[Senate Hearing 109-702]
[From the U.S. Government Publishing Office]
S. Hrg. 109-702
BIODEFENSE AND PANDEMIC INFLUENZA
=======================================================================
HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
__________
SPECIAL HEARING
MAY 23, 2006--WASHINGTON, DC
__________
Printed for the use of the Committee on Appropriations
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COMMITTEE ON APPROPRIATIONS
THAD COCHRAN, Mississippi, Chairman
TED STEVENS, Alaska ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico PATRICK J. LEAHY, Vermont
CHRISTOPHER S. BOND, Missouri TOM HARKIN, Iowa
MITCH McCONNELL, Kentucky BARBARA A. MIKULSKI, Maryland
CONRAD BURNS, Montana HARRY REID, Nevada
RICHARD C. SHELBY, Alabama HERB KOHL, Wisconsin
JUDD GREGG, New Hampshire PATTY MURRAY, Washington
ROBERT F. BENNETT, Utah BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas RICHARD J. DURBIN, Illinois
MIKE DeWINE, Ohio TIM JOHNSON, South Dakota
SAM BROWNBACK, Kansas MARY L. LANDRIEU, Louisiana
WAYNE ALLARD, Colorado
J. Keith Kennedy, Staff Director
Terrence E. Sauvain, Minority Staff Director
------
Subcommittee on Homeland Security
JUDD GREGG, New Hampshire, Chairman
THAD COCHRAN, Mississippi ROBERT C. BYRD, West Virginia
TED STEVENS, Alaska DANIEL K. INOUYE, Hawaii
ARLEN SPECTER, Pennsylvania PATRICK J. LEAHY, Vermont
PETE V. DOMENICI, New Mexico BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama HERB KOHL, Wisconsin
LARRY CRAIG, Idaho PATTY MURRAY, Washington
ROBERT F. BENNETT, Utah HARRY REID, Nevada
WAYNE ALLARD, Colorado DIANNE FEINSTEIN, California
Professional Staff
Rebecca Davies
Carol Cribbs
Shannon O'Keefe
Nancy Perkins
Mark Van de Water
Charles Kieffer (Minority)
Chip Walgren (Minority)
Scott Nance (Minority)
Drenan E. Dudley (Minority)
Administrative Support
Christa Crawford
C O N T E N T S
----------
Page
Opening Statement of Senator Judd Gregg.......................... 1
Prepared Statement of Senator Larry Craig........................ 3
Prepared Statement of Senator Robert C. Byrd..................... 4
Statement of Paul A. Offit, M.D., Chief of Infectious Diseases,
Children's Hospital of Philadelphia............................ 4
Prepared Statement of........................................ 6
Statement of John M. Clerici, J.D., Mckenna Long & Aldridge, LLP. 8
Prepared Statement of........................................ 10
Statement of Scott R. Lillibridge, M.D., Director, Center for
Biodiversity and Public Health Preparedness, University of
Texas Health Science Center, Houston School of Public Health... 13
Prepared Statement of........................................ 15
Challenges to National Preparedness.............................. 16
Road Map Forward................................................. 17
Statement of Frank J. Cilluffo, Associate Vice President for
Homeland Security, and Director, Homeland Security Policy
Institute, George Washington University........................ 19
Prepared Statement of........................................ 22
Prepared Statement of Steven D. Rice, Senior Manager, Battelle's
Health and Life Sciences Division.............................. 44
BIODEFENSE AND PANDEMIC INFLUENZA
----------
TUESDAY, MAY 23, 2006
U.S. Senate,
Subcommittee on Homeland Security,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:28 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Judd Gregg (chairman) presiding.
Present: Senators Gregg, Allard, and Kohl.
Also present: Senator Burr.
opening statement of senator judd gregg
Senator Gregg. We will begin this hearing, which is an
important hearing on bioterrorism and pandemic influenza and
our preparation, our status of the government's preparation for
either of these events, which we obviously hope will never
occur. As a society, I think we recognize and as a culture I
think we recognize that there are certain elements of threat
which the government has a responsibility to prepare for even
though we hope that they will never impact us.
Number one on that list, of course, is the use of a
biological or nuclear or weapon of mass destruction used by an
enemy of America, terrorists specifically, against us, and our
preparation for that has been a major focus of this committee,
myself and Senator Byrd. We have reoriented funds to address
that.
Number two--not in that sense; they are equal in status--is
the potential of a major outbreak of influenza along the lines
of what happened in the early part of the last century, which
would potentially harm and kill millions, potentially hundreds
of thousands, of citizens across the world and in the United
States and would obviously disrupt the entire world and the
economy of the world, especially America, if it were not
prepared for adequately. There has been a lot of talk about
that because of the issues of bird flu and the possible
mutation of that virus into a form that can be conveyed to
humans and human-to-human conveyance from there.
So these are big issues that need to be constantly focused
on and that we as a government need to be constantly addressing
and talking about and making sure that the agencies in our
government which are responsible are on top of these issues.
So what we have done today is convene a panel of experts
from outside the government who have looked at the government
response and will tell us, hopefully, where the weak points
are, where the good points are, what we should be doing, what
we should be strengthening, and what we are not doing that we
should be doing. That is the purpose of this hearing, to get
critical assessment, constructive critical assessment of where
the Federal Government is on the issue of preparing for these
potentially horrific events, but events which, even though we
do not want them to occur, we know we must be ready for.
We are joined today by Senator Burr. Senator Burr is the
chairman of the subcommittee on the HELP Committee which has
jurisdiction over bioterrorism. I have asked him to participate
in this hearing. This was originally going to be structured as
a joint hearing, but for logistical reasons we were not able to
get that going. So I appreciate Senator Burr participating in
this hearing. He is a leading expert on this.
Senator Byrd, who is equally an expert on this issue,
unfortunately has other commitments today, so he is not going
to be able to make this hearing. He has shown immense
leadership and commitment to making sure that these areas of
biological terrorism potential threat are prepared for, and I
have greatly appreciated his help and support and leadership.
More than help and support, he has shown the way in many
instances in how we try to tool up for these issues.
So with that, we are going to go right to the panel. I have
advised the panel that we have a vote at 11 o'clock and I
unfortunately am going to have to stay after the vote in order
to do a confirmation of Ambassador Portman to become OMB
Director, as chairman of the Budget Committee. So I may not be
able to make it back until about 11:20, 11:25. But we will
continue the hearing. If I am not here somebody else will take
the chair.
So why do we not begin going left to right and start with
our witnesses. Let me begin with Dr. Offit. Why do I not
introduce all the witnesses first and then we will begin. Dr.
Offit is the Chief of Infectious Diseases at the Children's
Hospital of Philadelphia and is a professor of pediatrics at
the University of Pennsylvania School of Medicine. He is an
internationally recognized expert in immunology. Dr. Offit has
published over 130 scientific medical journal articles. He has
also co-authored several books, including The Cutter Incident,
which chronicles how the first polio vaccine led to the current
vaccine crisis.
We have John Clerici, who is a partner with McKenna Long
and Aldridge and specializes in homeland security and
procurement of anti-terrorism technology. Mr. Clerici is a
recognized expert on liability reform policies.
We have Dr. Lillibridge, who is professor of epidemiology
and Director of the Center of Biosecurity and Public Health
Preparedness at the University of Texas Health Science Center
at Houston. Dr. Lillibridge recently served as Special
Assistant for National Security and Emergency Management at
HHS, where he oversaw the development of the National
Bioterrorism Preparedness Program. He also established and
directed the bioterrorist preparedness and response programs at
CDC and was the lead physician during the Oklahoma City bombing
and the 1995 sarin terrorist attack in Tokyo.
We have as our final witness Frank Cilluffo.
He is the Associate President of Homeland Security at
George Washington University and the Director of the Homeland
Security Policy Institute. Prior to joining the faculty at GW
he served as the Special Assistant to the President for
Homeland Security at the White House. He also served in a
senior policy position with the Center for Strategic and
International Studies, with a focus on homeland security and
counterterrorism.
Obviously an extraordinarily qualified panel and we look
forward to their critique of where we are and where we are
going.
We have written statements from Senator Craig and Byrd that
will be entered into the hearing.
Prepared Statement of Senator Larry Craig
Thank you Mr. Chairman. I appreciate your holding this hearing
today to focus our Subcommittee on the important topic of bioterrorism
and pandemic flu preparedness.
Mr. Chairman, there has been no shortage of reviews of the Federal
Government's capability to respond to another serious emergency across
this country. Countless assessments have been done by non-governmental
entities, such as the ones represented by our panel this morning. There
have been dozens of hearings by multiple Committees in the House and
Senate. And certainly the media has highlighted several areas that must
be addressed.
I do not want to take a lot of the Subcommittee's time this morning
outlining my thoughts on all of those assessments and where I think we
need to move this government to respond to a bioterrorism attack or a
pandemic flu. But, what I will say is that Congress must make some
decisions about which agency of this government will be in charge
during an emergency and who in that agency should direct all of our
efforts. I know that Senator Burr and the HELP Committee have been
working on a bill to answer some of these questions. Once we answer the
questions though, I think this subcommittee must ensure that all of the
Federal financing efforts necessary to carry out the Federal
responsibilities will be available to the right agency for their part
of the mission.
That may sound obvious to some. But, I say that Mr. Chairman
because, as you know, I Chair the Veterans Affairs Committee. And many
people in and out of government believe that VA's performance in
response to the terrible storms that ravaged the Gulf Coast was so
impressive that they should be given a larger role in the overall
Federal response plan. Frankly, I think I agree with those who want to
assign a larger role for VA. The agency has the medical infrastructure,
the dedicated Federal employees, the purchasing power, and the
logistics management system to do the job. But, I don't really want to
argue the merits of the agency's role right now.
What I am concerned about is that VA, or other agencies like it,
will be given an expanded role and then expected to find the financing
within their current budget to carry out their new mission. I don't
know if that is even possible in the case of VA, let alone how that
would impact its other missions. But, what I do know is that such an
approach--if applied government-wide--would have us relying on each
subcommittee of the Appropriations Committee to separately fund the
needs of each agency under its jurisdiction for a nationwide response
plan. Then, we would be relying on appointed officials and bureaucrats
to dedicate the proper amount of money to the preparedness and response
missions of their agency. I sincerely hope we do not go down that road
Mr. Chairman.
So, as we work through these issues and consider the HELP
Committee's legislation on the floor later this year, I want to make
certain that we identify what needs to be funded and for what efforts
in each Federal agency for preparedness and responsiveness. We then
have to weigh all of those needs in this subcommittee and provide
preparedness and response funding from this subcommittee for that
specific purpose.
There are many Federal agencies, like VA, that are well-suited to
assist in the Federal response to a national emergency or a pandemic
flu. But, the old adage is that we are only as strong as our weakest
link. And it is incumbent on this subcommittee to make sure we are
coordinating the funding for our response efforts in one bill so that
we do not discover a weak link that cripples our response efforts right
in the middle of the next emergency.
Mr. Chairman, again I want to thank you for holding this hearing. I
look forward to the testimony and asking some questions of our
witnesses.
______
Prepared Statement of Senator Robert C. Byrd
A flu pandemic or bioterror event is a real threat to the United
States. Medical experts warn that a global, cataclysmic pandemic is not
a question of ``if,'' but ``when.'' Like any natural disaster, it could
hit at anytime. And when it does, it could take the lives of millions
of people.
Our current public health infrastructure and emergency management
system are not equipped today to cope with a major flu pandemic or
biological event. A coordinated, comprehensive, and aggressive national
plan must be implemented for combating biological weapons or infectious
diseases. This plan must serve to detect, identify, contain, and
respond to threats abroad and to bolster domestic preparedness and
response.
The September 11, 2001, terrorist attacks cost America many
precious human lives. Hurricane Katrina's impact was devastating in its
harsh impact over 93,000 square miles. A pandemic or biological attack
will combine human toll and geographic dispersion with an added element
of long duration that previous disasters have not yet demonstrated.
A pandemic or biological terrorist attack would likely overwhelm
our medical capabilities. In the Twentieth Century, there were three
influenza pandemics, killing over 600,000 people in the United States,
including my beloved mother. The anthrax attacks of 2001 fell short of
mass causalities, but five lives were lost, and the attack serves to
illustrate the viability of a biological attack. We should be prepared,
not scared.
Congress has appropriated over $4.1 billion for pandemic influenza
prevention and preparedness and the Senate has approved another $2.3
billion on the supplemental. Since 9/11, Congress has appropriated over
$10 billion for State and local government efforts to prepare for and
respond to a bioterrorist attack, or other public health emergency. In
addition, Congress has advance-appropriated $5.6 billion for Project
BioShield to procure countermeasures for biological threats.
Our job here in the Congress is to write the law, appropriate
funding, and provide oversight. I continue to be frustrated with this
Administration's pace in getting the job done, and I have told the
Administration as much. I am concerned that we have appropriated
billions of dollars and, yet, we do not seem to be prepared for the
wide range of threats facing us. I am particularly concerned that our
public health system lacks the surge capacity to deal with mass
casualties.
I thank our witnesses for being here today to discuss how we--as a
nation--are doing in preparing for pandemic and biological threats. I
look forward to hearing their frank comments and insights so that the
Congress can continue to provide the leadership that the nation needs
on this important topic.
I commend Chairman Gregg for his leadership on this important
issue.
Senator Gregg. Dr. Offit.
STATEMENT OF PAUL A. OFFIT, M.D., CHIEF OF INFECTIOUS
DISEASES, CHILDREN'S HOSPITAL OF
PHILADELPHIA
Dr. Offit. Good morning, Senator. My name is Paul Offit. I
am Chief of Infectious Diseases at Children's Hospital in
Philadelphia and a former member of the Advisory Committee on
Immunization Practices to the CDC.
I would like to talk briefly today about an event that
occurred 50 years ago in 1957, the only time in our history
that we have made influenza vaccine in advance of a pandemic,
because I think there are several lessons that can be learned
from that event. On April 17, 1957, Maurice Hilleman, a
scientist working at the Walter Reed Army Medical Research
Institute, read an article in the New York Times titled ``Hong
Kong Battling Influenza Epidemic.'' The article stated that
250,000 people, 10 percent of the entire population of Hong
Kong, had suddenly come down with the flu.
Hilleman found that this outbreak signaled--feared that
this outbreak signaled the start of the next pandemic. So the
next day he sent a telex to the Army's 406th Medical General
Laboratory in Zama, Japan, asking them to send him specimens
from people infected with the virus. The first specimens
arrived 1 month later on May 17, 1957.
For 5 days and nights, Hilleman worked to determine whether
the influenza virus circulating in Hong Kong could be a
pandemic strain. He tested sera from members of the American
military and adults in the general population, but could not
find anyone whose immune systems had seen this virus before.
Hilleman then sent the virus for testing to the United States
Public Health Service, the Commission on Influenza of the Armed
Forces Epidemiological Board, and the World Health
Organization. They found that only a handful of people in the
United States and the Netherlands had antibodies to the virus.
Because few people in the world had antibodies to stop it, the
influenza virus circulating in Hong Kong in 1957 could spread
from one country to the next unchecked.
Hilleman then sent the virus, now called Asian flu, to six
American-based companies. He figured that if he were to have
any chance of saving lives companies would have to make and
distribute tens of millions of doses in only 4 months. Hilleman
sped up the process by ignoring the Division of Biologic
Standards, the Federal agency responsible for regulating
vaccines.
He also asked vaccine makers to advise chicken producers
not to kill their roosters, even though it was late in the
hatching season. He knew that production of tens of millions of
doses of vaccine would require at least 200,000 eggs a day.
As predicted, in September 1957 Asian flu entered the
United States from both coasts. The first laboratory-proven
cases occurred aboard naval vessels in Newport, Rhode Island,
and San Diego, California. The first outbreak was triggered by
a San Diego girl who carried the virus to an international
church conference in Grinnell, Iowa. The second occurred in
Valley Forge, Pennsylvania.
Companies made the first lots of Asian influenza vaccine in
June 1957 and vaccination began in July. By late fall, 40
million doses were distributed in the United States. Within a
few months, influenza infected 20 million Americans. 70,000
died from the disease. Worldwide, the pandemic killed at least
4 million people.
The Surgeon General of the United States, Leonard Burney,
later said, quote: ``Many millions of persons we can be certain
did not contact Asian flu because of the protection of the
vaccine.'' For his efforts, Maurice Hilleman won the
Distinguished Service Medal from the American military.
Several features of this outbreak and our response to it
are instructive. First, Hilleman had to rely on reading an
article in a newspaper to know what was happening in Southeast
Asia and he had to wait 1 month before he received samples of
the virus. Today the international community of scientists,
clinicians, and public health officials, armed with
sophisticated virological techniques, are much better at
surveillance of outbreaks and characterization of possible
pandemic strains.
Second, Hilleman called on six U.S.-based influenza vaccine
makers. Today no U.S.-based companies make the inactivated
vaccine. Sanofi Pasteur has a manufacturing facility in
Swiftwater, Pennsylvania, but is not a U.S.-based company.
Third, Hilleman had to rely on eggs to produce vaccines.
Recognizing that egg production is unreliable, the President's
pandemic flu plan has effectively encouraged vaccine makers to
gear up facilities to grow influenza virus in mammalian rather
than avian cells. For example, GlaxoSmithKline recently
purchased a manufacturing facility in Marietta, Pennsylvania,
and MedImmune, the makers of a live attenuated influenza
vaccine, will manufacture vaccine in mammalian cells in
Maryland. Given that the influenza vaccine is generic and
inexpensive, it is unlikely that vaccine makers would have done
this without financial encouragement.
Fourth, Hilleman completely ignored the Division of
Biologic Standards, the Federal agency responsible for
regulating vaccines. At the time vaccine regulation was in its
infancy, regulated by a small division within the National
Institutes of Health. Today vaccines are regulated by the Food
and Drug Administration and they do an excellent job. Vaccine
regulation I think has helped to make vaccines arguably the
safest and best-tested products that we put into our bodies.
But the process is slow and if we are to make vaccine quickly
the regulatory process would have to be streamlined
significantly.
Fifth, Hilleman was a committee of one. He took
responsibility for shepherding each step of the process. It
would be impossible for him to do that today, but it would
certainly be of value for one central agency to be held
accountable for making sure that vaccine was made, tested, and
distributed quickly and efficiently.
Sixth, Hilleman never considered liability protection for
vaccine makers. In 1957 pharmaceutical companies were not held
liable if they were not negligent in the production or design
of their product. Ironically, the birth of liability without
negligence for pharmaceutical companies began with a jury
verdict against a vaccine maker, Cutter Laboratories, only a
few months later. However, it is clear that vaccine makers
would not make a pandemic flu vaccine today without substantial
protection from frivolous litigation.
Thanks for giving me an opportunity to speak before this
committee.
[The statement follows:]
Prepared Statement of Paul A. Offit
My name is Paul Offit. I'm the Chief of Infectious Diseases at The
Children's Hospital of Philadelphia, Professor of Pediatrics at the
University of Pennsylvania School of Medicine, and a former member of
the Advisory Committee on Immunization Practices to the CDC.
I'd like to talk briefly today about an event that occurred 50
years ago, in 1957: the only time in our history that we have made
influenza vaccine in advance of a pandemic. Several lessons can be
learned from that event.
On April 17, 1957, Maurice Hilleman, a scientist working at the
Walter Reed Army Medical Research Institute, read an article in the New
York Times titled Hong Kong Battling Influenza Epidemic. The article
stated that 250,000 people--ten percent of the entire population of
Hong Kong--had suddenly come down with the flu. Hilleman feared that
this outbreak signaled the start of the next pandemic. So the next day
he sent a Telex to the Army's 406th Medical Laboratory in Zama, Japan
asking them to send him specimens from people infected with the virus.
The first specimens arrived 1 month later, on May 17, 1957.
For 5 days and nights Hilleman worked to determine whether the
influenza virus circulating in Hong Kong could be a pandemic strain. He
tested sera from members of the military and adults in the general
population, but couldn't find anyone whose immune systems had seen this
virus before. Hilleman then sent the virus for testing to the United
States Public Health Service, the Commission on Influenza of the Armed
Forces Epidemiological Board, and the World Health Organization; they
found that only a handful of people--in the United States and the
Netherlands--had antibodies to the virus. Because few people in the
world had antibodies to stop it, the influenza virus circulating in
Hong Kong could spread from one country to the next, unchecked.
Hilleman then sent this virus--now called Asian flu--to six
American-based companies. He figured that if he were to have any chance
of saving lives, companies would have to make and distribute tens of
millions of doses in about 4 months.
Hilleman sped up the process by ignoring the Division of Biologics
Standards, the Federal agency responsible for regulating vaccines. He
also asked vaccine makers to advise chicken producers not to kill their
roosters, even though it was late in the hatching season. He knew that
production of tens of millions of doses of vaccine would require at
least 200,000 eggs a day.
As predicted, in September 1957, Asian flu entered the United
States from both coasts. The first laboratory-proven cases occurred
aboard naval vessels in Newport, Rhode Island and San Diego,
California. The first outbreak was triggered by a San Diego girl who
carried the virus to an International Church Conference in Grinnell,
Iowa. The second occurred in Valley Forge, Pennsylvania.
Companies made the first lots of Asian influenza vaccine in June
1957 and vaccinations began in July. By late fall, 40 million doses
were distributed in the United States. Within a few months influenza
infected 20 million Americans; 70,000 died from the disease. Worldwide,
the pandemic killed at least 4 million people.
The Surgeon General of the United States, Leonard Burney, later
said ``many millions of persons, we can be certain, did not contract
Asian flu because of the protection of the vaccine.'' For his efforts,
Maurice Hilleman won the Distinguished Service Medal from the American
military.
Several features of this outbreak, and our response to it, are
instructive.
First, Hilleman had to rely on reading an article in a newspaper to
know what was happening in Southeast Asia and he had to wait 1 month
before he received samples of the virus. Today, the international
community of scientists, clinicians, and public-health officials, armed
with sophisticated virological techniques, are much better at
surveillance of outbreaks and characterization of possible pandemic
strains.
Second, Hilleman called on six US-based influenza vaccine makers.
Today, no US-based companies make the inactivated influenza vaccine.
Sanofi pasteur has a manufacturing facility in Swiftwater,
Pennsylvania, but is not a US-based company.
Third, Hilleman had to rely on eggs to produce vaccine. Recognizing
that egg production is unreliable, the President's pandemic flu plan
has effectively encouraged vaccine makers to gear up facilities to grow
influenza vaccine virus in mammalian rather than avian cells. For
example, GlaxoSmithKline recently purchased a manufacturing facility in
Marietta, Pennsylvania. And MedImmune, the makers of a live, attenuated
influenza vaccine, will manufacture vaccine in mammalian cells in
Maryland. Given that the influenza vaccine is generic and inexpensive,
it is unlikely that vaccine makers would have done this without
financial encouragement.
Fourth, Hilleman completely ignored the Division of Biologics
Standards, the Federal agency responsible for regulating vaccines. At
the time, vaccine regulation was in its infancy, regulated by a small
division within the National Institutes of Health. Today vaccines are
regulated by the Food and Drug Administration and they do an excellent
job. Vaccine regulation has helped to make vaccines arguably the safest
and best tested products that we put into our bodies. But the process
is slow. And if we were to make vaccine quickly, the regulatory process
would have to be streamlined signficantly.
Fifth, Hilleman was a committee of one. He took responsibility for
shepherding each step of the process. It would be impossible for him to
do that today. But it would certainly be of value for one central
agency to be held accountable for making sure that vaccine was made,
tested and distributed quickly and efficiently.
Sixth, Hilleman never considered liability protection for vaccine
makers. In 1957, pharmaceutical companies were not held liable if they
weren't negligent in the production or design of their product.
Ironically, the birth of liability without negligence for
pharmaceutical companies began with a jury verdict against a vaccine
maker--Cutter Laboratories--only a few months later. However, it is
clear that vaccine makers would not make a pandemic flu vaccine today
without substantial protection from frivolous litigation.
Thank you for giving me the opportunity to speak before this
committee.
Senator Gregg. Thank you, Dr. Offit.
Mr. Clerici.
STATEMENT OF JOHN M. CLERICI, J.D., McKENNA LONG &
ALDRIDGE, LLP
Mr. Clerici. Chairman Gregg, Senator Burr, members of the
committee: It is an honor for me to testify before you today
regarding my views on the state of biodefense and pandemic
planning in the United States. Just over a year ago I had the
opportunity to testify before this same committee on these
subjects and particularly the need for liability protection to
promote participation in these markets. I am happy to report
since that time significant progress has been made.
In the area of biodefense, the Department of Health and
Human Services has recently acquired 10 million doses of a
safe, effective, FDA-licensed anthrax vaccine. From a policy
standpoint, Deputy Secretary Azar has recently announced that
he and Secretary Leavitt have completed a revised
implementation strategy for BioShield and intend to implement
that policy. Of course, reintroduction of legislation by
Senator Burr with the chairman's co-sponsorship creating the
Biomedical Advanced Research Development Agency and the
commitment of the President to fund advance development to
almost $200 million in his budget is a very, very critical
development and deserves strong industry support.
In the area of research and development of pandemic
vaccines, recent events have also been very positive. On May 3
Secretary Leavitt announced the award of almost $1 billion in
advanced development contracts for cell culture influenza
vaccines. The committee should take heart in both the size and
the diversity of the companies awarded these contracts. From
the very large companies like GlaxoSmithKline to emerging
innovative biotechs like MedImmune, which developed the first
licensed innovation in flu vaccine in almost 50 years in its
FluMist vaccine, it is clear that HHS has made substantial
progress in attracting the best and brightest of industry over
the last year.
But perhaps most importantly, under your leadership, Mr.
Chairman, as well as the leadership of Majority Leader Frist
and Senator Burr in the Senate and Speaker Hastert, Congressman
Lewis, Congressman Issa in the House, the President has signed
into law the Public Readiness and Emergency Preparedness Act of
2005. Through this legislation, the PREP Act, the Congress has
provided a key tool to protect the Nation from infectious
disease and other threats that could cripple the United States
in a global economy.
As a result of the PREP Act, vaccine and countermeasure
developers are now better protected from the massive lawsuits
that could have eviscerated and have eviscerated the vaccine
and countermeasure manufacturing base in the United States.
With the implementation of these strategic and valuable
protections, the United States is now in a far better position
to revitalize the domestic capabilities and to produce the
tools needed to secure the health and wellbeing of its
citizens.
However, with all the outstanding progress we have made
over the last year, both in the area of biodefense and
pandemic, much more can and should be done. First, I would urge
Congress to consider providing incentives to private entities
to better prepare for a pandemic. A recent study by Mercer
Human Resources Consulting has estimated that only 7 percent of
U.S. companies have established budgets for pandemic
preparedness, with 12 percent of European companies and over 25
percent of Asian companies having such budgets. The private
sector must take the lead in preparing for a pandemic, not only
for their own businesses but also for the communities in which
they operate. They cannot rely on the government to prepare the
Nation on its own.
To that end, Congress should now consider changes in policy
similar to those asked to prepare the Nation for the Y2K
threat. This includes providing additional incentives such as
expanded liability protection to those entities that have
reasonable and prudent efforts to prepare for a pandemic.
Congress should provide at a minimum the same level of
protections provided by Congress on a bipartisan basis in the
Y2K Act of 1998, signed by President Clinton.
Like Y2K, if a pandemic worst case scenario never happens,
providing the legal certainty for businesses to upgrade their
infrastructure and adequately prepare the Nation's fragile
health care system, leading to better patient care, lower
costs, fewer medical mistakes, and better patient privacy, is a
win-win scenario.
Second, we must examine the supply chain delivery of
clinical countermeasures that would be deployed in a pandemic.
Congress should deal now with the policies to ensure
protections from both counterfeiting of these critical
countermeasures as well as theft. Congress should encourage
private sector solutions to these problems. In fact, given the
timing, the Federal Government should rely on the expertise and
experience of the private sector in developing and executing
supply chain management inventory controls.
Finally, Congress should act now to implement policies that
will bolster our fragile public health infrastructure,
especially the hospital systems. Should a pandemic strike the
Nation, the surge in the hospitals nationwide from patients who
are actually sick with influenza or other illnesses as well as
the worried well could cripple our American health care system
for years to come. Painfully hard triage decisions on who will
receive care and when they will receive it are certain to lead
to baseless lawsuits unless some protections from liability are
provided to these health care providers. The trial lawyers are
already lying in wait, planning their litigation strategies
around the occurrence of these events. The last thing the
Nation needs during a flood of illness is a flood of lawsuits,
and Congress should act now to stem the tide of these events.
Turning briefly to implementation of BioShield, there were
many challenges that we made to the Department last year when I
had the opportunity to testify to you. Unfortunately, progress
has not been made in certain areas. In particular, the
regulations implementing Project BioShield required by the
statute have yet to be promulgated. The material threat
assessment process, which has come under criticism as slowing
BioShield, still has not provided the clarity to industry that
it needs.
I close by noting that none of the proposals I have
suggested, Mr. Chairman, call for a single appropriation
outside of what has been appropriated or within the chairman's
budget--within the President's budget. I know that will appeal
to your senses as chairman of the Budget Committee. There are
real things that we can do here today without taxing the
American taxpayers any more than they are to prepare the
country for a pandemic.
I welcome your questions and thank you for your support and
the support of the President in this effort.
[The statement follows:]
Prepared Statement of John M. Clerici
Chairman Gregg, Senator Byrd, and Members of the Committee, it is
an honor for me to testify before you today regarding my views on the
state of biodefense and pandemic planning in the United States.
Just over 1 year ago, I had the honor to testify before you and
this Committee on the state of implementation of the Project BioShield
Act of 2004 and the need for liability protections to promote
participation in the biodefense market, but also to stimulate
development of influenza pandemic countermeasures. Since that time,
significant progress has been made.
In the area of biodefense, the Department of Health and Human
Services (HHS) has acquired 10 million doses of a safe and effective
FDA licensed anthrax vaccine from BioPort Corporation to better prepare
the Nation against another anthrax attack like the one suffered by this
body in October 2001. In addition, HHS has announced that the long-
awaited purchase of anthrax therapeutics for postexposure treatment of
anthrax victims will be completed very shortly.
From a policy standpoint, Deputy Secretary Alex Azar recently
announced that he and Secretary Leavitt are about to complete a revised
implementation strategy for Project BioShield to eliminate many of the
delays that have been observed in the BioShield program. Given the
substantial talents of Deputy Secretary Azar, his personal involvement
in this effort is welcome and encouraging.
Of course, reintroduction of legislation by Senator Burr, with the
Chairman's co-sponsorship, creating the Biomedical Advanced Research
and Development Agency (BARDA), and the commitment by the President in
his fiscal year 2007 budget to fund such an effort with nearly $200
million, is a very positive development. Creation of BARDA will go a
long way to address the ``valley of death'' in biodefense
countermeasure development and merits the strong support of industry
for passage this year.
In the area of research and development for pandemic vaccines,
recent events have also been very positive. On May 3, 2006, Secretary
Leavitt announced the award of almost $1 billion in advance development
contracts for cell-culture influenza vaccines. These contracts are
milestone driven, and support multiple companies pursuing diverse
technologies. Given the recent challenges HHS has faced with its
contractor, VaxGen, for an experimental anthrax vaccine being developed
under BioShield, it is clear that HHS understands the need not put its
eggs in one basket with influenza countermeasures.
We should also take heart in the size and diversity of the
companies awarded the cell-culture contracts. From successfully
engaging a large company like GlaxoSmithKline, to making awards to
innovative biotechnology companies like MedImmune--which has developed
the first licensed innovation in flu vaccine technology in over 50
years with its FluMist vaccine--it is clear that HHS has made
substantial progress over the last year. HHS is now moving forward with
development of adjuvant technology to improve the disappointing
effectiveness of the H5N1 vaccine purchased last year, as well as to
continue development of exciting new vaccine technologies such as DNA-
based vaccines and novel antivirals. At the same time, HHS has
recognized the need to accelerate the development of critical rapid
diagnostics, and has announced plans to move forward with an advance
development program for such technology in the coming weeks.
But perhaps most importantly, under your leadership, Mr. Chairman,
as well as the leadership of Majority Leader Frist and Senator Burr in
the Senate, and Speaker Hastert, Congressman Lewis, and Congressman
Issa in the House, on December 30, 2005, President George W. Bush
signed into law the ``Public Readiness and Emergency Preparedness Act''
(PREP Act).
Through this legislation, the United States Congress has provided a
key tool to protect the nation from infectious disease and other
threats that could potentially cripple the United States and the global
economy. As a result of the PREP Act, vaccine and countermeasure
developers are now better protected from the mass of lawsuits that have
basically eviscerated the U.S. vaccine and countermeasure manufacturing
base, leaving it ill prepared for threats such as avian influenza. With
the implementation of these strategic and valuable protections, the
United States is now in a far better position to revitalize its
domestic capability to produce the tools needed to secure the health
and well-being of its citizens.
In short, the PREP Act offers targeted liability protections to
those involved in the development, manufacturing and deployment of
pandemic and epidemic products and security countermeasures. The Act
creates a shield of immunity for claims arising out of, related to, or
resulting from the administration or the use of a covered
countermeasure (i.e., vaccines, countermeasures, devices and certain
other products). This immunity covers a wide range of uses, including
design, development, testing, manufacturing, distribution,
administration, use and other activities so that the protections can be
applied as broadly as possible.
This law dramatically improves the ability of the United States to
develop the tools it needs to be prepared for a naturally occurring or
terrorist-related public health emergency. However, it is absolutely
critical for HHS take the necessary steps now to implement fully the
PREP Act, as intended by Congress and the President, to prepare the
Nation for a influenza pandemic. To that end, industry eagerly awaits
the Secretary's declaration of a potential public health emergency for
an influenza pandemic, thereby triggering the protections of the PREP
Act for covered countermeasures. In addition, industry looks forward to
the release of the 4 regulations required by the Act to provide further
clarity on the scope of the Act and its protections.
However, will all the outstanding progress the United States has
made over the last year, both in the area of biodefense and pandemic
planning, more can, and must, be done.
First, I would urge Congress to consider providing incentives to
private entities to better prepare for a pandemic. A recent study by
Mercer Human Resource Consulting has estimated that only 7 percent of
U.S. companies have established budgets for pandemic preparedness,
compared with 12 percent for European companies and 25 percent for
Asian businesses. The private sector must take the lead in properly
preparing for a pandemic threat, not only for their own businesses, but
also, for the communities where they operate, and not rely upon
government to prepare the Nation on its own.
Pandemic preparedness is first and foremost an issue of public
health. But it is also an issue of ensuring American competitiveness in
the global markets. If we are less prepared than the rest of the World,
not only will our Nation's health suffer more, but so will our economy
and our path to recovery from such an event. Companies must plan now
for the possibility that 40 percent or more of their work force may not
be able to show up to work during a pandemic, including, according to a
recent study by the Johns Hopkins Bloomberg School of Public Health, up
to 67 percent of back office health care workers providing technical
support, payroll and payment processing, and other administrative
functions. Public companies, of course, have an even greater obligation
to implement internal controls to address such an event to assure that
shareholder assets are protected and their business recovers as quickly
as possible.
To that end, Congress should act now to consider changes in policy
similar to those passed to prepare the Nation for the Y2K threat. This
includes providing additional incentives, such as expanded liability
protections, to those entities that make reasonable and prudent efforts
to prepare for a pandemic. Congress should provide, at a minimum, the
same level of protections provided by Congress on a bipartisan basis in
the Y2K Act of 1998, signed by President Clinton.
Policy changes to improve telework and increase high-speed internet
access should also be part of this effort. The Administration's
pandemic plan recommends that employers keep employees three feet apart
in a pandemic event. Given that more and more companies are enabling
employees to work remotely, perhaps Congress should provide incentives
now to ensure that telework options are widely available. With
sufficient bandwidth and data security to operate with large numbers at
the same time, workers could work safely from home, thereby stemming
spread of the pandemic while reducing the economic impact.
To the greatest degree possible, we must also ensure that certain
critical functions for maintaining the operations of our health care
infrastructure can be automated or operated remotely in those
circumstances. Thus, Congress should expedite passage of legislation
promoting electronic medical records as soon as possible.
The Y2K legislation served as a national wake up call to Americas
businesses and gave them the comfort of liability protection to
identify and correct the problems with their IT infrastructure. Many
businesses then (like many hospitals, health insurers, and other
businesses critical to our nation's health care infrastructure today),
were afraid to even explore their vulnerabilities for fear of creating
a paper trail for eager trial lawyers to launch baseless lawsuits in
the future. U.S. businesses, particularly those critical to our health
care infrastructure, need a similar wakeup call--and equal liability
protection--to upgrade, test, and retest our public health
infrastructure to ensure pandemic readiness. Like with Y2K, even if a
pandemic worst case scenario never happens, providing the legal
certainty for businesses to upgrade their infrastructure and adequately
prepare will improve our Nation's fragile health care system--leading
to better patient care, lower costs, fewer medical mistakes, and better
patient privacy. It is truly a winwin scenario.
Second, we must examine the supply chain for delivery of critical
countermeasures that must be deployed during a pandemic, as well as the
supply chain for delivery of good and services, as a whole, during a
state of emergency caused by a pandemic. Most certainly, some--if not
all borders--will close during a pandemic, thereby crippling food
distribution and delivery of critical goods and component parts made
outside of the United States. For critical countermeasures, Congress
should deal now with policies to ensure protection from counterfeiting
and theft of public health supplies. Congress should encourage the
private sector to pursue implementation of workable, non-burdensome
tracking mechanisms, while ensuring the protection of data and other
information needed to allow the supply chain to function.
Because timing is essential, the Federal Government should rely on
the expertise and experience of the private sector in developing and
executing missioncritical functions like supply chain management and
inventory control. We should ensure that policies encourage
implementation of commercially tested systems--preferably those already
in place in key parts of the health care infrastructure, that can be
quickly and easily implemented. Effective supply chain management
solutions for the strategic stockpiles must be proven and reliable, and
be able to link thousands of stakeholders including pharmaceutical and
medical supply companies, health care providers, distributors,
shippers, security and customs organizations, and private and public
local, State, Federal and international health care agencies.
Effective supply chain management may also require considerable
automation, since significant numbers of personnel throughout the
supply chain may be sick or fail to show up for work. Information must
also, to the greatest degree possible, be readily accessible, but yet
secure, among multiple jurisdictions. In addition, the communication
channels must be easily interoperable with multiple existing systems
using different levels of technical standards and training of operating
personnel.
Finally, Congress must act now to implement policies that will
bolster our fragile public health infrastructure, and especially, our
hospital system. Should a pandemic strike the Nation, the surge on the
hospitals, nationwide, both from patients who are actually sick with
influenza or another illness, as well as the ``worried well,'' will
cripple our Nation's healthcare system unless we are fully prepared.
Addressing a U.S. News & World Report meeting on health and
preparedness, Secretary of Homeland Security Michael Chertoff noted
that hospitals, nursing homes, and other health facilities ``have a
legal and moral obligation to develop evacuation plans and other
emergency plans to ensure that people with special needs whose care has
been entrusted to these caregivers will, in fact, be taken care of and
will get the appropriate care in an emergency.'' We must give these
entities the tools they need to meet this legal and moral obligation.
Under the best of circumstances, emergency response workers may
receive a vaccine that provides some level of immunity prior to a
pandemic, and thus, will have some small degree of protection. However,
the hospital administrators, claims processors, and support personnel
are unlikely to receive any vaccine in time. With hospital support
staff either at home to avoid illness, or already sick, while the
hospitals are being pummeled by acute care patients, no claims will be
processed to insurers. Thus, hospitals will be under significant
financial strain, potentially unable to recover, and likely will be
taken over by the Federal Government, as has already occurred in some
of the areas impacted by Katrina.
In addition, painfully hard triage decisions on who will receive
care, and when they receive it, are certain to lead to baseless
lawsuits unless some protections from liability are provided to health
care providers. Trial lawyers are already lying in wait, planning their
litigation strategies around the occurrence of such an event. The last
thing the Nation will need during a flood of illness is a flood of
lawsuits--Congress should act now to stem the tide of such an event.
In terms of other policy changes that would benefit overall
preparedness for a pandemic, the United States has the opportunity to
build the infrastructure today to support improved access to influenza
vaccine and better immunization for annual influenza--which kills over
30,000 American each year. Expanded immunization recommendations for
influenza vaccine, particularly among the young who drive disease
transmission, should be strongly considered. Congress should also
challenge healthcare providers and the public health system to not
squander the opportunity to begin building and testing the influenza
vaccine infrastructure within the framework of current immunization
recommendations. Policymakers should act quickly to accelerate those
recommendations, including universal pediatric vaccination up to 18
years of age, in order to build as much vaccine infrastructure capacity
as possible to better prepare the Nation for a pandemic without the
expenditure of any additional Federal dollars. The bottom line is that
we should build out the vaccine infrastructure with a seasonal flu
approach, which will, in turn, not only protect the population today
for the annual flu strain, but also allow us to look for any leaks that
might sink the ship under the wave of a pandemic flu crisis.
Turning briefly to the implementation of Project BioShield, while
implementation has been improved, and according to HHS, additional
improvements are under way, more can be done. When I last testified
before you in April 2005, I noted that the regulations mandated under
Project BioShield had yet to be promulgated. Unfortunately, that is
still the case today. I also noted that the material threat assessment
(MTA) process conducted by the Department of Homeland Security under
BioShield provided neither the speed nor the clarity necessary to allow
the full promise of BioShield to ``build a market'' to materialize.
While some improvements have been announced in the MTA process,
industry has seen little evidence that this problem has been adequately
addressed. For example, when I testified last year, I noted that the
market for badly needed countermeasures for cyanide--a well known and
clearly established threat--was uncertain due to implementation issues
with BioShield. Again, unfortunately, that remains the case today.
Finally, HHS must learn from the set back in the VaxGen anthrax
contract and not allow itself, or industry, to be deterred from this
apparent failure by a single contractor. It is clear from the recent
statements by Secretary Leavitt that HHS appears to be doing just that,
and that is very encouraging. However, additional clarity and greater
speed in implementing BioShield, along with the fast passage and
implementation of BARDA, will provide industry with greater confidence
in the long-term viability of the overall effort.
I close by noting that the proposals I have suggested have one
thing in common--they do not require the appropriation of any
additional dollars other than those that have already been passed or
are proposed in the President's budget. While that may not appeal to
you, Mr. Chairman, in your role as an Appropriations Cardinal, I
suspect it may appeal to your views as Chairman of the Budget
Committee. Thus, through changes in policy alone, we can make
substantial progress in improving the Nation's preparedness for a
pandemic or bioterrorist attack, as well as enhancing and protecting
public health as a whole.
I very much appreciate the opportunity to offer testimony on this
very important public health and anti-terrorism issue. Again, I applaud
your efforts, and the efforts of President Bush and his Administration,
and look forward to continuing our work with Congress and the
Administration in this critical area.
I am happy to respond to any questions you may have.
Senator Gregg. Thank you, Mr. Clerici. I would note that
the supplemental there is an additional $2.3 billion for this
effort relative to pandemic flu. So the commitment remains
fairly strong from the administration.
Dr. Lillibridge.
STATEMENT OF SCOTT R. LILLIBRIDGE, M.D., DIRECTOR,
CENTER FOR BIODIVERSITY AND PUBLIC HEALTH
PREPAREDNESS, UNIVERSITY OF TEXAS HEALTH
SCIENCE CENTER, HOUSTON SCHOOL OF PUBLIC
HEALTH
Dr. Lillibridge. Thank you, sir. Good morning, Chairman
Gregg, Senator Burr, other guests. I am Scott Lillibridge. I am
a professor at the University of Texas School of Public Health.
I am honored to be here today to talk about the important issue
of bioterrorism preparedness and pandemic influenza
preparedness.
Let me step back a little bit from when I used to be in my
Federal role as CDC Director of Bioterrorism Preparedness and
Response. As I survey the landscape over the past 5 years, I
think we have had great strides in the area of stockpiling. I
think we have a national laboratory response network in place
and we have bioterrorism coordinators at work in almost every
State and major county in the United States. That is progress.
However, as we look forward there are things that need to
happen to move to the next level of preparedness to face the
new threats that we have, ranging from influenza to SARS to
NEPA virus to any other emerging disease that we have around
the corner, and we still have the specter of bioterrorism
dogging us.
My comments really fall into six major areas: leadership,
organization, accountability, surge capacity, stockpile, and
training. Let me just from the grassroots level as an ex-
administrator, a person who has been both in the private and
public sector, kind of give you my overview of these things.
First of all, under the issue of leadership, I look at this
as a complex of biomedical, clinical, hospital, health system
endeavor preparedness activity. The feeling at the State and
local level where I work is that this has not been under clear
medical control associated with a clear agency responsible for
this endeavor.
I will give you a case in point. If you look at the issue
of the National Disaster Medical System, which was crafted to
take care of mass care contingencies for civilian populations,
we find that that resides in one Department, yet the lifesaving
disease detection, epidemic control measures reside in another
Department. Now, as a former administrator I will tell you that
you can coordinate across and integrate, but you cannot develop
in the Federal context a budget, personnel issues, when the
responsibility for one program resides in one Department and
the program resides in another Department. It just does not
happen. I think that that is a setup for failure.
The issue of accountability has been on our desk for some
time now. I think after $28 billion, nearly 7 years, as we look
back some things are still on the to-do list. We looked at in
2003, when the GAO looked at DHS, HHS, and began to look at
what the training doctrine was and how to coincide those things
and bring those into harmony. That is still on the to-do list.
I think that is an important accountability issue.
The second, on Trust for America. A number of things in
2005 really were left undone. Those were issues of having a
common surveillance strategy, our surge capacity issues were
not intact, and about half the States really did not have
hospital preparedness fully in order. Those are still out there
and I think we need to look at some solutions for those things.
Might I propose the following. We have been through
benchmarks in 1999, performance capacities. We have been
through capabilities and now we are looking at target
capabilities, and we are on to the next measure of
accountability, somehow to make sure this Federal money ends up
in the right place, doing the right sorts of things. I think
until we get the leadership and until we get the organizational
framework, until we get a regional plan that is understandable
to the States, I think getting more compliance and
accountability at the State and local level simply will not
happen.
Let me move to surge capacity, as I want to highlight that
as probably the most undone part of emergency preparedness in
the Nation. I think we have achieved a place where we can
detect and warn people better than ever about bioterrorism and
flu. We are less able to take care of patients in surge and
large meaningful capacity, to mobilize hospital level services
or regional medical activities, than ever before. I think
fixing and resourcing and getting the NDMS properly situated
will go a long ways to addressing those issues.
The second thing is I think the medical services that we
need and the health services really reside in private and
public sector at the State and local level and HMO's,
hospitals, academic health centers. Those things need to get
mobilized to do the job at hand to a greater extent.
Let me talk briefly about stockpile and vaccine. I am
really for a stockpile that is strategic, less things in the
stockpile that can actually be moved into areas and implemented
in harm's way.
The other thing that I think we have been dancing around
with for a lot of years is the issue of whether we need
Government capacity in vaccine production, and I say yes, we
do. The Government will need all the tricks in its toolbox to
respond to an epidemic. It needs both private and public
capacity. The first thing that we did when we set about to
develop the smallpox vaccine after the 2001 threats of anthrax
was we had to contract with the private sector and build
capacity internally.
Last, let me close with a few statements on training and
exercise. I want to tell you that, after 7 years, I think this
is an area that we really need to emphasize because it brings
the issues of stockpile, vaccine implementation, surveillance,
and leadership together. That is the training and education.
Unfortunately, those who have most to offer, the academic
health centers, academic sectors, our schools of medicine,
nursing, and public health, so forth, have been the least
involved in that effort when you look at the total amount of
money spent and the amount of money that went into satisfying a
national strategy.
I think getting those groups involved and those
powerhouses, academic powerhouses, are going to do a great
chore for us in getting our national strategy implemented and
our health providers trained.
Let me close by saying just simply thank you for this
opportunity to testify. We have made great progress, but I
think those issues still require leadership, accountability,
organizational changes, strategic orientation of our stockpile,
and we have got to emphasize our training if we are going to be
prepared.
Thank you very much.
[The statement follows:]
Prepared Statement of Scott R. Lillibridge
introduction
Good morning, Chairman Gregg, Senator Byrd and distinguished
members of the Subcommittee. I am Dr. Scott Lillibridge of the
University of Texas Health Science Center at Houston, where I serve as
Director of the Center for Biosecurity and Public Health Preparedness,
and am Professor of Epidemiology at the School of Public Health. It is
an honor to appear before you today to discuss our Nation's
preparedness for bioterrorism and pandemic influenza.
As a Nation, we have made steady improvements in medical and public
health preparedness since the founding of the CDC Bioterrorism
Preparedness and Response Program in fiscal year 1999. At that time, as
the former Director of that program, I surveyed a landscape where CDC
had no bioterrorism preparedness laboratory; few early detection
disease surveillance programs were in place in our urban areas; and no
health department within the United States had a bioterrorism
coordinator to foster preparedness or planning. Today, we have a
National Laboratory Response Network and expanded biological detection
systems in urban areas throughout the United States. Drills and
exercises involving influenza and bioterrorism are common place in
almost all municipal jurisdictions throughout the United States.
However, there are several important issues to be addressed if we are
to move forward with National preparedness for epidemics, pandemic
influenza or other emerging infectious diseases.
challenges to national preparedness
I believe the most important challenges related to National
preparedness for bioterrorism and pandemic influenza fall into six
major categories.
--Leadership
--Organization
--Accountability
--Medical and Public Health Surge Capacity
--Stockpiling
--Training and Education
Leadership
Bioterrorism and pandemic influenza preparedness are areas of great
concern to the public because of their potential for catastrophic
effects on our population's health. The policies that guide these
programs are based on complex biomedical and life science decisions
that must be crafted with the expertise of health professionals,
hospital workers and public health guilds whose constituents provide
the life-saving, ``hands on'' measures that these programs seek to
provide. However, most health care providers and public health workers
feel these programs reside outside clear medical control by health
professional's, and that there is no clear Federal lead health agency
(research or operational) guiding this endeavor.
Organization
Nearly 5 years after the anthrax attacks of 2001 and after spending
$28 billion Federal, there is still confusion as to which organization
within the Federal Government is directly responsible to address the
medical and public health needs of citizens from these types of
disasters. The most glaring example of this inconsistency relates to
the National Disaster Medical System (NDMS), which was originally
founded as a loose federation of DHHS, DOD, VA and FEMA. NDMS was
designed to provide catastrophic health services to our populations
following a disaster.
Currently, the responsibility for NDMS resides within DHS while the
essential disease surveillance, control, medical personnel, and health
authorities reside in an agency of another department (most notably
DHHS). In the Federal Government this is a problem because proper
budget and staffing decisions cannot be made for activities that reside
outside of one's Agency or Department's authority. I believe the
current organizational framework is a setup for failure and leaves our
population's health at risk. Ironically, we are spending more money on
public health preparedness than the rest of the world combined, and in
my opinion we are getting less than we deserve, largely because the
leadership and the organizational framework have yet to be connected
effectively.
Accountability
After 7 years of funding for biodefense and recently pandemic
influenza, there are still no common measures available to evaluate
medical and public health readiness for States, hospitals, or health
departments. The General Accounting Office recommended in a 2003 report
that DHHS and DHS collaborate to develop specific benchmarks that
define adequate preparedness for a bioterrorist attack that can be used
by jurisdictions to guide their preparedness efforts. To date, DHHS and
DHS have not finalized performance measures to guide these preparedness
efforts. A recent report by Trust for America's Health published in
2005 revealed the following problems:
--The CDC recognized only 7 States as adequately prepared to
administer and distribute vaccines and antidotes in the event
of an emergency.
--Over one quarter of States do not have sufficient bioterrorism
laboratory response capabilities.
--Almost half of the States do not use national standards to track
disease outbreak information.
--Hospital Preparedness--Nearly one-third of States are not
sufficiently prepared, through planning or coordination with
local health agencies, to care for a surge of extra patients.
Medical and Public Health Surge Capacity
Much of the U.S. healthcare system operates at or near capacity on
a daily basis. We have witnessed over the past several years an
attrition of available hospital beds due to the downsizing of
facilities and the rising costs of health care. In the United States,
in every major city, on any day, is not uncommon for one of their
medical centers to be in a position where the beds needed to receive
emergency patients are full. Lack of health care access due to lack of
health insurance adds to this strain. Consequently, I am worried that
we have developed a system where we are better able to alert the health
community to bioterrorism and pandemic influenza but less able to
actually care for victims.
In developing our Nation's clinical and public health surge
capacity strategy, we have not gone far enough to invest the private
and non-Federal public sector into regional mass care strategies. In
addition, we still continue to funnel preparedness dollars into mass
care strategies on a ``per capita'' or formula basis. This results in a
cycle of planning and ``replanning'' and adds little or no additional
emergency bed capacity to deal with victims from such catastrophes.
Stockpiling
The strategic national stockpile has grown based on requests,
passing threats, and amid confusion as to whether it is to supply all
matters of medical equipment to victims or whether it is to be
strategic in design, and focus on critical vaccines and medications
that will be needed for victims affected by bioterrorism or other
epidemic.
Currently, the stockpile resides within DHHS but has been moved
twice in the past 3 years. The main problem with the growth of the
stockpile has been disagreement on what its contents should be and how
distribution should be implemented. In addition, States are being asked
to determine their own risks and are in the process of making their own
stockpile decisions and supplemental stockpiles. This has led to the
development of a cumbersome collection of drugs for ailments, ranging
from exotic radiation exposures to equipment caches for ventilators for
patients suffering from respiratory distress. These activities may be
undermining the strategic focus of stockpiling, drive up the costs and
ultimately hurt the cause of preparedness.
Training, Education, and Exercises
The backbone of public health preparedness is not merely the
purchase and storage of expensive equipment, but rather a continual
cycle of education, training, exercises, and evaluation. Hospitals and
healthcare delivery organizations, particularly those in the private
sector have not been fully included in such a training cycle;
therefore, they lag behind in the needed training to address community
or regional planning goals. It is also important to mention the fact
that there is also no consensus as to the needed core-level of training
and education to achieve our Nation's public health and medical
planning goals. Today, the menu of educational offerings is disparate
and non-uniform. Specifically, there is no national training curricula
to support NDMS capacities or our regional preparedness efforts. This
deficiency is compounded by the fact that those who have the most to
offer in terms of health training and education (our Nation's academic
health centers) have been the least incorporated into our preparedness
strategies.
road map forward
In summary, from a public health and medical standpoint there is no
significant difference between epidemic preparedness for SARS, Pandemic
Influenza, bioterrorism, or any other emerging infectious disease at
the National level. The differences are only in the nuances of
prevention, treatment, and public health disease control measures. The
key to saving lives in epidemics resulting from new and unexpected
threats is early detection and timely epidemic control. The areas which
I would emphasize are as follows:
Leadership
Our National bioterrorism and influenza preparedness programs
should move forward under clear medical and public health leadership by
professionals experienced in emergency clinical and public health
services. While the lessons of military medicine are extremely
important, this preparedness task primarily involves the mobilization
of the civilian public and private health care sectors.
Organization
Strengthening the public health infrastructure remains important.
However, the ability to alert populations to danger via early disease
detection or surveillance will be meaningless if we are not able to
ultimately address the medical and public health needs of victims in
harms way. Consider the resulting anger and frustration citizens and
victims will feel when health interventions do not occur on a timely
basis, as in the recent case following Hurricane Katrina. I believe the
most important priority for Federal preparedness at this time is to
refine our notions for mass patient care involving the National
Disaster Medical System (NDMS) and define how these capacities will
support regional preparedness efforts. NDMS needs a clear
organizational ownership and a better definition of its roles and
responsibilities. It also must be resourced properly.
Accountability
The implementation of these programs will need more accountability
if we are to achieve the bioterrorism and pandemic influenza
preparedness goals of the Administration. First, I would start with
better clarity concerning the leadership and organizational framework
of these programs. Second, the Federal authorities in charge of these
programs have already issued a series of benchmarks, performance
measures and target capabilities, and are moving to the next oversight
measure that attempts to ensure that grant money is spent appropriately
at the State and local level. However, I seriously doubt that another
accountability gimmick under a new label will stop the supplanting of
funds, the presence of large carry-over monies, and the fragmentation
of this National effort.
I believe the emphasis on accountability should start with a focus
on the development of National capacities that result in the
development of regional (multi-state) capabilities that are supported
by strong central government reference laboratory and clinical
capacities. In my opinion it will be easier for the State and local
health preparedness programs to achieve measurable outcomes if they
know how to link to the larger emergency response system.
Medical and Public Health Surge Capacity
We have made great strides in public health preparedness, but our
clinical surge capacities have not been as well developed. These
capacities cannot be developed without a fundamental shift in the
emphasis of our clinical preparedness programs. First, the clinical
capacities in the United States reside largely within the private
sector and public sector at the State and local level. The Federal
Government should look towards developing a collaborative preparedness
program that allows Academic Health Centers, Large HMOs, and major
hospital organizations to play key regional roles in addressing the
medical needs of victims during disasters. In addition, given the
limited clinical resources available in the Federal system when
compared to what is available in the State private and public sector, a
strategy that fully utilizes State-to-State mutual aid should be
emphasized and supported.
Stockpiling
Stockpiling of medical equipment, vaccines or therapeutics should
be strategic and based on medical and public health priorities linked
to what we know about the risks confronting our population. The
Strategic National Stockpile cannot be all things to all people without
consideration for economic trade-offs. From a preparedness standpoint,
I recommend developing the stockpile with fewer items, which have a
greater likelihood of actually being used effectively at the time of
crisis rather than expanding the program until it becomes a static
warehouse enterprise.
Vaccines deserve special mention in the context of National
preparedness for bioterrorism and pandemic influenza. The most pressing
need at this time is to commit to the development of a Government
Owned--Contract Operated (GOCO) vaccine production capacity. The
Federal Government must use all the tools in the biotechnology tool box
in both the private and the public sector to address biological threats
to human health. Our government needs to have standby vaccine
development capacity so it can quickly begin the production of life
saving vaccines at the time of crisis. In addition, it must be able to
produce vaccines that will never have a viable commercial market. Such
a facility should meet FDA requirements for production and quality
control. My preference would be to have such a facility tied closely to
the academic research community and private sector expertise.
Training and Education
The cycle of preparedness is straightforward and involves the
assessment of capacity, which is then followed by training to develop
the desired proficiency. Subsequently, we exercise and evaluate the
performance of those who were trained to ascertain a state of
readiness. To the extent that our program fits into this model, it will
be easier for DHHS to connect with the other partners in the Federal,
State and local response.
One of the first priorities is to finally establish training
standards that support field deployments and other emergency planning
notions. The academic health community is well suited to this
challenge. Once such a doctrine is clearly enunciated, educators in
schools of medicine, public health, nursing, and allied health fields
can then concentrate their training efforts to prepare our health care
providers for the task at hand. I do not believe this training capacity
currently resides (or will ever reside) within the Federal Government.
DHHS should be required to immediately establish the core training and
educational requirements for our health care providers and public
health workers that address these important preparedness efforts. We
need the powerhouses of health education in America squarely behind
this training effort. To accomplish this task we need to finalize our
Nation's training doctrine so we can better target of our vital
training resources.
In conclusion, the threats of bioterrorism and pandemic influenza
will always present challenges to our health and medical community, but
we are making steady progress in preparing our Nation. It is time to
refine and redirect this National effort if we are to advance the cause
of preparedness.
Thank you for the opportunity to be here today. I would be happy to
address any questions that you may have.
Senator Gregg. Thank you, Dr. Lillibridge.
Mr. Cilluffo.
STATEMENT OF FRANK J. CILLUFFO, ASSOCIATE VICE
PRESIDENT FOR HOMELAND SECURITY, AND
DIRECTOR, HOMELAND SECURITY POLICY
INSTITUTE, GEORGE WASHINGTON UNIVERSITY
Mr. Cilluffo. Chairman Gregg, Senator Burr. It is a
privilege to join you today for this important dialogue. I will
try to be brief, not my strong suit as I have rarely had an
unspoken thought, but a lot of territory to cover. Five years
ago, in testimony before the Senate Foreign Relations Committee
on the threat of bioterrorism and infectious diseases I
suggested that the country was at a crossroads and that the
time had come for a cold-eyed assessment and evaluation. While
much has been accomplished in the intervening period, our level
of preparedness remains very much a work in progress and it is
not yet where it needs to be.
Bioterrorism and infectious disease preparedness marks the
convergence of public health and national security. The
intersection gives rise to the pressing need for careful
coordination on a range of matters, including budgets and
resources, policies and programs, and organizations and
structures. The cultural differences between these areas are
significant. Not to be tongue in cheek, but historically the
law enforcement community focused on stringing people up, the
intelligence community on stringing people along, whereas the
health community focused on treating the strung out.
Bioterrorism and pandemic influenza preparedness represents
a challenge for the full spectrum of traditional and in this
instance nontraditional first responders. Federal leadership
requires that clear guidance be provided for those at the tip
of the spear--State and local governments, hospitals and health
care workers, businesses, families, and communities. It is at
the State and local levels where the rubber truly meets the
road, and it would be folly to try to micromanage from
Washington. Expectations of all involved must be framed in
realistic terms before something happens.
The good news--and I agree with Scott--is that important
strides have been made. The United States is a global leader in
terms of pandemic preparedness, leveraging international
partnerships, and Secretary Leavitt's outreach and engagement
of the States to foster jurisdiction-specific response efforts
is laudable. At the end of the day it all comes down to
implementation and execution. To this end, several pieces of
Federal legislation already exist on the biodefense side, and
with respect to pandemic flu the President issued his national
strategy last November, followed up by an implementation plan
earlier this month.
Collectively, these initiatives helped move the ball
forward by defining parameters for action and serving as a
catalyst. The danger is if we allow these measures to instill a
false sense of security when we should be conducting an honest
and rigorous assessment of whether we are truly prepared. On
this front, I am sorry to say that we are currently
experiencing a pandemic, a proliferation of plans. What we need
now are the operating tenets that will marry up national and
State strategies with implementation. Unless and until the
focus shifts to competent execution, the Nation's preparedness
posture will not be solidly grounded.
Despite this need, the various moving parts of the
preparedness and response enterprise are not yet fully
synchronized and harmonized. As Scott mentioned, the ongoing
debate as to where we should situate NDMS suggests that we are
still stuck to some extent in neutral and are not using our
time and mind share to best advantage. What we should really be
focusing on are the back end capacities and capabilities,
irrespective of where NDMS is situated.
From plans to planning, and I believe we need to leverage
an all-hazards approach. Where do we go from here? To shrink
the delta to get to where we need to be, the most critical
first step is to shift our focus from plans to planning and
execution. To do so will require the development and
elaboration of doctrine. Without significant doctrine, our best
laid plans will never be translated into action. Being prepared
means standing ready to exercise command and control through a
fully integrated incident command system. Therefore it is
crucial to align the National Response Plan, with the national
pandemic influenza strategy and implementation plan. Unless the
two fully mesh up operationally, we will have nothing more than
a series of plans to plan.
The difficulty of this task should not be underestimated,
as the NRP's focus tends to be on events that are
geographically and temporally concentrated, not characteristics
shared by pandemics. Underlying the NRP is an all-hazards
approach which has consistently guided our preparedness
efforts. Too often, to our detriment, we have allowed ourselves
to be focused on the crisis de jure. Yes, there are important
differences when it comes to preparedness for bad weather, bad
people, and bad bugs. But we need to leverage the fact that
many similarities exist.
Measures undertaken to prepare for a pandemic should not
and will not constitute wholly sunken costs even if a pandemic
does not materialize. Many of these steps have broader
applicability and enable us to maximize secondary and tertiary
returns on our investment beyond simply guards, guns, gates.
This is an important concept since we simply cannot afford to
protect everything, everywhere, all the time, from every
perpetrator and every modality of attack. With finite
resources, near infinite vulnerability, and a morphing threat,
we simply must prioritize our actions based on solid risk
management principles.
Public health capacity. This is clearly the touchstone and
the foundation upon which everything else rests, and we need to
have nationwide public health infrastructures that make sure we
can maintain and enhance the capacities across the board.
Bioterrorism in particular merits greater attention, I think,
in two areas. First, the strategic national stockpile. There
must be a robust capacity not only to deliver needed items to
affected communities, but also to rapidly distribute
prophylaxis on site. Depending on the situation, I think we can
also look to some unique ways to do that by leveraging UPS, the
U.S. Postal Service, FedEx, DHL, WalMart and others, all of
whom ran circles around the feds after the Katrina response,
and I believe there is no shortage of ingenuity and creativity
in our communities, but the time to do so is now, not after the
balloon goes up.
Second, although our epidemiological investigation
capabilities and supporting lab capacity are in much better
shape than they were 5 years ago, our biosurveillance
capacities still need work. An effective national bioterrorism
surveillance system should allow public health and emergency
managers to monitor the condition of human, livestock, and crop
populations simultaneously, track outbreaks, and act as an
alert in the event of an attack.
Nontraditional first responders such as agricultural
services inspectors, entomologists, veterinarians, they need to
be lashed up into this effort fully. A holistic approach also
requires consideration of the pre-hospital piece of the puzzle,
and that is EMS. Here again, surge capacity is an issue. The
vast majority of EMS systems in this country operate at close
too max capacity daily. A large-scale event, particularly a
sustained one like pandemic flu, would tax most of our EMS
systems beyond their ability to respond unless we are able to
ramp up from the ordinary to the extraordinary. We should not
be creating little black boxes that say ``break glass when
something bad happens.'' The trick should be to make sure we
can ramp up from ordinary events to extraordinary events.
Clearly, when we're looking at these issues, vaccination
policies and priorities, who gets vaccinated first, is a big
issue. If people are afraid that their families are not
protected, obviously they will have hesitancy going into harm's
way.
I also believe, and in the interest of time, that we need
to look at a Goldwater-Nichols Act, not only in the traditional
sense, in the military sense, as it aligned budgets,
priorities, and plans, but specifically with respect to
homeland security and specifically with respect to the health
and medical community. That will go a long way in driving unity
and unifying plans, programs, policies, procedures, and
exercises, where we should make the big mistakes on the
practice field, not Main Street, USA.
Let me just touch really quickly performance metrics. What
gets measured gets done, but we need to constantly ask
ourselves if we are measuring what really matters. I think
there is an awful lot more that can go on in terms of
performance measures to make sure that there is an alignment
between all the funds coming out from DHS and HHS and to make
sure that the HRSA grants, the CDC grants, and the DHS grants
are based on outcome, performance-driven objectives.
I think that the national planning guidance, the national
planning goal, HSPD-8, will do a good job in the 15 scenarios
to be able to look to how we can do that most effectively.
Regions. We have got to regionalize our approach, and I can
get into that in much greater depth during question and answer.
But I think, Senator Burr, North Carolina is the model we
should be looking to, not only in terms of mobile hospitals,
but also in terms of how they have aligned some of their grants
to be able to get an outcome-driven perspective.
I also think there is an area that most people have not
touched on and that is community shielding. This is a concept
where it is shelter in place. Think of it as shelter in place
on steroids, where most people will not shelter themselves even
if they are being told to do so, but if they have the right
vehicles and mechanisms to distribute food, prophylaxis, and
the like, they will be much more likely to do so in the event
of a crisis.
Let me just close with a couple of thoughts here. The
subcommittee should clearly be commended for its determination
to address the difficult issues before us today. Nothing short
of a highly sophisticated, multifaceted, and integrated
response will suffice. But I am confident that the creativity
and the resolve demonstrated by the American people as they
have done so often in our history will once again meet the bar,
which has been set so high.
I thank you, Mr. Chairman, for the opportunity to share my
thoughts.
[The statement follows:]
Prepared Statement of Frank J. Cilluffo
Chairman Gregg, Senator Byrd, and distinguished members of the
Homeland Security Subcommittee of the Senate Committee on
Appropriations, it is a privilege to appear before you today to testify
on this subject of national importance. Your leadership on preparedness
issues related to bioterrorism and pandemic influenza in particular is
both crucial and commendable. While our Federal, State and local
governments as well as the private sector and healthcare community,
have taken steps in the right direction, our level of preparedness
remains a work in progress and it is not yet where it needs to be. Five
years ago, the Senate Committee on Foreign Relations invited me to
testify on the threat of bioterrorism and how we, as a Nation, might
best organize and marshal our resources so as to meet that threat and
combat the spread of infectious diseases. At the time, I suggested that
the country was ``at a crossroads'' and that, ``[w]hile credit must be
given where it is due, the time has come for cold-eyed assessment and
evaluation . . . .\1\ These words are equally apt today.
---------------------------------------------------------------------------
\1\ Testimony of Frank J. Cilluffo, ``The Threat of Bioterrorism
and the Spread of Infectious Diseases,'' Before the U.S. Senate
Committee on Foreign Relations, September 5, 2001.
---------------------------------------------------------------------------
Neither bioterrorism nor pandemic influenza is a challenge for the
Federal Government alone. It is at the State and local level that the
rubber will truly meet the road, and it would be folly to try to
micromanage these matters from Washington. What Federal leaders can and
should offer, however, is clear guidance to their partners at the tip
of the spear, including hospitals and healthcare providers, so that
expectations are framed in realistic terms in advance of an event and
preparedness plans are implemented effectively. To this end, several
pieces of Federal legislation already exist on the bio-defense side,
and with respect to pandemic flu, the President issued a National
Strategy in November 2005, followed by an Implementation Plan earlier
this month. Collectively, these initiatives and many others undertaken
help move the ball forward by defining parameters for action and
serving as a spur to it. The danger is if we allow these measures to
instill a false sense of security, when we should be asking ourselves
honestly whether we are truly prepared.
The good news is that important strides have been made. For
instance, it is no exaggeration to say that we are a global leader in
terms of pandemic preparedness (while recognizing that this is not an
area where we can go it alone; to the contrary, international
partnerships are, and will remain, crucial). Certainly Secretary
Leavitt's national tour, reaching out to all U.S. States to foster
tailored, jurisdiction-specific response efforts, is laudable. At the
end of the day, though, it all comes down to implementation and
execution. Yet currently we are experiencing a ``plandemic''--a
proliferation of plans. Unless and until the focus shifts to competent
execution, the nation's preparedness posture will not be solidly
grounded.
Similarly, extant legislation concerning bio-defense is in
principle an important piece of the puzzle but, in practice, there have
been difficulties with applying the law. While challenges including the
financing of vaccines and countermeasures have been partly addressed by
legislation such as the Project BioShield Act of 2004, delays have
plagued the process and framework established by that law. By way of
illustration, only a handful of the roughly sixty ``material threat''
assessments envisioned by BioShield have actually been completed.
Further, while BioShield addressed the need for a guaranteed market for
countermeasures, the so-called ``valley of death'' problem relating to
investment in advanced development remains, and there is still a lack
of clarity regarding who is in charge of the overall effort. This sends
the wrong signal to industry and the manufacturing community, which are
crucial components of the solution, and is at odds with the public
interest.
These areas which could stand improvement highlight a broader
issue, namely the convergence of public health and national security.
This intersection gives rise to a pressing need for careful
coordination of a range of matters including budgets and resources,
policies and programs, and organizations and structures. Despite this
need, the various moving parts of the preparedness and response
enterprise are not yet as synchronized and harmonized as they ought to
be. Indeed, ongoing debates such as that over where to situate the
National Disaster Medical System (NDMS) suggest that we are still stuck
in neutral, and not using our time and mindshare to best advantage.
Focusing on where to place the NDMS is a distraction from the real
issues, which are function and capacity--where NDMS sits is at best a
subsidiary matter, so long as it gets the job done. To do so, the NDMS
must be empowered with the authorities and resources required to
effectively execute the mission, whether within the Department of
Health and Human Services (HHS) or the Department of Homeland Security
(DHS).
From Plans to Planning
To shrink the delta and get to where we need to be in terms of
preparedness, the most critical first step is to shift our locus from
plans to planning and execution. Doing so will require the development
and elaboration of doctrine--something that has never been done in a
meaningful way for bio-defense. Without significant doctrine, however,
all of our best-laid plans will remain paper tigers, never translated
into action or operationalized. As we transition squarely into the
realm of implementation, moreover, it will be crucial to thoroughly
align the National Response Plan (NRP) with, among other things, the
National Pandemic Influenza Strategy and Implementation Plan. The
potential for conflict clearly exists given the NRP's focus on events
that are both geographically and temporally concentrated--
characteristics not shared by the pandemic phenomenon. Being prepared
means standing ready to exercise command and control through a fully
integrated incident command system. Unless the NRP and the President's
Implementation Plan fully mesh with each other in actual operational
terms, we will have nothing more than a series of plans to plan.
Leveraging an All-Hazards Approach
Underlying the NRP is an all-hazards approach, which should
consistently guide our planning and preparedness efforts. Too often,
and to our detriment, we have allowed ourselves to become focused on
the ``crisis du jour.'' While recognizing that there are important
differences when it comes to preparedness for bad weather, ``bad
guys,'' and ``bad bugs,'' we should aim to leverage the fact that many
similarities exist. Measures undertaken to prepare for a pandemic, for
instance, will not constitute wholly sunk costs even if a pandemic does
not materialize. Many of these steps will have broader applicability
and we should bear that in mind while also seeking to maximize
secondary and tertiary returns on our investments, beyond simply guns,
guards, and gates.
Public Health Capacity--The Touchstone
Our medical and public health response structures are the
foundation upon which all else rests. To meet the challenges posed by
bioterrorism and pandemic influenza, these structures must be shored up
and bolstered. A uniform system, whose hallmark is enhanced public
health capacity, must be built nationwide. Every community must have
surge capacity. Admittedly, this is an ambitious goal, especially when
market forces press in the opposite direction, against the creation or
maintenance of any excess capacity. It is also important to consider
that the safety net that is the NDMS may be of limited value if there
is a need to maintain those healthcare practitioners in their local
communities. The challenge is not insurmountable though, and Homeland
Security Presidential Directive 8, which establishes the National
Preparedness Goal (NPG) and accompanying scenarios, demands nothing
less. Expanding the medical reserve corps would certainly be one step
in the right direction.
Concerning bioterrorism in particular, two areas merit heightened
attention and focus. First, with respect to the Strategic National
Stockpile (SNS), it is crucial that there be a robust capability not
only to deliver needed items to affected communities, but also to
rapidly distribute prophylaxes once they have arrived on-site.
Depending on the situation, it may be possible to convey the relevant
items directly to affected residents. When a healthcare provider is not
required in order to administer the treatment, it may be possible to
draw on existing distribution and delivery systems, such as that of the
U.S. Postal Service or other private sector entities like FedEx, DHL,
UPS, and Wal-Mart. There is no shortage of ingenuity and creativity in
communities across the country, but the generation of ideas should take
place now, in advance of an event, and feed into planning efforts that
should also be ongoing currently, at the local level.
Second, although our epidemiological investigation capabilities
(and supporting laboratory capacity) are in better shape than they were
5 years ago, our bio-surveillance capabilities still need work. An
effective national bioterrorism surveillance system would: allow public
health and emergency managers to monitor the condition of human,
livestock, and crop populations; track outbreaks; and act as an alert
in the event of an attack. (This list is merely illustrative, not
exhaustive). Non-traditional first responders, such as agricultural
services inspectors, entomologists, and veterinarians, must have a seat
at the national security table, and their expertise must be lashed up
and fed into the broader surveillance effort. Moreover, since ``bugs''
know no borders, partnerships at the international level are important,
and the United States should continue to work with the World Health
Organization (WHO) to monitor infectious disease trends and outbreaks.
Similarly, with U.S. military services deployed around the globe, our
military medical organizations may provide us with a sentinel system to
monitor a multitude of health environments and serve as an early
warning system.
A holistic perspective on preparedness for bio-terrorism and
pandemic flu also requires consideration of the pre-hospital piece of
the puzzle, that is, emergency medical services (EMS).\2\ Here again,
surge capacity is an issue. More often than not, EMS systems in this
country operate at close to capacity on a day-to-day basis. A large-
scale event, particularly a sustained one, would tax the majority of
our EMS systems beyond their ability to respond unless we commit now to
focusing, with unprecedented determination, on the ramp-up from the
ordinary to the extraordinary. In connection with such efforts, perhaps
we should examine the merits of creating an equivalent to the Emergency
Management Assistance Compact (EMAC), not only for EMS but also for the
public health system more generally. In any case, expansion of
operational capabilities should not take place in a vacuum--supporting
policy and doctrine must be developed concurrently. Continuity of EMS
operations may not be assured if EMS providers fear that their own
families may not be taken care of during extraordinary times. This
issue resonates across the board with all first responders, and
highlights the need to think through carefully the implications of
allocating and prioritizing the distribution of finite amounts of
vaccines, antidotes, and the like.
---------------------------------------------------------------------------
\2\ For a more detailed examination of EMS issues, see: Homeland
Security Policy Institute (HSPI) Issue Brief, Back to the Future: An
Agenda for Federal Leadership of Emergency Medical Services, May 2,
2005.
---------------------------------------------------------------------------
A Goldwater-Nichols Equivalent for Public Health
Honing our technical capacities alone will not be enough.
Intangibles are an equally important element of the equation.
Specifically, a culture of preparedness that is common to the health
sector and the national security sector alike, as well as beyond, is
the glue that will hold together the sprawling enterprise that is our
national preparedness and response system. Cultural change is
notoriously difficult to bring about, but it is absolutely essential
that we cultivate the mindset that will support the convergence that
has taken place on the ground, between public health and national
security. The two are now inextricably and indisputably intertwined,
and only if a genuine culture of ``jointness'' prevails will we be able
to achieve in practice the requisite reforms to our system, be they
structural, procedural, budgetary, programmatic, or policy-related.
Notably, this is a two-way street: the national security community
needs to be well versed in public health matters where the two domains
intersect, just as healthcare providers and medical experts need to be
fluent in the language and practice of national security.
Put another way, perhaps a Goldwater-Nichols equivalent is needed
for the homeland context and for the public health and medical arena in
particular. In recent testimony before the Senate Homeland Security and
Government Affairs Committee, during their after-action hearings on
Hurricane Katrina, I emphasized that the challenge of successfully
executing interagency coordination is age-old and that, although we
probably should never transpose wholesale a military model into the
civilian context, there is substantial merit in looking to the military
context given its success in institutionalizing the concept of
jointness.\3\ As you know, the 1986 Goldwater-Nichols Act unified and
streamlined the defense structure, and realigned budgets accordingly.
Over time, greater cohesion has resulted in heightened effectiveness. A
Goldwater-Nichols equivalent for the homeland should not be limited to
the Federal level, but should apply also between and among the States
themselves.
---------------------------------------------------------------------------
\3\ Testimony of Frank J. Cilluffo, ``Hurricane Katrina:
Recommendations for Reform,'' Before the Senate Homeland Security and
Government Affairs Committee, March 8, 2006.
---------------------------------------------------------------------------
Performance Metrics, End-States, and Budget Realignment
As a starting point, better and sustained coordination (at all
levels) between the Departments of Health and Human Services, and
Homeland Security, is sorely needed. By way of illustration, both HHS
(the Centers for Disease Control and Prevention, the Health Resources
and Services Administration, and the National Institutes of Health) and
DHS are directing substantial funds towards bio-terror and pandemic
preparedness and response initiatives. Yet, these monies are not being
distributed or allocated according to a streamlined and well-
coordinated process. Instead, there is a multiplicity of funding
sources and the left hand does not always know what the right hand is
doing at least in so far as grants are concerned. An outcomes-based
system, with built-in performance measures and metrics, would go a long
way towards remedying the present situation. By focusing on end-States
and capabilities, just as the outcome-oriented NPG scenarios guide us
to do, and by giving life to the adage ``what gets measured gets
done,'' both our goals and the paths to achieving them would be
clarified. Realignment of budgets, and coordination of the various
departmental and agency funding streams would follow, as a logical
corollary. This level of organizational rigor would promote an
efficient and effective use of our limited resources. It would, after
all, break the bank if we were to try to fight each ``bug of the day''
with vaccines, antidotes, and prophylactics.
A more harmonized approach at the Federal level would also serve
the nation well. As things now stand, no common threat assessment
exists in the form that is truly needed. This is a disservice to us
all. At the very least, the various departments concerned should be
looking to one another to remain informed, and relevant information
should be disseminated to the frontlines, where it may be acted upon.
A Regional Approach
It is on the frontlines that the bulk of decisions during an event
will, and should be, made. For this reason, we need to build capacity
in the field, and regionalizing our national preparedness system--the
linchpin that connects all of the elements of our preparedness and
response--is, to my mind, perhaps the best way to build the robust
capabilities that we seek to achieve on the ground. Co-locating
Regional Health Administrators with regional components of DHS and
field components of DOD as well as other stakeholders, including
representation from the private sector, would foster synergies and
forge strong partnerships before disease or disaster strikes. In turn,
these bonds would (among other things) facilitate the management and
deployment of the SNS and the NDMS. Encouragingly, it appears that DHS
is, in fact, expecting to establish a planning mechanism through joint
field offices that would serve as a framework for coordinating response
for all levels of government (including any military joint task forces
that may be established), non-governmental organizations, and the
private sector.
A muscular regionalized system serves the best interests of the
States and their governors by providing the latter with an all-purpose
Federal point of contact that is well-versed in the particularities of
a relevant area. Conversely, from a national perspective,
regionalization offers a means of unifying planning, training, and
exercising efforts--a prerequisite for identifying and developing
needed Federal, State, and local capabilities and capacities. Looking
forward, HHS and its regional coordinators should be consistently
plugged into DHS' exercise schedule, and future exercises should
specifically focus on bioterrorism and pandemic influenza scenarios. At
a time when the convergence of public health and national security is
plain, it is at our peril that we allow any disconnect to persist. It
should also go without saying that after-action ``hotwashes'' should be
conducted to identify lessons learned during exercises, and that such
lessons should then be fed back into the system in order to prevent the
same mistakes from being made once again as well as to benefit those
who were not party to the actual exercise.
Taking a regional approach to hospital preparedness would also be
valuable, though most hospitals are not now regionally oriented in
their planning, activities, and outlook. Exceptions to the rule include
the National Capital Region (NCR) and North Carolina, where real
regional medical capabilities exist in the form of mobile hospital
capacity. The lessons learned from these experiences should serve as a
model for the country as a whole, demonstrating the benefits of joint
planning and exercising between and among hospitals at the regional
level.
Although limited regional surge capacity remains a significant
problem, it is undeniably mitigated by surge protection--a strategic
solution known as ``community shielding.'' A recent study of the NCR
revealed that many area residents would abandon their protected home
and work environments during a contagious epidemic, despite government
instructions to shelter-in-place. However, if there is an effective
mechanism for community shielding through distribution of food, water,
medication, and information to those who need it, those potential
evacuees would in fact follow instructions, thereby enhancing community
resilience by remaining safely in their homes and localities until the
regional threat has abated.\4\
---------------------------------------------------------------------------
\4\ M.T. Williams, G.B. Saathoff, T.M. Guterbock, A. MacIntosh, and
R. Bebel, Community Shielding in the National Capital Region: A Survey
of Citizen Response to Potential Critical Incidents (Final Report,
Volume 16), September 2005, http://cipp.gmu.edu/archive/Vol-16-
%20Community%20Shielding%20in%20the%20NCR.pdf.
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Key Partners
In our zeal to ``get it right'' when it comes to preparedness for
bioterrorism and pandemic influenza, we should take care not to stretch
too thin those assets that have proven their worth time and again in
many and varied contexts. Our military forces proved to be able and
responsive in the aftermath of Katrina and, as the saying goes, ``no
good deed goes unpunished.'' This month alone, the National Guard has
been assigned a significant role in furthering border security as well
as implementation of the National Strategy for Pandemic Influenza.
While the National Guard brings valuable skill sets to domestic needs,
the Guard has a dual character and mission, and its war-fighting aspect
should be respected and retained. Moving forward, it will be important
to bear this bigger picture in mind, and exercise caution and balance
accordingly, when drawing and planning to draw on such treasured and
proven national resources.
The nature of the challenges before us dictate that everyone be
involved in preparing for them. It is no exaggeration to suggest that
this is not only a community-wide responsibility, but also an
individual one. Families, schools, places of worship, and business--all
have an important role to play in containment of infectious disease,
and all must be well integrated into the operationalization of relevant
strategies and plans. Personal preparedness will take on a much greater
importance in pandemic influenza than even natural disaster.
Ultimately, it will be up to individuals to take personal
responsibility for their own support, namely enough food and water
should they be required to stay at home. Framing expectations in
advance will be necessary to avoid hysteria. Just last week, Buncombe
County, North Carolina, provided an excellent example of a local
physician and the local media partnering to manage expectations and to
let people know that they will not be able to rely on State and local
governments, in particular health departments. There, a small newspaper
in Asheville published an editorial piece written by the doctor in
question, stating that the Federal and State governments have outlined
what they will need to do to respond to pandemic flu, but in the final
analysis, ``[o]ur job as citizens is to be informed and prepared.'' \5\
---------------------------------------------------------------------------
\5\ Marilyn A. Roderick, ``As threat of the avian flu looms, one
question remains: Will we be ready?'' Asheville Citizen-Times (May 16,
2006). See also David Heyman, Model Operational Guidelines for Disease
Exposure Control (Center for Strategic & International Studies, 2005),
at http://www.csis.org/media/csis/pubs/051102_dec_guidelines.pdf
[offering detailed guidance on non-pharmacological measures that public
officials and individuals could take for protective purposes].
---------------------------------------------------------------------------
Preparing for bioterrorism and pandemic influenza also requires
robust partnerships between the private and public sectors. At the same
time, each sector must do its utmost to put its own house in order.
While a majority of U.S. businesses have expressed their concern about
pandemic flu, only a much smaller fraction have actually done robust
continuity of operations planning, which is crucial to maintaining
critical infrastructure operations and services in a crisis.\6\ During
and after Hurricane Katrina, however, the private sector was a
tremendous source of both materiel and expertise, including logistical
support. Industry, and particularly ``Big Pharma,'' offers a wealth of
knowledge that must be thoroughly tapped for present purposes. With
proper incentives, the private sector's research and development
capacity, and production capability, could be fully marshaled and
harnessed for national ends, with striking results. Incentives offered
by Project BioShield have been insufficient to garner the full support
of investors, whose support of the fledgling countermeasure industry is
critical. To the extent that prevailing legislation and frameworks come
up short in their incentive structure, it is crucial to complement
those measures with needed new ones, and to re-structure and redesign
existing mechanisms in a more rational, market-oriented manner that
effectively addresses potential deterrents such as liability issues,
and profit and cost factors. The ``DARPA-like'' proposed Biomedical
Advanced Research and Development Authority, contained in bill S. 2564,
could serve to assist companies in crossing crucial thresholds and
allow relatively advanced products to actually reach the marketplace.
In order to make progress on this front, it is imperative that industry
perceive the Federal Government to be a reliable partner in this
endeavor.
---------------------------------------------------------------------------
\6\ David Brown, ``Business Plan for a Pandemic? Most Firms Haven't
Prepared for Possibility of a Global Outbreak,'' Washington Post (May
2, 2006), p. D1.
---------------------------------------------------------------------------
Conclusion
As we strive to create a performance-based, outcomes-driven
preparedness system that is responsive to all hazards but also to the
unique needs under study at this hearing, it must be remembered that
policy without resources is rhetoric. Though redressing a number of the
gaps and shortfalls in our preparedness posture identified herein will
turn less on matters of financing than on other issues, in some cases
funding will be essential to realizing requisite unique capabilities.
The SNS is but one area which would benefit strongly from an injection
of new monies, specifically to ``plus up'' its contents. Not only are
the caches for that ``very bad day'' insufficiently supplied, but our
current stock of basic but fundamental items such as facemasks and
ventilators is simply not adequate, and the same is true of certain
drugs and countermeasures. Dual-use elements that are also instrumental
to the provision of ``ordinary'' or day-to-day medical care should be
viewed as sound investments that will yield significant rates of
return--an important fact and a feature that is consistent with a
system founded on accountability and on end-State capabilities and
capacities. Throughout, it bears remembering that what gets measured
gets done, though we need to make sure that we are always measuring
what matters.
The Subcommittee should be commended for its determination to study
the difficult issues before us today. Tempting as it might be to alter
focus, and direct time, money, and energy exclusively to other less
complex challenges that might be easier to master, it would be a
mistake to do so. The scale of the challenges under examination today
is undoubtedly large, and even an entity the size of the Federal
Government cannot tackle these issues alone. Northing short of a highly
sophisticated, multifaceted, and integrated response will suffice--but
I am confident that the creativity and resolve demonstrated by the
American people so often in our history will once again serve as a
solid foundation upon which to build as we endeavor to meet that bar
which has been set so high. Thank you and I would be pleased to try to
answer any questions you may have.
The George Washington University Homeland Security Policy Institute
(HSPI) is a unique, nonpartisan ``think and do tank'' that builds
bridges between theory and practice to advance homeland security,
through a multi and interdisciplinary approach. By convening
policymakers and practitioners at all levels of government and the
private sector, HSPI creates innovative strategies and solutions to
current and future threats to the Nation.
Senator Gregg. Thank you very much.
Those were excellent presentations and I appreciate that
you were under time restraints.
What I am going to do now I think is recess this, and then
Senator Burr is going to come back and chair as soon as he
votes. I will have to do this and then I want to come back. I
have got a whole series of thoughts and questions I want to
engage with you on.
So this is a typical Senate situation. They always call
votes in the middle of hearings that are interesting and
important and we have to rush off and vote and then come back.
So if you do have the time, we hope you will be able to stay
and indulge us for this vote, and then I suspect Senator Burr
will be back about quarter after, and I will try to get back
here by 11:30. Thank you.
We will recess until Senator Burr returns.
Senator Burr [presiding]: I call the hearing back to order.
I will take whatever time that we need to until Senator Gregg
comes back. Let me thank all of you again for your willingness
to be here.
I asked the question last week of my committee staff,
should we take the fact that we have not heard anything
publicly about pandemic flu as publicly as we did for literally
the entire first part of this year as a sign that the concern
is over with. I was very quickly pointed to an article of May
18, with an additional seven cases of human infections in
Indonesia, six members of an extended family all dead, at this
point no sign of human to human transmission. This is the
largest cluster of cases closely related in time and place
reported to date in any country and is being carefully
investigated.
I put that into the record for the purposes of suggesting
to other Members of the United States Senate that might not
have seen it prominently placed on the evening news or the
front page of the morning paper that pandemic threats are not
something that are here today and gone tomorrow. Until the
scientific community and health community looks at it and says,
this particular strain is no longer a threat, there has to be a
very concerted effort on the part of the United States, on the
part of the world, to prepare for.
I draw that distinction because I think somebody's
testimony talked about plans and preparation and we are at the
point that we need to be in the preparation stage.
Mr. Offit, let me turn to you for just a second. Are
children more susceptible to becoming ill from pandemic flu?
And do you know of any special considerations that would impact
our planning as it relates specifically to treating children
for pandemic?
Dr. Offit. It depends on the virus that is causing the
pandemic. So for example, the 1918 pandemic, which has
certainly gotten a lot of play following John Barry's book,
that virus caused a very interesting problem, which is that
when it infected people it actually turned their immune systems
against them. So it would infect these specific kind of cells
that actually present foreign proteins, including viruses, to
the immune system and it would cause those cells to make large
quantities of a protein, proteins called cytokines. It would
induce this phenomenon of cytokine storm. So just paradoxically
what happened in 1918 is it was the healthiest people among us,
the sort of 20 to 40 year olds, who died disproportionately of
that disease because they had the healthiest immune systems,
therefore they made the largest quantities of this protein.
So I think, so there is an example where children were
especially at risk for death. Now, traditionally children are
actually the reservoir of flu. So if you look at the way flu
spreads across our country or other countries, it usually goes
from children, and that is why the 1957 pandemic that I talked
about started in schools. It started in church congresses and
schools. It started in September because that is when schools
got, all those kids got together.
So they are often the reservoir of infection, and so that
is why I think they are a perfect group to target because you
target the reservoir.
I think in terms of treatment, if you are talking about
agents like Tamiflu, ossiltamavir, it again depends on the
virus. I think, for example, if you took Tamiflu back to 1918 I
honestly do not think it would have made much difference, the
reason being that what Tamiflu does is it prevents the virus
from reproducing itself, from replicating. I am not sure it
would have done anything for a cytokine storm.
Senator Burr. If in fact we were exposed to a strain like
1919, that healthy community that you talked about that was
most susceptible died how quickly?
Dr. Offit. Very quickly, within 36, 48 hours. I will say
this. Children still die of that kind of phenomenon. I tell
you, we had a child last year in our hospital who came in, a
healthy 11-year-old, no risk factors, boy, who within 36 hours
died of flu, and came into our hospital laughing and making
jokes. So it can be overwhelming. That child was treated with
ossiltamavir very early in its course; it made no difference.
I got the feeling from watching this child go from face
mask oxygen to a ventilator to an oscillator to a heart-lung
machine to his death that if we had taken our entire intensive
care unit and transported it back in time to 1918 we would have
had the same effect, which is no effect.
One thing I just wanted to pick up on, the business about
whether our interest in pandemic flu is maybe fading a little
bit, is that I think the one, it is not a mistake necessarily,
but I personally, as do many scientists, do not believe that
this particular bird flu, this H5N1 strain, is going to be the
next pandemic strain. It just, it is not transmitted easily
from person to person, and H5 viruses never have been and they
have been around for 100 years. This virus has been around for
about 9 years.
So I do not think this is going to be the pandemic strain.
But the good of all this preparedness is that there will be a
pandemic. There are three pandemics a century. There is no
reason to believe this century is spared, will be spared. So I
think getting things in place to get ready for that is all a
good thing.
Senator Burr. Well, we all hope that in fact you are right
and those that have suggested that this strain may not be the
one--and I think that supports the reason that anything that we
do and everything that we do should be an all-hazards approach,
that we should use this opportunity to make sure, not knowing
what that threat is or what that strain is, but knowing that it
is down the road, or that new biologic threat or chemical
threat, or in fact something else that Mother Nature throws at
us, that we have got an infrastructure that is able to adapt to
whatever in fact we throw at it.
Let me just ask you one more question about children,
because I think you reference to the fact that historically
they are the source of spreading this infection. Who decides
when to close the schools? If H5N1 becomes the pandemic or if
next year there is a pandemic with a different strain, is it
the local community, is it the State, or is it the Federal
Government that triggers that?
Dr. Offit. I am not sure I am the one to answer that
question. But I will say just this one thing. There was a study
done in Japan a number of years ago, just to sort of amplify
your point, where they immunized all children below 5 years of
age. What they found was that not only did they decrease
hospitalizations and the less common deaths in that group, they
decreased hospitalizations and deaths in the elderly.
So when you attack the reservoir, in this case children,
you really have an impact on all people who come in contact
with children. When the elderly die of this disease, they die
often because they are coming in contact with children. But in
terms of the logistics of who closes schools, I am not the one
to answer that question.
Senator Burr. So if the health professionals that are
tasked with the job of determining who is vaccinated first,
given that you have a delay in full production--where would you
tell them children fit?
Dr. Offit. You are asking a pediatrician, but I would
obviously put children first on the list.
Senator Burr. Yes, but I truly believe that you look at it
from an overall perspective.
Dr. Offit. That is true. I think that is true. I think if
you are trying to--the disease invariably starts in children.
They are commonly hospitalized. They do not die as commonly,
obviously, as the elderly, but they are typically the source.
That is true of many viral infections. This is sort of the
opposite of whooping cough, where adults and adolescents give
the disease to children. This is the opposite of that.
Senator Burr. Dr. Lillibridge, you talked about an all-
hazards approach, but you also mentioned something really
important that I would like you to expand on. Clearly, your
prior life gives you some degree of expertise on this. How
important is the structure of our logistics plan, from a
standpoint of how we respond to this or any threat?
Dr. Lillibridge. Senator, I think our logistics plan in
support of regional planning or our preparedness strategy is
extremely important. Let me emphasize that health care
organizations are typically weak or absent in their capacity to
have logistics mobilization, staff, support, field units, or
even expanded units in warehouses, hotels, and so forth, if you
need supernumerary beds in a major epidemic.
We have looked at that. We think that there are probably
two ways to begin to look at that. One is partner with the
private sector; second, deal with larger organizations that
have internal logistics. For example, when expanding health and
medical services during Hurricane Katrina, Houston had
somewhere between 100,000 to 200,000 people come into our town.
We put them in the Dome, in the Coliseum activity, and we
supported them with two field hospitals.
Now, that worked because each of those field hospitals were
supported in turn by health care organizations that had
multiple hospitals and logistics capacities in place to nurse,
resource, and to service those things. I think it is those
kinds of arrangements as you begin looking through HMOs,
academic health centers, large hospital organizations, that are
going to be extremely important.
The second part is that there may be a security element
with the logistics support or a rugged field element of
airplane transportation, security, and so forth. We have always
thought and made a decision to do this in the private sector,
but always thought at CDC early in the inception of this
program that maybe the Department of Defense or an organization
like that needed to be intimately involved when you needed to
have a no-fail transport in a security context, as in a
bioterrorism attack or an event like Katrina, where law and
order were clearly at a premium.
Senator Burr. Let me ask the same question in a slightly
different way. Does the Federal Government understand the
importance logistics will play in our ability to meet the
threat?
Dr. Lillibridge. Sir, I think they understand the issue of
logistics when it comes to standard emergency management. I
think we have yet to learn the lessons of resourcing and
providing logistics support to health and medical operations in
the field.
Senator Burr. I look at the national stockpile and question
whether today we could move the stockpile to the place that we
need it in a timely fashion to meet the current threat. It is a
concern that many on the Hill have engaged, not just this
administration but past administrations, and will future
administrations, the importance to plan and to prepare.
I know that we have looked at all sorts of options on
logistics. But I am not sure in the Federal plan that a
determination has been made on this piece and whether we are
going to hand it over to DOD, or use UPS, or use the Postal
Service. To me, that seems like one of the most important
things for us to get an answer to, because if it were to happen
tomorrow we would not be prepared to execute that piece. I see
that as a vital piece and a necessary component.
Agree, disagree?
Dr. Lillibridge. Senator, I agree. Let me frame it how I
see this. One is we cannot get to those kinds of decisions and
cooperative engagement unless we can fix the sort of medical
high ground and make the decision what really needs to be in
the stockpile and then organizationally frame it in an
organization to make those decisions.
Senator Burr. I agree totally.
Mr. Cilluffo. Senator Burr, if I could just expand on that,
because I think you are hitting the crux of much of the
operational side of the issues here. There is an old Marine
adage: Amateurs talk strategy, professionals talk logistics.
Quite honestly, it does come down to logistics, logistics,
logistics, supply chain, and to make sure that you have a
requirements-driven process put in place.
One of the take-aways after Katrina was you do not
necessarily want to say, we need 5,000 MREs. What you
ultimately want to have is a system or a requirements system in
place that says, we need to be able to feed 5,000 people for 3
days, and then you find the best way to be able to meet those
needs. The military has done that well and they have got the
scar tissue and learned the lessons the hard way to be able to
do that most appropriately.
I do not think that that has been translated as robustly as
we need it in the domestic context. So I do think you are
hitting a key issue.
Mr. Clerici. Senator, if I may just add one comment. There
is a commonality between your question to Dr. Offit and your
question to Dr. Lillibridge. At least in the area of influenza
and the area of influenza vaccines, we run a war game every
year. We vaccinate people every year for annual influenza, and
we need to do that in order to keep public health.
That is a good thing because at least there is a system in
place to get, depending on what kind of year it is, 70 million
doses of vaccine out to the American people. With respect to
pediatrics, if we can increase that penetration up to 18 years
old, then that war game, if you will, is going to be run in the
event of a pandemic, all the better. And when you are dealing
about annual vaccine, if we look at the supply chain
distribution, there is only a handful of providers of licensed
vaccine right now. We can look at the way that they are doing
things and try to emulate that, and also drive that demand up
because there is no down side to vaccinating more people
annually. That is only a good thing. If we get that demand up
to where the market can sustain it, the manufacturing base
could sustain it, the logistic transport can sustain it, and we
have enough vaccine for kids all the way up to the elderly,
then when the pandemic hits all we just do is turn the system
around, secure it, make sure that there is security surrounding
it, make sure that there is authenticity measures surrounding
it, and we are off and running. That is a great opportunity
that we have with the annual flu vaccine program, to build from
that and learn from it.
Senator Burr. Let me throw one last question out to anybody
that would like to address it. Can we address a pandemic threat
or any other potential threat that we will face in the future
without redefining the face of public health in America?
Be brave, Dr. Lillibridge.
Dr. Lillibridge. Okay, Senator, I will take that one. One
of the things I think is refining and developing the public
health infrastructure is extremely important. We have put an
effort that largely concentrated on that with our first $28
billion that we put in the last 6 or 7 years. I think there are
some things we need to redirect, to think about how we get more
value out of that money in the future in terms of building
preparedness, that looks the same or has an all-hazards
approach, whether you are dealing with radiation exposure or a
pandemic influenza.
The kinds of things that we talked about with leadership
organization are important. The surge capacity, building the
clinical element, needs to get under the tent this time, and we
need to galvanize our academic health centers. I think we need
a better training doctrine, and get those solidified.
But I think you are going to have to make a shift from
infrastructure and public health building into national
preparedness around health and security if you are going to get
more value out of these dollars in the future.
Senator Burr. Can you have a Federal response plan or a
State response plan without public health having a uniform
consistancy of services that are provided everywhere in the
country?
Mr. Clerici. I think you are absolutely right. I think you
need the bedrock of surveillance, laboratory detection, and a
basic public health infrastructure. But you also must have an
honest purchase on the preparedness measures that you need in
place to build those capacities. I honestly believe North
Carolina is the model. I have worked there extensively lately
and they have what I think is a good tradeoff between
infrastructure, training, capacity-building from the public
health base out there to the critical capacities they need to
respond regionally. And they have built a system that can
respond nationally.
The North Carolina system responded admirably to bring
hospitals into Mississippi and provide health care on a State
emergency management compact. That is a real model.
Senator Burr. Dr. Offit.
Dr. Offit. Just to extend what Dr. Lillibridge said, it has
started to happen. It is interesting, the CDC has started to
sing a different tune regarding influenza, epidemic influenza
preparedness. So a couple of years ago they increased their
recommended group to include the healthy 6 to 23 month old, and
in the last year the healthy 6 month to 5 year old. That has
really for the most part exceeded the capacity of physicians'
offices to give vaccine. You are talking about giving a yearly
seasonal vaccine to basically your entire group, meaning less
than 5 year olds.
My wife is in private practice pediatrics and so what they
have done, what she has started doing, I think what many people
are starting to do, is they are trying to sort of expand out so
that, for example, you have school-based programs. So that has
changed things a little bit. So now, because we are expanding
the vaccine recommendation in children with hopefully a goal
toward a universal recommendation, I think you have to get it
at some level out of the physician's office into the community,
and that all works toward pandemic preparedness.
Mr. Cilluffo. Senator Burr, could you briefly expand on
that? I do think that it is the cultural things as well. I
think Scott touched it at the end. It is the health and
security. Right now the two are treated to some extent as if
they are mutually exclusive, short some of the implementation
plans and the national strategy that came out recently. These
take time, though. This is not something that instantaneously
can merge and converge.
But I do think that unless you look at it through the full,
not a particular lens, but a prism that reflects both those
perspectives, it will not occur. You cannot expect the public
health infrastructure to suddenly have all the transportation
assets that perhaps Department of Transportation or DOD or some
of the other entities do. They are going to have to leverage
and ramp up from the extraordinary to the extraordinary, to
certain capacities and capabilities that reside through the
country.
The way I look at it, it is Federal, Federal-State-local,
Federal-State-local-community, Federal-State-local-community
down to the individual. In this case, unlike most natural
disasters, the role of the individual is very significant in
terms of what they can do to better protect themselves, their
families, and their communities from the spread of infectious
disease.
Senator Burr. Once again, I thank the witnesses. I thank
the chairman for allowing me to participate in this hearing,
and I turn everything back over to the chairman.
Senator Gregg [presiding]. Well, it is great to have you
here. You are leading the efforts here in the Senate and we
very much appreciate your leadership on this, Senator.
Senator Kohl.
Senator Kohl. Thank you very much, Senator Gregg.
As ranking member on the Aging Committee, I chaired a
hearing last week on emergency preparedness for seniors. As you
know, seniors are particularly vulnerable during emergencies, a
point made clear during Hurricane Katrina, where 71 percent of
the people killed were older than 60, and our hearing witnesses
told us that seniors need more information to prepare for
emergencies, first responders need better training to help
seniors, and communities need better plans to locate seniors
who live alone during and after an emergency like the pandemic
flu.
Do programs exist to train first responders and medical
professionals to meet seniors' needs in the event of a pandemic
flu outbreak? Should the Federal Government provide funding for
programs such as these at the State and at the local level? Do
we have programs that particularly focus on seniors? Should the
Federal Government take an active role in developing these
programs? Do first responders have the resources to do this?
What is the role of the Federal Government in this whole
area as it relates particularly to seniors?
Dr. Lillibridge. Sir, I will take a stab at that, Senator
Kohl. There are two things. One is that there are programs in
HRSA, the Health Resources and Services Administration, to deal
with preparedness for seniors and for that segment of the
population. It is not one of our biggest programs and certainly
could be expanded. One of the two things that I think would be
a good direction to go was educating the health providers that
interface with seniors. That was a powerful way to provide
training. The second was community outreach to assist them at
the time of crisis with the things they needed to do to help
make themselves safe. Those have been the thrust of these
programs in the past.
My impression is they could certainly be expanded and
better integrated if we had a larger and more robust
educational program targeting our health providers.
Mr. Clerici. Senator, I am aware that at least HHS has
categorized and looked at special populations, and I would
imagine that both seniors living alone as well as seniors
living in retirement homes or collective areas are a targeted
population, much like students living in a dorm room. Any time
you have a collective living situation, the planning needs to
go into that.
So I would hope that HHS has taken into account the types
of resources as well as the type of surge capacity that might
be required or taps on other resources that seniors might be
living with that might get redirected in the event of a
pandemic perhaps to other areas. So I believe that is part of
their plan, but I do not have any great clarity into how much
that has risen through the ranks.
Mr. Cilluffo. Senator Kohl, just to expand on that and to
lead back to a previous point. I do think there are special
needs populations in general, not just seniors but many others,
that we need to be able to target, different languages,
different cultures, different perspectives, so we can actually
induce changes of behavior or initiate action; that we have got
to continually improve our capacities.
But I do not think that we should look at it in isolation
of our other plans, programs, and procedures. Quite honestly,
it is going to be the EMS, it is going to be those that deal
with these sorts of situations every day, that need to build in
and build the capacity to surge, not to create a separate
program per se targeted, obviously, to meet the special needs,
but ultimately it is going to be the people who act and
respond. You need to make sure that they are up to date.
There are some programs within EMS, the EMS community, to
deal specifically with seniors and geriatric programs that I
think could potentially deserve a boost. I do not know what the
budget numbers are here and I know policy without resources is
rhetoric, so I am coming out of this a little blind.
But I just want to underscore that it needs to be part of a
holistic approach. I do not think we should bifurcate some of
those responses, but rather enhance capacities of those who
respond to crises on a daily basis.
Senator Kohl. Well, generally speaking I would not disagree
with you, but we need to, I think, learn from Katrina, where
again 71 percent of the people who were killed were over 60. So
it does, I think, dramatically illustrate that the seniors
population is not like all the other segments of our
population, for all the reasons we can understand.
Mr. Cilluffo. You are right, Senator.
Senator Kohl. Another question. Many seniors live alone and
rely on others for transportation, supplies, and information.
One Florida county that we heard from last week set up a
voluntary registry so that first responders will know where to
find seniors who need help during or after an emergency. Do you
think that the Federal Government should participate in helping
to set up such registries as part of national preparation for
an outbreak of pandemic flu?
Dr. Offit.
Dr. Offit. I do not think I am the one who is best to
answer that question. I would turn it over to Dr. Lillibridge.
Dr. Lillibridge. Senator, I will tell you that at the State
and local level we are increasingly in the planning of
preparedness activities related to flu and so forth, beginning
to look at which community outreach things can we do to better
identify and get services to the elderly population at the time
of crisis. So whether it is a registry or a better planning
function or a block captain, how that unfolds at the State and
local level is unclear to me which is best. But I know that
greater emphasis in that area is needed.
We had the tremendous evacuation activity post-Katrina,
just before Hurricane Rita, when we thought when a level 5
hurricane was going to hit Houston. It veered to the east and
missed us. But we lost a lot of people on freeways, on
transportation, and we learned that our vulnerable population
is going to have a lot of trouble mobilizing, getting cared
for, without preplanning.
So those are now part of our routine planning elements in
Texas as well as in other States.
Mr. Clerici. Senator, without commenting on whether it is a
State, local, Federal, or family responsibility, I do think
that, as Mr. Cilluffo said, we need to kind of think one step
deeper. It is not just EMS care if we are in a pandemic. It is
whether they can get food, whether they have the ability to
transport, to get to a grocery store, and whether the shelves
of the grocery store are full when they get there.
So the whole supply chain issue as it impacts not only the
distribution of critical countermeasures, not only vaccines and
therapeutics and respirators, but also food, water, clothing,
medicine, typical medicine, not just the medicine to treat a
flu. What happens when 40 percent of the workforce is sitting
home in the event of a pandemic and how those populations are
impacted?
So those are the issues, I think, that are probably the
next level of penetration in the Nation's thinking and
preparedness. To Frank's point, those do not only necessarily
hit just pandemic. That is any natural disaster.
Dr. Offit. One point just regarding vaccines. As compared
to say 50 years ago, the demographics of our population as the
baby boomers get older has gotten older. Traditionally, what
the CDC has done, and I think in retrospect maybe not best, is
to target the greater than 65 year olds: Here is a person who
is most likely to die; let us make sure this person gets the
vaccine.
But the fact of the matter is that people at greater than
65 years old do not make a great immune response to the
vaccine, they do not. Their immune response in general is not
what it was when they were 18 or up to 30. So therefore it
becomes all the more important, I think, to try and immunize
those people to whom they are most likely to be exposed. In
this case, young children, that is certainly true.
I think the Japanese experience, where they immunized
children less than 5 and had a dramatic decrease in the number
of deaths in the elderly, I think was instructive. Just a
point. The greater than 65 year old is not great at responding
to flue vaccines.
Similarly, the other difference between 1957 and now is
that we have a lot more people who are immune compromised. We
use steroids a lot more than we did, we do solid organ
transplants and bone marrow transplants. So we have a much
greater population that are immune compromised. Now, that came
up I think with the smallpox vaccine, fears associated with
contact spread of smallpox.
Mr. Cilluffo. Senator Kohl, and this may suggest asking a
little more from some of the NGOs as well as the Medical
Reserve Corps and some of these other entities that can perhaps
plan a more active role in that special needs community,
because, unlike in the Katrina event, in most cases we are
going to want to shelter in place. The last thing you want to
do is evacuate and put everyone in a common place where it
could spread that much more quickly.
So I think that perhaps this could be a mission area for
the Medical Reserve Corps to play a more active role, not to
mention many seniors are very active in the Medical Reserve
Corps, playing an active role in protecting one another, and
that should not be lost in this, is that there is so much
talent that we want to be able to tap into that may not be in
the traditional way tapped into, and to be able to do that.
Senator Kohl. I thank you for your comments, gentlemen. It
has been very helpful.
Thank you, Senator Gregg.
Senator Gregg. Thank you. Thank you, Senator.
Senator Allard.
Senator Allard. Thank you, Mr. Chairman.
My question I guess I would direct to Dr. Lillibridge or
Dr. Offit. How do you assess risk with a disease that,
according to the last time I looked at the CDC web page, we
have only had one documented case of human to human
transmission? We have lost thousands of birds, but just a few
people have actually contracted influenza relatively speaking
to the bird population, and it does not occur yet in this
country.
So how do we assess risk to the population in America?
Dr. Lillibridge. Do you want to go first?
Dr. Offit. I think that traditionally with typical epidemic
influenza those most likely to die are those greater than 65,
those who have chronic medical conditions such as problems,
chronic conditions of the lung, heart, kidneys, etcetera. That
has traditionally always been true.
Senator Allard. Based on an individual basis. That is an
individual basis, is it not? I am looking at a public health
assessment for the total population.
Dr. Offit. Sir, I think it depends on what the nature of
the strain is. For example, you knew in 1957--you were not here
to hear my initial comments, but in 1957 you knew it was going
to be a pandemic because very quickly one-tenth of Hong Kong's
entire population was infected. Tens of thousands of people
were in line trying to get medical care. Then you know, so now
it has started. It is clearly spreading easily from person to
person. That has to happen in order for a pandemic to exist.
And not only do you know that it is now a likely pandemic
because it is easily spread and it is a novel virus, but you
know who it is infecting and who is getting hospitalized and
who is dying, which is to say what kind of strain it is.
I think the 1918 experience was an unusual experience. That
particular virus, the surface protein of that virus, which is
called the hemagglutinin, which is where the ``H'' comes from,
was a very unusual hemagglutinin. It had the unique capacity,
frankly, to stimulate the body's immune system to react against
itself, which put that 20 to 40 year old or even younger person
at great risk.
But you would know that early on, I think, in a pandemic.
Senator Allard. But early on in those outbreaks that you
described, we recognized early on that there was a pandemic
there because, like you said, the cases showed up and all of a
sudden you noticed. But even though we have had people get ill
now, we have no indication of a pandemic other than the fact
that we know that influenza virus has a tendency to mutate.
Dr. Offit. No, I think personally we have every indication
that the H5 virus is not going to be a pandemic strain. But
that does not mean there will not be a pandemic. There will be
a pandemic.
Senator Allard. Okay, so what is all the excitement about?
Dr. Offit. Well, the excitement is about the fact that
there are three pandemics every century, that this century will
not be spared, that you have what has clearly been a crumbling
in the infrastructure to make and produce vaccines.
Senator Allard. But should not our efforts be, instead of
thinking so much about this influenza attack and getting
everybody all hyped and everything, should we not be looking
generally at our public health procedures, on how we handle
public health infectious diseases generally, and whether--maybe
it is influenza this time, but it could be some other virus or
bacterial infection in some other aspect.
Would we not be better off to look at just the total public
health approach and how you handle infectious disease with a
very virulent organism, no matter what that is?
Dr. Offit. Well, keep in mind--good point. I think one has
to keep in mind that if you take the inter-pandemic periods and
just add up the number of deaths from epidemics, they dwarf the
amount of deaths that come during a pandemic. So I think we are
not very good, frankly, at taking care of the infectious
disease influenza, which kills 35,000 to 40,000 people in the
United States every year. Can we avoid a lot of that death by
expanding influenza immunization programs? Absolutely. But
somehow we seem to grandfather in that 35,000 to 40,000 deaths,
that is okay, because it is the pandemic that we focus on.
But as I said earlier, I think that the degree to which we
take the epidemic threat seriously, that we make vaccine and
educate the public that they need to get this vaccine, is the
degree to which we will have an infrastructure in place for
when the pandemic does come, and it will come. There will be a
pandemic. When the pandemic comes, it may be a pandemic like
1957 or 1968, when maybe 100,000 people in the United States
die or 150,000 die. But remember, 35,000 to 40,000 die every
year.
Senator Allard. My time is expiring, Mr. Chairman.
Senator Gregg. Do you have other questions?
Senator Allard. Yes, I could follow more.
Yes, go ahead.
Dr. Lillibridge. Senator, I think we are singing from the
same page. I agree with you that I think the issue at hand on
pandemic flue preparedness is that epidemic preparedness as a
Nation is an important issue. I do not see any difference from
bioterrorism preparedness, pandemic flu preparedness, SARS
pandemic, or preparedness for other emerging diseases.
I think we are right to focus on the detection and the
disease control measures of the system and the leadership,
organization, and methods by which we control disease, is much
more important to me than each individual widget or new vaccine
or new lab test.
Mr. Clerici. Senator.
Senator Allard. Yes?
Mr. Clerici. Senator, if I could follow up on that point. I
think your message is exactly correct. It is not just pandemic
or Avian flu or whatever it might be. It is the global
preparedness of public health. But if you look at what we have
done with Avian influenza in preparing, we passed liability
protection not just for Avian flu, for any pandemic, epidemic
or bioterrorist event. There are currently eight licensed
vaccine makers of any type of vaccine in the United States
versus the 30, 20 to 30, there were several years ago. That
problem hopefully is along the way to being fixed.
We make our annual flu vaccine, as Dr. Offit pointed out,
which kills 30,000 people every year, from chicken eggs. Last
month we ordered a contract for a billion dollars to multiple
companies, some very large companies, to go to cell-based
manufacturing.
So all of that progress--and the bird flu has been
analogized already by the New York Times to Y2K, as all about
nothing. I actually take a good heart in that because if Y2K
caused us to upgrade our IT infrastructure from 1980 to 2000,
led to a lot of increase in American efficiency, and nothing
happened, we are all the better. If we spend $7 billion here,
raise the awareness of public health preparedness, and a
pandemic does not happen to the degree that we think it will,
but yet we are better prepared as a society and our public
health infrastructure are upgraded, I think that is a win.
Senator Allard. But I think risk assessment is really
critical, because the treatment, there is a risk assessment,
too. So you need to know what are the risks. If you do not have
any risk on treatment, then that is mute. But I have yet to see
treatment that does not have at least a little bit of risk in
it, I think. Then you have got the other risk of the disease or
the virus, in this case the Avian influenza variety H5N2, and
that virus shows from what I can tell very little tendency
right now to spread from human to human.
But if you are going to go on to a vaccination program and
you have two people die out of every 100 vaccines you give,
that is not a very good--see, this is where risk assessment is
so very important, and I do not see many people talking about
how we get about doing risk. They are talking about, well, what
if. But we need to look at the degree of risk that we have
there, and that is what I am trying to get at.
Mr. Cilluffo, you had something.
Mr. Cilluffo. Senator Allard, not to speak lightly about a
very serious matter, but I think it is fair to say since the
end of the cold war to some extent threat forecasting has made
astrology look respectable. So I do not know what the future
will bring.
I do think that there are some back end capacities and
capabilities that will maximize and we need to be very diligent
to make sure our finite resources, our infinite vulnerability,
is based on a risk management, solid risk management
principles, where you can maximize those secondary and tertiary
returns on investment that will be beneficial, not only for the
bad bug, but also for the bad weather and also for bad people,
because the other component that I think is not being discussed
here is bioterrorism.
With respect to bioterrorism, that can be a transforming
sort of an event to the United States. Unfortunately, our
adversaries have made clear that if they could build the
capacity and disseminate and deliver the capacity to do so they
would. So I think that we want to look to what are the
resources that could be spread across the board that will get
that return on investment and maximize our efficiency.
I do think you are underscoring another important point. I
am not sure we have really built the business case yet for
homeland security, not just pandemic influenza, not just--
because I agree with you, if we were to chase every bad bug we
will break not only our bank but every bank. But we need to be
able to look to what is that business case across the board,
and I think it is incumbent upon us to look at it from an all-
hazards perspective, where we will yield return irrespective of
whether or not we see H5N1 or it morphs into H5N7 or whatever
it may be.
So I think you raise some very good points, but I do not
think the panel here--at least agrees with your points, but
recognize that, as President--or as Benjamin Franklin, not
President--they did not promote him yet--once said, failing to
prepare is preparing to fail. So I think we need to be able to
act.
Senator Allard. Thank you, Mr. Chairman.
Senator Gregg. Thank you. You have covered a lot of really
important topics and given us some interesting ideas.
Let me ask, to try to filter this off a little bit, if you
can each give a grade to where we are as a government in our
preparations for an all-hazards event and our preparations
specifically for influenza? Do you have a grade you would give
the Government at this point?
Dr. Offit. I think I can best answer the question, the
grade I would give the Government for influenza preparedness is
a B-plus, because I think the two things that have happened
that have been really important is a recognition that the
vaccine manufacturing infrastructure has crumpled and that it
needs to be bolstered; two, that we need to get away from what
is a fairly archaic, egg-based technology to mammalian cell
technologies. I think that is really important. So a solid B-
plus.
Senator Gregg. That is good news. I presume you think we
have got the vaccine issue moving in the right direction, in
part because we have addressed the liability issue?
Dr. Offit. So you want to talk about liability. I think
that liability--I guess I do not completely agree with the way
that we have done liability. Do you want me to talk about that?
Senator Gregg. Absolutely. That is why we are here. We want
to know your thoughts.
Dr. Offit. I guess the program that I think works is the
vaccine injury compensation program, because at the heart of
that program is essentially a Federal excise tax on every dose
of vaccine, that then creates a poll of money and then if there
is a problem following a vaccine, as occasionally happens, as
Senator Allard said, then the way that works in the vaccine
injury compensation program is essentially a group of
epidemiologists and clinicians and people who understand the
data look at the data and say, okay, this is a problem.
Rotashield, the rotavirus vaccine that was on the market for a
year, caused intestinal blockage. Influenza vaccine can--was,
at least for the swine flu, it was a rare cause of Guyon-Baret
syndrome. And influenza vaccine currently has egg proteins, so
it can be a rare cause of severe and occasionally allergic
responses.
Those things are real. What you worry about is--and this is
why it should never go to a jury, frankly--is the fact of all
these unreal things that vaccines are blamed for. That was what
was great about vaccine court. Essentially, the vaccine injury
compensation program is vaccine court.
So I think when you ask a populace, for example, to get a
vaccine en masse, if it does cause unanticipated side effects,
I think that it is fair to compensate those people who were
hurt by that, I do. I think my concern about the current plan
is that I think it sets too high of a bar for that. In other
words, it does not--other than, I think my understanding is it
is--I am not a lawyer, but I will pretend I am because they
pretend that they are doctors, so why not.
The notion of the bad actor provision, the knowingly
negligent provision, I think is a bit much. Believe me, I am a
big fan of tort reform. I just think it is not fair, if it
really was found to cause harm, harm that was not due to
negligence, harm that had nothing to do with design or
production, but was found to cause a negative effect--I think
it would be fair to compensate those who are being asked to get
that vaccine, but not like the $253 million you get if you have
an arrhythmia with Vioxx in east Texas, but something like what
the vaccine injury compensation program does, which is in the
sort of $250,000.
So I think that is fair.
Senator Gregg. I will move on in a second. I just want to
respond with the public policy reasons why we went the way we
did, which was because I presume and I think most of the people
who worked on the decision presume that if we had a national
epidemic and we had the vaccine, we had a huge national vaccine
program that was brought on line very quickly, that any sort of
personal harm that was caused by that vaccine would
inevitably--the responsibility would inevitably be picked up by
the Government for compensation. But to try to guess where that
was going with a pre-vaccine program, like we did with polio
where we had a predictable number or with smallpox where you
have a predictable number, was probably counterproductive to
bringing vaccines on line.
Everybody is presuming that there is going to be a
compensation event if, or at least I am, if there is a national
vaccination event which involves a vaccine that is rushed to
market or rushed to the population, simply because we had the
event and we had to respond and this was the only thing we had
available in our toolbox.
So I think it is almost a moot point. It is going to be
done. It is just to do it on an estimate that has no relevance
at all because nobody knows what the harm is going to be, as
compared with smallpox where we know the harm because you know
the percentage. That was why that decision was made on purpose,
to get the vaccine industry functioning.
I think the fact that you think we may have accomplished
that, that is good news. That is very good news if it is true.
Mr. Clerici, what would be your rating of where we are in
this exercise? A grade, you have got to start with a grade
here. We have got to keep this simple. We are simple people.
Mr. Clerici. In terms of flu preparedness, I would
definitely put it at a B. The good news is a year ago when I
sat at this table I would have put it at a D-minus to an F. So
I think the last year, both with liability protections as well
as the resources and focus that the Federal Government has put
into pandemic planning, has been very positive.
I would say, with respect to annual flu vaccine, we are
probably back at a C and, ironically, if we can get that annual
flu program up to an A, then that is going to make the stronger
grade for pandemics. So there is more that can be done in
messaging in terms of----
Senator Gregg. Well, what is it that gives us a B? Give me
a thumbnail. What are we doing right right now and what do we
still need to do, in a thumbnail?
Mr. Clerici. I think with respect to vaccination we are
well along our way there. I think the fact that the liability
leash has been removed from the neck of the industry to
actually participate, and that is all they want to do is
participate, has proven out with the billion dollars in
contracts that were given to big companies that were never in
the United States market before, which is very, very positive.
With respect to other countermeasures, including
antivirals, more needs to be done there, which is probably why
the grade is lower than even Dr. Offit gives, in terms of
finding next generation antivirals and promoting those
resources. As I understand it, stockpiling--I am a lawyer, not
a doctor, to take Dr. Offit's point. Tamiflu may not be the
solution, so perhaps we need to be putting that same type of
focus in finding those next areas.
Areas such as rapid diagnostics have not gotten the
attention they deserve. We need to know what we are dealing
with when these people show up at a hospital so we can treat
them appropriately and also triage the very few resources that
we have. As I understand it, HHS is moving toward that. They
have not yet. There is a lot of dysfunction between the CDC and
HHS in what sort of processes are in place for rapid
diagnostics.
Then with respect to annual vaccination, which is also
dragging down the grade with pandemic, until we get our
messaging right on who should take the vaccine--unfortunately,
things were moving along very nicely towards a very strong
message from the CDC up until October 2004, when we had to take
back that message and say: Okay, no one get a flu vaccine,
because one of the suppliers collapsed.
That set us back in terms of messaging. For the good of the
Nation, it was a very mild flu season that winter, which means
that people did not take a vaccine and did not get sick to the
extent that they had in the past, which was good for the
country. It was bad for the message to get people back on track
saying you really do need to take a vaccine, and to make sure
that we have the capacity to get that universal recommendation
where it needs to be as very, very important.
With respect to bioterrorism, I think we are still in the C
range. BioShield is still moving too slow in order to generate
the type of market interest that we need it to. As I said in my
testimony, Secretary Leavitt and Deputy Secretary Azar have
committed to fixing that, and they are both incredibly able and
capable of doing that.
We had a setback in the last few weeks, with the first
BioShield contract well on its way to failure. I think that we
cannot take that as a bad message. We need to learn from it,
build from it, as they have with flu, quite frankly, in
implementing the flu program, and not take the failure of
VaxGen to drag down all of BioShield.
There are good signs: the fact that they purchased another
vaccine, the fact that the anthrax therapeutic awards should be
made relatively shortly, according to HHS, and that new RFPs
are going to be hitting the streets for things we have not
dealt with--plague, botulism, antitoxin. But until that
happens, I think we need to keep the grade probably at a C to
encourage them to do better.
Senator Gregg. Dr. Lillibridge.
Dr. Lillibridge. Senator Gregg, I think I would give us a
respectable C. I think preparedness in my book is an ongoing
process. You do not just achieve an end result and then rest on
your laurels. The things that I think need to happen to move
that up over the next year or two--and I am pleased with the
progress of Julie Gerberding at CDC and Secretary Leavitt at
HHS and the other partners, DHS. But here is what I think I
would like to see happen or what I would like to focus on.
First of all, disease detection and epidemic control are
not an all-hazards enterprise. Those are complex biomedic
disease control activities. They require an infrastructure, a
leadership, and an organization that is a little different. I
believe they can work in an all-hazards framework, but I think
they are different than all-hazards preparedness because of the
science, the laboratory, the medical components, the health,
and so forth that have to be tickled, nurtured, and developed.
That is one.
The second thing, as I alluded to earlier in testimony, is
the issue of leadership and agency organization. I would fix,
and I would have high on my emphasis list to fix, the National
Disaster Medical System such that we really do have the surge
capacity and can get our academic health centers, HMOs, and
large hospital organizations better involved in supporting our
national strategies.
Senator Gregg. Thank you.
Mr. Cilluffo. Senator Gregg, let me preface my answer with
the fact that I believe anything short of an A-plus is
unacceptable. So with that as sort of a backdrop, I think at
the Federal level we are actually doing quite well in terms of
the strategies, in terms of the policies, in terms of the
plans, and in terms of the laws. I think we would be that much
further if we were to actually legislate and pick up your bill
in particular, Senator Gregg, Senate Bill 2792, which I think
would enhance our capacities that much more, and I think
Senator Burr's bill, S. 2564, in terms of bridging the so-
called valley of death from basic research to advanced research
to actual, would take us to an A-plus at the plans level.
But this really is not about what we are doing here in
Washington. It is ultimately about execution and implementation
at the State and local level, where the rubber hits the road.
There I do not know what to grade because you cannot give a one
size fits all. Some communities, some States, are much better
prepared than others. Some are further along than others.
Others are doing great work. So I do not know how you would
give a fair grade because you would have to actually grade a
whole lot of people.
Then you have got to look at the private sector, the
continuity of operations planning. I think there is an awful
lot of work we need to do here, and maybe even in terms of
prioritizing vaccines. You are going to have the owners and
operators of our critical infrastructure who are going to be
absolutely instrumental and critical to maintaining our
continuity of government and our day to day issues.
So here you have a majority of the companies recognizing it
as a problem, yet only one-third have actually put in robust
continuity of operations plans. So there is a delta between the
verbiage and the action.
I would say the same with the American public. We should
stop asking how afraid we should be, but what is it we can
honestly do to better protect ourselves and our families? Here
I am not sure we have hit saturation, and that is a risk
communication sort of issue which is a tough balance.
So I think it is the interface between Federal, State, and
local where there is an awful lot of work that needs to be done
and it is ultimately operationalizing. As General Eisenhower
said when he was then General: ``In preparation for battle I
have often found plans to be useless, but planning to be
indispensable.'' I am not suggesting plans are useless. They
are very important. But we need to get the operational tenets
that can bring the plans and the strategies together with
operations.
Senator Gregg. The subcommittee has received a statement
from Steven D. Brice, Battelle's Health and Life Sciences
Division which will be intered into the record.
[The statement follows:]
Prepared Statement of Steven D. Rice, Senior Manager, Battelle's Health
and Life Sciences Division
Thank you, Mr. Chairman and Members of the Subcommittee on Homeland
Security, for receiving my written testimony for the record. It is my
privilege to provide my opinion concerning our Nation's preparedness
and capabilities to respond to the kinds of cataclysmic events that
could face our Nation in the near future. Both natural and
technological disasters as well as terrorist-perpetrated incidents loom
on the horizon, and it is vital that we honestly and forthrightly
assess our capabilities, our strengths, and our weaknesses. Until
January of this year, I was a Federal employee working at the Centers
for Disease Control and Prevention (CDC). I directed the Strategic
National Stockpile from its inception in fiscal year 1999 until January
2006. Post-September 11, I was asked by CDC Director Dr. Julie
Gerberding to direct emergency response at that agency, as well.
I retired from CDC in January and joined Battelle's Health and Life
Sciences Division where I am responsible for development of strategic
plans for emerging infectious diseases and for overall emergency
response. Battelle is a non-profit 501C(3) organization with a long
history of dealing with a wide range of critical issues in the health
and life sciences. Battelle has substantial contract research
experience with various parts of the Department of Health and Human
Services (DHHS), including NIH and CDC. Battelle also has a long
history of support for bio-defense programs for a variety of Federal
agencies. In addition, Battelle has significant long-term relationships
with various pharmaceutical companies, primarily in clinical trial
support and vaccine development for defense and civilian applications.
My comments today are intended to emphasize and underscore the need
for proper prior planning, proper resourcing, proper coordination, and
the absolute necessity of establishing new partnerships. I will discuss
three examples to support my observations. Specifically, I will discuss
aspects of the Strategic National Stockpile; Federal, State, and local
preparedness; and the urgent need to develop and exercise public-
private partnerships.
The Strategic National Stockpile
My comments on this subject reflect only my knowledge of events
prior to January of this year. I have not worked either at CDC or in
the Strategic National Stockpile (SNS) since January 3, 2006. No doubt,
many changes have since occurred at DHHS, at CDC, and within the
Stockpile.
I believe the SNS is overburdened by missions for which it is not
adequately resourced and by missions that were not well thought out or
not properly planned. These shortcomings have made it very difficult
for CDC and its staff to operate at top effectiveness. Two examples
will, I hope, be helpful.
My first example comes from DHHS's implementation of project
BioShield, a multi-billion dollar program to acquire medical
countermeasures should our Nation be attacked by biological, chemical,
or radiological weapons of mass destruction. As originally conceived,
CDC's Strategic National Stockpile was not designed to handle drugs,
vaccines, or anti-toxins in its formulary that were not licensed by the
Food and Drug Adminstration (FDA). SNS's warehouses met the highest
industry standards for storage of pharmaceuticals and medical equipment
after the product had been licensed. However, the standards for
products prior to licensure are much more costly to adhere to. The cost
is due in good part to the labor-intensive documentation required by
the FDA (for its licensure application package). The general purpose
for adhering to these extra measures when handling products prior to
licensure is to ensure that nothing in the ``handling'' of the
unlicensed product could be responsible either for jeopardizing
licensure or for the product's failure to be licensed by the FDA.
Even though the SNS was not designed to handle unlicensed product,
the fact is that it has had to handle such product. Specifically,
licensure of a medical countermeasure may take several years and may
not be accomplished until well after the millions of doses of the
countermeasure are produced and stored in the SNS warehouses. It became
necessary for the SNS to stand up (that is, plan, staff, and implement)
a quality assurance/quality control unit similar to those of private
pharmaceutical manufacturers. The SNS was now considered by the FDA as
part of the manufacturing chain of events. The transport and storage
records of the SNS would be reviewed by the FDA as it assessed whether
or not to license a given product. The manufacturer and the SNS had to
assure, through meticulous record keeping, that the product was
transported and stored under good manufacturing practice (GMP)
standards. The record keeping is much more burdensome if one is dealing
with an unlicensed product, even though the transport and storage
standards for cleanliness, temperature control, etc. are virtually the
same for medical products stored at local pharmacy, hospital, or prime
vendor warehouses. Let us use as an illustration the moving of an
unlicensed product requiring refrigeration. A refrigerated truck that
transports a licensed product need only ensure the product was kept at,
let us say, 20 degrees Celsius, whereas a truck transporting an
unlicensed product must be certified as meeting GMP standards. This
requires many dozens of temperature probes to ensure that every place
in the trailer's storage unit is within exact tolerances--and
documentation of that fact becomes part of the licensure package
submitted to FDA for review.
This added burden was taken on willingly by CDC in order to have
the medical countermeasure on hand (even before final licensure) should
our Nation be attacked. Additional staff was required with expertise
that essentially came only from the private sector. The CDC/SNS budget
had never accounted for such hiring and program implementation. CDC was
told to take the costs and the program burden for standing up such a
unit out of current operating expenses. Equally debilitating, CDC was
told to have the unit operational in 3 months' time. While this was
indeed accomplished, it placed hardships on both CDC staff and budget
and is one example of an inadequately resourced requirement.
Another example occurred in 2003, when the DHHS Office of the
Assistant Secretary for Public Health Preparedness began exploring the
possibility of adding primary care, public health contingency beds to
the SNS inventory. Referred to at the time as Federal Medical
Contingency Stations (FMCS) or Federal Medical Stations, the beds,
bedding, and limited ancillary support items were to be shipped by CDC
to the site of an emergency and were to be used by local personnel. The
purpose of these beds was to provide the Nation with an additional
resource when responding both to the aftermath of natural disasters
(hurricane-displaced persons, for example) and/or to terrorism events.
Unfortunately, as of December 2005, the concept of operation and the
exact use of these beds remained unclear both to CDC staff and to state
and local emergency responders and public health personnel. Thousands
of beds were purchased, but very few were used in the 2004 hurricane
season in Florida and in response to hurricanes Katrina and Rita. Their
effectiveness was blunted because state and local responders were not
acquainted with the equipment; and further because state and local
responders did not know they had to provide power, water, food, linen
changes, laundry, and most importantly, health care providers to
support the patients who might occupy those beds. Thus, instead of
viewing the beds as an added asset, many state and local response
coordinators considered the beds to be a burden.
CDC was not given the human resources to train and exercise the use
of these beds with state and local responders; CDC was not given the
human resources to adequately store and kit the beds for use in the
field. Yet, despite not being properly resourced to accomplish this
mission, CDC once again did its best to purchase, kit (i.e., put
everything together so that when the ``beds' were transported they
arrived with as much supporting gear as CDC could afford given the
inadequate budget), transport, and set up this medical/public health
asset. Unfortunately, however, because the original concept of
operation was never well articulated to either CDC or to state and
local responders, this potential asset was rendered a liability during
disaster response.
Nor was the FMCS concept ever fully coordinated with the Department
of Homeland Security's National Disaster Medical System staff or their
primary response element, the Disaster Medical Response Teams (who
would, it could be assumed, be called upon to staff and use these
assets). The lack of a clear mission, the lack of a clear concept of
operation, and the lack of coordination with Department of Homeland
Security further reduced the potential effectiveness of these medical
and public health assets.
Before I leave this portion of my testimony, allow me to underscore
that I cannot think of a better place than CDC to carry out the
missions and assignments in the examples I provided. My point is that
CDC must be adequately resourced when they are given future missions
and that each assignment needs to be accompanied by a clear, well-
articulated concept of the operation that is vetted and fully
coordinated at all appropriate levels of government, at DHHS and the
Department of Homeland Security, down through the local level.
State and Local Preparedness
CDC has a long and fine record working with state and local public
health departments as the agency assists in the fight against illness
and injury. In recent years, CDC has also taken on the fight against
terrorism by working closely with state and local governments, not just
public health departments, but police, fire, public safety, and
emergency response elements as well. Within the past 2 years, CDC and
DHHS began planning for the worst-case scenarios of a clandestine
release of a biological agent that would require extremely close
coordination between agencies at all levels. When I left Federal
Service in January, I had not yet seen the kind of coordination,
planning, and exercising required in one critical arena: namely
coordination between the Department of Homeland Security's National
Disaster Medical System component and the various DHHS response
elements, including CDC's emergency responders and the SNS. The
interface between the National Disaster Medical System units, CDC, and
other DHHS assets such as the DHHS Secretary's Emergency Response Team
is necessary if we as a Nation are to be able to respond to
catastrophic natural disasters such as Katrina or to terrorists' use of
weapons of mass destruction. My hope is that in recent months, DHHS and
the Department of Homeland Security have undertaken such planning and
coordination and, ultimately, have exercised together. This should
ensure that, when they respond to the scene, they know how to
communicate with one another; their formularies are similar, if not
identical; their routes of supply and re-supply are well known to one
another; and their trust in mutual capabilities is well established.
Anything less is not good enough.
Partnerships
In the aftermath of Katrina, much has been said about partnerships.
I endorse and support each of the various recommendations that would
facilitate all entities working more closely together. I would like to
concentrate today on one aspect and in one area of partnership that I
believe is essential to the success of a national emergency response:
namely, partnership in the discipline of logistics, both medical
logistics and general emergency response logistics. I define medical
logistics' as getting medical supplies and equipment where needed, when
needed.
In Katrina, we failed as a Nation to move critical medical supplies
for the chronically ill, for the aged, and for children into New
Orleans rapidly enough. We should have known better. After every
catastrophic natural disaster, the people who suffer most quickly in
the hours post event are our elderly, our infants, and our chronically
ill who have lost their medications. Diabetics, heart and hypertension
patients, those with breathing difficulties, infants, and the elderly
can become critically ill very quickly. In New Orleans many of these
individuals survived the hurricane itself only to succumb to
dehydration or to a chronic disease that went unmanaged for days.
Keeping this example in mind, it would seem to me that the Federal
Government must do a better job in partnering with pharmaceutical
manufacturers, prime vendors, local suppliers, and transportation
businesses prior to such disasters. Specifically, I believe agreements
can be established between private corporations and public entities
such as state and local public health agencies and DHHS and the
Department of Homeland Security at the Federal level to ensure an
immediate supply of medications for the chronically ill, the aged, and
the children in an affected area.
Yet partnerships with medical suppliers and transportation
corporations are only one side of the partnership triangle I wish you
to consider. Both DHHS and the Department of Homeland Security require
help in establishing a well-functioning logistics response. There are
many private firms (both profit and non-profit) that have discussed the
need for a more robust logistics (and medical logistics) capability in
our Nation. Speaking as a representative of a private non-profit
organization, I urge Congress to call upon the private sector to create
meaningful long-term partnerships with our Federal, State, and local
counterparts to design, implement, and exercise a civilian logistics
capability. This can complement Department of Defense efforts when it
comes to responding to a natural disaster or a terrorism event, both
within the United States and internationally when necessary.
Thank you again for allowing me to submit my statement for the
record for your consideration.
CONCLUSION OF HEARING
Senator Gregg. Thank you.
Well, you folks have been very generous with your time and
this has been an excellent presentation, given us a lot to work
with, and ideas and thoughts, which we hopefully can convert to
action. We appreciate your courtesy in coming here to inform
us. It is very important. As you say, Dr. Lillibridge, this is
not a static event; it is a moving event. So as you have
thoughts and ideas as we go forward, please do not hesitate to
communicate them to our staffs or ourselves because we need
that information.
Thank you very much. I appreciate your time. The hearing is
recessed.
[Whereupon, at 12:10 p.m., Tuesday, May 23, the hearing was
concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]
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