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+
+ - DISEASE SURVEILLANCE SYSTEMS
+
+[House Hearing, 108 Congress]
+[From the U.S. Government Publishing Office]
+
+
+
+ DISEASE SURVEILLANCE SYSTEMS
+
+=======================================================================
+
+ HEARING
+
+ of the
+
+ SUBCOMMITTEE ON EMERGENCY PREPAREDNESS AND RESPONSE
+
+ of the
+
+ SELECT COMMITTEE ON HOMELAND SECURITY
+ HOUSE OF REPRESENTATIVES
+
+ ONE HUNDRED EIGHTH CONGRESS
+
+ FIRST SESSION
+
+ __________
+
+ SEPTEMBER 24, 2003
+
+ __________
+
+ Serial No. 108-27
+
+ __________
+
+ Printed for the use of the Select Committee on Homeland Security
+
+
+ Available via the World Wide Web: http://www.access.gpo.gov/congress/
+ house
+
+ __________
+
+
+ U.S. GOVERNMENT PRINTING OFFICE
+20-168 WASHINGTON : 2005
+_____________________________________________________________________________
+For Sale by the Superintendent of Documents, U.S. Government Printing Office
+Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512�091800
+Fax: (202) 512�092250 Mail: Stop SSOP, Washington, DC 20402�0900012005
+
+
+ SELECT COMMITTEE ON HOMELAND SECURITY
+
+ CHRISTOPHER COX, California, Chairman
+
+JENNIFER DUNN, Washington JIM TURNER, Texas, Ranking Member
+C.W. BILL YOUNG, Florida BENNIE G. THOMPSON, Mississippi
+DON YOUNG, Alaska LORETTA SANCHEZ, California
+F. JAMES SENSENBRENNER, JR., EDWARD J. MARKEY, Massachusetts
+Wisconsin NORMAN D. DICKS, Washington
+W.J. (BILLY) TAUZIN, Louisiana BARNEY FRANK, Massachusetts
+DAVID DREIER, California JANE HARMAN, California
+DUNCAN HUNTER, California BENJAMIN L. CARDIN, Maryland
+HAROLD ROGERS, Kentucky LOUISE McINTOSH SLAUGHTER,
+SHERWOOD BOEHLERT, New York New York
+LAMAR S. SMITH, Texas PETER A. DeFAZIO, Oregon
+CURT WELDON, Pennsylvania NITA M. LOWEY, New York
+CHRISTOPHER SHAYS, Connecticut ROBERT E. ANDREWS, New Jersey
+PORTER J. GOSS, Florida ELEANOR HOLMES NORTON,
+DAVE CAMP, Michigan District of Columbia
+LINCOLN DIAZ-BALART, Florida ZOE LOFGREN, California
+BOB GOODLATTE, Virginia KAREN McCARTHY, Missouri
+ERNEST J. ISTOOK, Jr., Oklahoma SHEILA JACKSON-LEE, Texas
+PETER T. KING, New York BILL PASCRELL, JR., New Jersey
+JOHN LINDER, Georgia DONNA M. CHRISTENSEN,
+JOHN B. SHADEGG, Arizona U.S. Virgin Islands
+MARK E. SOUDER, Indiana BOB ETHERIDGE, North Carolina
+MAC THORNBERRY, Texas CHARLES GONZALEZ, Texas
+JIM GIBBONS, Nevada KEN LUCAS, Kentucky
+KAY GRANGER, Texas JAMES R. LANGEVIN, Rhode Island
+PETE SESSIONS, Texas KENDRICK B. MEEK, Florida
+JOHN E. SWEENEY, New York
+
+ JOHN GANNON, Chief of Staff
+
+ UTTAM DHILLON, Chief Counsel and Deputy Staff Director
+
+ DAVID H. SCHANZER, Democrat Staff Director
+
+ MICHAEL S. TWINCHEK, Chief Clerk
+
+ ______
+
+ Subcommittee on Emergency Preparedness and Response
+
+ JOHN SHADEGG, Arizona, Chairman
+
+CURT WELDON, Pennsylvania, BENNIE G. THOMPSON, Mississippi
+W.J. ``BILLY'' TAUZIN, Louisiana JANE HARMAN, California
+CHRISTOPHER SHAYS, Connecticut BENJAMIN L. CARDIN, Maryland
+DAVE CAMP, Michigan PETER A. DeFAZIO, Oregon
+LINCOLN DIAZ-BALART, Florida NITA M. LOWEY, New York
+PETER KING, New York ELEANOR HOLMES NORTON, District of
+MARK SOUDER, Indiana Columbia
+MAC THORNBERRY, Texas BILL PASCRELL, JR., New Jersey
+JIM GIBBONS, Nevada DONNA M. CHRISTENSEN, U.S. Virgin
+KAY GRANGER, Texas Islands
+PETE SESSIONS, Texas BOB ETHERIDGE, North Carolina
+CHRISTOPHER COX, California, ex KEN LUCAS, Kentucky
+officio JIM TURNER, Texas, ex officio
+
+ (ii)
+ CONTENTS
+
+ ----------
+ Page
+
+ STATEMENTS
+
+The Honorable John B. Shadegg, a Representative in Congress From
+ the State of Arizona, and Chairman, Subcommittee on Emergency
+ Preparedness and Response...................................... 1
+The Honorable Christopher Cox, a Representative in Congress From
+ the State of California, and Chairman, Select Committee on
+ Homeland Committee
+ Oral Statement................................................. 3
+ Prepared Statement............................................. 4
+The Honorable Bennie G. Thompson, a Representative in Congress
+ From the State of Mississippi, and Ranking Member, Subcommittee
+ on Emergency Preparedness and Response......................... 2
+The Honorable Jim Turner, a Representative in Congress From the
+ State of Texas, and Ranking Member, Select Committee on
+ Homeland Security.............................................. 69
+The Honorable Donna M. Christensen, a Delegate From the U.S.
+ Virgin Islands................................................. 71
+The Honorable Jennifer Dunn, a Representative in Congress From
+ the State of Washington........................................ 67
+The Honorable Jim Gibbons, a Representative in Congress From the
+ State of Nevada, Prepared Statement............................ 6
+The Honorable Christopher Shays, a Representative in Congress
+ From the State of Connecticut.................................. 74
+
+ WITNESSES
+
+Ms. Janet Heinrich, Director, Public Health Issues, U.S. General
+ Accounting Office
+ Oral Statement................................................. 27
+ Prepared Statement............................................. 28
+Mr. Joseph Henderson, Associate Director for Terrorism
+ Preparedness and Response, Centers for Disease Control
+ Oral Statement................................................. 7
+ Prepared Statement............................................. 10
+Guest: Dr. John Loonsk........................................... 75
+Dr. Paul Keim, Cowden Endowed Chair in Microbiology, Northern
+ Arizona University and Director, Pathogen Genomics at T-Gen.... 63
+Dr. Richard Platt, Chair of the Ambulatory Care and Prevention,
+ Harvard Health Plan
+ Oral Statement................................................. 40
+ Prepared Statement............................................. 48
+Dr. Jonathon Temte, Infectious Disease Specialist, American
+ Academy of Family Physicians
+ Oral Statement................................................. 56
+ Prepared Statement............................................. 58
+Mr. Jeffrey Trent, President of the Translational Genomics
+ Research Institute and Former Director, National Human Genome
+ Research Institute
+ Oral Statement................................................. 61
+ Prepared Statement............................................. 62
+
+ APPENDIX
+ Material Submitted for the Record
+
+Prepared Statement of the Honorable Shelley Berkley, a
+ Representative in Congress from the State of Nevada............ 83
+Questions and Responses from Ms. Janet Heinrich, Director, Health
+ Care, Public Health Issues..................................... 85
+Prepared Statement of Mr. Christopher K. Lake, Director,
+ Hospital, Preparedness, Nevada Hospital Association............ 122
+Questions and Responses from Dr. Richard Platt, Chair of the
+ Ambulatory Care and Prevention, Harvard Health Plan............ 86
+Questions and Responses from Dr. Jonathan L. Temte............... 87
+
+
+ HOW CAN THEY HELP US
+ PREPARE FOR BIOTERRORISM?
+
+ ----------
+
+
+ WEDNESDAY, SEPTEMBER 24, 2003
+
+ U.S. House of Representatives,
+ Subcommittee on Emergency
+ Preparedness and Response,
+ Select Committee on Homeland Security,
+ Washington, DC.
+ The subcommittee met, pursuant to call, at 2:54 p.m., in
+Room 2318, Rayburn House Office Building, Hon. John Shadegg
+[chairman of the subcommittee] presiding.
+ Present: Representatives Shadegg, Shays, Diaz-Balart,
+Thornberry, Gibbons, Thompson, Norton, Christensen, Etheridge,
+Lucas of Kentucky, Cox, Turner and Dunn.
+ Mr. Shadegg. [Presiding.] The committee will come to order.
+I would like to welcome our panel. I apologize for the slight
+delay in starting. As you know, we had a series of votes on the
+floor. I am certain there will be members trickling in over the
+next few minutes.
+ Today, we will be examining the role of disease
+surveillance systems in preparing our nation for bioterrorism.
+Clearly, the most preventive action we can take in terms of
+bioterrorism prevention and preparedness is to develop
+countermeasures against them so that even if terrorists strike,
+their intentions would be thwarted because the American public
+would be immune.
+ The committee and the House took a critically important
+step by passing Project Bioshield, an effort to stimulate
+investment in bioterror countermeasures. I am pleased that
+funding for that important program was approved as a part of
+the homeland security appropriations conference report passed
+just earlier today.
+ While we wait for the innovation of biotech, pharmaceutical
+and medical device companies to develop those countermeasures,
+however, the second most preventive thing we can do is to be
+looking at ways in which to be able to detect a potential
+outbreak through either surveillance systems or monitors so
+that we can take proactive steps to stem its spread. That is
+the focus of our hearing today.
+ Whether terrorists choose to spread a pathogen through the
+air, through our food supply or through our water supply,
+although sensors are being developed and tested, we likely
+would not know that such an attack had occurred until many
+citizens showed symptoms of that disease or that sickness. But
+how would we know that these symptoms are more than just an
+outbreak of the flu or a series of colds? How would we know,
+indeed, that patient symptoms were the result of a release of a
+bioterror agent? Would our primary care and emergency
+department physicians, the so-called ``canaries in the coal
+mine,'' be able to decipher the difference? Or would we have to
+wait for additional investigation by health plans and insurers
+to take place before we were able to recognize a pattern of
+sickness as in fact a bioterror attack?
+ Today, our expert panel will help us answer these questions
+and walk us through how disease surveillance systems work and
+what can be done to improve them and our nation's ability to
+detect bioterror attacks. With passage of the Bioterrorism Act
+of 2002 and subsequent appropriations, Congress has invested
+over $2 billion in bioterrorism preparedness and response. The
+bulk of that money has gone to the Center for Disease Control
+which spent over $1 billion upgrading public health laboratory
+capacity. Some of this money was spent to update and modernize
+many State and public health labs and computer equipment for
+improved communications ability. The CDC has been working to
+establish several information surveillance systems to move
+disease reporting from a paper-based system to one that
+capitalizes on new technologies. We hope to learn what sort of
+real-time analysis capabilities exist within our system today.
+ Again, in the fiscal year scheduled to start next week, we
+will likely invest close to another $1 billion in bioterrorism
+preparedness grants. As members of this committee have
+discovered over the past 6 months, communication is critical in
+our ability to successfully secure the homeland. For these
+disease surveillance systems to work, people must be willing
+and able to communicate. Healthcare professionals will have to
+be able to share information because CDC's ability to connect
+the dots is largely dependent upon the quality and the quantity
+of the information that is collected.
+ Last, what is the role of technology? How can we capitalize
+on America's ingenuity and our unparalleled advances in health
+research? I hope that Dr. Trent from own State of Arizona will
+be able to shed some light on this important aspect, given his
+experience serving as direct of the National Human Genome
+Research Institute at the NIH, and his current experience
+working on pathogen diagnostics at the Translational Genomics
+Research Institute.
+ I am pleased to have the panel with us today. By agreement,
+we have agreed to limit the opening statements to the Chairman
+and the Ranking Member of both the subcommittee and the full
+committee. I will now turn to the Ranking Member of the
+subcommittee, Mr. Thompson, for his opening statement.
+ Mr. Thompson. Thank you, Mr. Chairman.
+ Almost 2 years ago, the Congress faced head-on the impacts
+of bioterrorism when both the Senate and House were infected
+with a weaponized strain of anthrax sent through the U.S. mail
+system. The lives that were lost as a result of this terrorist
+attack were a terrible tragedy, and we must never forget our
+experiences during the response to that attack. It is critical
+that Congress and the Administration work to ensure that in the
+event of future bio-attacks we do everything within our power
+to prevent the loss of life and to identify those responsible
+for those unconscionable acts of terrorism.
+ Therefore I am pleased to have the distinguished witnesses
+with us to describe the role of disease surveillance systems in
+our preparedness for and in response to acts of bioterrorism. I
+am very interested in the testimony we will hear today and I
+hope that our witnesses would discuss both the recent advances
+in disease surveillance systems and perhaps more important, the
+need for additional resources or focus on the issue in order to
+ensure that we are fully prepared for the next bioterrorism
+incident.
+ As we will hear from our witnesses today, the Center for
+Disease Control and Prevention, RCDC, manages a complex
+national network of surveillance systems designed to monitor
+the emergence of certain diseases such as the flu. However, I
+remain concerned about the capabilities of our disease
+surveillance system because they represent the first line of
+defense to responding to acts of bioterrorism. These systems
+will provide us with the first indication that there is a
+problem, and will guide our response to that incident. A robust
+surveillance system will also allow us to quickly get vital
+information out to the public health providers and the public
+at large about a disease outbreak, and will help prevent the
+further spread of disease.
+ When a person becomes ill, he or she most often seeks
+treatment from a primary care physician. However, there are
+significant communication disconnects between individual
+doctors and the public health community in reporting diseases.
+If surveillance is to work effectively, doctors must report
+timely and accurate diagnoses in a standardized manner. In
+2000, the Institute of Medicine convened workshops to follow
+their report emphasizing this point. For example, even when
+individual doctors are required by law to report certain
+diseases such as flu, they are, according to the Institute,
+notoriously lax in reporting such information to the public
+health authorities. One of the issues I will ask later is, when
+they are lax, what do we do? Slap them on the wrist, or just
+say better luck next time?
+ We must move faster, Mr. Chairman, and we must be stronger
+in our efforts to protect and defend the United States of
+America against acts of bioterrorism. I hope the testimony we
+hear today will assist us in developing a roadmap for doing so.
+ Mr. Shadegg. Thank you.
+ I call upon the Chairman of the full committee, Chris Cox,
+for his opening statement. Chairman Cox?
+ Mr. Cox. Thank you, Mr. Chairman. I want to thank you for
+assembling a fine panel to assist us today in considering how
+disease surveillance system can be of better use in the war on
+terror.
+ We know from several commissioned studies that we had
+information prior to 9-11 that, had we only pieced it together
+differently, might have permitted us, if not to learn of the
+terrorist plot before it was executed, at least to interrupt
+it. We might have taken enough of the individuals who were
+involved in it out of commission so that 9-11 might not have
+happened. Our government and the American people possessed
+information that they just did not put together because we were
+not thinking about this problem in this way.
+ We have I think the same problem presented to us today.
+Happily, the United States has not been hit with a bioterror
+attack on the scale that we saw on September 11, but I have to
+forecast that were such an attack to occur today, we have
+commissioned reports on its aftermath that would tell us that
+we did not piece together the information that we had in the
+early moments of that crisis that would have permitted us to
+respond to it and prevent it from causing the damage that
+ultimately it would carry out.
+ We can learn, and this committee will learn when we have a
+complete report on Top-Off 2 from exercises. We know that our
+emergency room physicians are going to be heavily involved in
+the early stages of response. We also know that our emergency
+rooms are very overcrowded. They are going to be especially
+overcrowded when people are all coming at a time of crisis. We
+have to consider how the emergency rooms not only are going to
+put information into this system so it can be analyzed and
+dispersed across the nation rapidly, but also how they are
+going to respond if called upon to do so.
+ At least some of the testimony that we will hear today is
+going to ask us to take a look at the role of primary care
+physicians. The truth is that we have not been accustomed to
+thinking of primary care physicians as first responders in the
+same fashion that we have the ER physicians, but we know from
+Top-Off 2 and we know from the fact that our emergency rooms
+are overcrowded that they will be. As a matter of fact, they
+will be in the first line of casualties if they are not
+properly inoculated. This, too, is something that we have got
+to take a look at.
+ What we will learn today from the testimony that our
+witnesses have already provided to us, and even more so from
+the interaction during questioning, is that there is a lot that
+we can do with data collection and dispersal and analysis.
+There is also a question then that will remain for our
+committee, and that is what exactly should be the role of the
+Department of Homeland Security in taking advantage of these
+good ideas and carrying them into effect.
+ So I want to congratulate you, Mr. Chairman, for placing a
+focus on bioterrorism before it happens in this committee, and
+for assembling this panel of expert witnesses.
+ Thank you, Mr. Chairman. I yield back.
+
+ PREPARED OPENING STATEMENT OF THE HONORABLE CHRISTOPHER COX, A
+REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA, AND CHAIRMAN,
+ SELECT COMMITTEE ON HOMELAND COMMUNITY
+
+ I would like to thank Chairman Shadegg and ranking member Thompson
+for their leadership in organizing today's hearing and recognizing the
+enormity of the bioterror threat. Many of us gathered here today
+witnessed first hand the effects ofbioterrorism in the fall of 2001,
+when Congress became a target of a biological attack. However, we are
+fortunate that only about 22 people were exposed to Bacillus anthracis,
+and as tragic as' any death is, that no more than 5 people died. One of
+the lessons that we learned from that event was that bioterrorism does
+not need a large body count to terrify our citizens, damage our
+economy, and threaten our democracy. Any terrorist with minimum
+technical sophistication and with some basic microbiology tools can
+accomplish the goal of bioterror- to inflict enormous social and
+economic disruption.
+ The recent SARS outbreak has taught us that natural emerging and
+reemerging diseases can cause widespread economic losses, devastating
+death tolls, and a heavy strain on the public health infrastructure.
+This outbreak provides a window into the damage that can be done by
+a"thinking" enemy using a biological weapon with a deliberate plan to
+harm our citizens.
+ It should be noted that of the almost 8,500 SARS cases world wide
+and almost 800 deaths, the US reported no deaths during this outbreak.
+This is a direct credit to our front line clinicians, public healthcare
+workers and the leadership of Secretary Thompson in providing nearly $1
+billion dollars from the Department of Health and Human Service over
+the past year for States and localities to develop bioterrorism
+response capabilities.
+ The members of this Committee, just last Spring, worked in a strong
+bipartisan manner to pass the President's BioShield legislation. This
+legislation not only provides for DHS and HHS to collaborate to provide
+countermeasures for potential biological weapons, but it also
+incentivizes the private sector to leverage its superior technology to
+produce vaccines and other countermeasures to help protect our
+citizens. Already, our focus in this area is paying dividends; recently
+we learned of a breakthrough in developing a vaccine against Ebola, a
+virus for which there is no other treatment. As a nation, we are making
+concrete strides in developing countermeasures and the technology to
+better prepare ourselves for a potential bioterror attack.
+ Our best defense, of course, is early detection. The sooner we have
+the capability to detect a bioterror attack, the more time we will have
+to intervene and lessen the effects on our society. I look forward to
+the testimony that each of you will offer in the area of early
+diagnosis and the status of public health systems, which will screen
+for trends in large numbers of patients. Early recognition is crucial
+to curbing the spread of a bioterror attack and administering
+treatments.
+ The dedication that each of you have shown in this area not only
+enhances our capability to respond effectively to a bioterror event but
+strengthens our healthcare infrastructure and the capacity to deal with
+natural epidemics.
+
+ Mr. Shadegg. I thank the gentleman for his opening
+statement. I now call upon the Ranking Member of the full
+committee, the gentleman from Texas, Mr. Turner.
+ Mr. Turner. Thank you, Mr. Chairman.
+ I appreciate our distinguished panel being with us today.
+In my view, the threat of biological attack is perhaps the most
+troubling, the most disturbing, potentially most catastrophic
+event that could ever occur as a result from terrorism. I am
+also firmly of the opinion that as we try to deal with the
+threat of terrorism, that we have to look further ahead into
+the future and anticipate what our terrorist enemies may try to
+do and have the capability to do in the future, than we are
+today.
+ For that reason, I commend the Chairman for his foresight
+in holding this hearing. There is no doubt that if we are going
+to plan to deal with bioterrorism, we have to start working on
+it now.
+ I also believe that when we look at bioterrorism, we know
+that we probably have a greater need to make a commitment of
+financial resources today than in any other area in terms of
+the terrorist threat. When we reviewed our legislation that
+this Committee dealt with just a few weeks ago, Project
+Bioshield, we were acutely aware that that legislation dealt
+with the tail-end of the vaccine production inresponse to a
+bioterrorist attack. What I think we need to be doing a better
+job of is dealing with the front end--dealing with the
+development of detection capabilities and developing the
+response capacities to biological pathogens that our terrorist
+enemies may be able to produce.
+ There is no question that trying to defeat bioterrorism up
+front is very difficult, because it can all be done within the
+confines of a small lab and spread by humans who may travel
+into our country by air or other method, and simply walk around
+among our populace, infecting literally tens of thousands of
+people in a very short period of time. So this is a threat that
+we must take very seriously. I am very pleased that our panel
+is here today to help us with this most important challenge. I
+am confident that with your help, we can bring the right amount
+of public and congressional attention to this issue to allow us
+to begin to move forward on an issue that we must address now.
+It not only deals with our survival, but perhaps the survival
+of the entire world.
+ So thank you, Mr. Chairman, for calling this hearing today.
+ Mr. Shadegg. I thank the gentleman for his opening remarks.
+ Without objection, the opening statements of all members
+will be included in the record. In that regard, I would ask
+unanimous consent to enter the opening statement of our
+colleague Mr. Gibbons who could not be with us here today.
+Without objection, so ordered.
+ I also ask unanimous consent that Mrs. Dunn, the Vice
+Chairman of the full committee, be allowed to sit and ask
+questions at today's hearings. Without objection, so ordered.
+ Now, to address the topic of disease surveillance systems
+and how they can help us prepared for bioterrorism, it is my
+privilege to welcome and introduce our distinguished panel.
+First, we have Joseph Henderson, associate director of
+terrorism preparedness and response at the Centers for Disease
+Control. Thank you for being here. Next is Janet Heinrich,
+pubic health specialist at the General Accounting Office; Dr.
+Richard Platt, chair of the Ambulatory Care and Prevention
+Department at Harvard Medical School and Harvard Pilgrim Health
+Plan. Thank you for being here. Dr. Jonathan Temte, infectious
+disease specialist with the American Academy of Family
+Physicians and associate professor at the University of
+Wisconsin; Dr. Jeffrey Trent, president and scientific director
+of T-Gen, the Translational Genomics Research Institute.
+ Ladies and gentlemen, we appreciate your being here today.
+At this point, we would appreciate your opening statements. We
+will not hold you strictly to 5 minutes, but hope that you will
+endeavor to stay somewhere close to that time limit.
+ [The statement of Mr. Gibbons follows:]
+
+ PREPARED STATEMENT OF THE HON. JIM GIBBONS
+
+ Mr. Chairman, thank you for your leadership and the insight to
+establish a panel with such knowledge on this critically important
+issue. I welcome the members of the panel and look forward to the
+information they will provide on the best proactive techniques and
+measures available to improve homeland security.
+ Different from biologic warfare which attempts to kill,
+bioterrorism thrives on public fear, potentially immobilizing or
+demoralizing a population. Countering such fears are public knowledge,
+and purposeful scientific and political pre-event action.
+ In the years since the attacks on the World Trade Center and the
+Pentagon, in big cities and in small towns, on bridges and at border
+crossings, Americans have been mustering resources in preparation for
+an assault from the shadows, recalculating the realm of possibilities.
+ In a sense, the effort to shore up the home front against terrorism
+is an exercise in seeking balance: between added security and reduced
+openness and convenience; between the likelihood a threat might
+materialize and the cost of eliminating it..
+ Bioterrorism involves the intentional or threatened uses of
+viruses, bacteria, fungi, toxins from living organisms, or chemicals,
+to produce death or disease in humans, animals, or plants. Many
+biological agents could be used to make weapons, however most experts
+agree that only a limited number of well-known biological agents would
+cause widespread illness and death.
+ As I understand the process, an announced event will be evaluated
+at the time by primary health care providers, public health and law
+enforcement. An unannounced event will be detected by private health
+care providers, infection control and/or public health surveillance as
+an unusual disease or death occurrence, once the disease starts to
+manifest itself in the victims. Prompt recognition and reporting is
+important to prevent spread and control future cases.
+ The Question we seek answers to today: How do best identify a
+bioterrorist attack and minimize the post-action effects?
+ Again, I welcome our witnesses and look forward to their keen
+perceptions on the latest disease surveillance systems.
+
+ Mr. Shadegg. We will begin with you, Mr. Henderson.
+
+ STATEMENT OF MR. JOSEPH HENDERSON, ASSOCIATE DIRECTOR FOR
+ TERRORISM PREPAREDNESS AND RESPONSE, CENTERS FOR DISEASE
+ CONTROL
+
+ Mr. Henderson. Good afternoon, Mr. Chairman and members of
+the subcommittee. I am Joseph Henderson, director of the Office
+of Terrorism Preparedness and Emergency Response at the Centers
+for Disease Control and Prevention. I am accompanied by Dr.
+John Loonsk who is CDC's associate director for informatics.
+ Thank you for this opportunity to discuss how disease
+surveillance systems can help to detect a potential terrorist
+attack. Disease surveillance systems or disease detection
+systems address one important aspect of our nation's overall
+public health preparedness strategy. The CDC, working with our
+Federal, State and local partners, is working to build systems
+that can rapidly detect an outbreak or an attack in our
+communities, mobilize the appropriate response to contain the
+event, and assure that our affected communities return to a
+sense of normalcy following the attack.
+ As requested by the subcommittee, I will focus on the rapid
+detection component of this overall preparedness system.
+Surveillance for diseases in the population is best described
+as the ongoing identification, reporting, collection, analysis
+and dissemination of critical public health data. These data
+inform public health officials of disease in their communities,
+enabling them to intervene, leading to control and containment
+of the disease. Without these systems, intervention would be
+significantly delayed, having much higher impact by way of
+increased illness, injury and in some cases death.
+ Recent events such as SARS and monkeypox have underscored
+the essential role early detection systems play in mobilizing
+rapid response. Detection of a disease almost always occurs at
+the local level where healthcare professionals and encounter
+patients seeking medical assessment or treatment. A clinician's
+ability to quickly recognize and identify symptoms of unusual
+illnesses on the frontline has been critical to CDC's ability
+to recognize unfolding disease events and implement containment
+measures.
+ Today, I will address three critical components of our
+disease detection systems: our current state of national
+disease detection capability; the public health information
+network which is our IT framework to enable and amplify
+detection and reporting capacities; and I will provide a brief
+glimpse of our global disease detection initiatives. I will try
+to do this within 5 minutes.
+ The most vital link in our current disease detection and
+reporting chain is the trained and astute clinician who would
+be the first to assess and diagnose individuals who are ill
+requiring care and treatment. CDC has been working with our
+State and local public health agencies, school and universities
+and numerous professional organizations across the country to
+educate our nation's health protectors. Frontline workers armed
+with the appropriate knowledge and information allows for rapid
+disease detection in our communities, whether naturally
+occurring or intentional, such as an act of terrorism.
+Clinicians and laboratorians report diseases to State and local
+agencies, in many cases required by law, which in turn share
+information with the CDC. The CDC and our State and local
+public health colleagues define conditions that should be
+reported and develop and disseminate guidelines to healthcare
+providers, infection control practitioners, emergency
+department physicians, laboratorians, and other members of the
+healthcare system to enable effective reporting.
+ However, improvements are necessary to do this work faster
+and with a higher degree of accuracy. Many local reporters of
+disease still report to public health agencies via fax.
+Reporting systems are largely paper-based and burdensome to all
+levels of the reporting effort. A comprehensive surveillance
+system requires a strong foundation at all levels of local,
+State and Federal public health agencies. Since September 11,
+2001, the Administration had budgeted for and Congress has
+approved over $2 billion to develop and sustain State and local
+public health readiness, specifically to enhance capacities to
+detect, respond, contain and recover from biological, chemical
+and radiological acts of terrorism and other public health
+emergencies. States are spending significant portions of these
+funds to enhance epidemiological and event detection capacities
+and to develop and leverage information technology and systems
+to support various public health functions. A number of
+examples of these efforts can be found in my written statement.
+ For many years, CDC has supported the development and
+implementation of information technology systems for State and
+local health agencies to improve the practice of public health.
+Many of these systems operate in isolation, not capitalizing on
+the potential for cross-fertilization of data exchange. A
+cross-cutting and unifying framework is needed to better
+integrate these data systems to support early detection of
+public health conditions and emergencies. The Public Health
+Information Network, or PHIN, provides this framework. The PHIN
+will enable consistent collection and exchange of response,
+health and disease tracking data among public health partners.
+ PHIN encompasses four components: detection and monitoring;
+analysis and interpretation; information dissemination and
+knowledge management; and public health response, which is
+described here on this poster. I will briefly describe each of
+these particular components.
+ Detection and monitoring. The CDC is in the proof of
+concept stage for a project called BioSense, which proposes
+early event detection associated with a possible bioterrorist
+threat. BioSense could establish the capability for rapid,
+around-the-clock electronic transmission of data to local,
+State and Federal public health agencies from national,
+regional and local health data sources such as clinical
+laboratories, hospital systems, health plans, the Department of
+Defense, VA medical treatment facilities, and pharmaceutical
+chains.
+ This proposal is based on utilizing existing data and
+information so as not to add to existing reporting burdens. The
+National Electronic Disease Surveillance System, or NEDSS, is
+another system that falls under the PHIN framework, supporting
+the development of real-time reporting of information for
+public health action. NEDSS requires adherence to standards-
+based approaches such as Federal e-government standards to
+ensure data and information are collected and disseminated as
+effectively and as efficiently as possible. The CDC strategy
+for implementation of the NEDSS system is to allow State and
+local health agencies to develop their own systems compatible
+with the established standards or utilize a CDC-developed
+version of NEDSS.
+ Currently, two States have fully implemented the CDC NEDSS
+system and 30 other States have requested assistance from CDC
+in installing this particular system. Other State and local
+health agencies continue to build or modify their disease
+surveillance systems to conform to our national standards.
+ Analysis and interpretation. CDC depends on its scientific
+and epidemiological expertise to interpret the volume of data
+received to ensure accurate conclusions are developed and
+disseminated to public health colleagues in a timely manner to
+impact health decisions. To ensure this effort is robust and
+can effectively deal with the increasing amount of data and
+information CDC receives, a bio-intelligence center is being
+conceptualized. This center would provide a centralized
+approach to analyzing and interpreting data and information,
+and will enable communications to ensure that this information
+and the conclusions drawn from the analysis are provided back
+to State and local health officials to enable appropriate
+action and support decisionmaking.
+ Information dissemination and knowledge management. Within
+this component of PHIN is CDC's health alerting capability,
+formally referred to as the Health Alert Network. Through this
+system CDC has the capacity to reach all State and local health
+officials and many other key responders such as hospitals,
+before, during and after any crisis that occurs within our
+communities. This system has been used to alert our colleagues
+of public health threats and emergencies over 150 times since
+September 11, 2001, reaching over 1.5 million recipients. Most
+recently the alerting capability was used to communicate
+critical health information in response to Hurricane Isabel.
+ CDC, through the PHIN, also supports the Epidemic
+Information Exchange Program, or EPI-x. EPI-x facilitates
+critical public health communication through a secure network
+between and among public health responders. Currently, there
+are approximately 1,800 users to subscribe to this service
+nationally.
+ Public health response. Since the majority of data
+management needs come after a disease is detected, CDC through
+the PHIN framework is developing new and improved systems to
+support public health response. Primarily, these efforts are
+supporting CDC's emergency operations, outfitting deployed
+staff with state-of-the-art information management tools, and
+supporting State and local efforts. These systems have been
+used to support the SARS outbreaks and special events such as
+the 2002 Winter Olympics in Salt Lake City. CDC has also
+developed the Pre-Event Vaccine System to support the National
+Smallpox Vaccination Program, which has proved and continues to
+prove to be a valuable information management tool.
+ The emergence of SARS, a previously unrecognized infectious
+disease, has provided a strong reminder of the threats posed by
+emerging infectious diseases and their global impact. CDC
+continues to build upon our strong relations with the World
+Health Organization, the Pan American Health Organization, and
+many other global partners to create a comprehensive global
+disease detection and reporting network. Currently, CDC has
+field epidemiology training programs, we call them FETPs, in 30
+countries, supporting disease detection, providing an essential
+link in global surveillance.
+ CDC has also created two International Emerging Infections
+Programs, one in Thailand, which we created in 2001, and one in
+Kenya, which is projected to be up and running by the end of
+this calendar year. These programs will help to foster the next
+generation of international public health leaders, while
+providing high-quality disease surveillance data and rapid
+response capacity for new and emerging diseases.
+ This year we are also providing increased levels of funding
+to enhance disease detection and response capacity with our
+Mexican and Canadian neighbors to enhance the disease
+surveillance over the borders.
+ In conclusion, CDC is committed to working with Federal,
+State and local partners to protect the nation's health. Our
+best public health strategy against disease is to develop the
+systems needed to rapidly identify the causative organism, and
+then unleash a control and containment strategy that will
+minimize illness and death. Keep in mind that the astute
+clinician remains the critical link in this disease detection
+and reporting strategy. The first case of West Nile virus in
+1999 and the first case of anthrax reported in early October
+2001 were identified by these astute clinicians. Training and
+education of these frontline health protectors remains a high
+priority for the Department of Health and Human Services and
+CDC, and will continue to be a priority as we strive to improve
+all components of the nation's disease detection system. While
+we have made substantial progress towards enhancing the
+nation's capability to rapidly detect diseases within our
+communities, respond and contain outbreaks of disease, and
+recover from these tragic events, much remains to be done. CDC
+is extremely grateful for the congressional support received to
+date and looks forward to working with members of Congress,
+especially this committee, as we strive to protect the public's
+health from terrorism and other public health emergencies.
+ Thank you for your attention. I would be happy to take
+questions.
+ [The statement of Mr. Henderson follows:]
+
+ PREPARED STATEMENT OF JOSEPH M. HENDERSON, M.P.A
+
+ CDC's Disease Surveillance Systems Efforts
+
+ Good morning, Mr. Chairman and Members of the Subcommittee. I am
+Joseph M. Henderson, Director of the Office of Terrorism Preparedness
+and Emergency Response at the Centers for Disease Control and
+Prevention (CDC). As the nation's disease prevention and control
+agency, CDC, working with state and local public health agencies is
+charged with detecting and responding to illnesses, both man-made and
+naturally occurring. This task is an integral part of CDC's overall
+mission to monitor and protect the health of the U.S. population.
+ Thank you for the opportunity to discuss how disease surveillance
+systems can prepare the nation for potential terrorist threats.
+``Disease surveillance systems'' or disease detection systems, address
+one important aspect of our nation's overall public health
+preparedness. CDC, working with our federal, state, and local partners
+is working to build systems that can: (1) rapidly detect an event in
+our communities; (2) mobilize the appropriate response to contain the
+event, and (3) ensure affected communities return to a sense of
+normalcy. These are what we refer to as our foundations of public
+health readiness. My testimony will focus on rapid detection of an
+event, which is the topic of discussion for this sub-committee today.
+ National disease detection can best be described as the ongoing
+collection, analysis and dissemination of public health data related to
+illness and injury. These ongoing data collection and analysis
+activities enable public health officials to detect disease early, thus
+resulting in faster intervention to control and contain the
+consequences created by the causative agents. Without these early
+detection systems, the consequences of outbreaks of infectious disease
+and human exposures to agents such as chemicals and radiation would
+take a much greater toll by way of increased illness, injury, and in
+some cases death. Recent events, such as the SARS and Monkeypox
+outbreaks, have underscored the essential role early detection systems
+play in mobilizing rapid response. Detection of a disease almost always
+occurs at the local level where health care professionals encounter
+patients seeking medical assessment or treatment. A clinician's ability
+to quickly recognize and identify symptoms of unusual illnesses on the
+frontline has been critical to the CDC's ability to recognize unfolding
+disease events and implement containment measures to prevent further
+spread of disease, thus mitigating further harm to the public. Today, I
+will address three critical components of our disease detection
+systems: (1) Current state of national disease detection systems; (2)
+the Public Health Information Network--PHIN; and (3) global disease
+surveillance.
+Current State of National Disease Detection Systems
+ One key to successful defense against any threat to the nation's
+public health, whether naturally occurring or deliberately caused,
+continues to be accurate, early recognition of the problem.
+ Awareness and diagnosis of a condition by a clinician or laboratory
+is a key element of our current disease detection systems. Clinicians
+and laboratories report diseases to state and local health departments,
+which in turn share information with CDC. CDC works with its public
+health partners to define conditions that should be reported
+nationally. 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 to ensure accurate and timely reporting.
+ Many local reporters of disease incidence still report to public
+health authorities on paper via facsimile. If a case of illness is
+particularly unusual or severe (such as a case of anthrax), the local
+health care worker may call the local health department immediately to
+report the case. Current reporting systems are largely paper-based and
+burdensome to both providers and health departments, often resulting in
+reports which are neither complete nor timely. In addition to initial
+detection, these detection and reporting systems play a pivotal role in
+the detection of subsequent cases and help support the management of
+the event once a response/investigation are initiated. Such information
+is vital to coordinating response decisions, which ultimately lead to
+the containment of an outbreak.
+ A comprehensive surveillance system requires a strong foundation at
+all levels of local, state, and federal public health agencies. CDC has
+been working with state and local health agencies for many years to
+build the public health infrastructure to improve disease detection and
+reporting systems. Since September 11, 2001, the Administration has
+budgeted for and the Congress has appropriated over $2 billion to
+develop and sustain state and local public health readiness,
+specifically to enhance capacities to detect, respond, contain and
+recover from biological, chemical, and radiological acts of terrorism.
+States estimate that they are spending significant portions of this
+funding in both fiscal year 2002 and fiscal year 2003, to: 1) enhance
+epidemiological and surveillance capacity and 2) develop and leverage
+information technology and systems to support various public health
+functions.
+
+ Some examples of how states used their funding in these areas
+include:
+ Michigan has begun implementation of a secure web-
+ based disease surveillance system to improve the timeliness and
+ accuracy of disease reporting.
+ Missouri has implemented a new hospital tracking
+ system to detect possible outbreaks by monitoring the number of
+ patient admissions and ambulance diversions at hospitals. This
+ system provides a way for hospitals to obtain instant messages
+ and alerts.
+ Virginia, Maryland, Washington DC, and Pennsylvania
+ are all developing early warning systems based on symptom data
+ from emergency departments to detect unusual patterns of
+ illness and automatically alert hospitals and public health
+ agencies when the incidence of disease exceeds a critical
+ threshold. Use of such early warning systems might enable the
+ earliest possible response and intervention before an outbreak
+ or epidemic spreads.
+
+ Other related activities useful for early detection of emerging
+infections or other critical biological agents include CDC's Emerging
+Infections Programs (EIP). Through the EIP, state and local health
+departments receive funds to conduct population-based surveillance that
+goes beyond their routine function to develop ``next generation''
+surveillance science, and often involves partnerships among public
+health agencies and academic medical centers. In addition, CDC has
+established networks of clinicians that serve as ``early warning
+systems'' for public health by providing information about unusual
+cases encountered in the clinical practices. As noted earlier, these
+relationships, particularly between health care providers and local
+health departments, are the foundation on which disease detection
+systems operate.
+
+Public Health Information Network
+ For many years CDC has made significant achievements in building or
+enabling state and local health agencies to build information systems
+that support the practice of public health. However, many of these
+systems operate in isolation, not capitalizing on the potential for a
+cross-fertilization of data exchange. A crosscutting and unifying
+framework is needed to better integrate these data streams for early
+detection of public health issues and emergencies. The Public Health
+Information Network (PHIN) provides this framework. Through defined
+data, vocabulary standards and strong collaborative relationships, the
+PHIN will enable consistent collection and exchange of response,
+health, and disease tracking data among public health partners.
+Ensuring the security of this information is critical as is the ability
+of the network to work reliably in times of national crisis. PHIN
+encompasses four key components: (1) detection and monitoring;(2)
+analysis and interpretation; (3) information dissemination and
+knowledge management; and (4) public health response. Each of these
+components is briefly described below.
+ Public health information systems must support functions that
+include:
+ Early event detection--BioSense is being developed to
+ support early event detection activities associated with a
+ possible Bioterrorism threat. Regional health data will be sent
+ to authorized health officials detailing health trends that
+ could be related to a possible Bioterrorism attack.
+ Routine public health surveillance--NEDSS supports
+ routine surveillance activities associated with the rapid
+ reporting of disease trends to control outbreaks. The NEDSS
+ platform allows states to enter, update and electronically
+ transmit demographic and notifiable disease data.
+ Secure communications among public health partners--
+ Epi-X technology allows for the secure exchange of
+ communications between participating public health partners via
+ the web by providing up-to-the-minute information, reports,
+ alerts, and discussions about terrorist events, toxic
+ exposures, disease outbreaks, and other public health events.
+ Management and dissemination of information and
+ knowledge--HAN's architecture upgraded the capacity of state
+ and local health agencies to communicate different health
+ threats such as emerging infectious and chronic diseases,
+ environmental hazards, as well as Bioterrorism related threats.
+ Other functions include--Analysis and interpretation
+ of relevant public health data and public health response
+ systems.
+ PHIN will provide the framework for these functions to serve as
+part of an integrated and interoperable network critical in
+establishing a more effective public health system.
+
+Detection and Monitorinq
+ The CDC is in the proof-of-concept stage of BioSense--a proposal in
+development to enhance early event detection for public health
+emergencies such as bioterrorism. BioSense is proposed to enhance the
+nation's capabilities to rapidly detect and quantify public health
+emergencies by enabling rapid access to, and analysis of, diagnostic
+and pre-diagnostic health data. BioSense could establish the capability
+for rapid, around the-clock electronic transmission of data to local,
+state and federal public health agencies from national, regional and
+local health data sources such as clinical laboratories, hospital
+systems, health plans, DoD and VA medical treatment facilities, and
+pharmacy chains. Many of the pre-diagnostic data sources need to be
+rigorously evaluated to determine which are most effective, but
+importantly, the initiative is based on the use of existing data and
+will not add to the reporting burden of clinical care or other
+healthcare professionals. BioSense data would not include patient names
+or personal identifiers, but may allow for the identification of early
+signs of a possible bioterrorist attack and facilitate appropriate
+public health investigation and follow-up by public health authorities.
+As proposed, BioSense will provide public health professionals a daily
+picture of normal diagnostic and therapeutic activities, provide
+indications of abnormal activities and also provide a way to rapidly
+investigate events to discern true concerns from false alarms.
+ Some early detection activities are currently occurring in local
+jurisdictions. BioWatch, which is a locally managed activity, is one
+source of data supporting BioSense. BioWatch involves the deployment of
+environmental air samplers in key locations throughout a city. Filters
+from these air samples are routinely gathered and analyzed by public
+health laboratories to determine if a potential release of a biological
+agent has occurred. Currently, many metropolitan areas within the
+United States participate in this project which is led by the
+Department of Homeland Security with support from CDC and our state and
+local public health partners.
+ CDC has initiated the development of the National Electronic
+Disease Surveillance System (NEDSS) which is a part of PHIN. 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 allowing medical
+information, such as diagnostic tests, to be shared electronically with
+public health officials as soon as a clinical laboratory receives a
+specimen or makes a diagnosis of a condition of public health
+importance.
+ NEDSS integrates the numerous existing disease detection and
+monitoring systems using a standards-based approach with standards for
+data, information architecture, security, and information technology.
+This adherence to standards will ensure that data be entered once at
+the point of patient care, without a need for re-entry of data at each
+level of reporting. Use of standards is critical in ensuring that
+public health practices use technology more effectively and
+collaboratively. The NEDSS strategy provides for state implementation
+of the CDC-developed version of NEDSS or state systems compatible with
+NEDSS. Some states are building their own NEDSS compatible systems. Two
+states have fully implemented the CDC NEDSS system and thirty other
+states have requested installation of the CDC-developed system.
+ As NEDSS progresses, we need to ensure that the data standards we
+use are compatible with those used in the health care delivery system.
+This will ensure ease of adaptation to future advancements in the field
+and ease of use for all levels of the clinical and public health
+systems. Moreover, NEDSS is fully consistent with Secretary Thompson's
+recently announced Consolidated Health Informatics (CHI) standards.
+These are health data interoperability standards established under one
+of the Administration's electronic government projects covering the
+federal health care enterprise. In addition, a standard information and
+security architecture will enable public health partners to share data
+while ensuring patients' privacy. The reliance on industry standards
+for information technology ensures the ability to interface with
+multiple commercial products to meet the needs of the public health
+community, including state-of-the-art analytic tools and geographic
+information system capacity.
+
+Analysis and Interpretation
+ CDC depends on its scientific and epidemiological expertise to
+interpret the volume of data received to ensure accurate conclusions
+are developed and disseminated to our public health colleagues in a
+timely manner to impact public health decisions. As we develop more
+integrated systems and open new channels of data and information, more
+powerful tools and systems will be needed to rapidly and accurately
+perform this critical public health task. CDC's concept of this effort
+is a Bio-Intelligence center or BIC. The center would provide a
+centralized approach to analyzing and interpreting data and information
+and will assure appropriate communication channels are established to
+provide this information and analysis back to state and local health
+officials. In fiscal year 2004, CDC will continue to develop and
+investigate this concept.
+
+Information Dissemination and Knowledge Management
+ Since September 11,2001, the anthrax attacks, and more recently the
+SARS and Monkeypox outbreaks, the general public, the first responder
+community, laboratory professionals, and our state and local partners
+have become more and more reliant upon the CDC website (www.cdc.gov)
+for critical public health information and knowledge resources. CDC
+will continue to refine this national resource as we improve our
+ability to provide information across the web.
+ Within this particular component of the PHIN is CDC's health
+alerting capability(formerly referred to as the Health Alert Network).
+Through this program all fifty states, four large cities and eight
+territories are receiving funding and technical assistance from
+ CDC to strengthen core infrastructure for information access,
+communications, and training at the community level. This effort has
+built the foundation nationwide for: 1) continuous, high-speed Internet
+connectivity to support rapid information access; 2) broadcast capacity
+to support emergency communication; and 3) distance-learning
+infrastructure to support just-in-time training.
+ On September 11, 2001, CDC issued the first Health Alert Network
+message advising state and local health agencies of the need to enhance
+their disease detection systems to look for any unusual signs or
+symptoms related to a bioterrorist event. Since 9/11, CDC has issued
+over one-hundred fifty health alerts and advisories reaching 1.5
+million health care professionals, as well as other first responder
+communities, on topics such as bioterrorism, West Nile virus, SARS,
+patient safety, and smallpox vaccination. Over 95% of our nation's
+public health agencies have the capability to receive and/or further
+distribute critical health alerts to their community stakeholders. The
+ability to access the web has allowed state and local health
+departments to utilize CDC's web based resources including CDC's secure
+communication system, Epi-X.
+ Epi-X (the Epidemic Information Exchange) is CDC's secure web-based
+communications system for public health professionals. This network
+provides secure communication of preliminary information regarding new
+health threats to a limited audience of authorized public health
+officials. Epi-X was created to provide a single source of up-to-the-
+minute alerts, reports, discussions, and comments contributed by their
+peers, and it is moderated by medical epidemiologists at CDC. Its
+primary goal is to inform health officials about important public
+health events, help them respond to public health emergencies, and to
+encourage exchange of information. Through Epi-X, health officials at
+CDC, other federal agencies, state and local health departments, poison
+control centers, and the military share preliminary health surveillance
+information--quickly and securely. Users are notified immediately of
+breaking health events as they occur. Currently, Epi-X has
+approximately 1800 users nationwide. Since its inception in December
+2000, health officials have posted approximately 1500 reports of
+disease outbreaks. Epi-X highlights include local and national
+responses to terrorism, responses to emerging diseases such as severe
+acute respiratory syndrome (SARS) and monkeypox, West Nile virus
+surveillance, influenza surveillance, foodborne outbreaks and food
+recalls that affected residents in multiple states, and investigations
+of travelers with contagious illnesses.
+
+Public Health Response
+ Since the majority of the data management needs come after disease
+is detected, CDC through PHIN is investing in information systems to
+support our public health response teams, our Director's Emergency
+Operations Center in Atlanta and to assist state and local health
+agencies in tracking and managing vital public health information
+before, during, and after an event has occurred. These systems have
+been used to support the SARS outbreak, special events such as the 2002
+Winter Olympics in Salt Lake City, and other events that could
+potentially be targets of a terrorist attack.
+
+Global Disease Surveillance
+ The emergence of SARS, a previously unrecognized infectious disease
+outbreak, has provided a strong reminder of threats posed by emerging
+infectious diseases. In March 2003, the Institute of Medicine (I0M)
+published Microbial Threats to Health: Emergence, Detection, and
+Response, a report describing the spectrum of microbial threats to
+national and global health, factors affecting their emergence or
+resurgence, and measures needed to address them effectively. Although
+much progress has been made, especially in the areas of strengthened
+surveillance and laboratory capacity, CDC is taking steps to make
+further improvements both domestically and internationally.
+ CDC is intensifying its efforts to work with the World Health
+Organization (WHO) and other partners to create a comprehensive global
+network that detects and controls outbreaks before they grow into
+worldwide pandemics. Currently, there are Field Epidemiology Training
+Programs (FETP's) in thirty countries throughout the world that support
+disease detection activities and provide an essential link in global
+surveillance. The FETP program is modeled after CDC's Epidemic
+Intelligence Service (EIS) training program which focuses on training
+public health practitioners in epidemiology and surveillance and their
+application as a means to detect and control outbreaks and to implement
+interventions to prevent the further spread of disease. Additionally,
+there is a concerted effort to develop and expand regional disease
+surveillance networks that include less developed nations as members.
+ CDC has also created two International Emerging Infections Programs
+(IEIPs)--one in Thailand (established in 2001) and one in Kenya
+(scheduled to open in 2003)--that are modeled on the domestic EIP
+Programs described earlier which have been so successful in the United
+States. The IEIPs will help to foster the next generation of
+international public health leaders while providing high quality
+disease surveillance data and rapid response capacity for new and
+emerging diseases.
+
+Conclusion
+ CDC is committed to working with federal, state and local partners
+to protect the nation's health. Our best public health strategy against
+disease is the development, organization, and enhancement of public
+health disease detection systems, tools, and the people needed to wield
+them. The astute clinician remains the critical link in disease
+detection and reporting. The first case of West Nile in 1999, and the
+first case of anthrax reported in early October 2001, were identified
+by astute clinicians. Training and education of these front-line health
+protectors remains a high priority for CDC and will continue to be a
+priority as we strive to improve all components of the nation's disease
+detection systems.
+ While we have made substantial progress towards enhancing the
+nation's capability to rapidly detect disease within our communities,
+improving our response and containment strategies, and developing plans
+to recover from tragic events, much remains to be done. CDC is very
+grateful for the congressional support received to date and looks
+forward to working with the Members of Congress, especially this
+committee as we strive to protect the public's health from terrorism
+and other public health emergencies.
+ Thank you very much for your attention. I will be happy to answer
+any questions you may have.
+
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+
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+
+ Mr. Shadegg. Thank you, Mr. Henderson.
+ Next we will hear from Janet Heinrich, director of public
+health issues at the U.S. General Accounting Office.
+
+ STATEMENT OF MS. JANET HEINRICH, DIRECTOR, PUBLIC HEALTH
+ ISSUES, U.S. GENERAL ACCOUNTING OFFICE
+
+ Ms. Heinrich. Mr. Chairman and members of the subcommittee,
+I appreciate the opportunity to discuss State and local
+preparedness to manage outbreaks of infectious diseases, be
+they naturally occurring or the product of bioterrorism.
+ Recent challenges such as the SARS outbreak and the anthrax
+incidents of 2001 have raised concerns about the nation's
+preparedness to manage a disease outbreak or a bioterrorism
+event. Existing surveillance systems have weaknesses such as
+chronic underreporting and outdated laboratory facilities,
+which have raised concerns about the ability of State and local
+agencies to quickly detect infection disease outbreaks.
+ My remarks will focus on the preparedness of State and
+local public health agencies for responding to infectious
+disease outbreaks, and the contributions of hospital
+preparedness for such an event. To assess bioterrorism
+preparedness, we conducted visits to seven cities and their
+respective State governments from December 2001 through March
+2002. We are currently reviewing the summer 2003 CDC and HRSA
+applications and progress reports, as well as interviewing
+State and local officials from these jurisdictions, and from a
+few additional States and two major municipalities.
+ In order to be prepared for infectious disease outbreaks,
+State and local public health agencies need to have several
+basic capabilities such as disease surveillance systems and
+epidemiologists to detect clusters of suspicious symptoms or
+diseases, laboratories with adequate capacity and staff to test
+clinical and environmental samples, and communications systems
+to easily communicate with other health care providers.
+Hospitals need the necessary capacity to treat infectious
+diseases, and emergency department staff needs to be able to
+recognize and report unusual illness patterns.
+ State and local officials for the cities we visited
+recognized and were attempting to address inadequacies in their
+surveillance systems. They were developing systems using
+electronic databases and several cities were evaluating the use
+of non-traditional data sources such as pharmacy sales.
+Officials reported that CDC funds have enabled them to make
+improvements, including the Web-based reporting that we just
+heard about and active surveillance.
+ According to preliminary data from our review this year,
+improvements have also been made in the laboratory
+infrastructure, including upgrading facilities, purchasing
+reagents and equipment, and improving capabilities to test for
+select biologic agents. Most of the cities we visited have
+purchased communication systems that allow officers and
+officials from different organizations to communicate with one
+another in an emergency. In addition, they have been working
+with CDC to build their capability with HAN, the Health Alert
+Network, which provides the high-speed Internet connectivity.
+ However, workforce shortages continue to be a major
+concern. Officials report concerns about not having enough
+epidemiologists to complete investigations, as well as
+retaining trained laboratory personnel. A continuing concern
+for response organization officials was the lack of planning at
+the regional level. There continues to be a lack of
+coordination between States that would severely hamper a
+response to an infectious disease outbreak.
+ Our surveillance capabilities also depend in large part on
+the capabilities of hospitals and trained staff in emergency
+departments. In our survey of over 2,000 metropolitan hospitals
+most hospitals reported training staff in biological agents,
+but fewer than half have participated in drills or exercises
+related to bioterrorism. We also found that most emergency
+departments have experienced some degree of overcrowding, which
+is more pronounced in the largest metropolitan areas and where
+there has been high population growth. Hospital capacity is
+expected to be strained if, for example, there were another
+SARS outbreak during the winter months when you have peak loads
+of patients with influenza.
+ In conclusion, efforts at the State and local level have
+improved their ability to identify and respond to infectious
+disease outbreaks and bioterrorism. Despite these improvements,
+gaps in preparedness remain. Some disease surveillance systems
+need to be upgraded. There are shortages of key personnel and
+hospital emergency departments across the country lack capacity
+for managing infectious disease outbreaks.
+ Mr. Chairman, that completes my prepared statement. I am
+happy to answer any questions you may have.
+ [The statement of Ms. Heinrich follows:]
+
+ UNITED STATE GENERAL ACCOUNTING OFFICE
+
+ INFECTIOUS DISEASES
+
+ Gaps Remain in Surveillance Capabilities of State and Local Agencies
+
+ Prepared Statement of Janet Heinrich, Director, Health Care--Public
+ Health Issues
+
+ Mr. Chairman and Members of the Subcommittee:
+ I appreciate the opportunity to be here today to discuss the work
+we have done on state and local preparedness to manage outbreaks of
+infectious diseases, which may be naturally occurring or the product
+ofbioterrorism. In order to be adequately prepared for such a major
+public health threat, state and local public health agencies need to
+have several basic capabilities, including disease surveillance
+systems.\1\ I Surveillance is public health officials' most important
+tool for detecting and monitoring both existing and emerging
+infections. Effective surveillance can facilitate timely action to
+control outbreaks and inform allocation of resources to meet changing
+disease conditions. Without adequate surveillance, local, state, and
+federal officials cannot know the true scope of existing health
+problems and may not recognize new diseases until many people have been
+affected.
+---------------------------------------------------------------------------
+ \1\ Disease surveillance uses systems that provide for the ongoing
+collection, analysis, and dissemination of health-related data to
+identify, prevent, and control disease.
+---------------------------------------------------------------------------
+ Recent challenges, such as the SARS \2\ outbreak and the anthrax
+incidents in the fall of 2001, have raised concerns about the nation's
+preparedness to manage a disease outbreak or a bioterrorist event
+should it reach large-scale proportions. Existing surveillance systems
+have weaknesses, such as chronic underreporting and outdated laboratory
+facilities, which raise concerns about the ability of state and local
+agencies to detect emerging diseases or a bioterrorist event. As a
+result, state and local response agencies and organizations have
+recognized the need to strengthen their public health infrastructure
+and capacity. The improvements they are making are intended to
+strengthen their ability to identify and respond to major public health
+threats, including naturally occurring infectious disease outbreaks and
+acts of bioterrorism.
+---------------------------------------------------------------------------
+ \2\ SARS is the abbreviation for severe acute respiratory syndrome.
+---------------------------------------------------------------------------
+ To assist the Subcommittee in its consideration of our nation's
+capacity to detect and monitor an outbreak of an infectious disease, my
+remarks today will focus on (1) the preparedness of state and local
+public health agencies for responding to an infectious disease
+outbreak, and (2) the contributions of hospitals to preparedness for an
+infectious disease outbreak.
+ My testimony today is based largely on our recent work, including a
+report on state and local preparedness for a bioterrorist attack.\3\
+For that report, we conducted site visits in December 2001 through
+March 2002 to seven cities and their respective state governments. We
+also reviewed each state's spring 2002 applications for bioterrorism
+preparedness funding to the Department of Health and Human Services'
+(HHS) Centers for Disease Control and Prevention (CDC) and Health
+Resources and Services Administration (HRSA), and each state's fall
+2002 progress report on the use of that funding. In addition, I will
+discuss some preliminary findings trom our current work that provides
+updated information on the preparedness of state and local public
+health agencies. For that work, we are reviewing the summer 2003
+applications and progress reports and interviewing public health
+officials trom 10 states and two major municipalities. I also will
+present some findings from a survey we conducted in 2002 on hospital
+emergency department capacity and emergency preparedness.\4\ We
+conducted our work in accordance with generally accepted government
+auditing standards.
+---------------------------------------------------------------------------
+ \3\ U.S. General Accounting Office, Bioterrorism: Preparedness
+Varied across State and Local Jurisdictions, GAO-03-373 (Washington,
+D.C.: Apr. 7, 2003).
+ \4\ Findings from the survey include those related to emergency
+department capacity, which we reported in U.S. General Accounting
+Office, Hospital Emergency Departments: Crowded Conditions Vary among
+Hospitals and Communities, GAO-03-460 (Washington, D.C.: Mar. 14, 2003)
+and to hospital emergency preparedness for mass casualty incidents,
+which we reported in U.S. General Accounting Office, Hospital
+Preparedness: Most Urban Hospitals Have Emergency Plans but Lack
+Certain Capacities/or Bioterrorism Response, GAO-03-924 (Washington,
+D.C.: Aug.6,2003).
+---------------------------------------------------------------------------
+ In summary, state and local officials in the cities we visited
+reported varying levels of public health preparedness to respond to
+outbreaks of emerging infectious diseases such as SARS. They recognized
+gaps in preparedness elements that have been difficult to address,
+including the disease surveillance and laboratory systems and the
+response capacity of the workforce. They also were beginning to address
+gaps in preparedness elements such as communication. We found that
+planning for regional coordination was lacking between states.
+ Because those with symptoms of an infectious disease might go to
+emergency departments for treatment, hospital personnel would likely be
+some ofthe first healthcare workers with the opportunity to identify an
+infectious disease outbreak. Therefore, the disease surveillance
+capacities of many state and local public health systems may depend, in
+part, on the surveillance capabilities of hospitals. Most hospitals
+reported training their staff and planning coordination efforts with
+other public health entities. However, even with these preparations in
+place, hospitals lacked the capacity to respond to large-scale
+infectious disease outbreaks.
+Background
+ Infectious diseases include naturally occurring outbreaks, such as
+SARS, as well as diseases from biological agents that are intentionally
+released by a terrorist, such as smallpox.\5\ An infectious disease
+outbreak, either naturally occurring or from an intentional release,
+may not be recognized for a week or more because symptoms may not
+appear for several days after the initial exposure, during which time a
+communicable disease could be spread to those who were not initially
+exposed.
+---------------------------------------------------------------------------
+ \5\ CDC developed a critical agent list that focuses on the
+biological agents that would have the greatest impact on public health.
+This list includes a category of agents identified by CDC as most
+likely to be used in a bioterrorist attack and includes communicable
+diseases such as smallpox and pneumonic plague.
+---------------------------------------------------------------------------
+ The initial response to an infectious disease of any type,
+including a bioterrorist attack, is generally a local responsibility
+that could involve multiple jurisdictions in a region, with states
+providing additional support when needed. Figure 1 presents the
+probable series of responses to a covert release of a biological agent.
+Just as in a naturally occurring outbreak, exposed individuals would
+seek out local health care providers, such as private physicians or
+medical staff in hospital emergency departments or public clinics.
+Health care providers would report any illness patterns or diagnostic
+clues that might indicate an unusual infectious disease outbreak
+associated with the intentional release of a biologic agent to their
+state or local health departments.
+
+[GRAPHIC] [TIFF OMITTED] T0168.026
+
+[GRAPHIC] [TIFF OMITTED] T0168.027
+
+ In order to be adequately prepared for emerging infectious
+diseases in the United States, state and local public health agencies
+need to have several basic capabilities, whether they possess them
+directly or have access to them through regional agreements. Public
+health departments need to have disease surveillance systems and
+epidemiologists to detect clusters of suspicious symptoms or diseases
+in order to facilitate early detection of disease and treatment of
+victims. Laboratories need to have adequate capacity and necessary
+staff to test clinical and environmental samples in order to identify
+an agent promptly so that proper treatment can be started and
+infectious diseases prevented from spreading. All organizations
+involved in the response must be able to communicate easily with one
+another as events unfold and critical information is acquired,
+especially in a large-scale infectious disease outbreak.
+ In the event of an outbreak, hospitals and their emergency
+departments would be on the front line, and their personnel would take
+on the role of first responders. Because hospital emergency departments
+are open 24 hours a day, 7 days a week, exposed individuals would be
+likely to seek treatment from the medical staff on duty. Staff would
+need to be able to recognize and report any illness patterns or
+diagnostic clues that might indicate an unusual infectious disease
+outbreak to their state or local health department. Hospitals would
+need to have the capacity and staff necessary to treat severely ill
+patients and limit the spread of infectious disease.
+ The federal government also has a role in preparedness for and
+response to major public health threats. It becomes involved in
+investigating the cause of the disease, as it is doing with SARS. In
+addition, the federal government provides funding and resources to
+state and local entities to support preparedness and response efforts.
+CDC's Public Health Preparedness and Response for Bioterrorism program
+provided funding through cooperative agreements in fiscal year 2002
+totaling $918 million to states and municipalities to improve
+bioterrorism preparedness and response, as well as other public health
+emergency preparedness activities. The funding supported development
+and improvements in a number of areas CDC considers critical to
+preparedness and response, including surveillance capacity to rapidly
+detect outbreaks of illness that may be the result of bioterrorism or
+other public health threats.
+ HRSA's Bioterrorism Hospital Preparedness Program provided funding
+through cooperative agreements in fiscal year 2002 of approximately
+$125 million to states and municipalities to enhance the capacity of
+hospitals and associated health care entities to respond to
+bioterrorist attacks. Earlier this month, HHS announced that
+approximately $870 million and $498 million have been provided for
+fiscal year 2003 through the CDC and HRSA programs, respectively, to
+states and municipalities to continue these efforts.
+Despite Improvements, Gaps Remain in Disease Surveillance Capabilities
+of State and Local Public Health Agencies
+ In the cities we visited, state and local officials reported
+varying levels of public health preparedness to respond to outbreaks of
+emerging infectious diseases such as SARS. They recognized gaps in
+preparedness elements that have been difficult to address, including
+the disease surveillance and laboratory systems and the response
+capacity of the workforce. They also were beginning to address gaps in
+preparedness elements such as communication. We found that planning for
+regional coordination was lacking between states.
+
+Progress Has Been Made in Elements of Public Health Preparedness, but
+Gaps Remain
+ States and local areas had weaknesses in some public health
+preparedness elements, including the disease surveillance and
+laboratory systems and the response capacity of the workforce. Gaps in
+capacity often are not amenable to solution in the short term because
+either they require additional resources or the solution takes time to
+implement. States and local areas were addressing gaps in
+communication.
+
+Surveillance Systems
+ State and local officials for the cities we visited in early 2002
+recognized and were attempting to address inadequacies in their
+surveillance systems. Local officials were concerned that their
+surveillance systems were inadequate to detect a bioterrorist event,
+and all of the states we visited were making efforts to improve their
+disease surveillance systems. Six of the cities we visited used a
+passive surveillance system \6\ to detect infectious disease
+outbreaks.\7\ However, passive systems may be inadequate to identify a
+rapidly spreading outbreak in its earliest and most manageable stage
+because, as officials in three states noted, there is chronic
+underreporting and a time lag between diagnosis of a condition and the
+health department's receipt of the report. To improve disease
+surveillance, six of the states and two of the cities we visited were
+developing surveillance systems using electronic databases. Several
+cities were also evaluating the use of nontraditional data sources,
+such as pharmacy sales, to conduct surveillance.\8\ Three of the cities
+we visited were attempting to improve their surveillance capabilities
+by incorporating active surveillance components into their systems. For
+our ongoing work, state and local officials told us that their
+surveillance systems had improved somewhat. The officials reported that
+CDC funds have enabled them make some of these improvements in their
+surveillance systems, including the development of Web-based disease
+reporting and active surveillance systems.
+---------------------------------------------------------------------------
+ \6\ Passive surveillance systems rely on laboratory and hospital
+staff, physicians, and other relevant sources to take the initiative to
+provide data on illnesses to the health department, where officials
+analyze and interpret the information as it arrives. In contrast, in an
+active disease surveillance system, public health officials contact
+sources, such as laboratories, hospitals, and physicians, to obtain
+information on conditions or diseases in order to identitY cases.
+Active surveillance can provide more complete detection of disease
+patterns than a system that is wholly dependent on voluntary reporting.
+ \7\ 0fficials in one city told us that although it had no local
+disease surveillance, its state maintained a passive disease
+surveillance system.
+ \8\ This type of active surveillance system in which the public
+health department obtains information tTom such sources as hospitals
+and pharmacies and conducts ongoing analysis of the data to search for
+certain combinations of signs and symptoms, is sometimes referred to as
+a syndromic surveillance system. A senior HHS official stated that
+research examining the usefulness of syndromic surveillance needs to
+continue. See S. Lillibridge, Disease Surveillance, Bioterrorism, and
+Homeland Security, Conference Summary and Proceedings Prepared by the
+Annapolis Center for Science-Based Public Policy (Annapolis, Md.: U.S.
+Medicine Institute for Health Studies, Dec. 4, 2001).
+
+Laboratory Facilities
+ Officials from all of the states we visited in early 2002 reported
+problems with their public health laboratory systems and said that they
+needed to be upgraded. All states were planning to purchase the
+equipment necessary for rapidly identifying a biological agent. State
+and local officials in most of the areas that we visited told us that
+the public health laboratory systems in their states were stressed, in
+some cases severely, by the sudden and significant increases in
+workload during the anthrax incidents in the fall of 2001. During these
+incidents, the demand for laboratory testing was significant even in
+states where no anthrax was found and affected the ability of the
+laboratories to perform their routine public health functions.
+Following the incidents, over 70,000 suspected anthrax samples were
+tested in laboratories across the country. According to preliminary
+data from our interviews and review of 2003 progress reports, officials
+reported that CDC funds enabled them to make improvements to their
+laboratory infrastructure, including upgrading their laboratory
+facilities, purchasing reagents and equipment, and improving their
+capability to test for select biologic agents.
+ Officials in the states we visited in 2002 were working on other
+solutions to their laboratory problems. States were examining various
+ways to manage peak loads, including entering into agreements with
+other states to provide surge capacity, incorporating clinical
+laboratories into cooperative laboratory systems, and purchasing new
+equipment. One state was working to alleviate its laboratory problems
+by upgrading two local public health laboratories to enable them to
+process samples of more dangerous pathogens and by establishing
+agreements with other states to provide backup capacity. Another state
+reported that it was using the funding from CDC to increase the number
+of pathogens the state laboratory could diagnose. The state also
+reported that it has worked to identify laboratories in adjacent states
+that are capable of being reached within 3 hours over surface roads. In
+addition, all of the states reported that their laboratory response
+plans had been revised to cover reporting and sharing laboratory
+results with local public health and law enforcement agencies.
+
+Workforce
+ At the time of our early 2002 site visits, shortages in personnel
+existed in state and local public health departments and laboratories
+and were difficult to remedy. Officials from state and local health
+departments told us that staffing shortages were a major concern. Two
+of the states and cities that we visited were particularly concerned
+that they did not have enough epidemiologists to do the appropriate
+investigations in an emergency. Officials at one state department of
+public health we visited said that the department had lost
+approximately one-third of its staff because of budget cuts over the
+past decade. This department had been attempting to hire more
+epidemiologists. Barriers to finding and hiring epidemiologists
+included noncompetitive salaries and a general shortage of people with
+the necessary skills.
+ Workforce capacity issues may also hinder implementation of
+infectious disease control measures. For example, the shortage of
+epidemiologists could grow worse if, in the event of a severe outbreak,
+existing health care workers became infected as a result of their more
+frequent exposure to a contaminated environment or became exhausted
+working longer hours. Workforce shortages could be further exacerbated
+because of the need to conduct contact tracing.\9\ According to World
+Health Organization officials, an individual infected with SARS came in
+contact with, on average, 30 to 40 people in Asian countries--all of
+whom had to be contacted and informed of their possible exposure.
+---------------------------------------------------------------------------
+ \9\ Contact tracing is the identification and tracking of
+individuals who may have been exposed to a person with a specific
+disease.
+---------------------------------------------------------------------------
+ During our site visits in early 2002, shortages in laboratory
+personnel were also cited. Officials in one city noted that they had
+difficulty filling and maintaining laboratory positions and that people
+that accepted the positions often left the health department for
+better-paying positions. Increased funding for hiring staff cannot
+necessarily solve these shortages in the near term because for many
+types of laboratory positions there are not enough trained individuals
+in the workforce. According to the Association of Public Health
+Laboratories, training laboratory personnel to provide them with the
+necessary skills will take time and require a strategy for building the
+needed workforce.\10\ For our current work updating these findings,
+many of the state and local officials we interviewed cited shortages in
+trained epidemiologists or laboratory personnel as persistent.
+---------------------------------------------------------------------------
+ \10\ Association of Public Health Laboratories, ``State Public
+Health Laboratory Bioterrorism Capacity,'' Public Health Laboratory
+Issues in Brief Bioterrorism Capacity (Washington, D.C.: October 2002).
+---------------------------------------------------------------------------
+ In 2002, state and local officials told us that sustained funding
+would be necessary to address one important need-hiring and retaining
+needed staff. They told us they would be reluctant to hire additional
+staff unless they were confident that the funding would be sustained
+and staff could be retained. These statements are consistent with the
+findings of the Advisory Panel to Assess Domestic Response Capabilities
+for Terrorism Involving Weapons of Mass Destruction, which recommended
+that federal support for state and local public health preparedness and
+infrastructure building be sustained at an annual rate of $1 billion
+for the next 5 years to have a material impact on state and local
+governments' preparedness for a bioterrorist event.\11\ We have noted
+previously that federal, state, and local governments have a shared
+responsibility in preparing for terrorist attacks and other
+disasters.\12\ However, prior to the infusion of federal funds, few
+states were investing in their public health infrastructure.
+---------------------------------------------------------------------------
+ \11\ Advisory Panel to Assess Domestic Response Capabilities for
+Terrorism Involving Weapons of Mass Destruction, Fourth Annual Report
+to the President and the Congress of the Advisory Panel to Assess
+Domestic Response Capabilities for Terrorism Involving Weapons of Mass
+Destruction (Arlington, Va.: RAND, Dec. 15,2002). The Advisory Panel
+was established to assess federal agency efforts to enhance domestic
+preparedness, the progress of federal training programs for local
+emergency responses, and deficiencies in federal programs for response
+to incidents involving weapons of mass destruction; to recommend
+strategies for ensuring effective coordination of federal agency
+response efforts and for ensuring fully effective local response
+capabilities for weapons of mass destruction incidents; and to assess
+appropriate state and local roles in funding effective local response
+capabilities. The Advisory Panel issues annual reports to the President
+and to the Congress and has submitted four annuals reports to date.
+ \12\ See U.S. General Accounting Office, Homeland Security:
+Effective Intergovernmental Coordination Is Key to Success, GAO-02-
+1013T (Washington, D.C.: Aug. 23,2002).
+
+Communication
+ We found that officials were beginning to address communication
+problems. For example, six of the seven cities we visited in early 2002
+were examining how communication would take place in a public health
+emergency. Many cities had purchased communication systems that allow
+officials from different organizations to communicate with one another
+in real time. In addition, state and local health agencies were working
+with CDC to build the Health Alert Network (RAN), an information and
+communication system. The nationwide RAN program has provided funding
+to establish infrastructure at the local level to improve the
+collection and transmission of information related to public health
+preparedness. Goals of the RAN program include providing high-speed
+Internet connectivity, broadcast capacity for emergency communication,
+and distancelearning infrastructure for training. For our current work,
+our preliminary review of the 2003 progress reports from 12
+jurisdictions shows that 11 reported that over 90 percent of their
+population was covered by HAN.
+
+Some State and Local Contingency Planning Underway, but Regional
+Coordination Is Lacking
+ As part of the effort to prepare for a possible outbreak of an
+infectious disease, there is contingency planning at the state and
+local levels. Health departments, for instance, are in the process of
+developing contingency response plans for SARS. The SARS preparations
+have been modeled after a checklist designed for pandemic influenza. To
+facilitate these preparations, the Association of State and Territorial
+Health Officials and the National Association of County and City Health
+Officials, in collaboration with CDC, published a checklist for state
+and local health officials to use in the event of a SARS resurgence.
+The checklist encompasses a broad spectrum of preparedness activities,
+such as legal issues related to isolation and quarantine, strategies
+for communicating information to health care providers, and suggestions
+for ensuring other community partners such as law enforcement and
+school officials are prepared.
+ During our 2002 site visits, however, we found that response
+organization officials were concerned about a lack of planning for
+regional coordination between states during an infectious disease
+outbreak. As called for by the guidance for the CDC and HRSA funding,
+all of the states we visited in 2002 organized their planning on the
+basis of regions within their states, assigning local areas to
+particular regions for planning purposes. A concern for response
+organization officials was the lack of planning for regional
+coordination between states. A hospital official in one city we visited
+said that state lines presented a ``real wall'' for planning purposes.
+Hospital officials in one state reported that they had no agreements
+with other states to share physicians. However, one local official
+reported that he had been discussing these issues and had drafted
+mutual aid agreements for hospitals and emergency medical services.
+Public health officials from several states reported developing working
+relationships with officials from other states to provide backup
+laboratory capacity.
+
+Hospital Preparedness Improved, But Limitations in Response Capacity
+Remain
+ Because those with symptoms of an infectious disease might go to
+emergency departments for treatment, hospital personnel would likely be
+some of the first health care workers with the opportunity to identiry
+an emerging infectious disease outbreak. Therefore, the disease
+surveillance capacities of many state and local public health systems
+may depend, in part, on the surveillance capabilities of hospitals.
+Most hospitals reported training their staff and planning coordination
+efforts with other public health entities. However, even with these
+preparations in place, hospitals lacked the capacity to respond to
+large-scale infectious disease outbreaks.
+
+Hospitals Provide Vital Disease Surveillance Capacity
+ The disease surveillance capacities of many state and local public
+health systems may depend, in part, on the surveillance capabilities of
+hospitals. During the recent SARS outbreak in North America, for
+instance, hospital emergency rooms played an important role in
+identirying those who had the disease. According to hospital officials
+in California and New York, hospital emergency room or other waiting
+room staff routinely used questiomaires to screen incoming patients for
+fever, cough, and travel to a country with active cases of SARS. They
+said that hospitals' signs in various locations generally used by
+incoming patients and visitors also asked individuals to identiry
+themselves to hospital staff if they met these criteria. In Toronto,
+which experienced a much greater prevalence of SARS than the United
+States, everyone entering a hospital was required to answer screening
+questions and to have their temperature checked before they were
+allowed to enter.
+
+Most Hospitals Reported Planning and Training Efforts, but Fewer Than
+Half Have Participated in Drills or Exercises
+ In our survey of over 2,000 metropolitan hospitals,\13\ most
+reported that they have provided training to staff on biological
+agents, but fewer than half have participated in drills or exercises
+related to bioterrorism. Most hospitals we surveyed reported providing
+training about identifying and diagnosing symptoms for the six
+biological agents identified by the CDC as most likely to be used in a
+bioterrorist attack. At least 90 percent of hospitals reported
+providing training for two of these agents--smallpox and anthrax-and
+approximately three-fourths of hospitals reported providing training
+about the other four--plague, botulism, tularemia, and hemorrhagic
+fever viruses.
+---------------------------------------------------------------------------
+ \13\ Between May and September 2002, we surveyed over 2,000 short-
+term, nonfederal general medical and surgical hospitals with emergency
+departments located in metropolitan statistical areas. (See U.S.
+General Accounting Office, Hospital Emergency Departments: Crowded
+Conditions Vary among Hospitals and Communities, GAO-03-460
+(Washington, D.C.: Mar. 14,2003) for information on the survey universe
+and development ofthe survey.) For the part of the survey that
+specificaIly addressed hospital preparedness for mass casualty
+incidents, we obtained responses from 1,482 hospitals, a response rate
+of about 73 percent.
+---------------------------------------------------------------------------
+ Our hospital survey found that 4 out of 5 hospitals reported having
+a written emergency response plan for large-scale infectious disease
+outbreaks. Of the hospitals with emergency response plans, most include
+a description of how to achieve surge capacity for obtaining additional
+pharmaceuticals, other supplies, and staff. In addition, almost all
+hospitals reported participating in community interagency disaster
+preparedness committees.
+ At the time of our site visits between December 2001 and March
+2002, we found that hospitals were beginning to coordinate with other
+local response organizations and collaborate with each other in local
+planning efforts. Hospital officials in one city we visited told us
+that until September 11,2001, hospitals were not seen as part of a
+response to a terrorist event but that city officials had come to
+realize that the first responders to a bioterrorism incident could be a
+hospital's medical staff. Officials from the state began to emphasize
+the need for a local approach to hospital preparedness. They said,
+however, that it was difficult to impress the importance of cooperation
+on hospitals because hospitals had not seen themselves as part of a
+local response system. The local government officials were asking them
+to create plans that integrated the city's hospitals and addressed such
+issues as off-site triage of patients and off-site acute care.
+
+Most Emergency Departments Have Experienced Some Degree of Crowding
+ Our survey of metropolitan hospitals found that most emergency
+departments have experienced some degree of overcrowding.\14\ Persons
+with symptoms of infectious disease would potentially go to emergency
+departments for treatment, further stressing these facilities. The
+problem of overcrowding is much more pronounced in some hospitals and
+areas than in others. In general, hospitals that reported the most
+problems with crowding were in the largest metropolitan statistical
+areas (MSA) and in the MSAs with high population growth. For example,
+in fiscal year 2001, hospitals in MSAs with populations of 2.5 million
+or more had about 162 hours of diversion (an indicator of
+crowding),\15\ compared with about 9 hours for hospitals in MSAs with
+populations of less than 1 million. Also, the median number of hours of
+diversion in fiscal year 2001 for hospitals in MSAs with a high
+percentage population growth was about five times that for hospitals in
+MSAs with lower percentage population growth.
+---------------------------------------------------------------------------
+ \14\GAO-03-460.
+ \15\ Diversions occur when hospitals request that en route
+ambulances bypass their emergency departments and transport patients
+that would have otherwise been taken to those emergency departments to
+other medical facilities.
+---------------------------------------------------------------------------
+ Hospitals in the largest MSAs and in MSAs with high population
+growth that have reported crowding in emergency departments may have
+difficulty handling a large influx of patients during a potential
+infectious disease outbreak, especially if this outbreak occurred in
+the winter months when the incidence of influenza is quite high. For
+example, public health officials with whom we spoke said that in the
+event of a large-scale SARS outbreak, entire hospital wards may need to
+be used as separate SARS isolation facilities. Moreover, certain
+hospitals within a community may need to be designated as SARS
+hospitals.
+
+Concluding Observations
+ Efforts at the state and local level have improved the ability to
+identify and respond to infectious disease outbreaks and bioterrorism.
+These improvements have included upgrades to laboratory facilities and
+communication systems. Hospitals have also begun planning and training
+efforts to respond to large-scale infectious disease outbreaks. Despite
+these improvements, gaps in preparedness remain. We found that some
+disease surveillance systems may be inadequate, that there are
+shortages of key personnel in some localities, and that some hospital
+emergency departments across the country have experienced some degree
+of overcrowding which could be exacerbated during a disease outbreak.
+ Mr. Chairman, this completes my prepared statement. I
+ would be happy to respond to any questions you or other
+ Members of the Subcommittee may have at this time.
+Contact and Staff Acknowledgments
+ For further information about this testimony, please contact Janet
+Heinrich at (202) 512-7119. Angela Choy, Krister Friday, Martin T.
+Gahart, Gay Hee Lee, and Deborah Miller also made key contributions to
+this statement.
+
+Related GAO Products
+ Hospital Preparedness: Most Urban Hospitals Have
+ Emergency Plans but Lack Certain Capacities for
+ Bioterrorism Response. GAO-03-924. Washington, D.C.:
+ August 6,2003.
+ Severe Acute Respiratory Syndrome: Established
+ Infectious Disease Control Measures Helped Contain
+ Spread, But a Large-Scale Resurgence May Pose
+ Challenges. GAO-03-1058T. Washington, D.C.: July 30,
+ 2003.
+ Bioterrorism: Information Technology Strategy Could
+ Strengthen Federal Agencies' Abilities to Respond to
+ Public Health Emergencies. GAO-03-139. Washington,
+ D.C.: May 30, 2003.
+ SARS Outbreak: Improvements to Public Health Capacity
+ are Neededfor Responding to Bioterrorism and Emerging
+ Infectious Diseases. GAO-03-769T. Washington, D.C.: May
+ 7, 2003.
+ Smallpox Vaccination: Implementation of National
+ Program Faces Challenges. GAO-03-578. Washington, D.C.:
+ April 30, 2003.
+ Infectious Disease Outbreaks: Bioterrorism Preparedness
+ Efforts Have Improved Public Health Response Capacity,
+ but Gaps Remain. GAO-03-654T. Washington, D.C.: April
+ 9,2003.
+ Bioterrorism: Preparedness Varied across State and
+ Local Jurisdictions. GAO03-373. Washington, D.C.: April
+ 7, 2003.
+ Hospital Emergency Departments: Crowded Conditions Vary
+ among Hospitals and Communities. GAO-03-460.
+ Washington, D.C.: March 14, 2003.
+ Homeland Security: New Department Could Improve
+ Coordination but Transferring Control of Certain Public
+ Health Programs Raises Concerns. GAO-02-954T.
+ Washington, D.C.: July 16,2002.
+ Homeland Security: New Department Could Improve
+ Biomedical R&D Coordination but May Disrupt Dual-
+ Purpose Efforts. GAO-02-924T. Washington, D.C.: July 9,
+ 2002.
+ Homeland Security: New Department Could Improve
+ Coordination but May Complicate Priority Setting. GAO-
+ 02-893T. Washington, D.C.:
+ Homeland Security: New Department Could Improve
+ Coordination but May Complicate Public Health Priority
+ Setting. GAO-02-883T. Washington, D.C.: June 25, 2002.
+ Bioterrorism: The Centers for Disease Control and
+ Prevention's Role in Public Health Protection. GAO-02-
+ 235T. Washington, D.C.: November 15,2001.
+ Bioterrorism: Review of Public Health Preparedness
+ Programs. GAO-02-149T. Washington, D.C.: October
+ 10,2001.
+ Bioterrorism: Public Health and Medical Preparedness.
+ GAO-02-14IT. Washington, D.C.: October 9,2001.
+ Bioterrorism: Coordination and Preparedness. GAO-02-
+ 129T. Washington, D.C.: October 5, 2001.
+ Bioterrorism: Federal Research and Preparedness
+ Activities. GAO-01-915. Washington, D.C.: September
+ 28,2001.
+ West Nile Virus Outbreak: Lessons for Public Health
+ Preparedness. GAO/HEHS-00-180. Washington, D.C.:
+ September 11,2000.
+ Combating Terrorism: Need for Comprehensive Threat and
+ Risk Assessments of Chemical and Biological Attacks.
+ GAO/NSIAD-99-163. Washington, D.C.: September 14, 1999.
+ Combating Terrorism: Observations on Biological
+ Terrorism and Public Health Initiatives. GAO/T-NSIAD-
+ 99-112. Washington, D.C.: March 16, 1999.
+
+ September 24, 2003
+
+ INFECTIOUS DISEASES
+
+ Gaps Remain in Surveillance Capabilities of State and Local Agencies
+
+ What GAO Found
+ The efforts of public health agencies and health care organizations
+to increase their preparedness for infectious disease outbreaks and
+bioterrorism have improved the nation's ability to recognize such
+events. However, gaps remain in state and local disease surveillance
+systems, which are essential to public health efforts to respond to
+disease outbreaks or bioterrorist attacks. Other essential elements of
+preparedness include laboratory facilities, workforce, and
+communication systems. State and local officials report that they are
+addressing gaps in communication systems. However, there are still
+significant workforce shortages in state and local health departments
+and laboratories. GAO also found that while contingency plans are being
+developed at the state and local levels, planning for regional
+coordination for disease outbreaks or bioterrorist events was lacking
+between states.
+ The disease surveillance capacities of many state and local pubic
+health systems depend, in part, on the surveillance capabilities of
+hospitals. Whether a disease outbreak occurs naturally or due to the
+intentional release of a harmful biological agent by a terrorist, much
+of the initial response would occur at the local level, particularly at
+hospitals and their emergency departments. Therefore, hospital
+personnel would be some of the first healthcare workers with the
+opportunity to identify an infectious disease outbreak or a
+bioterrorist event. Most hospitals reported training their staff on
+biological agents and planning coordination efforts with public health
+entities; however, preparedness limitations may impact hospitals'
+ability to conduct disease surveillance. In addition, hospitals still
+lack the capacity to respond to large-scale infectious disease
+outbreaks. Also, most emergency departments across the country have
+experienced some degree of overcrowding, which could be exacerbated
+during a disease outbreak or bioterrorist event if persons with
+symptoms go to emergency departments for treatment.
+
+ Mr. Shadegg. Thank you, Ms. Heinrich.
+ Next we will hear from Dr. Richard Platt, Chair, Department
+of Ambulatory Care and Prevention, Harvard Pilgrim Health Care.
+Dr. Platt?
+
+ STATEMENT OF DR. RICHARD PLATT, CHAIR OF THE AMBULATORY CARE
+ AND PREVENTION, HARVARD HEALTH PLAN
+
+ Dr. Platt. Thank you, Mr. Chairman and members of the
+committee.
+ I should also say that although I am a professor at Harvard
+Medical School, my medical school department is jointly
+sponsored by a health plan, Harvard Pilgrim Health Care. I
+appreciate the opportunity to talk with you today about the
+CDC-sponsored National Bioterrorism Surveillance Demonstration
+Program that my partners and I are undertaking. This is a
+three-way partnership that involves the health plans, the
+public health sector and the academic community.
+ The health plans bring to this partnership their rich
+information sources and ability to communicate with large
+numbers of clinicians and their patients. The public health
+sector brings the ability to set priorities and coordinate
+responses. The academic community is contributing its
+information and knowledge and tools.
+ This partnership has been active for some time and has been
+working on a number of important health problems, including
+bioterrorism preparedness. My own experience in detecting
+bioterrorism began in 2000 with a grant from the CDC to the
+Massachusetts Department of Public Health. I should point out
+that was before 9-11. We use information from the electronic
+medical records of a large physician group to gather diagnoses
+as soon as they are made, and then we analyze this information
+for evidence of unusual disease activity and we communicate
+that back to our public health colleagues.
+ You have handouts at your desk showing an example of the
+kind of information we give to our pubic health colleagues.
+This is a screen shot of our protected Web site showing the
+disease activity in the Greater Boston area yesterday. This
+information became available early this morning. It shows that
+nothing unusual happened yesterday. The way it does that is to
+highlight the five most unusual census tracts in the Greater
+Boston area. In this way, our public health colleagues do not
+have to evaluate a lot of numbers. They have to look at what is
+unusual, and we get to this unusualness by taking into account
+the number of health plan members who live in those census
+tracts and the number of other factors that affect disease
+incidence.
+
+[GRAPHIC] [TIFF OMITTED] T0168.028
+
+ This information provides early warning for both
+bioterrorism and naturally occurring illnesses. The system is
+also flexible enough to add additional purposes that we had not
+originally planned. For instance, soon after we activated this
+system, the State's influenza tracking branch asked us to track
+influenza-like illness and we added that at no cost to the
+system or to our sponsors, and report that on a regular basis
+now. We are currently in discussions about ways that we might
+monitor SARS if it appears in our community.
+ I believe that three major elements contribute to the
+success of our program. The first is the availability of
+electronic medical records. They are complete, they are
+available immediately, and the process of obtaining information
+does not require the clinicians to take any additional actions
+beyond the regular care they deliver.
+ The second important element was the development of a
+computerized method to identify potential outbreaks. The system
+takes into account historical patterns of illness and allows us
+to recognize unusual numbers of events as early as possible.
+This is important because recognizing an outbreak can be like
+viewing a mosaic while standing very close to it. At least
+initially, the key may be the pattern of cases, rather than the
+features of any individual case, and these patterns can differ
+at different times and in different places, and therefore be
+difficult to recognize early. Using computerized identification
+methods also allows us to provide alerts to public health
+officials so they do not have to examine the actual numbers of
+illnesses each day, especially when there is no special
+concern.
+ The third element of our success was the willingness of the
+health plan and the physicians to share their medical record
+information. The major reason for this is that we designed the
+system so that they continue to be the custodians of their
+patients's healthcare data. All that they provide to us is the
+number of new cases of different kinds of illness in each area.
+If we detect a potential cluster, then the health department
+requests information from the health plan about the specific
+cases that contribute to that cluster. We built a mechanism to
+allow them to obtain that additional information very quickly.
+This arrangement corresponds to the health plan's and
+clinician's understanding of their patients's strong desire
+that information about their individual medical visits be kept
+private unless there is an immediate and compelling public
+health need for it.
+ During the past year, the CDC has supported our work to
+create a system that uses these principles to integrate
+information from many health plans. Our principal partner in
+this activity is the American Association of Health Plans,
+which represents approximately 1,000 health plans that care for
+over 170 million Americans. Additional participants include
+health plans in Minnesota, Massachusetts, Colorado and Texas,
+and the National Nurse Call Center that cares for individuals
+in all 50 States.
+ The information on the second page of your handout shows
+the data flow for this system, with health plans identifying
+new episodes, communicating that to the data center using
+protected Internet technology. The data center uses that count
+information to identify unusual clusters. The information is
+posted on a protected Web site. When there is a cluster, we can
+notify both the health plan and the health department. The
+health plan and the health department then interact with each
+other to further their communication. Although we are still
+creating some parts of this system, our preliminary evidence
+indicates that it does identify outbreaks of public health
+interest.
+
+[GRAPHIC] [TIFF OMITTED] T0168.029
+
+ If you take a look at the third sheet of the handout,
+this is a national map showing the disease incidence in the
+middle of last December. I picked this date because although
+most of the nation, which is colored pink, is showing that
+there is no unusual data, in Massachusetts there is quite an
+impressive spike. It is hard to see on this sheet, but if you
+look at the next page it shows that in Massachusetts you can
+see that there are a number of zip codes in Massachusetts that
+have an unusually high volume of new respiratory illnesses. By
+our calculations, this was a once in 8-year event that lasted 4
+days and involved hundreds of people.
+
+[GRAPHIC] [TIFF OMITTED] T0168.030
+
+ We have several goals for the coming year. First, we
+want to make the transition to a stable, ongoing system. In
+addition, we are in discussion with our colleagues at the CDC
+about ways that we can collaborate with Project BioSense to
+adapt our detection methods to that system and to make the data
+from our health plans available through BioSense. We also want
+to work with CDC to improve health departments's ability to
+communicate quickly and effectively with practicing clinicians
+and the millions of individuals for whom they provide care. We
+also hope to make use of new types of medical information and
+to develop more sophisticated methods for developing disease
+outbreaks at the earliest possible time.
+ In summary, we have learned that routinely collected health
+plan data can be an important public health resource and it can
+be used in ways that minimizes patients's privacy concerns. My
+colleagues and I believe that this system can make a valuable
+contribution to the public health system's ability to identify
+and to respond to health threats at the earliest possible
+moment.
+ I also believe that our work is even more important as an
+example of the possibilities of the partnerships that we can
+create between the private healthcare delivery system, the
+public health sector, and the academic community. Because of
+this, I believe that this three-way partnership has the
+potential to transform the health of our society if we take the
+proper steps to nurture it.
+ Thank you very much.
+ [The statement of Dr. Platt follows:]
+
+ PREPARED STATEMENT OF RICHARD PLATT
+
+ Good afternoon Mr. Chairman and members of the Subcommittee. My
+name is Richard Platt; I am a Professor at Harvard Medical School,
+where I chair the Department of Ambulatory Care and Prevention, a
+department that is unique in being jointly sponsored by a medical
+school and by a health plan, Harvard Pilgrim Health Care. I am also an
+infectious diseases specialist, an epidemiologist, and a member of the
+Board of Scientific Counselors of the Center for Disease Control and
+Prevention's (CDC) National Center for Infectious Diseases.
+ I am very excited about this opportunity to discuss our National
+Bioterrorism Surveillance Demonstration Program and the work we do
+daily to detect and respond to both bioterrorism and naturally
+occurring disease outbreaks. The National Demonstration Program is the
+product of an evolving three-way partnership between private health
+plans and physician groups, public health agencies, and the academic
+community. This partnership makes an important contribution to
+protecting the overall health of our nation by combining our unique
+strengths:
+ the private health system's information infrastructure and its
+ability to communicate both with clinicians and with the people for
+whom they provide care;
+ the public sector's ability to set major health priorities and
+coordinate a response; and
+ the academic community's skills in developing the knowledge
+and tools to make the most of these capabilities.
+ In addition to the work I will describe today, this three-way
+partnership is currently making important contributions to our ability
+to prevent illness, treat disease, improve the safety of drugs and
+vaccines, and improve the delivery of health care.
+ Before I describe our National Demonstration Program, I think it
+will be helpful for you to know how it began. My work on detecting
+bioterrorism began in 2000 when the Massachusetts State Epidemiologist,
+Dr. Alfred DeMaria, and I developed a partnership between the
+Massachusetts Department of Public Health, Harvard Pilgrim Health Care,
+and Harvard Vanguard Medical Associates to enhance early-detection and
+public health communication capabilities. This project was supported by
+a bioterrorism preparedness grant from the CDC to the State of
+Massachusetts. We had three major goals: first to quickly gather the
+diagnoses made in everyday practice by hundreds of physicians in
+eastern Massachusetts; then to analyze this information for evidence of
+unusual disease activity; and finally to create a mechanism for public
+health officials to communicate rapidly with clinicians to follow up
+the outbreak signals we detected. Because of our early start, our
+eastern Massachusetts detection system went ``live'' in October of
+2001, within weeks of the anthrax attack that brought bioterrorism to
+prominence. This system is described in articles in Emerging Infectious
+Diseases (2002 Aug;8(8):753-60) and BMC Public Health (2001;1:9).
+ Our system has been active since then, identifying the census
+tracts in our region with the most unusual number of new cases of
+respiratory, gastrointestinal, and several other categories of illness,
+which may indicate potential outbreaks. This information is displayed
+via maps and tables on a secure internet site that is accessible to the
+state health department. The following illustration shows the
+information that public health officials view on a typical day.
+
+[GRAPHIC] [TIFF OMITTED] T0168.031
+
+ An important feature of this display is that it only highlights
+areas with the most unusual number of people who have a new episode of
+illness, after eliminating seasonal and other effects. On the majority
+of days, nothing unusual occurs. However, when we observe an unusually
+large number of cases in a specific locale, a clinician who works in
+the medical practice that provides the information, and who is
+responsible for public health reporting, provides additional
+information to the health department. Fortunately, there have been no
+cases of bioterrorism since our program became active. However, we
+understood from the outset that this information would also serve a
+separate purpose of providing routine, high quality, timely,
+information to the public health department about naturally occurring
+illnesses in these communities--earlier than is possible with
+traditional physician reporting of diagnosed diseases. Using historical
+data from the health plan and state records, we were able to
+demonstrate that office visits for wintertime respiratory illness
+increased about two weeks before an increase in respiratory
+hospitalizations occurred. In addition, we have been able to identify
+unusual clusters of respiratory infections, as shown in the following
+figure, which illustrates a once-in-eight-year cluster involving
+hundreds of people that occurred last December.
+
+[GRAPHIC] [TIFF OMITTED] T0168.032
+
+ Soon after we began providing routine reports to our colleagues
+in the Massachusetts Department of Health, the department's influenza
+tracking branch requested that we report a new disease category--
+influenza-like illness-- and we added this feature without any
+additional resources from the clinical system or the state. We are
+currently discussing with CDC ways to adapt this system to detect the
+occurrence of Severe Acute Respiratory Syndrome (SARS) if it appears in
+our region. The Institute of Medicine (10M) described this detection
+system in Massachusetts as an example of the ability of the health care
+delivery system to play an important role in disease detection and
+reporting in its recent report, ``The Future of the Public's Health in
+the 21st Century,'' (page 249).
+ Several critical elements contribute to the success of this
+program. The first is the fact that a large physician group, Harvard
+Vanguard Medical Associates, uses electronic medical records to provide
+routine patient care. Therefore, information about diagnoses, symptoms,
+and vital signs is available at the end of each day. Clinicians are not
+required to collect any additional information, to record it in any
+special way, or to take any additional steps to report needed
+information. Thus, we avoid burdening already overloaded clinicians and
+their support staff and we are confident that the clinical information
+is complete. In addition, since we focus on health plan members, we
+also know how many members are not sick. This provides added confidence
+that the detection system will alert us to problems that occur in the
+health plans' enrolled population.
+ The second important element was development of a method to
+identify potential outbreaks. We accomplish this using a computerized
+analysis program that takes into account historical patterns of illness
+and allows us to recognize when unusual numbers of events occur.
+Assessing patterns of illness is important because our system looks for
+clusters of individual cases that may not seem unusual to the
+clinicians who are providing care. The absence of distinguishing
+features is often the case for conditions like SARS. It causes severe
+symptoms in only a small fraction of infected people, yet detection of
+the larger number of people who develop mild symptoms and then recover
+may signal the arrival of the virus to an area. Additionally, even
+life-threatening illnesses like anthrax and smallpox typically begin
+with a few days of mild illness that cannot be distinguished in routine
+practice from common illnesses. Even highly experienced epidemiologists
+find it difficult to recognize unusual numbers of illnesses because of
+the difficulty of taking into account multiple factors--the day of the
+week, the season, whether it is the day after a holiday, the history of
+incidence over prior years, and the typical patterns of care in
+specific communities. An unusually high number of ill people on a
+Wednesday in August may be quite ordinary for a Monday in January, and
+a few cases in one community can be much more significant than a much
+larger number in a nearby community. Thus, our cluster detection
+analysis system is a key element in the system's effectiveness.
+ An additional reason to use computerized methods to identify
+unusual situations is to provide alerts to public health officials. Our
+public health colleagues have advised us that it is inefficient to
+examine the actual numbers of illnesses each day, especially when there
+is no special concern. In short, our detection system sifts and
+analyzes huge volumes of data and only in rare cases alerts public
+health officials to an unusual signal that requires attention.
+ A third important contributor to our success is the willingness of
+the health plan and physicians' practice to share this critical health
+information. One reason health plans and medical groups are willing to
+do this is that we constructed the system so that they continue to be
+custodians of their patients' health care data, providing only the
+information that is needed for tracking the public's health. The only
+information that health plans submit to us is the number of individuals
+in each zip code or census tract with visits for respiratory,
+gastrointestinal, or other types of medical problems. If the number of
+cases is unusually large, the health department requests the
+corresponding visit-by visit information, which is stored at the health
+plan. The health department contacts a designated clinical responder in
+the health plan for any additional information that is needed. The
+clinician responds in a timely manner and has ready access to
+information about the individual and the details of the illness.
+ Organizing the system this way is appealing to the health plans and
+the public for two major reasons. First, it corresponds to the public's
+desire for health plans and physicians to keep information about their
+individual medical visits private unless there is a compelling public
+health need for such information. Second, health plans know that visit
+level information can be used for other purposes, such as litigation
+and competitive purposes, and so they want to be as certain as possible
+that the information they provide is accurate and used only for the
+intended purpose--public health. Several health plans have had recent
+experiences in which a public health agency has not been able to assure
+the confidentiality of data that they provided. While many health plans
+believe strongly in contributing actively to our nation's public
+health, they also want to minimize the possibility that doing so will
+breach confidentiality.
+ During the past year, we have developed the capacity to integrate
+real-time bioterrorism and disease detection information from many
+health plans. This National Demonstration Program has been supported by
+the CDC through a grant to one of its Prevention Epicenters, which I
+lead. The design of this program has been guided by our work in
+Massachusetts, as well as the considerable experience of health plans
+in Minnesota and Colorado. Our major partner in this work is the
+American Association of Health Plans, which is the principal national
+organization representing more than 1,000 health plans that provide
+coverage for more than 170 million Americans nationwide. Additional
+participants are four health plans or physician groups--Harvard Pilgrim
+Health Care/Harvard Vanguard Medical Associates (Massachusetts),
+HealthPartners (Minnesota), Kaiser Permanente Colorado, and
+UnitedHealthcare's nurse call center, Optum. The coordinating center is
+at Harvard Medical School's Channing Laboratory.
+ We also recently began working with three health providers in
+Texas, Scott and White Healthcare System, the Austin Regional Clinic,
+and Austin Diagnostic Clinic, after a local health officer asked us to
+help him develop a disease surveillance system. The health officer
+secured necessary funding from the Texas Association of Local Health
+Organizations to support their participation. All of our health plan
+partners have some form of electronic health information. Detailed
+information about this program has been described in articles in the
+Journal of Urban Health (2003;80 #2, Supplement l:i25-i31) and the
+National Journal (April 19, 2003, p 1238-9).
+ We are making excellent progress and are enthusiastic about the
+prospects of this detection program. We have created computer programs
+that allow the health plans to automate the large majority of their
+activities. These programs analyze daily clinical information and group
+together visits with different diagnoses, for instance ``cough'' and
+``bronchitis'', identify new episodes of illness so that repeat visits
+for the same illness are not counted twice, assign the new episodes to
+the zip codes where the patients live, count the number of new episodes
+in each zip code, and then transmit only this summary information
+automatically over a secure internet connection to the coordinating
+center at Harvard. At the coordinating center, we combine the
+information from different health plans and search for unusual patterns
+of illness. The computer programs we have developed for the health
+plans also maintain detailed lists of the clinical information that
+underlies the numbers provided to the coordinating center. These
+detailed lists are kept by the health plan and are immediately
+accessible to the clinical responders when a public health department
+seeks additional information for investigation of a possible outbreak.
+The information flow is shown in the following diagram.
+
+[GRAPHIC] [TIFF OMITTED] T0168.033
+
+ We are currently working with our state and local health
+department partners to evaluate our surveillance system's capabilities
+by comparing the clusters that we identify through health plan data to
+confirmed past outbreaks that health departments have detected through
+their usual method of identification. Our preliminary comparison
+indicates that our system identifies the large majority of recognized
+outbreaks that occurred during the past two years, and it also
+highlights potential clusters that the public health system may not
+have detected.
+ We are also developing the ability to notify health departments
+automatically of clusters that they wish to know about, through pagers
+or e-mail. We expect this will be the most efficient method of ensuring
+that needed information is used by public health agencies at the
+earliest possible opportunity. At present, we are waiting for the
+public health departments to provide the specifications for these
+automatic notifications.
+ In all of our activities, we try to use definitions and methods
+that are consistent with evolving public health practice, with the goal
+of making our information compatible with other detection and response
+systems, including the ESSENCE system developed by the Department of
+Defense, and the CDC's BioSense initiative. We are currently discussing
+with CDC the contributions we can make to BioSense, both in adapting
+our signal detection methods to the broad range of data types in
+BioSense, and making data from our health plans available to the public
+health community through BioSense. We look forward to working with CDC
+and are certain that a continued public-private partnership provides
+the greatest opportunity for improved homeland security.
+ We have just been notified that we will receive funding to continue
+this program beyond its first year. Our goals include making the
+transition from program development and testing to a stable, ongoing
+system and collaborating with BioSense, as described above. We
+especially want to work with CDC to improve public health departments'
+ability to communicate quickly and effectively with the large majority
+of practicing clinicians in this country and with over 170 million
+individuals for whose care the health plans are responsible. We are
+convinced there is important additional work to do in acquiring new
+types of data, for instance emergency room visit information,
+additional information from health plans, and in developing more
+sophisticated mathematical models that will allow us to do a better job
+combining information from different data sources within a single
+health plan (for instance, regular office visits and emergency room
+visits) and aggregate information from several plans that serve a
+single area. We are also talking with other health plans and physician
+groups that are interested in contributing their information to this
+system. We also look forward to working with our public health partners
+to creating a wide array of new uses for health plans' data and their
+ability to communicate with clinicians and the people for whom they
+provide care. We believe the framework we have created will facilitate
+this development.
+ In conclusion, I want to thank you again for the opportunity to
+discuss our work with you. My colleagues and I believe this system can
+make a valuable contribution to the public health system's ability to
+identify and respond to bioterrorism and other emerging threats at the
+earliest possible moment and it can be expanded to report health plan
+data nationally. I also believe it is even more important as an example
+of the partnerships we can create between the private health care
+delivery system, the public health sector, and the academic community.
+I believe this three-way partnership has the potential to transform the
+health of our society during the coming years if we take the right
+steps to nurture it.
+
+ Mr. Shadegg. Thank you, Doctor.
+ We will next hear from Dr. Jonathan L. Temte, infectious
+disease specialist with the American Academy of Family
+Physicians. Doctor?
+
+STATEMENT OF DR. JONATHAN TEMTE, INFECTIOUS DISEASE SPECIALIST,
+ AMERICAN ACADEMY OF FAMILY PHYSICIANS
+
+ Dr. Temte. On behalf of the 94,000 members of the American
+Academy of Family Physicians, I thank Chairman Shadegg and the
+subcommittee for the opportunity to discuss detection of
+bioterrorism in primary care. As Mrs. Christensen can probably
+attest, family doctors like to talk a lot, but I will try and
+keep my comments within the 5-minute limit.
+ My goal today is to leave you with these three main themes.
+First, defense against bioterrorism is dependent upon frontline
+physicians. Second, surveillance is necessary for bioterrorism,
+but it is not sufficient. And third, there is a real and
+growing threat to the integrity of our first line of defense.
+ The United States needs frontline primary care physicians.
+Detection of bioterrorism requires that astute clinicians are
+available whenever and wherever a victim first presents for
+medical care. On October 2, 2001, an astute clinician made a
+diagnosis of anthrax. Ten additional cases of inhalational
+anthrax eventually presented to physicians from multiple
+specialties in multiple states. In each case, the correct
+diagnosis was made using usual medical care. In retrospect, no
+additional cases were discovered.
+ On May 20, 2003, a 3-year-old girl was brought to her
+primary care physician for evaluation of a bite wound to her
+finger. Within 10 days of the initial visit, the diagnosis of
+an unusual pox virus was made. The CDC confirmed the very first
+case of monkeypox in the Western Hemisphere. This diagnosis was
+made using the physicians and facilities in a town of 19,000
+people in rural Wisconsin.
+ In these examples, very rare diseases were detected by
+astute clinicians doing no more than what they were trained to
+do on a day-to-day basis. Will physicians immediately recognize
+illnesses due to bioterrorism? The answer is no. Will the cases
+of bioterrorism be identified through usual medical care? Here
+the answer is yes, if those patients have access to well-
+trained and competent physicians.
+ Family physicians are widely dispersed across America and
+see patients regardless of age, gender or affected organ
+system. It is estimated that family physicians evaluate and
+manage a total of one billion individual medical problems each
+year in this country, and can put these problems into context
+because we know our patients and their families, and we know
+their communities. Accordingly, in the event of future
+bioterrorism events, the first cases will likely present to
+family physicians and other primary care specialists.
+ Surveillance for bioterrorism events is totally necessary,
+but it is not sufficient. For surveillance to be workable, it
+has to be highly sensitive and have extreme timeliness of
+detection. These two properties, however, come at an extremely
+high price. When applied to things that are very, very rare,
+and bioterrorism is rare, surveillance will produce a high rate
+of false positive alarms and rapidly overwhelm everyone
+involved.
+ Surveillance of disease trends, on the other hand, can
+enhance the role of the astute clinician. Clinicians are better
+able to evaluate their patients when informed of current trends
+in infectious diseases. Moreover, established communications
+systems between public health and primary care physicians that
+are reliable and relevant can also be used to alert clinicians
+of new and upcoming threats.
+ While we are facing some significant threats to our first
+line of defense, primary care in the United States is
+declining. Family physicians deal with an ever-increasing
+number of problems, coupled with less compensation and
+increased regulation. The number of graduating family
+physicians peaked in 2000. More telling, the number of training
+positions filled with U.S. medical school graduates peaked in
+1997 and has been steadily declining ever since.
+ The message I would like to leave you with today is this.
+Our nation is blessed with an abundance of well-trained,
+competent and compassionate physicians. If an act of
+bioterrorism occurs again, it is highly likely that an astute
+primary care physician doing what he or she is trained to do,
+will detect the first case and sound the alarm. Moreover, it is
+highly likely that that physician and his or her colleagues
+will not only provide the appropriate treatment to that
+patient, but educate and reassure the other worried patients
+that come in, and reduce the panic and terror that is
+associated with bioterrorism.
+ Thank you.
+ [The statement of Dr. Temte follows:]
+
+ PREPARED STATEMENT OF DR. JONATHAN L. TEMTE
+
+ It is a great honor and privilege to represent the American Academy
+of Family Physicians and its 94,300 members before the House Select
+Homeland Security Subcommittee on Emergency Preparedness and Response.
+We, along with our colleagues in pediatrics, general internal medicine,
+and other medical specialties represent the first line of defense and
+the cornerstone of defense against bioterrorism. We are primary care
+physicians-or a term that I tend to prefer--comprehensive care
+physicians.
+ I sit before you today to provide the viewpoint of a practicing
+family physician on the primary care physician's role in the detection
+and response to bioterrorism.
+
+Biodefense in Medical Practice
+ Much of today's real biodefense dates back to 1910--the year that
+the Flexner Report was published. This report set into motion a system-
+wide revolution in American medicine. It called for standardization in
+medical education. Out of the recommendations of the Flexner Report
+came what we expect and demand today from our physicians: comprehensive
+and competent medical care. Through the review and accreditation of our
+four-year medical schools and through the review and accreditation of
+our post-graduate residency training programs, the American medical
+system has yielded a wonderful fruit, and that is the realized
+expectation that medical care is relatively stable across geographic,
+economic, ethnic and cultural divisions.
+ That is not to say that disparities do not exist. We all know they
+do. Nevertheless, I have the greatest confidence that were I to slump
+over with chest pain here before you and were whisked off to a local
+medical center, I would receive care similar to that which I would
+receive at home.
+ Physicians are trained to interact with people, and once one
+interacts with people, one faces uncertainty. Medical practice consists
+of equal parts of science and art. We face uncertainty on a daily basis
+and are trained to take the complaints and concerns placed before us
+and make good choices regarding advice and treatment. The core product
+of an encounter with a patient is the differential diagnosis--that set
+of diagnostic possibilities that could explain our patient's symptoms
+and findings. For example, in the case of inhalational anthrax, we have
+shown that family physicians identify no less than 35 separate and
+distinct diagnostic categories based on the initial presentation of
+this disease. Once set, our job is to narrow the diagnosis using clues
+from our experience, physical examination, the progression of the
+disorder, laboratory tests, radiographs and other technological tools.
+Across the nation, physicians approach similar problems in similar
+ways. The first line of defense against bioterrorism, therefore, is
+nothing more than the comprehensive, competent, complete and
+compassionate application of medical knowledge, skill and experience.
+This has been a given since 1910. Let me provide two examples:
+ On October 2, 2001, an incoherent, 63-year-old man with a fever
+presented to a Florida emergency room. Meningitis was a possible
+diagnosis, and later that day he underwent a spinal tap. An infectious
+disease specialist examined the resulting fluid, and noted unusual-
+appearing bacteria. A diagnosis of anthrax was first entertained.
+Within two days, the Florida Department of Health Laboratory had
+confirmed anthrax and CDC investigators were conducting epidemiological
+investigations. On October 5, at the invitation of the American Academy
+of Family Physicians, I provided a one-hour lecture about agents of
+biological terrorism to an audience of 2,500 family physicians at the
+Annual Scientific Assembly. Information flowed nearly instantaneously
+onto the Academy's website. In various fashions, similar information
+flowed out to physicians from all specialties across America. This same
+day, the patient died. By the following day--October 6--an autopsy
+confirmed a diagnosis of inhalational anthrax. . . and the dawn of
+modem bioterrorism.
+ Within the course of four days, the cause of a patient's illness
+was fully diagnosed, an epidemiological investigation initiated, and
+information disseminated to thousands of practicing physicians. This
+rapid identification occurred even though the last case of inhalational
+anthrax in the United States occurred 23 years previously.
+ Eleven cases of inhalational anthrax eventually presented over wide
+expanses of space and time, and to physicians from multiple
+specialties; yet all cases were rapidly diagnosed and appropriately
+treated. Despite widespread post-event assessments of unexpected
+deaths, no additional cases of inhalational anthrax were found.
+ On May 13,2003, a three-year-old girl was bitten on her finger by a
+pet prairie dog. One week later she was seen by her primary care
+physician and was treated with antibiotics. Due to her worsening
+condition and a rash, she was hospitalized two days later. On May 25, a
+dermatologist was asked to see the girl. Biopsies showed
+characteristics of a viral infection. On May 27, her mother developed a
+similar rash and skin samples were taken for electron microscopy and
+other testing. On May 30, the illness was shown to be due to a pox
+virus and further testing was performed at the CDC. By June 12, CDC had
+released a fact sheet on this disease. This was the first known case of
+Monkeypox in the Western Hemisphere. It was diagnosed using the medical
+facilities found in a small town of 19,000 people in rural Wisconsin.
+ In the fall of2001 and in the summer of2003, something right
+happened and that something was found within the usual responses of
+dedicated medical personnel. This is the legacy of Abraham Flexner.
+ In both of these episodes, rare diseases, with which there was no
+previous experience, were identified by astute clinicians who did no
+more than what physicians are trained to do on a day-to-day basis. We
+start with undifferentiated symptoms and stories, use our training and
+experience to consider the possibilities, exclude some diagnoses
+through physical examination, the appropriate use of laboratory and
+other testing and, sometimes, the passage of time. We narrow the
+diagnosis. At each step, we depend on the context of our interactions
+and our knowledge of our patients and their families.
+ The members of the American Academy of Family Physicians see
+patients regardless of age, gender or affected organ system. We provide
+care in America's urban areas and rural areas. In many rural areas, we
+may be the only physicians that staff the emergency room, deliver
+babies and operate on patients. We provide a great deal of care to the
+indigent, the underserved and others left behind by our medical care
+system. Without family physicians, 1332 of this nation's 3082
+counties--or 43 percent--would become Primary Care Health Personnel
+Shortage Areas, joining the 25 percent of counties that already are
+underserved.
+
+ Surveillance
+ Disease surveillance and detection ultimately depend on the
+patient-physician interaction. It is from this interaction that the
+core ingredients of surveillance emerge. They may take the form of
+individual patients matching a set of criteria, and those patients
+being reported to a public health agency--known as sentinel
+surveillance. They may be the one or two diagnostic codes that are
+assigned to describe the entire interaction for billing purposes--often
+used for mechanistic or electronic syndromic surveillance. They may be
+in the form of the diagnostic tests that are ordered at an encounter,
+forming the basis for laboratory surveillance.
+ Sentinel surveillance uses the human element to identify
+individuals in the population fitting a set of characteristics. It can
+be accurate and timely, but is limited by multiple demands placed on
+the sentinels. Nevertheless, approximately 1,600 family physicians
+currently participate in the U.S. Influenza Sentinel Provider
+Surveillance Network, a nationwide program for influenza surveillance
+run by the Influenza Branch of the CDC.
+ Mechanistic surveillance makes use of already collected data such
+as billing codes, pharmacy sales, hospital admission diagnoses, or
+other creative entities to rapidly identify changing patterns of
+disease or utilization. Data quality, the knowledge of underlying
+processes, and the reasonability of extrapolations limit mechanistic
+surveillance.
+ Laboratory surveillance provides the highest quality data, often
+using ``gold standard'' tests. It is limited by time delays, costs and
+lack of sensitivity.
+ All these forms of surveillance are useful and vital in an age of
+emerging microbial threats. The differing methods are complimentary. In
+the context of biological terrorism, however, they are all cursed with
+a fatal flaw. Biological terrorism demands extreme timeliness and high
+sensitivity. When surveillance tools with these characteristics are
+applied to extremely rare conditions, as is inherent in biological
+terrorism, they will produce false alarms at extremely high rates.
+ False alarms are costly in terms of the subsequent epidemiological
+investigations, the potential to create fear and panic, and the
+tendency for habituation--that is, learning to ignore the alarms.
+ The greatest role played by physicians following the anthrax
+release of 2001 was not treating cases of anthrax, but, rather, dealing
+with the fear and panic of their patients. Allison McGeer--from one of
+the Toronto hospitals affected by SARS--recently noted that it was
+``easier to control the disease than fear.'' In the face of biological
+terrorism, the reassurance of a trusted doctor is invaluable.
+ What, then, is the most compelling role of surveillance in
+biodefense? I must reiterate that surveillance is essential and of
+utmost importance for homeland security. Surveillance must first have
+multiple use functions. For biological terrorism and other rare events
+of public health, the primary role of surveillance is to set the
+background against which unusual clinical events can be evaluated. A
+well-informed astute clinician is better than an astute clinician.
+ Family physicians are at the core of biodefense by nature of their
+widespread location, their permeation into rural and urban areas, the
+scope of practice-from outpatient setting, to emergency rooms to
+intensive care units-and by the volume of care offered to the American
+populace. On average, family physicians see 90.7 patients per week in
+outpatient settings and deal with an average of 3.05 problems per
+patient encounter. Given the number of active family physicians, one
+can estimate that family physicians may deal with well over one billion
+separate medical problems each year in the United States.
+ When this number of problems is coupled with the contextual nature
+of primary care relationships, and if background information can be
+provided to clinicians on community trends in disease occurrence
+through surveillance systems, the value of the astute clinician is
+greatly enhanced. This is the core of rare disease detection and of
+biodefense. In addition to the continued support of primary care
+physicians, three additional components are necessary for biodefense:
+ (1) an understanding of the role and function of the public
+ health system.
+ There must be a core component of public health practice and
+ epidemiology within medical school curriculum and residency
+ training.
+ (2) connectivity of clinicians to sources of information on
+ emerging threats that are rapid, redundant, reliable and
+ relevant.
+ (3) easy and rapid means by which unusual cases and
+ presentations can be reported to public health personnel.
+ The ability of clinicians to fill the role of the astute clinician
+is hampered by ever increasing demands of the medical care system.
+Primary care physicians have less and less time to fully evaluate
+patient concerns, faced with ever-increasing demands of workload and
+paperwork, regulations and managed care organization compliance.
+ We are facing a decline in the number of clinicians choosing to
+practice in the primary care fields. The number of positions for family
+practice residents peaked in 1998; the number of graduating family
+practice residents peaked in 2000. Because of the increasing costs
+associated with medical school training and due to decreasing
+reimbursement for the work that primary care physicians routinely do,
+an increasing number of medical students are choosing other nonprimary
+care medical specialties. National biodefense is dependent on a core of
+well-trained and widely dispersed primary care physicians.
+ The current medical system in America is strong and has shown its
+effectiveness in identifying and responding to rare emerging diseases.
+It is essential, however, to acknowledge the key role played in the
+defense against a new world of emerging pathogens by the thousands of
+primary care physicians that dedicate their efforts to the health and
+well-being of their patients and their communities.
+ I thank you for the opportunity to address the Subcommittee on
+Emergency Preparedness and Response and thank the Honorable John
+Shadegg for his invitation to provide this testimony.
+
+ Mr. Shadegg. Thank you very much for your testimony.
+ Our final witness is Dr. Jeffrey Trent, president and
+scientific director of the Translational Genomics Research
+Institute. Dr. Trent?
+
+STATEMENT OF MR. JEFFREY TRENT, PRESIDENT OF THE TRANSLATIONAL
+GENOMICS RESEARCH INSTITUTE AND FORMER DIRECTOR, NATIONAL HUMAN
+ GENOME RESEARCH INSTITUTE
+
+ Mr. Trent. Good afternoon, Mr. Chairman and members of the
+committee. Thank you for this opportunity to present.
+ My name is Dr. Jeffrey Trent and I am the president and
+scientific director of the Translational Genomics Research
+Institute in Phoenix. Prior to my move to Arizona 8 months ago,
+I served for nearly a decade as the scientific director of the
+Division of Intramural Research for the National Human Genome
+Research Institute at the National Institutes of Health in
+Bethesda. I am accompanied by Dr. Paul Keim of Northern Arizona
+University, one of the foremost experts in the forensic
+analysis of pathogens, and Dr. Paul Tracy of Stanford Research
+Institute.
+ I have been asked to speak briefly on the dangers posed by
+a biological outbreak and the need for comprehensive end-to-end
+solutions to these events. I would like to emphasize several
+points for your consideration.
+ First, if history repeats itself we will be presented at
+the time of a bio-threat crisis with sick and dying people or
+animals, and the answer will lie in how quickly we can detect
+and identify these early cases. During the training of
+physicians, you are often reminded that if you hear hoof beats
+behind you, look for a horse and not a zebra. But to some
+extent, this logic is reversed in bio-threat identification.
+That is, it is important to develop new approaches and
+diagnostic tests that might reliably separate a bio-threat from
+a new pathogen from the background of the common cold or flu
+which may cause similar symptoms. We believe that one
+possibility for this is reading the signature of the pathogen
+in the host as a critical feature.
+ Mr. Chairman, for nearly 20 years I have worked to create
+and utilize tools, many from the human genome project, to
+identify the genetic signature of killers. I have worked on
+killers such as breast cancer, leukemia and melanoma. I had the
+privilege at the National Institute of Health of also working
+to identify the genetic signatures or molecular fingerprints of
+killer viruses such as HIV, various T-cell leukemia viruses,
+and in collaboration with investigators at Fort Dietrich, being
+able to expose cells from individuals with the dreaded ebola
+virus at different virulence to look at those effects. We
+believe that molecular signatures of either naturally infecting
+viruses or bio-weaponized strains can be identified by
+surveying a response in the host.
+ So I can emphasize one critical element today, and that is
+that early detection is the key. The reason that early
+detection is the key is that it will mean faster diagnosis and
+faster diagnosis will save lives, optimize treatment selection,
+enable rapid triage of at-risk population, and as we have just
+heard, will provide the vital goal of reassuring the worried-
+well and reduce public panic. To achieve this goal, we believe
+there are three major elements that in a systems approach must
+be put in place: 1) the molecular signature that I have spoken
+of previously; 2) very low-cost diagnostic platforms that can
+work in a variety of clinical settings and including of course
+the comprehensive care physicians; 3) a national information
+architecture that allows incident progression and containment
+action to be monitored and provided to relevant key
+decisionmakers within the medical and public health community
+and decision support systems.
+ This powerful end-to-end solution is really an obligate
+demand for also including, as we have also heard today in
+testimony, public-private partnerships in the solution to this.
+It really requires that effort. In that regard, I have joined
+my colleagues Dr. George Poste and Paul Keim, as well as
+members from Amersham Biosciences and Stanford Research
+Institute in trying to develop one of the types of end-to-end
+solutions, something we call Project Zebra, as one of the
+solutions for such a complex problem, to allow faster
+mobilization of incident management as one piece in our early
+detection network.
+ In closing, I would like to thank you, Mr. Chairman, for
+convening this hearing on an extremely critical subject matter,
+and offering the opportunity to testify before your
+distinguished subcommittee.
+ Thank you.
+ [The statement of Mr. Trent follows:]
+
+ PREPARED STATEMENT OF DR. JEFFREY TRENT
+
+ Good morning, Mr. Chairman and Members of this subcommittee. My
+name is Dr. Jeffrey Trent, and I am the President and Scientific
+Director of the Translational Genomics Research Institute in Phoenix,
+Arizona. Prior to my move to Arizona 8 months ago, I served for nearly
+a decade as the Scientific Director of the Division of Intramural
+Research of the National Human Genome Research Institute of the
+National Institutes of Health in Bethesda, MD. I also wish to thank the
+members of the Subcommittee on Emergency Preparedness & Response of the
+House Select Committee on Homeland Security and Chairman, John Shadegg
+for inviting us to testify at this hearing today.
+ I have been invited here today to speak briefly on the dangers
+posed by a biological outbreak and the need for a comprehensive and
+effective end-to-end solution. I commend you for your willingness to
+hear from representatives of the medical and scientific community about
+this serious and important issue. Both my colleague Paul Keim, and I
+represent many who are ready to work toward addressing shortcomings of
+our early detection and treatment capabilities.
+ Mr. Chairman, I would like to emphasize several points for your
+consideration.
+ First, history tells us that pre-exposure detection is not
+feasible--we will be presented at the time of a bio-threat crisis with
+sick and dying people or animals, and the answer will lie in how
+quickly we can detect and identify these early cases.
+ Also, the answer will lie in new approaches to diagnostic tests
+that can reliably separate bio-threats of new pathogens (such as SARS)
+from the background of the common cold/flu which may cause similar
+symptoms--thus "reading the signature" of the pathogen in the host is
+critical. Joshua Lederberg,\1\ a Nobel Laureate once said: ``The single
+biggest threat to man's continued dominance on the planet is the
+virus.'' With the September 11 terrorist attack and subsequent anthrax
+attacks, what was once a topic popularized for science fiction is now a
+startling reality for all of us.
+---------------------------------------------------------------------------
+ \1\ Dr. Lederberg is known for his studies of the genetic
+mechanisms of bacteria. He shared with G.W. Beadle and E.L. Tatum the
+1958 Nobel Prize in Physiology or Medicine for establishing that sexual
+recombination occurs in bacteria. Lederberg showed that although
+bacteria reproduce only by dividing, they are able to affect sexual
+recombination by processes that result in exchange of genetic material
+between different bacteria. In 1978, he joined Rockefeller Univ.; where
+he served as president until 1990.
+---------------------------------------------------------------------------
+ Mr. Chairman for nearly 20 years I have worked to create and
+utilize tools and techniques to identify the genetic signature of
+killers. I have worked on killers such as breast cancer, leukemia and
+malignant melanoma. While at the NIH I also worked on identifying the
+genetic signatures--the molecular fingerprint--of killer viruses such
+as HIV, human T-Iymphotropic virus type 1 (HTLV-1), human herpesvirus 8
+(kaposi's sarcoma-associated herpesvirus), and in collaboration with
+investigators at Ft. Dietrich, the dreaded Ebola virus. We know now
+that a molecular signature of a naturally infecting virus, or a
+bioweaponized strain of anthrax--can be identified by surveying the
+response in the host.
+ But, while there is hope that we may be able to identify by
+diagnostic testing a biothreat's genetic signature--the most important
+thing I can emphasize today is that an end-to-end solution is critical,
+and that early detection is the key. Mr. Chairman and Committee
+Members, the reason that early detection is the key is that it will
+mean faster diagnosis--and faster diagnosis will:
+ Save lives
+ Optimize treatment selection, and
+ Enable the rapid triage of at risk populations
+(which will provide the vital goal of reassurance to the worried well
+(thereby reducing the risk of public panic).
+ To achieve this goal of early detection four elements must be in
+place: and as this is a systems-based approach to the problem, the
+failure to develop anyone of the four will not address the critical
+needs in biodefense and improved public health and safety.
+ Molecular Signatures (BIOPRINT): Gene and
+ protein sequencing of selected pathogens; detection of
+ genomic, proteomic, and phenotypicsignatures of the
+ host immune response, and the creation of unique marks
+ for a broad range of biothreat.
+ Diagnostic Platform (ZPD): Incorporating the
+ signatures into a low-cost diagnostic platform suitable
+ for routine patient testing in a variety of clinical
+ settings.
+ National Information Architecture (Bioincident
+ Warning and Communications System--BWACS). Integrated
+ collection of data, syndromic surveillance, reliable
+ anomaly detection, and real-time alerting of local and
+ national decision-makers that a bioincident has
+ occurred and permit real-time assessment of incident
+ progression and the effectiveness of containment
+ actions. And,
+ Decision Support Systems--An infrastructure
+ linking key decision-makers with relevant medical and
+ public health authorities to ensure rapid launch of
+ optimum treatment protocols, rational allocation of
+ drugs and vaccines, and comprehensive incident
+ containment actions.
+ Mr. Chairman and Members of the Subcommittee, currently, health
+providers do not have the necessary tools to distinguish between an
+infection caused by a bio attack and .that caused by the average cold.
+They must rely on a series of sequential, inefficient and cumbersome
+actions that delay mobilization of prompt responses.
+ The requirement I believe is the pursuit of a purposeful end-to-end
+solution of all four of the aforementioned system elements--something
+that will require an obligate demand for public/private partnerships.
+ This is what has driven me to join my colleagues, Dr. George Poste
+and Dr. Paul Keirn, in a consortium involving the three universities in
+Arizona, linked with Dr. Michael Tracy and his team at the Stanford
+Research Institute, International in Menlo Park, California, with the
+involvement of one of the leading manufacturers of chip-based
+technologies, Amersham Biosciences, in New Jersey, in the development
+of a project called the Project Zebra, which can be part of the
+solution for this complex problem, allowing faster mobilization of all
+relevant incident management actions, a key piece in early detection.
+ In closing, I would like to thank you, Mr. Chairman, for convening
+this hearing on an extremely critical subject matter and offering me
+the opportunity to testify before your distinguished subcommittee.
+
+ Mr. Shadegg. Thank you, Doctor.
+ I appreciate the testimony of all of our witnesses.
+ Before we begin our questioning, Dr. Trent I understand
+that you would like to have Dr. Paul Keim, who is an expert in
+anthrax and plague, join you and complement you in answering
+any questions. Is that correct?
+ Mr. Trent. Yes, sir.
+ Mr. Shadegg. Dr. Keim, welcome. Would you state and spell
+your name for the record please?
+ Mr. Keim. My name is Paul Keim. The last name is spelled
+K-E-I-M. I am the Cowden Endowed Chair in Microbiology at
+Northern Arizona University and the director of pathogen
+genomics at T-Gen.
+ Mr. Shadegg. Thank you and welcome.
+ Let me begin the questioning. Mr. Henderson, let me begin
+with you. You made a reference to BioWatch in your testimony.
+BioWatch intrigues me. It is something I believe could go a
+long ways toward protecting the American public. I would like
+you to tell me about your work with the Department of Homeland
+Security on the BioWatch Program, and how the investment in
+disease surveillance fits into that equation.
+ Mr. Henderson. The BioWatch Program is a program that is a
+collaboration. It is being led by the Department of Homeland
+Security and CDC and the Department of Health and Human
+Services are supporting the concept of BioWatch. Fundamentally,
+what it is and how it works is there are a number of air
+samplers placed in participating cities. This is right now a
+proof of concept. We want to make sure it works and contributes
+to the overall detection system in a particular community.
+ Staff from the public health laboratories will on a routine
+basis collect the filters in these air samples that are placed
+in strategic locations, subways et cetera, and they will run
+tests across those filters to see if they detect any type of
+pathogen. If they do in fact detect a pathogen, then there are
+consequence management plans in place to execute or mobilize a
+response to determine who may have been exposed, if there is
+still agent in the atmosphere, et cetera.
+ Again, this is a proof-of-concept phase. It is taking place
+in a number of cities. We are trying to build systems to assure
+that once we have true positives, we can mobilize a response
+rapidly, but also develop a system for false positives which we
+feel could be a potential problem in the future.
+ Mr. Shadegg. I understand this is an airborne detection
+system.
+ Mr. Henderson. Right.
+ Mr. Shadegg. Is there thought being given to other types of
+detection systems, for example, in a water system?
+ Mr. Henderson. We have had discussions, but we have not yet
+developed a program to begin monitoring water.
+ Mr. Shadegg. Okay.
+ Dr. Trent, Project Zebra. It seems to me this holds
+tremendous potential. I would be interested in how genomics
+links into Project Zebra and how realistic it is. Maybe you
+should describe Project Zebra in a little greater detail and
+how realistic the concept is in terms of creating a device
+which could be used even in an individual doctor's office to
+detect bioterror attack.
+ Mr. Trent. Sir, clearly as one piece of the puzzle, we just
+heard environmental sensors are important, but we do think that
+biomedical sensors are equally important. The focus on people
+is as important as the focus on the environment. What we
+strongly believe is as you have heard for the distribution
+system of information within the health sector, that many of
+the available components that we have today for recognizing the
+signatures of pathogens and the type of hardware and software
+that is needed for a comprehensive program is in fact in place
+and capable. I think that my colleagues, Dr. Keim might have
+also have a comment in regard to that, with your permission.
+ Mr. Shadegg. Certainly.
+ Mr. Keim. So how I can address that question best is based
+upon our experience in the anthrax letter attacks. It may sound
+crazy, but in fact we were better prepared for an anthrax
+attack than any other pathogen, which is scary to think about.
+We had very highly developed genomic analysis already in place.
+In fact, we had analyzed the type of anthrax and knew probably
+where it came from before the first victim died in Florida.
+That type of very early-on information is really a type of
+genomic signature which gives you the information that in fact
+this was a bioterrorist attack.
+ There were in fact many naysayers in those first few days
+that did not think that this was a bioterrorism attack, but the
+identity of the strain and its probable source from a U.S.
+laboratory put all that to rest. So Project Zebra is in fact an
+information enhancement upon the current type of diagnostics
+that we have. The more information we can get and the earlier-
+on that we can get it about any type of disease, but in
+particular in this case bio-threat pathogens, is just going to
+lead us to better treatment and better response modalities.
+ Mr. Shadegg. You indicate that we already had the signature
+on hand for anthrax. Are we developing those signatures for all
+of the other pathogens that might present?
+ Mr. Keim. Absolutely, Chairman. We have been funded by the
+Department of Homeland Security and its predecessors for nearly
+a decade to do that. We are developing these signatures to work
+in the framework of BioWatch so that we can get the information
+such as I described from the very first moments of the
+detection process.
+ Mr. Shadegg. Dr. Temte, there was an article which appeared
+in the September-October issue of Health Affairs which surveyed
+a number of physicians across America and found that only 20
+percent of physicians felt well-prepared to play a role in
+handling a bioterrorist event. My first question is, do you
+think that is an accurate result? Second, why is that the
+situation and what can be done about it?
+ Dr. Temte. Very good questions, Mr. Chairman. I would agree
+that that is probably a good estimate of the current state of
+affairs. We ran a focus group of family physicians prior to the
+anthrax events in March 2001. At that point in time, people
+said we would not recognize any of the classic signs or
+symptoms of anthrax and we are not prepared. We had the
+opportunity to repeat that in March 2002. The big change was
+that everybody said yes, we know the basic diagnostic pattern
+of anthrax. We will recognize the chest x-rays and so on. We
+are still not prepared. We do not know what to do with
+preparedness planning.
+ So I think in the big picture, physicians in general have
+very little training, very little information on what to do if
+there are mass casualties, if there is mass panic. Whereas
+hospitals are required for accreditation to have emergency
+preparedness drills, most physicians do not participate. Most
+physicians are not hospital-based, but are clinic-based, and
+there is no incentive. To be honest with you, for most
+physicians there is no time to take out of a very packed
+schedule and participate in a half-day training exercise.
+ Mr. Shadegg. Thank you very much.
+ Mr. Thompson for questions?
+ Mr. Thompson. Thank you very much, Mr. Chairman.
+ Let me compliment the panelists on your presentations. Dr.
+Keim?
+ Mr. Keim. Yes, sir.
+ Mr. Thompson. For someone who might not be as up on
+pathogens as you would think, how many have we identified?
+ Mr. Keim. How many different types of anthrax?
+ Mr. Thompson. Yes.
+ Mr. Keim. In my laboratory, that is in fact exactly what we
+do. We have developed highly precise genomic analysis for
+identifying anthrax. We currently have a database that has
+about 450 unique types of bacillus anthracis or anthrax. That
+is based upon the world's largest collection of strains that
+exist anywhere in the world, right there in Arizona. So we have
+about 450. So in those early hours, we were able to zero in and
+say this strain that came from the victim in Florida belongs to
+this particular category, and that category has only been found
+in nature once. I can tell you exactly where in Texas that
+strain came from. I can tell you what cow it died from, and I
+can tell you its pathway up until it got to the U.S. Army.
+After that, I cannot tell you.
+ Mr. Thompson. Thank you.
+ Mr. Temte, what do you think we need to do to get
+physicians brought up to the level that you would feel
+comfortable in having them identify some of the problems we are
+talking about?
+ Dr. Temte. In a roundabout way, a concern I have is the
+direction that American medical practice took in diverging from
+public health practice approximately 100 years ago. These two
+practices, where as they have a lot of the same purpose and a
+lot of the same goals, operate fairly parallel. The amount of
+interaction has been far too little, especially I think we have
+seen that in the last decade or so.
+ That being said, in standard medical training quite often
+any approach to understanding epidemics, understanding the role
+of community, understanding some of these trends that occur
+beyond the level of the individual receive fairly short shrift.
+I think what is necessary is for us to incorporate into not
+only medical school training, but into residency training and
+into practice the means by which we better interact with public
+health.
+ Once someone gets into practice, one of the things that you
+find is quite often it is very difficult to establish any
+communication with public health. There was a mention of
+physicians being poor about turning in forms for reportable
+illnesses. I think if you polled most doctors out there, we
+would not know which ones were reportable or not. Why is that?
+Time and priorities. It is very difficult to sort out
+priorities in a busy practice. I have an HMO telling me all the
+guidelines I am not addressing with these certain patients. I
+have my HIPPA compliance. I have to think is this a disclosure
+or not. I have billing things. I have the ICD-9 codes which I
+have to pick from a list so someone knows that diagnosis I am
+making. All these things compete. So when it comes down to
+trying to communicate with public health and find that the
+person is not at the other end of the line, I get an answering
+machine or someone that is not there, it gets to be very, very
+difficult.
+ I think systems by which we can improve communication, and
+this has to be a two-way flow of information coming from
+clinicians to public health, to inform public health what is
+going on, but also the flow back to clinicians on a day-to-day
+basis about what is happening out there in the community. Are
+we in the middle of a flu outbreak? If that is, that really
+helps me address the concerns and the problems my patients are
+dealing with.
+ So we have to build better communication and be cognizant
+that communication systems need to be very succinct, very
+clinically relevant for clinicians. They have to be redundant
+and very reliable.
+ Mr. Thompson. Thank you.
+ One other question, Mr. Chairman. Dr. Platt, taking what
+you just heard and applying it to your operation, have you been
+able to streamline that? Have you been able to get the
+reporting faster? I would also like to know if you do, to what
+extent or what percentage of the country is using electronic
+medical records these days, or whether we are still doing it by
+hand?
+ Dr. Platt. Really, you have put your finger on both the
+problems and the solutions, I think. In the systems where we
+are working, many of the problems that Dr. Temte mentioned are
+somewhat ameliorated. Stepping back a bit, I believe that our
+nation has been building a very powerful adjunct to the
+traditional public health system in the form of health plans.
+They know all the people for whom they are responsible for
+care. They have communications systems with the clinicians who
+are taking care of their patients. Their communications are bi-
+directional, though they are not as robust as they can and
+should be. And an increasing number are using various
+electronic methods to communicate information about their
+patients.
+ The direct answer to your question about electronic medical
+records on which we have built our system is that they are used
+in a minority of practices now. It is hard to predict how soon
+they will disseminate very broadly. On the other hand for
+surveillance in communities, it is not necessary for the whole
+community to be served by clinicians who are using electronic
+medical records. Coverage of 10 percent of 30 percent would
+probably serve very well to act as an alerting system. The
+communications part-back from the public health system to the
+clinicians, and through them to their patients-can be
+substantially enhanced by the health plan's existing
+communications mechanisms.
+ Mr. Thompson. Thank you.
+ Mr. Shadegg. Ms. Dunn to question.
+ Ms. Dunn. Thank you very much, Mr. Chairman.
+ A fascinating presentation, panel, thank you for being here
+and giving us your time, because you are very helpful to us as
+we try to put some things together.
+ I am interested, and I am not quite sure whom to ask this
+question of, but I would like the broad-brush approach. Dr.
+Platt has some excellent pieces of paper that show us where
+there was a collection of outbreak of SARS, I think it was that
+you were showing us. Was that what that was?
+ Dr. Platt. It was respiratory illness. There was no SARS in
+Massachusetts that I am aware of.
+ Ms. Dunn. My interest is directly related to communications
+with the Department of Homeland Security. So if you come up
+with this sort of an indicator that there is an amazing
+collection of illness in a particular part of our country, how
+long does it take you to decide whether it is a terrorist
+invasion, a biochemical or a chemical weapon of mass
+destruction? How do you get that information to the Department
+of Homeland Security? Do you have to wait until you know it is
+a terrorist-caused outbreak? How do you determine that? What is
+the process you go through, and perhaps Mr. Henderson needs to
+be involved in this too, in reporting that? Let me just add to
+the complications. What happens if we have this occurring on a
+night like last Thursday night when communications were knocked
+out all over the country? What is the process and are we sure
+we are prepared now to be able to get this information where it
+needs to be?
+ Dr. Platt. I will begin and then defer to Mr. Henderson.
+The system that we have built is a real-time system. That is,
+it is possible to know very soon after the clinical encounter
+that there is a cluster. That is a considerable achievement.
+Interpreting that cluster really lies within the domain of the
+public health system. That is the point where I hand off.
+ Mr. Henderson. Nice segue. There are a couple of pieces to
+this. In my testimony, I talked about the creation of a bio-
+intelligence center, because we do need to have this data that
+is collected locally, analyzed locally first, and then of
+course captured on a national level and analyzed rapidly and
+then disseminated back to all the stakeholders who have a stake
+in making a decision to determine whether or not to fully
+investigate what they would perceive to be a potential blip on
+our radar that might indicate we have either a terrorist event
+or we are starting to see a potential emerging infection
+disease in our population.
+ So what we are looking to put in place as far as overall
+infrastructure I think amplifies our abilities to do that. I
+think today if you were to see clusters of disease, for
+example, generally young healthy people showing up in emergency
+departments, we are absolutely positively dependent upon those
+clinicians to call, be suspicious, and then depend upon the
+local and State health agencies to contact CDC so we can all
+support whatever response may be needed to investigate that and
+determine the extent of the potential issue in that community.
+ The question you raised about how soon would Homeland
+Security know, the minute that we find out from CDC, our
+emergency operations center communicates with the Secretary's
+command center in Washington. They are our vital link to the
+Department of Homeland Security. We essentially follow the
+command and control procedures that you see with the national
+incident management system. So there is that day-to-day ongoing
+connectivity, even when we see cases of disease say a full-
+blown illness outbreak, which we have been supporting at the
+State and local and Federal level for years. We include that
+information in our daily situation reports that go to Homeland
+Security, so they always have a sense of our background level
+of activity so that if they start to see an increase in that
+activity, they can work with us to determine if we need
+additional resources to contain and control the event.
+ Ms. Dunn. That is very helpful. How does that connect to
+the Department of HHS, the stockpile, for example, of
+antidotes? Does that come from the Department of Homeland
+Security, the request to enter?
+ Mr. Henderson. Keep in mind the operational responsibility
+for the strategic national stockpile is at CDC. We work very
+closely with Homeland Security on managing the stockpile. We
+have done this through exercises and we actually did this in a
+few real circumstances. The request comes to CDC. We process
+the request and get approvals from both the Secretary of Health
+and Human Services and Homeland Security at the same time. When
+we have done this through exercises, it is done literally in a
+matter of just 1 or 2 hours.
+ Ms. Dunn. What happens if all communications are out? What
+do you do then?
+ Mr. Henderson. We have redundant communications
+capabilities.
+ Ms. Dunn. Good.
+ Mr. Henderson. That is very similar to the Secretary's
+command center in Homeland Security and the National Command
+Center in the Pentagon. We follow a pattern to have that
+redundant communication capability. The one issue you brought
+up that we realized during the blackout of a few weeks ago is
+that our health alerting technologies are all dependent upon
+electronic transmission of an e-mail, essentially. So we were
+putting out health alert notices to talk about your water
+systems, what to do with food that would spoil in your
+refrigerator. Obviously, it is getting to all the people who
+have electricity and not getting to those who don't.
+ Ms. Dunn. The ones that have the problem.
+ Mr. Henderson. Right. One of the lessons that we learned
+from a visit to Israel was they have a standing public radio
+station that is always there that people know to tune to, and
+we have had discussions at Homeland Security about standing up
+that radio station so that people would know in a power outage
+when they pull out their family preparedness kits which include
+a radio and batteries, they would know this particular channel
+to tune to to get information in the absence of power.
+ Ms. Dunn. Good. Thank you very much.
+ Thank you, Mr. Chairman.
+ Mr. Shadegg. Mr. Turner to question.
+ Mr. Turner. Thank you, Mr. Chairman.
+ I want to direct my question to Dr. Trent and Dr. Keim. You
+have heard, and I am sure you are very familiar with, the pilot
+projects that place environmental sensors in different
+locations in our country to collect air samples, which are then
+collected and analyzed.. We could spend a lot of money doing
+that. What I would like to know from you, and have your expert
+opinion on, is whether it is better to proceed with investing
+millions of dollars in environmental sensors, or should we-and
+specifically can we-develop a biomedical center that could be
+used for immediate detection of infectious diseases, whether it
+is an engineered pathogen or a naturally occurring one; I'm
+referencing a device that could provide a diagnose within
+minutes after a blood sample was taken. Then whether we could
+develop the capability to analyze that information and be able
+to develop a response to it in a short period of time?
+ I know I am asking for the moon and the sky here, and I
+know we all understand that our traditional patterns of
+developing vaccines takes years, but if I was asking today for
+what I think is the answer to dealing with the terrorist threat
+that I know we are going to face just as soon as they gain that
+capability, it seems to me that we have got to have an ability
+to detect these threats once symptoms manifest themselves and
+the ability to then rapidly develop a response, a treatment, or
+an antibody.
+ I also would be interested not only in your advice as to
+whether we have the capability to do that, but whether that
+approach could also be helpful in dealing with ordinary
+illnesses, so that we might not pass out quite as many
+antibiotics in this country when, as all of us know,
+antibiotics are over prescribed and over used. Could we find
+some dual use in that kind of capability that would allow us as
+a government save money in other areas of healthcare, simply
+because we have been willing to make this kind of commitment to
+protect Americans against terrorism? but also to protect us in
+other public health areas.
+ I know this is a big wish list, but I just want to know if,
+from your vantage point, it is feasible, what would the costs
+be, and whether there are some offset savings.
+ Mr. Keim. That is a great question. I don't know where to
+start on that, except to say that we will always in this
+country need to have some type of environmental monitoring. The
+Super Bowl is a good example, or the Olympics. There are places
+where we are going to have environmental monitoring. But we are
+not going to be able to protect this entire country through
+environmental monitoring. The task is just incredible. The
+spatial scale and the breadth of pathogens that we are talking
+about that can be used in bio-crimes or bioterrorism events are
+just too enormous.
+ However, if you focus upon the point, which is the patient
+and the individual, and we start to use our genomic information
+and knowledge about human response to pathogens, I think that
+there is a real key here for where we can start to unify this
+monitoring. Again, it starts with the clinicians at the public
+health sectors, and then accumulating that information. A good
+example of what you talk about are in fact these strep tests
+that pediatricians use every day to try to decide if you give a
+kid antibiotics, if you say it is a virus or if it is a
+bacterial. So that is a very rapid, high-value of information
+that comes back to physicians, allowing them to make clinical
+decisions and therapy decisions right then and there. I think
+that this is not going to be available in 6 months, but I think
+it will be available in 2 to 5 years. I think that is the
+scale, and we have to invest today if we are going to get there
+in 2 to 5 years.
+ Mr. Turner. You are talking about a detection device that
+could be made available to a local hospital or a local doctor's
+office?
+ Mr. Keim. That is right. Your point is also very good about
+branching out. If we are focusing upon the patient, we are
+going to be moving beyond just whether it is anthrax or plague
+or smallpox, which is really a very low return on your day-to-
+day operations. But in fact if you are starting to get back
+more information to physicians, it is just going to move over
+into all of these different pathogens that they are going to be
+using on a daily basis. That is the only type of system that is
+going to be sustainable in the long term. If you going to focus
+for the next smallpox attack, we are going to lose interest in
+this country very quickly. Yet if you are monitoring and
+physicians are getting feedback on these diseases on a daily or
+even an hourly basis, they are going to use them and they are
+going to use them on a regular basis. Then we will be ready for
+when hopefully that one bioterrorism event occurs next.
+ Mr. Turner. So you can develop the device to know what you
+are dealing with.
+ Mr. Keim. Absolutely.
+ Mr. Turner. That is within the realm of possibility?
+ Mr. Keim. Absolutely.
+ Mr. Turner. Can you answer the question I asked about once
+a diagnosis is made whether we can develop a capability to
+develop some response to it in a shorter period of time than we
+normally have available today?
+ Mr. Keim. I think we have some great examples of where that
+is already occurring. The response to HIV may have taken us a
+decade, but we could not have done that 10 or 15 years ago. The
+therapeutics that are available now for HIV-AIDS patients are
+an amazing success story of our development of drugs in
+response to infectious diseases. You are probably asking can we
+do it in minutes. Well, if we have to respond in minutes,
+physicians are going to have to go for what they have on the
+shelf now, and in many cases that will be adequate.
+Antibiotics, there are new antivirals cropping up. Even without
+knowing exactly what that pathogen is, there have to be
+strategies that would be preferred or more probable of having
+success, given our knowledge of what is going on and how the
+patient is responding to this event.
+ Mr. Turner. Who is responsible for detection the private
+sector or the government? What entity is going to be
+responsible for responding to the unknown?
+ Mr. Keim. Traditionally it has always been a partnership
+between the private sector and government. Government usually
+has to invest money into the high-risk aspects, and then the
+private sector can pick up and run with the more commercially
+viable commodities such as the drugs that can make money. Those
+drugs would not be possible if the government does not sink
+that investment money in it, and maybe years ahead of time. So
+that is a very important component of the success in our
+biomedical area.
+ Mr. Turner. Thank you. My time has expired.
+ Mr. Shadegg. Dr. Christensen to question.
+ Ms. Christensen. Thank you, Mr. Chairman.
+ I would like to just make a few comments for the record. I
+want to thank you for this hearing. It is getting closer to
+some of those critical issues that we have been advocating for
+since this committee was established. While I am happy that we
+have begun to look at some of the more basic and important
+issues, I am still concerned that we are perhaps missing the
+mark because we are not, at least at the same time, focusing on
+the infrastructure needed to mount the response. I see my
+fellow family physician nodding in assent, as I was during your
+testimony.
+ If we know what we have and we are not able to respond
+because the facilities are not prepared, labs are not up to
+date, staff are not properly trained, we will not save lives. I
+think when we even look at the SARS epidemic, it is plain old
+ordinary public health and I am sure a lot of family physicians
+and other primary care providers saved the day. So I still hope
+that we will take a look at where our public health
+infrastructure is, because that is really critical.
+ I know that in a demonstration program, Dr. Platt, if I
+read it properly, it deals with people just in the plans. It is
+a demonstration program, so it is really people in plans. As an
+African American and knowing that people of color are over 50
+percent of the uninsured, and that our communities have the
+worst public health infrastructure, I am concerned and I am
+wondering how would we propose to do surveillance in
+populations that wait until the last minute to get care because
+they just avoid it, and those where there are not culturally
+competent physicians, they may be understood, so diseases may
+not be picked up. How do you propose to do that? If I was a
+terrorist, I would go to the weakest place, right there.
+ Dr. Platt. You are touching on an enormously important and
+difficult problem. Our horizon really is the medical care
+system such as it is. The couple of things worth noting are
+that all of the plans that we deal with have quite diverse
+populations. On the other hand, they are all people who have
+some kind of insurance. But we are also in discussion with
+local health departments that are the providers of care of last
+resort in many communities, and are far along in discussions
+about having them behave like health plans with respect to the
+system.
+ So it is our expectation that in the very near future we
+will have a new major contributor of data that is a local
+health department that is responsible for the care of the
+indigent population. It is a little different from the usual
+defined populations that we deal with. On the other hand, it is
+a recognizable population, too. So it is our expectation that
+to the extent that this mechanism proves to be useful, it can
+also be a useful aggregator of information that comes from
+those provider systems that deal with the traditionally
+uninsured populations.
+ Ms. Christensen. I recognize that you stress the importance
+of the public health, the private sector and academia working
+together. This is a concern that I always have and I think we
+all should have.
+ Dr. Temte, I quoted you in our press conference today. It
+is always good to have a fellow family physician on the Hill. I
+think Representative Thompson probably asked my question around
+the communication between the CDC, for example, and the private
+physicians. If you wanted to add to you answer, I would
+appreciate it. But I was also wondering how much and how
+accessible have you found training to be for physicians in
+bioterrorism, and who has offered it, and have many physicians
+in your community taken advantage of it?
+ Dr. Temte. I will answer your question, and I am going to
+pick up a former point before that, and that is the whole area
+of access to care, which I think is so very important not only
+in urban clinics, in urban settings, but also rural areas. I
+practice in a medically underserved area in an urban center in
+Madison, Wisconsin, in a very diverse patient population. The
+patients that I see that have disease that is far advanced, for
+example, a diabetic coming in with a toe that is gangrene, are
+my patients who have no insurance; who feel disconnected from
+the community.
+ I absolutely agree with your statement that if I were a
+smart bioterrorist, I would target an inner-city uninsured
+group of people with a lot of illegal aliens. I would target
+them with something that is contagious and it would brew there
+and it would seed, and they would take it into emergency rooms
+where they will sit for 10, 12, 14 hours and infect people
+there. And a number of them, like a number of our patients once
+they get sick, would head to Mexico because they can get care
+there. So I really pick up on that point on access to care. We
+have systems that will pick up things if someone is insured,
+but we don't pick them up very well if they are not insured.
+ Another point was made about systems by which we can get
+lab tests on all patients with respiratory illness, for
+example. There are close to 800 million ambulatory care visits
+in this country each year; 11 percent of those visits are for
+acute respiratory infections. When you look at any laboratory
+test, and especially if you have one that will give you the
+answer on 300 different pathogens, I can assure you that a
+number of those are going to be automatically falsely positive.
+If I am a clinician and I do a test on a patient and it shows
+positive for anthrax, what happens if I go to my local news
+media and say, hey, I have a patient here with anthrax; or hey,
+I have somebody with smallpox. This is a reality of any lab
+test. There are false positives and false negatives, and there
+will always be false positives and negatives.
+ So you have to be very, very careful when you apply a test
+to a broad population that is less than perfect and you are
+looking for something incredibly rare. Responding to false
+positives is incredibly expensive. We need to get some
+information from our public health sector about how much it
+costs to chase down false positives when they emerge.
+ I really got off the track there.
+ Ms. Christensen. I am glad that you took the time to give
+that response as well. Go ahead.
+ Dr. Temte. I got so far off the track that I forgot the
+question. My apologies.
+ Ms. Christensen. I was just wondering, as a practicing
+family physician, how accessible is training for physicians in
+bioterrorism?
+ Dr. Temte. An excellent question. To best define that, I
+think you have to look at what type of training is appropriate.
+There was a consultation at CDC in January 2002 looking at how
+do we train clinicians for bioterrorism and other emerging
+threats in the public health sector. There is a real
+differentiation between just-in-case training and just-in-time
+training. Just-in-case means going out and training clinicians
+to be very aware of the symptoms of tularemia for example. I
+have given talks on tularemia and I would have to go back to my
+notes to look up what the symptoms are, because it is just not
+important to me.
+ Just-in-time training, however, is when there is a threat
+out there, then we can get information that is factual, that is
+reliable, and that is very succinct and takes no more than a
+minute for a busy clinician to look at. If we can get
+information like that, and I will give a big nod to CDC, their
+information on the Web pages for clinicians is wonderful. I
+used that a lot for SARS. Because Wisconsin was the epicenter
+of monkeypox, I used the information there and was up very
+quickly. The information for clinicians on monkeypox was posted
+on June 12. This is just within days of the diagnosis being
+made. So the communication aspects to clinicians are very
+important.
+ Let me give you one other example. I gave a grand rounds in
+bioterrorism to my hospital in June 2000. I had a handful of
+clinicians come. Their response was, this is interesting, but
+not very relevant. In November 2001, I gave basically the same
+talk to the best-attended-ever grand rounds at our hospital,
+where not only were there family doctors and cardiac surgeons
+and neurosurgeons, but the anesthesiologist and the support
+nurses and everybody else was there.
+ There has to be systems to get information out very
+quickly, train out very quickly, but I do not think it is going
+to work very well to get training on multiple pathogens that
+are irrelevant to everyday practice done in a advance.
+ Mr. Shadegg. The time of the gentlelady has expired.
+ Mr. Shays to question?
+ Mr. Shays. Thank you, Mr. Chairman. Mr. Chairman, thank you
+for holding what is a very, very important hearing. I
+appreciate our panelists who are all, I am sure, giving this a
+heck of a lot of thought.
+ In my Subcommittee on National Security, we had a doctor
+with a major medical magazine 4 years ago before September 11
+express at the end of the hearing his major fear, and his major
+fear was that a small group of dedicated scientists could
+create an altered biological agent that could wipe out humanity
+as we know it. I am learning that that may be a fear that is
+unlikely, but still possible.
+ When I was meeting with the World Health Organization in
+Geneva, they told me SARS is going to be back, and that there
+are 30 other new pathogens out there and who knows what. So I
+am struck by the fact that whether it is man-induced or natural
+causes, this has tremendous benefit for society and we probably
+should have done it a long time ago, even if there wasn't the
+threat of terrorism.
+ What I would like to know is a few things. I would like to
+know how we fuse the non-patient specific data with the
+patient-specific data, like pharmaceutical sales and health
+plan nurse call-in topics and so on. How does that all get
+integrated? I do not know who I should be asking.
+ Mr. Henderson. Probably I should be the first to touch on
+this, and then Richard you may want to add something to it.
+ Right now, it does not happen. It happens in some
+localities, for example New York City where they have looked at
+data post-9-11 and they are trying to find ways to assimilate
+that data and have it influence their decisionmaking. In my
+testimony, I talked about the creation of the bio-intelligence
+center which is a conceptual process at CDC where we are
+looking to take these streams of data, have algorithms
+developed that will allow us to look for any suspicious
+clusters of disease presence in the population, and then
+provide information back rapidly to States and local public
+health agencies. We have not completely developed that yet, but
+we are moving fast and furious to do that.
+ Mr. Shays. Will we have to pay people to provide this
+information every day? Or will we just require it by law?
+ Mr. Henderson. That is a good question. I think the data
+that we are talking about, at least as it supports this notion
+of bio-science, is already existing streams of data that I
+believe we are going to depend upon to help give us some
+information. As we build our bio-intelligence center and we see
+that there is other valuable data components that we would like
+to feed into that, we may have to buy it. We may have to ask
+for legislation, if in fact we find the data to be that
+valuable.
+ Mr. Shays. I would think right now, though, that you would
+find a lot of folks out there who want to cooperate. Is that a
+fair statement?
+ Mr. Henderson. Yes.
+ Mr. Shays. Okay. Who could speak to the technology that is
+involved in this effort?
+ Mr. Henderson. I could refer to Dr. John Loonsk, who is
+with me. He is our director of informatics at CDC. Perhaps John
+could add a few comments.
+ Mr. Loonsk. Thank you. I am John Loonsk. To partly address
+your question about costs, there are a great number of people
+who are interested in providing data for these purposes, but
+there are still costs to get data out, to integrate the systems
+to make them work together. That is one of the costs that we
+face.
+ Technology is also an issue involved with what Dr. Platt
+spoke about earlier, which is that electronic medical records
+do not exist consistently nationally, and where they do exist
+they do not always store the same data. When you are collecting
+that data to use them together, that becomes an issue, so that
+you want to compare similar data and use them in a similar way.
+But there are a number of other data sources that are viable,
+such as clinical testing that is done; there is interest in
+over-the-counter drug sales and how they may be predictive for
+populations that are not represented in traditional health care
+as well.
+ Mr. Shays. And will we be collecting this information state
+by state, or are we looking to do it nationally? What is the
+model going to be?
+ Mr. Loonsk. Some of the data sources are very specific and
+very local, an individual hospital.
+ Mr. Shays. I know it is local, but is it going to be sent
+to a State repository or is it going to be sent to a national?
+ Mr. Loonsk. The proposal in BioSense is to share the data
+at national, State and local levels, to be able to provide the
+data to the jurisdiction that is analyzing those data.
+ Mr. Shays. I am a little confused by that. The model we are
+using right now is it is going State and the State is then
+sharing it with the Federal Government? Is that basically what
+we anticipate happening or are we going to bypass the States
+and just send it right nationally? Or do we know?
+ Mr. Loonsk. We anticipate both these paths actually to
+exist for some time. The traditional path of clinical, local,
+State, Federal and we think we can leverage data sources that
+may be accumulated at the national or regional level and use a
+single connection to that data source to then provide it to the
+State level or to the local level.
+ Mr. Shays. Thank you.
+ Thank you, Mr. Chairman.
+ Mr. Shadegg. I thank the gentleman for his questions.
+ I am just going to advise the members of the panel that I
+am at least going to ask one question in a second round, and I
+have let Mr. Turner know that he may do so if he would like to.
+ I want to follow up quite frankly on Mr. Turner's
+questioning. He asked some questions about the issue of
+environmental sensing, and I understood Dr. Keim to say that
+environmental testing was going to be a part of what we needed
+to do, and certainly there would be areas where you could do
+environmental testing. You mentioned sports arenas or something
+of that nature. But that environmental testing of the entire
+nation may be looking too far for that prospect.
+ I want to focus on the other type of testing, which is what
+I understand Project Zebra to do, which is testing which occurs
+on a patient-specific basis. There was some discussion here
+which has confused me on false positives. When you do a lab
+test, you can get a false positive. Everybody understands that.
+What I am trying to get a clear understanding of is that as I
+understand Project Zebra, it is the development of the analytic
+information and the loading of information into a testing
+device that could be inexpensively purchased and created,
+inexpensively enough so that as I understand it it could go in
+an average practitioners office or in an emergency room where
+there were uninsured patients or illegal aliens or others in
+the country who were not insured. And that through using
+genomics, it can test for at least these bioterror pathogens
+that we are interested in and give you a result back, and give
+that result back, as I understand it, instantaneously. My
+question is, is that correct, that understanding of the way
+Project Zebra is working? And how realistic is it?
+ Finally, using genomics to perform those tests, do we
+eliminate the possibility of false positives or false
+negatives? Or do we diminish it dramatically? Where do we stand
+with that?
+ Mr. Trent. Starting with the last question, you absolutely
+will never eliminate entirely false positives or false
+negatives from any test. Anyone who testifies to the contrary
+would not gain credibility with anyone, I am sure, including
+this committee. Certainly we recognize that. But there are
+clearly going to be occasions, including for example the
+unforeseen but difficult situation of thousands of individuals
+presenting for triage within an emergency response center that
+rapid identification may be an important component of the
+triage process.
+ The power of genomic technology will allow us to identify
+fingerprints for many pathogens. It won't eliminate completely
+by any stretch of the imagination false positives. But if we
+are looking for a Zebra of course to other common physiological
+responses in the context of a smart physician looking more
+broadly than just a single test. They don't do that now. They
+look at a test, incorporate it with the rest of their
+information, and then make a judgment. I think that we want to
+be believe that these type of approaches will add value to the
+practice setting in the combination through an educated
+physician.
+ Mr. Shadegg. Is it practical to develop a machine at that
+expense level?
+ Mr. Trent. I think so, absolutely. I think the goal for
+this type of a project and others like it are to have the
+testing cost driven down to a level to where it can occur
+within a population base, and that the actual detector
+instruments have to also be driven down in the cost estimates
+to be able to be placed within the framework of physicians's
+offices. So the answer is absolutely.
+ Mr. Shadegg. Thank you very much.
+ Mr. Turner?
+ Mr. Turner. Mr. Henderson, you mentioned that we are doing
+some experimental work with those environmental sensors, called
+BioWatch and we are funding that research, I assume. Are we
+doing any research into these biomedical centers that Dr. Trent
+is referencing?
+ Mr. Henderson. We are clearly supporting the research that
+is being done. At CDC we have looked at a whole variety of
+hand-held devices to determine whether or not it would actually
+prove valuable. I have to say we have dedicated a lot of time
+and effort in responding to events that were triggered by some
+of the hand-held devices, not these particular devices, that
+were all not true events, and created a lot of problems,
+frankly, in our response systems.
+ The one thing I just wanted to mention because it seems to
+me there is a theme forming around the use of these early
+detection systems. When looking at detecting a pathogen in the
+population, it is critically important that we have the tools
+necessary to confirm a particular organism as soon as possible
+for those first few cases. You will not continue to look to
+detect and confirm in every single instance once you see you
+have certain diseases in the population. This is where we
+become more dependent upon case definitions, because then the
+focus has to be on your response and how can you rapidly bring
+about the countermeasures so that you can halt disease
+transmission and reduce the severity of the illness and
+hopefully prevent additional deaths.
+ I just bring that to the committee's attention because it
+is important to know that. We would not look for hand-held
+devices per se for every case where a person has certain
+symptoms to confirm that this particular person is sick because
+of this causative organism. It would be invaluable if we had
+that, but we would be more focused on bringing the intervention
+in to play so we can reduce the impact of the particular
+outbreak in a population.
+ Mr. Turner. You mentioned hand-held devices. When I asked
+Dr. Trent the question earlier, I was envisioning devices that
+had a broader use than just detecting some of the traditionally
+known biological agents that are cause for concern. This would
+be something that would have a dual use capabilities, be
+diagnostic in nature, and be available to hospitals, doctors,--
+something that might be placed in the offices where that kind
+of diagnostic tool would quickly give a diagnosis. Is that an
+area that is worth looking into, or worth doing a little
+research on?
+ Mr. Henderson. I said ``hand-held,'' and really we are
+talking about portable diagnostic tools that are there at the
+point of service. You are seeing a person who is ill and
+potentially you could confirm that they have a particular
+causative organism, and you know it at the point of service.
+That is an ideal situation. The CDC clearly would want to work
+with any partners that are developing this technology, and we
+have. We continue to do it today.
+ Mr. Turner. So there are people out there who are trying to
+develop that?
+ Mr. Henderson. Lawrence-Livermore. There are a number of
+labs that we are working with to look into these technologies.
+Yes.
+ Mr. Turner. The second issue that I raised was once the
+pathogen is identified by genetic signature, whether anyone is
+researching development of a response capability or shortening
+the time frame for developing an antibody or response to a
+given biological agent? Are we still on this long track of
+developing these vaccines? As you know with Project BioShield,
+once we found the vaccine, then we are going to spend money to
+produce it.
+ I am referencing the gap between detection of a dangerous
+pathogen and response--how quickly we can develop a response.
+Are we conducting any work in that area?
+ Mr. Henderson. I have to say, to defend my colleague Tony
+Fauci at the National Institutes of Health, I always told him I
+would talk about BioShield in a very positive way, because it
+is very positive. I think it holds out great hope for us to be
+able to rapidly develop the countermeasures that we might need
+to deal with the types of threats and emergencies that we can
+predict we would have to deal with in a very, very fast manner.
+ But if you look at diseases like SARS, where there still is
+no treatment for SARS, we rapidly were able to confirm what the
+causative organism was. That helps us determine the type of
+supportive therapy that we would need to provide for the
+patient, so that we could at least assure they would not die
+from the particular illness. I think all of our response
+strategies are looking at the same things that you are offering
+here, is that how can we rapidly detect what the organism is
+and then bring about the delivery of the countermeasure as
+rapidly as possible so you do not have severe illness and
+death. Everything we are doing is to try to minimize those time
+lines.
+ If you asked me specifically what are we doing, we are
+working with NIH in trying to push BioShield to the full
+distance we think it needs to travel to help us in that
+respect.
+ Mr. Turner. When you mentioned BioShield, I caught in your
+inflection your acknowledgement that it does not deal with the
+development or identification of a response. BioShield applies
+after a response is identified--it deals with mass production
+of the response. What I want to know is what kind of research,
+what kind of investment are we making, whether through CDC or
+NIH or, Ms. Heinrich, any areas that you research, what kind of
+investment are we making to try to shorten that time frame
+between the detection and the development of a response.
+ Mr. Henderson. Mr. Turner, can we get back to you in
+writing with a response?
+
+ Questions and Responses Submitted by Joseph Henderson
+
+Question: 1. Are we doing any research to try and shorten the time
+frame for the development of an antibody or a response to a given
+biological agent? Or are we still on this long track of developing
+these vaccines? I am talking about the middle piece between the
+detection of a dangerous pathogen and the determination as to what you
+do to counteract it. Are we doing any work in that area?
+Answer: 2. Combating emerging infectious disease is a long term process
+that requires continuous research and scientific development to
+identify appropriate countermeasures to prevent and treat illness. An
+important piece of the long-term model is the development of vaccines
+and drug therapies to fight emerging infections. However, the
+development of countermeasures can be a long process. Take SARS as an
+example. CDC was able to identify and type SARS within a relatively
+short period of time (a matter of weeks). However, the development of a
+vaccine is a much slower process that involves complicated, time
+consuming scientific processes which may not produce a viable
+biological countermeasure for quite some time.
+ In the absence of a drug or vaccine, several strategies that can be
+implemented immediately have been developed to limit the effects of a
+disease on the population. Between the point at which an illness is
+identified and a countermeasure or cure is developed, the key to
+protecting the public's health lies in effective interventions, such as
+infection control, supportive therapies and containment strategies, to
+prevent the disease's spread and limit the damage that it can do.
+ In this short-term time-frame, CDC engages in a variety of
+activities to prevent the rise of illness in the population and to stem
+the spread of infectious diseases. Once an infectious disease emerges,
+CDC utilizes epidemiology to type the disease (its strain) and to
+identify its cause, source, and mode of transmission. Once this
+information is ascertained, CDC establishes treatment guidelines for
+those who are ill and containment or infection control guidelines to
+prevent the spread of the disease to additional populations. In cases
+where countermeasures do exist, CDC deploys appropriate medical
+supplies (medicine, vaccine, etc.) to localities for distribution.
+ Again, we can take SARS as an example of the use of effective
+epidemiology and infection control practices to illustrate the benefit
+of such strategies in the absence of biological countermeasures. Upon
+the identification of the cause of SARS and an investigation into its
+mode of transmission, CDC was able to implement highly effective
+infection control measures (including the monitoring of international
+passengers, use of information pamphlets to those entering the U.S.
+from affected countries, standard infection control practices such as
+hand hygiene in hospitals, schools and homes around the nation) that
+kept the disease at bay in the United States.
+ In time, we do expect that biological countermeasures will be
+developed to combat SARS. However, in the meantime, we will continue to
+rely on public health measures to combat the re-emergence and spread of
+SARS.
+
+ Mr. Turner. That would be fine, but I want to know, does
+that answer mean that we are not doing anything? Or does it
+mean that you are just not aware of it? Or are you going to ask
+somebody else? What does it mean?
+ Mr. Henderson. I am just not aware of it. I would have to
+ask my colleagues at CDC. I want to give you a definitive
+response because I believe there is research, but I do not have
+the particulars to talk about today.
+ Mr. Turner. Ms. Heinrich, do you have knowledge of any of
+those efforts?
+ Ms. Heinrich. From our previous work, we know that there
+are a number of efforts underway at NIH at the National
+Institute of Allergy and Infectious Diseases. There is a lot of
+basic research that is going on to really understand the immune
+system and the response to various pathogens. What I think you
+are asking is when we have had a disease outbreak such as SARS,
+is it possible to ramp-up both the public and the private
+sector research capabilities to actually identify antidotes
+that could be useful in the treatment and care of people that
+have this particular infectious disease.
+ I think that using SARS as an example, it was really quite
+phenomenal to see the work that went on internationally,
+globally, in identifying the disease agent, as well as at CDC.
+And then how that information was actually used by labs within
+NIH, certainly, to begin to try to identify substances that in
+fact could be helpful in the treatment of SARS. But I do not
+think there is an answer to your question. I really think it is
+going to be highly variable based on the disease agent, to be
+quite honest.
+ Mr. Turner. I am just looking for the development of that
+response capability. My distinct impression is that capability
+does not exist in the public or the private sector. If we are
+going to fight bioterrorism in the years ahead, we must have a
+lab fully-funded somewhere with competent people who can deal
+with that. I do not really think it is there, and if any of you
+are aware of its existence in the public or private sector, I
+would really appreciate the information.
+ Mr. Shadegg. I appreciate the gentleman's questions, and
+would turn now to Mr. Shays for a second round.
+ Mr. Shays. Thank you.
+ I did not ask specifically a question I want on the record,
+and I would like each of you to answer. The syndromic
+surveillance system, it is something you think makes sense?
+Should we be investing a lot of money in it or not? I would
+like each of you to tell me what you think.
+ Mr. Henderson. Syndromic surveillance, it is a good
+question. It is one of those programs that we find in some
+jurisdictions it works very well. In other jurisdictions, it
+doesn't.
+ Mr. Shays. Is it more the urban areas that it works better,
+where you have more concentration of people?
+ Mr. Henderson. I think it really depends upon the people
+who are standing up the system; the types of syndromes they are
+looking to report; the reporting entry points; and are they
+willing to put forth the effort to assure that they can capture
+the information and put it into the system, and then maintain
+that level of effort over time.
+ We have even seen some jurisdictions where they made an
+investment in syndromic surveillance, but at this point it is a
+waning thing. They just don't continue to see it as being
+valuable. So we have a program at CDC where we are going out
+evaluating the syndromic surveillance systems to see where in
+fact we find value, what are their success factors, and maybe
+that will help identify what is really needed to stand up a
+syndromic surveillance system.
+ Mr. Shays. Thank you. Anybody else care to answer, express
+an opinion? Yes, sir.
+ Dr. Temte. I believe syndromic surveillance is very
+important in the practice of usual clinical medicine. In that,
+the information flowing from syndromic surveillance can inform
+clinicians about usual trends out there. I agree entirely with
+Mr. Henderson in terms of it depends on what we are looking for
+and what population. But things like syndromic surveillance for
+influenza-like illness are invaluable because they inform us
+when influenza is in the community. It informs us when we can
+expect hospitals to be terribly crowded. It informs us about
+appropriate care, because we know that when flu is around, it
+really narrows down the diagnosis of patients that are
+presenting with fever and a cough.
+ Mr. Shays. Thank you. Dr. Platt?
+ Dr. Platt. This is a concept that makes every kind of good
+sense. We really have to do the hard work of understanding when
+and under what circumstances it provides information that is
+useful. Then I think we have to make the second decision about
+where to spend scarce healthcare and public health dollars,
+because the support that goes to syndromic surveillance or
+other surveillance systems is support that is not going to many
+other critical needs. We only started this conversation
+seriously a couple of years ago, and I think we will be in a
+much better position to answer your question in a year or two.
+ Mr. Shays. Thank you. That is very helpful. Thank you all.
+ Mr. Shadegg. I want to thank all the members of our panel.
+This has been a very informative discussion. We certainly
+appreciate your time and your thoughtful testimony.
+ We stand adjourned.
+ [Whereupon, at 4:45 p.m., the subcommittee was adjourned.]
+
+
+ A P P E N D I X
+
+ ----------
+ --________
+
+ Material Submmited for the Record
+
+ Additional Member Statements
+
+ Prepared Statement of the Honorable Shelley Berkley, a Representative
+ in Congress from the State of Nevada
+
+ I would like to thank Chairman Shadegg and Ranking Member Thompson
+for holding this important hearing to assess our nation's bioterrorism
+preparedness and to investigate what further steps are needed to ensure
+our state and local health officials are adequately prepared to respond
+to a possibility that was unthinkable not that long ago.
+ Even before September 11th, we were concerned about the state of
+our nation's health infrastructure. Of particular concern were
+shortages of nurses, the availability of necessary technology, the lack
+of adequate disease surveillance protocols and a generally overburdened
+hospital system nationwide. September 11 th woke our nation to the fact
+that we have enemies ready and willing to take dramatic and
+unconventional action against the United States. This realization
+brings our public health care crises into an even greater focus.
+ How would a fragile public health infrastructure respond to a
+disaster involving mass casualties? A terrorist attack demands a
+skilled and prepared workforce working within a broader public health
+infrastructure that requires the tools to tackle such a tragedy. Our
+country's first responders are on the front line of homeland security
+and our government is taking steps to ensure their preparedness and
+protection in the event of an attack, but it must be recognized that
+our nation's hospitals are in the same chain as our first responders
+when it comes to reacting to an attack. In fact, our hospitals are an
+essential link in that chain and must be adequately funded to meet
+potential challenges.
+ This past August I had the opportunity to hear from the University
+Medical Center (UMC) in Las Vegas, Nevada, on their terrorism concerns.
+UMC is the largest public hospital in Nevada. In fact, UMC serves a
+10,000 square mile area covering parts of Nevada, California, Arizona
+and Utah. This amounts to a service population of 1.5 million
+residents, plus the 35 million visitors to Las Vegas every year.
+Additionally, UMC is the only freestanding trauma center west of the
+Mississippi River. If a bioterrorist attack was to occur in Las Vegas
+or anywhere in the region, UMC would be on the front lines. However,
+under our federal homeland security programs, public hospitals like UMC
+are neglected. Public hospitals are excluded from receiving the
+resources they need by narrow funding fonnulas and a lack of
+recognition that they too are first responders.
+ In August, the Department of Homeland Security held Operation
+Determined Promise 2003, the nation's largest bioterror drill to date,
+in Southern Nevada. Federal, state and local agencies participated in
+an event to test their responses to a possible bioterrorist attack on
+Las Vegas. While this successful event focused on the vital ability of
+our traditional first responders to react to such an attack, UMC
+pointed out a few important factors that were not adequately addressed.
+ First, much of the concern during the drill was about
+decontamination measures ``in the field,'' with very little concern
+focused on decontamination ``on-site.'' In other words, funding and
+training has been focused on protecting those working where the
+contamination is first released, but not enough has been focused on the
+ultimate destination of those contaminated, the hospital. In a
+biological attack our nation's health workers will be among our first
+responders, and we will be relying on them to treat those affected and
+to prevent any potential spread of disease or contamination. On-site
+decontamination equipment and facilities are important to protect our
+doctors and nurses, and ultimately our communities.
+ Second, public hospitals are essentially excluded from our federal
+homeland security funding programs. Currently, homeland security grants
+administered by the Department of Justice and Department of Homeland
+Security are very strict about what entities a state may award those
+funds. These approved entities do not include public hospitals. There
+is a pressing need for our federal homeland security grant programs to
+be expanded and made more flexible to include our vital public
+hospitals.
+ As we have heard from our first responders, such as police and
+firefighters, interoperability of communications must be enhanced. UMC
+also has an essential need for improved communications between the
+hospital and the various levels of first responders, including police,
+fire and emergency medical personnel, in the event of an attack.
+Additionally, UMC requires personal protective equipment, special
+isolation capacity, security-related technology, mobile hospital
+facilities, increased training and specialized personnel. Under our
+current grant programs, these needs go virtually unaddressed.
+ Again, thank you Mr. Chairman for this hearing and for the
+opportunity to speak to what I feel is one of the most important
+homeland security issues our nation faces. I look forward to working
+with you and the Committee to ensure that our public hospitals are
+adequately funded and that we avoid depleting existing resources used
+for the everyday treatment of patients in order to meet our
+preparedness needs as we move forward to meet our nation's security
+challenges.
+ United States General Accounting Office
+ Washington, DC, November 14, 2003
+Hon. John Shadegg
+Chairman, Subcommittee on Emergency Preparedness and Response,
+ Washington, DC 20515
+ Dear Chairman Shadegg: Thank you for the opportunity to
+appear before the Subcommittee on Emergency Preparedness and
+Response hearing entitled ``Disease Surveillance Systems: How
+Can They Help Prepare the Nation for Bioterrorism?'' on
+September 24, 2003. Subsequent to the hearing, you forwarded
+additional questions from Representative Jim Turner, the
+Ranking Member of the Select Committee on Homeland Security.
+Here are Mr. Turner's questions and my response.
+ (1) What role does international disease surveillance
+ play in detecting bioterrorism or naturally-occurring
+ diseases? Could it also be very useful for detecting
+ terrorist experimentation with bioweapons? What work is
+ CDC doing with the World Health Organization or other
+ international organizations to promote international
+ disease surveillance?
+ (2) What Department of Defense programs exist for
+ disease surveillance and how are these being integrated
+ with CDC? How do you see the DOD programs fitting into
+ civilian surveillance programs? How can they be
+ coordinated with civilian systems? Is there ny
+ unnecessary duplication of capabilities?
+ Unfortunately, I am not able to provide specific answers to
+most aspects of these questions now. At the request of Senator
+Norm Coleman, Chairman, Permanent Subcommittee on
+Investigations, Committee on Governmental Affairs, United
+States Senate, we have recently begun a study of both U.S. and
+international infectious disease surveillance systems. Among
+other issues, the study will examine the coordination between
+different surveillance systems, including the CDC and DOD
+systems.
+ I can tell you that the CDC works closely with WHO to
+improve international diseases surveillance capabilities. CDC
+is a major partner in WHO's Global Alert and Response Network
+(GOARN) and provides resources (e.g. staff, laboratory
+materials, etc.) and expertise to WHO in epidemiological
+investigations. For example, CDC played a major role in the
+global response to SARS, providing technical consultations and
+deploying staff overseas. On an ongoing basis, CDC also serves
+as a technical consultant to ministries of health on projects
+that address disease surveillance. Through its Field
+Epidemiology Training Programs, the Epidemic Intelligence
+Service, and other programs, CDC has also supported research
+and public health education on disease surveillance around the
+world.
+ Sincerely yours,
+
+ Janet Heinrich,
+ Director, Health Care, Public Health Issues
+
+ ------------------
+
+ Dr. Platt Response to additional questions from the House Select
+ Committee on Homeland Security, Subcommittee on Preparedness and
+ Response
+
+Subcommittee Ranking Member-Bennie G. Thompson
+Question: 1. In response to a question from the subcommittee regarding
+strategies for improving disease surveillance among local
+practitioners, you briefly described a potential solution that would
+utilize existing health plans to provide better communications and
+interaction with the public health syStem.
+ Please briefly expand upon this solution, specifically identifying
+any strategies that might benefit from legislative action at the State
+or Federal level.
+ Congressional action may be needed to stabilize and increase
+funding for advancing a health information infrastructure that supports
+early detection and improved interactions between the private and
+public sectors. Efforts at the State and Federal level that support
+current health information technology initiatives and enhance the
+dissemination of electronic health records and other health
+communications rely on stable funding from Federal or state
+demonstration projects and/or financial incentives to build compatible
+information systems. In addition, promulgating the development of IT
+standards will be instrumental in transforming health care generally,
+and improving our ability to detect unusual outbreaks of disease and
+bioterrorist threats.
+ Second, it will be important to ensure sufficient funding to allow
+state and local departments of health to fully implement the technology
+improvements that are being developed as part of the Public Health
+Information Network (PHIN), including the National Electronic Disease .
+Surveillance System (NEDSS), and rapid public health communications
+systems.
+ Third, it will be worthwhile to create incentives for software
+vendors to incorporate public health surveillance and reporting
+capabilities into their products. These reporting capabilities should
+be under the control of the clinicians and health plans, so that they
+can modify their reporting to accommodate state and local reporting
+needs as well as their own needs. My partners and I believe there is
+special value in enabling providers and health plans to report
+routinely at various levels of detail, including simply the counts of
+new episodes of illness that are the basis of the National
+Demonstration Program I described in my testimony and refer below to
+the model we have developed to provide high level protection to
+individual level data, by having the health plans retain possession of
+individual level data unless there is a need to evaluate a specific
+apparent cluster of illness.
+
+Subcommittee Member-Dave Camp
+Question: 1. In your written testimony you discussed Harvard's National
+Bioterrorism Surveillance Demonstration Program. Does your program
+receive any intelligence information or threat assessments from the
+federal government to help focus or supplement your surveillance?
+ Our project does not receive intelligence information or threat
+assessments. We recommend this information be provided to public health
+agencies, which can then lower the threshold above which they respond
+to unusual clusters of illness in specific locales. This would allow
+public health officials to evaluate clusters of illness in a particular
+area of interest that they might otherwise choose not to evaluate
+because of other priorities.
+ We have asked that our partnering public health agencies ``set the
+threshold'' for detecting possible outbreaks according to their needs.
+One state may want to look more closely at an alert that statistically
+is expected to occur twice per year. Others may want to set the
+threshold very high (once in two years) or very low (once in a month).
+Intelligence or threat estimates could prove useful in establishing a
+more appropriate threshold level as threats are recognized.
+
+Question: 2. Have you encountered difficulties in acquiring the
+necessary data from some hospitals and community health centers that do
+not have adequate or appropriate computer systems or technology? Is any
+progress being made to facilitate sharing this information? What
+recommendations can you give to improve real-time data reporting from
+these facilities?
+ As mentioned above, adoption of an electronic medical record that
+captures patient level information during the delivery of care is a key
+requirement to performing ``real-time'' assessments.
+ Our project is based on health plans, clinicians, and public health
+volunteering to participate in the demonstration program. The
+participating groups in Texas began their participation due to the
+efforts of a local public health official interested in developing
+their capacity to support improved disease surveillance.
+ We are in discussion with community health centers that have
+electronic medical records and an interest in supporting this work.
+Community health centers serve both a ``known'' and a ``dropin''
+population presenting unique challenges and opportunities for improving
+our surveillance net. Many academic centers sponsor community health
+centers and currently have, or are in the process of implementing, an
+electronic medical record system. These centers are good candidates for
+joining our program.
+ Because our system primarily focuses on ambulatory care data, we
+have not actively sought out participation from hospitals. The
+advantage of this is that sick individuals may seek care sooner in
+ambulatory settings than at hospitals or emergency rooms. Additionally,
+our system benefits from knowing how many people are at risk for
+illness in each zip code (members of a health plan); this improves our
+analytical accuracy for detecting a possible outbreak.
+ We have developed a detailed plan to evaluate the relative value of
+a wide variety of data streams for bioterrorism surveillance (e.g.,
+nurse call centers, ambulatory care, emergency rooms, hospital
+admissions, pharmacy, laboratory and radiology). However, we currently
+do not have funding to carry out this evaluation.
+
+Full Committee Ranking Member-Jim Turner
+Question: 1. How do we avoid ``false alarms'' from syndromic
+surveillance systems? Too many of these could undermine the public's
+confidence and might desensitize them to an actual attack. How will
+followup investigations be conducted so as not to overly alarm the
+public?
+ There is a tradeoff in setting the ``alarm threshold'' to find
+signals at the earliest possible time while avoiding too many false
+alarms. Our system allows public health officials to set the alarm
+threshold that best meets their local needs. Because our system alerts
+public health and the health plan simultaneously about an unusual
+number of illnesses, there is an opportunity to use the full electronic
+medical records to determine quickly and at minimal cost if an alert is
+a false alarm.
+ One of our evaluation approaches to helping health departments set
+the alarm threshold has been to use known infectious disease clusters
+that have occurred in the past and use this data to test our current
+system. The combination of these tests with the actual experience of
+investigating unusual events will mitigate some of the negative impact
+of false alarms.
+
+Question: 2. How is the privacy of the individual patient's medical
+information ensured in your systems? Do you know if other surveillance
+systems have considered privacy issues in their development?
+ Privacy of the individual patient's medical information is a key
+feature of our program. We have avoided many problems that other
+surveillance systems must address because our participating health
+plans do not share the confidential health information of their
+members, unless there is specific evidence of a cluster of illness that
+requires follow-up by public health officials. We accomplish this by
+having the health plans routinely report only the number of people with
+new episodes of illness. This is sufficient to alert health departments
+about potential problems and to trigger follow-up. Investigation of
+specific events has been standard public health practice for many
+years.
+ Our model thus provides a new method to balance individuals' right
+to privacy and the public health system's need to investigate a likely
+threat.
+ It is my understanding that other surveillance systems have
+considered privacy issues in different ways.
+
+Questions and Responses from Dr. Jonathan L. Temte to Member's Written
+ Questions
+
+Response to Subcommittee Ranking Member Bennie G. Thompson.
+Re: Strategies for improving disease surveillance among local
+practitioners
+
+i: Enhanced medical education on disease surveillance
+ At present, there is little guarantee that medical students and/or
+medical residents in any specialty receive meaningful training in the
+purpose, role, and practices of the public health system in the United
+States, including issues of disease surveillance. Accordingly, the
+patient-focused healthcare system and the public health system often
+function in parallel instead of interactively. A basic understanding of
+population approaches to health, emergency response, and disaster
+preparedness is an essential component of homeland security. For
+example, a recent study conducted by the American Academy of Family
+Physicians has indicated that prior training of clinicians in
+bioterrorism preparedness was associated with significant enhancement
+of comfort and communication around potential bioterrorism events.
+ In 2002, the Accreditation Council for Graduate Medical Education
+(ACGME) mandated that all graduate medical education (i.e., residency)
+programs in the United States must assure that their trainees attain
+competence in six areas:
+
+ Patient Care that is compassionate, appropriate, and
+ effective for the treatment of health problems and the
+ promotion of health
+ Medical Knowledge about established and evolving
+ biomedical, clinical, and cognate (e.g. epidemiological and
+ social-behavioral) sciences and the application of this
+ knowledge to patient care
+ Practice-Based Learning and Improvement that involves
+ investigation and evaluation of their own patient care,
+ appraisal and assimilation of scientific evidence, and
+ improvements in patient care
+ Interpersonal and Communication Skills that result in
+ effective information exchange and teaming with patients, their
+ families, and other health professionals
+ Professionalism, as manifested through a commitment to
+ carrying out professional responsibilities, adherence to
+ ethical principles, and sensitivity to a diverse patient
+ population
+ Systems-Based Practice, as manifested by actions that
+ demonstrate an awareness of and responsiveness to the larger
+ context and system of health care and the ability to
+ effectively call on system resources to provide care that is of
+ optimal value
+
+ None of these competencies appropriately addresses an understanding
+of public health function or the interaction of public health resources
+within traditional patient care models.
+
+ Proposed Enhancements:
+1. Work with the American Association of Medical Colleges [AAMC] to
+support curriculum development and implementation into all U. S. based
+medical schools. Please refer to information available at http://
+www.aamc.org/preparedness/start.htm for information on initiatives
+already underway at the AAMC.
+2. Work with the Accreditation Council for Graduate Medical Education
+[ACGME] to expand the current six core competencies to include a 7th
+competency on public health function, emergency preparedness and
+disaster response.
+3. It may be the appropriate time for Congress to commission an in-
+depth strategic report--similar to the Flexner Report of 1910--that
+addresses the gap between public health practice and individually
+oriented medical care and makes recommendations as to the required
+training components and competencies that should become incorporated
+into the training of both public health professionals and medical
+professionals.
+
+ii: Improve public health system interaction with local practitioners
+ This is an area where there has been little directed study.
+Accordingly, recommendations on improving health system interactions
+are limited. A recent Agency for Healthcare Research and Quality (AHRQ)
+funded evidence report on training clinicians for response to
+bioterrorist attacks (available at http://www.ahra.gov/clinic/tp/
+biotrtp.htm) concluded that there existed only modest evidence about
+effective ways to train clinicians as to how to respond to bioterrorist
+attacks.
+ There are, however, several success stories of ongoing interactions
+between public health systems and local practitioners. Perhaps the best
+example is the U. S. Influenza Sentinel Provider Surveillance Network,
+which exists as a cooperative effort between the Influenza Branch at
+the CDC and approximately 1,600 volunteer primary care clinicians
+scattered across the United States. This low-cost surveillance system
+has functioned successfully over the past 30 years, informing public
+health professional and clinicians on the presence and intensity of
+influenza.
+
+Proposed Enhancements:
+ 1. Ensure sufficient and longitudinal funding for continuation and
+expansion of the CDC's U.S. Influenza Sentinel Provide Surveillance
+Network. This support requires core support of the Influenza Branch at
+CDC, support of state influenza surveillance coordinators, and support
+for primary care liaisons to function as mediators between public
+health and primary care communities. Such funding also ensures an
+ongoing system that can function to detect events that share
+significant features with bioterrorist agents.
+ 2. Enhance funding through the Agency for Healthcare Research and
+Quality to provide direct research grants for studying effective means
+of enhancing primary care clinician education and performance in issues
+relevant to public health and bioterrorism response. It is highly
+important to evaluate this function of primary care clinicians within
+the United States--the venue wherein most citizens receive most of
+their care most of the time.
+
+iii: Provide better understanding of public health processes to local
+practitioners
+ There are few opportunities for healthcare providers to interact in
+meaningful ways with local and state public health professionals. Most
+interaction currently occur around the mandated reporting of cases of
+public health interested (usually communicable disease or significant
+environmental exposures). Few clinicians understand the vital role
+played by public health agencies in outbreak investigation, disease
+control, and public education.
+ Participation in sentinel surveillance--in which the clinician
+actively detects cases, reports to a central agency, and receives
+clinically relevant feedback--is a clear example of a means to enhance
+better understanding of public health function. Participation in
+influenza surveillance activities is especially beneficial in this
+regard because response to influenza involves a wide cross section of
+public health activities: local, regional, national and international
+surveillance, vaccination policy, utilization of health care
+facilities, public education. Added benefits lie in the fact that
+influenza-related activities are extremely clinically-relevant,
+especially in primary care medicine. Cases of influenza are commonly
+seen by almost all clinicians and almost every year.
+
+Proposed Enhancements:
+ 1. Provide funding to enhance influenza surveillance and create
+incentives for the participation of clinicians that will be developed
+into liaison roles, thus helping to bridge the gap between clinicians
+and public health professionals. This could be done at state and
+national levels. A reasonable goal may be two to four surveillance
+clinicians per each U. S. Congressional district.
+ 2. Create funded, short-term fellowships in public health for
+primary care and other interested clinicians. These could take the form
+of abbreviated ``Epidemiologic Intelligence Service'' training through
+the CDC. The goal would be the creation of a cohort of clinicians that
+would mediate between patient care and public health agendas.
+
+iv: Improve and regularize communications between public health systems
+and clinicians
+ There are no systems that currently exist for the purpose of
+regular communication between public health agencies and clinicians.
+Information tends to flow to select clinicians regularly (via
+publications such as MMWR) or irregularly (via local or regional public
+health alerts). Most information to public health agencies from
+clinicians occurs in the form of mandated, reportable illness case
+reports. There is good evidence that many reportable cases go
+unreported and that action steps taken by public health in response to
+reports are not communicated back to the clinician.
+ Ongoing information exchange between public health agencies and
+clinicians around topics that are clinically relevant can serve to
+maintain appropriate, bi-directional conduits for communication.
+Excellent examples of this exchange again are found in functional
+influenza and respiratory virus surveillance systems such as the U.S.
+Influenza Sentinel Provider Surveillance System or the National
+Respiratory and Enteric Virus Surveillance System (htp://www.cdc.gov/
+ncidod/dvrd/revb/nrevss/rsvtre1.htm). These systems are currently
+limited, however, in the amount of information flow to clinicians.
+ A proposed, complete surveillance system is illustrated below
+demonstrating not only reporting of surveillance information to public
+health agencies and feeding back clinically-relevant information to
+clinicians, but also serving as a means to rapidly provide clinicians
+with ``Just in time'' information and education and encouraging
+clinicians to report ``unusual'' events.
+
+[GRAPHIC] [TIFF OMITTED] T0168.034
+
+ One key deficiency is the lack of a reliable and redundant
+communication pathways (e.g., e-mail addresses, fax numbers, telephone
+numbers) of all clinicians.
+
+Proposed Enhancements:
+ 1. Create a national priority, coupled with adequate funding, to
+establish systems of common disease sentinel surveillance, which could
+be utilized for special circumstance surveillance (e.g., bioterrorism).
+Such a system is ultimately dependent on the availability and flow of
+clinically relevant information to clinicians. A potential first step
+would be to provide funding to demonstration and evaluative projects
+involving primary care, practice-based research networks. Mechanisms
+for such funding currently exist through the Agency for Healthcare
+Research and Quality.
+ 2. Legislate mandated reporting of each clinician's e-mail address,
+fax number and telephone number as a part of state and territorial
+level licensure procedures to maintain direct and redundant conduits of
+communication.
+
+Response to Subcommittee Member Dave Camp.
+Re: Tbe role of primary care physicians in alleviating the fear and
+panic accompanying bioterrorism threats and attacks
+ Whereas the subcommittee hearing focused on the detection of and
+surveillance for agents of biological terrorism, an equally important
+component of response exists in the control of panic. To quote from
+Sidell FR et al: ``The real force multiplier in BW (biological warfare)
+is the panic, misinformation and paranoia associated with it.'' [Sidell
+FR, Patrick WC, Dashiell TR. Jane's Chem-Bio Handbook, Jane's
+Information Group, Alexandria, VA, 1998]. And so it goes with
+bioterrorism.
+ In the days following the October 2001 anthrax attacks, wholesale
+panic gripped the American public. As a family physician practicing
+hundreds of miles from the nearest case of inhalational anthrax, I was
+amazed at the number of questions regarding white powder that patients
+brought to our clinic. Likewise, the Wisconsin State Laboratory of
+Hygiene was inundated with samples of powder for anthrax testing (see
+figure). The
+
+[GRAPHIC] [TIFF OMITTED] T0168.035
+
+temporal pattern of specimens submitted for testing also describes
+panic well. As the general public was reassured, the level of comfort
+increased, and panic, hysteria and fear declined. To manage
+bioterrorism, one needs to focus on the terror as much as on the
+detection and treatment of bioterrorism related disease.
+ To best understand the role of primary care physicians in
+countering the fear and panic associated with bioterrorist threats and
+events, one must first understand the structure and function of the
+U.S. medical system-often referred to as the ecology of medical care
+and the widespread location of primary care physicians. The ecology of
+medical care in the U.S. has been relatively stable for the last 40
+years. Each month, approximately 32.7% of Americans consider a medical
+care visit. Of those seeing a physician, more than half see a primary
+care physician.
+
+[GRAPHIC] [TIFF OMITTED] T0168.036
+
+ It is estimated that family physicians evaluate and manage
+about one billion medical concerns each year in the United States. Many
+of these concerns are best addressed with reassurance, education and
+anticipatory guidance. Primary care physicians, due to basic core
+values, provide longitudinal care to individuals and communities across
+the spectrums of age, gender, ethnicity and race, and affected organ
+system. A central tenet of the primary care physician's relationship
+with his/her patients is trust. Accordingly, it is to trusted
+healthcare providers that patients come with issues resulting from
+fear.
+ The widespread location of primary care physicians, and
+specifically family physicians, is noteworthy. Bioterrorist events have
+been and will likely be rather limited in geographic distribution. The
+specific locations of covert bioterrorist events are not predictable,
+but the venue of fear and panic is incredibly widespread. The graphics
+on the following page underscore the wide distribution of family
+physicians in the U.S.
+ In summary, following a bioterrorism event, or under the threat
+thereof, individuals with significant fear and panic will greatly
+outnumber individuals affected with a biological agent. These ``worried
+well'' will commonly seek out trusted and available physicians. The
+essential role of the primary care physician, equipped with appropriate
+and up-todate ('just-in-time'') information, is to use the patient-
+physicians relationship from which to provide reassurance, education
+and comfort. Efforts to ensure the future supply of well-trained,
+competent and compassionate primary care physicians are of paramount
+important to biological defense and homeland security.
+
+[GRAPHIC] [TIFF OMITTED] T0168.037
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+
+ PREPARED STATEMENT OF CHRISTOPHER K. LAKE, DIRECTOR, HOSPITAL
+ PREPAREDNESS, NEVADA HOSPITAL ASSOCIATION
+
+ Thank you, Mr. Chairman for holding this important hearing today on
+bioterrorism preparedness efforts, and for giving the Nevada Hospital
+Association the opportunity to be heard. For our nation's hospitals,
+preparing for an outbreak, whether from a bioterror event or from an
+emerging disease such as SARs is of paramount importance.
+ The Nevada Hospital Association is one of the nation's National
+Bioterrorism Hospital Preparedness Program administrators. As such we
+work collaboratively with all hospitals, city, county and state
+governmental units and emergency response organizations within Nevada
+and in neighboring jurisdictions. We are responsible for evaluating the
+needs of hospitals and health systems and for the implementation of new
+technologies and equipment providing early identification of potential
+terrorist events as well as to protect our nurses, doctors and other
+biological terror first response personnel.
+ In April of last year, we conducted a comprehensive hospital
+assessment and analysis that identifies the strengths, weaknesses,
+opportunities and threats to our healthcare system as related
+specifically to bioterrorism preparedness. Disease and syndromic
+surveillance as well as various technology implementation projects were
+found to be an area where some opportunities exist.
+ The assessment documented that more then half of the hospitals
+conduct syndromic surveillance activities and have policies in place
+for practitioners to notify appropriate infection control professionals
+as well as public health officials when needed. The most common
+syndromes that are monitored at regular intervals include: influenza-
+like illnesses, rashes with fever, gastroenteritis, sepsis and septic
+shock, unexplained deaths, and undifferentiated pneumonias. It is
+believed that these types of patient presentations at our hospital's
+emergency departments (EDs) will be recognized first by an astute nurse
+or physician and they will in most cases alert the appropriate
+personnel that closer study and evaluation may be warranted.
+ It is difficult to automate real time disease and syndrome
+surveillance activities for a number of reasons. One of the primary
+reasons that automation remains complicated is the possibility that the
+initial number of patients that present at EDs will be low as the
+outbreak starts to take off and thus may not trigger any alarms that
+are programmed based on statistically significant variations in patient
+populations or complaint type. When the numbers become high enough to
+trigger an alarm, the outbreak would be large enough for physicians to
+easily identify without the use of the new technology.
+ Recognizing these hurdles, the Nevada Hospital Association has
+begun implementing a multi--Prong solution. The first prong is to
+continually reinforce to all healthcare providers, if you see unusual
+clinical presentations or unusually high numbers of the same medical
+complaint think outbreak and alert the appropriate infection control
+personnel. Our second priority is to standardize the syndromes and
+patient presentations that hospitals continually monitor so that all
+hospitals are watching for the same group of diseases affording us the
+ability to identify possibly subtle or smaller clusters of patients
+located within a single metropolitan service area. The third prong in
+our approach will involve the use of technology and the real time
+collection of ED data.
+ Nevada EDs are all receiving internet based communications tools
+that will allow each facility the ability to monitor the current status
+of all hospitals within our state. This program will provide a
+magnitude of benefits to help coordinate any healthcare response to
+terrorism including: the ability for hospitals to send alerts to each
+other or to groups of provides requesting help, equipment or supplies
+with the click of a button; the ability to monitor surge capacity
+within the system and; the ability to monitor system- wide critical
+inventories just to highlight a few.
+ We are also working with our vendor to develop a biosurveillance
+module that will collect real time data regarding the types of patients
+that are being seen in the hospitals. This device will give doctors and
+nurses an easy to use, non-laborious and quick tool in which to send
+data to public health agencies and track identified potential bioweapon
+syndromes and clinical presentations. The concept of operations is
+simple. Each hospital's communication screen will have a series of
+touch buttons that represent the clinical syndromes to be watched. If a
+physician or nurse sees a patient that presents with one of these
+syndromes they will simply touch the screen. The computer will track
+how many individuals at that particular hospital as well as within the
+State are seeing those types of patients within the last 24 hours.
+ Local public health departments and state officials will also have
+the ability to see and monitor all of the syndromes and or each
+hospital individually or in user defined groups. Each agency will be
+able to set alarms if defined thresholds are reached and will also have
+the ability to run reports, query the database and or export the data
+into other health department computer programs.
+ We believe this approach will provide the type of information that
+epidemiologist require to begin an investigation. The collection method
+will be fast, simple and non-time consuming freeing up the doctors and
+nurses to be with the patient and not in front of the computer. Lastly
+and perhaps most importantly the system keeps the clinical
+interpretation of potential syndromes with the practitioners and does
+not shift them to a computer routine that could not functionally be
+programmed with all of the possible medical scenarios.
+ In conclusion, disease surveillance is a tool which lends itself to
+the use of technology. However, as with most elements of medicine the
+hospitals and individual practitioners remain the first line of defense
+and the primary identifiers of suspected syndromes. Balancing of
+priorities is critical to ensure that any desire to fund new or
+unproven surveillance technology will not compete with the fundamental
+need to adequately protect and equip our hospitals, nurses and doctors
+to respond and treat the patients that will be inevitable during any
+terrorist attack or emerging contagious disease. Thank you Mr.
+Chairman.
+
+
+
+