[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]



             SARS: ASSESSMENT, OUTLOOK, AND LESSONS LEARNED

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

                                HEARING

                               before the

                            SUBCOMMITTEE ON
                      OVERSIGHT AND INVESTIGATIONS

                                 of the

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED EIGHTH CONGRESS

                             FIRST SESSION

                               __________

                              MAY 7, 2003

                               __________

                           Serial No. 108-20

                               __________

       Printed for the use of the Committee on Energy and Commerce


 Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                 house

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                            WASHINGTON : 2003
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                    COMMITTEE ON ENERGY AND COMMERCE

               W.J. ``BILLY'' TAUZIN, Louisiana, Chairman

MICHAEL BILIRAKIS, Florida           JOHN D. DINGELL, Michigan
JOE BARTON, Texas                      Ranking Member
FRED UPTON, Michigan                 HENRY A. WAXMAN, California
CLIFF STEARNS, Florida               EDWARD J. MARKEY, Massachusetts
PAUL E. GILLMOR, Ohio                RALPH M. HALL, Texas
JAMES C. GREENWOOD, Pennsylvania     RICK BOUCHER, Virginia
CHRISTOPHER COX, California          EDOLPHUS TOWNS, New York
NATHAN DEAL, Georgia                 FRANK PALLONE, Jr., New Jersey
RICHARD BURR, North Carolina         SHERROD BROWN, Ohio
  Vice Chairman                      BART GORDON, Tennessee
ED WHITFIELD, Kentucky               PETER DEUTSCH, Florida
CHARLIE NORWOOD, Georgia             BOBBY L. RUSH, Illinois
BARBARA CUBIN, Wyoming               ANNA G. ESHOO, California
JOHN SHIMKUS, Illinois               BART STUPAK, Michigan
HEATHER WILSON, New Mexico           ELIOT L. ENGEL, New York
JOHN B. SHADEGG, Arizona             ALBERT R. WYNN, Maryland
CHARLES W. ``CHIP'' PICKERING,       GENE GREEN, Texas
Mississippi                          KAREN McCARTHY, Missouri
VITO FOSSELLA, New York              TED STRICKLAND, Ohio
ROY BLUNT, Missouri                  DIANA DeGETTE, Colorado
STEVE BUYER, Indiana                 LOIS CAPPS, California
GEORGE RADANOVICH, California        MICHAEL F. DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire       CHRISTOPHER JOHN, Louisiana
JOSEPH R. PITTS, Pennsylvania        TOM ALLEN, Maine
MARY BONO, California                JIM DAVIS, Florida
GREG WALDEN, Oregon                  JAN SCHAKOWSKY, Illinois
LEE TERRY, Nebraska                  HILDA L. SOLIS, California
ERNIE FLETCHER, Kentucky
MIKE FERGUSON, New Jersey
MIKE ROGERS, Michigan
DARRELL E. ISSA, California
C.L. ``BUTCH'' OTTER, Idaho

                  David V. Marventano, Staff Director

                   James D. Barnette, General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

              Subcommittee on Oversight and Investigations

               JAMES C. GREENWOOD, Pennsylvania, Chairman

MICHAEL BILIRAKIS, Florida           PETER DEUTSCH, Florida
CLIFF STEARNS, Florida                 Ranking Member
RICHARD BURR, North Carolina         DIANA DeGETTE, Colorado
CHARLES F. BASS, New Hampshire       JIM DAVIS, Florida
GREG WALDEN, Oregon                  JAN SCHAKOWSKY, Illinois
  Vice Chairman                      HENRY A. WAXMAN, California
MIKE FERGUSON, New Jersey            BOBBY L. RUSH, Illinois
MIKE ROGERS, Michigan                JOHN D. DINGELL, Michigan,
W.J. ``BILLY'' TAUZIN, Louisiana       (Ex Officio)
  (Ex Officio)

                                  (ii)
?



                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Benjamin, Georges C., Executive Director, American Public 
      Health Association.........................................    70
    Bloom, Barry R., Dean, Harvard School of Public Health.......    69
    Brenna, John M., President and Chief Operating Officer, 
      Computerized Thermal Imaging, Inc..........................   100
    Burger, Denis R., Chief Executive Officer, Avi Biopharma.....   129
    Capetola, Robert J., President and Chief Executive Officer, 
      Discovery Laboratories, Inc................................   104
    Fauci, Anthony S., Director, National Institute of Allergy 
      and Infectious Disease.....................................    27
    Fischer, Paul H., Chief Executive Officer, GenVec, Inc.......   122
    Gerberding, Julie L., Director, Centers for Disease Control 
      and Prevention.............................................    21
    Hauer, Jerome M., Acting Assistant Secretary for Public 
      Health and Emergency Preparedness, U.S. Department of 
      Health and Human Services..................................    18
    Heinrich, Janet, Director, Health Care and Public Health 
      Issues, United States General Accounting Office............    38
    Hodge, James G., Jr., Deputy Director, Center for Law & the 
      Public Health, Johns Hopkins Bloomberg School of Public 
      Health.....................................................    81
    Kerby, Karin, Registered Nurse, Loudoun Hospital Center......    90
    Lonberg, Nils, Senior Vice President, Scientific Director, 
      Mederex, Inc...............................................   126
    Lumpkin, Murray, Principal Associate Commissioner, Food and 
      Drug Administration........................................    32
    Schwartz, Jared N., College of American Pathologists.........    75
Additional material submitted for the record:
    Benjamin, Georges C., Executive Director, American Public 
      Health Association, response for the record................   137
    Brenna, John M., President and Chief Operating Officer, 
      Computerized Thermal Imaging, Inc., additional testimony 
      submitted..................................................   138

                                 (iii)

  

 
             SARS: ASSESSMENT, OUTLOOK, AND LESSONS LEARNED

                              ----------                              


                         WEDNESDAY, MAY 7, 2003

                  House of Representatives,
                  Committee on Energy and Commerce,
              Subcommittee on Oversight and Investigations,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 1:30 p.m., in 
room 2123, Rayburn House Office Building, Hon. James C. 
Greenwood (chairman) presiding.
    Members present: Representatives Greenwood, Stearns, Bass, 
Deutsch, DeGette, Davis, and Schakowsky.
    Also present: Representatives Markey and Green.
    Staff present: Alan Slobodin, majority counsel; Peter 
Spencer, majority counsel; William Carty, legislative clerk; 
David Nelson, minority investigator and economist; and Jessica 
McNiece, minority staff assistant.
    Mr. Greenwood. The subcommittee will now come to order. And 
without objection, the subcommittee will proceed pursuant to 
committee Rule 4E. So ordered. And the Chair recognizes himself 
for an opening statement.
    Good afternoon, and welcome. The world continues to fight 
an unpredictable killer called Severe Acute Respiratory 
Syndrome or SARS. Much progress has been made in containing 
this highly infectious disease, as we have just heard during 
our briefing. And shortly we will hear more details about the 
so far successful efforts in controlling SARS in the United 
States.
    We will also hear that for all of the good and aggressive 
work of our frontline public health professionals buoyed by 
some good luck, we cannot rest assured that the largest threat 
of this deadly menace is past us.
    We hold this hearing today because of the clear need to 
continue our vigilance in the fight against SARS to determine 
whether we are appropriately prepared for any possible SARS 
upsurge, especially next winter, and to identify where we might 
improve public health response for future deadly infectious 
disease outbreaks or bioterrorism attacks.
    SARS continues to be of urgent concern for a number of 
reasons. Because it is presently untreatable and its means of 
transmission is not fully known, because it appears to have 
potential for rapid international spread in this interconnected 
globe, and because it has a death rate, that while low in 
comparison to the rates of AIDS and ebola, would be devastating 
if SARS spread rapidly and infections reached numbers of a 
magnitude of, for example, the 1918 flu pandemic.
    Fortunately, there is evidence that SARS is not easily 
transmissible as influenza, and that the tools of public health 
have been working well to contain it. On the other hand, there 
is much the public health authorities do not know and the 
present uncertain and dynamic situation suggests that the 
success or failure in containing SARS will probably depend on 
what happens during the next few months, or perhaps years, 
rather than what has been done already. In other words, the 
question is, ``Has the Pandora's Box of SARS been permanently 
opened or can we put the SARS genie back in the bottle?'' This 
hearing will help us learn how to increase the chances of 
containing SARS.
    Is SARS a harbinger of the eventual pandemic the disease 
experts warn we must be prepared to face? It certainly has 
focused our attention on broader questions of preparedness 
which at, present fortunately, have not been put to the test. 
How would we handle large infection rates or isolate and treat 
infected people? Is our hospitalization infrastructure 
prepared? Do public health laws measure up to the realities of 
the day? And what about gaps in international and local 
surveillance? Will we be able to develop vaccines and other 
treatments? Do we have the resources? Are we proceeding now to 
enhance our overall ability to battle infectious outbreaks?
    The broader issues that we will consider today are not new 
to the public health community nor to this subcommittee. Three 
years ago the General Accounting Office prepared for this 
subcommittee a report warning that the Federal Government 
lacked a plan to combat the inevitable outbreak of pandemic 
influenza. It is important to see what progress we have made on 
that front.
    Another rather sobering assessment of our current 
preparedness for a major disease outbreak was released this 
past March, coincidentally less than a week after the World 
Health Organization issued its global alert on SARS. The 
Institute of Medicine Report ``Microbial Threats to Health: 
Emergence, Detection and Response'' states quite plainly that 
even the developed countries of the world are unprepared for an 
influenza or other infectious disease pandemic.
    Other assessments in recent years have called into question 
the ability to detect new and deadly emerging infectious 
outbreaks; something that this current SARS experience may be 
particularly helpful to eliminate.
    We have three panels of witnesses today which I believe 
will provide us with a thorough and well rounded picture of the 
current situation and the outlook for our ability to combat 
SARS. They will also provide the needed perspective for us to 
identify actions and tools that will help ensure that we can be 
successful should this or any other outbreak spread upon us.
    Our first panel will features witnesses from the Health and 
Human Services Department and its component agencies, some of 
whom have become familiar faces to the American public. They 
will provide us with authoritative information on the actions 
taken in response to SARS and related planning for future 
outbreaks.
    We will also hear on this panel from the General Accounting 
Office whose expert will discuss how State and local agencies 
efforts to prepare for bioterrorist attacks can help battle 
infectious disease outbreaks, and whether hospitals can respond 
adequately to such outbreaks in other major public health 
threats.
    Our second panel features witnesses from the public health 
community who will provide some differing perspectives on the 
SARS outbreak and its lessons for our preparedness. We will 
hear from people with experience internationally, with the 
domestic public health community, the clinical perspective, the 
legal perspective, and from the true front line--the nurse who 
treated the first probable SARS patient identified within the 
United States.
    Our third and final panel will provide a view from the 
therapeutic product industries. We will hear from companies who 
have produced or who are attempting to produce medical products 
potentially useful in combating SARS and related diseases and 
gain some perspectives on the issues confronting them in terms 
of uncertainties, planning and the prospects for breakthroughs.
    Let me say we have an informative array of expertise before 
us. So let me welcome the panelists, and especially those who 
made special last minute arrangements to travel here to 
testify. We appreciate your efforts.
    And I now recognize the ranking member for his opening 
statement.
    Mr. Deutsch. Thank you, Mr. Chairman. I would like to thank 
you for holding this hearing today in an effort to address 
fears and concern about the epidemic SARS or Severe Acute 
Respiratory Syndrome.
    Scientists around the world, some of the very individuals 
who we will hear from today, have moved quickly to identify the 
SARS virus, develop diagnostic tests and formulate a possible 
vaccine. Some of the recent statistics showed SARS killing one 
in five patients hospitalized with the virus in Hong Kong, with 
over half the population aged over 60. It is these alarming 
statistics coupled with the uncertainty of how this virus is 
spread that has triggered a global response to that threat. The 
WHO, who has recently sent an investigation team to China, the 
U.S. Government has authorized Immigration and Customs 
inspectors to use force to detain passengers who appear to have 
SARS symptoms and States have alerted health professionals of 
what to do with a suspected case.
    In Florida I am please to report that aggressive outreach 
in the medical community and to the travel industry have taken 
place already, including extensive meetings and conference 
calls to the popular theme parks and all partners in the hotel 
and related travel industry.
    Discussions on the various legal and social issues 
associated with quarantine situations have occurred between 
Canadian officials and with our Department of Health. AIDS, mad 
cow, West Nile, ebola and the flu all rank among some of the 
most serious health concerns worldwide, and much work has gone 
into their prevention and treatment. Now as the SARS virus 
ranks among these other well known epidemics, public health 
officials must cooperate in training and lab development to 
prepare for an effective response to possible larger scale 
future outbreaks, which lead us to where we are here today.
    I look forward to the hearing and the witnesses.
    Mr. Greenwood. The Chair thanks the gentleman.
    The gentleman from Florida is recognized for 3 minutes for 
an opening statement.
    Mr. Stearns. Thank you, Mr. Chairman.
    And let me just say, as I said earlier, that I think it is 
very important to have this hearing so that we can shed light 
on this troublesome disease.
    But I want to say something positive, because I think we 
will be listening to these different panelists. I think in my 
understanding, I think rarely have we come together so quickly 
in this country and the world to, I think, combat this 
infectious disease. And between the World Health Organization 
and all the other groups that we have in the international 
community I think we can be pretty proud of the fact that we 
have not only alerted other countries. We had a little bad 
start in China, but at this point I think we are moving in the 
right direction. This hearing is a good example of that.
    And I think we have reason to be encouraged that we are 
going to be able to find what SARS is all about, and perhaps in 
the end come up with a vaccine. And with the help of these 
panelists and others, I am confident we will. And that about 
it. We deployed experts all over the world very quickly. And 
now here in the United States I guess the big question is if we 
have it under control in Canada, and we have our airports 
covered, then we would not have to worry about the surge of 
hospitals, help and beds because we would have it under 
control.
    So I think there is a lot of positive, even through SARS is 
thought of as negatively. But I think in the end, Mr. Chairman, 
that the international community is reacting pretty quick. And 
I think we just will continue to learn more about it. And just 
pray and hope that we have a vaccine.
    So, again, I commend your hearing. And the more people tune 
in and watch and hear and understand this, I think the better 
off for everybody. And I think we are making a positive step 
toward that end.
    Thank you, Mr. Chairman.
    Mr. Greenwood. The Chair thanks the gentleman.
    The gentlelady from Colorado, Ms. DeGette is recognized for 
3 minutes for her opening statement.
    Ms. DeGette. Thank you, Mr. Chairman.
    We have learned a lot, I think, in the United States from 
the AIDS crises, from the anthrax crises about public health 
and about how to deal with outbreaks like SARS. And the good 
news is that our public health system has improved 
dramatically, as has our method of advising Americans whenever 
there is any kind of outbreak.
    Many countries that have experienced SARS outbreak have 
been able to control that relatively well because of the 
hierarchial nature of their health care system and because they 
were able to put public health processes in place that work, 
places like Hong Kong, Vietnam, Toronto and others, and that is 
where there has been success in containing SARS. But I cannot 
help but think about some letters that I found in my desk 
yesterday when I was cleaning it out. High school students in 
my district, which they sent to me in October of 2001, right 
after the anthrax scare.
    Now, these are high school students in Denver, Colorado, 
probably one of the least likely groups to be effected by 
anthrax. But they were all writing me letters just pouring out 
their thanks to me for coming to their high school and assuring 
them that they were not going to get anthrax.
    And my point is often times with diseases like SARS, 
anthrax, the fear of the disease or the infection is much worse 
than the likelihood of being infected. What I am afraid of is 
things like the United States and international economies, our 
travel economies, if we get SARS outbreaks in this country 
around international airports or other places, I worry about 
the affect on the public from the fear of infection even though 
it may not be a realistic fear in this country.
    And so one thing I think that has not been addressed so far 
today, I would like to hear some of our panels, particularly 
our second panel, address these issues as what do we do in our 
public health system in not only containing this disease and 
outbreaks, but also in us waging a very nervous public, and 
they are still nervous from recent events.
    Finally, I am interested in hearing from everyone as to the 
status of research into some kind of vaccine or other programs 
that can prevent this outbreak as much as possible.
    I thank you for holding this hearing, Mr. Chairman. Once 
again, I think that you are really visionary in figuring out 
the issues that affect us. And I am looking forward to hearing 
all the panels.
    Mr. Greenwood. The Chair thanks the gentlelady.
    Does the gentleman from New Hampshire wish to make an 
opening statement?
    [Additional statements submitted for the record follow:]

 Prepared Statement of Hon. W.J. ``Billy'' Tauzin, Chairman, Committee 
                         on Energy and Commerce

    Thank you, Mr. Chairman. This afternoon's hearing to examine the 
government's response to SARS, what we can learn from it, and what we 
must prepare for down the road, promises to be very informative. Let me 
thank you, Mr. Chairman, for preparing the most thorough Congressional 
look at the SARS situation to date.
    As the Committee of jurisdiction over matters of public health, it 
is essential that we build a solid oversight record early on, so we 
have the correct perspective to help us monitor developments with 
respect to SARS, as well as other infectious disease outbreaks--be they 
produced naturally or by man.
    At the outset, we should acknowledge the remarkable, and decisive, 
actions taken by public health authorities in the United States--at the 
CDC especially, and NIH, FDA, and HHS--and those working with the World 
Health Organization (WHO) and various health ministries abroad.
    The SARS threat continues and may yet get worse, but we can at 
least breathe a sigh of relief because it could have been much, much 
worse already. Some people note that we escaped harm because of luck. 
We have been fortunate, but I don't think we should let that overshadow 
the actions of people, of individuals, that really made the crucial 
difference on the ground, actions that may have saved the lives of 
hundreds and possibly thousands of our fellow citizens.
    In the United States, we should appreciate the decisions of the CDC 
leadership--Dr. Gerberding, who is before us today--for casting a very 
wide surveillance net to ensure that SARS cases wouldn't escape 
detection. This type of thinking and proactive effort is what saves 
lives.
    Decisions by HHS Secretary Tommy Thompson--who said the 
government's response on potential SARS vaccines ``wouldn't be business 
as usual''--and the rapid moves by Dr. Fauci and others at NIH to be 
ready to battle any outbreak all suggest we are taking aggressive steps 
to combat SARS.
    This response has been effective to date. And we can trace it right 
to the decision that led to the discovery of the deadly SARS outbreak, 
beginning at a hospital in Hanoi this past February.
    There, a WHO physician and investigator--one Carlo Urbani--was 
treating a cascade of deadly infections and urgently pressed Vietnamese 
health officials to impose protective health measures, which they did, 
and he raised the initial alarm for Dr. David Heymann and his 
colleagues at WHO in the field who made the bold decision to issue the 
rare global alert for SARS.
    Carlo Urbani died of a SARS infection, but he saved lives by his 
decisive actions, in Vietnam and around the world. We should appreciate 
that.
    Mr. Chairman, I think we should remember how decisions and actions 
by people, by individuals like Dr. Urbani and Dr. Heymann make a 
difference here, because part of our job on this Committee should be to 
ensure that such life-saving decisions aren't hampered by poor 
planning, out-of-date regulations and laws, or other barriers that 
hinder appropriate public health response.
    The panels assembled today will offer us a range of views on what 
we have learned, and what we might do to improve the process. I look 
forward to learning about the state of public health laws and 
surveillance systems, for example, and the state of research and 
innovation in the area of infectious disease treatment and vaccines.
    Innovation--in this case, the development of cutting edge medicines 
and technologies--is sparked by individual insight and decisions, 
against a backdrop that encourages such effort. Whether in the area of 
combating SARS or bioterrorism--such as through Project BioShield--our 
efforts should be to help provide the certainty and incentive that is 
necessary to encourage such innovation and for us to reap the benefits 
from its fruits.
    Mr. Chairman, let me also welcome the witnesses for their testimony 
today at this timely hearing, and I yield back the remainder of my 
time.
                                 ______
                                 
Prepared Statement of Hon. Jan Schakowsky, a Representative in Congress 
                       from the State of Illinois

    I want to thank Chairman Greenwood and Ranking Member Deutsch for 
bringing this important issue before the subcommittee today. I also 
want to thank our witnesses appearing before the committee to discuss 
their efforts to combat the spread of SARS.
    SARS has presented a serious public health concern to the 
international community and it is critical that we learn how to 
identify, treat, contain, and hopefully eradicate this epidemic. 
Fortunately, no one in the United States has died of SARS and the World 
Health Organization has removed the US from the list of affected 
countries. However, we cannot lull ourselves into complacency. We are 
still vulnerable to a SARS outbreak.
    My constituents are particularly concerned about a potential 
outbreak in Illinois. After all, O'Hare International Airport is in 
Chicago and has the great distinction of offering more connections to 
international cities than any other airport in the world. As we know, 
the majority of people infected with SARS initially contracted the 
disease on airplanes or in public health settings. I am very interested 
to learn about protocols in place for both airports and public health 
settings should there be a sudden outbreak of SARS.
    I think this epidemic clearly illustrates how critical it is for us 
to reinvest in our public health system. Because of President Bush's 
economic policies, an outbreak of SARS or some other infectious disease 
in the United States would overwhelm an already stressed public health 
system. Health programs on the local, state, and federal level are 
already experiencing funding cuts. They are being forced to take on 
more responsibilities with fewer resources. Now is not the time to cut 
funding. Now is the time that we invest in our nations health care 
systems by increasing funding for trained personnel, adequate 
laboratories, technology updates, and improved communication networks.
    We must take a hard look at the communication systems we have in 
place in the event of emergency situations. I believe it is essential 
that all health providers, at every level, have access to information. 
The only way providers can respond in the event of an emergency is to 
have a public health system capable of rapid and effective 
communication.
    Another issue before us is the grave threat the President's 
Medicaid reform poses to our country, one that would be exacerbated in 
a future public health emergency. If Medicaid is actually overhauled 
into a block grant, states will have even fewer resources to handle a 
health emergency than they do today. We must be able to respond quickly 
and effectively to public health threats, and the Medicaid reform 
principles on the table would only further undermine these efforts.
    Again, I want to thank our witnesses for coming in today and 
sharing with us the lessons learned since the initial outbreak and 
explaining how we can work together in the future to combat the spread 
of SARS.
    I want to conclude by saying that we should see SARS for what it 
is. It is an infectious outbreak that we must immediately respond to. 
Further, it is yet again another wake up call that we need to pay 
serious attention to our vulnerable public health system. We must 
infuse our public health system with funding so that we can adequately 
respond to our country's health care needs.
                                 ______
                                 
    Prepared Statement of Hon. John D. Dingell, a Representative in 
                  Congress from the State of Michigan

    Severe Acute Respiratory Syndrome (SARS) is a deadly illness that 
has recently been reported in Asia, North America, and Europe. While 
most cases of SARS in the United States have occurred among travelers 
returning from other parts of the world affected by this lethal virus, 
we should be concerned about the possibility that SARS could spread 
more widely in the U.S. community.
    As of today, it appears that SARS spreads primarily by close 
person-to-person contact. Most cases of SARS involve people who cared 
for or lived with someone with SARS, or had direct contact with 
infectious material from a person with SARS. But researchers have 
become increasingly suspicious that there are alternative methods of 
SARS virus transmission because cases of SARS have been reported by 
people who did not have any close personal contact with a SARS victim. 
In fact, new laboratory studies have produced the first scientific data 
that the SARS virus can survive in various places and conditions 
outside the human body. Recent reports out of Hong Kong, Japan, 
Germany, and Beijing show that the SARS virus can survive on common 
surfaces at room temperature for hours or even days.
    The outbreak of the SARS epidemic in Toronto is well known. And 
trucks, jammed with a total of 4,000 tons of trash from Toronto, cross 
Michigan's Blue Water Bridge and travel down a 90-mile stretch of 
Interstate 94 every day en route to a landfill in southern Wayne 
County. If recent reports are correct, and if the SARS virus can 
survive in various places and conditions for an extended period of 
time, then this trash could conceivably pose a health risk to the 
people of Michigan and to the people of America. We need to know more, 
and quickly, about the nature and extent of this and other possible 
threats.
                                 ______
                                 
  Prepared Statement of Hon. Gene Green, a Representative in Congress 
                        from the State of Texas

    Mr. Chairman, thank you for allowing me to join you here for this 
oversight hearing on Severe Acute Respiratory Syndrome.
    The SARS story reads like something out of a science fiction novel. 
A new and frightening disease develops in a foreign country, and before 
we know it, the disease spreads from continent to continent, killing 
people before they even know what's happening to them.
    According to the World Health Organization (WHO), there are more 
than 6,500 probable cases of SARS and more than 460 of these persons 
have died. For a disease that has been in existence for less than six 
months, these are troubling statistics.
    But I think the real cause of concern for most people is that this 
disease seems to be easily transmitted. I know I was particularly 
troubled when I heard that many individuals in one Hong Kong apartment 
complex were infected without actually interacting with an affected 
person.
    You know, my daughter is currently doing her residency at the 
University of Texas Medical Branch (UTMB) in Galveston, Texas, and she 
plans to specialize in Infectious diseases.
    I often say that I'd rather have her specialize in anesthesiology 
or orthopedics, because I don't want her to come face to face with 
unknown diseases like SARS.
    As a father, and a public policy maker, I am concerned by this 
outbreak, and am glad that we are having this opportunity to learn 
about our public health response to the disease, and ways we can learn 
from this illness to prepare for other public health threats, including 
possible bioterrorist attacks.
    I would like to take a moment to highlight the work that has 
already been done on SARS in my hometown of Houston, TX.
    I have spoken to various folks in the hospitals and public health 
departments and I was pleased to learn that most have implemented 
protocol to deal with possible SARS cases.
    At Ben Taub hospital, the largest public hospital in Houston, every 
patient that presents with cold, flu-like symptoms is screened.
    If it is determined that the patient has traveled to or has had 
contact with a person that has traveled to the effected areas the 
patient is then masked and all medical personnel attending the patient 
are specially masked.
    The patient is then moved to a negative air flow patient room. 
Currently, there are six rooms that meet the negative air flow 
criteria.
    Dr. Robert Atmar, an internationally recognized infectious disease 
physician from Baylor College of Medicine, is then made the attending 
physician for this patient.
    At this point, the patient will be moved out of Ben Taub to a 
quarantine facility as we do not want to shut down Ben Taub to other 
essential community services, such as trauma.
    This is a good plan that takes early measures to prevent the spread 
of the disease and involves partnerships with other providers in the 
area. I am proud of the work they have done in this area.
    But the most obvious problem with this plan is that Ben Taub only 
has six negative air-flow rooms.
    In a situation where we are facing a massive epidemic of a highly 
infectious disease, it is clear that our facilities could quickly 
become overwhelmed.
    This is a good opportunity to develop systems that will help us 
build on what we've learned, so that we can continue our efforts to 
improve public health.
    I know that our witnesses will provide us with some useful 
information on this matter, and I look forward to their testimony.
    Thank you, Mr. Chairman, and I yield back the balance of my time.

    Mr. Greenwood. All right. In that case the Chair will, 
first, with unanimous consent enter into the record three 
documents. First, the statement by Dr. Heymann, Executive 
Director for Communicable Diseases at the World Health 
Organization.
    [The prepared statement of David L. Heymann follows:]
    Prepared Statement of David L. Heymann, Executive Director for 
            Communicable Diseases, World Health Organization

    This statement describes the evolution of severe acute respiratory 
syndrome, or SARS, and explains some of the features that make this new 
disease an especially challenging threat to international public 
health. Brief examples of economic, social, and political repercussions 
illustrate the wide-ranging impact a new disease can have in a closely 
interconnected and highly mobile world. Lessons learned from efforts to 
contain SARS, particularly concerning the strengths and weaknesses of 
systems for surveillance and response, are then used to assess global 
capacity to respond to other infectious disease threats, most notably 
the next influenza pandemic and the possible deliberate use of 
biological agents to cause harm. Priority areas for urgent improvement 
are identified and discussed.
               sars: a puzzling and difficult new disease
    SARS is the first severe and easily transmissible new disease to 
emerge in the 21st century. Though much about the disease remains 
poorly understood and frankly puzzling, SARS has shown a clear capacity 
for rapid spread along the routes of international air travel. At 
present, the outbreaks of greatest concern are concentrated in 
transportation hubs or spreading in densely populated areas. WHO 
regards every country with an international airport, or bordering an 
affected area, as at potential risk of an outbreak.
    The first cases of SARS are now known to have emerged in mid-
November 2002 in Guangdong Province, China. The first official report 
of an outbreak of atypical pneumonia in the province, said to have 
affected 305 persons and caused 5 deaths, was received by WHO on 11 
February. Around 30% of cases were reported to occur in health care 
workers. Confirmation that cases were consistent with the definition of 
SARS was made after permission was granted, on 2 April, for a WHO team 
to visit the province.
    In the meantime, SARS was carried out of Guangdong Province on 21 
February by an infected medical doctor who had treated patients in his 
home town. He brought the virus to the ninth floor of a four-star hotel 
in Hong Kong. Days later, guests and visitors to the hotel's ninth 
floor had seeded outbreaks of cases in the hospital systems of Hong 
Kong, Viet Nam, and Singapore. Simultaneously, the disease began 
spreading around the world along international air travel routes as 
visitors at the hotel travelled home to Toronto and elsewhere, and as 
other medical doctors who had treated the earliest cases in Viet Nam 
and Singapore travelled internationally for medical or other reasons.
    Today, close to 7000 probable cases of SARS have been reported from 
27 countries on five continents. More than 450 deaths have occurred. 
China is reporting a cumulative total of probable cases that will soon 
reach 6000 as each day's nationwide reporting adds at least 100 new 
cases. ``Hot zones'' of particular concern include Toronto, Hong Kong, 
Singapore, Beijing and, increasingly, much of the rest of China. 
Although the outbreaks in Hong Kong, Singapore, and Toronto show signs 
of having peaked, new cases and deaths continue to be reported. Taiwan, 
with a rapidly growing number of cases and deaths, is a worrisome new 
development. With the exception of Taiwan, all of these areas belonged 
to the first wave of outbreaks, prior to a WHO global alert issued on 
15 March. Viet Nam, another country in the initial wave of outbreaks, 
became the first country to control its SARS outbreak on 28 April.
    A particularly serious threat. SARS demonstrates dramatically the 
global havoc that can be wreaked by a newly emerging infectious 
disease. At this moment, public health authorities, doctors, nurses, 
scientists, and laboratory staff around the world are struggling to 
cope with SARS at a time when some hope remains that the disease might 
still be contained. Economists and market analysts are simultaneously 
struggling to calculate the present and future costs, initially 
estimated at $30 billion in the Far East alone. Public panic is 
widespread, some government officials have lost their jobs, and social 
stability has been jeopardized in some of the hardest hit areas. 
Hospitals, schools, and borders have been closed, and several 
governments have advised their citizens not to travel to hard-hit 
areas. In Hong Kong, an electronic tracking system developed by the 
police force for use in criminal investigations has been adapted for 
contact tracing and monitoring of compliance with quarantine. In 
Singapore, military forces have been deployed to assist in contact 
tracing and to enforce quarantines that have halted the normal lives of 
thousands of people. No visitors are allowed at any public hospital.
    SARS needs to be regarded as a particularly serious threat for 
several reasons. The disease has no vaccine and no treatment, forcing 
health authorities to resort to control tools dating back to the 
earliest days of empirical microbiology: isolation and quarantine. The 
virus comes from a family notorious for its frequent mutations, raising 
important questions about the future evolution of outbreaks and 
prospects for vaccine development. Epidemiology and pathogenesis are 
poorly understood. The initial symptoms are non-specific and common. 
All available diagnostic tests have important limitations. If tests are 
poorly conducted or results wrongly applied, patients excreting virus 
and thus capable of infecting others can slip through the safety net of 
isolation and infection control. The disease continues to show a 
disturbing concentration in previously healthy hospital staff--the 
human resource vital to control. A significant proportion of patients 
require intensive care, thus adding to the considerable strain on 
hospital and health care systems. Evidence is mounting that certain 
source cases, or ``superspreaders'', make a special contribution to 
rapid spread of infection. SARS has an incubation period that allows 
rapid spread along international air-travel routes.
    With the notable exception of AIDS, most new diseases that emerged 
during the last two decades of the previous century or have become 
established in new geographical areas have features that limit their 
capacity to pose a major threat to international public health. Many 
(avian influenza, Nipah virus, Hendra virus, Hanta virus) failed to 
establish efficient human-to-human transmission. Others (Escherichia 
coli O157:H7, variant Creutzfeldt-Jakob disease) depend on food as a 
vehicle of transmission. Diseases such as West Nile fever and Rift 
Valley fever that have spread to new geographical areas require a 
vector as part of the transmission cycle. Still others (Neisseria 
meningitidis W135, and the Ebola, Marburg, and Crimean-Congo 
haemorrhagic fevers) have strong geographical foci. Although outbreaks 
of Ebola haemorrhagic fever have been associated with a case-fatality 
rate in the range of 53% (Uganda) to 88% (Democratic Republic of the 
Congo), person-to-person transmission requires close physical exposure 
to infected blood and other bodily fluids. Moreover, patients suffering 
from Ebola during the period of high infectivity are visibly very ill 
and too unwell to travel.

                CHRONOLOGY OF THE EMERGING SARS OUTBREAK

    SARS was first identified in Viet Nam on 28 February, when Dr Carlo 
Urbani, an epidemiologist from the Hanoi WHO office, examined a patient 
with a severe form of pneumonia with no known cause. By 10 March, at 
least 22 hospital workers in Hanoi's private French Hospital were ill 
with a similar acute respiratory syndrome, and by 11 March similar 
outbreaks had been reported among hospital workers in Hong Kong.
    SARS occurred at a time of heightened surveillance for atypical 
respiratory disease. From 11 February, the WHO office in Beijing, which 
reinforced its staff with two epidemiologists, had been working with 
the government of China to learn more about the outbreak of atypical 
pneumonia in Guangdong. Surveillance was heightened further when a 33-
year-old man who had travelled with his family to Fujian Province in 
China died of unknown causes in Hong Kong on 17 February. The next day, 
Hong Kong authorities announced that avian influenza A(H5N1) virus, the 
cause of ``bird flu'', had been isolated from both the man and his 
nine-year-old hospitalized son. Another member of the family, an eight-
year-old daughter, died while in Fujian and was buried there.
    On 12 March, after an assessment of the situation in Asia with WHO 
teams in Hanoi, Hong Kong, and Beijing, a global alert was issued about 
cases of severe atypical pneumonia with unknown etiology that appeared 
to place health workers at high risk.
    Two days later, on 14 March, WHO received a report from the 
government of Canada that health authorities had taken steps to alert 
hospital workers, ambulance services, and public health units across 
the provinces that there were four cases of atypical pneumonia within a 
single family in Toronto that had resulted in 2 deaths. At 2 a.m. 
Geneva time on the following day, 15 March, the government of Singapore 
notified WHO, by urgent telecommunication, of a similar illness in a 
32-year-old physician who had treated cases with a severe respiratory 
syndrome in Singapore, all subsequently linked to the Hong Kong hotel. 
This Singapore physician had travelled to the United States for a 
medical conference, and at the end of the conference boarded a return 
flight to Singapore in New York. Before departure he had indicated to a 
colleague in Singapore by telephone that he had symptoms similar to the 
patients he had treated in Singapore. The colleague notified health 
authorities. WHO identified the airline and flight, and the physician 
and his two accompanying family members were removed from the flight at 
a stopover in Frankfurt, Germany, where the three were immediately 
isolated and placed under hospital care. As a result of this prompt 
action, Germany experienced no further spread linked to the three 
imported cases.
    A rare emergency advisory. Later in the morning of 15 March, with 
this background and chronology of events, a decision was made by WHO to 
increase the level of the global alert issued on 12 March. The decision 
was based on five different but related factors. First, the causative 
agent, and therefore the potential for continued spread, of this new 
disease were not yet known. Second, the outbreaks appeared to pose a 
great risk to health workers who managed patients, and to the family 
members and other close contacts of patients. Third, many different 
antibiotics and antivirals had been tried empirically and did not seem 
to have an effect. Fourth, though the numbers were initially small, a 
significant percentage of patients (25 of 26 hospital staff in Hanoi, 
and 24 of 39 hospital staff in Hong Kong) had rapidly progressed to 
respiratory failure, requiring intensive care and causing some deaths 
in previously healthy persons. Finally, the disease had moved out of 
its initial focus in Asia and appeared to have spread to North America 
and Europe.
    At this time, the epidemiology of SARS was poorly understood. A 
virulent strain of influenza had not been ruled out as a possible 
cause, even though transmission patterns were not characteristic for 
influenza. There was also some hope that the new disease, like many 
other new diseases of the recent past, would fail to maintain efficient 
person-to-person transmission, or that it might attenuate with passage 
and eventually self-contain. Despite the lack of understanding about 
the disease, its cause, and future evolution, the need was great to 
introduce a series of emergency measures to contain SARS outbreaks in 
the affected areas and prevent further international spread, thus 
reducing opportunities for the new disease to establish itself. WHO 
thus decided, on 15 March, to issue a rare emergency travel advisory as 
a global alert to international travellers, health care professionals, 
and health authorities.

                          THE GLOBAL RESPONSE

    The existing system for alert and response. In April 2000, WHO 
formally launched the Global Outbreak Alert and Response Network 
(GOARN) as a mechanism to link together, in real time, 110 existing 
networks which together possess much of the data, expertise, and skills 
needed to keep the international community alert to outbreaks and ready 
to respond. By electronically linking together existing networks the 
World Health Organization is able quickly to learn of significant 
events and to mobilize verification and response activities in spite of 
WHO's limited resources. From January 1998 through March 2002, the WHO 
has investigated 538 outbreaks of international concern in 132 
countries.
    One of the most powerful new tools for gathering epidemic 
intelligence is a customized search engine that continuously scans 
world Internet communications for rumors and reports of suspicious 
disease events. This is the Global Public Health Intelligence Network 
(GPHIN), a computer application developed by Health Canada and used by 
WHO since 1997. GPHIN operates as a sensitive real-time early warning 
system by systematically searching for key words in over 950 news feeds 
and electronic discussion groups around the world. Human review and 
computerized text mining are used to filter, organize and classify the 
more than 18,000 items it picks up every day, of which around 200 merit 
further analysis by WHO. GPHIN provided some of the earliest alerts to 
the November outbreak in China.
    In outbreak alert and response, every hour counts, as the window of 
opportunity for preventing deaths and further spread closes quickly. 
GPHIN has brought tremendous gains in timeliness over traditional 
systems in which an alert is sounded only after case reports at the 
local level progressively filter to the national level before being 
formally notified to WHO. GPHIN currently picks up--in real time--the 
first hints of about 40% of the roughly 200 to 250 outbreaks 
subsequently investigated and verified by WHO each year. While the 
early alert to outbreaks of genuine concern is most important, GPHIN 
also allows WHO to step in quickly to refute unsubstantiated rumors 
before they have a chance to cause social and economic disruption.
    During outbreak response, WHO uses a custom-made geographical 
mapping technology to assist in the location of cases and rapid 
analysis of the epidemic's dynamics. This epidemiological mapping 
technology is also used to predict environmental and climatic 
conditions conducive for outbreaks. An event management system, 
introduced in 2001, is now used to gather and communicate data 
throughout the course of outbreak investigation and response. The 
system generates a dynamic picture of operations, aids organization of 
logistics, and provides a systematic way to prepare better, respond 
faster, and manage resources more effectively.
    SARS: sealing off the opportunities to establish endemicity. SARS 
has been an extremely demanding test of the effectiveness of WHO and 
its GOARN partners to mount an adequate response, get teams and 
supplies into countries, and ensure adequate monitoring and reporting. 
The urgency of SARS has further challenged WHO to set in motion high-
level international scientific and medical collaboration in which 
natural competition for publication and prestige is set aside in order 
to identify the SARS causative agent with unprecedented speed and to 
develop diagnostic tests and effective treatment protocols.
    To date, the global response, coordinated by WHO and strongly 
supported by the U.S. Centers for Disease Control and Prevention and 
other partners, has been designed to rapidly seal off opportunities for 
SARS to establish itself as a common disease. The initial emergency 
plan, mapped out from 12 to 15 March, called for an attack on the 
ground and in the ``air''. On the ground, WHO sent teams of experts and 
specialized protective equipment for infection control in hard-hit 
hospitals to countries requesting such assistance. In the ``air'', WHO 
used the model of its electronically interconnected global influenza 
network to quickly establish a similar ``virtual'' network of 11 
leading laboratories, connected by a shared secure website and daily 
teleconferences, to work around the clock on identification of the SARS 
causative agent and development of a robust and reliable diagnostic 
test. This network, in turn, served as a model for similar 
electronically linked groups set up to pool clinical knowledge and to 
compare epidemiological data. WHO also decided to issue daily updates 
on its website to keep the general and travelling publics informed and, 
to the extent possible, counter rumors with reliable information.
    Following the emergency advisory issued on 15 March, global 
vigilance was immediately heightened, with the result that most 
countries subsequently reporting cases have managed, through prompt 
detection, isolation and good infection control, to prevent the scale 
of transmission experienced in the SARS ``hot zones''. On 2 April and 
again on 19 April, WHO issued the toughest travel advisories in its 55-
year history when it recommended postponement of all but essential 
travel to designated high-risk areas.
    WHO teams continue to provide operational support and specialized 
expertise in the most seriously affected areas. Requests for additional 
country assistance continue to be received, most notably from 
authorities in China. Abundant additional support is available to all 
through information posted at the WHO website (www.who.int/csr/sars). 
Guidance ranges in nature from forms for collecting and reporting data, 
through guidelines for clinical management and infection control in 
hospitals, to the materials for local production of diagnostic tests. 
The evolution of the outbreak is constantly and closely monitored and 
daily updates are posted on the website. On 17 April, exactly a month 
after its establishment, the laboratory network announced conclusive 
identification of the SARS causative agent: a new coronavirus unlike 
any other known human or animal virus in its family. The laboratory 
reagents needed to calibrate, standardize and assure the quality of 
laboratory tests are being made available by WHO, at no cost, to 
laboratories designated by ministries of health. Earlier this week, 
network scientists released the first results of studies on the 
survival time of the SARS virus on various environmental surfaces and 
in various bodily specimens, including faeces, respiratory secretions, 
and urine. The results will provide solid scientific guidance for 
recommended public health measures and may shed some light on why so 
many staff in sophisticated and well-equipped hospitals continue to 
become infected.
    On 28 March, at the end of the second week of the global response, 
China, a reluctant partner in the global alert and response at the 
start, became a full partner in the three working groups that were 
studying SARS, and concluded that the outbreaks of SARS elsewhere in 
Asia were related to the outbreak in Guangdong Province. The Chinese 
government has announced that SARS is being given top priority. A 
system of alert and response for all emerging and epidemic-prone 
diseases is being developed. Daily electronic reporting of new cases 
and deaths, by province, has begun. Equally important, health officials 
have begun daily televised press conferences, thus taking the important 
step of increasing the awareness of the population and hospital staff 
of the characteristic symptoms, the need to seek prompt medical 
attention, and the need to manage patients according to the principles 
of isolation and strict infection control.

  LEARNING FROM SARS: HOW TO PREPARE FOR OTHER EMERGENCIES CAUSED BY 
                          INFECTIOUS DISEASES

    When the first suspected SARS cases began appearing in the U.S., 
many hospital staff cited the WHO advisory, and their subsequent high-
level of awareness, as one reason why cases were quickly detected and 
isolated, with the result that further transmission was either avoided 
entirely or kept to a very small number of cases. A second explanation 
offered for the comparatively mild and well-contained SARS situation in 
the U.S. is the high level of nationwide planning and preparedness that 
followed the deliberate distribution of anthrax-tainted mail in the US 
postal system in October 2001.
    The International Health Regulations provide the legal framework 
for global surveillance and reporting of infectious diseases and a 
mechanism by which measures to prevent international spread can be 
enforced. The regulations, which are currently undergoing a substantial 
revision, will be discussed by Ministers of Health at the World Health 
Assembly later this month. The SARS outbreak provides firm evidence of 
the need for such regulations and concrete examples of the areas in 
which revision and updating are urgently needed.
    The novel nature of the SARS virus created an extra step in the 
containment response: scientific identification and characterization of 
the causative agent to allow development of a diagnostic test, 
treatment protocols, and a scientifically sound basis for recommending 
control measures. Experience with SARS has shown that, with strong 
global leadership by WHO, scientific expertise from around the world 
can work in a very effective collaborative manner to identify novel 
pathogens. This function would be invaluable in the event of the 
deliberate release of a biological agent or during future emergence of 
a novel or poorly understood pathogen.
    WHO is continuing its aggressive containment activities aimed at 
preventing SARS from becoming a widely established threat. The 
immediate scientific priorities include development of a robust and 
reliable diagnostic test, improved understanding of the modes of 
transmission, and identification of effective treatment regimes. If, 
despite extraordinary efforts, the disease does become endemic, WHO and 
its international partners will have to settle in for a long and 
difficult fight. In this case, existing mechanisms developed for other 
public health emergencies, such as the Medicines for Malaria Venture, 
the Global Alliance for Vaccines and Immunization, the Global TB Drug 
Facility, and the International Coordinating Group for meningitis and 
yellow fever, would have to be looked to as possible models for 
ensuring the rapid development of SARS drugs and vaccines and equitable 
access in all at-risk countries. Use of the influenza network as a 
model for the SARS laboratory network suggests that such an approach 
brings great speed as well as efficiency.

                         LESSONS FOR THE FUTURE

    Just as the SARS response has been guided by lessons learned during 
preparedness planning for the next influenza pandemic and for a 
possible bioterrorist attack, both of these types of potential public 
health emergencies will benefit from lessons learned as the 
international response to SARS continues.
    The response to SARS has already brought to light a number of 
positive lessons as well as highlighted a number of challenges for 
future preparedness planning. The SARS experience has shown the 
capacity of global alerts, widely supported by a responsible press and 
amplified by electronic communications, to improve global vigilance and 
awareness at all levels, from health professionals and national 
authorities, to politicians and the travelling public. The quick 
detection and reporting of the first cases in South Africa and India 
are indicative of the high level of global awareness and the vigilance 
of the world's health systems. The present climate of high alert also 
helps explain the speed with which developing countries--from Namibia 
to Mozambique--have readied their health services with preparedness 
plans and launched SARS campaigns, often with WHO support, to guard 
against imported cases.
    The SARS experience in Viet Nam has shown that immediate political 
commitment at the highest level can be decisive. Viet Nam demonstrated 
to the world how even a very poor country, hit by an especially large 
and severe outbreak, can triumph over a disease when reporting is 
prompt and open and when WHO assistance is quickly requested and fully 
supported.
    And finally, stimulation of very rapid, high-level research has 
been critical in accelerating the scientific knowledge needed to 
determine the best control interventions.
    The major challenges to be addressed in future planning are those 
of transparency and surge capacity. SARS is now known to have begun in 
mid-November in Guangdong Province. Cases during the earliest phase of 
the SARS outbreak there were not openly reported, thus allowing a 
severe disease to become silently established in ways that made further 
international spread almost inevitable. This is the most important 
lesson for all nations: in a globalized, electronically connected 
world, attempts to conceal cases of an infectious disease, for fear of 
social and economic consequences, must be recognized as a short-term 
stop-gap measure that carries a very high price--loss of credibility in 
the eyes of the international community, escalating negative domestic 
economic impact, damage to the health and economies of neighboring 
countries, and a very real risk that outbreaks within the country's own 
territory can spiral out of control.
    The report of the first WHO expert team to investigate the SARS 
situation in Guangdong Province reached the following conclusion:
        ``If SARS is not brought under control in China there will be 
        no chance of controlling the global threat of SARS. Control of 
        a new and rapidly disseminated disease like SARS is 
        challenging, especially in a country as large and diverse as 
        China. Effective disease surveillance and reporting are key 
        strategies in any attempt to control the spread of a serious 
        new communicable disease such as SARS.''
    Lessons about the importance of transparency are particularly 
strong. This week observers of China have begun to speculate that the 
recent openness about SARS--the daily news reports and electronic 
updating nationwide of cases--may mark a turning point in the way 
government officials communicate information to the public and 
facilitate frank reporting by the media. The next weeks and months will 
determine whether the current outbreaks of international concern can be 
contained, thus preventing SARS from becoming another endemic 
infectious disease in human populations that has no vaccine and no 
effective treatment. It is already clear, however, that the 
responsibility for containing the emergence of any new infectious 
disease showing international spread lies on all countries. In a world 
where all national borders are porous when confronted by a microbial 
threat, it is in the interest of all populations for countries to share 
the information they may have as soon as it is available. In so doing, 
they will allow both near and distant countries--all neighbours in a 
globalized world--to benefit from the understanding they have gained.
    Inadequate surge capacity in hospitals and public health systems 
has clearly been a major problem with SARS, especially since health 
care workers have themselves been victims of the disease and are the 
frontline troops at risk. The shortage of expert staff to co-ordinate 
national and global responses to a rapidly evolving public health 
emergency is also an issue needing additional investment and attention. 
In some areas, hospitals have been closed. In others, the heavy burden 
imposed by SARS on existing hospitals has necessitated the hasty 
construction of new facilities. As another lesson, evidence from SARS 
has shown that local and national capacities can be assisted by 
coordinated networks such as WHO's GOARN that can and do mobilize 
additional support during times of public health emergencies. Further 
strengthening of the surge capacity of the WHO ``hub'' of the global 
alert and response system would also assist in preparedness for future 
infectious disease threats.
    The SARS experience also has some lessons about the importance of 
international collaboration and strong but politically neutral global 
leadership. Though exceptional in terms of its impact, severity, rapid 
international spread, and many puzzling features, SARS is only one of 
around 50 internationally important outbreaks to which WHO and its 
partners respond in any given year. The high level of medical, 
scientific, political, and public attention focused on SARS is helping 
the world to understand the severity of the infectious disease threat 
and the importance of international solidarity in the face of this 
threat. It is also helping the world to understand the importance of 
global leadership and of politically neutral and privileged access to 
all affected countries. Finally, the response to the SARS outbreak is 
helping the public to understand that WHO's activities of global 
coordination, capacity development, communications, and mobilizing 
expertise enable rapid response and actually save lives. To date, in 
the vast majority of countries, these WHO activities have helped health 
authorities to identify imported SARS cases quickly, prevent a SARS 
outbreak, and thus avoid the devastating consequences seen elsewhere.

    Mr. Greenwood. A letter, dated May 5 to me from the Embassy 
of the People's Republic of China.
    [The letter follows:]

                  Embassy of the People's Republic of China
                                                        May 5, 2003
The Honorable Jim Greenwood
Chairman of the Subcommittee on Oversight and Investigations
Committee on Energy and Commerce
United States House of Representatives
2436 Rayburn House Office Building
Washington, D.C. 20515-3808
    Dear Chairman Greenwood, today, I am writing to share with you 
information on the measures taken by the Chinese Government to combat 
SARS.
    The SARS epidemic, which is a new contagious disease, has posed a 
grave threat to life and health of mankind. Still faced with a serious 
SARS situation, the Chinese Government has put health, safety and life 
of the people above everything else, and is determined to face the 
difficulties squarely. In order to turn around the current situation, 
we have taken, and will continue to take resolute and effective 
measures.
    First, we have been strengthening prevention efforts across the 
board to contain the spread of the disease. We have made SARS a 
statutory epidemic under China's legislation, and established an open 
and transparent system for epidemic reporting and news briefing, 
including making daily report to the WHO and publishing it to the 
communities in the meantime. We have also taken all necessary measures 
to guard against cross infection in hospitals, and conducted publicity 
campaigns to increase the public awareness and capability for self-
protection so that prevention can be ensured with mass participation.
    Second, we have been going all out to treat SARS patients and 
setting up the SARS funds. China's provinces, regions and 
municipalities have designated special hospitals and enlarged medical 
facilities to bring timely treatment to SARS patients. We have set up a 
two-billion-yuan special fund for SARS control and prevention, which 
will mainly be used to provide free treatment for the patients in rural 
areas and the needy patients in urban areas.
    Third, we have established a national public health contingency 
response mechanism, a disease monitor and data collection network and 
an ascertaining network of laboratories. The central government has 
allocated 3.5 billion yuan for infrastructure development of a national 
disease control system.
    Fourth, we have stepped up critical SARS research by mobilizing 
multi-disciplinary experts to explore effective methods of diagnosis 
and treatment. We have developed a fast diagnostic method and are 
trying to improve it and testing it clinically. The central government 
has provided special fund for SARS research.
    Fifth, we have increased cooperation with the international 
community and have been drawing on others' successful experience. We 
value, and have acted upon, the useful advice by WHO experts after 
their field inspections in China. At the just-concluded Special China-
ASEAN Leaders' Meeting on SARS on April 29 in Bangkok, China and ASEAN 
issued a joint statement, committing themselves to more effective 
cooperation in the fight against SARS. Let me say that we also 
appreciate the U.S. Government's readiness to offer support, as 
indicated by President Bush in his phone call to President Hu Jintao.
    We believe that through the joint efforts of mankind, the problem 
of SARS will be successfully solved in the end.
    Mr. Chairman, the Chinese Government, while tackling the SARS 
problem, will continue to push forward China's economic cooperation 
with foreign countries, including the United States. As you know, even 
under the current circumstances, the Chinese economy still has a lot of 
dynamism. I believe that with the joint efforts of the people with 
vision in China and the U.S., our economic cooperation will achieve 
further progress.
    I hope you will find this information useful. I am looking forward 
to seeing you soon.
    With warm regards,
            Sincerely,
                                                Yang Jiechi
                                                         Ambassador

    Mr. Greenwood. And a letter addressed to me from the 
Ministry of Public Safety and Security in Ontario.
    [The letter follows:]

             Ministry of Public Safety and Security
                            Commissioner of Public Security
                                                        May 7, 2003
The Honourable James Greenwood
Chairman
House Energy and Commerce Committees
Subcommittee on Oversight and Investigations
U.S. House of Representatives
2125 Rayburn House Office Building
Washington DC 20515
USA
    Mr. Chairman, and Members of the Committee: I am pleased to provide 
this written brief regarding the important issue of Severe Acute 
Respiratory Syndrome (SARS), and tell you about the effective measures 
we have taken to contain and control this new disease in Ontario. This 
paper also updates information provided on April 29th, 2003, to the 
Health, Education, Labor & Pensions Committee.
    I also wish to thank US Consul General Antoinette Marwitc and her 
staff for their strong support of Toronto during our SARS outbreak.
    The Centers for Disease Control is also playing a key role in our 
efforts, and I will elaborate further on this in my remarks.
    By way of introduction, I am a medical doctor who serves in a 
number of capacities within the Ontario government. I am the Assistant 
Deputy Minister of Public Safety and Security, the Chief Coroner for 
Ontario and Commissioner of Public Security. The public security office 
also coordinates Ontario's approach to terrorism and manages emergency 
situations within Ontario, including such things as SARS, 9/11, Y2K and 
the Ice Storm of 1998.
    The problem with responding to SARS has centered on the fact that 
we know so little about it. What is it? What are its characteristics? 
How is it spreading? When are people infectious? How do we test for it? 
And how do we control and treat it?
    In the case of Toronto and the province of Ontario, we faced these 
questions very early in the known history of SARS and knew only that we 
were facing the challenge after the disease was already spreading in a 
local hospital.
    Our index case is clear. A Toronto resident contracted SARS in an 
elevator in the Metropole Hotel in Guangdong, China. That person 
returned to Toronto, became ill and died. The 43-year old son of that 
person went to hospital on March 16th for treatment of what turned out 
to be SARS, and while in the emergency department and after being 
admitted was not in respiratory isolation. This person in retrospect is 
believed to have been superinfective and our cluster of cases takes off 
from this point. This person and the next two persons who were infected 
through contact in that emergency department all went on to infect 
large numbers of other patients, health care workers and family 
members.
    Initial information about SARS was only beginning to flow around 
March 16th, and it took time to recognize the initial hospital case and 
the other contacts from that case. Once that recognition was made, we 
imposed strict and effective isolation measures.
    By this time, however, because of the highly infectious nature of 
our early cases, enough staff and patients were affected that the 
hospital was closed to new admissions, emergency cases, and transfers. 
We also started to alert the entire health care system.
    On March 25th, we decided that a provincial health emergency should 
be declared in order to mobilize the full resources of the province. We 
decided to act quickly and boldly to attempt to eradicate SARS from our 
community. We started by restricting activity in all of the hospitals 
in the province while we put in place stringent infection control 
procedures. Everyone, including all staff, were checked for illness 
before entering a hospital. Staff were required to gown, glove, and 
mask in patient areas of hospitals; masks were provided for all 
patients entering an emergency department, and isolation was required 
for respiratory patients until their conditions were determined. 
Initially we also stopped all elective surgery, stopped any visitors or 
volunteers from coming to hospitals, and organized a new very strict 
system of ambulance transfers between hospitals.
    On the community side we also took strong measures. Public Health 
vigorously tracked contacts of SARS cases and imposed 10-day isolation 
or quarantines for all contacts. If persons were found to be ignoring 
isolation orders, legal remedies were used. The public has also been 
encouraged not to go to work if they show early symptoms of SARS 
including headache, malaise or muscle ache, and before they develop 
fever. Frequent hand washing has been encouraged and a calm approach to 
the problem advocated. These measures continue to this day.
    Before our initial measures had time to take hold, a transfer of a 
highly infectious patient occurred to a nearby hospital. This patient 
was another superinfectious individual, and this transfer resulted in 
more medical staff, their families and other patients getting SARS. 
This hospital was also closed.
    A short time later, we also discovered a potential ``leak'' into 
the community. Relatives of one patient who took their patriarch to 
hospital on March 16th, became infected. They subsequently visited 
doctors, and a funeral home, and were involved in a religions 
community. This series of unprotected contacts took some time to trace 
and piece together, and is referred to as the BLD Cluster (named after 
the religious group). There were 31 cases within this group, and we 
ultimately isolated more than 500 people. There have been no new cases 
from this group since April 9th. However, it is very important to note 
that all of our so-called ``community'' cases track back to the 
original index case. We have had no sporadic or unexplained SARS spread 
in our community.
    Over the Easter weekend we experienced a setback in our efforts. We 
had some incidents of SARS developing in medical staff working in SARS 
units. In one instance a very difficult and very long intubation in a 
SARS unit infected, we believe, 15 staff who were in attendance. We 
immediately rewrote our procedures, and we have invited Health Canada 
and the CDC to work with us to study this unfortunate event and 
recommend the best ongoing infection control standards for our SARS 
units. We appreciate the fact the CDC agreed to come and are working 
diligently and well with our people.
    Our actions, both in hospitals and in the community, have proven to 
be effective. Both hospitals have now been through more than two 
incubation periods (20 days) without any further spread or new cases 
and so both hospitals are in the process of reopening. All our known 
SARS cases are in SARS units in our hospitals or, if well enough, at 
home in isolation finishing recovery.
    I would like to note that Dr. Julie Gerberding, Director of the 
U.S. Centers for Disease Control and Prevention, has endorsed Ontario's 
approach. She said: ``One of the specific lessons I learned in Canada, 
if it becomes necessary, you have to be bold. And you have to do it 
quickly. You have to be aggressive in implementation. There isn't time 
for a lot of committee meetings or discussions and debate. You've got 
to get the job done.''
    There has also been a lot of attention paid to the now-rescinded 
World Health Organization travel advisory issued against Toronto. WHO 
did not visit Toronto or discuss our outbreak, or its management, 
directly with us before taking this action; nor did they give us the 
required warning before issuing it. We believe that this advisory was 
based on old data and an incomplete understanding of our situation.
    The WHO advisory unnecessarily and wrongly alarmed our own 
population, resulted in huge economic loss, and demonstrated that it 
wastes valuable health resources in other countries such as the US by 
causing authorities to think they might have cases of SARS from Toronto 
when in fact there is no possible epidemic link to our cases. It 
emphasizes the need for reliable information and careful screening 
based on facts, not erroneous news reports.
    Finally, I will comment on where we are today.
    We have many SARS patients who are now well and back in the 
community.
    As of May 6th, Ontario had:

 28 active probable SARS patients in hospitals--11 fewer than 
        April 29th
 1 active probable SARS patient at home finishing his/her 
        order, the same as April 29th
 179 SARS patients discharged and back in the community, up 23 
        from April 29th, and
 23 SARS patients have died (up 3 from April 29th), virtually 
        all of these had significant other medical conditions and most 
        were elderly.
    There has been no spread of SARS through casual community contact. 
More than 20 days have passed since the last transmission among close 
contacts outside health care settings.
    We continue to work with the CDC on infection control for our 
medical staff who are working within SARS units. This, along with 
finding and isolating new travel cases that arrive from outside 
Ontario, is our current challenge.
    The streets of Toronto are as safe from SARS as the streets of 
London, Paris or Washington. In fact, a BBC reporter told me recently 
that he saw far more masks in London than Toronto. However, the lesson 
for all us that it only takes one case to start the new breakout.
    Thank you for this opportunity to present our experience in 
Ontario. On behalf of the Ontario government, let me express our 
appreciation for your interest and understanding.
            Sincerely,
                                       James G. Young, M.D.
                                    Commissioner of Public Security

    Mr. Greenwood. Those documents will be made part of the 
record.
    And now we welcome our witnesses. We have an august panel 
and we are delighted to have you here.
    Let me introduce our witnesses. They are Mr. Jerome Hauer, 
Acting Assistant Secretary for Public Health and Emergency 
Preparedness at the U.S. Department of Health and Human 
Services. Welcome, sir.
    Dr. Julie Gerberding, Director of the Centers for Disease 
Control and Prevention. You have been very busy. We welcome you 
as well.
    Dr. Anthony Fauci, M.D., Director of the National Institute 
of Allergy and Infectious Disease. Welcome. Good to have you 
with us.
    Dr. Murray Lumpkin, Principal Associate Commissioner of the 
Food and Drug Administration. Thank you.
    And Ms. Jan Heinrich, Director of Health Care and Public 
Health Issues, The United States General Accounting Office. 
Welcome.
    I believe that you understand that we are holding an 
investigative hearing. And it is the practice of this 
subcommittee when holding investigative hearings to take 
testimony under oath. Do any of you object to giving your 
testimony under oath? Very well.
    We should also advise you that pursuant to the Rules of the 
House you are entitled to be represented by counsel. Do any of 
you wish to be represented by counsel? This is not an Enron 
hearing, so we suspect you probably would not. But we would we 
ask you to rise and raise your right hand, please.
    [Witnesses sworn.]
    You are under oath. And we will begin with Mr. Hauer and 
ask for your opening statement, sir.

 TESTIMONY OF JEROME M. HAUER, ACTING ASSISTANT SECRETARY FOR 
 PUBLIC HEALTH AND EMERGENCY PREPAREDNESS, U.S. DEPARTMENT OF 
   HEALTH AND HUMAN SERVICES; JULIE L. GERBERDING, DIRECTOR, 
 CENTERS FOR DISEASE CONTROL AND PREVENTION; ANTHONY S. FAUCI, 
DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASE; 
 MURRAY M. LUMPKIN, PRINCIPAL ASSOCIATE COMMISSIONER, FOOD AND 
DRUG ADMINISTRATION; AND JANET HEINRICH, DIRECTOR, HEALTH CARE 
AND PUBLIC HEALTH ISSUES, THE UNITED STATES GENERAL ACCOUNTING 
                             OFFICE

    Mr. Hauer. Thank you, Mr. Chairman and members of the 
committee. I am Jerry Hauer, Acting Assistant Secretary for 
Public Health Emergency Preparedness. I appreciate this 
opportunity to share our Department's response to the SARS 
virus within the context of public health emergency 
preparedness. Dr. Gerberding, Dr. Fauci, and Dr. Lumpkin will 
speak to the clinical details of the response, so I will keep 
my comments focused on the overall coordination.
    The Department of Health and Human Services continues to 
work vigorously to ensure that the Nation is ready to respond 
to terrorism and other public health emergencies as we strength 
our public health infrastructure against bioterrorism, we are 
simultaneously enhancing our ability to respond to emerging 
public health threats. There is no question that the work we 
have done over the past 18 months has prepared us to meet the 
challenges we are facing in managing the SARS outbreak.
    Rarely have the international and national health 
communities worked so well and so rapidly together in response 
to an emerging infectious disease. As soon as the international 
community became aware of the SARS situation in March, the 
Director General of the World Health Organization was in 
communication with experts at HHS headquarters in Washington 
and the CDC in Atlanta. Despite the seriousness of the virus' 
impact worldwide, we have reason to be encouraged by the 
response to SARS for several reasons.
    First, the identification of the agent that causes the 
disease was completed in record time. In contrast to diseases 
including HIV, legionella, and Lyme Disease which took over a 
year or even longer to pinpoint. We had and continue to have 
daily video conference calls to share information, map the 
response, and coordinate our activities. We have deployed teams 
of experts and support staff to each of the impacted countries, 
including Canada, mainland China, Hong Kong, Taiwan, the 
Philippines, Singapore, Thailand and Vietnam to collect first-
person data and to assist in conducting surveillance and 
epidemiologic studies, and the implementation of infection 
control precautions and other interventions.
    We are partnering with industry to organize a full-court 
press on vaccine development. We are taking maximum advantage 
of technology to facilitate information sharing; the map of the 
SARS virus genome was published on the Internet soon after it 
was successfully sequenced by an international team of 
laboratories lead by CDC and Health Canada.
    Improvements in laboratory capacity and coordination that 
were made recently as part of our enhancing of our overall 
public health preparedness has contributed to the speed and 
accuracy with which we have responded to SARS. The technology 
built into the Secretary's Command Center has been 
indispensable, providing a forum for real-time, face-to-face 
exchange of information with public health officials in 
Atlanta, Toronto, Geneva and most recently in Hong Kong and 
China. The Command Center maps the distribution of SARS cases 
across the globe with geographic information system software 
for use during our planning discussions.
    The Command Center did not exist a year ago, it became 
operational last November. Although the situation in Canada 
appears to be coming under control, it is critical that we are 
prepared to confront an outbreak of SARS on U.S. soil. Our 
recent efforts to enhance the Nation's preparedness to respond 
to a small pox outbreak have laid the foundation for managing a 
potential SARS event in cities throughout the country. One of 
the most important elements of an effective response plan is 
the development of hospital surge capacity, including the 
ability to isolate a number of infectious patients.
    In fiscal year 2002 we awarded $1.1 billion to 50 States, 
three municipalities and the American territories to enhance 
public health preparedness and to upgrade the readiness of 
hospitals and other health care entities to address 
bioterrorism and other public health emergencies. In fiscal 
year 2003 CDC and HRSA will award additional $1.4 billion to 
further enhance State and local preparedness. I should note 
that these preparations are applicable to a broad range of 
public health emergencies. Our team is unified and ready to 
deal with a variety of health response issues.We are taking a 
variety of steps to ensure that States and other awardee 
jurisdictions have the resources they may require immediately 
to strengthen and upgrade their readiness. In fiscal year 2002, 
we awarded $1.1 billion to 50 States, 3 municipalities, and the 
American territories to enhance public health preparedness and 
to upgrade the readiness of hospitals and other healthcare 
entities to address bioterrorism and other public health 
emergencies. In fiscal year 2003, CDC and HRSA will award an 
additional $1.4 billion to further enhance State and local 
preparedness.
    The bioterrorism preparedness funding has made a material 
difference at the State and local levels. Over 90 percent of 
the 50 States and three municipalities that have been awarded 
funds have developed systems for 24/7 notification or 
activation of their public health emergency response plans, and 
87 percent of these grantees have developed interim plans to 
manage and distribute pharmaceuticals, equipment and supplies 
from the Strategic National Stockpile.
    While our State and local partners work to improve their 
preparedness and response capabilities, the Department is 
implementing an aggressive research and development program. 
Dr. Fauci will address this momentarily.
    The FDA works very closely with these partners to provide 
advice during the development process with a view toward 
facilitating subsequent submissions for regulatory review.
    The research and development efforts are on a very 
compressed timetable and reviews of their progress are 
discussed on a regular basis by an interagency team consisting 
of NIH, CDC and FDA.
    These are truly challenging times for our Department. I 
believe that we are up to the task and we look forward to 
working closely with Congress to ensure that the Nation is 
prepared to respond to bioterrorism and other public health 
emergencies such as the SARS virus.
    Mr. Chairman, thank you for the opportunity to appear 
today. My colleagues and I would be happy to take any 
questions.
    [The prepared statement of Jerome M. Hauer follows:]

 Prepared Statement of Jerome M. Hauer, Acting Assistant Secretary for 
  Public Health Emergency Preparedness, U.S. Department of Health and 
                             Human Services

    Thank you, Mr. Chairman and members of the Committee. I am Jerome 
M. Hauer, Acting Assistant Secretary for Public Health Emergency 
Preparedness. I appreciate this opportunity to share our Department's 
response to the SARS virus within the context of public health 
emergency preparedness. Dr. Gerberding, Dr. Fauci, and Dr. Lumpkin will 
speak to the clinical details of the response, so I will keep my 
comments focused on more global issues and coordination.
    The Department of Health and Human Services continues to work 
vigorously to ensure the Nation's response readiness to terrorism and 
other public health emergencies. We are doing this by pursuing a multi-
pronged approach that consists of enhancing public health and hospital 
preparedness at state and local levels, and conducting research and 
development on countermeasures for the biological, radiological, and 
chemical agents most likely to be used as weapons of mass destruction. 
As we strengthen our public health infrastructure against bioterrorism, 
we are simultaneously enhancing our ability to respond to emerging 
public health threats. There is no question that the work we've done 
over the past 18 months has prepared us to meet the challenges we are 
facing in managing the SARS outbreak.
    Rarely have the international and national health communities 
worked so well and so rapidly together in response to an emerging 
infectious disease. As soon as the international community became aware 
of the SARS situation in March, the Director General of the World 
Health Organization was in communication with the experts at HHS 
headquarters in Washington and the CDC offices in Atlanta. Despite the 
seriousness of the virus' impact worldwide, we have reason to be 
encouraged by the response to SARS for several reasons. First, the 
identification of the agent that causes the disease was completed in 
record time. CDC identified the coronavirus within a few short weeks of 
receiving the first specimens from Asia. In contrast, scourges 
including HIV, legionella, and Lyme Disease took a year or even longer 
to pinpoint. The unprecedented cooperation between the World Health 
Organization, HHS headquarters and CDC headquarters in Atlanta resulted 
in significant progress. We had and continue to have daily video 
conference calls to share information, map the response, and coordinate 
our activities. We have deployed teams of experts and support staff to 
each of the impacted countries, including Canada, mainland China, Hong 
Kong, Taiwan, the Philippines, Singapore, Thailand and Vietnam to 
collect first-person data and to assist in conducting surveillance and 
epidemiologic studies, and the implementation of infection control 
precautions and other interventions.
    We are partnering with industry to organize a full-court press on 
vaccine development. We are taking maximum advantage of technology to 
facilitate information sharing; the map of the SARS virus genome was 
published on the Internet soon after it was successfully sequenced by 
an international team of laboratories including CDC and Health Canada.
    Improvements in laboratory capacity and coordination that we've 
made recently as part of enhancing our overall public health 
preparedness has contributed to the speed and accuracy with which we've 
responded to SARS. The technology built into the Secretary's Command 
Center has been indispensable--providing a forum for real-time, face-
to-face exchange of information with public health officials in 
Atlanta, Toronto and Geneva. Secretary Thompson has communicated 
directly with officials in China via telephone conference call. The 
Command Center maps the distribution of SARS cases across the globe 
with geographic information system software for use during our planning 
discussions. The Command Center did not exist a year ago--it became 
operational last November.
    Although the situation in Canada appears to be coming under 
control, it is critical that we be prepared to confront an outbreak of 
SARS on U.S. soil. To this end, I recently co-chaired a meeting of the 
Council of Governments with Mike Byrne of the Department of Homeland 
Security to bring together health professionals from across the 
national capital region to aggressively prepare for an outbreak of the 
SARS virus here. One of the most important elements of an effective 
response plan is the development of hospital surge capacity. I should 
note that these preparations are applicable to a broad range of public 
health emergencies. Our team is unified and ready to deal with a 
variety of health response issues.
    We are taking a variety of steps to ensure that states and other 
awardee jurisdictions have the resources they may require immediately 
to strengthen and upgrade their readiness. In FY 2002, we awarded $1.1 
billion to 50 states, 3 municipalities, and the American territories to 
enhance public health preparedness and to upgrade the readiness of 
hospitals and other healthcare entities to address bioterrorism and 
other public health emergencies. In FY 2003, CDC and HRSA will award an 
additional $1.4 billion to further enhance state and local 
preparedness. In addition, HRSA will provide $28 million to academic 
health centers and other health professions training entities for a new 
initiative--bioterrorism preparedness education and training for 
clinical providers.
    The bioterrorism preparedness funding has made a material 
difference at the state and local levels. Over 90% of the 50 states and 
three municipalities (New York City, Chicago and Los Angeles County) 
that have been awarded funds have developed systems for 24/7 
notification or activation of their public health emergency response 
plans, and 87% of these grantees have developed interim plans to manage 
and distribute pharmaceuticals, equipment and supplies from the 
Strategic National Stockpile. In 95% of the jurisdictions, systems are 
being developed to receive and evaluate urgent disease reports on a 24/
7 basis. Ninety-one percent indicated that they could initiate a field 
investigation within six hours of an urgent disease report.
    While our state and local partners work to improve their 
preparedness and response capabilities, the Department is implementing 
an aggressive research and development program to develop and acquire 
biological, chemical, nuclear and radiological countermeasures. These 
initiatives have involved close coordination among NIH, CDC, FDA, DoD, 
and the Office of the Assistant Secretary for Public Health Emergency 
Preparedness. Research programs at NIH, involving a broad array of 
scientific initiatives, provide new approaches for developing 
countermeasures to threat agents most likely to be used as terrorist 
weapons. NIH is conducting and supporting basic research in immunology, 
microbiology, disease pathogenesis, genome sequencing and proteomics 
related to the organisms/toxins that could be used as bioterrorist 
agents. Both NIH and CDC support not only early product development 
efforts but also advanced development that is carried out in 
collaboration with industry partners. The FDA works very closely with 
these partners to provide advice and guidance during the development 
process with a view towards facilitating their subsequent submissions 
for regulatory review.
    The research and development efforts are on a very compressed 
timetable and reviews of their progress are discussed on a regular 
basis by an interagency team consisting of NIH, CDC and FDA.
    The most exciting news in the R&D arena is, of course, Project 
BioShield, announced by the President on February 3, 2003. BioShield is 
a comprehensive and ambitious effort to develop and make available 
modern, effective drugs and vaccines to protect against attacks by 
biological and chemical weapons. BioShield seeks to: encourage industry 
participation in the effort develop and procure next-generation medical 
countermeasures by establishing a stable source of funding; ensure that 
NIH has the authority to expedite the research and development of 
promising countermeasures; and to give the FDA authorization that would 
permit and facilitate the emergency use of preventive and therapeutic 
countermeasures that have not yet completed the formal process for full 
FDA licensure.
    These are truly challenging times for our Department. I believe 
that we are up to the task and we look forward to working closely with 
Congress to ensure that the Nation is prepared to respond to public 
health emergencies in general and terrorism in particular.
    Mr. Chairman, thank you for the opportunity to appear before the 
committee. My colleagues and I will be glad to take any questions that 
you and other members of the Committee may have.

    Mr. Greenwood. Dr. Gerberding?

                TESTIMONY OF JULIE L. GERBERDING

    Ms. Gerberding. Thank you, Mr. Chairman. I really 
appreciate the opportunity to speak here in front of the 
committee. And I also thank you and the committee because I 
understand that this committee took on the issue of security 
long before 9/11. And I think you certainly helped us have the 
beginning platform of preparedness at CDC. So, thank you think 
for that.
    I would like to just give you an update on the SARS 
epidemic as it looks from the CDC perspective. You have already 
heard from Dr. Heymann that this is a global epidemic. And when 
you think about the global epidemic, I think it is also helpful 
to think about the global collaboration that has so quickly 
come together under WHO's leadership to lead to a much greater 
understanding about how to contain this and what we might 
successfully do to prevent its continued spread. But that also 
tells us about the speed with which this problem was 
distributed throughout the international community. We have had 
to meet that speed with some speed of our own at CDC.
    On March 14 we initiated our Emergency Operations Center to 
increase our response capacity to handle SARS, because we 
recognized immediately that this was going to be a complex 
multi-jurisdictional outbreak investigation and we were going 
to need lots of coordination and lots of logistics support for 
our overall effort. Within 24 hours we were able to communicate 
guidance to State and local health officials through our Health 
Alert Network, and we held a press briefing with Secretary 
Thompson to alert the public about the problem. We sent out 
information to clinicians to help them understand what a case 
of SARS looked like and what they should do in terms of 
protecting themselves and the health care workers, and so 
forth.
    So since that first 24 hour period we have emphasized speed 
of response. And I think the fact that we were able to identify 
the virus within just a few weeks of having our first sample, 
that we were able to sequence the genome and publish it on the 
Internet so that the scientific community could take advantage 
of that information, and that within just a few weeks we were 
able to develop a diagnostic test that we are working with FDA 
on right now to make available throughout our 120 laboratory 
response network facilities: These are remarkable achievements 
of speed. However, it is very sobering to appreciate that 
despite all of this technology capacity and our strong emphasis 
on communicating information and science to people, that we are 
experiencing ongoing vulnerability because until this disease 
is contained everywhere in the world, it remains a problem for 
all of us.
    The steps we are taking now to protect Americans from SARS 
include the ongoing travel advisories to prevent exposure to 
travelers in Hong Kong, China and Taiwan. Singapore was on that 
list until yesterday, but they have been able to go two 
incubation periods without a new case in the community, and so 
we have now lessened their travel advisory status.
    We also are alerting incoming travelers about their risk of 
having SARS if they have been an area where the disease is 
ongoing within the past 10 days. And travelers returning are 
receiving these health alert cards that advise them to contact 
a clinician if they have any symptoms, including fever or other 
nonspecific symptoms so that the clinicians can protect 
themselves before the person even shows up in the emergency 
room or the clinic.
    We have distributed more than 850,000 of these at portals 
of entry in the United States, and are working with Department 
of Homeland Security and the Customs officials to make sure 
that we achieve 100 percent coverage.
    This has been an evolutionary process, and we are confident 
that we are getting at least 98 percent of passengers right 
now, but we aim for perfection. So we are working our way up to 
the full 100 percent.
    We also are advising clinicians to remain vigilant about 
potential SARS cases and to be sure to report them to local 
health officials, and we have disseminated very specific 
guidance to health care workers about self protection.
    We know, as Dr. Heymann said, that this is primarily 
transmitted face-to-face and requires fairly sustained and 
prolonged contact for transmission to occur. But there are 
those worrisome situations such as the hotel in Hong Kong, 
where it seemed perhaps to be an airborne and environmental 
problem. And so we have advised airborne precautions and 
droplet precautions, as well as contact precautions, to make 
sure that our health care workers are fully protected against 
any mode of transmission that could come up in the health care 
environment.
    Looking at this globally, the common denominator for 
leaking the SARS infection into the community has been spread 
to health care workers in the hospital and then their infection 
causing transmission in their homes. So our highest priority is 
protecting our health care workers and ensuring that the 
patients get the care they receive in a safe and humane manner.
    I last want to emphasize the importance of the fear issue 
here. I am an infectious disease doctor, so I have had a lot of 
experience with this in the AIDS era, and we have had anthrax 
and West Nile and smallpox, so we see this time and time again 
that whenever there is an epidemic of a disease, it is followed 
very quickly by an epidemic of fear. We have put a very high 
premium on communicating the truth as it evolves in this 
process, and we also are communicating our uncertainties as 
honestly and openly as we can. But I do feel that we need to 
send very strong messages to people that this is about a virus, 
not about a group of people or a community or a population. And 
that we are prepared to contain the virus, we know what to do 
to contain it, and our public health system has stepped up to 
the plate to do that. But we still need to remain vigilant.
    Thank you.
    [The prepared statement of Julie L. Gerberding follows:]
   Prepared Statement of Julie L. Gerberding, Director, Centers for 
Disease Control and Prevention, Department of Health and Human Services

    Good afternoon, Mr. Chairman and Members of the Committee. I am Dr. 
Julie L. Gerberding, Director, Centers for Disease Control and 
Prevention (CDC). Thank you for the invitation to participate today in 
this timely hearing on a critical public health issue: severe acute 
respiratory syndrome (SARS). I will update you on the status of the 
spread of this emerging global microbial threat and on CDC's response 
with the World Health Organization (WHO) and other domestic and 
international partners.
    As we have seen recently, infectious diseases are a continuing 
threat to our nation's health. Although some diseases have been 
conquered by modern advances, such as antibiotics and vaccines, new 
ones are constantly emerging, such as Nipah virus, West Nile Virus, 
vancomycin-resistant Staphylococcus aureus (VRSA), and hantavirus 
pulmonary syndrome. SARS is the most recent reminder that we must 
always be prepared for the unexpected. SARS also highlights that U.S. 
health and global health are inextricably linked and that fulfilling 
CDC's domestic mission--to protect the health of the U.S. population--
requires global awareness and collaboration with domestic and 
international partners to prevent the emergence and spread of 
infectious diseases.

                           EMERGENCE OF SARS

    In February, the Chinese Ministry of Health notified WHO that 305 
cases of acute respiratory syndrome of unknown etiology had occurred in 
Guangdong province in southern China since November 2002. In February 
2003, a man who had traveled in mainland China and Hong Kong became ill 
with a respiratory illness and was hospitalized shortly after arriving 
in Hanoi, Vietnam. Health-care providers at the hospital in Hanoi 
subsequently developed a similar illness. During late February, an 
outbreak of a similar respiratory illness was reported in Hong Kong 
among workers at a hospital; this cluster of illnesses was linked to a 
patient who had traveled previously to southern China. On March 12, WHO 
issued a global alert about the outbreak and instituted worldwide 
surveillance for this syndrome, characterized by fever and respiratory 
symptoms.
    Since late February, CDC has been supporting WHO in the 
investigation of a multi-country outbreak of unexplained atypical 
pneumonia now referred to as severe acute respiratory syndrome (SARS). 
On Friday, March 14, CDC activated its Emergency Operations Center 
(EOC) in response to reports of increasing numbers of cases of SARS in 
several countries. On Saturday, March 15, CDC issued an interim 
guidance for state and local health departments to initiate enhanced 
domestic surveillance for SARS; a health alert to hospitals and 
clinicians about SARS; and a travel advisory suggesting that persons 
considering nonessential travel to Hong Kong, Guangdong, or Hanoi 
consider postponing their travel. HHS Secretary Tommy Thompson and I 
conducted a telebriefing to inform the media about SARS developments.
    CDC's interim surveillance case definition for SARS has been 
updated to include laboratory criteria for evidence of infection with 
the SARS-associated coronavirus As of May 5, 2003, a total of 6,583 
probable cases of SARS have been reported to WHO, and 461 of these 
persons have died. In the United States, there have been 65 probable 
SARS cases reported, of which 6 are laboratory confirmed, and none have 
died. In addition, 255 suspect cases of SARS have been reported and are 
being followed by state and local health departments.

                          CDC RESPONSE TO SARS

    CDC continues to work with WHO and other national and international 
partners to investigate this ongoing emerging global microbial threat. 
We appreciate the continued support of Congress in our efforts to 
enhance our nation's capacity to detect and respond to emerging disease 
threats. The recent supplemental appropriation of $16 million to 
address the SARS outbreak will aid our identification and response 
efforts. SARS presents a major challenge, but it also serves as an 
excellent illustration of the intense spirit of collaboration among the 
global scientific community to combat a global epidemic.
    CDC is participating on teams assisting in the investigation in 
Canada, mainland China, Hong Kong, the Philippines, Singapore, Taiwan, 
Thailand, and Vietnam and at WHO headquarters in Geneva. In the United 
States, we are conducting active surveillance and implementing 
preventive measures, working with numerous clinical and public health 
partners at state and local levels. As part of the WHO-led 
international response thus far, CDC has deployed approximately 50 
scientists and other public health professionals internationally and 
has assigned over 500 staff in Atlanta and around the United States to 
work on the SARS investigation.
    CDC has organized SARS work teams to manage various aspects of the 
investigation, including providing domestic and international 
assistance and developing evolving guidance documents. These work teams 
have issued interim guidance regarding surveillance and reporting; 
diagnosis; infection control; exposure management in health-care 
settings, the workplace, and schools; biosafety and clean up; specimen 
handling, collection, and shipment; travel advisories and health 
alerts; and information for U.S. citizens living abroad and for 
international adoptions. We have updated our travel advisories and 
alerts for persons considering travel to affected areas of the world. 
We have distributed more than 850,000 health alert notice cards to 
airline passengers entering the United States from mainland China, Hong 
Kong, Singapore, Taiwan, Vietnam, and Toronto, Ontario, Canada, 
alerting them that they may have been exposed to SARS, should monitor 
their health for 10 days, and if they develop fever or respiratory 
symptoms, they should contact a physician. We have begun distributing 
health alert notices at selected sites along the U.S.-Canada border.
    WHO is coordinating frequent, regular communication between CDC 
laboratory scientists and scientists from laboratories in Asia, Europe, 
and elsewhere to share findings, which they are posting on a secure 
Internet site so that they can all learn from each other's work. They 
are exchanging reagents and sharing specimens and tissues to conduct 
additional testing.
    On April 14, 2003, CDC announced that our laboratorians have 
sequenced the genome for the coronavirus believed to be the cause of 
SARS. Sequence information provided by collaborators at National 
Microbiology Laboratory, Canada, University of California at San 
Francisco, Erasmus University, Rotterdam and Bernhard-Nocht Institute, 
Hamburg facilitated this sequencing effort. The sequence data confirm 
that the SARS coronavirus is a previously unrecognized coronavirus. The 
availability of the sequence data will have an immediate impact on 
efforts to develop new and rapid diagnostic tests, antiviral agents and 
vaccines. This sequence information will also facilitate studies to 
explore the pathogenesis of this new coronavirus. We are also 
developing and refining laboratory testing methods for this novel 
coronavirus, which will allow us to more precisely characterize the 
epidemiology and clinical spectrum of the epidemic. These discoveries 
reflect significant and unprecedented achievements in science, 
technology, and international collaboration.
    In order to better understand the natural history of SARS, CDC is 
investigating aspects of the epidemiologic and clinical manifestations 
of the disease. In collaboration with our partners, we have implemented 
or planned investigations to describe the spectrum of the illness, to 
assess the natural history of the disease, to estimate the risks of 
infection, and to identify risk factors for transmission. These 
investigations are being conducted in concert with ongoing surveillance 
and epidemiologic efforts.
    Rapid and accurate communications are crucial to ensure a prompt 
and coordinated response to any infectious disease outbreak. Thus, 
strengthening communication among clinicians, emergency rooms, 
infection control practitioners, hospitals, pharmaceutical companies, 
and public health personnel has been of paramount importance to CDC for 
some time. CDC has had multiple teleconferences with state health and 
laboratory officials to provide them the latest information on SARS 
spread, implementation of enhanced surveillance, and infection control 
guidelines and to solicit their input in the development of these 
measures and processes. WHO has sponsored, with CDC support, a clinical 
video conference broadcast globally to discuss the latest findings of 
the outbreak and prevention of transmission in healthcare settings. The 
faculty was comprised of representatives from WHO, CDC, and several 
affected countries who reported their experiences with SARS. The video 
cast is now available on-line for download. Secretary Thompson and I, 
as well as other senior scientists and leading experts at CDC, have 
held numerous media telebriefings to provide updated information on 
SARS cases, laboratory and surveillance findings, and prevention 
measures. CDC is keeping its website current, with multiple postings 
daily providing clinical guidelines, prevention recommendations, and 
information for the public.

                          PREVENTION MEASURES

    Currently, CDC is recommending that persons postpone non-essential 
travel to mainland China, Hong Kong, Singapore, and Taiwan. We are 
recommending that U.S. travelers to Toronto, Canada, and Hanoi, 
Vietnam, observe precautions to safeguard their health, including 
avoiding settings where SARS is most likely to be transmitted, such as 
health care facilities caring for SARS patients. Persons planning 
travel to Toronto or Hanoi should be aware of the current SARS 
outbreak, stay informed daily about SARS, and follow recommended travel 
advisories and infection control guidance, which are available on CDC's 
website at www.cdc.gov/ncid/sars.
    Persons who have traveled to affected areas and experience fever or 
respiratory symptoms suggestive of SARS should use recommended 
infection control precautions and contact a physician. They should 
inform their healthcare provider about their symptoms in advance so any 
necessary arrangements can be made to prevent potential transmission to 
others. Health care facilities and other institutional settings should 
implement infection control guidelines that are available on CDC's 
website.
    We know that individuals with SARS can be very infectious during 
the symptomatic phase of the illness. However, we do not know how long 
the period of contagion lasts once they recover from the illness, and 
we do not know whether or not they can spread the virus before they 
experience symptoms. The information to date suggests that the period 
of contagion may begin with the onset of the very earliest symptoms of 
a viral infection, so our guidance is based on this assumption. SARS 
patients who are either being cared for in the home or who have been 
released from the hospital or other health care settings and are 
residing at home should limit their activities to the home. They should 
not go to work, school, or other public places until ten days after 
their fever has resolved and respiratory symptoms are absent or 
improving.
    If a SARS patient is coughing or sneezing, he should use common-
sense precautions such as covering his mouth with a tissue, and, if 
possible and medically appropriate, wearing a surgical mask to reduce 
the possibility of droplet transmission to others in the household. It 
is very important for SARS patients and those who come in contact with 
them to use good hand hygiene: washing hands with soap and water or 
using an alcohol-based hand rub frequently and after any contact with 
body fluids.
    For people who are living in a home with SARS patients, and who are 
otherwise well, there is no reason to limit activities currently. The 
experience in the United States has not demonstrated spread of SARS 
from household contacts into the community. Contacts with SARS patients 
must be alert to the earliest symptom of a respiratory illness, 
including fatigue, headache or fever, and the beginnings of an upper 
respiratory tract infection, and they should contact a medical provider 
if they experience any symptoms.

                   EMERGING GLOBAL MICROBIAL THREATS

    Since 1994, CDC has been engaged in a nationwide effort to 
revitalize national capacity to protect the public from infectious 
diseases. Progress continues to be made in the areas of disease 
surveillance and outbreak response; applied research; prevention and 
control; and infrastructure-building and training. However, SARS 
provides striking evidence that a disease that emerges or reemerges 
anywhere in the world can spread far and wide. It is not possible to 
adequately protect the health of our nation without addressing 
infectious disease problems that are occurring elsewhere in the world.
    Last month, the Institute of Medicine (IOM) published 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. The report, Microbial Threats to 
Health: Emergence, Detection, and Response, serves as a successor to 
the 1992 landmark IOM report Emerging Infections: Microbial Threats to 
Health in the United States, which provided a wake-up call on the risk 
of infectious diseases to national security and the need to rebuild the 
nation's public health infrastructure. The recommendations in the 1992 
report have served as a framework for CDC's infectious disease programs 
for the last decade, both with respect to its goals and targeted issues 
and populations. Although much progress has been made, especially in 
the areas of strengthened surveillance and laboratory capacity, much 
remains to be done. The new report clearly indicates the need for 
increased capacity of the United States to detect and respond to 
national and global microbial threats, both naturally occurring and 
intentionally inflicted, and provides recommendations for specific 
public health actions to meet these needs. The emergence of SARS, a 
previously unrecognized microbial threat, has provided a strong 
reminder of the threat posed by emerging infectious diseases.

                               CONCLUSION

    The SARS experience reinforces the need to strengthen global 
surveillance, to have prompt reporting, and to have this reporting 
linked to adequate and sophisticated diagnostic laboratory capacity. It 
underscores the need for strong global public health systems, robust 
health service infrastructures, and expertise that can be mobilized 
quickly across national boundaries to mirror disease movements. As CDC 
carries out its plans to strengthen the nation's public health 
infrastructure, we will collaborate with state and local health 
departments, academic centers and other federal agencies, health care 
providers and health care networks, international organizations, and 
other partners. We have made substantial progress to date in enhancing 
the nation's capability to detect and respond to an infectious disease 
outbreak; however, the emergence of SARS has reminded us yet again that 
we must not become complacent. We must continue to strengthen the 
public health systems and improve linkages with domestic and global 
colleagues. Priorities include strengthened public health laboratory 
capacity; increased surveillance and outbreak investigation capacity; 
education and training for clinical and public health professionals at 
the federal, state, and local levels; and communication of health 
information and prevention strategies to the public. A strong and 
flexible public health infrastructure is the best defense against any 
disease outbreak.
    Thank you very much for your attention. I will be happy to answer 
any questions you may have.

    Mr. Greenwood. Thank you, Dr. Gerberding.
    Dr. Fauci?

                  STATEMENT OF ANTHONY S. FAUCI

    Mr. Fauci. Mr. Chairman and members of the committee, thank 
you for the opportunity to testify before you here today.
    SARS, unfortunately, is not really a surprise because SARS 
is an example of what we have experienced as shown on this map 
here over the last decades, and in fact through all of 
civilization; the emerging and re-emerging of diseases. SARS is 
one of those that has significant public health impact.
    An emerging disease is a brand new disease that we have not 
seen before. HIV/AIDS is a classic example of an emerging 
disease with major public health impact. West Nile virus is a 
re-emerging disease, because it is not new. It just re-emerged 
in the wrong location, namely in 1999 here in the United States 
and now essentially the entire country and in North America. 
SARS is one of those.
    Several of these new emerging and reemerging diseases 
occasionally are little blips on the radar screen where they 
are curiosities, but they either spread from an animal to a 
human but don't efficiently go to human-to-human or else they 
just infect a relatively small number of people. We have seen 
instances of that, for example, with ebola in Africa.
    SARS is different. It has several characteristics. One, it 
is transmissible relatively easily with regard to face-to-face 
contact, but luckily not beyond that except for some occasions, 
as you have heard from previous witnesses. However, it is a 
very important disease that we need to take seriously. And in 
the research community with our public health colleagues at the 
CDC and WHO, we are doing just that.
    It is our unfortunate our global societies were beset with 
SARS. However, it is fortunate that in fact this is a virus 
that belongs to a category of viruses that we do have 
experience with, namely the coronaviruses which, incidentally, 
are the cause of approximately 20 percent of common colds.
    The other fortunate situation--in the setting of misfortune 
of being in an epidemic--is that this particular virus grows 
well in culture. It has been isolated, as you know, by the CDC, 
by individuals in the Hong Kong and now it is growing in a 
number of laboratories. It grows well in a type of tissue 
culture that would make it amenable to grow it for the 
development of vaccines.
    Another important point is that animals are infected with 
this. This is normal. Coronaviruses in general. We don't know 
where this virus came from, but it would not be surprising that 
it did what many microbes do, that is, jump species from an 
animal to a human. We saw that with H5N1 influenza virus, which 
went from an animal to a human. Fortunately it didn't go human-
to-human. HIV/AIDS did, though. It went from a chimpanzee to a 
human but then had the capability of rapidly spreading. So that 
is the unfortunate aspect of this particular emerging disease.
    I want to spend the last minute or so on telling you a bit 
about the vaccine agenda and the other research activities at 
NIH.
    As I mentioned, the virus grows well in culture in a cell 
type called vero cells, which is a monkey cell. Others have 
already infected monkeys successfully. The plan with regard to 
vaccine development is several fold. The first and easiest is 
to grow the virus up, kill it or inactivate it and vaccinate an 
animal model, in this case a non-human primate monkey model. 
Then, to challenge that monkey following the vaccination with 
the killed virus and determine if you could prove the concept 
that you would be able to protect an animal. That would take a 
matter of several months and likely by the end of this calendar 
year we will or will have not proven the concept that you can 
protect an animal. After that, again if we are lucky, it will 
take a couple of years at least to develop a vaccine.
    The other vaccine candidates are more of a molecular model 
where we use tried-and-true techniques of taking the genes from 
the SARS virus, the relevant genes, and inserting them into 
what we call a vector of a harmless virus like adenovirus. We 
can do that because we now have the sequence of the SARS virus 
and we are already involved in research that is proceeding 
rapidly to do just that; to insert those genes into an 
adenovirus vector.
    There is the DNA virus approach, there is the live 
attenuated and there is the purified protein. All of these 
things have hit the ground running.
    And I might make the comment, Mr. Chairman, that this has 
happened because we have had to face emerging and reemerging 
diseases for decades, particularly the rather large 
acceleration of effort that has accompanied our approach toward 
protection with countermeasures against bioterrorism. That has 
been very important in positioning us where we are right now.
    And finally, drug development. Drug development is very 
important in collaboration with our colleagues with the CDC and 
at the USAMRIID we are screening large amounts and large 
numbers of drugs that either already exist on the shelf and are 
approved or are there, have been developed but not used 
successfully for other diseases, other viruses. If that fails, 
and even if we do get some success, we will then target 
antiviral development against the particular vulnerable 
components of this coronavirus. So the research enterprise is 
rapidly responding to the public health crises that our public 
health colleagues have responded to quite successfully up to 
now.
    I would be happy to answer questions, Mr. Chairman.
    [The prepared statement of Anthony S. Fauci follows:]
Prepared Statement of Anthony S. Fauci, Director National Institute of 
     Allergy and Infectious Diseases, National Institutes of Health
    Mr. Chairman and Members of the Committee, thank you for the 
opportunity to discuss how the National Institutes of Health (NIH) is 
responding to the global outbreak of Severe Acute Respiratory Syndrome, 
or SARS. I am pleased to appear today with my colleagues from our 
sister agencies, within the Department of Health and Human Services. As 
of April 29, 2003, 5462 cases of SARS have been reported across the 
globe, with 54 probable cases identified in the United States; there 
have been no deaths from SARS thus far reported in the United States. 
The relatively low number of probable cases reported in the United 
States is likely the result of early diagnoses and effective public 
health measures put in place by the CDC and state and local health 
authorities to contain the imported SARS cases and prevent secondary 
transmissions.
    While travel alerts and advisories and recommended infection 
control measures can help slow the progression of the SARS epidemic, 
these alone are not long-term solutions to this new and unpredictable 
disease. Instead, we must develop safe and effective treatments and 
vaccines that can protect the American people. The SARS epidemic is 
still evolving and it is unclear whether the incidence of the diseases 
will decline, plateau or accelerate. Therefore we must be prepared for 
any eventuality.
    Like HIV/AIDS, Ebola and West Nile virus, SARS reminds us that 
emerging and reemerging infectious diseases are constant threats to 
national and international public health. Dr. Gerberding and her CDC 
team, together with the World Health Organization (WHO) and others, 
have done an outstanding job in identifying and tracking the SARS 
epidemic, illuminating the clinical features and etiology of the 
disease, and providing the world with information about the epidemic in 
real time.
    Complementing the efforts of the CDC and WHO, the National 
Institute of Allergy and Infectious Diseases (NIAID), a component of 
NIH, has a significant role in the efforts against SARS, notably in 
diagnostics, therapeutics and vaccine development, drug screening, and 
clinical research. As has been the case with other emerging infectious 
diseases, we anticipate that the strong NIAID research base in 
disciplines such as microbiology, immunology and infectious diseases 
will facilitate the development of new interventions to help counter 
SARS.
    The CDC and WHO have accumulated evidence, which we now believe is 
close to definitive, that SARS is caused by a novel coronavirus that 
may have crossed species from an animal to humans, although this latter 
point has certainly not been proven. This hypothesis is based on the 
detection and isolation of coronaviruses from unrelated SARS patients 
from different countries and on the finding that SARS patients mount an 
immunological response to coronavirus as they proceed from the acute 
illness to the recovery or convalescent stage. Furthermore, data from 
the Netherlands show that non-human primates infected with this 
coronavirus develop a SARS-like disease, suggesting that this virus is 
the cause of SARS. Although some questions remain, the strong evidence 
for a causative role for a coronavirus has prompted the ongoing 
development of diagnostic tools, therapies, and vaccines that target 
coronaviruses.
    Coronaviruses are best known as one of the causes of the common 
cold, a benign condition that very rarely results in life-threatening 
disease. The coronavirus associated with SARS is a type of coronavirus, 
possibly of animal origin, that has not been previously identified.

                         NIAID RESEARCH ON SARS

    NIAID maintains a longstanding commitment to conducting and 
supporting research on emerging infectious diseases, such as SARS, with 
the goal of improving global health. In carrying out its global health 
research mission, the Institute supports a myriad of activities, 
including intramural and extramural research and collaborations with 
international agencies and organizations.
    Since the earliest indications that we were dealing with a new 
disease, very likely caused by a newly recognized virus, the NIAID has 
marshaled its resources to rapidly initiate the development of 
diagnostics, therapeutics, and vaccines against SARS. NIAID has 
assembled a multi-disciplinary working group to develop a broad-based 
program that addresses the research needed to combat SARS. Key 
intramural laboratories have begun to pursue a range of research 
strategies to develop a SARS vaccine as well as therapeutics, including 
immune-based therapies, and our extramural programs are poised to help 
as well. We also have initiated and expanded collaborations with our 
colleagues in other federal agencies, academia, and private industry. 
In addition, NIAID recently released three ``Sources Sought'' 
announcements, a special mechanism to rapidly identify contractors who 
can develop treatment strategies, vaccines, and antibody preparations 
to address SARS.

                     SURVEILLANCE AND EPIDEMIOLOGY

    NIAID supports a long-standing program for the surveillance of 
influenza viruses in Hong Kong, led by Dr. Robert Webster of St. Jude's 
Children's Research Hospital in Memphis. Dr. Webster and his team in 
Hong Kong have collaborated with WHO, CDC, and others in helping to 
illuminate the SARS outbreaks in Asia. At the request of WHO, NIAID 
assigned a staff epidemiologist to provide technical assistance during 
the early stages of the epidemic. In addition to global surveillance 
activities, NIAID will support epidemiological studies of populations 
at potentially greater risk for SARS, including individuals with HIV/
AIDS.

                          DIAGNOSTICS RESEARCH

    As Dr. Gerberding has indicated, the CDC already has made 
significant progress in developing diagnostic tests for SARS. As part 
of these efforts, NIAID-sponsored researchers in Hong Kong also devised 
a diagnostic test based on polymerase chain reaction (PCR) technology 
as well as a diagnostic tool using the immunofluorescence assay 
technique. In other research, the NIAID-funded Respiratory Pathogens 
Research Unit (RPRU) at Baylor College of Medicine has developed 
methods to detect known human coronaviruses using cell culture and 
molecular diagnostic tools and can also assess the host immune response 
to known coronavirus infections. During this calendar year, NIAID will 
expand this capacity for research on emerging acute viral respiratory 
diseases. Also, NIAID is using existing funding mechanisms, such as the 
contract with St. Jude's Hospital, to help support the development of 
other sophisticated diagnostic tools.
    It is anticipated that a sensitive and specific diagnostic test for 
SARS may be available within six to 12 months. Within one to three 
years, it may be possible to develop a rapid, accessible easy-to-use 
test for SARS that could be widely deployed in diverse healthcare 
settings.

                            VACCINE RESEARCH

    As the SARS epidemic continues, it will be necessary to consider a 
broad spectrum of vaccine approaches. NIAID is supporting the rapid 
development of vaccines to prevent SARS through both our extramural and 
intramural programs, including the NIAID Vaccine Research Center on the 
NIH campus. NIAID scientists have received samples of the SARS 
coronavirus from CDC and have already successfully grown the virus in 
cell culture, a first step towards developing a vaccine. Initial 
efforts have focused on the development of an inactivated (or killed) 
virus vaccine. As more knowledge about SARS becomes available, other 
types of vaccine candidates will soon follow, including novel 
approaches such as vector-based and recombinant vaccines, DNA-based 
vaccines, and live-attenuated vaccines.
    Fortuitously, vaccines against common veterinary coronaviruses are 
routinely used to prevent serious diseases in young animals, such as a 
vaccine given to pigs to prevent serious enteric coronavirus disease. 
Insight from veterinary coronavirus vaccines could prove useful as we 
develop vaccines to protect humans.
    To accelerate SARS vaccine research and development efforts, NIAID 
has initiated contracts and other relationships with companies, 
institutions and other organizations with specialized technologies, 
cell lines and containment facilities relevant to SARS research for the 
purpose of supporting the development of reagents needed for vaccine 
development, and developing animal models such as mice and relevant 
species of monkeys. For example, the NIAID Vaccine Research Center 
recently expanded an existing agreement with GenVec, a 
biopharmaceutical company in Gaithersburg, Maryland, to begin the 
development of a candidate vaccine against SARS. NIAID is negotiating 
with other companies to develop additional candidate vaccines. Another 
important component of SARS vaccine research will be to identify ways 
to generate mucosal immunity against the SARS coronavirus. Within the 
next six to 12 months, NIAID anticipates that it will be possible to 
demonstrate whether an inactivated vaccine against SARS is a workable 
concept, e.g., to show that we can protect a monkey against the SARS 
virus. If so, Phase I trials of such a candidate vaccine can be 
accelerated. If research and development proceed on schedule and if 
animal testing is successful, a first-generation inactivated SARS 
vaccine could become available within several years.

                         THERAPEUTICS RESEARCH

    With the emergence of SARS, NIAID responded rapidly to a request 
from CDC to evaluate candidate antiviral agents through a collaborative 
antiviral drug-screening project at the U.S. Army Medical Research 
Institute of Infectious Diseases (USAMRIID). To date, NIAID has 
supplied approximately 40 FDA-approved antiviral drugs to USAMRIID such 
that their efficacy against the SARS coronavirus can be evaluated. The 
Institute also is pursuing the development of novel antivirals, such as 
compounds that block viral fusion with and entry into host cells. In 
addition, NIAID has initiated discussions with the pharmaceutical 
industry about candidate antiviral drugs already in the research 
``pipeline,'' and is reviewing a proposal for a clinical trial of 
antiviral therapy to be conducted by investigators of the NIAID 
Collaborative Antiviral Study Group and the NIH Clinical Center.
    In addition to antiviral drugs, NIAID is supporting the development 
of passive immunotherapy (monoclonal and polyclonal antibodies) as a 
therapy for SARS. Within the next one to three years, it may be 
possible to have available therapeutic monoclonal antibodies for SARS.

                           CLINICAL RESEARCH

    Clinicians treating SARS patients have not yet identified treatment 
strategies that consistently improve prognosis, beyond good supportive 
and intensive care. Conventional antibiotics do not work, a fact that 
is consistent with SARS being a viral disease. NIAID is pursuing 
several strategies to determine whether any existing drugs or 
combinations of treatments can simultaneously block viral replication 
and boost the immune response to the virus.
    At the NIH Clinical Center in Bethesda, MD, and through the NIAID 
Collaborative Antiviral Study Group, NIH is developing protocols to 
admit SARS patients for evaluation and treatment, should this become 
necessary. This will be an opportunity to evaluate the pathogenesis of 
the illness and the efficacy of antiviral and immune-based therapies in 
patients with SARS. We also plan to evaluate approaches to improve 
management of patients with severe forms of the disease, such as the 
passive transfer of antibodies from SARS patients who have recovered 
from the disease.
    In addition to ensuring state-of-the-art treatment of potential 
patients, our clinical experts will be able to study the clinical 
characteristics of patients with SARS. We are particularly interested 
in answering key questions about the disease mechanisms of SARS. For 
example, are severe outcomes such as acute respiratory distress and 
mortality entirely caused by the presence of virus, or does the immune 
system play a role in causing the severe outcomes in some patients? 
What are the sites and the duration of viral shedding? What is the 
nature of the immune response? These are central questions to address 
because they may open up avenues for treatment as well as better 
preventive strategies.

                             BASIC RESEARCH

    NIAID's long-standing commitment to and investment in emerging 
disease research is allowing us to expeditiously pursue research on 
SARS. For example, NIAID continues to support the Emerging Viral 
Disease Research Centers, which have been conducting SARS antibody 
studies and will be able to assist in the development of animal models 
for SARS. NIAID currently is supporting 18 grants on coronavirus 
research. Also, the study of patients, as well as specimens in NIAID 
laboratories, will facilitate our understanding of the natural history 
of the SARS virus and its potential animal reservoir, and help 
illuminate the risk factors and epidemiology of SARS. NIAID will 
support and conduct basic research studies on the pathogenesis of the 
disease and viral replication mechanisms, in order to identify targets 
for antiviral drugs, diagnostic tests, and vaccines. Finally, the 
Institute will support and conduct genomic sequencing, proteomics, and 
bioinformatics of coronaviruses.
    The identification or development of animal models that mimic human 
SARS is critical to our understanding of the SARS virus and how it 
causes disease. Of note, an existing NIAID animal model of a virus 
infection that causes a disease in mice very similar to SARS has been 
identified. The relevance of this animal model to SARS will be 
evaluated and may prove an important tool for defining treatment 
approaches that involve modulation of the immune system. NIAID will 
also support the development of other relevant animal models for SARS.

                             INFRASTRUCTURE

    A central concern when working with the SARS virus or SARS patients 
is the availability of facilities with the required safety level for 
the clinicians and staff, as well as for the community. Our ongoing 
plans to develop high-level containment facilities, towards which funds 
were appropriated in FY 2003, will facilitate SARS research, as well as 
planned studies of potential bioterror agents and other emerging 
diseases. Research with the SARS coronavirus will occur in Biosafety 
Level-3 facilities.

                               CONCLUSION

    Mr. Chairman, thank you again for allowing me to discuss NIH's 
efforts to address SARS. Despite ongoing research and early successes, 
we still have much to learn about the disease. As you have heard, 
NIAID-sponsored coronavirus research, studies of other viral diseases, 
and clinical research already have positioned us well in our quest for 
tools to detect, treat, and prevent SARS. In the weeks and months 
ahead, NIH will continue to collaborate with our sister agencies, the 
CDC and the Food and Drug Administration, as well as other relevant 
agencies, to accelerate and expand our research aimed at improving the 
diagnosis, prevention, and treatment of SARS.
    I would be pleased to answer your questions.

    Mr. Greenwood. As indicated by the buzzers that have been 
interrupting your testimony, we have a series of five votes on 
the floor of the House of Representatives. And so I think it 
would be best rather than to try to cram your testimony in, Dr. 
Lumpkin, we will recess here.
    It will probably be at least 30 minutes or 40 minutes until 
we get back. But we will recess to the call of the Chair, which 
will be in about 30 to 40 minutes.
    [Brief recess.]
    Mr. Greenwood. The committee will come to order.
    I apologize to all of our witnesses, particularly those on 
the third panel, but we are finished voting for the day and we 
should not have any further interruptions.
    So I believe we are just about to hear from Dr. Lumpkin. 
And so you are recognized, sir.

                 TESTIMONY OF MURRAY M. LUMPKIN

    Mr. Lumpkin. Correct. Thank you, sir.
    Mr. Chairman, members of the subcommittee, I appreciate 
very much the opportunity of being with you here today to 
discuss the FDA's role in our response to the threat from SARS, 
and particularly to be here with my HHS colleagues and with my 
colleague from GAO.
    I know that many people tend to think of FDA's role 
primarily being one of looking at marketing applications and 
the review of marketing applications. And I think as you have 
heard from Dr. Fauci and others, and as you will hear later, 
many of us hope that very soon that will be one of our 
responsibilities as far as SARS is concerned. But right now we 
do not have any marketing applications in any of our centers at 
FDA for products specifically for SARS. But this really 
shouldn't be a surprise, given as you have heard from Dr. Fauci 
and from Dr. Gerberding how early we are in our knowledge of 
this particular disease, and a lot of science about this 
disease is yet to be learned.
    Nonetheless, FDA is playing what I think is a very crucial 
role in the national and international battle against SARS in 
five specific areas.
    The first area is that we are working very proactively with 
both the private and the public sector to try to expedite the 
development of a reliable, validated diagnostic tool. Clearly, 
this is one of the things that we need, and I will talk about 
this a little bit more in just a few minutes.
    Second, we are working very proactively with the public and 
private sector to try to identify potential therapeutic agents. 
And if they can be identified, then to work with them on their 
development schemes so that we can get good marketing 
applications with good data for these particular products as 
soon as possible.
    Third, we are working as proactively as we can with the 
public and private sector to see whether, indeed, it is 
possible to develop a safe and effective vaccine. And if it is, 
then to do so as quickly as possible. And as you have heard 
from Dr. Fauci, the mechanisms for doing that in the research 
community are well underway.
    The fourth thing we are doing is trying to work with our 
colleagues at HHS and at other public and private sectors to 
assess the adequacy of the medical supplies we have in this 
country that would be needed to support critically ill patients 
on a large scale if we needed to do that in this country. Even 
though we do not have, as you have heard, a specific therapy 
for this particular disease, we have seen around the world that 
if we were to have a large outbreak in this country, there is 
going to be a need to provide medical support and to have the 
medical facilities to provide that kind of support.
    And last, I think we have taken what we believe is a 
prudent action to protect our Nation's blood supply until we 
learn more about whether this SARS agent, indeed, can or cannot 
be spread by blood transfusions and the transfusions of other 
blood products.
    I just want to spend a couple of minutes, because I know we 
are pressed for time this afternoon, just highlighting some of 
these particular activities.
    Regarding the development and approvals of diagnostics, as 
I think you have already heard, our colleagues at CDC have done 
an extraordinary job in a very short amount of time to develop 
some experimental devices and diagnostics for this particular 
disease. We have worked very closely with them to develop an 
investigational device exemption under which they will soon be 
providing this particular test to a series of labs around the 
country so that it can be further evaluated and its reliability 
validated. And I think we believe that this is the kind of 
thing that will clearly lead to the development of an improved 
definitive diagnostic test.
    We are also working with the private sector as they develop 
diagnostic tests that they wish to bring to market. And I think 
clearly as you have heard, SARS is a disease that is serious 
and life threatening for which we do not have approved 
diagnostic tests at this time, and so as we get marketing 
applications, this is clearly an indication for which we can do 
priority reviews of these applications. And it is the kind of 
situation where we think this kind of very proactive 
interaction during the development will help expedite the 
development and ultimate approval for marketing.
    Regarding therapeutics, along the same lines, we have been 
working with CDC to get in place protocols for emergency use of 
various therapies should that become necessary in this country 
and also to work with them and others to look at various 
compounds to see if, indeed, they might have activity against 
this particular virus. And if they do, then to be able to work 
with them to develop the data needed to show the community at 
large, that indeed a product could offer a safe and effective 
therapy.
    The same is true in vaccines, and both with vaccines and 
with drugs we are committed to using all of the fast track 
authorities that we have to expedite the development and the 
approval of these.
    I think one thing, as far as vaccines is concerned, we have 
learned a lot from the history of vaccine development. There 
are a lot of very positive things. There are also some negative 
things that have happened in the history of vaccine 
development. I think the main thing we have learned is that we 
want to do it quickly, but we want to do it right the first 
time because so many people are going to be dependent upon 
that.
    In conclusions here, I would just like to say that our 
Commissioner asked me to apologize to you for not being here 
today. He is in Indiana at a previous commitment. But he said 
that I was to tell you that, indeed, we will use all of the 
fast track authorities that we have. We are committed to 
working with our colleagues at HHS to bring reliable diagnostic 
tools and safe and effective treatments and vaccines for SARS 
to the American people.
    Thank you.
    [The prepared statement of Murray M. Lumpkin follows:]

     Prepared Statement of Murray M. Lumpkin, Principal Associate 
 Commissioner, Food and Drug Administration, U.S. Department of Health 
                           and Human Services

                              INTRODUCTION

    Mr. Chairman and Members of the Subcommittee, I am Dr. Murray 
Lumpkin, Principal Associate Commissioner at the Food and Drug 
Administration (FDA or the Agency). I appreciate the opportunity to 
appear today to discuss FDA's role in the national and international 
response to the emerging threat of severe acute respiratory syndrome 
(SARS).
    FDA is presently helping in five specific areas in the battle 
against SARS by working with other government agencies, industry and 
academia to:

 Facilitate the development of reliable diagnostic tools;
 Facilitate the development of safe and effective treatments 
        for patients suffering from SARS;
 Facilitate the development of a safe and effective SARS 
        vaccine;
 Help assure that adequate supplies of various medical products 
        are available in the event of the broader spread of SARS in the 
        United States; and
 Help safeguard the blood supply against the potential threat 
        of SARS.
    Our goal is to continue to work closely with public and private 
entities to protect the U.S. population from the public health risk 
associated with SARS and to facilitate the development of products in 
which American practitioners and patients can have confidence to help 
those afflicted with this disease.
          department of health and human services coordination
    The Department of Health and Human Services (DHHS or the 
Department) is providing overall national direction, guidance and 
coordination in the fight against SARS. Under this umbrella, FDA is 
working closely with other agencies, such as Centers for Disease 
Control and Prevention (CDC) and National Institutes of Health (NIH), 
as well as with the private sector, State health officials, and other 
relevant agencies, to expedite the development of reliable diagnostic, 
preventive, and treatment tools for SARS and to provide emergency 
access to promising products as needed.

                               FDA'S ROLE

    The epidemic of SARS has been very fast moving. Because of the 
novelty of this pathogen and the lack of previous experience with this 
specific disease, as with other public health agencies, FDA is 
presently in the initial stages of its response to the disease. Yet the 
Agency has already taken a number of steps to address a possible 
escalation of SARS cases in the United States. Let me elaborate on 
specific measures with which the Agency is involved.

                DEVELOPMENT AND APPROVAL OF DIAGNOSTICS

    Currently, there are no marketing applications for a SARS 
diagnostic product before the Agency. This is not surprising given that 
we are still in the preliminary stages of our understanding of SARS. 
However, FDA is working closely and proactively with other government 
agencies such as CDC and NIH, as well as with the private sector, to 
foster the development of reliable diagnostic tools that will help 
identify the microbiological agent of SARS from patient specimens and 
will help confirm whether or not a patient is or has been infected with 
this SARS agent.
    The mission of FDA's Center for Devices and Radiological Health 
(CDRH) includes guaranteeing the safety and reliability of diagnostic 
tools, such as those under development that will allow the 
identification of the SARS agent. CDRH is working with CDC, who along 
with others in the SARS Laboratory Network organized by World Health 
Organization (WHO), is helping further the scientific understanding of 
the virus. A diagnostic test for SARS, based on the detection of RNA 
sequences in the novel coronavirus, is currently under development 
along with an ELISA (enzyme-linked immunosorbent assay) test for 
antibodies to the SARS-related virus. The first of these tests, using 
polymerase chain reaction (PCR) technology, will help with acute 
diagnoses of patients, while the ELISA test will be used to confirm a 
case during or after convalescence. CDC developed these prototype 
experimental reagents over the past two months in an effort to address 
this unmet public health need. FDA rapidly reviewed information for the 
investigational use of this test, and is working closely with CDC to 
develop appropriate information for patients and health professionals, 
and an approach for further evaluation of this new test. Working with 
our CDC colleagues, FDA guided CDC in drafting an investigational 
device exemption (IDE) for the PCR technology assay. This IDE has been 
provisionally approved. This test methodology will be distributed to 
approximately 100 specialized laboratories around the country. Under 
the terms of this test's wider distribution, patients and practitioners 
will receive clear information about the test when it is used to assist 
in diagnosing SARS. Hopefully, this information will facilitate the 
development and evaluation of an approved diagnostic test as quickly as 
possible.
    As SARS is a serious and life-threatening disease for which there 
are no presently approved diagnostic tests, the disease meets our 
standard for priority review to expedite the development of new tests 
and the review of these tests marketing applications. CDRH is already 
reaching out to industry to ensure that any development plans for new 
tests are well designed and that premarketing applications submitted to 
the Agency are of such quality that a priority review can swiftly 
proceed. In addition, FDA has already cleared or approved dozens of 
tests for use in differential diagnosis of acute respiratory syndromes 
and has put in place a postmarket surveillance program to measure how 
well these tests are working. These tests do NOT diagnose SARS; rather 
they help to diagnose other conditions that may have symptoms similar 
to SARS. In this way SARS can be ruled out as the diagnosis in these 
patients.

                DEVELOPMENT AND APPROVAL OF THERAPEUTICS

    Although to date there have been no marketing applications for 
therapeutic products for the treatment of SARS submitted to FDA, the 
Agency is indeed working to help facilitate the development of safe and 
effective treatments for patients suffering from SARS. The Center for 
Drug Evaluation and Research (CDER) and the Center for Biologics 
Evaluation and Research (CBER) are both responding to this need by 
identifying drugs and other therapeutics products that may be effective 
in combating the SARS agent or modifying the course of the disease. 
CDER is working expeditiously with CDC and NIH to design and implement 
both emergency protocols and protocols for properly controlled clinical 
trials for using these anti-viral products to treat SARS patients who 
meet certain medical criteria for inclusion in the protocols. Because 
of this close collaboration, the U.S. is now better prepared to respond 
quickly to any escalation of SARS cases and to evaluate the potential 
effectiveness of treatments and thus help patients and practitioners 
around the world further their understanding of the best ways to treat 
this disease.
    With regard to specific therapeutics, CDER is engaged with those 
who are trying to identify compounds for additional screening and is 
interacting with pharmaceutical companies on these compounds. CDER has 
identified 16 compounds, mostly nucleoside analogues, from ten 
companies for in vitro screening against the coronavirus and has 
provided those companies contact information from the NIH and U.S. Army 
Medical Research Institute for Infectious Diseases (USAMRIID) screening 
program. CDER is also working with NIH and USAMRIID to prioritize 
candidate products for initial in vitro susceptibility testing with the 
USAMRIID assay.
    Much has been written in the press about a drug called ribavirin. 
The oral and inhalation dosage forms of this product are already 
approved in the U.S. for treating certain viral infections. The 
intravenous formulation of ribavirin is still an experimental drug only 
available in the U.S. under an Investigational New Drug (IND) 
Application. Various places outside the U.S. have used the intravenous 
and oral formulations of the product to try to treat those most 
severely affected by SARS. CDER worked with CDC on the development of 
an emergency use protocol, which has now been allowed to proceed, that 
would allow suspected SARS patients who meet certain medical criteria 
to be treated with intravenous ribavirin should the need arise. To 
date, no one in the U.S. has been treated with intravenous ribavirin 
under this protocol. In addition, CDER has assessed the adequacy of 
ribavirin supplies if it shows therapeutic promise and there is 
increased demand for the drug in the event that SARS spreads to many 
more patients.
    Unfortunately, in the USAMRIID susceptibility assay, ribavirin did 
not appear to inhibit the growth of the SARS agent. The relevance of 
this laboratory finding to the clinical situation remains to be 
determined; however, what role, if any, ribavirin will play in future 
therapeutic regimens for SARS in still quite unclear.
    No matter what the product being used, it is important to note that 
caution must be exercised and patients and family members must be fully 
informed when participating in trials that study investigational drugs 
to treat SARS. As there is usually little available information about 
these investigational agents, and the safety and efficacy profiles in 
SARS have not yet been defined, use must be predicated on adequate 
informed consent.
    Again, SARS is a disease whose novelty and nature make it a prime 
candidate for therapeutic development under FDA's previously 
established programs to expedite the drug development and review 
process through our ``fast track'' program. The ``fast track'' program 
is designed to quickly facilitate the development and review of new 
drugs intended to treat serious or life-threatening conditions and that 
demonstrate the potential to address unmet medical needs (``fast track 
products''). This program emphasizes the critical nature of close, 
early communication between the Agency and a sponsor, outlines 
procedures such as pre-IND and end-of-phase-I meetings as methods to 
improve the efficiency of preclinical and clinical development, and 
focuses on efforts by the Agency and drug sponsor to reach early 
agreement on the design of the major clinical efficacy studies that 
will be needed to support approval. Most importantly, under this 
program, as various elements of a marketing application are completed 
these pieces of the application can be submitted for review as soon as 
they are finished, rather than having to wait for the entire 
application to be completed, analyzed, assembled, and submitted. In 
these cases, FDA can begin review of the marketing application much 
earlier. FDA has made clear that it considers SARS candidate therapies 
eligible for ``fast track'' designation.

                  DEVELOPMENT AND APPROVAL OF VACCINES

    FDA is part of the team striving to develop a safe and effective 
SARS vaccine. On April 9, 2003, Dr. Jesse Goodman, Director of CBER, 
joined Secretary Thompson and key leaders from NIH, CDC, and the 
National Vaccine Program Office to answer questions from vaccine 
manufacturers concerning approaches to developing a SARS vaccine. CBER 
is strongly committed to working proactively with industry and 
government partners to facilitate such development under the same type 
programs for these kinds of public health needs as those utilized by 
CDRH and CDER. The Center is pursuing multiple potential vaccine 
development strategies. CBER is working with other government agencies 
and the private sector to address many of the most difficult issues in 
early vaccine development. In this process, CBER provides guidance on 
the use of animal test data and on safe manufacturing practices. The 
Center will also be a major participant in the design of clinical 
trials and in defining the needs of special populations (such as 
pregnant women). As the SARS vaccine program is in its infancy, much 
painstaking work will be necessary to assure that the development and 
manufacturing processes meet the standards required to develop and 
produce safe and effective vaccines from which people have benefitted 
so much over the years. While we hope that a safe and effective SARS 
vaccine can be developed, and we will do everything feasible to help 
facilitate and speed the development process, at this early stage of 
scientific knowledge about the nature and stability of the virus and 
the human immunological response to the virus, it would be imprudent 
and unfair to over-promise about any possible timeline for a SARS 
vaccine.
    As with therapeutic products, FDA can and will expedite the vaccine 
review process to address critical needs. Given the potential public 
health impact of SARS infection, FDA places a high priority on 
facilitating the development and review of such products. We work to 
maintain open and continued dialogue with vaccine manufacturers and to 
assist firms that seek to enter the vaccine manufacturing market. FDA 
routinely meets with manufacturers during all stages of the development 
of vaccines and prior to submission of a licensing application to 
facilitate the regulatory process and provide guidance on requirements 
for new vaccines. The Agency also encourages and works with 
manufacturers to enhance their production capabilities and capacities.
    FDA's Center for Veterinary Medicine (CVM) has investigated 
products used in the treatment of animal coronaviruses, and that 
information has been relayed to CBER and the wider community so that 
any potential relevance to SARS can be investigated. For example, 
effective and safe vaccines are marketed for enteric diseases caused by 
coronaviruses in cattle, swine, dogs, and cats; effective and safe 
vaccines, both live and killed, are marketed for avian infectious 
bronchitis caused by a coronavirus; and diagnostic test kits are 
marketed for feline infectious peritonitis, and for avian infectious 
bronchitis due to coronaviruses.

        ASSURING AN ADEQUATE SUPPLY OF RELATED MEDICAL PRODUCTS

    FDA is working with manufacturers to assure adequate supplies of 
various medical products that would be needed in the event of a broader 
spread of SARS in the U.S. For example, CBER, CDER, and CDRH are 
developing master lists and evaluating the adequacy and supplies of 
respirators, emergency medical supplies (gowns, gloves, masks), complex 
medical devices (ventilators, cardiac monitors), and the routine 
therapeutic products required to adequately support critically ill 
patients.

                  PROTECTING THE NATION'S BLOOD SUPPLY

    While there is no evidence that the SARS agent can be spread by 
blood, in mid-April, FDA nonetheless issued guidance to the nation's 
blood establishments on measures to further safeguard the blood supply 
against the threat of SARS while further scientific knowledge about the 
potential spread of this agent is obtained. This decision was based on 
the preliminary scientific data indicating that SARS is caused by a 
unique coronavirus that may be present in the blood of some infected 
persons early in their illness. Although the SARS epidemic has been 
limited in the U.S. and transfusion transmission of SARS has not been 
documented to date, it seemed prudent to act as quickly as possible to 
implement measures to restrict its spread, and in particular to protect 
the blood supply so that, if it is ultimately shown that the agent can 
be spread by blood, we will have taken steps to protect the nation's 
blood supply. The new SARS guidance sets forth measures for temporarily 
deferring potential donors who may have been exposed recently to SARS 
or recently had SARS. These measures include limited additional 
questioning of potential donors to help ascertain if they may be at 
elevated risk for SARS due to recent travel to known high risk areas as 
defined by CDC or due to exposure to a person with SARS or suspected 
SARS. FDA regularly exchanges information with CDC, NIH, the Department 
of Defense, and blood collection and distribution organizations to 
monitor SARS epidemiology and pathogenesis, in particular, as it 
relates to blood safety. FDA will continue to monitor this evolving 
situation and revise or supplement the guidance as needed to preserve 
the safety and availability of the blood supply, based on the best 
available information.
    It is important to re-emphasize that transfusion transmission of 
SARS has not been reported. However, CDC and others are conducting 
studies to clarify if the implicated coronavirus is present in the 
bloodstream during the asymptomatic incubation period of early 
infection. The public health need for testing donors, therefore, has 
yet to be established but FDA believes, given the state of scientific 
knowledge at this time, that this is the most prudent way to proceed. 
In addition, FDA is also in dialogue with SARS test kit manufacturers 
to help lay the groundwork for development of blood screening assays, 
should it be necessary.

               SARS AS A MODEL FOR BIOTERRORISM RESPONSE

    The President's Initiative on Countering Bioterrorism is comprised 
of a number of essential elements in which FDA plays an integral role. 
One such element is the expeditious development and licensing of 
products to diagnose, treat or prevent outbreaks from exposure to 
pathogens that have been identified as bioterrorist agents. These 
products must be reviewed and approved prior to the large-scale 
distribution necessary to create and maintain a stockpile. FDA 
scientists must guide the products through the development and 
marketing application review processes, which includes review of the 
manufacturing process, pre-clinical testing, clinical trials, and the 
licensing and approval process. This process is extremely complex and 
early involvement of FDA scientists is crucial to the success of the 
expedited development and review process. Our scientists must have 
expertise in these areas in order to expedite the licensing and 
approval process for these products. The resources that FDA has 
received to support bioterrorism preparedness and the expertise we have 
gained in rapid response and proactive approaches to product 
development have been helpful as we respond to SARS.
    Preparedness for and response to an attack involving biological 
agents are complicated by the large number of potential agents (most of 
which are rarely encountered naturally), their sometimes long 
incubation periods and consequent delayed onset of disease, and their 
potential for secondary transmission. In addition to naturally 
occurring pathogens, agents used by bioterrorists may be genetically 
engineered to resist current therapies and evade vaccine-induced 
immunity.
    How we respond to emerging infectious diseases can serve as a model 
for preparedness and response to a bioterrorism event in that we are 
dealing with a previously unknown infectious agent that has proven 
rapid worldwide diffusion and secondary transmission. The SARS 
experience reinforces the need for strong public health systems, robust 
health service infrastructures, and expertise that can be mobilized 
quickly across national boundaries to mirror disease movements. It has 
highlighted the need for on-going coordination and communications among 
international public health organization, counterpart public health 
organizations in other countries, Federal, State and local governments 
in our country, the public health and medical infrastructures thought 
the U.S., and with private industry.

                               CONCLUSION

    Clearly, much remains unknown about SARS at this time. FDA is 
carefully tracking and participating as a full partner where we have 
expertise to offer in the scientific undertakings to further define, 
treat, and, ultimately, defeat SARS. In meeting its public health 
mandate in this situation, we are ensuring that FDA resources are 
aggressively, safely, and intelligently deployed in the battle against 
this new virus. We will continue to work closely and share information 
with our partners in CDC and NIH, as well as with the private sector 
and other relevant agencies, to speed the development of reliable 
diagnostic, preventive, and treatment tools for SARS.
    Thank you very much for the opportunity to testify today. I welcome 
your ideas and your questions.

    Mr. Greenwood. Thank you very much, Dr. Lumpkin. Appreciate 
that.
    Ms. Heinrich.

                  TESTIMONY OF JANET HEINRICH

    Ms. Heinrich. Mr. Chairman and members of the committee, I 
appreciate the opportunity to be here today as you consider the 
Nation's preparedness to manage public health threats such as 
the SARS epidemic.
    My remarks will focus on what we know about State and local 
preparedness to respond to a large scale infectious outbreak, 
preparedness of hospitals for such an event and the 
relationship of Federal and State planning for an influenza 
pandemic to preparedness for emerging infectious diseases. All 
of these issues have become much more pertinent in light of the 
SARS epidemic.
    We recently released our review of State and local 
preparedness for bioterrorism. In visiting selected States and 
cities, local officials reported varying ability to respond to 
a major public health threat. They recognized gaps in 
communication and were beginning to address them, however gaps 
remain in elements such as disease surveillance, laboratory 
capacity and a trained work force. Although States have moved 
to electronic systems to compile data on disease in a 
community, for the most part they still rely on voluntary 
reporting of unusual diseases by health care providers. Such 
passive systems suffer from chronic under reporting and time 
lags between diagnoses of the condition and the health 
department's receipt of the report.
    To increase their capacity to test and identify disease 
organisms, State officials were planning to purchase new 
equipment for public health laboratories and hire laboratory 
personnel. Hiring epidemologists and trained laboratory 
personnel to do the appropriate investigations in an emergency 
has been hampered by a general shortage of people with the 
necessary skills, as well as non-competitive salaries.
    Other recent work we have done shows that progress in 
improving public health response capacity has lagged in 
hospitals. Persons with symptoms of infectious diseases would 
likely go to emergency departments for treatment. Most of these 
emergency departments across the country have experienced some 
degree of crowding and may not be able to handle a large influx 
of patients during a potential SARS outbreak.
    In addition, although most hospitals reported participating 
in basic planning activities and providing training to staff on 
recognition of symptoms of likely biological agents, few have 
acquired the medical equipment and isolation facilities they 
would need.
    The completion of final Federal influenza pandemic response 
plans seems to be a feasible step with potential benefit. These 
plans would address problems related to the purchase, 
distribution and administration of supplies of vaccines and 
antiviral drugs during a pandemic and could facilitate the 
public health response to emerging infectious diseases by 
avoiding uncertainty during crises.
    Key decisions related to vaccines and antiviral drug 
distribution have yet to be made, such as determining the 
amount of vaccines and antiviral drugs that will be purchased 
at the Federal level, the division of responsibility between 
the public and private sectors, and how populations groups will 
be prioritized and targeted to receive limited supplies.
    In summary, many actions taken at the State and local level 
to prepare for a bioterrorism event have enhanced the ability 
of our agencies at the local level to respond to management of 
a major public health threat, but significant gaps remain. 
Clearly progress has been made, but much more needs to be done.
    Mr. Chairman, I would be happy to answer any questions.
    [The prepared statement of Janet Heinrich follows:]

Prepared Statement of Janet Heinrich, Director, Health Care and Public 
        Health Issues, United States Gerneral Accounting Office

    Mr. Chairman and Members of the Subcommittee: I appreciate the 
opportunity to be here today to discuss the work we have done 
pertaining to the nation's preparedness to manage major public health 
threats, such as the emerging infectious disease known as 
SARS.1 The initial response to an outbreak of infectious 
disease would occur at the local level, with support from state and 
federal agencies, and could involve disease surveillance,2 
epidemiologic investigation,3 health care delivery, and 
quarantine management. The SARS outbreak has not infected large numbers 
of individuals in the United States, but it has raised concerns about 
the nation's preparedness to manage these components of response should 
it, or other infections, reach large-scale proportions.
---------------------------------------------------------------------------
    \1\ SARS is the abbreviation for severe acute respiratory syndrome.
    \2\ Disease surveillance uses systems that provide for the ongoing 
collection, analysis, and dissemination of health-related data to 
identify, prevent, and control disease.
    \3\ An epidemiologic investigation seeks to determine how a disease 
is distributed in a population and the factors that influence or 
determine this distribution.
---------------------------------------------------------------------------
    Public health officials and health care workers have learned 
lessons applicable to preparedness for large-scale infectious disease 
outbreaks from experiences with other major public health threats. 
Because of prior worldwide influenza outbreaks--known as pandemics 
4--federal and state agencies have begun to focus special 
attention on planning for such events. Similarly, following the anthrax 
incidents of fall 2001, the Congress expressed concern that the nation 
may not be prepared to respond to a large-scale bioterrorist event. 
State and local response agencies and organizations have recognized the 
need to strengthen their infrastructure and capacity to respond to 
bioterrorism. The improvements they are making will also strengthen 
their ability to identify and respond to other major public health 
threats, including naturally occurring infectious disease outbreaks. 
Planning for a response to bioterrorism and influenza pandemics targets 
the public health resources essential for a response to emerging 
infectious diseases.
---------------------------------------------------------------------------
    \4\ Influenza pandemics are worldwide influenza epidemics that can 
have successive ``waves'' of disease and last for up to 3 years. Three 
pandemics occurred in the twentieth century: the ``Spanish flu'' of 
1918, which killed at least 20 million people worldwide; the ``Asian 
flu'' of 1957; and the ``Hong Kong flu'' of 1968.
---------------------------------------------------------------------------
    To assist the Subcommittee in its consideration of our nation's 
capacity to respond to a major public health threat such as SARS, my 
remarks today will focus on (1) the preparedness of state and local 
public health agencies for responding to a large-scale infectious 
disease outbreak, (2) the preparedness of hospitals for responding to a 
large-scale infectious disease outbreak, and (3) the relationship of 
federal and state planning for an influenza pandemic to preparedness 
for emerging infectious diseases.
    My testimony today is based largely on our recently released report 
on state and local preparedness for a bioterrorist attack.5 
For that report, we conducted site visits to seven cities and their 
respective state governments. We also reviewed each state's spring 2002 
applications for bioterrorism preparedness funding distributed by 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 present some findings from 
a survey we conducted on hospital emergency department capacity and 
emergency preparedness,6 as well as some information 
updating our 2000 report on federal and state planning for an influenza 
pandemic.7
---------------------------------------------------------------------------
    \5\ U.S. General Accounting Office, Bioterrorism: Preparedness 
Varied across State and Local Jurisdictions GAO-03-373 (Washington, 
D.C.: Apr. 7, 2003).
    \6\ These findings 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 hospital 
emergency preparedness for mass casualty incidents from ongoing work. 
We did our work on the survey from May 2002 through May 2003 in 
accordance with generally accepted government auditing standards.
    \7\ U.S. General Accounting Office, Influenza Pandemic: Plan Needed 
for Federal and State Response, GAO-01-4 (Washington, D.C.: Oct. 27, 
2000).
---------------------------------------------------------------------------
    In summary, while the efforts of public health agencies and health 
care organizations to increase their preparedness for major public 
health threats such as influenza pandemics and bioterrorism have 
improved the nation's capacity to respond to SARS and other emerging 
infectious disease outbreaks, gaps in preparedness remain. 
Specifically, we found that there are gaps in disease surveillance 
systems and laboratory facilities and that there are workforce 
shortages. The level of preparedness varied across cities we visited, 
with jurisdictions that have had multiple prior experiences with public 
health emergencies being generally more prepared than others. We found 
that planning for regional coordination was lacking between states. We 
also found that states were developing plans for receiving and 
distributing medical supplies for emergencies and for mass vaccinations 
in the event of a public health emergency.
    We found that most hospitals across the country lack the capacity 
to respond to large-scale infectious disease outbreaks. Most emergency 
departments have experienced some degree of crowding and therefore in 
some cases may not be able to handle a large influx of patients during 
a potential SARS or other infectious disease outbreak. Although most 
hospitals report participating in basic planning activities for such 
outbreaks, few have adequate medical equipment, such as ventilators 
that are often needed for respiratory infections such as SARS, to 
handle the large increases in the number of patients that may result.
    The public health response to outbreaks of emerging infectious 
diseases such as SARS could be improved by the completion of federal 
and state influenza pandemic response plans that address problems 
related to the purchase, distribution, and administration of supplies 
of vaccines and antiviral drugs during an outbreak. CDC has provided 
interim draft guidance to facilitate state plans but has not made the 
final decisions on plan provisions necessary to mitigate the effects of 
potential shortages of vaccines and antiviral drugs in the event of an 
influenza pandemic.

                               BACKGROUND

    SARS is a respiratory illness that has recently been reported 
principally in Asia, Europe, and North America. The World Health 
Organization reported on May 5, 2003, that there were an estimated 
6,583 probable cases reported in 27 countries, including 61 cases in 
the United States. There have been 461 deaths worldwide, none of which 
have been in the United States. Of the 56 probable cases in the United 
States reported through April 30, 2003, 37 (66 percent) were 
hospitalized, and 2 (4 percent) required mechanical ventilation. 
Symptoms of the disease, which may be caused by a previously 
unrecognized coronavirus,8 can include a fever, chills, 
headache, other body aches, or a dry cough.
---------------------------------------------------------------------------
    \8\ The coronavirus is one of a group of viruses that are 
responsible for some but not all common colds. They are so named 
because their microscopic appearance is that of a virus particle 
surrounded by a crown.
---------------------------------------------------------------------------
    A Canadian official recently reported that more than 60 percent of 
probable SARS cases in Canada, where the bulk of North American cases 
have occurred, resulted from transmission to health care workers and 
patients. Canada's experience with managing the SARS outbreak has shown 
that measures used to prevent and control emerging infectious diseases 
appear to have been useful in controlling this outbreak. One of the 
measures that it has undertaken to control the outbreak is isolating 
probable cases in hospitals, including closing two hospitals to new 
admissions.9 Other measures include isolating people, either 
in their homes or in a hospital, who have had close contact with a SARS 
patient and providing educational materials regarding SARS to people 
who have traveled to locations of concern.
---------------------------------------------------------------------------
    \9\ The two hospitals have since been reopened.
---------------------------------------------------------------------------
    In order to be adequately prepared for a major public health threat 
such as SARS 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 addition, 
plans that describe how state and local officials would manage and 
coordinate an emergency response need to be in place and to have been 
tested in an exercise, both at the state and local levels and at the 
regional level.
    Local health care organizations, including hospitals, are generally 
responsible for the initial response to a public health emergency. In 
the event of a large-scale infectious disease 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. In addition, 
hospitals would need adequate stores of equipment and supplies, 
including medications, personal protective equipment, quarantine and 
isolation facilities, and air handling and filtration equipment.
    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. 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. In March 2003, 
HHS announced that the CDC and HRSA programs would provide funding of 
approximately $870 million and $498 million, respectively, for fiscal 
year 2003. Among the other public health emergency response resources 
that the federal government provides is the Strategic National 
Stockpile, which contains pharmaceuticals, antidotes, and medical 
supplies that can be delivered anywhere in the United States within 12 
hours of the decision to deploy.
    Just as was true with the identification of the coronavirus as the 
likely causative agent in SARS, deciding which influenza viral strains 
are dominant depends on data collected from domestic and international 
surveillance systems that identify prevalent strains and characterize 
their effect on human health.10 Antiviral drugs and vaccines 
against influenza are expected to be in short supply if a pandemic 
occurs. Antiviral drugs, which can be used against all forms of viral 
diseases, have been as effective as vaccines in preventing illness from 
influenza and have the advantage of being available now. HHS assumes 
shortages of antiviral drugs and vaccines will occur in a pandemic 
because demand is expected to exceed current rates of production. For 
example, increasing production capacity of antiviral drugs can take at 
least 6 to 9 months, according to manufacturers.
---------------------------------------------------------------------------
    \10\ CDC participates in international disease and laboratory 
surveillance sponsored by the World Health Organization, which operates 
in 83 countries.
---------------------------------------------------------------------------
  STATE AND LOCAL OFFICIALS REPORTED VARYING LEVELS OF PUBLIC HEALTH 
             PREPAREDNESS FOR INFECTIOUS DISEASE OUTBREAKS

    In the cities we visited, state and local officials reported 
varying levels of public health preparedness to respond to outbreaks of 
diseases such as SARS. They recognized gaps in preparedness elements 
such as communication and were beginning to address them. Gaps also 
remained in other preparedness elements that have been more difficult 
to address, including the disease surveillance and laboratory systems 
and the response capacity of the workforce. In addition, we found that 
the level of preparedness varied across the cities. Jurisdictions that 
had multiple prior experiences with public health emergencies were 
generally more prepared than those with little or no such experience 
prior to our site visits. We found that planning for regional 
coordination was lacking between states. In addition, states were 
working on plans for receiving and distributing the Strategic National 
Stockpile and for administering mass vaccinations.

Progress Has Been Made in Elements of Public Health Preparedness, But 
        Gaps Remain
    States and local areas were addressing gaps in public health 
preparedness elements, such as communication, but weaknesses remained 
in other 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.

Communication
    We found that officials were beginning to address communication 
problems. For example, six of the seven cities we visited 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 (HAN), an information and 
communication system. The nationwide HAN 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 HAN program include providing high-speed 
Internet connectivity, broadcast capacity for emergency communication, 
and distance-learning infrastructure for training.

Surveillance Systems and Laboratory Facilities
    State and local officials for the cities we visited recognized and 
were attempting to address inadequacies in their surveillance systems 
and laboratory facilities. 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 11 to detect infectious disease 
outbreaks.12 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.13 Three of 
the cities we visited were attempting to improve their surveillance 
capabilities by incorporating active surveillance components into their 
systems.
---------------------------------------------------------------------------
    \11\ 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 identify cases. 
Active surveillance can provide more complete detection of disease 
patterns than a system that is wholly dependent on voluntary reporting.
    \12\ Officials in one city told us that although it had no local 
disease surveillance, its state maintained a passive disease 
surveillance system.
    \13\ This type of active surveillance system in which the public 
health department obtains information from 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. One federal official has 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).
---------------------------------------------------------------------------
    However, work to improve surveillance systems has proved 
challenging. For example, despite initiatives to develop active 
surveillance systems, the officials in one city considered event 
detection to be a weakness in their system, in part because they did 
not have authority to access hospital information systems. In addition, 
various local public health officials in other cities reported that 
they lacked the resources to sustain active surveillance.
    Officials from all of the states we visited 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.
    Officials in the states we visited 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 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. One state department of public health we visited 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.
    Shortages in laboratory personnel were also cited. Officials in one 
city noted that they had difficulty filling and maintaining laboratory 
positions. 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.14
---------------------------------------------------------------------------
    \14\ Association of Public Health Laboratories, ``State Public 
Health Laboratory Bioterrorism Capacity,'' Public Health Laboratory 
Issues in Brief: Bioterrorism Capacity (Washington, D.C.: October 
2002).
---------------------------------------------------------------------------

Level of Preparedness Varied across Cities We Visited
    We found that the overall level of public health preparedness 
varied by city. In the cities we visited, we observed that those cities 
that had recurring experience with public health emergencies, including 
those resulting from natural disasters, or with preparation for 
National Security Special Events, such as political 
conventions,15 were generally more prepared than cities with 
little or no such experience. Cities that had dealt with multiple 
public health emergencies in the past might have been further along 
because they had learned which organizations and officials need to be 
involved in preparedness and response efforts and moved to include all 
pertinent parties in the efforts. Experience with natural disasters 
raised the awareness of local officials regarding the level of public 
health emergency preparedness in their cities and the kinds of 
preparedness problems they needed to address.
---------------------------------------------------------------------------
    \15\ Presidential Decision Directive 62 created a category of 
special events called National Security Special Events, which are 
events of such significance that they warrant greater federal planning 
and protection than other special events. In addition to major 
political party conventions, such events include presidential 
inaugurations.
---------------------------------------------------------------------------
    Even the cities that were better prepared were not strong in all 
elements. For example, one city reported that communications had been 
effective during public health emergencies and that the city had an 
active disease surveillance system. However, officials reported gaps in 
laboratory capacity. Another one of the better-prepared cities was 
connected to HAN and the Epidemic Information Exchange (Epi-
X),16 and all county emergency management agencies in the 
state were linked. However, the state did not have written agreements 
with its neighboring states for responding to a public health 
emergency.
---------------------------------------------------------------------------
    \16\ Epi-X is a secure, Web-based exchange for public health 
officials to rapidly exchange information on disease outbreaks, 
exposures to environmental hazards, and other health events as they are 
identified and investigated.
---------------------------------------------------------------------------

Planning for Regional Coordination Was Lacking between States
    Response organization officials were concerned about a lack of 
planning for regional coordination between states of the public health 
response to an infectious disease outbreak. As called for by the 
guidance for the CDC and HRSA funding, all of the states we visited 
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.

States Have Begun Planning for Receiving and Distributing Items from 
        the Strategic National Stockpile and for Administering Mass 
        Vaccinations
    States have begun planning for use of the Strategic National 
Stockpile.17 To determine eligibility for the CDC funding, 
applicants were required to develop interim plans to receive and manage 
items from the stockpile, including mass distribution of antibiotics, 
vaccines, and medical materiel. However, having plans for the 
acceptance of the deliveries from the stockpile is not enough. Plans 
have to include details about dividing the materials that are delivered 
in large pallets and distributing the medications and vaccines.
---------------------------------------------------------------------------
    \17\ HHS is planning to purchase approximately 2,700 ventilators by 
September 2003 to supplement those now available in the Strategic 
National Stockpile to enhance preparedness for a potential outbreak of 
SARS in the United States.
---------------------------------------------------------------------------
    Of the seven states we visited, five states had completed plans for 
the receipt and distribution of items from the stockpile. One state 
that was working on its plan stated that it would be completed in 
January 2003. Only one state had conducted exercises of its stockpile 
distribution plan, while the other states were planning to conduct 
exercises or drills of their plans sometime in 2003.
    In addition, five states reported on their plans for mass 
vaccinations and seven states reported on their plans for large-scale 
administration of smallpox vaccine in response to an outbreak. Some 
states we visited had completed plans for mass vaccinations, whereas 
other states were still developing their plans. The mass vaccination 
plans were generally closely tied to the plans for receiving and 
administering the stockpile. In addition, two states had completed 
smallpox response plans, which include plans for administering mass 
smallpox vaccinations to the general population, whereas four of the 
other states were drafting plans. The remaining state was discussing 
such a plan. However, only one of the states we visited has tested in 
an exercise its plan for conducting mass smallpox vaccinations.

   MOST HOSPITALS LACK RESPONSE CAPACITY FOR LARGE-SCALE INFECTIOUS 
                           DISEASE OUTBREAKS

    We found that most hospitals lack the capacity to respond to large-
scale infectious disease outbreaks. Persons with symptoms of infectious 
disease would potentially go to emergency departments for treatment. 
Most emergency departments across the country have experienced some 
degree of crowding and therefore in some cases may not be able to 
handle a large influx of patients during a potential SARS outbreak. In 
addition, although most hospitals across the country reported 
participating in basic planning activities for large-scale infectious 
disease outbreaks, few have acquired the medical equipment resources, 
such as ventilators, to handle large increases in the number of 
patients that may result from outbreaks of diseases such as SARS.
Most Emergency Departments Have Experienced Some Degree of Crowding
    Our survey found that most emergency departments have experienced 
some degree of overcrowding.18 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),19 
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.
---------------------------------------------------------------------------
    \18\ GAO-03-460.
    \19\ Diversions occur when hospitals request that en route 
ambulances bypass their emergency departments and transport patients 
that would have been otherwise taken to those emergency departments to 
other medical facilities.
---------------------------------------------------------------------------
    Diversion varies greatly by MSA. Figure 1 shows each MSA and the 
share of hospitals within the MSA that reported being on diversion more 
than 10 percent of the time--or about 2.4 hours or more per day--in 
fiscal year 2001. Areas with the greatest diversion included Southern 
California and parts of the Northeast. Of the 248 MSAs for which data 
were available,20 171 (69 percent) had no hospitals 
reporting being on diversion more than 10 percent of the time. By 
contrast, 53 MSAs (21 percent) had at least one-quarter of responding 
hospitals on diversion for more than 10 percent of the time.
---------------------------------------------------------------------------
    \20\ The 248 MSAs include those MSAs for which (1) more than half 
of hospitals in the MSA returned surveys and (2) more than half of 
those hospitals that returned surveys provided data on diversion hours.
---------------------------------------------------------------------------
    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 SARS 
outbreak, especially if this outbreak occurred in the winter months 
when the incidence of influenza is quite high. Thus far, the largest 
SARS outbreaks worldwide have primarily occurred in areas with dense 
populations.21
---------------------------------------------------------------------------
    \21\ These areas include mainland China and the Hong Kong Special 
Administrative Region within the People's Republic of China; Singapore; 
Taiwan; and Toronto, Canada.
---------------------------------------------------------------------------

Most Hospitals Reported Planning and Training Efforts, but Fewer Than 
        Half Have Participated in Drills or Exercises
    At the time of our site visits, 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.
    In our survey of over 2,000 hospitals,22 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.
---------------------------------------------------------------------------
    \22\ 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 of the survey.) For the part of the survey 
that specifically addressed hospital preparedness for mass casualty 
incidents, we obtained responses from 1,482 hospitals for the third 
section of the survey addressing emergency preparedness, a response 
rate of about 73 percent.
---------------------------------------------------------------------------
    Our survey showed that hospitals have provided training to staff on 
biological agents, but fewer than half have participated in 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.

Most Hospitals Lack Adequate Equipment, Facilities, and Staff Required 
        to Respond to a Large-Scale Infectious Disease Outbreak
    Most hospitals lack adequate equipment, isolation facilities, and 
staff to treat a large increase in the number of patients for an 
infectious disease such as SARS. To prevent transmission of SARS in 
health care settings, CDC recommends that health care workers use 
personal protective equipment, including gowns, gloves, respirators, 
and protective eyewear.23 SARS patients in the United States 
are being isolated until they are no longer infectious. CDC estimates 
that patients require mechanical ventilation in 10 to 20 percent of 
SARS cases.24
---------------------------------------------------------------------------
    \23\ CDC, Interim Domestic Guidance for Management of Exposures to 
Severe Acute Respiratory Syndrome (SARS) for Healthcare and Other 
Institutional Settings (Apr. 12, 2003), http://www.cdc.gov/ncidod/sars/
exposureguidance.htm (downloaded May 5, 2003).
    \24\ CDC, Frequently Asked Questions: Severe Acute Respiratory 
Syndrome (SARS), http://www.cdc.gov/ncidod/sars/faq.htm (downloaded May 
5, 2003).
---------------------------------------------------------------------------
    In the seven cities we visited, hospital, state, and local 
officials reported that hospitals needed additional equipment and 
capital improvements--including medical stockpiles, personal protective 
equipment, quarantine and isolation facilities, and air handling and 
filtering equipment--to enhance preparedness. Five of the states we 
visited reported shortages of hospital medical staff, including nurses 
and physicians, necessary to increase response capacity in an 
emergency. One of the states we visited reported that only 11 percent 
of its hospitals could readily increase their capacity for treating 
patients with infectious diseases requiring isolation, such as smallpox 
and SARS. Another state reported that most of its hospitals have little 
or no capacity for isolating patients diagnosed with or being tested 
for infectious diseases.
    According to our hospital survey, availability of medical equipment 
varied greatly between hospitals, and few hospitals seemed to have 
adequate equipment and supplies to handle a large-scale infectious 
disease outbreak. While most hospitals had, for every 100 staffed beds, 
at least 1 ventilator, 1 personal protective equipment suit, or 1 
isolation bed, half of the hospitals had, for every 100 staffed beds, 
fewer than 6 ventilators, 3 or fewer personal protective equipment 
suits, and fewer than 4 isolation beds.

KEY FEDERAL DECISIONS FOR INFLUENZA PANDEMIC PLANNING COULD FACILITATE 
                RESPONSE TO EMERGING INFECTIOUS DISEASES

    The completion of final federal influenza pandemic response plans 
that address the problems related to the purchase, distribution, and 
administration of supplies of vaccines and antiviral drugs during a 
pandemic could facilitate the public health response to emerging 
infectious disease outbreaks. CDC has provided interim draft guidance 
to facilitate state plans but has not made the final decisions on plan 
provisions necessary to mitigate the effects of potential shortages of 
vaccines and antiviral drugs. Until such decisions are made, the 
timeliness and adequacy of response efforts may be compromised.
    In the most recent version of its pandemic influenza planning 
guidance for states, CDC lists several key federal decisions related to 
vaccines and antiviral drugs that have not been made. These decisions 
include determining the amount of vaccines and antiviral drugs that 
will be purchased at the federal level; the division of responsibility 
between the public and the private sectors for the purchase, 
distribution, and administration of vaccines and drugs; and how 
population groups will be prioritized and targeted to receive limited 
supplies of vaccines and drugs. In each of these areas, until federal 
decisions are made, states will not be able to develop strategies 
consistent with federal action.
    The interim draft guidance for state pandemic plans says that 
resources can be expected to be available through federal contracts to 
purchase influenza vaccine and some antiviral agents, but some state 
funding may be required. The amounts of antiviral drugs to be purchased 
and stockpiled are yet to be determined, even though these drugs are 
available and can potentially be used for both treatment and prevention 
during a pandemic.
    CDC has indicated in its interim draft guidance that the policies 
for purchasing, distributing, and administering vaccines and drugs by 
the private and public sectors will change during a pandemic, but some 
decisions necessary to prepare for these expected changes have not been 
made. During a typical annual influenza response, influenza vaccine and 
antiviral drug distribution is primarily handled directly by 
manufacturers through private vendors and pharmacies to health care 
providers. During a pandemic, however, CDC interim draft guidance 
indicates that many of these private-sector responsibilities may be 
transferred to the public sector at the federal, state, or local levels 
and that priority groups within the population would need to be 
established for receiving limited supplies of vaccines and drugs.
    State officials are particularly concerned that a national plan has 
not been issued with final recommendations for how population groups 
should be prioritized to receive vaccines and antiviral drugs. In its 
interim draft guidance, CDC lists eight population groups that should 
be considered in establishing priorities among groups for receiving 
vaccines and drugs during a pandemic. The list includes such groups as 
health care workers and public health personnel involved in the 
pandemic response, persons traditionally considered to be at increased 
risk of severe influenza illness and mortality, and preschool and 
school-aged children.
    Although state officials acknowledge the need for flexibility in 
planning because many aspects of a pandemic cannot be known in advance, 
the absence of more detail leaves them uncertain about how to plan for 
the use of limited supplies of vaccine and drugs. In our 2000 report on 
the influenza pandemic, we recommended that HHS determine the 
capability of the private and public sectors to produce, distribute, 
and administer vaccines and drugs and complete the national response 
plan.25 To date, only limited progress has been made in 
addressing these recommendations.
---------------------------------------------------------------------------
    \25\ GAO-01-4.
---------------------------------------------------------------------------
                        CONCLUDING OBSERVATIONS

    Many actions taken at the state and local level to prepare for a 
bioterrorist event have enhanced the ability of state and local 
response agencies and organizations to manage an outbreak of an 
infectious disease such as SARS. However, there are significant gaps in 
public health surveillance systems and laboratory capacity, and the 
number of personnel trained for disease detection is insufficient. Most 
emergency departments across the country have experienced some degree 
of overcrowding. Hospitals have begun planning and training efforts to 
respond to large-scale infectious disease outbreaks, but many hospitals 
lack adequate equipment, medical stockpiles, personal protective 
equipment, and quarantine and isolation facilities. Federal and state 
plans for the purchase, distribution, and administration of supplies of 
vaccines and drugs in response to an influenza pandemic have still not 
been finalized. The lack of these final plans has serious implications 
for efforts to mobilize the distribution of vaccines and drugs for 
other infectious disease outbreaks.
    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 me at 
(202) 512-7119. Robert Copeland, Marcia Crosse, Martin T. Gahart, 
Deborah Miller, Roseanne Price, and Ann Tynan also made key 
contributions to this statement.
[GRAPHIC] [TIFF OMITTED] T7484.001

    Mr. Greenwood. Thank you very much.
    And the Chair recognizes himself for 10 minutes for 
questions. And let me begin with you, Mr. Hauer. Dean Barry 
Bloom in his testimony for today's second panel to follow you 
states in his written statement, ``Neither the CDC nor the NIH 
currently has the resources or flexibility to use its funds to 
allocate personnel and resources rapidly to meet ever changing 
emerging infections without neglecting other health 
responsibilities.'' The question is do you agree with that 
statement?
    Mr. Hauer. No, I don't. I think the SARS outbreak has shown 
that both the flexibility exists and the ability to address 
multiple issues exists. I think that CDC has shown in an 
incredible degree to address emerging threats while at the same 
time maintain focus on other issues.
    Mr. Greenwood. Okay. The New York Times is reporting in 
today's paper, in today's edition, that the administration has 
authorized Immigration and Customs agents at the Nation's 
airports to use force to detain arriving possible SARS 
carriers. The question is, has the Department of Homeland 
Security consulted with HHS about what precautions need to be 
taken for the Immigration and Customs agents?
    Mr. Hauer. Let me defer that question to Dr. Gerberding, 
because CDC is working closely with DHS on this issue.
    Ms. Gerberding. CDC has the Division of Global Migration 
and Quarantine, and it is their responsibility to deal with 
quarantine at our Federal borders.
    Our quarantine officials have the responsibility for 
conducting the medical assessments, but they do not have the 
law enforcement authority. So traditionally it has been the 
Customs officials who have the responsibility for enforcing the 
authority of our quarantine individuals.
    In the particular case of SARS where we recognize that it 
could be necessary to exercise quarantine authorities at our 
borders, we work very collaboratively with the Department of 
Homeland Security to engage their assistance. We doubt we will 
need to ever use that level of enforcement, because almost 
always this happens on a voluntary basis. But it is important 
to know where you would turn for the enforcement capacity if 
you needed it, and that, I think, is what the New York Times 
article is referencing.
    Mr. Greenwood. Very well. And let me address a question 
directly to you, Dr. Gerberding. The GAO reports that the 
public health response to outbreaks of emerging infectious 
diseases such as SARS could be improved by the completion of 
Federal and State influenza pandemic response plans that 
address problems related to the purchase, distribution and 
administration of supplies of vaccines and antiviral drugs 
during an outbreak. Do you agree with that?
    Ms. Gerberding. I do agree with that.
    Mr. Greenwood. Okay. The GAO also reports that the CDC has 
provided interim draft guidance to facilitate State plans but 
has not made the final decisions on plan provisions necessary 
to mitigate the effects of potential shortages of vaccines and 
antiviral drugs in the event of an influenza pandemic. Do you 
agree with that?
    Ms. Gerberding. I partially agree with it. We have made 
some draft recommendations. We are working with our partners in 
the Department of Health and Human Services to get a 
collaborative organized approach here, because obviously it is 
not just up to CDC, we have to work with FDA and NIH, and with 
Assistant Secretary Hauer's office to make sure that we are all 
on the same page here.
    We are expecting the department to have a uniform pandemic 
flu plan before next flu seasons. That is, obviously, a high 
priority right now given the lessons we have learned from SARS.
    Mr. Greenwood. Dr. Jared Schwartz on the second panel 
states in his testimony that, ``Our public health system would 
benefit from an interconnected electronic communications 
network to monitor for disease outbreaks.'' The question is 
what actions is CDC taking to establish such an interconnected 
electronic communication network?
    Ms. Gerberding. I have a vision of a completely 
interconnected system that starts in the health care delivery 
system and moves through the local and State health agencies 
and throughout the Federal partners here, and that it is a two-
way communication system or a multi-directional communication 
system so it is not just about us getting information from the 
local jurisdictions, but it is about creating knowledge and 
information of use to those people.
    We have made already substantial investments in this, and 
the billion dollars that have gone out just this past year for 
State and local preparedness includes a significant investment 
in enhancing this network further. It is not finished yet, but 
it is very functional. We use it for our health alerting now, 
and we have more than 90 percent of local health departments 
engaged in that alerting capacity.
    We have electronic reporting of some sort in almost every 
State. I think 30 States are now engaged in using the uniform 
standardized integrated data system, which includes standards 
for architecture and vocabulary. So our intent is to have a 
seamless system. We are working very fast to make that vision 
become a reality.
    Mr. Greenwood. Okay.
    Let me turn to you, Dr. Fauci, and ask you can you walk us 
through the pathology of SARS? What happens to an individual 
once infected with this virus?
    Mr. Fauci. All of the steps of the pathophysiological 
mechanisms have not been worked out, but we have a pretty good 
idea of what goes on.
    An individual gets exposed and infected with the virus, 
generally from a droplet that contains the virus from an 
infected individual. It gets into the nasal and oral passages 
and, very likely as most viruses do, they then from that point 
generally go to lymph node areas and start to replicate. 
Patients develop what we call we viremic state where 
individuals have virus that circulates throughout the body. 
That generally leads to symptoms that are due both to the virus 
itself as well as to what we call cytokines, which are proteins 
that the body secretes in response to noxious stimuli such as 
microbes.
    These cytokines cause fever, they cause headache, they 
cause muscle aches and a general flu-like syndrome. That part 
of the SARS pathophysiology is likely similar, if not 
identical, to many of the microbes that cause flu-like 
syndromes.
    What this microbe then has the capacity to do is that it 
seeds itself in the lungs, and that is why you start to get the 
dry cough and then some of the shortness of breath. And in 
people who go into advance disease, they develop what we call 
pulmonary infiltrates.
    An infiltrate means if you look at the chest x-ray, it is 
dense. You don't see that nice crystal-clear appearance that 
you look at when you see an x-ray. You get infiltrates in the 
lung and its most severe form, the lung is so infiltrated that 
it actually looks like it is ``whited out,'' as we call it.
    Now, the important thing is that we are starting to see 
that individuals who get infected and go to this advanced 
stage, the actual inflammatory response and immunological 
response to the virus itself is contributing greatly to the 
inability to move air in and out into the infiltrates. So when 
you look at a chest x-ray, it is not just a lot of virus that 
is whiting out the chest x-ray, it is the inflammatory response 
to that virus.
    Now what happens is that the vast majority of people, and 
you have heard discussion this afternoon about mortality rate, 
but the 90 percent or so of people who survive, immunologically 
their body can ultimately clear the virus and then the 
inflammation disappears. In those individuals who succumb, the 
inflammation is so overwhelming that they die a respiratory 
death. They need to go on a respirator and they die with a 
syndrome that is called acute respiratory distress syndrome, 
which has a very high mortality when you get to that point.
    Mr. Greenwood. And what seems to be the determining factor? 
I know their age seems to be a critical issue.
    Mr. Fauci. Yes.
    Mr. Greenwood. As to who gets sick and who gets sicker.
    Mr. Fauci. Well, certainly in any serious respiratory 
illness, including influenza and certainly including SARS, 
individuals who are elderly or who have other underlying 
diseases have a compromise of their ability to mount an 
inflammatory or an immunological response. Their mortality is 
almost always greater than a young, robust, vigorous healthy 
person. However, microbes like the coronavirus of SARS and in 
certain situations with influenza when you have a really bad 
year, young individuals even though they are healthy, can 
actually get sick enough to succumb. So although the weight of 
it is heavily weighted toward older individuals and those who 
might have underlying conditions, young healthy individuals are 
not exempt from getting serious complications including death.
    Mr. Greenwood. And how do you treat a patient?
    Mr. Fauci. Well, right now it is with what we call 
supportive therapy. Supportive therapy means it is nonspecific. 
We don't have a specific antiviral drug. So if someone would 
come into the hospital in the serious beginning of a 
respiratory problem, you would have to see that their 
respiratory function is able to be supported. So you give them 
supported therapy, which might include putting them on a 
respirator. You would try to keep their airways clear, because 
when you have those many infiltrates in your lung, you 
generally have secretions that need to be cleared. You have to 
have intensive nursing care, which prior to the realization 
that it was transmissible that way, that certainly was the way 
the nurses and the doctors were getting infected, via the 
intensive care that you have to give to someone who has a 
serious pulmonary disease.
    You also look at the fluid and the electrolytes. Because 
when people get into dire straights with systemic disease, 
their body's ability to balance the fluid that is in your blood 
vessels versus that which goes out into the tissue is very much 
disrupted, so you need to balance the fluid. And then you need 
to be alert for any secondary infections. Because when people 
have difficulty moving air in their lungs, they are more prone 
to a secondary bacterial infection. When they are in bed, they 
are prone to urinary tract infection.
    All of those things. But they do not directly go against 
the SARS virus. They come under the category of what we call 
supportive care.
    Mr. Greenwood. Thank you. My time has expired.
    The gentleman from Florida for 10 minutes.
    Mr. Deutsch. That you, Mr. Chairman.
    Thank you, Dr. Fauci. And I appreciate your help in issues 
that we have worked together over the last several years.
    WHO is now reporting that the SARS virus can live for days 
in the stool and urine of patients. Additionally, Hong Kong 
scientists suspect that the virus can live in sewage. Do you 
think that we should be concerned about the potential for the 
SARS microbes to remain viable on certain objects such as trash 
which are being imported into the United States from SARS 
infected such as China? Did you want to try to answer that? Are 
you qualified? I mean, is that your area?
    Mr. Hauer. Julie, do you want to take a shot and then I 
will be happy to fill in?
    Ms. Gerberding. First of all, finding the SARS virus in 
stool of human beings is not surprising because we know this is 
a commonsite of infection in animals. So we have evidence that 
the SARS virus can be found in diarrheal stool of some people, 
and we are not surprised to find that it can last alive on 
certain on certain surfaces for periods of time. But our 
evidence tells us that that is not likely to be the way it is 
being transmitted. Rather, it is being transmitted person-to-
person through respiratory droplets.
    The exception to that in an apartment complex in Hong Kong 
is very complicated because their sewage system is very 
different from ours. Basically due to a failure to keep the 
sewer separate from the bathroom plumbing, there was a problem 
where there was reflux of the sewage back into the bathroom 
sinks, and then a fan in these bathrooms was pulling air up 
into the ceiling and potentially aerosolizing sewage into the 
bathrooms. That is a very extreme and uncommon situation, and 
that is something that we would not be likely to be concerned 
about in the kind of plumbing regulations we have in this 
country. We do not have proof that that is how those people 
were infected, but it is the leading hypothesis according to 
the Hong Kong experts.
    Our concern about stool or contaminated objects is why we 
have recommended that health care workers wear gloves and that 
people maintain good hand hygiene to protect themselves against 
SARS should they happen to come in contact with a contaminated 
object. But the major concern is still that direct sustained 
face-to-face contact with someone who is sick. And that really 
is the common denominator here.
    Mr. Deutsch. Okay. Yes, go ahead.
    Mr. Fauci. Mr. Deutsch, let me just add to that 
explanation, which I agree with completely. That we need to be 
careful when we hear reports of experiments that are relevant 
and do inform us and help us. But many times experiments do 
what we call spiking the virus on a particular surface, on a 
table, whatever, in an experimental fashion to see if it will 
live there. The fact that it does really doesn't necessarily 
mean that that is a major threat. The major threat is still, as 
Dr. Gerberding delineated, through to the respiratory droplet 
route.
    Historically we went through some of the same things with 
HIV/AIDS back, in fact I even testified before this committee 
on that, that we investigated. Experimentally put HIV in a 
petri dish or HIV in this and HIV in that and said well gee, 
does that mean that if I have a cut on my hand and I go sit 
down next to a table with someone and rub my hand, can I get 
HIV/AIDS. The answer is that for practical public health 
purposes the answer is no, but it is important to know the 
viability of these microbes under certain circumstances.
    So we are still left with the major modality being what was 
described thus far this afternoon.
    Mr. Deutsch. Thank you.
    Thus far the SARS epidemic has been relatively confined to 
North America, Europe and parts of Asia. Although the 
possibility that this virus could spread to other areas is 
obviously possible at this point. How is the NIH or CDC 
preparing for the possibility that this disease might spread to 
the Third World countries who have the additional disadvantage 
of having to combat other dire health situations such as the 
poor health system, high numbers of HIV infected residents?
    Ms. Gerberding. We are concerned about the possibility of 
spread into additional countries with very inadequate public 
health infrastructures. What is containing this epidemic right 
now is the old fashioned public health approach, and that is 
detecting cases, isolating them and quarantining exposed people 
during their incubation period. If we have a problem emerge in 
countries that have very limited public health capacity, they 
are not going to be able to easily do these things. And, of 
course, WHO teams will do everything possible to assist. But a 
priority right now is to do everything possible to keep that 
from happening.
    What we are really doing is buying some time and focusing 
so much on containment right now in the hope that we will be 
able to prevent the kind of scenario you are describing before 
we get a vaccine or some kind of treatment.
    Mr. Deutsch. Are there additional precautions or 
preparations for that possibility? I mean, assuming it would 
occur in a country without an adequate public health care 
system?
    Ms. Gerberding. One of the important things going on right 
now that has not come up in the discussions so far is the 
incredible investment in the affected countries in quarantine; 
China, Hong Kong, Taiwan are very aggressively quarantining 
anyone who is possibly exposed. This really reduces the 
probability that a traveler who is exposed and incubating is 
going to leave that country and set up a chain of transmissions 
somewhere else. So that is to the advantage of all of us in 
terms of protecting the rest of the globe from traveling cases. 
Of course, it is not perfect and we still have to remain 
vigilant.
    WHO is calling a meeting of all of the health countries and 
the World Health Assembly is happening next week, and this 
discussion about what we can do collectively to try to make 
sure that we are doing everything possible to either prevent or 
respond to the emergence and containment contingencies in a new 
country is going to be a very major point of discussion and 
already some resolutions have been prepared for the assembly to 
take this on.
    Mr. Deutsch. Typically people with compromised immune 
systems from HIV or organ transplants or cancer chemotherapy 
suffer worse from infections. Do we have any indication that 
people with HIV/AIDS have the highest susceptibility or 
affected more seriously than people with health immune systems?
    Ms. Gerberding. So far the clinical information has 
indicated that age is the major risk factor. We have not seen 
HIV infection emerge because there have not been any HIV 
infected patients that I am aware of in the U.S. or Canada who 
have been in the case lists. It is possible that they are in 
there and it is not common enough for us to know about or see. 
But we are noticing that diabetes, other chronic medical 
conditions are more common in the patients who have the worst 
disease compared to those that have minor cases of SARS. So it 
would be expected that those people with immunosuppression may 
have a worse outcome.
    Mr. Deutsch. Is NIH doing the majority of the testing and 
studying of the SARS virus at this point?
    Mr. Fauci. There is a considerable amount of work that is 
going on at the CDC. The way it turned out, the CDC isolated 
the virus, gave it to the NIH who are now growing it up for the 
purpose of the vaccine development that I mentioned in answer 
to a previous question. And in addition, the CDC, the NIH and 
USAMRIID are in a collaborative venture in screening drugs to 
determine if they have activity against the SARS virus. So it 
is work that is going on both at the CDC, the NIH and actually 
at FDA also.
    Mr. Deutsch. Are there any universities involved?
    Mr. Fauci. Oh, yes. Yes. Yes.
    Ms. Gerberding. We have gotten numerous requests from the 
private sector, from the academic sector and from international 
entities for either the virus or for genetic components of the 
virus. And we have been able to streamline the application 
process to remove some of the bureaucratic barriers to making 
it available. So as soon as people complete their biomedical 
licensing agreement, we can expedite and release of the 
materials to them.
    We have taken a very open posture on this. And I think that 
this is unprecedented that we have been able to get new agents 
or this kind of information so quickly.
    Like I mentioned earlier, we have put the sequence of the 
virus up on the Internet as well.
    Mr. Fauci. We actually have 18 grantees who are working on 
coronavirus that antedated the SARS virus. And we are trying 
now to get them samples.
    As Dr. Gerberding mentioned, one of the critical limiting 
factors is getting samples to individuals to be able to study 
and making sure they have the proper facilities within which to 
study them. And we are right now already starting to work on a 
reagent repository to supply our grantees and contractors on 
the outside.
    Mr. Deutsch. My last question is similar to the question I 
asked earlier to the gentleman from WHO, obviously you are 
aware of Taiwan's relationship not being in the WHO and he 
described, which I was aware of, going through CDC. Do you 
think that is an impediment in terms of what is going on in 
Taiwan at the present time?
    Ms. Gerberding. We have a tradition of engaging in specific 
health issues in Taiwan so there are a number of relationships 
that are already set up there.
    CDC has something called an international emerging 
infections program in Thailand that provides regional 
assistance to various countries in Asia. So the CDC staff at 
our Thailand field station were the first to be able to engage 
in Taiwan.
    It has worked very well. We have had consecutive teams of 
people going there with different kinds of expertise, and we 
have been able to respond to the requests from the Minister of 
Health there for technical assistance. But as the problem 
enlarges, more people are needed and fresh sets of eyes and 
fresh perspectives are certainly welcome. So we are very happy 
that the WHO individuals can now join our teams there.
    Mr. Deutsch. Thank you.
    Mr. Bass [presiding]. Thank the gentleman from Florida.
    The Chair will recognize himself for 10 minutes.
    Thanks for being here today. I guess to start off with, for 
me the bottom line question, and for Americans to know, if this 
disease gets established in this country and in the near 
future, say in the next year, and gets out of control, so to 
speak, how many Americans are going to die?
    Ms. Gerberding. Of course, I do not know the answer to the 
question. I wish we could have a stronger predictive power to 
really appreciate where this will next, and what we can be 
doing now to prevent that.
    As Dr. Fauci pointed out, although it is certainly capable 
of being efficiently transmitted, particularly in certain 
situations, it is not nearly as infectious, thank goodness, as 
influenza. So what we would predict is that we could see 
limited chains of transmission from, say, health care workers 
who get infected and then have this problem develop. But we 
know some things from the lessons we have learned from Canada 
and the other countries.
    And one of the lessons is we have to be bold and we have to 
act fast, and we cannot sit around and have a lot of committee 
meetings or discussions about what public health action steps 
to be taken. We need to implement quarantine. If we have a 
problem in the hospital, we need to shutdown the hospital, 
cancel elective surgery and maximize the contain of the virus 
or either cohorting or infection control practices.
    Mr. Bass. Well, theoretically is the death rate is, say, 5 
or 6 percent and everybody got it, it would be 14 million 
people at the worst, right?
    Ms. Gerberding. That is a scenario that certainly came to 
my mind when I first heard about what was happening in Asia in 
the early stages of the epidemic.
    I think that is extremely unlikely. But, again, we are 
contingency planning to identify what steps we would take. And 
even though I do not think we are going to end up in that 
situation with SARS, we could end up in that situation if we 
had another flu pandemic.
    As Mr. Hauer knows from the Department's perspective, one 
of the major efforts right now is to have a plan that allows us 
that kind of regional surge capacity. We are purchasing 
ventilators for the stockpile. Secretary Thompson has asked us 
to purchase 3,000 ventilators----
    Mr. Hauer. 3,000 additional.
    Ms. Gerberding. [continuing] for the stockpile to 
supplement the 100,000 that our Nation already has. But we have 
got, really, to look at all of the elements of care in a 
situation like that. And there are still some gaps that need to 
be filled.
    Mr. Bass. Ironically, this may be the first test of the 
Homeland Security system that we are setting up in this country 
right now. I guess, Dr. Gerberding, you mentioned that you were 
working fast to make this vision a reality. I think that is 
somewhat out of context. The fact is that communication between 
CDC, Health and Human Services and all local law enforcement 
and hospitals and everything else are going to be critical to 
this.
    I am wondering if you can describe CDC's quarantine 
authority as amended under the President's Executive Order 
exactly what it is.
    Ms. Gerberding. The Federal quarantine authority resides in 
the borders, the points of entry into our country. So we have 
the responsibility for ships or planes that are arriving here. 
Our responsibility is to ensure the health of arriving 
passengers and to make sure that communicable diseases are not 
brought into the country.
    The States have the authority for intrastate issues of 
public health and disease containment. But if there is an issue 
of a border between States, Federal jurisdiction can then apply 
if the States fail to resolve the health threat. So we have 
some residual authority at the interstate transfer of 
infectious disease.
    What that really means in simple terms is that we have 
quarantine officers strategically positioned at our borders. 
They have a long tradition of assessing ill patients arriving 
on planes. They have the authority to board planes and ships 
and evaluate illness there. And they have the authority to 
request or in cases where voluntary request is not successful, 
require people to either enter isolation if they are sick or 
quarantine if they are believed to pose a health risk to 
others.
    Mr. Bass. Are people at the borders asking incoming 
individuals if they have a fever or they are sick or every 
single person or not?
    Ms. Gerberding. We are not asking individually every single 
person coming in. But our goal from the people coming in from 
the places where SARS is a problem, is that every person 
receives that yellow health alert card that gives them advice 
about seeing a clinician if they get sick.
    In addition, our quarantine officers and their deputies are 
meeting the planes as they arrive and asking the crew and 
officials on the plane is there a problem, has anybody been 
sick, do you notice that anybody appears to be ill on this 
plane. And if there is a suspicion, they will ask that 
passenger to step aside and have a quick assessment. And if 
there is reason to be concerned about SARS or another 
infectious disease, they get taken to the appropriate clinic 
evaluation facility.
    Mr. Bass. So are you using this quarantine authority as was 
directed under the President's Executive Order to its fullest 
extent right now?
    Ms. Gerberding. What the Presidential authority provided 
was the capacity to include SARS specifically as an illness for 
which we could require a quarantine. There are only a few----
    Mr. Bass. When was the last time you had that, you used 
that authority, actually quarantine? Do you know or not?
    Ms. Gerberding. Well, quarantine can be voluntary or it can 
be required. We have been using the voluntary quarantine 
authority fairly often meeting passengers coming in with 
suspected illnesses. We have used it a few times in the context 
of bioterrorism.
    I cannot tell you exactly when we last used the requirement 
when someone failed to comply with it voluntarily. But I can 
find out for you for the record. It has been a while, I will 
put it that way.
    Mr. Bass. You have described how State and Federal 
authorities are responsible for intrastate quarantining. Do 
they have the adequate knowledge information communication? I 
know this may be somewhat repetitive with your discussion in 
response to another question, but how do you feel about that?
    Ms. Gerberding. Well, I think that with the reorganization 
of the Department of Homeland Security and the awareness that 
SARS is an issue that does raise a quarantine and isolation 
needs, we have a Memorandum of Understanding that we have 
developed with the Department of Homeland Security. They have 
already stepped up to the plate to assist in the distribution 
of these health alert cards and to help us identify potentially 
ill passengers. There will be additional training in terms of 
protection for themselves and reassurance that they are not 
putting themselves in harm's way.
    So we are continuing to engage in an ongoing basis of 
interaction to ensure both the effectiveness, but also the 
safety of the personnel involved.
    Mr. Bass. Can you get SARS twice do you know or not?
    Ms. Gerberding. I do not know the answer.
    Mr. Bass. Maybe Dr. Fauci knows. Have you heard anything 
about that? Can you get it again once you get it?
    Mr. Fauci. We do not know that. There have been some 
reports of individuals who left the hospital and then came back 
who were apparently well. But when you carefully look at those 
individuals, there were other reasons for them to go back in 
the hospital.
    So the stage that we are in right now, I do not think there 
is enough data to make any statement about whether or not you 
can get SARS twice.
    Ms. Gerberding. If I could just add something. With 
coronaviruses that cause the common cold, there actually are 
examples of reinfection with the same strain. So the immune 
response that Dr. Fauci described may not be long term and we 
do not know yet. We will just have to wait to see.
    Mr. Bass. Ms. Heinrich, I was wondering if you could 
address the issue of a pandemic response plan. Do you think 
that with the lack of an influenza pandemic response plan have 
comprised response efforts to a broader SARS outbreak?
    Ms. Heinrich. Our point here is that if you have made the 
decisions about how you are going to purchase vaccine and 
antivirals that are expected to be in short supply and you have 
thought through your plans for distribution, and you have been 
very clear about how you are going to prioritize the 
populations that will be receiving these medications that are 
in short supply, you are going to be in a better position when 
you are in a crises mode, such as a large epidemic.
    In SARS at this point it is not directly applicable. 
Because as we have heard, we do not have drugs and do not have 
vaccines. But with the promising research, it sounds like we 
might in the future. And so I would say it has not compromised 
our current response.
    Mr. Bass. I guess this point was made, indirectly at least. 
It looks to me as if the SARS epidemic could be really 
catastrophic in countries where people are under nourished and 
lack access to health care. For example, a country like North 
Korea where people are eating grass, probably the fatality rate 
would just be astronomical. I do not know whether this is the 
proper panel to address that kind of issue. The issue for this 
disease, though, may be really in developing nations where very 
quickly it has the qualities to be cataclysmic. I do not know 
if anybody wants to comment on that. If not, I will stop.
    Okay. Dr. Gerberding, did you want to comment, and Dr. 
Fauci?
    Mr. Fauci. Certainly----
    Mr. Bass. What would this do in North Korea, for example? 
It is right next to China.
    Mr. Fauci. Well, I think we have to make the point again 
that we have been making this afternoon is that although we 
take this very, very seriously as a potential for a cataclysmic 
event, if you had a scenario where the virus did get into North 
Korea and the public health officials implemented the types of 
surveillance, isolation and quarantine that is going on now in 
countries that are beginning to control it, it is not 
impossible, but there would be little chance that it would 
spread like influenza could spread because influenza is so much 
more easily spread than SARS. But we cannot guarantee that. We 
take it seriously and we are concerned about developing 
nations, not only nations that have difficulty economically and 
with nutrition and with general health, but also nations that 
don't have the public health infrastructure to be able to 
implement the surveillance, the isolation and the quarantine. 
So there is concern on both our parts, I am sure.
    Mr. Bass. My time has expired.
    The Chair recognizes Ms. DeGette for 10 minutes.
    Ms. DeGette. Thank you, Mr. Chairman.
    Dr. Fauci, I listened with interest to what you said a few 
minuets ago about making the virus and the components widely 
available for research and development of vaccines and so on. 
It struck we are walking kind of a fine line here, because at 
the same time we are in race to eradicate SARS, we are also in 
a race to prevent bioterrorism. And I wonder if you have any 
concerns about terrorists trying to use the SARS virus if you 
are making it so widely available to researchers?
    I could easily see a bioterrorist trying to take and 
distribute the SARS virus. Dr. Gerberding?
    Ms. Gerberding. One of the criteria for distributing the 
virus or components of the virus from CDC is that the recipient 
entity has to demonstrate that they have the appropriate safety 
procedures, but also that they have the appropriate containment 
procedures.
    And we have had some criticism initially that we are not 
just immediately sending the virus out. And part of that 
relates to the fact that we do want to be sensitive to your 
concerns.
    This is not a virus that has the characteristics that would 
make a particularly efficient terrorism agent, but it is 
certainly causing harm and fear, and has the other elements of 
a potential terrorism target. So it has to be taken seriously 
from that framework.
    Ms. DeGette. Dr. Fauci?
    Mr. Fauci. We use the virus, Ms. DeGette, in a containment 
facility that is called BSL 3+, which is biosafety level three 
with a little bit more. So we do not allow the virus to go to 
any investigator that does not have, as Dr. Gerberding said, 
the capability of the proper safety containment of that.
    Ms. DeGette. And would that be the same containment level 
that you just described?
    Mr. Fauci. Right. Exactly.
    Ms. DeGette. So I just want to be able to assure my 
constituents. When you say that you are distributing this and 
you are breaking down bureaucratic barriers, you are not saying 
that you are cutting any corners on keeping it safe?
    Mr. Fauci. No. No. Not at all. And I would not use the word 
``widely distributed.'' I would use the word----
    Ms. DeGette. That was not my word.
    Mr. Fauci. No. No. Well, if I used it, I apologize. I do 
not think I did, but if I did it was not the correct word.
    We will be making it available to qualified investigators. 
Not only when we talk about reagents do we mean the virus 
itself, but we mean the appropriate antisera as well as the 
molecular components of it, which we use to probe for the 
presence of virus. And that is not something that, in and of 
itself, is infective or dangerous.
    Ms. DeGette. Thank you.
    Dr. Gerberding, I am wondering, you have explained some of 
the precautions that we are taking with planes and so on. But 
in your written testimony you have said that the United States 
could still enhance our public health infrastructure to better 
detect and respond to an infectious disease outbreak. I am 
wondering if you can explain what, if anything, you think that 
we need to do to enhance our capacity in this area?
    Ms. Gerberding. Well, sadly as I know you know, our public 
health system was really allowed to deteriorate for decades. It 
is tattered. And we, I think, see great heroism. Our system has 
been asked to respond to anthrax, to West Nile virus, to a 
smallpox vaccination program, and now to SARS. Boom, boom, 
boom. The people throughout the entire system have, in my view, 
heroically stepped up to the plate and have accomplished 
miracles.
    They have done that with a great degree of effectiveness 
and courage. And I think the investments that we have made in 
trying to shore up our public health system in the last many 
months have made a tremendous impact. Clearly the billion 
dollars that has gone out is not going to solve the problem, 
but we are much better off today than we were even a year ago.
    Ms. DeGette. Doctor, I apologize. We get limited time. And 
I know everything has been heroic. But what more do you think 
specifically can we be doing as Congress right now to help you 
in this effort?
    Ms. Gerberding. There are really six target areas here. One 
is preparedness planning. It is the plans, the products, the 
people and the practice that we need to make these systems 
work.
    The second is laboratory capacity. Our laboratories are 
getting a bit better because of these investments, but a lot of 
them are in dire straights and we have got a ways to go to 
shore them up and rehabilitate and renovate them.
    A third relates to the epidemiologic capacity to 
investigate and respond and notice when something has happened.
    A fourth relates to the information network, the capacity 
to rapidly communicate back and forth. The next is training. We 
have a tragedy in our public health workforce. We need trained 
professionals everywhere.
    And finally, it is sort of the overall communication 
strategy. How do we deliver information to the public in a way 
that is informative but not fearmongering?
    These are all critical capacities that are included in the 
grant program that we have put out, but we are going to need 
sustained investments to really bring them as far as they need 
to.
    Ms. DeGette. Thank you.
    Mr. Chairman, I am wondering if I can unanimous consent to 
have Dr. Gerberding supplement her testimony today by flushing 
out each one of those six areas that she has described for us, 
specific recommendations that you have where you need more 
resources and if possible, the kinds of money that you would 
need. I assume it would be quite costly and this is an ongoing 
issue.
    The Chairman and I traveled together down to Atlanta and 
saw some of the facilities. And I have seen the facilities up 
at Fort Collins that include, you know, grass growing up 
through the floor of research labs. So I know exactly what you 
are talking about. And I think it would be very helpful for the 
committee to have that supplement.
    Mr. Greenwood. If you could submit that, and perhaps put a 
little more detail in your answer to Ms. DeGette's question, 
and submit it in writing. The committee would appreciate that.
    [The following was received for the record:]

    I am enclosing as my answer, my response to a similar question 
asked recently by the Senate Appropriations Committee, Labor, Health 
and Human Services, and Education Subcommittee. Please note that my 
response represents my professional judgment as CDC Director and is 
provided without the constraints of the competing priorities that the 
President and his advisors must consider as budget submissions to the 
Congress are developed.

               RESPONSE TO PROFESSIONAL JUDGEMENT REQUEST

    Senator Specter: ``I understand the constraints under which you 
operate, but I want, for the official record, directly from you, the 
expert, your professional judgment concerning what resources CDC needs 
to protect the public's health.
    Please address all relevant public health issues, such as terrorism 
and Homeland Security, emerging infectious diseases, including SARS, 
buildings and facilities, the obesity epidemic, and other critical 
research that needs to be done by your agency. I am requesting that 
this information be delivered to the Subcommittee with ten (10) working 
days at the latest.''
    Dr. Gerberding: This response represents my professional judgment 
as CDC Director and is provided without the constraints of the 
competing priorities that the President and his advisors must consider 
as budget submissions to the Congress are developed.
    We believe that the President's budget is strong in its efforts to 
protect the public's health, especially in the context of all health 
priorities and needs. As I have stated publicly, I support the CDC 
request in the President's budget for fiscal year 2004. I am pleased 
that the President's request includes key increases in the areas of 
chronic disease prevention, global HIV/AIDS, and public health 
information systems, just to name a few.
    We are facing continued threats to health, such as terrorism, 
emerging diseases, the aging of the population. There are also 
expanding opportunities to improve health through science, technology, 
and communications. In summary, these actions fall into three broad 
categories:

 Investments in public health research, buildings and 
        facilities, and public health communications.
 Preparing for Health Threats Here and Abroad, which includes 
        investments in terrorism and emergency preparedness and 
        response; global disease detection; and security; and,
 Transforming Knowledge into Impact, which includes investments 
        in public health program accountability and health status 
        assessment.
    I have provided more detailed information about these actions 
below. This professional judgment estimate includes increases of $1.2 
billion in FY 2004 and approximately $1.8 billion per year for each of 
the next 4 years, for a total funding of $15 billion.

                                       CDC Professional Judgment Estimate
                                              (dollars in billions)
----------------------------------------------------------------------------------------------------------------
                                                                     FY 2004  FY 2005  FY 2006  FY 2007  FY 2008
----------------------------------------------------------------------------------------------------------------
CDC/ATSDR Request/prior year base..................................     $6.5     $7.7     $9.5    $11.3    $13.1
Prof. Judg. Increase...............................................     $1.2     $1.8     $1.8     $1.8     $1.9
CDC/ATSDR Prof. Judg. Total........................................     $7.7     $9.5    $11.3    $13.1    $15.0
----------------------------------------------------------------------------------------------------------------

    Terrorism, emerging global infectious diseases, and the obesity 
epidemic pose continued threats to health at the onset of the 21st 
Century. At the same time innovations in science, information 
technology and communications offer opportunities to improve health

            I. BRINGING PUBLIC HEALTH INTO THE 21ST CENTURY

Public Health Research
    Meeting the public health challenges of the 21st Century demands 
that our nation create the scientific evidence base. CDC's leadership 
and credibility is entirely dependent on the quality of the scientific 
evidence at the core of its public health programs, policies, and 
practices. Our nation's substantive economic investment in biomedical 
research has created new knowledge about the causes of illness, 
allowing us to diagnose and treat an astonishing array of medical 
conditions, and increasingly identifying effective prevention 
interventions. However, in order for these new discoveries to truly 
benefit people in all communities, they must be translated into 
effective public health programs. CDC's public health research--driven 
by concrete, human needs identified by frontline public health 
progams--can move knowledge from academic journals into the communities 
and clinics that reach people where they live. CDC's public health 
research moves basic research discoveries from the laboratory to the 
community, or ``from the bench to the trench.''
    CDC's response to SARS illustrates important facets of public 
health research--rapid pathogen identification, diagnostic testing, 
mechanisms of disease transmission, effectiveness of isolation methods, 
and effectiveness of prevention strategies. The experience with SARS, 
West Nile virus, anthrax, and other recent health threats shows the 
benefits of a cadre of public health researchers--at CDC, in academia, 
and in the private sector--to respond to emerging health threats.
    Public health research helps to define the best strategies for 
detecting new diseases, assessing the health status of populations, 
motivating healthy lifestyles at all life stages, communicating 
effective health promotion messages, and acquiring and disseminating 
information in times of crisis. Public health research can help 
overcome barriers that prevent people in every community from 
benefiting from the interventions we already know are effective.
    Public health research generates solutions. The pragmatic nature of 
public health means those solutions will be relevant to the health 
needs of a variety of populations in a variety of settings. This kind 
of practical, applied research enables our nation to plug the gap 
between what the laboratory tells us and the way people actually 
behave.
    Funds could be used to Build a comprehensive public health research 
agenda to prepare this nation for the threats of the new century These 
funds could help expand CDC's current research portfolio and further 
add to our strong record of public health accomplishments. The program 
would consist of three parts. First, an investigator-initiated, peer-
reviewed extramural grant program to derive the knowledge necessary to 
translate biomedical science into effective programs that directly 
affect quality and length of life and address health disparities. 
Second, an extramural peer-reviewed grant program to accelerate our 
capacity to respond rapidly to emerging and urgent public health 
threats, such as SARS. Third, extramural programs to engage and support 
the best innovative scientists in our medical and public health schools 
in the field of public health research.
    Substantial and sustained investment in public health research 
could generate targeted public health interventions that work for this 
nation's increasingly diverse population. Stronger, more robust public 
health research could translate to stronger, more robust public health 
programs and a healthier public.

Public Health Communications and Information Systems
    CDC could take greater advantage of 21st Century communications and 
information technology in its role as the premier credible source of 
information to help guide public health decisions, and expand its 
capacity to give people the information that will help them take charge 
of their own health decisions. To affect the public health, CDC should 
effectively market health information, in the same way that businesses 
market their products, by capitalizing on the growing array of 
communication tools to reach diverse populations where they are.
    In addition to the communications research that will help design 
cost-effective and impactful health communications strategies, we could 
exploit communications and information technology to help constituents 
and stakeholders have access to the information they need at the time 
they need it. A comprehensive Public Health Information Network could 
seamlessly connect people across our nation with CDC, other HHS 
agencies, state and local public health agencies, healthcare 
organizations, and many other stakeholders. This network could serve as 
the backbone for: emergency health alerts, distance learning, knowledge 
management, disease detection, reporting and surveillance functions, 
health tracking, secure data transmission, and many other functions 
important to public health. The public health information network could 
not only create and disseminate the information to promote health and 
safety in this country, but is a cost-effective means to support global 
public health advances. The Public Health Information Network is 
already in development, but funding could allow us to scale up and 
speed up its implementation.

Physical Infrastructure
    CDC is engaged in an intensive effort to rebuild our physical 
infrastructure. Using innovative procurement and design methods, we 
continue to build on time and on budget. Our ten-year master plan will 
replace World War II-era buildings with facilities that will meet the 
scientific research challenges of the 21st Century. For example, our 
Fort Collins, Colorado laboratory, which leads the nation's response to 
such diseases as West Nile virus, plague, and several Select Agents, 
will be moved from decades-old leased space to a modem safe and secure 
facility. Sustained investment in buildings and facilities improvement 
could allow CDC to recruit and retain world-class scientists and 
support them with state-of-the-art laboratory and research facilities 
so they can continue effectively protecting the public's health at home 
and abroad, to respond to public health emergencies, and to remain on 
the leading edge of emerging infections.

                 II. TRANSFORMING KNOWLEDGE INTO IMPACT

Program Accountability
    The 21st century health care system should be accountable to 
taxpayers for investments in public health programs. CDC could achieve 
substantial improvements in the public's health by implementing 
evidence-based programs through state and local health agencies that we 
already know are working in some locales. Expansion of programs that 
work will benefit people who now are not able to access health 
promotion, screening, and prevention programs, and could translate to a 
significant improvement of the health status of the nation.
    For example, robust programs to prevent chronic diseases, which 
account for 70% of all deaths each year, could generate significant 
returns.

 If every state adopted the programs we know can control the 
        onset and severity of diabetes, we could prevent 10,000 to 
        21,000 cases of eye disease and blindness, 165,000 cases of 
        kidney failure, and up to 43,000 amputations.
 If every state implemented the programs we know can reduce 
        obesity at full capacity, we could effect a substantial 
        reduction in the prevalence of obesity, which costs the health 
        care system an estimated $93 billion each year, and a 
        corresponding reduction in the incidence of associated 
        conditions like diabetes, heart disease, osteoarthritis, and 
        cancer.
 At full capacity, CDC's domestic HIV prevention programs could 
        cut in half the number of new HIV infections in the U.S., from 
        an estimated 40,000 per year to 20,000 per year; increase to 
        95% the proportion of HIV-infected people who know they are 
        infected; and link eight out of ten HIV-infected people in the 
        U.S. to appropriate treatment services.
 CDC studies find that we can reduce the risk of alcohol-
        exposed pregnancies by \2/3\ with full implementation of 
        programs that counsel high-risk women.
 Full implementation of CDC's injury prevention work promoting 
        restraint use among motor vehicle occupants could save up to 
        9,000 lives and prevent as many as 160,000 non-fatal injuries 
        each year.
 Full implementation of CDC's occupational safety and health 
        initiatives would reduce the direct costs of occupational 
        injuries, which Liberty Mutual's 2002 Workplace Safety Index 
        estimates at more than $40 billion.
 Putting a comprehensive environmental health program into 
        every state would eliminate childhood lead poisoning, which 
        affects more than I million children under the age of six, by 
        the year 2010. Eliminating lead poisoning would reduce the 
        prevalence of learning disabilities, behavior problems, and 
        other serious problems associated with high blood lead levels.

Assessment of Health Status
    Health policy decision-makers can improve decisions with better 
state and local data. Equally, improved, accurate information about the 
health status of Americans will help improve the allocation of 
resources in the highest priority health needs. Reliable health 
information underpins every effort to improve health, and our nation 
may be missing opportunities to make the strongest impact. At the 
national level, core health surveys could benefit from expanded 
funding. Changing needs, populations and technologies call for more 
resources to keep pace. Considerable gaps remain in our understanding 
of racial and ethnic disparities in health, and CDC's performance in 
generating information required to track health goals and holding 
programs accountable has been limited. CDC could build an effective, 
nationwide system to deliver the information needed to improve health.

           III. PREPARING FOR HEALTH THREATS HERE AND ABROAD

Terrorism Preparedness and Emergency Response
    CDC plays a critical role in ensuring that the nation's public 
health system is prepared to respond to public health emergencies, 
particularly with respect to chemical, biological, radiological and 
nuclear terrorism, and to emerging infectious diseases such as SARS. 
CDC has taken substantial strides in strengthening the system. Yet 
substantially more work remains.
    CDC, states and communities could use additional funds to address:

 Comprehensive regional preparedness planning and exercise, 
        including plans for isolation and quarantine of potential 
        infected persons (with increased personnel at ports of entry, 
        which would have assisted with SARS.)
 Further improvement of CDC and regional laboratories to 
        provide coordinated surge capacity in times of pandemics or 
        terrorist attack,
 a nationwide electronic data system to detect emerging 
        threats, that use existing confirmation from national sources 
        (such as pharmacy chains) and local sources (such as emergency 
        department visits) to detect and monitor terrorism and emerging 
        infectious diseases,
 Comprehensive network of satellite communication and other 
        communications capacity to ensure health information can reach 
        all clinicians in times of crisis.

Global Disease Detection System
    CDC could continue to strengthen the capacity of the public health 
community, both at home and abroad, to respond to global threats, such 
as SARS, pandemic flu and bioterrorism attacks. CDC's Global Disease 
Detection System would seamlessly connect local and state health 
departments with CDC's and its detection system through these 
components:

 Provide technical support to ensure clinicians and 
        laboratories around the globe can diagnose emerging infectious 
        disease events.
 Link clinicians and laboratories via secure methods with CDC 
        and the WHO to ensure real time reporting of emerging threats
 Support sentinel sites in key regions around the globe to 
        ensure in-country disease detection and reporting and prompt 
        referral to a regional laboratory service
 Provide for emergency transport of infectious specimens, 
        evacuation of contagious patients, and movement of CDC's 
        Emergency Response Teams worldwide. These capacities are 
        critical to mitigate the consequences of a catastrophic public 
        health event, whether the cause is an intentional act of 
        terrorism or the natural emergence of a deadly infectious 
        virus, like SARS.

Security
    While CDC is engaged in protecting the health of this country and 
the world, a substantial investment is required to assure the security 
of CDC assets. These include personnel, scientific equipment and 
laboratory specimens. These resources need to be protected in times of 
normal operations, during emergencies, and when continuity of 
operations is required.
    We believe that the President's budget is strong in its efforts to 
protect the public's health, especially in the context of all health 
priorities and needs. As I have stated publicly, I support the CDC 
request in the President's budget for fiscal year 2004.

    Ms. Gerberding. I will certainly do that.
    Ms. DeGette. Thank you.
    I am wondering if anybody on the panel can talk to us about 
what specifically is the status of the search for a vaccine. We 
have heard about that you are putting out proposals and so on. 
But where are we with that search, and does someone have any 
idea how soon we might have some kind of vaccine?
    Dr. Fauci?
    Mr. Fauci. Yes. There are multiple concepts that are being 
pursued. The one that it is the simplest and most 
straightforward we are pursuing at the NIH with our own 
investigators as well as in collaboration with industry. And 
that is to grow the virus up, inactivate or kill it, vaccinate 
a monkey model, an animal model and challenge the animal. That 
is something that will take several months to prove or disprove 
the concept that you can feasibly protect an animal. Once that 
is shown to be possible or not, then you move into phase one 
studies. And then, as we are already are partnering with 
industry, to scale up to have enough to give phase one for 
safety, then phase two for more safety and then ultimately to 
do a Phase 3 trial.
    Also we can invoke, if necessary, the animal capabilities 
of being able to show true effectiveness in an appropriate and 
relevant animal model.
    There are other approaches that are simultaneously ongoing 
that are more molecularly based where you take the genes, now 
that we know the sequence of the SARS virus, insert them into 
other benign viral carries like adenovirus.
    We have already started a collaboration with GenVec company 
through the Vaccine Research Center at NIH to pursue that 
approach.
    There is an approach to make large amounts of purified 
protein through a baculovirus vector.
    And then there is the DNA approach.
    And then finally, we have not started this yet but 
certainly this is something we would consider, is the live 
attenuated virus approach.
    So it is a combination.
    Ms. DeGette. And what kind of timeframe? I mean, those two 
latter ones I think would take longer.
    Mr. Fauci. Yes. They take very long. I would think at best 
the one--the two that are actually ongoing now are the vector 
approach with the adenovirus and the whole killed or 
inactivated.
    To prove a concept that you can do it in animal is going to 
take up to a year. So, hopefully, by the end of this calendar 
beginning of next calendar year we will be able to show that.
    Even at rather rapid speed to get a vaccine that is safe, 
effective and approved for use and distribution in humans will 
take a few years. So it is not going to be something that is 
going to be overnight.
    Ms. DeGette. Thank you very much.
    Thank you. I yield back.
    Mr. Greenwood. The gentlelady from Chicago is recognized. 
Ten minutes.
    Ms. Schakowsky. Thank you, Mr. Chairman.
    And thank you panel. Appreciate it very much.
    I wanted to ask Dr. Gerberding about--I know some questions 
were already asked about what happens in the protocol at 
airports. But O'Hare Airport has the most international flights 
of any, and so it effects our area.
    I am wondering you said and then they are referred. If you 
could follow through with and then they are referred to an 
appropriate setting, is it diagnoses, determination, 
quarantine, what? What happens when they are possibly suspected 
of having SARS?
    Ms. Gerberding. Thank you.
    I do not know specifically at O'Hare if the medical 
evaluation clinic is onsite at the airport, or whether they 
utilize a nearby medical facility of some sort. But I will be 
happy to provide you that information. It is probably onsite, 
because it is such a large airport.
    Ms. Schakowsky. The CDC has a division of Global Migration 
and Quarantine based in O'Hare International Airport. Does that 
mean yes, we do have?
    Ms. Gerberding. CDC has its facility there. We have 
personnel there.
    Ms. Schakowsky. Right.
    Ms. Gerberding. But in terms of an actual medical clinic.
    Ms. Schakowsky. Okay. That is not it.
    Ms. Gerberding. So what happens is a quarantine officer in 
the SARS environment if a flight is landing in O'Hare that has 
come, let us say, from Hong Kong.
    Ms. Schakowsky. Yes.
    Ms. Gerberding. The flight is met by a quarantine officer 
or a deputy, a Federal official who is deputized to act on 
their behalf. The crew is interviewed to determine whether or 
not there were any passengers that were ill or appeared to be 
ill. If there was such a passenger, the quarantine officer 
would assess that passenger, board the plane, interview or 
assess the situation. And if there was a concern, they may do 
one of several things.
    They may take a more extensive interview and do a very 
quick physical assessment of the patient. If there seemed 
credible reason to be concerned, they would remove the 
passenger from the airplane and take them either to the medical 
clinic at O'Hare or whatever is the dedicated medical 
assessment facility. In addition, they would ask the remaining 
passengers to provide information about where they could be 
contacted if there did seem to be a communicable threat to 
them.
    This is a time consuming process, and part of the reason 
when we have to board a plane to assess a situation, there is a 
long delay. The plane sits on the ground. And one of the things 
that is going on there is that the passengers are being asked 
to provide information.
    Ms. Schakowsky. So you do all this before anybody gets off?
    Ms. Gerberding. Correct.
    Ms. Schakowsky. Yes.
    Ms. Gerberding. Now if something has gone awry and that 
step was missed, then it is also possible to go back in and 
find the passengers. At least for a period of time the airlines 
keep the manifest of passengers. But that is a much more time 
consuming process, because we do not have all the address 
information and it takes a lot of detective work and a lot of 
work on the part of the State health officers.
    Ms. Schakowsky. You said you have not utilized the 
quarantine? All of it has been voluntary so far?
    Ms. Gerberding. We had a situation before the President's 
Executive Order was signed where an individual with arrival 
from a SARS country who had an illness did not agree to stay 
for the evaluation of their illness. They left the airport and 
we had no authority at that point in time to retain them. That 
individual then traveled on a train, and this resulted in a 
very extensive search for potentially exposed people and a lot 
of extra work for our health departments. That was one of the 
major examples that helped us identify the key importance of 
getting that Executive Order signed, and that is really why I 
think the President was able to expedite action on that issue.
    Ms. Schakowsky. Is there anything in the Executive Order 
that has provisions to protect people who do not have SARS from 
being detained and quarantine? Anything to protect the rights 
of people for whom this may not be appropriate?
    Ms. Gerberding. Yes, I understand the concern. We are 
trying to balance here the public issue with the rights and 
inconvenience to individual citizens. And I can only say that 
we have had quarantine officers involved in these kinds of 
assessments for many decades now. And I think that we are 
public health officials and we really do try to be respectful 
of citizens rights. And we do not take an action like this 
lightly.
    There are in individual States and in individual courts 
provisions for maintaining someone in quarantine. There is a 
right of appeal and some other steps that can be taken if there 
is a more prolonged intervention.
    Most often what happens is there is a concern, there is an 
assessment. It is deemed to be not a threat and the individual 
is inconvenienced temporarily, but they can go on their way.
    Ms. Schakowsky. And is there a limit of the number of the 
days a person would be held in quarantine?
    Ms. Gerberding. The authority allows quarantine of exposed 
persons for the period of time at which they would present a 
threat to others. More to the point, and just for a point of 
clarification, isolation is what happens to people who have 
quarantine, is what happens to people who are exposed but not 
sick. So mostly what we are talking about in airports is 
isolation of potentially infectious people. And we can under 
various authorities retain someone in isolation for as long as 
they pose a threat to the health of other individuals.
    Ms. Schakowsky. And how long is that? How long is the 
exposure period?
    Ms. Gerberding. It depends entirely on the infectious 
disease. But for SARS we do not know. We actually do not know 
the full period of infectivity. But WHO has developed criteria 
for discharge and has made the decision based on observation of 
the many patients that have been ill so far, that once the 
person is recovering from their infectious illness and they can 
wear a mask to cover their own face and mouth when they cough 
or sneeze, that they can be released from the hospital and are 
allowed to go home.
    Ms. Schakowsky. And when you speak of isolation, that is in 
the hospital?
    Ms. Gerberding. Most often it occurs in the hospital. But 
in this country where we have cast such a wide net and probably 
have many cases listed as probable SARS cases who do not have 
SARS, we do have many patients who have been in isolation in 
their homes. They have the capacity to do that, and there is a 
system of monitoring and evaluation that has assured the 
responsible health officials that that is an appropriate step.
    Ms. Schakowsky. Thank you.
    I cannot see from here, is Ms. Heinrich? Ms. Heinrich, I 
was looking through, though I have not read carefully the GAO 
report, did you take into consideration at all things like 
changes in Medicaid and Medicaid funding, and how that might 
impact the ability of public health systems to respond to a 
SARS outbreak?
    Ms. Heinrich. We were drawing from several reports that we 
have done in terms of putting together this testimony. And when 
you are looking at the State and local levels in preparedness, 
we did not look specifically at Medicaid funding.
    The component of our report that focused on emergency room 
crowding and hospital capacity, we certainly did look at 
Medicaid funding as well as uncompensated care or lack of 
insurance and certainly found that in those communities where 
you have a higher rate of no insurance or you had hospitals 
that were more dependent proportionately on Medicaid funding, 
they had more problems with crowding. And what we are 
contending is that if our hospitals are having difficulty with 
crowding now, and it was occurring to a greater extent in 
communities that have large populations, and that is indeed 
where across the world we are seeing the SARS epidemic play out 
to the greatest extent, yes that would be a factor in terms of 
being able to respond to a large SARS epidemic.
    Ms. Schakowsky. So any decrease in Medicaid funding would 
exacerbate the problem of a proper response to a SARS outbreak?
    Ms. Heinrich. It certainly has the potential to, yes.
    Ms. Schakowsky. Okay. Thank you.
    Mr. Chairman, I would just like to ask now that I be able 
to put my statement into the record. And I thank you.
    Mr. Greenwood. Without objection, the gentlelady's 
statement will be incorporated into the record.
    The Chair wishes to----
    Ms. DeGette. Mr. Chairman, while we are on the subject, I 
would ask unanimous consent to place Mr. Dingell's statement 
and any other members who wish to place----
    Mr. Greenwood. Without objection, the record will remain 
open for that purpose.
    We have kept you quarantined for about three and a half 
hours, and we have decided it is safe to release you.
    Thank you very much for not only your testimony, but all 
the work you do on behalf of the country. Thank you.
    You are excused. And we would call the second panel.
    And our witnesses from the second panel will be Mr. Barry 
R. Bloom, Dean of the Harvard School of Public Health.
    Dr. Georges Benjamin, Executive Director of the American 
Public Health Association.
    Dr. Jared N. Schwartz, College of American Pathologists.
    And Mr. James G. Hodge, Jr, Deputy Director of Center for 
Law & the Public Health of Johns Hopkins Bloomberg School of 
Public Health.
    And Ms. Karin Kerby, Registered Nurse, Loudoun Hospital 
Center in Leesburg, Virginia.
    We thank you for your presence today and for your patience.
    And I need to inform you that this is an investigative 
hearing. And when this subcommittee holds investigative 
hearings we take testimony under oath, and I need to ask if any 
of you object to giving your testimony under oath this 
afternoon. Okay. Seeing no such objection, I would advise you 
that pursuant to the Rules of this committee and the House, you 
have the right to be represented by counsel this afternoon. Do 
any of you wish to be represented by counsel?
    Okay. If you would then stand and raise your right hands.
    [Witnesses sworn.]
    You may be seated. You are under oath.
    And, Dr. Bloom, we will begin with you and you are 
recognized for 5 minutes for your opening statement. Welcome.
    You will need to push that button on your microphone and 
pull it close.

  TESTIMONY OF BARRY R. BLOOM, DEAN, HARVARD SCHOOL OF PUBLIC 
   HEALTH; GEORGES C. BENJAMIN, EXECUTIVE DIRECTOR, AMERICAN 
   PUBLIC HEALTH ASSOCIATION; JARED N. SCHWARTZ, COLLEGE OF 
AMERICAN PATHOLOGISTS; JAMES G. HODGE, JR., DEPUTY DIRECTOR OF 
CENTER FOR LAW AND THE PUBLIC HEALTH OF JOHNS HOPKINS BLOOMBERG 
SCHOOL OF PUBLIC HEALTH; KARIN KERBY, REGISTERED NURSE, LOUDOUN 
                        HOSPITAL CENTER

    Mr. Bloom. Thank you, Mr. Chairman and members of the 
subcommittee. I am appreciative of the opportunity to share my 
thoughts, and am very grateful to be able to here.
    I am Barry Bloom, Dean of the Harvard School of Public 
Health.
    You have heard, I think, extraordinarily good testimony 
from a group of experts. I would like to just focus on three 
issues as briefly as I can.
    The first is a question that is raised about the earlier 
questions on terror, is SARS to be taken as seriously and is it 
a frightening threat? And it would seem to me it is for a 
number of reasons.
    One is that anything transmitted by the respiratory route 
has a history of having the potential to do very bad things. 
Twenty to 40 million people succumbed to the 1918 flu, as you 
know. Perhaps you know less well that when measles was 
introduced into the Hawaiian Islands, again a new virus in a 
new community, it wiped out in 18 months 90 percent of the 
population.
    And finally tuberculosis, now respiratorial disease endemic 
to many countries around the world, infects 8 million people 
and kills 2.4 million every year.
    So it really must be taken seriously and the challenge then 
is how to communicate that without causing unnecessary terror, 
and that is what ways we have to empower people to protect 
themselves.
    A second point is that I believe that the agencies that 
have taken a stand on this issue, starting with the courageous 
decision of WHO knowing that it was going to cost billions of 
dollars in lost trade to whatever countries were put under 
global alert, would cause enormous inconvenience. These are 
decisions that are not taken lightly and the people that you 
have heard here today, I think have had an enormously 
courageous and foresighted way of thinking about it. The impact 
is enormous if they guessed wrong as in the case of plague in 
India. India lost $2 billion. A not so big epidemic in Peru 
cost $2 billion. And the estimates here is that even with the 
early warnings, China may lose up to $60 billion from its 
economy according to the Economist Magazine.
    So that I think that these agencies have done a fantastic 
job. And I think that to the question why we have not got more 
of an outbreak here, Dr. Gerberding and everyone says that we 
have been lucky, and that is wonderful. But I think that the 
preparedness that came from bioterrorism that you heard from 
Mr. Hauer and the other speakers in every State has been a 
complete discontinuity in public health over the previous time 
before September 11, it is not fully protective of any new 
disease.
    I would point out that a patient in Toronto who spent 12 
hours in an emergency room is one of the key people who have 
spread to the Scarborough Grace Hospital. You don't have to be 
greatly imaginative to know that someone could come into an 
emergency room at some hospital in this country and spend very 
long periods of time before they were isolated. We have to 
tighten up on that. But respiratory infections, flu pandemic 
and SARS is on everybody's mind, and I think has been done 
terrifically.
    Third, I did give in my written testimony the view that 
these agencies are making do with less than is adequate and I 
think are gravely under funded. I would find it hard to justify 
an increased effort against emerging infectious diseases when 
the budget, as I understand it between the fiscal year 2002 and 
2003 budgets, dropped by in essence a half a billion dollars.
    I find it extraordinary that the emerging infections budget 
in that same timeframe for the National Center for Infectious 
Diseases, except for three targeted diseases, was reduced by 
$10.5 million. These are people who are responsible for dealing 
with food and all kinds of other infectious diseases now being 
mobilized in an exhaustive way.
    I was at CDC and a week ago the bags under their eyes are 
enormous. At every level these people are working at full 
capacity, going to Geneva, going to China with very few 
resources that are flexible enough to allow them to do what we 
need them to do.
    So my plea would be they do need more resources. I would 
say, for example as you will hear in a moment, that if we want 
to strengthen our international capabilities, only 5 percent of 
the NIH budget or Dr. Fauci's budget is spent on international 
research. And we need to strengthen that.
    Finally, my final point would be why do we need to 
strengthen that? Not only is it a good thing and a right thing 
to do for the country that has the greatest biomedical 
establishment in the world, but to protect against emerging 
infection requires information.
    Why would any country make that information available to 
the United States of America if it threatened their economies, 
unless there was some return? And my view is with 
collaborations between the CDC and WHO, between the NIH and 
universities and health centers in developing countries, with 
collaborations between universities that train people and 
experts in China or North Korea, that is the best insurance we 
have to protect this country against emerging infections. And 
in so doing, it will not only protect our health, but I believe 
and as I have indicated, will change the image of this country 
from self-interest to human interest.
    Thank you.
    Mr. Greenwood. Thank you very much, Mr. Bloom.
    Dr. Benjamin?

                TESTIMONY OF GEORGES C. BENJAMIN

    Mr. Benjamin. Good evening. And thank you very, very much 
for being here. And also let me just thank the committee for 
their support for public health.
    I have been at the American Public Health Association for 
about 5 months. Prior to that I was the health officer for the 
State of Maryland, which basically means that I had to go 
through West Nile virus, anthrax, malaria and if infectious 
diseases weren't enough, a few snipers in our community.
    We have as a public health community learned a lot since 
1999. And let me just talk about those briefly and then let me 
talk about some of the things that I think we do need to do, 
and more specifically within our States and the local 
communities.
    No. 1, obviously we have learned to get ahead of an 
epidemic. You know, when West Nile virus entered our community, 
there was a kind of, ``well, we do not quite want to deal with 
that issue,'' and there was a kind of ``go slow but let us deal 
with it'' mentality. You do not see that with SARS. We saw a 
very aggressive, let us get out ahead of this epidemic and get 
our arms around it very quickly. And more importantly, it was 
done before it hit the shores of this country.
    The second thing is the concept of communicating frequently 
and widely. You do not hear a lot of complaints by practicing 
clinicians that they are not hearing the information about SARS 
because there is a lot of communication going on not only 
between the Federal Government and the local State and local 
public health officials, but also with our clinical colleagues 
as well.
    We learned a lot about getting clear consistent messages, 
how extraordinarily important that was so that we are speaking 
from the same sheet of music so that as the media brings us up 
on split screen, we are pretty much trying to say, to the 
extent we can, the same thing unless there is a big 
disagreement. And then you certainly hear those publicly.
    Learn to use and apply the science that we know and not 
guess. Because that creates some problems and you hear a lot of 
people trying to tell you exactly what we do know, trying to 
tell you what we do not know and not doing a lot of guessing, 
because this is clearly a new virus and we just need to watch 
it as it goes forward.
    We certainly learned that the best treatment of fear is 
good information and you share that information broadly so that 
people are not as afraid as they could be without good 
information.
    And we also learned, finally, that public health is 
actually good and it is possible to protect the public, but 
more importantly only able to do so if adequately staffed and 
adequately resourced.
    We know there are several capacities that the public health 
system needed locally. We clearly need the ability to prevent 
an outbreak through good science. And we also need the ability 
to know when a disease has entered the community, be able to 
track that disease, provide a definitive diagnoses clinically, 
but from a laboratory perspective to confirm it. To be able to 
contain the disease, much of what you talked about with the 
last panel. Ensure proper treatment. But those capacities come 
at a cost. Because local health departments and State health 
departments are having to do that by pulling resources from a 
variety of places.
    Certainly the public health preparedness dollars we got 
helped a lot, but I can tell you that the base upon which they 
were built is being continually eroded by reductions at the 
State and local level, by other problems with the public health 
system. And the fact that this is going to take a while and we 
are going to have put a sustained investment in public health.
    And finally, I think that one of the things we really want 
to do is begin thinking about not simply throwing money at 
every single crises that comes up. That we need to sit down and 
say okay, what is the blueprint for the best public health 
system on the planet, and then let us figure out what we want 
and fund it properly. And it will take us a few years to get 
there, but I think that this is probably the most important 
health issue that we need to do over the next several years, is 
rebuild this public health system and do it in an organized, 
thoughtful manner with enough money to do the job, and that 
means doing it at both the Federal level, at the State level 
and at the local level.
    Thank you very much.
    [The prepared statement of Georges C. Benjamin follows:]

Prepared Statement of Georges C. Benjamin, Executive Director, American 
                       Public Health Association

    Mr. Chairman and members of the subcommittee, my name is Dr. 
Georges Benjamin and, I am the executive director of the American 
Public Health Association (APHA). APHA is the oldest and largest public 
health association in the world, representing approximately 50,000 
public health professionals in the United States and abroad. I am very 
grateful for the opportunity to discuss Severe Acute Respiratory 
Syndrome (SARS) and its implications for the future.

                   THE PROBLEM OF EMERGING INFECTIONS

    SARS is an emerging infectious disease. It is not the first and 
certainly will not be the last. In fact, within the past 30 years, we 
have seen 35 new infectious diseases around the world several within 
our own borders. One can anticipate that the problem of emerging 
infectious diseases is likely to become more acute in the future, not 
less. In fact, infectious disease in general continues to be a major 
public health problem despite the wonder of antibacterial agents, 
improvements in health care and a better understanding of the 
pathogenesis of disease. The best illustration of this issue is the 
U.S. death rate from infectious disease. This rate, which dropped in 
the first part of the 20th century, is now double what it was in 1980.
    The Institute of Medicine of the National Academy of Sciences 
attributed the surge in infectious disease to 13 specific changes in 
the world and the way we live. Those 13 factors are microbial 
adaptation and change; human susceptibility to infection; climate and 
weather; changing ecosystems; human demographics and behavior; economic 
development and land use; international travel and commerce; technology 
and industry; breakdown of public health measures; poverty and social 
inequality; war and famine; lack of political will; and bioterrorism.

                       LESSONS HAVE BEEN LEARNED

    The lessons learned from managing two recent infectious outbreaks, 
West Nile and anthrax (one apparently naturally occurring and one 
intentional), have helped the public health community address SARS. 
These lessons demonstrated the need for a strong public health system 
as one component of an integrated homeland security program. We also 
learned what capacities we need to ensure preparedness and where some 
of the gaps remain that must be filled. Ensuring an effective public 
health infrastructure is a top priority for the APHA. An adequate 
public health infrastructure to manage the infectious disease threat is 
one where there is an adequate work force that is well trained, with 
the proper tools and resources to effectively respond to current and 
emerging infections. SARS is an excellent example of the need for a 
strong public health system and the infrastructure required for it to 
be effective. This infrastructure includes the capacity to:

 Prevent disease outbreaks;
 Know when a new disease has entered the community;
 Provide definitive diagnosis and laboratory verification;
 Track the spread of the disease;
 Contain the disease;
 Ensure effective treatment;
 Demonstrate an adequate legal framework for this work;
 Effectively communicate with the public, medical and public 
        health providers and other stakeholders; and
 Partner on a local, regional, national and global level.
    The effective use of many of these capacities have been 
demonstrated at the federal, state, and local level in the initial 
response to SARS, and represents a significant improvement over our 
response to the anthrax attacks of 2001 and some improvement over the 
early response to West Nile virus.
    In the fall of 2001, I was Secretary of health for the state of 
Maryland. During the anthrax outbreak, as with West Nile virus two 
years before, we learned a lot that helped the public health community 
to better prepare to respond to SARS. We learned that any disease 
outbreak is a community event that can quickly grow in scope and size. 
These events require a high degree of coordinated communication and 
cross-jurisdictional cooperation. It is critical that in times of 
crisis, the public trust their public health officials and receive a 
clear, consistent message. In order to accomplish this, we have learned 
that rapid, early communication by credible spokespersons is essential.
    During the current SARS event, the U.S. Department of Health and 
Human Services communicated early and frequently to a broad range of 
both medical and public health providers. What is important is that 
this communication occurred before the disease entered the borders of 
our country and gave us a head start on preparedness. These briefings 
were held by experts who were able to adequately tell us what they knew 
and what they did not know. Today there are frequent SARS briefings 
from either the high-tech, secure, command center at the Department of 
Health and Human Services or the Centers for Disease Control and 
Prevention (CDC) new Emergency Operations Center.
    The Health Alert Network, which received its first real workout 
after September 11th, has become a mainstay of communication to the 
medical and public health community. CDC has set up and is using a free 
registry to provide clinicians with real-time information to help 
prepare for and respond to terrorism and other emergency events. 
Participants receive regular e-mail updates on terrorism and other 
emergency issues and on training opportunities relevant to clinicians. 
This highly focused, centrally coordinated effort has made a difference 
in the ability of local public health authorities to control the 
outbreak and also to educate clinicians and the public in their 
communities. This rapid and consistent message has allowed for those 
clinicians and medical facilities to properly manage suspect and 
probable SARS cases in the United States with minimal risk to others.
    Anthrax also taught us that it was important to aggressively 
coordinate our external communications efforts, not just our response 
efforts, very early in order to ensure that we had control of the 
message and that we spoke with a single, consistent voice. This 
approach is imperative to avoid confusion, misinformation and panic. 
This is extremely important in an event like SARS when our 
understanding of the science shifts rapidly. Both the World Health 
Organization (WHO) and the CDC have done a much better job at being 
clear about telling us what they know and what they do not know, and 
quickly sharing new knowledge when it becomes available.
    We need to be proactive in monitoring the global situation. SARS is 
a good example of a proactive approach and how with good public health 
practice and some luck, we have had only a few cases and no deaths in 
the United States. More than 20 years ago HIV--the virus that causes 
AIDS--emerged from Africa and since then has killed millions of people 
and devastated entire communities and countries. When West Nile first 
hit our shores it also was not new. West Nile virus was first isolated 
in Uganda in 1937 and was later recognized in Egypt in the 1950s and in 
Israel in 1957. In the 1990s, outbreaks occurred in Algeria, Romania, 
the Czech Republic, the Democratic Republic of the Congo and Russia. 
When it finally reached our shores in 1999 we were perplexed and 
surprised. It has now spread throughout North America and will probably 
enter the few remaining communities during the coming summer. The 
response to SARS has been much more proactive with every community on 
alert and vigilant.
    Similarly, when the anthrax outbreak occurred in our region, much 
of the management focus initially was narrowly directed at the District 
of Columbia with less attention to Maryland and Virginia. This made it 
very difficult to have an effective regional strategy. SARS not only 
required managing a regional strategy around individual cases but a 
global one as well. This is a substantial improvement over our response 
to the anthrax attacks. I do want to caution, however, that our limited 
experience with suspect and probable SARS cases is limited and we 
should not get overconfident in our capacity to manage and coordinate a 
large biological event.
    The CDC and the WHO have been doing yeoman's work on SARS and there 
has been unprecedented global communication. The WHO has been effective 
in helping to contain SARS and coordinating research at major 
institutes around the world once the disease became known. As cases 
popped up from China to Canada, WHO officials linked a network of 11 
laboratories in nine countries to identify the agent causing the 
illness and devise treatments. In the past, international laboratories 
have competed to solve an epidemiological challenge. But in this case, 
labs have been exchanging data on a daily basis. Lines of communication 
between research facilities, physicians treating cases, and the public 
have been strengthened. Recently, scientists in Canada and the United 
States have broken the genetic code of the coronavirus that apparently 
causes SARS.
    There are also global lessons to be learned. The WHO's Global 
Outbreak Alert System, set up after its experience with Ebola, and 
unfortunately proved inadequate because China failed to alert the WHO 
immediately. Currently, notifications are voluntary and limited to 
yellow fever, plague and cholera. The SARS experience should be used to 
identify gaps in the global response system. SARS also serves as a 
reminder that there is no alternative to effective multilateral 
institutions and global cooperation. While SARS is a human tragedy, 
what is remarkable is how quickly--leaving aside earlier Chinese 
secrecy--the world has joined together in responding to it. In June, 
WHO will host an international scientific gathering to plan the next 
steps in dealing with the disease.

                          NEEDS FOR THE FUTURE

    SARS has reminded us once again that in this age where we not only 
have a global economy but a globalization of disease, the 20th 
century's model of protecting ourselves from disease is no longer 
sufficient. We need to look at new, more strategic models of doing 
business.
    The SARS outbreak and others, including anthrax and West Nile, have 
also exposed gaps in our own public health system in the United States. 
We are at a critical juncture in public health. For many years, experts 
have been warning us that our nation's public health infrastructure is 
in disarray. Recent preparedness funding has provided for improvements 
in the public health preparedness infrastructure, however gaps remain. 
There still is a lack of adequate personnel and training, laboratory 
surge capacity and there are still holes in our communications 
networks. There remain serious gaps in our disease surveillance 
systems. These and other shortcomings have been known for sometime, but 
have also been more recently documented by the Institute of Medicine, 
the General Accounting Office and others as current pressures on the 
public health system make these failings more visible. One big problem 
today is the erosion of the foundation upon which we are building the 
new preparedness system due to funding cuts at the federal, state and 
local level in core public health programs. Today these programs allow 
for a surge capacity in public health to address emerging issues. This 
foundation needs to be strengthened.
    Perhaps never before has it been so important to shore up our 
public health system. This system is being asked to support our 
response to some of the most threatening emerging diseases of our time 
and to prepare for diseases yet unknown. In this age when biological 
and chemical terrorism is added to the portfolio of public health 
threats, we need to be assured that the system works and works well.
    I want to thank you for your support for the emergency supplemental 
funding this year for both the smallpox preparedness and the SARS 
response effort. These funds are critically important. However, it is 
time for Congress to take the next step and support the public health 
system in a more holistic way--to support public health as a system--
not crisis by crisis. The public health system serves as the front line 
for our nation's public health defense system against emerging and 
reemerging infectious diseases. From anthrax to West Nile to smallpox 
to SARS, the CDC is our nation's and the world's expert resource and 
response hub, coordinating communications and action and serving as the 
nation's laboratory reference center. It continues to need strong 
support from Congress.
    Public health is being asked to do more with less. Unless we start 
supporting our public health base in a more holistic way, we are going 
to continue to need to come to Congress for special emergency requests 
for funds as each new threat emerges. Funding public health outbreak by 
outbreak is not an effective way to ensure either preparedness or 
accountability.
    In the absence of a robust public health system with built-in surge 
capacity, every crisis ``du jour'' also forces trade offs-attention to 
one infectious disease at the expense of another, infectious disease 
prevention at the expense of chronic disease prevention and other 
public health responsibilities. This is true especially given the 
current budget pressures facing states and the federal government.
    It is time to think more strategically about the future of our 
nation's public health system, to develop a blueprint for where we want 
to be 10 years from now and how best to fund it. Because of their 
impact on society, a coordinated strategy is necessary to understand, 
detect, control and ultimately prevent infectious diseases. We believe 
that far more significant investments in public health will need to 
occur if we are to prepare the nation's public health system to protect 
us from the leading causes of death, prepare us for bioterrorism and 
chemical terrorism, and respond to the public health crises of the day.
    I hope we all recognize that this SARS event is not over and that 
we still have a ways to go to ensure containment. In the future we will 
always be one plane ride away, one infected person away, and one 
epidemic away from a global tragedy. We cannot lower our guard, not 
today, not tomorrow.
    Mr. Chairman and members of the subcommittee, I thank you for this 
opportunity to testify before you today about one of the most important 
public health issues of our time. On behalf of the American Public 
Health Association, I look forward to working with you to strengthen 
our nation's public health system.

    Mr. Greenwood. Thank you, Dr. Benjamin.
    And let me correct the record, it is Dr. Bloom, not Mr. 
Bloom.
    Dr. Schwartz for 5 minutes, please.

                 TESTIMONY OF JARED N. SCHWARTZ

    Mr. Schwartz. Good afternoon, Chairman Greenwood and 
committee members. On behalf of the College of American 
Pathologists I appreciate this opportunity to participate in 
today's hearing on SARS.
    The College is a national medical specialty society 
representing over 16,000 pathologists who diagnose disease 
through laboratory medicine. I serve as the College's Chair of 
its national laboratory preparedness committee, but I am also 
here as a practicing pathologist, microbiologist and laboratory 
director from Charlotte, North Carolina. I will bring you a 
first hand clinical and local perspectiveness to the 
preparedness needs for SARS, none public health. My testimony 
will focus on the critical role of clinical laboratories in 
combating SARS work force protection and the need for a strong 
public/private health sector partnership at the community 
level. When a patient presents with symptoms of SARS, your 
local community's physicians and nurses and laboratory are the 
first in line to combat this new disease. They have significant 
responsibility for the preliminary diagnoses and ongoing care 
of patients who may become infected with SARS. As with the 
bioterrorist anthrax event, the first signs of trouble emerged 
locally. It was a vigilant physician who identified the 
Nation's first anthrax case in Florida. The pathologist 
reviewing a blood smear in the laboratory identified the 
anthrax bacillus.
    Pathologists working with other laboratory professionals 
and other medical professionals through the use of laboratory 
testing, examination of tissue samples and the performance of 
autopsies are responsible for determining the cause of disease 
in patients. This occurs everyday in your community. And this, 
at the local community level, is where the battle will be won 
or lost in the war against SARS if there is an outbreak.
    This will become extremely important when large number of 
patients with symptoms of fever and cough present during the 
next flu seasons, particularly if there are no diagnostic tests 
for SARS readily available at the local level, and we have 
heard it could be years away. Like many other respiratory 
viruses, SARS could become dormant through some seasons, only 
to return in others. This apparent current lull in the U.S. 
should not be viewed as victory or that work has been done. We 
should use this time to marshal our resources and enhance our 
local community's capacity to respond. This is an opportunity 
that should not be squandered. Failure could be catastrophic 
economically and in human terms, as seen in China and other 
outbreak locations.
    And I ask each of you to ask the question, ``what is going 
on in my community?'' CDC's communication and coordination with 
clinical laboratories and hospitals concerning bioterrorism has 
markedly improved. The work on SARS has been outstanding, 
excellent. But more regional planning to ensure a coordinated 
plan between the Nation's clinical laboratories, non public 
health, and hospitals and public health resources are 
desperately needed.
    No preparedness and containment strategy without health 
care worker safety. Recent data from China suggests that up to 
18 percent of SARS cases are health care workers. Sick health 
care workers cannot take care of patients.
    In your hometown patients will present to the local 
emergencies rooms or your private practitioner. The patient 
specimens will be sent to the laboratory for examination by 
technologists and pathologists. The specimen arrives in the 
laboratory as an unknown. Laboratory professionals and other 
health care workers need to follow the CDC recommendations for 
protection. Budget constraints cannot be a barrier for a 
worker's preparedness.
    As was learned from our fighting troops in Iraq, success in 
decreasing casualties in a war is dependent on having the very 
best resources, equipment and training. Nothing less should be 
available to our Nation's hospital and laboratory workers in 
their battle against bioagents.
    The SARS experience today teaches many lessons. One of the 
most important is the need to enhance the vital link between 
private and the public health sector, particularly at the local 
level. While it is clearly important to prepare, coordinate, 
respond and communicate globally, we must implement locally to 
successfully control the outbreak of SARS and other microbial 
threats.
    I caution, however, against reinventing a new system for 
every disease that comes along. This is costly and unworkable. 
We should continue to improve existing mechanisms for dual 
protecting against both biologic agents used in terrorism as 
well as naturally occurring pathogens.
    A significant weakness in our public health system is that 
it remains fragmented. Every county and State can have 
different procedures and methods for reporting infectious 
diseases and handling outbreaks. We need a system for seamless 
reporting. We certainly applaud the continuing modernism of the 
public health system, and they need more resources. The world 
is interconnected. Our Nation's clinical and public health 
resources must be just as interconnected.
    The College of American Pathologists has programs to 
educate and train laboratory professionals to improve response 
capabilities. We are currently expanding our laboratory 
preparedness education tool designed for pathologists and 
laboratorians to identify potential bioterrorist agents, to 
also be able to identify emerging pathogens such as SARS.
    In conclusion, maintaining the health of the public is the 
responsibility of both the public and private health sectors. A 
failure in either will be a failure in our ability to control 
SARS and other microbial threats.
    The College of American Pathologists is committed to 
continued collaboration with Congress and Government agencies 
to respond to public health emergencies and bioterrorism. We 
believe that private sector resources such as those we can 
offer and others can contribute much to the coordination and 
improvement of our collective efforts in this battle against 
microbes from all sources.
    Thank you very much. Glad to answer questions.
    [The prepared statement of Jared N. Schwartz follows:]

     Prepared Statement of Jared N. Schwartz, College of American 
                              Pathologists

    Chairman Greenwood, Congressman Deutsch, distinguished Committee 
members. I am Dr. Jared Schwartz, a practicing pathologist and 
microbiologist from Charlotte, North Carolina, Chair of the College of 
American Pathologists (CAP) National Laboratory Preparedness Committee 
and Secretary Treasurer of the College. I was also recently appointed 
by Health and Human Services Secretary Tommy Thompson to the Clinical 
Laboratory Improvement Advisory Committee. On behalf of the CAP, I 
appreciate the opportunity to participate in today's hearing before the 
Energy and Commerce Subcommittee on Oversight and Investigations to 
assess the emerging threat of Severe Acute Respiratory Syndrome (SARS) 
and what we can do to improve our ability to contain its spread and 
safeguard the public.
    The CAP is a national medical specialty society representing over 
16,000 pathologists who provide pathology services in community 
hospitals, independent clinical laboratories, academic medical centers 
and federal and state health care facilities across the country. CAP 
members have extensive expertise in providing and directing laboratory 
services and serve as inspectors in the College Laboratory 
Accreditation Program. In addition, the CAP provides laboratories with 
a wide array of proficiency testing programs and educational solutions 
to assist in the improvement of the laboratory's performance. These 
programs combined are designed to improve the quality of laboratory 
services and to ensure the accuracy and reliability of test results.

          ROLE OF THE CLINICAL LABORATORY IN IDENTIFYING SARS

    As a Physician Director of a large integrated laboratory, I 
understand first-hand the challenges we face in both accurately 
identifying and responding to the public health threat of emerging 
pathogens, such as SARS. It is important to recognize that your local 
laboratory and community hospital are the first line of defense against 
this new disease. The laboratory and its hospital facility are 
responsible for the initial evaluation, preliminary diagnosis and 
ongoing care and treatment of patients who become infected with SARS. 
My testimony will focus on the critical role of the clinical 
laboratories and community hospitals as the first contact with 
individuals who can be infected with SARS or other communicable 
pathogens. We must prepare ourselves now for an oncoming surge of new 
patients.
    Most individuals with possible SARS have, in fact, other causes for 
their symptoms and present a diagnostic challenge for both clinicians 
and laboratory professionals. This highlights the essential role of the 
clinical laboratory--that laboratory in a hospital or established as an 
independent adjunct to the hospital lab providing diagnostic services 
to residents of a local community. The CAP represents pathologists who 
are Physician Directors of our nation's clinical laboratories, perform 
forensic and anatomic pathology, with the common objective of providing 
a diagnosis as to the cause of disease through laboratory medicine. The 
clinical laboratory has a major responsibility for ruling out SARS 
cases so they can be appropriately treated and for referring those 
cases where SARS cannot be ruled out to the public health system for 
definitive diagnosis and management. As such, pathologists are on the 
front lines in diagnosing viral and other causes of microbiological 
disease. This outbreak of SARS demonstrates the critical role of the 
clinical laboratory, as partners with government and public health 
laboratories, to contain any new emerging pathogen, particularly at the 
community level.
    Diagnosing a patient with SARS may be significantly delayed without 
the vigilance of a pathologist, clinical scientist and other laboratory 
professionals. The laboratory has the responsibility to rule out flu-
like cases that are not SARS so individuals receive proper treatment 
and are not inappropriately quarantined. By the same token, the 
laboratory will also have the responsibility to determine and refer 
those flu-like cases where SARS may in fact be present as new tests 
become available. This analysis is critical because it allows for 
actions and resources to be quickly and effectively targeted to those 
individuals where SARS is diagnosed or cannot be ruled out. The 
laboratory staff and the pathologist medical decision-makers are 
essential to the proper treatment and thus helping to control the 
spread of the disease. If not accurately identified, patients with SARS 
could be sent home to infect others instead of being treated and if 
necessary quarantined. Pathologists also conduct autopsies both as 
forensic medical examiners and at community hospitals to determine the 
cause of death. In this role, pathologists serve as an early warning 
system in detecting new diseases and provide critical information to 
our public health system about the course and etiology of the disease 
in the population.

                ASSESSING SARS AS A PUBLIC HEALTH THREAT

    Prior to assessing the impact of a SARS epidemic in the Untied 
States, it is important to understand why this illness has emerged as 
such an important global public health threat. In many ways, SARS is no 
different from any other flu-like illness to which Americans are 
frequently exposed. SARS shares many of the components of common 
respiratory illness--it appears to be caused by a virus, it is spread 
by respiratory droplets and its symptoms can mimic other respiratory 
infection. Why then have governments, the media and public health 
officials around the world moved with unprecedented speed to alert the 
public to the possible threat of SARS? The answer is multi-factorial. 
SARS appears to be a new virus and no vaccine is available, at this 
time, to prevent this disease. This leaves the population vulnerable to 
attack. SARS can spread rapidly and kill. The frequent international 
travel of the population; crowded living conditions; the ability to be 
exposed without personal contact (from respiratory droplets or from 
surface contact); among others all contribute to a formula for 
worldwide outbreaks. U.S. health officials are investigating 54 
probable cases of SARS in this country with another 237 cases under 
close surveillance. Worldwide, 6,234 cases have been reported in 27 
countries associated with 435 deaths. The economic impact of SARS in 
affected countries has been devastating despite the relative small 
number of cases as compared to cases of influenza worldwide.
    Although it is encouraging to know that SARS cases are declining in 
some areas, we cannot become complacent. SARS is likely to follow 
seasonal patterns much like many other respiratory viruses. SARS could 
become dormant through some seasons only to return in others. That's 
why this apparent current lull should not be viewed as victory or that 
our work has been done. To the contrary, we should use this time to 
marshal our resources and collaborate with other countries to combat 
this threat and enhance our local communities' response capabilities. 
This is an opportunity that should not be squandered.
    SARS is one of many new infections that have surfaced in the recent 
years--West Nile, Hantavirus, Ebola, Nipah, Hendra, AIDS among others. 
Subsequent to 9/11, we also experienced an unprecedented bioterrorist 
attack with anthrax. In fact, one of the anthrax attacks occurred here 
in our nation's capital. There is no reason to believe that these 
outbreaks--either through natural occurring agents or the intentional 
distribution of microbiological agents will not continue. Furthermore, 
it is important to note that whether the infectious and dangerous agent 
is the result of mother nature or a terrorist, our health system both 
public and private must be prepared to respond. And, in many ways, the 
response needs are the same.
    We applaud the Centers for Disease Control and Prevention in 
recognizing the importance of a responsive and complete public health 
infrastructure to meet these threats. Much as been done to improve the 
CDC's communication and coordination with clinical laboratories 
regarding bioterrorism. Similarly, the CDC's communications to the 
medical community on SARS has been excellent. However, more needs to be 
done particularly in regional planning and ensuring a seamless link 
between the nations clinical laboratories, hospitals and public health 
resources if our nation is to contain this outbreak as well as other 
microbial threats.

                  CURRENT STATE OF DIAGNOSTIC TESTING

    Diagnostic tests for SARS are currently under development. The 
tests can give both false positive and false negative results. A recent 
Canadian study found that just 40% of likely SARS patients actually 
tested positive for the virus. At this point, the technology to perform 
SARS tests is available only at sophisticated public health 
laboratories. There is a need for readily available diagnostic tests 
which clinical laboratories can use at the local level. Unfortunately, 
a test of this nature could be years away. The uncertainty in SARS 
testing reinforces the important contribution of the clinical 
laboratories in being able to perform those tests that can clearly 
identify those individuals with symptoms of SARS who have the common 
flu or bacterial pneumonia--thereby screening out individuals who are 
not infected with SARS. This will become extremely important when large 
numbers of patients with symptoms of fever and cough present for 
diagnosis during the onset of the next flu season.

              PROTECTING THE CLINICAL LABORATORY WORKFORCE

    No preparedness and containment strategy can succeed without 
adequate healthcare workforce protection. We have all heard the news 
stories about health care workers who have contracted SARS in the 
course of caring for patients infected with the disease. An emphasis 
must be placed on finding the most effective ways to protect health 
care workers. Failure to do so will not only spread the disease to 
other hospital patients and the population at large, but will also put 
at risk the very individuals we will need to rely on if an outbreak 
occurs.
    In the U.S., patients first present to the local emergency 
department or to a private health care practitioner for care. Patient 
specimens are then sent to the laboratory to determine the presence of 
disease, and in this case, the possibility of SARS. However, when the 
specimen arrives at the laboratory for analysis, the presence of SARS 
is not known. This reinforces the need for laboratory professionals and 
other front line health care workers to follow universal precautions in 
handling and collecting specimens. Laboratory procedures such as 
centrifuging and opening sample containers may release microbial agents 
to the air that can spread the disease to workers and patients in the 
area. The clinical laboratory and local medical provider community will 
look to the CDC and other government health agencies to provide them 
with the latest and most scientifically valid knowledge about 
respirator effectiveness and use, handling precautions and modes of 
transmission. With hospitals and providers operating on shoestring 
budgets, this becomes an even more critical issue. Health care 
infrastructure weaknesses should not be a barrier to our preparedness 
efforts. As was learned from our fighting troops in Iraq, success in 
decreasing casualties in a war is dependent on having the very best 
resources, equipment and training. Nothing less should be available to 
our nation's hospital and laboratory workers in their battle against 
bioagents.

    LESSONS LEARNED--NEED FOR A STRONG PUBLIC-PRIVATE HEALTH SECTOR 
                              PARTNERSHIP

    The SARS experience can teach us many lessons. From my perspective 
as a pathologist in my local community working with clinicians and 
public health officials, one of the most important lessons is the need 
to enhance the vital link between the private and public health sector, 
particularly at the local level. While it is clearly important to 
prepare, coordinate and respond globally, we must implement locally to 
successfully control the outbreak of SARS and other diseases. Proper 
policies and procedures for coordination and communication between the 
private sector laboratories and the public health system have improved 
since 9/11 but need to be strengthened so that potential SARS cases, 
and other emerging threats, can be quickly identified and managed. 
However, I would caution against reinventing our system for each new 
disease that comes along. This would be a costly and unworkable 
approach. Actions taken at the federal, state and local level in 
collaboration with our private health care system has done much to 
improve our response capabilities with respect to bioterrorism. We 
should continue to improve and refine these existing mechanisms for 
dual use in terms of both biological agents used in a bioterrorist act 
as well as microbial agents that are naturally occurring.
    As a private sector initiative, the CAP has developed programs to 
educate and train pathologists and laboratory personnel to improve 
response capabilities. The College has developed a Laboratory 
Preparedness educational tool designed for laboratories to better 
identify microbiological agents that could be used in a bioterrorist 
attack. This program sends surrogate microbial samples to laboratories. 
These safe samples mimic biological agents and are sent to the 
laboratory in a blind manner so we can assess the laboratory's ability 
to accurately identify select agents of bioterrorism. The program also 
educates laboratories about how to properly coordinate with the public 
health infrastructure for referral and reporting activities. There are 
plans underway to expand this program to ensure that clinical labs are 
prepared to identify emerging pathogens, including SARS.
    As we think about lessons learned from this outbreak, its 
comforting to know that progress has been made in terms of public 
health system procedures for responding to biological threats of any 
nature, but the system remains fragmented. Every county and state can 
have different procedures and methods for reporting infectious disease 
and handling outbreaks. This does not allow for seamless reporting from 
the clinical laboratories and local health providers and does not allow 
for integrated electronic surveillance systems. The technology is 
available to implement interoperability coordination and electronic 
reporting and its adoption should be accelerated. A March report from 
the prestigious Institute of Medicine indicates that today's outlook 
with regard to microbial threats to health is bleak. Microbial threats 
will present us with new surprises every year. We applaud the continued 
modernization of the public health system. However, there is a critical 
need for more coordination at the highest level in order to ensure full 
implementation at the local level. Our public health system would 
benefit from an interconnected electronic communication network to 
monitor for disease outbreaks. The world is interconnected on a daily 
basis--our nations clinical and public health resources should be just 
as interconnected.
    The CAP was pleased to assist CDC in providing timely communication 
to laboratory personnel following the anthrax outbreaks and working to 
improve the private sector clinical lab connection to the public health 
networks. We are committed to continued collaboration with the 
Department of Health and Human Services and other government agencies 
to respond to public health emergencies and bioterrorism events. We 
have witnessed the severe economic consequences and panic that has 
resulted in other countries from SARS outbreaks. We need to be sure our 
local communities have a coordinated plan to handle their outbreak in 
the near future. The CAP believes that private sector resources, such 
as those we offer, can contribute much to the coordination and 
improvement of our collective efforts in our battle against microbes 
from all sources.

                               CONCLUSION

    In closing I would like to reemphasize the key points of my 
testimony:

1. SARS is one of many new infections that have surfaced in the recent 
        years. Since 9/11 we have also experienced an unprecedented 
        bioterrorist attack. There is no reason to believe that this 
        trend--either through natural occurring agents or intentional 
        distribution of microbiological agents will not continue. 
        Regardless, the need for preparedness is the same, both 
        nationally and locally.

2. The outbreak of SARS demonstrates the critical role of the clinical 
        laboratory, as partners with government and public health 
        laboratories, to contain any new emerging infectious disease. 
        As the point of initial evaluation for individuals who can be 
        infected with SARS, clinical laboratories are one of the first 
        lines of defense against this new disease. Significant 
        responsibility rests with the clinical laboratories for the 
        preliminary diagnosis of the patient, including the ability to 
        accurately rule out non-SARS cases and appropriate referral of 
        those displaying characteristics of SARS.

3. Education on workforce safety is extremely important. Laboratory 
        professionals and other front line health care workers must be 
        fully informed about the need to follow universal precautions 
        in handling and collecting specimens. Our health care workers 
        deserve the very best equipment and technology to protect them 
        as they combat this disease.

4. It is expected that SARS will follow a seasonal pattern, becoming 
        dormant through some seasons and returning in others. This 
        possible lull provides an opportunity to marshal our resources 
        and work with other countries to combat this threat. This is an 
        opportunity that should not be squandered.

5. As we think about lessons learned from this outbreak, its comforting 
        to know that progress has been made in terms of public health 
        system procedures for responding to biological threats of any 
        nature, but the system remains fragmented. The world is 
        interconnected on a daily basis--our nations clinical 
        laboratories, hospitals and public health resources should be 
        just as interconnected.

6. There is much to learn about the etiology and diagnostic testing for 
        SARS. Questions remain about the cause of the disease and how 
        best to identify it in patients. Proper policies and procedures 
        for coordination and communication between the private sector 
        laboratories and the public health system have improved since 
        9/11 but need to be strengthened so that potential SARS cases, 
        and other emerging threats, can be quickly identified.

7. The diagnosis of SARS may be significantly delayed if not for a 
        vigilant pathologist, clinical scientist and other laboratory 
        professionals. Pathologists, through conducting autopsies for 
        the cause of death, serve as an early warning system to detect 
        new diseases and provide critical information about the course 
        and etiology of the disease in the population.

8. As a private sector initiative, the CAP has developed programs to 
        educate and train pathologists and laboratory personnel to 
        improve response capabilities. The CAP has developed a 
        Laboratory Preparedness educational tool designed to educate 
        laboratories to better identify microbiological agents that 
        could be used in a bioterrorist attack with plans underway to 
        expand the questions to SARS. We look forward to working with 
        the public and private sector in similar efforts.

    Mr. Greenwood. Thank you, Dr. Schwartz.
    Mr. Hodge, you are recognized for 5 minutes, sir.

                  TESTIMONY OF JAMES G. HODGE

    Mr. Hodge. Thank you, Mr. Greenwood. Thank you members of 
the committee. It is a pleasure to be able to join you here as 
a public health lawyer and scholar at the Center for Law & the 
Public's Health at Georgetown and Johns Hopkins Universities.
    Mr. Chair, you have very appropriately termed this hearing 
in appropriate ways in the sense of lessons learned from SARS 
to date. And I think the fundamental lesson that I bring to the 
table and to this committee today is that we very much need to 
see law as a tool for public health improvements. It has played 
an integral role in relation to our national response to SARS. 
And yet at the same time, additional legal reform, particularly 
among the States where so much of public health power resides, 
is very much ongoing but very much needed.
    We have heard time and time again here today of the impact 
of SARS in the community and the ways in which it is spread, 
specifically in other nations, and what that may mean here in 
the United States. I think very appropriately our response to 
the Federal, tribal, State and local governments is quite 
nicely and in commendable ways limited the spread of this 
disease to date in the United States thanks very much to 
leadership from CDC, from its parent at HHS, FDA, NIH. We have 
heard from many of these folks as well, as well as Dr. 
Benjamin's American Public Health Association.
    Public health authorities, as we have noted, have engaged 
in a variety of techniques to bring this disease under control 
in the United States. Everything from surveillance techniques 
to trap suspected and actual cases, used epidemiologic 
investigations to build knowledge about the disease. We have 
engaged in implemented travel advisory, we have provided 
information to people about SARS. And we have also, as we have 
seen, engaged in isolation and quarantine techniques.
    Each and every one of these actions owes its authorization 
to the law in one phase or the other, be it at the Federal, 
State, local or tribal level, be it constitutional, statutory, 
administrative, regulatory or even in some cases court-based 
case law. However, specifically statutory public health law, 
which in general authorizes so much of what may occur through 
public health agencies, particularly at the State level, has 
serious deficiencies. And these may actually in same ways 
impede or limit the ability of public health authorities during 
certain types of epidemics like SARS to respond effectively.
    Some of these public health laws, as we have studied 
systematically through our Center, may be antiquated, they may 
be fragmented, they are often inconsistent.
    By antiquated, I mean quite simply they are old. Some of 
these laws may be on the books in various States for a 100 
years or so. Old laws do not necessarily make bad laws, of 
course, unless of course they fail to comply with modern 
constitutional norms, modern public health science standards, 
even ethical norms. And that we do see in some statutory 
authorizations. They are fragmented in many cases.
    One of the key features that we see among State public 
health laws in particular is how specific they are to various 
conditions or diseases. This phenomenon has not been seen yet 
in SARS, but as you reread and reveal State code in various 
jurisdictions you see specific responses to diseases like HIV/
AIDS, tuberculosis, venereal diseases; all of the sorts of 
step-by-step processes, and they are inconsistent. The State 
public health laws across the States vary drastically. They may 
even have inconsistencies between local and State laws in 
various individual States.
    The Department of Health and Human Services, CDC, our 
institutive medicine have all recently recommended the need for 
statutory reform in public health law.
    And I am very pleased to alert this committee to the fact 
that our Center has been very generously funded through CDC and 
other resources to develop some model law proposals which we 
think could be helpful, including what we call the Model State 
Emergency Health Powers Act, very much drafted quickly after 
the anthrax exposures in the fall of 2001. This model act 
introduces a series of modern provisions that very much try to 
balance individual liberties and individual dignity with the 
need for public health powers and/or surveillance and other 
techniques.
    This has been introduced in some form or another in 39 
States, presently passed in 22 of those States including a 
version here in the District of Columbia. And then this model 
act has actually been folded into a much larger, even more 
comprehensive model State public health act as part of a 
turning point project under the Robert Wood Johnson Foundation.
    Together with my colleague at the Center, Professor Larry 
Goston we are at the forefront of trying to work on final draft 
of this particular comprehensive proposals. And we very much 
believe and hope that this type of model law does not 
necessarily issue a mandate to States nor the Federal 
Government of exactly how to legislate in the form of public 
health protections, but provides the type of guidance that we 
systematically heard from so many policymakers across the 
Nation that is really quite missing.
    So together these model proposals, additional scholarship, 
the efforts that are occurring through various agencies like 
APHA and so many other public health associations, and 
fantastic schools of public health as well, I think are working 
very much together to evolve public health law as the 
meaningful tool that it is becoming in relation to responding 
to these particular types of conditions like SARS.
    Thank you very much.
    [The prepared statement of James G. Hodge, Jr. follows:]

Prepared Statement of James G. Hodge, Jr., Deputy Director, Center for 
      Law and the Public's Health at Georgetown and Johns Hopkins 
 Universities; Faculty, Georgetown University Law Center and the Johns 
               Hopkins Bloomberg School of Public Health

   SARS AND PUBLIC HEALTH LAW: CHALLENGES, RESPONSES, AND REFORM \1\
---------------------------------------------------------------------------
    \1\ This document is based, in part, on Gostin, LO, Hodge, JG. The 
Model State Emergency Health Powers Act--a brief commentary. Seattle: 
Turning Point Statute Modernization Committee, 2002; 1-42. I would also 
like to thank my Center colleagues, Lance Gable, JD/MPH, and Lesley 
Stone, JD, for their research and editing assistance with this 
document.
---------------------------------------------------------------------------
                           executive summary
    The spread of SARS in the U.S. presents significant challenges for 
federal, tribal, state, and local public health authorities, as well as 
the private health sector. Laws at each level of government may 
facilitate the planning, preparation for, response to, and prevention 
of existing and future SARS cases. Ideally, public health laws 
authorize government to employ proven powers while respecting 
individual rights. As such, laws are tools for improving public health 
outcomes.
    However, there is considerable variation among existing public 
health laws, particular at the state and local levels. These laws may 
be antiquated, inconsistent, and fragmented. They may not reflect the 
most current scientific, ethical, and legal norms or standards for 
public health practice. Such laws may limit or actually interfere with 
effective communicable disease controls. Not surprisingly, calls for 
state public health law reform have emanated from federal and state 
authorities.
    In response, faculty at the Center for Law and the Public's Health 
developed the Model State Emergency Health Powers Act (MSEHPA) in 2001. 
Introduced in whole or part in 39 states and passed in 22 states (and 
D.C.), MSEHPA provides a structured, balanced approach to using law to 
control communicable diseases, the spread of which may constitute a 
public health emergency. Additional work on a larger ``Turning Point'' 
project to develop a larger model state public health law is ongoing. 
Upon completion in late 2003, this model law will provide a 
comprehensive, structural approach for states considering extensive 
reform. These existing and future public health law reforms will help 
improve our national public health system, and its ability to control 
new and emerging threats like SARS.

                              INTRODUCTION

    There is perhaps no duty more fundamental to American government 
than the protection of the public's health. Protecting communal health 
is the quintessential goal of federal, tribal, state, and local public 
health authorities. Yet, in the last decade alone, novel threats to the 
public's health have emerged. Beginning in 1999, West Nile Virus (WNV) 
began to spread across the nation through mosquitos carrying the virus 
from infected birds. Thousands of persons have been infected, and 
several deaths (particularly among older persons) have occurred. In the 
ensuing weeks following the terrorism of September 11, 2001, public 
health and law enforcement officials discovered that some person or 
group had intentionally contaminated letters with deadly anthrax 
spores. These letters were mailed to individuals in government and the 
media in several states and the District of Columbia. Thousands of 
persons were tested for exposure, hundreds were treated, and five died 
from inhalational anthrax.
    In 2003, severe acute respiratory syndrome (SARS) has emerged as 
another serious threat to public's health in the United States. Unlike 
WNV and the anthrax exposures, persons infected with SARS may transmit 
the disease to others through close human contact. Additional modes of 
infection are being investigated. To date, the Centers for Disease 
Control and Prevention (CDC) reports 291 cases of SARS in the U.S., of 
which 54 are listed as probable (advanced symptoms of the disease have 
been diagnosed). No deaths from the disease have occurred domestically, 
although the World Health Organization conservatively reports 435 
deaths worldwide among 6,234 cases (as of May 3, 2003).
    The underlying challenge for the U.S. public health system 
concerning an emerging, infectious disease like SARS is to prevent new 
or recurring infections, as well as reduce morbidity and mortality, to 
the fullest extent possible. From an epidemiological perspective, this 
can be difficult. SARS is relatively easily communicated from person to 
person. Persons who have been infected may acquire the disease again 
[although public health professionals are investigating this potential 
for reinfection]. There is currently no cure or vaccine for SARS. 
Effective treatment is lacking. In less than 6 months, SARS has spread 
to 30 countries, largely through persons who have traveled from 
infected areas. Even if the disease is controlled for a time, it has 
the potential to flare again if adequate precautions are not taken, 
especially in larger urban centers that have a regular influx of 
foreign travelers or returning passengers from foreign destinations.
    For these and other reasons, SARS has become a dominant focus of 
the nation's public health system. Federal, tribal, state, and local 
public health authorities have effectively utilized modern 
epidemiologic surveillance and investigations to build knowledge about 
the diseases, project its potential spread, and identify at-risk 
persons. In collaboration with the private sector (e.g., physicians, 
health care workers, hospitals, and primary care institutions), public 
health authorities have worked diligently to apply a range of measures 
to slow, detect, and eradicate the spread of SARS from person to 
person. Persons with known cases of SARS have been isolated (usually 
voluntarily) from others to prevent infection. Close contacts of 
infected persons have been asked to limit their exposure to others and 
engage in a series of hygienic practices. Individuals entering the 
country [especially from known infected areas] have been targeted for 
potential screening or provided information about SARS. Places where 
SARS may have contaminated surfaces or other items with which humans 
may come into contact have been temporarily closed for decontamination.
    The practice of these and other public health measures in response 
to SARS rely upon existing and new legal powers at the federal, state, 
and local levels. Through an Executive Order, President Bush has 
included SARS among a short list of diseases for which the Department 
of Health and Human Services (HHS) may employ limited quarantine or 
isolation measures. Federal, state, and local public health authorities 
have utilized existing laws to monitor SARS through ongoing 
surveillance, investigate factors leading to the spread of the disease, 
determine contacts of SARS ``cases,'' and implement quarantine and 
isolation measures. A foreign tourist in New York City was 
involuntarily detained in a hospital for days because of suspected SARS 
symptoms. College roommates of a suspected SARS case in Minnesota were 
voluntarily quarantined for 3 days. A twelve-year old boy who likely 
contracted SARS from a trip to Toronto has been isolated in Florida. 
Local authorities in Wisconsin charged a man with failing to cooperate 
with a public health investigation of SARS. These and other examples of 
SARS-related legal responses are not new to epidemic diseases. As a 
health official with the Wisconsin Division of Public Health recently 
stated, ``The ideas of isolation, quarantining, closing buildings, 
prohibiting public gatherings have been around since the early 1900s . 
. . Those are the basic tools.'' 2
---------------------------------------------------------------------------
    \2\  Associated Press, Milwaukee: State Ready for SARS, Officials 
Say, St. Paul Pioneer Press, 4/29/03 @ 1B.
---------------------------------------------------------------------------
                   NEED FOR PUBLIC HEALTH LAW REFORM

    Law has long been considered an essential tool for improving public 
health outcomes, especially among state and local governments that have 
traditionally been the repositories of public health powers. Statutory 
laws and administrative rules generally guide the activities of public 
health authorities, assign and limit their functions, authorize 
spending, and specify how authorities may exercise their delegated 
authority. Laws can establish norms for healthy behavior and create the 
social conditions in which people can be healthy.
    However, obsolescence, inconsistency, and inadequacy in existing 
state public health laws expose flaws and can render these laws 
ineffective, or even counterproductive. State public health statutes 
have frequently been constructed in layers over time as lawmakers 
responded to varying disease threats (e.g., tuberculosis, polio, 
malaria, HIV/AIDS). (To date, no state has legislatively sought to 
amend its public health powers in response to SARS). Consequently, 
existing statutory laws may not reflect contemporary scientific 
understandings of disease (e.g., surveillance, prevention, and 
response) or legal norms for protection of individual rights. 
Administrative regulations may supplement existing statutes with more 
modern public health approaches, but also be limited by original grants 
of delegated rule-making authority. Existing public health laws may 
pre-date vast changes in constitutional (e.g., equal protection, due 
process) and statutory (e.g., disability discrimination, privacy, civil 
rights) law that have changed social and legal conceptions of 
individual rights. Public health authorities acting pursuant to these 
provisions may be vulnerable to legal or ethical challenges on grounds 
that their actions are unconstitutional or preempted by modern federal 
or state laws.
    The independent evolution of health codes across states, tribal 
authorities, and locales has led to variation in the structure, 
substance, complexity, and procedures for detecting, controlling, and 
preventing disease. Without a coordinated, national public health 
system, disease detection and reporting systems, response capabilities, 
and training capacity differ extensively among jurisdictions. These 
differences could hamper coordination and efficient responses in a 
multi-state public health emergency (perhaps involving a large outbreak 
of SARS). Confusion and complexity among inconsistent state public 
health laws may create ambiguities that also prevent public health 
authorities from acting rapidly and decisively in an emergency. Public 
health authorities may be unsure of the extent of their legal 
authority, the chain of command during an emergency, or the proper 
exercise of existing legal powers.
    Reforming current state public health laws is particularly 
important to strengthen key elements of public health preparedness:
    Planning, Coordination, and Communication. Most state statutes do 
not require public health emergency planning or establish response 
strategies. Essential to the planning process is the definition of 
clear channels for communication among responsible governmental 
officials (e.g., public health, law enforcement, emergency management), 
the private sector (e.g., health care workers and institutions, 
pharmaceutical industry, NGO's), and the public. Coordination among the 
various levels (e.g., federal, tribal, state, local) and branches 
(e.g., legislative, executive, judicial) of government is also 
critical. State public health laws can implement systematic planning 
processes that involve multiple stakeholders. However, many public 
health statutes not only fail to facilitate communication, but may 
actually proscribe exchange of vital information among principal 
agencies due to privacy concerns. Some state laws even prohibit sharing 
data with public health officials in adjoining states. Laws that 
complicate or hinder data communication among states and responsible 
agencies could impede thorough investigation and response to public 
health emergencies.
    Surveillance. Ongoing, effective, and timely surveillance is an 
essential component of public health preparedness. As with SARS, early 
detection could save many lives by triggering an effective containment 
strategy that includes reporting, testing, partner notification, and 
isolation or quarantine. Some existing state laws may thwart effective 
surveillance activities. Many states do not require immediate reporting 
for all the critical agents identified by the CDC. At the same time, 
states do not require, and may actually prohibit, public health 
agencies from monitoring data collected through the health care system. 
Private information that might lead to early detection (e.g., unusual 
clusters of fevers or gastrointestinal symptoms) held by hospitals, 
managed care organizations, and pharmacies may be unavailable to public 
health officials because of insufficient reporting mechanisms or health 
information privacy concerns.
    Managing Property and Protecting Persons. Authorization for the use 
of coercive powers are the most controversial aspects of public health 
laws. Nevertheless, their use may be necessary to manage property or 
protect persons in a public health emergency. There are numerous 
circumstances that might require management of property in the 
interests of protecting the public's health--e.g., decontamination of 
facilities; acquisition of vaccines, medicines, or hospital beds; or 
use of private facilities for isolation, quarantine, or disposal of 
human remains. Consistent with legal fair safeguards, including 
compensation for takings of private property used for public purposes, 
clear legal authority is needed to manage property when needed to 
contain serious health threats.
    There may also be a need to exercise powers over individuals to 
avert significant threats to the public's health. Vaccination, testing, 
physical examination, treatment, isolation, and quarantine each may 
help contain the spread of infectious diseases. Although most people 
will comply with these programs during emergencies for the same reason 
they comply during non-emergencies (i.e., because it is in their own 
interests and/or desirable for the common welfare), compulsory powers 
may be needed for those who will not comply and whose conduct poses 
risks to others. These people may be required to yield some of their 
autonomy or liberty to protect the health and security of the 
community.

              RECOMMENDATIONS FOR PUBLIC HEALTH LAW REFORM

    The federal Department of Health and Human Services (HHS), the 
Centers for Disease Control and Prevention (CDC), and the Institute of 
Medicine (IOM) (part of the National Academy of Sciences chartered by 
the U.S. Congress) have each cited the need for public health statute 
reform. In its November 2002 report, The Future of the Public's Health 
in the 21st Century, IOM noted that ``public health law at the federal, 
state and local levels is often outdated and internally inconsistent.'' 
IOM recommended HHS appoint a national commission to provide guidance 
to states in reforming their laws to meet modern scientific and legal 
standards. HHS' Office of Inspector General is currently assessing the 
status of state bioterrorism laws. Additional public and private sector 
legal assessments are ongoing.
    Threats of bioterrorism and emerging infectious conditions like 
SARS have vaulted the state public health law reform to national 
prominence. Faculty at the Center for Law and the Public's Health at 
Georgetown and Johns Hopkins Universities have led two important 
initiatives to reform public health laws. Following the anthrax attacks 
in October, 2001, CDC asked the Center to prepare draft legislation 
that states could use in reviewing their existing laws related to 
response to bioterrorism and other potentially catastrophic public 
health emergencies. Center faculty drafted the Model State Emergency 
Health Powers Act (MSEHPA) in collaboration with national entities 
(i.e., National Governors Association, National Conference of State 
Legislatures, Association of State and Territorial Health Officials, 
National Association of County and City Health Officers, and the 
National Association of Attorneys General). MSEHPA presents a modern 
synthesis of public health law for controlling infectious diseases 
during emergencies that balances public health needs with the rights 
and dignity of individuals. The Act was completed in December, 2001, 
and is available at the Center's website [www.publichealthlaw.net] (a 
copy of the Act is available at www.publichealthlaw.net/ Resources/
Modellaws.htm.
    MSEHPA has been widely used by state and local law- and policy-
makers, health officials, and representatives in the private sector as 
a guide for considering reforms of existing legal protections. As of 
April 21, 2003, it has been used by most states in assessing their 
existing laws regarding public health emergencies. The Act has been 
introduced in whole or part through legislative bills or resolutions in 
39 states, and passed in 22 states.
    Although MSEHPA was drafted as a stand-alone model act, it was 
previously conceived as part of a larger, multi-year project convened 
by the Turning Point Public Health Statute Modernization National 
Collaborative, [www.hss.state.ak.us/dph/APHIP/collaborative] 
(hereinafter ``National Collaborative'') to develop a Model State 
Public Health Act. Many of the provisions of MSEHPA are part of this 
larger model act. The purpose of the National Collaborative is to 
transform and strengthen the legal framework for the public health 
system through a collaborative process to develop a model state public 
health law. Through intensive research and consensus building among 
national, state, and local experts and public health representatives, 
the Model State Public Health Act shall provide legislative language 
concerning public health administration and practice by public health 
agencies at the state and local levels. The National Collaborative, 
comprised of a multi-disciplinary panel of experts in public health, 
law, and ethics, has already developed various portions of the multi-
chapter, comprehensive model public health act for states. The Turning 
Point Model Act is scheduled for completion later in 2003, but has 
already been referred to or introduced in part through a state 
resolution in Hawaii and a comprehensive reform bill in North Carolina.

  IMPROVING EMERGENCY PUBLIC HEALTH RESPONSES THROUGH LAW: THE MODEL 
                   STATE EMERGENCY HEALTH POWERS ACT

    MSEHPA provides a modern illustration of a public health law for 
controlling infectious diseases like SARS during emergencies that 
balances the needs of public health with the rights and dignity of 
individuals. Though developed quickly following the anthrax exposures 
in the Fall of 2001, the Act's provisions and structure are based on 
existing federal and state laws and public health practice.
    MSEHPA includes a modern series of legal provisions that equip 
public health authorities with necessary powers to respond to 
catastrophic public health emergencies while also respecting individual 
and group rights. The Act vests state and local public health 
authorities with modern powers to track, prevent, and control disease 
threats resulting from bioterrorism or other public health emergencies. 
These powers include measures (e.g., testing, treatment, and 
vaccination programs; isolation or quarantine powers; travel 
restrictions) that may infringe individual civil liberties (e.g., 
rights to due process, speech, assembly, travel, privacy). However, the 
exercise of these powers is restricted in time, duration, and scope. 
Coercive public health powers, particularly isolation and quarantine, 
are exercised on a temporary basis, only so long as reasonably 
necessary, and only with respect to persons who justifiably may pose 
risks to others because of their contagious conditions. In addition, 
procedural due process and the dignity of individuals are respected. 
For example, their rights to contest the coercive use of public health 
powers, even during an emergency, are secured.
    Although some have suggested that MSEHPA sets forth new and 
expansive powers for public health authorities, this is actually not 
the case. The Act does not create new powers for public health 
authorities; each of the Act's provisions are based on existing theory 
and practice of public health law. Rather, MSEHPA organizes and 
modernizes these legal powers to facilitate a coordinated approach to 
public health emergency response.
    Central Purposes. MSEHPA addresses each of the key elements for 
public health preparedness discussed above. Among its central purposes, 
the Act:

1. Sets a high threshold definition of what constitutes a ``public 
        health emergency'' [Art. I];

2. Requires the development of a comprehensive public health emergency 
        response plan that includes coordination of services, 
        procurement of necessary materials and supplies, housing, 
        feeding, and caring for affected populations, and the 
        administration of vaccines and treatment [Art. II];

3. Authorizes the collection of data and records and access to 
        communications to facilitate the early detection of a health 
        emergency [Art. III];

4. Vests the power to declare a public health emergency in the state 
        governor, subject to appropriate legislative and judicial 
        checks and balances [Art. IV];

5. Grants state and local public health officials the authority to use 
        and appropriate property to care for patients, destroy 
        dangerous or contaminated materials, and implement safe 
        handling procedures for the disposal of human remains or 
        infectious wastes [Art. V];

6. Authorizes officials to care and treat ill or exposed persons, to 
        separate affected individuals from the population at large to 
        prevent further transmission, collect specimens, and seek the 
        assistance of in-state and out-of-state private sector health 
        care workers during an emergency [Art. VI];

7. Requires public health authorities to inform the population of 
        public health threats through mediums and language that are 
        accessible and understandable to all segments of the population 
        [Art. VII]; and

8. Authorizes the governor to allocate state finances as needed during 
        an emergency, and creates limited immunities for some state and 
        private actors from future legal causes of action [Art. VIII].

    Public Health Emergencies. Most of the public health powers granted 
to state and local public health authorities through MSEHPA are 
triggered by the governor's declaration of a public health emergency in 
response to dire and severe circumstances. A declared state of 
emergency terminates as soon as the health threat is eliminated, or 
automatically after 30 days, unless reinstated by the governor or 
annulled through legislative or court action. Bioterrorism events 
involving intentional efforts to spread infectious diseases may present 
a scenario for a declaration of emergency. Public health emergencies 
can also arise through the spread of emerging infectious diseases, like 
SARS, through unintentional means. MSEHPA covers either scenario under 
its inclusive definition of what constitutes a ``public health 
emergency,'' summarized as (1) the occurrence or imminent threat of an 
illness or health condition, caused by bioterrorism, a highly fatal 
biological toxin, or novel or infectious agent that (2) poses a high 
probability of a significant number of human fatalities or incidents of 
serious, permanent or long-term disability in the affected population.
    Some civil libertarians and others have objected to the Act's 
emergency declaration. They view the declaration of a state of 
emergency as an authorization for public health authorities to do 
virtually anything to abate the existing threat. This includes 
infringing individual rights in the interests of protecting public 
health. Indubitably, during an emergency, certain civil liberties may 
need to be restricted as compared to the exercise of these rights in 
non-emergencies. Yet, the Act specifically protects individual 
interests from authoritarian actions in government. The governor of a 
state may be empowered to declare a state of public health emergency, 
but the legislature, by majority vote, may discontinue the declaration 
at any time. Similarly, courts may review whether a governor's actions 
fail to comply with the standards and procedures in MSEHPA. Thus, each 
branch of state government has a role in sustaining an emergency 
declaration consistent with constitutional principles of checks and 
balances.
    Furthermore, the provisions of MSEHPA better protect individuals 
than most existing state laws. Under the Act, a public health emergency 
is viewed as a distinct event that requires specific governmental 
responses. The Act sets a very high threshold for the declaration of a 
public health emergency and further conditions the use of a defined and 
limited set of powers on the declaration and continuation of the 
emergency status. In many state public health laws, however, there are 
no definitive statutory criteria for the declaration of a public health 
emergency. Rather, existing state emergency management laws may be used 
to broadly address public health emergencies. Declaring a general state 
of emergency in response to a bioterrorism event may allow government 
to act in indeterminable ways to address the public health threat. 
Lacking effective statutory guidance, public health authorities may 
have to rely on existing, antiquated statutory laws, or regulations 
that are hastily created in specific response to potential or unknown 
threats.
    Information Sharing and Surveillance Measures. MSEHPA enhances 
existing state surveillance and reporting practices to facilitate the 
prompt detection of a potential or actual threat by requiring:

 Health care providers to report cases of bioterrorist-related 
        or epidemic diseases that may be caused by any of the 
        infectious agents listed in federal regulations or other non-
        listed agents;
 Coroners and medical examiners to report deaths that may have 
        resulted from an emerging or epidemic infectious disease or 
        from a suspected agent of bioterrorism;
 Pharmacists to report unusual trends in prescriptions for 
        antibiotics and other medications used to treat infectious 
        diseases in addition to substantial increases in the sale of 
        various over-the-counter (OTC) remedies; and
 Veterinarians or veterinary laboratories to report animals 
        having or suspected of having any diseases that may be 
        POTENTIAL CAUSES OF A PUBLIC HEALTH EMERGENCY.

    Reports are to be made within 24 hours to the appropriate health 
authority, and should contain identifying information about the 
reporter and subject of the report. Upon receiving a report, public 
health officials can use the information to ameliorate possible public 
health risks. They may contact and interview individuals mentioned in 
the report and obtain names and addresses of others who may have been 
exposed to the individual. The Act encourages the sharing of this data 
among public safety and emergency management authorities at the 
federal, state, local, and tribal levels to prevent, treat, control, or 
investigate a public health emergency. To protect individual privacy, 
officials are restricted from sharing any more information than 
necessary to control or investigate the public health threat. Stricter 
regulations in the Act govern access to the medical records and charts 
of individuals under quarantine or isolation where individual privacy 
interests may be heightened.
    Managing Property. Once a public health emergency has been 
declared, MSEHPA allows authorities the power to seize private property 
for public use that is reasonable and necessary to respond to the 
public health emergency. This power includes the ability to use and 
take temporary control of certain private sector businesses and 
activities that are of critical importance to epidemic control 
measures. To safely eliminate infectious waste such as bodily fluids, 
biopsy materials, sharps, and other materials that may contain 
pathogens or otherwise pose a public health risk, authorities may take 
control of landfills and other disposal facilities. To assure safe 
handling of human remains, officials may control and utilize mortuary 
facilities and services. They are also authorized to take possession 
and dispose of all human remains. Health care facilities and supplies 
may be procured or controlled to treat and care for patients and the 
general public.
    Whenever health authorities take private property to use for public 
health purposes, constitutional law requires that the property owner be 
provided just compensation. Correspondingly, the Act requires the state 
to pay fair compensation to the owner of any facilities or materials 
temporarily or permanently procured for public use during an emergency. 
Where public health authorities, however, must condemn and destroy any 
private property that poses a danger to the public (e.g., equipment 
that is contaminated with anthrax spores), no compensation to the 
property owners is required although states may choose to make 
compensation if they wish. Under existing legal powers to abate public 
nuisances, authorities are able to condemn, remove, or destroy any 
property that may harm the public's health.
    Other permissible property control measures include restricting 
certain commercial transactions and practices (e.g., price gouging) to 
address problems arising from the scarcity of resources that often 
accompanies emergencies. MSEHPA allows public health officials to 
regulate the distribution of scarce health care supplies and to control 
the price of critical items during an emergency. In addition, 
authorities may seek the assistance of health care providers to perform 
medical examination and testing services.
    Protection of Persons. Section 601 of MSEHPA states: ``During a 
state of public health emergency, the public health authority shall use 
every available means to prevent the transmission of infectious disease 
and to ensure that all cases of contagious disease are subject to 
proper control and treatment.'' MSEHPA allows public health authorities 
to ask any person to be vaccinated or submit to a physical exam, 
medical testing or treatment, or provide a biological sample. Each of 
these measures may be needed to assist the individual and evaluate the 
epidemiologic consequences of an emerging condition during an 
emergency. These measures may be taken without any form of due process 
(e.g., right to a hearing) because individuals are free to choose to 
participate or not. Any person who may be impacted by a declaration of 
a public health emergency that gives rise to systematic vaccination or 
testing programs may challenge the basis for declaring the emergency in 
court.
    Although participation in vaccination, testing, or treatment 
programs is voluntary, those who choose not to participate and whose 
contagious condition may pose risks to others may be subjected to 
isolation or quarantine measures. The Act's quarantine and isolation 
provisions may be used to limit the freedom of individuals exposed to 
or infected with a contagious disease to circulate in the general 
public. Quarantine and isolation are classic public health powers. 
During non-emergencies, their practice is typified by limiting the 
transgressions of a very small number of persons whose behavior may 
lead to infecting others with a serious, contagious disease (like SARS) 
or other potential harms. During a public health emergency, where 
potentially thousands of persons are exposed or infected with a 
contagious disease, the use of quarantine or isolation powers may be 
widespread to protect community populations.
    MSEHPA attempts to balance the welfare and dignity of individuals 
with communal interests in implementing quarantine or isolation 
measures. Accordingly, public health authorities must: (1) use Athe 
least restrictive means necessary to prevent the spread of a contagious 
or possibly contagious disease to others.@ Arbitrary or discriminatory 
quarantines will not satisfy this standard; (2) maintain safe, hygienic 
conditions for persons in isolation or quarantine that minimize the 
risk of further disease transmission; (3) provide adequate food, 
clothing, medication, health care, means of communication, and other 
necessities; and (4) adhere to strong due process protections for 
affected individuals.
    Except where failure to quarantine or isolate persons immediately 
may significantly jeopardize the health of others, public health 
officials must obtain a court order before implementing these measures. 
The court can approve the use of isolation or quarantine only if the 
public health authority can show the measures are reasonably necessary 
to prevent or limit the transmission of a contagious or possibly 
contagious disease to others. Persons or groups subject to quarantine 
or isolation must receive written copies of orders accompanied by an 
explanation of their rights. They are entitled to be represented by 
counsel at individual or collective hearings to challenge the order 
generally or the conditions, terms, and treatment of their confinement. 
Even in cases of immediate quarantine or isolation, a court order must 
be sought as soon as possible.
    Private sector HCWs are encouraged to assist in vaccination, 
testing, examination, treatment, quarantine, and isolation programs. 
The Act allows public health authorities to condition future licensing 
status of in-state HCWs on their providing assistance (where possible), 
and to waive licensing requirements for out-of-state HCWs who are 
willing to help. Thus, the Act does not compel any private HCW to 
participate in public health measures during an emergency. It does 
provide some strong incentives to encourage participation because of 
the critical role of private sector HCWs during a public health 
emergency.
    Health Information Privacy. In the events leading to or during a 
public health emergency, MSEHPA envisions the need for a wide variety 
of federal, state, and local actors in the public and private sectors 
to share information that may relate to an individual's health status. 
Private sector HCWs may need to report identifiable health data to 
local public health authorities who may need to share this data with 
state and federal authorities to respond to a potential threat. 
Although there is a strong need to share such data for public health 
purposes, MSEHPA respects the privacy interests of individuals 
concerning their health data. The Act (1) limits the amount of 
information that may be conveyed to that which is necessary to respond 
to the public health emergency; (2) limits access to such data during 
an emergency to those persons having a legitimate need to acquire or 
use the information to provide treatment, conduct epidemiologic 
research, or investigate the causes of transmission; and (3) prohibits 
most disclosures outside the public health context. Additional privacy 
protections from the Model State Public Health Privacy Act of 1999 [by 
Lawrence O. Gostin and James G. Hodge, Jr] supplement MSEHPA, and are 
largely replicated in the comprehensive Model State Public Health Act.

                               CONCLUSION

    Preparing for and preventing public health threats like SARS in the 
United States requires a strong national public health infrastructure. 
Federal, state, tribal, and local public health authorities must 
collaborate with public and private sector partners in preparedness 
planning and emergency responses. Working to improve public health 
detection, prevention, and response capabilities requires effective 
training, additional resources, use of existing and new technologies, 
and public health law reform. Inadequacies in existing state public 
health laws can fail to authorize, or may even thwart, effective public 
health action. Law reform is needed to improve public health planning, 
detection, and response capabilities.
    MSEHPA (and the forthcoming comprehensive model public health law) 
present a modern statutory framework of public health powers that 
allows public health authorities to better plan, detect, manage, and 
control public health emergencies. The provisions of the Act are 
balanced against the need to safeguard individual rights and property 
interests. Reaching this balance is not easy. Tradeoffs and compromise 
are inevitable. Legal reform may not be a panacea for the unforeseeable 
conflicts between individual and community interests that may arise 
from emerging threats like SARS. There continue to be sharp debates 
about the extent to which the state should restrict individual rights 
to safeguard the public's health and safety. Finding an acceptable 
balance that allows government to fulfill its duty to protect the 
public's health while respecting individual rights is a worthy goal. 
Ultimately at stake is the health of each individual, protected through 
a public health system that relies upon each person's contribution to 
the larger whole.

                          Select Bibliography

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Threats and Responses.'' DePaul Business Law Journal. 12:59-81.
    Cantigny Conference on State Emergency Health Powers & the 
Bioterrorism Threat, April 26-27, 2001, sponsored by The Centers for 
Disease Control and Prevention, the American Bar Association Standing 
Committee on Law and National Security, and The National Strategy 
Forum.
    Chin, J., ed. (2000). Control of Communicable Diseases Manual. 
Washington, DC: American Public Health Association.
    Choo, K. 2002. ``Controversial Cure: Proposed CDC Model Act on 
Bioterrorism Seeks to Clarify State Enforcement Powers.'' ABA Journal. 
April:20-21.
    Fialka, J., et al. 2001. ``Are We Prepared for the Unthinkable?'' 
Wall Street Journal, Sept. 18, B1.
    Gostin, Lawrence O. ed. 2002. Public Health Law and Ethics: A 
Reader. Berkeley: University of California Press and Milbank Memorial 
Fund.
    Gostin, Lawrence O. 2001. ``Public Health Law Reform.'' Amer J Pub 
Health. 91:1365-1368.
    Gostin, Lawrence O. 2000. Public Health Law: Power, Duty, 
Restraint. Berkeley: University of California Press and Milbank 
Memorial Fund.
    Gostin, Lawrence O., James G. Hodge, Jr. 2002. ``Protecting the 
Public in an Era of Bioterrorism: The Model State Emergency Health 
Powers Act.'' In Bioethics After the Terror: Medicine and Morality in a 
Time of Crisis, edited by Jonathan D. Moreno, ______ (forthcoming). 
Boston: MIT University Press.
    Gostin, Lawrence O., James G. Hodge, Jr. 2002. State Public Health 
Law--Assessment Report. Seattle: Turning Point Public Health Statute 
Modernization National Collaborative.
    Gostin, Lawrence O, Scott Burris, Zita Lazzarini. 1999. ``The Law 
and the Public's Health: A Study of Infectious Disease Law in the 
United States.'' Columbia L. Rev. 99:59-128.
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Osterholm. 1996. ``The Public Health Information Infrastructure: A 
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Choices in Public Health.'' J Law, Med & Ethics. 30:2: 254-261.
    Horton, Heather, J.J. Misrahi, Gene W. Matthews, P.L. Kocher. 2002 
``Disease Reporting as a Tool for Bioterrorism Preparedness.'' J Law, 
Med & Ethics. 30:2: 262-266.
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City: Observations from TOPOFF,'' Biodefense Quarterly. 2: 1-10.
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Growing Sense of Anxiety.'' USA Today, Oct. 15, A1.
    Pavlin, J.A. 1999. ``Epidemiology of Bioterrorism.'' Emerging 
Infectious Diseases. 5: 528-30.
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Emerging Infectious Diseases. 5: 492-93.

    Mr. Greenwood. Very good, Mr. Hodge. Thank you very much.
    Ms. Kerby, for 5 minutes. Welcome.

                    TESTIMONY OF KARIN KERBY

    Ms. Kerby. Good afternoon Mr. Chairman, members of the 
committee. My name is Karin Kerby. I am a registered nurse and 
a Team Leader at Loudoun Hospital Center's emergency room in 
Leesburg, Virginia. I would like to thank you for the 
invitation to testify today especially on the issue of clinical 
staff safety as it relates to infectious disease triage and 
treatment.
    On the morning of February 17, 2003, the Nation's capital 
had just experienced a 2-foot snowfall. As I made it in to my 
job, little did I know that awaiting me was the first suspected 
case of SARS in the U.S. At that point, there was, to our 
knowledge, no such disease. This was weeks before an emerging 
pattern was recognized and addressed by the WHO and the CDC.
    This patient had just arrived by ambulance into our 
emergency department. Her symptoms were easy to recognize: she 
had acute shortness of breath, fever and cough. Her oxygen 
level was such that she required supplemental oxygen therapy 
and her chest x-ray revealed pneumonia. This particular patient 
was quickly moved from her stretcher into a room with oxygen. 
This happened to be our negative airflow room which, when 
activated, creates an environment where infectious airborne 
elements are vented away from the rest of the emergency 
department.
    Approximately 2 hours after her arrival I received a phone 
call from her nephew which helped guide the course of events. 
He related to me that the patient had just returned from the 
Guangdong Province in China. He had just received information 
from their family in China that there was an ``atypical 
pneumonia'' in their area from which people were dying. This 
information correlated with what I had read in the Washington 
Post just a few days previous.
    I alerted the emergency department physician and isolation 
procedures were reinforced and contacts with the Health 
Department and Infection Control were made.
    The protocol that we developed after 9/11 guides us in 
reporting suspected bioterrorism and infectious cases. While 
the physician contacted the infectious disease specialist, I 
immediately called the Loudoun County Health Department's 
epidemiologist, Benita Boyer, to consult. She confirmed that 
there was a reported outbreak of an unidentified pneumonia in 
China, and agreed that this patient should be kept in isolation 
at this point.
    The CDC, in conjunction with our Health Department and 
emergency department at the hospital, launched an 
epidemiological investigation, contacting every person who had 
come in contact with this patient; even isolating the emergency 
room physician for 3 days because she had a mild upper 
respiratory symptoms. Remember, SARS did not become a known 
entity until weeks later.
    This event shows how, on any given day in any emergency 
department or physicians' office, a new, emerging threat to our 
society's health can present and infiltrate. An enormous amount 
of work and planning has taken place since 9/11 as we have 
struggled to research and develop protocols to respond to the 
threat of smallpox, and in our community the reality of 
anthrax, West Nile Virus and malaria. Countless hours and 
thousands of dollars of unbudgeted funds have had to be poured 
into training, surveillance, decontamination equipment and 
education of our staff.
    However, no matter how prepared and equipped one is, there 
will always be that moment of vulnerability before we can 
respond when an unknown virus or bacteria may infect a triage 
nurse; it is a risk we in emergency medicine choose to take.
    This event could have had a very different outcome. For 
example, had she been without proper isolation precautions and 
infection control measures, not only would our staff but our 
community would have been negatively affected.
    Suffice it to say that since 9/11, if not before, the 
concerns related to infection control have migrated out of 
epidemiological departments to the general public awareness via 
county health departments and local hospital ERs.
    From my perspective as a staff nurse on the front line in 
the emergency department, I would offer these observations:
    Hospitals should assume all patients suspected of having 
SARS risk factors are highly infectious until proven otherwise, 
since the various modes of transmission of SARS remain unclear.
    To protect vulnerable patients, staff, visitors and the 
surrounding community, hospitals should activate all 
transmission precautions; including airborne, droplet, contact 
and contaminated material control measures.
    Caregivers should not ignore the basics of personal 
protective equipment, which includes gowns, gloves, N-95 masks, 
goggles as well as particular attention to hygiene.
    No. 2: No amount of training or preparedness can substitute 
for a well-informed public aware of an infectious disease and 
how to limit its spread. The difference between a person 
presenting to the emergency department stating, ``I might have 
been exposed'', and a person or physician calling us ahead to 
forewarn us of their arrival cannot be emphasized enough. Being 
able to isolate individuals BEFORE they enter a health care 
facility is absolutely imperative to stemming the spread among 
healthcare workers. The only way this can be accomplished is 
via public education.
    Case in point: this past week I overheard a conversation 
between a Southeast Asian couple and their English as a second 
language instructor. I overheard them saying ``We just heard 
about something called SARS.'' That was just last week. Why?
    There is a large contingent of people in this country who 
either do not speak English, do not own computers, who work two 
or three jobs and never read a newspaper or watch TV. I submit 
that public education needs to immediately go forward in 
multiple languages using a variety of media to inform everyone 
of this disease.
    As we have seen in Hong Kong, Toronto and China the impact 
on health has been devastating from infected health care 
workers to the overwork of those left to serve, creating unsafe 
isolation environments due to fatigue. Continued development of 
surge capacity plans for response to outbreaks, quarantine and 
the economic impacts must continue to be addressed between 
local hospitals, county and State health departments as well as 
Federal health authorities.
    Thank you. I will be happy to address any questions you may 
have.
    [The prepared statement of Karin Kerby follows:]

   Prepared Statement of Karin Kerby, Registered Nurse, Team Leader, 
             Emergency Department, Loudoun Hospital Center

    Good afternoon Mr. Chairman, members of the committee. My name is 
Karin Kerby and I am a registered nurse and Team Leader for the 
Emergency Department at Loudoun Hospital Center in Leesburg, Virginia. 
I would like to thank the Committee for the invitation to testify today 
specifically on the issue of clinical staff safety as it relates to 
infectious disease triage and treatment.
    On the morning of February 17, 2003, the nations' capital had 
experienced a 2-foot snowfall the previous day. As I made it in to my 
job, little did I know that awaiting me was the first suspected case of 
SARS in the U.S. At that point, there was, to our knowledge, no such 
disease. This was weeks before an emerging pattern was recognized and 
addressed by the W.H.O. and C.D.C.
    A patient had just arrived by ambulance into our ED. Her symptoms 
were easy to recognize: acute shortness of breath, fever and cough. Her 
oxygen level was such that she required supplemental oxygen therapy and 
chest X-ray revealed pneumonia. This particular patient was quickly 
moved from her stretcher into a room with oxygen. This was our negative 
airflow room which, when activated, creates an environment where 
infectious airborne elements are vented away from the rest of the 
Emergency Department.
    Approximately 2 hours after arrival I received a phone call from 
her nephew which helped guide the course of events. He related to me 
that the patient had just returned from the Guangdong Province in 
China. He had just received information from family in China that there 
was an ``atypical pneumonia'' in their area from which people were 
dying. This information correlated with what I had read in The 
Washington Post. I alerted the ED physician and isolation procedures 
were reinforced and contacts with the Health Department and Infection 
Control were made.
    The protocol that we developed after 9/11 guides us in reporting 
suspected bio-terrorism and infectious cases. While the physician 
contacted the infectious disease specialist, I immediately called the 
Loudoun County Health Department's epidemiologist, Benita Boyer, to 
consult. She confirmed that there was a reported outbreak of an 
unidentified pneumonia in China, and agreed that the patient should be 
kept in isolation at this point.
    The CDC, in conjunction with our Health Department and our 
hospital, launched an epidemiological investigation, contacting every 
person who had come in contact with this patient; even isolating the 
Emergency room physician for 3 days because of mild Upper respiratory 
symptoms. Remember, SARS did not become a known entity until weeks 
later.
    This event shows how, on any given day in any Emergency department 
or physicians' office, a new, emerging threat to our society's health 
can present and infiltrate. An enormous amount of work and planning has 
taken place since 9/11 as we have struggled to research and develop 
protocols to respond to the threat of smallpox, and in our community 
the reality of Anthrax, West Nile Virus and malaria. Countless hours 
and thousands of dollars of unbudgeted funds have had to be poured into 
training, surveillance, decontamination equipment and education of our 
staff.
    However, no matter how prepared and equipped one is, there will 
always be that moment of vulnerability before we can respond when an 
unknown virus or bacteria may infect a triage nurse; it is a risk we in 
emergency medicine choose to take.
    This event could have had a very different outcome. For example, 
had she been without proper isolation precautions and infection control 
measures, not only would our staff but community been negatively 
affected.
    Suffice it to say that since 9/11, if not before, the concerns 
related to infection control have migrated out of Epidemiological 
Departments to general public awareness via county health department's 
and local hospital ER's. If there is an additional action that has come 
about not just related to SARS, but infection threats in general, it 
has been this migration to the forefront of triage and public venues 
for education.
    From my perspective as a staff nurse on the front line in an 
Emergency department, I submit the following observations:

1. Hospitals should assume all patients suspected of having SARS risk 
        factors are highly infectious until proven otherwise, since the 
        various modes of transmission of SARS remain unclear. To 
        protect vulnerable patients, staff, visitors and the 
        surrounding community, hospitals should activate all 
        transmission precautions; including airborne, droplet, contact 
        and contaminated materials control measures. Caregivers should 
        not ignore basics of Personal Protection Equipment, which 
        includes gowns, gloves, N-95 masks, goggles as well as 
        particular attention to hygiene.

2. No amount of training or preparedness can substitute for a well-
        informed public aware of an infectious disease and how to limit 
        its spread. The difference between a person presenting to the 
        ED stating, ``I might have been exposed''. . . and a person or 
        physician calling ahead to forewarn of their arrival cannot be 
        emphasized enough. Being able to isolate individuals BEFORE 
        they enter a health care facility is absolutely imperative to 
        stemming the spread among healthcare workers. The only way this 
        can be accomplished is via public education. Case in point: 
        this past week, in a conversation between a Southeast Asian 
        couple and their ESL instructor I overheard the following: The 
        couple asked about ``something called SARS''. They were just 
        last week hearing about this! Why? There is a large contingent 
        of citizens in this country who do not speak English, who do 
        not own computers, who work 2 or 3 jobs and never read a 
        newspaper or watch TV. I submit that public education needs to 
        immediately go forward in multiple languages using a variety of 
        media to inform everyone of this disease.

3. Hospitals in the US are not generally equipped to handle large 
        outbreaks of this disease. Most hospitals have limited numbers 
        of isolation beds, many of which are already taken by 
        Tuberculosis patients. The expense involved in creating more 
        negative-airflow rooms to accommodate more patients is almost 
        cost-prohibitive and few hospitals have the budgeted amounts to 
        spend on this as-yet emerging threat.

4. As we have seen in Honk Kong, Toronto and China, the impact on 
        healthcare has been devastating, from infected healthcare 
        workers to the overwork of those left to serve creating unsafe 
        isolation environments due to fatigue. Continued development of 
        surge capacity plans for response to outbreaks, quarantine and 
        the economic impacts must continue to be addressed between 
        local hospitals, county and state health departments as well as 
        federal health authorities.
    Thank you. I will be happy to address any questions you may have.

    Mr. Greenwood. Thank you very much. It is very interesting, 
indeed.
    The Chair recognizes himself for 10 minutes for questions.
    And let me begin with Dr. Bloom. In your testimony on page 
six you discuss the creation of scientific linkages between 
health ministries and institutions around the world, and in 
this country, including the World Health Organization sharing 
in technology and knowledge to protect all of us from emerging 
threats. Do you believe that the public health and scientific 
response to SARS has in fact created the start of such a 
scientific linkage?
    Mr. Bloom. I wish I were so optimistic. I think it has 
created both the opportunity and the awareness of the value, 
but those linkages are very hard to establish.
    As I indicated, funding for students from developing 
countries for any kind of educational program here are 
extremely difficult to come by. Collaborative research projects 
between countries and institutions in the U.S. are very 
difficult to establish. It is very hard to get long term 
commitments.
    The greatest desire and need have been----
    Mr. Greenwood. Commitments from whom?
    Mr. Bloom. Pardon me?
    Mr. Greenwood. Hard to get commitments from whom?
    Mr. Bloom. From the Federal Government, from most of the 
usual foundation sources. The amount of resources with the 
exception of the Gates Foundation, which is a private rather 
pioneering organization and trying to create that is a rare 
exception.
    My sense from our students, a tremendous interest in global 
health from domestic students as well as international 
students, and that which is most desired in these countries is 
our knowledge, the access to knowledge, which I would argue we 
should be willing to provide in return for the information we 
need about the health status to protect our own country.
    Mr. Greenwood. Thank you.
    Let me direct a question to Mr. Hodge, if I might.
    If a State or local quarantine law was found invalid to 
confine patients infectious with a deadline disease, are there 
Federal laws and regulations that would serve as a secondary 
source of quarantine authority?
    Mr. Hodge. A very good question, Mr. Chair. We heard some 
testimony from Dr. Gerberding to that effect, and I can 
honestly say I think she very much got it right. The Federal 
authority in relation to quarantine or isolation is rather 
limited to the use of that for the purpose of border 
protections as well as intrastate spread of a particular 
epidemic disease or otherwise.
    So as a result to the extent to which we have the 
quarantine or isolation authority in every other setting, it 
largely does reside at a State or local level. And it is the 
case that we have seen certain instances of the use of that be 
egregious in relation to constitutional norms or otherwise. And 
I do not mean recently, but certainly in our Nation's history 
in the past.
    I would dare say that the scenario more likely to spin is 
that a court reviewing a statutory authorization for quarantine 
may look to impose the sort of constitutional protections that 
these statutes might not.
    Our model act, for example, talks about the need for 
potentially advanced due process where necessary, the potential 
to keep that use of a course of power to the least restrictive 
means necessary, not to be overboard or, certainly, in anyway 
try to infringe individual rights beyond what is needed.
    So I think in deference to what Dr. Gerberding said, the 
use of Federal quarantine power would be legitimate in a 
federally constitutional sort of way, but otherwise we would 
have to defer to a State or local authority.
    Mr. Greenwood. And this is a question of Ms. Kerby. Do you 
believe your hospital center has been positively impacted by 
the Federal investments in bioterrorism preparedness, and did 
it help your hospital's preparedness in this response to the 
SARS case you just described?
    Ms. Kerby. I do believe that they have been encouraging. 
The funds that we have been allocated have actually not 
arrived, but we have been assured that--we have gone forward 
with most of our planning and preparedness with unbudgeted 
funds. And we are anticipating support from the Federal 
Government.
    Mr. Greenwood. Okay.
    Dr. Benjamin, in your testimony you stated that the problem 
of emerging infectious diseases is likely to become more acute 
in the future and that the Institute of Medicine attributes the 
surge of infectious diseases to 13 specific changes in the 
world and in the way we live. Which changes are most important, 
and are these changes ones that are realistically within our 
control to alter?
    Mr. Benjamin. A great question. You know, I think there are 
several things that are important, maybe two or three.
    One, obviously, we humans are coming more in contact with 
parts of the world in which we probably had not been in contact 
before. That is one. But I think the biggest is the speed in 
which we do everything. Speed of travel makes a significant 
difference on the impact of this world in terms of these 
emerging infections, how quickly they can get to us.
    And the other part that was kind of not talked about a lot 
is the fact that we are on the verge of having the capacity to 
make these organisms ourselves. And that is also a significant 
threat in terms of emerging infections. And maybe not to do 
harm to ourselves, but simply all you have to do is have 
someone to work with an organism in a lab and that organism get 
out. So you still have significant problem with that.
    So, I mean, those two or three things, I think, as I think 
through those issues are probably the biggest ones that we have 
to deal with.
    Now, what do we do about them? We are probably going to 
continue to move very fast in travel. And I do not know if that 
is going to change much. But I do think we can certainly give 
it more thought as we do the science. We certainly can be more 
thoughtful about the effects of the environment on our plant. I 
do not think we understand exactly all the impacts of that, but 
we can certainly be a lot more thoughtful of that.
    I think what it really means is all those 13 factors argue 
for a much stronger public health system so that we can act 
quicker when these things happen.
    Mr. Greenwood. The last time I got on an airplane to fly 
back to the United States, as I was leaving my hotel room I saw 
the basket, I hadn't completed eating the basket of fruit on 
the table. And being sort of tightwad, I decided to put all of 
the remaining fruit into my bag. And I thought maybe I would 
eat it on the way to the airport, but I did not. And so I got 
to the airport and I had to unload these beautiful pieces of 
fruit into the trash can.
    Mr. Benjamin. Yes.
    Mr. Greenwood. We have a pretty good system of being asked 
now. I was asked do you have any fruit with you, and that sort 
of thing, any plants and a variety of questions. Pretty good at 
that aspect, but of course there is nobody asking me or being 
able to determine what sort of critters might be in my body.
    Do we need to get to the point where we start to think 
seriously with international travel being what it is and, as 
you said, Americans going into remote places with greater and 
greater frequency in a global business environment, for 
instance, global tourist environment where we need to have 
different kinds of screening or at least different questions 
asked of passengers before they board planes to come to the 
U.S. and after they get off the plane and are coming through 
Customs?
    Mr. Benjamin. Let me state that----
    Mr. Greenwood. And I would ask anyone who would like to 
respond to that to do so.
    Mr. Benjamin. Yes. Let me step back and say I do not know 
that questioning is the right answer. I think we need to 
understand what protections we need to put in place to identify 
people who are at risk. And not do some of the things we had to 
do after September 11, very draconian things in terms of us now 
getting through the airport and those kinds of things. I think 
we need to study it.
    Mr. Greenwood. I mean, it is one thing to take my shoes off 
at the airport. Now do I have my temperature taken now?
    Mr. Benjamin. Yes. Well, see, those are some of the kinds 
of things, you know. Ask the question, you know, the fact that 
you have a temperature, does that really put everyone at risk? 
It may or may not. This is a very, very broad case definition. 
And I would suspect if someone simply did a study on the number 
of people that went through airports that had fever, you may 
very well find that that number is higher than one might think. 
I do not know that, but I think we need to study it.
    So that is the kind of practical research that absolutely 
has to be done so that we can answer your question.
    Ms. Kerby. If I might, I have had some experience with a 
few patients who have traveled and then come to our emergency 
departments, having had received the little yellow informative 
thing from the CDC. They do not read it, other than to see 
that, oh, I need to go to a doctor if I have a fever. They do 
not read all of it knowing--we are trying to tell them they 
need to call ahead, they need to consult with someone on the 
phone and not sit in a waiting room.
    So my point once again is education in all languages and 
all venues so people will be better prepared to understand it. 
They just do not get it.
    Mr. Greenwood. One wonders if that ought to be something 
one sees on the video screen in an airplane in the way as 
opposed to something that is handed and more paper that we do 
not read.
    Any other comments in response to my question?
    Okay. My time has just about expired. And the gentlelady 
from Colorado is recognized for 10 minutes.
    Ms. DeGette. Thank you, Mr. Chairman.
    Ms. Kerby, as I heard your rivetting story about the 
patient who came in, I could not help but wonder what would 
have happened under two scenarios. The first one, what would 
have happened if that room had not been available, just 
coincidentally? Because you would have just put that patient in 
a regular room, I assume, right?
    Ms. Kerby. That is correct.
    Ms. DeGette. And the second thing I was wondering is what 
would have happened if the family member had not called and 
said ``Oh, we heard this rumor that something was going on in 
China.'' And what I am wondering is at that early stage, that 
was February you said?
    Ms. Kerby. Yes, ma'am.
    Ms. DeGette. I am wondering in your view could there have 
been better alerts, at least to hospitals and health care 
professionals that there was something going on in China, so at 
least even if all this global effort we are making now had not 
been called for yet, if you would have had some way as an 
institution to know there was something going on and to look 
for those symptoms?
    Ms. Kerby. I think that currently the CDC does an 
incredible job of alerting us. Our health department are 
constantly sending us updates on any emerging threat.
    When you look back to this particular situation, there was 
a very small window where information came out of China, and 
that is what I happened to have read in the paper. If I am not 
mistaken, it was about a week's worth of information and then 
it was shut down again and the information did not come out of 
China. So I think we were hampered by the lack of information.
    So, I do not see how it could have been any different at 
that time. Right now the openness of the entire world at this 
point seems to be helping all of us be aware.
    Ms. DeGette. But see here is the thing, and maybe someone 
else has a comment on this as well, if you read it in the 
newspaper there was information about this that was coming to 
the United States. Does anyone else have a view of how we can 
take even limited information like that and make it of some use 
to health care institutions? Because, frankly, if that person 
had not been isolated and the family member had not called, we 
would have had a much more serious SARS outbreak in this 
country right now that we were dealing with.
    Mr. Benjamin. Let me say that right now as an example, CDC 
has told us about some early influenza cases that we need to be 
concerned about in another country. So that kind of thing does 
happen when you get the information, and it has gone out to 
both the public health community and the practicing medical 
community through their health alert network.
    Now, again, the problem is, is that when I used to work in 
hospital emergency departments you get one of those little 
things and you print it out, and it gets tacked on the 
information board. And it may very well not be read by all and 
taken down at some point in time and trashed.
    So, consistent communications is just, as Ms. Kerby said, 
the only way to do it is to just continue to keep it in the 
minds of the public, the minds of the public health community, 
the minds of the acute care medical community.
    Ms. DeGette. But it sounds like with SARS we knew something 
was going on in the early stages in China, at least for a short 
window, and it sounds like those kind of warnings were not at 
that early stage given to hospitals. And believe you me, I 
think it is fantastic what the CDC does. But I am just 
wondering if there is something else we could be doing?
    Ms. Bloom?
    Ms. Bloom. Part of the problem was and is the fact that the 
World Health Organization, for example, or any other national 
government cannot get into a country unless they are invited 
in. So, in fact, there is a Net program called ProMed that in 
November of last year was reporting an atypical pneumonia 
epidemic in Guangdong China, but no one could verify that 
because no one could get in. And that becomes very difficult 
unless you have actual people on the ground, and that would be 
one advantage to maintaining long term linkages.
    Ms. DeGette. Do you think that the recent experience with 
SARS will help some of these countries like China understand 
that they do need to let the World Health Organization in 
earlier? Do you think it will help with the worldwide 
communication?
    Ms. Bloom. It has clearly transiently done so, and the 
question and the kind of intimation that concerned me from Dr. 
Heymann's statement is the pipeline still open for information 
or as we try to reach the more remote areas, will the data be 
accessible. We do not know.
    Ms. DeGette. Dr. Bloom, continuing with you, in your 
testimony you criticized the decision to cut the National 
Center for Infectious Diseases at CDC by $8 million in fiscal 
year 2003, and I think you talked about that specifically as we 
are increasing other areas. I am wondering if you have any 
recommendations to the Congress and the President for the next 
budget request, and what evidence you would have to support 
those requests?
    Ms. Bloom. I am enormously grateful for the question. I am 
not a budget expert. But I think the advice that you have heard 
from this panel, I would support strongly, which is there is 
something called emerging infections. We do not know what they 
are, what they will be, whether they will be new or old. We 
know they will come and that some of them will be serious. And 
the agencies have money so targeted for anthrax or smallpox 
that when something new comes, I do worry. What if we were to 
have West Nile coming up soon, while people are in China and 
Singapore and all over the world from CDC looking at SARS? And 
if there were a food borne outbreak in this country in 
addition, would they have the surge resources? And my sense is 
what we need is funding for a category called emerging 
infections. And I would trust these people to have the best 
judgment imaginable where to put their personnel and resources 
to make the biggest difference.
    Ms. DeGette. Do you have a comment on----
    Mr. Benjamin. Yes, I can get that number back to you for 
the record, but----
    Ms. DeGette. I would appreciate that.
    Mr. Benjamin. But the American Public Health Association is 
part of something called the CDC Coalition, and we have been 
specifically asked this year as we go through the rest of the 
appropriations process for the CDC.
    Ms. DeGette. Thank you.
    Well, while I am on you, Dr. Benjamin, I have another 
question, which is in your written testimony and also you 
alluded in your verbal testimony today, you say that Congress 
needs to start supporting our public health base in a more 
holistic way. I am wondering if you can elaborate on your 
recommendations to this committee to ensure that the Nation's 
public health care infrastructures are adequately prepared and 
able to deal with these public health crises?
    Mr. Benjamin. You know, one of the things that we do with 
public health systems is we basically play a shell game. We 
fund something on the left and we take it away on the right. 
You know, and not recognize the inner relationship between the 
two. Let me give you a couple of examples.
    When we are doing smallpox vaccinations, many of the people 
that helped us do those vaccinations are school health nurses. 
So if you cut the school health programs, you have not gotten 
any additional capacity. Or if you use the Federal funds to 
hire epidemiologists and then the State funds get cut, you have 
not accomplished any additional capacity.
    Purely at the Federal level when we had the anthrax 
attacks, in fact right after September 11 to man a lot of the 
epidemiologic support in the Washington metropolitan region 
here, we were taking folks from our chronic disease program, 
from our AIDS programs, from our injury programs; a broad range 
of programs. Obviously that, from a public health perspective, 
that is our surge capacity when something happens. So when that 
overall capacity disappears or diminishes, you are actually 
taking away capacity.
    So, you know, it is great that we are putting a billion 
dollars into public health, you know, each year for the last 
couple of years, but at the same time we are not looking at the 
whole system recognizing relationships between some of these 
other very, very important programs, which not only protect us 
for bioterrorism, but protect us for diseases that are here 
today. So they protect us for, you know, adult immunizations, 
childhood diseases, food safety; all of those kinds of things 
are extraordinarily important as the base to build a strong 
preparedness system, Ms. DeGette. Thank you.
    I yield back.
    Mr. Greenwood. Did the gentleman from Florida wish to 
inquire?
    In that case, the Chair thanks each and everyone of the 
panelists for your traveling to be with us and for your very 
valuable assistance. Thank you.
    You are excused. And the Chair would call the third panel, 
which consists of Mr. John M. Brenna, President and Chief 
Operating Officer of Computerized Thermal Imaging, Inc. from 
Lake Oswego, Oregon.
    Dr. Robert J. Capetola, President and Chief Executive 
Officer, Discovery Laboratories, Inc. of Doylestown, 
Pennsylvania.
    Dr. Paul H. Fischer, Ph.D., Chief Executive Officer of 
GenVec, Inc.
    Dr. Nils Lonberg, Ph.D., Senior Vice President, Scientific 
Director of Mederex, Inc. from Milpitas, California.
    Welcome, gentlemen. I think most of you have been here all 
afternoon and so you know the drill. This is an investigative 
hearing, and when we hold investigative hearings we take 
testimony under oath. And so I need to ask if any of you object 
to giving your testimony under oath. Seeing no such objection, 
then I would need to advise you that you are entitled to 
represented by counsel today if you choose. Do any of you wish 
to be represented by counsel? Okay.
    In that case, if you would stand and raise your right 
hands.
    [Witnesses sworn.]
    You are under oath.
    And, Dr. Brenna, we will begin with you and ask you to give 
an opening statement for about 5 minutes.

  TESTIMONY OF JOHN M. BRENNA, PRESIDENT AND CHIEF OPERATING 
    OFFICER, COMPUTERIZED THERMAL IMAGING, INC.; ROBERT J. 
  CAPETOLA, PRESIDENT AND CHIEF EXECUTIVE OFFICER, DISCOVERY 
 LABORATORIES, INC.; PAUL H. FISCHER, CHIEF EXECUTIVE OFFICER, 
 GenVec, INC.; NILS LONBERG, SENIOR VICE PRESIDENT, SCIENTIFIC 
DIRECTOR OF MEDEREX, INC.; AND DENIS R. BURGER, CHIEF EXECUTIVE 
                     OFFICER, AVI BIOPHARMA

    Mr. Brenna. Good afternoon, Mr. Chairman and members of the 
subcommittee. On behalf of Computerized Thermal Imaging I thank 
you for the opportunity today to testify as to how infrared 
imaging can be used for SARS screening. My name is John Brenna 
and I am the President of the company. The material I will 
present is based on recent experiences learned from our 
technology being used in China for SARS Screening.
    Before I begin, Computerized Thermal Imaging is a small 
manufacturing company, specializing in medical and industrial 
applications for infrared camera technology. These cameras are 
sensitive scientific instruments that measure heat and 
temperature changes. Our industrial products were developed for 
non-destructive testing, principally for turbine blades to 
reveal minute imperfections that could result in a catastrophic 
turbine blade failure.
    Our medical products are used primarily in the field of 
pain management. And in 1999, we started an FDA Pre-Market 
Approval process for a noninvasive infrared breast imaging 
system, which studies have shown can be used as an diagnostic 
adjunct to mammography x-ray to reduce biopsies of benign 
masses. This product application is currently pending, and we 
are working with FDA to obtain approval.
    The CDC tells that SARS is an atypical pneumonia 
transmitted by contact with body fluids and air particles 
coughed or sneezed by an infected person. Symptoms may include 
respiratory distress, coughing, shortness of breathe, and 
breathing difficulty and is accompanied by a fever greater than 
100 degree Fahrenheit. A chest x-ray finding of pneumonia or 
respiratory distress syndrome is the only known way now to 
confirm SARS: although other companies are working on various 
serum blood tests.
    Our authorized dealer in China has been working with 
various provincial health care administrators over the past 
several weeks and have installed six of our infrared cameras 
specifically for SARS screening. Four of the cameras are 
located at hospital entrances, one at a railway depot ticket 
counter, and one at an airport with a special health care 
screening gate. The magnitude of the challenge facing China is 
staggering, with over 300 major airports, over 1,000 railway 
stations and over 12,000 medical hospitals. These are crowded 
mission critical facilities that are, unfortunately, terrific 
amplifiers for any airborne disease.
    The early learning experiences indicate that using infrared 
camera technology for SARS screening has been beneficial. When 
a human image is taken with an infrared camera, we know that 
skin temperature is lower than the normal 98.6 degrees 
Fahrenheit body temperature. This is the result of well studied 
heat evaporation, conduction and convection principles.
    Medical specialists in China use a facial temperature 
baseline of 33 degrees centigrade or 91.4 degrees Fahrenheit as 
the upper limit for normal healthy temperature. When an 
infrared image indicates a body temperature above this 
baseline, the subject's body temperature is taken with a 
thermometer and then checked for respiratory distress symptoms. 
A chest x-ray at the screening location or nearby clinic may 
then be used to confirm the presence of a pneumonia.
    Now I have an example of the kind of images that are used 
in this process. By using gray scale, imaging techniques and 
temperature thresholds there are no interpretation 
requirements. The screening test is either positive or 
negative. And you will note the normal image on my right is an 
image of a subject exhibiting a facial temperature below 33 
degree centigrade. And highlighted in red, okay, is the 
suspicious image detecting a skin temperature above 33 degrees 
centigrade. That suspicious condition can also be signaled by 
an audible alarm.
    Early results provided by our dealer distributor, indicate 
that half of the subjects screened, who had temperatures 
exceeding 33 deg. centigrade required further examination and 
treatment. The other half of the subjects following initial 
examination were found to be false positives caused by some 
form of physical exertion, pharmaceuticals, menopausable 
activity or metabolic disorder.
    The Computerized Thermal Imaging infrared camera is a 
scientific instrument designed to image the human body skin 
temperatures. And let me briefly explain.
    First, the camera is ``radiometric'' meaning it measures 
actual skin temperature. Most other cameras measure 
``relative'' heat, which differentiates humans from inanimate 
objects, as used in military or weather forecasting 
applications.
    Second, the camera was designed with ``high sensitivity'', 
meaning using a Mercury Cadmium Telluride detector providing 
optimal measurements for human temperatures in the 20 to 40 
degree centigrade range.
    This technology detects infrared transmissions in the 
wavelengths range of 8 to 12 microns. The human body's peak 
emission wavelength is about 10 microns. Thus, our technology 
is optimized for human applications.
    Most other infrared cameras operate in the three to five 
micron range and are designed for industrial applications.
    And finally, the system captures images dynamically in near 
real time, providing the capability for high volume throughput 
for volume screening as passengers and subjects pass through 
security check points.
    In a single screening line one system can image up to 12 
subjects per minute or over 700 per hour yielding a 
``positive'' or ``negative'' test result.
    In closing, we are learning much from the experiences in 
China. Infrared camera technology offers much promise as a 
first defense early warning indicator. We know that Mercury 
Cadmium Telluride detectors optimally capture human infrared 
frequencies. And that ``radiometric'' technology works best for 
human temperature measurement accuracy.
    I would strongly recommend to this subcommittee that 
additional Government research and development support be 
considered for advancing infrared technology as a SARS 
screening device, including consideration for establishing a 
trial site or sites at a high risk or at high risk 
international entry locations.
    I thank you for the opportunity to appear today.
    [The prepared statement of John M. Brenna follows:]

 Prepared Statement of John M. Brenna, President, Computerized Thermal 
                                Imaging

    Good afternoon ladies and gentlemen. On behalf of Computerized 
Thermal Imaging I thank you for the opportunity today to testify before 
this sub-committee as to ``How Infrared Imaging could be used for SARS 
Screening''. My name is John Brenna and I am the president of the 
company. The material I will present is based on recent experiences 
learned from our technology being used in China for SARS Screening.
    Before I begin, Computerized Thermal Imaging is a small 
manufacturing and research and development company located in Portland, 
Oregon and Ogden, Utah. Our core competence is specializing in medical 
and industrial applications for Infrared Camera technology. These 
cameras are sensitive scientific instruments that measure heat and 
temperature changes.
    In industry, our technology is used for non-destructive testing, 
principally for turbine blade testing where conventional forms of 
testing fail to reveal minute imperfections that could result in a 
catastrophic failure.
    Our medical products are used primarily for the location and 
therapeutic treatment of pain and pain management. In 1999, we started 
the FDA Pre-Market Approval process for an infrared breast imaging 
system that provides physiological information, which studies have 
shown can be used as an diagnostic adjunct to mammography x-ray to 
reduce biopsies of benign masses. This product application is currently 
pending, and we are working with FDA to obtain approval.
    We are fortunate to have an authorized dealer in China who has been 
working with various provincial healthcare administrators over the past 
several weeks, and has installed six of our infrared cameras 
specifically for SARS screening. Four of the cameras are located at 
hospitals, one at a railway depot and one at an airport. The magnitude 
of the challenge facing China is shown by their having over 300 major 
airports, over a 1000 railway stations and over 12,000 hospitals.
    Their early learning experiences indicate that, using Infrared 
camera technology for SARS screening has been beneficial.
    We know that SARS is an atypical pneumonia transmitted by contact 
with body fluids and air particles coughed or sneezed by an infected 
person. Symptoms may include respiratory distress, coughing, shortness 
of breath and breathing difficulty and is accompanied by a fever 
greater than 100 degrees Fahrenheit. A chest x-ray finding of pneumonia 
or respiratory distress syndrome is the only known way now to confirm 
SARS: although other companies are working on serum blood tests.
    As I mentioned earlier, our infrared cameras are at four hospitals, 
one railway station and one airport; these are crowded, mission 
critical facilities that are, unfortunately, terrific amplifiers for 
any airborne disease.
    When a human image is taken with an infrared camera, we know that 
skin temperature is lower than the normal 98.6 degrees Fahrenheit body 
temperature, because of well-studied heat evaporation, conduction and 
convection principles. Medical specialists in China use a facial 
temperature baseline of 33 degrees centigrade or 91.4 degrees 
Fahrenheit as the upper limit for normal healthy temperature.
    Let's now turn to the practical application of the technology to 
SARS Screening and the logistical considerations that must be 
addressed.
    At the airport, a special health-screening gate was established to 
detect facial temperatures exceeding 33 degrees centigrade, before a 
passenger passes through security. At the railway station, passengers 
are screened at the ticket counter and at the hospitals all patients 
and visitors are screened.
    A temperature reading above 33 degrees centigrade signals a 
potential fever. When a fever like symptom is detected, the subject's 
body temperature is taken with a thermometer and then checked for 
respiratory distress symptoms. A chest x-ray at the screening location 
or nearby clinic may then be used to confirm the presence of pneumonia.
    These are example images of the screening process. You will note 
the ``normal'' image of a subject exhibiting facial skin temperature 
below 33 degrees centigrade and the abnormal image detecting skin 
temperature above 33 degrees centigrade. The abnormal condition can 
also be signaled by an audible alarm. (See attachment)
    This is what the Infrared camera system looks like. (See 
attachment)
    Early results provided by our dealer distributor, indicate that 
half of the subjects screened, who had temperatures exceeding 33 
degrees centigrade required further examination and treatment. The 
other half of the subjects, for which examination was required, were 
false positives caused by some form of physical exertion or 
pharmaceuticals.
    The Computerized Thermal Imaging infrared camera is a scientific 
instrument designed to image the human body skin temperatures. Let me 
explain in more detail:
    First, the camera is ``radiometric'' meaning it measures actual 
skin temperature. Most other cameras measure ``relative'' heat, which 
differentiates humans from inanimate objects, as used in military or 
weather forecasting applications.
    Secondly, the Computerized Thermal Imaging camera was designed with 
``high sensitivity'' using a Mercury Cadmium Telluride detector 
providing optimal measurements for human temperatures in the 20 to 40 
degree centigrade range.
    This technology detects infrared transmission in the wavelengths 
range of 8 to 12 microns; those are wavelengths between 8 and 12 
millionths of an inch. The human body's peak emission wavelength is 
about 10 microns. Thus, our technology is optimized for human 
applications.
    Most other infrared cameras are either not radiometric, meaning 
they do not measure actual temperature, or do not operate in the 8 to 
12 micron spectral range for sufficient resolution and accuracy. Most 
operate in the 3 to 5 micron range and are designed for industrial 
applications.
    And last, the Computerized Thermal Imaging system captures images 
dynamically in near real time, providing the capability for high volume 
throughput as subjects pass through security check points. Just one of 
the systems can image up to 12 subjects per minute or over 700 per hour 
yielding a ``positive'' or ``negative'' test result. Subject images for 
storage and retention purposes are structured in common Microsoft 
ACCESS and compatible with standard WORD and Microsoft programs.
    In closing, we are constantly learning from the experiences in 
China. Infrared Camera technology offers much promise in SARS screening 
as it measures facial body temperature as a first defense early warning 
indicator. We know that Mercury Cadmium Telluride detectors optimally 
capture human infrared frequencies. And that ``radiometric'' technology 
works best for temperature measurement accuracy.
    The SARS death toll is rising. SARS clearly is a global microbial 
threat.
    I would strongly recommend to this sub-committee that additional 
government research and development support be considered for advancing 
infrared technology as a SARS screening device; including consideration 
for establishing a trial site or sites at high risk international entry 
locations.
    I thank the sub-committee for this opportunity to describe infrared 
camera technology as a potential means for first defense SARS 
Screening.

    Mr. Greenwood. Thank you, Mr. Brenna. That is certainly 
interesting.
    Dr. Capetola?

                TESTIMONY OF ROBERT J. CAPETOLA

    Mr. Capetola. Mr. Chairman, thank you very much. Members of 
the committee as well.
    My name is Bob Capetola. By training I am an experimental 
clinical pharmacologist, having spent about 30 years in the 
pharmaceutical business and drug discovery through drug 
development and having been fortunate enough to put a lot of 
drugs on the market that are in use today.
    Our company is a biotechnology company devoted toward 
development and commercialization of surfactant replacement 
therapy for respiratory diseases. And as you saw from our 
written testimony, the primary diseases that we are focused on 
at the moment at critical care diseases, principally focused in 
premature babies at the moment, but also as you see, from phase 
two trials we are in a condition called acute respiratory 
distress syndrome, which is the ultimate manifestation of 
something like SARS.
    So our company, as you saw today from the testimony of the 
first two sessions, the major focus of a industry and 
government effort at the outset of something like this is to 
throw the resources toward the two primary focuses, and that 
would be antiviral drug screening and also the development of 
vaccines.
    I think having been experienced in this business for 
several decades, you are probably aware from previous testimony 
that antiviral drugs are probably the most difficult drug 
discovery targets in all of the pharmaceutical business, 
principally because they are so simple. And if they are so 
simple, they do not have defined targets that can differentiate 
them from normal cell processes. Even a bacteria is many fold 
times more complicated than a virus, and that is why we have 
very effective antibiotic drugs but not very effective 
antiviral drugs.
    Vaccination in terms of treating therapy at the outset is 
probably the best approach in the near term. But you heard what 
the near term means from Dr. Fauci, 3 years at best, most 
likely five to seven if everything goes very, very well. And 
that is if the virus does not mutate at a rate that would be 
unexpected.
    So while companies are here discussing ways of essentially 
killing the virus, our company is focused on treating the 
patients with the fundamental pathological defect that they are 
undergoing and ultimately leads to their chronic sickness and 
ultimately, perhaps, morbidity and mortality. And that is in 
the lung, the lung exists to house about 250 million little air 
sacs. These air sacs go by the name of alveoli. And each one of 
us here has those. And we have inside that air sac in a 
monolayer something called the human surfactant system.
    Now during an inflammation of the lung, whether it be from 
the SARS virus, the pneumococcal bacteria, whether it be from 
trauma, aspiration of gastric contents, near drowning, smoke 
inhalation, anything that traumatizes that alveolar or that air 
sac network, leads to a migration into that air sac of classic 
white blood cells which can destroy, along with the protein and 
fluid that come from the circulatory system, destroy the 
surfactant that exist in the lungs. That is why these SARS 
patients go into the hospital. And if they progress to the 
point where they need mechanical ventilation, that really means 
that most of the little air sacs have collapsed. And they have 
collapsed because so much of the surfactant system is 
destroyed.
    Surfactants keep the lungs open. Surfactants are critical 
for life. They are critical for breathing.
    So our company is devoted toward the development of these 
products in a variety of respiratory diseases. One of them is 
the ARDS condition. ARDS stands for acute respiratory distress 
syndrome. These would be the sickest patients that would go 
through the SARS episode. These patients are in the critical 
care unit. They are mechanical ventilation. If you do not open 
up a bunch of those lung air sacs that we talked about 
previously, these patients are going to have decreased 
oxygenation in their arterial blood, and that is when the vital 
organs begin to shutdown.
    So our approach, and the approach that we are in right now 
as phase II B trial in the United States with ARDS and soon to 
enter ten sites in Toronto, is likely to enter a SARS patient 
in the not distant future, is to treat the patients basic 
defect. That is, we are not going to kill the virus, but we are 
going to keep the patient alive long enough by replacing the 
damaged surfactant so that their endogenous immune system can 
take over and, perhaps, maybe get the patient well sooner and 
off the ventilator. Because it is an axiom in critical care 
medicine the length of time on the chemical ventilation is 
associated with a poor clinical outcome.
    So in the interest of time, we have put a pretty extensive 
written testimony which describes how surfactants work. They 
are not, certainly, trivial drugs. They are very complicated 
biotechnology drugs. And all that we ask that this committee 
serve to be a catalyst in conveying this important message that 
the surfactant replacement therapies can be included in the 
assessment of therapies currently under consideration by the 
various health authorities.
    Thank you.
    [The prepared statement of Robert J. Capetola follows:]

Prepared Statement of Robert J. Capetola, President and Chief Executive 
                Officer of Discovery Laboratories, Inc.

    Severe Acute Respiratory Syndrome (SARS) is an acute respiratory 
illness in which patients have difficulty breathing.\1\ The path of 
SARS is a highly contagious viral infection \2\ that leads to 
pneumonia, and in severe cases, progresses to life-threatening Acute 
Lung Injury (referred to as ALI), the most serious manifestation of 
which is Acute Respiratory Distress Syndrome (referred to as ARDS). A 
prominent characteristic of ARDS is the destruction of a patient's lung 
surfactant.\3\ Surfactants are produced naturally in the lungs and are 
essential for breathing. (See Illustration 1). Should these surfactants 
degrade or be destroyed, millions of alveoli, or tiny air sacs, in the 
lung collapse, airflow becomes constricted and the lungs do not absorb 
sufficient oxygen. (See Illustration 2).
---------------------------------------------------------------------------
    \1\ The Centers for Disease Control (CDC ) has identified that SARS 
patients can experience dry cough, shortness of breath and difficulty 
breathing because of lung congestion.
    \2\ Scientists believe that SARS is caused by a newly discovered 
coronavirus, a member of a family of viruses linked previously to mild 
cold symptoms in humans. Sorting the Facts, Guesses and Mysteries of 
SARS, The Wall Street Journal, May 2, 2003, at B1 (hereinafter Facts 
and Mysteries of SARS).
    \3\ ARDS is characterized by an excess of fluid in the lungs, 
decreased oxygen levels, and the destruction of surfactants present in 
lung tissue. See generally Gregory TJ, Steinberg KP, Spragg R, Gadek 
JE, Hyers TM, Longmore WJ, Moxley MA, Cai G-Z, Hite RD, Smith RM, 
Hudson LD, Crim C, Newton P, Mitchell BR and Gold AJ, Bovine Surfactant 
Therapy for Patients with Acute Respiratory Distress Syndrome, Am J 
Respir Crit Care Med 155:1309-1315 (1997); Ashbaugh DG, Bigelow DB, 
Petty TL and Levine BE, Acute Respiratory Distress in Adults, Lancet 
2:319-323 (1967); Hallman M, Spragg RG, Harrell JH, Moser KM and Gluck 
L, Evidence of lung surfactant abnormality in respiratory failure: 
study of bronchoalveolar lavage phospholipids, surface activity, 
phospholipase activity, and plasma myoinositol, J Clin Invest 70:673-
683 (1982); Pison U, Seeger W, Buchhorn R, Joka T, Brand M, Obertacke 
U, Neuhof H and Scmit-Neuerburg KP, Surfactant abnormalities in 
patients with respiratory failure after multiple trauma, Am Rev Respir 
Dis 140:1033-1039 (1989); Pison U, Overtacke U, Brand M, Seeger W, Joka 
T, Bruch J and Schmit-Neuerburg KP, Altered pulmonary surfactant in 
uncomplicated and septicemia-complicated courses of acute respiratory 
failure, J Trauma 30:19-26 (1990); Gregory TJ, Longmore WJ, Moxley MA, 
Whitsett JA, Reed CR, Fowler AAI, Hudson LD, Maunder RJ, Crim C and 
Hyers TM, Surfactant chemical composition and biophysical activity in 
acute respiratory distress syndrome, J Clin Invest 88:1976-1981 (1991).
---------------------------------------------------------------------------
    No proven treatment for SARS presently exists. For now, SARS 
treatment amounts to keeping patients isolated and dealing with their 
symptoms while the infection runs its course. SARS patients are 
currently getting the same treatments as patients suffering from 
pneumonia or other respiratory infections, including antibiotics to 
combat bacterial infections, mechanical ventilation to help them 
breathe, and treatment for fever.\4\ With the number of world-wide SARS 
cases approaching 6,000, the lack of an effective treatment has 
resulted tragically in at least 400 deaths, or a mortality rate of 
greater than 6.5%.
---------------------------------------------------------------------------
    \4\ See Facts and Mysteries of SARS (discussing that the current 
treatments for SARS consist solely of providing supportive care).
---------------------------------------------------------------------------
    Although public health officials are hopeful that the spread of 
SARS may have temporarily peaked, at least outside China, most 
researchers fear that SARS will return in force next winter.\5\ An 
additional concern is that the virus could be quickly mutating and new 
SARS strains, possibly more virulent forms, are likely to develop. 
Indeed, Hong Kong has recently reported that a dozen former SARS 
patients had relapsed, indicating that treating the disease may be even 
more difficult than expected.
---------------------------------------------------------------------------
    \5\ See Id. Many respiratory illnesses are most prevalent in cold 
weather. Researchers fear that although SARS may decline during the 
summer months it will return in force next winter.
---------------------------------------------------------------------------
    World health authorities, including the United States National 
Institutes of Health, are taking a logical first step to address the 
SARS virus by searching for an effective antiviral treatment. They are 
urgently screening a number of virus-fighting drugs, medicines already 
on the market or close to it, including protease inhibitors and 
compounds that block viral replication. No antiviral presently exists 
that is specifically aimed at this coronavirus (the form of virus 
identified by the CDC and the World Health Organization as the cause of 
SARS). Even the ribavirin/steroid ``cocktail'' that doctors in Asia and 
Canada had been using extensively to treat SARS has been abandoned 
because of lack of effectiveness in combating the disease and harmful 
side effects, with many patients suffering anemia and liver 
inflammation because of it. Dr. Anthony Fauci, Director of the National 
Institute of Allergy and Infectious Diseases, has commented that he 
hopes to have a possible vaccine ready for human testing in just over a 
year. But Dr. Fauci has cautioned that it would still be years before a 
vaccine would be available for distribution and that its development 
can never be guaranteed.
    While these efforts need to be continued and supported both 
scientifically, financially and politically, the harsh reality is that 
SARS patients have difficulty breathing--they are suffering the 
destruction of their essential lung surfactant system and are at risk 
for life-threatening ALI or ARDS. No approved therapies for ARDS 
currently exist. Current therapy for ARDS patients remains entirely 
supportive and mechanical ventilation is the present standard of care. 
In the face of the SARS crisis, a logical precaution for world health 
officials to take is to ensure that an adequate number of mechanical 
ventilators are available. Indeed, the United States government has 
recently improved its ability to respond to a SARS outbreak by adding 
3,000 mechanical ventilators and has asked the states to identify space 
for extra hospital beds during an emergency. However, mechanical 
ventilation is an unfortunate last resort--the only way to oxygenate 
and keep the vital organs functioning. It is used only to assist in the 
patient's breathing while an attempt to adequately address the 
underlying cause of the disease is made. However, mechanical 
ventilation is very costly and it is axiomatic in critical care 
medicine that the longer a patient is on mechanical ventilation the 
higher the likelihood that mortality and morbidity results. Even with 
mechanical ventilation, the reported mortality rate for ARDS is between 
40-50% worldwide.
    Public health officials have focused on a search for effective 
agents to combat SARS and have recognized the need for improving 
mechanical ventilation resources and attendant facilities. The next 
logical step for world health authorities is to fully evaluate 
therapies that can restore proper lung function in SARS sufferers. 
Surfactants are essential for breathing and one of the prominent 
characteristics of ARDS is the destruction of lung surfactants. (See 
Illustration 3). Surfactant Replacement Therapy has the potential to 
address the SARS crisis. The goal of Surfactant Replacement Therapy is 
to maintain or restore proper lung function. Surfactant Replacement 
Therapy will not directly address the SARS virus. However, SARS 
patients are suffering destruction and degradation of their lung 
surfactant system. If the condition of a SARS patient degrades to ARDS, 
Surfactant Replacement Therapy has the potential to be a treatment by 
using the same or similar logical approach that we are presently using 
in our ongoing ARDS trial. If a SARS patient exhibits symptoms of 
progressing to ARDS, our engineered lung surfactant, as an inhalable 
aerosol, has the potential to prevent the widespread surfactant 
destruction that can occur as a result of SARS.
    The remainder of this statement is about the possible benefits of 
Surfactant Replacement Therapy for the treatment of SARS.\6\ I will 
discuss the critical role that lung surfactants play in proper 
pulmonary function and how Surfactant Replacement Therapy is already 
being used for the treatment of severe respiratory diseases. I will 
also describe our engineered version of human lung surfactant--its 
safety and pharmacological profile, our ongoing Phase 2 clinical trial 
for the treatment of patients suffering from ARDS and the potential for 
our engineered surfactant as an inhalable aerosol formulation to 
maintain lung function in SARS patients. Discovery has the only 
surfactant technology engineered to mimic the essential properties of 
human lung surfactant. We focus exclusively on treating respiratory 
diseases.
---------------------------------------------------------------------------
    \6\ Damage to the human lung surfactant system is a component of 
ARDS, and both the chemical composition and functional activity of lung 
surfactant are altered in patients with ARDS. Thus, compromise of the 
lung surfactant system plays an important role in the development of 
ARDS. Since many of the major pulmonary consequences of ARDS may be 
directly influenced by surfactant dysfunction, replacement treatment 
with Discovery's engineered humanized surfactant is potentially 
efficacious in this disorder.
---------------------------------------------------------------------------
 LUNG SURFACTANT TECHNOLOGY AND CURRENT SURFACTANT REPLACEMENT THERAPY

    Surfactants are produced naturally in the lungs and are essential 
for breathing. Should surfactants degrade or be destroyed, the air sacs 
in the lungs collapse, airflow becomes restricted and the lungs do not 
absorb sufficient oxygen. (See Illustrations 1 and 2).
    Surfactants are protein and lipid (fat) compositions that cover the 
entire alveolar surface, or air sacs, of the lungs and the terminal 
conducting airways which lead to the alveoli. Surfactants facilitate 
respiration by continually modifying the surface tension of the fluid 
normally present within the alveoli that line the inside of the lungs. 
In addition to lowering aveolar surface-tension, surfactants play other 
important roles which include lowering the surface tension of the 
conducting airways and maintaining airflow and airway patency (keeping 
the airways open and expanded). Loss of patency leads to compromised 
pulmonary function. (See Illustration 4). Human surfactants include 
four known surfactant proteins, A, B, C and D. It has been established, 
through numerous studies, that surfactant protein B (SP-B) is essential 
for respiratory function.
    Pulmonary surfactants have additional properties such as:

(i) Physical barrier to inhaled particles and noxious agents;I14(ii) 
        Host defense against infection; and
(iii) Anti-inflammatory properties
    There is a large body of scientific evidence associating the loss 
or lack of endogenous surfactant function with respiratory diseases. 
(See, e.g., Illustration 4). Clinically, all of these diseases are 
characterized by one or more symptoms such as shortness of breath, 
chest tightening, and loss of pulmonary function as measured by 
FEV1, FVC, PO2, and PCO2. Studies 
demonstrate that Surfactant Replacement Therapy would be a viable 
pharmacological approach for patients suffering from respiratory 
diseases such as Acute Lung Injury, ARDS, asthma, and Chronic 
Obstructive Pulmonary Disease.
    Presently, surfactants are approved as replacement therapy only for 
Respiratory Distress Syndrome in premature infants, a condition in 
which infants are born with an insufficient amount of their own natural 
surfactant. The most commonly used of these approved replacement 
surfactants are derived from pig and cow lungs. Though the animal-
derived surfactants are clinically effective, they have drawbacks and 
cannot readily be scaled or developed to treat broader populations and 
other respiratory diseases such as ARDS or SARS.
    Animal-derived surfactant products are prepared using a chemical 
extraction process from minced cow and pig lung. Because of the animal-
sourced materials and the chemical extraction processes, there is 
significant variation in production lots and, consequently, product 
quality specifications must be broad. In addition, the protein levels 
of these animal-derived surfactants are inherently lower than the 
protein levels of native human surfactant. The production costs of 
these animal-derived surfactants are high, relative to other analogous 
pharmaceutical products, generation of large quantities is severely 
limited, and these products cannot readily be reformulated for aerosol 
delivery to the lungs.

             DISCOVERY LABS SURFACTANT REPLACEMENT THERAPY

    Discovery's engineered version of human lung surfactant is designed 
to precisely mimic the most essential attributes of natural lung 
surfactant. Discovery's surfactant technology contains a proprietary 
peptide that mimics human lung surfactant protein B (SP-B), the protein 
in natural pulmonary surfactant known to be the most important 
surfactant protein for promoting surface-tension lowering and oxygen 
exchange.\7\ Discovery's surfactant has anti-inflammatory properties 
and can be engineered as a liquid instillate or an inhalable aerosol as 
therapy for specific diseases being treated. (See Illustrations 5 and 
6). Our engineered humanized surfactant can be manufactured less 
expensively than the animal-derived surfactants, in sufficient 
quantities, in more exact and consistent pharmaceutical grade quality, 
and has no potential to cause adverse immunological responses in young 
and older adults, all important attributes to potentially meet 
significant unmet medical needs. In addition, we believe that our 
engineered humanized surfactants might possess other pharmaceutical 
benefits not currently found with the animal surfactants such as longer 
shelf-life, reduced number of administrations to the patient's lungs, 
and elimination of the risk of animal-borne diseases including the 
brain-wasting bovine spongiform encephalopathy (commonly called ``mad-
cow disease''). Our humanized surfactant technology was invented at the 
world-renowned Scripps Research Institute and was further developed and 
licensed to us by Johnson & Johnson.
---------------------------------------------------------------------------
    \7\ Discovery's humanized surfactant product candidates, including 
our lead product, Surfaxin ', are engineered versions of 
natural human lung surfactant and contain a humanized peptide, 
sinapultide. Sinapultide is a 21 amino acid protein-like substance that 
is designed to precisely mimic the essential human surfactant protein B 
(SP-B).
---------------------------------------------------------------------------
    There is significant scientific and clinical literature 
establishing the safety and pharmacological activity of our proprietary 
surfactant technology. To date, hundreds of subjects have received 
Surfactant Replacement Therapy with Discovery's lead surfactant 
product, Surfaxin ', and such treatment has been well-
tolerated.\8\ Surfaxin is in three Phase 3 and two Phase 2 clinical 
trials addressing critical respiratory indications where there are few 
or no therapies currently available. Surfaxin has been shown to remove 
inflammatory and infectious infiltrates from patients' lungs when used 
by our proprietary lavage (or ``lung wash'') and replenish the vital 
surfactant levels in the lungs.
---------------------------------------------------------------------------
    \8\ See, e.g., Discovery Laboratories, Inc., Study KL4-ARDS-02, 
April 3, 1998, clinical report.
---------------------------------------------------------------------------
Discovery's Surfactant Replacement Therapy for ARDS--Phase 2 Clinical 
        Trial
    Currently, Discovery is developing Surfaxin for the treatment of 
Acute Respiratory Distress Syndrome in adults (ARDS). Acute Respiratory 
Distress Syndrome in adults is a life-threatening disorder for which no 
approved therapies exist anywhere in the world. (See Illustration 7). 
It is characterized by an excess of fluid, inflammatory cells and 
debris in the lungs that leads to decreased oxygen levels in the 
patient. One prominent characteristic of this disorder is the 
destruction of surfactants naturally present in lung tissue that are 
essential to the ability to absorb oxygen. Current therapy for ARDS 
patients remains entirely supportive and mechanical ventilation is the 
present standard of care.
    Discovery's approach to treating ARDS is based on the scientific 
rationale supporting Surfactant Replacement Therapy as an effective 
lavage, or ``lung wash,'' designed to alter the course of this disease 
by rinsing out damaging infiltrates and debris in the lungs and 
restoring normal surfactant function. (See Illustrations 8 and 9). We 
are presently conducting a Phase 2 open-label, controlled, multi-center 
clinical trial of Surfaxin for adults in up to 110 patients with Acute 
Respiratory Distress Syndrome. This trial will compare the safety and 
effectiveness of standard of care, including mechanical ventilation, to 
high concentrations of Surfaxin administered to patients via a 
proprietary lavage technique that administers the drug sequentially 
through a tube, called a bronchoscope.
    In July 2002, we completed the first part of this trial, a dose 
escalation safety and tolerability study in 22 patients in four groups 
(of up to six patients per group). In consultation with the trial's 
Independent Safety Review Committee that was comprised of three 
prominent pulmonologists, we determined that the Part A portion of the 
trial procedure is generally safe and tolerable and that it was 
appropriate to proceed onto the larger safety and efficacy portion of 
the study. These early results, although in a small number of patients, 
are encouraging because they suggest that the most effective dosages 
are the higher Surfaxin concentrations. In fact, some of the sickest 
patients were in the highest dose groups and, nevertheless, in these 
groups we experienced the most promising results, including no 
mortality and a significant reduction in the number of days on 
mechanical ventilation. (See Illustration 10).
    The following table presents summary data of certain key clinical 
endpoints from the dose-ranging part of the trial:

----------------------------------------------------------------------------------------------------------------
                                                                                     Clinical Results
                                                                         ---------------------------------------
             Patient Group                 Number of         Surfaxin                           Average Days On
                                            Patients         Dosage*      Mortality ((#) and      Mechanical
                                                                            % of Patients)        Ventilation
----------------------------------------------------------------------------------------------------------------
A.....................................               5        22,800 mg             (3)-60%                20.8
B.....................................               6        34,200 mg             (2)-33%                17.5
C.....................................               6        57,000 mg              (0)-0%                12.8
D.....................................               5        61,000 mg              (0)-0%                17.2
----------------------------------------------------------------------------------------------------------------
* Based on phospholipid content.

    The last part of this Phase 2 trial, Part B, will evaluate safety 
and efficacy of Surfaxin in direct comparison to standard of care at 
approximately 50 centers in the United States and Canada. The primary 
endpoint of this part of the trial is to determine the incidence rate 
of patients being alive and off mechanical ventilation at the end of 
day 28 with one of the key secondary endpoints being mortality.
    The FDA has granted Fast-Track Approval Status and Orphan Drug 
Designation for Surfaxin for the treatment of Acute Respiratory 
Distress Syndrome for adults. The European Medicines Evaluation Agency 
has granted Orphan Product designation for Surfaxin for the treatment 
of Acute Lung Injury in adults (which in this circumstance encompasses 
Acute Respiratory Distress Syndrome).
    If the necessary activities and adequate resources could be 
properly organized, including, but not limited to (1) training of 
medical personnel in the bronchopulmonary segmental surfactant lavage 
procedure, (2) regulatory procedures, and (3) supply of sufficient 
drug, this program could be positioned to evaluate Surfactant 
Replacement Therapy for the most severe SARS patients on mechanical 
ventilation by mid-to late-summer of 2003.
Discovery's Inhalable Aerosol Surfactant--Positioned to enter Phase 1b 
        / 2a Clinical Trials
    Discovery recently prepared its proprietary engineered version of 
lung surfactant as an inhalable aerosol formulation that successfully 
retained the critical therapeutic properties of fully-functioning 
natural lung surfactant. This development now evolves surfactant 
therapy to the point where inhalable aerosol formulations of engineered 
lung surfactant have the potential to be developed to treat respiratory 
diseases that so far have been unable to benefit from Surfactant 
Replacement Therapy. The immediate focus of our aerosol development 
program is on surfactant-based therapy to help restore lung function of 
hospitalized patients suffering from severe respiratory conditions (for 
example, SARS), hopefully avoiding the progression to ARDS, the need 
for mechanical ventilation, thereby preventing respiratory conditions 
from becoming severe, even life-threatening events.
    Discovery's lung surfactant was aerosolized as a liquid formulation 
that exhibited all of the essential pharmacological properties of a 
functioning surfactant, including the surface-tension lowering 
abilities necessary to restore lung function and keep the airways open 
and expanded. An aerosolized Surfactant Replacement Therapy may be 
effective as a preventive measure for patients at risk for Acute Lung 
Injury by providing a functioning surfactant to act as an anti-
inflammatory and to maintain proper lung function.
    Importantly, our inhalable aerosol surfactant could be readily 
administered to ambulatory patients with a number of already-available 
devices or could be used with aerosol generators designed for in-line 
use with mechanical ventilators. With a highly communicable disease 
such as SARS, this could be a closed system reducing the risk of 
disease transmission to health care workers and others. We have every 
reason to expect that our inhalable aerosol Surfactant Replacement 
Therapy would demonstrate the same safety and pharmacological profile 
exhibited throughout our surfactant pre-clinical and clinical programs 
to date, including our five ongoing Phase 3 and Phase 2 studies. Our 
present development plan calls for us to enter Phase 1b/2a clinical 
trials to evaluate our inhalable aerosol Surfactant Replacement Therapy 
by late-2003 or early-2004. However, with a concerted effort by all 
necessary parties, this program can be positioned to evaluate the 
possible benefits of Surfactant Replacement Therapy for SARS patients 
by early-fall of 2003.

                               CONCLUSION

    Scientists around the world have moved with unprecedented speed to 
identify the SARS virus and screen potential treatments. Public health 
officials have employed intense efforts to contain its spread and are 
exploring numerous medical treatments, focusing on antivirals, 
vaccines, and mechanical ventilation. The logical next step is for 
world health authorities to fully evaluate pulmonary therapies aimed at 
restoring or maintaining proper lung function in SARS sufferers. SARS 
patients have difficulty breathing and are suffering degradation and 
destruction of their lung surfactant system. Surfactants are critical 
for breathing and the goal of Discovery's Surfactant Replacement 
Therapy is to maintain or restore proper lung function.
    Surfactant Replacement Therapy has the potential to play an 
important role in addressing the SARS crisis. Discovery's surfactant 
technology, engineered to mimic the essential properties of human lung 
surfactant, is the only surfactant technology that could play this 
role. We focus exclusively on treating respiratory diseases. In 
summary, Discovery and its medical advisors are convinced that 
Surfactant Replacement Therapy has the potential to be an effective 
therapy to treat a variety of respiratory diseases, including SARS. We 
ask this Committee to be a catalyst in conveying the message that 
Surfactant Replacement Therapy be included in the assessment of 
therapies currently under consideration by the various health 
authorities.

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    Mr. Greenwood. Thank you, Dr. Capetola.
    Dr. Fischer?

                  TESTIMONY OF PAUL H. FISCHER

    Mr. Fischer. Chairman Greenwood, and members of the 
subcommittee, thank you for having invited me here today to 
discuss SARS outbreak and the potential for developing a 
vaccine to prevent this disease.
    My name is Paul Fischer, and I am the CEO of GenVec. GenVec 
is a publicly held biopharmaceutical company focused on the 
development and commercialization of novel therapies for severe 
diseases with inadequate therapy. We are currently in a clinic 
testing products that use our specialized technology to treat 
various forms of cancer, including pancreatic cancer as well as 
advanced heart disease and macular degeneration, which is a 
major cause of blindness.
    GenVec is also pleased to be collaborating with the U.S. 
Government for the development of new vaccines including AIDS, 
malaria, Dengue fever virus, and most recently SARS.
    I would like to take this opportunity to especially thank 
the NIH, the NIAID Vaccines Research Center. Only a few short 
weeks ago I had a telephone conversation with Dr. Gary Nabel, 
Director of the Vaccine Research Center. In 30 minutes, we had 
agreed to expand our work to include a vaccine for SARS, and 
within hours our teams were discussing the strategy of how that 
might be done. Two weeks after that discussion, an amendment to 
our existing research contract, which is now administered by 
SAIC of Frederick, gave GenVec the green light to start working 
on the construction of the initial vaccine vectors against 
SARS. And that within 2 weeks that whole process was completed 
and researchers were actually able to get to work. I think that 
is great. An indication of what is often not thought of, which 
is a rapid response by Government.
    I believe this is precisely the type of leadership on the 
part of the Government, facilitating rapid action by the 
private sector, which is needed to effectively really put 
together and rally these resources and expertise to address 
SARS and other potential epidemics.
    GenVec is proud to be part of this effort, and we hope SARS 
will end up being simply a page in a medical history books, but 
for now, there is much to be done and a great deal of concern.
    So any quick read of the news, and certainly all of what we 
have heard today, has indicated that this is an epidemic which 
we really do not know that much about, but does include 
pneumonia like syndrome. It is rapidly becoming clear that the 
death rate may be higher than we thought. There is a number of 
unknowns. But what we do know are several key things.
    If we are unable to isolate and contain this pathogen, it 
could lead to an extensive and widely traumatic event.
    So what are we going to do to directly attack this problem? 
In our quest to defeat SARS, or for that matter, other new 
pathogens, several factors are key:
    First speed. Speed is crucial. The SARS virus could become 
seasonal and return year after year. In fact, this is likely. 
It will also mutate and change.
    Flexibility is critical. The approach could and should 
accommodate the potential changing or slightly different 
strains of the virus from year-to-year, since viruses do tend 
to change each year, and they become resistant not only to 
drugs, but also vaccines.
    Of course, safety is important. Any contemplated measure, 
particularly a preventative one to which you may expose a large 
number of people, such as with a vaccine, is important. Safety 
is key here. And avoiding the use of live viruses is the 
preferred strategy when that is possible so that the recipient 
populations, whether healthcare workers or the general public, 
are placed at the minimum risk possible.
    And we also need to be able to manufacture these vaccines 
and be able to distribute them in a cost effective way.
    GenVec's approach is to use technology of an inactivated 
cold virus, which is the adenovector, and you have heard Dr. 
Fauci actually mention that several times today. In this case 
what we are doing is using the cold virus as a vehicle to 
deliver a small fragment of DNA of the SARS virus that codes 
for an important protein that would stimulate an immune 
response by the body. So we are actually only using a small 
fragment of information, essentially the blueprint of these 
proteins, putting them into a different vector, a vector which 
itself cannot replicate or cause disease. It then sort of 
tricks the body into expressing the protein of the SARS virus. 
The body then recognizes that as a foreign protein, that 
particular interaction primes the pump, so to speak, teaches 
the body about this protein and it recognizes it as a foreign 
protein so that if in the future that individual who is 
vaccinated actually gets confronted with the real virus, it 
mounts a very immediate and rapid immune response. That is the 
goal.
    The extensive experience that we have had working with the 
NIH, for example, on our AIDS program, has actually allowed us 
to move very quickly into this using this information we have 
in AIDS to leverage the technology. So that is why within weeks 
we could jump on this problem with the NIH. The technology also 
needs to be flexible so that we can modify it.
    We have to assume that there will be changes in the code 
protein, that in fact the virus will mutate. If we have the 
right delivery vehicle and we understand the gene, then it is 
simple understand what those mutations are, put them right back 
in and have a new vaccine ready to go very rapidly.
    In fact, this whole approach is one we have been working 
with in other areas, including with the Navy in their agile 
vaccine program. They are, obviously, interested from a 
bioterrorism point of view, but in our case we are also working 
with them on malaria as well as the Dengue fever virus.
    So what are the next steps? Well, these synthetic genes 
that I mentioned are actually being made now, being put 
together. The information that allowed us to do that you have 
heard about today came quickly from the cooperation of a number 
of agencies. The sequence is known. Those synthetic genes are 
now being readied to be put into these vectors, these vaccine 
candidates at GenVec, and we will actually begin doing that 
within weeks.
    We actually expect to have new vaccine candidates available 
for testing within months. The NIH will actually do that 
testing in animal models. You heard about some of that earlier 
from Dr. Fauci again. And we think clinical grade production of 
these vectors could begin as early as they share them.
    Now, depending on the results of those animal models and 
the safety and efficacy of this approach, we could be in 
clinical trials as early as next year.
    So, in conclusion, what I would like to say is that the 
investments that have been made over the last decade in the 
core biology of genomics, the information technology, 
bioinformatics and with the biotechnology industry itself in 
learning how to make things such as these new vectors has 
allowed us to deal with this at least initial phase of response 
to the SARS outbreak very rapidly. That investment being put 
into the biomedical research community has actually primed the 
pump, again, to be able to jump on this problem.
    So as we move forward, I would like to see that kind of 
support continue. I would really like to pat on the back the 
NIH for their rapid response to this. The Government has been 
very quick to respond to this problem, and in actually 
involving the private sector, in this case GenVec, to start on 
this program without a lot of red tape. It was actually 15 days 
from the time we had that conversation to actually been through 
the network and have that contract expanded.
    Thank you.
    [The prepared statement of Paul H. Fischer follows:]

Prepared Statement of Paul H. Fischer, Chief Executive Officer, GenVec, 
                                  Inc.

                              INTRODUCTION

    Chairman Greenwood and Members of the Subcommittee, thank you for 
having invited me here today to discuss the SARS outbreak and the 
potential for developing a vaccine to prevent this disease.
    My name is Paul Fischer, and I am the CEO of GenVec, Inc. GenVec is 
a publicly held biopharmaceutical company focused on the development 
and commercialization of novel therapies for severe diseases with 
inadequate therapy. We are currently in the clinic, testing product 
candidates that utilize our specialized technology to treat various 
forms of cancer, including pancreatic cancer, as well as advanced heart 
disease, and macular degeneration, which is a major cause of blindness.
    GenVec is also pleased to be collaborating with the U.S. Government 
for the development of new vaccines, including AIDS, malaria, dengue 
fever virus, and most recently, SARS.
    I'd like to take this opportunity to especially thank the NIH/
NIAID's Vaccine Research Center. Only a few short weeks ago, I had a 
telephone conversation with Dr. Gary Nabel, Director of the Vaccine 
Research Center. In 30 minutes, we had agreed to expand our work to 
include a SARS vaccine, and within hours our teams were discussing 
strategy. Two weeks after our discussion, an amendment to a research 
contract being administered by SAIC of Frederick, MD giving GenVec the 
green light to initiate construction of vaccine vectors for testing 
against SARS by the NIH/NIAID was completed, and our researchers were 
able to get to work. I believe that this is precisely the type of 
leadership on the part of the government, facilitating rapid action by 
the private sector, which is needed to effectively rally resources and 
expertise to address SARS and other potential epidemics. GenVec is 
proud to be part of this effort, and we hope that SARS will one day be 
simply a page in the medical history books--but for now, there is much 
to be done.

                           SARS: THE PROBLEM

    As any quick check on the news tells us, the SARS epidemic is a 
rapidly evolving story. It is unclear whether SARS will become a major 
recurrent health problem, or at what rate the coronavirus that induces 
SARS, triggering pneumonia-like symptoms in patients, mutates. What we 
do know is that as of May 5th, as reported in the Wall Street Journal, 
some 6,234 SARS infections have been reported, claiming some 435 lives 
in China, Hong Kong, Canada and elsewhere. We also know that the 
treatment of patients affected by SARS is time-consuming and costly, 
that the full-blown disease leaves people weakened for an extended 
period of time, and that the virus is capable of surviving for 
prolonged periods under a variety of conditions. While containment is 
certainly a worthwhile strategy, we also know that there are areas of 
the world where containment can become increasingly difficult. We have 
seen the alarming rate of infection in China. The disease could easily 
recur and spread to other sectors of the world. The isolation and 
treatment protocols required to contain it may not be widely available 
and the results could be traumatic. In seeking to counter the impact of 
SARS, time clearly is our enemy.

                           SARS: THE SOLUTION

    In our quest to defeat SARS, or other new pathogens, several 
factors are key:

 Speed is crucial. The SARS virus could become seasonal and 
        return year after year, and will likely mutate.
 Flexibility is critical. The approach should accommodate 
        potential mutations, since viruses tend to mutate over time and 
        become resistant to drugs or vaccines.
 The safety of any contemplated preventative measures, such as 
        a vaccine, is important. Avoiding the use of live viruses is a 
        preferred strategy when feasible, so that the recipient 
        populations--whether healthcare workers or the general public--
        are placed at the least possible risk.
 Ease of manufacture is also a concern, as only a vaccine or 
        other preventative that can be rapidly produced and distributed 
        can be widely effective.

                           GENVEC'S APPROACH

    GenVec's technology involves the use of an inactivated cold virus, 
known as an adenovector. The genes that the adenovirus needs to 
replicate are removed, and the resulting adenovector acts as a delivery 
vehicle for the gene of interest. In the case of a potential SARS 
vaccine, the adenovector will carry small pieces of the DNA from the 
SARS virus as its payload--not the entire genome for SARS, but only 
enough to position the body to generate an immune response to target 
all SARS proteins. This response will then be retriggered, on a greater 
scale, if the vaccine recipient is actually challenged by the disease.
    The extensive experience that GenVec's researchers have accumulated 
during the course of our work is being placed at the disposal of the 
current project to rapidly construct test candidates. Our goal is to 
cooperate with the NIH/NIAID in preparing several vaccine candidates 
for evaluation, and then modifying the vaccine or vaccines that show 
the greatest degree of promise to be safe and effective as needed. We 
hope to have one or more vaccines result from our work that can be 
rapidly modified in response to future potential mutations. Vaccines of 
this type could be used to help contain an outbreak by protecting first 
responders and individuals at high risk, and could eventually be of 
potential use as a widely-delivered vaccine, such as the flu vaccine is 
today.

                               NEXT STEPS

    Synthetic SARS genes are already being made and within weeks the 
first adenovectors will be under construction at GenVec. New vaccine 
candidates should be ready for preclinical testing in animals by the 
NIH within months. Clinical grade production is possible this current 
year; and depending on the results of the preclinical studies, the 
first trials in human subjects could begin next year.

                               CONCLUSION

    The investments that have been made over the last decade in core 
biology, genomics research, information technology and the biotech 
industry have made this rapid response to the SARS outbreak possible. 
GenVec has been able to put the same approach we have just outlined 
today to work in our collaborative research with the Navy for the 
production of agile vaccines against dengue fever and malaria. In the 
case of these and other biological threats, time is of essence and the 
lessons we learn in our laboratories now can and will be put to use to 
help defend against the health threats facing our nation and the world 
today, and potentially facing us tomorrow.

    Mr. Greenwood. Thank you, Dr. Fischer.
    Dr. Lonberg?

                   TESTIMONY OF NILS LONBERG

    Mr. Lonberg. Thank you. Thank you for giving me the 
opportunity to speak.
    I am going to talk about how a particular class of 
biotechnology products, monoclonal antibodies, could play a 
role in combating SARS. Also, how one U.S. biotechnology 
company in partnership with a non-profit publicly owned 
research and manufacturing group are working together in this 
effort.
    And I want to make three points. First of all, monoclonal 
antibody technology is one of the tools of modern biotechnology 
that can be employed to combat the SARS virus.
    Second, finding new medicines is never a quick fix. We are 
not competing with isolation and quarantine here; however, we 
will be working as rapidly as possible. And I will try to give 
you some idea of how quickly we can work.
    Finally, the Federal Government can play a role in 
facilitating the efforts of biotechnology companies in the 
emerging disease area.
    A little bit of background. Medarex is collaborating with 
the Massachusetts Biologic Laboratories in this project.
    Medarex is a publicly listed US biotechnology company with 
facilities in New Jersey and California.
    MBL is a nonprofit FDA-licensed manufacturer of vaccines 
and other biologic products in the United States and we have 
been working together with MBL on other infectious disease 
projects. And it is because of that ongoing collaboration that 
we have been able to jump very quickly into this area.
    First, I am going to give you a little bit of background on 
antibiotic therapy. Antibodies are a critical natural component 
of the body's immune defense against viruses and other 
infectious agents.
    Vaccines stimulate the body to produce antibodies that will 
recognize a particular virus. In the absence of an effective 
vaccine, therapeutic preparations of exogenous antibodies can 
potentially provide protection from infection. This type of 
therapy has been around for over 100 years, in fact the first 
Nobel Prize in medicine went to Behring for the development of 
this form of therapy. Early forms of antibody therapy used 
serum from immunized large animals, such as horses, and human 
and animal serum products are still used today. However, we now 
have neutrals that allow for the development of genetically 
engineered monoclonal antibodies based therapeutic drugs. And 
there are 12 monoclonal antibody based therapeutic products 
that are now approved by the FDA. The 12 monoclonal antibody 
based therapeutic products are used in a variety of different 
indications, including cancer, heart disease, arthritis and 
infectious diseases.
    The one particular example that I think is relevant here is 
Synagis. Synagis was developed by MedImmune in Gaithersburg, 
Maryland. It is directed against a virus called Respiratory 
Syncytial Virus. Synagis was developed as a safe--non-blood 
product derived--and consistent--molecularly characterized--
alternative to a human serum derived therapy. It is approved to 
prevent serious lower respiratory tract disease caused by RSV 
in high risk pediatric patients. And the success of Synagis 
suggests that similar monoclonal antibody based therapeutic may 
be useful for preventing SARS infection.
    So the point that I want to make is that antibody based 
products for the prevention of infectious disease are a well 
established part of our current therapeutic arsenal.
    Medarex has it's own proprietary technology, proprietary 
technology for the generation of human monoclonal antibodies. 
These are designed to be well tolerated and safe in humans.
    We use genetically engineered strains of mice that carry 
human immune system genes within their genome. So we have 
slightly humanized the mouse and these mice now breed stably 
and we can use them to make human antibodies directly.
    There is now ten different human antibody based drugs in 
human clinical testing that are based on our technology. Some 
are being developed by Medarex alone, and others by major 
pharmaceutical companies like Novartis and Johnson & Johnson.
    What are we going to do together with MBL?
    We are going to immunize transgenic mice with the SARS 
virus antigens We are going to generate a panel of potential 
therapeutic candidates. Test these candidates for their ability 
to neutralize the SARS virus. Select a lead candidate and then 
develop a manufacturing cell line.
    These first five steps are the preclinical development 
stage. And we have gone through preclinical development very 
rapidly in the past. The most rapidly we were able to go 
through it is about a year, but I think that it is unlikely in 
this particular case that we would be able to move that 
rapidly. I think it is not unrealistic to think that it would 
be possible to do it in as little as 2 years.
    The next steps involve testing the material for safety in 
animals and humans and for efficacy in humans. And it is that 
clinical testing that carries the greatest uncertainty in as 
far as the amount of time that it will take.
    The last point that I want to make is how biotech companies 
make pipeline decisions and what possible role the Federal 
Government could have in this process.
    Resources for biotech companies are extremely scarce and 
must be allocated based upon calculated value of future 
product. This calculated value is derived from estimates of the 
chance of success, time to development, cost of goods, price of 
drug, size of market, and the competition. For an emerging 
disease such as SARS, it is very difficult to calculate any of 
the above. And for this reason, the Federal Government can play 
a role to encourage biotech and pharmaceutical companies in 
this area by removing some of these uncertainties, such as 
establishing a defined market or by underwriting some of the 
research and development costs.
    I think that the NIH has actively been underwriting some of 
the research and development costs for biotechnology companies, 
and we certainly appreciate that. We received some NIH funding 
for the development of our technology platform.
    The biggest uncertainty is figuring out what the market is 
going to be. And that uncertainty may be established relatively 
rapidly for the case of SARS. However, another case such as 
bioterror we are still scratching our heads 2 years later and 
wondering who is going to be the customer, for example, for an 
antibody that could be used for preventing infection from 
anthrax. And so I think the Federal Government may be able to 
step up to the plate there Thank you.
    [The prepared statement of Nils Lonberg follows:]

  Prepared Statement of Nils Lonberg, Senior Vice President, Medarex, 
                                  Inc.

    I will try to give you a very brief snapshot of how a particular 
class of biotechnology products (monoclonal antibodies) could play a 
role in preventing SARS infections. And, in particular, how one US 
biotechnology company in partnership with a non-profit publicly owned 
research and manufacturing group are working together in this effort. I 
will try to leave you with Three take-home messages:

1. Monoclonal antibody technology is one of the tools of modern 
        biotechnology that can be employed to combat the SARS virus.

2. Finding new medicines is never a quick fix; however, we will be 
        working as rapidly as possible.

3. The government can play a role in facilitating the efforts of 
        biotechnology companies in the emerging disease area.

    Medarex is collaborating with the Massachusetts Biologic 
Laboratories (MBL) to develop a monoclonal antibody to prevent 
Coronavirus associated SARS.
    Medarex is a publicly listed US biotechnology company with 
facilities in NJ and CA.
    MBL, University of Massachusetts Medical School is the only non-
profit FDA-licensed manufacturer of vaccines and other biologic 
products in the United States. MBL has seven FDA licensed vaccines and/
or polyclonal antibody products. In addition MBL has manufactured 4 
monoclonal antibodies for clinical trials in collaboration with NIH 
and/or private collaborations.
    Antibodies are a critical component of the body's immune defense 
against viruses and other infectious agents.
    Vaccines stimulate the body to produce antibodies that will 
recognize a particular virus.
    In the absence of an effective vaccine, monoclonal antibodies 
(i.e., genetically engineered antibodies) can potentially provide 
protection from infection.
    Antibody based therapies have been employed since their first 
discovery over a hundred years ago by Kitasano and Behring.
    The first such therapies used serum from immunized large animals 
such as horses and sheep.
    Human and animal serum products are still used today; however, we 
now have new tools that allow for the development of genetically 
engineered--monoclonal--antibody based therapeutic drugs.
    There are now 12 monoclonal antibody based therapeutic products 
that are approved by the FDA.
    The 12 monoclonal antibody based therapeutic products are used in a 
variety of indications, including cancer, heart disease, arthritis, and 
infectious diseases.
    One of these monoclonal antibodies, Synagis' (MedImmune, 
Gaithersburg MD), is directed against a virus called Respiratory 
Syncytial Virus (RSV).
    Synagis ' was developed as a safe (non-blood product 
derived) and consistent (molecularly characterized) alternative to a 
human serum derived therapy, RespiGam '.
    The success of Synagis ' suggests that a similar 
monoclonal antibody-based therapeutic may be useful for preventing SARS 
infections.
    Medarex is focused primarily on the development of monoclonal 
antibodies derived from its own proprietary technology for the 
generation of human monoclonal antibodies.
    This technology uses genetically engineered strains of mice that 
carry human immune system genes within their genomes
    There are now 10 different human antibody based drugs in human 
clinical testing based on Medarex's technology. Some are being 
developed by Medarex and others by major pharmaceutical companies like 
Novartis and Johnson & Johnson.
    To develop a SARS drug, Medarex and MBL plan to:

1. Immunize transgenic mice with SARS virus antigens
2. Generate a panel of potential therapeutic candidates
3. Test these candidates for their ability to neutralize the SARS virus
4. Select a lead candidate
5. Develop a recombinant manufacturing cell line that produces large 
        quantities of the lead candidate.
6. Test this material for safety in animals and humans
7. Test for efficacy in humans.
    The first 5 steps may be completed in as little as two years. The 
development of laboratory and animal model assays for step 3 will be 
critical.
    Human efficacy testing will probably be the most time consuming 
step.
    How do biotech companies make pipeline decisions?
    Resources are scarce and must be allocated based on calculated 
value of future products
    The value of future products is derived from estimates of chance of 
success, time to development, cost of goods, price of drug, size of 
market, and competition
    For emerging disease indications it is very difficult to calculate 
a risk adjusted value for a future product (for SARS we do not yet know 
enough to calculate any of the above with a reasonable degree of 
certainty).
    The government can play a role to encourage biotech and 
pharmaceutical companies in this area by removing some uncertainties 
(such as establishing a defined market) or by underwriting some of the 
research and development costs.

    Mr. Greenwood. Thank you, Dr. Lonberg.
    Dr. Burger?

                  TESTIMONY OF DENIS R. BURGER

    Mr. Burger. Good afternoon. I am Denis Burger. I am CEO of 
AVI BioPharma. Among other drug development programs, we make 
specific antibiotics for viruses, including SARS.
    I would like to thank the committee for inviting me here 
this afternoon to participate in this hearing. It is an honor 
to share with you our science, technology and vision.
    To begin, I would like to describe the research and 
development at AVI and what we have been doing since being 
founded in 1980. AVI's technology is called antisense, it 
enables us to develop a wide variety of products for a variety 
of diseases rapidly.
    Antisense technology is now beginning to reach its 
potential. AVI is conducting clinical trials to evaluate 
antisense drugs against cardiovascular disease, cancer and 
other indications, but it is our application of antisense for 
viral infections in the past 2 years that is most relevant in 
our discussion this afternoon on the spread and containment of 
SARS.
    I would like to cover two key points in my testimony. 
First, AVI's antisense drugs target and inhibit the source of 
the infection, not the symptoms. In the case of SARS, the 
infection is an RNA virus.
    Second, the way we develop antisense drugs represents a new 
kind of rapid drug development that we believe may have 
significant impact in today's threatening viral landscape. We 
are making specific antibiotics for viruses.
    AVI's NeuGene antisense drugs are like key blanks that can 
be cut precisely to match a virus' or a disease's genic lock. 
Each antisense drug is designed to block the activity of a 
particular gene or organism responsible for disease, whether 
human, bacterial or viral.
    When an antisense drug comes in contact with a viral 
target, it binds to specific portions of the gene sequence and 
like fabric caught in a zipper, prevents the virus from 
replicating.
    Once the SARS outbreak was attributed to a human 
coronavirus, scientists at AVI knew there was a good chance our 
technology could be effective. We have spent the past several 
years researching the use of antisense on other RNA viruses, 
including hepatitis C and West Nile virus, and have had success 
against these diseases. In fact, we have completed preclinical 
testing for our West Nile drug and expect to file an 
Investigational New Drug application with the FDA later this 
year.
    We knew that once the sequence of the human coronavirus was 
identified, we could rapidly manufacture an antisense drug for 
testing in the laboratory and animals. We accomplished this in 
less than 2 weeks, a response time faster than any other 
technology I'm aware of. This drug is now in the hands of NIAID 
for evaluation at USAMRIID.
    The developmental process I'm describing represents a new 
way to shut down viral infections. Rather than simply 
addressing the symptoms of the disease, AVI's antisense drugs 
actually slow the infection by targeting and shutting down the 
viral replication. This reduces viral ``load'' in the body and 
gives the immune system a chance to mount an effective 
response, similar to antibiotics for bacterial infections. The 
importance of this type of rapid response platform for viral 
outbreaks should not be understated. We hope to learn a great 
deal from the testing of our compounds in the weeks and months 
to come, and also to have our coronavirus antisense drug 
available to other WHO affiliated laboratories.
    AVI's approach to viral therapeutics is different and new, 
but it is founded on 20 years of solid scientific research. We 
are making progress in all aspects of our development platform, 
but the opportunity to address a public health issue of this 
magnitude is work we embrace and we plan to devote considerable 
resources toward it. We truly hope to make a difference in the 
treatment of SARS, and appreciate your focus on the subject.
    Thank you.
    [The prepared statement of Denis R. Burger follows:]

      Prepared Statement of Denis Burger, CEO, AVI BioPharma, Inc.

    Good afternoon and thank you for the introduction. I'm Denis 
Burger, CEO of AVI BioPharma. AVI is a biopharmaceutical company with 
headquarters in Portland, Oregon, with research and manufacturing 
facilities in Corvallis, Oregon.
    I'd like to thank the committee for inviting me to participate in 
today's hearing. It is an honor to share information about our science, 
technology and vision as you endeavor to understand and effectively 
address the spread of SARS.
    To begin, I'd like to turn briefly to the research and development 
AVI has been conducting since our company was founded in the early 
1980s. AVI's drug development platform, a technology called antisense, 
enables us to develop therapeutics to address a range of life-
threatening illnesses.
    Antisense technology is now beginning to reveal its potential. AVI 
is conducting clinical trials to evaluate antisense drugs against 
cardiovascular disease, polycystic kidney disease and cancer, but it is 
our application of antisense to viral infections in the past two years 
that is most relevant in our discussion of the spread and containment 
of SARS.
    I'd like to cover two key points in my testimony. First, AVI's 
antisense drugs target and inhibit the source of infection, not just 
the symptoms. In the case of SARS, the infection is caused by a single-
strand RNA virus, a coronavirus.
    Second, the way we develop antisense drugs represents a new kind of 
rapid response therapeutics that we believe may have significant impact 
in today's threatening viral landscape. We are making specific 
antibiotics for viruses.
    AVI's NeuGene antisense drugs are like key blanks that can be cut 
precisely to match a disease's lock. They are made from snippets of 
DNA-like material known as oligonucleotides, or ``oligos,'' the 
technical term for a stretch of genetic material. Each antisense drug 
is designed to block the activity of a particular gene or organism 
responsible for disease, whether human, bacterial or viral.
    When a NeuGene compound comes in contact with its viral target, it 
binds to specific portions of the sequence and, like fabric caught in a 
zipper, prevents the organism from replicating.
    Once the SARS outbreak was attributed to a human coronavirus, the 
scientists at AVI knew there was a good chance our technology would 
apply. We have spent the past several years researching the use of 
antisense on other single-strand RNA viruses, including hepatitis C 
virus, calicivirus and West Nile virus, and have had success in animal 
``outbreak'' trials against two of those targets. In fact, we have 
completed preclinical testing for our West Nile virus compound and 
expect to file an Investigational New Drug (IND) application with the 
FDA later this year.
    Earlier this winter AVI initiated preclinical studies evaluating 
our antisense compounds against two animal variants of the coronavirus 
and achieved antiviral activity against these targets in culture.
    As a result, we knew that once the sequence of the new human 
variant was identified, we could rapidly synthesize and purify research 
quantities of a coronavirus antisense drug for testing in culture or in 
an animal model. We accomplished this in less than two weeks, a 
response time faster than any other technology I'm aware of.
    The developmental process I'm describing represents a new way to 
shut down viral infections. Rather than simply addressing the symptoms 
of the disease, NeuGenes actually slow the rate of infection by 
targeting and shutting down the virus's replication mechanism. This 
reduces viral ``load'' in the body and gives the immune system a chance 
to mount an effective response.
    In the case of the SARS virus, we all witnessed the rapid 
international effort to determine the virus's genetic structure, and 
we've heard about possible mutations in that structure. Another 
advantage of the antisense approach is that we are able to target 
portions of the viral sequence that we believe are conserved during 
mutations of the organism. This is certainly true of hepatitis C virus 
and the species-jumping calicivirus, two of our first viral targets, 
which have shown mutations.
    In nine clinical trials for the nonviral indications I mentioned 
earlier, we have achieved a positive safety record with no drug-related 
adverse effects to the approximately 200 patients we have treated. In 
the case of viral antisense drugs, the viral gene sequence we target is 
not found in the human genome, so the body simply does not recognize or 
process the drug unless the viral target is present. We have confidence 
in the safety profile of our antisense chemistry, but I should add that 
we have not yet tested viral antisense in human subjects.
    The importance of this type of rapid response platform for viral 
outbreaks should not be understated. We hope to learn a great deal from 
the testing of our compounds in the coming weeks and months, and have 
made our coronavirus antisense available on a limited basis to other 
WHO-affiliated laboratories.
    We are committed to undertaking the broadest evaluation of the 
compound possible, both because the demographics of the disease demand 
rapid and decisive response and because replication of results is 
critical. AVI's approach to viral therapeutics is different and new, 
but it is founded on 20 years of solid scientific research.
    We are making progress in all aspects of our development platform, 
but the opportunity to address a public health issue of this magnitude 
is work we embrace and that we plan to devote considerable resources 
toward. We truly hope to make a difference in the treatment of SARS, 
and appreciate your focus on the subject.

    Mr. Greenwood. Thank you, Dr. Burger.
    The Chair recognizes himself for 10 minutes for inquiry.
    Let me start with Dr. Capetola.
    You heard Dr. Fauci say when I asked him earlier what the 
treatment was for SARS patients, it is basically supportive 
treatment and that ultimately it involves ventilators. Could 
you walk us through the steps? What would it take, assuming 
that this disease in fact spreads and becomes more of a problem 
in the United States than it is now, what are the steps and the 
time lines that it would take to have your product available to 
treat these patients, either in place of ventilators or as an 
alternative?
    Mr. Capetola. Well, we have two approaches to it, Mr. 
Chairman. One is the trial that I described, which is called a 
phase II B trial. From the written testimony, with these very 
severe patients that have ARDS, the acute respiratory distress 
syndrome, we finished the rising dose trials some months ago 
and have published that data. Now we are in the next phase of 
it, which is going to enroll up to about 110 patients.
    In these patients that have the very, very severe disease, 
we take the humanized engineered surfactant that we have and we 
actually go in with a bronchoscope and we wash the pus out of 
their lung, whether it is from a SARS virus and pneumococcal 
virus, just inflation in general. Because we want to restore 
and get rid of the fluid and proteinase and oxidants, and all 
the bad things that exist in those little air sacs and restore 
the alveoli, little air sacs, to their normal open state and 
get the patient off the ventilator. We are doing that as we 
speak.
    We set up a division about a year and a half ago in Redwood 
City, California with Ph.D chemical engineers devoted toward 
aerosolizing our technology. And that is ready to go as we 
speak. We have done all the science behind it. We know we can 
aerosolize----
    Mr. Greenwood. When you say ``ready to go,'' ready to----
    Mr. Capetola. We can enter clinical trials----
    Mr. Greenwood. Ready to begin clinical trials?
    Mr. Capetola. [continuing] within any time. The safety 
considerations have all been taken care of, because the 
patients that we are doing, you probably know from the written 
testimony, we are doing the world's largest pharmaceutically 
sponsored trial in premature babies ever conducted. And that is 
a phase III trial. The data from that trial is going to be 
released this October.
    So between the dosages and exposure to have to humans 
there, is the massive doses that were given to ARDS patients. 
The aerosol product is not a toxicological concern, we do not 
think.
    But we have scaled that up and we know we can produce an 
aerosol that becomes an effective surfactant. We have the 
devices ready to go with it. It is just a question of time and 
resources, and finding a defined patient population.
    You heard from testimony of Dr. Lumpkin, Fauci as well as 
Dr. Gerberding, there is two approaches to this thing. You can 
do it scientifically or unscientifically.
    Unscientifically, we can make the drug available as we 
speak. Scientifically, we would want to engage into proper 
clinical trials, which is defining the patient population, 
defining the controls and understanding the outcomes from these 
so that we can express the data and represent it in a 
scientifically valid form.
    But just to answer your question again and to summarize. In 
the very sick patients we are doing those trials as we speak. 
We are ready. We can scale it. We cannot scale it for the whole 
world yet, but we manufacture the compound in several sites and 
we can make enough to meet quite a bit of a demand.
    In the less severe patients ready for the aerosol approach 
to it, we are ready to enter clinical trials.
    Mr. Greenwood. But you think your clinical trials are going 
to be finished when?
    Mr. Capetola. The premature babies are going to be finished 
October. The end of this year the ARDS trials phase II B trial 
will be finished. Phase III in that could be started as early 
as March 2004.
    Mr. Greenwood. Okay. So then in each of those cases then 
the FDA needs to do its work at the end of your trials and make 
do its approval process.
    Mr. Capetola. Absolutely. That is correct.
    Mr. Greenwood. And theoretically if there was a crises, the 
FDA would want to prioritize and fast track their approval 
process.
    Mr. Capetola. We have for the ARDS indication already, we 
have the fast track designation by the FDA as we speak.
    Mr. Greenwood. Okay. Thank you.
    Mr. Capetola. You are welcome.
    Mr. Greenwood. Mr. Brenna, can you walk us through, you 
talked about I think you recommended that there be a trial done 
at a particular site. Walk us through your vision of the future 
as to how the technology that you demonstrated today could be 
widely used in this country to identify patients or travelers 
coming into the country with fever, and then if for instance if 
at every airport and at every seaport where, and for that 
matter road bridge, where travelers came into this country you 
had this kind of detection equipment, then what? So someone 
gets off an airplane and they walk past a thermal imager and we 
see that they have a temperature exceeding temperature, then 
what would we do?
    Mr. Brenna. I think we are learning quite a bit from the 
Chinese model over the past few weeks and we are trying to 
gather and collect as much information regarding the success 
they are having with the systems and the experience being 
gained at the four hospitals, the airport and the railway 
station.
    Before entering the airports, passengers would go through a 
special health care screening gate. If there is a temperature 
exceeding the baseline, as I mentioned before, 33 degrees 
centigrade, that patient goes on into another area. And they 
are examined. They are looked at and their temperatures are 
taken. They fill out a questionnaire as to what possibly could 
elevate the temperature beyond normal 98.6 or 33 degrees in the 
infrared world.
    From that point, if a respiratory syndrome is suspected, 
the patient either at the airport or at a nearby clinic will be 
chest x-rayed. It is mandatory at this point.
    And that is about all we know at this point. We do know it 
is working. We----
    Mr. Greenwood. But do you envision, I mean is it your 
vision that someday in this country we would want travelers 
entering the country to routinely be imaged in this way and 
diverted for some further action or not?
    Mr. Brenna. Well, I have a major concern. In fact, that was 
exacerbated this morning in The New York Times article when I 
read that 51 flights come into this country everyday from 
Bejing, Hong Kong and Singapore. And those are the highest 
infected sites for SARS at this point. And I definitely would 
encourage incoming high risk international ports of entry for 
temperature screening.
    The results so far that we have obtained from China, half 
of the patients or half of the, let us say, suspects who 
exhibit below or normal temperature, okay--let me rephrase 
that. A temperature above 33 degrees centigrade, half of those 
required further examination and the chest x-ray. The other 
half were false positives caused by some type of metabolic 
activity, menopausal, pharmaceutical type effect, or just 
physical exertion. So we are learning quite a bit about it.
    I think it is a very inexpensive price to pay for security 
purposes. In fact, I look at that false positive rate as being 
very positive; that we are learning from this experience.
    Mr. Greenwood. But to get back to my point here or my 
question, in terms of your vision for this technology for its 
routine application, is it your thought that perhaps rather 
than this be a routine activity at all points of entry in the 
United States, that this is a technology that might be useful 
in a particular instance where there is a new outbreak of some 
kind that is potentially very infectious and it might be used 
to screen only those patients--I keep saying patients--only 
those travelers from particularly high areas where there is a 
high infection rate? Is that what you are thinking?
    Mr. Brenna. I think that is a starting point for this. I am 
not sure we could limit this to SARS, but if there are other 
diseases which are airborne in nature, that can elevate 
temperature, I think this is an excellent screening device.
    I am very impressed with what I have seen so far by the PRC 
in terms of adapting this technology at airports, hospitals, 
all visitors, incoming patients, railroad ticket counters 
especially for mass transit. And when I look at the magnitude 
of the number of airports, railroad stations, hospitals, we are 
looking at over 300 major airports, over a 1,000 railroad 
facilities, over 12,000 hospitals. That type of a problem could 
occur here.
    Let us take, for example, one step forward points of entry, 
shipping.
    So if you asked what my vision is, yes, I think for the 
short term, high risk international risk entry points I think 
would require some type of screening at this point. If we do 
not, and without having the cure or a better of understanding 
of SARS, then we run the risk of having that disease take over 
this country.
    Mr. Greenwood. The Chairman's time has expired.
    The gentleman from Florida is recognized for 10 minutes.
    Mr. Deutsch. Thank you, Mr. Brenna.
    The Hong Kong government tells us that the infrared cameras 
installed on both sides of the border of China have identified 
37 individuals out of the hundreds of thousands that cross 
daily as having temperatures in excess of 100 degrees 
Fahrenheit. Does that number suggest that the Hong Kong/
Guangdong border equipment is working or not working?
    Mr. Brenna. I think I missed the last part of your 
question.
    Mr. Deutsch. Is 37 out of several hundred thousand, does 
that mean the equipment is working or not working?
    Mr. Brenna. I am not sure I understood that number before 
37. We have six systems in two provinces. I don't have a total 
number. And I am not sure I understood where that 37 came from. 
I believe they were from Hong Kong or Singapore. We are not in 
that area----
    Mr. Deutsch. I do not know if you were here when the 
official from the WHO, but I mean that is actually the number 
that he confirmed earlier in this hearing.
    Mr. Brenna. Okay.
    Mr. Deutsch. And it is 37 out of several hundred thousand. 
I mean, it is neat cool equipment, but I mean is it working. I 
mean, which is really the question.
    Mr. Brenna. Our feedback is, yes. I do not have the type of 
data to support that were presented by the WHO this morning.
    If I understood that number, I thought it was between Hong 
Kong and Singapore, if I am not mistaken.
    Mr. Deutsch. All right. I mean, if you can follow up with 
our staff, I would appreciate it.
    Mr. Brenna. I will.
    Mr. Deutsch. Thank you.
    Mr. Fischer, do you have any anticipated time table for 
when different phases of your research will be completed?
    You have to turn on the microphone.
    Mr. Fischer. We are actually putting the vaccine candidates 
together now. We have planned to present to the NIH within 
months the initial candidates that they can be looking at in 
their animal models, so that by the end of the year we will 
have initial data we believe in those animal models as to 
whether we are getting a robust immune response against the 
SARS proteins of interest. If that is the case, we will then in 
parallel, actually, be making the vector for potential clinical 
testing so that early to mid next year we would be in the 
clinic to be able to evaluate the safety of the initial 
candidates.
    Mr. Deutsch. I mean phase one, I mean do you have a----
    Mr. Fischer. Well, as you hear today, I think the NIH, the 
FDA, the CDC; there is going to be a lot of cooperation with 
the health authorities to look at how best to expedite the 
testing of these. Phase one testing in this case could go very 
rapidly, because we are really looking at safety only. We think 
that that will be expedited.
    The next stage is to look at that with a dose dependence in 
a phase two setting, which will take a little bit longer. And 
the key for a situation such as this is where would you 
actually test it in terms of challenging. And I think that is 
what I mean by challenging, is actually giving a patient the 
virus itself, which at this point would not be realistic, or be 
an area of the world such as China where there is an endemic 
high infection rate. That is the part that I think will require 
significant interaction between the health care authorities, 
the FDA. And part of the key question there is has the epidemic 
increased, is it getting worse or is it slowing down. So the 
risk benefit of that analysis will happen, I think on an 
ongoing basis as we see how the epidemic emerges.
    Mr. Deutsch. Mr. Capetola, what are the potential dangers 
or suspected side effects or contradictions of surfactant 
replacement therapy?
    Mr. Capetola. Well, it differs according to the patient 
population that we are treating. In the large trial that I 
described in very premature babies, these are babies that are 
one to three pounds, for the most part, who are born without 
their own surfactant. So essentially we are just replacing what 
is missing in these little children until their own genes are 
turned on within the first day.
    And when you are putting things down into the lung like an 
intratracheal administration in those patients, you get 
temporary desaturation, you can get temporary cessation of 
breathing for a few second. But for the most part these drugs 
are considered, and as you probably know from the written 
testimony, in that patient population there are animal derived 
products on the market which are considered the greatest single 
breakthrough in neonatal medicine in terms of reducing infant 
mortality. So not a lot of side effects that cannot be 
controlled by the neonatologist at the bedside.
    In the adult population, it is even safer we think in our 
opinion, according to the phase II data, because there is 19 
major segments of the lung and as a pulmonologist or trauma 
surgeon goes into each one of the segments, that's only one 
nineteenth of the surface area, and they could control the 
patient's medical condition in a fairly robust way.
    So, we do not know enough to fully access the safety yet. 
We will know that after phase III, but so far we are very 
encouraged by what we see.
    Mr. Deutsch. Thank you.
    Mr. Burger, are there any known or potential health risks 
identified or associated with antisense technology.
    Mr. Burger. Our antisense chemistry has completed nine 
human clinical studies in nonviral indications; cancer, 
cardiovascular restenosis, polycystic kidney disease, drug 
metabolism. So in treating over 200 patients, we have not seen 
a single drug-related adverse event, so it is remarkably safe. 
It is stealthy, if you will. This small molecule is not 
recognized by your body, so it is specific for the gene target, 
yet is not recognized and therefore, so far, quite safe.
    Mr. Deutsch. Do you have any anticipated time table for 
when antisense technology might be available for the general 
population?
    Mr. Burger. For SARS?
    Mr. Deutsch. Yes.
    Mr. Burger. We expect to be in phase I B studies with our 
West Nile agent later this year, presumably by the time summer 
comes around. We are intending to file an IND shortly.
    We have the SARS antisense agent in the hands of NIAID now 
for testing at USAMRIID. If those tests were positive, and we 
have been effective against five or six other similar RNA 
viruses and other animal coronaviruses, so we anticipate it is 
going to be able to stop the replication of the SARS agent. If 
it does in clinical studies, then the next step is to sit down 
with the FDA, assess risk-benefit, and how quickly to initiate 
clinical studies. That could be months.
    Mr. Deutsch. Mr. Lonberg, in your testimony you stated the 
Government can play a role in encouraging biotech and 
pharmaceutical companies by removing some uncertainties such as 
establishing a defined market by underwriting some of the 
research and development costs. Clearly there are difficulties 
with this request to us. And if the Government were to enter 
into a contract with a pharmaceutical company for 10 years, 
what would happen if a better, safer, more effective drugs was 
developed, let us say 2 years down the road at that point in 
time?
    Mr. Lonberg. I guess what I am proposing is not a contract 
up front, but rather a defined market. If the Government says--
--
    Mr. Deutsch. Would you bring the microphone a little bit 
closer?
    Mr. Lonberg. Sorry.
    If the Government states that up front that over X years 
they are going to purchase so many doses of a therapy that 
meets this specification as opposed to a therapy from a 
particular company, that would define the market.
    Mr. Deutsch. Has venture capital dried up for projects such 
as yours?
    Mr. Lonberg. Our company is not dependent on venture 
capital for its funding. We are a publicly traded company.
    At this point funding, venture capital funding and public 
market funding for biotechnology companies is quite scarce.
    Mr. Deutsch. And why is that?
    Mr. Lonberg. I think a thorough analysis of that would 
probably require somebody with a different set of expertise 
than myself. But I can least out that there are boom and bust 
cycles in biotechnology. And we are not at a boom cycle right 
now.
    Mr. Deutsch. If the Government eliminates your risk by 
guaranteeing the eventual market, should the Government then be 
able to help you formulate the price or otherwise share in the 
resulting rewards?
    Mr. Lonberg. I am certainly not suggesting the Government 
would be eliminating risk. And I am also not advocating that 
the Government step in and do something. I think that is a 
public policy decision and that is up to you to think about. I 
am just trying to convey to you what decisionmaking, what 
components go into our decisionmaking. And the biggest problem 
we have with something like SARS or with bioterror is that we 
cannot identify the market up front. And I think that is why 
you do not see a lot of biotech companies jumping in at this 
point.
    Mr. Deutsch. Thank you very much.
    Mr. Lonberg. Thank you.
    Mr. Greenwood. The Chair thanks the gentlemen. And if I may 
say so, I find it so exciting and so encouraging to see the 
entrepreneurial world out there so busy producing and 
experimenting and learning about these products that are going 
to mean so much to the human race. And thank you for doing that 
work.
    Thank you for testifying before us today. Thank you for 
your patience and we thank you for being with us.
    The Chair will hold the hearing record open for 30 days for 
additional submissions to the record.
    The hearing is adjourned.
    [Whereupon, at 6:41 p.m., the subcommittee was adjourned.]
    [Additional material submitted for the record follows:]

                 American Public Health Association
                                             Washington, DC
                                                       May 12, 2003
The Honorable James Greenwood
Chair
House Energy and Commerce Committee
Subcommittee on Oversight and Investigations
2125 Rayburn House Office Building
Washington, DC 20515
    Dear Chairman Greenwood: On behalf of the American Public Health 
Association (APHA), the largest and oldest organization of public 
health professionals in the nation, representing more than 50,000 
members from over 50 public health occupations, I write to thank you 
for the opportunity to testify before the Oversight and Investigations 
Subcommittee on the public health response to the SARS epidemic last 
Wednesday, May 7.
    During the hearing, Representative Diana DeGette requested that 
APHA supply for the subcommittee's hearing record our request for the 
National Center for Infectious Diseases (NCID) for FY04. NCID plays a 
critical role in preventing and controlling infectious diseases. 
Specifically, the center focuses on four areas:

 surveillance and response to detect, investigate, and monitor 
        emerging pathogens, the diseases they cause and the factors 
        influencing their emergence;
 applied research through the integration of laboratory science 
        and epidemiology to optimize public health practice;
 infrastructure and training to strengthen the nation's public 
        health system to support surveillance and research, and to 
        implement prevention and control programs; and
 prevention and control to ensure timely implementation of 
        prevention strategies and to enhance communication of public 
        health information about emerging diseases.
    In our best professional judgment, NCID will require funding of at 
least $467 million in FY04 to support these efforts to protect the 
nation and the world from infectious diseases, including emerging and 
re-emerging infectious diseases like SARS and West Nile, and to combat 
the growing problem of antimicrobial resistance. APHA believes that it 
is essential to fully fund NCID to avoid repeated requests for 
emergency funding from Congress every time new threats emerge. We are 
hopeful that Congress will restore the proposed cuts to NCID in the 
president's budget and fund the center at $467 million in FY04.
    Thank you again for allowing us to share our views on these 
important issues with you and members of the Subcommittee. We look 
forward to working with you on other important public health issues in 
the future.
            Sincerely,
                              Georges C. Benjamin, MD, FACP
                                                 Executive Director
cc: Representative Diana DeGette
                                 ______
                                 
 Prepared Statement of John M. Brenna, President, Computerized Thermal 
                             Imaging, Inc.
    Dear Mr. Chairman and members of the sub-committee: I would like to 
submit the following information as a supplement to the material 
presented to the Subcommittee on Oversight and Investigations on May 7, 
2003 concerning SARS. At the Subcommittee meeting, I described how 
Infrared imaging technology developed by, Computerized Thermal Imaging, 
Inc., was being used in China as part of a SARS Screening protocol for 
public facilities, such as airports, railway stations, bus terminals 
and hospitals. Since that meeting, we have gained additional experience 
in China, and have extended our Infrared Camera technology for SARS 
Screening to Canada. I would like to briefly share those experiences, 
as I believe they can be very useful to the Subcommittee and to the 
U.S. agencies responsible for protecting our citizens from biological 
threats.
    Approximately ten weeks have elapsed since our Infrared cameras 
were installed in China as a first line of defense for SARS screening. 
To date, there are 10 systems in operation. Two systems are now in 
constant use at Nanjing International Airport, two at the Nanjing 
Railway Station and two systems at the Nanjing Bus Terminal. Four units 
are used at the following Chinese hospitals: Golou Hospital, a 100+ 
year old U.S. missionary hospital, Nanjing Peoples Hospital & 
Rehabilitation Center, largest hospital in JiangSu province, JiangSu 
Province Traditional Chinese Hospital, Beijing Anti-SARS Hospital, and 
XiaTang Shan Hospital. We have official contact information at these 
facilities that may be helpful to the Subcommittee in the future.
    On May 7, 2003, the day of my testimony, our company was finalizing 
its response to a tender issued by the Public Works & Government 
Services Canada (PWGSC) on behalf of Health Canada. CTI's Infrared 
camera was ultimately selected for this important pilot program 
designed to assess the usefulness of Infrared imaging as a SARS 
screening tool at Canadian airports. Three systems are currently 
installed at the Toronto International Airport, two in Terminal 2 and 
one in Terminal 3. After 4 weeks in Toronto, they will be moved to 
Vancouver International Airport where the evaluation process will be 
repeated. Based on the data collected in Toronto and Vancouver, Health 
Canada officials will determine how, where and when Infrared cameras 
will be used in Canadian airports, as well as other public facilities.
    To date, over 50 Canadian operators have been trained to use 
special SARS-screening software developed by CTI based on it's now 
substantial China experience. CTI representatives are working with 
Health Canada and Greater Toronto Airport Authority (GTAA) officials on 
an on-going basis to assist in establishing formal screening procedures 
and to show how to use the system's full capabilities to simplify the 
many facets of their screening program. The CTI system's inherent 
flexibility has been very useful in this process. Its database 
structure allows operators to quickly identify passengers exhibiting 
suspiciously high temperatures and record their images. It 
automatically records time and date on each image to further speed the 
process. Suspicious images can then easily be networked to on-line 
workstations where additional evaluation post-processing analysis, 
printing, etc., can occur and where information can be added such as 
subject's name and other important data without disrupting the normal 
flow of traffic. Once this data is captured, the CTI system generates 
reports summarizing activity levels such as number of suspicious images 
per shift and other information deemed important by screening 
supervisors. Response to CTI for this type of functionality has been 
very positive from both Canada and China. Temperature recording 
accuracy and data management are a necessity for this type of screening 
system.
    Limited performance data at this time makes it difficult to 
conclude that Infrared imaging is a cure all tool for screening viruses 
like SARS. However, early indications and results suggest that it does 
support a first defense strategic approach. Chinese officials are 
convinced of its usefulness as evidenced by installation of additional 
Infrared cameras on a routine basis. Initial input from Health Canada 
officials has been very encouraging. Canadian citizens have given the 
program considerable attention, since several new SARS cases surfaced 
in recent weeks. Without the clear and present danger of a SARS 
outbreak in the United States, our citizens have put little pressure on 
government officials to execute similar airport-based virus screening 
programs. However, I believe that they will enthusiastically support a 
government-sponsored program that is prepared to take serious measures, 
like those used in China and Canada, should an outbreak occur in the 
U.S.
    Listed below are early statistics from our experience in China that 
should be useful in considering a U.S. pilot SARS-screening program:
    Number of Subjects Screened with Infrared imaging: It is important 
to note these are ``post'' SARS traffic levels. a) 4,000/day at Nanjing 
Airport; b) 4,000/day at Nanjing Bus Terminal; and c) 10,000/day at 2 
Nanjing Railway Stations.
    Infrared Screening Results: a) Total subjects detained for medical 
evaluation--2,400; b) Total subjects quarantined as SARS suspects--50; 
and c) Total SARS cases confirmed--10.
    Pre SARS Traffic Levels: It is important to note the negative 
effect SARS is having on transportation. a) 25,000/day at Nanjing 
Airport; b) 20,000/day at Nanjing Bus Terminal; and c) 60,000/day at 2 
Nanjing Railway Stations.
    Negative impact on China's economy from the SARS outbreak: 
estimated $100B
    It is important to note that Infrared Screening has allowed a large 
majority of passengers to continue on their way without significant 
delay, just a few seconds/person for the Infrared image. Most 
passengers who exhibited suspicious facial temperatures were only 
delayed 5 to 10 minutes as interviewers and medical personnel 
determined if there was a sufficient basis for further medical 
evaluation such as oral or ear temperature measurement, respiratory 
function assessment and/or chest x-ray. Only those subjects with a 
history of travel to SARS-affected areas or had contact with known SARS 
victims, and/or exhibited a sufficiently high fever and cough were held 
over for more extensive evaluation. The Infrared Screening strategy 
appears to be working as a first defense system. A number of subjects, 
upon further examination required quarantine as well as those actually 
diagnosed with SARS.
    In conclusion, I believe that appropriate U.S. agencies should 
seriously consider conducting an Infrared imaging-based SARS screening 
pilot project at several high-risk points of entry, similar to the 
programs being administered in China and by Health Canada at the 
Toronto and Vancouver international airports. CTI is available to 
facilitate communications between U.S. Health Officials and the various 
Chinese and Health Canada Administrators to develop either a trial 
pilot program or preparedness plan.
    If at all possible, I would like to request any assistance that can 
be offered by the Subcommittee in facilitating communications between 
our company and appropriate U.S. agencies such as the Center for 
Disease Control, the Department of Homeland Defense and/or the 
Transportation Safety Administration to further discuss the use of 
Infrared Imaging for SARS Screening.
    Thank you again for the invitation to speak at the May 7, 2003, 
Subcommittee meeting, and the opportunity to supplement my initial 
testimony. I hope that you find the additional information useful. 
Please let me know if I can be of any further service.

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