[Senate Hearing 111-910]
[From the U.S. Government Printing Office]
S. Hrg. 111-910
H1N1 FLU--2009
=======================================================================
HEARINGS
before the
COMMITTEE ON
HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
of the
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
----------
APRIL 29, 2009
COORDINATING THE FEDERAL RESPONSE
SEPTEMBER 21, 2009
PROTECTING OUR COMMUNITY
FIELD HEARING IN HARTFORD, CT
OCTOBER 21, 2009
MONITORING THE NATION'S RESPONSE
NOVEMBER 17, 2009
GETTING THE VACCINE TO WHERE IT IS MOST NEEDED
----------
Available via the World Wide Web: http://www.fdsys.gov
Printed for the use of the
Committee on Homeland Security and Governmental Affairs
S. Hrg. 111-910
H1N1 FLU--2009
=======================================================================
HEARINGS
before the
COMMITTEE ON
HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
of the
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
APRIL 29, 2009
COORDINATING THE FEDERAL RESPONSE
SEPTEMBER 21, 2009
PROTECTING OUR COMMUNITY
FIELD HEARING IN HARTFORD, CT
OCTOBER 21, 2009
MONITORING THE NATION'S RESPONSE
NOVEMBER 17, 2009
GETTING THE VACCINE TO WHERE IT IS MOST NEEDED
__________
Available via the World Wide Web: http://www.fdsys.gov
Printed for the use of the
Committee on Homeland Security and Governmental Affairs
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
U.S. GOVERNMENT PRINTING OFFICE
51-020 PDF WASHINGTON : 2011
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20402-0001
COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
MEMBERSHIP AS OF APRIL 29, 2009
JOSEPH I. LIEBERMAN, Connecticut, Chairman
CARL LEVIN, Michigan SUSAN M. COLLINS, Maine
DANIEL K. AKAKA, Hawaii TOM COBURN, Oklahoma
THOMAS R. CARPER, Delaware JOHN McCAIN, Arizona
MARK L. PRYOR, Arkansas GEORGE V. VOINOVICH, Ohio
MARY L. LANDRIEU, Louisiana JOHN ENSIGN, Nevada
CLAIRE McCASKILL, Missouri LINDSEY GRAHAM, South Carolina
JON TESTER, Montana
ROLAND W. BURRIS, Illinois
MICHAEL F. BENNET, Colorado
COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
MEMBERSHIP AS OF OCTOBER 21, 2009
JOSEPH I. LIEBERMAN, Connecticut, Chairman
CARL LEVIN, Michigan SUSAN M. COLLINS, Maine
DANIEL K. AKAKA, Hawaii TOM COBURN, Oklahoma
THOMAS R. CARPER, Delaware JOHN McCAIN, Arizona
MARK L. PRYOR, Arkansas GEORGE V. VOINOVICH, Ohio
MARY L. LANDRIEU, Louisiana JOHN ENSIGN, Nevada
CLAIRE McCASKILL, Missouri LINDSEY GRAHAM, South Carolina
JON TESTER, Montana ROBERT F. BENNETT, Utah
ROLAND W. BURRIS, Illinois
PAUL G. KIRK, JR., Massachusetts
Michael L. Alexander, Staff Director
Aaron M. Firoved, Professional Staff Member
Carly A. Steier, Research Assistant
Brandon L. Milhorn, Minority Staff Director and Chief Counsel
Asha A. Mathew, Minority Senior Counsel
Priscilla H. Hanley, Minority Professional Staff Member
Trina Driessnack Tyrer, Chief Clerk
Patricia R. Hogan, Publications Clerk and GPO Detailee
Laura W. Kilbride, Hearing Clerk
C O N T E N T S
------
Opening statements:
Page
Senator Lieberman................................... 1, 37, 79, 119
Senator Collins......................................... 3, 82, 122
Senator McCain.............................................. 14, 99
Senator Tester............................................. 18, 107
Senator Voinovich............................................ 20
Senator Pryor................................................ 22
Senator Burris............................................. 24, 105
Senator Graham............................................... 25
Senator Kirk.............................................. 102, 138
Senator McCaskill......................................... 110, 141
Senator Carper............................................... 113
Prepared statements:
Senator Lieberman............................... 153, 195, 248, 337
Senator Collins...................................... 155, 252, 341
Senator Burris............................................... 254
Senator Kirk with attachment................................. 345
WITNESSES
Wednesday, April 29, 2009
Hon. Janet A. Napolitano, Secretary, U.S. Department of Homeland
Security....................................................... 5
Anne Schuchat, M.D., Interim Deputy Director for Science and
Public Health Program, Centers for Disease Control and
Prevention, U.S. Department of Health and Human Services....... 8
Alphabetical List of Witnesses
Napolitano, Hon. Janet A.:
Testimony.................................................... 5
Prepared statement........................................... 157
Schuchat, Anne, M.D.:
Testimony.................................................... 8
Prepared statement........................................... 167
APPENDIX
Responses to post-hearing questions for the Record from:
Secretary Napolitano with attachments........................ 174
Dr. Schuchat................................................. 186
Wayne Pacelle, President and CEO, Humane Society of the United
States, statement for the Record............................... 193
Monday, September 21, 2009
Rear Admiral Michael R. Milner, U.S. Public Health Service,
Regional Health Administrator, Region I, U.S. Department of
Health and Human Services...................................... 40
Matthew L. Cartter, M.D., State Epidemiologist, Connecticut
Department of Public Health.................................... 44
Hon. Peter J. Boynton, Commissioner, Connecticut Department of
Emergency Management and Homeland Security..................... 48
Stephen G. Jones, M.D., Director, Outpatient Medicine and Center
for Healthy Aging, Chief Patient Safety Officer, Yale New Haven
Health System.................................................. 51
Julie A. Polansky, Parent, Vernon Public Schools................. 63
Roseann Wright, Director, Waterbury Department of Public Health.. 66
Daniel Aloi, Manager, Business Continuity Services, Aetna, Inc... 69
Michael Kurland, Director, Student Health Services, University of
Connecticut.................................................... 72
Alphabetical List of Witnesses
Aloi, Daniel:
Testimony.................................................... 69
Prepared statement........................................... 244
Boynton, Hon. Peter J.:
Testimony.................................................... 48
Prepared statement........................................... 228
Cartter, Matthew L., M.D.:
Testimony.................................................... 44
Prepared statement with attachment........................... 204
Jones, Stephen G., M.D.:
Testimony.................................................... 51
Prepared statement........................................... 233
Kurland, Michael:
Testimony.................................................... 72
Prepared statement........................................... 246
Milner, Rear Admiral Michael R.:
Testimony.................................................... 40
Prepared statement........................................... 197
Polansky, Julie A.:
Testimony.................................................... 63
Prepared statement........................................... 236
Wright, Roseann:
Testimony.................................................... 66
Prepared statement........................................... 238
Wednesday, October 21, 2009
Hon. Janet A. Napolitano, Secretary, U.S. Department of Homeland
Security....................................................... 84
Hon. Kathleen Sebelius, Secretary, U.S. Department of Health and
Human Services................................................. 86
Hon. Arne Duncan, Secretary, U.S. Department of Education........ 90
Alphabetical List of Witnesses
Duncan, Hon. Arne:
Testimony.................................................... 90
Prepared statement........................................... 279
Napolitano, Hon. Janet A.:
Testimony.................................................... 84
Prepared statement........................................... 255
Sebelius, Hon. Kathleen:
Testimony.................................................... 86
Prepared statement........................................... 266
APPENDIX
Chart submitted for the Record by Senator Lieberman.............. 251
Responses to post-hearing questions for the Record from:
Secretary Napolitano with attachments........................ 284
Secretary Sebelius........................................... 309
Secretary Duncan............................................. 333
Tuesday, November 17, 2009
Anne Schuchat, M.D., Director, National Center for Immunization
and Respiratory Diseases, Centers for Disease Control and
Prevention, U.S. Department of Health and Human Services....... 124
Nicole Lurie, M.D., Assistant Secretary for Preparedness and
Response, U.S. Department of Health and Human Services......... 127
Hon. Alexander G. Garza, Assistant Secretary for Health Affairs
and Chief Medical Officer, U.S. Department of Homeland Security 130
Alphabetical List of Witnesses
Garza, Alexander G., Hon.:
Testimony.................................................... 130
Prepared statement........................................... 387
Lurie, Nicole, M.D.:
Testimony.................................................... 127
Prepared statement with attachments.......................... 362
Schuchat, Anne, M.D.:
Testimony.................................................... 124
Prepared statement with attachment........................... 348
APPENDIX
Chart submitted for the Record by Senator Lieberman.............. 340
Combined responses to post-hearing questions for the Record from:
Dr. Schuchat and Dr. Lurie................................... 391
Jeffrey Levi, Ph.D., Executive Director, Trust for America's
Health, statement for the Record............................... 403
Letter to Hon. Kathleen Sebelius from Senator Collins, dated
October 26, 2009............................................... 409
Letter to Hon. Kathleen Sebelius from Senators Lieberman and
Collins, dated October 27, 2009................................ 411
Letter to Senator Collins from Hon. Kathleen Sebelius, dated
October 30, 2009............................................... 414
Letter to Senator Lieberman from Hon. Kathleen Sebelius, dated
November 10, 2009.............................................. 418
SWINE FLU: COORDINATING THE FEDERAL RESPONSE
----------
WEDNESDAY, APRIL 29, 2009
U.S. Senate,
Committee on Homeland Security
and Governmental Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 10:05 a.m., in
room SD-342, Dirksen Senate Office Building, Hon. Joseph I.
Lieberman, Chairman of the Committee, presiding.
Present: Senators Lieberman, Pryor, Tester, Burris,
Collins, McCain, Voinovich, and Graham.
OPENING STATEMENT OF CHAIRMAN LIEBERMAN
Chairman Lieberman. Good morning and thanks to all who are
here. I particularly want to thank Secretary Janet Napolitano
and Dr. Anne Schuchat for joining us today to discuss our
government's response to the current outbreak of swine flu.
We are in the midst of a growing public health emergency
whose ultimate course is not clear. But one thing is certain,
and that is that swine flu is moving very quickly and harmfully
from the first outbreak barely a month ago in a small village
in Mexico to the first two cases in America confirmed in
California barely a week ago, to the first American death, a
23-month-old child in Texas, announced and confirmed this
morning. This flu has moved very quickly.
By yesterday afternoon in Mexico, more than 2,000 people
have been hospitalized and 149 people have died from swine flu.
This morning's numbers here in America are 66 confirmed cases
in six States--New York, California, Texas, Kansas, Ohio, and
Indiana. Globally, excluding Mexico and the United States,
there are 39 confirmed cases in six other countries, including
New Zealand, Spain, Great Britain, Germany, Canada, and Israel.
On Sunday, our government declared this to be a public
health emergency. A day later, the World Health Organization
(WHO) raised its pandemic alert to Phase 4. So this is no
media-created or media-exaggerated story, as some have
suggested. This is a genuine public health crisis.
The reassuring news, I believe, is that this is a case in
which our government was prepared for the crisis, as best one
can be prepared for a swine flu outbreak whose course is not
clear, and our top government officials responsible for
responding have done so, I think, with great strength and
effect.
The fact is, as I said, that we do not know the course that
this disease will follow. It is possible, as some have
suggested, that the incidence of swine flu may diminish in the
weeks ahead and then return with a vengeance in the flu season
later this year.
So the American people are understandably anxious and want
to know what they can do to protect themselves and what their
government is doing and will do to protect them from swine flu.
This morning, we have two people with us who are really
best prepared and most responsible for answering those
questions. Secretary of Homeland Security Janet Napolitano is
the person in our government given the authority and
responsibility by statute and presidential directives to be the
overall emergency manager of the Federal Government's response
to this kind of threat. That reminds us that this newest of
Federal departments created in the aftermath of the terrorist
attacks of September 11, 2001, was from the start intended to
be at the center of prevention and response not just to
terrorist attacks but to natural disasters and to pandemic
outbreaks, which in many ways mirror the effects of a potential
attack by a weapon of mass destruction.
In the current attempt to limit the spread of swine flu,
the presence within the Department of Homeland Security (DHS)--
and not just the Federal Emergency Management Agency (FEMA),
but also of agencies that concern and control immigration and
access in and out and across our border, such as Immigration
and Customs Enforcement (ICE), Customs and Border Protection
(CBP), and the Transportation Security Administration (TSA) has
been very important to consolidate the response, as has been
the ongoing relations that the Secretary of Homeland Security
has with State and local officials.
Dr. Schuchat is here this morning representing the Centers
for Disease Control and Prevention (CDC), which works under the
Department of Health and Human Services (HHS) in this case and
its new Secretary, Kathleen Sebelius. That Department in turn
leads the public health and medical response parts of the
Federal Government plan now being coordinated by Secretary
Napolitano.
I thank you both and all who have worked with you in the
last several days for your rapid, strong, and reassuring
response to this public health crisis. You have tracked the
spread of the disease, identified and addressed new cases in
this country, communicated your findings frequently to the
American people, and implemented, or begun to implement, an
array of preventive and response programs.
I think it is important to note for the record and hope
that this gives some reassurance to the American people that,
unlike other crises we have faced, pandemic flu is a threat
that our Federal Government anticipated and planned. Nearly two
decades ago, in 1992, the Institute of Medicine warned that
emerging microbial diseases were a serious threat and that a
number of modern demographic and environmental factors would
facilitate rapid spread. We have seen since then global
outbreaks of avian bird flu, West Nile virus, severe acute
respiratory syndrome (SARS), and a host of other infectious
diseases.
In response, in the early 1990s or mid-1990s, the CDC
developed a National Emerging Infectious Diseases Strategy, and
President Clinton issued a presidential directive for Federal
agencies to begin coordination for a national response to the
growing threat of infectious diseases. But in 2003, we
experienced a particularly bad seasonal flu outbreak and a
particularly inadequate governmental response. After that,
President Bush issued presidential directives, and in 2006, the
Homeland Security Council agreed on and issued a National
Strategy for a Pandemic Influenza Implementation Plan, which
sets out a detailed road map for what to do in a crisis such as
the swine flu outbreak we are in now.
States, supported by grants from the Department of Homeland
Security and the Department of Health and Human Services, have
pursuant to that plan developed their own plans for addressing
pandemic flu. In fact, State and local governments have gone
through demonstrations of preparedness exercises for exactly
what we are going through now. But that does not mean that we
do not have a lot of work yet to do and that we do not have to
remain very prepared, ready, and agile, because we are facing a
disease here whose course really is unpredictable.
This morning, we on this Committee are going to ask and
hope that our witnesses will be able to answer some of the
tough questions that remain on the minds of our constituents
and on ours as well, and we look forward to your answers to
those questions.
Again, I thank you for what thus far has been a very strong
and a very reassuring response to a very real public health
emergency.
Senator Collins.
OPENING STATEMENT OF SENATOR COLLINS
Senator Collins. Thank you, Mr. Chairman. All of us are
extremely concerned about the human swine flu outbreak that
continues to grow in our country and around the world. While
the disease has thus far been confined to six States, it is
likely to spread further in the days to come.
As the Chairman mentioned, more than 150 people in Mexico
are believed to have died from the virus, and just this morning
the first death in our country was confirmed by the CDC.
There is also the dangerous potential that the flu strain
will mutate into an even more deadly strain or one that is even
more infectious. The American people have the right to expect
that the Federal Government is doing everything possible to
combat this potential pandemic, and to date, I would agree with
the Chairman that it appears that our Federal officials have
taken this threat very seriously and responded very
effectively.
Today's hearing will give us the opportunity to learn more
about what the Federal Government has done and what it plans to
do to meet this growing public health threat.
As the Chairman mentioned, on Sunday the Department of
Health and Human Services declared this incident a public
health emergency. That alarmed many in the public. But as
Secretary Napolitano has carefully explained, that was
necessary to allow for the release of Federal resources to
support our preparedness and response efforts. It also gives
agencies greater flexibility to put rapid measures in place
should the flu virus become an even more prevalent threat.
The declaration also places the Secretary of Homeland
Security in charge of the overall Federal Government's
response. Consequently, DHS must work closely with HHS and its
component agency, the Centers for Disease Control and
Prevention, in shaping our response, and I look forward to
hearing the testimony of our witnesses today.
Congress has provided authorities and funding to strengthen
our Nation's ability to respond to a pandemic incident,
including the establishment of the Biomedical Advanced Research
and Development Authority (BARDA), at HHS. I strongly supported
the creation of BARDA and the increases to its funding.
To date, almost $7 billion has been appropriated for
Federal pandemic preparedness activities. This funding has been
used for stockpiling antiviral drugs for the treatment of more
than 50 million Americans. It has been used to license a pre-
pandemic influenza vaccine, to develop rapid diagnostics, and
to complete the sequencing of the entire genetic blueprints of
more than 2,000 human and avian influenza viruses.
I mentioned that figure--it is actually 2,250--because it
shows how many strains of flu we are already dealing with, and
yesterday the President asked for an additional $1.5 billion to
combat this disease as part of the supplemental appropriations
bill that Congress will soon be considering.
Despite these authorities and this funding, this Committee
has uncovered weaknesses in pandemic flu planning and
coordination in the past. Just last year, our Committee held a
hearing on mass medical care that would be needed in the
response to a pandemic flu or the detonation of a terrorist
nuclear device. This hearing revealed some serious gaps in the
Nation's capacity to provide mass care if thousands were to
become ill.
The Committee has also held a hearing on HHS' development
and procurement of the necessary vaccines, drugs, and
countermeasures for public health emergencies just like this
one. In addition, we previously looked at the poor
communications and coordination between DHS and the CDC in an
incident involving a Mexican citizen with a multiple-drug-
resistant form of tuberculosis who was able to enter our
country 21 times after being identified by the CDC.
These incidences lead us to several important questions
that we will explore today. What has the Federal Government
done thus far to protect the American people from this
potential pandemic? Since the Department of Homeland Security
has put relatively passive inspection techniques in place at
the border, should more be done to protect against cross-border
spread of the disease? How are the plans working? And have we
encountered any unanticipated problems? What role should the
State and local health departments play? What is the role for
hospitals? I met with 21 hospital administrators from Maine
yesterday who talked about the number of inquiries that they
are fielding about this disease.
I particularly look forward to hearing about the status of
the Federal Government's pandemic planning efforts. A critical
part of this planning is the antivirals and other medical
countermeasures from the Strategic National Stockpile that must
be distributed rapidly to the public when needed. I would like
to have more information on how that distribution is working.
Is it getting out to every State? How are the priorities set?
As the previous hearings in this Committee's investigation
into the Mexican national with tuberculosis highlighted,
coordination between DHS and HHS is essential, as is
communication with Mexican officials. These are issues we will
be exploring today as well.
Finally, let me indicate that I have been concerned about
how the lack of appointees at top positions at HHS and DHS may
be hindering the response. I am sure that HHS has been
handicapped by the absence of a Secretary, and I am pleased
that the Senate finally voted last night to confirm Governor
Sebelius' nomination. But we still do not have a permanent head
of the CDC, though we have many very capable individuals from
the CDC, and DHS still lacks a Chief Medical Officer. I mention
this because effective leadership is so important to the
effectiveness of our response, and in this regard, I am very
pleased with the leadership that has been shown so far.
Thank you, Mr. Chairman.
Chairman Lieberman. Thank you very much, Senator Collins,
and now we will go right to the witnesses, again with thanks
for your accommodating and moving your schedule to be here with
us today. Secretary Napolitano, thank you.
TESTIMONY OF HON. JANET A. NAPOLITANO,\1\ SECRETARY, U.S.
DEPARTMENT OF HOMELAND SECURITY
Secretary Napolitano. Thank you, Mr. Chairman, Senator
Collins, Members of the Committee. Thank you for the
opportunity to testify on the national response to the H1N1 flu
outbreak.
---------------------------------------------------------------------------
\1\ The prepared statement of Secretary Napolitano appears in the
Appendix on page 157.
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This is, as you have noted, a serious situation that we are
treating aggressively. As President Obama said yesterday, it is
a cause for concern but not for alarm. There is a lot we do not
yet know about this outbreak, but we have been preparing as if
we are facing a true pandemic, even though we do not know the
ultimate scope of what will occur.
We also have been preparing with the understanding that
this will be a marathon and not a sprint. We are going to be at
this for a while.
Mr. Chairman, as you noted, the Secretary of Homeland
Security is the principal Federal officer for domestic incident
management, including outbreaks like this one. Under that role,
we have been leading a true collaborative effort. HHS and the
CDC also have lead roles on the health and science aspects of
this outbreak. But every department of the Federal Government
or virtually every one has a role to play.
For example, the Department of Education already has had a
conference call with 1,400 participants on how to identify, and
prevent H1N1 in school facilities.
The U.S. Department of Agriculture has been working to
reassure people of the safety of our pork and pork products and
to work with other countries with respect to the import of our
pork products. The U.S. Trade Representative I was with
yesterday is doing the same.
As you noted, our State, local, and tribal partners are
absolutely indispensable because on many questions they
actually have the lead role. They are the first responders. We
are now at the Department of Homeland Security conducting daily
conference calls with these partners. Some days we have had as
many as 48 States participating. We have 40-plus States
participating on a regular basis.
Indeed, the public has a role to play here and a
responsibility--a responsibility to cover our mouths when we
cough, a responsibility to wash our hands regularly; if you are
sick, not to go to work, not to get on a plane or a bus; and if
your child is sick, not to send them to school to avoid
infecting others.
I am pleased to be here with Dr. Anne Schuchat from the
CDC. I want to commend the CDC for their work on this. They
have been absolutely phenomenal to work with here and educating
all of us about this particular strain and about flu outbreaks
in general. The career public health officials there are doing
a terrific job, as are the career officials at the Department
of Homeland Security, and I want to praise them as well.
As you noted, part of the preparation is analyzing what we
have with respect to antivirals. The National Stockpile has 50
million courses, and we are releasing 25 percent of the State
portion already.
Senator Collins, you asked about who has been delivered
already. Indiana, Nevada, Kansas, Kentucky, and Ohio have
received antivirals from the stockpile. Today, antivirals are
on their way to Arizona, California, Texas, and Utah. And I
would be happy to supply the other schedule for the delivery.
But that is the status as of this morning.
We have placed priority on States with confirmed cases of
H1N1 and, of course, along the southwest border. But all States
will ultimately get resources, and we intend to have complete
delivery by May 3, 2009.
The State Department is also----
Chairman Lieberman. Excuse me. That would be complete
delivery of the 25 percent.
Secretary Napolitano. Correct.
Chairman Lieberman. Not of the full 50 million, right?
Secretary Napolitano. Correct, Mr. Chairman.
Chairman Lieberman. Thanks.
Secretary Napolitano. The State Department also has been
involved with the CDC. We have issued travel health alerts and
travel warnings for non-essential travel to Mexico, and I
anticipate those warnings and alerts will be up until the
public health officials tell us they no longer need to be. Our
actions are being guided by science and by what the public
health community is telling us.
In addition, with respect to the Department of Homeland
Security, we are moving forward in accord with planning and
frameworks that have been worked on for several years. At the
land ports and at the airports, Customs and Border Protection
(CBP) is monitoring incoming travelers for possible H1N1 flu
symptoms. Those who appear sick are put in separate rooms to be
evaluated by health officials.
TSA also has protocols, similar protocols for air travelers
who appear ill, and the Coast Guard is working with shipping
companies with respect to possibly ill crew members.
The Travelers Health Advisory Notices made by the CDC tell
travelers about the H1N1 flu, what to do if they have symptoms,
and CBP is distributing tear sheets, cards, at the land ports
and to those coming in on planes from Canada and Mexico. We are
also distributing materials to passengers on cruises that
stopped in Mexico, and, of course, TSA is posting all of this
information at airport checkpoints.
The actions at the border are consistent with and match the
recommendations of the CDC and the World Health Organization,
and here I want to pause a moment. There has been some question
raised about closing the borders. First, the actual statutory
authority is not with respect to closing an entire border. It
is with respect to closing a particular port or series of
ports. But I think as Dr. Schuchat will explain in greater
detail, making such a closure right now has not been merited by
the facts. It would have very little marginal benefit in terms
of containing the actual outbreak of virus within our own
country.
As I mentioned, our coordination with State and local
partners is very robust. We are also coordinating with our
international partners and with the private sector. I have been
in phone contact with the governors of many of the States, and
I will be making another series of calls this afternoon. I have
spoken with my direct counterparts in Mexico and Canada. We
have adopted in many respects a tri-national approach to this
because the virus itself does not know when to stop at a border
or not. And the Private Sector Office and the Infrastructure
Protection Office of the Department are working with the
private sector informing them that it is time to dust off their
pandemic flu plans, if they have not exercised them, to get
them ready and to focus on business continuity planning as we
move forward.
Within the Department, we are working to prepare the health
of our own employees. We are pre-positioning antivirals as well
as personal protective equipment in case those are needed. And
we continue our operations in full force.
Let me conclude with this: Every American has a
responsibility here with this outbreak. Every community has a
responsibility to work on and get the word out about
preparedness. Obviously, our thoughts, prayers, and sympathies
go out to the families already affected by this H1N1 virus, but
our goal is to make sure that the country is prepared, that we
respond with alacrity and with efficiency to the current
outbreak.
Thank you, Mr. Chairman.
Chairman Lieberman. Thanks, Madam Secretary, for an
excellent opening statement.
Dr. Schuchat, thanks to you and your colleagues at CDC for
your service all the time, but really for your very impressive
ability to communicate facts to the American public at this
time, which is most important. Please proceed.
TESTIMONY OF ANNE SCHUCHAT, M.D.,\1\ INTERIM DEPUTY DIRECTOR
FOR SCIENCE AND PUBLIC HEALTH PROGRAM, CENTERS FOR DISEASE
CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Dr. Schuchat. Thank you. Good morning, Chairman Lieberman,
Ranking Member Collins, and other distinguished Members of the
Committee. I am Dr. Anne Schuchat, the Acting Deputy Director
for CDC's Science and Public Health Program. I appreciate the
opportunity to join the Secretary and to tell you about the
current steps of what is going on and what we are doing about
it. Our hearts go out to the people of the communities in the
United States, in Mexico, and around the world who are coping
with this challenge, and I think all of us this morning are
thinking of the family in Texas who did lose a loved one.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Schuchat appears in the Appendix
on page 167.
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People are concerned, and we are concerned as well. We are
responding aggressively at the Federal, State, and local levels
to understand the complexities of this outbreak and to
implement control measures. Our aggressive actions are possible
in many respects because of the investments and the support of
the Congress and the hard work of State and local health
officials at the front line across the country.
Flu viruses are extremely unpredictable, making it hard to
anticipate the course that this outbreak will have with any
certainty. We do expect increases in the number of cases, the
number of States that are affected, and the severity of
illness. And during this uncertainty we hope that we can remain
clear in communicating what we do know, what we are doing to
protect the health of Americans, and help Americans understand
the steps that each one of us can take to protect ourselves,
our families, and our communities.
Influenza arises from a variety of sources, and in this
case, we have determined that there is a novel 2009 H1N1 virus
that is circulating both in the United States and Mexico that
contains genetic pieces from four different virus sources.
Additional testing is underway on this virus, including the
complete genetic sequencing. CDC has determined that this virus
is contagious. It is spreading from human to human, similar to
seasonal influenza, likely through coughing and sneezing.
Sometimes people may become infected by touching something with
the flu virus on it and then touching their mouth or nose. But
there is no evidence to suggest that this virus has been found
in swine in the United States, and there have been no illnesses
attributed to handling or consuming pork. There is no evidence
that you can get this new influenza from eating pork or pork
products.
I want to reiterate that as we look more intensively for
cases, we are finding more cases. We fully expect to see not
only more cases, but also potentially greater severity of
illness. The specific numbers are really less important in
understanding the outbreak than the more general patterns that
we use to help guide our interventions.
Aggressive actions are being taken. They are being taken
here and around the world. We are working very closely with
State and local public health officials in the United States on
the investigation to implement control measures. We are
providing both technical support on the epidemiology as well as
the laboratory support for confirming cases. We are also
working with the World Health Organization, the Pan American
Health Organization, and the governments of Mexico and Canada
on really understanding and responding to this outbreak.
There is a tri-national team that is working in Mexico,
including members from CDC, to better understand the outbreak
and enhance survival and lab capacity so that we can answer
critical questions, such as why the cases in Mexico appear to
be more severe than the initial ones that were seen in the
United States. We are working closely with Secretary Napolitano
and other Federal partners to ensure that our efforts are
coordinated and effective.
CDC has issued numerous health advisories for individuals,
health care practitioners, schools, and communities, and these
continue to evolve as our understanding of the situation
changes. On Monday, CDC issued a travel health warning for
Mexico, recommending that travelers defer non-essential travel
to Mexico. We are also evaluating information from other
countries and will update travel notices as necessary.
But, as always, people with flu or flu-like symptoms should
stay home and not attempt to travel. In fact, a key message
from us is that there is a role for everyone to play in this
outbreak. At the individual level, it is important to
understand how each one of us can help prevent respiratory
infections. Frequent hand washing is effective to reduce
transmission of disease. If you are sick, stay home. If your
kids are sick, have a fever and flu-like illness, they should
not go to school. And if you are ill, you should not get on an
airplane or public transport to travel. So taking personal
responsibility for these things will help reduce the spread of
this new virus, just as it helps reduce the spread of other
respiratory illnesses.
It is important for people to think ahead about what each
one of us would do if this outbreak deepens in our own
communities. Communities, businesses, schools, and local
governments should plan now for what to do if cases appear
where you live or work. For example, parents should prepare for
what they would do if faced with a temporary school closure. Do
you have all your plans in place?
We also have issued additional community guidance to
clinicians, laboratory workers, and other public health
officials so that they know what they should do if they see
cases in their community. All of these specific
recommendations, as well as other regular updates, are on our
website--www.cdc.gov.
CDC maintains the Nation's Strategic National Stockpile of
medications for the eventuality that they may be needed in a
situation such as we face. As part of the pandemic preparedness
efforts that the Senator was speaking about, the U.S.
Government purchased extensive supplies of antiviral drugs, and
our preliminary testing is reassuring that the virus that is
circulating can be treated with the drugs in our stockpile.
That is a really good thing.
We have released one quarter of the States' share of the
antiviral drugs and personal protective equipment to help
States prepare to respond to the outbreak. We also, working
with the Food and Drug Administration (FDA), have achieved an
emergency use authority to facilitate the effective use of some
of these materials. Distribution has begun, starting with the
States where we already have confirmed cases, and the
Department of Defense and individual States have also
stockpiled these antiviral drugs.
Whenever we see a novel strain of influenza, CDC begins
work toward the development of a vaccine in case one needs to
be produced. CDC worked to develop what we call a ``vaccine
seed strain'' that is specific to this novel virus, which is
the first step in vaccine manufacturing. We have initiated
steps so that, should we need to make a vaccine as a
government, we can work towards that goal very quickly. Rapid
progress will be possible through the combined efforts of CDC,
the National Institutes of Health (NIH), FDA, BARDA, and, of
course, the manufacturing community.
Finally, it is important to recognize and acknowledge that
with the strong support of the Congress, there have been
enormous efforts in the United States to prepare for this kind
of outbreak and to prepare really for pandemics in general. Our
detection of this strain in the United States came as a result
of that investment. Our enhanced surveillance and laboratory
capacity are critical now in understanding and mitigating this
threat. While we must remain vigilant throughout this and
subsequent outbreaks, it is important to note that at no time
in our Nation's history have we been as well prepared as we are
today.
As we face the challenges in the weeks ahead, we look
forward to working closely with Congress to best address the
evolving situation, and I look forward to answering your
questions.
Chairman Lieberman. Thanks very much, Dr. Schuchat. That
was very helpful. I appreciate what you have said and I agree
with you, though, that we are fighting a serious public health
challenge, and we do not know now exactly what path it will
follow. I want to paraphrase what you said. At no time in our
Nation's history have we been better prepared to deal with
exactly this kind of crisis, and I appreciate what all of you
at CDC do to put us in that position.
We are going to have 7-minute rounds of questions for each
Senator, and I will begin now.
Let me ask you a few of the medical questions. You are
right, we are fortunate to have 50 million--``doses,'' is that
the right term?
Dr. Schuchat. It is actually ``courses.''
Chairman Lieberman. ``Courses,'' right, of treatment.
Dr. Schuchat. Yes.
Chairman Lieberman. Of two drugs, I gather: Tamiflu and
Relenza, both of which have been found to be effective, and
this is treating swine flu if it occurs.
Do you think now that the 50 million courses are adequate
to the need? And if not, what should we be doing, both on your
end and on ours, to finance an increase of that inventory?
Dr. Schuchat. The estimates of how much was needed for the
Strategic National Stockpile involved a mixture of Federal and
State responsibilities, and our planning assumptions were to
make sure that we had enough antiviral medications to treat 25
percent of the population. Among our 50 million courses, there
are 6 million that are designated for strategic priorities,
things like containment, should that have been possible. And I
think we are re-evaluating the issue of whether additional
antivirals may be needed in the future. We are so fortunate
that we made those investments and that, with the coordination
and planning, we have been able to deploy the 25-percent
portion of the assets. We do not really know if we are going to
need to use large numbers of them, but I think we are ready if
we do.
Chairman Lieberman. There is a feeling, in response to some
of the things that experts like yourself have said, that it is
possible that the current outbreak will diminish as what we
have come to call ``flu season'' ends, but then may pick up
again in a much greater way next flu season later this year. Is
that accurate? Do we know that with a reasonable certainty? Or
is it possible that the swine flu will just keep on expanding
and going further?
Dr. Schuchat. Unfortunately it is very unpredictable.
Seasonal flu has a fairly clear season and really goes away in
our summer months. And in pandemics that have been studied in
the past, sometimes there have been second waves--one spring,
and then a second wave the next fall or winter. So we do not
know what pattern we will see, whether cases will continue to
increase or whether there will be a decline.
What we would like to communicate is that if we do see a
decline, that does not necessarily mean we are out of the
woods. We need to be planning and preparing for an eventual
recurrence, and that is part of the thinking involved with the
vaccine discussions that we are having right now.
Chairman Lieberman. Right. And, again, I am sure the public
understands this. We are talking about two things: We are
talking about the antivirals, which are a treatment for people
who come down with swine flu; and then we are talking about
trying in a really aggressive schedule to develop a vaccine
which hopefully would prevent the flu from spreading.
Dr. Schuchat. Yes, that is right, Senator. The antiviral
drugs or medicines, like Tamiflu and Relenza, can treat an
influenza illness. We have influenza vaccines that we use every
year to treat the seasonal flu, and we are discussing, across
government and the scientific community, the issue of
developing a vaccine specific to this new influenza virus that
has been detected.
Chairman Lieberman. I know that President Obama has
requested an additional $1.5 billion to be prepared to deal
with this. I presume that a good amount of that money is meant
to be available for either acquiring more antiviral courses and
investing in the development of the vaccine for the next flu
season. Is that right, Secretary?
Secretary Napolitano. Yes, Mr. Chairman. And I think it is
a rough estimate, and we just wanted to have a pool of money,
as it were, that could be drawn down quickly.
Chairman Lieberman. Let me ask you now one of the questions
that my constituents at least asked me, which you touched on in
your opening statement, which is this: Since this swine flu
outbreak began in Mexico, and a lot of the stories we are
hearing in the media about people who seem to have it,
including now some suspected cases in Connecticut, more often
than not--certainly in a disproportionate number of cases--
involve people who visited Mexico or had some contact with
somebody who did. Why not, within the terms that you described
statutorily, close the border, and both ways, both people
coming from Mexico to here or Americans--in other words, why
not just say no, you cannot go to Mexico from the United States
for some period of time, not just have a travel advisory?
Secretary Napolitano. Well, I am going to ask Dr. Schuchat
to respond because we have been taking our guidance there from
the public health community as to when the facts merit actually
closing a port. What is the best thing to do for the safety of
the American populace?
Chairman Lieberman. Dr. Schuchat, go ahead.
Dr. Schuchat. Thank you. This is a reasonable question that
people are asking, and we want to make sure we get clear
information out.
There has been a formal policy analysis of this issue,
including analysis with infectious disease modeling, and the
estimates are that in 2007 this effort was carried out.
Chairman Lieberman. OK. Was this done now or previously?
Dr. Schuchat. And there have, of course, been updates as
new information comes along, with just that idea of whether it
would be effective to try to close or partially close the
border. And the estimates were that if there were cases in
Canada or Mexico, within days the ability to stop that
introduction into the United States would be gone.
So what we have been doing is really looking at the
epidemiologic patterns, the spread of disease, where it is
occurring, and the scientific assessment is the most effective
strategy right now to focus on where we have illness, those
families and the communities around them, and that it is really
not an effective approach to try to block things at the border.
Of course, we have our efforts to suggest to the travelers
from the United States to defer non-essential trips to Mexico,
and we have a strong partnership with the Customs and Border
Protection staff to recognize ill passengers or travelers and
deal with them.
There is a personal responsibility element in all of this
in terms of when each of us is ill not getting on an airplane
or crossing a border. In fact, the Director General of the
World Health Organization has said, at this point the most
effective assets really need to be focused elsewhere, and the
border is a real diversion.
Chairman Lieberman. Let me just follow up, because the
response from my constituents to the answer that I think I
heard you give, which is the swine flu is already here so we
have to contain it here, and closing the border or stopping
people from going to Mexico or coming from Mexico to here does
not help at all.
Their response to that is, well, the more people who go
back and forth between Mexico and here, isn't it more likely
that there will be more contagion occurring? What do you say to
that from a medical point of view?
Dr. Schuchat. From a medical point of view, I think that is
not the case. I think it is reasonable for people to be asking
that question, but that is where that infectious disease
modeling goes on. We have infectious cases or confirmed cases
in many communities in the United States, so the probability of
exposure from someone who has no contact with Mexico is also an
important issue right now. So I think it is reasonable that
they are asking, but we do not think that is a good strategy.
Chairman Lieberman. OK. I am sure that others on the
Committee will want to continue this discussion. Thank you.
Senator Collins. I will continue it.
Chairman Lieberman. Senator Collins, it is all yours.
Senator Collins. Madam Secretary, you have explained, as
has the doctor, why you do not think the border with Mexico
should be closed, but there are other steps that could be taken
to enhance the screening at the border.
Now, last year, Customs and Border Protection inspected
almost 400 million travelers coming across our borders, so we
are talking about a very high volume. And as I understand it,
DHS has instructed the border officials to use passive
surveillance at our ports of entry to try to identify
individuals who could have symptoms of the flu. But other
countries are being far more aggressive in their screening.
Singapore, Thailand, Japan, Indonesia, South Korea, and the
Philippines are all using thermal scanners. Those were also
used during the SARS crisis in 2003 at airports, and as I
understand it, these scanners are able to detect if a passenger
has a fever, and the person can be set aside.
Now, I heard you on television say that you did not think
the technology was good enough, but, in fact, we have half a
dozen countries who are employing that. It seems to me that
there are steps that could be taken to strengthen the screening
at the border if closing the border is neither practical nor
called for, according to the public health assessment. Why
aren't we doing more to try to screen?
Secretary Napolitano. Senator, thank you. Actually, the
term ``passive surveillance'' is really not an accurate
depiction of what is going on. What our CBP officers are doing
is actively monitoring travelers that are attempting to cross
the border, asking for those who appear ill, asking questions
about whether they are ill, their travel history and the like.
And there is a protocol that is in place for how that is done.
We take our guidance, as I said before, from the public health
officials as to what steps really would work and would be
effective.
With respect to the thermal scanners, they are not always
accurate. They are not always as precise as one would wish.
But, in addition, you have travelers who actually have the flu
who do not have a temperature. So they do not really help you
sift out travelers who are ill from those who are not. And so
the recommendation to us has been that would not be a
particularly useful technology. I do not know if Dr. Schuchat
has anything to add there.
Dr. Schuchat. Yes, that is exactly right. Some countries
are doing this now, and, of course, during the SARS experience,
this was done quite a bit. The science right now really does
not hold that up. I was personally scanned many times during
the SARS issue when I was in China, but I think that we are
really trying to follow the science here.
Senator Collins. I guess my concern is that even if that
technology is not perfect, even if individuals who have the flu
do not necessarily have a fever at the early stages, it seems
to me using technology to try to identify some of the
individuals would make sense. And if you have six other
countries doing it, then clearly there must be some value in
identifying individuals who have fevers, since that is a common
symptom, who could be set aside for additional screening. It
just strikes me that--and maybe ``passive'' is the wrong term,
as the Secretary suggests, but, in fact, the reports that we
are getting is that the volume is such that it is very
difficult for officials at the border who are not medically
trained, after all, to do this kind of selection process or
surveillance.
Dr. Schuchat. I just want to make sure that I am clear. We
are looking at the pattern of illness that we have here in the
United States and the many places within our own borders where
there are now laboratory-confirmed cases and what that tells us
about our risk within the United States. And I think much of
our attention comes from previous outbreaks and modeling and
suggests that the focus is really in looking aggressively for
cases here in the United States, responding in our own
communities.
And so I think it is understandable for there to be
questions about this, and the issues in countries that have not
yet seen cases may be quite different. But here in the United
States we are really focusing on what we can do within our own
communities where we have several States with active cases.
Senator Collins. Doctor, let me ask you a more fundamental
question. I believe that most Americans would be surprised to
learn that 36,000 people every year die from the regular
seasonal flu and that regular seasonal flu produces some
200,000 hospitalizations. Those statistics were surprising to
me, and I suspect that they would be to most Americans.
What makes this particular strain of flu particularly
dangerous and alarming?
Dr. Schuchat. This situation that we are experiencing now
reminds us that seasonal flu is a bad thing also--as you say,
the 36,000 estimated deaths--and we make intense efforts to try
to protect people from seasonal flu. The difference right now
is that we are dealing with a novel virus. We do not know yet
all of the characteristics of how it will behave in human
populations, but we know that it is a virus that has not been
around before, that we have not seen immunologically. So what
we think is that the general population does not have immunity
to this virus.
With seasonal flu, a good proportion of the population has
some immunity because of the viruses that circulate every year,
and one of the risks for future pandemic potential is a new
virus that there really is not widespread population immunity
to.
We are trying to understand now whether some people who are
older seniors might actually have some protection, some natural
immunity against this particular virus because perhaps it is
close enough to things that were circulating a long time ago.
But we really worry about that novel strain that is not like
the circulating seasonal flu strains.
Senator Collins. Thank you. Thank you, Mr. Chairman.
Chairman Lieberman. Thanks very much. Senator McCain.
OPENING STATEMENT OF SENATOR MCCAIN
Senator McCain. Thank you, Mr. Chairman, and again, I want
to thank Secretary Napolitano and Dr. Schuchat also for doing a
fine job in keeping the American people informed, coming here
and testifying, appearing on national television. This is
something that really has Americans deeply concerned, and
understandably so. Thank you for your continued communication
with the American people.
Madam Secretary, if we close the border with Mexico--
obviously you have the responsibility to make that
recommendation. I would imagine it would be a presidential
decision. And you said that conditions right now do not warrant
the closure of the border. What conditions would warrant that
you recommend that the border between the U.S. and Mexico be
closed?
Secretary Napolitano. Well, if the CDC told us that closing
the border would have a significant impact on the prevention of
disease within our country, I think that would be a highly
relevant factor. But the analysis has been that closing ports,
closing the border, would not have that kind of preventive
impact at this stage.
Dr. Schuchat. And I would actually like to add to that.
Some of the planning that we have been doing over the years
past had the primary assumption that a new strain of influenza
was going to come from very far away. We were worried about the
H5N1 bird flu strain of influenza, and we wondered, if we see
illness in a very distant place, what should be our posture.
Senator McCain. But I say with some respect, Dr. Schuchat--
and I do not have much time--if we are not going to close the
border because the conditions do not warrant it, what
conditions do warrant the closure of the border?
Dr. Schuchat. What I am trying----
Senator McCain. Are there any conditions that would exist
that would? For example, the European Union is just
recommending that there be no flights from Europe to Mexico.
And I would imagine that there will be reciprocal action.
I think the American people need to know, if we do not have
to close the border now--and with all due respect, we all know,
Madam Secretary, that millions of people move back and forth
across the border on a daily basis. And just observing them, I
think, is certainly not totally effective, to say the least.
What conditions would prevail that would say we need to close
the border between the U.S. and Mexico, if any?
Dr. Schuchat. I do not think there are any.
Senator McCain. You do not think there are any. I thank
you. And, by the way, I think it is appropriate, again--as
Senator Collins pointed out--36,000 people do tragically die
every year from the flu that we experience in this country.
What do you think the percentages are, Dr. Schuchat, the
likelihood that it tails off, as you said in your prepared
statement, during the summer but then we find a reoccurrence
takes place when flu season begins again?
Dr. Schuchat. Unfortunately, we really cannot predict
exactly what is going to happen. There are many things that we
will be doing to try to understand the probability that there
will be another wave. There are issues like looking in the
Southern Hemisphere at the pattern of disease that they have.
We can also do some things to try to understand our
population's immunity. Did we already see this new strain go
through a lot of the population and develop some protection?
So there has been planning in terms of the research and the
epidemiologic studies that could help us better predict. But
even with all of those, we will not be able to perfectly
predict. So our posture is to prepare and to be ready if things
do get worse.
Senator McCain. Is it possible, given your experience, to
tell me your personal prediction?
Dr. Schuchat. My personal prediction is that I will get in
trouble if I make a guess. [Laughter.]
Senator McCain. Well, that is a good point.
Madam Secretary, Dr. Schuchat's point about no conditions
warranting closing the border is a very important one. Then if
that is the case, I really hope that we would pursue vigorously
better technological and scientific and, frankly, closer
observation of people going across the border than is presently
the case. And I know that we have a huge border with Mexico,
and it would be hard to implement immediately. But if the
possibility is that we may be in for the long term here, as Dr.
Schuchat, I think very appropriately, refuses to predict but is
a possibility, then we ought to look at ways of checking people
more carefully as they go across the border between the U.S.
and Mexico.
I know you know that the report of the first death from
swine flu in the United States just took place in the State of
Texas, so I think we need to--and I believe you are--maintain a
careful balance between not causing panic out there amongst the
American people, but at the same time making them aware of the
implications of this threat, much of which is really not
totally known to us. But we have experienced SARS and other
viruses in the past and have been able to gain some control.
Does the present vaccine, Dr. Schuchat, that a lot of
Americans routinely get have any beneficial effect on H1N1?
Dr. Schuchat. Based on the studies that have been done so
far of this new virus, we do not expect there to be protection.
There are some additional things that we are looking at to
understand whether our pessimistic prediction might be wrong
and, in particular, looking at serum from certain populations
to understand whether there might be any cross-protection. But
based on the laboratory testing that has been done so far, we
do not expect there to be any cross-protection.
Senator McCain. In a best-case scenario, how long would it
take us to discover and develop a vaccine that would combat
H1N1?
Dr. Schuchat. There are active efforts right now. At CDC
our role is to develop the vaccine strain that is handed off to
industry. The steps after that would be pilot lot developments
by manufacturing and studies really undertaken by NIH and FDA
to make sure that we know how to administer the vaccine, the
dosing, and whether or not you need what is called an adjuvant
to increase the immune response.
If everything goes well, production could lead to
availability as early as September, but, of course, with
influenza vaccine production, or even seasonal flu, everything
does not always go great smoothly.
So there are lots of entities meeting and taking steps to
aggressively move forward and being ready to produce a vaccine
should we need to. But even with the best case and decisions
made quite promptly, we would not have product until the fall.
Senator McCain. Madam Secretary, I hope you will keep
revisiting this issue of whether we need to close the border or
not.
I thank you, Mr. Chairman. I thank you all for your fine
work.
Chairman Lieberman. Thanks, Senator McCain. I must say I
did not come here this morning feeling--and I still do not--
that we have to close the border with Mexico. But I am
surprised at your answer, Dr. Schuchat. In the second round, I
will ask you more questions about it, that you cannot foresee a
circumstance in which we would possibly want to do that. My own
feeling--I am not a doctor, to say the obvious--is if we can
contain the spread of the flu here, one thing we might want to
do, just as the Mexican Government is thinking about, is
stopping public gatherings, even in the worst case, closing
down parts of the business sector in Mexico City because they
do not want it to be communicated. There is a kind of common
sense that says, well, if it reaches that point, don't we want
to avoid increasing the probability of contagion, even for a
temporary period of time? I understand there would be
horrendous economic and personal effects of this on both sides
of the U.S.-Mexican border. And, of course, this death that
occurred today in Texas, this child apparently went from Mexico
to Texas. So presumably there was some connection there.
Secretary Napolitano. Mr. Chairman, first of all, you are
right, and this situation keeps changing. For example, the CDC
is going to announce that four other States now have confirmed
contagion: Arizona, Nevada, Massachusetts, and Michigan. They
are going to announce now 91 confirmed cases. We cannot
anticipate that those sorts of reports now are going to
continue. But the decisions about closure of events, closing a
school, not having a meeting, that sort of thing, those
primarily are generated at the local level based on the
circumstance and environment at the local level.
That is why it is so important that we work with cities and
States in terms of their own implementation of their criteria
for when they would close or not close. And, again, it needs to
be informed by the size, the extent of contagion, and what you
can prevent by making a closure.
Returning to Senator McCain's question, obviously we will
watch those ports of entry very closely, and I will be happy to
share with you the protocols that have been given to our CBP
officers of what exactly they are supposed to be doing at the
ports.
Chairman Lieberman. Thanks, Secretary. I just hope that--
and I understand, Dr. Schuchat, you are not a political person.
You are giving your best medical advice, and we ought to give
it respect. But I hope we will keep open, as we watch the
course of this disease, the possibility that we might want for
some period of time to close some of the ports of entry between
Mexico and the United States, and if not that, then to greatly
ramp up the kind of review of people going back and forth that
we are doing at this point. But I am delaying my colleagues,
and I thank you for the responses.
Senator Tester, you are next.
OPENING STATEMENT OF SENATOR TESTER
Senator Tester. Thank you, Mr. Chairman, and I want to
thank both participants here today for their information. It is
good stuff. And I think that we do have a serious problem that
we face, and I think it is partially because of your good work
and your leadership that this will be minimized as much as
possible. I think so far the response in the country has been
good from your end and from the local level and everywhere in
between, and I think it is good news when all parts of
government step up to the plate and really do their job,
potentially to rethink their flu response plans and things like
that. That is good news.
I think that the best news is, as I think we all recognize,
that there are still some gaps. There are still some things we
need to iron out. I come from a frontier community in a very
rural State with a border of 545 miles with Canada in this
particular case, with many ports of entry between Canada and
Montana, and I think we all realize how important those ports
are. We all understand how important trade is. And we also
understand how serious this potentially could be as it starts
to unfold. But we need to make sure we take the right
precautionary trail as we go forth here.
Some have said we need to close the border. We have heard
today that potentially is an option until this blows over. I
tend to agree with the good doctor. I think that we need to let
science lead the way here and make reasonable decisions,
rational decisions based on sound science, mainly because we
already have some confirmed cases here in the United States and
we see how it is starting to expand throughout the United
States, with four more today.
Secretary Napolitano, you talked in your opening remarks
about what is going on on the border right now from a
perspective of the cars and trucks coming across the line, that
you--let me see. How did you put it? You were monitoring, and
the folks who look sick, you are pulling them in. What exactly
do you do after that? Are they looked at by a medical doctor?
What transpires then?
Secretary Napolitano. Yes, Senator, they are put in an
isolation room, basically, and some of our ports have a public
health official right there. Other times, they have to call and
have one brought over to examine the individual.
Senator Tester. So how quickly could they know if these
folks have some other kind of flu or this kind of flu?
Secretary Napolitano. Well, fairly quickly. I mean, I think
the longest wait we have had to date has been 2 hours.
Senator Tester. What is the incubation period for this, do
you know? That is maybe directed at the doctor.
Dr. Schuchat. This is a novel virus, so we are beginning to
characterize the incubation period. And from the information we
have so far, it looks to be between 2 and 5 days.
Senator Tester. OK.
Dr. Schuchat. But that is changing as we get more
information.
Senator Tester. In many of the rural States around this
country, we have critical access hospitals that have fewer than
25 beds. Oftentimes, there is a nursing home attached to them.
Although I have heard that this attacks healthy adults, we see
the first confirmed death is an infant, a 2-year-old. What are
you recommending critical access hospitals that have nursing
homes attached to them do to help stop the spread of a
potential contaminant coming in, a person, to the elderly
population that might be living in those nursing homes?
Dr. Schuchat. CDC has been issuing many new guidance
documents and pushing them out to the clinical community--the
doctors and nurses, the laboratories, and hospital workers--so
that they know about infection control practices--the kinds of
``droplet precautions'' is sort of one of the terms we use; the
things about how to diagnose cases, making sure that patients
are isolated, that they will not be in a room with someone else
and able to spread.
But what we are also doing is making sure that we do not
get dogmatic, that we learn from what we are seeing, and that
we update recommendations when guidance needs to be changed
because of the events that we observe.
Senator Tester. Can you tell me, how many confirmed cases
are there in Canada? I do not know that I have read that.
Dr. Schuchat. Unfortunately, I do not have Canada's counts
myself today.
Secretary Napolitano. The last I heard was several, some
were in Nova Scotia and some were in British Columbia. So they
were spread out.
Senator Tester. All around the country. Do you have the
ability to--CDC or do others have the ability to--my guess is
if you get a group of folks that get sick, it could become
bigger pretty quick. So it could affect communities, a certain
community much greater than 150 or 200 miles away in a State.
Are there agreements to be able to transfer medical personnel
between hospitals or States to make sure we have the medical
personnel that can meet the need?
Dr. Schuchat. There are some of those agreements. In fact,
during the SARS epidemic in Canada, there were American doctors
that went and helped them. State to State, we also have those
kinds of approaches.
Senator Tester. Who is ``we''? Is that done at the local
level, or is that done at your level?
Dr. Schuchat. Well, no, I think it is more at the State
level. But the issue that is important to realize, though, in
our pandemic planning we really had to recognize that the way
pandemics of influenza unfold, many communities may be
affected, and so few places are likely to want to spare their
professional staff because they may be just around the corner.
So this is where our guidance helps clinicians know what to do,
even with a reduced workforce.
In particular, we may see a point in the future where we
have to have simpler ways to care for people--only the most
sick coming to the hospital and such.
Senator Tester. Do you see any challenges dealing with
critical access hospitals that are going to over and above what
you would see in urban areas? And what are they? And how will
you deal with them?
Dr. Schuchat. What I would like to say is that we do not
know whether things will be better or worse in those kinds of
communities. It may be that the more remote communities will
not have the kind of problems that we are seeing in New York
City, for instance. But another part--well, there is planning
on trying to sort out how the Federal Government can enhance
what is available at the State or local level in terms of the
medical surge issues.
Senator Tester. Thank you, Mr. Chairman. Thank you both.
Chairman Lieberman. Thank you, Senator Tester. Good
questions. Senator Voinovich.
OPENING STATEMENT OF SENATOR VOINOVICH
Senator Voinovich. First of all, I would like to thank both
of you for the quick action that you have taken and trying to
walk that fine line in terms of making sure people have good
information and at the same time not be panicked by this. I
think that is very important.
But, also, I think that we should be comforted, because
Congress and the former Administration understood how important
this issue of pandemic was, that we do have antiviral drugs
available to us to respond to the folks that are getting sick.
Some simple questions that people are asking--this is not
swine flu. It is H1N1. Is that what we say? And we have a lot
of pork producers in Ohio that have called me and have said,
please clarify for the public that they should not stop buying
pork, or that countries that are having our pork exported to
them should not stop having it being exported. They said, ``We
are hurting now, so please clarify that.'' So it is H1N1 that
we are talking about.
The other thing is thank you very much for your quick
response to the situation that we had in Ohio. Because you need
the help of the local officials so much, are you confident that
they have the proper protocol in terms of how to identify this
and deal with it, and then getting into the question of when or
not you would, for example, close a school? When I was
president of the student body at Ohio University many years
ago, I had to cancel Homecoming and Mother's Weekend, and it
was not a lot of fun for me. But we decided that we wanted to
keep folks from coming into the campus. And you are going to
have instances, throughout the United States, where people are
going to take local action, and I think they need to know that
the folks that are acting locally have been properly briefed in
terms of just how they ought to handle this situation.
Could you comment on that?
Dr. Schuchat. Yes, I can comment on that. We have issued
community recommendations about things such as school closures
and the gatherings that are associated with schools, as well as
other large gatherings in a community. And what I think is
important to say is that we have issued guidance that we think
is prudent, that is relatively aggressive, but that recognizes
the role of local authorities to modify based on the
circumstances on the ground. We want to make sure every
community has good information, but some of the local and State
officials have even better information. So we are pushing this
out to make sure everyone has guidance, but that it recognizes
the local people may want to do more or even less than what we
said.
Senator Voinovich. Does the communication, Ms. Napolitano,
go to the governors and then down through to the counties?
Because usually in our State, the county health officials and
the city health officials are the folks that are on the ground?
Secretary Napolitano. Senator, it is both. It is moving
communication out to local public health officials and
communication with governors and the like. So we are trying to
get as much out to the relevant decisionmakers as possible.
Senator Voinovich. We have talked about the antiviral. The
purpose of that is that somebody has the virus, and the
antiviral deals with it so they do not get sick and die. The
other part of this is the issue of vaccines, and millions of
Americans have taken flu shots, including George and Janet
Voinovich, my wife and I. And I think that you need to clarify
that because you have flu shots does not necessarily mean that
you are going to be exempt from this. Is that correct?
Dr. Schuchat. That is right. It is great that you have
gotten your flu shot, and I got mine as well. But that protects
against the regular flu, the seasonal flu, not against this new
virus, this new H1N1 strain.
Senator Voinovich. When are you going to be able to tell
whether or not folks should be vaccinated for this? And, also,
as somebody else, I guess, asked the question, how long do you
think it would take to develop the vaccine? Is the CDC working
with other world organizations so you can gather the best
experts together to come up with this thing on an international
basis?
Dr. Schuchat. Yes, CDC has a role at the beginning in
growing the virus strain and then handing it off to partners to
make the product. We are working collaboratively, both here
across the U.S. Government, the FDA, the NIH, and BARDA is
really quite important. And through the World Health
Organization, we are involved in a global basis. CDC's
influenza experts are part of WHO's committee that picks the
seasonal flu virus strains each year and that would also, going
forward, advise about a pandemic vaccine if we needed to make
it. So that is happening.
In terms of the decision to vaccinate, I am glad that you
separated the question of the decision to make a vaccine from
the decision to vaccinate. Some people look back to 1976 when
we had an outbreak of swine flu in New Jersey and, reviewing
the government response to that, wonder whether there was
enough deliberation in separating the two ideas. So what I can
say is we are working aggressively to make sure that if we need
to produce a vaccine, we will be able to, and it could be
available as soon as September 1, 2009, if all went well; but
that we also are separating that particular decision from a
later decision about use of a vaccine in the fall or when the
vaccine was available. And I think that the best scientific
minds will be contributing to that decision.
Senator Voinovich. Right, because sometimes the vaccine in
itself gets people sick, doesn't it?
Secretary Napolitano. Senator, yes, and that decision, once
there is a vaccine, about who to vaccinate and how to do it is
not an easy one, and it will be informed by the best scientific
advice we can get. I spent last night reading a book about what
happened in 1976 with the decisionmaking on the last iteration
of swine flu. So we can learn from past history in terms of
what kind of decisionmaking process we need to go through.
Senator Voinovich. Have you decided yet in terms of who is
most vulnerable, or is it across all ages? Is it that young
people are more vulnerable or the older people? Or is it just
they are all about the same?
Dr. Schuchat. The information so far suggests that we have
not been seeing confirmed cases in older populations, but it is
early. We have teams trying to get better information verified
from Mexico, and here in the United States we are looking at
the cases we have. Our cases have an average age that is quite
young, in the 20s, or teens, not seniors. But we are also
prepared to see changes, and so we are not able to say yet the
highest risk group, but we are looking into that.
Senator Voinovich. Thank you.
Last but not least, I am Ranking Member on the
Appropriations Committee's Homeland Security Subcommittee, and
I understand you have enough money to take care of the
situation now, but that you are going to be looking for money
in the supplemental. Is that correct?
Secretary Napolitano. Senator, the President announced
yesterday he was going to seek $1.5 billion, and I think that
is a rough estimate, and it is gauged on perhaps having to
purchase more antivirals.
Senator Voinovich. But you have enough money right now to
hold it over because we do not know when that supplemental will
be finally----
Secretary Napolitano. Yes, sir.
Senator Voinovich. Thanks very much.
Chairman Lieberman. Thank you, Senator Voinovich. Senator
Pryor, good morning.
OPENING STATEMENT OF SENATOR PRYOR
Senator Pryor. Thank you, Mr. Chairman. Thank you for doing
this.
Let me start with you, Dr. Schuchat, and ask about this
particular strain of flu. And it may be too early to know the
answer to some of these questions, but there is a perception
that it is worse in Mexico, more lethal in Mexico than it is in
the United States. Is that a fair perception? Or do we know
yet?
Dr. Schuchat. The initial impression was that confirmed
cases from Mexico were severe, hospitalized young adults with
pneumonia. As the investigation in Mexico expands, apparently
they are confirming illness in milder circumstances, and so I
think we may yet find that truly they have a worse problem in
terms of severity than we do, or that it may have just been the
quality of the information early on in terms of where we were
looking.
Senator Pryor. I do not know how the process works in terms
of you determining the mortality rate of a particular strain of
flu virus. How long does that take you? And what factors do you
consider?
Dr. Schuchat. There has been a lot of planning around the
severity index for a pandemic. Sort of like categories for
hurricanes, we have been thinking of categories for pandemics,
where a seasonal flu would be a Category 1, and a Category 5
pandemic would be a higher mortality situation.
We are in early days. We are looking at the illness that we
see and calculating the proportion that is fatal. But until
there is a larger number of definite cases experienced, we
cannot precisely say things.
I can say that we are acting aggressively, implementing
these community guidance efforts to tamp down transmission,
assuming that this is a serious situation that we can improve
through reduced transmission at the community level.
Senator Pryor. And I understand that the flu virus mutates.
Is it, again, too early to know whether you are seeing the
mutations in this virus?
Dr. Schuchat. It is very important that we continue to
learn, that we not make all of our response efforts based on
the first few isolates of virus that we tested, because it is
possible that the strain will change over time. It may become
more severe or less severe. It may acquire resistance, which it
does not have right now. So we are following it, and the
laboratory scientists at CDC--24 hours a day we have shifts
working on the specimens that we have, really doing a
phenomenal job.
Senator Pryor. Is the news media helping you in your
efforts right now? I know there is almost wall-to-wall coverage
on this, and there is a little bit of a media feeding frenzy.
Is that helpful?
Dr. Schuchat. One of the most important things during an
outbreak such as this is clear, accurate, timely communication,
and the media has a very important role to play. We are
committed at CDC--and I know the Department of Homeland
Security feels the same way--to be accessible, to get
information out as we know it, and the media is our partner in
that. So I appreciate the help that they have given us in
making sure people know what is going on. I think they are
getting tired of a few of our faces at this point, but we
really do want to get our information out, and we need them.
Senator Pryor. Good. Thank you.
Secretary Napolitano, it is good to see you again. Thank
you for your public service. I know you are doing great things
at DHS already, and now you have this pandemic, or at least
this flu episode that you are dealing with. So thank you for
your service.
Secretary Napolitano. Thank you, Senator.
Senator Pryor. Let me ask you about vaccines and
antivirals. I am assuming that there has been a lot of
preparation on how to distribute those around the country. One
of the questions I have is for the States. When the States
receive vaccines and other materials, should they use them on
their population, or should they use them in a neighboring
State that may have a worse situation?
Secretary Napolitano. Well, there is a robust plan for how
things like vaccine and antivirals are distributed through the
public health community, and on this one, what we are doing is
the first States that are getting the antivirals are the ones
where we already have either confirmed cases of disease or
along the southwest border. But we are moving things out very
quickly, so by next week every State will have its
proportionate share. And because this is a rapidly changing
picture and every time we get a new report, there are more
States that have either reported suspect cases or confirmed
cases, every State then will get it distributed within its own
boundaries, according to its own plan.
Senator Pryor. And I know it is way too early to be putting
together a lessons learned memo on this, but as early as we are
in this process, are you already seeing areas where you know we
can do better next time?
Secretary Napolitano. Senator, it is awfully early. It has
been less than a week that we have been at this, although we
have been at it, it seems, 24 hours a day. But obviously we are
keeping track of what we are doing, and there will always be
lessons learned from an episode like this. There are going to
be things at the end that we say we would do differently, but
right now we are kind of in it.
Senator Pryor. Well, you are both doing great work, and we
appreciate you, and I think both of you, as well as Federal
agencies generally, have done a very good job of keeping the
public informed and giving realistic assessment of what is
going on out there. We appreciate it. Thank you very much.
Secretary Napolitano. Thank you.
Chairman Lieberman. Thank you very much, Senator Pryor.
Senator Burris.
OPENING STATEMENT OF SENATOR BURRIS
Senator Burris. Thank you, Mr. Chairman. I want to add my
thanks to these two distinguished public servants for their
prior service and current service and, of course, being right
in the middle of the firestorm. So you have our
congratulations, and we want you all to keep up the good work.
Just prior to coming to the Committee, I was on the phone
with my public health director from the State of Illinois, and
we do have eight cases that now are suspect. They are now going
through the testing process, and it is primarily in northern
Illinois. So we can hope and pray that they are not, but I do
not think it looks that promising.
Madam Secretary, I was just concerned about the challenges
surrounding this flu and the treatment and the information and
how you communicate. In the community of Chicago, we have about
30-plus languages that have to be spoken, and getting the word
out in all those different languages will put a strain on the
resources of the city and the State. And I just wondered if any
of those dollars that the President has asked for would be some
type of grant funds that could go to assist in the overall
costs that the States and local governments would be
experiencing during this situation.
Secretary Napolitano. Senator, I think that the initial
request from the President is rather general, and we are
working now on how to sculpt it to be best used as we go
through this epidemic. So that will be one of the ideas that we
will take back.
Senator Burris. Please do because budgets are already in
bad shape in the cities and State government. I know mine are
operating at major deficits, and these types of crises bring
additional responsibilities and expenses that have not been
budgeted for, which means you have to rob Peter again and you
will not be able to get it from Paul because Paul does not have
anything either. So keep that in mind that we are going to need
some assistance as we try to go through the financial part of
this.
Secretary Napolitano. Senator, as a former governor myself,
I am very sensitive to the fiscal situation of the States and
cities in the country. And what we want to make sure of is that
resources are put in the best place to have the greatest
impact. And, again, all our decisions are going to be based on
science and an evaluation of what is the most efficacious way
to protect the safety of the American people.
Senator Burris. I also agree with Senator Voinovich. I have
been in contact with my pork producers in the great State of
Illinois, and they are requesting that we come up with some
other name for this influenza, this virus, because they call it
``swine flu,'' but you always hear the reports saying it has
nothing to do with swine. And so if that is the case, how do we
come up with some other name for this? By the way, is it strain
A? I thought it was strain A.
Dr. Schuchat. Right, this is influenza A, H1N1, and for the
time being we are calling it 2009 H1N1 influenza.
Senator Burris. That is not sexy.
Dr. Schuchat. It really is not catchy, no. But I think I
said before you were here that there is no evidence that eating
pork or pork products is associated with this condition, and we
think that is an important message to get out, that this is not
something that you get by eating pork.
Senator Burris. But has it gotten so in the system that you
cannot back it off and come up with some immediate terminology?
Because our pork producers are really concerned that people are
going to stop buying it. And you hear when Japan and some other
countries have stopped--I think it was China that said they are
not taking any American exports of pork. Madam Secretary, is
there any type of name we can--I know you are not the medical
one. Put on your legal hat. You were also an Attorney General,
right?
Secretary Napolitano. Yes, I have had many jobs. And in my
written testimony for this hearing, I just call it ``H1N1,''
and actually, once you say ``H1N1'' a few times, it does roll
off the tongue. But I know I was with the Secretary of the
Agriculture and the U.S. Trade Representative yesterday, and we
were talking about our coordinated and joint efforts to get the
word out that this is not a pork-borne illness and that you
cannot get it by eating pork. But I think we need to
continually send out that message, and I know the Secretary of
Agriculture is dealing with some countries that are using this
as a purported reason to restrict imports.
Senator Burris. I want to thank you all. I think that is
the end of my questions. Thank you all very much.
Thank you, Mr. Chairman.
Chairman Lieberman. Thank you, Senator Burris. Senator
Graham, good morning.
OPENING STATEMENT OF SENATOR GRAHAM
Senator Graham. Good morning, sir. Can you get this from
eating pork? [Laughter.]
Secretary Napolitano. No.
Senator Graham. OK. Making sure we are on message here.
The opportunity to deal with this problem in terms of
creating a vaccine--maybe by September. Is that right, Dr.
Schuchat? Do we have the legal protections in place that would
encourage the pharmaceutical companies to develop a vaccine
that fast without being sued for trying?
Secretary Napolitano. Well, Senator, there are several
protections in place. There is the Public Readiness and
Emergency Preparedness Act at 42 U.S.C. 247d, and you might
examine that. But that is a statute that is guided by the
Secretary of HHS, but designed to provide that sort of
protection. That is one of the things in place now.
Senator Graham. Well, from my point of view--and I would
assume that most of the Committee would share this--if we are
going to embark on such a bold project, which it seems like it
would be smart to do, we need to make sure we have the laws in
place that think through what happens to those who try to help
solve this problem. So as you go back and inventory the legal
environment, if you find gaps or you think you need it to be
beefed up in terms of providing liability protection for those
to help us with this problem, please let this Committee or the
appropriate committees know.
Now, let us talk about the worst-case scenario for a
moment, hoping it never happens, but let us just put it on the
table. I guess the worst-case scenario would be that in the
fall this thing spreads, that you have to consider closing the
border with Mexico. Would that be one of the worst-case
scenarios?
Dr. Schuchat. I would like to clarify my previous remarks
when we were speaking about closing the border. Going forward,
there is no circumstance in which I think border closure might
have value. It was a question of if we had no cases here and
the first case was someplace far away, a border intervention
makes sense.
Senator Graham. Well, let us talk about that. Let us say
that we have more cases here, but we have a vaccine that works,
but they do not have one in Mexico that is not working, and
they keep having more cases. We are controlling the ones we
have. Why wouldn't you want to consider closing the border
there?
Dr. Schuchat. Just a few comments. I think that populations
that have extensive disease are likely to be protected going
forward. Mexico may be in the best place going forward because
this thing may have already run through their communities.
Senator Graham. Do you think that has happened in Mexico,
that it has run through----
Dr. Schuchat. No, I am just saying that if we are talking
about 6 months from now when a vaccine might be available. But
this is really a global issue and a global problem with global
solutions, and the World Health Organization has been focusing
on the international vaccine questions and development and
deployment. For us, we expect if we went ahead and made
vaccine, it would be available by the fall.
Senator Graham. Well, Madam Secretary, if I may be so bold,
I could foresee a scenario where Mexico or Canada--one of our
neighbors that this problem could get worse while it is getting
better here, that you would have to take some pretty drastic
action. Do you have a plan in such a situation? Is there any
contemplation by the Administration of a plan that would indeed
seal the border if it was required?
Secretary Napolitano. We have plans for a number of
different contingencies and scenarios, but I will tell you,
Senator, this situation really changes daily.
Senator Graham. Right.
Secretary Napolitano. So we will make decisions informed by
science and what we think makes sense under----
Senator Graham. Yes. I am not suggesting that you need to
do that and hope we never will. I am just suggesting a lot of
criticism about Iraq is you always assume the best and never
plan for the worst. Let us not repeat that.
We have guest worker programs--I think Senator Chambliss
mentioned it to you yesterday--where we get a lot of labor in
the agriculture community coming from Mexico and the H-2A and
H-2B visa program, and the farmers need the labor. Where do we
stand in terms of making sure that legal immigrant population
that is coming in to work here during the summer and the fall--
what are we doing about that problem when we are going to bring
a lot of people from Mexico here to work in agriculture?
Secretary Napolitano. Senator, we really are handling the
H-2A population the way we are handling travelers in general;
that is to say, they are monitored to see if they have any
signs of disease, asked if they have any signs of disease, and
handled in that fashion. But, otherwise, they are legal
travelers because they have visas. So they would come in.
Senator Graham. Are you doing anything new for that
population beyond just what you do at the border for somebody
driving a car through?
Secretary Napolitano. Not currently.
Senator Graham. Do you think it would be wise to look at
doing something new?
Secretary Napolitano. Yes.
Senator Graham. That is fair. Now, if we have to administer
immunization to the population as a whole--is that a remote
possibility, Dr. Schuchat, in a worst-case scenario event?
Dr. Schuchat. These are early days to know whether that is
the type of step we would take. One of the things we try to do
in this stage is learn as much as we can about who is getting
sick and who is not, and that can inform who might----
Senator Graham. Can you see any reasonable possibility down
the road based on science where that might be required?
Dr. Schuchat. Yes, absolutely. There is a reasonable
possibility.
Senator Graham. And you are planning for that, I take it.
Dr. Schuchat. Absolutely. That is why the past several
years we have been investing in better manufacturing capacity
and new technologies and so forth. So certainly the planning
cases have been whole population, two doses.
Senator Graham. All right. Now, while we have some legal
protections for companies that would help develop the vaccine--
you have talked about that, Madam Secretary. Look and see if
you need more. What about the people who would administer the
vaccine? What about the health care professionals that would be
tasked under the worst-case scenario to go out and administer
this drug to the population as a whole? Do we have any
liability protection for them on the books?
Dr. Schuchat. I am going to need to get back with you about
that. I am not aware that is a concern. I think the primary one
had been about the manufacturers. Remember that if vaccine is
delivered in this context, it would be under the Federal
Government's authority.
Senator Graham. The only reason I mention that, being a
military lawyer, is we have a requirement you get vaccinated
for certain problems in the military, and we had a problem with
anthrax, and we had mandatory vaccinations, and we had a few
cases of people that react. Well, they do not have the choice
in the military because you are part of the military, that is
your job. But if we do go to a mandatory immunization to the
population as a whole like we have done in the past, I think we
need to really think about what exposure the health care
professionals have and do something about it now while we have
the time.
Thank you both. I think you have done a good job. And the
only reason I am talking about this is if it gets better that
is great. If it gets worse, that is not so great. And I can
understand how hard this is, but we have guest workers coming
in through a legal system. We have legal liability that is
there, I think, in a limited way, and we need to look robustly
at the guest worker program, a worst-case scenario to seal the
border if you had to, and certainly to look at legal
protections for those who are going to produce the vaccine and
administer it, so that if that worst-case situation ever
happens, we will not be behind the eight ball.
Secretary Napolitano. Senator, thank you, and I think you
are right that we have to be planning for the worst and hoping
for the best. The statute that I referred to does include
distributors, program planners, persons who prescribe,
administer, or dispense.
Senator Graham. Great. If you could send me a little memo
about how detailed that is, what kind of liability protections,
I would like to talk with you about making sure that is enough
and improving it if we have to. Thank you.
Chairman Lieberman. Thanks very much, Senator Graham.
Secretary I appreciate your answer to Senator Graham's
conditional question about whether you would be open to
considering increasing the checks on people coming in from
Mexico--guest workers, for instance--with regard to their
health, because I think if you do not, there will be growing
pressure to really close the ports of entry. And I understand
it is complicated with the number--the volume is what, 800,000
to a million a day coming across? Does that sound right?
Secretary Napolitano. I will double check. It is an awful
lot.
Chairman Lieberman. It is an awful lot of people. So the
thought--because, really, in our minds what we would like to
think is that everybody would be stopped, and you would take
their temperature. You would look at them to see if they are
coughing or sweating or whatever. And the Mexicans would have
the right to do that to people going in, if they wanted. So how
we go from where we are now, which frankly does not sound like
much--and I know how hard it is--to something that will create
a slightly more demanding screen for people coming in is, I
think, very important to think about, or I believe the pressure
will grow to do something much more definitive, like closing
some of the ports of entry.
Secretary Napolitano. Mr. Chairman, I agree, if we go to an
enhanced closing the ports or enhanced every individual gets
screened protocol, we are going to have to be able to explain
because that will cause delays and lines in processing. What is
the advantage we are getting from that other than symbolism in
terms of actually preventing disease in our country? And right
now what the scientists are telling me is, beyond symbolism, we
really do not get an advantage in terms of spread of disease.
But if we go that far, we are continually thinking and
rethinking this. That is really the explanation we are going to
have to be prepared to give.
Chairman Lieberman. Yes, this is a classic of the very hard
decisions when you are balancing factors. Obviously, you have
to listen to the science. And, again, common sense would say if
we are trying to stop people from congregating places, which
they are doing in Mexico already--and, of course, it is
starting in places here; a couple of schools are closed in
Connecticut today because of suspected cases--then there is a
natural next step to say, well, maybe we should then try to
stop mixing of people coming over the border for the same
reason.
So you have got to weigh what is the public health benefit
from that. How much does it cost you to implement such a
system? And then what are the economic consequences and
personal consequences on our country and our neighbors in
Mexico? These are not easy decisions. But if it spreads, I
think we are going to be faced with those questions, and I
think what you are hearing today from Members of the Committee
is what we are not only thinking but hearing from our
constituents. And I think those calls will grow louder, and you
understand that.
I want to go to another subject. Talk about tough decisions
to make. I wanted to ask about both the antivirals and the
vaccines. Here is a basic sort of uninformed patient's question
about the medical consequences. Am I correct in assuming that
in the case of the infant that died in Texas today, the
confirmed death from swine flu, and the almost 150 people,
maybe more now, in Mexico that have died, that was because they
were not administered a course of the antiviral? In other
words, why do some people, apart from their own vulnerability--
and maybe that is it. Why do some people die from this and
others seem to get it and go on?
Dr. Schuchat. Influenza is a virus that can cause severe
disease, even the seasonal flu. So each year in the United
States, about 20,000 young children are hospitalized from flu
and between 50 and 150 do die with just regular seasonal flu.
I do not have the specific circumstances of the child in
terms of treatment. We know that antiviral drugs can improve
the response, but people may die with or without them. But we
do think antiviral drugs are effective at reducing the risk of
bad complications.
Chairman Lieberman. That helps me to understand it. So if
we hear that people are dying from the swine flu, it is a
result both of their own vulnerability and perhaps--although
this would be the rare or unusual circumstance--the antiviral,
if they got it, just did not work. Or it was administered too
late, for instance.
Dr. Schuchat. Yes, all of those circumstances are possible.
Chairman Lieberman. But the probability is if you get the
antiviral treatment, once you have been confirmed, you are
going to get better.
Dr. Schuchat. The prompt treatment increases that
probability, but for vulnerable hosts, sometimes the medicines
are not enough, and babies are among those at greatest risk for
seasonal flu.
Chairman Lieberman. So one of the judgments that you are
making, I assume, is how many more of the antiviral courses do
we need? We have 50 million. We are giving out a quarter of
them now. Am I right, you are trying to make some projection
and then go ahead and purchase them with part of this $1.5
billion the President has asked for?
Dr. Schuchat. Yes, that is right. We are looking into what
we have on hand and what we may need going out. When we made
the original estimates of how much to procure in the Strategic
National Stockpile, it was really forward thinking in a supply-
limited environment. If we have time now to produce more for
the years ahead, there may be some benefit in that, but it is
being looked at.
Chairman Lieberman. So now let me go to the vaccine. Am I
correct that a decision has been made that if we can develop a
vaccine for swine flu, we will definitely make it?
Dr. Schuchat. I do not believe that decision has been made
yet. What has been made is that we are taking all the steps
necessary, if we decide to make a vaccine, to make one. So we
have the seed strain being looked at both with the traditional
egg-based cultures and then also with this reverse genetics
approach. We have the industry lined up to be partnering with
the government. We have NIH ready to do the clinical trials
that would be needed. But there is this phase before you
actually go to large-scale production, which will define
whether or not you are going to, and which kind of vaccine you
should make.
Chairman Lieberman. If you all with your extraordinary
capabilities develop a vaccine that works against swine flu,
why would we not make it?
Dr. Schuchat. First off, CDC does not actually make the
vaccine. We are just one part of the family----
Chairman Lieberman. Understood. But you know what I am
saying. I am asking a public policy question. I assume if we
could develop it, we would make it.
Dr. Schuchat. Well, I think we will be learning quite a bit
about what it is going to take to make one in terms of--we were
disappointed originally with the H5N1 vaccine products. You
needed a huge amount of antigen in order to get a response. If
you added an adjuvant component, you did not need so much.
There is a lot of science that will be going on in the next few
weeks or months that will help us understand what we could
expect, how much could we make, how much response might it
give.
Some of the influenza virus strains do not grow that well,
and it is hard to make a vaccine from them. So we do not know.
Chairman Lieberman. Secretary, do you want to weigh in on
this? Because I would assume that if we can make it, we will.
Secretary Napolitano. Well, these are obviously--exactly.
And, again, I want to just say these decisions need to be
informed by science.
Chairman Lieberman. Right.
Secretary Napolitano. But vaccines are not in and of
themselves benign, and so they can themselves cause a certain
amount of illness and mortality in the population at large. And
so one of the things that you need to look at is what is the
overall benefit of a large-scale vaccine program in terms of
the severity of this H1N1 virus versus what you might get from
a vaccine. So that just illustrates for you, I think, Mr.
Chairman, that there are a lot of factors that need to be taken
into account.
Chairman Lieberman. I assume that if we decided to produce
a vaccine because we found one that worked on swine flu, the
aim here would be to produce 300 million doses so that we could
at least have the capacity to administer one to every American?
Dr. Schuchat. The planning that was done was with that in
mind, and including who would be among the first to get such a
vaccine, critical infrastructure, and some other groups.
Chairman Lieberman. Talk about hard judgments to make.
Dr. Schuchat. Yes, and we actually did both expert group
input and also public engagement about what did people value
the most, those who were most likely to die from an illness,
those who would keep society going. We got very good input from
a series of public engagement efforts about that in our
planning a couple years ago.
Chairman Lieberman. Do we have the domestic capacity to
produce sufficient quantities of vaccine up to the 300 million?
Dr. Schuchat. The investments in pandemic preparedness that
Congress made possible have resulted in phenomenal expansion in
manufacturing capacity so that we are very optimistic going
forward about what we can expect. But this virus can surprise
us, and even with all those investments, it may just
technically be difficult.
Chairman Lieberman. Thank you very much. Senator Collins.
Senator Collins. Thank you, Mr. Chairman.
Doctor, I want to talk further with you about the vaccine
issue because the 1976 experience is a real cautionary tale,
and I know that Secretary Napolitano was saying that she was
reading a book about it, and I have refreshed my memory about
it as well.
In this case, it turns out that health experts were
mistaken about the kind of flu--it turned out to be an avian
flu, not a swine flu--and the CDC Director had urged the
President and Congress to undertake a mass inoculation program
of the population. And within a few months, almost 25 percent
of the population had received the vaccine, but it was not a
very happy result. It turned out that the vaccine had serious
consequences for some individuals, producing a rare
neurological disease. Five hundred people contracted the
disease as a side effect of the vaccine; 25 of them died.
What have we learned from that terrible experience? It
really was a debacle. It caused the head of the CDC at the time
his job. What have we learned from that experience in 1976 that
we can apply to the situation today?
The reason I ask this is for those who were not around in
1976 or who are too young to remember what happened, there is a
tendency to see the vaccine as the magic answer, as the
solution.
Could you talk to us about what lessons CDC has learned
that would prevent a reoccurrence of what happened in 1976?
Dr. Schuchat. Thanks for that question. I think that it is
humbling going forward to look at the complexity of
decisionmaking that will be necessary, and I think an important
lesson to be learned is how important careful deliberation,
best case and worst case scenarios, looking really at all sides
of an issue, will be needed--the health benefits, the health
risks, the social benefits and social risks, the economic
issues.
I think that we hope to have--CDC is just part of the
story, of course, but I think we really hope to be able to step
back and make decisions carefully amongst the affected groups
and to seek wise counsel from dissenting views, to really get
people to look at things from a different perspective.
I can mention that CDC pretty much routinely, for our
emergency responses and also for this one, has a Team B, a
group that is really not involved in the response but stepping
back and looking at it and trying to think about issues where
we really might not be going on the right track or where other
perspectives might be very useful.
I think Secretary Napolitano might have some other ideas
since you refreshed your memory last night.
Senator Collins. Secretary Napolitano.
Secretary Napolitano. Well, I was a college freshman in
1976, so my memory was a little stretched. [Laughter.]
Senator Collins. It really bugs me when our witnesses are
younger than I am, Mr. Chairman.
Secretary Napolitano. But, yes, I think the doctor has it
right. And what we want to do is make sure moving forward that
we are getting lots of different inputs as we approach what can
be some very difficult decisions where you are constantly
weighing what is the benefit to be gained versus the cost. And
it is not just the CDC, but other members of the academic and
scientific community. It is members of the private sector who
have to give us input about what would be the economic impacts
of some of our decisions. And it really has to be taking into
account a myriad of different factors in terms of whether you
do a universal vaccine program.
Senator Collins. That is the point that I wanted to make.
It is not an easy decision to decide to do a mass inoculation,
and while I am sure that the science behind vaccines has
improved in the last 30 years, the experience of 1976 should
cause us to proceed with caution. And I am confident that you
will do that.
Madam Secretary, I want to turn back to the border issue
that we discussed earlier. You took some issue with my
description of the process that CBP is using when I described
it as ``passive surveillance,'' and I think it is important for
the record to note that is the term that the Department of
Homeland Security is using, and, indeed, as recently as 2 days
ago in a press update, the Department has said that the Customs
and Border Protection has also implemented passive surveillance
protocols.
Furthermore, in that same document, where there is a
frequently asked questions part, when the question was asked,
``What steps are you taking to prevent those with flu-like
symptoms from crossing the border?'' The response is not very
reassuring to me and, indeed, to many other Members, because
the response is, ``As part of CBP's routine procedures, if
someone is crossing the border appears ill, the person is
referred to a quarantine station or a local public health
official.''
We should be going beyond routine procedures given the
threat.
Secretary Napolitano. Senator, first of all, I think your
point is well taken. We have used the phrase ``passive
surveillance.'' But we have also used the phrase ``swine flu.''
As we go through this over these days, we are determining
better ways and more precise ways to communicate. So
``passive'' seems to suggest that nobody is doing anything, and
the answer is they are following a direct protocol to examine,
to look, to ask questions.
And when they say ``routine,'' what they mean to say--what
that is is that, for example, we are constantly at the border
trying to check to see whether individuals who may have
tuberculosis are crossing the border as a problem within
Mexico, so that if you see somebody present who has signs of
illness, coughing and the like, they have a travel history in
Mexico, particularly certain States within Mexico, they can be
isolated in a room and examined further, that is the routine.
But that is virtually identical to how we are dealing with
identifying those who may have flu.
Senator Collins. Well, let me tell you why I am so
concerned. In 2007, our Committee did an investigation of the
case of the Mexican citizen who crossed 21 times back and forth
across the border, despite the fact that CDC had identified him
as having a highly contagious, drug-resistant strain of
tuberculosis. So here is an individual who has been identified
by CDC, and yet Customs and Border Protection was still unable
to stop him from crossing almost two dozen times.
Now, I have a great deal of respect for how hard the
Customs and Border Protection officials are working. I also
know that they are very well meaning and that they are well
trained. But if they cannot catch an individual who has been
specifically identified as being a public health threat, whose
name they actually have, then why should I have any confidence
that they are going to be able, using just what are described
as ``passive surveillance'' protocols, not using electronic
scanners or other technology, why should I have confidence that
they are going to be able to screen for this serious flu,
particularly since, as the Chairman mentions, the volume of
people crossing every day is just enormous?
Secretary Napolitano. Senator, I think the question you
raise is the same question in a way that Senator Graham was
raising: Are there some things that we can do with respect to
visa issuance and the like that will diminish the possibility
of somebody carrying flu coming over? And we are open to those
ideas and suggestions. But, again, the decision to actually
close the entire border, which is what has been raised--and
since we have flu in Canada, I would anticipate that the same
argument would be made there. So closing both borders, with all
of the huge impacts that would have, in light of the fact that
the scientists and the epidemiologists say would have virtually
no impact on the amount of disease in our country, when you
balance those things, particularly in light, as you say, of the
difficulty of knowing whether any individual has disease, and
when you make that whole package of decisions, you understand
why closing the border is not an adequate answer to this
epidemic.
Senator Collins. I realize my time has long since expired,
but let me just make very clear: I am not advocating closing
the border. That is not my position. The only time that would
make sense to me based on the expert testimony we have had
today is if you temporarily close the border in order to allow
the distribution of medicine to key areas or perhaps the
vaccination of Customs and Border Protection officials at the
border. Then it might make sense to close it for a brief time
to allow that to occur. So that is not what I am advocating.
I am advocating for a stepped-up medical presence at the
borders. I am advocating for the use of technology, perhaps
these scanners that six other countries are using. Even if they
are not perfect, they are going to catch some of the cases. And
I am advocating for enhanced, active questioning surveillance
techniques.
So I just want to clarify that I think there are steps that
can be taken between what we are doing now, which I do not
consider to be adequate, versus closing the border. There are
more effective enhanced methods that could be put in place, and
I just urge you to consider them, which you have already
indicated you are willing to do.
Secretary Napolitano. Absolutely.
Senator Collins. And, again, I do want to applaud you for
the response. I have talked to bioterrorism experts who say
that we are doing so much better a job. And as the doctor has
made clear, our preparedness has grown by leaps and bounds due
to the investments that Congress has made, and effective
leadership. So I thank you for that.
Secretary Napolitano. Thank you, Senator.
Chairman Lieberman. Thanks, Senator Collins.
I echo Senator Collins. I was thinking here at the end,
naturally, we--Members of the Committee, myself included--
pushed you on some of the tough questions that are in some
sense ahead. That is the nature of what we are thinking about
and what people are asking us. But I do not want that to
diminish our feelings--again, I speak for myself here--that
this was one of those cases where the Federal Government is
prepared, that we have a plan, that we have a Department that
is relatively new but that coordinates quite a wide array of
the agencies that are directly involved here, and in cases
where it does not have all that direct expertise, it works very
closely obviously under your incident management position,
Secretary Napolitano, with groups like CDC and now Secretary
Sebelius at HHS.
So I think there is a lot of reason for the American people
to feel encouraged that the Federal Government is really there
on this occasion protecting them. I think you have heard--
obviously the President has indicated this by his request for
$1.5 billion--from Senator Voinovich, Ranking Member on the
Appropriations Homeland Security Subcommittee, that there is
going to be no resistance here to providing you and the other
departments of our government with all the money you need to
protect the American people from the spread of this disease,
which we are rightly taking seriously.
So I appreciate everything you have done. We are going to,
as a Committee, stay involved in this. I cannot help but
express a certain amount of not only gratitude to you,
Secretary Napolitano, but pride since this is the Committee
from which the Department originated, and I think you have
shown us thus far in this crisis why it was a good idea to form
it, not just in response to September 11, 2001, but to help our
government better manage a host of other emergencies, including
this kind of public health emergency.
So we are going to keep the record of the hearing open. I
suppose I should ask each of you--it is a bit unusual--whether
you have anything you would like to say in closing.
Dr. Schuchat. Just that we really appreciate the support
that Congress has had for preparedness in the past and to help
us with the situation now.
Chairman Lieberman. Thank you.
Secretary Napolitano. I echo that, but also to say that
communication here is going to be so important. This is an
evolving situation. I was just handed a note that they now have
13 confirmed cases in Canada, which I was not able to answer
earlier. So every half-hour or hour we get a different picture,
and my goal is to communicate with the Committee, with the
Congress, what we are doing, why we are making decisions as we
make them, and to communicate the same with the American
people.
Chairman Lieberman. It is very important. We appreciate it
a lot. Thank you.
The record will stay open for 15 days for additional
questions and statements as desired. For now, that is it for
this morning. Thanks for your time.
The hearing is adjourned.
[Whereupon, at 12:12 p.m., the Committee was adjourned.]
H1N1 FLU: PROTECTING OUR COMMUNITY
----------
MONDAY, SEPTEMBER 21, 2009
U.S. Senate,
Committee on Homeland Security and
Governmental Affairs,
Hartford, CT.
The Committee met, pursuant to notice, at 10 a.m., at the
Legislative Office Building, Hearing Room 2E, 300 Capitol
Avenue, Hartford, Connecticut, Hon. Joseph I. Lieberman,
Chairman of the Committee, presiding.
Present: Senator Lieberman.
OPENING STATEMENT OF SENATOR LIEBERMAN
Chairman Lieberman. I thank everybody for being here, and I
particularly thank the witnesses. I particularly want to thank
my wife, Hadassah, because I rarely have the opportunity to say
that. She is in attendance today. This speaks to the fact that,
like everybody else, she is concerned about the topic of this
hearing, which is the extent to which we are prepared to deal
with an outbreak of H1N1, what we used to call swine flu, and a
lot of people still do.
This is a field hearing of the Senate Homeland Security and
Governmental Affairs Committee. We want to particularly look at
Connecticut's preparedness for a resurgence this year of H1N1
influenza. Some might ask why the Committee on Homeland
Security and Governmental Affairs is interested in this.
The Committee on Homeland Security and Governmental Affairs
was created after September 11, 2001, to organize various
agencies of our government to do everything we could to make
sure that there were no gaps, there was no lack of
communication, so that the vulnerabilities that the terrorists
exploited on September 11, 2001, would not be there--to the
best of our ability--in the future, but it was also put
together to make sure that in a coordinated way we could deal
with natural disasters. The Federal Emergency Management Agency
(FEMA), for instance, is in the Department of Homeland Security
now.
The Department of Homeland Security (DHS) is designated
under Executive Order as the Department that manages incidents
of national significance. And the President has declared this
to be an incident of national significance, so Secretary Janet
Napolitano at the Department of Homeland Security is the lead
Federal coordinator of our response, even though you see
Secretary Kathleen Sebelius of the Department of Health and
Human Services (HHS) a lot, which is quite understandable
because of the nature of this.
I would also say that one of the things that I have worried
about in this post-September 11, 2001, age is when we were told
by the 9/11 Commission that one of the reasons September 11,
2001, happened was because of a failure of imagination. And
what did they mean by a failure of imagination? The failure to
imagine that people would actually do what was done to us on
September 11, 2001.
So we spend time--it is not the most pleasant way to spend
time--trying to imagine what others might do to do damage to
us. We just had a report come out from the Commission that said
that in terms of fear of terrorists using a weapon of mass
destruction, that the most likely weapon would not be
everybody's nightmare scenario of a nuclear weapon, but it
would probably be a biological attack because of the relative
ease of taking pathogens and making them into biological
weapons.
So, obviously, there is a lot that our intelligence
community and others, Customs and Border Patrol (CBP), the
Transportation Security Administration (TSA), a whole range of
others, will do to try to prevent such an awful thing from
happening to our country. But then part of what will be on the
line, which will determine the extent to which, God forbid,
such an attack ever happened, we can both limit its impact and
treat those who have been affected by it involves much the same
kind of work we are doing with our public health system and
with communications to the public to limit the spread of H1N1.
So in those ways, this hearing falls both directly into the
Homeland Security Committee and relates to the antiterrorist
work that the Homeland Security Department and our Committee
does.
Again, I want to thank the witnesses who are here today.
They represent a broad range of experts in the field, people
with responsibility. And they will help us determine what the
nature of this flu is now, what the potential is during this
flu season, and what we all can do together to inhibit the
spread.
We are obviously holding this hearing now because we are at
the beginning of the flu season, but September also happens to
be National Preparedness Month, and it therefore gives me an
occasion because National Preparedness Month is about what each
of us can do to secure our country.
Each of us can contribute in our own communities to
inhibiting the spread of flu by the way we conduct ourselves,
things as simple as washing our hands and covering our mouths,
not with our hands but with our elbows when we sneeze, for
instance. The point is that preventing the spread of the flu is
actually something that every individual can and I hope will
help with, and this hearing I am hopeful will help to spread
that message.
H1N1, as we learned last spring, is a fast spreading
disease. It was just detected last spring. It reached pandemic
proportions, worldwide, over the summer, and appears to be
making a comeback as the traditional flu season begins.
The Centers for Disease Control and Prevention (CDC)
estimated a few months ago that a million people in the United
States had become ill with this flu, and they could imagine
that millions more likely had been exposed to it since then. We
know that 9,000 have been hospitalized in our country from the
flu; that 593 have died from flu-related symptoms. Here in
Connecticut, about 2,000 cases have been confirmed, and by the
records, I have seen that nine people have died from flu-
related symptoms.
I would say that unlike other crises of this kind that we
face, fortunately pandemic flu is one, through various means,
that we have planned for and I think are better prepared for,
but not as well as we should be.
In response to global outbreaks in recent years of avian
flu, West Nile virus, and severe acute respiratory syndrome
(SARS), the CDC developed a strategy for a coordinated national
response to infectious diseases. The Homeland Security Council
adopted a national strategy for how to respond to pandemic
influenza. And with support from the Department of Health and
Human Services and the DHS in Washington, our States, including
Connecticut, have both been encouraged, pushed, and enabled to
develop plans for addressing pandemic flu.
Following the spring outbreak, the medical and
pharmaceutical communities have had time to study the H1N1
virus and, I think with remarkable speed, to begin to produce a
vaccine; in other words, a vaccine to a flu that we just
learned about last spring. That is the kind of world in which
we live.
I never got to meet my paternal grandmother because she
died in the flu epidemic of 1918 in New York. Obviously, there
was not this extraordinary ability we have today to isolate a
flu, to figure out how to develop a vaccine to it, and here it
is now. Agencies at all levels of government have gotten
advance warning that they need to be prepared for the
possibility of a more severe strain of the virus this fall,
even though today, thankfully, that has not happened.
So today, I am going to ask our witnesses representing
State and Federal agencies what their H1N1 response plans are
and whether they are working together or is there anything else
we, at the Federal level, can do to address this challenge. I
am going to ask our witnesses on the second panel from public
educational institutions and businesses if the government
planning has been constructive to them and what, if anything
else, they are doing and they think we might do.
The good news to report today, perhaps it has already been
known, is that the Federal Government apparently can begin
delivery of the H1N1 vaccine to States as early as the week
after next. Connecticut is expected to receive approximately a
half a million doses by mid-October, which will be distributed
first to those that public health officials believe are most at
risk. That would include pregnant women, young children,
daycare workers, health care and emergency medical personnel,
and those with certain health conditions that make them more
vulnerable to the flu, such as diabetes or immune deficiencies.
The Federal Government is also providing money to States to
help prepare for the fall flu season and to administer the
vaccine. The Connecticut share of that will be about $4
million.
At this point, the State appears to me--but I want to hear
from you today--on track to stay out in front of a broad H1N1
outbreak. The truth is that we are very fortunate that, thus
far, most cases of the virus have continued to show the same
mild to moderate symptoms as we observed last spring, but
outbreaks of infectious diseases are very hard to predict. That
is, the course infectious diseases follow is very hard to
predict. So circumstances could still change significantly to
become more serious over the coming months. And look, let's
just be specific; nine people have already died in Connecticut
from H1N1-related disease. So this was not, of course, a mild
or moderate disease for them or their families or friends.
Therefore, our responsibility is to stay on heightened
alert, to continue to take preventive action to work together,
to communicate effectively with the public. And, as always,
while hoping for the best and at this moment being confident of
the best, we also have to prepare our public health system for
the worst, for real demands on it.
So I thank the witnesses. I hope in sum that we can get a
clear sense of preparedness for this influenza pandemic here in
Connecticut and to see what our Committee and the Congress can
do to help in the months ahead.
That is my opening statement. I am now delighted to go to
the first panel. I think we are going to keep you to 7 minutes.
We probably will not eject you forcibly if you have to go over
a moment or two to convey the message.
This is a very distinguished panel. The first is Admiral
Michael Milner, who is the Regional Health Administrator,
Region I of the U.S. Public Health Service of HHS.
Admiral Milner, thanks for coming to Hartford to be with us
this morning.
TESTIMONY OF REAR ADMIRAL MICHAEL R. MILNER,\1\ U.S. PUBLIC
HEALTH SERVICE, REGIONAL HEALTH ADMINISTRATOR, REGION I, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Admiral Milner. Good morning, Chairman Lieberman, and your
staff. I am Mike Milner, as you said. I am with the U.S.
Department of Health and Human Services and the Regional Health
Administrator in Boston for HHS.
---------------------------------------------------------------------------
\1\ The prepared statement of Admiral Milner appears in the
Appendix on page 197.
---------------------------------------------------------------------------
I wanted to deviate just a second and tell you how much I
know personally your involvement. The last time I spoke with
you, sir, was coming off the USS Iwo Jima in New Orleans, and
we were having a congressional delegation related to our
response to Hurricane Katrina.
Chairman Lieberman. Yes. We came right down after Hurricane
Katrina.
Admiral Milner. Yes, sir.
Chairman Lieberman. And thank you for what you did. You are
the heroes.
Admiral Milner. I certainly appreciate your passion for
this activity and appreciate the opportunity to be here today
to share with you what our Federal Government has been doing,
what our office has been doing, and what our Northeast States
have been doing together, and specifically partnering with our
Connecticut colleagues to prepare for the pandemic 2009 H1N1
influenza.
By way of background, I thought you should know briefly
about my role and responsibilities with Health and Human
Services as the Regional Health Administrator and how I came to
be before you today. I have served as the senior Federal public
health official for the six New England States since August
2003 and report to the Assistant Secretary for Health, Dr.
Howard Koh.
Additionally, I serve as the senior Federal health official
for both Regions I and II, HHS, as the health official for the
regional coordination team as part of the Department of
Homeland Security. You know that used to be called the
Principal Federal Official Regional Program.
You have already stated broadly the outbreak related to the
2009 H1N1. It has triggered a worldwide pandemic and it is
currently the dominant flu strain in the southern hemisphere as
it is making its way north. The evidence to date shows that the
virus has not changed to become more deadly. Unlike our typical
flu season, we continue to see flu activity in the United
States, and over the summer, of course, we had a lot of
outbreaks in our summer camps here in New England. More
recently, we have seen an increase in the activity in States in
the Southeast and beginning to get reports of increasing
numbers of cases here in New England.
As the fall comes, we anticipate that our communities will
see more viral transmission, and we are preparing for that.
This particular virus will be difficult to distinguish between
seasonal flu and H1N1, which adds some complexity for us, and
we are working together to both message and do the outreach and
clinical care that will be needed.
Chairman Lieberman. Let me interrupt and we will not run
the clock on you. But just as a matter--I know people ask me
this.
How does somebody know if they have H1N1 as opposed to
regular flu or seasonal flu or even just sort of a bad cold?
Admiral Milner. Well, there are a series of symptoms that
we associate with influenza that tend to be different from the
allergy reactions, runny nose, and sneezing that would be
associated with allergies. The clinical presentation--you have
to think about what is happening in the community. And so when
we know that there is an increase of a certain type of
infectious disease in a community, our suspicion goes up.
We have chosen, I think, to limit the amount of testing
that we do simply because of the fact that the H1N1 seems to
have crowded out the seasonal flu in the southern hemisphere.
And we recognize that were we to do clinical testing of every
one that comes into an emergency room (ER) or into primary care
office, it would just completely overwhelm our laboratory
capacity.
Chairman Lieberman. In other words, based on what has
happened south of us, where the H1N1 has dominated--I mean, it
is much more frequent than the regular seasonal flu--we are
reaching a judgment that if you show certain symptoms----
Admiral Milner. We will make an assumption clinically that
you have this particular strain.
Chairman Lieberman. And begin to treat with antivirals.
Admiral Milner. Correct. That prompts your clinical
decision-making surrounding the care of that particular
patient.
Chairman Lieberman. I have heard different answers to this.
Maybe there is not a single answer, but are there any symptoms
that are particularly characteristic of the H1N1 virus or the
flu?
Admiral Milner. Dr. Carter is our resident epidemiologist,
for infectious diseases.
Dr. Cartter. Good morning, Senator.
Chairman Lieberman. Good morning, Doctor.
Dr. Cartter. A lot of folks keep asking, well, is it just
the flu? And my response to that is it is and it is not. I
mean, for the vast majority of us, H1N1 is going to feel just
like seasonal flu; sudden onset of fever, headache, cough,
muscle aches. And you are going to be sick for about a week and
feel like you have been run over by a truck. So it is clearly
much different than the common cold.
But there is no defining feature. What is interesting in
this particular pandemic is that many of the younger people,
children, also have gastrointestinal symptoms, and they have
nausea, diarrhea. And this is a bit different thing than what
we sometimes see with seasonal flu.
Chairman Lieberman. Yes. Anybody else want to add anything?
If not, go ahead, Admiral.
Admiral Milner. Thank you. I am going to try to streamline
things a bit.
Chairman Lieberman. No. Do not be rushed.
Admiral Milner. I think that the important thing from my
perspective is that the Northeast States, the health officials,
the emergency managers, communication directors, public health
and preparedness directors, and a real array of Federal folks--
we have CDC project officers, FEMA and Department of Defense
planners, our Assistant Secretary for Preparedness and
Response; we have emergency coordinators. All of us are working
together, Homeland Security and HHS.
We have been engaged in very aggressive, detailed pandemic
planning now for a number of years, and we have done it through
face-to-face meetings. We have done it through active listening
with our stakeholders, the communities we represent, the
hospitals, the physician groups, the business sector, and our
critical infrastructure sector. We have listened to their needs
and tried to identify things that we can do to meet their needs
during this kind of response.
We have gone as far as hosting multi-day meetings here in
New England where all of our folks come together. We had an
executive communications exercise a few years ago which really
expanded our awareness of our communication challenges. We had
the first regional exercise in the Northeast that exercised our
FEMA concept of operations in terms of how the Department of
Homeland Security, HHS, and FEMA will operate together to
support our States.
So from the Federal perspective, we feel like we have been
ahead of the curve nationally. And I think all of those efforts
have really centered around our communication strategies from a
regional perspective, the interstate and interregional
cooperation, and work to try to improve our understanding of
the scientific guidance as it is being identified. And we are
then applying it to certain things that we do and we implement
in terms of mitigation.
We have tried to see what the ground truth is, and we had a
good opportunity in the spring to really field test this.
Beginning April 24, we started--every morning, I was on a
conference call with our New England State health officers. We
talked about the ground truth and what they were experiencing
and how this virus seemed different from what we had been
planning for.
In my perspective of this, in my discussions with
colleagues around the country, I believe New England and the
Northeast was the tip of the spear in terms of our response. We
were able to at 7:30 in the morning talk about why school
closure guidance was not making sense because of the challenges
that it presented. And later in the morning, we had calls from
CDC and we shared the ground truth, and later in the day, after
that, the guidance begin to shift.
So I really applaud the work of Connecticut and our New
England health officers because they really were sharing things
that helped the Federal Government identify areas that we could
improve and modify our guidance.
So I think the truth is that I have been blessed to be in
New England, to work here and to live here. And my own personal
feeling is if I were to live anywhere with this particular
virus looking at us, I am glad I am in New England and glad I
am in the Northeast.
The rest of my remarks include information about CDC and
the money that has been provided for the State of Connecticut.
The Assistant Secretary for Preparedness and Response asked for
that bit of money. But I believe the specific relationships
that we have in the Northeast, our States, the working
relationship we have here is very strong, and I am very
respectful and very happy that I have the opportunity to work
with such a great group of public health and emergency
management leaders here in New England.
I see this light blinking. It is creating nervousness, so I
will thank you for what you have done on behalf of the----
Chairman Lieberman. Thanks, Admiral Milner.
Admiral Milner [continuing]. The Northeast, for all of the
resources that you have provided here. I believe this group is
excellent stewards of those resources, and I believe that we
are on the leading edge of this response from a Federal
perspective. Thank you.
Chairman Lieberman. Thanks, Admiral Milner. That is very
reassuring. I appreciate your testimony. I would just say for
the record that your full statement, and that of all the other
witnesses, will be printed in the official transcript of the
hearing, and I will have some questions for you, based on the
testimony you have given.
Second is Dr. Matthew L. Cartter, State Epidemiologist
working out of the State Department of Public Health.
Thanks for being here. It is good to see you again.
TESTIMONY OF MATTHEW L. CARTTER,\1\ M.D., STATE EPIDEMIOLOGIST,
CONNECTICUT DEPARTMENT OF PUBLIC HEALTH
Dr. Cartter. Good morning, Senator. Thank you.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Cartter with an attachment
appears in the Appendix on page 204.
---------------------------------------------------------------------------
As you pointed out in your remarks earlier, H1N1 has been a
particular interest of yours since the beginning, and I would
like to thank you and the other members of our congressional
delegation for visiting us here at the State Health Department
in the spring. For those of us who are working on this issue,
it has meant a lot to have you there, and we greatly
appreciated that.
Chairman Lieberman. Well, we learned a lot and we thank
you.
Dr. Cartter. I am here to give you an update on the current
status of the influenza pandemic in Connecticut and the plans
to distribute the newly licensed H1N1 vaccine to the residents
of the State. As a preliminary matter, I will defer to my
colleague, Commissioner Peter Boynton, on issues relating to
planning and preparedness, information sharing and outreach,
and collaboration, although both of us will try to answer your
questions on those issues. I am sure you will have some.
As you mentioned in your introductory remarks, almost 2,000
Connecticut residents have tested positive for H1N1 infection,
I want to point out that is really just the tip of an iceberg,
and that for every person who has tested, there are many more
people who became ill, stayed home and got better; they had
seen a physician and not been tested. So when we see those
numbers, people should not think that there are only 2,000
people that became ill; there were many more than that that
became ill during that period.
Most of those folks who tested positive actually tested
positive back in May, early on, because their focus was to
determine where is this virus and is it here. And clearly, we
saw the spread of this virus largely from the New York City
area into Fairfield County, parts of New Haven County, and
Litchfield County as well.
What I have found to be one of the most important
indicators of widespread community transmission is looking at
hospitalizations related to H1N1, and I think this has become
an important marker for widespread community transmission of
interest. Even though we were looking for this throughout May,
we did not have our first hospitalization in Connecticut until
the last week of May when we had four admissions for H1N1. So
even though there was a lot of publicity about this in May, we
did not see the impact on hospitalizations until then. In June,
there were 104 hospitalizations related to H1N1, and there were
29 hospitalizations in July.
Pandemics occur in waves, and we should view that period as
the first wave of a pandemic of 2009; very distinct, last week
of May to the first 3 weeks of July. Actually, the peak week
was the last week of June when there were 40 hospitalizations,
a very distinct period.
What is remarkable is that we have only had two
hospitalizations for H1N1 since the third week of July.
Which really suggested we had this first peak, and then we
had a bit of a break and we are waiting for the second wave to
start.
Chairman Lieberman. Is that because it was not flu season.
Dr. Cartter. Well, in many ways, we had a second flu
season.
Chairman Lieberman. Yes.
Dr. Cartter. Pandemics do not happen in the normal
seasonality of influenza, and this was our first wave. I think
largely a number of schools in Connecticut run late compared to
the rest of the country, and in the Northeastern part of the
State, the schools were still in session until the end of June.
And I think it is quite remarkable that within 3 weeks we saw a
dramatic decline in the number of cases.
In general, though, the pandemic waves, whether it is in
1918 or 1957 or 1968, tend to last 6 to 8 weeks, which is also
true for seasonal flu. Once seasonal flu hits, we usually see
intense community activity for 6 to 8 weeks in a particular
place, and then it moves on.
Chairman Lieberman. Is there any guidance, based on
history, as to how many waves a pandemic flu will go through?
In other words, how many times will we be dealing with this?
Dr. Cartter. Well, in 1918, there were three waves. Some
people actually talked about a herald wave in the spring of
1918, but certainly in the fall, and then it returned in 1919.
But I think what is important is that this virus eventually
will become one of our seasonal flu viruses. When a new virus
gets introduced that first year, first 2 years, it keeps
returning. But eventually, it becomes one of the seasonal
viruses.
So this one is here with us from here on out. It will
change a little bit every year, just like all the influenza
viruses, but in terms of what we are experiencing right now,
this is characteristic of a new one.
Chairman Lieberman. Interesting. Does that mean that the
vaccine that has been developed for H1N1 may become part of the
regular flu shot, as we all call it, that we take every year?
Dr. Cartter. Well, that certainly would be the goal. The
idea is--the way seasonal flu vaccine decisions are made in the
United States is that there is a group that meets in February,
chaired by the CDC and others, that looks at the experience of
the influenza season, and then decides what should go in the
seasonal flu vaccine. That information is transmitted to the
vaccine companies. They start manufacturing in the spring and
they start shipping in the summer. So this February, they will
have to make a decision about what goes into the next year's
seasonal flu vaccine.
The virus did not disappear over the summer. There were
cases in summer camps. But importantly, we have not yet seen in
Connecticut any evidence of widespread community transmission.
One of the systems that we use to track influenza-like
illness is called the Hospital Emergency Department Syndromic
Surveillance System, and that is a very long name. Essentially,
more than 20 of our hospitals report electronically to us about
syndromes that are seen in the emergency department, like the
total number of visits. And what we are looking at specifically
is the percentage of visits for fever or flu or that is written
down in the chart. This has been an important indicator for us
as to what is going on out there in the community, looking at
emergency department visits.
While we have not seen anywhere near the level of activity
in emergency departments that we saw in May and June, the
percentage of visits for fever, flu are starting to go up,
which may indicate that we are starting to see the beginning of
the second wave.
Chairman Lieberman. But so far, a very small number. How
many did you say; two or three, actual hospitalizations?
Dr. Cartter. We have only had two hospitalizations since
the end of July.
Chairman Lieberman. Yes. That is great. We will see,
though.
Dr. Cartter. I expect first to see the emergency department
visits for fever, flu go up, followed by hospitalizations for
H1N1. That would be our best marker of widespread community
transmission of H1N1.
Again, influenza pandemics differ in their severity. This
pandemic is at least as severe as seasonal influenza. Over the
summer, CDC and State and local health departments looked at
our experience from the spring and revised many of those
guidelines and recommendations that were put out.
Our State public health laboratory has geared up for
testing, but again, as has been mentioned, the focus of our
testing is for public health purposes, and we are ready to use
that to track this pandemic when it returns. We are going to
focus on hospitalizations for H1N1. Our communication and
public education plans are in place.
Now, as has been mentioned before, the best way to prevent
influenza is with a vaccine. There have been a lot of work over
the summer preparing it. I just want to give you some details
about how we are going to be handling the vaccine here in
Connecticut.
Chairman Lieberman. This will be of interest.
Dr. Cartter. We began a preregistration process for public
sector and private sector providers who are interested in
administering H1N1. The model of the country is moving toward a
private sector-public sector blend, where we have some vaccines
given out by doctors in their offices as well as Public Health
Departments at clinics.
Essentially, preregistering in Connecticut, the provider
has to fill out a provider agreement, and the provider then has
a list of terms and conditions defined largely by the Federal
authorities that providers must sign off on in order to receive
the H1N1 vaccine from the State. In this scenario, all of the
vaccine is owned by the Federal Government and it is being
distributed through State Health Departments out to providers.
There is no cost to preregister, and folks who register
with our immunization programs are actually using a system that
we have in place for the Vaccine for Children Program.
Essentially, there is an existing program for getting healthy
vaccines out there. So this endeavor is built on top of that
system, and we are expanding it to other providers who want to
give influenza vaccines.
As of this past Friday, we have had 1,439 providers who
have signed on, indicating that they are interested and willing
to give H1N1 vaccine. Examples of providers who signed up, we
have OB/GYN offices, pediatricians, family physicians,
internists, hospitals, community health centers, local health
departments, and school-based clinics. In addition, there are
41 mass dispensing areas that are led by local health
departments. We have broken the State into regions and we are
working with these mass vaccination areas to coordinate the
public sector vaccine.
I wanted to talk about the amount of vaccine that we expect
to see. As you pointed out, Connecticut is expecting to get
about 500,000 doses of the vaccine sometime in October. This
past Friday, the CDC had a media briefing and announced that
there would be 3.4 million doses of the live, attenuated
vaccine. This is the nasal spray vaccine, which will be
available the first week of October. This is the vaccine that
is coming first.
The nasal spray version, it is a nasal spray, not a shot,
and it is approved for use only in healthy persons, age 2 to
49, who are not pregnant. So many of the people in those groups
that you had talked about earlier, the target groups, actually
cannot get this vaccine. So children who have underlying
medical conditions, for example, or pregnant women cannot get
the FluMist vaccine.
So this will be a challenge as we move forward. Many of
those shots we are planning on prioritizing for healthcare
workers. But based on our population, we should be getting
about 38,000 doses of the nasal spray vaccine at the beginning
of October. So at the health department, we will be meeting to
talk about how best to distribute those doses.
Chairman Lieberman. Am I right that you will be imposing or
requesting that the private providers follow your judgment
about vulnerable populations; in other words, who comes first?
Dr. Cartter. Yes. Well, what is in the provider agreement
is actually based on the provider agreement that was drafted
and agreed upon by CDC and HHS, which includes those risk
groups. So that is part of the provider agreement that they
will sign.
Chairman Lieberman. So is there any time frame now for the
non-nasal spray vaccine that presumably will be effective or
can be used by pregnant women and others?
Dr. Cartter. From what I have heard in CDC briefings, the
first supply of the shots should be 1 or 2 weeks after the
nasal spray vaccine comes out.
Chairman Lieberman. OK.
Dr. Cartter. One of the things to remember about October is
that much of our efforts to vaccinate people will be driven by
the formulation of the vaccine that we received. There will be
a lot of the nasal spray vaccine available because the yield of
that vaccine was much better than the yield for those who are
making the vaccine that is injectable. So we really will have
to be very flexible over the course of October. We will have to
see what we are getting and then get it to the people for whom
it is indicated as quickly as we can.
Chairman Lieberman. Thanks. Is that your testimony at this
point?
Dr. Cartter. That is my testimony. I would like to thank
you for the opportunity to talk about this today and I would be
happy to answer any questions you have.
Chairman Lieberman. Thanks, Dr. Cartter. That was very
informational, very helpful, and we will try to spread that
word.
Commissioner Boynton, it is a pleasure to greet you for the
first time as Commissioner. I have seen you in other capacities
before. Welcome as the Commissioner of the Department of
Emergency Management and Homeland Security.
TESTIMONY OF HON. PETER J. BOYNTON,\1\ COMMISSIONER,
CONNECTICUT DEPARTMENT OF EMERGENCY MANAGEMENT AND HOMELAND
SECURITY
Mr. Boynton. Thank you very much, Senator. It is good to
see you again. Thanks for your invitation to be here. As the
others have noted, thanks for your interest and attention and
the interest of your Committee and your staff. We really do
appreciate that here.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Boynton appears in the Appendix
on page 228.
---------------------------------------------------------------------------
In my role as Commissioner of the Department of Emergency
Management and Homeland Security for the State of Connecticut,
I would like to focus and emphasize on three themes today. The
first is planning and preparedness; the second theme is
information sharing and outreach; and the third is
collaboration.
With respect to collaboration, you heard Dr. Cartter in his
statement say that he defers to me for incident management. I
have the exact same statement here saying I defer to him for
medical issues. But as I was sitting here, I had to reflect
that, really, we have a typo in our statement because we really
are not deferring; we are collaborating.
We spend an awful lot of our time these days at the
Connecticut Department of Public Health, and that terrific
staff, likewise, spends a lot of their time with us at the
Department of Emergency Management and Homeland Security. We
have a tradition of working closely between those two
departments, and all the more so now in preparing for the H1N1
outbreak.
That leads to my first theme, the importance of planning
and preparedness. And as I have said, both agencies are working
towards that, and let me offer some examples.
The State of Connecticut has a pandemic influenza response
plan and an H1N1 vaccine distribution response plan. Both of
these are authored by the Department of Public Health, which is
the State agency designated by Governor Rell to lead the H1N1
response in Connecticut.
In addition to the statewide planning that has been done,
we have also taken many steps to ensure continuity of
operations in critical State government functions. Going all
the way back to December 2005, Governor Rell directed State
agencies to engage in pandemic continuity of operations (COOP)
planning. Led by the Department of Administrative Services here
in Connecticut, State agencies have participated in COOP
training, and that culminated in the development of continuity
of operation plans for 55 State agencies.
Each State agency in these plans has identified its
essential functions, created a pandemic incident management
team; and with that foundation in place, going all the way back
to 2005, this past August, Governor Rell directed State
agencies to review their continuity plans, convene their
incident management teams in preparation for an H1N1-related
incident.
In its emergency management role, the task for my agency,
Emergency Management and Homeland Security--we, like many
people in government, refer to ourselves with our acronym,
which is DEMHS. Our role is not only to maintain our own
essential functions but also to assist others at the State and
local levels to maintain their operations.
The role of DEMHS is to coordinate, as we do in every
emergency, but in a pandemic incident, the coordination or
incident management role is a bit different. Rather than
dealing with a quickly occurring, acute type incident, such as
a hurricane or tornado, we must be ready to deal with the long-
term or chronic incident in this case.
DEMHS has established three activation levels. The first is
monitoring, the second is partial activation, and the third is
full activation. We are currently in the monitoring mode prior
to any activation of our State Emergency Operation Center
(EOC).
A key component of the monitoring mode is the subject of my
second theme, information review and sharing and outreach to
all our partners, as well as to the community at large. DEMHS,
the Department of Public Health and the State Department of
Administrative Services are working with the governor's office
to provide accurate, current, and consistent information on the
H1N1 situation.
Some examples. The governor has held three H1N1 summits
here in the State: The first for school administrators K
through 12; the second for higher education and residential
schools; and the third just a couple of weeks ago for municipal
officials.
These summits provided up-to-date information on H1N1 and
State planning efforts from subject matter experts. They were
all very well attended with hundreds of people present. They
received media coverage, and as an additional way to reach out
to the general public, these summits were broadcast on the
Connecticut Television Network, which as you know is broadcast
throughout the State.
The governor has also prepared public service announcements
(PSAs), which have already begun to air on television and
radio, and the first PSA emphasized the importance of personal
preparedness. The governor's message also directs Connecticut
residents to go to the Connecticut Flu Watch Web site,
www.ct.gov/ctfluwatch, for more information. And this Web site
is a central Web portal not only for the public, but also for
schools, universities, healthcare providers and businesses.
Beginning with the first outbreak of H1N1 in the spring of
this year, information sharing with our partners, such as
public and private health directors and providers; emergency
management directors and municipal chief executive officers;
school officials and State agencies, was accomplished through a
series of regular telephone conferences that included both
DEMHS and the Department of Public Health. We are going to use
those teleconferences again this fall to reach out to the 169
communities and that key triad of officials, the chief elected
official, the health director and the emergency management
director.
In addition to that, DEMHS is also sharing information on
the H1N1 incident through a computer system known as Web EOC.
Web EOC is a real-time, Web-based, situational awareness tool
that allows us to communicate with Federal, State, and local
partners. DEMHS uses Web EOC as a tool to communicate in
particular with the emergency management directors and other
officials at the local level.
Over 650 individuals across the State have been trained in
Web EOC from 150 towns as well as State agency representatives.
This tool not only allows us the pass information but rely on
this to maintain the common operational picture across all
partners.
My third theme, collaboration, leverages the success of all
other efforts. I have already described many of the
collaborative efforts that have taken place, and continue to
take place, such as teleconferences, Web EOC, flu summits, and
public education.
At the local level, collaboration is encouraged in a
variety of ways. For example, each municipality, each 169, is
required by State statute to have an all-hazards local
emergency operations plan, which must be reviewed annually, not
only by the local emergency management director but also the
local chief executive and myself as well. And this all-hazards
plan is important because it defines key roles and
responsibilities for any emergency.
The State of Connecticut also passed legislation in 2007
creating an Intrastate Mutual Aid System that allows
municipalities to assist each other. In addition, the State of
Connecticut collaborates with other States--and we have some
great examples of that--and our Federal partners.
For example, just this past July, Governor Rell joined five
other governors and representatives from DEMHS and public
health, participating in a national flu summit to discuss the
spring time H1N1 outbreak and planning for the fall.
Finally, on August 20, the Northeast States Emergency
Consortium held its quarterly meeting of State emergency
management directors, chaired by the Connecticut Director of
Emergency Management, Bill Hackett, in Brattleboro, Vermont.
The August meeting was dedicated to H1N1 issues and included
not only emergency management directors from each of the New
England States and the State of New York, but also State public
health directors; the FEMA Region 1 acting administrator, Paul
Ford; Admiral George Naccara, who is the DHS regional
coordination team leader; Admiral Michael Milner, with us here
today; as well as Admiral Scott Deitchman from CDC.
So in closing, these opportunities at the local, State,
regional and national levels for all to meet and exchange
ideas, best practices, concerns in anticipation of a potential
incident enhances our collaborative effort, and enhances it
across geographic areas, across disciplines, and across levels
of government, which will be essential.
Thank you very much, and I look forward to addressing any
questions.
Chairman Lieberman. Thanks, Commissioner. That was very
interesting, very encouraging. I want to ask you one question
at this point.
I presume that the kind of network that you have set up of
communication and the idea that this is an all-hazards network
really responds to the goals that I was talking about in my
opening statement. In other words, in the event of a hurricane,
or a biological terrorist attack, as well as in the event of a
flu outbreak, is the basic structure there to spring into
action and is it multidisciplinary and multi-agency?
Mr. Boynton. I could not agree more, Senator. And as a
great example, since 2007, there have been nine exercises that
are related to H1N1, and yet many of them are not specific to
H1N1. Some of them relate to continuity of operations planning
and practicing that. Some of them refer to different aspects of
the response.
But if you look at this history of exercises, some at the
State level, some at the regional level within Connecticut,
some with local partners, some with Federal partners, even
though the topic may not have been an H1N1 exercise, you can
see how they relate to this incident. It is very much along the
theme of an all-hazards approach, which is an efficient
approach to being prepared.
Chairman Lieberman. Well, thank you for that. And people in
the State should feel better about the fact that is coming
together here.
Our final witness on this panel is Dr. Stephen Jones,
Director of Outpatient Medicine and Center for Healthy Aging.
As I get older, I am more interested in that subject myself;
Chief Patient Safety Officer as well, at Yale New Haven
Hospital.
Thanks, Dr. Jones, for being here.
TESTIMONY OF STEPHEN G. JONES, M.D.,\1\ DIRECTOR, OUTPATIENT
MEDICINE AND CENTER FOR HEALTHY AGING, CHIEF PATIENT SAFETY
OFFICER, YALE NEW HAVEN HEALTH SYSTEM
Dr. Jones. Thank you, Senator Lieberman, and thank you for
everyone here. And my apologies to you behind me who are
getting my back. I am told that is my best side, so enjoy it.
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\1\ The prepared statement of Dr. Jones appears in the Appendix on
page 233.
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It has been said that the most predictable thing about
pandemic flu is its unpredictability, and that certainly holds
true. The emergence of this H1N1 flu earlier this spring was an
unwelcomed event, but I think in many ways it was also an
opportunity for us to really look at our preparedness models
and our readiness models, which we have been working on for a
number of years. And I think this is a good opportunity for us
to test those models.
It is important to understand that pandemic flu is a rare
event. In the past 300 years, there has been only 10 pandemics
that have occurred. The last one was 40 years ago in 1968, and
the worst one occurred, as we all know, in 1918, where over 50
million people died worldwide, 675,000 Americans. And we would
remind you, at that period of time, the population of both the
United States and the world was significantly smaller than it
is today. So this was an event of massive magnitude.
One of the problems with pandemic flu is that people do not
appreciate the potential for how bad it can be because not many
of us are still around from that period of time. Having said
that, we should not expect the worse, but it is always out
there.
Chairman Lieberman. That is a very important point. Well,
obviously, there have been deaths, as I said--the numbers that
are growing are mild, but that is not a definite predictor of
what is going to happen.
Dr. Jones. The two things we look at, Senator, are
infectivity and virulence. This is a highly infective flu, as
all pandemics would be, and virulence is the key thing. This is
not a virulent flu at this point; 1918 was, and that really was
the difference in the magnitude.
I would also remind everyone here that in 1918, the flu
also began in the spring like this one did and was a mild form,
and mutated probably in Europe during World War I with the
troops and returned here as a mutated killer strain. So
although we are hoping that is not going to happen, that is
always a potential.
The present H1N1 flu is a direct descendent of the Spanish
flu, and it is a milder version of it, obviously. So the one
thing I would point out is that any deficiencies that we see in
the strategies we have in place now would be magnified with a
more virulent strain.
The challenges facing the healthcare system in a pandemic
outbreak are truly daunting. Under normal circumstances, absent
a pandemic, the following facts hold true for hospitals. On any
given day, hospitals are operating at near capacity. Intensive
care units that will receive our sickest of sick are almost
always full. There are approximately 110,000 respirators,
ventilators in the United States. Again, on an average date,
75,000 are in use. During normal seasonal flu, that goes up to
100,000. We have very little reserve in that capacity.
Emergency rooms these days are being used more and more by
people coming in for their care because of lack of insurance or
for whatever the reasons, and they are already literally
clogged with people waiting for care. People sometimes wait for
hours to days to get a bed in the hospital. Staffing is
strained, particularly in nursing, and the recent economic
downturn has only magnified that problem as well because
hospitals have had to reduce staffing just to survive.
Hospitals operate in a just-in-time environment. In other
words, we keep enough supplies to keep us operational for a day
to 2 or 3 days. Blood products, perishables cannot be kept for
long term. Even food and water has limited supplies. So in
short, hospitals have limited capacity to flex up for any
situation that may increase above their normal baseline.
As far as this pandemic situation is concerned, the biggest
challenge facing hospitals with this current strain is their
capacity to absorb this overwhelming potential for patients
seeking care. It is estimated that at its peak, this pandemic
could afflict 30 to 50 percent of the general population. Bear
in mind, that healthcare personnel are also part of the general
population. So you would have this perfect storm of patients
requiring more and more care and healthcare workers not being
there to provide it. Again, this in the setting where hospitals
are normally operating at capacity to begin with and little
margin to absorb any extra numbers.
Let me share with you just a few of the things we
experienced early this spring in the Yale healthcare system
with the emergence of the H1N1 pandemic flu. Private physicians
were also impacted in their offices, and where do you think
they sent their patients when they had too many? To the
hospital. They sent their patients to the hospital for medical
care and they sent them there for testing, increasing our load
of business as well.
Our emergency rooms saw significant increases in the
worried well, people coming in just for sniffles, not really
having the flu, who were concerned that they had pandemic flu.
And to your point, Senator, not distinguishing between the
symptoms of a cold versus the flu.
There were logistical challenges in terms of isolating
people who are suspected with swine flu versus those who are
not infected, and where we could put them at these particular
numbers. Respiratory therapists, lab workers who tested these
patients, were working overtime just meeting the demand of this
particular population, and these were not significant numbers.
In addition, CDC and the State were not always in sync on their
recommendations to hospitals in terms of testing guidelines and
recommendations.
Our infectious disease teams were worked to the hilt
between patient care, patient hospital planning, media and just
dealing with the particular pandemic situation. And amazingly,
we saw flu continue into the summer. This is almost unheard of.
Even though the cases were reduced, we do not see flu in the
summer. Seasonality is one of those things that has to be
addressed with pandemic flu.
Again, bear in mind this was all happening when the flu was
not widespread, when our hospitals were fully staffed and
operating at full capacity. The scenario would clearly be
different, and likely will be different, when and if this flu
reaches its peak in our communities.
Just other considerations quickly--schools were closed,
sometimes appropriately, to address this, and maybe that is the
proper approach in some cases. But when schools close, parents
are required to take those children, and they drop out of the
workforce as well. They are also healthcare workers like
nurses. Supply chains may also be compromised with the
pandemic; truckers, shippers, people stocking shelves, are less
likely to come into work.
It is also not a local event. This is not like a hurricane
or an earthquake. With a local event, there are services that
can rush in from external areas to help. A pandemic, people are
basically on their own, and hospitals and communities will not
be able to tap into each other, to any great extent, to care
for each other. And again, we are operating in a just-in-time
environment, so those supplies are very limited. Availability
and distribution of vaccines is also a challenge. We face the
same things that were mentioned earlier, when will they come
in, who gets them first, and how are they distributed.
Finally, Federal funding has been wonderful. Since several
years ago when we first identified the importance of addressing
this, Federal funding has appropriately stepped up. However,
hospitals only receive a small percentage of this funding. In
Connecticut, hospitals receive about 20 percent of this
funding; in other States, hospitals receive even less.
So in summary, much has been done to prepare for this and
it is commendable on all levels, Federal, State and community.
The Yale Center for Emergency Preparedness works tirelessly to
provide services to our hospitals and our communities to make
sure we are ready.
With that in mind, we offer the following recommendations
for considerations.
To help hospitals build into this system to capacity to
respond and absorb patients under these surge conditions. Here
in this particular outbreak, since it is mild, we are going to
be seeing that impact mostly on the outpatient areas. If it
gets worse, it will certainly be on inpatient as well.
To increase allocation of funding to hospitals to meet the
cost of managing a pandemic, including staffing, overtime,
training, pharmaceutical supplies and testing.
To improve the coordination between the State and the CDC
in having their recommendations be timely and in sync.
To encourage--and I am going to step out of my Yale role
for a second to speak as a personal physician--healthcare
workers to step up and do the right thing and get their
vaccines to protect their patients and also maintain themselves
in the workforce.
One of the things I hear people say to me is, ``Dr. Jones,
I do not get the flu shot because I've never gotten the flu and
I do not need it.'' Well, that is simplistic logic. It is the
same logic that suggests that if I have never gotten into an
automobile accident, I do not need to wear my seat belt. It
does not make sense.
Finally, we need to support and educate our general
population on prevention, handwashing gels, and vaccinations.
There was a study that came out recently that showed that
putting hand gel dispensers into our elementary schools reduced
spread by 20 percent and reduced teacher absenteeism by 10
percent. My own kids' school had that done recently, and I
think it has made a difference.
Recognition of the symptoms, educating the population and
what we talked about earlier. And finally, preparedness; home
planning, supplies, medications, advanced planning for child
care, what have you.
As stated earlier, the most predictable thing about this is
its unpredictability. We would strongly advise that at the
conclusion, on the other side of this event, that we implement
a statewide review and debriefing on what happened to look back
as to how we can look at our victories and look at how we can
improve things for the future. And having done that, we think
we will come out of this, again, with the opportunity to
improve our already improved situation and preparedness.
Chairman Lieberman. Thanks very much, Doctor. That was an
excellent panel, and thank you for concluding it.
Well, why don't you just take a moment to develop that last
thought that you had, that there ought to be a statewide
review. You mean, after the flu season, for instance?
Dr. Jones. At the conclusion of this, more on the other
side of this event, in the pass through, that we again get
together with the appropriate agencies to look at where we had
successes and where we had deficiencies.
I just want to underscore one other important thing about
the seasonality. It is a misrepresentation, even in physicians,
if they think that this is a winter event. Pandemic flu is non-
seasonal. We have a southern hemisphere and a northern
hemisphere. This is circulating the planet continuously, and we
need to maintain our readiness throughout the calendar year,
not just in the winter and the early spring.
Chairman Lieberman. That is a very important point. And,
obviously, even as compared to 1918, and certainly as compared
to 1919, a lot more people are traveling around. It is true
that it coincided with World War I, so people were moving from
here to there and back, but in the normal course of a day,
there are many more people traveling the southern hemisphere
and everywhere else, and coming back to the United States. So
it spreads.
Dr. Jones. In 1918, the flu came across on the ships back
from Europe and traveled the train routes across the United
States. It took weeks. Now someone can be on a plane in Hong
Kong and be in New York City in a few hours, so it is a
completely different scenario.
Chairman Lieberman. Let me focus in a line of questions
that comes off of what you said because it really is important
now, but it is important in terms of the larger, longer-term
capability of the public health system to respond to other
kinds of disasters which require surge capacity.
It is one thing to have a large national inventory of
antivirals, that fortunately we had and we have spread them
around now, to treat people with the symptoms, even to produce
a vaccine, but quite another to try to increase the physical
structure and all the services that go with it of a hospital or
public health.
I mean, the fact that we do not have enough is why we have
reached a national conclusion, and I cannot argue with it, that
we have to assume when people are showing flu symptoms that it
is H1N1. We are not going to go through a test because the
people coming into the emergency rooms would overwhelm the
emergency rooms. And as you say, in the hospital, generally, in
terms of beds and in the emergency rooms, most of them, in our
State and around the country, are already at or near capacity.
So short term, how do we plan for--and I agree with you;
what you said is right. The only thing predictable about a flu
pandemic is that it is not predictable.
Let's say it takes a negative turn and we need more bed
space. What do we do?
Dr. Jones. Well, in that capacity, we have come a long way.
Most of the hospitals, including the Yale system have put
together plans for such a scenario, where we can ramp up a
number of beds, either through moving to off-site areas,
cutting areas that are normally done for elected procedures,
elective surgery.
We have some capacity to ramp up space for beds. What we
lack is staffing and equipment. A classic example are
respirators. With a pandemic flu, if it was a severe pandemic
flu, a number of people would need to be put on ventilators. We
do not have those ventilators. What do we do when those people
show up and you have to decide the ethical question of a young
person versus an elderly person; who gets to decide to put that
person on the ventilator?
So it is more equipment, Senator. It is more staffing than
it is space. The space, the hospitals can find ways to deal
with that in a short term. It is really not having anybody to
stand next to that person's bed and provide those services to
them.
Chairman Lieberman. That is very interesting. One, I
appreciate that the hospitals have those kinds of plans.
Would you say, Dr. Cartter, that most of the hospitals in
this State have those kinds of fallback plans, for space
anyway, if there is a surge need for additional bed space?
Dr. Cartter. This has been a major focus of pandemic
planning. One of the things that you need to remember is that
we were all planning for a pandemic bird flu, and many of these
plans have been developed over the last 3 or 4 years. But the
structural issues that Dr. Jones mentioned are significant. It
is not easy to increase the surge capacity of our acute care
medical system.
Chairman Lieberman. So longer term, as a Nation, what
should we be doing, particularly in terms of personnel and
equipment? Obviously, in a resource constrained time, this is
more money that may need to be spent. Really, say what is the
ideal as a Nation we should be investing in now.
Dr. Jones. To give us more capacity to see patients.
What has been happening across the country is hospitals are
struggling financially, that they are going out of business. We
have had hospitals around us close, and those patients wind up
coming into our healthcare system, and that overburdens our
emergency room and taxes our staffing as well.
As we have this domino effect of healthcare systems
collapsing, it puts a greater strain on the established
healthcare systems. And again, it just is a problem going in
opposite directions. And so when we reach a situation, whether
it is a pandemic or even a local event, we have limited
capacity to step in and really provide help to these people.
So funding would help tremendously. Really, Senator,
staffing is a major issue. We need people at the bedsides.
Chairman Lieberman. And that is tough because, obviously,
you cannot just bring--well, I suppose is something hit a
particular area--now, this is national, but if there was a
particular problem here, we could have a system for bringing
personnel in for a short-term to deal with it from elsewhere.
Dr. Jones. We do table-top exercises in the State of
Connecticut and through the emergency preparedness, just to do
that, where the healthcare systems will step in and help each
other, but pandemics are different.
Chairman Lieberman. Let me come back to the flu in this
way, just for a final question to you on this, and, Dr.
Cartter, if you want to get into it, or Admiral Milner.
I presume that one of the ways we can take the pressure off
of hospitals in the public health system, if this does get
worse, is to have the doctors and the public be advised about
how they can take care of themselves, unless it gets serious
enough that they have to become inpatients at a hospital.
Am I correct? In other words, what people can do self-
diagnose and what a doctor can do to take care of the patient
in the office as opposed to sending them to the emergency room.
Dr. Jones. We have already started telling our patients who
are coming into the hospital for routine care what to do in the
event that they get symptoms, that they should probably stay at
home if they have kind of run-of-the-mill flu symptoms that Dr.
Cartter mentioned earlier. The symptoms from the head up where
it really represents a cold is not something you come into the
emergency room for.
The other thing is that absenteeism, although a huge
problem in a situation like this, is also exacerbated by
presenteeism, people showing up for work who are sick and
decide they want to be heroic and do the right thing. That is
not in the interest of our communities. We encourage people who
are sick with the flu, with fever, to stay home, and that is a
message we are constantly striving to get out.
Chairman Lieberman. Well said.
Admiral Milner, let me go to you in terms of the scope of
what may happen. We were all unsettled last month when the
President's Council of Advisors on Science and Technology
released a report. And it may be that some of the numbers,
which were suggestions, were taken too seriously. But they did
say that there was a plausible scenario in which they could see
up to half of the American population infected by this H1N1
flu, with almost 2 million hospitalizations and as many as
90,000 deaths.
Acknowledging what we will now call Jones' law, which is
that the only thing predictable about a flu pandemic is that it
is unpredictable, based on our current understanding of how
this outbreak is proceeding, does HHS expect the United States
to experience as large an outbreak that the Council of Advisors
is suggesting?
Admiral Milner. I think that we are planning for the worse
and hoping for the best, like all of us. I think a lot of the
messaging that has come out of the Department recently has been
centering around the issue that Dr. Jones raised, that I know
our State partners have been working on, and that is how to
care for yourself at home, how to care for your children, and
so on, to try to decompress some of the issues related to
hospitalizations. I know, for example, Connecticut is working
hard, as our other States are, on alternative care facilities
and how we would staff those up and so on.
I think that, again, the jury is still out on how this is
going to morph and how the pathogenicity of the virus will
change. Again, I think all of us are trying to give the right
tone to our messages that we have shared responsibility
personally and we have to work together to get through this.
Chairman Lieberman. So what I hear you saying is that you
are not prepared to say that the 90,000 death projection is
accurate, but you are not prepared to predict a number either
because it is unpredictable.
Admiral Milner. Correct.
Chairman Lieberman. OK. We touched on this a bit. Last
week--I will give you an intro to this--we held a hearing, the
Committee in Washington, for the nomination of the new deputy
administrator for FEMA, Chief Richard Serino of Boston.
Probably you know him.
Admiral Milner. Yes, sir.
Chairman Lieberman. Well, he was quite impressive, he heads
Boston's emergency medical services, and he relayed what I find
to be a striking statistic about Boston experiencing the flu
last spring, which was that 23,000 residents were stricken with
H1N1, and that 11 percent of the student population had it--so
this is obviously an important factor for the schools, the
judgments to make.
I know that the government is trying to encourage schools,
at this point, to stay open, even as they experience cases of
H1N1 among their student population.
I wanted to ask you, what are we saying to the schools
about what the threshold is for when a school should in fact
close?
Dr. Cartter.
Dr. Cartter. Let me also answer and comment on the earlier
question that you raised about severity and about that report
because it leads into the discussion of education.
Pandemics differ in severity. And also, as part of that,
they also differ in the number of people that are affected. The
1918 pandemic affected about 30 percent of the population, the
1957 pandemic, about 20 or 25 percent, and the 1968 pandemic
was 40 percent of the population was affected. So that report
was really describing the range of possibilities because we do
not know yet exactly what percentage. But so far, this appears
to be most similar to the 1957 pandemic, and we are looking
more at a range of 25 to 30 percent rate of illness in our
population.
Seasonal influenza is about 10 to 15 percent of the
population every year, although that can vary, but that gets to
your perspective. And looking at our control methods, obviously
schools are important places of transmission for influenza, but
we also have to look at the severity of the disease. And this
particular illness, at least at this point in time, does not
seem to be more severe than seasonal flu.
If this were a 1918 situation, the recommendation of the
Federal Government, as well as the State, is that schools would
have been closed at the very beginning of the pandemic, and
they would stay closed for 6 to 8 weeks. Given the severity of
this and that this is actually very acute, similar to seasonal
flu, we are not recommending that schools close to control this
illness, as we do not make the same recommendation for seasonal
flu. We would be closing schools every year in that case.
The point here is that the best place for well children to
be is in school; the best place for sick children to be is at
home.
Chairman Lieberman. That is the key. The students who have
it should go home.
Dr. Cartter. Exactly. And working with parents, working
with teachers and others to make sure that there is a
continuity of education is critical. And one of the things that
we have been doing with our education partners is working on
that piece. As for a threshold, it really varies. It is
important to point out that the State of Connecticut Department
of Public Health, did not recommend any school closures in May
or June. We work closely with our communities to keep schools
open.
The second point along that line is that we need to be
aware that there may be circumstances where schools need to
close because there are not enough students and teachers
present to have a reasonable or meaningful class. And we know
of schools that reached 40 to 50 percent absentee rates last
May and June, those who are getting into the area where they
have to make an administrative decision does it make sense to
hold class. And we let that decision be made at the local level
between the school superintendent and the local health
director.
Chairman Lieberman. I assume, incidentally, that if a
student is sent home or a worker is sent home from a job
because they got the symptoms of H1N1, they really should stay
home. I mean, in the sense of not going out to the mall or
going to a movie.
Dr. Cartter. The term used by CDC is social distant things;
you go home and then go to the mall, and that defeats the
purpose of going home.
One of the problems that we have in our society in terms of
this is that many children may be going home to a home where
nobody is present because they are at work. So this is a
difficult issue at the community level because not every child
can go home to a mother or father or other significant person
to take care of them. We have to do just like we did in 1918,
to call on families and friends to take care of those who are
sick and make sure that they are not at school.
Chairman Lieberman. Of course, I never knew my grandmother
because my dad was three when she got the flu in 1918 and died.
But the picture they painted, not to frighten anybody from
doing something altruistic, was that she was healthy and she
started to help other families who were affected by it, and
then she got it, and she died pretty rapidly.
I wanted to ask you a medical question just for the record.
So far, what has been the effectiveness of the antivirals?
In other words, we see symptoms that look like it, and the
person has not received the vaccine. We give them Tamiflu or
the other one, I forget what it is.
Are they working, Dr. Jones?
Dr. Jones. The antivirals are one of those things that
people have been clamoring for because they think they are a
panacea, and they probably do not represent that.
First of all, if the antiviral is to be effective, it has
to be given very early on in infectivity, within the first 48
hours. And the CDC presently is not recommending these
medications be used prophylactically or just for kind of
simple, run-of-the-mill symptoms. It really should be reserved
for those who truly needed and are demonstrating either
underlying immunocompromised states or situations where they
are advancing and becoming more critically ill.
The Tamiflu at this point probably is responsive to
treating the infectivity, but, again, it is not something that
would be recommended at this point as a first line treatment.
Chairman Lieberman. I take it that in a lot of cases of
people with H1N1, they will get over it because their bodies
ultimately reject it or it finishes its course and the body
gets better again. Is that correct?
Dr. Jones. It is like a flu shot you get to keep from
getting the virus. It is essentially the same thing. You
develop immunity through a flu shot or through infectivity.
Most people will get over this just fine and have some level of
immunity as a consequence. We have to have this balance between
people who overreact to these situations and are too
complacent, and the answer lies somewhere in between.
Chairman Lieberman. And at this point, some of the
populations that you have designated as vulnerable on the list
for vaccines, they are showing a little less natural resistance
to it, some of them.
Am I right, young children particularly?
Dr. Jones. Young children have less immunity because they
have not been exposed to this. People born before 1957 probably
have some background immunity just from having been exposed to
this in the past.
Chairman Lieberman. This gets to the healthy aging idea
again.
Dr. Jones. It gets to the healthy aging as well.
Chairman Lieberman. Just a few more question, and then we
will go to our second panel.
Commissioner Boynton, you mentioned that your office is
responsible for reviewing all local emergency operation plans.
Since you have learned of H1N1 at the end of April--I know you
are new on the job, but from what you have found, how would you
rate the seriousness with which different communities in
Connecticut have prepared for H1N1 over the last 6 months?
Mr. Boynton. One example I think of the seriousness,
Senator, is that the requirement for an annual review is a new
one that started just this year by State statute. And under the
statute, the reviews are not due until January. By the end of
the summer, already over a third of them were in, which is way
ahead of schedule. I do not think that is because those
communities do not have anything else to do.
So I think they are taking it seriously. And I would also
comment that at the flu summits that the governor hosted,
particularly the third in a series of three, which was focused
on municipal officials, there was a huge turnout, tremendous
interest, and we had panels from a couple of municipalities. In
fact, I think some of them are in the second panel with you
today. And they spoke of the type of actions they took back in
April, which I think showed seriousness and preparedness even
back then, which I think, again, reflects on what Dr. Cartter
said, that we are not just now starting because of H1N1.
Really, this preparation goes back to 2005 or earlier with
substantial preparations for the potential avian pandemic. And
it does not mean our work is done, but I think there is a
substantial record of preparation because of that.
Chairman Lieberman. Admiral Milner, I must say that
listening this morning, I am encouraged by the extent of the
cooperation that I have heard testified to between the State
and local government, and between the Federal, State and local.
I want to ask you from your larger regional perspective--I do
not want to put you in the awkward position of grading
Connecticut in the presence of the people you are grading.
Are we looking good compared to the other States in the
region that you oversee?
Admiral Milner. Absolutely. No question that Connecticut is
one of the leaders, and they have been one of the leaders
through all of this planning that we have discussed here. We
did an exercise in December 2007, where it was open to all of
the States. Connecticut was a very active player. Dr. Cartter
was one of our key participants.
So from my perspective, looking at all the States, as I
mentioned earlier, I am glad that I live here and my family
lives here in New England because all of the States have helped
each other stand up even more. And we had a call first thing
this morning at 7:30 with updates about what their thoughts are
regarding some of the third level of funding that is coming out
of CDC, and what some of the incidence is in their States and
colleges and so on.
So they are helping each other, and by doing that it is
raising the boat for all of us. And I would say that
Connecticut is in the top of the top.
Chairman Lieberman. Thank you. Yes, Commissioner Boynton.
Mr. Boynton. Senator, if I could just add to that. There is
a Federal publication that talks about how States can approach
volunteers to help, not just through the H1N1, but with all
hazards. And it gets to your earlier point about the
efficiency, the economy, and the effectiveness of an all-
hazards approach.
In this publication--I forget what page it is, about a
third of the way through--it states that Connecticut has the
best practice for addressing liability issues for volunteers,
and the State worked with the legislature, and a lot of that
work is now behind us.
But it is another great example where that work in
addressing liability issues for volunteers was not directed
specifically for H1N1, but in the all-hazards environment, it
helps prepare us for H1N1. And I do not want to say all is done
because it is not. There is more work to be done, but it is
another example where Connecticut is cited as a best practice.
Chairman Lieberman. It is good to hear.
Let me ask the last question. I am going to leave you out
of this, Admiral Milner, because I am going to ask the other
three, briefly, if there is anything particular that the
Federal Government is not doing right now to be of help to you
in dealing with this H1N1 pandemic? I ask that since I am from
the Federal Government and I am here to help.
Dr. Cartter. Well, I am here from State government and I am
here to help. The way I would approach that question is to say
that Mother Nature has not read our pandemic plan. And at this
point in time, we are close to starting the second wave of a
pandemic of 2009.
We need to be flexible, not only at the State level but
also at the level of the Federal Government because as much as
we plan, obviously things can be different. We have the virus
that is unpredictable, and we also have a supply chain that is
going to be challenged, as well as the influenza vaccine
arriving in different forms and various times. So this is
really the moment of truth at this point in time moving
forward.
Chairman Lieberman. Good point. Commissioner Boynton,
anything more?
Mr. Boynton. Sir, I would just say it depends. As we go
forward, it depends on the severity of the incident. I think we
are pretty well schooled across the country with how we get
resources to respond to more traditional incidents: Hurricanes,
tornados, ice storms, etc.
I think it is important to remember that if incidents are
severe, we do have a system of incident management that relies
on support. As Dr. Jones pointed out, the Mutual Aid Support is
more likely to not be available for a pandemic, because if we
use the equivalent of an ice storm, we could all get this ice
storm no matter where you live.
Chairman Lieberman. Right.
Mr. Boynton. So we might not be able to borrow from our
neighbors. If it is severe enough, our method of incident
management relies on support, for example, like the Stafford
Act. We are pretty clear on how the Stafford Act works in ice
storms, hurricanes, and tornados. We need to be clear on how
that would work if the severity of this incident is
significant.
Chairman Lieberman. Good point. Dr. Jones.
Dr. Jones. The final thing I would say is this. We all know
that vaccines seem to be one of the central approaches to
addressing this issue, and we have come a long way towards
vaccine development, and the government has done wonderful
things in terms of funding and reducing liability to
pharmaceutical companies in the development of these vaccines.
However, vaccines right now take a significant amount of time
to make because it is mostly egg-based technology. We have the
capacity now to improve that. That is in process right now.
Those efforts need to be supported.
The final thing, I mentioned early on, this is an
opportunity as well as a challenge, and the opportunity is to
learn. And again, we really need to step back at the end of
this and look at what those lessons are.
The final point I will make is this. People have a
misconception that since pandemics are rare events and they
occur every 30 or 40 years, and that we may be off the hook
come next year. It does not work that way. The probability of a
pandemic next year, and the year after, and the year after is
no less than it was prior to this particular event as well. And
that is why we need to be on our toes preparing and ready to
go.
Down the road, we will have the technology and the science
to address this with, hopefully, a universal vaccine where we
can stop having to create vaccines that address one particular
influenza. That is a significant way down the road, but we have
the opportunity to make that happen and we need to get on the
ball to do that.
Chairman Lieberman. Thanks. Those are very constructive
suggestions. And to take your words, Dr. Carter, I think, at
the Federal level--I speak for Congress, but I talk to
Secretary Napolitano at the Department of Homeland Security
enough to know that I can speak for her on this--we are staying
flexible. It is a good point. So far, we are feeling fortunate
that the intensity of the flu has not been as great as we
thought it might be, and yet we know it is unpredictable.
There is a history that no matter what the times
economically, that Federal Government responds to disasters. If
this becomes more severe, I am sure we will do everything we
can, both with financial assistance and perhaps with some
provision of more personnel from Federal Government, including
the military.
We have now divided FEMA after Hurricane Katrina, in
addition to their national headquarters, they have 10 regional
offices, which drill for a series of disasters that could
potentially happen in those regions. And each one of those
regions has representation from various Federal departments,
including the military. There is one in each one of those.
You have been really helpful. I thank you for what you are
doing everyday. I thank you for the testimony that you provided
here. I think it is a great idea when this is behind us to do a
lessons learned, and then we will do our best to learn from
what you learn to protect us into the future.
Have a good day. Thank you very much.
We will now call the second panel
Julie Polansky is a parent from the Vernon Public Schools;
Roseann Wright is Director of Public Health for the City of
Waterbury; Daniel Aloi, Manager of Business Continuity Services
at Aetna, Inc.; and Michael Kurland, Director of Student Health
Services at the University of Connecticut (UConn).
I want to thank the other folks who have come out, a lot of
whom who have responsibilities in the public and private sector
related to dealing with outbreak of H1N1.
Well, good morning. Thanks for your patience. I hope you
have found the first panel as interesting as I did, although
you have probably been hearing a lot of that give and take all
along the way.
We thought that it would be good to have--I was about to
say just a normal person here; not to say the first panel was
abnormal, but a parent to reflect on their experience with
this. Julie Polansky has come to do exactly that. So we welcome
your testimony now.
TESTIMONY OF JULIE A. POLANSKY,\1\ PARENT, VERNON PUBLIC
SCHOOLS
Ms. Polansky. Thank you. As you mentioned, I am a working
parent within the Vernon Public Schools. I have two children in
the school system right now. I have a middle schooler and an
elementary school student. And we did have an experience in the
spring of this past year, where our schools closed due to
suspected cases of H1N1.
---------------------------------------------------------------------------
\1\ The prepared statement of Ms. Polansky appears in the Appendix
on page 236.
---------------------------------------------------------------------------
It was shortly after spring vacation and Vernon Public
Schools closed for 2 days due to a suspected case. Most
parents, including myself, learned of the closure via local
television news outlets. The school system initially did not
notify parents via e-mail or phone calls. However, a notice was
posted on the school's Web site.
Since it was an unexpected closure, or not a snow day, I
did hear of a few parents who had not watched the local news
and were unaware of the situation. Having and utilizing an
emergency notification system within the school system would
have greatly helped facilitate communications to parents.
Additionally, communication regarding the reasoning for the
closure was vague. Parents were aware the closure was due to
H1N1, but initially did not receive information about the
number of suspected cases, the location, or the school of the
potentially infected individual or individuals. This lack of
communication caused unnecessary speculation and rumor on the
part of parents and the community.
Additionally, guidelines for the community of Vernon were
lacking. Due to the closure of schools, all Little League
practices and games were canceled for the 2-day period. In
fact, on the day that administration closed the schools for the
following 2 days, which was announced on the news outlets at
approximately 4:30 p.m., parents and players were turned away
when they arrived for practices at the various Little League
fields.
In the case of Vernon, the suspected case that caused the
closure turned out to be influenza but not H1N1. I understand
administration's cautious decision in the interest of the
children, however, it was merely one suspected case, and it may
have been adequate to either wait for the results of testing or
close the one impacted school, not the whole district.
I would also like to point out that I do believe the
closure of schools could be truly warranted if a significant
number of children and/or staff become infected in one
location.
The impact of the 2-day closure on myself and a number of
other parents was relatively significant. For myself, I work
locally, I have a flexible schedule, but I was forced to
rearrange my work day and make arrangements with friends for
daycare. Many other parents simply utilized daycare facilities
for their elementary age children.
So my question at that point becomes, does the closure of
schools actually help to stop the spread of the school virus?
What is the difference between the children being together at
school or at a daycare facility, assuming they are healthy?
I would like to also point out, I have no problem taking
time off from work and keeping my children home if they are
sick, however, if schools are closed and my children are
healthy, I will continue to allow them to play with their
friends.
Subsequent to the closure, the system distributed the State
guidelines for ill children, and in my view, these guidelines
are clear and reasonable. Guidance from school administration
regarding the make up of the days that the district had to take
off was also vague.
In Vernon, initially parents were informed that the days
would need to be made up at the end of the school year. This
would have made the last day of the 2008-2009 school year, June
30. The situation caused issues for a number of parents and
staff, since it was the Fourth of July week.
Subsequently, the Board of Education reversed the decision,
and through negotiation and coordination with the teachers'
union, the students did not make up the H1N1 closure days. This
situation caused confusion for a number of parents and staff
because they went back and forth on whether the days would need
to be made up. Some guidelines or guidance from the State on
whether districts need to make up these days would have been
helpful.
My hope for the current school year is for clear
communication and careful preparation. I am happy to report
that just last week, the Vernon public school nurses
distributed a flyer to parents outlining the district's
recommendations on how to stop the spread of flu and other
illnesses. The flyer included details of flu symptoms,
recommendations on how long children should remain home,
information on the vaccine, and prevention kits. It was also
noted that the nurses are working closely with a local
physician and the Department of Public Health to monitor the
flu condition and make decisions about the best steps to take
concerning schools. I hope the district will continue to
provide periodic updates via additional flyers, guest speakers
at Parent Teacher Organization meetings and the school Web
site.
In terms of preparation, I believe it would be prudent for
schools to have funding set aside for continuous supplies of
hand sanitizer and periodic extra cleaning of the building.
These preventive measures will help to avoid closures in the
future. Since most school budgets are extremely lean, I wonder
if it is possible to have State or Federal funding for these
preventive measures. Also, a quick note. Just Friday, parents
started receiving notices asking if they could donate hand
sanitizer, tissues, all of these items to also help the
situation.
Guidance from the government is also crucial. Keeping
parents informed is part of all these guidelines. So guidelines
regarding who should get a flu shot, whether sick children
should visit their primary care physician, how long a child
should remain home after being ill, when and if a school should
close, and how community sports, groups, or leagues should
handle any outbreaks should be readily available to the public.
Thank you for the opportunity to participate in this
hearing.
Chairman Lieberman. Thank you. That was very helpful. I
hope and I would guess that some of the response of the Vernon
public school system was to the complaints that you registered
last spring. Do you think so?
Ms. Polansky. Oh, I absolutely do. I think that what
happened was they were being extra cautious in the interest of
the children. And it also was a result of all of the media, and
just not knowing what to do at that point. But I also believe
that they have set a number of guidelines this year to help the
situation.
Chairman Lieberman. Right. Your conclusion is that they are
handling it a lot more sensibly this year than they did last
spring.
Ms. Polansky. Right.
Chairman Lieberman. That is good. And the advice now
nationally and from the State is not to close schools, but to
send kids home who seem to be sick. You are suggesting a
problem or you are describing a problem, one part of it here,
which is very hard to deal with. But you are absolutely right.
If the child comes home from school, and for various reasons,
because of the pressures and demands on the family, the child
ends up at a childcare center, that is no better.
Ms. Polansky. Right.
Chairman Lieberman. And that is something that is hard for
the government to handle. It is something we have to ask
parents to try to do their best to avoid spreading it.
I like your idea about the hand sanitizers. The experts
tell us that just washing with soap and water is not bad, but
it is obviously easier--I was out at Stop and Shop the other
day. It is too bad my wife is not still here because she would
say he hardly ever goes shopping, but he is going to talk about
that today. [Laughter.]
But anyway, as I walked in, there was a container with hand
sanitizers there. Around the Capitol, they are all over, and in
Washington, that is important.
Thank you very much for being a good parent and a good
citizen and coming forward and telling us what you did.
Second, Roseann Wright, Director of Public Health,
Waterbury, Connecticut. Welcome.
Ms. Wright. Good morning, Mr. Chairman.
Chairman Lieberman. Good morning.
TESTIMONY OF ROSEANN WRIGHT,\1\ DIRECTOR, WATERBURY DEPARTMENT
OF PUBLIC HEALTH
Ms. Wright. Thank you for this opportunity to testify. I am
Roseann Wright, Director of Public Health for the City of
Waterbury. I am here today to share our experiences in
Waterbury about how the Public Health Department, the school
district, and the school nurses dealt with the influenza
outbreak.
---------------------------------------------------------------------------
\1\ The prepared statement of Ms. Wright appears in the Appendix on
page 238.
---------------------------------------------------------------------------
The Public Health Department employs three nursing
supervisors, 39 nurses, 20 health aides, and cares for over
22,000 students and 39 public, private and parochial schools.
And with the 22,000 students, that is a fifth of Waterbury's
population.
As the Director of Public Health, I cannot place enough
stress on the importance of the school nurse in the academic
environment in terms of identifying, assessing, and tracking
communicable disease. Identification of a communicable disease
outbreak by the school nurse is also a potential indicator of a
communicable disease outbreak within our community. The school
nurse is often the first staff member to identify common signs
and symptoms of a communicable disease and alert public health
administrators.
During the pandemic of H1N1, the Waterbury school nurses
became integral in conducting surveillance in school
populations. Early in 2009, a number of confirmed H1N1 cases
were reported with increasing frequency, prompting the Public
Health Department to proactively educate the public and
minimize the spread of H1N1.
The Public Health Department planned for the possibility of
this becoming our next pandemic, and we needed to protect our
school personnel, such as our school nurses and our health
aides, and to do this, we set up several public health
initiatives.
With the school nurses, we reviewed the number of incidents
of absenteeism to determine if outbreaks were occurring in our
schools. The school nurses and the supervisors became our
sentinels for the community's health. We also increased
communications between the Public Health Department, the school
nurses, the superintendent's office, and all of our private and
parochial school principals to see if any H1N1 cases were
confirmed in their academic environment.
The Public Health Department sent all of our environmental
sanitarians to inspect all the school bathrooms to ensure hand
soap, paper towels, and hot water were available. We also had
bilingual communication sent to parents of the school-aged
children, addressing signs and symptoms of H1N1, prevention
tips, respiratory etiquette, and information regarding swine
flu.
In January 2009, the Public Health Department conducted a
table-top exercise with the school nurses regarding the roles
and responsibilities if a pandemic were to occur. This was an
opportunity for the nurses to immerse themselves in a scenario
that would test the responses if and when the pandemic did
emerge.
In addition, the school nurses also participated in a
collaborative effort with the Waterbury Fire Department to
distribute H1N1 flyers to 12,000 households. This was
accomplished by staff literally walking door to door and
speaking to residents face to face.
As the Nation experienced school closures, so did
Waterbury, as the superintendent of Waterbury closed an
elementary school for 2 days. In order to avoid additional
school closures, the nurses worked collaboratively with the
Board of Education, and the following non-pharmaceutical
mitigation interventions began.
We instituted several infection control techniques,
installation of hand sanitizer dispensers for all the health
rooms and the cafeterias. We distributed disinfectant wipes to
the school nurses and teachers. We encouraged frequent bathroom
breaks so students could wash their hands, especially in the
elementary schools. In addition, we encouraged all students and
staff to stay home when they are ill, and we encouraged them
only to attend school when they are well. The custodians are
also cleaning all surfaces that are likely to have frequent
hand contact.
In anticipation of the 2009 school year, the superintendent
sent out a letter to all parents and guardians to highlight
proper protocols when a child exhibits influenza-like illnesses
and how the schools will maintain a healthy environment within
the school district. The letter also mandated that students
must stay home until signs and symptoms are gone and not to
return for 48 hours rather than the current guidance of 24
hours.
This message was also shared with private and parochial
principals, so our message was consistent throughout Waterbury.
In anticipation of the 2009 school year, the Public Health
Department began to prepare for H1N1, which consisted of
several staff meetings. Data collection tools were developed,
which were used to monitor students with influenza-like
illness. These new data collection tools will allow the school
nurse to monitor siblings and will determine if a child has
been returned to school per the superintendent's 48-hour
guidance. In addition, school nurses will conduct a brief risk
assessment of the entire student household to determine if
other family members are ill.
The school nurse is also responsible to identify students
and staff with special medical needs, which will potentially
put them at higher risk for complications as a result of
seasonal influenza. The school nurses are our medical
professionals in our academic environments and can offer
education to students and staff, as well as mitigating
interventions that will help minimize the infectious agent of
H1N1. Last year, our 39 school nurses encountered 175,000
students through our health rooms. The school nurses have the
ability to provide continuous, repeated education to this
population.
The Waterbury Public Health Department is also utilizing
State and Federal guidance documents as a tool to develop
specific strategies that are customized to the needs of
Waterbury's academic environment. These guidance documents are
assisting the health department and school nurses to minimize
the spread of H1N1 amongst our students and school staff, while
limiting the disruption of day-to-day activities, thus
facilitating educational continuity.
We continue to prepare our school nurses by informing them
of new guidance from the CDC and the Public Health Department
in Connecticut. Waterbury recognizes we are not alone in the
prevention of H1N1, and we share the same challenges and
burdens as other municipalities across the State of Connecticut
and the Nation.
The Public Health Department administrators are constantly
meeting with other directors of health and nursing supervisors
from various forums, such as Connecticut's Department of
Emergency Management and Homeland Security, Region 5. And here,
we share our important information, such as mitigation
strategies, lessons learned and other valuable information, all
of which is shared by our school nurses.
In conclusion, as the pandemic continues to increase in
intensity, the school nurse will continue to provide care to
our students, educate our students in keeping themselves
healthy and act as our sentinels for the community's health.
Chairman Lieberman. Thanks very much, Ms. Wright, for a
very thorough report. I will have some questions for you after
we hear the final two witnesses.
Daniel Aloi, as I mentioned, is the manager of Business
Continuity Services at Aetna.
So we have heard from a parent, a public health official at
the local level, and now we want to hear some thoughts about
how businesses are dealing with this problem. Thanks for being
here.
You have a great title, the Manager of Business Continuity
Services. Tell us what that means.
Mr. Aloi. Yes. The terminology used in the first panel is
continuity of operations. My job basically is to make sure we
keep the lights on, the phones answered, the claims paid, the
patients communicated with, and all our critical customer
facing operations, as well as, of course, the core function of
keeping the corporation running as well.
Chairman Lieberman. Presumably, in an emergency situation.
Mr. Aloi. Yes.
Chairman Lieberman. You are, in a way, sort of the
secretary of emergency management for Aetna.
Mr. Aloi. You could say that. And we do subscribe to an
all-hazards plan, as mentioned in the first panel, where we
have a central team, crisis response team, that is well versed
and practice over and over again in dealing with minor outages
while preparing for the major outages due to hurricanes or
widespread disaster. It is an interesting job; never a dull
moment.
Chairman Lieberman. Yes, I bet. What is your background?
Mr. Aloi. Emergency planning since 1983. I was a manager of
emergency planning for Millstone Nuclear Power Station, where
we prepared plans, procedures, training exercises, and worked
with State and Federal local agencies in exercising those
plans, basically from one frying pan to another.
Chairman Lieberman. Yes. It sounds like you are ready.
So you are going to tell us what Aetna is doing in regard
to this. Do you give advice to your business clients about what
they should do?
Mr. Aloi. Yes, we do, actually.
Chairman Lieberman. Well, go ahead. I am interrupting you.
Mr. Aloi. Since 2006, again, we took the first guidance
that came out--actually, late 2005--very seriously. We
established teams to deal with internal operations, but as well
as communicating and creating plans for communicating with our
plan sponsors to help them help their own members and creating
their own operations deal effectively and weather a pandemic
along with us.
Chairman Lieberman. Very good.
TESTIMONY OF DANIEL ALOI,\1\ MANAGER, BUSINESS CONTINUITY
SERVICES, AETNA, INC.
Mr. Aloi. Aetna is pleased to be in attendance today to
share our plans and experience with the panel. We are members
of the Homeland Security Critical Infrastructure Subcommittee
on Health Care and are actively involved with the public and
private sector in advancing all preparedness, as I said
earlier, since 2005. We are continually learning, as everyone
is, and constantly testing our plan. We see no limits on the
sharing of information when it comes to the public good and the
Nation's resilience.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Aloi appears in the Appendix on
page 244.
---------------------------------------------------------------------------
Aetna occupies over 100 facilities at various sites
throughout the country which house a variety of Aetna
departments and functions. We are fairly dispersed throughout
the country in our operations center, which is a strength for
us.
To prepare for pandemics, Aetna has developed many recovery
and coping strategies to ensure continuity of operations and to
keep employees healthy. Although not implemented solely for
pandemic planning, among the most notable element is our very
robust telework program, with large numbers of our employees
already able to fully function from home effectively. Roughly
one-third of our workforce today work from home.
The second most significant capability includes a
comprehensive work reallocation process, where customer service
calls and claim adjudications can be redirected to other Aetna
offices with almost seamless transition. We are very fluid in
the way we can transition work back and forth amongst our
geographically dispersed work sites.
Another important element is that Aetna has a considerable
bench of contingent workers who are trained and can augment
critical staff if there are high absentee rates, as we would
expect. Contingent workers are routinely used to help during
peak periods. Typically, they can consist of trainers, quality
service folks, management that may have had some training in
that area. It is basically needed every season.
Actually, the first part of the year is our most intense
period where all the plans renew. Our customer service people
see an overload at that point. So we have the ability to bring
in additional people that are trained and qualified and we test
them every year.
Chairman Lieberman. That is fascinating. These are people
who are not working when you are not calling on them?
Mr. Aloi. These are people who are doing other functions
within the corporation----
Chairman Lieberman. I got you.
Mr. Aloi [continuing]. Functions that we can put aside and
change our work model to prioritize on the most core functions.
Chairman Lieberman. Do you use retirees at all in that way?
Mr. Aloi. We have a program to look at retirees and to call
them back. We are working on that. That is one of the things we
want to develop.
Another important line of events in our capability is to
keep employees healthy in the face of a pandemic. Aetna has
created many strategies to accomplish that. It starts with a
short and pointed, online course that employees are expected to
take. The course provides instructions on hand hygiene as well
as sneeze and cough etiquette, because we believe, as others
do, that this can be one of the best measures in minimizing the
spread of virus in the workplace. This course is available on
line for our employees. It also is available for our members
and our plan sponsors as a public service.
Aetna has placed hand hygiene and stay at home when sick
posters at all our Aetna sites as a constant reminder, along
with permanent Internet and home page messaging on our Intranet
Web net page. Aetna's human resources policies strongly
encourage sick persons to stay home when symptoms appear with
non-punitive, pandemic pay policies. Beyond these strategies,
Aetna has provided a personal supply of antiseptic hand
sanitizer to all office based persons within our facility,
along with the common bulk space dispensers you mentioned
earlier.
Aetna has purchased a stockpile of surgical masks and has
deployed these to site crisis managers, along with instructions
to issue them to any person that is symptomatic or who
otherwise feel they may be coming down with the flu. Sick
persons will be sent home or to a healthcare provider if
symptoms are severe. There is also provision to quarantine that
person in the office until they are sent home and taken care
of.
Another important planning element is our rapid telework
deployment capability for office based workers. This is
accomplished with an infrastructure, procedures and plans where
we can transition additional large numbers of workers to a
temporary work-at-home setting within days, leveraging the
Internet.
We implement a scaled-down version of this each winter when
severe weather occurs. During a traditional nor'easter, we
typically have only 10 to 20 percent of our employees coming
into the Connecticut office, and our customers see little or no
impact. Under rapid deployment to telework, employees will be
prioritized by mission critical function, as well as by their
technological readiness to transition, i.e., broadband
capability.
Efforts will be made to adhere to CDC guidance, where
employees in high risk groups are offered an opportunity to
work at home consistent with employment laws. At many sites,
there will still be a need for office based workers to come on
site no matter the threat to keep serving our customers. For
these employees, social distancing strategies will be employed.
To that end, we have plans ready to cancel or curtail physical
meetings and substitute virtual meetings through our robust
teleconferencing network capability. Additionally, we will
enhance facility cleaning, control visitation, eliminate
unnecessary travel, and spread out employees geographically if
needed.
Efforts will be made to coordinate actions with local and
State health officials to adhere to any triggers that may be
provided by health officials for taking additional actions. All
site crisis leaders have been instructed to establish two-way
communications with their local and State contacts so they are
apprised of the local situation as it changes and they are
advised of local actions that should be taken.
The objective of all this is to flatten out the absentee
curve at all affected sites and maximize our production to
serve our customers and members during the peak of each wave.
It is our hope that if strategies are employed effectively, we
believe we can lessen that peak absentee curve by about 5 to 10
percent, and this would make a big difference if we could do
that. There is no scientific evidence in that; that is just our
belief internally.
Last, a separate but very significant part of our response
capability is the ability to deal with member needs due to
widespread disasters, such as hurricanes, wild fires, or terror
attacks. We have established a dedicated team to review health
benefit policies that may need to change due to a provider
network overload, or due to provider network failure, or due to
a mass evacuation as in Hurricane Katrina.
Changes once identified through our evaluation or due to
regulator order will be communicated to members and plan
sponsors so that they can avail themselves of alternate ways to
obtain the care they need. This process has been successfully
demonstrated on September 11, 2001, and in natural disaster
after disaster, in recent years, and would be implemented if
necessary during a pandemic as well.
We thank you for the time today.
Chairman Lieberman. Thanks, very much, Mr. Aloi. That was
really interesting. I am going to come back and have a few
questions for you.
The final witness, and we thank you for being here. Michael
Kurland is the Director of Student Health Services at the
University of Connecticut. We know that college campuses have
been an area in some cases where there has been an outbreak of
H1N1. The Coast Guard Academy had one here earlier in the year,
and then some other campuses around the country have been
really quite severely impacted.
So I will be interested in hearing what you are doing and
also to what extent you are reacting to what you have learned
from your colleagues at the other campuses that have been more
impacted. But thank you for coming.
TESTIMONY OF MICHAEL KURLAND,\1\ DIRECTOR, STUDENT HEALTH
SERVICES, UNIVERSITY OF CONNECTICUT
Mr. Kurland. Thank you so much for letting me speak. The
message I am really going to convey is that the key strategy in
dealing with any type of H1N1 preparation is collaboration and
partnership among many university departments, the Connecticut
State Department of Public Health, local health districts,
Centers for Disease Control and Prevention, Department of
Education, and the American College Health Association. So it
is a team effort, and we are partnering with parents and with
students.
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\1\ The prepared statement of Mr. Kurland appears in the Appendix
on page 246.
---------------------------------------------------------------------------
The University of Connecticut has a Pandemic Flu Continuity
of Operations Committee, which follows an operational plan
based upon the National Incident Management System (NIMS)
model. The committee is comprised of representatives from a
number of departments throughout the university, including
Student Affairs, Student Health Services, Facilities, Academic
Affairs, Public Safety, Environmental Health and Safety, Human
Resources, the Office of the Attorney General, the Office of
Communications, Finance, our regional campuses, and experts in
emergency preparedness from our continuing studies area.
The committee has been meeting for the past several months
in order to plan for all aspects of the health, safety, and
continuity of operations in the event of an H1N1 flu outbreak.
The committee is chaired by Major Ron Blicher, who is sitting
directly behind me. He serves as the incident commander, and in
my capacity as director of Student Health Services, I serve as
the operations section chief.
Additionally, the Division of Student Affairs maintains an
H1N1 task force, which has been meeting weekly in order to
operationalize plans for the health and safety of students and
staff. This task force is comprised of representatives from
Student Affairs, Student Health Services, Residential Life,
Dining Services, the Office of Student Services and Advocacy,
and Wellness and Prevention Services. Meetings have included
staff from Environmental Health and Safety also.
The issues that we have been addressing include but are not
limited to the following: Prevention strategies in community
education. The university is embarking upon a multifaceted
health communications campaign in order to help prevent the
transmission of the H1N1 virus. The focus is on respiratory
etiquette, social distancing, proper handwashing, staying
healthy, proper cleaning of personal and work space, and
encouraging students and staff to self-isolate if they are
infected with the flu.
The methods of dissemination of information include
bulletin boards, pamphlets, table tents, curriculum infusion,
mass e-mails, letters, use of a dedicated H1N1 Web site,
training of staff, cable TV, and radio PSAs.
The Web site includes many helpful links as well as
frequently asked quetions pages for both employees and
students. Additionally, students have been encouraged to be
prepared and to purchase supplies of hand sanitizer, fever
reducing medications, fever thermometers, and surgical face
masks. Hand sanitizer has been made readily available in many
public areas of the university and has been disseminated to
students by many departments throughout the university.
Isolation and support services: The key to preventing
transmission is to encourage isolation of sick people. I might
add, UConn has over 20,000 students and we have 12,400 students
living on campus. Students who are ill are encouraged to call
an advice nurse to seek medical assistance for the flu. They
are provided with an assessment via the phone and are requested
to visit the Student Health Services, only if medically
indicated, in order to avoid burdening the healthcare system
and to reduce potential virus transmission.
They are encouraged to remain isolated if they do not share
a bedroom with another student. If they share a bedroom with
another student, they are asked to return home if their family
lives within driving distance. Fortunately, 85 to 90 percent of
UConn students live within driving distance of our campus.
If it is unfeasible for a student to return home, the
university has designated a number of beds to provide isolation
for these individuals. Students who are self-isolating or have
been moved to an isolation area are provided with meals
delivered from dining services, and are provided with a limited
supply of flu kits and supplies such as Tylenol, Advil, fever
thermometers, and surgical face masks. If medically indicated,
they will be admitted into the infirmary unit (or inpatient
unit) of the Student Health Services facility.
In terms of academic consideration, in order to reduce the
transmission of H1N1, students are advised to be absent from
classes if they have the flu. Professors have been advised to
not require medical excuse notes and to expect higher than
normal rates of absenteeism. Additionally, professors have been
encouraged to utilize Web-based course tools which can assist
students in keeping up with the curriculum in the event of
illness.
Vaccination is also very important. Students are encouraged
to receive both the seasonal flu vaccine as well as the H1N1
vaccine. Seasonal flu vaccine clinics have already been
scheduled. They are going to be earlier than usual. We are
going to have them next week. H1N1 vaccination clinics will be
scheduled as soon as the vaccine is available. Doses of H1N1
have already been requested through the Department of Public
Health and will be provided free of charge to all students who
fall within the target groups, defined by the Centers for
Disease Control and Prevention.
As I mentioned previously, we have had coordination with
many outside resources. The university has been in close
contact with the Connecticut Department of Public Health and
has coordinated with the Eastern Highlands health district,
which is one of those 41 health districts that was referred to
earlier. And they are the local health department for our local
10 town area.
Now, the current status at UConn, as of this week, we have
been very fortunate. We only have one confirmed case of H1N1,
two probable cases of H1N1, less than 20 cases of influenza-
like illness. We are, of course, monitoring the situation
closely as we know it can change at any time.
Some of the challenges that we face are maintaining an
ample number of isolation beds as the university residents
halls are at 100 percent capacity, so there is no swing bed
space.
Another challenge is maintaining continuity of operations
in the event of large numbers of employee absences. UConn is
its own little city. We have a sewage department. We have
dining services. We have a police department, a fire
department, and a payroll office. You name it, they are all
essential, and we need to maintain continuity of operations.
Another challenge is maintaining an adequate amount of
supplies to care for those who are sick with the flu. They are
not really readily available. There are back orders on a number
of the supplies. Also, deciding when to cancel public events or
classes due to a large number of cases of the flu; there is no
magic number. It is a challenge.
Another challenge is staffing H1N1 vaccination clinics for
an unprecedented number of inoculations. If all 20,000 of our
students on the Storrs campus decide to get an inoculation,
that is a lot of people to vaccinate with limited staff. And
then, the last challenge is the cost of supplies and personnel
to accommodate the outbreak. It is not cheap.
Thank you very much for allowing me to speak.
Chairman Lieberman. Thank you. Let me ask you a few
questions. I am interested in the idea of telling students who
live within driving distance to go home.
Does the university define driving distance?
Mr. Kurland. That is a great question. My definition of
driving distance and other people's definition of driving
distance may not be the same. But two to three hours would be a
reasonable driving distance. We have had students from New
Jersey already go home, students from Massachusetts and Maine.
The key thing is they cannot drive themselves and they
cannot go on public transportation.
Chairman Lieberman. Right.
Mr. Kurland. So it really needs to be a family or friend.
Chairman Lieberman. That seems like a reasonable rule,
taking any student from Connecticut and then from the
surrounding States as well.
Do you think that the students are taking the H1N1 pandemic
seriously, in the sense that if vaccines become available,
there really will be a large demand among the UConn students?
Mr. Kurland. I would hope so. I know the students are very
knowledgeable. Massive information campaigns are out there, at
the State level, at the Federal level, and at the university
level. I know they are aware of the precautions. Whether they
are taking those precautions, time will only tell. But they
have found at a number of universities that cases have begun to
spike after the sorority and fraternity rush and other large
events that do not promote social distancing.
I would hope that most students would avail themselves of
the vaccine when the vaccine is readily available because they
are in the target risk group of those up to age 24.
Chairman Lieberman. Well, that is an important point.
Mr. Kurland. In Connecticut, the median age of people who
have contracted H1N1 is age 14, so it is a much younger
population.
Chairman Lieberman. So the small number of cases is good to
hear but do you have it at UConn now?
Mr. Kurland. Right.
Chairman Lieberman. But I presume there were more in the
spring?
Mr. Kurland. No. We had no confirmed cases in the spring.
Chairman Lieberman. Oh, that is great; a healthy population
up there.
Mr. Kurland. No, lucky.
Chairman Lieberman. They do not call them Huskies for
nothing. [Laughter.]
Mr. Kurland. If you were to look at a map of--and Dr.
Cartter probably would have explained it. But the flu moves up
from New York City. It started in Fairfield County. By the time
it got to Windham and Tolland County----
Chairman Lieberman. That is interesting.
Mr. Kurland [continuing]. It was later in June. So we were
just lucky because we graduated them and sent them home before
they could get sick.
Chairman Lieberman. Yes, great.
Ms. Wright, tell me about what you understand to be the
role of the schools in a vaccination program once the vaccines
become available?
Ms. Wright. Since the Public Health Department does oversee
the 39 school nurses, once the vaccine does become available to
the student population, we have every intention of going into
the school district and taking care of Waterbury students.
I am not sure what other directors of health are doing.
Their pandemic flu plans, I believe, are due the first week in
October, so everyone is starting to talk about that now. But we
have been talking with the mayor's office and the
superintendent of schools.
Our biggest obstacle that we need to overcome is we need to
develop maybe a team of nurses. We cannot utilize the school
nurse that is in the building. Our middle school nurse might
see 110 students a day, so you cannot pull her. And our hope is
to go from classroom to classroom to keep it more organized and
really try to keep the educational continuity the same.
Chairman Lieberman. Interesting. So what you will do then
is to bring some nurses on----
Ms. Wright. Bring a team of nurses to each school. And our
middle and our high schools are our largest populations, of
over 1,200 students, so we will probably take a much longer
period of time in those buildings in terms of dates.
Chairman Lieberman. Right.
Ms. Wright. And then we are hoping that the elementary
schools, the private, and the parochials, some of which are
about 200, will be a little bit easier for us.
Chairman Lieberman. I presume that the Public Health
Department of a city like Waterbury would be a natural place
for the distribution of vaccines generally to vulnerable
populations. In a week and a half or two, we expect the first
wave of vaccines that you heard today, when the nasal spray
comes available.
What are your plans about how to handle this?
Ms. Wright. Well, our guidance will come from the State
Health Department in terms of where the vaccine will actually
land once it hits Waterbury. But we are talking to our medical
providers, and the medical providers are now signing up to be
vaccinators.
We will help them if we need to. We put ourselves out there
as the Public Health Department to hold public health clinics.
And again, our flu plans are all due, so once we start putting
things down in writing--and once we really have to figure out
how many vaccines are coming to Waterbury because that is going
to depend on where our push is.
Chairman Lieberman. So you will be the point of
distribution for Waterbury to private providers; is that right?
Ms. Wright. We probably will be, but, again, that guidance
has to come from----
Chairman Lieberman. It is not clear. But you will certainly
be one of the points of distribution for people who come in and
show that they are in one of the vulnerable or priority
populations, and you will give them the vaccine right there.
Ms. Wright. Yes. We are hoping that they do stay with their
private provider. Their private provider actually knows their
medical history and will be able to interview them much better
than we will. They will have their medical record. But in the
event that they cannot, then, yes, we hope to--the health
department always views itself as the last safety net, and we
hope to definitely do that.
Chairman Lieberman. Good. Mr. Aloi, just a couple of
questions for you. I was fascinated, if I heard you correctly,
that one-third of the Aetna workers in the State telecommute or
work by telephone all the time or part of the time?
Mr. Aloi. Nationally, yes.
Chairman Lieberman. Nationally. So it may be a little off
for that in Connecticut, but that is the national number.
Mr. Aloi. Right. We invested very wisely a few years ago in
a very robust backbone of infrastructure that can take
connectivity from home teleworkers through the Internet. So we
can accommodate almost our entire staff that way if we had to.
So one-third has already transitioned to telework.
Chairman Lieberman. That is impressive.
Mr. Aloi. Yes, we are one of the leading companies in this
area, and we are finding very good results from happiness in
employees, productivity, saving of money for travel, all kinds
of benefits from it. And it just happens to help us a great
deal for this threat.
Chairman Lieberman. So in this case, if you have somebody
who is showing the symptoms of H1N1 flu, you can ask them to
telecommute for a while.
Mr. Aloi. Well, if they are showing symptoms, we are going
to send them home because we do not want them in the workplace.
Chairman Lieberman. That is what I mean. You are going to
send them home.
Mr. Aloi. Once they get better, then a decision will be
made 24, 48 hours, whatever, to bring them back.
Chairman Lieberman. I presume it takes some kind of capital
investment, or does it, to enable a worker to work from home?
Mr. Aloi. Yes.
Chairman Lieberman. So if a worker was going to be out 3 or
4 days, it would not be worth it?
Mr. Aloi. Right.
Chairman Lieberman. I got you.
Mr. Aloi. The group I was talking about that we would send
home would be--and this is some of the things we are looking
for, for the triggers, is that once it is so significant and so
severe in any given area, we are going to go to the next level,
which is, as I said, the social distancing. And part of that
social distancing is to send as many of those critical workers
home because we know that, sooner or later, their children are
going to be at home and they are not going to be able to come
to work due to that. And also it will help minimize the spread
in the workplace because you have a lot less folks there able
to communicate it to each other. So we can go to the next level
if we have to.
Chairman Lieberman. A question about a different kind of
Aetna relationship to this.
Ms. Polansky talked about the obvious problem with a
working parent--let's say two working parents--when a child is
sent home from school.
Has Aetna adjusted its policies in any way to deal with
that, particularly if the H1N1 becomes more prevalent than it
is now?
Mr. Aloi. It behooves us to accommodate workers that are
encumbered by sick loved ones at home because they are more apt
to be able to at least spend part of the day at home working
for us versus losing their whole day of productivity. So they
also would be prioritized up front for the first wave of folks
to be sent home and set up pretty rapidly. We can do that in
about 24 hours on average.
Chairman Lieberman. Is there a company policy that shows
some leniency toward parents that have to go home and take care
of a sick child?
Mr. Aloi. There will be a filtering process. Those that are
predisposed to a high risk group, of course, that have not
received the vaccine, we would want to make sure they get home,
and that is going to minimize their risk. Then next is a
mission-critical worker.
Chairman Lieberman. Let me ask you the broader question
because obviously Aetna is a big business and in some sense,
therefore, has the capacity to invest in systems like this, and
also happens to know the area because it is a health insurance
company.
I asked you earlier and you mentioned that you are doing
some work with business customers, advising them about this. I
am thinking particularly of smaller businesses
What is your impression of how they are handling the
potential for a spread of this pandemic?
Mr. Aloi. We get a lot of questions from customers, big and
small, on recommendations on how they should prepare because
they see us as one of the experts in the field. We have to that
end created messaging on our sales Web, which are our account
managers who communicate with our customers. And also we have
provided policies and recommendations on employer preparations,
and then also linked it over to CDC and other federally
available guidance that we use ourselves, which is the CDC
recommendation on business preparation. So we push them in that
direction.
Chairman Lieberman. So that is very good. Are you
affirmatively sending out guidance to the business customers?
Mr. Aloi. Yes, we are. And we also, as I said earlier, make
our course available, the handwashing and the good practices.
It is an online course. It only takes about 10 minutes. We have
made that available, free of charge, to all our customers.
Chairman Lieberman. Are people using it as far as you know?
Mr. Aloi. Yes. We are getting pretty good hits, especially
when April occurred; everybody went back and re-took it that
had taken it in 2006.
Chairman Lieberman. That is great.
I have no further questions. You all have been extremely
helpful. I must say I am impressed by how our society gears up,
governmentally, but also in a lot of different private ways,
including by an active parent, to deal with the problem. And I
think it is part of the reason, though we never know, why we
are prepared to inhibit the spread of this as we go through
this second wave.
As the earlier panel said, and we all know, we have to
remain flexible and ready because this could take a lot of
twists and turns before it is over, and a lot of people's
health and, worse, lives will be on the line.
I really thank you for coming in. It has been very helpful.
I leave here reassured by our state of preparedness, not with
any superior knowledge about what path the influenza will take,
but that in many ways we are prepared. And also, in the broader
sense that I said this, every time we get ready to deal with
something like H1N1, we also prepare ourselves to deal better
with other kinds of public health or natural or unnatural
disasters, like terrorist activities, so that is encouraging in
all those ways.
We will leave the record of this hearing open for 7 days.
If there are any further questions or statements--you may want
to add to your statements. Others on the panel may want to ask
you a question; even I may want to ask you some questions in
writing. But, again, I thank you. It is good to end a hearing
feeling encouraged about our state of preparedness.
The hearing is adjourned.
[Whereupon, at 12:15 p.m., the Committee was adjourned.]
H1N1 FLU: MONITORING THE NATION'S RESPONSE
----------
WEDNESDAY, OCTOBER 21, 2009
U.S. Senate,
Committee on Homeland Security and
Governmental Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 9:36 a.m., in
room SD-342, Dirksen Senate Office Building, Hon. Joseph I.
Lieberman, Chairman of the Committee, presiding.
Present: Senators Lieberman, Carper, McCaskill, Tester,
Burris, Kirk, Collins, McCain, and Bennett.
OPENING STATEMENT OF CHAIRMAN LIEBERMAN
Chairman Lieberman. Good morning. The hearing will now come
to order. We have called today's hearing to discuss measures
that are being taken to manage the spread of the H1N1 influenza
virus, which reached pandemic proportions this summer and
continues to claim new victims every day, especially among
young people.
I want to thank Homeland Security Secretary Janet
Napolitano, Health and Human Services Secretary Kathleen
Sebelius, and Education Secretary Arne Duncan for being with us
today. These are the three Federal officials who have really
been coordinating the Federal Government's and our Nation's
response to this public health challenge--I would call it now a
``crisis''--and we very much appreciate that you made the time
to be with us here today for this oversight hearing.
Each of your agencies has critical responsibilities for
dealing with the H1N1 public health emergency that has already
taken the lives of thousands and thousands of people across the
globe. Here in the United States, the Centers for Disease
Control and Prevention (CDC), I gather, are no longer counting
cases because of the difficulty of staying on top of the
increasing numbers and confirming those numbers. But we do know
that at least 2,300 people have died in the United States from
the H1N1 flu in the last few months.
Under existing Federal Government emergency protocols, the
Department of Homeland Security (DHS) is the overall incident
manager, coordinating resources across the Federal Government
and assisting State and local governments in their response to
the H1N1 virus. The Department of Health and Human Services
(HHS), including the CDC, has been responsible for leading the
public health and medical response. And because this H1N1
outbreak poses greater risks for children than the traditional
flu, the Department of Education has helped guide local
districts on how to protect their students, under what
circumstances to close schools, and what to do if a school must
be closed.
This particular strain of influenza--H1N1--has moved with
alarming speed and taken an exceptionally high toll at a time
of year when we do not normally encounter significant cases of
flu. The CDC reports that the H1N1 flu has spread to all parts
of the country, with almost all States reporting widespread or
regional outbreaks.
I want to draw your attention to this chart that my staff
has prepared.\1\ It is actually from the CDC, and we have blown
it up. It gives you a sense--the three lines chart--of the
course of the flu outbreak over the preceding three seasons.
This is what you might call normal flu, seasonal flu, and you
can see that the spikes occur in January, the highest being
2007-08. It went way up here. We are in October now, of course,
and these lines all go down to a low point, except for the red
line, which is the H1N1 outbreak, which is now, at a time of
year that is normally low in terms of flu impact, higher than
the regular flu was at its peak in January. Of course, this
raises real concerns for us about where this line will go in
the months ahead.
---------------------------------------------------------------------------
\1\ The chart submitted for the Record by Senator Lieberman appears
in the Appendix on page 251.
---------------------------------------------------------------------------
Alarmingly, what we do know is that young children are at
very serious risk, with 43 pediatric deaths tallied so far--11
of which occurred just the week before last, the most recent
period for which we have data. These pediatric mortality
statistics for H1N1 flu are already equal to what we usually
see over the entire course of a normal flu season for children.
Presumably, and regrettably, these numbers will climb higher as
the outbreak shows no signs of waning.
Pregnant women are also being hit hard by the flu. Of the
100 pregnant women who required intensive care through late
August, there were 28 deaths. The CDC, obviously, is concerned
about that.
Thus far, the Federal Government, I will say to the three
of you Secretaries and your agencies, have responded
aggressively and I think as effectively as possible to the
threat of the H1N1 virus. You have quite skillfully tracked the
spread of the disease and who it is afflicting. You have worked
with private sector partners to pull off what to us non-science
majors looks like a miracle, which is to develop a vaccine
quickly. You have provided important information to guide State
and local officials through perils they may face as the virus
escalates. And you have remained very publicly accessible and
visible, communicating critical developments in this public
health emergency to the American public.
I presume that previous presidential directives and
national strategies for infectious diseases and influenza
pandemics that were issued over the last several years informed
and in some sense facilitated your decisions, which proves
again the immense value of planning. So there is a lot that
should be reassuring and encouraging to the American people.
I want to say frankly to you this morning that I am
concerned, as we meet this morning, that the flu is spreading
so rapidly and in some cases with such intensity that it may
well be getting ahead of the Federal Government's ability and
the public health system's ability to prevent and respond to
it. And I want to give you three reasons why I have these
concerns and, of course, ask you to respond during your
testimony.
First, the schedule for the production and availability of
vaccine--whose existence was really quite remarkable--has
slipped. The 28 million to 30 million doses that will
apparently be available by the end of the month is 25 percent
below initial governmental projections of the 40 million
vaccines that you thought would be available by the end of
October. And there are now very unsettling reports of growing
vaccine shortages that are leading a lot of people to ask us,
and we are asking ourselves, if enough vaccine will be produced
in time for all who will need it as we continue to experience
the spread of H1N1 flu.
This week, one television reporter used the term ``quiet
desperation'' to describe the feeling of public health
officials around the country facing shortages of the H1N1
vaccine in their areas, and I am sure that is as unsettling and
unacceptable to you as it is to the rest of us.
Second, I want to express my concern that hospitals and
Public Health Departments do not have the capacity to care for
the surge of people who may need hospitalization as a result of
the spread of the virus. And here I am going to refer to a
recent report--and this is not a stunning new problem. We have
worried in terms of this pandemic--and, of course, the concern
that this Committee as the Homeland Security Committee has
generally--about the capacity of our public health system, for
instance, to deal with the consequences of a bioterrorist
attack on the United States.
I want to quote from a report this month from the Trust for
America's Health that found that 27 States, including my own
State of Connecticut, could exceed or come close to exceeding
available hospital bed capacity during the peak of the outbreak
if 35 percent of the American people become infected with the
flu, which the Trust says is a plausible number. Just to make
it more explicit, based on the 35-percent modeling scenario,
more than a million people in Connecticut could develop the
H1N1 virus, which would result in more than 17,300
hospitalizations at the peak of such an outbreak, which is
about 150 percent of the total hospital bed capacity in
Connecticut. I am sure that situation repeats itself in other
States and throughout the country. So that is my second
concern.
The third is about the availability of intravenous
antiviral medications to treat people who are critically ill
with the H1N1 virus. Secretary Sebelius, you have an
encouraging but general sentence in your prepared testimony
about this. And here I want to go from a report by the
President's Council of Advisors on Science and Technology
(PCAST), which posed a plausible scenario in their case in
which 30 percent of the population would be infected with the
H1N1 virus, resulting in almost two million hospitalizations.
But what particularly struck me is their estimate that between
150,000 and 300,000 of those hospitalizations could be so
serious that they would require intensive care treatment,
Intensive Care Unit (ICU) treatment. A lot of those people,
from what I have heard from doctors, are probably not going to
be able to be treated with the existing antivirals, such as
Tamiflu and Relenza. The encouraging part of this story--and I
want to ask, to the extent you can this morning, Secretary
Sebelius, to tell us about it. I know that HHS under the
Biomedical Advanced Research and Development Authority (BARDA)
program, which Congress adopted and the President signed a
couple of years ago, has actually been very farsighted about
this and invested some money in some breakthrough work that is
being done to develop intravenous antivirals for those who are
critically ill with this flu. But this is one of those moments
that poses a public health, also a kind of ethical, moral
dilemma because I gather that they have not fully completed all
the trials, but at least one of them appears to be moving
along, and it is under the capacity that the Food and Drug
Administration (FDA) has to grant compassionate usage
authorization. These intravenous (IV) antivirals have been used
in some critical cases, and I gather generally, though not in
every case, have saved the lives of some people who their
doctors at least thought would have died otherwise. So I want
to hear from you and probably will ask you about the state of
development and of decisionmaking about the availability of
those intravenous antivirals.
Bottom line, the three of you, your departments, and all
who are working with you have worked very aggressively and to
the best of your ability. It is just my concern as we meet this
morning that this flu, the H1N1 virus, is moving very rapidly.
And while it seems to still be affecting most people mildly, it
is clearly affecting a small percentage, but nonetheless a
significant number of people, quite seriously. And so, I
repeat, I am worried that the virus is getting ahead of the
public health system's capacity at this moment to prevent it
and respond to it, particularly with adequate treatment. So it
is in that spirit that I thank you for being here, and I very
much look forward to your testimony.
Senator Collins.
OPENING STATEMENT OF SENATOR COLLINS
Senator Collins. Thank you, Mr. Chairman.
By now, everyone in this room is familiar with the threat
that we currently face from the H1N1 virus. This oversight
hearing is important, however, because we must continually
assess the effectiveness of Federal, State, and local efforts
to respond to this pandemic, which appears to strike pregnant
women, young children, and young people with particular
ferocity.
Just this past week in Maine, Bates College made the news
when the number of H1N1 flu cases jumped from 6 to 160 in less
than a week. As of yesterday, 245 Bates students are infected
with H1N1.
Public health experts are learning as they go along,
sometimes with surprising results that run counter to their
earlier assumptions about H1N1. For example, the CDC just
released a report that found that 46 percent of 1,400 adults
hospitalized with H1N1 were healthy and did not have underlying
chronic illness before they got sick with the flu. While this
was a preliminary analysis, the new report paints a different
picture than previous studies, which had concluded that the
vast majority of H1N1 patients who became severely ill had
chronic or other underlying health conditions. New data like
this report must constantly be taken into account as we handle
our Nation's pandemic flu.
It is clear that much work and preparation has gone into
preparing for this outbreak. Our country has mobilized as
government officials at all levels, doctors and other health
care professionals, nonprofit organizations and private
businesses have devoted significant time and resources to
tackling the many challenges posed by this virus. Principals in
the State of Maine have told me that virtually every school in
Maine has a plan for dealing with the pandemic flu.
The Post-Katrina Emergency Management Reform Act of 2006,
which was written by this Committee, mandated comprehensive and
coordinated disaster planning to improve our preparedness and
response for both man-made and naturally occurring catastrophes
like this pandemic. In addition, Congress has allocated nearly
$9 billion to HHS alone over the past 5 years for pandemic
preparedness. These efforts have laid a strong foundation for
the response that we have seen to date.
Nonetheless, while the government and private sector have
accomplished a great deal, significant concerns remain. For
example, despite the repeated assurances of Federal officials,
millions of Americans nevertheless remain worried about the
safety of the vaccine. They want to know if it is safe to give
to their children, what kind of testing was done, and whether
it contains any dangerous additives. The State CDC in Maine
reports many calls from citizens asking these questions.
State officials also remain concerned about whether there
will be a sufficient number of doses of the vaccine. In the
next 8 weeks, the State of Maine is scheduled to receive only
340,000 doses of the vaccine. This falls short of the amount
needed to vaccinate everyone in the priority groups that the
CDC has identified.
Like the Chairman, I am very concerned about recent reports
on inadequate supplies of the vaccine. The CDC has been telling
us since last September--or since earlier this year that the
Federal Government had purchased 250 million doses of the
vaccine, of which 40 million would be available by the end of
this month. It now appears, as the Chairman indicated, that
production delays will result in 25 percent fewer doses than
had been projected for October. This disturbs us because we are
seeing such an early peak in the flu.
Another issue is whether or not we have a sufficient supply
of pediatric formulations of the antiviral medication Tamiflu.
That is particularly important since the virus
disproportionately affects children. There are also reports of
phony Tamiflu being sold over the Internet.
Another significant concern that the Chairman has raised
and that I share is whether or not our Nation's emergency rooms
have sufficient capacity to cope with a massive influx of sick
patients if the pandemic worsens.
The fact that three Cabinet Secretaries are here today
demonstrates the seriousness with which the Federal Government
is preparing for and responding to the H1N1 pandemic. I look
forward to hearing from our witnesses, particularly on the
issue of shortages of the vaccine. Thank you, Mr. Chairman.
Chairman Lieberman. Thanks very much, Senator Collins.
We will go to Secretary Napolitano first. Just to say for
the record, this Committee has a particular interest in this
oversight hearing because we are the Homeland Security
Committee. Secretary Napolitano regularly is in contact and
works with us, of course, and she is the incident manager for
this response with overall responsibility.
And I would just repeat very briefly that this Committee
was given homeland security jurisdiction in response to
September 11, 2001, and the concern of raising our defenses to
terrorist attack, but also, of course, to prepare for natural
disasters and threats such as this one. So I thank you for all
your good work in that regard and welcome your testimony now.
TESTIMONY OF HON. JANET A. NAPOLITANO,\1\ SECRETARY, U.S.
DEPARTMENT OF HOMELAND SECURITY
Secretary Napolitano. Well, thank you, Mr. Chairman,
Senator Collins, and Members of the Committee, for the
opportunity to update you on the steps we have taken Americans
for the H1N1 flu.
---------------------------------------------------------------------------
\1\ The prepared statement of Secretary Napolitano appears in the
Appendix on page 255.
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In April, I testified before this Committee that DHS and
our Federal partners were addressing this situation
aggressively and collectively. That was true then; it is true
today.
As you note, Mr. Chairman, under Homeland Security
Presidential Directive 5, the Department of Homeland Security
is the lead coordinator, but we work with our Federal partners
in a very close way. We have actually been joined at the hip
over the past months. The Department of Health and Human
Services, of course, with the CDC is the lead on issues related
to the public health and vaccine. The Department of Education,
as you note, under the leadership of Secretary Duncan, is the
lead with respect to our schools and our young people. But
there are many other departments of the Federal Government that
you could have at this table that have been working with us in
planning for the flu, and let me just note that our planning
has assumed that there would be some gap period between when
vaccine would be commonly available and when the flu would
actually be present. In other words, we have assumed a lag time
between the flu spiking and vaccine availability. So if you
were to look at the planning, you would see that was built in.
In addition, we are working with State, local, and tribal
partners on their planning and prevention issues, and,
importantly, we are working with the American people. They are
really our most important partners here. Communicating the
message about how they can just by very simple actions, like
washing hands and coughing properly, help slow the transmission
of this virus.
Let me, if I might briefly, update you on the activities
since April.
First, there has been, as noted, extensive Federal
interagency work and planning that has gone on. We have been
working on preparation and response actions. We have been
making sure that mission-critical, mission-essential functions
could continue to be performed. We have clarified workforce
protection steps, and we have been in constant communication
with key stakeholders--State and local governments, the public,
our employees, and the like.
We are also coordinating planning across the Federal
Government for continuity in case, in light of this pandemic,
we really see a surge in absenteeism as well as a surge of
entrants into our health system. The Federal Emergency
Management Agency (FEMA) has been coordinating that planning.
They have now reviewed continuity plans for all Federal
agencies and conducted 30 training sessions over the summer in
terms of continuation of operations and continuation of
government during a pandemic. We call that COOP and COG, but
that is really what it is about: How do we work our way through
this and make sure the business of the country continues?
We have--and this goes to your point, Senator Collins,
about the need to continually update data--deployed a common
operating picture. It is updated. It is a Web-based tool. It
collects all data around the country of all different types and
provides that data both to the government and to the private
sector. I myself get an update at least once a day from the
common operating picture about what we are seeing on H1N1
across the country.
We have clarified issues about workforce protection. This
was one of the areas that was unclear in the spring outbreak of
the disease, and we have provided guidance to employees based
on the best science available as to what needs to be done and
on human resources flexibility, personal protective equipment,
and the like. And all of this guidance, by the way, is
available on our Web site.
I mentioned State, local, and tribal governments. We have
through FEMA provided training to 56 Incident Management
Assistance Teams (IMAT). These teams are designed to be
available should a State or locality say, ``We need help.'' The
surge in H1N1 we are seeing is beyond what our own planning has
accommodated or accounted for and our own personnel can handle.
Those IMAT teams are on the ready, and we also have a national
team. The Office of Intergovernmental Programs at the
Department has biweekly calls with all State homeland security
advisers.
One of the lessons learned from this spring, Mr. Chairman,
was that we had a pretty robust homeland security
communications system here, and HHS had a very robust system of
communicating with public health directors, but they were not
communicating with each other oftentimes at the local and State
level. Lashing those things together has been one of our
efforts over the summer, and it is going to be not only one of
the lessons learned, but one of the improvements made in light
of the H1N1 epidemic.
Over the course of the summer, the Department, with HHS,
the Department of Education, and others, has released updated
guidance for schools, for small businesses, for others affected
or impacted by the flu, by this new strain, so they can do
their own planning.
We have also been engaged in private sector outreach. We
have released, with the Department of Commerce, updated private
sector guidance. We also have been meeting with critical
infrastructure and key resource leaders, again, under the
theory that we could have a surge before everyone is
vaccinated, and we need to keep the business of the country
moving with particular attention paid to critical
infrastructure. So it is basic things: How to ensure continued
operations, ways employees can protect themselves, human
resources steps companies can take during a severe pandemic.
And there have been daily update calls over the course of the
past weeks, particularly with our key private resource
partners.
Last but not least--it was not mentioned in either of your
statements, but we did talk about it in April--is the
international aspect of this, particularly with response to
Mexico and Canada. Suffice it to say that we have been working
with both of those countries. The Deputy Secretary was in
Mexico City just 2 weeks ago to meet with our Mexican and
Canadian counterparts to review emergency information sharing,
communications, and issues with respect to our borders.
Through this all, we have been, as I said earlier, making
assumptions that we will work our way through this flu epidemic
over several months, and during part of that time, the vaccine
would not be commonly available.
With respect to the surge issue in the health care arena,
while the Secretary of Health and Human Services, Secretary
Sebelius, will address a lot of the vaccine and public health
issues that are of concern at today's hearing, let me just
share with you that there has been at least $3 billion shared
with hospitals throughout the country to do surge planning. And
not only that, we know from our own review of what is going on
in States and localities that many health providers across the
country have plans, for example, if necessary, to handle
patients outside of the hospital, outside of the emergency
rooms (ERs), so that the actual acute care is reserved for
those who are most in need of it. And it can be anything from
in some cities actually doing some triage in tents, should they
need to. Houston and Kansas City are two examples of that. In
Albuquerque, New Mexico, they are using an old cancer center as
a place to handle flu patients during the course of the height
of this pandemic. So a lot of that sort of surge planning has
gone on.
Let me close in just a moment and thank the work of this
Committee and my predecessors at DHS. They had done a lot of
the groundwork on pandemic. We have taken that many steps
forward in light of the different nature of this flu. It is not
the same as avian flu. It has different issues with respect to
homeland security planning, but, nonetheless, we worked from a
basis that was quite well done.
Chairman Lieberman. Thanks very much for that testimony,
Madam Secretary.
Secretary Sebelius, welcome and we look forward to your
testimony now.
TESTIMONY OF HON. KATHLEEN SEBELIUS,\1\ SECRETARY, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Secretary Sebelius. Thank you, Mr. Chairman. Chairman
Lieberman, Ranking Member Collins, and Members of the
Committee, I am pleased to have a chance to appear with my
colleagues and give you an update at this critical time. And I
would start by echoing what Secretary Napolitano has said, that
the collaboration and cooperation of not only the three of us
representing three critical front-line agencies but across this
government has been remarkable, and we have had wonderful
results also with State and local partners, tribal partners,
the private sector, and others. There is no question that we
would not be where we are today without that collaboration.
---------------------------------------------------------------------------
\1\ The prepared statement of Secretary Sebelius appears in the
Appendix on page 266.
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I wanted to point out to the Committee Members that you
have, I think, packets at your desks which have a couple of
important pieces of information. We believe strongly, as the
President indicated from the outset, that we should be guided
in our response by the science, and CDC is our lead agency for
the science-based advice. Dr. Anne Schuchat, who is with me
today, has been widely available, but what I have given to
Committee Members is a situational update as of October 21.
These updates are now being done twice a week by CDC to give
you an overview. We have some information that gives you some
ideas of the kinds of things we have been putting forward for
business and employers and the private sector, and then some
examples of what is on flu.gov. And, Mr. Chairman, I would tell
you that our flu.gov Web site, which early on was constructed
as a sort of one-stop shop, is now getting 5 million hits a
week. So people are using that tool, and I think that is very
good news because it gives some regular detailed, scientific
information on a consistent basis.
We have some good news about this flu epidemic. The virus
has not changed significantly since April, and that means that
the vaccine target is appropriate. It is getting a robust
response. And that, again, is good news. Except for a couple of
cases that seem to be outliers, the virus continues to be
susceptible to Tamiflu and Relenza. That, again, is very
positive that we are in a situation where the antivirals that
we have are working.
No question, as the Chairman has already said, that we are
seeing some very unusual activity. Flu season officially began
on October 4, but as the Chairman indicated in the chart he has
passed out, this does not look like a typical flu season.
Visits to doctors are higher than expected. Forty-one States
represent what we call now ``widespread level of activity,''
which is just the count that they are giving, and the remaining
States are at elevated levels of flu. So this is a national
issue.
One of the most troubling aspects is the higher rate of
illness among children and young people. There are actually 86
H1N1 lab-confirmed pediatric deaths since we began reporting
this in April. And the number is equivalent to the entire flu
season of past years' lab-confirmed deaths of children, so we
are already at that level. And, tragically, pregnant women are
also among those seriously affected.
Half the hospitalizations for flu-like illness are for
people under the age of 25, very different picture than
seasonal flu, and nearly 90 percent of the deaths from H1N1 are
among people under 65--again, a very different picture than
seasonal flu, where 90 percent of the deaths year in and year
out are for Americans over the age of 65.
Those are pretty grim facts, but thanks to the work of this
Committee and your colleagues across Congress, I think we are
better prepared to deal with the current challenge than ever
before in history.
I want to just touch on a couple of efforts that you have
helped put in place.
First of all, we have a greatly enhanced surveillance
system, so the numbers that we are giving you probably 2 or 3
years ago would have been anecdotal, at best. The system is
very critical to monitoring what we are doing and making sure
we have adequate supplies of materials and vaccine and we can
have that relying on the fact that we are getting accurate
numbers.
We have an expanded testing capability, again, thanks to
the planning work that has been done intensely monitoring
changes in the virus around the United States, but also across
the world, we need to know what is happening with this virus
so, again, we stay out ahead of it and using a variety of
systems to do that.
The efforts improve our understanding of the magnitude and
the trajectory of what we are seeing and help us stay ahead of
it.
We have provided significant recommendations, working hand
in hand with the Departments of Education and Homeland
Security, but also Labor and Commerce, clear, actionable
guidelines for businesses, for K-12 schools and universities
and colleges, which the Secretary will address in a few
minutes, with community and faith-based organizations, based on
the best scientific information--again, it is on flu.gov, easy
to print, run in multiple languages, updated on a regular
basis--but trying to make sure that the information that we
know in the scientific community is shared.
The vaccination program is underway, and as the Chairman
and the Ranking Member have indicated, the production is slower
than we would have hoped at this point. But I want to put this
in a little bit of context. The virus, first identified in
April, now has a robust vaccine available. That in and of
itself is fairly remarkable.
We are dealing with five producers. That is a very
different situation than even we were in as recently as 3 or 4
years ago, so the capacity for vaccine has been built.
As of Monday, we have 11 million doses of that vaccine
ordered by the States, and those orders are being done on a
daily basis. As the vaccine becomes available, States and local
regions are ordering, and we are pushing them out. We are now
up to 150,000 sites around the country identified by our State
and local partners where the vaccine is automatically
delivered, so it is not being held at points along the way.
And, Mr. Chairman and Madam Ranking Member, I would remind
the Committee that when the more robust estimates were being
made--and, again, these are production estimates that come
directly from the manufacturers. We have not made estimates. We
are relying on their numbers. We were in a situation where we
anticipated a two-dose regimen, and those two doses required a
3-week gap, and then 2 weeks at the end to have a robust
response. So approximately 36 days from first dose to immunity
was what we were looking at earlier.
We now have some good news. Everyone over the age of 10
will need only one dose of the vaccine, and the immune response
is hitting at a much shorter time. So rather than 2 weeks, it
is in an 8 to 10-day period. So we are getting their lowers
numbers available but a faster response time than we had
anticipated, and with a one-dose regimen, we actually are in
better shape than we had hoped with people being immunized at
an earlier basis.
The vaccine early delays are really due to two issues that
we have identified. One is that the antigen production was
yielding lower results than had initially been anticipated. We
have been assured by the producers that has been fixed, so
their yields are now more robust, and those numbers are
beginning to change. The second is that we have some production
lines that have been put in place by the manufacturers. That is
the good news. The bad news is there were glitches in some of
those production lines. The fill and finish did not work as
they had anticipated. We are seeing some hurdles. Again, in
discussions with all the manufacturers, those two issues were
corrected so we anticipate that number growing exponentially as
we move through the season.
By early November, we are confident that vaccine is going
to be far more widely available. There is enough vaccine and
will be to vaccinate every American who wants to be vaccinated.
And we are pushing it out as quickly as we can.
So I just want to mention finally a couple of lessons that
we have learned in this experience. Again, thanks to the
Committee, a lot of planning has been done, but we are still
too dependent in the United States on vaccination production in
other countries, and we are using old technology. We are still
using egg-based technology. Thanks to investments through this
Committee and others, we are committed to developing cell-based
and newer technology, faster growth time, and that is underway,
Mr. Chairman. And we need to make all aspects of the
manufacturing process appropriate for the 21st Century. That
does not just help our country. It really helps the entire
world. So continuing to focus on those issues, I know many in
this Committee have been very focused on that.
Vaccination safety is essential, and CDC and FDA monitor
the safety of all vaccines. And I know in the Ranking Member's
comments, there still are lingering questions. We are in a
Catch-22. Where is the vaccine on the one hand, and have you
taken enough time for the clinical trials on the other. We can
assure this Committee, this vaccine is being made exactly the
way seasonal flu vaccine is made, so we have specific clinical
trials on H1N1, but more than that, 100 million people each
year receive a seasonal flu vaccine, and we expect the same
very positive safety results from this vaccine as we have had
in the past.
In terms of the antiviral, which is, again, a question that
was asked, PCAST did recommend the acceleration of an
intravenous antiviral as part of the recommendation to the
President. We took that very seriously. That is underway. The
good news is we have encouraging results from several different
candidates, and we anticipate final decisions being made by the
scientists very shortly. BARDA was wise to move ahead of this
pandemic and begin that process, so we are very encouraged by
the results. But the scientists will lead our recommendations
in terms of getting that antiviral on the market.
And, finally, Mr. Chairman, we are continuing to focus on
mitigation. In the meantime, there still are some fairly simple
steps that people need to take: Social isolation, staying home
when you are sick, washing hands, coughing and sneezing into
arms. I have been very impressed that children are listening to
Elmo, and they are correcting their parents in terms of sneeze
technique. And we are doing everything we can think of with our
partners in terms of the communication effort, not only using
traditional media, but we have great partners in ``Sesame
Street,'' in Sid, the Science Kid, where the Secretary and I
will launch a new program today, and on Facebook and Twitter.
ESPN that runs the score scrolls into colleges dorms is a
partner in encouraging that age group to get the vaccination.
We have had YouTube videos. So we are trying to get the word
out to folks that vaccination is the best offense against this
flu, and the good news is, I think, it is beginning to become
available around the country.
And with that, Mr. Chairman, I will wait and answer
additional questions.
Chairman Lieberman. Thanks, Madam Secretary. Very helpful
testimony. I am sure we will have questions. Also, let me
express my admiration for your quite appropriate cough into
your elbow.
Secretary Sebelius. Thank you. [Laughter.]
Secretary Duncan. Great technique.
Chairman Lieberman. Great technique. It is not our reflex
because for all of our lives, we have been trained otherwise.
Also, I want to express gratitude to the staff here for the
hand cleanser that has been left here.
You are not Arne, the Science Kid, are you?
Secretary Duncan. I am not. I wish I was. He is a lot
smarter than I am.
Chairman Lieberman. Secretary Duncan, it is an honor to
have you here, and we welcome your testimony now.
TESTIMONY OF HON. ARNE DUNCAN,\1\ SECRETARY, U.S. DEPARTMENT OF
EDUCATION
Secretary Duncan. Thank you so much, Chairman Lieberman,
Ranking Member Collins, and Members of the Committee, for
inviting all of us to testify before you today. I really
appreciate your collective leadership on this issue.
---------------------------------------------------------------------------
\1\ The prepared statement of Secretary Duncan appears in the
Appendix on page 279.
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I really want to thank my partners here, Secretary Sebelius
and Secretary Napolitano. The interagency coordination and
cooperation in the Federal H1N1 effort from top to bottom, I
think, has been absolutely extraordinary. I also want to thank
our partners at CDC. Dr. Anne Schuchat, who is here, and Dr.
Tom Frieden, the Director, have been great partners.
Our team at the Department of Education has been working
very closely with the Departments of Health and Human Services
and Homeland Security and the CDC since the initial outbreak of
the H1N1 influenza in April to prepare thoughtful guidance for
early learning programs, elementary, middle, and secondary
schools, and institutions of higher education. We have brought
copies of our guidance here, copies of guidelines for early
childhood, guidelines for K-12, and then, finally, information
for schools of higher education. It has been an extraordinary
team effort, one that I hope can serve as a model for dealing
with other problems and issues that cross agency boundaries.
I want to spend most of my time this morning discussing our
efforts to keep children, students, faculty, and staff safe
during the fall wave of the H1N1 pandemic. And I think I want
what I know every parent wants: To first and foremost keep our
children safe; and, second, to keep them learning.
While I want to concentrate on our current efforts--and by
``our'' I mean all of our agencies together--I think it is also
important to take a moment and look back to see where we were
in the spring. I think you will agree that we have made
significant progress in a short period of time.
In the spring, from April to June, we found that schools
closely followed school dismissal guidance developed by the
CDC. For example, on April 26, 2009, the CDC advised schools to
consider closing when they had a confirmed or suspected case of
H1N1, and we found that schools adhered to that advice.
On May 4, 2009, the CDC revised the guidance to state that
schools should not close ``unless there is a magnitude of
faculty or staff absenteeism that interferes with the school's
ability to function,'' and fewer schools closed and many that
were closed reopened. From April 27 through June 12, more than
1,350 schools in 35 States closed for at least one day. These
closures affected over 824,000 students and about 53,000
teachers. The greatest number of school dismissals occurred on
May 5, when 980 schools and 607,000 students were affected. As
school districts started to implement the new guidance on
closures, those numbers rapidly declined.
The lesson we learned in the spring was not only that
schools follow the CDC's advice on flu-related issues, but also
that quickly closing a school is a complex undertaking that has
consequences beyond the loss of valuable and desperately needed
school time. For example, unplanned school closures led to the
loss of millions of school meals for children who rely on these
Federal programs to eat; loss of wages for parents who had to
stay home from work to take care of their children; and older
students were left home without proper supervision.
Further, we learned that we had to develop a new way to
better track school closures and dismissals; the way we were
doing it did not work well, especially when there were a large
number of schools that were closed.
Examination of our efforts during the spring outbreak
helped us to understand where we could do better. In
particular, we needed to improve on several things.
First, we needed to offer schools balanced, measured,
clear, and concise guidance that reflects the best science
available.
Second, we needed to design a tracking system that provides
accurate and on-time data on school dismissals.
Third, we needed not only to continue to reach out to those
we reached out to in the spring, but we needed to get to a much
expanded audience. Getting the message out and making sure it
is the right message, and getting it out quickly to as many
schools, school officials, and parents as possible is the key
to our ongoing communication strategy.
Fourth, and finally, we needed to develop more materials
for schools and educators and to develop those materials in a
format that made them understandable, useful, and easy to use
for schools and for educators.
Let me briefly expand on each of those points.
With regard to the first point on guidance, we knew that
while in a limited number of cases school dismissals were
warranted, if conditions in the fall mirrored those in the
spring, schools could remain open as long as they took various
prudent measures, such as encouraging educators and students to
practice good hygiene such as washing hands and coughing into
their sleeves, having students stay home if they are sick, and
practicing social distancing such as rearranging desks so
students could sit a little further apart.
With regard to the second point, we developed a new K-12
school dismissal tracking system this summer. The new school
dismissal monitoring system is a collaborative effort between
the CDC and the Department of Education, and it is supported by
State and local health and education agencies, as well as
national nongovernmental organizations. The system is built on
a nationwide Federal and State partnership. The new voluntary
system includes daily, direct reporting from State and local
agencies as well as daily, systematic searches and
confirmations of media reports.
As I mentioned, this past spring almost 900,000 students
and more than 1,350 schools were impacted by school closures.
This fall, however, so far schools are heeding the new
guidance. School dismissals are significantly lower. In fact,
between August 3 through October 15, only 628 schools closed
for at least one day, affecting approximately 219,000 students.
As of yesterday, just 88 schools were dismissed in 13 States
affecting 28,000 students and 1,800 teachers.
In a front-page story in the New York Times on October 8,
they pointed out that ``[a]ttendance in the New York City's
public school system, with just over a million students, was 91
percent. . . . Last spring, when the virus was rampant, nearly
60 schools were closed and about 18 percent of students were
absent.''
The reductions in the number of schools that closed as a
result of H1N1 are a direct result of a number of things,
including much improved outreach and communication.
In our effort to prepare the education community for H1N1,
and to prevent the virus from spreading to a point that it
fundamentally disrupts education, we have worked with our
Federal partners to develop and distribute guidance for early
childhood, K-12, and higher education institutions. In this
effort, there is a role for nearly every major stakeholder
group to play.
Over the summer, we convened a group of representatives
from many of education's major associations--those representing
teachers, principals, school administrators, school boards,
colleges and universities, counselors, and, very importantly,
school nurses, and parents. We talked about ways that every
partner could contribute to this massive preparation and
prevention effort, and I want to thank all of them for stepping
up and answering the call.
For instance, the National Association of School Nurses,
the National Parent-Teacher Association (PTA), and the National
Association of School Psychologists collaborated on a guide for
parents to help them talk to their children about H1N1 and
support prevention methods. Available initially in English and
Spanish, that guide--and so many other useful H1N1 resources--
has been translated into many other languages as well. And the
school nurses association recently heard that a Japanese
newspaper had translated it into Japanese.
Also, in September, HHS, CDC, and the Education Department
held a call for the child-care community to discuss the steps
to be taken by providers and parents of young children to keep
everyone safe. We had about 800 participants on that call from
around the country. We had another 800 participants on a
similar call with the higher education community.
We have also been working with the business community,
especially educational publishers and national companies in
media and technology, to make resources available so that
students can continue learning if they are home sick or their
school is dismissed. Thanks to these companies' commitments,
America's students will have a variety of both hi-tech and low-
tech ways to stay connected to their classrooms.
As part of this effort, we have developed continuity of
learning guidance, recognizing that different schools will have
different ways of carrying this out depending on their
situation and where they are located. In our appendix to that
guidance, we cite a number of efforts by States and school
districts around the country, including, for example, the
Arkansas Distance Learning Development Program. While our
prevention efforts must and will continue, we are now putting
the full-court press on the importance of vaccinating children.
Let me say here that my wife and I certainly intend to try
and lead by example by getting our two young children
vaccinated at the appropriate time.
We realize that vaccinating students is the best way to
ensure that the flu does not spread. We have made available for
all 14,000-plus school districts an easy-to-read document that
explains how schools can work with public health officials to
establish or host a vaccination clinic. Also, CDC has provided
a sample letter for schools to use to get parental consent for
the vaccine now so shots can be given absolutely as soon as
they become available. And I am delighted to say that we have
seen some terrific examples of States doing this well.
For example, the Rhode Island Department of Health has made
plans to operate clinics in every single school in the State,
using licensed medical professionals enrolled through its
Statewide Emergency Registry of Volunteers. The Public Health
Department plans to vaccinate middle- and high-school students
during the school day and offer after-school and weekend
clinics for younger elementary school students.
In Kansas, the Sedgewick County Health Department has
partnered with several local public and non-public K-12 schools
in the Wichita area, as well as higher education institutions,
to provide vaccines through school-based clinics.
And in Utah, the Salt Lake Valley Health Department has
solicited bids from nursing agencies to provide vaccinations in
schools. These providers already have demonstrated capacity for
managing these large-scale efforts. Timing may vary by school
but officials envision setting up clinics in large spaces, such
as an auditorium, and vaccinating one class at a time those
students whose parents have provided consent.
To conclude, all of these efforts will continue so that we
can do our best to help schools be as prepared as they can be
to handle the flu. Again, thank you so much for allowing me to
testify today, and we look forward to your questions.
Chairman Lieberman. Thank you very much, Secretary Duncan.
Very helpful information. Obviously, a lot of parents are very
concerned about this, and the schools are the significant point
of daily contact.
We will do 7-minute rounds of questioning.
Secretary Sebelius, I have been following this, of course,
as a parent, a citizen, and a grandparent, but also because of
the Committee, and I must say this chart from the CDC really
clarified how serious this has become because of this
extraordinary surge now,\1\ which is way above what typical flu
activity is at this time of year, and also the reported cases
and deaths.
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\1\ The chart submitted for the Record by Senator Lieberman appears
in the Appendix on page 251.
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I understand this is an unusual--it is hard to predict
here, but to the best of your ability, what do we expect--in
other words, this line representing the patient doctor visits
has really shot up. Is it going to continue to go up? Is it
going to merge with the normal increase in seasonal flu that
would come around January? So, to the best of our ability,
understanding that, if I may use military terms, we are facing
an enemy whose movement is unpredictable, what do the experts
tell you to expect so we can be prepared to, if you will,
defeat the enemy?
Secretary Sebelius. Well, Mr. Chairman, I think you used
the appropriate term in ``unpredictable,'' and what the experts
tell me is a couple of things. We are not seeing a massive
surge at this point in communities that had significant
outbreaks in the spring. And if you remember what the spring
looked like, it was very sporadic around the country. New York
City, as the Secretaries just said, had a very significant
outbreak, and two States away there was very little flu. We are
still seeing the same kind of activity of hot spots in various
parts of the country and others without a lot of activity.
We anticipate, though, that line will continue to rise
until we can make a fairly significant dent through the
vaccination programs, and that is what is very good news, that
the vaccine is appropriate, it is targeted, and so continuing
the mitigation efforts, which are having some impact, even the
short-term periodic school closings are far less, but they
seemed to quell the outbreak for a bit and go on. But getting
people vaccinated is the key.
Chairman Lieberman. Yes. So this is really a question of
the vaccinations catching up with and moving ahead of the
spread of the disease because so far there has been indication
that the vaccines are working, of course.
Secretary Sebelius. Absolutely. The clinical trials say
that vaccines are right on target, and the robust response hits
in about 8 days, shorter than expected, and people need one
dose fewer than expected.
Chairman Lieberman. OK.
Secretary Sebelius. So the goal is to get the vaccine out
as fast as possible and get as many people, particularly, start
with the high-priority groups, but get it to everyone who wants
a dose.
Chairman Lieberman. Right. You clarified--and I appreciate
it--the fact that at the end of October we are going to have 25
percent less of the vaccine than you had predicted. Your
predictions were obviously based on what the manufacturers had
told you.
Secretary Sebelius. That is correct.
Chairman Lieberman. And they simply, although as I said
earlier--and I give everybody credit--they worked with
remarkable efficiency to develop the vaccine quickly, but they
just have not been able to produce it as quickly as they had
thought.
Secretary Sebelius. Well, as I said, the early yields were
significantly lower than they had predicted when we started
this modeling in May. That has been corrected. They now have
yields which are back up to where they thought they would be,
so we anticipate, again, a much more robust production line.
And some of the early lines, the new lines of production,
particularly the fill and finish, had some early glitches, a
hard rollout, if you will, that they were trying to ramp up.
But those both have been corrected, and we are in daily contact
with the manufacturers.
Chairman Lieberman. OK. So your goal is--and you predicted,
in a way guaranteed--that there will be enough vaccine to
vaccinate every American who wants to be vaccinated. But am I
right that there is not now enough vaccine to vaccinate every
American who now wants to be vaccinated?
Secretary Sebelius. That is correct, Senator. Right now we
are at a point where the demand is ahead of the yield, and we
are working--that is why I think it has been very good news
that we have a distribution contract that really gets the
vaccine on a daily basis to these multiple sites, 150,000
sites. So as soon as it is out, it is being allocated on a per
capita basis to States. States can order daily and they are
taking advantage of that. So we have about 13 million doses
available. They are being pushed to States, overnight. Every
day that they come in, we are pushing them out the door.
Chairman Lieberman. OK. Not for now, but I am just going to
say quickly, and go on to another question, there is an
important question for all of us to ponder about the fact that
if I am right, of the five producers of the vaccines for use in
the United States, only one is in the United States. And we
have got to ask ourselves questions about what is happening
that we have lost that edge, that domestic supply.
But let me go on to the more urgent question I want to ask,
and that is about the availability of the intravenous antiviral
medications. And as a result of the broadcast news report a
couple of nights ago, there has been a lot of anxiety expressed
about this, because these are the most serious cases. These are
the people--again, the percentage of the population quite
small, but if this is your relative in an ICU with a serious
case of H1N1, facing death possibly, you want whatever science
can give you to deal with this. And I gather that, again, the
existing antivirals--Tamiflu and Relenza--do not work with
these most serious cases.
I also understand that the FDA has issued some
compassionate-use rules in a limited number of cases, as I
mentioned. Some of these intravenous antiviral medications have
worked and have been largely successful in saving lives. So
with these extraordinary predictions of 150,000 to 300,000
cases that will require ICU placement of people, I want to push
you a little bit on the status here because, truthfully, your
response in your testimony was a little less reassuring than
your statement in your prepared testimony. I will read it
again. In your prepared testimony, you said, ``Physicians
treating critically ill patients with H1N1 influenza will soon
have access to new antiviral drugs supported by HHS/BARDA and
administered intravenously under a CDC-sponsored Emergency Use
Authorization.''
I know that at a National Biodefense Science Board meeting
last week, the FDA said that they will be making a decision
fairly soon about the use of a tested but still experimental IV
antiviral drug, and this is that power that FDA has to issue an
Emergency Use Authorization before the drug goes through all
the clinical trials because of the urgency.
So give us a better understanding, if you can--and I
understand this is FDA's decision--about how soon people who
are in these severe situations can expect, if they choose, to
have an IV antiviral available.
Secretary Sebelius. Well, Senator, I would tell you that it
is, I think, among the highest priorities with FDA and CDC
working very close together. It has been identified early on by
BARDA as a need. PCAST recommended that, as we saw the
outbreak, we move forward.
I would say that we are very close to having several
candidates that are being tested in the final stages, and I
think that it is imminent. I cannot give you a precise
timetable.
Chairman Lieberman. I understand, but we are really talking
a matter of days.
Secretary Sebelius. We hope that is the case.
Chairman Lieberman. Yes. And just to clarify, the FDA and
you take these threats seriously enough so that what is being
considered is an Emergency Use Authorization--in other words,
that it will be available even though the full clinical trials
have not been gone through because, for a lot of people and
their families, this will be a life-and-death decision.
Secretary Sebelius. Yes, Senator, all of that is correct,
and it is imminent.
Chairman Lieberman. OK.
Secretary Sebelius. The other antiviral issue, which the
Ranking Member mentioned, is the pediatric antivirals and the
so-called pediatric suspension that is available. We have done
two things with pediatric suspension, which, again, it is not
in the same situation where it is in the pipeline in terms of
being licensed for use. It has been licensed, but there is a
shortage.
HHS took steps to push 75 percent of the stockpiles out to
States, so 300,000 doses are now in the hands of State and
local health officials as of earlier this week. We also
simultaneously published guidelines which deal with
compounding. On the ground, pharmacists can separate the pills,
mix them with syrup, and have this available for children who
are too young to actually take pills. And so both of those
steps have been taken earlier this week. There is plenty of
compounding production available throughout the country, so we
have gotten the stockpiles out and the guidance about
compounding and asked the manufacturer to ramp up the
production of this.
As you all know, sometimes the private market is reluctant
to anticipate what may be a market, which is why investments in
BARDA and elsewhere have been so effective. So we are catching
up. But in terms of the pediatric antivirals, I think there is
an on-the-ground solution that is being taken advantage of.
Chairman Lieberman. Good. Thank you. Senator Collins.
Senator Collins. Thank you, Mr. Chairman.
Secretary Sebelius, you have given us the good news today
that the vaccine is effective, that it is as safe as the
seasonal vaccine, but there still is an issue of whether the
vaccine is going to get to people too late. You stated in your
written testimony that there will be enough vaccine for anyone
who wishes to receive it.
But a study that was published last week by Purdue
University stated that the vaccine will arrive too late to help
most Americans who will be infected. The authors of this study
estimated that the greatest number of infections will actually
occur this very week while most people are still waiting for
the vaccine.
Are you concerned that even though we have been very
successful in developing an effective vaccine that it is going
to arrive too late to do the good that we would hope?
Secretary Sebelius. Well, Senator, we would love to have
lots more available today, no question about it. I would
suggest, though, that we are at the very beginning of seasonal
flu, and what we anticipate is not necessarily a dropping off
but a continued rise, and particularly as people get seasonal
flu and it mixes with H1N1, that continues to be a concern. So
we have all along urged people to take advantage of the
seasonal flu shot, and, again, there is a good news/bad news
about seasonal flu. The demand is significantly higher and
earlier than ever before given all of the discussion about the
flu, so it has caused, again, a shortage in some areas of the
country. That is being made up quickly.
But we anticipate, Senator, that there are still hundreds
of millions of Americans who are potential victims of the flu,
who have not gotten the flu, who will be protected by the
vaccine, and what the scientists are urging is even if people
experienced flu earlier this spring or this fall, to go ahead
and get the vaccine because, as different strains develop over
the course of the flu season, it will immunize them for what is
likely to come.
Senator Collins. The Chairman raised the issue of the fact
that our country has largely lost the capability to produce
vaccines, and we have to rely on companies that are located in
other countries. And it is my understanding that a major reason
that we have lost that capability is because of liability
concerns.
Is the Administration developing any kind of plan or
recommendations to try to ensure that we have the capability to
produce vaccines right here in the United States?
Secretary Sebelius. Well, Madam Ranking Member, the
Congress invested in an entity within the Department of Health
and Human Services, the Biomedical Advanced Research and
Development Authority (BARDA).
Senator Collins. BARDA.
Secretary Sebelius. Which is actually, I think, a very
significant entity because a lot of these vaccines are
developed anticipating something will happen. So there is not a
lot of private market appetite to spend money and time with
development.
I would say that this vaccine development was a
collaborative effort from the outset, where the scientists from
FDA sat down with the manufacturers and discussed the
timetable. They figured out a way to reduce the growth time. No
safety steps were cut, but the production occurred as quickly
as could conceivably be done from the time that the virus was
identified.
And, finally, in terms of the liability issues, in the
various steps to deal with pandemic efforts, you have created a
liability immunity, not only for the production but every step
along the way for distribution. So that has been in place for a
number of years and actually was designed to address just the
issue that you raise. But the legal protections have been in
place I think for the last 5 or 6 years.
Senator Collins. Thank you.
Speaking of liability, Secretary Duncan, in Maine many
school systems have stepped up to the plate and are conducting
school-based vaccination clinics. But the issue of liability
has arisen in the State of Maine of whether schools that
administer these vaccines could potentially be held liable in
the rare case that there is an adverse reaction to the vaccine.
The Governor of Maine has attempted through an executive order
to deal with this issue, but is this an issue that you are
hearing about from school systems?
Secretary Duncan. It is obviously a really important
question, and we are thrilled that your schools are stepping
up. We want schools to be part of the solution, and with young
children being such an at-risk and vulnerable population, it
makes logical sense that schools be vaccination clinics.
In all likelihood, schools will not be liable, which is the
good news. Schools that are being used as vaccine distribution
sites are generally protected by the Public Readiness and
Emergency Preparedness (PREP) Act, and this law protects school
districts and their employees from liability for claims that
may result from administration of H1N1 vaccine in schools. So
unless someone is intentionally doing something to harm a
child, they are going to be protected.
Senator Collins. Thank you.
Secretary Napolitano, my staff has passed me a note to say
that there has been a new development with the outbreak of H1N1
at Bates College that I mentioned in my opening statement,
where we have gone from 6 cases to 245 in just a little over a
week's time. And the Maine CDC has now requested that a
component of the Northern New England Metropolitan Medical
Response System (MMRS) deploy to the campus. And that system,
as you may know, is part of DHS's efforts and it is funded
through a DHS grant program to enhance the medical response in
a mass casualty situation.
Are you aware across the United States of the deployment of
other MMRS units?
Secretary Napolitano. Madam Ranking Member, I am not aware
specifically of the deployment of others, but it does not
surprise me. And, with Bates College, that is a large
percentage of their students.
Senator Collins. It is.
Secretary Napolitano. But the IMAT teams, the other teams
that I referenced in my formal testimony were all designed to
provide back-up to localities, to States at their request when
they had a particular outbreak.
Senator Collins. Thank you, Mr. Chairman.
Chairman Lieberman. Thanks very much, Senator Collins.
As is the Committee's rule, we call the Senators in order
of arrival. Just for information, that would be Senators
McCain, Bennett, Kirk, Carper, Burris, Tester, and McCaskill.
Senator McCain.
OPENING STATEMENT OF SENATOR MCCAIN
Senator McCain. Thank you, Mr. Chairman, and I thank the
witnesses.
Secretary Sebelius, this chart is one that would cause
concern. Is that an accurate description of what this chart
indicates?
Secretary Sebelius. It is, Senator, and I was reminded by
Dr. Schuchat that, in response to the question of is it too
late for vaccine? Again, what we saw in 1957 was a significant
outbreak in the fall, and then a die-down, and then another
significant outbreak in the spring.
Senator McCain. So you think that in the winter months this
will come down?
Secretary Sebelius. Well, we are hoping that as vaccine
becomes available and people get vaccinated that will at least
help to stem the spread because what we are now seeing is a
spread that is not mitigated by any immunity.
Senator McCain. But you also just said there are millions
of people who will not be vaccinated.
Secretary Sebelius. There may be people who choose not to
be vaccinated, Senator.
Senator McCain. Are you worried about hospital
overutilization, lack of capacity in the hospitals in America?
Secretary Sebelius. Well, as Secretary Napolitano said,
about $3 billion has been pushed out over the last number of
years for surge capacity. What we are trying to do is minimize
the demand of the worried well on hospitals, which is why a lot
of the self-evaluation tools, a lot of the information on the
flu.gov Web site is trying to get people to the point where
they understand they do not need to show up at the hospital
unless certain situations are present.
Senator McCain. So you have significant confidence that
will not be a problem?
Secretary Sebelius. Well, Senator, I am worried about all
of this, and I think we are doing everything we can to work
with hospitals across the country, including an additional $100
million that you helped to make available.
Senator McCain. In your testimony concerning the
availability of the vaccine, according to a news report
yesterday, ``Arizona will be getting only a fraction of its
first orders of swine flu vaccine which could throw a wrench
into health officials' plans to vaccinate hundreds of thousands
of residents in coming week. So far, the State has only been
allowed by Federal health officials to order about 156,000
doses of H1N1 vaccine, less than half of which has arrived,
with the rest expected sometime next week. Original planning
called for 800,000 to 1 million doses to arrive around next
Thursday.''
That is a rather significant difference from what they
expected to receive in Arizona, Madam Secretary.
Secretary Sebelius. Yes, sir.
Senator McCain. And your statement, as I quote from, ``a
series of manufacturing delays has caused significant
reductions in the manufacturers' projected vaccine output.''
Maybe for the record you could tell us about these
manufacturing delays and whether are they in the one facility
we have in the United States or are they from our foreign
sources of vaccine?
Secretary Sebelius. Well, Senator, as I had said earlier,
the production yields are lower than what the manufacturers
estimated when they first started. So with the egg-based
technology there are lower yields of the antigen, and they were
wrong with what they anticipated. Those yields are now up. They
have changed strains. They are working now. The virus is
equally robust, but they are now getting much higher production
yields than first anticipated.
Senator McCain. And what is your estimate as to when they
will catch up?
Secretary Sebelius. Well, we are hoping by early November
that they will be back on the track of the number of
vaccination doses per week that we had originally anticipated.
Senator McCain. How long would you expect a State like mine
to not have the quota fulfilled that they had expected?
Secretary Sebelius. Senator, what is happening in Arizona
and every other State is that daily orders are being made on a
per capita basis, they are being pushed out the door, so as
soon as it----
Senator McCain. When would you expect them to be caught up?
Secretary Sebelius. Senator, I have no idea. I could get
you that information based on--I cannot tell you when Arizona
will be at the----
Senator McCain. I mean all States. When will all States be
caught up? Maybe you could supply that for the record. I am
sure that people are concerned about that.
Secretary Sebelius. I will try to get that.
Senator McCain. When would we have a sufficient number of
vaccines necessary? I would be interested in when you
anticipate for those original estimates will be met.
Secretary Sebelius. We can get you that number, Senator,
and as you know we are not sure how many people will take it
up. The seasonal flu take-up rate is below 50 percent.
Senator McCain. But you did make original estimates as to
what is needed, and so I would be interested in knowing when
you are able to--with the manufacturing capability now
restored, when we will restore to what the original
requirements are.
Secretary Sebelius. We will get you that information.
Senator McCain. Thank you.
INFORMATION SUBMITTED FOR THE RECORD FROM SECRETARY SEBELIUS
What is the projected date when you believe all States will receive
their requested number of H1N1 vaccines?
HHS has now received all its vaccine orders and any American who
wants to be vaccinated should be able to do so. As of March 12, 2010,
States have been allocated 149,977,200 2009 H1N1 vaccine doses. Thus
far, States have consistently ordered approximately 80-90 percent of
the vaccine doses available to them. So there is sufficient H1N1
vaccine for all States to receive their requested amount.
When will we have sufficient number of vaccine to make sure we do
what is necessary?
As of December 1, 2009, sufficient amounts of H1N1 vaccine (229
million doses) had been produced to serve the U.S. population and to
meet international commitments for donated vaccine. As a result,
production of additional H1N1 vaccine was halted.
When will we be restored to the original requirements?
The original estimate in the summer was that we would need as many
as 600 million doses to cover the entire U.S. population. When clinical
results showed that only those ages 9 and under would need two doses
and everyone else one dose, the number needed was dropped to about 340
million doses. As information on uptake and public desire for the
vaccine became available, the number was revised downward. By the
beginning of December it was determined that 229 million doses would be
sufficient.
Senator McCain. Secretary Napolitano, have we still a big
concern about visitors to the United States being screened for
H1N1?
Secretary Napolitano. Senator, we take our guidance from
the CDC, and we are doing our standard screening, but we are
not doing any different type of screening than we would
normally, in part because this is not like an avian flu
situation. This virus is already widespread through the
continent.
Senator McCain. So it is already here.
Secretary Napolitano. If we thought screening would help
the public health situation in the United States, we would do
something differently. But everything we have been advised is
that what we are doing is the most that can be expected, and
anything else would have no practical impact on the public
health of the American people.
Senator McCain. Thank you.
Secretary Duncan, it may not be a large item in the scheme
of things, but when you close schools, parents have to stay
home with the children; some of those are health care
providers. What is the answer?
Secretary Duncan. Well, the answer is we have worked
extraordinarily hard to dramatically reduce the number of
schools that are closed, and those numbers are down--as I
mentioned in my testimony--very significantly from the peaks in
the spring. So closing schools is an absolute last resort. We
have seen great response so far this school year, and, again,
those numbers are down almost 90 percent from their peak last
spring. And so we are doing everything we can to keep schools
open. It puts a strain on families. I worry about children who
do not eat--who rely on those school lunches--when schools are
closed. That is very difficult to do. The social disruption of
closing schools is huge, not to mention the loss of learning
opportunity. So our guidance has been very clear that, whenever
possible, keep schools open, keep sick children home, and let
the majority of students attend school. That is critically
important to us for a multitude of reasons.
Senator McCain. Well, thank you. My time has expired. I
have been observing you, Secretary Duncan, and your efforts at
improving education in America, and I applaud many of your
efforts, and also occasional displays of courage.
Secretary Duncan. Thank you, sir.
Senator McCain. Frequent displays of courage. Thank you.
Chairman Lieberman. Thanks very much, Senator McCain.
Do you have that on tape, Secretary Duncan? [Laughter.]
Secretary Duncan. I hope someone captured it.
Chairman Lieberman. Well, you deserve that. I thank Senator
McCain for saying that.
Senator Kirk, you are next.
OPENING STATEMENT OF SENATOR KIRK
Senator Kirk. Thank you, Mr. Chairman, and thank you to the
Secretaries for your service, and through your prepared
testimony and your oral testimony, the obvious collaboration
that is going on is making a difference in terms of making an
effective effort on this important issue.
This morning's Boston Globe had a lead story that basically
points up the issues that have been discussed, and that is the
shortage of the H1N1 vaccine and the overrun for the
traditional seasonal flu vaccine. As a result of the lack of
supply or delay in supply of the H1N1 vaccine, your partners at
the State and local levels who have planned for their clinics
have been advised to shut down the clinics until the supply
takes place. So there has been some disruption in the supply
chain and obviously some frustration at the local level.
I just wanted to understand. On the overrun of the vaccine
for the seasonal flu, I assume that parents and others are
saying, ``If I cannot get the H1N1 flu vaccine, I should try to
immunize my children by getting the seasonal flu vaccine.'' Is
that a fair medical assumption? In other words, will the
seasonal flu help to immunize at all from the H1N1 flu?
Secretary Sebelius. Unfortunately not, but we would
strongly recommend and have recommended that particularly for
vulnerable populations they get both. If this virus had been
identified earlier than April when it was found, it would be
mixed with the seasonal flu vaccine this year. It is just a
different novel strain. But since it is a different novel
strain and it is not mixed, there really is the requirement of
two separate vaccinations.
Right now, Senator, just to give you the numbers, we
typically have about 114 million Americans who get seasonal flu
shots. Already here in mid-October, 82 million of those
vaccination doses have been out to States and in some cases are
running out, I think because people were hearing a lot of flu
dialogue, so they are showing up a lot earlier at flu clinics,
and that is, frankly, good news, but they need to go back and
get the H1N1.
Senator Kirk. And just as a follow-up on that, given the
overrun, if you will, on the seasonal flu at this time, is
there any danger that we will be in short supply of that as we
move down the trail here?
Secretary Sebelius. No. Actually, we have been assured that
production is, again, ramping up. We had an early run, if you
will, much earlier than typical, on seasonal flu. So the
production manufacturers are backfilling that, and, again, that
will be widely available.
We may have a much higher take-up rate, though, than is
usual. I was very alarmed when I saw the data that typically
for seasonal flu, which kills 36,000 people a year and
hospitalizes a couple hundred thousand people a year, our take-
up rate is less than 50 percent for most categories, including
health care workers. Fewer than 50 percent of health care
workers ever get a seasonal flu shot. The only category of
Americans who take great advantage of the seasonal flu vaccine
are the older Americans, over 65.
But I think what we are going to see this year is a more
robust response from every category, and, frankly, that is good
news.
Senator Kirk. Thank you. The other question I had related
to the colleges in Massachusetts, and, happily, we have a
number of colleges and universities. And as I understand it,
the allocation of the vaccine is determined by population per
State. Is that correct?
Secretary Sebelius. Yes. As it becomes available, it is
being pushed out on a per capita basis.
Senator Kirk. Right. Has there been any consideration given
to the inclusion of out-of-State student population, of which
we probably have as many as perhaps any other State? Is that
configured or considered at all as you measure population and
distribution of the vaccine?
Secretary Sebelius. Senator, I think it would determine how
students are counted in Massachusetts and what your per capita
count looks like. What is happening, though, is that those
decisions about how much to order and where those orders are
going are all being made at the State and local level. So I can
assure you that whether it is Governor Patrick or your State
health officials or others, they are very mindful of getting
the vaccine to the spots needed and drawing down those orders
and making sure that they show up on campuses and at schools.
Senator Kirk. Thank you, and perhaps Secretary Duncan can
help on this.
Again, in terms of the delayed delivery of the H1N1 and the
oncoming Thanksgiving holidays and so forth, if students, for
instance, go home for the holiday and come back, and let us
assume, sadly, one or more is afflicted with the H1N1 flu, are
the colleges encouraged to use their facilities as clinics and
health facilities?
Secretary Duncan. Absolutely, and many colleges are
prepared to do that and are stepping up. They have health care
clinics. This is a natural part of their outreach, so, yes, and
I could check some of your colleges and universities
specifically, but we absolutely are encouraging that, yes.
Senator Kirk. Thank you. The final area is one that has
been brought up as well by the Chairman and the Ranking Member,
and it is the question of why we are not helping ourselves and
our neighbors across the globe in terms of production,
manufacturing, licensing of these products? And I understand
that we cannot really get the perfect vaccine until the flu is
in the air somewhere and that takes some time and has some
challenges. But I am troubled by the fact that we do have these
glitches, that only one of five, as I understand it, producers
is a United States producer. And maybe not for this morning,
but I wonder if there are some things that Health and Human
Services, Homeland Security, and the public health officials of
the country could recommend, perhaps through this Committee or
another, what we collectively should be thinking about to bring
that talent and research and development skill and production
skill back here--first, as a global partner; but, second, in
terms of our homeland security should flu be inflicted for some
deliberate reason, we want to be able to protect our citizens
as well. And for the long term, I would think this would be an
important investment and would encourage our departments to be
thinking together about that and maybe suggesting to the
Congress how we might be helpful as well.
Secretary Sebelius. Well, Senator, I think that is a very
wise suggestion. Clearly, we are going to have a lot of lessons
learned from dealing with this pandemic situation that will, I
think, be enormously helpful.
What is the good news, I think, is that Congress, starting
in 2005, began a multi-year investment in a variety of planning
efforts, including our own research and development wing at
HHS--BARDA--which exists as a laboratory to begin to look at
potential issues. We do have five manufacturers at this point.
That is up from two in 2004. HHS has been investing in helping
build capacity around the world. It not only is important here
in the United States, but we are now in a situation where also
much of the world relies on our manufacturing capacity to,
again, supply vaccines. So helping our nations around the world
build capacity to take care of their own populations is part of
that multi-year investment.
But I think you are absolutely right. We need to refocus on
more internal manufacturing capacity and, again, new technology
because we are still using vaccination technology of a number
of decades ago, so we need to accelerate the cell-based
technology that could more rapidly get from an identified virus
to a vaccine.
Senator Kirk. Thank you all. Thank you, Mr. Chairman.
Chairman Lieberman. Thanks, Senator Kirk.
If I could just add an exclamation point to the last
question Senator Kirk raised, there have been news reports that
in at least one case--I believe it was the Canadian producer of
a vaccine that was under very understandable pressure from the
Canadian Government to fill Canadian needs for the vaccine
before they filled ours. It is exactly what we would do with an
American producer. And it just puts up an exclamation point on
the importance of developing domestic capacity for production
of vaccine in these cases.
I am not blaming Canada, but I suppose in some sense you
could say that--it is not the whole answer--the shortage of the
vaccine today, beneath what we would want it to be, is
attributable to foreign countries telling their local
manufacturers, ``Hey, you got to fill our needs before you fill
anybody else's.'' Thank you.
Next is going to be Senator Burris.
OPENING STATEMENT OF SENATOR BURRIS
Senator Burris. Thank you, Mr. Chairman. The distinguished
Secretaries have answered most of the questions, so I just have
a couple of brief ones before I run off to the floor to make a
speech, and I just hope that we could deal with this area. A
couple of questions.
Now, we know that certain minority populations are
considered high risk due to the prevalence of pre-existing
conditions such as diabetes and asthma. We also know that
minorities and low-income populations are less likely to get
vaccination against the flu. How are your departments working
to reach out and educate these groups about preventing measures
and encouraging them to get vaccinated? And that goes for the
schools, too, for Secretary Duncan, but first, Secretary
Sebelius?
Secretary Sebelius. Well, Senator, I think you have raised
a very important point, and we identified early on some of the
challenges of getting to high-risk populations in a variety of
ways. So, in addition to the normal sites, we asked very early
on for our State and local partners to think carefully about
sites that would be available to encourage hard-to-reach
populations to get vaccinated, and that is going on. We are
working closely with the faith-based outreach office for not
only HHS's office but the White House's office to talk about
how we reach into communities where people may not be
presenting themselves traditionally for seasonal flu but to get
the word out.
We have had an enormous effort outreaching to not only the
African American press--radio, TV, print--but also the same
thing in the Latino community and working with tribal leaders
to try and make sure that information is available. So that
combination we hope will not only get the word out but hope to
encourage people that it is safe, it is secure----
Senator Burris. To go get vaccinated.
Secretary Sebelius. You bet.
Senator Burris. Yes, Secretary Duncan, on the educational
side, you have those urban schools. How are we dealing with
this?
Secretary Duncan. I think, again, what you have is folks
who traditionally maybe did not trust--and this is why I think
schools are so important. There is a level of trust. Every low-
income minority child hopefully is in school. They have a
relationship with the teacher. They have a relationship with
the principal. So having schools as sites to be vaccination
clinics I think is hugely important. They know the families,
they know the community, and they can say, ``Hey, this is
important to do.'' And, again, there always has to be parental
consent. We are not going to mandate anything like this. But
having schools step up in, whether it is an urban or rural
area, in Illinois or around the country, I think is hugely
important. So far I have been just extraordinarily impressed by
school officials' willingness to be part of the solution here.
Senator Burris. So you do not see any lag in any of the
areas where you are making the emphasis?
Secretary Duncan. Well, we will see, and again, the
question that Secretary Sebelius keeps raising is how many
folks are actually going to step up to the plate. But having
schools as sites, reaching out to the religious community,
reaching out to faith-based leaders, we need to continue to
work hard at this, but we do not know yet. And we have to do
everything we can to make sure that not only is it available
but people are taking advantage of what is available, and there
is a difference between those two.
Senator Burris. Thank you.
Secretary Napolitano, you had mentioned the hospitals and
all of these areas that you are setting up with the tents and
making sure that you are having facilities available. I am just
wondering how you are going to be dealing with medical staffing
to cover these--should the overload of people show up in
emergency rooms that they cannot handle, are there medical
personnel capable of then being able to handle all this?
Secretary Napolitano. Thank you, Senator. I was just giving
some examples of what localities have built into their plans.
It is not as if we are going to see tents all over the United
States. But it is part and parcel of each locality, making
decisions about how you triage patients, how you deal with
those with milder cases of the flu who may present or even the
worried well, without using the actual emergency room and
really reserving that for those who need the most serious care.
With respect to health care providers, we have worked
with--and, again, we start with local and State. They are the
primary planners, as it were, of how to handle any type of
epidemic within their own State boundaries. And then we have
augmented that with identifying teams that can at a State or
locality's request--Senator Collins mentioned an example--come
in to provide assistance.
Senator Burris. Yes, but, Madam Secretary, it would raise a
question to me whether they come into the emergency room or
whether they come into a situation of overcrowding. Maybe the
CDC can answer that question. I am concerned about the medical
personnel being able to then handle the situation, whether you
put a tent up or whether you have them lined up in the
emergency room. If the doctors just came off their 48-hour
shift in the emergency room and they had two or three cardiac
situations, and now the people are coming in with the H1N1, is
the staffing of the hospital going to be adequate to handle
that onslaught? Is that being planned by the States or any
other health care providers?
Secretary Napolitano. That is part of the planning process
that has been underway, and we are going to see that not just
this fall but this spring as well. And there is no uniform
answer across the country because the situation will vary where
you are in the country, where hospitals are located in the
country; urban, rural, that is a big issue across the country.
But, again, that is why the focus has been on doing this kind
of planning.
Senator Burris. Thank you.
Secretary Sebelius. Senator, I think also that part of the
planning effort underway has been this multi-year strategy so
hospitals deal not only with their bed capacity but with the
provider capacity, where they can draw down additional
personnel. We have, among other things, a sort of medical
reserve corps that came together after September 11, 2001,
about 200,000 people identified--some of whom are medical
personnel who are retired, others are volunteers--to help with
the triage situation. We have about 6,500 commissioned corps
members who are able in situations to be deployed if needed, so
people who can move around to areas.
But, for instance, here in Washington, I visited one of the
surge hospitals. There is a facility set up here in D.C.--and
there are five of these around the country--designed
specifically so that as local hospitals would reach capacity,
you would actually have a unit that would come into high
readiness who could figure out where to send patients, where to
send personnel, who is ready and able to do just that. So the
infrastructure, I think, for planning is there.
What you see right now in some of the tent situations--and
there are hospitals with tents--they have wisely decided,
rather than having a potentially very sick person sit in an
emergency room and cough and sneeze on everyone around him or
her, sharing the virus, to actually triage those folks in a
more isolated situation outside. So some of what you are seeing
is really the planning that the Secretary has talked about
being implemented, how we separate people who really may need
to be eventually in the hospital, but how to make sure that
they do not make other people sick while they are waiting to be
seen.
Senator Burris. You have satisfied my questions, and I am
glad to hear that those plans are underway, and good luck to
you. Let us do it. Thank you all very much. God bless you.
Secretary Napolitano. Thank you, Senator.
Senator Burris. Thank you, Mr. Chairman.
Chairman Lieberman. Thanks very much, Senator Burris.
Senator Tester.
OPENING STATEMENT OF SENATOR TESTER
Senator Tester. Thank you, Mr. Chairman, and I want to
thank all three of you for your testimony and for being here
today.
In a previous question, Secretary Napolitano--and this is a
question for you, Secretary Sebelius--had said that additional
screening is not being done at the border, and I tend to agree
with that. So just for my information, is the outbreak of H1N1
greater or about the same in Canada, Mexico, China, India, and
Europe?
Secretary Sebelius. Well, again, we are monitoring that
regularly. We are seeing about the same presentation as this
travels around the world. The good news was at least in the
Southern Hemisphere, which went through their flu season
without vaccine, is we did not see a mutation.
Senator Tester. OK. So we are----
Secretary Sebelius. But it is spreading, the same target
populations, the same----
Senator Tester. The same target population, about the same
occurrence for population.
Secretary Sebelius. Right.
Senator Tester. For example, is Canada or Mexico doing the
same thing we are?
Secretary Sebelius. Yes, there is a very coordinated effort
not only in the Americas, if you will, who we are out in front
of this, but throughout the world in terms of vaccination,
mitigation, and sharing information, sharing strains,
surveillance teams. The reason it is a pandemic is it is
global.
Senator Tester. And to get to the point that Senator Kirk
had raised and that the Chairman had followed up on, should the
United States be more entitled to that vaccine than some other
country in the world?
Secretary Sebelius. Well, I think the balance is difficult.
The President clearly has made it clear that his priority is
safety and security of the American people, and immediately he
also adds that we are a global partner. So we have joined now
with 11 nations in terms of 10 percent of the vaccine will be
made available to developing countries. We stepped up and
organized.
Senator Tester. I mean, I agree with that. But since there
are four suppliers outside this country and one inside this
country, why wouldn't they supply, for instance, to the highest
bidder or to their own people first?
Secretary Sebelius. Well, it is the orders, and one of the
things that we urged Congress to do--and, wisely, you did it--
is that in the supplemental appropriation bill, you granted
resources so we could place orders on behalf of the United
States, and it really is--the orders will be filled in priority
terms.
So we are really sort of at the front of the line with some
of these in terms of getting vaccine as it is produced.
Senator Tester. I appreciate that. I guess the whole
concern of outsourcing everything and now we are here
outsourcing this, and I know you have the same concerns.
You talked about cell-based versus egg-based research that
is being done. I was wondering. Is that research being done in
this country?
Secretary Sebelius. Yes, not only is BARDA engaged in that,
but a lot of work being done at the National Institutes of
Health (NIH) right now. But I would say it is going on all over
the world, too. Really at this point, everybody is trying to
get a much faster growing technique.
Senator Tester. You talked about the robust response to the
vaccination. At this point in time, can you tell me if you get
the vaccination, is it 100 percent you will not get the flu?
Secretary Sebelius. I do not think anything is 100 percent,
but we are seeing an 85-, 90-percent response, which is very
good.
Senator Tester. And how about if you have had the flu, the
H1N1, can you get it again?
Secretary Sebelius. We do not know, but the scientists are
saying get the vaccine.
Senator Tester. Rural versus urban, have you seen any
difference in outbreaks there?
Secretary Sebelius. Not that we know of. I am asking my CDC
sources. I thought that was the answer, but I want to give you
correct information.
Senator Tester. This is for you, Secretary Duncan, and you
touched on it a little bit in your opening remarks. That is,
there are a lot of folks that get school lunch programs, school
breakfast programs. They get sick, they head home. Are there
any concerns as to whether they are going to get the proper
nutrition at home? And this is really wild for me. It shows
where we are at, I guess. It is just crazy. But is there any
concern about nutrition at home versus what they would get in
the school? And what can be done about that?
Secretary Duncan. Absolutely. That is a very real concern.
I think there are multiple reasons, that being one of the main
ones, why it is so important to keep schools open and do that
whenever possible. Just to put it in context, at its peak last
year one day we had 980 schools closed. As of yesterday, we
only had 88 around the country--so a 90-percent reduction. That
is 88 out of 95,000 schools in the country. So we are trying to
keep schools open so that kids can eat.
Senator Tester. But for those kids that go home, I mean,
that is beyond your purview, correct?
Secretary Duncan. No. We are actually working on it. It is
beyond my direct purview, but we are working very closely with
Secretary of Agriculture Tom Vilsack and his team and really
thinking about, if these closures are for a protracted period
of time, how we do some----
Senator Tester. I appreciate that.
Secretary Duncan [continuing]. Feeding at the school, and
so the Department of Agriculture (USDA) has been really
thoughtful on this and is part of the partnership.
Senator Tester. I appreciate that. School nurses, are they
still a part of the equation, or did they go by the wayside?
Secretary Duncan. No. They are leading this thing. They
have been phenomenal.
Senator Tester. OK.
Secretary Duncan. We would not be in this position without
their extraordinary leadership.
Senator Tester. Is their availability in rural America the
same as it is in urban America?
Secretary Duncan. I think there is a scarcity of nurses
everywhere. I do not know if it is a rural versus urban issue.
We do not have enough school nurses.
Senator Tester. Any idea on what the staffing of school
nurses are in our public education system today? Are we
understaffed by 20, 30, 40, or is it near 100 percent?
Secretary Duncan. I think education is underfunded, and one
of many places where education is underfunded in school nurses.
So, yes, I would say we are underresourced in nurses--urban,
rural, and suburban.
Senator Tester. Could you find out what that is? I would
really like to know what that is. I do not expect you to know
it, but I would love to find that out. And if there is a
difference between urban and rural, I would like to know that.
Secretary Duncan. I will check that.\1\ I will tell you
they are working unbelievably hard, the ones we have, and I
could not be more proud of them.
---------------------------------------------------------------------------
\1\ Secretary Duncan's response to Senator Tester's question
appears in the Appendix on page 334.
---------------------------------------------------------------------------
Senator Tester. Yes, but I think it is one of the keys to
maybe getting our arms around this.
Secretary Duncan. Yes.
Senator Tester. Secretary Napolitano, I did not want to
leave you out of this. We are bringing in vaccines from other
countries, produced in other countries. Is there anything that
you have done to expedite their ability to get across the
border? Or can it be done as per usual?
Secretary Napolitano. There has been no reported delays at
that particular issue, Senator, and there will not be.
Senator Tester. Good. I want to thank you all very much for
your testimony and your concise answers. Thank you very much.
Chairman Lieberman. Thanks, Senator Tester.
Senator Carper, with your permission--you got here a little
earlier, but Senator McCaskill has been here all morning, so I
am going to call on her first.
Senator Carper. You are kidding. [Laughter.]
I just want you to show me--no, go ahead.
Senator McCaskill. There you go.
Chairman Lieberman. Yes, Missouri. Senator McCaskill, then
we will go to Senator Carper.
OPENING STATEMENT OF SENATOR MCCASKILL
Senator McCaskill. Thank you.
I want to make sure I understand. You know, we have a
problem with reporting both ways, I think. We want to make sure
that the information we are getting is accurate, but there is
also, I think, right now because of the heightened awareness,
some inflationary reporting that may be going on. I want to
make sure I understand this document.
This says the percentage of all visits to doctors' offices
that are due to flu symptoms, is my understanding.
Secretary Sebelius. Flu-like symptoms.
Senator McCaskill. Flu-like symptoms. So, indeed, this
spike is not confirmed cases of H1N1. It is, rather, the
tendency of the population right now to go to the doctor more
quickly when they have flu-like symptoms because of all the
attention that we justifiably have put on this new flu virus.
Correct?
Secretary Sebelius. That is correct, Senator. We are
actually not testing individual cases any longer. We are
testing cases of hospitalizations and deaths to make sure that
we are tracking really whether the virus has mutated. But the
treatment for the flu is the flu is the flu is the flu, so we
are not testing at that point. So these are not confirmed H1N1
cases.
Senator McCaskill. So in some ways, this chart is good news
because it means people are more likely to go to the doctor
right now because of flu-like symptoms than they were this time
last year. Would that be a fair statement?
Secretary Sebelius. I think that is a very fair statement.
I have been told by Dr. Schuchat, we have virological
surveillance, and that is also showing an uptick, and we use
multiple systems to get the tracking. But you are right, this
may indicate that people are concerned. We have seen definitely
an uptick in seasonal flu vaccine uptake, which is good news.
Senator McCaskill. Right, which is good news.
Secretary Sebelius. Getting that public health information
out, we have a vaccine, go get vaccinated. In the past, people
did not pay a lot of attention to it except older Americans,
and now a lot of people are paying attention, and that is good
news.
Senator McCaskill. So that we can have some perspective of
what the numbers are that we can confirm, what are the
confirmed deaths to H1N1 this year compared to what the typical
deaths of regular flu would be in a year?
Secretary Sebelius. I want to get you the accurate--I know
we have 86 confirmed H1N1 pediatric deaths, and that is as
high, if you average the last several flu seasons, as we have
in the entire regular flu season. So that is a high number
because typically----
Senator McCaskill. Obviously, because of the kids.
Secretary Sebelius [continuing]. The kids do not die with
seasonal flu.
Senator McCaskill. Right. But the overall numbers, what are
they, regardless of pediatric or otherwise?
Secretary Sebelius. What I have been told by Dr. Schuchat
is that is really the number that is probably the best number
to track, that and the hospitalizations. What we know now is 90
percent of the hospitalizations are the under-25-year-old,
which is a very different number than we see in seasonal flu.
So those trends are really what we are looking--36,000 people
every year die from the seasonal flu. About 200,000 are
hospitalized. So we are significantly below those numbers, but
this is a very different population, and it is moving.
Senator McCaskill. Well, and I understand the point you are
making is that we need to pay attention because we have a
different population that appears to be vulnerable to this flu,
and obviously it is a population----
Secretary Sebelius. And flu is serious, year in and year
out.
Senator McCaskill. Absolutely. But I still want us to get
perspective, that the number of deaths per year from the flu
that we are all familiar with wildly exceeds any confirmed
death number for H1N1 at this juncture.
Secretary Sebelius. That is absolutely correct.
Senator McCaskill. Speaking of statistics, it is my
understanding now you guys have quit trying to collect
individually and now you are just doing regionally. Is that
correct?
Secretary Sebelius. We are not----
Senator McCaskill. Hospitalizations?
Secretary Sebelius. Oh, hospitalizations, we are getting
reporting, yes, out of State, yes.
Senator McCaskill. Let me talk about fraud for a minute.
Because of this heightened awareness, the good news is we have
a lot more people going to the doctor because of the heightened
awareness. We have more people getting the regular flu
vaccination because of the heightened awareness. I think
everyone is paying attention, which is terrific. But there are
also hoaxes out there right now.
Secretary Sebelius. You bet.
Senator McCaskill. There are people advertising fake drugs,
going on the Internet and saying, ``Click here, and we can save
you from H1N1.'' Can someone address for me the fraud issue and
what you all are doing to protect consumers in this country
from scumbag con men and women?
Secretary Napolitano. Well, with respect to our scumbag
initiative---- [Laughter.]
No, we are addressing that and have been through
Immigration and Customs Enforcement (ICE) and Customs and
Border Protection (CBP), going after counterfeit narcotics. We
have undercover investigations on the way. We are looking both
at undercover physical sales, mail sales, Internet sales, and
the rest. Field offices have all been given guidance in terms
of these kinds of investigations. We are also coordinating
inspections at the border. And it is my understanding that the
State attorneys general are also going after the fraud element.
There is a fraud element that seems to accompany any kind
of----
Senator McCaskill. Any problem we have got, somebody is
going to take advantage----
Secretary Napolitano. Yes, there is going to be a fraud
element.
Senator McCaskill. Right.
Secretary Napolitano. And so part and parcel of what we
have been implementing and planning for now is dealing with
that fraud element.
Secretary Sebelius. Senator, also, I would say the Food and
Drug Administration is being very aggressive in terms of--
actually the Deputy Director recently ordered a series of
products to determine indeed that they were scurrilous and
fraudulent, and they are clamping down in terms of medical
claims being made, making it very clear that people need to be
very cautious about purchases. But, unfortunately, there are
folks selling things out there to take as medication or flu
prevention that are totally bogus, and so we are not only going
after it in the legal realm, but also in the medical realm.
Senator McCaskill. Well, I think with the heightened
awareness out there right now and the media interest in this,
the sooner you guys can put somebody in handcuffs on TV for
doing this kind of thing, the better off we are all going to
be, because it would get a great deal of attention right now,
and that would have the kind of deterrent effect, as you all
know--I know certainly Secretary Napolitano knows--there are
certain crimes you can deter and there are certain ones you
cannot. This is one you can deter with some high-profile
prosecutions, and I would certainly urge you in your
collaborative fashion--which is great the way you are working--
to get with the Attorney General and to get with Justice and to
get with the National Attorneys General Association and even
the National Prosecuting Attorneys Association, and see if you
guys cannot ramp up some significant prosecutions as quickly as
possible so we can save some heartache for a lot of people that
are going to be taken advantage of.
Finally, let me just ask one definitive question. There are
thousands of hard-working Missourians that make their living
raising hogs in Missouri, and this is a difficult time for them
in this economy. Can we state for the record definitively--it
cannot be said often enough--that no one can contract H1N1 from
eating pork?
Secretary Sebelius. No one can contract H1N1 from eating
pork.
Senator McCaskill. Did you hear that, Mr. Chairman?
Secretary Sebelius. No one.
Senator McCaskill. No one can contract H1N1 from eating
pork.
Chairman Lieberman. Yes.
Secretary Sebelius. In fact, it may protect you. I am not
exactly sure, but it may.
Senator McCaskill. Pork is delicious. You can go bacon if
you are not on a diet. You can go lean, the other white meat,
if you are on a diet. Pork rules. There is no reason to avoid
pork. Thank you, Mr. Chairman. [Laughter.]
Chairman Lieberman. Unless, of course----
Secretary Napolitano. Yes, let us be specific about the
kind of pork we are talking about, right? [Laughter.]
Senator McCaskill. Unless it is an earmark.
Chairman Lieberman. No. Unless, of course, you respond to a
higher authority. [Laughter.]
Senator McCaskill. Sorry about that, Mr. Chairman.
Secretary Sebelius. You will not get H1N1.
Chairman Lieberman. It has nothing to do with H1N1. Thanks,
Senator McCaskill.
Senator Carper, thank you for your patience.
OPENING STATEMENT OF SENATOR CARPER
Senator Carper. For those of you responding to a higher
authority and for those of you just somewhat leery of eating
pork, as a guy who comes from a State where there are 300
chickens for every person, there are other alternatives.
[Laughter.]
I would just lay that at your feet.
Before Senator McCaskill leaves, I just want to say how
much I enjoyed listening to her questioning. We serve on a
couple different committees together, and I love especially the
new words that I learn from her. One of my favorites is ``pond
scum.'' That is a word we are starting to spread around
Delaware as well, not the pond scum but certainly the
terminology.
My colleague from Montana has left, but he raised the issue
of school nurses and whether they have too few school nurses
and so forth. In one State--and that is my State--every public
school has a school nurse. In my State, every high school has a
wellness center. And we are very proud of that, and we decided
to do that about a dozen or so years ago. We are not the only
State, I am sure, who has done that, but we feel that it has
positioned us for challenges just like the one that you all are
helping us to address.
I want to say, too, to the Chairman, I do not think you
could have three better witnesses here today. This is the A
Team, and we are delighted not just for the work that you are
doing and your Departments are doing, I love the way you are
collaborating. And I remember we used to battle in my old job,
there were a whole bunch of challenges in our State,
traditionally the departments worked in stovepipes and there
was not the kind of collaboration. We worked on it for 8 years
to try to change that, and I think with some good effect. I am
sure that Governor Napolitano and Governor Sebelius are fully
familiar with that in your own States. But I love the way that
the three of you are collaborating, and it is not just the
three of you, but the folks who work for you as well.
I want to say, Mr. Chairman, I think this idea of taking
the right approaches, being careful ourselves in things that we
do, the way we cough and wash our hands and so forth. I think
it is starting to spread. I was walking down the hall for the
second time coming back to this hearing. As I walked down the
hall, I walked by a lady standing at the elevator, and I
watched her as I walked along. She removed from her purse a
tissue, and she use that tissue over her finger then to hit the
down button, and I have never seen that in my life. [Laughter.]
I think the message is getting out there.
We have had a couple of personal brushes with H1N1 in our
own family. Our oldest son, who goes to school up in the Boston
area, is a senior up there, and he is a pretty good athlete,
too. And he was stricken about 3\1/2\ weeks ago, with H1N1. Did
not miss any classes but was sick every day for about 3 or 4
days. And just to show you how quickly you can bounce back from
this stuff, he ran a marathon on Sunday. So I would not suggest
that people get H1N1 just so they can prepare for marathons,
but they do bounce back.
I mentor on Mondays at a K-5 public charter school in
Wilmington, and last week they closed that school on Wednesday
and closed it for the balance of the week and reopened it on
Monday. I was there Monday, and we had just about everybody
back. So kids are resilient. They do bounce back.
I want to, if I could, mention two things, and a question
first of all, if I could, for Secretary Napolitano and
Secretary Sebelius. In addition to the terrific men and women
who comprise our first responders and hold the lines every day
in protecting the public from the spread of serious illness, we
also have in our back pocket an immense technological arsenal
to help our government to fight diseases and influenza from
taking over our communities. And whether it is the various
surveillance models, modeling programs that help us predict
where to apply countermeasures next or advanced vaccines such
as through vapor mechanisms, I feel that we must continue to
invest in these kinds of technologies, and I would urge you to
continue to do that.
If possible, would either or both of you please take a
moment to describe your respective departments' approaches to
incorporating or seeking out new technologies to fight current
and future pandemic outbreaks?
Secretary Napolitano. I will start, Senator. We have an
entire Directorate that is called ``Science and Technology.'' I
would mention that we are still waiting for the Under Secretary
to be confirmed there. Her name has been pending for quite a
while. But that department is where we focus a lot of our
research and outreach efforts, and, one of the goals that we
have is to be actually more robust in some of the research that
we are doing, not just in terms of pandemic, but other issues
that can affect the public safety of the populace.
Senator Carper. All right. Thank you. Secretary Sebelius.
Secretary Sebelius. Senator, we have, I would say, multiple
agencies within the Department who are, again, collaborating on
this. We have the science team led by NIH, which has the
vaccine program; the Food and Drug Administration, who has the
regulatory and safety steps authority; and the Centers for
Disease Control and Prevention, which has surveillance and
outreach capabilities. And they work very closely on things
related to vaccination.
We have an assistant secretary who is specifically focused
on emergency response. As you know it is not only the pandemic
effort, but what happens after a different kind of disaster, a
regional disaster, how that medical response is done,
everything from search and rescue to ongoing meeting the
medical needs. So we have a focused unit on that.
We have a very robust Global Health Affairs Office that is,
again, trying to coordinate some of this activity
internationally, and we work closely with the World Health
Organization in terms of responsiveness efforts.
I have an Assistant Secretary on Health. I would say that
within our agency we have virtually every department kind of
teed up on this. Our Office of Children and Families is looking
at everything from Medicaid waivers to try and get populations
out and reimbursed to what we do with kids in foster care. We
had a meeting last week on homeless shelters, a real challenge
in terms of isolating sick people. If you have families in a
shelter, where is an ancillary isolate? So working with the
Department of Housing and Urban Development (HUD) on trying to
figure this out.
So we have had a sort of ``all hands on deck'' moment
within the Department, which I would say has been a very good
effort not only within the Department but certainly with
colleagues across the Cabinet.
Senator Carper. That is great. One of the things I am very
proud of that is going on in my State--and my guess is it is
going on in your States and other States as well--is trying to
find new ways to develop vaccines using things like tobacco
plants in order to derive them, and trying to move away from an
egg-based vaccine that sometimes takes a long time to create
and a long time to replicate.
As this outbreak continues to grow, and with the
vaccination programs that are being rolled out in all of our
communities across the country, we have been seeing an immense
amount of misinformation surrounding not only the vaccinations
but also the Federal Government's policy on who is to receive
it as part of their profession. Specifically, I am referring to
the false reporting of how the Federal Government is employing
a mandatory vaccination program, which, as we know, is not
true. And this may have been discussed when I was out of the
room, but let me just ask you to take a moment and just briefly
describe the work that you all are doing to dispel these false
rumors, and maybe give us some advice as to how we can help.
Secretary Sebelius. Well, Senator, it is a great point.
What we are trying to do, among other things, is encourage
people to visit flu.gov, the one-stop shop. We have a whole
series of myths and facts: Is the vaccine safe? What are you
finding out in clinical trials? What has happened to try and
dispel some of the rumors that are, unfortunately, making
people have second thoughts about vaccinating their children or
getting the vaccination themselves.
In terms of the mandatory versus voluntary, I think the
confusion has been that there are some local health systems who
have decided that their employees must be vaccinated in order
to come to work, and I would suggest this did not start with
H1N1 vaccine. There are some local health units that decided
that a number of years ago with seasonal flu vaccines. They did
not want their workers either to be sick with the seasonal flu
or potentially make patients more sick than they already were
in the hospital. But that has led to, I think, misinformation.
The Department from the outset has recommended a voluntary
vaccination program. We continue to recommend that. That does
not override the local authorities' opportunity to impose some
mandatory guidelines, but that has not come from our
Departments, been advised by our Department, or been advised by
the CDC. So we are just continuing to try and get the message
out.
You are a great messenger in Delaware, so I hope you are
helping us spread the word about what is real and what is not,
but urging folks to visit flu.gov I think is a very good way to
get parents, employers, and providers some real information.
Senator Carper. Great. Thank you. Flu.gov it is. I want to
say, Secretary Sebelius, we were so grateful to you in Delaware
for coming to our State earlier this year. We look forward to
welcoming Secretary Duncan to the First State next Tuesday
morning with Race to the Top. Race to the Top with Arne Duncan.
Thanks so much.
Chairman Lieberman. Thanks, Senator Carper.
I want to thank the three of you for your testimony this
morning and go back to the beginning and thank you for the work
that you have done since this H1N1 virus appeared and broke out
in April of this year. Obviously, you are hearing from the
Committee some of what you are feeling, which is the
impatience, the restlessness, and frankly just plain anxiety
about the H1N1 flu spreading. Senator McCaskill was right. The
chart does reflect the percentage of all doctor visits that are
due to the flu, but I think that parallels the increase in not
just anxiety but the actual incidence of the flu. So this is a
real problem.
And on the three points that I raised at the beginning, I
come away understanding better why we are going to be about 25
percent short of the vaccine at the end of October that the
manufacturer said that we would have. But I know that you
understand it, and I know you will do everything you can to
push them to get this to us as quickly as possible.
I appreciate what you have done to expedite the
distribution system, too. That is very important. But the
reality is that there is not enough now, and we have got to get
ahead of the spread of the disease.
On the second point, on the hospital preparedness, on how
the public health system is prepared for the potential surge
that is beyond its capacity, I am encouraged from what you have
said to conclude that there is a lot of emergency planning
being done in which the hospitals will have essentially off-
site--if I am hearing you right--locations for the less severe
cases, if that happens, and then use in-hospital facilities for
the most severe.
I am also encouraged about the intravenous antivirals from
your testimony, Secretary Sebelius, that a decision for
emergency usage authorization will happen soon. My appeal to
you after that happens is to the extent that you can, really
the hope that you can, I want to say ``over-order.'' I do not
think any of us want to be in a situation where there are
people in critical condition in an ICU, their doctor and their
family wants an IV antiviral, and we do not have enough of it.
So based on--again, I hope the PCAST projections of 150,000 to
300,000 people in the country needing ICU care because of H1N1
infections, do not ever materialize. But God forbid they do,
there are going to be a lot of people looking for the IV
antivirals.
So, bottom line, thanks for everything you are doing. I
know you are working really hard at this, and overall I am very
grateful for what you have done. Senator Collins.
Senator Collins. Thank you, Mr. Chairman. I want to thank
you for holding this hearing and the three Cabinet Secretaries
for appearing before us today.
I am heartened by the coordinated response. There is one
issue that I had hoped to bring up that I will bring up for a
response to the record, and that is, our investigation into the
failed response to Hurricane Katrina showed a large variation
among the States in their capabilities and their response when
there is a crisis, whether it is man-made or naturally
occurring. And for the record, I would ask that our witnesses
today evaluate the evenness of the response across the United
States and answer the question of whether you are targeting
specific States that may not do as good a job as Maine or
Connecticut is doing right now to ensure that just because some
of our citizens live in states that have less developed
capabilities they are not left behind as we fight this
pandemic.
So that is an issue that we did not get to today, but that
I would appreciate your responding to for the record. Thank
you.
INFORMATION SUBMITTED FOR THE RECORD FROM SECRETARY SEBELIUS
It is important that States and local jurisdictions have the
capability to appropriately respond during a crisis. Our Nation's
investment in public health infrastructure, particularly at the State
and local levels, remains a critical challenge that has real life
consequences. Our experience with the 2009 H1N1 pandemic, and the
lessons we have learned, demonstrate a need to examine new paradigms
for leveraging the public health infrastructure and our healthcare
system to develop the needed capabilities to ensure every community is
prepared to respond to and recover from future disasters.
As I mentioned earlier during my testimony, HHS is using multiple
systems to track the impact of the 2009 H1N1 influenza outbreak on our
health care system. We are in constant communication with State health
officials and hospital administrators to monitor stress on the health
care system and to prepare for the possibility that Federal medical
assets will be necessary to supplement State and local surge
capabilities. To date, State and local officials and health care
facilities have been able to accommodate the increased patient loads
due to 2009 H1N1 influenza, but HHS is monitoring this closely and is
prepared to respond quickly if the situation warrants.
Since its inception in 2002, HHS has provided nearly $7 billion to
States through our Public Health Emergency Preparedness Program to help
them develop and maintain critical public health, communications, and
laboratory capabilities at the State and local level that are needed to
prepare for and respond to emergencies. To supplement traditional PHEP
funding, in 2009 Congress appropriated funding to prepare for and
respond to the influenza pandemic. This funding became the Public
Health Emergency Response (PHER) grant program. Through its four
phases, over $1.4 billion was provided to States to support activities
including vaccination, antiviral distribution, community mitigation,
laboratory, epidemiology, and surveillance activities. In addition,
since its inception in 2002, our Hospital Preparedness Program (HPP)
has provided more than $3 billion to fund the development of medical
surge capacity and capability at the State and local level. A result of
Congress' investment in these programs is that State and local health
departments have developed plans for distributing and dispensing
critical medications, have better mechanisms in place for disease
surveillance efforts, and have initiated or improved coordination of
their emergency response assets. Hospitals can now communicate with
other responders through interoperable communication systems; track bed
and resource availability using electronic systems; protect their
healthcare workers with proper equipment; train their healthcare
workers on how to handle medical crises and surges; develop fatality
management, hospital evacuation, and alternate care plans; and
coordinate regional training exercises.
As we learn from the experiences of the 2009 H1N1 pandemic, we look
forward to working with you to improve strategies to ensure that our
Nation has the right assets at the right time to minimize the health
impacts of an influenza pandemic, hurricane, bioterrorism event, or
other national emergency
Chairman Lieberman. Thanks for raising that point. I agree
totally. Do any of you want to say something in conclusion?
Secretary Napolitano. No. I would simply say that an
enormous planning effort is underway. The frustration now is
with delay--not shortage but delay, although in context, this
is a new flu that we did not even know about a few months ago.
But the vaccine will be pushed out to over 150,000 locations as
quickly as humanly possible, and in the meantime, we have a web
of other plans underway so that business as usual proceeds in
the United States and that we take care of our critical
operations and critical information as we work through the
problem.
Chairman Lieberman. Thanks.
Secretary Sebelius. Mr. Chairman, I would just say that
from the outset, Dr. Tom Frieden, the new head of CDC, reminded
us that we will either have more than enough vaccine or a
shortage of vaccine. There may never be the right amount.
The good news is, I think, people are educated and are
eager for this immunization, and we will do our best to
continue to ramp up the production and push it out the door and
hopefully to work with our partners to mitigate the spread in
the meantime.
Chairman Lieberman. You know, it is a good point. I saw a
couple of a stories that indicated it. In California, there
were some people in the priority categories--I forget which was
which, but in one State--this was California or New York. In
one State, people in the priority categories were complaining
that they did not have enough vaccine. In another State, they
had it and some of them refused to take it. So that is the
place we are in.
Secretary Duncan. Thank you for your leadership.
Chairman Lieberman. Thank you all very much. We are going
to leave the record open until Friday at the close of business
for additional statements and questions, and because this is
ongoing, to the extent that you can answer the questions as
quickly as possible, we would appreciate it.
Secretary Sebelius. Sure.
Chairman Lieberman. Thank you very much. The hearing is
adjourned.
[Whereupon, at 11:52 a.m., the Committee was adjourned.]
H1N1 FLU: GETTING THE VACCINE TO WHERE IT IS MOST NEEDED
----------
TUESDAY, NOVEMBER 17, 2009
U.S. Senate,
Committee on Homeland Security and
Governmental Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 2:57 p.m., in
room SD-342, Dirksen Senate Office Building, Hon. Joseph I.
Lieberman, Chairman of the Committee, presiding.
Present: Senators Lieberman, Carper, Pryor, McCaskill,
Kirk, and Collins.
OPENING STATEMENT OF CHAIRMAN LIEBERMAN
Chairman Lieberman. Good afternoon. Thanks for your
patience. As you know, we had two roll call votes on the Senate
floor which intervened with our getting here on time, but I
appreciate your being here.
We hold this hearing on the H1N1 flu outbreak against the
backdrop of two crucial numbers going the wrong way: More flu
deaths than previously realized and fewer vaccine doses than
originally promised. And this has led to understandable public
frustration and anger, mixed with confusion over just who
should get vaccinated, with States and even individual cities
and counties creating different priority lists.
It also has led, I am afraid, to some of the highest-risk
individuals, such as pregnant women and children with asthma,
waiting in those long lines for vaccine shots that ultimately
were not available. And it has created anxiety, sometimes fear
among parents going on wild goose chases trying to get vaccine
for their children that their government says they need but
that they, the parents, cannot find.
As I said in our previous hearings, I am very grateful for
the work that Administration officials from the three agencies
that are represented before us today have done since the H1N1
virus appeared in April. Particularly, the H1N1 vaccine was
developed in record time and safely. And I know how hard each
of you and the people you work with have been working since the
onset of this global pandemic.
But with so many eligible Americans still unable to get the
vaccine, I am afraid that a good situation has turned bad. I
worry that we are undermining confidence generally in our
public health system, and, of course, as I mentioned before,
that some of the people most at risk from the H1N1 virus not
only are having a hard time getting vaccinated--some of them--
but they may actually stop trying.
Last week, to get to the numbers, the Centers for Disease
Control and Prevention (CDC) released new estimates of the toll
the H1N1 virus has taken to date, and they are significant: 22
million Americans have become ill with this virus; 98,000
people have needed hospitalization; and approximately, a little
short of 4,000 people, including about 540 children, have
passed away, either directly from H1N1 flu or from a
combination of the flu and complications from it.
That is a quadrupling of the previously reported death toll
as it was understood in October, and I know a different count,
a different system was used, which I think is actually a more
accurate system, and I appreciate it and I look forward to Dr.
Schuchat's testimony on it.
Another set of estimates, which is the amount of vaccine
available, has unfortunately been revised downward again and
again since planning for the pandemic began in April, and this
I believe is really at the heart of what has caused so much
frustration and fear, which I think was unnecessary. And,
again, I want to explore this with the witnesses.
Three months ago, CDC estimated the Nation would have 120
to 160 million doses on hand by the end of October. That, as we
heard in our previous hearing, was based on estimates that the
manufacturers of the vaccine had made. Those doses would be
used, first, to inoculate five target groups based on
vulnerability: Pregnant women, caregivers of infants under 6
months, health care providers, anyone between the ages of 6
months and 24 years, and high-risk adults under the age of 65.
These groups total a very large number, actually more than
half of the U.S. population, about 160 million people. And the
consistent message to the public coming from the Department of
Health and Human Services (HHS) and CDC was that these initial
target groups needed to get vaccinated. So where did those
numbers come from?
Well, we learn a lot as we go on. The Advisory Committee on
Immunization Practices, a longstanding committee, is the one
that identified those priority groups, but I was interested to
learn that they also generated a secondary and smaller list of
approximately 42 million people who were the most at risk--not
just at risk but the most at risk--in case vaccine availability
fell short of what was planned for. Those most-at-risk groups
included pregnant women, again, caregivers of infants under 6
months, health care workers, but then a smaller subset:
Children aged 6 months to 4 years and high-risk children aged 5
to 18.
Dr. Schuchat described this target alternative at a press
briefing that CDC gave at the end of July as a ``just-in-case
scenario'' that likely would not be needed, but which we should
have in our--I think you said ``back pocket.'' And that made
sense. Then 2 months ago, the just-in-case scenario became the
reality we are dealing with today as the estimate of available
vaccine dropped to 85 million doses, then by the end of October
to under 27 million doses. Now there are here past the middle
of November approximately 42 million doses available--
remarkably and I guess coincidentally the exact same number as
the small most-at-risk target group by the Advisory Committee.
So the States were handed two sets of guidelines and told
to use their own discretion with respect to how to implement
them, either the broader group of those who are vulnerable more
than most, which is 160 million, or the smaller group of those
who are most at risk, 42 million. Some States opened their
vaccination programs to everyone in the initial large target
groups; other States, including Connecticut, took a more
conservative approach and have started with the smaller
targeted subset. But the general notification to people,
including a lot of media focus on this, I think created
tremendous interest and, in fact, anxiety about getting the
vaccine.
The chart up there based on CDC data shows how significant
the gap between what would be needed to provide enough vaccine
for the 160 million people in the broad priority groups and the
42 million people in the targeted subset and what is actually
available.\1\ And I think--and I want to really invite the
witnesses to respond to this--that is what has caused the
public outrage, basically the initial description of the 160
million people who are eligible--not just eligible but at risk,
and then ending up with now finally 42 million, which happens
to be the number in the smaller subset.
---------------------------------------------------------------------------
\1\ The chart sunmitted for the Record by Senator Lieberman appears
in the Appendix on page 347.
---------------------------------------------------------------------------
At our hearing last month, Health and Human Services
Secretary Kathleen Sebelius expressed optimism that the
problems with manufacturing and production of the vaccine that
had been the obvious cause for the much smaller number than had
been predicted had been resolved. Things looked better 2 weeks
ago when 11 million more doses were delivered, with another 8
million projected to be available last week. But by last Friday
only about 5 million were available, and I am concerned, I want
to ask the witnesses, whether this was a problem of forecasting
or whether something again has happened at the manufacturing
facilities.
Senator Collins and I wrote a letter to Secretary Sebelius
after our last hearing raising many of these concerns, and I
must say, respectfully, I did not find the Secretary's response
to our letter satisfactory. She did explain in some detail why
HHS made some of the decisions it made along the way, but the
response to me just did not say that we have learned from this
disappointing experience and we have learned how to make it
better next time.
Look, bottom line what I continue to be concerned about is
that after it became clear that the manufacturers were not
going to deliver the number of vaccine doses that we expected,
HHS did not say to everybody in the country, ``Wait a second,
we do not have as many as we thought. Now these are the ones
who are most at risk, and, therefore, you should come in and
everybody else should wait.'' Obviously, people who got there
first got the doses, so some people who were not in that most-
at-risk population got vaccinated, and others--pregnant women,
children with asthma, etc.--who are most at risk did not get
the vaccine.
So, mistakes are made. Things like this do not just happen,
and I think it is important that we acknowledge them so that we
can have confidence that we have adjusted our thinking going
forward as this pandemic continues, and then that we have
learned from this in a way that will make us better prepared
for the next public health crisis of this kind.
Senator Collins.
OPENING STATEMENT OF SENATOR COLLINS
Senator Collins. Thank you, Mr. Chairman.
Mr. Chairman, thank you for holding this important hearing
to focus on the continuing problems regarding the supply and
distribution of the H1N1 flu vaccine.
This hearing is critical to peeling away the layers of
misinformation and miscommunication that have hampered the
Federal Government's flu response strategy.
Many of our constituents, especially those most vulnerable
to the virus, are frustrated and perplexed by the problems they
face in getting vaccinated. To illustrate that frustration, let
me tell you the story of an 11-year-old boy named Brendon
Stearns from Greenwood, Maine.
On October 27, Brendon wrote me a letter. He described his
attempts to get the vaccine. He has two autoimmune diseases and
asthma, placing him in the high-risk group for complications.
Yet even after his mother called several possible sources--
schools, the Maine CDC, doctors' offices both in Maine and in
Boston, hospitals, health care clinics, and pharmacies--she
could not find any vaccine available for her son. Finally, her
persistence paid off when a source was found at a home health
agency in Rockland. That was a nearly 6-hour round trip from
this family's home in Greenwood.
I was dismayed to learn about the extraordinary effort this
family had to undertake in order to get the vaccine for their
high-risk child.
Brendon's mother also wrote me a letter in addition to his.
She talked about the worry that her son went through. She said,
``Brendon has already asked me what hospital he would have to
go to if he contracts the virus.'' What a difficult discussion
to have with your son. To have this thought running through an
11-year-old's mind is just not right. And that is indeed why we
are here today.
Such extreme measures should not be required. And it raises
troubling questions: How many others, just like Brendon, are
still waiting for their vaccination?
Despite consistent reassurances from the Federal Government
that the vaccine would be available for all who wanted it, the
bottom line is that people like Brendon and his mother often
have been left to fend for themselves. Scores of people in
Maine are telling me similar stories. A veteran from Biddeford
with a compromised immune system due to a liver transplant came
to my Biddeford office asking for help. School nurses have
contacted me frustrated with last-minute changes regarding
vaccine delivery and availability.
What is the national strategy? Where was the plan? And as
Senator Lieberman has said in his opening statement, why wasn't
the plan altered when manufacturing problems first became
evident? And those problems appear to have become evident in
late June and early July, according to our interviews with the
manufacturers. Instead of false assurances, why wasn't the
Federal Government explaining the challenges with the
manufacturing process and distribution and revising and clearly
communicating a new vaccine distribution strategy?
If I were to summarize the sentiments of so many Mainers
and so many others across the country who have hit obstacle
after obstacle in trying to obtain the H1N1 flu vaccine, I
would choose one word: ``Frustrated.''
Parents are frustrated that they cannot get the vaccine for
their children.
Doctors and nurses are frustrated because they cannot give
their patients accurate timelines for vaccine arrival.
State and local officials are frustrated because they
cannot plan a cohesive community response because the promised
supply of vaccines often does not arrive on time--if at all.
Americans across the Nation are frustrated because they
want to take recommended steps to help protect themselves and
their family's health, but they cannot.
Let me cite another example across the country from Maine.
The Web site for the Department of Public Health for San
Francisco has a section called ``Frequently Asked H1N1 Swine
Flu Vaccine Questions.'' Let me read some of the questions and
the frustrating answers.
Question: My pediatric office has live virus vaccine. When
will they get the injectable vaccine? Since obviously the live
virus vaccine is not suitable for everyone.
Answer: The Health Department has no way of knowing that,
and neither does your doctor's office. All orders are being
filled on a random basis.
Question: I go to an internal medicine doctor for my care.
When will she have the vaccine?
Answer: This is unknown. At the rate vaccine has been
trickling in, it could be in 1 to 2 months.
Question: Why does the doctor's office across the street
from where I take my children have the vaccine, but my
children's doctor does not?
Answer: Orders are being filled on a random basis. There is
no way to predict who will get what and when.
The final question that I will read is perhaps the most
poignant. Question: What am I supposed to do if I am in a high-
risk category and I cannot find any vaccine?
Answer: Take comfort in the fact that you are not alone. It
remains unclear to all involved when the full supply of vaccine
will be in place, so please remain patient and calm and know
that the whole country is experiencing the same wait.
What an awful answer to have to give to someone like my
constituent who had a high-risk child with two autoimmune
diseases and asthma and is searching the entire State to find a
supply of the vaccine.
It is also frustrating, confusing, and aggravating to our
constituents when we learn that while a high-risk veteran has
been unable to get vaccinated at the Veterans Affairs (VA)
hospital, terrorist detainees at Guantanamo Bay may be getting
the vaccine ahead of Americans in priority at-risk groups. We
learned that executives at bailed-out banks, such as Goldman
Sachs and Citigroup, may be getting the vaccine ahead of
children and pregnant women.
Just this last month, this Committee held a hearing to
examine the government's efforts, and as the Chairman said,
there is much to applaud with the early identification and
development of a vaccine. But when we asked about vaccine
availability, we received rosy reassurances from the Secretary
of HHS about the supply. She said--and I want to quote because
it has not come to pass. Secretary Sebelius said, ``By early
November we are confident that vaccine is going to be far more
widely available. There is enough vaccine, and will be, to
vaccinate every American who wants to be vaccinated, and we are
pushing it out as quickly as we can.''
Well, Mr. Chairman, it is now mid-November, and we know
that supply production is still lagging behind those repeated
assurances.
Only after our October 21 hearing did the truly dire nature
of the vaccine shortage come into clear focus, and I join the
Chairman in expressing great disappointment in the responses
that we have received from Secretary Sebelius in reply to our
specific questions. What we received in response were
generalizations and non-answers.
The Administration needs to do a better job working with
State and local public health officials who can then set
attainable goals, and surely all of us should agree that the
vaccine, while it is still limited, should be distributed to
the most vulnerable groups.
Americans--like Brendon Stearns--deserve answers. H1N1 may
well resurge, perhaps in a more powerful form, next year. In
any event, we know well that this will not be the last pandemic
that we face.
Thank you, Mr. Chairman.
Chairman Lieberman. Thank you very much, Senator Collins. I
appreciate that. I welcome the witnesses. Do you have a
preferred order to go in?
Mr. Garza. No, Senator.
Chairman Lieberman. Is it appropriate to start with Dr.
Schuchat? I want to just move across the table. We welcome you
back.
Anne Schuchat, doctor and admiral, if I am not mistaken, is
Director of the National Center for Immunization and
Respiratory Diseases, Centers for Disease Control and
Prevention. Thank you for being here.
TESTIMONY OF ANNE SCHUCHAT, M.D.,\1\ DIRECTOR, NATIONAL CENTER
FOR IMMUNIZATION AND RESPIRATORY DISEASES, CENTERS FOR DISEASE
CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Dr. Schuchat. Thank you, Chairman Lieberman, Ranking Member
Collins, and Members of the Committee. I am really pleased to
be able to speak with you today to update you on the
Administration's response to the H1N1 pandemic. I am going to
give a brief update of the situation and then go into more
detail into the response and the vaccination situation, which I
believe is the heart of the focus.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Schuchat appears in the Appendix
on page 348.
---------------------------------------------------------------------------
Chairman Lieberman. Right.
Dr. Schuchat. As you mentioned, we did last week update the
estimates of the full toll that we believe the virus has had in
the first 6 months. We do not think the reporting of lab-
confirmed cases really tells the whole story, so we are
estimating 22 million people have been infected and ill since
the first 6 months.
Chairman Lieberman. So the big difference is that the
previous estimates were just, as you said, based on laboratory-
confirmed cases.
Dr. Schuchat. That is right. What we have done is taken a
number of surveillance systems and efforts to correct for
underreporting the accuracy of the lab result and so forth, and
we have come up with this 98,000 hospitalizations, nearly 4,000
deaths, and as you said, tragically, over 500 deaths in
children, probably.
Right now the H1N1 virus is still widespread in 46 States.
In many States it is beginning to decrease, but it is still way
above the estimates of what is normal for this time of year,
and it is continuing to increase in the northeastern part of
the country, where you both live.
So far there has been no change in the illness pattern. The
majority of illness is in younger people. Many of the severe
cases are in people with underlying conditions or in pregnant
women. So far there is no change in the virus. It has not
mutated to become even more virulent. The good news is the
vaccine is an excellent match with the virus that is still
circulating, so we expect high efficacy of the vaccines that we
have.
But, unfortunately, influenza, including H1N1, is
unpredictable, and we cannot tell you the trajectory, how much
longer we will have this widespread disease, how many more
waves will follow, whether we will have a substantial
additional wave after the first of the year, which is what
happened in 1957.
It is important, I think, to thank Congress for the
incredible investments in preparedness that have made the rapid
detection and the response that we have had possible. Without
those investments, things would be much worse. We know that
there are many places where there is room for improvement, but
I do believe that we are much better off than we would have
been without the years of preparedness investments.
On the poster and then in the handout that you have, I have
tried to summarize CDC's role in the response, and you will
hear from Dr. Lurie about HHS's broader role.\1\ We, as you
mentioned, identified and rapidly characterized the virus. We
developed candidate vaccine strains that could be handed off to
industry. We used our epidemiology and laboratory efforts both
in the United States and globally to understand what was going
on, how far this was spreading, and to develop science-based
interventions.
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\1\ The chart referenced by Dr. Schuchat appears in the Appendix on
page 361.
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We have had aggressive comprehensive science-based response
with rapid deployment of the assets in the Strategic National
Stockpile, life-saving antivirals, and other measures,
including respiratory protection.
We developed and distributed laboratory kits to all of the
public health labs in the United States and to 150 countries so
that we could understand what was going on abroad. That was all
based on investments that had come through the preparedness
resources. And we deployed field teams to provide technical
assistance at home and abroad and continue to do that.
We issued science-based guidelines for key sectors,
including mitigation efforts that focused on schools,
businesses, and health care workers, including treatment with
antivirals such as those in the Strategic National Stockpile,
and also additional products that came to be available through
emergency use authorization.
Communication and State and local support were key
underpinnings to our response, and then, of course, one of the
key pillars of the response has been vaccination. This has been
an unprecedented effort to develop the strain, to prepare to
carry out clinical trials, to develop recommendations for use,
and, of course, to launch the voluntary program.
I share your disappointment in the initial production and
the set of supply constraints that we have today. We have all
been victim to the biologic processes of a slow-growing virus,
and it really underscores the need for those long-term
investments in vaccine technology and expanding production
capacity. But production is accelerating and substantial
amounts are becoming available, not as much as we want, but
more every day.
Today, 48.5 million doses of H1N1 vaccine are available for
the States to order. About a quarter of that is the nasal mist
that you mentioned, which, of course, can only be given to
healthy people 2 to 49 years of age.
We have prioritized for the use of this vaccine groups that
were at the highest risk for disease or the highest risk to
spread. The national standards were set by that Advisory
Committee for Immunization Practices that you referenced, but
we have been supporting State and local decisionmaking on the
best ways to put vaccine in the path of the priority
populations.
We know that States are carrying this out in a variety of
ways. Thirty-four States so far have initiated school-located
vaccination efforts. Virtually all of the States are providing
vaccine to providers. Some are using lotteries to decide who
gets the vaccine. Some have ethics boards. Some are focusing on
the high-risk providers that serve the highest-risk children or
adults.
We have heard of some success stories in the midst of all
of this challenge. I have to say that the State of Maine has
been doing an extraordinary job. At the end of this week they
expect to have completed vaccinations at all 130 school
districts. They have also provided vaccine to providers with
those highest-risk patients--unfortunately, not early enough
for many of the families who had to go through the nightmare
that you described, Senator Collins.
We know that Connecticut, Delaware, and others really
focused on the high-risk providers, hospitals, Federally
qualified health centers, and others are now actually beginning
to be able to provide some vaccine to retail venues which can
reach additional people or to workplace clinics that can reach
the high-risk groups while they are at work and not requiring
them to leave work to get vaccinated.
This is definitely a State and city-run implementation
effort. Our Advisory Committee reiterated in October, once we
knew about the supply shortages, that the State and local
people were in better shape to sort out the subprioritization
efforts and how best to reach the important groups.
It has been critical to use the vaccine doses as quickly as
they become available and not have them sit on the shelf, and I
really want to applaud the public health folks at the State and
local level who have been working day and night to carry this
program through.
I also want to mention safety. We are committed to a safe
vaccine system, and although we do not expect any problems with
this product, we are carefully monitoring the situation,
working with external advisory groups and so forth, to make
sure that if anything unusual occurs we are able to intervene
promptly.
We have been working very hard across HHS and with other
parts of the U.S. Government to make sure that the State and
local health departments are in the best position possible to
support prevention efforts on the ground. I think that this
H1N1 pandemic really highlights the need for long-term
investments in that infrastructure that is the front-line
response system.
And just in closing, I want to say I will be happy in the
questions and answers to address the specifics of the
distribution system and really share the frustration that you
describe. I wish that we had more vaccine and that it was much
easier for people at risk to get vaccine.
Chairman Lieberman. Thanks, Doctor. I am sure you do. I am
sure you are at least as troubled as we are and as people in
our States are when they cannot get the vaccine. We want to
come back to it, but I want to know what you would do
differently next time to try to avoid a similar crisis,
particularly once the production was way below what the
estimates of the need were.
Dr. Nicole Lurie, this is actually a good room to get sick
in, if you want to--we have three doctors as witnesses. I am
not suggesting anything serious, but there is a plethora----
Dr. Lurie. I thought you were commenting on my virus.
Chairman Lieberman. Dr. Lurie is the Assistant Secretary
for Preparedness and Response (ASPR), Department of Health and
Human Services, who will provide testimony, I hope, detailing
the development and production of the H1N1 vaccines, including
monitoring of manufacturers' timelines for vaccine
distribution.
Dr. Lurie, thanks for being here.
TESTIMONY OF NICOLE LURIE, M.D.,\1\ ASSISTANT SECRETARY FOR
PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Dr. Lurie. Great, and thank you so much for the opportunity
to come and talk with you today about our efforts during this
pandemic. I, too, would like to start by taking the opportunity
to thank you for your continued support. It was really due to
your foresight that we began rebuilding the vaccine
infrastructure several years ago when we decided to pursue
vaccine for H1N1. It turned out we already had pre-existing
contracts with manufacturers already licensed in the United
States, enabling us to get out of the blocks quickly with
vaccine manufacturing, and the right-hand side of that graphic
\1\ really identifies some of the investments that were made to
make that possible.
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\1\ The prepared statement of Dr. Lurie appears in the Appendix on
page 362.
\1\ The chart referenced by Dr. Lurie appears in the Appendix on
page 385.
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I want to really start by just reviewing for you the role
of my office in this, which is really four-fold.
First, our role is to coordinate across-department response
and to work across the interagency, including with my colleague
Dr. Garza.
Second, ASPR stimulates the development of and contracts
for vaccines and antivirals.
Third, is to ensure that we can backstop States and
communities when they get overwhelmed and request our help.
And, fourth, really importantly, is to stay prepared for
any other emergency, not to take our eye off the ball during
this critical time. And you will remember that we did respond
to the tsunami in American Samoa in the middle of this.
I want to say that this H1N1 response has been a public-
private partnership from the beginning. I think you have
already highlighted the incredible speed with which vaccine was
made, and I want to say that also would not have been possible
without our partnerships with industry. But while modest
amounts of vaccine came a little ahead of schedule, a
combination of poor production yields, late completion of
seasonal vaccine, problems with new filling lines, decisions in
the home country of a manufacturer, all caused delays--and,
frankly, repeated delays--in the availability of vaccine, but I
want to stress not just for the United States but for the
world. And the left side of the graphic,\1\ the pieces in
orange in that graphic go through the vaccine manufacturing
process and show you really all of the places where things have
gotten stuck along the way.
While we have all been, I think, really frustrated by the
delays and tear our hair out each time we hear about another
problem and another delay, I think from my perspective we have
done our best to communicate directly with the American public
each time we have learned of one of these problems. As said,
now the number of doses that have been produced and
distributed, as you heard, continues to grow steadily, and we
continue to expect increasing amounts of vaccine in the coming
weeks.
We remain incredibly vigilant here. We talk to the
manufacturers every day. Right now we have full-time people at
two of the manufacturing facilities just to monitor and assist,
to give us a heads-up if any problems are occurring, and to
help with on-the-ground problem solving. In addition, Secretary
Sebelius and I have spoken directly with the chief executive
officers on more than one occasion to identify opportunities to
work together to speed the delivery of vaccine and, frankly, to
be sure that there are not any arcane, bureaucratic obstacles
in the way at our end to making that happen.
So while the delays are really frustrating to everybody--
and we hear that, and it is frustrating to us as well--it is
really the virus that is the real enemy here. I think as Dr.
Schuchat said, and I think you know well, it continues to
really reinforce the need to move forward to new technologies,
to more robust manufacturing capacity, to more robust filling
capacity so that, frankly, a virus of the future does not
defeat us.
Although the focus of this hearing is on vaccines, I do
want to highlight progress that we have made in antivirals. As
you know, we now have the first ever intravenous antiviral
available under emergency use authorization. We are procuring
over 30,000 doses across three different types of IV antiviral
drugs to treat critically ill in-hospital patients.
We have also been really focused on ensuring that the
health care system itself--in communities--can remain able to
care for people. The President's emergency declaration has
enabled us to support hospitals and health systems that need to
be decompressed with 1,135 waivers, and we stand ready to
deploy Federal assets where necessary to support health care
facilities. Our first Federal vaccination team is actually
being deployed to Delaware next week to help with vaccination
there.
We have partnered very closely with the private sector
health care system--health insurers, pharmacists, big box
stores, the American Medical Association (AMA), the public
health community--to find ways to pay for vaccine
administration so that cost is not a barrier.
Let me move on a little bit to some lessons learned.
First, as I said, the support of Congress has been really
critical in helping us to strengthen the vaccine
infrastructure, enabling us to respond quickly. But yet it is
clear to all of us, I think, that chronic underinvestment in
public health, whether in that infrastructure, at the Federal,
the State, or the local level has real-world consequences. And
I think we are seeing some of those. We cannot afford to let
that happen again ever. And while we have made vaccine in
record time without cutting any corners, in retrospect the
original projections which were based on the collective
experience with seasonal flu manufacturing and H5N1 pandemic
preparedness manufacturing, were optimistic in the face of what
proved to be daunting challenges provided primarily by Mother
Nature and despite the best efforts of the Federal Government
and our manufacturing partners.
Congress and the public have rightfully asked for
projections about the numbers of doses, and we want to be
transparent. But at the same time, we have to provide all of
the caveats about the uncertain and changeable nature of these
projections. In the face, again, of Mother Nature, this
continues to be fraught with uncertainty.
A real challenge here, though, especially has been the fact
that as messages get captured with shorter and shorter sound
bites, you lose all the detail about all of these caveats and
these contingencies. This has led to frustration for everybody
involved. So as the supply improves and we incorporate early
lessons now from the vaccination efforts--and I want to say
that there have been a number of those, and each time we learn
one of these lessons, we incorporate it, we pass it on to our
partners in State and local areas. And so, they are able to
work to do things, to get those lines shorter and to make it
easier for people to have an easier time getting vaccinated as
time goes on.
I do want to mention the past week because you talked about
this week's projections. The storm that was the remnants from
Hurricane Ida delayed shipment to one of the major depots and,
frankly, nearly derailed vaccination campaigns in States from
Maine to Alabama. I want to credit the staff at CDC and the
office of the Assistant Secretary for Preparedness and Response
that worked all weekend to be sure that vaccine could be
ordered and shipped on Sunday night so that clinics scheduled
for this week could go on as planned.
Importantly, we are far from done with the science and
advanced development related to vaccines and with building
manufacturing capacity in the United States. In other words,
that underinvestment in advanced development is also chronic.
And as you said, Senator, my fear is that when this is over, we
will decide we do not need to worry about another pandemic for
the next 30 years, and nothing could be further from the truth
or be more dangerous.
I also want to point out that much of what we do today is
relevant for any new threat we need to confront, whether made
by Mother Nature or made by human beings. Despite these
challenges, I think that much of what we have learned and we
are continuing to learn through this pandemic and the
investments we have made to address it will serve us well in
confronting public health emergencies and threats for many
years to come.
I, too, look forward to providing a more detailed
explanation of the graphic, the timelines, and other matters
during our question-and-answer period.
Chairman Lieberman. Thanks, Dr. Lurie.
Finally, we have Dr. Alexander Garza, welcome back, Chief
Medical Officer and Assistant Secretary for Health Affairs at
the Department of Homeland Security. Dr. Garza will testify
about the Department's actions since our Committee's hearing on
October 21 and the Department's assessment of how States are
managing the outbreak.
Welcome back. Thank you.
TESTIMONY OF HON. ALEXANDER G. GARZA,\1\ ASSISTANT SECRETARY
FOR HEALTH AFFAIRS, AND CHIEF MEDICAL OFFICER, U.S. DEPARTMENT
OF HOMELAND SECURITY
Dr. Garza. Thank you, Mr. Chairman, and good afternoon to
you and Ranking Member Collins and the rest of the Committee
today, and thank you for allowing me to testify here this
afternoon.
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\1\ The prepared statement of Dr. Garza appears in the Appendix on
page 387.
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Before I get started, I wanted to offer a quick thanks as
well for my confirmation hearing this summer. This is the first
time I have been able to testify before you, and I thank you
for that.
The current H1N1 pandemic is a unique event. There is no
ground zero. There is no location where it is most likely to
make landfall. There is no discrete beginning or end, and
although this pandemic will not destroy buildings, it can cause
a lot of stress to our society, as you have mentioned. And
although this hearing is focusing on vaccine, I wanted to
discuss some of the Department of Homeland Security's efforts
in dealing with the H1N1 pandemic.
To this end, we have focused our efforts on protecting the
people and the country from the effects of the pandemic. As you
know, Senator, DHS has a dual mission in combating the flu.
While we are intimately involved in the national planning and
response efforts, we also work internally with our policies and
procedures to protect our workforce so that they can continue
to safeguard our country.
The principal tasks of the Office of Health Affairs (OHA)
regarding the current pandemic are providing information,
analysis, and advice to Secretary Napolitano, co-leading the
DHS H1N1 planning effort, helping ensure that the DHS workforce
is protected, and serving as the lead representative for the
Department of Homeland Security in the interagency coordinating
body.
Together with our interagency partners, DHS has led a
strong Federal response. We have learned from our experiences
and have implemented changes to help us both currently and in
the future. The key lessons that I would like to describe are
interagency coordination, planning, workforce protection, and
communication.
The spring outbreak illustrated the necessity of strong
interagency coordination. We have worked closely with our
Federal partners, including my colleague Dr. Lurie at ASPR,
with the Department of Health and Human Services, with the
Centers for Disease Control and Prevention, as well as the
Department of Education and the White House.
In addition to working horizontally across our Federal
partners, we have also worked vertically with State, local,
tribal, and territorial governments, as well as the private
sector and faith-based communities in providing guidance. The
DHS Office of Intergovernmental Programs conducts weekly calls
and meetings with our homeland security advisers across the
country, and National Protection and Programs Directorate
(NPPD) coordinates with critical infrastructure
representatives, and this is just to name a few of our efforts.
And we will continue to collaborate and push information out to
all.
As my experience in the Army has taught me, plans must be
flexible enough to adapt to the reality on the ground. This
Department has learned this as well. As we all know, plans
never survive first contact with the enemy.
While we originally planned for a worst-case scenario of
pandemic flu that originated outside of our continent, we
quickly realized that this was not the case. Having plans
flexible enough to adapt and maneuver to the changes of the
current reality are imperative if we are going to meet future
challenges.
Additionally, we tested our internal coordination and
planning by conducting tabletop exercises that brought together
the leaders across the Department of Homeland Security and
which were actually attended by the Secretary as well as the
Deputy Secretary in order to test our programs for the stress
that H1N1 would place on our components. This provided an
opportunity for us to identify how to meet our mission-critical
functions while protecting employees during an influenza
pandemic event.
As I mentioned earlier, DHS has a dual mission where one
complements the other. Eighty percent of the Department of
Homeland Security personnel are operational, and for
comparison, this is roughly the size of the Marine Corps. OHA
and DHS have moved aggressively to ensure that our forces are
protected. We have widely disseminated evidence-based guidance
to our employees and posted it on our Internet sites. In
addition, we spearheaded the acquisition, storage, and forward-
positioning of our protective measures, including personal
protective equipment and antiviral medications.
By performing these functions, we are helping assure that
the threat of the current pandemic will not influence the
security posture of this Nation. Because our job at DHS is to
ensure a coordinated Federal response, information sharing is
essential. OHA co-led the operational planning team that served
as a hub for the collection of data to present leadership a
clear picture of what was occurring during the pandemic. In
addition, our National Biosurveillance Integration Center led a
modeling effort in the spring to get a better idea of what was
possible with the resurgence in the fall, especially the impact
on our critical infrastructure and key resources.
We recently shared this with our leadership as well as our
partners at the State, local, and private sector. As a result
of these efforts, we have partnered with Health and Human
Services on further modeling efforts to understand the effects
of the flu. As we move forward through the fall flu season, we
will continue to build on these strong relationships formed
with our partners across all levels of government and the
private sector.
Again, I would like to thank you for the opportunity to
testify before you today, and I look forward to answering any
questions. Thank you.
Chairman Lieberman. Thank you very much, Dr. Garza. We will
do 7-minute rounds of questioning for Members of the Committee.
Dr. Schuchat, let me just start with the numbers here on
the incidence of the virus, and as you said, you changed the
method of calculating--in other words, going beyond laboratory
confirmed cases. If my recollection is right, in the new
projections or estimates you are making, both the incidence and
particularly the number of deaths has gone up significantly
from what originally had been thought to be the case. Am I
right? And if so, what does that tell you as an expert in this
about the incidence of H1N1?
Dr. Schuchat. Since the beginning of the pandemic, we have
tried to use approaches to surveillance that were appropriate
to the resources available and the stage of the pandemic. So,
initially, we were counting individual cases. It was very
important for testing to occur in a widespread way so that we
would know whether it had arrived in additional places.
At a certain point, individual case counting was no longer
an efficient use of resources or an efficient use of the health
care system, and so individual case counting was stopped, and
we worked with the State health departments to identify other
approaches to tracking the disease.
All the way through, we have been saying that reported
cases, whether lab confirmed or based on other definitions,
would be an underestimate of the true burden of infection. Many
people do not seek care when they are ill. Many people who are
ill do not get a test performed. Many people who get a test
performed have a negative result because the tests are not 100
percent accurate. And then not all positive tests get reported
into the various systems.
So, really, since the beginning we spoke about the measured
burden and then the unmeasured burden, and we worked to find a
science-based approach to accurate estimates. We released some
estimates earlier this year about the disease from April
through July and last week were able to talk about the first 6
months of the pandemic, and there came away with these numbers
that were much greater than reported cases, but we believe much
more accurate.
Chairman Lieberman. Were you surprised when the numbers
came in? They are pretty high. I was surprised, 22 million
illnesses, 98,000 hospitalizations, more than 3,900 deaths,
including, as we said, about 540 children.
Dr. Schuchat. I would say that I was not surprised. I was
sobered. But I also want to say that we have been taking this
seriously from the beginning. Some people thought we were
overreacting to this new threat, but I think the idea of a new
strain of influenza that the population is susceptible to means
that you can get these kinds of tolls. Even if the virus is not
as virulent as the H5N1 bird flu strain or the 1918 strain, a
new virus in a susceptible population can lead to large-scale
illness. And that is really why we have had this focus on
methods to decompress the health care system, have the sickest
people cared for, rapid use of antivirals for them, but people
with less severe illness were able to be cared for at home
without clogging up the emergency departments.
So I think we have been taking this very seriously, so the
numbers were expected for me.
Chairman Lieberman. Let me go on to this main question,
which is the lines, the frustration, and the fear of people not
getting the vaccines. And I want you to respond. My theory on
this--and I am just observing--is that the government, HHS,
CDC, should have done a large national announcement of a
reduced list of people who had to go out and get the vaccine
and everyone else should stay home for a while when it was
clear we were going to get fewer vaccines.
If that was not the case--again, you have spent so much
time on this. You have got to be as frustrated and in some ways
embarrassed as anybody else, more so about the problem with
distribution of the vaccine. So is my theory right? And if it
is not, what did cause this problem? Because it did not just
happen. Something went wrong.
Dr. Schuchat. Yes. You mentioned the just-in-case scenario
with the smaller population.
Chairman Lieberman. Yes.
Dr. Schuchat. Our Advisory Committee met July 29, 2009, but
they met again in October. We re-asked the question to them.
Are the scenarios of supply that we are looking at now such
that we really ought to go systematically nationwide for that
smaller group? We also consulted State and local health
department leaders, the Association of Immunization Managers.
There was an active discussion at our public meeting of the
Advisory Committee.
What we heard pretty consistently was leave the flexibility
to the State and locals, let them decide whether to
subprioritize--and a number did--or go broader.
We also had a bit of an unfortunate occurrence in the
beginning of the supply that, the first week or two, almost all
of the supply was the nasal spray. That does not stretch very
far with the highest-risk group. It will not get a child with
asthma. It cannot be used in pregnant women. We wanted to be
able to use those doses.
We also heard clamors from many that they really wanted to
do school-located clinics. They thought protecting children was
important, and also slowing spread by protecting children would
be important, and also children under 10 need two doses. So
many States wanted to be able to move forward with the school-
located clinics.
Chairman Lieberman. Let me interrupt. So looking back,
don't you think mistakes were made here? Because it did not
work as you hoped it would. It is possible--I am a lay person.
I know there are experts on the Advisory Council, but, my own
reaction to this is that they were wrong.
Dr. Schuchat. I think that looking back is very important,
and we are also trying to look forward and learn. I think we
are committed to continuous learning in this.
One thing I think we can look back and say was a mistake is
some of our communication, that whether we meant to or not, I
think we led expectations of availability to be higher than
they have been, and so that I think can lead to frustration.
But I would say that, I have tremendous faith in the
American public. I hate that people had to wait in line or that
people have not been able to find vaccine. But our surveys tell
us that those who looked for vaccine and were not able to get
it, nine out of 10 plan to look again. And, fortunately, it is
getting a little bit easier each day, although not yet at the
point where demand and supply have gotten close enough
together.
Chairman Lieberman. All right. I appreciate that. And,
actually, I think you used the word ``mistake,'' and it is
important to acknowledge that here because this is going to
happen again and we do not want to let the mistakes happen
again.
I tell you, one of the things that, it seems to me,
happened here is that this is a national problem, and there was
a focus on national alerts about this, so that the fact that
you gave the States some latitude did not really sink in
nationally. And, of course, if you happen to live adjacent to
another State where the distribution was different or even in
another community in the same State where one set of parents
could get the vaccine at their doctor's and the other could
not--I mean, we have all had this in all of our families. I was
hearing from my children who are trying to get vaccines for my
grandchildren.
I think this is a case really where it would have been
better to have a national answer and in this case not go for
federalism--in other words, not let the States and localities
make their own decisions on prioritizations--because everybody
was focused on the national warnings about the disease and the
urging to go out and get vaccinated.
Dr. Schuchat. Yes, just briefly, I think that we did really
feel that local and State experts and authorities were in a
better position than we were in Atlanta or others were in
Washington to know how to best reach the populations in their
midst--some of them, as I said, going very heavily with the
private sector providers, others making mass clinics available
for priority groups, others using sort of a hybrid approach.
I think that the sense of trust and the sense of planning
really needed to be closer to the community level. Whether we
supported the States and locals sufficiently, we did give
resources for communication so they could do messaging. I am
not sure it was, as effective as it could have been.
Chairman Lieberman. I do not think it was. My time is up,
but I understand about the particular places of distribution.
That is an appropriate decision for State and local public
health authorities to make. But I honestly believe, looking
back, that CDC or HHS, when it was clear that the production of
the vaccine was going to be so much lower than expected and
predicted, should have just nationally said, OK, you decide,
States and locals, who is going to give it out, but here is the
most at-risk population, 42 million, and this is who you have
got to concentrate on first.
My time is up. Senator Collins.
Senator Collins. Thank you, Mr. Chairman.
Doctor, let me continue on the line of questioning that the
Chairman has just begun. It is my understanding that in July
your Advisory Committee met and it identified 159 million
people that could be categorized in the priority group. Now,
that is a very large number, and that was based on CDC's
initial estimates that there would be approximately 120 million
doses by October. Is that correct?
Dr. Schuchat. Well, one clarification is that in the
summer, when the Advisory Committee met and set the policy of
that group, there was actually an expectation that everyone was
going to need two doses of vaccine. So the number of doses is
not directly translatable to the number we are looking at now,
because, fortunately, it turned out that people 10 and up only
need one dose of vaccine.
Senator Collins. Well, that actually makes the situation
worse because if you were assuming that two doses might be
needed for much of this population, then there is a far greater
mismatch on the number of high-priority individuals, almost 160
million people, versus 120 million doses. So that is even a
bigger mismatch. And that was the July 29 meeting. Is that
correct?
Dr. Schuchat. Yes. And let me give you a sense of where the
Advisory Committee was coming from. Our Advisory Committee
recommends influenza vaccine for about 263 million people, and
about 100 million people get vaccinated each year with seasonal
flu vaccine.
It was impossible to know what demand for vaccine would be
like, but we rarely equate a size of a population with a number
of doses. They felt that they wanted a broad priority group.
They did not want to micromanage the risk groups because they
felt that demand may be fickle. It may be different in New York
City from Maine. It may be different in October from November.
And so they looked at the epidemiology of who was getting sick,
who was hospitalized, who was dying, where was the social
disruption, and focused on a group that was quite large, the
159 million group.
Senator Collins. But then what happens is the Advisory
Committee, I believe in August, created a smaller priority
group.
Dr. Schuchat. It was actually at that same July 29 meeting.
The publication was finally issued in August, but on July 29,
they voted on both the 159 million and the 42 million groups.
Senator Collins. The larger group and the smaller group. My
point is that the Advisory Committee in the summer had
identified a smaller priority group of 42 million people at
highest risk. That included pregnant women and children. These
are the people that we really want to make sure are going to
get the vaccine. And yet at the same time, you are starting to
realize that there are manufacturing problems that are beyond
your control, beyond the Federal Government's control, that are
greatly reducing the production of the vaccine.
So we have already identified the priority group that is
smaller, and we know the good news that most people are
protected with just one dose of the vaccine.
I just do not understand why the Federal Government did not
then instruct States and local public health officials to
concentrate on this priority group. And I believe the American
people will put the highest priority people first gladly. But
if they are not getting a revised distribution plan from the
Federal Government, you create chaos. You create the chaos that
we have seen of clinics not having enough, of people standing
in long lines, and people who need it most not getting it.
And I so agree with the Chairman's point. I do not
understand why, when it became evident that there was a
mismatch with supply and demand, the priority group was not
clearly communicated and Plan B put into effect.
Dr. Schuchat. We did a substantial amount of outreach that
was targeted to the 42 million population, working with
caregiving groups, health care providers, and advocacy groups
that served the very children with disabilities, high-risk
condition groups. We also were somewhat cornered by the
availability of the nasal spray, as I say, which cannot be used
for pregnant women, children with asthma.
One of the striking features of the pandemic was the effect
on children. Every time a healthy child has been hospitalized,
it has been very different for each family and for each
community or school. I think it is important to recognize that
the 42 million group does not include healthy school-aged
children. And I know so many parents who have been really
anxious to get their young children and older children
vaccinated; they are not in the 42 million group.
I would say that each decision that has been made has been
taken very seriously. We have sought external advice. We have
tried to look at things in different ways. And I think
reasonable expert people could disagree on the best way to go
forward. We are trying to improve every day.
Senator Collins. I think one of the lessons here is that
when we do run into these problems, we need to prioritize the
distribution of supplies.
Dr. Lurie, in my remaining minute, I want to raise two
issues with you. When I have talked to public health officials
and other experts, they say to me that they believe HHS made
mistakes in two areas that would have made a real difference in
terms of increasing the supply. The first was the requirement
that individual syringes be filled with the vaccine. The
manufacturers tell me that took longer than if you had approved
batches to be distributed and then syringes could be filled at
the local level, that it was a lot more complicated for
individual syringes to be filled.
The second issue that I have heard repeatedly--and I know
it is more controversial--is the use of adjuvants, and it is my
understanding that the use of an adjuvant in a vaccine can
dramatically increase the supply of the vaccine since each
vaccine dose requires less antigen, for reasons that I realize
we do not fully understand. But it is my understanding that in
the European Union the vaccine is being made with the adjuvant
and, thus, the supply is more abundant.
So I would like you to comment on those two decisions
because from what I am hearing they would have had an impact on
supply.
Dr. Lurie. Sure. Well, let me take each of them in turn.
First, with regard to the prefilled syringes, we did
contract for a mixed supply of prefilled syringes and what are
called multi-dose vials, the biggest bulk ones. As soon as we
became aware--and that was pretty early on in the season before
most vaccine was even being put into vials--one of the things
we did was say to the manufacturers our priority is to get the
most doses out fast. And so what that meant was, first, taking
all of the available vaccine, the antigen you had, and putting
it in those multi-dose vials to kind of saturate those filling
lines; and then if you had stuff left over, go ahead and
continue to fill the prefilled syringes instead of letting them
lie fallow because you could get more doses out with that
combination than with just the prefilled syringes.
So while you are right, it takes longer to fill a prefilled
syringe than a multi-dose vial, I think in the long run
everybody was asked to do those multi-dose vials first so that
we could get as many doses out as possible. And, frankly, some
of the manufacturers changed plans early on after we had the
discussion about that to say how do you get as many doses out
as possible.
And so while I hear that, I guess I do not think that it
has contributed substantially to a shortage. At the same time,
we need to have sort of an array of products out there that are
acceptable to the kinds of choices that different people want
to make.
Let me address the use of adjuvant because I think it is a
really important question on a couple of fronts.
First of all, from the beginning, we sat down and have done
this whole huge decisionmaking set of matrices or trees, and
one of the really early things we said was at several points
along the way we are going to have to decide if we want to use
an adjuvant. And we said, well, what would be the early warning
signs that we would need to use an adjuvant and what would make
us go there. And at very regular intervals we have revisited
that. So the early warning signs would be if the disease got
worse, if people did not have a good immune response to the
vaccine, or if there were not enough doses.
Every time we have had a decrement in projections, we have
gone back, and we have looked at those decision trees and those
triggers and convened senior scientists at the highest level to
say should we move ahead with adjuvants. And every time the
answer has been no, for two reasons. One is if we shifted to
adjuvants, it would take a lot of the unadjuvanted vaccine out
of the system while we made that shift. And two, as I think the
public's confidence in vaccines in this country is just not as
robust as we want it to be. The adjuvants would be a new
vaccine. They might have to be used under an emergency use
authorization. And so we did not really want to rock the
public's confidence in a new vaccine.
A last point I want to make--and I think I said it in my
testimony--this is a worldwide problem. Even with adjuvanted
vaccine being licensed and available, we are still one of the
very first countries to mount a large-scale vaccination
campaign. Most developed countries have not. And we have
distributed, even with unadjuvanted egg-based vaccine, more
doses to be administered than any country in the world. So as
frustrated as we are with the vaccine supply--and we are all
really frustrated--I think it is just really important to keep
that perspective.
Chairman Lieberman. Thanks, Senator Collins.
I noticed a column in the Washington Post today by Anne
Applebaum, and it speaks to the global confusion, if you will,
about the problem. And I think when this is all over--and
hopefully it will be before long--it is not just the U.S.
Government but the World Health Organization that has to go
back and take a look at how this all developed. Again, part of
it is the global nature of media today and the way in which it
portrayed the outbreak. This is serious and this is a real
disease. Obviously, it has killed almost 4,000 people here in
the United States in the last 6 months. But the media coverage
created a kind of panic in some countries around the world,
which makes our lines seem relatively mild. But they weren't
mild for people who were waiting in them.
The Senators in order of appearance: Senators Kirk,
McCaskill, and Carper. Senator Kirk, thanks for being here.
OPENING STATEMENT OF SENATOR KIRK
Senator Kirk. Thank you, Mr. Chairman, and thank you for
the timeliness and importance of this follow-up hearing.
Like my colleagues, we had a promise of some 3.5 million
doses to Massachusetts by this time. We have 900,000, I think,
that have been distributed, so it is roughly 25 percent of what
is needed at this time. And from what I understand from the
testimony in the earlier hearing, in large part what your
Departments tell us about what will be available is dependent
on what the manufacturers have estimated. And I am wondering
whether--in addition to site visits and monitoring and so
forth--do the Departments have the ability to develop an
expertise where they could make their own independent analysis
in something like this? And if so, how is that applied? And if
not, should we develop that expertise so we are not just
totally dependent on the word of the manufacturer and they say
this is what they have told us so, America, this is what you
will get?
Dr. Lurie. I think it is a really good question. What I
would say is that in our Department and in the Biomedical
Advanced Research and Development Aurhority (BARDA), we have a
really professional staff, many of whom came from the vaccine
industry and I think have a pretty good sense of how all the
supply chains work. We track every single lot of vaccine and
are able to watch it in the pipeline.
That said, that early part, growing the vaccine and getting
to those early doses, I think was the biggest problem. As we
watch it come through the pipeline, I think we have pretty good
visibility on what goes on with it, but I do want to say, per
that schematic over there, you do continue to run into problems
with production lines or at the end, even if you ship stuff to
CDC and a temperature sensor goes off or a box breaks open in
the truck, that makes you have to pull that amount of vaccine
out and test it to be sure that it is still safe and effective
before you can release to the public. So while we watch it, we
cannot necessarily change it.
That said, one of the things that we have been really
working hard on in our partnership with the manufacturers is
additional ways to communicate about the vaccine supply. We are
working with them to see if we can put out, public information
by manufacturer, or by product numbers.
I hope that we will get to a point soon where we figure out
how to do that so that we can provide an additional level of
transparency for the public. But as I said, right now we have
people in the plants, and I actually feel quite good about the
communication that the manufacturers are having with us,
sometimes multiple times a day.
That said, things still go wrong--not that we do not always
know about them, but there is not an easy fix. But I very much
take your point about forecasting and projections. I think the
best way to do that is to have a more reliable way of making
vaccine so that we are not dependent on the vagaries of growing
virus in eggs.
Senator Kirk. Another question going to dependency, if you
will, and that is--I mentioned this in the prior hearing to the
Secretary--that four out of the five suppliers, as I understand
it, are offshore. And I am wondering whether there really is
serious thinking and planning about dealing with that issue.
We know in the instance of one of the suppliers, in Canada,
quite understandably, said Canadians first and are taking care
of their population. I did not know whether that was in the
thinking and the estimates that were initially projected, that
Canada might do that or whether you knew they would. That is
sort of one question, but a side question.
The larger question really is whether the Administration
and the health professionals are thinking about what we should
be doing to encourage development and manufacture of these
vaccines in the United States.
Dr. Lurie. I think it is just a really great point, and I
might want to make a clarification first; that, early on we
learned--it was actually the Australian Government that was
experiencing a really severe first wave that said Australians
first. And as soon as we knew that, we were able to say to the
American public we are going to have a lot fewer doses early on
than we thought because of that.
That said, I think BARDA is in about year 3 of a 5-year
strategic plan to modernize vaccine manufacturing. We have done
a lot of retrofitting of facilities just to be ready for this
one. A new cell-based manufacturing facility is going to open.
Many of us are going to the ribbon cutting next week for a new
Novartis facility that I think will be able to start making
seasonal flu vaccine in 2011. It is only going to get us to
half of the required doses we think that we might need to
surge, and I do not know that cell-based vaccines are the end
game because they still require virus to grow.
So we actually want to go ahead and make a mid-course
revision to our 5-year strategic plan to think about even more
modern science, even more robust manufacturing capacity, more
advanced development. We are supporting very innovative
manufacturing techniques, for example, in a company in
Connecticut that is making recombinant vaccine in insect cells
and others, and a lot of things that really show a lot of
promise. But we have to get to domestic issues, say, robust,
fast manufacturing capacity in the United States. We are taking
this very seriously, and we very much look forward to further
partnership with this Committee as we try to move that forward.
Senator Kirk. Thank you. Maybe one more question, Mr.
Chairman?
Chairman Lieberman. Go right ahead, Senator Kirk.
Senator Kirk. This is perhaps to Dr. Schuchat, and it is a
question that has been written about the hybridization and the
possibility, the ``what ifs'' if this particular flu should
cross-pollinate, or whatever, with the bird flu.
Can you give us any thoughts about that? Is that a
realistic possibility? And, in any event, will we be prepared
for something like that?
Dr. Schuchat. Influenza viruses change and they reassort.
They can combine between viruses. Right now, the world is
seeing a very transmissible virus in the 2009 H1N1 strain, and
we still do have a very severe virus in the H5N1 bird flu
strain. It has not figured out to be efficiently transmitted,
but it is very fatal. Two-thirds of those infected with the
H5N1 suffer death.
There are parts of the world now where both strains are
circulating, the H5N1 primarily in birds and H1N1 in humans. So
that idea of reassortment is not science fiction. That could
actually happen. But if that does not happen, we still have the
real probability of future pandemics, whether they are H5N1
derived or H1N1 or the H9 strain. Influenza is out there, and
really the seriousness with which the Committee has been taking
pandemic preparedness in the past just needs to be
reinvigorated.
Some of us wish that now that we are having one it would
mean we have 30 years off, but, unfortunately, I do not think
we do. And so everything we can learn about preparedness from
this, to be better able to cope if we had a more severe virus
or if we have one where the circumstances are even more grave
than what we are seeing now.
Senator Kirk. Thank you. Thank you, Mr. Chairman.
Chairman Lieberman. Thanks, Senator Kirk. I appreciate it.
OPENING STATEMENT OF SENATOR MCCASKILL
Senator McCaskill. Thank you, Mr. Chairman, and I would
like to formally on the record thank the Ranking Member for my
pork hat. After I tried to make a very big point of the fact
that this virus had nothing to do with the delicious meal of
pork in our country, the Ranking Member was kind enough to send
me a pink hat that points out my love of pork--the kind you
eat, not the kind you appropriate. [Laughter.]
So I thank the Ranking Member for that.
Senator Collins. My pleasure.
Senator McCaskill. I decided to do a little secret shopping
today in my office in preparation for this hearing. After
reading the Chairman and Ranking Member's letters that were
sent,\1\ I think yesterday, I was concerned and so I asked some
members of my staff today to call around Missouri and see what
would happen if they asked about the availability of the
vaccination. I had women in my office do it, and I said if you
are asked, say you are pregnant. And it really was surprisingly
a good exercise. We called seven different communities of
various sizes, including the two major metropolitan areas, some
very rural areas, and in between.
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\1\ The letters referenced by Senator McCaskill appear in the
Appendix on page 409.
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Almost all of them did the appropriate checklist about risk
factors when we called, and once it was determined that this
was a woman who was pregnant, three of the seven that we called
made available today or tomorrow a vaccination. Two said this
week they would have clinics. One said in 2 weeks there would
be another clinic. And one said you need to check with your
doctor or your local pharmacy.
Now, in all of them, they did say to us, ``You should check
with your doctor first.'' So it is clear to me that what the
local and State health organization in Missouri is doing is
they are distributing part of this to the doctors' offices, and
they are holding on to part of it for their own clinics. And I
think in fairness, I think that can be confusing to people.
Now, should I be going to the clinic to get the vaccination or
should I be calling my doctor?
We got pretty clear guidance on the phone when we called
today, and I was pretty impressed that we got as clear a
guidance as we did. But I take it this is totally a local
decision as to how they are distributing this virus between
doctors' offices and hospitals and local health-based clinics.
Dr. Schuchat. The State health departments or in four large
city or county areas are the ones doing the ordering. Many are
working with their local health departments, and most are
working with the provider community. They may have the local
health departments enroll the providers, or they may be doing
it centrally at the State level.
We do know that we have had, I think, 116,000 distinct
shipments of vaccine from the central distributor to date, and
they have gone to a variety of venues, to the local health
departments, hospitals, doctors' offices, and so forth.
One challenge for the provider offices is the minimum
shipment of 100 doses, and so some of the providers' offices
are not able to use 100, and they are asking for smaller
amounts, so there is a little bit of breaking up amounts to get
them their supply or sharing between practices. But we do
believe right now that a substantial amount of the vaccine has
gone to providers' offices.
In some places, there has been tremendous interest in
signing up to be a provider for the H1N1 vaccine, but in others
it has been a mixed uptake. Providers' offices are really busy,
lots of people who are ill. For obstetricians, it is not always
the usual thing. In many States, there has been great turnout
by the obstetricians to be providers, to be able to give
vaccine to their pregnant patients. But in other areas, the
providers have had to say, ``We are not going to be able to
handle it. We do not have the right kind of refrigerator
storage. We do not want the vaccine to spoil. But here is the
hospital that we are partnering with. Here is where you as my
patient can go to get your vaccine.''
Senator McCaskill. I am confused, though, who is making
that decision. I mean, I think the problem here, Dr. Schuchat,
is, who is deciding whether a doctor's office is getting it and
who is deciding whether the Jackson County Health Department is
having those doses for a clinic that they advertise and is open
to the public based on risk groups?
Dr. Schuchat. Right. Well, at the CDC level we have advised
here are the priority populations, these are the groups that
need to be reached. At the State leadership level, they are
designating the strategies. Should we focus on providers?
Should we have a mix of health departments and providers? Part
of it depends on the fragility of the health care system in
that State. Is the provider community able to do this? Part of
it depends on the robust public health infrastructure----
Senator McCaskill. OK, so it is the State health department
that is making this decision?
Dr. Schuchat. Absolutely.
Senator McCaskill. It is not being made at HHS. It is not
being made at CDC. It is not being made at the Department of
Homeland Security. The State health directors are deciding
where the dosage that is going to their State is actually
landing.
Dr. Schuchat. That is right, and a lot of them have been
updating their plans. They have identified plans, and then they
have realized, well, we are going to need to make a few more
venues available because we are getting calls and people are
not able to get it from the ones we have set up. But they are
in the lead on the implementation. That is right.
Senator McCaskill. Of the 160 million that were identified
at the very beginning in the risk groups, how many do we
anticipate will actually get--let us assume that we did not
have a problem in the private sector with the availability of
as much vaccine as we had been told we were going to get. I
mean, the government was clearly told by the private sector
they were going to get more vaccine than we got. Let us assume
for a minute that there was no problem with the supply and that
there was plenty of vaccine out there.
Best-case scenario, what percentage of that 160 million
based on previous influenza problems in this country did you
anticipate would step up and get the vaccination?
Dr. Schuchat. I will give you two figures. For seasonal
flu, it is about a third of people that step up, but we have
been doing surveys throughout the summer and fall and find
right now that up to 50 percent of people in those groups are
interested in being vaccinated or having their kids vaccinated.
There is a group that is distinctly not interested, and their
principal reason is they do not think this is a serious threat.
But of the group that is interested there, it is pretty steady
that they are remaining interested. We know, though, from a lot
of behavioral surveys that intent to take a behavioral action
is different than actually following through with it. And, of
course, the easier we can make it for people, the more likely
they will be to follow through.
Senator McCaskill. So if we get 80 million people
vaccinated in the at-risk groups, you are going to consider
this a great success?
Dr. Schuchat. I regret every person who has waited in line
and not made it through, and I think the ease with which people
can be vaccinated is an important metric as well.
Senator McCaskill. That is fair enough.
Let me talk about the military for a minute, and Wall
Street. I am assuming the decision to give any vaccinations to
major companies in New York was made by the city of New York?
Dr. Schuchat. The city had a plan of how to distribute
their vaccine.
Senator McCaskill. And was there any role at all for the
Federal Government in that decision?
Dr. Schuchat. No. But we are aware that their
decisionmaking was--they had a first tier, which was hospitals
and provider offices and the community clinics, and a second
tier that included employer-based occupational health clinics,
which is a place where a lot of adults in the workplace are
vaccinated. That was not their first tier. It was a lower tier.
But it was with a distinct provider agreement signed saying
this will be for priority populations--pregnant women, parents
of newborns, and so forth.
Senator McCaskill. It just was really weird that a company
on Wall Street would get the same number as a hospital. That
looked horrible. It made all of us really mad.
Dr. Schuchat. Absolutely, and based on the information that
I have seen, most hospitals got a lot more vaccine.
Senator McCaskill. A final question about the military. It
is my understanding--I think we have two members of the
military here that can speak to this. It is my understanding
that the Department of Defense controls all the vaccinations
for the military and that the armed forces are, under their
directive, required to be vaccinated first, and that it is only
after 90 percent of the forces are vaccinated that we even get
to civilian personnel within the military, and only after 100
percent of the forces have been vaccinated and all of the
civilian personnel would we ever get to any detainees
everywhere. Is that correct?
Dr. Schuchat. Yes. I am actually wearing the uniform of the
Commissioned Corps Public Health Service, but that is correct.
Senator McCaskill. Close enough. [Laughter.]
In government work, close enough, right? Unfortunately. Is
that correct?
Dr. Schuchat. Yes.
Senator McCaskill. So the rumors out there that we are
supposedly giving the vaccination to anybody at Guantanamo that
is being detained is just not true?
Dr. Schuchat. You are right.
Senator McCaskill. Thank you. Thank you, Mr. Chairman.
Chairman Lieberman. Thank you, Senator McCaskill.
Senator Carper, with an amazing sense of timing, has come
through the door at exactly the moment I was otherwise going to
proceed. Senator Carper.
Senator Carper. Thanks, Mr. Chairman. That was pretty good
timing.
Our thanks to each of our witnesses for joining us today
and for trying to explain what is going on here and what you
all are trying to do to expedite the situation and maybe what
we need to do to help.
Let me just ask this, and you may have covered this already
in earlier questioning. But we have been asking you what you
are doing and what our country is trying to do to expedite the
availability of the vaccine for people throughout our country,
particularly on a most urgent basis. What do we need to be
doing on the legislative side? Anything? I think we have
appropriated money. Hopefully we have appropriated resources.
What else do we need to be doing?
Dr. Lurie. I think that is a great question. Thank you for
that. I guess I would say that there are a couple of things
that you could help with, and I very much, again, want to say
how grateful we are for the support to date, both on the
manufacturing side and in response to this pandemic, not only
so that the Federal Government could buy vaccine for people,
but also to support public health on the ground, which you know
has been really struggling because of the kinds of cutbacks in
Federal, but also in State and local budgets. So as we talk to
public health people on the ground, their workforces are down
by about a third, and they are trying to really struggle with
this pandemic.
So this whole experience has told us that it is really time
to think seriously about how it is that we revitalize public
health at all levels and how it is that we revitalize our
public health infrastructure.
So I think a lot of what we would love to talk with you
about going forward is very much to look forward, how to do
that. How do we not get in this situation again? We have talked
about it with the advanced development of vaccines and
countermeasures. We have talked about it with manufacturing. We
need to have that same conversation about the rest of the
public health infrastructure, whether it is about surveillance,
whether it is about public health on the ground, or whether it
is about the fact that while we have a good system to buy and
distribute vaccine for children in this country, we have no
system to do that for adults. So going forward, I think that
there is an awful lot that we take away from this that helps us
be a lot better prepared.
Senator Carper. All right. Thanks very much.
Anybody else with a real quick response? Or I will go right
to my next question. Anybody?
Dr. Garza. Well, I will put in a plug for Homeland
Security. I think what H1N1 did illustrate is that the health
effects to national security are real. And although DHS does
focus a lot on terrorism and overt acts of aggression against
our country, this is a primary example on how health effects
can and do affect national security, and those issues need to
be taken into account when we are looking at planning, funding,
and issues such as that.
The Office of Health Affairs is a fairly small office.
However, we carry a big mission: Taking care of our forces as
well as planning for disasters and responding to the health
effects. And I think the pandemic has brought that to the
forefront.
Senator Carper. OK. Thanks very much.
I think the Department of Health and Human Services last
month announced contract awards, I think for up to about
120,000 treatment courses of intravenous antiviral drugs, known
as IV, to help treat hospitalized 2009 H1N1 influenza patients.
The IV alternative has been proven, I am told, to be very
effective in treating sick people.
Could I ask each of our HHS witnesses today to briefly
detail the deployment plan for IV vaccines? And just to let us
know, is there a plan to order any more of the initial 120,000?
Dr. Lurie. Let me make a quick clarification here. We have
right now procured about 30,000 doses across three different
kinds of vaccines. As you know, the vaccine is not yet--I mean,
the antivirals are not yet licensed. They are available under
an emergency use authorization because they have not gone
through the full array of clinical testing to know that they
are really safe and effective.
So one of the things that we need to do through this is to
learn just how effective they are so that if they are
effective, they can move forward on a pathway to full
licensure.
In the meantime--and, frankly, I think learning from a lot
of our experience with distribution; this is an example where
we took experience and turned it around to immediate learning--
we have done a couple of things. We have set up a Web site that
is open 24 hours and a telephone line that is open 24 hours so
that any clinician in the country who feels as though they need
to have this antiviral for their patients can call. It is
managed by a distribution site, and there is overnight shipping
so that it can be there within 24 hours. So far, there have
been orders for--as of yesterday, I do not know as of today--
634 treatment courses. So that is really right now the
distribution system.
Should there be a really big demand for more intravenous
antivirals, we will go ahead and procure more. But we are
monitoring carefully that burn rate so that we are sure that we
do not run out.
Senator Carper. All right. Did you want to add to that,
please?
Dr. Schuchat. Yes, just to say CDC is managing that Web
ordering system, and we have been getting orders through the
weekend and at night and are able to commit through the vendor
that shipment should arrive within 24 hours of order, usually
much earlier, depending where it is getting shipped. This is an
intravenous antiviral, and so it is primarily critically ill
people in intensive care units that are receiving it. But it
has been stood up very quickly and tried to be as responsive as
possible to the health need.
Senator Carper. All right. Thanks.
There are reports that if the H1N1 pandemic grows more
potent and ubiquitous throughout our communities, we as a
Nation could face a serious drop in blood donations. While it
is proven that a low-level flu strain cannot travel through the
bloodstream as the West Nile virus does, for example, some
scientists feel that a more potent H1N1 flu could infect our
body's circulatory system and prevent people from donating
blood. This, of course, could create a serious problem for
hospitals who rely on these blood donations for minor to
serious medical procedures, as you know.
Could either of you perhaps comment on this and if you have
a battle plan for if the H1N1 strain morphs?
Dr. Lurie. Well, let me first start by telling you that we
monitor very carefully the country's supply of blood, and I get
a report on that every week. One of the things that we have
noticed coincident with this pandemic is that the supply of
blood, which is usually about 8 days in most hospitals, is down
to about 6 days. Whether it has anything to do with H1N1 or
canceled blood drives or any other kinds of things, I do not
think we know cause and effect, but we are keeping a very close
eye on it.
We also have, I believe, very good ways to look at the
country's supply and to be able to move blood from one place to
another were that to happen. But despite the fact that it is
down to 6 days, we are not aware of any shortages.
Is there a battle plan? I think any part of preparedness
requires a battle plan to be sure that blood as a critical
resource is always available as needed. And, the battle plan
really means stepping up blood donation and calls for blood
donation, in which case, the American public is usually very
responsive. To prepare for that, the CDC has issued guidance
for blood donation centers to help them figure out how to have
blood donation go on safely and without transmitting the virus
among the people who work there or the people who choose to
give blood.
Senator Carper. All right. Thanks. Thank you both. In fact,
thank you all very much.
Thanks, Mr. Chairman.
Chairman Lieberman. Thanks, Senator Carper, for those
questions. We will do one more round for Senator Collins and
me.
I mentioned in my opening statement about the two numbers
that were going the wrong way, the way we would not like to see
them go: The number of cases of H1N1 going up, and understand
that part of that is the recalculation; and then the vaccines
available going down. But you have reassured us, and I just
want to come back to that, Dr. Lurie, the explanation for the
drop in the availability of vaccines last week was not a
problem in the manufacturing but, according to your testimony,
was the result of the hurricane and the distribution problems.
Am I right?
Dr. Lurie. Let me say that it was two-fold. The way we do
these projections and allocate is that we have a cutoff for
when vaccine has to arrive at a warehouse, let us say Wednesday
at 2 o'clock. If it gets there at 2:01, it gets counted for
next week.
Chairman Lieberman. OK.
Dr. Lurie. And so one of the things that happened was,
because of the hurricane, some of the vaccine manufacturers'
insurance companies did not want them to ship, and they did not
want to take that risk of shipping and destroying their cold
chain driving through this. And some of the vaccine got there
late, and that is why when we woke up--or when we heard on
Friday that there was potentially no vaccine to be allocated--
we first heard from Maine, then from Massachusetts, then from
others--we said, well, we know that their vaccine is there; it
just did not get in under the wire, let us stay open this
weekend and allocate it.
A second thing had to do with some doses of vaccine that--
remember how I said at that last stage, when you ship, if a
temperature sensor goes off or a box opens?
Chairman Lieberman. Yes.
Dr. Lurie. So a second thing that happened was that for
some vaccines some temperature sensors went off, and so they
could not go ahead and distribute those vaccines right away,
but they had to be sure, in fact, that those vaccines were
still safe to be able to use. So that is what happened.
Chairman Lieberman. So no new problems within the
manufacturing chain.
Dr. Lurie. That is right.
Chairman Lieberman. Other than what you have said about
weather delays along the way, we can anticipate--I am not going
to ask you to predict another problem--a pretty steady
production now in availability of the vaccines, increasing
every week. Obviously, we have a long way to go until we get to
the 160 million of the initial group at risk.
I have forgotten the facts on this, but I am not sure--and
I ask you now--whether we had as many Federal employees--I
presume HHS or maybe CDC--in the manufacturing facilities as we
do now monitoring activities there. Is that one of the lessons
we have learned in this? In other words, am I right that we
have more people on site now from the Federal Government?
Dr. Lurie. That is correct.
Chairman Lieberman. So would you say that next time we get
into this, that will be something that we will do? Or maybe we
will just keep our representatives there from now on.
Dr. Lurie. I would say it depends. I think certainly
throughout the rest of this or until things even out and there
is really a very ample supply of vaccine and we understand that
things are stable, we very much want to keep Federal employees
at the manufacturing facilities.
As I said, we have talked to them every day. We do frequent
site visits. It has been helpful to have people on site.
Another way it has been helpful to have people on site--and
it is not related to manufacturing--is to have representatives
from State and local health departments and the Association of
State and Territorial Health Officials and National Association
of County Health officials actually embedded in the operations
center at CDC so that there is another level of what is going
on, what do you expect, how do you communicate that back.
So I think at every step along the way--more people on
site, more exchange, more transparency is better.
Chairman Lieberman. All right. Well, that is an important
lesson learned, and I appreciate it.
Let me go back to the intravenous antivirals, which I asked
several questions about at the last hearing. The first thing I
want to do is say thank you that the Food and Drug
Administration did issue an emergency use authorization. And
for people in the room or watching on TV, as I have learned as
we have gotten into this, the IV antivirals are needed for the
people with H1N1 who are the most sick, usually in intensive
care, and, therefore, cannot take the normal antivirals by
mouth and so have to have IV medication. So I appreciate very
much that was done.
I was interested in how you are distributing them. I want
to urge you, as I did last time, particularly because of the
problems we have talked about with the vaccine, that you really
stay on top of it to make sure that we do not come to a point
where there is a shortage of the IV antivirals because that
would be the worst of all because these are the most seriously
ill patients, obviously, and it literally could be life or
death if they do not have it.
Dr. Lurie. You have that commitment.
Chairman Lieberman. I appreciate it.
Following the CDC reports, as my staff does, I note, sadly,
that last week 35 children died of influenza in hospitals,
which was up from 28 the week before, as we mentioned earlier,
a total of approximately 540 children. I wondered if either of
you know whether any of those were treated with the IV
antivirals.
Dr. Schuchat. I do not have that information. I know that
of the children that we are seeing who die, about two-thirds
have underlying diseases.
Chairman Lieberman. Right.
Dr. Schuchat. Some die at home. They do not actually make
it to the hospital. But we are collecting additional
information. So I do not know yet whether any of those children
got the medicine.
Chairman Lieberman. OK. To the extent that you can find
that out--you have other things to do--I would appreciate just
having an answer to that for the record.
Dr. Schuchat. Sure.
[The information follows:]
INFORMATION SUBMITTED FOR THE RECORD FROM DR. SCHUCHAT
CDC does not track specific patient outcomes related to
administration of antiviral drugs, and therefore does not have the
information on how many pediatric patients died after receiving IV
antiviral drugs. Based on data from the Emerging Infections Program,
among hospitalized laboratory confirmed pediatric patients between
September 1 and November 24, 85 percent of patients received the
antiviral. That compares to 58 percent during the spring wave (April
15, 2009-August 31, 2009) and 17 percent during the previous season
(2008-2009).
As of December 13, 992 requests to CDC for IV Peramivir doses have
been filled, including 89 requests for pediatric Peramivir.
Chairman Lieberman. I am going to stop at that point and
let you go ahead, Senator Collins, because the vote has just
been called on the floor. Thank you.
Senator Collins. Thank you, Mr. Chairman.
I am just going to bring up one final issue in light of the
vote beginning. Dr. Garza, I know you thought you might get off
scot free at this hearing. [Laughter.]
And I just could not allow that to happen at your first
appearance.
Dr. Garza. Thank you, Senator.
Senator Collins. I knew you would appreciate that.
You have some responsibility in this area for making sure
that State and local public health agencies can handle a
pandemic or a bioterrorism attack. In other words, DHS in
general has a responsibility for assisting State and local
governments in their preparedness and response capabilities.
That is why we have appropriated literally billions of dollars
in homeland security grants to help improve the preparedness at
the State and local levels.
Dr. Schuchat mentioned that the State of Maine has done an
excellent job--and it has, and I am very proud of that--and one
reason is they had a plan in Maine to use the schools as a
basis for the clinics. And I believe every single school in the
State of Maine participated. That gives you a great
distribution method, and I think a lot of other States could
learn from Maine's experience.
But then we have what appears to be the situation in San
Francisco, a much larger public health division than the whole
State of Maine would have, where we have answers being given on
their Web site saying orders are being filled on a random
basis, there is no way to predict who will get what and when.
That to me is an appalling answer to someone who has a child
who is at high risk and needs the vaccine.
My point is that as we found with our investigation into
the response to Hurricane Katrina, there are huge variations in
the capabilities at the State and local level, and I can see
Dr. Lurie is nodding her head in agreement.
So when we are through the peak of this pandemic, what is
DHS going to do, working with HHS and the CDC, to evaluate the
response at the State and local level?
Dr. Garza. Well, I would say even before the pandemic is
through that DHS has been working together with HHS in
evaluating State plans, primarily through the Federal Emergency
Management Agency (FEMA) which partnered up with HHS at the
regional levels to ask questions of emergency managers and to
review their plans and evaluate whether there are any gaps that
need to be filled, were there any issues that needed to be
resolved.
Furthermore, FEMA has worked together with HHS to provide
any logistical support should that be needed for vaccine
distribution or any other issues related to the emergency
response.
Fortunately, it has not risen to that level where we have
needed to interact at that level, but they have done a
tremendous amount of work in working with our partners
throughout the interagency to be prepared.
If I may, ma'am, one success story I believe that you
mentioned in an earlier hearing with Secretary Napolitano was
Bates College, particularly the Metropolitan Medical Response
System (MMRS) team, which was requested to come up and assist
with the vaccinations since they had a large vaccine allotment
and not enough people to do that. But that is precisely the way
the system should work, that they requested the MMRS team to
assist them. The request went through Emergency Management, it
was approved, and within 2 days a team was sent up there to
vaccinate the students. And so if I may, I would say that is
one example of a very good success story and how DHS is
assisting.
Senator Collins. It is, but we need to learn from this
experience, and when we have a major public health department
saying it is all random, it should not be all random. It should
be prioritized. And I still share the Chairman's view that it
would have been fine to leave it to State and local governments
regardless of their capabilities if there had been plenty of
vaccine. But once we realized the vaccine supply was falling
far short, I believe the Federal Government should have stepped
in and set the priorities to ensure that those at highest risk
were being served first. And I do believe--just as you said,
Dr. Garza, that the best of plans always collide with reality,
I do believe that we need a thorough evaluation of the
preparedness at the State and local levels. It does vary
enormously because some States devote a lot of resources and
some States do not. Some States are making good decisions, and
some States are not. And that applies to big-city health
departments as well. So I hope that will be done.
Doctor Schuhat, I can see you want to say something----
Dr. Schuchat. Yes, I just wanted to respond to two points.
One is we are not waiting for States or cities to fail. We
are working very actively monitoring the ordering,
understanding what is going on, offering assistance, and
working on some of the missteps that we believe may be
happening in some areas. As you heard, we have liaisons from
the city and county health agency and the State health officer
agency in Atlanta, and we are working daily with the States to
help them succeed.
The second point I just want to make because I forgot to
make it is that our survey data suggests that we are reaching
the priority populations in much higher levels than others. So
I know this is of keen importance to both of you, and our
survey data bears out that they have higher receipt of the
vaccine than others do, which I think is important to all of
us.
Senator Collins. Thank you, Mr. Chairman.
Chairman Lieberman. Thank you, Senator Collins. I
appreciate that.
I want to ask you one take-away, Dr. Schuchat, and, Senator
Collins, I will understand if you got to vote before it gets
too close to the end.
Senator Collins. Thank you.
Chairman Lieberman. She has got a perfect record. I do not
want to be the cause of creating a flaw there.
Am I right, from what I have heard previously and what you
said in your opening statement, that you cannot as a scientist,
or any of the others on the panel, predict what the course of
the H1N1 virus is going to be from here on out?
Dr. Schuchat. That is right, and we looked to the past, to
other pandemics, to see what has happened. We do not know
whether we will continue to have this high level of activity
all the way through May, which is the usual end of flu season.
Chairman Lieberman. And then coincide with the seasonal
flu?
Dr. Schuchat. Right. It could coincide with seasonal, but
we looked very closely at 1957 where they had this fall
increase like what we are having. It got a little better in
December, and then they had another big wave after the first of
the year. People actually thought we do not need to bother
vaccinating in December, and we do not want to make that
mistake. So we do think we need to be ready for additional
waves here in the United States.
Chairman Lieberman. So the plan is, because of that
unpredictability, although somewhat informed by experience,
that the manufacturing facilities are going to continue to turn
out the vaccine, and the country is going to continue to urge
people, particularly in that 160 million at-risk population, to
get the vaccine. Am I right?
Dr. Schuchat. Yes, that is right, and we would imagine for
the following year that if this strain is persisting, it might
be rolled into the seasonal vaccine, a trivalent vaccine. For
the winter----
Chairman Lieberman. In other words, in the same shot.
Dr. Schuchat [continuing]. And spring, we do feel like,
ongoing efforts at prevention are going to be important.
Chairman Lieberman. Well, I appreciate the testimony. I had
a question for you, but since Senator Collins put you in the
limelight and I have got to go vote, Dr. Garza. Obviously, the
Secretary of Homeland Security is the incident manager here,
and I know you staff her and support her in that role. I hope
that you and she together will go back and look at this and try
to draw some lessons from it so that some of the great things
that have been done here do not for some reason end up causing
the kind of frustration and anxiety that occurred this time
around.
I appreciate that you looked back here in testimony today
and acknowledged some things that you would do differently, and
this is very important to the Committee not only because of the
concern that influenza epidemics and pandemics will continue in
the years ahead--you are right, we cannot expect to wait
another 30 years--but also, of course, because of our homeland
security responsibility to do our best to get the public health
system up and ready to respond, God forbid, to, for instance, a
biological terrorist attack, a bioterrorist attack. So, I thank
you for all the hard work you have put in, for the testimony
you have offered today, which is encouraging, and we look
forward to seeing you again.
The record of the hearing will stay open for another 15
days for any additional statements or questions.
I thank you. The hearing is adjourned.
[Whereupon, at 4:47 p.m., the Committee was adjourned.]
A P P E N D I X
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