[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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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
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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.
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\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.
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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.
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\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.
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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
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\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).
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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.
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\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.
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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.
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\9\ The two hospitals have since been reopened.
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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.
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\10\ CDC participates in international disease and laboratory
surveillance sponsored by the World Health Organization, which operates
in 83 countries.
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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.
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\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).
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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
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\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).
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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.
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\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.
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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.
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\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.
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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.
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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.
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\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
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\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.
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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.
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\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.
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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
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\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).
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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.
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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.
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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
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\2\ Associated Press, Milwaukee: State Ready for SARS, Officials
Say, St. Paul Pioneer Press, 4/29/03 @ 1B.
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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
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Disease Control and Prevention, the American Bar Association Standing
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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
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Fialka, J., et al. 2001. ``Are We Prepared for the Unthinkable?''
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Gostin, Lawrence O. ed. 2002. Public Health Law and Ethics: A
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``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.
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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.