensive should be our drug stockpile to react to attacks, or
to the spread of infectious or biological diseases. We will be
looking at how well we currently incentivize vaccine research,
and whether or not we ought to do more to encourage not only
the production, but the research and development of new
vaccines to protect our country against these new forms of
attack.
We will be looking at whether or not the infrastructure of
the CDC is sound, or whether or not some of the systems of
communications within the CDC are adequate. We know that one-
third of all the labs and medical facilities in this country
are not on the emergency alert system of the CDC. They need to
be connected.
And every lab, and every medical facility, needs to be part
of a medical alert when it goes out. We want to look at how
well we are currently educating hospitals, doctors, and nurses,
in the special needs of bioterrorism attacks and infectious
disease spread.
We are going to look at whether we are doing a good enough
job in public education to make sure that its citizens
understand and can deal with some of these threats and
understand the nature of these threats so that they don't have
to be afraid. They can deal with them without fear.
We are going to be looking as I said at EPA and its
authority to respond quickly and to clean up properly when
buildings or systems like our mail systems become contaminated.
We were very blessed to have the Marine Corps response team
available to us here in Washington when our own buildings were
contaminated, but we need to make sure that all of that is
organized and we have proper lines of authority, and proper
funding for these agencies when they are called upon to act.
We know that we have four major medical response teams in
this country established in the four district regions of our
country. How well are they organized, and how well are they
prepared to respond if in fact a medical alert goes out to our
country.
We are going to be looking at all of that next week and
through the next 8 to 10 days, and under the instructions of
the leadership our Energy and Commerce Committee will be
producing the major package on bioterrorism for the House to
consider.
So, Mr. Chairman, the work that you do today examining how
technology and how improved communications infrastructures can
assist in our Nation dealing with these problems is a critical
step.
And most importantly, I want to thank you for being awake
at the switch when so many others were asleep, and working on
this problem even before September 11. Our work now is urgent.
Our work now is extraordinarily important and the
responsibilities of our committee are deeply felt.
Mr. Deutsch, I want to assure you, and I see that Mr.
Dingell has arrived, and all the members on the other side,
that in the next 8 or 10 days we are going to have to all be
working in locked step, and we are going to work as we always
do in a close bipartisan fashion for a good piece of
legislation for the floor. This is the first step, Mr.
Chairman, and I thank you for it.
Mr. Greenwood. The Chair thanks the chairman of the full
committee, and notes the diligence with which he attends all of
our hearings, as well as the other five; I don't know how you
manage to do it. The Chair recognizes the ranking member of the
full committee, the gentleman from Michigan, Mr. Dingell, for 5
minutes for an opening statement.
Mr. Dingell. Mr. Chairman, thank you for your courtesy, and
thank you for holding this very important and informative
hearing. Effective disease surveillance is an essential part of
the successful operation to protect the public health system at
the local, State and national levels, whether we are talking
about disease control or bioterrorism attacks.
The public health system, which has been functioning for
more than a century in this country, is grounded in the skills
and dedicated skills of medical personnel who identify unusual
symptoms and diseases and then alert the public health
departments of the Federal, State, and local units of
government.
Their information allows the public health system to
identify and deal with outbreaks of things like salmonella, E.
coli, food poisoning, flu, HIV, hepatitis, and tuberculosis
epidemics.
Just like politics, however, disease surveillance is local.
Sick people go to doctors or an emergency room and not to the
Centers for Disease Control and Prevention, or government
contractors. Doctors go to their local health departments for
help, and not the Federal Government.
And that is where the emphasis of our effort must be. Many
people, especially those who stand to benefit from lucrative
government projects, say this old system no longer works. A
Florida State epidemiologist, who talked to our staff, but who
was not able to be here, vehemently denies that position.
The traditional system has functioned exactly as it should
have when anthrax appeared in Florida last month, and an alert
doctor saw something in Mr. Stevens that looked like anthrax.
He immediately alerted the State health department.
The State lab identified anthrax from a blood sample, and
this became the indicator case that alerted the entire national
public health system. Fancy syndromic surveillance systems
would never have alerted the health department to anthrax
because there was only one case there at that time.
Hospitals also do not need computers to tell them that
something unusual is going on if a thousand people show up in
the emergency room with plague-like symptoms. So we must be
very careful about developing high-powered surveillance systems
that provide daily reams of information that cannot be
analyzed, are not useful, and in the words of one public health
official, ``wear people out.''
They will likely cost much, and probably confer little
benefit. A good public health disease surveillance system is
not one that sits on the shelf sprewing out endless reams of
useless information while we wait for another bioterrorism
attack.
It is one that is an integral part of a health department's
day to day operations tracking communicable diseases and
outbreaks of other diseases, and educating the medical
establishment and the public as to health risks.
A good system puts most of the investment into State and
local systems, and not into inside the Beltway projects that do
not meet the needs or realities of existing structures.
That said, however, there are many improvements that can be
made to our long-neglected public health system to make it more
effective and timely. It needs quicker electronic reporting
that link laboratories, hospitals, and medical providers to the
Public Health Department.
It needs interactive systems so that alerts and treatment
information can be sent from the health department back to the
providers. It needs better trained medical providers and lab
personnel, and it needs more epidemiologists.
It needs more staff so that the public health departments
can be staffed 24 hours a day for a quick response. It needs
money to upgrade laboratory facilities and to train lab
personnel.
This morning, we will hear from public health officials who
have taken relatively small amounts of money and are using them
to establish electronic systems to speed up disease
surveillance, to rebuild their labs, and to train medical
personnel.
This is to be commended. Mr. Chairman, we in the Congress
need to encourage these kinds of efforts and to fund them at a
higher level than we do today. We can also no longer put off
rebuilding our public health system. It has fallen into sad
states of disarray because of neglect by the Congress and other
agencies responsible for that kind of undertaking.
This is the first and best defense we could have against
bioterrorism. I heard the comments of our Chairman just a
minute or 2 ago, and I am pleased to hear his comments and to
know that we on this side will be very happy to work with him
and with the leadership to come up with a meaningful,
effective, useful, and intelligent program, legislative in
character, to deal with the problems of bioterrorism. I thank
you for your courtesy, Mr. Chairman.
Mr. Greenwood. The Chair thanks the gentleman and
recognizes the gentleman from Florida, Mr. Stearns, for 5
minutes for his opening statement.
Mr. Stearns. Good morning, and thank you, Mr. Chairman.
Again, like my colleagues, we appreciate holding this hearing
and the fact that you were going to have this hearing well
before September 11 is a commendation to you and to your staff.
And I believe that while it is essential and worthwhile to
hear from the public health department officials, it is also a
great opportunity for all of us to hear from those in the
private sector, in academic health, and in the Department of
Energy contracted laboratories.
My colleagues, these witnesses have valuable real world
experiences in disease surveillance, and now more than ever is
the time to learn from them. I am particularly interested to
hear how we might employ data base systems to report outbreaks,
thereby injecting automation in a system that now is manual,
voluntary, and not highly complied with.
As the chairman has mentioned there is a problem that the
terribly low compliance rate with reporting some diseases. We
have got to correct that. The system which relies on ``passive
surveillance'' by doctors often has been criticized as too
slow, and has been plagued by poor compliance from overworked
health care personnel.
And as the chairman of our committee has mentioned, we need
to correct that. I also read in the Washington Post this
morning that Dr. Zelicoff, who is one of our witnesses, a
senior scientist with the Center for National Security and Arms
Control, Sandia National Laboratories, in Albuquerque, New
Mexico, he said, Mr. Chairman, ``Investigators need to begin to
focus less on the microbiology than the physics which is
impressive.''
He goes on to say that ``We didn't think that anybody could
come up with the appropriate coatings for anthrax spores to
make them float through the air with the greatest of ease.
Exposing 28 people with a single opened envelope is no mean
trick.''
So I think he has pointed out and pointed to all of us a
nuance of this debate that we have to understand as to how this
could be accomplished. The tentacles of this anthrax menace are
spreading from the Postal Service and locations in the Federal
Government, to Indiana, Kansas City, Missouri, a hospital in
Manhattan, and the British Embassy in Beijing, recently.
What more devastation might lurk from anthrax or other
biological agents. Who knows. These are very chilling fears
that Americans have. We must be prepared and so I think this
hearing is crucial and timely.
And I would be anxious to hear from the other witnesses how
we can get higher compliance and so we can improve the system
so that it is faster and more automated, and more universal,
and I thank you, Mr. Chairman.
Mr. Greenwood. The Chair thanks the gentleman from Florida
for his opening statement, and recognizes the gentleman from
Michigan, Mr. Stupak, for his opening statement.
Mr. Stupak. Thank you, Mr. Chairman, and thank you for
holding this timely and important hearing on Federal
bioterrorism. As we sit here today the reality of bioterrorism
has hit home for many Americans and us here on Capitol Hill.
And the reality is that we are not prepared. Today's
hearing focuses on how best to prepare our local communities to
monitor and integrate a public health surveillance system.
The logistical elements of coordinating our efforts are
staggering to say the least, but necessary because local
monitoring is where the epidemics and major health problems
first get noticed.
Effective communications, means establishing links among
law enforcement, local health departments, clinics, and
hospitals, so that the critical data in the emergency situation
can identify, contain, and respond to an emergency efficiently.
However, we lack the personnel and the resources to do
this. I remain highly interested in just how we aim to have a
completely integrated public health system in this country. The
systems that we will discuss today seem like good ideas, but
again good ideas are not necessarily a mark of success.
We need a proactive health surveillance system, and not
systems where data and information lie untouched. I look
forward to the testimony of today's witnesses to see how we can
best accomplish these goals without unnecessarily burdening the
front lines of our health care system; that is, our providers
and our doctors.
Thank you, Mr. Chairman, and I will yield back the balance
of my time as I look forward to hearing from our witnesses.
Mr. Greenwood. The Chair thanks the gentleman, and
recognizes the gentleman from Kentucky, Mr. Whitfield, for 5
minutes for his opening statement.
Mr. Whitfield. Mr. Chairman, thank you very much. This
obviously is a timely hearing, and I am not going to make a
long statement, except to say that I am looking forward to the
testimony on the electronic surveillance information system.
I know that there have been pilot projects in some States
with a desire to expand that, and I do look forward to that
testimony, particularly on that issue as well as others.
Mr. Greenwood. The Chair thanks the gentleman, and
recognizes the gentlelady from Colorado, Ms. DeGette, for her
opening statement for 3 minutes.
Ms. DeGette. Thank you, Mr. Chairman, and I would
particularly like to welcome Dr. Davidson, who is with us here
today, and who I only found out was appearing here last night.
And so I would particularly like to welcome him. I met with
Dr. Davidson and a number of representatives of the Denver
Health Departments team that is charged with some kind of early
response to bioterrorism.
And I must say, and not to be a local bragger, but we have
a fantastic program in Denver and Colorado designed to
coordinate agency responses with physician responses, and I
know that the committee will love hearing about it today.
I am very proud of it, but I also know that to have any
kind of effective network that it has to be a national network,
and I know that we are looking forward to hearing about that
today.
We had a hearing on October 10 in this subcommittee about
the threat of a biological or chemical attack, and at that time
Americans feared that post-September 11 that a biological or
chemical assault was imminent. Well, guess what. Here we are
today.
At the time of October 10, bioterrorism experts pointed out
the difficulties of pulling off such an attack. They said that
the No. 1 obstacle is disseminating the agent, and pointed to
the attempts and relative failures made by terrorists across
the world as an illustration of the difficulty.
Unfortunately, what most Americans feared back then has now
come to pass. The attack that we are in the midst of appears to
be small in scale, but it is clear that we must be better
prepared in the event of a larger, more widespread assault.
Issues surrounding biological weaponry, and how various
agents can be spread, and their effect on the human anatomy,
for example, need greater understanding and clarity. We had an
exercise about a year ago.
Some of you have probably seen Dr. Davidson and Dr. Steve
Cantrell from the Denver Health Department talking about
Operation Top Off, where we actually had an exercise involving
the plague.
And what was really disturbing in that exercise is how many
thousands of people were affected by it, and equally disturbing
is because of the movements in our society today, how almost
immediately the plague in this exercise was spread throughout
the United States and even around the world.
And so early response and coordination is clearly the key,
and is what we need to work at. There are gaps at the State and
local level because of a lack of coordination at the Federal
level.
For example, the September 2001 General Accounting Office
report on bioterrorism, Federal research and preparedness
activities, points out that at the Federal level alone several
agencies share responsibility for coordinating various
functions, which limits accountability and hinders unity of
effort.
What is even more amazing to me is some of these agencies
that are dealing with emergency preparedness don't even have e-
mail capability, and so they cannot coordinate with their
fellow agencies.
I look forward to hearing from each of the panelists. I
think that this is an urgent need that we need to address
before we see widespread bioterrorism or chemical terrorism,
and not after, and I know that everybody can contribute to this
effort, and I yield back.
Mr. Greenwood. The Chair thanks the gentlelady, and with
unanimous consent, would recognize the gentlelady, Ms. Harman,
from California, who while not a member of this subcommittee,
is a member of the full committee, and a very active
participant as a member of the Intelligence Committee in all of
these issues, and she is recognized for 3 minutes for an
opening statement.
Ms. Harman. Thank you, Mr. Chairman, and I appreciate the
opportunity to attend this meeting and participate even as an
outsider in what I think are the most important issues that our
country faces.
This hearing, as I understand it, will highlight the most
important functions of our public health system in confronting
and combating terrorism. Disease surveillance, and outbreak
detection, as we are now learning are the greatest challenges
of our terrorism response. This is the foundation of all other
health consequence management actions by doctors and government
officials.
Much of the language that we use in discussing health
security is the same as in discussing national security.
Syndromic surveillance, epidemiological intelligence. This link
just highlights what more and more people are coming to
realize--that our public health system is an essential part of
our homeland defense strategy.
I am particularly glad that we will hear from infomatics
experts on how to upgrade our surveillance system. I have long
advocated the need to eliminate barriers of communication
between our intelligence and defense agencies, and for
upgrading our intelligence technologies for the digital era. In
fact, I often say that we have analog capacity to confront a
digital threat. Our public health system must have integrated,
advanced, digital communications systems so it can respond
quickly and effectively to the bioterrorist threat and disease
outbreaks.
Only yesterday, Mr. Chairman, some of us who visited the
Center for Disease Control last week introduced a bill to
accelerate $300 million in infrastructure investments in a new
infectious disease building at the CDC.
This new facility is critical to our surveillance effort,
and I would hope that all members of the subcommittee, and in
fact the full Commerce Committee, will get behind the Lender-
Harman bill.
I also hope, Mr. Chairman, that as we develop the
bioterrorism package that you and Chairman Tauzin talked about,
we might consider this bill as part of the package. It may seem
strange to think that a building is a critical part of a
bioterrorism effort. But this building will conduct the
critical cutting edge research and design the strategies to
confront the threat, and as we think about moving forward as
you say in real time to our ability to respond, I think it
relies on three things.
One, talented people; two, technology that integrates all
aspects of the response, starting with understanding what is
going on out there, and who is coming to our hospitals; and,
three, having the infrastructure to house the people in that
technology in a safe and secure fashion.
So I thank you for letting me participate, and I am very
eager to hear these witnesses. I yield back.
Mr. Greenwood. The Chair thanks the gentlelady, and notes
or appreciates the reference with regard to the CDC
infrastructure. In fact, if the schedule permits, some of the
members of this committee will be flying to Atlanta tomorrow to
visit the CDC.
Without objection, the opening statements of any other
members not present will be entered into the record.
[Additional statement submitted for the record follows:]
Prepared Statement of Hon. Michael Bilirakis, a Representative in
Congress from the State of Florida
Thank you, Chairman Greenwood, for holding this important hearing
today. The Oversight and Investigation Subcommittee's hearings on
bioterrorism have been instrumental in assessing the needs of our
nation in the event of a bioterrorist attack. In particular, these
hearings have informed the bipartisan process that Chairman Tauzin,
Ranking Member Dingell, Representative Brown and myself have been
engaged in to develop new comprehensive and appropriate legislative
authorities that will protect us from a bioterrorist event.
Since the horrific events of September 11th, the United States has
been engaged in a war on terrorists who threaten our way of life. Our
thoughts and prayers are with those whose lives have been forever
altered by the evilness of terrorism. Unfortunately, the weapons of
terrorism are not limited to hijacked airplanes and bombs, but also
biological agents. Through these hearings and our legislation the
Energy and Commerce Committee is taking the lead to ensure that our
nation can tackle this very difficult issue.
I share the concerns of many Americans who are worried about
possible bioterrorism attacks such as anthrax exposure and outbreaks of
smallpox. There recently have been several cases of anthrax exposure
through the postal mail which have not only complicated the mail
delivery process, but have caused all Americans to fear for the health
and well-being of their families.
An outbreak of smallpox is another potential threat. The United
States currently maintains national smallpox vaccine stocks sufficient
to immunize 6 to 7 million people. Efforts are being undertaken to
expand this reserve so that more Americans can be protected from the
threat of smallpox.
Cases of anthrax exposure can be treated and infection can be
prevented through antibiotics. Great quantities of antibiotics for
anthrax and smallpox vaccines are being stockpiled by the Centers for
Disease Control and Prevention (CDC) in the event of additional
biological attacks. We must ensure that the United States has a
sufficient stockpile of vaccines and antibiotics, and that these
medications are securely protected. We must also make certain that our
public health infrastructure can detect disease outbreaks that may
represent a bioterrorism attack.
This is a time for all of us to pull together as Americans. I
personally thank and honor those who are on the front lines fighting
this war. The United States is a great country, and we are all blessed
to enjoy our freedoms.
Again, thank you Chairman for holding this important hearing.
Mr. Greenwood. And with that, the Chair welcomes the first
panel of witnesses. And they are Dr. Claire Broome, who is the
Senior Advisor of Integrated Health Information Systems, Office
of the Director, Centers for Disease Control and Prevention, in
Atlanta.
And Dr. Anita Barry, Director, Communicable Disease
Control, of the Boston Public Health Service; and Dr. Arthur J.
Davidson, Director, Public Health Informatics, Denver Public
Health Department.
I assume that each of you have been advised that this is an
investigative hearing and it is the practice of this committee
to take testimony under oath. And so I should ask if any of you
have any objections to offering your testimony under oath.
[No response.]
Mr. Greenwood. Seeing no such objections, I would advise
you that under the rules of the House and the rules of the
committee that you are entitled to be advised by counsel. Do
any of you care to be advised by counsel today?
[No response.]
Mr. Greenwood. In that case, if you would please rise and
raise your right hand, I will swear you in.
[Witnesses sworn.]
Mr. Greenwood. You are now under oath, and we will turn to
Dr. Broome first, and you are recognized for 5 minutes for your
testimony. Thank you for being with us.
TESTIMONY OF CLAIRE BROOME, SENIOR ADVISOR, INTEGRATED HEALTH
INFORMATION SYSTEMS, OFFICE OF THE DIRECTOR, CENTERS FOR
DISEASE CONTROL AND PREVENTION; ANITA BARRY, DIRECTOR,
COMMUNICABLE DISEASE CONTROL, BOSTON PUBLIC HEALTH SERVICE; AND
ARTHUR J. DAVIDSON, DIRECTOR, PUBLIC HEALTH INFORMATICS, DENVER
PUBLIC HEALTH DEPARTMENT
Ms. Broome. Good morning, Mr. Chairman, and members of the
subcommittee. Thank you for the invitation to discuss CDC's
public health surveillance activities. As the events of the
last month have shown, and as the subcommittee has so
eloquently described, public health surveillance is a crucial
monitoring function for CDC, its partners, and the country.
Ongoing data collection activities help us detect threats
to the health of the public in time to prevent the further
spread of disease. Usually the original source of information
is the health care provider.
For example, the Florida physician's ability to recognize a
suspected case of anthrax and his role in rapidly reporting it
to the local health department, was critical to our original
recognition of the current bioterrorist events.
There is no substitute for this heightened awareness for
diagnosis of conditions of public health importance by doctors.
They are the front lines, and they need to be aware, and they
need to know who to notify in the local health department, the
State health department, and the CDC.
We work with our public health partners to define
conditions that should be reported to public health
departments. Health Departments then work with their local
partners in the health care system to be sure that they have
the information needed.
You have received copies of an October 19, 2001 issue of
our MMWR, recognition of illness associated with the
intentional release of a biologic agent. I think this is a
concrete example of the kind of information that we are
constantly distributing to our partners to ensure that they
have the latest information.
Of course, this information also goes out electronically.
If a case of illness is particularly unusual or severe, such as
a case of anthrax or rabies, the provider will call the local
health department immediately.
However, routine public health surveillance, the reporting
is still done largely by paper or fax. This largely paper based
system is burdensome both to providers and health departments,
and therefore reports are often incomplete and not timely.
I have discussed the role that surveillance plays in early
detection, but surveillance data are also crucial for the
public health response. Surveillance data helps us to determine
where cases are occurring, and where they are not occurring, so
we can target the response appropriately.
It tells us when cases are occurring. Are they increasing,
or are they decreasing. It also helps us to take our laboratory
test results and match them with the case information so that
we can track down the source and define areas at risk.
Such information is vital to directing our investigation
and control efforts, but it requires a well designed system to
rapidly input and analyze the voluminous data required, such as
the thousands of swabs tested for anthrax in the current
investigations.
We also recognize the need to take advantage of recent
information technology advances to bring our surveillance
systems into the 21st century, and I would like to describe a
little bit about our new system that has been developed based
on infomatics principles.
Several years ago we initiated the development of the
national electronic disease surveillance system, NEDSS, a web-
based surveillance system for use at State and local levels.
The goal of NEDSS is electronic real time reporting of
information for public health action.
NEDSS includes direct electronic linkages with the health
care system. For example, information about relevant diagnostic
tests can be shared electronically with public health as soon
as a clinical laboratory receives a specimen.
For example, requesting testing for anthrax.
NEDSS emphasizes national standards, and using national
standards for data content, security, and information
technology architecture. As we build NEDSS, we are ensuring
that the data standards we use are compatible with the leading
standards for health care systems, so the public health can
receive data electronically from the health care delivery
systems with less burden on data providers.
The reliance on de facto industry standards for information
technology means that NEDSS can incorporate sophisticated
commercial products for security, for analysis, for mapping.
This is particularly critical for guiding the public health
response to an epidemic.
Standards also mean that systems can inter-operate between
States so we can detect problems occurring in multiple
locations. The CDC has worked with our State and local partners
on the development of NEDSS. We have provided funding and
support to all 50 States for activities related to NEDSS
planning and development.
A NEDSS based system that incorporates the standards and
functions mentioned will be deployed in at least 20 States
during 2002. This project is critical for ensuring our ability
to capture data efficiently, electronically, and to use it
effectively for public health response.
And a public health surveillance system that spans the
Nation will be essential to detect threats to the public,
wherever they might occur and whatever they might be.
Recognizing the need for immediately increased capacity while
NEDSS is implemented, CDC and its public health partners
initiated various activities to improve their ability to detect
events of importance.
For example, with the first CDC funding for countering
bioterrorist activities, many State health departments were
able to purchase the most advanced pattern recognition analytic
capacity available today, a trained human being.
We funded States to hire epidemiologists, whose duties
included coordinating bioterrorism surveillance, informing
health care providers of what to look for, and who to contact
if something suspicious turned up.
CDC also funded eight States for special surveillance
projects, and projects looked at the utility of possible early
warning systems, such as emergency medical systems, 911 calls,
hospital emissions, emergency department visits, absenteeism
rates, pharmacy data.
After September 11, these systems were explicitly called on
to provide heightened surveillance information. CDC is
undertaking a critical review of these activities to identify
the most useful and practical approaches that may be
implemented on a national basis.
Key questions to address include how rapidly are data
available for analysis; can the systems identify true outbreaks
in the noise of ongoing illness; what effort to enter data is
required from already busy health providers; can the systems be
used in geographic areas beyond those where they were
developed.
In addition, CDC has established networks of clinicians,
infectious disease specialists, travel medicine specialists,
emergency department physicians, whose functions are to serve
as early warning systems for public health by providing
information about unusual cases encountered in the clinical
practice of their members.
In conclusion, our public health surveillance systems
provide a critical piece of the public health infrastructure
for recognizing and controlling deliberate bioterrorist
threats, as well as naturally occurring new or re-emerging
infectious diseases.
We have made substantial progress to date in enhancing the
Nation's capability to detect and respond to problems that
threaten the public's health. These cross-cutting efforts to
build the surveillance infrastructure will be useful to detect
any problem, and not just potential bioterrorist events.
The ongoing use of this surveillance capacity will assure
that it is familiar and functional should bioterrorist events
continue to occur. A strong and flexible public health
infrastructure is the best defense against any disease
outbreak. Thank you very much for your attention. I will be
happy to answer any questions you may have.
[The prepared statement of Claire Broome follows:]
Prepared Statement of Claire Broome, Senior Advisor to the Director,
Centers for Disease Control and Prevention, Department of Health and
Human Services
Good morning, Mr. Chairman and Members of the Subcommittee. I am
Dr. Claire Broome, Senior Advisor to the Director for Integrated Health
Information Systems at the Centers for Disease Control and Prevention
(CDC). Thank you for the invitation to update you on CDC's public
health surveillance activities. I will describe the function of our
current surveillance systems, update you on recent efforts to build
surveillance capacity in state and local health departments, and
discuss the status of the National Electronic Disease Surveillance
System.
As the nation's disease prevention and control agency, CDC has the
responsibility on behalf of the Department of Health and Human Services
(HHS) to provide national leadership in the public health and medical
communities to detect, diagnose, respond to, and prevent illnesses,
including those that occur as a result of a deliberate release of
biological agents. This task is an integral part of CDC's overall
mission to monitor and protect the health of the U.S. population.
Much has been in the news lately about the disease detective
function of CDC and its epidemiologists, including Epidemic
Intelligence Service Officers. What has not been often emphasized is
the need for continued watchfulness to first detect problems that our
disease detectives then investigate. We refer to this function--this
constant state of alert--as public health surveillance.
Public health surveillance is a crucial monitoring function for CDC
and its partners. It is these ongoing data collection activities that
help us detect threats to the health of the public. Without our public
health surveillance systems, we might not identify outbreaks or other
important problems in time to prevent the further spread of disease. We
cannot investigate problems, identify their causes, and implement
control measures if we have not detected them. Recent events have
underscored this essential role of public health surveillance, as well
as the integral role of health care providers in the overall public
health system. For most of our surveillance data, the original source
of information is the health care provider; the Florida physician's
ability to recognize a suspected case of anthrax and his awareness of
his role in reporting it to the local health department was critical to
our initial recognition of the current bioterrorist events. Indeed,
identification of subsequent anthrax cases has also relied on
heightened awareness among health care professionals that the wounds
and respiratory syndromes they were seeing were actually cutaneous and
inhalation anthrax, not merely spider bites and pneumonia.
current surveillance systems
The best initial defense against any threats to the health of the
public, whether naturally occurring or deliberately caused, continues
to be accurate, timely recognition of a problem. Key elements of our
current surveillance systems include awareness and diagnosis of a
condition of public health importance, whether by a clinician or
laboratory, with subsequent notification of the local health
department, which in turn reports to the state health department, which
shares information with CDC. We work with our public health partners to
define conditions that should be reported to public health departments;
health departments share these definitions and guidelines with health
care providers, infection control practitioners, emergency department
physicians, laboratorians, and other members of the health care system.
A timely example of such guidelines was included in the October 19,
2001, issue of the Morbidity and Mortality Weekly Report (MMWR), in the
report that dealt with ``Recognition of Illness Associated with the
Intentional Release of a Biologic Agent.'' Copies of the MMWR have been
provided to the Subcommittee.
The traditional operation of our surveillance systems generally
consists of paper or facsimile reporting by providers to health
departments. If a case of illness is particularly unusual or severe
(such as a case of anthrax or rabies), the provider will call the local
health department immediately. As mentioned, health care provider
recognition of the illness and awareness that certain health events
require immediate notification of public health authorities, is
critical to our ability to detect problems and mount a public health
response. It was another alert clinician in 1993, a pediatric
gastroenterologist, who provided the early warning about a potential
diarrheal disease outbreak to the Washington State Department of
Health. Within one week, the Health Department identified hamburgers
from Jack-in-the-Box as the cause of the outbreak, and the fast-food
chain voluntarily recalled all hamburger meat from their restaurants in
the state. However, for routine public health surveillance, this
largely paper-based system is burdensome both to providers and health
departments, and therefore reports are often incomplete and not timely.
In addition, the volume of paper reports and the need to enter the
information collected into various information systems leads to errors
and duplication of efforts.
These shortfalls influence more than our ability to detect an
event; surveillance also plays a pivotal role in event management.
Surveillance data help us to determine where cases are occurring and
who is affected (e.g., particular age groups or occupations such as
children or postal workers), when cases are occurring (i.e., are cases
still occurring; are the numbers increasing or decreasing with time?),
and matching such information to the laboratory data about the
particular agent, to trace its origin as well as to identify whether
cases in different geographic locations might have resulted from the
same source. Such information is vital to directing our investigation
and control efforts, but it requires a well-designed system to input
and analyze the voluminous data required, such as the thousands of
swabs tested for anthrax.
Given the crucial function of public health surveillance, we have
recognized the need to take advantage of recent information technology
advances to bring our surveillance systems into the 21st century. First
I will describe the overall direction that we are headed to transform
our public health surveillance systems, and then I will describe some
of our short-term efforts to enhance current surveillance systems in
the aftermath of September 11, as described in the MMWR report
mentioned previously.
integrated, electronic surveillance information systems
CDC and its partners have recognized the need to build more timely,
comprehensive surveillance information systems that are less burdensome
to data providers. Several years ago, we initiated the development of
the National Electronic Disease Surveillance System (NEDSS). The
ultimate goal of NEDSS is the electronic, real-time reporting of
information for public health action. NEDSS will include direct
electronic linkages with the health care system; for example, medical
information about important diagnostic tests can be shared
electronically with public health as soon as a clinical laboratory
receives a specimen, or makes a diagnosis. In the future, NEDSS coupled
with a computer-based vital statistics system and computerized medical
records, not only in hospitals but also in ambulatory care offices,
could facilitate immediate awareness of unusual illnesses such as
anthrax or smallpox, as well as our ability to detect more subtle
problems that may be dispersed across the country.
NEDSS emphasizes a standards-based approach, relying on the use of
standards for data, information architecture, security, and information
technology (de facto industry standards). This reliance on standards
will ensure that data need only be entered once, at the point of care
for a patient, without a need for re-entry of data by our local and
state partners. Use of standards is critical to ensure that our public
health partners can use technology more effectively and
collaboratively. As we build NEDSS we are ensuring that the data
standards we use are compatible with those used in health care systems,
so that we can make sense of health-related data and therefore detect
potentially related cases across the country. In addition, a standard
information architecture and appropriate, high level security will
enable public health partners to share data in a secure fashion, which
is critical for identifying problems that cross jurisdictional
boundaries. And finally, the reliance on de facto industry standards
for information technology ensures the availability of multiple
commercial products to meet the needs of our public health partners,
including state-of-the-art analytic tools and geographic information
system capacity.
CDC has worked with our state and local partners on the development
of NEDSS. We have provided funding and support to all 50 states for
activities related to NEDSS planning and development. NEDSS is an
ambitious project; defining appropriate standards and ensuring
appropriate data sharing among the myriad health care systems, over
2000 local health departments, 50 state health departments, and
numerous federal public health agencies is a complex process. As a
start, a NEDSS Base System that incorporates the standards and
functions mentioned will be deployed in at least 20 states during 2002.
This project will ensure our ability to capture data efficiently,
electronically, and to use it effectively for public health response.
And a public health surveillance system that spans the nation will help
detect threats to the public, wherever they might occur.
Indeed, 2 related projects also provide a key part of the effort to
ensure the development of the public health communications
infrastructure. Health Alert Network (HAN) is a nationwide program, the
goals of which include provision of Internet connectivity and rapid
communications capability among local and state health departments,
which will also facilitate linkage of local health departments and
health care providers. This connectivity will be crucial for rapid
sharing of surveillance data among public health agencies. In addition,
the Epidemic Information Exchange, or Epi-X, provides secure, high-
speed, Web-based communication about outbreaks and other acute or
emerging health events among public health officials from CDC, state
and local health departments and the military. One of the unique
features of Epi-X is the ability to provide a forum for secure
communications for state epidemiologists to post information on
surveillance and response activities for approximately 500 public
health officials around the country, including the U.S. military.
Another unique feature of Epi-X is emergency notification by telephone
and/or pager to defined groups of public health officials.
Support to date for these important national projects has
strengthened our public health infrastructure for detection of events
of concern and subsequent communication to ensure appropriate public
health response.
near term surveillance efforts
Recognizing the need for near term increased capacity while NEDSS
is implemented, CDC and its public health partners initiated various
activities to improve their ability to detect events of importance to
the health of the public. For example, with the first CDC funding for
countering bioterrorist activities, in Fiscal Year 1999, many state
health departments were able to purchase the most advanced pattern
recognition analytic capacity available today--a trained human being:
an epidemiologist whose duties included coordinating bioterrorism
surveillance and rapid response activities. The activities range from
enhancing communications (between state and local health departments
and between public health agencies and health-care providers) to
conducting special surveillance projects. These special projects have
included active surveillance for changes in the number of emergency
medical system/911 calls, hospital admissions, emergency department
visits, and occurrence of specific syndromes. After September 11, these
systems were explicitly called on to provide heightened surveillance
information. CDC is undertaking a critical review of these activities
to identify the most useful and practical approaches that may be
implemented on a national basis. One key question to address is the
feasibility of capturing medically relevant data in a timely and
appropriately representative fashion, since we do not know when or
where the next event might occur. Furthermore, what effort do proposed
systems require from health care providers to report, or enter data in
the systems? Can the systems be used in geographic areas beyond those
where they were developed? In addition, given the substantial burden of
investigating potentially concerning events, we are evaluating
mechanisms for minimizing the proportion of alerts generated by the
system that are false alarms.
Other related activities useful for early detection of emerging
infections or other critical biological agents include CDC's Emerging
Infections Programs (EIP). CDC funds EIP cooperative agreements with
state and local health departments to conduct population-based
surveillance and research that goes beyond the routine functions of
health departments, and often involve partnerships among public health
agencies and academic medical centers. In addition, CDC has established
other networks of clinicians--whether infectious disease or travel
medicine specialists, or emergency department physicians--whose
functions are to serve as ``early warning systems'' for public health
by providing information about unusual cases encountered in the
clinical practices of its members. The guidance provided in the October
19 MMWR is intended to heighten awareness among these clinical partners
about what to watch for, and what to report to public health. It is
important to note that these relationships, particularly between health
care providers and local health departments, are the foundation on
which our surveillance systems operate. The local health department is
the front-line of defense for the public health system. Many other
projects and proposals for rapid surveillance omit the vital connection
to public health, especially the local public health agency, which is
responsible for the initial public health response.
conclusion
In conclusion, CDC is committed to working with other federal
agencies and partners as well as state and local public health
departments to ensure the health and medical care of our citizens. The
best public health strategy to protect the health of civilians against
illness, regardless of cause, is the development, organization, and
enhancement of public health prevention systems and tools.
Our public health surveillance systems provide a critical piece of
the public health infrastructure for recognizing and controlling
deliberate bioterrorist threats as well as naturally occurring new or
re-emerging infectious diseases. We have made substantial progress to
date in enhancing the nation's capability to detect and respond to
problems that threaten the public's health. Recognizing that there is
no simple solution for our surveillance needs, we have supported
augmenting the staff in state and local health departments, as well as
special projects to explore the usefulness of various clinical data
sources. We are undertaking a critical review of current efforts to
determine what would be feasible and useful to implement more broadly
in coming weeks. We are implementing the National Electronic Disease
Surveillance System, which will provide direct linkages with the health
care system in 2002, improving the timeliness, efficiency, and
usefulness of our surveillance efforts. These cross-cutting efforts to
build the surveillance infrastructure will be useful to detect any
problem, not just potential bioterrorist events; the ongoing use of
this surveillance infrastructure will assure that it is familiar and
functional should bioterrorist events continue to occur. A strong and
flexible public health infrastructure is the best defense against any
disease outbreak.
Thank you very much for your attention. I will be happy to answer
any questions you may have.
Mr. Greenwood. Thank you, Dr. Broome. I appreciate your
testimony.
Dr. Barry, you are recognized for 5 minutes for your
testimony.
TESTIMONY OF ANITA BARRY
Ms. Barry. Chairman Greenwood and honorable committee
members, thank you for inviting me here to speak with you today
about public health surveillance. My name is Dr. Anita Barry,
and I am the Director of Communicable Disease Control for the
Boston Public Health Commission, which is the local health
authority for the city of Boston under the leadership of our
mayor, Tom Menino.
In 1999, the Boston Public Health Commission participated
in a city-wide disaster tabletop exercise that simulated an
outbreak of pneumonic plague. Through this exercise, we
realized that in a medical or public health crisis, health care
providers must have timely and accurate information, including
clinical guidelines.
Boston's disease monitoring system at that time relied
primarily upon local hospitals, health care providers, or
laboratories, to call when they diagnosed a reportable disease
or identified a cluster of unusual illness.
Unfortunately, this method often provides late and
incomplete information, especially in an emergency. It became
clear that we needed an active system to let us know about
problems early on.
Thanks to the Federal Centers for Disease Control and
Prevention, Boston received a grant for $1 million over 5 years
to develop and implement an early warning system to detect
bioterrorism or any other infectious disease mass casualty
event.
For the last 2 years, we designed and set up this system,
which has now been operational for 6 months. Additional
components of the system, including daily information from the
Poison Control Center located in Boston, Boston Emergency
Medical Services, and death certificates, will be on-line in
the next few months to supplement the already incoming health
care site data.
One of the first things we did to create our surveillance
system was to convene a task force of key stakeholders to
develop a workable system. We invited representatives from
emergency departments, acute care sites, infectious disease
departments, the State Health Department, and our local zoo,
among others, to help us develop this system.
As a group, we designed the Boston system to minimize the
effort on the part of emergency department personnel and other
hospital based personnel. We heard very clearly from the
emergency department directors that drop in surveillance
systems, in which a separate additional sheet of information
for each patient is required to be filled out by their
personnel, is completely unworkable.
The Boston system works as follows. Each night the medical
information system at each facility automatically sends our
secure web-based server the number of persons seen in that
emergency department or other acute care site.
This figure is automatically compared to the expected
number of visits for that site, adjusted for season of the year
and day of the week. If it is higher than expected, a one page
follow-up form is automatically sent to a pre-identified
contact at that hospital.
This form asks more detailed questions about the nature of
cases seen in the acute care site to determine if anything
unusual is going on. This follow-up information determines
whether or not further investigation is required.
Hospital staff appreciate the fact that they are asked to
take time to provide detailed information only when the system
indicates that something may be going on. While this volume
based system will not identify an isolated case like the
anthrax cases in other cities, the constant reminders that we
send to health care providers through this system increases the
chances of timely reporting.
Our experience in the past 6 weeks has also highlighted how
this system provides important public health data, whether or
not there is a mass incident. Although we have had no
bioterrorist events in Boston, during the first week of reports
of anthrax cases, we observed a surge in patient volume at
several hospital sites.
Follow-up investigation revealed that this was not due to
any unusual clusters of symptoms, but rather to an influx of
frightened people requesting nasal swabs and cipro
prescriptions, despite the absence of any confirmed or
suspected anthrax exposures in Massachusetts.
At the local health department, we used this information as
an indicator of the need for increased public education and
increased public timely information release. One of the most
important purposes of the system is to create a flow of
information between that local health department and local
health care providers.
The Boston Public Health Commission, with our surveillance
task force, also developed a provider education initiative on
bioterrorism. This program, which began about 1\1/2\ years ago,
uses a train-the-trainer model to teach physicians and nurses
to educate their peers.
This training has been much in demand of late.
Additionally, we use this electronic surveillance system to
post and send regular clinical advisories and updates out to
the surveillance task force members and others, including the
city's 25 community health centers, the college health centers,
Boston Emergency Medical Services, and others.
These guidelines have served as the foundation for
protocols developed by local hospitals regarding the medical
management of people being seen with possible anthrax exposure.
I believe that the Boston system is replicable with
modifications in other cities and regions, as well as on state-
wide levels. Our experience has also implications regarding
what is needed for local health departments to maintain an
effective early warning system, as well as the ability to
respond to public health events detected by these systems.
First, key stakeholders must be at the table to design the
system. Second, the system should serve as a communication
network, as well as a surveillance system. Third, the system
should be simple and as automated as possible so it is doable
by busy health care systems.
And finally at the same time, it should account for the
human factor, which is essential both to maintain the system,
and to obtain the data if the electronic system is delayed or
temporarily not functioning.
I also would like to share some thoughts about the broader
implications of Boston's experience. Last week, Boston Mayor
Menino and City Public Health and Safety Officials joined
mayors from across the country at the U.S. Conference of
Mayors' Emergency, Safety, and Security Summit.
The following suggestions combined public health action
steps recommended by the Boston Public Health Commission, and
the U.S. Conference of Mayors. First, the technical
capabilities in communication infrastructure of local health
departments must be improved.
Our ability to create this surveillance system was the
result of a CDC grant. Without Federal funding, we could never
have designed this system. Second, all local health departments
should have direct access to communications systems like CEC's
Epi-X to receive ongoing timely updates.
Such a system is key to having accurate and timely
information from local public health officials, and so we
strongly support full funding and expansion of the health alert
network.
Third, we need to think regionally about surveillance and
communications systems, and we need Federal support to
implement such regional systems. Boston is currently in
discussion with surrounding communities about sharing and
expanding our surveillance system, because the impact of an
infectious disease or bioterrorist events will not end at the
Boston city borders.
Fourth, Federal Agencies should direct more funding
directly to local communities. National public health
organizations recommend that at least $835 million of the
Emergency Bioterrorism Funding Request go directly to local and
State health departments.
Local communities must receive a significant portion of
that funding. Too often local health departments are left out
of the equation, and we bear the major burden of the day to day
response.
For example, in Boston alone, the health department
anticipates spending $700,000 by the end of this fiscal year on
bioterrorism-related emergency medical service response, and a
surveillance, epidemiology, communication, and coordination of
activities within the communicable disease control program.
Federal funding should be flexible. We need to track and
respond to a range of public health concerns, including not
only bioterrorist agents, but also influenza and other emerging
problems.
And finally local public health departments should be
represented at the table in national emergency planning. A
permanent commission, including mayors, local public health
officials, and local public safety officials, should
immediately be established by the Director of Homeland
Security.
Local officials are on the front lines of homeland
security, and it is essential to forge direct lines of
communication among the Office of Homeland Security, Federal
Agencies, and local governments.
In closing, I thank Chairman Greenwood and the committee
for inviting me to speak today on behalf of local health
departments, and I would be pleased to provide any further
information you would like.
[The prepared statement of Anita Barry follows:]
Prepared Statement of Anita Barry, Director, Communicable Disease
Control, The Boston Public Health Commission
Chairman Greenwood, Honorable Committee Members, thank you for
inviting me here to speak to you today about public health
surveillance. My name is Dr. Anita Barry. I am the Director of
Communicable Disease Control for the Boston Public Health Commission,
the health department for the City of Boston, under the leadership of
Mayor Thomas Menino.
In 1999, the Boston Public Health Commission participated in a
citywide disaster tabletop exercise that simulated an outbreak of
pneumonic plague. Among the participants were representatives from all
the major Boston hospitals. Through this exercise, we realized that in
a medical or public health crisis, health care providers must have
timely and accurate information, including clinical guidelines. At that
time, Boston had only what most local health departments have: a
passive surveillance system. We waited for local hospitals, health care
providers, or laboratories to call us when they diagnosed a reportable
disease or identified an unusual cluster of illness. Unfortunately,
this method can provide late and incomplete information, especially in
an emergency. For example, influenza--one of the diseases we are most
interested in identifying early--is not required to be reported in
Massachusetts. Influenza outbreaks tended to be reported late--or not
at all, making it impossible to introduce timely measures to contain
the spread of disease. It became clear that we needed a system to let
us know about problems early on.
Thanks to the federal Centers for Disease Control and Prevention,
Boston received a $1 million five-year grant to develop and implement
an early warning system to detect a bioterrorist or other infectious
disease mass casualty event. We were one of about seven localities in
the country to be awarded such a grant, and the only city to monitor
volume in emergency room and acute care facilities through an
automated, electronic, real time system.
For the last two years, we designed and set up the system, which
has now been operational for about six months. Additional system
components, including daily information from the Poison Control Center
in Boston, Boston Emergency Medical Service, and death certificates
will be on line in the next few months to supplement the health care
site data. I will give you a brief overview of how the hospital-based
system works and then share what we have learned that is relevant to
other localities, as well as federal bioterrorism preparedness planning
and funding.
One of the first things we did to create our surveillance system
was to convene a task force of key stakeholders to help develop a
workable system. We invited representatives from emergency departments,
acute care sites, hospital infectious disease specialists, state health
department infectious disease specialists, representatives from Zoo New
England, Emergency Medical Services, the Poison Control Center, the
Chief Medical Examiner, and others.
As a group, we designed the Boston system to minimize the effort on
the part of emergency department and other hospital-based personnel. We
heard very clearly from emergency department directors that drop-in
surveillance systems in which a separate additional sheet of
information on each patient is required to be filled out by ED
personnel are unworkable. The system works as follows. Each night the
Medical Information Systems at each facility send to our secure web-
based server by FTP the number of persons seen in their Emergency
Department or other acute care site. This figure is automatically
compared to the expected number of visits for that site, adjusted for
season of the year and day of the week. If it is higher than expected,
a one page follow-up form is automatically sent to a pre-identified
contact at the hospital.
This form asks more detailed questions about the nature of the
cases seen in the acute care site to determine if anything unusual is
going on. We usually receive these completed forms back from hospitals
within 1-2 hours. If a form is not returned from a site, the system
automatically pages a contact at that site to obtain further
information. This follow-up information determines whether or not
further investigation is required. Hospital staff appreciate the fact
that they are asked to take the time to provide detailed information
only when the system indicates that something may be going on.
In order to determine the normal volume thresholds as well as what
is a statistically significant increase in volume for each site, we
obtained retrospective data from all of the sites and analyzed it. To
validate the system's ability to detect clusters of illness, we
retrospectively compared volume spikes above threshold at sites with
the first confirmed presence of influenza in Boston in 1999. Changes in
volume detected using the system correlated well with the first
laboratory confirmed case of influenza. We believe the system will give
us early warning of other public health concerns, including a range of
infectious diseases.
While this volume-based system will not identify an isolated case,
like the anthrax cases in other cities, the constant reminders that the
system allows us to send health care providers increases the chances of
timely reporting.
Our experience in the last 6 weeks has also highlighted how this
system provides important public health data. Although we have had no
bioterrorist events in Boston, during the first week of reports of
anthrax cases, we observed a surge in patient volume at several
hospital sites. Follow-up investigation revealed that this was not due
to any unusual clusters of symptoms, but rather to an influx of
frightened people requesting nasal swabs and Cipro prescriptions,
despite the absence of any confirmed or suspected anthrax exposure in
Massachusetts. At the local health department, we used this information
as an indicator of the need for increased public education and
increased public information efforts.
Because one of the most important purposes of the system is to
create a flow of information between the health department and local
health care providers, the Boston Public Health Commission, with the
Surveillance Task Force, also developed a curriculum on bioterrorism
for physicians and nurses. This educational initiative which began
about a year and a half ago, uses a ``train the trainer'' model. The
health department provides a CD containing slides as well as handouts
to these trainers, who are physicians and nurses, to educate their
peers. This training has been much in demand of late.
Additionally, we use our electronic surveillance system to post and
send regular clinical advisories and updates out to surveillance task
force members and others, such as community health centers, college
health centers, and Boston Emergency Medical Services. These guidelines
have served as the foundation for protocols developed by local
hospitals regarding medical management of patients with possible
anthrax exposure.
I believe Boston's system is replicable, with modifications, in
other cities and regions, as well as on a statewide level. Our
experience also has implications regarding what is needed for local
health departments to maintain effective early warning systems as well
as the ability to respond to public health events detected by
surveillance systems.
1. Key stakeholders must be at the table to design the system.
2. The system should serve as a communication network as well as a
surveillance system.
3. The system should be simple, and as automatic as possible, so it is
``doable'' for busy health care systems.
4. At the same time, it should account for the ``human factor,'' which
is essential both to maintain the system and to obtain the data
if the electronic system is delayed or temporarily not
functioning.
I'd also like to share some thoughts about the broader implications
of Boston's experience. Last week, Boston Mayor Menino and City public
health and safety officials joined mayors from across the country at
the U.S. Conference of Mayors Emergency, Safety, and Security Summit.
The following suggestions combine public health recommendations from
the Boston Public Health Commission and the U.S. Conference of Mayors
National Action Plan for Safety and Security in America's Cities:
<bullet> The technical capabilities and communication infrastructure of
local health departments need to be improved. Our ability to
create this surveillance system was the result of a CDC grant.
Without federal funding, we could not have designed this
system.
<bullet> All local health departments should have access to
communications systems like Epi-X to receive ongoing timely
updates. Such a system is key to having accurate and timely
information from local public health officials, so we strongly
support full funding and expansion of the Health Alert Network.
<bullet> We need to think regionally about surveillance and
communication systems, and we need federal support to implement
such regional systems. Boston is currently in discussion with
surrounding communities about sharing and expanding our
surveillance system because the impact of an infectious disease
or bioterrorist incident will not end at city borders.
<bullet> Federal agencies should direct more funding to local
communities. National public health organizations recommend
that at least $835 million of the emergency bioterrorism
funding request go directly to local and state health
departments. Local communities must receive a significant
portion of that funding. Too often, local health departments
are left out of the equation, and we bear the major burden of
day-to-day response. For example, in Boston alone, the health
department anticipates spending $700,000 by the end of this
fiscal year on bioterrorism-related emergency medical service
response and the surveillance, epidemiology, communication, and
coordination activities of the communicable disease program.
<bullet> Federal funding should be flexible--we need to track and
respond to a range of public health concerns, including
bioterrorist agents as well as influenza and other emerging
problems.
<bullet> And local public health departments should be represented at
the table in national emergency planning. A permanent
commission including mayors, local public health officials, and
local public safety officials should be immediately established
by the Director of Homeland Security. Local official are on the
frontlines of homeland security, and it is essential to forge
direct lines of communication among the Office of Homeland
Security, federal agencies, and local governments.
In closing, I again thank Chairman Greenwood and the Committee for
inviting me to speak on behalf of local health departments, and I would
be pleased to provide any further information in the future.
Mr. Greenwood. Thank you, Dr. Barry. I appreciate your
testimony as well, and coming here, and Dr. Davidson, you are
recognized for 5 minutes for your testimony. Thank you for
being with us as well.
TESTIMONY OF ARTHUR J. DAVIDSON
Mr. Davidson. Thank you. Mr. Chairman, and members of the
committee, I am Arthur J. Davidson, a family physician,
epidemiologist, and the Director of the Denver Public Health
Informatics at Denver Health.
I consider it a privilege to testify before the committee,
providing a local perspective about our public health
surveillance system. I guide Denver's public health
surveillance activities, and am the principal investigator of
the Denver Center for Public Health Preparedness, where I have
been involved in the preparation and training from weapons of
mass destruction over the past 2 years, including the planning
and execution of Operation Top-Off.
What I would like to do today is describe Denver Health as
an example of how an integrated safety net system may play a
role in public health surveillance, and then discuss linkages
and potential barriers with other critical health care
entities, including State and Federal systems.
Denver Health is a highly integrated safety net
institution, serving a quarter of Denver's half-million
residents. Some of its components include Denver's emergency
response system, an acute care hospital, neighborhood and
school based health clinics, the public health department, and
a regional poisonous center.
Each of these entry points has capacity to contribute to
surveillance activities. Linked by a unique patient identifier,
an integrated electronic medical record includes patient
demographics, image medical records, laboratory, radiology,
pharmacy, and ancillary systems.
Denver Health information technology investments have
exceeded $100 million in the past 5 years. From an infomatics
perspective, data achieves value through conversion to
information that guides action.
Examples of such action within Denver Health include
electronic reporting of laboratory data to nurse
epidemiologists for communicable disease surveillance and
control; or patient-specific pharmacy adherence measures for
tailored HIV outreach worker interventions.
While these customized applications have value, our vision
is to achieve even greater yield through building around
industry standards. Denver Health, in collaboration with the
Agency for Health Care Research and Quality, our information
systems vendor, Siemens, and the CDC, are developing a real
time method to identify patients at risk for tuberculosis, and
then alert providers of screening guidelines using a
standardized rules language.
These partnerships seek to use our information
infrastructure to enhance our return on investment by industry
standard messaging. The ultimate goal is appropriate and timely
surveillance data with less expended effort.
Physician identification of disease remains a critical
component of surveillance. Physicians must be informed to fill
this role. CDC's health alert network, HAN, has been a wise
investment, rapidly bringing the latest anthrax information to
3,000 local health departments and beyond.
In Denver, I personally disseminate these alerts to all
health care providers, enabling heightened awareness. While
disease surveillance is a time honored public health skill, the
concept of syndromic surveillance is new.
In Denver, we are testing this concept using an existing
emergency department electronic data base, and with asthma as a
disease model, we found symptoms surveillance to be less
sensitive than diagnosis surveillance, but then more timely.
While we found spikes and seasonal patterns, thresholds
still need to be established to assist in interpretation. I
believe the jury is still out on this one. Although an
integrated health care delivery system with advanced
information technology has much potential, these data must be
integrated with other local, State, and Federal health care
institutions for a truly robust surveillance system.
Through preliminary discussions with local health
maintenance organizations regarding electronic sharing of
symptom and diagnosis data, issues of patient confidentiality
have arisen to detect disease and guide local response to
intentional biologic releases.
We need laws that protect individual confidentiality, but
do not inhibit information flow to protect the larger
population. Your committee may wish to review HIPAA legislation
toward modifying laws that excessively regulate information
sharing for public health surveillance activities.
Regarding Federal and State data linkages, CDC's national
electronic disease surveillance system, NEDSS, provides a
coordinated surveillance framework, developing standards and
conceptual models that maximize information technology.
Accepting health information industry standards will
enhance electronic information transfer and capacity for
automated electronic surveillance. In Colorado, NEDSS, HAN, and
our center's preparedness funds, are coordinated to help build
an integrated data repository, support direct laboratory
transfer of data to the Colorado Electronic Disease Reporting
System, or CEDRS, develop hand-held devices as surveillance
tools, establish secure wireless CEDRS access, add geographic
information functionality, and assure an informed Colorado
public health work force.
These are new and exciting challenges for a public health
infrastructure that has been significantly under-funded in
information technology for so long. While an effective early
warning surveillance system is desirable, a major preparedness
concern persists, insufficient surge capacity within the entire
public health core system.
Today, in the absence of a bioterrorist event, most Denver
hospitals are at capacity, and often cannot receive ambulances.
Denver Health typifies safety net health care systems with
extremely tight financial status and no additional support to
build capacity to respond after a terrorist attack.
Given these comments, I want to thank Congress and the
leadership of this committee for the efforts already
accomplished. Exercises such as Operation Top-Off have proven
invaluable to stimulate interest and planning for the
unthinkable.
CDC's efforts to build and utilize HAN, develop and
disseminate NEDSS, and focus on work force development, are
bright spots with real potential to improve operational
readiness and surveillance capacity.
However, as shown in numerous other industries information
can drive feedback, quality control, and triggers for
intervention. Such an integrated health data environment, with
proper protection of individual confidentiality, should
accelerate outbreak investigation, enhancing our public health
response.
Your committee has the opportunity to promote and encourage
this data integration. You should build on these initial
positive steps and expand capacity to achieve early warning
systems in every community.
In closing, I want to thank you, Mr. Chairman, and the
committee, for this opportunity to discuss some issues of
concern regarding early decisions detection and response to
terrorist events at the local level.
Mr. Chairman, this concludes my testimony, and I am pleased
to answer any questions that you or the committee might have.
[The prepared statement of Arthur J. Davidson follows:]
Prepared Statement of Arthur J. Davidson, Director, Public Health
Informatics, Denver Public Health Department
Mr. Chairman and members of the Committee, I am Arthur J. Davidson,
a family physician, epidemiologist and Director of Public Health
Informatics at Denver Health. I consider it a privilege to testify
today before the Committee to provide a local perspective and concern
about our public health system surveillance system and its role in our
preparedness for bioterrorism. One of my roles is to guide Denver's
public health surveillance activities and I am the principal
investigator for one of three CDC-funded local health department
projects, the Denver Center for Public Health Preparedness. For the
last two years, I have been involved in the local preparation and
training for weapons of mass destruction and was a participant in the
planning and execution of Operation TopOff.
What I would like to do is describe Denver Health's system as an
example of how an integrated safety net system may play a role in
public health surveillance, discuss linkages with other critical health
care entities, the state and federal systems, and the barriers existing
at each of these levels.
Denver Health is a highly integrated safety net institution serving
Denver, the state of Colorado and the Rocky Mountain Region. Some of
its components (see attachment 1), which are relevant to today's
discussion, include the 911 medical response system for the City and
County, an acute care hospital with a regional trauma center, 10
neighborhood health clinics, 13 school based clinics, the public health
department and a regional poison center. This system has multiple entry
points, each with capacity to contribute to surveillance initiatives.
In addition, the system served more than one in four people in Denver
last year and thus provides an ability to sample a large segment of the
population at any given time. Care is provided by one group of employed
academic physicians, enabling standardized approaches to monitoring,
reporting and care. The system is linked by a single patient identifier
and an electronic integrated medical record. The electronic record
includes patient demographics, imaged medical records, laboratory data,
radiology, pharmacy and ancillary systems. A picture of the information
system is include with my remarks (see attachment 2). Denver Health's
information technology investments have exceeded $100 million dollars
in the last 5 years.
We have begun to use and assess the ability of this system to serve
as a public health and disease surveillance system and to improve
health care delivery. From an informatics perspective, the true value
of data can only be achieved through conversion to information that
guides action. A few examples of such action within Denver Health
include electronic reporting of laboratory data to Denver Public Health
nurse epidemiologists for use in communicable disease surveillance and
control. Patient-specific pharmacy adherence measures for prophylaxis
and treatment regimens, are provided to HIV outreach workers to target
interventions. Feedback to providers, using an immunization registry
and administrative data, enhance efforts to keep children up to date
with immunizations. While these customized applications have value, our
vision is to achieve even greater yield through building around
industry standards.
In that regard, Denver Health has a task order from the Agency for
Health Research and Quality to work with our information systems
vendor, Siemens and the CDC to develop a methodology to identify
patients at risk for tuberculosis and alert the providers of the need
for tuberculosis screening. Preliminary data suggest that we may have
as many as 12,000 at risk patients in our system. We are
collaboratively developing a real-time system to alert care providers
of needed action for tuberculosis screening using a standardized rules
language. Appropriately applied rules can be powerful tools to change
provider behavior or improve surveillance efforts. This rules-based
surveillance approach has the potential to dramatically reduce the
incidence of this important infectious disease. Our goal, and that of
Siemens and CDC, is to seek ways to take advantage of our information
infrastructure capabilities and enhance our return on investment. These
partnerships can improve electronic communication and provide models
for using industry standard Health Level 7 messaging and extensible
markup language. The ultimate goal is appropriate and timely
surveillance data with less expended effort.
Currently and into the foreseeable future, physician identification
of disease remains a critical component of surveillance. The two most
recent nationally recognized emerging infections, West Nile Fever and
anthrax were identified by astute clinicians. But physicians must be
informed to fulfill this role. The Health Alert Network (HAN)
exemplifies how we can wisely invest in infrastructure to quickly bring
the latest information to the front lines. Now in it's third and final
year, CDC continues to use the HAN daily, to inform and advise nearly
3000 local health departments of the latest and rapidly changing
developments since identifying anthrax released through the mail. In
Denver, I personally disseminate these alerts to all health care
providers enabling heightened awareness.
While disease surveillance is a time-honored public health skill,
the concept of syndromic surveillance is new and one worth a few
specific comments. As part of our CDC-funded Center for Public Health
Preparedness, we are still early in testing this concept. The goal
would be to identify patterns of patient symptoms to alert public
health care providers of potential illness. Using the chief complaint,
recorded in an existing emergency department electronic database, we
tested asthma as a model disease for our syndromic surveillance. We
found symptom surveillance to be less sensitive than diagnosis
surveillance but more timely. While we found spikes and seasonal
patterns in asthma diagnosis, we need to establish thresholds to
appropriately interpret the output from any symptom-based surveillance
systems. Symptom data were easily collected as part of routine patient
care in our integrated information systems, but a more structured
format (rather than free text fields) would improve their surveillance
utility. To date, we are just entering the evaluation stage. The jury
is still out on this one.
Although this integrated health care delivery system and its linked
information technology has much potential, data from such a system must
be integrated with that of other local, state and federal health care
institutions for a truly robust surveillance system. A local public
health system needs to share information across all local health care
institutions for early recognition and ongoing monitoring of an
epidemic. We have had preliminary discussions with some local health
maintenance organizations regarding electronic sharing of symptom and
diagnosis data. There no doubt will be hurdles regarding
confidentiality before this is achieved. To detect disease, assess
threat and guide local response to intentional biologic releases, we
need laws that protect individual confidentiality but do not inhibit
information flow to protect the larger population. Since September
11th, with our national emergency, Congress and the President have
modified laws that determine how information is shared between
financial institutions and law enforcement and even diminished some
civil liberties for the purpose of surveillance and national security.
Given our recent tragedies, this seems reasonable and prudent.
Similarly, your committee may wish to review HIPAA legislation toward
modifying laws that excessively regulate information sharing for public
health surveillance activities.
Regarding federal and state data linkages, CDC is in the early
phases of building the National Electronic Disease Surveillance System
(NEDSS) to provide a coordinated surveillance framework. Bringing
local, state and national health departments to the table, NEDSS has
worked to acknowledge and accommodate our unique data needs while
developing standards and conceptual models that maximize information
technology. Defining common information system architectures improves
our return on investment with decreased maintenance costs. Accepting
standards, like those within the health information industry, enhances
our capacity for electronic information transfer, whether that be
laboratory data or other health-related data such as symptoms or
diagnoses. If public health surveillance ascribes to these industry
standards, health care information systems may be better interfaced for
automated, electronic surveillance seeking syndrome patterns and/or
diagnostic trends for earlier alerts of potential biologic or chemical
releases.
NEDSS within Colorado has permitted us to define a statewide,
integrated data repository that becomes the hub for information
organization. Our goal of direct laboratory transfer of data to the
Colorado Electronic Disease Reporting Systems (CEDRS) is anticipated
during this NEDSS funding cycle ending June 30, 2002. Direct laboratory
reporting would improve surveillance completeness as busy clinicians
are less likely to contact their local or state health department for a
reportable disease. This should enhance early warning systems given
improved reporting accuracy. However, laboratory reporting does not
solve all surveillance needs as some demographic information (e.g.,
address of patient) would not be provided. With combined NEDSS/HAN
funds, we are developing CEDRS geographic information system capacity
to report visually based on space and time. Before achieving visual
presentations of laboratory data, linkage with administrative databases
for patient address would be necessary. This is a non-trivial task
given issues of patient confidentiality.
To improve the timeliness of reporting, we are working to develop
and test alternative data entry mechanisms. Using Health Alert Network
and Denver Center for Public Health Preparedness funds, efforts are
under way to build applications on hand-held devices as surveillance
data collection tools. Training and testing public health employee
skills in adapting to these devices is in progress. We have plans to
develop secure wireless access for rapid data entry into CEDRS from
multiple surveillance sites (e.g., hospitals). The pilot projects,
using readily available technology already incorporated in other
industries are new and exciting challenges for a public health
infrastructure that has been significantly under funded in information
technology for so long.
Making sure that the personal and public health care workforces are
adequately informed and trained in these new technologies is essential.
In many rural and smaller urban communities in my state, public health
workers need training on how to best use the surveillance measures that
they collect or receive. Even if we had perfect information systems,
the poorly skilled public health worker may lack the knowledge to put
that information to good use. Similarly, medical and public health
sectors that address medical aspects of a biological or chemical
terrorist attack, sorely lack knowledge and planning to deal with such
an incident. Enhancement of CDC- and HRSA-funded programs to create a
knowledgeable and prepared public health system workforce is now of
central importance to our national security. Coordinated public health
systems will require additional funding to support planning, readiness
training and an equipped infrastructure to deal with medical
consequences of weapons of mass destruction.
While an effective early warning surveillance system is desirable,
there remains a major preparedness concern regarding adequate resources
or ``surge capacity'' within the entire public health core system. From
Operation TopOff, our local hospital system quickly overloaded with
patients infected with pneumonic plague. In Denver, over the last
decade, cost-reduction and a competitive health care market have
resulted in the loss of over 1000 hospital beds. Thus, at baseline even
without a bioterrorist event, most Denver hospitals are at capacity and
cannot receive ambulances on a normal day. Given recent events, we work
to enhance our local readiness but Denver Health typifies safety-net
health care systems with extremely tight financial status. Without
additional support, public safety net hospitals, needed in a terrorist
attack, will not have the necessary capacity to respond.
Given these comments, I want to thank Congress and the leadership
of this committee for the efforts already accomplished. The federal
government's investment in local training and planning for a potential
WMD event have in my opinion made significant strides in our awareness
and preparedness. Exercises such as Operation TopOff have proven
invaluable to stimulate interest and planning for the unthinkable.
Efforts to build and utilize the Health Alert Network and disseminate
National Electronic Disease Surveillance System plans from the CDC as
well as workforce development by CDC and HRSA are bright spots with
real potential to improve our operational readiness and surveillance
capacity. Public health surveillance however can benefit even more from
information technology. As has been shown in numerous other industries,
information can drive feedback, quality control and triggers for
intervention. That same technology, in an integrated health data
environment, with proper protection of individual confidentiality,
should accelerate outbreak identification enhancing our public health
response. Your committee has the opportunity to promote and encourage
that data integration. We should build on these initial positive steps
and expand capacity to achieve early warning surveillance systems in
every community.
In closing, I would like to thank you, Mr. Chairman, and the
Committee, for this opportunity to discuss some issues of concern to
medical and public health communities in our preparedness for early
detection and response to terrorist events at the local level. Mr.
Chairman, this concludes my testimony. I am pleased to address any
questions that you or the Committee might have.
[GRAPHIC] [TIFF OMITTED] 76304.001
Mr. Greenwood. Thank you for your testimony, Doctor
Davidson, and the Chair recognizes himself for 5 minutes for
inquiry. Dr. Davidson, in your testimony, you said that while
disease surveillance is a time honored public health skill, the
concept of syndromic surveillance is new.
The hypothesis that I think this hearing is meant to test
is this one. It is that by it is possible to create, using
state-of-the-art information systems, a nationwide early
surveillance system that would by means of identifying spikes
in early symptomatology for diseases that would result from a
bioterrorist event, to get a head start and to move more
quickly to deploy into that geographical location, or those
geographical locations, and thereby diminish the infectious--
the rate of infection and save lives.
And so that is the question that we are asking here, Dr.
Davidson, and you also talked about a truly robust surveillance
system, and I think that is what we are thinking about.
So the question that I would like to pose to each of you is
do you believe that that hypothesis is a valid one, and
therefore would you in fact recommend to the Congress that what
we do is as quickly as is practicable, without throwing money
at the wall, but to do it as quickly as it is possible, build
such an early surveillance system nationwide that would
obviously have great value for health care in general, and for
such diseases in general, but would be of particularly acute
value in protecting our country from a bioterrorist event, and
I will start with Dr. Broome.
Mr. Davidson. Thank you, Mr. Chairman. I think your
question is an excellent one, but I think the answer is not
either/or. I do not think there is a single magic bullet which
will address all surveillance issues.
I think the critical issue is to be prepared to detect and
respond to whatever may come along. If it is isolated single
cases, as I have indicated, physician awareness, health care
provider awareness, and contact with a strengthened local
health department, and a public health infrastructure, is
critical.
If it is routine--for example, a low level contamination
across a commercial food product--and let's go away from
bioterrorism for a minute and just consider something that does
happen, the kind of systematic information about specific
cases--you are looking for the proverbial needle in a haystack,
and the best way to do that is to be able to define the needle.
It may not cause a big bump in disease. It may just cause a
bump in a particular organism, and then finally you have the--
and that is the kind of effort that NEDSS is designed to
address, among others.
Then finally you have the potential that some of these
supplementary surveillance systems might provide early warning
information that would be more timely. But I agree with the
other panelists that we need to look critically at what kinds
of supplementary information would actually improve our ability
to detect certain kinds of scenarios.
Mr. Greenwood. Let me see if I understand what you said. I
gather from what you are saying that it may--would I be
paraphrasing you correctly if you said that it is necessary,
but not a sufficient response?
In other words, that it is worth doing this as long as we
don't consider it to be sufficient, but rather a part of a
broader approach to surveillance?
Mr. Davidson. I think the critical elements of a
surveillance system we know, and those are the first two points
that I made; that we need to have educated capacity and
information communication.
And then second, we need to have a systematic collection of
what you might call traditional surveillance information, but
in a far more timely, less burdensome, and more precise, way.
Then the final or third leg of the stool if you will is are
there additional tools out there where we can benefit from
syndrome surveillance technology and innovative approaches, and
we are very interested in looking at those. But we think they
need critical evaluation.
Mr. Greenwood. Okay. Dr. Broome, would you respond to the
same question, please?
Ms. Broome. Yes. I think the timely identification of
clusters of infectious disease is critical, and I think it is
possible. The way our system works, all our 11 sites close
their books at midnight essentially, and their MIS system beams
one number to ours at the health department.
We know by 1 a.m. if a site is over-threshold, and frankly,
we can automatically page out to our onsite contact, but they
would stop working with us if we made their beepers go off at 1
a.m. all the time.
So, typically at about 8 a.m., if a site has exceeded, they
get a one page telling us so they can report to us if they have
seen any type of syndromes. So I think it is helpful for us to
identify changes in uses of health care very, very quickly in
the city of Boston.
And as I mentioned, we did pick that up with the influx of
people looking for cipro and nasal swabs. One thing that you
should be aware of is that once we believe there is a cluster,
the story doesn't stop there.
So we send out a one pager and Mass General, or whomever,
reports back to us that we are seeing a cluster of febrile
respiratory illness. That is one of our boxes that they could
check on the one pager. I then need to have a public health
nurse from the local health department then do more
investigation.
We think that something is going on now, and she or he
needs to get a line listing on those cases, and find out what
was common about those cases so we can start to take
appropriate control measures and move along with diagnostics.
I agree that the individual provider reporting is key in
surveillance. You can't ever lose that. You have to have those
providers. But I think that the cluster based systems, at least
in my experience, can also do that.
We are constantly on the incoming side hearing about
excedences and threshold, and we also are feeding back to
people: here are the symptoms of cutaneous anthrax, folks--post
it in your emergency department, and here is who you call if
you think that is what you have.
So I think that we need to merge many of these components.
Our system has been validated to date and we clearly need to
more work in this area. But we have looked at patterns of
influenza illness in the city of Boston using retrospective
data from our surveillance system.
And it turns out that what our system detected very well
correlated with the first isolytes of influenza in the city of
Boston in 1999. I think that there needs to be much more
emphasis on data mining.
You know, health care providers aren't going to fill out
that extra sheet in the ED. We need to figure out how to suck
out pieces from the medical record and have that make sense.
And some of the folks in Boston have tried to do that or we
are currently doing it. Once instance is that one of the
fellows at a major hospital tried to electronically pull out
RESP, standing for respiratory illness, electronically from
records to see if that would help give us more information.
And I think a lot more work in that area will provide us
very useful information. We are also looking in some of our
sites at the use of laboratory data, because hospital labs can
tell you in a matter of hours how many of certain lab tests are
being requested.
So we are analyzing data from a few sites to say, well,
they have ordered a lot more complete blood counts, and what is
that telling us. So we think that he base for one of these
systems, I feel pretty comfortable with what we have built, and
if our funding doesn't drop out after these few years, I think
we can use it to mine a lot more information.
Mr. Greenwood. Thank you. Dr. Davidson.
Mr. Davidson. Yes. I think I agree with the other panelists
that our current systems for disease surveillance, where we are
dependent on physicians, have been serving us fairly well
throughout the--at least in the last years, the incident of
anthrax was identified by an astute physician.
And Westnow fever as well by astute physicians, and who
have provided that front line for us.
I have reservations still about the value of a syndromic
surveillance system only because we have not tested it enough.
We know that the systems that have been available for a long
time are a way that our society has dealt with diseases for
centuries.
But for us to say that mining the data at this point has
Dr. Barry mentions will definitely yield a benefit? I am
uncertain. I think we still need to study this. I think that
living in Denver, and working in a busy public care health
system, physicians are overburdened with paperwork and
activities just to get through their day.
And to put another computer that will be collecting
additional information in an emergency room is just untenable
to my colleagues; to Dr. Cantrell, who Ms. DeGette mentioned
earlier.
I think that in terms of syndromic surveillance that we
need to work to identify what are thresholds. Can we even
establish a threshold. As we enter the influenza season, how
does that threshold change if we are trying to look for
symptoms consistent with inhalational anthrax.
How will we respond. At present, Dr. Barry mentions using
her system to inform and have the nurse epidemiologist conduct
some surveillance activity. I wonder how that may change as we
get further into the influenza epidemic.
What will happen. How will the worried well be appearing
and how will that impact on our need to act on syndromic
surveillance monitoring.
Mr. Greenwood. Thank you, Dr. Davidson. Dr. Broome, if you
can be very brief, we have a vote on, and so we are going to
try and work the time out here.
Ms. Broome. Just very briefly. I was trying to also reframe
it not as syndromic surveillance versus routine. You have to
define what you are trying to find. We have a very interesting
system which has automatically detected outbreaks, but it is
based on detailed information about salmonella, a food borne
disease.
We picked up an outbreak in 13 States that nobody was aware
of, but we needed to have not syndromic information, but
detailed information about the pattern of isolation of that
kind of salmonella. So it is complicated.
Mr. Greenwood. Thank you. The Chair recognizes the
gentleman from Florida, Mr. Deutsch, for 5 minutes for
questions.
Mr. Deutsch. Thank you. Dr. Broome, just to follow up, but
I guess in a different capacity, what would you need to
implement the national electronic disease surveillance system
across all 50 States today?
Ms. Broome. The implementation of this across all 50 States
is partly a matter of the resources. That includes trained
personnel and it includes being sure that information security
is at a level that can handle this sensitive information.
So there is certainly a monetary figure, but there is also
a huge active role for our State and local partners in either
working with the NEDSS bay system that I described, which is an
option that the States can choose, or some States have
developed their own solutions using the standards.
Mr. Deutsch. So at this point, you are really just saying
that it is a resource decision for us to make really. The
bottom line is that based upon the positive effect you have
seen in your test sites, it would appear as if there is almost
no reason not to fully implement this system?
Ms. Broome. We feel that this is a critical part of the
public health infrastructure that it will support our local and
State partners in detecting and responding to disease.
Mr. Deutsch. Let me jump to some of the issues that I
mentioned in my introduction, and really ask very specifically
if there were cases of smallpox in American today, I that all
of us understand at this point that if someone had a full case
of smallpox that they would look very obvious, assuming they
didn't wear makeup of some sort.
Would it be possible to pick up a precursory of that a week
before, 10 days before, 5 days before, because of a respiratory
increase in hospitals in a certain location in America?
Ms. Broome. As you are indicating, we have to be prepared
for whatever might appear, and smallpox is very high on the
list of syndromes. In the information that I mentioned, we do
include information about early diagnosis of smallpox to our
partners and to help care providers.
The most--really, the only way to identify that smallpox is
occurring is to pick up the very earliest stages of the rash.
Mr. Deutsch. So the actual rash, as opposed to any other
symptoms, would be the indicator?
Ms. Broome. Essentially, yes.
Mr. Deutsch. All right. So, Dr. Barry, you are shaking your
head, and so basically the system doesn't really help with
smallpox because we are back to a clinician basically picking
up a phone and saying that I have got a patient with smallpox?
Ms. Barry. Well, I think I have a patient with smallpox. I
guess the point that I was trying to make earlier is that there
are a lot of different scenarios for different diseases, and it
is not going to be a one size fits all.
Mr. Deutsch. And actually, Dr. Barry, do you want to
respond to that, specifically the smallpox?
Ms. Barry. Sure. I think it depends on how the smallpox
exposure occurred. I think if someone did widespread
dissemination of smallpox, you are going to have a whole
cluster of people coming in to hospitals, and it is going to
set off our threshold.
But more importantly, I think because of the system,
because of the surveillance system feeding back and forth to
these health care providers, they are going to know who to call
and say I have all these adults with what looks like chicken
pox, but you know what, and that is how we are going to pick
that up. So it could be an isolated case, but it could be quite
a number of cases.
Mr. Deutsch. Right. But I guess that the value of the
system, in terms of basically bioterrorism, and it is not an
unlimited number of agents that we are talking about, but for
those particular agents I am trying to get a sense of--and as
we are sort of in a funding mode, and let's just talk about
bioterrorism.
And not to say that the work that we are doing in all these
other areas are not very significant; such as with influenza,
and in terms of food poisoning, et cetera, but I am trying to
get a sense of the value added in any of these other types of--
well, the plague.
If there was an instance of plague in America, would we
pick that up through this system. And related to that, I guess
it is sort of a contrast between just a traditional clinical
approach.
I mean, one of the questions that I have, which is sort of
a related question, is how much are we doing that on the public
health side, and there are no physicians in America, I assume,
who have seen the plague, because it has not existed, although
we know that it exists in a sort of--in a bioterrorist world,
but not in terms of the clinical world.
Now, I assume that there is probably still some clinicians
out there who have seen smallpox, but the percentage has to be
extraordinarily low at this point in time. So I am trying to
get a sense from the system that we have in place how does it
help us from a bioterrorism perspective?
Ms. Broome. But I think even though not all physicians have
seen it personally, the whole point of some of the training
materials is to make available, for example, descriptions of
the rash form smallpox, and descriptions of typical x-rays for
anthrax, and making physicians aware to look for hemostasis
with plague.
There are both pictorial and teaching aids which help us
get from line physicians up to speed in both considering the
diagnosis and then in being comfortable in making it. So that
is a very explicit part of the material that has been developed
with the support for bioterrorism preparedness.
Mr. Deutsch. Dr. Davidson or Dr. Barry, did either one of
you want to add to that? I know that my time is up as well, and
this will be my last question.
Mr. Davidson. In Denver, we are trying to inform our
physicians, and we are working based on the CDC advice that we
receive almost daily on the health alert network to build an
algorithm that is useful within our own environment.
Something that tells people exactly what to do, and who to
call, and how do you evaluate if someone had a known exposure
to anthrax spores, versus someone who is not. One of the
clinical signs and symptoms that we would expect on how to
evaluate a patient who comes in with concern, and whether they
are symptomatic or not, and whether they need to get
prophylactics or not.
I think all of this information, even though I have not
seen a case of anthrax, and I doubt that my colleagues have
seen a case of anthrax, we now know how to deal with this. We
are distributing that information. That sort of information
provided to the front line is key.
And that comes from a disease surveillance system that says
we found cases, and now we need to act and give the information
to our front lines.
Ms. Barry. One thing that I wanted to add is that with our
current surveillance system that we have a secure website, and
so if Hospital A thinks they have seen a case of bubonic
plague, I post an alert that says Hospital A has a 45 year old
man who they suspect has plague, and do any of the other nine
acute care hospitals in the city of Boston seen anything like
this, and that goes up right away on our website.
Mr. Greenwood. Thank you. The gentleman, Mr. Whitfield, is
recognized for 5 minutes of inquiry.
Mr. Whitfield. Mr. Chairman, I know that we have a vote
pending, and so I won't take too long, but it is my
understanding, of course, that smallpox is quite contagious,
and would spread rapidly. And I suppose that the bubonic plague
would be the same.
And on the anthrax, it is my understanding that there is an
abundant supply of drugs to deal with anthrax, but it is my
understanding that there is a significant shortage to deal with
smallpox; is that correct, if there was a mass outbreak of
smallpox?
Ms. Broome. For smallpox, the issue is the availability of
vaccine.
Mr. Whitfield. Right.
Ms. Broome. And it is very complex assessing what the
likely scenario is and using the available vaccine effectively,
and being sure that we have sufficient quantities being
produced.
Mr. Whitfield. And we are making efforts to do that at this
time?
Ms. Broome. Yes.
Mr. Whitfield. Okay. How would you compare our reporting
system with, say, the reporting system in Europe?
Ms. Broome. Well, maybe I am--well, anyway, I think the
U.S. actually has invested in a reporting system which in many
ways is a leader in terms of approaches from the public health
side.
I do think--and this was alluded to by Dr. Davidson--our
ability to work with our health care colleagues to get
information is a critical part of that. So we train providers,
but to the extent that our health care information systems are
more difficult to interface with, that does make life more
difficult. So certain countries in Europe may have an easier
time of getting that information.
Mr. Whitfield. Dr. Davidson, you had touched on briefly the
patient's right of privacy, versus the right to dispense
information necessary to protect the public health. Do you
consider there to be a significant problem in that area?
Mr. Davidson. Well, as I mentioned, the local health
maintenance organizations with whom we would like to
collaborate on collecting symptom information and diagnosis
information, they want to collaborate with us, but they are
concerned about the HIPAA regulations.
Mr. Whitfield. And do you feel that way, too, Dr. Barry and
Dr. Broome?
Ms. Barry. Well, our system to identify clusters, which the
hospital MIS system, and not a health care provider, has to
push to us is a number. It does not include names.
We only get into looking for names once we have reason to
believe that there is an outbreak, and then as we would do with
an outbreak of anything, we have access to names as needed.
Ms. Broome. I think also one of the things that the CDC is
trying to do is be sure that people have accurate information
about the HIPAA privacy regulation. In fact, the regulation
permits the continued sharing of identifiable information
needed for public health activities.
There is certainly a level of concern and need for
information in clarifying how that applies with some of these
novel systems. So it is a very important issue, but the reg,
per se, does permit legally authorized public health
authorities to collect individually identifiable health
information.
Mr. Whitfield. So it is not a major concern from your
perspective?
Mr. Davidson. Let me just explain a little bit more because
this gets back to the issue of syndromic surveillance. I agree
with Dr. Broome that we can collect that information for
reportable communicable diseases. There is no question about
that. We have the right to do that.
The question is around these syndromes or symptoms that we
are looking for. Those are not required reportable diseases.
How we use that when we want to figure out how many people does
this really represent, and did someone call the nurse advice
line more than once for the same patient.
Did the person who presented to the nurse advice line then
go to the emergency room and that is still the same patient. So
we are looking for unduplicated counts, and not just numbers of
people who may be in duplicate when we use multiple different
surveillance pathways to collect and create this picture of
syndromes or symptoms in the population. That is my concern.
Ms. Barry. Just one thing. I think that the reporting
requirements and the ability to follow up probably vary by
State, and Massachusetts clusters, even without an identified
agent or outbreaks, are reportable to the local health
department.
And we have the authority to follow up, even if there is
not a specific agent, and even if there is just a cluster or
outbreak of disease.
Mr. Whitfield. Thank you very much. I see that my time has
expired.
Mr. Burr [presiding]. The gentleman's time has expired, and
the Chair would recognize, if the gentlelady is ready.
Ms. DeGette. One moment, please.
Mr. Burr. I would be happy to go and let the gentlelady
take a few minutes.
Ms. DeGette. Okay. Well, that is what happens when you do
tag-team questioning, you miss the answers.
Mr. Burr. The gentlelady is recognized.
Ms. DeGette. So I apologize if I re-ask some of the
questions that have just been asked, but I am getting the
sense, particularly from Dr. Barry and Dr. Davidson, that these
syndromic surveillance systems are not really what you think is
needed right now in local health departments.
And I am wondering if you can talk specifically about why
you think that might be the case. Dr. Barry.
Ms. Barry. Well, I think that syndromic surveillance gives
us an opportunity to identify many problems early on. However,
in some sites, syndromic surveillance has been carried out by
having people in the emergency department fill out a separate
sheet on every patient that comes in and that is never going to
fly, and certainly not in Boston.
Ms. DeGette. Do you think it gives you any better
diagnostic tools than the coordinated approach that you are
using now, which by the way sounds very similar to what we are
doing in Denver.
Ms. Barry. I don't think it gives us enough of an advantage
to try to put the burden on health care providers. I believe
that the future here lies in mining data in already existing
records that are coming in, and not in current syndromic
surveillance.
Ms. DeGette. Dr. Davidson. I would agree with Dr. Barry
that we need to find systems that use already existing datasets
to identify these clusters or symptom patterns. A concern of
ours is that the infrastructure for routine disease
surveillance using systems such as NEDSS needs to be expanded.
We need to make sure that that is solid, and the syndromic
surveillance system may assist, and I can't say whether it will
or will not, but at this point I want to be sure that the
fundamental surveillance systems that we have used for decades
are improved and move into this 21st Century.
Ms. DeGette. Well, I know that we have two of the shining
stars here with Boston and Denver. Do you know--and perhaps,
Dr. Broome, you can speak to this, but are there other health
systems whose traditional methods of surveillance could be
improved as Dr. Davidson suggests?
Ms. Broome. Well, to me, I think it is extremely valuable
to hear what is happening in Boston and in Denver, and to me
this shows what can be done with resources and smart people,
and a commitment.
I wish that were true of every local health department in
the country, and I hope that it will be true.
Ms. DeGette. But do you think that the way to go to improve
the coordinated responses in these other communities is through
the techniques that Dr. Barry and Dr. Davidson talked about, or
this syndromic surveillance system, or some other method?
Ms. Broome. I think the two critical pieces are that there
are resources to hire trained staff. The trained recognition
capacity of a human being is still what I am counting on.
Ms. DeGette. That is how we found the anthrax in Florida.
Ms. Broome. The second is the kind of system that NEDSS
represents is an automation, and it does have the electronic--
what Dr. Barry is calling data mining capacity built in, but it
goes way beyond detecting flu like illness. It lets you find
out if there is an increase in lab tests submitted for Anthrax
testing.
Ms. DeGette. Right.
Ms. Broome. So it does have some of those capabilities, but
in addition it supports the standard surveillance functions.
Ms. DeGette. So it would seem to me that that would be a
place where we should put our resources to helping the other
municipal systems like that.
Ms. Broome. We think that this will make a huge difference
in capacity.
Ms. DeGette. Okay. Thank you. Dr. Davidson--oh, you wanted
to add something?
Mr. Davidson. So that I think if we had a perfect robust
information system is not enough. We need to have trained
individuals who are able to use the data that come out of those
systems or to look at those systems and say here is a pattern.
I think we need to underscore training here, because in all of
the health departments of the country there are insufficiently
trained staff.
We know that from within my own State that we have people
for whom I can give information about surveillance activities
that we have conducted, and they look at it as if it doesn't
make sense. I think that is something that we need to focus on
as well.
Ms. DeGette. Thank you. Just one last question, although it
is kind of a big question. Dr. Davidson, as I mentioned in my
opening statement, when I visited--and I guess it was just last
week, and it seems like about a month ago--with you and the
rest of your crew over at Denver Health, what struck me was the
highly integrated public health system you have put into place
with your closed electronic system.
And as a result the reporting of data is made easier. I
wonder if you can let me know what challenges Denver Health
encountered in establishing that system, and what lessons other
systems who are less integrated can learn. If you can--I know
that I spent 1\1/2\ hours, and maybe you can tell me just in a
brief moment.
Mr. Davidson. There are 50 years of history in making
Denver Health what it is today. It started back in the late
1940's when Florence Hayden decided to put the public health
department inside of a personal health care agency, and we
spanned from personal health care all the way to population
bays for public health.
The coming of the community health clinics in the 1960's
then contributed an outpatient focus. I don't think that there
is another institution in the country similar to Denver Health.
I feel privileged to work there in an integrated system like
that, but I think there is some lessons that can be learned.
Keeping turfs separate makes for less integration. Finding
standards to make better integration is very, very important.
Making each information system adhere and ascribe to those
standards is essential if we are ever going to be able to mine
the data from each of these separate turfs that exist in most
other cities.
Ms. DeGette. And just for one example, the 911 reporting
system goes into Denver Health, and not into the fire
departments?
Mr. Davidson. That's correct.
Ms. DeGette. And so that helps you find early reporting on
issues like this.
Mr. Davidson. That's correct.
Ms. DeGette. Thank you. Thank you very much for your
indulgence, Mr. Chairman.
Mr. Burr. The gentlelady's time has expired. The Chair
would recognize himself for questions. Let me take this
opportunity to welcome this panel since I chose to forego an
opening statement so that we could get into the questions. So,
Dr. Broome, welcome, and like Ms. Harman, we had an opportunity
several weeks ago to visit you at the CDC in Atlanta from
another committee.
You mentioned the Florida detection, and how it was
important it was that a health provider identified the problem
and that that was certainly a key. If you will comment very
briefly on the inability in Washington, DC, though health care
providers treated two individuals, one of which I think has
passed away, and tell us where the breakdown was there.
Ms. Broome. I am afraid that the current events are under
intense investigation, and it really would not be appropriate
for me to comment on the details.
Mr. Burr. Well, let me ask it in a different fashion if I
can. Was there a city in America where more education was done
on the risk that existed, and the symptoms that went along, the
profile of where one worked, that we would have felt confident
that every health provider would have seen this matrix that we
were looking at, and if anybody was close to the line would
have said this is one that we need to look at. Clearly that was
not done.
Ms. Broome. It is an ongoing challenge. I mean, education
is not something that happens once, and people are perfectly
informed and clearly we are trying to reach every deliverer of
health care in the country. That is an enormous task that we
are continually trying to look at better ways to do.
I think that it is also important to point out that the
kind of initial symptoms can be non-specific and can vary. So
we do not minimize the challenge of doing this. I have enormous
respect for the folks who are on the front lines and who are
trying to do an incredibly difficult job.
Mr. Burr. As I do, and this is not a shot at any attending
physician that saw these individuals, but I think you made my
point for me, is that we can't rely just on the provider
network to identify something that we feel we have successfully
communicated to a health delivery network.
And if it just happens to be a bad day and somebody misses
something, or there was an individual that was not included in
the dissemination of the information that you distributed or
that the public health distributed, then we have a potential
problem.
And were this a contagious pathogen that we dealt with,
that problem would be magnified greatly. Therefore, there are a
lot of tools out there that we not only can use, we should use,
and we should find a fast way to incorporate them.
I am a little curious on NEDSS, because this is a program
that the CDC has been focused on since 1999, I think, when it
was first talked about or initiated, and our goal was 20
States. I think everybody's goal is probably 50 States now, or
I hope it is.
Ms. Broome. Well, we received Congressional funding in 2000
to move ahead with NEDSS, and we actually have funded all 50
States, six cities, and one territory, for at least planning
functions.
Mr. Burr. But the connectivity of these States is the
crucial thing. I mean, we still haves a third of public health
in America not technologically connected to CDC. So, two-thirds
are covered and for a third, we have to rely on another means
other than your internal tools to disseminate information or
warnings.
Ms. Broome. Well, I think it is important to also focus on
the systems that Dr. Davidson and Dr. Barry have mentioned, in
terms of the urgent communications, and building the
connectivity with the local health departments.
The health alert network support from Congress, and the
Epi-X secure communications systems, are also critical parts of
getting this information out.
NEDSS is--and forgive me if I get too much into the jargon,
but NEDSS is a tougher job. It is basically using standards to
actually collect the raw data that will help inform the
decisions, and that will give us what we want to communicate to
our partners.
Mr. Burr. The real capabilities that we have is data. I
mean, that really is a key to our ability to understand what is
going on isn't it?
Ms. Broome. Well, I think it is, because it also can take
information, and not just from providers, but it also can take
information from laboratories, and it can take information
about what is going on.
So we do see this as a critical part, but it takes more
time to get that kind of complex system to functionality.
Mr. Burr. HHS has received $1.5 billion out of the $20
billion emergency bioterrorism money. Of that, my understanding
is that $40 million by CDC is directed toward preparedness,
NEDSS, health alert network, and other things.
Now, of the money that is left over after the stockpile,
which is $1.1 billion, there is $400 million. So, less than 10
percent of the bioterrorism emergency money is directed to the
thing that all of you, and I think all of us, would agree is
the most crucial challenge that we have today to put in place.
Why only 10 percent of over and above the stockpile money
is devoted to this crucial effort?
Ms. Broome. I think that is a good question.
Mr. Burr. And I don't want to put you on the spot if the
question is something that needs to be answered by somebody
else, and I assure you that the Secretary will be in next week,
and I am sure that he will get this question.
But if it is important that 50 States be connected, and we
see that as a first step to our ability to rebuild our public
health infrastructure, and to make sure that the dissemination
of information about potential biologic attacks in fact is
transmitted, then it seems like the single greatest thing that
this Congress and the CDC can do is to take enough money and
devote it to connectivity of public health with our Federal
entities.
And to make sure that at least we can get this information,
or in the reverse, at least they can access the data that they
need to successfully monitor public health in their communities
and localities that they live in.
So I am a little bit troubled in the fact that maybe in
your testimony or in CDC's public statements you should be out
there demanding to extend this to 50 States today. You can take
that back in whatever form you would like to Jeff, and to the
rest of them, and I will certainly take it to the Secretary.
My time has expired, and the Chair would recognize Mr.
Stupak for questions.
Mr. Stupak. Thank you. You know, as I sat here and listened
to the testimony, and looked forward to the testimony,
especially from Dr. Barry and Dr. Davidson, I got the
impression that we don't really need NEDSS.
And that there is a system in place now that works that the
money should really go toward providing stuff at the local
level, and not another federally developed system, and with it,
Federal regulations, and with it more reporting on doctors and
health care professionals.
And, of course, the money never really gets back to the
local people. Is that a fair summation?
Mr. Davidson. I would say not. I think from a local public
health perspective as a Director of Public Health Informatics,
NEDSS is my hope for the future. The current systems that we
have are probably--I think a dozen, that are CDC developed
systems that require intensive maintenance on a daily basis in
a local health department.
Having 12 systems built with different standards and in
different languages is very labor intensive at a local health
department. Having a system that is common across all the
surveillance activities that we do is important for us not to
expend effort when we don't need to.
Making everything come together with a standard language on
operating assumptions, and all the necessary requirements for a
information system is important at a local level.
So from my perspective, NEDSS brings an integration. It
reduces the burden locally, and I feel that while we certainly
do need local public health infrastructure support, we need
guidance to make that happen not only in a local area, but with
our State partner and our Federal partners as well.
Mr. Stupak. Dr. Barry, did you want to comment?
Ms. Barry. I certainly am in favor of data consistency
among systems, and from my perspective I really haven't as a
local health department been involved in NEDSS at all, and what
I think what we need right now in the city of Boston is the
ability to expand and keep building our local surveillance
system, which I would be very happy to connect to NEDSS, or
whatever other consistent system will provide the most data for
us nationally.
Mr. Stupak. I went back before the hearing and checked with
my local folks, and I have got a very rural area. My biggest
city is 20,000 and I am rural. They just saw this as another
Federal program that would do nothing for them.
They need quarantine rooms, and they need supplies, and
they need things like that at the local level so that if an
epidemic does start, there is something there. We had testimony
here about 3 weeks ago from an expert who testified before us,
a Dr. Smithson, and basically they said, look, last year you
appropriated $8.7 billion in your terrorism appropriations, but
only 300 ever made it past the Beltway in Washington, $300
million out of $8.7 billion.
So, $8.4 billion stayed here in Washington, and I am real
skeptical. Are we building another system where all the money
is going to go to a few places, and cost us hundreds of
millions of dollars, and nothing gets to local people where
they really need it.
Ms. Broome. We also think that local health departments are
where the action is, and 75 percent of NEDSS funding has gone
to State and local partners because we think they are the folks
who need systems.
Some of those State health departments are building their
own systems, but as Dr. Davidson has pointed out, NEDSS
provides standards for them to use in building those systems so
that they can connect with the health care sector, and so they
can do the data mining that Dr. Barry was mentioning.
However, some States don't feel that they have the
resources or the capacity to build their own systems. So they
explicitly asked CDC to create an option that they could use.
But I think it is very important that this is not building
another Federal stove pipe of the kind that Dr. Davidson
described.
That is sort of past history of these categorical systems.
It is based on modern infomatics standards, and it uses state-
of-the-art commercial software packages. You can drop in the
leading mapping software so that that local health department
will be able to take the data and actually use it to see where
things are occurring in their district.
And that also lets them hire people and use them for
intelligent activities rather than data entry.
Mr. Stupak. So that 75 percent you said that went to
locals, was that just to set up the system, or are you paying
the salary of these local people? And Dr. Davidson said this
would be very labor intensive, and you need people there.
In small areas like mine, if you want to hire one person
and dedicate it to it, that is something out of our budget.
Ms. Broome. Well, in fact, the NEDSS' awards include
funding for skilled information technology personnel, because
that capacity has not been available at State health
departments in a number of the smaller States.
Mr. Stupak. And how long is that for, just to set up the
program?
Ms. Broome. Pardon?
Mr. Stupak. How long is that for, that contracting of
personnel?
Ms. Broome. It is built into the NEDSS awards, and it will
depend on the duration of Congressional support. But we also
see in many settings as people realize the value of these
information systems very--it has made a change in local and
State investment in this infrastructure.
So, for example, the State of Missouri has invested major
State funding in their information system because they see the
value of it. So I see the Federal funds as providing real
benefit, but also providing and leveraging additional resources
for this critical function.
Mr. Greenwood. The gentleman's time has expired, and the
Chair recognizes the gentleman from Florida, for 5 minutes of
inquiry.
Mr. Stearns. Mr. Chairman, thank you. Dr. Broome, the
initial version of NEDSS that will be implemented next year in
20 States as I understand it will not contain what you
described as aberration software, which is the ability to
automatically sort and review the data for unusual activity,
considering where we are at, why not? As I understand it this
software is commercially available, and is already in use in
some parts of this country.
Ms. Broome. I would like to clarify that the 20 States are
the States that have requested and have been funded for the
NEDSS base system, which is this NEDSS compatible platform that
we are developing. An additional 16 States have received
funding to develop NEDSS compatible systems or to modify
existing systems.
So there are actually 36 States in the development phase. I
am sorry that was not clear. In terms of the aberration
detection software, this is a target for inclusion in NEDSS,
and we will be looking at a range of commercially available
tools, tools developed by a range of entities, such as the
Department of Defense, to see which ones are appropriate.
Because of the standards based approach to developing
NEDSS, it is very feasible to drop in software which has been
developed according to industry standards for interoperability.
Now, your question is, okay, why isn't it done now, and that
is----
Mr. Stearns. Well, just a sense of urgency in when are you
going to do this. I mean, you can drop it in, but the question
is when is this going to occur.
Ms. Broome. We do think that the first absolute priority is
getting basic capacity out to all 50 States. At the same time,
we----
Mr. Stearns. And when would that be, that all 50 States
would have the basic capacity?
Ms. Broome. Well, with the resources that we have, we will
be deploying in 20 States in 2002. We would certainly--we have
certainly proposed ways to accelerate that.
Mr. Stearns. And so you are saying today that you will
accelerate it?
Ms. Broome. With the resources, yes, we will accelerate it.
Mr. Stearns. Dr. Broome, NEDSS, even when implemented, will
only be as good as the data input into it by local health care
practitioners and health departments. In this vein, you discuss
CDC's funding of special surveillance systems at the State and
local level, and how these systems have actually been put into
place since September 11.
Can you discuss in more detail what the benefits and
shortcomings of these systems have been in this real world
test, and what advantages they offer beyond NEDSS? And I would
like the other witnesses to respond as well.
Ms. Broome. First of all, I would like to clarify. NEDSS
does permit inputting by practitioners over the web, but it
also permits electronic input. Data from a clinical laboratory
can be sent electronically without having to have a person
think, oh, here is a reportable disease.
We can automatically get all appropriate information about
specimens or conditions. So it actually represents a real step
forward in one of the big problems----
Mr. Stearns. So a clinical laboratory could input it
through the web?
Ms. Broome. No, they don't have to do anything.
Mr. Stearns. They just are going to do it through the
telephone?
Ms. Broome. No, no. This is basically--well, we are working
with the multi-jurisdictional laboratories which cover
basically all the States, and for them to send out an automatic
electronic message over the Internet, appropriately encrypted
and secure, that would be routed to the State health
departments basically as soon as that laboratory result, or
even a specimen, is submitted.
So this means that it is just a huge step forward in the
speed and completeness, and accuracy, and the ease with which
relevant information can get to the people who need it at State
and local health departments.
So there is a real difference. It's not just counting on
that overburdened physician to actually report a case. Your
question then was what about NEDSS and what about these other
alternate approaches to surveillance.
Mr. Stearns. Particularly in light of what happened in
September.
Ms. Broome. First of all, we did support these pilots with
the very first bioterrorism--with these surveillance grants. So
those have been undertaken by States since late 1999/2000.
There has been a range of sources looked at, and I think the
kind of experience that you are hearing from Dr. Barry is
really very useful in looking at how they might be useful.
We have had other folks discover that some of the
information that they were getting from their heightened
surveillance was not timely. Some of the sources they thought
might be promising either were not feasible or not timely.
What we are doing is collecting systematic information on
these pilots to try to provide some broader guidance about what
worked and what didn't work.
Mr. Stearns. Dr. Barry.
Ms. Barry. Yes. I would like to comment that we were one of
those special surveillance sites that was funded with the
initial CDC funding in 1999, and have really tried to look
locally in very creative ways to build a system that is not
going to burden people.
In our current system the ED people don't have to do
anything. The MIS just sends us that data. So there are some
aspects of the system that I think might be useful to other
localities.
Mr. Stearns. Dr. Davidson.
Mr. Davidson. Since September 11, there have been
relatively few changes in terms of NEDSS activities within the
State. We still are targeting completion of laboratory
reporting from the State labs into our version of NEDSS, called
Colorado Electronic Disease Reporting System, by the end of
this fiscal year, and that would be June 30, 2002.
So our goal is still to achieve that, but we have not been
able to accelerate that in the last 6 weeks. That is a
difficult project. It is not easy to make these systems talk to
one another.
Mr. Greenwood. The gentleman from Florida's time has
expired, and the Chair recognizes the gentleman from Illinois,
Mr. Rush, for 5 minutes of inquiry.
Mr. Rush. Thank you, Mr. Chairman. I want to commend not
only you, but also the witnesses, for this hearing and for the
testimony that they have provided so far. I have a couple of
questions that I would like to ask both Dr. Davidson and Dr.
Barry.
You have stated, and I guess everyone can agree, that the
ability to identify a bioterrorist attack depends on the
ability to diagnose medical conditions. And we have also
further agreed that this requires a laboratory test at the
local level spanning the entire Nation.
My question is do local health departments have access to
the modern up-to-date labs, and if they don't, what resources
do the local health departments need in order to make sure that
they are up to speed, and that they can provide the most
accurate and up-to-date laboratory tests that is possible?
Ms. Barry. I think for many conditions a laboratory
diagnosis is not going to be the most important feature. It is
going to be the number of people with a clinical syndrome. But
with regard to laboratory----
Mr. Rush. A clinical syndrome?
Ms. Barry. A clinical syndrome. So, even if we don't know
what is causing all those people to have fever and pneumonia,
we realize that we have a problem. With regard to laboratories,
we are very fortunate to have the Massachusetts State
Laboratory Institute, which has also received funding from CDC,
to be in the network to be able to identify for us very quickly
agents of concern for bioterrorism. It works very well, that
system.
Mr. Davidson. Within Colorado, we have an excellent
laboratory as well, and the State lab has been the recipient of
Federal funds. The epidemiologic laboratory capacity program, I
think it is, that you have supported in the past, and currently
through the larger bioterrorism preparedness grant, there is
support for the laboratory as well.
We are using NEDSS funds to support development of a
laboratory information system. I think that the capacity to do
the diagnostic testing is there, at least in Colorado.
Mr. Rush. Dr. Broome.
Ms. Broome. I am really delighted that you asked this
question, because the laboratory really is a critical partner
in this. I agree with Dr. Barry that sometimes you would love
to do it before the laboratory makes the diagnosis, but that is
the backup, and it also gives you specific information.
So I consider it a critical part of the system, and it is
one which requires particular attention. In addition to the
funding and programs that Dr. Davidson mentioned, we also have
made available on the web information that laboratories can use
about what procedures to use.
They can order reagents so that they can diagnose these
conditions, and there is a network set up so that there is a
way for a State to decide how they want to organize their
laboratory system and get the information, and testing
materials that they need.
And then finally this information is most valuable if it
can get into the surveillance information systems that we are
talking about. So again this is a place where we need to be
integrated, and where we have to be able to take the results of
testing and be sure it gets to the people who need to use those
results.
Mr. Rush. And can we assume that if we have an adequate lab
system that we can assume that there would be an adequate
number of trained lab technicians, or is that too much of an
assumption?
Ms. Broome. I think as with all of these that you have
areas that are very well equipped and staffed. But we are
talking about the country, and a country-wide system, and that
is where you really have to be thoughtful about the resources
that are needed so that there are the trained personnel, and so
that they have the laboratories, and they have the biosafety
capacity, and they have the information systems to participate
in a national network.
Mr. Rush. If one thing that has come out of our tragedy of
September 11, or one good thing, is the focus on the local
public health system. And I think that we need to take this
opportunity to strengthen our public health system for the long
term.
And I wanted to ask you what long term changes should we
make to our surveillance system, particularly at the local
level, but also where they want us to focus on, and the two-
tiered health system in this country.
And whereby--and maybe you could tell me the impact, the
possible impact that you can envision, because there is a
significant population segment in our Nation that is not really
adequately tuned into the public health system or to the
private health system.
And I will just give you an example. Maybe it is not
congruent, but about 6 years ago in my city, there was a heat
epidemic. And 700 people died from heat stroke. I mean,
something that could be readily identifiable, but yet still it
took my city at least--well, longer than necessary--a week or 2
weeks, to really get in front of the issue and respond.
And I am trying--I believe that this kind of example will
be duplicated many times if in fact a bioterrorist attack or a
natural tragedy will occur. And I just want you to respond to
what can we do to buttress the public health system in order to
make it touch as many Americans, or more Americans than it
currently touches?
Ms. Barry. Well, I think you have touched on a critical
characteristic of the public health system, and that is that it
has to cover the whole population. It has to be able to detect
health problems wherever they may occur, and it has to be able
to respond to protect the health of the entire population.
I do think that there are ways in which the kind of
information systems that we have been talking about, and the
kind of response systems, are truly population based. The
challenge really is to be sure that all local health
departments and that the medical care delivery system is there
to participate.
Mr. Rush. Dr. Broome, would you care to respond?
Ms. Broome. Yes. What I would say is please give us some
funding at the local level so that we can hire nurses, so we
can hire outreach workers. You know, if we have an event in the
city of Boston, we have a very large Haitian community.
Somebody has got to be able to speak to that community, and
go out to that neighborhood, and speak to those folks, and help
them out. Right now I am the only infectious disease physician
in the City Health Department in Boston.
And it is a resource issue. We need direct funding to the
local health department to take care of those very people that
you are talking about.
Mr. Rush. Dr. Davidson.
Mr. Davidson. I agree with my colleagues. We definitely
need more support at the local health department level, but I
think to answer some of the questions that you asked earlier,
you need to support the safety net institutions.
You can't expect people to show up at an emergency room and
wait a dozen hours, and then say, well, you have to wait
another 10 hours because there is just too many people in front
of me.
I think we need to have institutions that can be responsive
to those patients who were suffering from heat stroke, and I am
sure that the emergency rooms were overwhelmed, and the
community health centers were overwhelmed, and the hospitals
had insufficient beds.
So if we are talking about dealing with a large issue in
the public health infrastructure, it spans all the way from the
local health department as Dr. Barry just mentioned, all the
way to those safety net institutions.
Mr. Greenwood. The gentleman's time has expired, and all
the questioning for this panel has expired. So we thank you
again, each of you, for coming, and for helping us to
understand this complex issue, and you are excused.
We will now call up the second panel, and it will take a
couple of minutes for the second panel to set up some of their
equipment for demonstrations.
[Brief recess.]
Mr. Greenwood. While we are waiting for Dr. Wagner to
arrive, I will introduce the witnesses for our second panel.
They are Dr. Alan P. Zelicoff, who is the senior scientist at
the Center for National Security and Arms Control, at Sandia
National Laboratories.
And, Mr. Zelicoff, let me tell you that Congresswoman
Heather Wilson had hoped to be here to introduce you, and have
some questions for you, but she is tied up at the White House.
Also, we are pleased to have Dr. Michael Wagner, Director
of the RODS Laboratory, Center for Biomedical Informatics, from
the University of Pittsburgh; and Mr. John S. Russell,
Executive Vice President and General Counsel of Quintiles
Transnational, which is from North Carolina.
And we thank each of you for coming. I think that you have
been informed that this is an investigative hearing, and it is
our custom to hold to ask the witnesses to provide their
testimony under oath. Do any of you have an objection to
offering your testimony under oath?
[No response.]
Mr. Greenwood. You should then be advised that under the
rules of this committee and the rules of the House, you have
the right to be represented by counsel. Do any of you choose to
be represented by counsel?
[No response.]
Mr. Greenwood. Seeing no such desire, then I would ask you
to rise and I will administer the oath.
[Witnesses sworn.]
Mr. Greenwood. Okay. So saying, you are now under oath, and
you may give your testimony, and I will start with you, Dr.
Wagner. You are recognized for 5 minutes for your testimony.
Thank you for being here.
TESTIMONY OF MICHAEL M. WAGNER, DIRECTOR, RODS LABORATORY,
CENTER FOR BIOMEDICAL INFORMATICS, UNIVERSITY OF PITTSBURGH;
ALAN P. ZELICOFF, SENIOR SCIENTIST, CENTER FOR NATIONAL
SECURITY AND ARMS CONTROL, SANDIA NATIONAL LABORATORIES; AND
JOHN S. RUSSELL, EXECUTIVE VICE PRESIDENT AND GENERAL COUNSEL,
QUINTILES TRANSNATIONAL
Mr. Wagner. Good morning, Mr. Chairman, and members of the
subcommittee. My name is Michael Wagner, and I am a Physician
and Assistant Professor of Medicine at the University of
Pittsburgh.
My training is in the fields of internal medicine and
medical infomatics and artificial intelligence, and for the 2
years my research has been focused exclusively on the building
of an early warning system for detection of outbreaks of
disease.
I wish to thank the subcommittee for this opportunity to
share information with you. The research that I am going to
describe has been funded by the National Laboratory of
Medicine, and the Agency for Health Care Research and Quality,
and the Centers for Disease Control and Prevention, and the
Defense Advanced Research Projects Agency.
Please note that the views that I express today are my own,
and not necessarily those of the agencies. In our research on
early warning systems, we have been concerned about early
detection of disease outbreaks caused by medium-to-large scale
bioaerosol releases of anthrax, smallpox, plague, or any other
aerosolizable agent.
With this type of outbreak, early notice of detection is of
paramount importance, and our improvement in early notice can
translate into scores of lives saved. A product of this
research is a system named RODS, which stands for real time
outbreak and disease surveillance. It is an early warning
system that has been deployed in Western Pennsylvania for 2
years.
The key feature of RODS is that it receives data directly
and without delay from computers in emergency departments and
hospitals. This anonymous data includes patient's symptoms,
age, gender, address information, and results of tests.
The data are transferred directly computer to computer,
which means that seconds after a patient registers in an
emergency department complaining of a cough, this fact is
pooled with data from other patients in the region at a central
location, and is available for automatic analysis.
At present, RODS emphasizes data collection from emergency
rooms and hospitals monitoring 800 visits per day for like
symptoms of diarrhea, rash, and other key symptoms, and all the
approach is general, and it can include data collection from
other computer sources, such as direct entry of case reports by
clinicians.
The earliest of detections approach is achieved first by
identifying as many people in the region as early as possible
in their disease process while they have non-specific symptoms,
such as cough or diarrhea, and then by using brute force
computer power to find any interesting patterns among the sick
individuals that would suggest an unusual outbreak is
occurring.
An interesting pattern, for example, might be an unusually
high number of sick people in the past 24 hours who happen to
live in the same zip code area. Our design for the RODS system
was heavily influenced by prior work in the field of medical
infomatics.
From this experience, we knew that the most important
ingredient for success would be obtaining the right data
electronically in real time and without asking doctors to fill
out forms or enter data into computers.
We knew that computers in emergency rooms and hospitals
would be able to provide useful data through standard computer-
to-computer interfaces. We also knew the importance of
standards in building early warning systems, especially those
having regional, State, and national coverage.
We ascribe to the standards now recommended by the National
Electronic Disease Surveillance System project, and we think
that those standards are excellent. One new lesson that we have
learned from the research is that health departments may have
limited resources to do this kind of work due to their front
line responsibilities.
And that this problem in our case can be addressed by the
creation of a trusted broker, which is an administrative entity
created by a memorandum of understanding with the health
department that allows pooling of data regionally for mutual
defense.
Another lesson from the research is the central importance
of obtaining data about patient's symptoms even earlier than at
present, even before they seek emergency care.
Other lessons include the importance of large
interdisciplinary research groups with experience in medical
infomatics, public health, computer science, statistics,
emergency response, and to conduct the research in as big a
region as possible so that there is sufficient data available
about naturally occurring outbreaks for system validation.
So as a result of my basic and implied research on early
warning systems for public health surveillance, I would like to
offer the following recommendations to the subcommittee.
First, Congress should provide funding directly to ongoing
regional efforts to build early warning systems, and not
necessarily limit it to those that are affiliated with health
departments, and not necessarily funding all the money through
State and local health departments, although that basically is
a very sound approach.
And stipulate that every funded project adhere to the
National Electronic Disease Surveillance System standards. The
rationale for this recommendation is that the regional efforts
will be most effective in obtaining access to the data needed
for early detection.
And additionally the reality is that right now that many of
these research projects are being called on to rapidly deploy
and provide reliable 7-by-24 services in defense of the
community without sufficient resources to take on the task.
My second recommendation is that in the near term the
greatest improvement in capability will depend on obtaining
information from or about sick individuals as early as possible
in their illness.
There are many potential ways to do this, and therefore the
Nation's health systems need to conduct research to find
workable solutions. The Congress should fund centers of
excellence to do this research, and these centers need to be
interdisciplinary and need to have multiple year funding.
And Congress may need to prove incentives for specific
industries with needed data to construct real time privacy
protected data feeds. Congress may need to also enact
legislation to facilitate data collection that balances the
needs of the community for defense, with the rights of
individuals to confidentiality.
My last recommendation is that Congress should encourage
through Federal funding several regions to participate in an
intensive level in early warning research. The reason is that
the field of bio-defense is a lot like the field of particle
physics, by which I mean that a large particle accelerator is
necessary to answer certain questions in particle physics and
in the field of bio-defense, a very large region with rich,
multi-year datasets, are needed to persist in validation and
hypothesis testing.
In closing, I would suggest that Congress note that
developing very early detection of major public health threats
is an ambitious scientific undertaking that resembles in both
urgency and technological breathe the space race in the 1960's
and the Manhattan Project in the 1940's.
And that there are lessons to be learned from those
projects, such as the value of having clear goal statements,
such as short term objectives to reduce detection time by 2
days over current levels, and stretch goals of being able to
reduce detection time within 1 day of release for any
biological agent that threatens the health of our citizens.
And I thank you very much for the opportunity to speak here
today.
[The prepared statement of Michael M. Wagner follows:]
Prepared Statement of Michael M. Wagner, Assistant Professor of
Medicine and Intelligent Systems, University of Pittsburgh
Good afternoon, Mr. Chairman and Members of the Oversight and
Investigations Subcommittee. My name is Dr. Michael Wagner. I am a
physician and an assistant professor of Medicine and Intelligent
Systems at the University of Pittsburgh. I am also co-scientific
director of an institute in Pittsburgh that focuses on bioterrorism
research.
My training is in the fields of biology, internal medicine, medical
informatics, and more recently I received a PhD in artificial
intelligence. Over the past decade, I have been building computer
systems that detect cases of disease and potential medical errors. For
the past two years, my work has been focused exclusively on the
building of early warning systems for outbreaks of disease.
I wish to thank the Subcommittee for this opportunity to share
information with you about this research and to offer my observations
and recommendations to the Subcommittee in its deliberations on public
health early warning systems.
My research has been funded by four federal agencies--the National
Library of Medicine, the Agency for Healthcare Research and Quality,
the Centers for Disease Control and Prevention, and the Defense
Advanced Research Projects Agency, but the views I express today are my
own and not necessarily those of the agencies.
the real-time outbreak and disease surveillance (rods) system
Why are we doing the research?
A scenario we have been most concerned about is early detection of
disease outbreaks caused by large-scale aerosol release of Anthrax.
Without very early detection of this type of outbreak, it has been
estimated that there will be mortality rates of hundreds per hour
within 4 or 5 days of release. In this kind of outbreak, hours count,
and detection needs to occur very early to allow time for response and
treatment to occur.
What is RODS?
A product of this research is RODS, an early warning system that
has been deployed in Western Pennsylvania for two years. The acronym
RODS stands for Real-time Outbreak and Disease Surveillance. The
purpose of RODS is to provide early warning of infectious disease
outbreaks, possibly caused by acts of terrorism using biological
weapons, so that treatment and control measures can be begun, to
protect and save larger numbers of people.
A key feature of RODS is that it receives data directly and without
delay from computers in emergency departments and hospitals. The data
include patient symptoms, age, gender, address, and results of tests.
The data are transferred directly computer-to-computer and without
delay, which means that seconds after a patient registers in an
emergency department complaining of cough, this fact is pooled with
data from other patients in the region at a central location and is
available for automatic analysis. At present, RODS emphasizes data
collection from emergency rooms and hospitals--monitoring 800 visits
per day for flu-like symptoms, diarrhea, rash and other key symptoms--
although our approach is general and includes data collection from
other computer sources as well as direct entry of case reports by
clinicians.
How is early detection achieved?
Early detection is achieved in this approach by identifying as many
patients as possible early in the disease process when they have
nonspecific symptoms such as cough or diarrhea, and then using brute-
force computer power to find any interesting patterns among the sick
individuals that would suggest that an unusual outbreak is occurring.
An interesting pattern, for example, might be an unusually high number
of sick people showing up at emergency departments in the past 24 hours
who happen to live in the same zip code area.
Why did we take this approach, and what have we learned?
Our design for RODS was heavily influenced by prior work in the
field of medical informatics. From this experience, we knew that the
most important ingredient for success would be obtaining the right data
electronically, in real time, and without asking doctors to fill out
forms or to enter data into computers; so, we spent a great deal of
time being clever about this. The approach builds on electronic medical
records and other existing computer systems. These elements are widely
available in the country and represent an enormous resource. We knew
that computers in hospitals and emergency departments contained
relevant data, and we knew that they would be able to provide the data
through standard computer-to-computer interfaces, in fact, from the
beginning we used many of the standards now being recommended by the
National Electronic Disease Surveillance System (NEDSS) project, and we
think those standards are excellent.
We have learned that health departments have limited resources for
any kind of participation in this kind of project due to their front-
line responsibilities. Therefore, we developed the concept of a trusted
broker, which is an administrative entity that allows pooling of data.
The trusted broker is created by formal memoranda of understanding
between the health department, data providers, and an outside technical
group. This organizational model has proven effective, especially with
the facilitation of a highly respected local foundation with contacts
in the community.
We also understand that although the approach taken in RODS can
significantly reduce the time delay to detection, it is not a complete
solution to the country's needs. As you know, the earliest possible
detection will eventually be accomplished by biosensors that detect
bacteria and viruses when they first appear in our environment, but
before they infect us. However, such technology is a ways off
especially in a sufficiently cheap form that every person can carry a
personal monitor, or every building and open space can be monitored
continuously. In the meantime, early detection of a surreptitious
release will depend on monitoring people and animals for the early
effects of that release, and through detailed analysis of the
epidemiological characteristics of sick individuals.
From the research, we know that the earliness of detection in RODS
can be improved further if we can obtain data about patient symptoms
even earlier than at present, even before they seek emergency care.
This latter point is the subject of a specific recommendation.
recommendations
I would like to use the remaining time available to me to offer my
recommendations to the subcommittee for rapid improvement in detection
capabilities.
1. Congress should provide funding directly to all ongoing
metropolitan and regional efforts to build early warning capability,
provided they adhere to National Electronic Disease Surveillance System
standards. Early warning can be implemented most quickly by regional
efforts, with federal coordination. Some of these efforts are research
projects that are becoming regional or national resources for early
warning, and they are not currently staffed or funded for rapid
deployment or for the provision of 7x24 services.
2. The earliness of outbreak detection depends fundamentally on
obtaining data about early symptoms of disease. In the near-term, the
greatest improvements in capability will depend on improving the
earliness with which such data---and epidemiologically relevant
information such as work location--are collected. There are many
potential ways to do this, and the nation and its health systems need
to find workable solutions. This goal may require legislation to
facilitate such data collection. Congress may need to provide
incentives to specific industries that have needed data to develop
real-time, privacy-protected data feeds for public health early warning
systems.
3. There is a need for basic and applied research in early warning
systems for biological threats. Congress should provide funding through
the National Library of Medicine and the Agency for Healthcare Research
and Quality to support several interdisciplinary Centers of Excellence.
The National Library of Medicine is the principal federal funding
source for research and training in the field of medical informatics, a
field that has and can continue to provide tools and expertise needed
to accomplish these objectives. The Agency for Healthcare Research and
Quality has extensive experience in medical process improvement and
change management. The centers of excellent must be large and
interdisciplinary, comprising teams of public health physicians,
epidemiologists, contractors, medical informatics researchers,
mathematicians, and computer scientists, and they need to have multi-
year funding to attract and maintain highly qualified individuals.
4. Congress should encourage, through federal funding, several
cities and regions to participate in early warning research. The field
of biodefense is like the field of particle physics: a large particle
accelerator is necessary to answer certain questions, and in general
the bigger the accelerator the better. In the field of biodefense, the
equivalent of a large particle accelerator is a large geographic region
for which rich, multiple-year data sets are available for research and
system validation.
In closing, I would suggest that the Congress note that early
detection of major public health threats is an ambitious undertaking
that resembles in both urgency and technological breadth the Space Race
in the 60's and the Manhattan Project in the 40's. Those projects had
clear goal statements that facilitated the work of multiple teams
located in different regions of the country that were necessary to
accomplish the mission. The DARPA Biosurveillance Program is an example
of a program with a clear short-term objective to reduce detection time
by two days over current levels and a stretch goal of being able to
detect within a day of release, biological or toxicological agents that
threatens the health of its citizens.
Thank you very much for the opportunity to speak here today.
information about federally funded research
National Library of Medicine
The initial funding for this research into early warning systems
began in fall 1999, and came from the National Library of Medicine. The
agency approved a request to redirect an ongoing project (to develop
capability to detect rare health events automatically using health
system data) to the problem of early detection of bioterrorism. In the
ensuring two years, NLM has provided direct grant support of $200,000.
The National Library of Medicine has also supported this work by
funding trainees in medical informatics and infrastructure development
under grants for training in Medical Informatics and the Integrated
Academic Information Management Systems program.
Agency for Healthcare Research and Quality
In September 2000, the Biomedical Security Institute received a
$1,020,000, 1.5-year contract from the Agency for Healthcare Research
and Quality (AHRQ) to study basic questions including (1) What is the
capacity of existing information systems to detect outbreaks of
disease? (2) How can existing systems can be adapted to enhance early
detection of a bioterrorist release? (3) What data elements are needed
for early detection of a bioterrorist event? (4) What are the
performance characteristics (including sensitivity, specificity, and
timeliness) of different approaches to early detection of a
bioterrorist threat? And (5) How can computerized clinical decision
support be linked to early detection strategies?
Results of the AHRQ contract are described in two reports. The
first is entitled The Nation's Current Capacity for the Early Detection
of Public Health Threats including Bioterrorism, and the second is a
report due in late November entitled The Availability and Comparative
Value of Data Elements Required for an Effective Bioterrorism Detection
System. We have published additional results in papers titled Modeling
the Effects of Epidemics on Routinely Collected Data, and The Emerging
Science of Very Early Detection of Disease Outbreaks. The references
are listed for your convenient use in the next section.
Centers for Disease Control and Prevention
Also in September 2000, the Biomedical Security Institute entered
into a cooperative agreement with the Centers for Disease Control and
Prevention. In the first year of this agreement ('01), approximately
$540,000 (of $920,000) was provided for research on early detection.
The results of this research are described in five technical papers
that are also listed in Appendix II. The papers describe data modeling
for the National Electronic Disease Surveillance System, evaluation of
an electronic laboratory reporting system for notifiable diseases, the
use of routinely collected emergency department data for early
detection of respiratory outbreaks, and the use over-the-counter sales
of cough syrup and other products for early detection.
In the current fiscal year ('02), the Centers for Disease Control
and Prevention is providing an additional $400,000 (of $720,000) for a
number of projects including development of a health-system-resident
component for RODS, development of a trusted broker, analysis of how a
``zebra chip'' could optimally be deployed in a detection scheme, and
further support of ongoing work in natural language processing of chest
radiographs to identify patients with inhalational anthrax.
Defense Advanced Research Projects Agency (DARPA) Biosurveillance
Program
Recently (August 2001), we were awarded a contract by the Air Force
providing $1.6 M over 1.5-years to participate in the Defense Advanced
Research Projects Agency (DARPA) Biosurveillance Program. The program's
goal is to develop and validate city-scale prototypes of early warning
systems. The emphasis of the program is on the use of nontraditional
data. Our specific tasks include development of automatic detection
algorithms, computer-based simulations of epidemics for ``what-if''
analyses, and computer models of early response decision-making under
uncertainty.
Mr. Greenwood. Well, we thank you, Dr. Wagner, and thank
you for joining us this afternoon. I believe we are going to go
to Dr. Zelicoff next. You are recognized for 5 minutes for your
testimony.
TESTIMONY OF ALAN P. ZELICOFF
Mr. Zelicoff. Thank you, Mr. Chairman. I am going to be
departing from my prepared remarks. I would ask that if it is
possible and proper that my prepared remarks be entered into
the record.
Mr. Greenwood. Without objection, your remarks will be part
of the record.
Mr. Zelicoff. I will spend just a few moments introducing
myself. My name is Al Zelicoff, and as you heard, I am a senior
scientist at the Center for National Security and Arms Control
at Sandia National Laboratories, which is a Department of
Energy government owned laboratory.
I am a physician and physicist, and our center develops
technologies for counter-proliferation of weapons of mass
destruction, and for verification of the entire panoply of arms
control agreements of which the United States is a party.
I was in medical practice for about a decade, but my area
of interest since joining Sandia has been in non-proliferation
of biological weapons, and specifically in coming up with
clinical tools that could be of use for people who are actually
at the front lines of medicine.
There were a number of things that my colleagues in the
previous panel testified to with which I agree, and there were
a number with which I profoundly disagree, and I hope that I
will have a chance to flush some of those out in the question
period.
But let me tell you where I certainly do agree with some of
the generic and not so generic statements that were made
previously. Any system that we use for early surveillance has
to have a couple of characteristics that are pretty obvious.
You can't wear people out, and it should be local, and I
will be coming back to that point in a moment. It has to
maintain patient confidentiality. Obviously, the key
stakeholders who will be using the system should be involved in
its design.
It has got to be simple, and it has to serve as a
communication tool between physicians and public health
officials. I think all of those things are very obvious. Let me
lay a couple of other items on the table and then show you at
Sandia how we believe we have achieved at least an 80 percent
solution for all of those exacting requirements.
The information has to be accessible to other agencies and
decisionmakers on a need to know basis and that will vary from
agency to agency. The system has to be cheap, fast, and most
importantly of all, it has to be sustainable on its own merits.
If the system doesn't work because it helps physicians in
their daily practice, it is not going to survive, no matter
what. It does no good to send CDC officials, however well
trained they are, to sit in emergency rooms around the country
when we all know that there aren't nearly enough CDC officials
to go around. It is far too expensive, and therefore, not
sustainable.
Remember that we have a private health care system in this
country, and I don't know if that is going to change in the
future, but for the foreseeable future I expect it is going to
be private and it is fractionated.
Now, if I can call your attention to the screen, and if I
could ask that some of the lights go out. Let me tell you a
little bit about the Rapid Syndrome Validation Projection, or
RSVP for short.
This is a syndrome-based disease surveillance system that
has been developed with the help of the New Mexico Department
of Health in Albuquerque, and in my view some of the best
disease sleuths that the country has to offer.
As has been indicated earlier, we have broken all of the
rules of epidemiology. We are not using disease based or
laboratory based diagnosis. We are looking at syndromes which
are listed here, and I will have more to say about those in a
moment.
We do, however, permit the physician to enter reportable
diseases, and just to show you how awful that is in the real
world, let me indicate to you that the reportable diseases that
physicians are actually supposed to be aware of in the
community.
And let me tell you that the rapid syndrome validation
project is designed to be used by primary care physicians in
their offices and clinics, and the human in the loop is the
local public health official, the local epidemiologist who
unquestionably is the most knowledgeable person in the
community about diseases.
And the reason that I emphasized local a little bit earlier
is that disease patterns in communities vary from place to
place, and here is no one who knows the disease patterns in
their community or to borrow a phrase I think from Dr. Barry
earlier, who has the highly trained sophisticated genetically
engineered neuro network algorithm called the Mark One Eyeball
that can recognize disease patterns as they come and go through
a community, and determine simply by extent of experience what
is normal and what simply is not normal.
So, if you will give me 1 more minute, I will bring up the
software again. By the way this is not a canned presentation.
This is actually on-line and is precisely what physicians see
when they are using it in the community. And we have had this
on-line now for about 9 months in New Mexico.
And you will see in a moment that the only software that is
required for the person to use it is any available web browse,
which are all free, and so the barriers to entry here are
extremely small, and I believe that the cost, which I can
provide to you in some detail if you would like during the
questioning period, are also very small as well.
All right. So the physician logs in by choosing their user
name, and what we have put in in the local emergency rooms and
primary care clinics is a touch screen, because it is much,
much faster than using a mouse.
We were after about 45 seconds of the physician's time,
which most of you will recognize is about the attention span of
the average clinical physician today. Demographics are the
first part of epidemiology, and it answers three questions;
what, where, and when.
In the early disease investigation what you are trying to
determine if you are a local public health official is whether
or not to worry, and then begin a disease investigation as I
think has been indicated earlier.
So I will enter a zip code of work, and notice that the
system asks for additional information if you happen to hit yes
on travel, for example, and it asks if you traveled
internationally.
We have certain high risk occupations, like a postal
worker, for example; and I am going to pick one of the
syndromes, which is influenza like and that is the one that you
hear so much about.
This is a term of art in medicine. It is not a head cold.
It is severe illness, with fever, myalgia, muscle aches and
headache, generally accompanied by respiratory symptoms.
What we are after here to try to get the noise down and get
the information content up is the clinical judgment of the
physician. And I disagree with one of the previous testifiers
who stated that physicians aren't going to welcome one more
computer screen into their clinic.
Indeed, I have many people asking me for this system,
simply because as you will see, it gives something back to the
physician, as well as giving something to the epidemiologist.
All the other screens look pretty much the same, and
symptoms are at the top, and so I am going to enter somebody
who has a productive cough here, with severe muscle aches, and
I am going to allow this physician to say that they got a chest
x-ray and it was abnormal.
And the system actually prompts the doctor to look for
certain signs and symptoms that are actually classically
associated with terrorism diseases or diseases of public health
importance.
Not that the average doctor would know that. They don't.
But the system does. So in this case wide media stannum is a
particular finding on the chest x-ray, and almost always
associated with anthrax in the setting of an acute respiratory
illness.
In fact, it is anthrax until proven otherwise, although the
vast majority of physicians won't recognize that. We are done.
In practice, that takes about 30 seconds for the average
physician to do, and when we are done, three things happen.
The data goes off to the local server, which is sitting in
the local public health department. Second, that data that I
just entered got screened for combinations of signs and
symptoms that the local public health authority once again, and
besides local, are strongly correlated either with diseases of
public health importance--measles, for example--or are
associated with bioterrorism related illnesses.
If that combination of signs and symptoms happens to be
picked, the system automatically e-mails, faxes, and pages the
local epidemiologist who is on-call--there is almost always one
in every jurisdiction in the country--with all of the
information that I just entered, including the name of the
physician who logged in and their phone number.
That happens within 30 seconds, and so the State
epidemiologist, and in our case in New Mexico, can get on the
phone and call Dr. Zelicoff at UM Hospital, and remind him that
he might be seeing a case of anthrax, and would you please hold
that patient there.
And we will start the case investigation 2 days before that
person pops into the hospital, or at worst, 3 days when they
are having their autopsy done. But the most important thing of
all is what comes back to the physicians.
In all cases, this screen comes back and in the lower left-
hand corner what you see is the results of all culture data, of
all major respiratory passages, and it varies from syndrome to
syndrome.
And from the entire State, going all the way back to March,
and it would be foolish for a physician in October in New
Mexico to make a diagnosis of flu, for example, because there
is no flu in the communities at that time.
There is a temporal plot that shows similar cases, and most
important of all, there is an advisory message which is
controlled by the local public health authority that I like to
refer to as medical intelligence.
I think one of the committee members referred to the links
between epidemiology and intelligence, and indeed the advisory
message is the sum total knowledge of all information of local
public health officials have with reference to that particular
State, and it varies from syndrome to syndrome.
And finally the physician also gets a map, and this map is
zoomable to any portion of the United States, down to zip code
level, and it shows you that the epi-center right now of
respiratory disease in the Albuquerque area is in fact in
Albuquerque and it is coded.
And then it is color coded and then indeed other maps can
be laid on top of that for analysis. I will wrap up now, Mr.
Chairman, by making one final point. I served for 9 years on
the U.S. Delegation to the Biological Weapons Convention. It is
the only treaty that regulates or in fact bans the ownership of
biological weapons.
As a participant in that process, I believe that the
current administration was correct to reject the protocol to
straighten the biological weapons convention. I believe that
that protocol was not nearly worthless, but was actually quite
a bit worse than that.
In fact, it was worse than worthless. This is not merely an
opinion. My conclusions are backed up by the only
scientifically cogent, technically meaningful, mock inspections
done by any of the State's parties to the convention, which
were done here in the United States, yet actively ignored by
the decisionmakers during the time of the negotiation.
Let me be clear that the failure of that protocol lies
squarely at the feet of the previous Administration. The
delegation and the inter-agency working group suffered
enormously from a near total lack of leadership and a complete
absence of vision, which is a great tragedy.
Despite protestations to the contrary, there was no
thoughtful senior level involvement in the U.S. negotiating
strategy beyond a single tired phrase that appeared yearly in
the State of the Union address.
Because of the events of the last several weeks, I am very
sympathetic to the argument that for the short term and at the
moment, there is little time for policymakers to rethink our
approach to future protocol negotiations.
But when management of the current price no longer
dominates all the attention of the decisionmakers, I would urge
the U.S. Government to appoint a seasoned negotiator with one
key goal in mind; to establish an international system of
disease monitoring that is electronically based and a value to
clinicians, veterinarians, and their patients.
So in summary I believe we have identified a set of
electronic tools for both epidemiologists and clinicians in New
Mexico that meet the very exacting requirements that you heard
about from the previous speakers, and I would be very, very
grateful if you will take time to ask me more questions about
it, and I will be happy to entertain any other questions the
committee might have.
[The prepared statement of Alan P. Zelicoff follows:]
Prepared Statement of Alan P. Zelicoff, Senior Scientist, Sandia
National Laboratories
Mr. Chairman and distinguished members of the Committee, thank you
for the opportunity to testify today. My name is Alan Zelicoff, and I
am a senior scientist at Sandia National Laboratories in Albuquerque,
New Mexico. Sandia is a multiprogram laboratory of the National Nuclear
Security Administration (NNSA) of the United States Department of
Energy.
I am a physician and physicist at Sandia's Center for National
Security and Arms Control. Our center develops technologies for
counter-proliferation of weapons of mass destruction, and for
verification of the entire spectrum of arms control treaties to which
the United States is a party. I practiced internal medicine for about a
decade. My area of interest since joining Sandia twelve years ago has
been in biological weapons nonproliferation. I have pursued technical
work in the laboratory, as well as in my capacity as an Advisor for
nine years on the U.S. Delegation to the Biological Weapons Convention.
These activities have repeatedly demonstrated to me that we, as a
country, have not taken the biological weapons proliferation problem
seriously, and we have squandered important opportunities in the
international arena to strengthen norms against the acquisition and use
of biological materials as weapons. But more important, Mr. Chairman,
is that our public health systems and traditional medical care delivery
systems are minimally prepared to detect the early manifestations of
disease that is intentionally introduced into a community.
In any biological weapons attack, large or small, hours matter. I
hope to make this particularly important point vivid for the Committee,
and to make a suggestion for a simple measure that we can implement
immediately, not merely to plug the obvious gaps, but as a step toward
a systematic solution that will be of day-to-day benefit in the
diagnosis and treatment of all infectious diseases of public health
importance.
There are many dirty little secrets in medicine. One of them is
this: Practicing physicians don't report unusual diseases to local
public health officials (including signs and symptoms that could be due
to bioterrorism), and public health officials don't have the ability to
provide timely disease information to physicians working in clinics and
hospitals. In my ten years of medical practice, I never--not once--saw
a physician or physician assistant pick up the phone to report a so-
called ``reportable'' disease. Even in areas of the country where
reporting of a small set of key infectious diseases is a legal
requirement, physicians rarely comply. Why? The process is burdensome,
inefficient, and most importantly, almost never gives anything back to
the physician that is of relevance to the patient she is caring for.
The reporting network--and I use this term loosely--relies on
physicians first to recognize that they are dealing with an unusual
disease; second, to know the phone number of whom to call; third, to be
willing to wait for a public health officer to be available; and
fourth, to field follow-up phone calls and answer what seems to be a
never ending stream of questions. The first three are unlikely to come
to pass, and the fourth is a powerful disincentive against
accomplishing the first three.
Busy doctors--and they are busier, though not necessarily more
productive, than ever before--don't have time for this. Yet, they are
desperately in need of information about even common diseases
circulating in the community. As but one example, we know that 60
percent--yes, 60 percent--of antibiotics prescribed in the primary care
setting are unnecessary or inappropriate. During flu season when
viruses are causing disease, physicians routinely reach for the
prescription pad and write orders for antibacterial antibiotics. Part
of this is due to ignorance, and the other part is due to pressure from
patients who are themselves ill informed about the diseases that are
prevalent in their community. A system that provided physicians with
this knowledge alone, and the means with which to show their patients
what is going on in the disease mix at any given time would, in and of
itself, greatly improve the quality of medical care in the United
States and substantially reduce costs and the emergence of antibiotic
resistance.
You may be surprised to learn that the repository of knowledge
regarding infectious diseases resides not with the primary care
physician but in local (and I emphasize local) public health officials.
These highly trained specialists--physicians with specialties in
disease outbreak investigation (epidemiologists), veterinarians, and
nurses--know by dint of their long experience, the pattern diseases in
their area--which viruses are normal, what microbes are unusual, what
seasonal course diseases take, all of which varies tremendously from
place to place in the United States. Further, while public health
officials rarely see patients in the clinical setting, they are well
bearded in the truly novel diseases that primary care physicians and
community veterinarians see once in a lifetime if at all: plague,
anthrax, foot-and-mouth disease, and other potential bioterrorism
related diseases. It is perhaps best to think of epidemiologists as
disease hunters with the wits and senses of fine detectives, reinforced
by strong backgrounds in medicine and statistics. They are much more
than the usual doctor or veterinarian.
What is required immediately (actually, it has been required for a
long time) is an inexpensive tool that will establish and maintain
communication between overworked clinicians and out-of-reach public
health officers. The tool must be easy and intuitive to use,
ubiquitous, very fast, and sustainable on its own merits. It does
little, if any, longterm good to assign CDC epidemiologists to a few
hospitals in New York City only during a crisis, when we all know that
the costs involved are prohibitive and that there are far too few CDC
personnel to be in even the fifty largest metropolitan areas, let alone
everywhere.
But physicians and patients are everywhere; so are veterinarians
and the animals they care for. The challenge I have faced in my work is
figuring out a way to help these earliest-possible ``sensors'' of
disease report accurately to public health officials and meet all of
the demanding requirements I have just outlined. I think we have a
solution. It is not a ``complete'' solution, but it is an essential
part of a systematic solution. At Sandia, we have developed an
Internet-based, secure, inexpensive, simple reporting system that we
call the Rapid Syndrome Validation Project (RSVP). The Department of
Energy's Chemical and Biological Non-Proliferation Program--a small,
forward-looking, and creative bunch of planners--has funded this work.
What they realized about two years ago is that good health
surveillance (of animals and humans) is also good counter-terrorism
against biological weapons. Automated sensors are still a little way
off, and more to the point, will never be as ubiquitous as people. But
with some straightforward modeling, we at Sandia were able to show that
if public health authorities can be apprised of the earliest cluster of
illness that occurs a few days after a large scale bioterror attack
(rather than at the time of first death or even the time of first
positive laboratory test result), the vast majority of people exposed--
even to anthrax and smallpox--can be saved. This is because, by
definition, there will always be a few percent of the exposed
population who will show symptoms first. This will occur because some
people receive a larger dose of the biological agent, or because some
people are more susceptible to disease, biological variability being
what it is.
Equally important--and I can not emphasize this enough in light of
our recent experience in Florida and in the Washington area--is that
the system can show whether there is widespread exposure, or instead,
that it is likely to have been more localized. This is critical
information for decision makers. It goes directly to the question of
how many people need to be tested, how many people need prophylaxis,
and how many people should be followed-up. Mark Twain had it about
right when he said, ``It ain't so much knowing about that what is, but
not knowing about that what ain't.'' Reassuring the public with
substantive knowledge of the limits of exposure will make all the
difference in the use of resources should there be a large scale
dissemination, and all the difference in degree of disruption of our
lives should the use of decidedly low-tech but nonetheless terror-
inducing dissemination of anthrax by mail be repeated in other cities.
Let me show you briefly, how the system works.
I don't purport that syndrome-based surveillance is the complete
answer to our bioterrorism problem, nor that it is the salvation of the
decaying public health infrastructure in the United States. What it
does do, however, is provide an easy, inexpensive way to get the real
experts (public health officials) the data they need to decide whether
or not a disease outbreak investigation is warranted, at the earliest
possible time, well before our laboratory-based surveillance system
would alert them to serious disease in the community. It also gives
back to physicians something useful in the bargain.
We need a decision at the highest levels to begin with a system
like RSVP that is built with a view toward add-ons and augmentation for
various potential users, from local authorities (such as public health
officials and local governments) to national-level decision makers and
those who allocate precious remedial resources (such as FEMA and the
CDC).
One final thought: for the past nine years or so, the United States
has participated in negotiations in Geneva to implement measures to
strengthen compliance with the Biological Weapons Convention. As a
participant in Geneva and in the interagency work in Washington, I
believe that the current Administration was correct to reject the draft
Protocol. As I have testified and written previously, the Protocol is
not merely worthless; it is worse than worthless, as it would provide
easy refuge for cheaters and place unacceptable burdens on U.S.
industrial and military facilities. This is not merely an opinion. My
conclusion is backed up by the only scientifically cogent, technically
meaningful mock inspections conducted by any States Party to the
Convention--done here in the United States and actively ignored by the
low-level staffers who pretended or presumed to direct the formation of
our policy on the Protocol at the time. Let me be clear: The failure of
the Protocol lies, in my view, at the feet of the previous
Administration. The delegation and interagency working group suffered
enormously from a near total lack of leadership and a complete absence
of vision. Despite protestations to the contrary, there was no
thoughtful senior level involvement in the U.S. negotiating strategy
beyond a single tired phrase repeated yearly in the State of the Union
address.
Because of the events of the last several weeks, I am sympathetic
to the argument that for the short term, and at the moment, there is
little time for policy makers to re-think our approach to future
Protocol negotiations. But when the management of the current crisis no
longer dominates all of the attention of decision makers, I would urge
the United States government to appoint a seasoned negotiator with one
key goal in mind: to establish an international system of disease
monitoring that is electronically based and of value to clinicians and
veterinarians and their patients.
Ladies and gentlemen of the Committee, we have dawdled far too long
in addressing the collapse of the public health system. We have always
had, and will continue to have, a mostly non-government, private health
care system. Yet, the expertise for population health lies not in
individual practitioners but with the oft-forgotten state and county
public health epidemiologists who work with a dearth of data but a
plethora of expectation. We can and must do better than this. A simple,
Internet-based, syndrome-based reporting system is the key component of
a renewed, effective surveillance network that will serve us during
this critical hour, as well as after we have resolved this most acute
crisis, as we surely will. The questions are: How many lives will be
lost in the process, and how quickly can we restore a sense of
confidence to the American people? With inexpensive, readily available
tools, the medical and public health communities will be among your
chief agents and allies in relieving uncertainty and restoring faith,
which are so essential to getting people back to living their lives and
fulfilling their hopes.
Thank you Mr. Chairman.
Mr. Greenwood. Thank you, Dr. Zelicoff, and we certainly
will ask you questions. Mr. Russell, you are recognized for 5
minutes to provide your testimony, please.
TESTIMONY OF JOHN S. RUSSELL
Mr. Russell. Thank you, Mr. Chairman. Perhaps I should
pause and see if I am hooked up here to the system.
Mr. Burr. Mr. Chairman, while he is hooking up to that,
could I just take the opportunity to introduce John.
Mr. Greenwood. I wish you would, please.
Mr. Burr. He is from North Carolina, and he is the
Executive Vice President and General Counsel of Quintiles.
Quintiles is one of the largest data warehouses of medical data
in the United States, and it collects identified data from
hundreds of insurance companies, pharmacy benefit managers,
hospitals, and physicians.
They also conduct numerous clinical trials. Quintiles has
over 18,000 employees located in 38 countries, and they have
some of the most state-of-the-art de-identification software in
the private or public sector.
John, let me take this opportunity to welcome you since I
didn't earlier, and I certainly encourage my colleagues to pay
special attention to the resources that they have at their
fingertips today, and how that might be able to help us.
Mr. Russell. Thank you very much, Congressman Burr, for
that gracious introduction. Chairman Greenwood, Congressman
Deutsch, members of the subcommittee, my name is John Russell,
and I am the Executive Vice President of Quintiles
Transnational, which is the world's largest manager of clinical
trials for the pharmaceutical and bio-tech industries.
And, Mr. Chairman, while my comments will be brief, I ask
that my written statement be made part of the record.
Mr. Greenwood. And it will.
Mr. Russell. Thank you, sir.
What I want to speak to you this morning about is one of
our areas of expertise, which is health care and infomatics. We
have developed for commercial purposes a national system to
register on a daily basis prescription use and diagnostic
trends.
This system draws on a de-identified data base that
consists of pharmacy claims and medical claims posted for
insurance payment. The data base contains currently over 2.4
billion transactions, and is refreshed by 3 million claims per
day, representing health care experiences for more than 100
million anonymous persons in the United States.
It is also longitudinal. It has a 3-year life to it.
Through matching these medical claims with pharmacy
prescriptions, we can track disease trends and patterns. For
example, we can track the prescription of a certain drug in any
city of the United States.
In fact, in any zip code, and for the country as a whole.
We can by matching the prescriptions to the medical claims see
a disease pattern as it develops nationally overnight. The
system is automatic. It is fast, with reports that can be
delivered daily.
It is based on a pioneer technology that we developed in
the late 1990's. The technology is proven and in use. Now, let
me say why I think briefly how this system can begin to be part
of the solution.
We believe that this system can provide a complimentary
solution to a problem that we are all addressing today. It is
not--this system does not in any way substitute for the
absolutely indispensable work of local intelligence.
The problem as we see it is that the detection of a disease
outbreak is episodic, relying primarily on reports from the
field. If I may use a battlefield analogy, I would call this--
and I believe the chairman himself used this term, but I would
call this human intelligence.
It is indispensable, but incomplete. What is also needed is
an electronic national early warning system that we would
characterize as satellite intelligence to compliment this human
intelligence.
I am reminded of how perhaps we follow a storm, even on the
nightly news. I mean, we have a weatherman or a weatherwoman
who just reports from the field. And then we have a weather
satellite that tells us how the storm is approaching, and what
the speed and direction of it is.
And with these two things put together, we are better
informed, and I think we can have that system. Now, how does
our system work? The system as I said matches medical and
pharmacy claims to anonymous patients over the whole country.
It is both historical and current. That is, it tells a
story now and over time, and has the ability to benchmark
normal trends and spot the unusual, which is key to this
exercise; benchmarking and spotting anomalies.
It can be in its current state readily adapted with disease
markers, and what we would call sentinels. Also, intelligence
software in the form of neural networks that would actually
spot these anomalies and also throw out false positive
indicators.
And also with a communications capability that we have
already developed which would make this system send messages
out through E-mail and voice mail either to public health
officials or to doctors in the field, or to both, because it
would be adaptable in that way to both a national and a local
form of communication.
So equipped, let me give you an example of how it might
work and what it might do. Imagine five cities in five
different States, all located on a different reservoir. Suppose
in an overnight reading we saw that each of those cities showed
an increase against a benchmark of gastrointestinal symptoms
which we had previously marked for surveillance.
Our system would light up like a Christmas tree. It would
signal out to the health authorities. It would allow perhaps
precious hours, and maybe even a day, so that these symptoms
could be readily diagnosed by the expert doctors in the field.
Now, perhaps I could pause and show you some real examples
of how our current data base works. Let me refer you up to the
screen. This is a slide that represents a study that we
initiated immediately after the September 11 attacks, where we
decided to follow cipro use in New York City.
This is from our prescription data base. You see
interestingly an uptick on the actual day of September 11. That
might be because of the anticipation of casualties, because
cipro has many uses other than for anthrax.
Or also it could be for some preliminary stockpiling. But
then you see actually interestingly a large spike up, reaching
its apogee at October 12 when we had begun to hear warnings of
bioterrorist attacks, indeed first reports.
Now if I could show you this slide. As my diagnoses
increase in New York City after the terrorist attack, this is
from the medical side of the data base, also matched against
prescription claims.
And what we can infer is that after the September 11
attacks there is something of an uptick that you can notice in
asthma and upper-respiratory type ailments along the ICD-9 or
medical diagnosis patterns that we would see.
This could be because of air quality or because of stress.
It is an interesting piece of data, and it can be produced on
an overnight basis. Let me go to something else which shows you
a bit of benchmarking.
This is a lime disease study, and this was provided to CDC
as a means of tracking lyme disease in the year 2000. What you
see is that our automatic reporting system picked up over
27,000 cases to follow, and you can see that the spread of
those cases is somewhat beyond the traditional northeastern
United States locations.
Now, this is what the CDC reported, a little over 13,000
cases through the voluntary system. If you recall the slide
before, the spread is greater, and the concentration is very
similar, but again an interesting piece of complimentary data
to the local reporting system, that we would refer for further
analysis.
Now, to stress the point that this is both local and
national, I showed you a New York City slide about cipro use.
Now, this is the same slide on a national basis which actually
does show if you recall the New York City slide the bump up on
the week of October 12.
But that would be normalized on a national trend, and so
both local and national. Mr. Chairman, let me sum up by saying
that there are many things that I could say in summary, but let
me leave you with these thoughts.
The system in the data base necessary for real time
bioterrorism surveillance system exists today. It works
nationally and locally. It is a proven technology and it
operates on agreed reporting standards. This automated
surveillance system will operate without any additional
reporting by health professionals.
All the reporting is already done in order to affect
payment through the national payment system that you in your
wisdom so regularized through the HIPAA legislation and its
attendant regulations.
This system can be quickly adapted to use as a national
electronic early warning system to provide that satellite
intelligence that I was talking about. Mr. Chairman, with a
system like this, we can deliver more information faster. We
can inform those doctors in the field so that they can make
those ready diagnoses that we all talked about today.
We can get ahead of the threats that lie before us, and we
can play offense rather than defense. I thank the committee for
hearing our presentation today, and I would be glad to answer
any questions that you may have.
[The prepared statement of John S. Russell follows:]
Prepared Statement of John Russell, Executive Vice President, Quintiles
Transnational Corp.
Introduction
Chairman Greenwood, Congressman Deutsch, members of the
Subcommittee: My name is John Russell. I am Executive Vice President of
Quintiles Transnational Corp., the world's largest clinical research
organization and also the leader in monitoring medical and
pharmaceutical data to improve drug development and healthcare.
Thank you for the opportunity to participate in this critical
discussion about improving our nation's ability to detect and respond
to bioterrorism.
The Challenge
The key to our preparedness for biological attack is rapid
detection, determination of the source, and response. Every minute that
we can speed up that process can reduce the number of individuals
infected, and provide better odds for recovery for those who are. The
intentional release of a biological agent may not be recognized for
several days or more, during which time a biological agent can spread
to others who were not initially exposed. Some biological agents
produce symptoms that can be easily confused with influenza or other,
less virulent illnesses, leading to a delay in diagnosis or
identification.
Over the past few weeks, we have seen how our nation's current
disease surveillance system works. It relies primarily on reports from
the field. Health care professionals contact local, state or national
public health officials to report unusual diagnoses, reportable
diseases, or odd disease patterns, often prompted by specific alerts.
Analysis and response follows from this survey process.
This process is rightfully being improved to real-time standards;
but bringing an electronic environment to this network is deliberate
and fragmented work. Even as improvements take hold, for the
foreseeable future large segments of the public health surveillance
system will remain local, voluntary and people-intensive. While it
compiles critical information and provides definitive analysis of
confounding events, this ``human intelligence'' system--if I may borrow
a military term--should not stand alone in the current crisis.
The fact is that the technology exists today to deploy a parallel
system--a national early warning system--that could quickly signal
bioterrorist events directly to CDC and to any state and local public
health office online. The system works by collecting pharmacy and
medical data and relating it to de-identified patients to create
inferences of disease patterns. It is built on the national health
insurance payment system that exists now. This system would not replace
current reporting; rather, it would augment and complement local level
data with a near real-time national picture. In effect, it would give
local, state and national public health authorities a big-picture
perspective, a kind of ``satellite intelligence''--if I may continue
the military analogy--that complements ``human intelligence.''
The effect of running these systems in parallel is to permit public
health officials to react quickly to the truly surprising fact--flu-
like symptoms in West Coast port cities or gastrointestinal symptoms
near five scattered reservoirs--which can give the opportunity to
respond proactively. The advantages of this approach can be stated
succinctly. This electronic system is automatic, not voluntary. It
never gets tired. It covers the whole country, or any part, down to a
zip code. It operates daily. It is a proven technology. With a national
early warning system built on this foundation at their disposal, public
health officials at all levels could be deployed in advance, to play
offense rather than defense.
National Early Warning System: How It Works
The electronic early warning system we will describe will be built
on a system we currently use to generate weekly statistical analyses of
disease trends and treatment patterns across hundreds of conditions and
over 8,000 prescription drugs, which can be enhanced as needed. In
effect, this national early warning system could produce a virtual,
daily snapshot of disease trends and treatment patterns across the
United States. Its reach is both broad and specific in that it can
survey the whole country, or any Metropolitan Statistical Area (MSA),
or even any zip code. The data driving this system is de-identified
health data. Over 100 million patients are assigned a unique code that
attracts diagnostic and prescription events from insurance claims. The
results are both rapid and historical; in other words the story is told
in near real time and longitudinally over time.
Our health monitoring system analyzes the largest, integrated
warehouse of current medical and pharmaceutical data in the world--a
database that contains information derived from more than 2.4 billion
de-identified hospital, medical and pharmaceutical transactions. The
system is refreshed with about 3--million new transactions per day.
These include claims from thousands of pharmacies, hospitals and
physicians, and more than 680,000 total providers of pharmacy, medical
and dental services. [See Exhibit 1] This longitudinal data, linked for
each patient through a unique encryption engine, can provide, with
adaptation, a powerful tool for our national security.
To support this national early warning system, we will install
neural networks--software programs that ``learn'' and become
increasingly accurate over time in pattern identification and trend
prediction, that can distinguish, for example, between seasonal
variations in flu cases and real anomalies.
To give you an example of what this electronic early warning system
captures, if there is an outbreak of flu-like symptoms, the trend can
show up locally in our database as early reports begin to come into the
CDC and other public health authorities, often within a day. Similarly,
if there is a significant increase in antibiotic use, asthma diagnoses,
or anxiety disorders--all of which we have recorded in the New York
area since September 11 [Exhibits 2, 3, and 4]--the system can track
the progression of those events through the health system in something
close to real time, and we can analyze the data by age group, or zip
code, or date. To illustrate the sensitivity of the current data
sample, in the year 2000 we recorded a little more than 27,000 cases of
Lyme disease in the United States [Exhibit 8], while the CDC case count
projected about 13,000 cases. [Exhibit 9]
This system could be used to scan millions of patient medical and
pharmacy encounters per day, and--with the application of appropriate
analytics--provide U.S. public health officials with a near real-time
picture of disease patterns and treatment trends.
Let me stress further that deploying this system to monitor
indicators of potential bioterrorist events will not require any new
reporting mechanisms; that is, we don't need to ask doctors or
hospitals or pharmacies to do anything they don't already do today. As
suggested by our Lyme disease findings, the electronic claims payment
system--the mechanisms by which health care providers get compensated
for providing services--is likely to capture more and broader data than
a voluntary or special reporting system. Today, most pharmacy claims
and payments are submitted electronically and paid before the patient
leaves the store. Similarly, many hospitals and large provider groups
electronically transmit key health care data--the diagnosis and the
care rendered--daily. Certainly, while we wish to see more data--such
as claims from small general medical practices--submitted just as
quickly, a critical mass of health care encounter information flows
electronically today, and a national model that can take immediate
advantage of this fact can be built rapidly.
This system would allow for significantly faster and more accurate
detection of possible bioterrorist events than currently possible. In a
matter of weeks, we can demonstrate a prototype system to provide
critical bioterrorism tracking data to designated public health
officials at the local, state and national level. Moreover, the system
can be programmed to trigger electronic or voice-mail alerts to
designated federal and state government officials when anything out of
the ordinary is detected. This could provide significant benefits in
mitigating injuries or deaths from bioterrorism and tracking points of
origin of bioterrorist events, and for ongoing use in improving
effectiveness and efficiency of public health delivery by physicians on
the front line.
Prior Public Health Uses
Using this patient-level database and Web-based analytical tools,
we have performed several discrete projects in health care monitoring
and analysis, including vaccination monitoring (e.g., hepatitis),
public health screening (e.g., peptic ulcer disease), disease
prevalence trends (e.g., respiratory conditions), preventive health
(e.g., hormone replacement therapy), safety surveillance and risk
monitoring of drugs, and medical treatment patterns (e.g., surgical
techniques). The results of some of these projects have been provided
to federal agencies such as CDC and FDA. Indeed, CDC, while it had the
funding, used our database as part of a pilot project on anti-
bioterrorism. Speaking of our system, a former CDC official stated,
``In addition to their public health role, . . . information products .
. . promote an important national security interest--the detection and
prevention of biological terrorism . . . the breadth, reliability and
timeliness of . . . healthcare data are critical to this effort . . .
CDC can use this data for early detection of unusual prescription
patterns that could be evidence of an intentionally introduced disease
. . . such as smallpox . . . [which] would be a national and global
calamity if the earliest possible detection of the first wave of ill
person is delayed . . . [T]he saving of even a single day in detection
and response time can translate into the saving of hundreds or
thousands of lives and the prevention of a global pandemic.''--Sworn
testimony of Joel Greenspan, M.D., M.P.H., former CDC commissioned
officer and medical epidemiologist.
This capability is the result of developments in the commercial
sector and government regulations during the 1990s. By mid-decade the
private health insurance industry introduced a nationwide electronic
data interchange--or EDI--network that processed in real-time
pharmaceutical and medical insurance claims that were in electronic
form. The purpose was to route claims immediately from providers for
the proper payment sources for reimbursement. Congress encouraged this
development through the passage of the Health Insurance Portability and
Accountability Act (HIPAA) in 1996, and the Department of Health and
Human Services issued a series of regulations to provide oversight to
this national EDI system.
As this payment system developed, the aggregation of data from
these claims for analytical purposes to improve public health became a
possibility. By late decade, longitudinal databases were in use, and
the marriage of developing technology to healthcare improvement began
to show results. The latest HIPAA regulations generally encourage the
use of aggregated healthcare data, explicitly recognizing the benefits
of these data sets in improving healthcare quality and efficiency.
The pharmaceutical industry has been an initial user of the
system's capabilities. Now the national public health surveillance
system stands to benefit greatly.
Technological and Regulatory Origins of the System
The current monitoring system was created for commercial purposes,
following the confidentiality standards established by the HIPAA
privacy rule, and, consequently, registers particularity of zip codes
to the two or three-digit level. See, e.g., 45 CFR Sec. 164.514.
However, I would note that several exceptions to the HIPAA privacy rule
are permitted for activities in the public interest, such as: for
public health activities (e.g., CDC), for health oversight activities
(e.g., FDA), for law enforcement, to avert serious threat to health or
safety, for national security and intelligence activities, and for
protective services for the President and others. See, e.g., 45 CFR
Sec. 164.512. Therefore, in accordance with HIPAA provisions and the
government's specifications, the database could be enhanced to include
additional data fields and zip-code particularity to refine and augment
the accurate tracking and location of infectious disease patterns of
bioterrorism agents, such as smallpox and anthrax.
Benefits to Entire Public Health System
The usefulness of this system would extend considerably beyond
detection of possible bioterrorist events. Once in place, it could be
used by federal and state public health officials to analyze disease
patterns and treatment trends, aid vaccination monitoring and public
health screening, conduct cost-benefit analyses of alternative
treatments, enhance safety and risk monitoring of drugs, and improve
allocation of disease prevention resources.
To demonstrate the current effectiveness of this system, we have
attached several exhibits of particular research projects, some of
which we alluded to briefly above.
Exhibits 2, 5, 6, and 7 demonstrates the use of Cipro--the powerful
antibiotic typically prescribed for treatment (or prevention) of
serious bacterial infections, including gastrointestinal ailments,
pneumonia, bronchitis, and for conditions resulting from burns and
compound fractures, but also for anthrax--before and after the tragic
day of September 11--normalized for the day of the week and seasonal
variations. On September 12, our prescription database detected
[Exhibit 2] a small (~35%), though significant, increase in Cipro use
in New York City on September 11. This may be attributed to
prophylactic treatment against infections of the victims of the
terrorist attack and possibly some early stockpiling of Cipro. Then,
there was a rapid decrease, which was followed by a gradual, then
dramatic ~500% increase on October 12th in Cipro prescriptions in a 60
mile-radius of the World Trade Centers. This increase is likely due to
stockpiling of the drug from fears of bioterrorism attack with anthrax.
For the same time period, Exhibits 3 and 4 demonstrate an increase in
New York City of asthma symptoms and anti-anxiety drug prescription,
respectively, after September 11. These findings have been provided to
the CDC.
In a 60-mile radius of the Pentagon, Cipro use increased by ~100%
immediately following President Bush's warning on October 12th of
increased risk of terrorist attacks. [Exhibit 5] Moreover, our system
shows that Cipro utilization increased by more than ~200% in Miami-Dade
County on October 9th, which aligns with the first reported anthrax
case in that area. [Exhibit 6] Note, too, that on a national level,
Cipro use also increased after October 12th, but to a lesser extent
(~50%). [Exhibit 7]
In Exhibit 8, we showed to the CDC tracking of the spread of Lyme
disease in the year 2000 from actual cases reported in our system.
Compare this to the data shown in Exhibit 9 of the accumulated cases of
Lyme disease reported to CDC from State Health Departments. Note that
the claim-based database detected approximately twice as many Lyme
disease cases than did the physician-reporting system for the same
period. The spread of cases is also greater in the claims-based data,
although the areas of highest concentration remain constant.
In Exhibit 10, using the medical diagnosis database, we presented
to the CDC the detection of an E.coli outbreak in a county fair in
Washington County in New York State in 1999. Note the concomitant
increase in diagnosis of E.coli in fair attendees from the surrounding
counties.
Hard-to-find patients diagnosed with rare diseases also can be
tracked with this system. Exhibit 11 demonstrates the detection of 85
Brucellosis patients nationally in the year 2000 compared with 63 cases
reported to the CDC for the same period. We provided our results to the
CDC. Note that Brucellosis has been identified as a possible biological
agent for bioterrorism.
Summary
We urge the government to deploy an electronic national early
warning system as a 21st century tool in its defense arsenal against
21st century warfare--bioterrorism.
The database, infrastructure and statistical tools needed to build
and operate a national early warning system are already in place. Upon
commencing the project, experienced statisticians and healthcare
analysts could be turned to the bioterrorism challenge. In a matter of
weeks, modifications could be made to the basic infrastructure to
create a prototype system that detects a range of events and enhances
public health response.
First, we should determine, in consultation with public health
authorities, the ``marker'' or ``sentinel'' symptoms of a possible
bioterrorist event, such as flu-like symptoms and upper respiratory and
gastrointestinal distress, which are likely to be seen in hospital
emergency rooms and pharmacies, and which should be screened for
continuously.
Additionally, with neural network enhancements, we can deploy
increasingly sensitive modeling; that is, truly intelligent software
that can detect spikes such as those detected in Florida, or unusual
patterns in the data in order to alert public health officials, and at
the same time minimize false alarms. Our neural networks can ``learn''
and become increasingly accurate over time--distinguishing, for
instance, between seasonal variations in disease reports and real
anomalies. Finally, we can increase cooperation with local and state
public health networks that are striving themselves to migrate to near
real-time electronic data interchange. For public health purposes, the
government can encourage the use of patient health information reported
through Medicare, Medicaid, public hospitals, and U.S. Public Health
Service facilities to enhance the de-identified patient database.
Our existing electronic system can be configured to allow queries
by local, state or national public health officials who want
information specific to a given geographic area or a particular symptom
cluster, and it can be pre-set to send out e-mail or voice mail alerts
to those officials when certain patterns are recognized. Future
modifications could add even more communication capability for public
health officials across the national system.
Conclusion
History offers us many examples in which seemingly disparate, and
sometimes tragic, events converge to produce profound change for the
good. I believe we are at one of those moments in history.
This body had the foresight in 1996 to pass legislation regulating
healthcare electronic data interchange processes and technology. This
technology--created at first to improve the efficiency and speed of
medical and pharmacy reimbursements--now offers us a platform for a
greater good. Good intelligence from several sources and levels is
absolutely key to our fight against terrorism. This especially applies
to our fight against bioterrorism. We have already seen the sad results
of bioterrorism in our country. We need to bring every tool to bear for
the challenges ahead. We have an excellent system of human intelligence
that is even now improving. We need to complement this system with
healthcare's version of an electronic national early warning system.
Technology and the public health can be joined at this historic
moment. The result could be, and I believe it should be, a national
early warning system that can be employed in the fight against
bioterrorism--and used every day by public health officials seeking to
halt the spread of disease and save lives.
Thank you.
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Mr. Greenwood. Thank you, Mr. Russell. I appreciate your
testimony as well. The Chair recognizes himself for 5 minutes
for inquiry. Let me pose to each of you the question that I
posed to the first panel, and that is this.
This hearing is really designed to test a hypothesis, and
the hypothesis is that using the state-of-the-art information
technology, some of which we have just seen displayed, we could
in fact build a national and robust system that--and I will add
a little bit to the question, that does in fact not intrude
unnecessarily into the health care profession, but that can by
identifying abnormal increases in symptomatology anywhere in
the country give us the opportunity not only to do a better job
with infectious diseases in general, but to get a head start on
a potential outbreak caused by a bioterrorist attack.
And let me add to that, that if you believe that that is
the case, I would like to know your opinion as to what it might
take us in order to have that system ready as soon as possible.
We will start with you, Dr. Wagner.
Mr. Wagner. Well, the direct answer to your question is
that I believe that the hypothesis has already been partly
tested. We do know, for example, that epidemics leave
footprints in routinely collected data, and you just saw some
examples.
And we know that for quite a number of epidemics, and
different types of diseases, including water borne, food borne,
influenza, contagious diseases, like rubella and measles. And
we know it for quite a number of data sources, including health
services research data, which I guess is a broad category that
would include the data that we just saw on the screen.
We know it for grocery data; sales of tylenol, cough
syrups. We know it for clinical data, data being collected by
clinicians. And we also know that there are quite a number of
automatic methods for analyzing the data to actually detect
epidemics.
And we feel that the way in which we have partly answered
the hypothesis is through all the years in medical infomatics
research which have identified ways to integrate these data at
a national scale.
And we have also seen examples, and so that is my reason
for believing that the hypothesis is half-answered or two-
thirds of the way answered. I think it is probably answered
sufficiently well that we are sort of at the same point of the
Manhattan project and the space race of the 1960's, where at
the beginning--namely that the scientists and engineers--that
they were pretty confident that the job could be done, and a
decision was made to do the job.
They weren't certain, but the collective opinion was that
given the circumstances that it was worth making a try for it.
What steps would be needed to go from here to there? I think
incentivizing industries, like Mr. Russell, that have access to
certain types of data that are known to show early evidence of
epidemics is one step.
I think incentivizing regions and other data providers that
are outside the scope of fortuitous national data collection
schemes such as this one is another step that we would have to
take on that path.
We have to do it at a regional level because the number of
scientists and the number of engineers that are going to be
required, the talent is out there, but it is going to take a
concerted effort by all the talent to build that kind of a
system.
I think that actually the analytic part that sits on top of
this rocket if you will is made dependent upon that
infrastructure, but also an important piece, but not actually
the most critical piece. I think we pretty much know how to do
the analytics, but getting the data is going to be the critical
piece.
Mr. Greenwood. Thank you. Mr. Russell.
Mr. Russell. Mr. Chairman, I agree with a lot of what Dr.
Wagner said, but in particular the good news is that we are
probably further along than we think as far as being able to
put together the national system that you are talking about.
I mean, I can speak for what I just showed and what our
company's capabilities are. We have to start from somewhere,
and we could start right now. I mean, our system would answer
queries on a near real time basis and does.
We have worked with CDC on a bioterrorism pilot project in
the year 2000 and where some of these issues were explored. I
think to get a national system that works on the automatic
reporting that is already done through the health insurance
network, you are talking about a matter of weeks.
I mean, you are talking about putting or taking a system
that I showed you and putting together surveillance indicators
that we call the sentinels. You are talking about neuro
networks which would then begin to intelligently sort the data
and normalize it against baselines.
You are talking also about a communications system coming
out that would allow alerts to go out. That type of thing is
not far away. I mean, as I said, it is a matter of weeks that
we could adapt the system that I showed you to that particular
specification.
Mr. Greenwood. Dr. Zelicoff, and if you would also in your
response just make a note about with regard to the cyber-
security of the system, because obviously if we had a national
system, we would want it to be quite tamper proof.
Mr. Zelicoff. Okay. I will pick up on the positive points
with Dr. Wagner and Mr. Russell. I do think that we are a lot
closer. Understand that in order to have a so-called national
surveillance system that you do not have to have the system
everywhere.
Fortunately, statistics help us out a great deal. By my
calculations, they show that if we can survey 5 percent of the
clinics, and I would choose the 5 percent of doctors that are
most flexible in doing reporting, and believe it or not there
is such a 5-percent.
Then you have indeed covered the country with a high level
of confidence and you have minimized the amount of noise. What
does that mean? 2,500 clinics around the country, and it is a
few thousand dollars per site to buy a computer, and another
few hundred dollars a month to have an Internet connection, and
poof, you are done.
I would agree also with Mr. Russell that there are
automatic analysis tools out there that are in development, and
having written several papers on neuro networks myself, let me
warn you a little bit about the mystery of neuro networks.
They require an extensive training set against which they
can compare the data that is coming in. That means that you
have to have a lot of data already, and you have to know what
it is that you are looking for.
Having so done that, it is possible, and in fact
automatically train computers to do that. But I personally
believe that we are a long way away from that. That is why we
have put the human in the loop, which is the local public
health official, because they are the best neuro network that
we know of, and as was correctly stated earlier.
But having said that, we also do have a neuro network model
working in the background all the time, and that has nowhere
near enough data to actually make a call itself, but local
public health officials do.
With regard to security, our fundamental--and I think the
fundamental issue that confronts anybody who engages in a
system like this is protecting patient confidentiality. And the
we do that is three-fold.
There are no names, and we can smear out identifiers that
are not necessary. For example, the precise age. We smear it
out because it doesn't matter for an epidemiologist to someone
who is 18 or 19 years old in an epidemic, and if they are 75
versus 30, it speaks volumes.
And then finally all of our data is encrypted, going in
both directions, and authenticated; by which I mean that the
only people who can do data submission are people who have
recognized hardware addresses on their computer.
Anybody can go to the demo site and check it out, but it
would take quite a hacker to--it is not impossible, but it
would take quite a hatchet to break the authentication system
that we have.
So I believe that we have again the 90 percent solution as
far as security is concerned, and our most important concern,
if only to get this through institutional review boards, is
protecting patient confidentiality.
Mr. Greenwood. Thank you, Dr. Zelicoff. The Chair would
announce that we have a series of votes--we have three votes
now--and it will be at least 15 to 20 minutes until we can
complete that process.
So with your indulgence, we will recess until one o'clock
and if you ask around, you can find out where the Rayburn
places to eat are, and maybe you can grab yourself a bite in
the meantime. We will recess until one o'clock.
[Whereupon, at 12:33 p.m., the subcommittee recessed, to
reconvene at 1:15 p.m., the same day.]
Mr. Greenwood. If the witnesses will resume their stations,
we will resume the questioning, and the Chair recognizes the
ranking member, Mr. Deutsch, for 5 minutes to inquire.
Mr. Deutsch. For the three of you, are you suggesting that
basically we junk the NEDSS system? Is that your
recommendations? Are you suggesting that we basically get rid
of the present system, the NEDSS system, assuming that we
adopted NEDSS?
Mr. Zelicoff. I think you may be a little bit confused
about something. NEDSS is intended for epidemiologists, and not
doctors, to do reporting to the CDC. No clinician that I know
has or ever would entertain NEDSS in their office. I am sure
that there is some rare exceptions to this, because it is a big
on-line reporting form that gives nothing back.
As a tool between laboratories, or epidemiologists, and the
CDC, yes, it is just fine. But it is really bolstering the
laboratory side of surveillance, and I think the point that you
are missing, or maybe I have not made it clear, is that there
are two types of surveillance.
There is the laboratory type and there is the clinical
type, meaning what the doctor sees in the office or in the
clinic. The importance of that is two-fold, as I think Dr.
Bloom mentioned earlier.
You need the clinical information for knowing when to
trigger your laboratory system, and that is surveillance; and
then you need the clinical reporting system to know how many
people to test.
If we were faced with a large scale exposure and not
necessarily infection, but exposure, to anthrax spores in
Washington, we will never be able to test a million clinical
samples in a reasonable period of time.
What you need to be able to do is to decide where you are
going to apply your laboratory resources, and that is what the
clinical surveillance will do as Dr. Bloome correctly pointed
out. So, NEDSS is between the local public health authority or
laboratory and the CDC, and not from the clinician's office.
Mr. Deutsch. Do you want to respond?
Mr. Russell. Yes, I would like to respond. I think that
these systems are complimentary. I don't believe that the NEDSS
system as I understand it, and as it relates to our system at
least, is in any way in conflict.
What our system does is that it takes a very, very large
sample, one out of every three people in the United States,
over a couple of billion data points, and shows disease trends
that can be national or completely local on a near real time
basis.
And I do think that the NEDSS question though brings up
something that I have noted in this discussion this morning,
which is that there seems to be a false conflict between the
local and the national here.
I mean, I really don't see that. The system that we have,
for example, really acts at a State level, at the local level,
and at the national level. You can make it very specific for
certain indicators in any city, in any State, in any zip code,
and then across the whole country.
So that kind of dichotomy between should we fund local
efforts and knit them together nationally, or do we have a
national system, and is it inside the Beltway or outside the
Beltway. I think the technology exists here not to have that
even be a debate, and that is the way that I would look at it.
Mr. Deutsch. Dr. Wagner.
Mr. Wagner. I have some experience with NEDSS because I
helped write the Pennsylvania successful NEDSS proposal about a
year ago, and I have participated, and I think NEDSS is an
excellent project that has no shortcomings, and it is very
complimentary with everything that everyone else is trying to
accomplish.
And what it is really providing is a set of specifications
for infrastructure. This is the data base model that every
system that does public health surveillance in each State
should adhere to so that the data can be merged to form a
national picture.
The NEDSS project does not limit what kind of data is used
in public health surveillance. So in addition to the laboratory
data, the main stay of public health surveillance for the past
few decades, and reportable diseases, the NEDSS project is
going to incorporate all of these unusual types of data that we
have been talking about.
Mr. Deutsch. Let me at least give the opportunity to Dr.
Davidson and Dr. Barry, who are still here, to try to respond
to that. Would you like to respond to that and to my question?
My question is whether this is a complimentary system, or is
this an alternative system?
Mr. Greenwood. If either of you would care to comment or
response, please take one of the available chairs at the table
and use the microphones.
Ms. Barry. Thank you very much. I think technology has a
lot to offer, but I have some very specific concerns. For
example, in the system that the Quantiles has developed, I am
sure that they can pick up aberrations in data, but who is
going to follow up on those aberrations in data at the local
health department. It is me and my five nurses.
Where are we going to get the resources to follow up on
whatever signal that might or might not be detecting. And the
other concern that I have is timeliness of data. I see denying
data, which is a disease coding process, typically takes some
time.
We tried to get this into our Boston system, but we don't
know diagnosis until 30 to 60 days after the person leaves the
emergency department, and that is too late. We have got to know
within 24 hours if something is going on.
So I think technology is the answer, and we should use it,
and we should try to work to resolve some of these issues, but
I have some concerns both about timeliness and for resources
for follow-up with signal detection systems, which I think some
of these are.
With regard to the New Mexico system, the touch screen
technology is really quite nice, but there is no way in the
city of Boston--and I think I have excellent relationships with
the health care providers in the hospitals, but there is no way
that they are going to fill in a separate extra data screen to
try to give us data. We have got to mine what is there.
Mr. Russell. I would like to clarify one thing, because
this is complicated and I wanted to respond to what Dr. Barry
said. If you took the city of Boston and you were trying to get
daily reads on a disease trend, then what you would have in our
system would be all the private doctors offices.
You would have all the drug stores, and you would have the
entire panoply of what the providers are, both on the
pharmaceutical and the medical sides. So you would not be
relying entirely on what the hospital said and how they filed
their ICD-9 forms.
The ICD-9 forms are actually filed promptly by a lot of
doctors' offices and not as promptly by others. But you would
have a sample so large that you would have a trend line
developing. So it is complicated, and I take what you say that
it is hard to get the hospital themselves to process the ICD-9
forms.
Mr. Greenwood. Dr. Davidson, did you want to respond?
Mr. Davidson. Yes. I think one of the things that we need
to work toward--and this was brought up by one of the members
of the committee earlier, was establishing criteria for
surveillance systems.
There are some criteria for surveillance systems that have
been promulgated by CDC. And most recently about 4 months ago
there was a publication. We need to put those criteria out
there and see how they work with both of these systems. See
whether they meet the appropriate criteria for a surveillance
system.
In terms of timeliness, our experience is that the ICD-9
codes are coming in later than the syndrome-based systems. That
we found in our analysis, and that there is a delay, and
typically in our system--and that may not be typical of all
systems, especially in the private sector where they may be
getting these bills in quicker than we do in the public sector.
But we found that it could be a 10 to 20 day delay even in
a good clinic. So I think that is a concern for us. That is the
timeliness factor, and one of the criteria. The issues of
specificity and sensitivity are discussed in that document, and
I think those are some things that need to be addressed as
well, in terms of both of the systems that have been presented.
Let me get back to one point that Dr. Zelicoff mentioned
earlier about my comment, stating that this would not work in
some emergency rooms. I think I agree with Dr. Barry that many
physicians would not want that there.
I want to specifically speak about Denver Health, and where
we have this integrated electronic medical record. Here we are
trying to create a computer on every physician's desk, to enter
data into an organized data system to allow us to collect all
the information you need.
That system is built by our vendor. Now we have another
system that may be able to collect important public health
information. But we don't want to have to put that one on top
of the one that we are already entering data into.
So there may be a place for us--and once again using those
industry standards--to take what our vendor is building, and
put it through a process such as this. I don't know whether
that is possible. I think once again working toward standards
is the most important thing, and NEDSS pushes us toward that.
Mr. Russell earlier mentioned about a false conflict
between national and local efforts. I don't see this as a
conflict at all when we talk about NEDSS. They are methods to
integrate data across all jurisdictions. There is no conflict
here.
Mr. Greenwood. The time for the gentleman from Florida has
expired, and let me indicate to Drs. Barry and Davidson that if
you are willing to, you can stay at the table in case others
want to consult with you as well. The Chair recognizes the
gentleman from North Carolina, Mr. Burr, for 5 minutes, to
inquire.
Mr. Burr. That you, Mr. Chairman, and I am not sure what I
have come back in the midst of, but I will try to focus my
thoughts and legitimately say that I don't know that any of us
have the answers.
I mean, if we did, I think that you would hear it in our
opening statements, and you would certainly see us on a
legislative track to try to present some solution. Thank god
for once that Congress has turned to not only the public
entities, but the private entities and said what are our
capabilities today.
What we found in a very short period of time is that there
is a wealth of data. There is a wealth of effort that has been
put to try to create a system that works, a system that can
cross-check things, and a system that stretches outside of just
big cities and gets into rural America.
I would ask all of you as you are asked questions and as
you answer them to please understand that if everything we do
is turf related--well, this is already here, and so we can't be
replaced; or CDC already has this initiative, and so we can't
change.
What we are looking for is a solution now. It disturbs me,
and I think I made that very clear, that we didn't have a goal
today of 50 States on NEDSS. I don't know how the problem can
get more pronounced than it is right now. This is a domestic
threat.
Our ability to do the right thing is how we will be judged
and ultimately how the infrastructure for health will be
judged, and potentially each one of you who are connected to
it.
But we also have a responsibility not only to see that
large areas have access of connectivity, and access to data
bases, and accesses to everything that is happening in the
health community, but to make sure that the small ones do, too.
I would have hoped that there was a request from Congress
to connect the third of public health that is not
technologically connected to CDC today. But I have yet to hear
that request. I am sure that it won't take Jeff Koplan longer
than next Thursday when he testifies in front of this committee
to understand that that request should be made.
But even with a substantial amount of resources there was
very little devoted to what all five of you are here to talk
about, our ability to respond to the public health threat in
communities that you live in, or communities around the
country.
I am delighted with what the labs are doing. I am delighted
to know that we are trying to create a system out there, and
whether it overlaps something else or whether it can be
integrated into it, for once we are ahead of the game, and we
are working on something.
And, John, to Quintiles, you know, the question is why
didn't we look to a data base that we had that gave us some
clues before we had a problem? And I think that those are
certainly some of the questions that we have got to ask of
those entities that are responsible.
Not you at the table, but the entities that are responsible
for the network of public health in this country, because what
I heard both of you in the first panel talk about was that data
is invaluable to us when we get to the point that we have a
problem.
And our ability to look at it and to analyze it, and to go
specifically where we see a problem, is our ability to treat
that threat. I think Ms. Harman and I are the only ones on the
Intelligence Committee and she is not here right now.
But I can only thank God every night that this was not a
contagious disease that we were trying to address initially,
but that it was one that gave us some degree of flexibility,
and treatability.
And that time was not necessarily of the essence, but the
reality is that we have also had examples that this myth that
we worked under, that education alone, that dissemination of
the threat alone to our health care providers assured us that
nobody fell through the net.
And when we relied on that, we had two people that fell
through the net. We will deal with the other things, but I
think that we have got to stay focused on the fact that you can
fall through this net.
So, Mr. Chairman, I don't have a question. I just want to
thank everybody who is here--the witnesses from the first
panel, and our witnesses from the second panel. And I do hope
that in a coordinated way CDC and HHS will look at how we use
the combination of tools that are there today to try to put
together a solution to the problem that is here today.
And if in fact it requires resources on our part, and that
there is a request, because I think we are willing to address
it, and if it requires new partnerships that are public and
private, then I would like for those partnerships to be created
today or tomorrow, and not next year or 2003.
Because I assure you that the threat will change, the
challenge will change, and there is some things that we know
that we just can't accomplish without an infrastructure in
public health to accommodate those types of threats.
And my hope is that next week we will hear that request for
at least the infrastructure, and then we can talk about
facilities at CDC and other places. And I yield back.
Mr. Greenwood. Okay. I thank the gentleman, and I also
thank him for bringing to the attention of this committee Mr.
Russell and his work, which has been very helpful to us. The
Chair recognizes the gentlelady from Colorado for 5 minutes to
inquire.
Ms. DeGette. Thank you. Dr. Zelicoff, in order to implement
your system, and to really have it work from an epidemiological
standpoint, it would have to be pretty much universal with
doctors and emergency rooms, correct?
Mr. Zelicoff. No.
Ms. DeGette. Why not?
Mr. Zelicoff. I don't know if you were here when a somewhat
similar question was asked earlier.
Ms. DeGette. I probably wasn't; otherwise, I would not have
asked it again.
Mr. Zelicoff. Statistics helps us out here a great deal.
All you have to do is sample about 5 percent of the population.
Ms. DeGette. So does that mean that you would only have to
have your computer program in 5 percent of the doctors' offices
in this country?
Mr. Zelicoff. As long as you have them reasonably
distributed, accounting for geographic, racial, and
socioeconomic examples, yes.
Ms. DeGette. Well, here is the problem that I have, and as
I looked at what it cost to do that, did someone ask that also?
Mr. Zelicoff. Yes, $2,000 a site. So we actually got a
little bit further in the questioning. We estimate 2,500
clinics roughly, at $2,000 a site, and call it $15 million.
Ms. DeGette. So it would cost about $15 million to do this?
Mr. Zelicoff. Right.
Ms. DeGette. And would it mainly be in private doctors'
offices or in public hospitals, or both?
Mr. Zelicoff. We have it in both, and the reason that we
have it in both----
Ms. DeGette. Well, I don't need to know the reason. I want
to know----
Mr. Zelicoff. We have it in both right now.
Ms. DeGette. Okay. And at those 25,000 (sic) sites or
whatever, they would be in both also?
Mr. Zelicoff. Oh, sure.
Ms. DeGette. And those would be sites that volunteered to
do it?
Mr. Zelicoff. The way we have done it is to ask local
public health officials who know the docs in the community best
to nominate sites.
Ms. DeGette. Like the doc in my community who is sitting
next to you, they may not need it in Denver, because they have
already got a vendor that has an integrated system, and they
are tied into the CDC, and so they wouldn't need it, right?
Mr. Zelicoff. Not in my view.
Ms. DeGette. So, my question----
Mr. Zelicoff. Let me finish the question. In my view, I
think your conclusion is incorrect.
Ms. DeGette. But it would be voluntary on their part, and
you are not going to force them to do it?
Mr. Zelicoff. Oh, sure. Of course. They are doctors and
they can do anything that they want.
Ms. DeGette. Well, that is generally the view of every
doctor that I have ever met. So, you are right. But here is my
problem. Denver Health says we have got a very good system, and
it is working great, and it is integrated, and we can't put
your system in our vendor. So go somewhere else.
Go to New Mexico, or go to wherever, and then we have some
kind of biological or chemical weapon that is dispensed over
Mile High Stadium during a Bronco game. So by using your
statistical derivatives, you would not get that through your
system because you wouldn't have it in that city, right?
Mr. Zelicoff. Let me try to shed a little light on this
question, because I think there is a little bit of a
misperception. As long as any of the systems that are out
there, ours included, have compliance with the existing medical
data base architectures--COAS is the standard one, H-7--and
ours does, there is no problem in sharing the data.
It is solely then as a matter of the interface, and getting
the system sustainable so that people will use it.
Ms. DeGette. Right. But what you are saying is that you are
extrapolating data through 25,000 sites.
Mr. Zelicoff. No, 2,500.
Ms. DeGette. I'm sorry, 2,500 sites throughout the entire
country.
Mr. Zelicoff. Yes.
Ms. DeGette. When we are talking about biological or
chemical welfare, we are not necessarily talking--and the
recent attacks are a perfect example. We are not talking about
attacks over San Diego, California, or Chicago, Illinois, or
Denver.
We are talking about attacks apparently at this point
isolated in a few cities. So if they weren't tied into your
network, that wouldn't necessarily be the best tool in
predicting the attack, correct?
Mr. Zelicoff. Well, if what you are saying is that we are
gathering data and no one is looking at it, correct. It won't
work. But the data----
Ms. DeGette. Well, the----
Mr. Zelicoff. And let me finish the answer. I am supposed
to tell the truth and the whole truth. The answer is that the
data structure is such that all existing commercial medical
data base compliance systems will be able to use the data that
we are gathering, and it is up he local public health officials
if they want to release it.
Ms. DeGette. Right, but they are not required to fold in,
and so you don't know. Now, this hearing is called, ``Review of
Federal Bioterrorism Preparedness Programs: Building an Early
Warning Public Health Surveillance System.'' And this is--and
we are all really concerned. I mean, I was listening to what
Mr. Burr was saying, and I agree with much of it. Unlike what
many people think right now, Congress is not an unlimited pot
of money.
We have to try to figure out where we are going to put our
resources, which frankly are becoming more strained every day.
My concern with the recent attacks that we have seen--and like
Mr. Burr, I think we have to extrapolate.
We have to say let's not assume the next attack is going to
be some letters with anthrax in it. Let's say it is going to be
a poison gas attack, or a communicable disease attack. The
question we have to answer is, No. 1, are our existing public
health systems sufficient to have early detection of that.
And if the answer is no, then we had better do something
fast. But it seems to me that in the recent attacks we actually
had pretty good early detection by physicians in Florida, and
other places, of risks.
And tragically some people died, but at least we were
able--I mean, a physician was able to diagnose anthrax, for
example.
Mr. Zelicoff. All right.
Ms. DeGette. So my question is if we had your system or any
other new system in place, and we had a massive attack, what
would be better, having a computer system in place to know that
we are having a massive attack, or having the extra resources
going toward public health officials or beds or quarantine
units, so that we could actually treat those patients.
I think that those are the very real decisions that we are
making in a public health context right now.
Mr. Russell. Could I respond to that? I think that to
answer your question where is it better to put the money--I
mean, that is always the choice. I think, however, that if we
are at war and the President says so, and I believe him, then
you have got to have at least several types of intelligence to
deal with.
And I think to say that you are going to choose among
several systems, and choose one that is the very best one, and
the silver bullet is not going to get you there. But I do think
you can do something.
One message to take away is that we don't have to start
from scratch. I think all these systems are good. The virtue of
the existing data base that we have introduced is that it is
not a development project.
If you are looking for money that will go to work now, then
you could--and it is not just our data base, as you have data
bases that are there.
Ms. DeGette. And what your data base basically does is it
tells physicians that there is a lot of cipro being prescribed
here and what does that mean, right?
Mr. Zelicoff. Well, that's not--let me say that in order to
make a working prototype of a surveillance system from what you
saw on the screen, you would make it much more specific, and I
alluded to this in the testimony.
You would take sentinels and markers, and they would say
exactly what you wanted to look for, in Denver, or in Boise, or
wherever.
Ms. DeGette. Right, based on drug prescriptions.
Mr. Zelicoff. Well, based on a combination of drug
prescription and medical diagnoses.
Ms. DeGette. Okay.
Mr. Zelicoff. And the match of those against----
Ms. DeGette. And what do we do with that information that
we don't have the ability to do now?
Mr. Zelicoff. Okay. Let's say that you wanted to measure an
increase of flu-like symptoms in Denver against a baseline, and
because the data base is longitudinal, you could establish a
baseline.
And then you would have an alert that would come up, and it
would be communicated out to whoever in Denver wanted to have
it. Would it be the public health official, or would it be a
network of physicians.
Ms. DeGette. Well, excuse me. My time is way up, and the I
appreciate the Chair's indulgence. Don't we have that ability
right now under the NEDSS system and other systems?
Mr. Davidson. No.
Mr. Zelicoff. No, I am sorry to say that you don't. You
don't have that ability.
Ms. DeGette. I would like to have Dr. Davidson respond.
Mr. Davidson. Currently, we don't have that available.
NEDSS is built to allow us to collect that information, the
same way that they would be collecting it from ICD-9 codes
using billing data.
Part of the issue as I mentioned earlier is whether this is
timely. Does this meet criteria for an effective surveillance
system, and that is the question.
Ms. DeGette. I just have one last question, and then I know
that my time is long up, because something really leaped out at
me in your written testimony, Dr. Zelicoff, and it is a little
bit off-subject, but I would like to get a clarification.
Mr. Zelicoff. Sure.
Ms. DeGette. Which is that you said that 60 percent of
antibiotic prescriptions written in the primary care context
are unnecessary and inappropriate partly because of the lack of
knowledge.
Mr. Zelicoff. Right.
Ms. DeGette. I am wondering if you can extrapolate from
your data how many cipro prescriptions written in the past
month would fit into this category.
Mr. Zelicoff. Well, I couldn't other than to make the
general statement that I think it has been vastly over-
prescribed.
Ms. DeGette. But you don't have a scientific conclusion
based on any data?
Mr. Zelicoff. I have not seen the raw data on the clinical
cases. I would have to do that. I would have to correct one
thing that you said early on, which was with regard to the
success of the existing public health system. No scientist
would ever declare a success based on an end of two.
There were two cases that were diagnosed promptly. We know
from many studies that have been done that when you take
pictures, for example, of classic smallpox rash into academic
medical centers all over the country, and just say what is
this, nobody, and I mean nobody, gets the diagnosis right. Now,
this week, they might get the diagnosis right, but 6 months
from now, I don't know.
Ms. DeGette. Well, thank you for the clarification. I guess
I am just not seeing how if in that hospital where the anthrax
was found and diagnosed, if they didn't have this system, how
it would be of any additional help. I tend to be sort of a
budget hawk, and so that is what I am looking at here. Thank
you very much.
Mr. Greenwood. The gentlelady's time has expired. I think
that part of the answer is that we are talking about two very
different scenarios, and the anthrax scenario is very isolated
at least so far; whereas, we are talking about epidemics, and
in the case of infectious disease, that if a particular clinic
was not equipped with this data, this data collection system,
the assumption is that other clinics would be picking it up in
the environments.
I want to ask Dr. Wagner a question, and that is just
simply would you just take a couple of minutes and explain in
detail how your system works, because I am not really sure that
we have that quite on the record quite yet.
Mr. Wagner. Thank you for that question, because I felt
like I had not explained it sufficiently in my spoken
testimony. As I said, the system relies most heavily on data
that is delivered computer to computer in real time.
The most early data about illness that is collected at
present by the system is the symptoms of the patient when they
first present to the emergency room. And those symptoms are
either coded in ICD-9, and so the comment that ICD-9 codes are
inherently late is not accurate.
ICD-9s are just a coding scheme, and when it is applied, it
determines whether it is early or late; or the pretext, where
the patient has a cough and shortness of breath, and we use
natural language processing to extract the nature of the
symptoms.
So for a large sample of patients, there are symptoms where
when they should up at the emergency room, and prior to the
time that they see a physician, are known immediately
regionally, and available for analysis. That is the earliest
data.
Then the additional data that flows in behind those initial
data about patients are their tests that were ordered, and then
subsequently the results of the patient that is seen in the
emergency room as blood cultures are ordered, and that
information is known at the time that it is ordered, which is
usually pretty early in the case.
And then subsequently when the results come back, they are
available, and there is natural language processing that
determines whether the gram stain of a blood culture is growing
gram positive rods, which is a specific finding, or a
relatively specific finding; when coupled with chest x-ray
findings, which are also being automatically processed by
natural language processing.
So the combination of gram positive rods in the blood, with
a wide medium stannum, or some other finding on the chest x-
ray, triggers an alert that there is an anthrax patient
potentially that needs to be followed up.
One related thought that I just want to mention is the
issue of whether public health will be overwhelmed by the
output of these systems in electronic lab reporting, and if all
of these features are necessary.
And we have been operating for 2 years, and we see very few
false alarms. I can understand why the impression is out there
that these systems should have more false alarms than they do,
because that was our expectation.
But we are seeing an alarm a month, and we are monitoring
for respiratory disease, diarrhea, rash, encephalitic.
botulinic, and the anthrax detector, the single case detector,
went off once.
Mr. Greenwood. Thank you, Dr. Wagner. I thank all of the
panelists for your generosity with your time, and for your
testimony, and for your health. This hearing is adjourned.
[Whereupon, at 1:47 p.m., the subcommittee was adjourned.]
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