[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
INFLUENZA: PERSPECTIVE ON CURRENT SEASON AND UPDATE ON PREPAREDNESS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
FIRST SESSION
__________
FEBRUARY 13, 2013
__________
Serial No. 113-3
Printed for the use of the Committee on Energy and Commerce
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
RALPH M. HALL, Texas HENRY A. WAXMAN, California
JOE BARTON, Texas Ranking Member
Chairman Emeritus JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska ANNA G. ESHOO, California
MIKE ROGERS, Michigan ELIOT L. ENGEL, New York
TIM MURPHY, Pennsylvania GENE GREEN, Texas
MICHAEL C. BURGESS, Texas DIANA DeGETTE, Colorado
MARSHA BLACKBURN, Tennessee LOIS CAPPS, California
Vice Chairman MICHAEL F. DOYLE, Pennsylvania
PHIL GINGREY, Georgia JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana JIM MATHESON, Utah
ROBERT E. LATTA, Ohio G.K. BUTTERFIELD, North Carolina
CATHY McMORRIS RODGERS, Washington JOHN BARROW, Georgia
GREGG HARPER, Mississippi DORIS O. MATSUI, California
LEONARD LANCE, New Jersey DONNA M. CHRISTENSEN, Virgin
BILL CASSIDY, Louisiana Islands
BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida
PETE OLSON, Texas JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia JERRY McNERNEY, California
CORY GARDNER, Colorado BRUCE L. BRALEY, Iowa
MIKE POMPEO, Kansas PETER WELCH, Vermont
ADAM KINZINGER, Illinois BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia PAUL TONKO, New York
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
Subcommittee on Oversight and Investigations
TIM MURPHY, Pennsylvania
Chairman
MICHAEL C. BURGESS, Texas DIANA DeGETTE, Colorado
Vice Chairman Ranking Member
MARSHA BLACKBURN, Tennessee BRUCE L. BRALEY, Iowa
PHIL GINGREY, Georgia BEN RAY LUJAN, New Mexico
STEVE SCALISE, Louisiana EDWARD J. MARKEY, Massachusetts
GREGG HARPER, Mississippi JANICE D. SCHAKOWSKY, Illinois
PETE OLSON, Texas G.K. BUTTERFIELD, North Carolina
CORY GARDNER, Colorado KATHY CASTOR, Florida
H. MORGAN GRIFFITH, Virginia PETER WELCH, Vermont
BILL JOHNSON, Ohio PAUL TONKO, New York
BILLY LONG, Missouri GENE GREEN, Texas
RENEE L. ELLMERS, North Carolina JOHN D. DINGELL, Michigan
JOE BARTON, Texas HENRY A. WAXMAN, California (ex
FRED UPTON, Michigan (ex officio) officio)
C O N T E N T S
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Page
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 3
Hon. Diana DeGette, a Representative in Congress from the state
of Colorado, opening statement................................. 4
Hon. Fred Upton, a Representative in Congress from the state of
Michigan, opening statement.................................... 5
Prepared statement........................................... 6
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 7
Witnesses
Thomas Frieden, M.D., M.P.H., Director, Centers for Disease
Control and Prevention, Department of Health and Human Services 8
Prepared statement........................................... 11
Jesse L. Goodman, M.D., M.P.H., Chief Scientist, Food and Drug
Administration; Department of Health and Human Services........ 23
Prepared statement........................................... 26
Marcia Crosse, Ph.D., Director, Health Care, Government
Accountability Office.......................................... 42
Prepared statement........................................... 44
INFLUENZA: PERSPECTIVE ON CURRENT SEASON AND UPDATE ON PREPAREDNESS
----------
WEDNESDAY, FEBRUARY 13, 2013
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:05 a.m., in
room 2123 of the Rayburn House Office Building, Hon. Tim Murphy
(chairman of the subcommittee) presiding.
Members present: Representatives Murphy, Burgess, Gingrey,
Harper, Olson, Griffith, Johnson, Ellmers, Barton, Upton (ex
officio), DeGette, Lujan, Butterfield, Castor, Tonko, and
Green.
Staff present: Gary Andres, Staff Director; Matt Bravo,
Professional Staff Member; Karen Christian, Chief Counsel,
Oversight; Sean Hayes, Counsel, Oversight and Investigations;
Sean Hayes, Counsel, Oversight and Investigations; Katie
Novaria, Legislative Clerk; Andrew Powaleny, Deputy Press
Secretary; Krista Rosenthall, Counsel to Chairman Emeritus;
Alan Slobodin, Deputy Chief Counsel, Oversight; John Stone,
Counsel, Oversight; Brian Cohen, Democratic Staff Director,
Oversight and Investigations, and Senior Policy Advisor; Kiren
Gopal, Counsel; Elizabeth Letter, Democratic Assistant Press
Secretary; Anne Morris Reid, Democratic Professional Staff
Member; and Stephen Salsbury, Democratic Special Assistant.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Murphy. Good morning, everyone.
Today we convene the first hearing of the Subcommittee on
Oversight and Investigations in the 113th Congress. I would
like to welcome back the members who served here in the 112th
and welcome our new members joining us for 113th. I want to
particularly welcome my colleague and my friend, the ranking
member, Dianna DeGette of Colorado. I am looking forward to
working with you and your team here. And this is the first of
many hearings and issues that we will be dealing with in an
organized, bipartisan way, and I appreciate the witnesses for
coming here today.
Today we are here to examine the current flu season and
discuss the lessons that will help us prepare for seasonal
influenza and pandemics in the future. This committee has
investigated into response efforts during previous sessions,
last during the H1N1 pandemic in 2009, and oversight of the
agencies involved will remain a priority going forward.
I welcome our distinguished witnesses whose agencies play
key roles in the federal government's response to influenza.
Dr. Thomas Frieden, Director of the Centers for Disease Control
and Prevention, welcome here today. Dr. Jesse Goodman, Chief
Scientist at the Food and Drug Administration, welcome here,
Doctor. And I also thank Marcia Crosse, Director of the Health
Care Division at the Government Accountability Office. Welcome
here as well, Doctor. The GAO has done a number of reports
analyzing federal response to seasonal and pandemic outbreaks.
Well, this year's flu season came a little earlier than
expected and it looks as though it will have been unfortunately
worse than average. This is particularly true in my home of
southwestern Pennsylvania, which has the highest percentage of
seniors in the country outside of Florida. In the Pittsburgh
region, for one, this year's flu season has been labeled a
nightmare at local nursing homes that have taken to restricting
visitors and quarantining sick patients. For seniors in
southwestern Pennsylvania and across the country,
hospitalization rates and deaths have increased sharply. And
sadly, this season has also taken its toll on the most
vulnerable. Through February 2, there have been 59 pediatric
deaths.
Today, I hope to hear how the CDC, FDA, and the vaccine
manufacturers are working together through development of new
medications, better surveillance to prevent shortages, and
increased vaccination to protect the public from deadly flu
viruses. Remember, all of us should consider vaccination to not
only protect ourselves from getting sick, but also our
children, grandparents, coworkers, and neighbors. The CDC
recommends annual vaccinations for all persons aged 6 months
and older, yet less than 50 percent of Americans actually get
immunized. Today, I hope to learn what the biggest barriers are
to people getting vaccinated and how can we remove them.
Each year a new vaccine is produced and administered to
protect against the strains expected to be most prevalent that
year. Because of the increased activity this season, many have
wondered about the process that creates this seasonal vaccine
and whether it can be improved. Questions have also been raised
about vaccine effectiveness. We have heard from government
representatives that this year's vaccine has an effectiveness
rate of 62 percent, meaning that someone who is vaccinated is
62 percent less likely to see a doctor for the flu than someone
who hasn't been vaccinated. To some this might seem low, but we
have heard that this is actually within the range of what is
expected. How can we improve upon that and what efforts are
currently underway in the government and the private sector to
ensure that we do?
This year, we have also heard reports of spot shortages of
vaccine and certain antiviral treatments. Yet we know that,
overall, vaccine and antiviral supply will still exceed demand.
What role did the federal government play, along with its
public health partners at the State and local level, in
responding to these supply issues and what can we learn from
these efforts going forward?
Finally, I wish to again thank the ranking member of the
Committee, Ms. DeGette. This hearing has been a bipartisan
effort, and the ranking member and I have been working together
on a number of issues. I thank her for her support on this and
other issues as we move forward. As well, I would also like to
thank the witnesses, as I said before, and I had time to meet
with representatives from the CDC, and staff also reports to me
that all of your agencies have been more than helpful in
addressing their concerns, so thank you in preparation for
these complex issues.
[The prepared statement of Mr. Murphy follows:]
Prepared statement of Hon. Tim Murphy
Today we convene the first hearing of the Subcommittee on
Oversight and Investigations in the 113th Congress. I'd like to
welcome back the members who served here in the 112th and
welcome our new members joining us for 113th.
Today we're here to examine the current flu season and
discuss the lessons that will help us prepare for seasonal
influenza and pandemics in the future. This committee has
investigated into response efforts during previous sessions--
last during the H1N1 pandemic in 2009--and oversight of the
agencies involved will remain a priority going forward.
I welcome our distinguished witnesses whose agencies play
key roles in the federal government's response to influenza:
Dr. Thomas Frieden, Director of the Centers for Disease Control
and Prevention, and Dr. Jesse Goodman, Chief Scientist at the
Food and Drug Administration. I also thank Marcia Crosse,
Director of the Health Care Division at the Government
Accountability Office, for being here. The GAO has done a
number of reports analyzing federal response to seasonal and
pandemic outbreaks.
This year's flu season came a little earlier than expected
and it looks as though it will have been worse than average.
This is particularly true in Southwestern Pennsylvania, which
has the highest percentage of seniors in the country outside of
Florida. In the Pittsburgh region, this year's flu season has
been labeled a ``nightmare'' at local nursing homes that have
taken to restricting visitors and quarantining sick patients.
For seniors in Southwestern Pennsylvania and across the
country, hospitalization rates and deaths have increased
sharply.
Sadly, this season has also taken its toll on the most
vulnerable. Through February 2, there have been 59 pediatric
deaths.
Today, I hope to hear how the CDC, FDA, and vaccine
manufacturers are working together--through development of new
medications, better surveillance to prevent shortages, and
increased vaccination--to protect the public from deadly flu
viruses.
Remember, all of us, should consider vaccination to not
only protect ourselves from getting sick, but also our
children, grandparents, co-workers, and neighbors. The CDC
recommends annual vaccinations for all persons aged 6 months
and older, yet less than 50 percent of Americans actually get
immunized. Today, I hope to learn what the biggest barriers are
to people getting vaccinated and how can we remove them.
Each year a new vaccine is produced and administered to
protect against the strains expected to be most prevalent that
year. Because of the increased activity this season, many have
wondered about the process that creates this seasonal vaccine
and whether it can be improved.
Questions have also been raised about vaccine
effectiveness. We have heard from government representatives
that this year's vaccine has an effectiveness rate of 62
percent--meaning that someone who is vaccinated is 62 percent
less likely to see a doctor for the flu than someone who hasn't
been vaccinated. To some this might seem low, but we have heard
that this is actually within the range of what is expected. How
can we improve upon that and what efforts are currently
underway in the government and the private sector to ensure
that we do?
This year, we have also heard reports of spot shortages of
vaccine and certain antiviral treatments. Yet, we know that,
overall, vaccine and antiviral supply will still exceed demand.
What role did the federal government play, along with its
public health partners at the state and local level, in
responding to these supply issues and what can we learn from
these efforts going forward?
Finally, I wish to thank the Ranking Member of the
Committee, Ms. DeGette. This hearing has been a bipartisan
effort and the ranking member and I have been working together
on a number of issues. I thank her for her support. As well, I
would also like to thank the witnesses: I have had time to meet
with representatives from the CDC, and staff also reports to me
that all of your agencies have been more than helpful in
addressing these complex issues.
# # #
Mr. Murphy. With that, I will now recognize Ranking Member
Ms. DeGette for her opening statement for 5 minutes.
OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Thank you very much, Mr. Chairman, and
welcome, Mr. Chairman. We are delighted to have you. And the
chairman is correct. We have been working quite closely
together ever since his appointment on issues that are facing
this committee, and given the Energy and Commerce's broad
jurisdiction, really, the world is our jurisdiction on this
subcommittee. Mr. Dingell and I think even Mr. Barton would
agree, this is probably one of the most venerable and important
committees in the U.S. House of Representatives, and I look
forward to working very hard with you, Mr. Chairman, and the
rest of the committee to making sure that we have very thorough
and important investigative hearings.
Flu preparedness is one of those issues. This committee has
had a number of hearings over the years on preparedness, not
just for the next flu season but also in the event, which we
hope will never happen, of a pandemic, and I am glad that you
have scheduled this first oversight hearing on this issue
because it is one that the committee has had concern about for
many years. According to the CDC, this was a bad flu season.
The worst of it is now nearing its end, and fortunately, this
flu season did not reach pandemic proportions.
If you can find good news in this flu season, it has been a
good demonstration of the public health system operating as it
should. The FDA worked closely with manufacturers to ensure
adequate vaccine supply, and the CDC collaborated with the
States in its surveillance and tracking efforts. When the
season peaked in January, CDC got the word out and many people
who had delayed were still able to get vaccinated. Now, while
we saw spot shortages of vaccine and antiviral drugs in certain
areas of the country, unlike previous seasons, we didn't have
any serious shortages. But I must say, the threat of influenza
is one that we cannot underestimate, given its potential impact
on the Nation and the world's public health, security and
economy.
Vaccination rates are one area in particular where we can
make significant progress. The latest data from November shows
that only 36.5 percent above those who are 6 months old got
vaccinated. The most important step in protecting against the
flu is to get a flu shot, so I am interested in hearing from
the witnesses how we can improve our vaccination rates. The
Affordable Care Act is going to be one way to improve flu
prevention and care. Because of this Act, 54 million Americans
can now receive a free flu shot through their private health
care plan, and next year CBO estimates that 14 million
Americans who would otherwise be uninsured will instead have
health care coverage. That number will increase to 27 million
by 2017.
Each flu season is a practice run for how well we would do
in a pandemic. After the H1N1 pandemic in 2009, it became
really apparent that we would need more vaccine alternatives to
deal with potential shortages. We need to be able to make
vaccines faster and to make them more effective against the
flu, and that is why I am excited to see that the FDA has
approved numerous alternative vaccine technologies that hold
the potential for faster startup of the manufacturing process
in the event of a pandemic. These new approvals provide
alternatives to our current decades-old use of time-intensive
egg-based technology to produce vaccines. In the event of a
pandemic, egg-based production would be too slow to meet
heightened demand for vaccine with the potential loss of
millions of lives around the world. In November, the FDA
approved the first seasonal flu vaccine using cell-based
technology. With cell-based technology, the virus strains are
grown in animal cells instead of eggs. This is a huge step
forward in expanding vaccine supply. And last February, FDA
approved FluMist, the first vaccine to protect against four
rather than three strains of the flu. By improving protection
against the flu, these new quadrivalent vaccines will protect
millions of Americans.
So Mr. Chairman, these are great examples of laudable
government investment, but beginning in 2005, HHS recognized a
gap in the public health system and subsequently made
investments to deal with this, and that is truly a government
success story. While I am encouraged by the fact that these
alternative technologies have come to fruition, we have a long
way to go. We must remain vigilant against the risks of a flu
pandemic. Pandemics are infrequent, highly unpredictable and
come on suddenly, and so we have to have constant vigilance. I
appreciate our witnesses coming here today. I am eager to hear
what they have to say about the progress that we have made and
the state of vaccine innovations and improvements because,
frankly, we must do whatever we can to make sure that we have
better flu preparedness.
Thank you, and I yield back.
Mr. Murphy. I appreciate the gentlelady's comments, and I
now recognize the chairman of the full committee, the gentleman
from Michigan, Mr. Upton.
OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Upton. Well, thank you, Mr. Chairman, and welcome you
to your first chairmanship of the Oversight Subcommittee here
in the big House. I want to welcome you to that.
I had the opportunity, as you know, to chair this
subcommittee a number of years ago, so I know firsthand the
important work that can be done from that post. Oversight has a
number of very, very important purposes, but one of the most
significant is ensuring that our federal programs are working
properly and efficiently, especially in matters relating to
public health and safety. It is often a bipartisan role, and I
appreciate the role that your ranking member has well, Ms.
DeGette.
With regard to the flu, this committee examined the
response to the H1N1 pandemic 3 years ago and had probed
influenza vaccine shortages in 2004. We have a tradition of
doing strong oversight in this area and we are well aware that
this has been a very tough flu season and we have been
especially troubled by this season's particularly harmful
impact on the elderly and some kids too. We have also heard
reports of spot shortages, especially in hard hit areas, and
questions about the effectiveness of this year's vaccine.
The good news is that while outbreaks appear to be on the
decline overall, parts of the country are experiencing
increases, so it remains important to hear the most up-to-date
facts and figures on the current season and examine what the
government is doing to prepare for future seasons as well as
pandemics.
Personally, some of what I have heard from my neighbors in
Michigan about this year's flu is similar to what we have seen
in the national press. Lakeland Healthcare, which provides care
in my hometown, reported to my office that while they did not
have a shortage of vaccine, they had to help supplement their
supplies with other health care providers. I am pleased
whenever I hear that providers are communicating with each
other to address these issues at the local level, but remain
concerned about whether there is enough supplies available in
the next outbreak.
While we are still evaluating the responses to the flu
season, we need to be prepared for the possibility of a worse
outbreak or even a pandemic in the future. I am excited about
the recent innovations in vaccine technology and the role they
play, and I welcome our witnesses and I yield the balance of my
time to Dr. Burgess.
[The prepared statement of Mr. Upton follows:]
Prepared statement of Hon. Fred Upton
I would like to welcome you to your first hearing as
Chairman of the Oversight and Investigations Subcommittee.
I had the opportunity to chair this subcommittee a number
of years ago, so I know firsthand the important work that can
be done from this post. Oversight has a number of important
purposes, but one of the most significant is ensuring our
federal programs are working properly and efficiently,
especially in matters relating to the public's health and
safety.
With regard to influenza, this committee examined the
response to the H1N1 pandemic three years ago and probed
influenza vaccine shortages in 2004. We have a tradition of
doing strong oversight in this area. We are all aware that this
has been a tough flu season and we have been especially
troubled by this season's particularly harmful impact on the
elderly and some children. We've also heard reports of spot
shortages, especially in hard hit areas, and questions about
the effectiveness of this year's vaccine. The good news is that
while outbreaks appear to be on decline overall, parts of the
country are experiencing increases, so it remains important to
hear the most up-to-date facts and figures on the current
season and examine what the government is doing to prepare for
future seasons as well as pandemics.
Personally, some of what I have heard from my neighbors in
Michigan about this year's flu is similar to what we have seen
in the national press. Lakeland Healthcare, which provides care
in my district, reported to my office that while they did not
have a shortage of vaccine, they had to help supplement the
supplies of other health care providers. I'm pleased whenever I
hear that providers are communicating with each other to
address these issues at the local level, but remain concerned
about whether there will be enough supplies available in the
next outbreak.
While we are still evaluating the response to this flu
season, we need to be prepared for the possibility of a worse
outbreak or even a pandemic in the future. I am excited to hear
about recent innovations in vaccine technology and the role
they will play in these efforts. I welcome Dr. Frieden of the
CDC, Dr. Goodman of FDA, and Marcia Crosse of the GAO, and look
forward to their testimony.
Thank you again to the witnesses for joining us today, and
again congratulations and good luck to our new Oversight and
Investigations Chairman.
# # #
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. I thank the chairman for the recognition. I
thank our witnesses for being here today. We have heard already
that this flu season was one of the worst that the United
States has experienced in several years. It began early and was
particularly harsh. It is most often thought to affect infants
and the elderly, but as we saw many times in this outbreak, all
age groups are susceptible to infection and the implications of
a flu infection.
Talking about the statistics is one thing but I will tell
you from firsthand experience, when you lose a vibrant 17 year
old, a member of the golf team from one of your high schools in
your hometown over the Christmas holidays, it has a profound
effect on the entire community. Max Schwolert was that
individual from Flower Mound, Texas. He actually became ill
while on holiday with his family up in Wisconsin and Minnesota
but ultimately succumbed. He became ill at Christmas and
succumbed by December 29 to a staph infection that was
superimposed on his influenza. His dad is a youth minister at
Faith Lutheran Church and obviously a very high-visibility
family within the community and certainly took its toll on
members of the community. They have done good work since that
time in encouraging vaccination, and as we have already heard
this morning, the vaccination was available this year, was
perhaps a little bit better, so thank you for your efforts on
that to develop a better vaccine. It doesn't protect everyone
in every instance but it certainly improves the odds, and as we
saw in this unfortunate case, being young and healthy does not
always confer the immunity that we think it should.
We have got a lot to learn yet about the future of
vaccination, and while I recall the enthusiasm of the cell-
based cultures in 2005 and the enthusiasm for finding a vaccine
that didn't have to be changed every year, we are now 7 years,
8 years later and I do have some questions about when those
things will be coming online.
The flu season is almost done, not quite done. The overall
effectiveness of the vaccine this year was good to better than
we might have expected and preparedness was something that
certainly is laudable, so I am grateful to all our witnesses
for being here today. We do have a big task ahead of us and we
need to keep vigilant, and I will yield back.
Mr. Murphy. I thank the gentleman from Texas.
I would now like to introduce the witnesses testifying
today. First, Dr. Thomas Frieden, the Director of the Center
for Disease Control and Prevention. Dr. Frieden was appointed
in 2009 and also serves as the Administrator for the Agency of
Toxic Substances and Disease Registry. Dr. Jesse Goodman is the
Chief Scientist for the Food and Drug Administration. Dr.
Goodman has served in that position since 2009 and has
previously testified before the subcommittee on influenza
preparedness. Thank you. And Marcia Crosse. Dr. Marcia Crosse
is Director of the Government Accountability Office Health Care
Team. Dr. Crosse is responsible for overseeing GAO evaluations
in the area of biomedical research, bioterrorism, disease
surveillance and other health issues.
You are all aware that the committee is holding an
investigative hearing, and when doing so has the practice of
taking testimony under oath. Do you have any objections to
testifying under oath, any of you? Seeing no objections, the
Chair then advises you that under the rules of the House and
the rules of the committee, you are entitled to be advised by
counsel. Do you desire to be advised by counsel during your
testimony today? The panel answers no. As chairman, I say that
case, please rise and raise your right hand and I will swear
you in.
[Witnesses sworn.]
Mr. Murphy. You are now under oath and subject to the
penalties set forth in Title XVIII, section 1001 of the United
States Code. You may now give a 5-minute summary of your
written statement. So we will start off with Dr. Frieden. Dr.
Frieden, you are recognized for 5 minutes.
TESTIMONY OF THOMAS FRIEDEN, M.D., M.P.H., DIRECTOR, CENTERS
FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND
HUMAN SERVICES; JESSE L. GOODMAN, M.D., M.P.H., CHIEF
SCIENTIST, FOOD AND DRUG ADMINISTRATION; DEPARTMENT OF HEALTH
AND HUMAN SERVICES; AND MARCIA CROSSE, PH.D., DIRECTOR, HEALTH
CARE, GOVERNMENT ACCOUNTABILITY OFFICE
TESTIMONY OF THOMAS FRIEDEN
Dr. Frieden. Thank you very much, Mr. Chairman and members
of the subcommittee. I am Dr. Tom Frieden, Director of the
Centers for Disease Control and Prevention, and I appreciate
this opportunity to share with you the latest information about
influenza.
I think there are four basic bottom-line issues here.
First, flu is a deadly and costly disease. Second, this year's
season has been worse than average and particularly severe for
the elderly. Third, we are making progress applying the best
tools, vaccine and treatment that we have, but fourth, we still
do need better tools and we are making some progress in that
area.
Every year in the United States on average, between 5 and
20 percent of all Americans get influenza. That results in tens
of millions of cases, more than 200,000 hospitalizations, more
than $10 billion in direct medical costs, and over $80 billion
in societal costs including an estimated $17 million lost work
days, many of which could be prevented by vaccination.
Flu seasons are unpredictable and they can be severe. We
estimate that in recent decades, between 3,000 and 49,000
people have died each year from influenza. The 1918 pandemic
killed more than 50 million people around the world, and of all
of the infectious diseases that occur in nature, influenza
remains the one that results in those of us who work in public
health losing the most sleep.
This year's flu season began early, and for most of the
country the 2012-2013 season has already peaked and begun to
decline, but there are still many cases around the country, and
it is likely that flu activity will continue for several weeks.
I would like to just show a series of slides that shows the
spread of influenza through the country. You can see it
emerging in the South, Southeast, spreading throughout the
country until virtually the entire country was seeing
relatively high rates. So we have seen a relatively hard-
hitting flu season this year. The predominant virus is H3N2,
which tends to cause more severe illness among the elderly, and
the next slide shows the hospitalization rate among the
elderly, and what you can see is that it is about twice as high
this year as in previous years, and this is for laboratory-
confirmed influenza hospitalization.
Although it is far from perfect, flu vaccination is by far
the best tool we have to fight the flu. Unfortunately, it is
not as effective as we would like and is less effective for the
elderly, particularly the frail elderly. Vaccination of health
care workers and children not only protects these individuals
but also appears to benefit the community. Despite some spot
shortages late in the season, there was a good supply of
vaccine this year with about 145 million doses and about 40
percent uptake. Individuals who have underlying health
conditions only had a 42 percent flu vaccination rate, so we
really need to do better for particularly the higher-risk
populations.
We can all reduce flu by staying home when we have a cough
and covering coughs and sneezes and, importantly, for people
who are under 2 or over 65 or have underlying conditions,
getting seen promptly and treated can reduce the severity of
influenza.
Flu is also a great example of global collaboration. A
hundred and ten countries track the spread of flu, and we have
staff around the world who work with countries because if they
identify it sooner, it helps us to identify what we should put
in the vaccine and what we can do to reduce the burden of flu
here. We have a unique role in monitoring and providing
recommendations and guidance and supporting State and other
partners but we also work very closely with other federal
agencies including FDA, NIH, and BARDA to ensure an adequate
and safe supply of vaccine.
There is a great example of collaboration between federal,
State and local levels through the 317 and VFC programs and
with the private sector for manufacturing, distribution,
treatment with health care systems that protect their patients
by increasing health care worker vaccination.
Looking to the future, I think we can see improvements in
technology. In manufacturing, some progress is being made. FDA,
BARDA, NIH and private manufacturers are coming up with new
products. You could describe these as important and useful
tweaks but yet no breakthroughs in terms of a better, longer
lasting, more effective vaccine. One of the tweaks has been a
potency assayed to speed up the process of producing flu by
about a month through work of CDC scientists that is now being
validated in collaboration with the FDA. We have also
increasingly been unleashing the genomic revolution to come up
with faster growing and more effective strains that we provide
to the manufacturers. We are also looking at the next
generation of diagnostics that use the genomic revolution again
to identify strains more rapidly.
Flu emphasizes that we are all connected by the air we
breathe, and the emergence or spread of flu anywhere in the
world is a potential risk anywhere else in the world. In
conclusion, there is light at the end of this year's flu season
tunnel but many are still at risk. At this point prompt
treatment of those at high risk is key to reducing illness and
death. We are already tracking flu strains in the southern
hemisphere as we head toward developing a vaccine for next
year's flu season, and we continue to build on our global
capacity to find and stop new pandemic threats where and when
they emerge rather than waiting for them to reach our shores.
Thank you, and I look forward to answering your questions.
[The prepared statement of Dr. Frieden follows:]
[GRAPHIC] [TIFF OMITTED]
Mr. Murphy. Thank you, Dr. Frieden.
Dr. Goodman, you are recognized for 5 minutes.
TESTIMONY OF JESSE GOODMAN
Dr. Goodman. Thank you. Mr. Chairman and members of the
subcommittee, I am Jesse Goodman, Chief Scientist at the FDA
and also a practicing infectious disease physician. I
appreciate the opportunity to be here today and talk about
FDA's role in protecting the public from influenza.
You know, flu seasons are quite unpredictable, and this
year's season is a very telling reminder of how seriously we
have to take flu, and as Dr. Burgess pointed out, I too have
seen or heard of instances where even very healthy young people
can be struck down by this disease. Some people tend to think
what they have is a cold or something but most things that are
colds are not influenza and most influenza can be quite severe
and kill even healthy young people.
Our basic message is while this is a major public health
problem we need to pay attention to, we have also made
tremendous progress. To meet the threat of flu and other
infectious diseases, we work very closely with our partners
throughout the government in what we call the Public Health and
Emergency Medical Countermeasures Enterprise, which includes
numerous HHS partners as well as DOD, the VA, the USDA, etc.
and the DHHS Assistant Secretary for Preparedness and Response.
This year, in response to this flu outbreak, we have
expeditiously approved and released all available vaccines from
six different manufacturers, and as Dr. Frieden said, and as
reflected in the GAO report, this 140 million doses is a
dramatic improvement from where we were a few years ago. We
also helped divert shortages of antiviral medicines such as
Tamiflu. We authorized the rapid release of 2 million doses in
manufacturers' stockpile. We have also worked with the
manufacturers and CDC so that pharmacists could use capsules to
make liquid Tamiflu needed to treat small children, and that
has been very helpful.
Unfortunately, every time we have a bad flu season, there
is a bunch of unscrupulous people who come out of the woodwork
with fraudulent flu products and try to take advantage of the
public. So we have heightened our FDA surveillance of these
various scams including looking at Web sites. We have taken
action where needed and we have actually put information out to
the public about fraudulent flu products that includes red
flags they should look for in assessing these kinds of claims.
Now, with respect to vaccines, FDA doesn't make vaccines,
but with influenza vaccine, we have a very unique and intimate
working relationship with numerous partners to get the job done
every year. Vaccine preparation is a very intensive, year-
round, coordinated response involving working closely with
manufacturers on almost a daily basis as well as with our
global public health partners, WHO, CDC and others. It has
numerous steps. I won't go through here based on time, and
manufacturers exhaustively test their vaccines and submit
results.
Now, why we are testifying here today, in part, is because
of this virus. This is a unique virus. It is constantly
changing. It is a crafty and unpredictable virus. The surface
proteins on the virus are changing all the time and that helps
it evade our immune systems and it also helps it evade our
vaccines, which is part of the challenge there. Ten years ago,
we had only three U.S.-licensed influenza vaccine
manufacturers. We initiated significant efforts including a new
accelerated approval pathway to increase the diversity and
amount of vaccine supply as well as to upgrade manufacturer
quality and hopefully do all we can to prevent failures in
manufacturing. As a result, we now have seven vaccine
manufacturers and an approximate doubling of supply.
In addition, I would say as a result of substantial ASPR,
BARDA and industry investment and very intense interactions
with FDA, as you have heard, we have two recent innovative flu
vaccine approvals. The first is Flucelvax, made by Novartis,
the first U.S.-licensed cell-based flu vaccine. The advantages
of the cell-based vaccine include elimination of the need for a
large number of fertile eggs, which can be a problem if there
were an avian flu outbreak, better growth of strains that
sometimes grow poorly in eggs, and faster startup and scale of
manufacturing. Also good news is that Novartis is planning to
manufacture this in their new facility at Holly Springs, North
Carolina, that was built with a lot of ASPR and BARDA support
as well and will substantially increase U.S. manufacturing
capacity.
The other new vaccine is Flublok, manufactured by Protein
Sciences, again developed with government support, and it is
the first influenza vaccine using recombinant DNA technology.
This is produced using an insect virus grown in insect cells to
produce the flu virus protein. It can be manufactured just
based on the genetic sequence of the virus. We don't need a
living virus at all in order to produce the vaccine, which can
therefore be obtained within days instead of weeks. In a time-
limited situation like a pandemic, this could be very
advantageous.
We have also worked with BARDA to retrofit existing
manufacturing facilities to increase their surge capacity.
Recently FDA is working with BARDA in a collaborative way to
provide technical assistance in three very exciting recently
funded centers called Centers for Innovation in Advanced
Development and Manufacturing located in Texas, North Carolina,
and Maryland.
You probably have heard about the need for more effective
flu vaccines, and this is also a high priority for FDA. There
are a number of promising approaches under active research and
development for this technology. They are not here today but we
are hoping to get there. These include efforts to induce a
stronger, more effective, longer lasting immune response that
could protect against viruses that change over time. As another
strategy, there are efforts going on directing vaccines against
recently identified parts of the virus's genes that are
conserved among multiple strains.
Another thing we are doing is trying to improve
diagnostics. Accurate diagnostics are incredibly important.
They can avoid unneeded use of antivirals and antibiotics, and
as well, we are trying to facilitate development and use of the
antiviral drugs.
In conclusion, we have come a long way in enhancing our
ability to prepare for and respond to influenza. We are fully
engaged in an ongoing, intensive effort to enhance our Nation's
preparedness. We are much better prepared. There have been
several landmark recent approvals and new science is developing
that promises a bright future.
I did want to mention that the response to influenza is
every single year a remarkable public-private partnership. We
are all working together, and I am optimistic that the gains
that have been made are on track to continue. Thank you very
much.
[The prepared statement of Dr. Goodman follows:]
[GRAPHIC] [TIFF OMITTED]
Mr. Murphy. Thank you, Dr. Goodman.
Dr. Crosse, you are recognized for 5 minutes.
TESTIMONY OF MARCIA CROSSE
Ms. Crosse. Thank you, Chairman Murphy, Ranking Member
DeGette and members of the subcommittee. I am pleased to be
here today as you examine issues related to the current
influenza season and influenza preparedness.
As we have already heard, this season there has been early
and intense influenza activity throughout much of the country
with some spot shortages of vaccine. My remarks today focus on
lessons learned from federal responses to prior influenza
outbreaks and federal investments to strengthen the U.S.
vaccine supply. My testimony is based on multiple GAO reports
on seasonal and pandemic influenza. Our prior work has
identified a number of lessons from the response to seasonal
vaccine shortages and the 2009 H1N1 pandemic and actions the
government has taken to improve the vaccine supply.
The primary lessons we observed can be grouped into four
broad interrelated categories: the value of planning, the
importance of effective communication, the difficulties in
predicting the predominant influenza virus strains that will be
circulating in a given season, and the challenge of matching
available vaccine supply with public demand.
First, planning is critical to an effective response. For
example, planning activities conducted prior to the H1N1
pandemic such as exercises and interagency meetings built
relationships among federal, State and local governments and
positioned them to respond effectively. This type of planning
is especially important in years when there are vaccine
shortages or when there are specific groups for which vaccine
must be prioritized.
Second, clear and consistent communication is key,
especially regarding the availability of vaccine. The failure
to effectively manage public expectations of vaccine
availability can undermine government credibility and
contribute to individuals' failure to seek vaccination. This
has been a problem in years when vaccine is in short supply or
is delivered later than anticipated, but it can even be a
problem in years with no shortage, such as this year, if
individuals are uncertain of when or where to obtain vaccine.
Third, predicting the influenza virus strains that will
predominate in a given season and their likely severity is
difficult. Because the selection of the three viral strains
normally included in the vaccine is typically made in February,
in some years the vaccine may not be well matched to all the
strains that are circulating during the following winter. A
positive development is that FDA recently approved two new
vaccines that each protect against a total of four influenza
strains, one more strain than traditional seasonal vaccines.
These new vaccines are expected to be available for the next
influenza season.
And fourth, matching influenza vaccine supply to demand is
challenging. Because of the lengthy production cycle,
manufacturers make production decisions months in advance of a
seasonal outbreak, and vaccine supply orders are generally
placed before providers know what the severity of the outbreak
will be. Manufacturers may be reluctant to produce and
providers may be reluctant to order vaccine that exceeds their
projected demand because if the product is not used by the end
of the season, it must be destroyed.
Over the last decade, HHS has taken steps to strengthen the
influenza vaccine supply by making investments in the
development of alternative vaccine production technologies and
by enhancing domestic production capacity. Since 2005, HHS has
awarded over $1 billion in contracts to manufacturers to
develop new influenza vaccines that rely on cell-based or
recombinant technologies, and two of these alternative vaccines
are expected to be available for the next influenza season.
In summary, over the last decade progress has been made in
the federal government's preparation for and response to both
seasonal and pandemic influenza events. Planning activities
have helped with response efforts, communication with the
public regarding where and when to get vaccine has been clearer
and more effective, and manufacturers have been encouraged to
enhance domestic production capacity and develop alternative
production technologies. Yet the fact remains that when facing
a typical influenza season, manufacturers must make decisions
about how much vaccine to produce, providers must determine how
much vaccine to order, and individuals who may be influenced by
a particular season's perceived severity and media reports must
make their own decisions about whether, when and where to seek
vaccination. These factors along with challenges inherent in
the vaccine production process and influenza seasons that are
unpredictable in terms of duration and severity can still
present barriers to successfully making vaccine available when
and where it is needed.
Mr. Chairman, this concludes my prepared remarks. I would
be happy to answer any questions that you or other member of
the subcommittee may have.
[The prepared statement of Ms. Crosse follows:]
[GRAPHIC] [TIFF OMITTED]
Mr. Murphy. Thank you, Dr. Crosse, and thank you to all the
panelists here. Every member will have 5 minutes to ask some
questions. At this point the Chair recognizes himself for 5
minutes.
Dr. Frieden, the Centers for Disease Control recommends
every American over the age of 6 months get a vaccine. I
believe it is less than 50 percent of Americans actually get
immunized. First of all, what is the optimal percentage that
you hope for, for example, the herd effect, for people to get
immunized?
Dr. Frieden. We like to see at least 80 percent vaccination
rates and obviously higher is better.
Mr. Murphy. So why aren't more people getting vaccinated?
Dr. Frieden. What we find is that the easier you make it
for people, the more likely they are to be vaccinated. One
encouraging trend in recent years is that an increasing
proportion of all vaccinations are being given in workplaces
and in pharmacies. In fact, more than a third of vaccines so
far this season have been given in either of those settings for
adults. We also find that the health care system can make a big
difference, so things like standing orders or routinely
providing it to all people who come into emergency departments,
having subspecialists who see patients also recommend
vaccination and arrange it, either at a pharmacy or elsewhere,
sanding orders, reducing barriers, eliminating cost sharing,
which is something that is expanding to the private insurance
market through some of the provisions of the Affordable Care
Act and also education. Hearings like this, community outreach,
public education all makes a difference.
What we found this year as an example is in the one group,
pregnant women, we have looked very closely at and what we find
is that if the obstetrician actually provides flu vaccine in
the office, we have about a 75 percent vaccination rate among
pregnant women whereas overall it is at about 50 percent. That
is actually a big increase from previous years. There was a
bump during the 2009-2010 pandemic, and that has been
sustained.
The second group that we have looked at closely is health
care workers because when someone is vaccinated, they not only
protect themselves, they protect those who they have contact
with, and we know that there is some evidence that suggests
that low vaccination in health care workers in nursing homes in
particular can have very severe ramifications. What we find is
that pharmacists, nurses and doctors have vaccination rates of
80 to 90 percent, so quite good, but that allied health workers
and people who work in nursing homes may be under 50 percent,
so we have identified the areas where we need to reach out
more. The bottom line is, fewer barriers, more convenience
makes a big difference.
Mr. Murphy. I am just curious because you say that about
the barriers with cost sharing. Have you done any follow-up
studies? For example, you mentioned a pharmacy or somewhere
else might provide these vaccines. I mean, I have seen some for
free, some for extremely lost cost. Have you done any
correlational studies to help understand that part?
Dr. Frieden. I am not familiar with whether we have done
this in influenza. This has been looked at in a variety of
programs and it is pretty consistent, that cost sharing reduces
utilization, but we can get back to you to see if that has been
looked at in influenza specifically.
Mr. Murphy. And just a quick myth check. When a pregnant
woman gets a vaccine, is that any risk to her child?
Dr. Frieden. No, there is not. We recommended the
inactivated vaccine for pregnant women rather than the live,
attenuated vaccine.
Mr. Murphy. Thank you. Now, we know it has been
particularly hard on seniors, so Dr. Frieden and Dr. Goodman,
why has this been the case for seniors this year?
Dr. Frieden. H3, for reasons that we don't fully
understand, years that are H3 predominant, and this season is
overwhelmingly H3 predominant, tend to be more severe among the
elderly. There are various theories for that but bottom line,
is we are not sure why. It is something that we see in 2003-
2004 as well as 2007-2008. Those were our two prior H3-
predominant seasons and similarly in those years the disease is
more severe among the elderly. That is one of the reasons we
try to vaccinate around the elderly so that we can reduce
spread in the population, and we encourage prompt treatment
because treatment particularly in the first 48 hours can
improve outcomes.
Mr. Murphy. Dr. Goodman, let me add a little part to that
too. Can you speak to any recent innovations in vaccine
technology that can lead to more effectiveness for seniors?
Dr. Goodman. Well, I think this is a big challenge, and
part of the challenge is inherently related to the answer to
your last question to Dr. Frieden, which is that we don't
respond that well even to the virus itself. This is why we get
so sick and why so many infections end up doing badly. Part of
the problem is that when you give the same material that is in
the virus in the vaccine, we don't always respond that well to
that either. There are a number of approaches being taken to
potentially enhance the immune response, and most of these are
in the research and development stage. Some are being supported
through HHS and NIH funding. For example, if you package the
proteins of a virus in a particle that appears or the immune
system sees as a virus, sometimes called a virus-like particle,
that can sometimes induce a stronger immune response. The use
of adjuvants or substances that boost the immune response can
give a stronger immune response. So these things are all being
examined and they need thorough examination for safety and
effectiveness.
There are also parts of the virus that have been discovered
recently. For example, something called the stalk is part of
the protein we immunize against but it is not normally in the
vaccine. Yet, it seems to be conserved year after year in
multiple isolates. Therefore, if we can induce a good immune
response against that, it would help.
I want to take one opportunity to add to Tom's response on
your comment about pregnancy.
Mr. Murphy. If you can do it quickly. I am out of time.
Dr. Goodman. Yes, because I think one of the ways we can
increase uptake of vaccines for people is for them to better
understand the science. There was recently published a study in
Norway that showed in 115,000 women who received influenza
vaccine, their fetal outcomes were, if anything, better than
people who hadn't received vaccine. The study showed that a
significant reduction in influenza disease was associated with
vaccine use. So, the science is there to support the safety of
the vaccine in pregnant women.
Mr. Murphy. Thank you. I am out of time. I will now
recognize Ms. DeGette for 5 minutes.
Ms. DeGette. Thank you very much, Mr. Chairman.
First of all, to the panel, this is encouraging news and I
am glad to hear it after the number of hearings we have. Dr.
Crosse, you talked about a number of advancements that we have
made and also the challenges that we are facing. I am wondering
if you can just briefly tell me about intergovernmental
cooperation in identifying potential pandemics and
communication. Has that also improved?
Ms. Crosse. That has improved. CDC's global surveillance
has improved significantly in the last decade, and as we know,
many of these strains emerge somewhere else in the world. In
fact, people were surprised that the H1N1 emerged in North
America.
Ms. DeGette. But has that communication improved?
Ms. Crosse. It has improved. Across the board, we are in
much better shape than we were 10 or 12 years ago.
Ms. DeGette. That is great.
Ms. Crosse. There is still room for improvement.
Ms. DeGette. Sure, and what about surge capacity? That was
the other thing we have always been concerned about.
Ms. Crosse. Surge capacity remains a significant challenge.
Emergency rooms every winter are flooded with patients who are
sick with, as we saw this winter, influenza, norovirus, other
kinds of infectious diseases and, you know, that capacity has
not significantly changed.
Ms. DeGette. And Dr. Frieden, is this something we are
working on? Yes or no.
Dr. Frieden. Absolutely.
Ms. DeGette. Thanks. If you can supplement and let me know
what you are doing, that would be great.
Dr. Goodman, I wanted to ask you, Dr. Crosse had said that
these new types of vaccines, the non-egg-based ones, are coming
into production for next season. Is that right?
Dr. Goodman. Well, they have both been licensed and both
manufacturers have stated they intend to produce the vaccine.
Ms. DeGette. OK. And what about some of these methods for
increasing the effectiveness? Are those also coming online
quickly?
Dr. Goodman. There we are talking about that they are in
active research and development, However, as you know, even for
a promising technology now being looked at in research that
looks good, that will be several years at least.
Ms. DeGette. OK. So that is several years, but the other
ones are coming online?
Dr. Frieden. Yes.
Ms. DeGette. Now, what would happen if we had an avian flu
pandemic or something? Would we be able to make vaccines more
quickly than we can now?
Dr. Goodman. Well, we are definitely better prepared in a
number of ways.
Ms. DeGette. I am sorry. I only have 5 minutes. So would we
be able to make a large number of vaccines more quickly now
with these new techniques, say in the next couple of years?
Dr. Goodman. Yes. Between the new techniques and the
increased capacity, yes, but we have a way to go.
Ms. DeGette. Yes. So now I want to ask you a question in
that direction which, as you know, next month we are supposed
to have this sequester hit, and under the sequester, non-
defense discretionary spending is going to be cut across the
board by 5.2 percent. So I am wondering, maybe Dr. Frieden, Dr.
Crosse and Dr. Goodman, if you can talk to me about what this
would do for operations at the FDA and CDC, both in terms of
the research that is going on and also in terms of the
preparedness. If we put a 5.2 percent cut immediately, what
would this do to our ability to do all these preparations? Why
don't we start with you, Dr. Frieden?
Dr. Frieden. Well, the threats to our health and influenza
are not reduced by 5 percent, so if we have fewer resources, we
have to do everything we can to limit the harm that that would
do, and we are focusing on efficiencies. We have already
eliminated substantial administrative costs, but more than two-
thirds of our funding goes out to State and local health
departments, and while we would try to protect the front lines,
there would be no alternative but to reduce funding there----
Ms. DeGette. So you would have to reduce funding in the
short term but also I would assume you would have to reduce
funding as you are working towards increasing surge capacity
and communication and interoperability and all of that, right?
Dr. Frieden. With fewer resources, we would have less
capacity to detect, respond and develop better tools in the
future.
Ms. DeGette. What about your agency, Dr. Goodman?
Dr. Goodman. Well, a substantial cut would have effects,
and we certainly hope we are able to avoid that. It would
affect, for example, the work we are doing to try to provide
science and highly interactive review processes with
development of these new technologies. It also affects FDA's
user fees program, so that would potentially have some effects
on review process, but we are hoping this can be avoided.
Ms. DeGette. And Dr. Crosse? And maybe you can also talk to
the NIH since we don't have an NIH person here.
Ms. Crosse. Well, I am afraid I don't know how HHS plans to
implement any sequester and whether or not they are going to
take money across the board or from particular pockets.
Ms. DeGette. OK. Thank you. Thank you, Mr. Chairman.
Mr. Murphy. Thank you. I now recognize the vice chairman of
the committee, Dr. Burgess from Texas.
Mr. Burgess. Thank you, Mr. Chairman.
I actually wasn't going to pursue this line of questioning
but since it has already been broached, I mean, any of us who
are charged with running a small business or a large agency
understand that from time to time we are going to have to make
adjustments, and part of our role as leaders in whether it be a
small business, a medical practice or the CDC or the FDA, you
have to be able to look at those things that you do within your
agency or your organization and decide how to prioritize, and I
just--you know, a 5 percent cut, did I ever have to deal with
that in my medical practice? You bet I did, and I had to go
through every line in the budget and decide what is mission
critical and what is not. I don't think that you all are any
less capable of doing that, and certainly my goal in the past
had been to get the Department of Health and Human Services in
here and talk about this last year. There seems to be an
unwillingness to do that. But just from where I sit, I think if
you are not already doing that within your agencies and
organizations, I would encourage you to do so because this may
very well be the reality and the question is not will a
sequester go through but how many will you face over the next
several years. So I just felt obligated to make that editorial
statement. Again, it wasn't part of our hearing agenda today.
It is too bad we haven't had anyone from HHS or Office of the
Management and Budget come in and talk to us about their plans,
and I think that certainly affects the governance of this
committee but it also affects your role and your lives on a
daily basis.
Now, it is unfortunate that the National Institute of
Health is not here because Dr. Goodman, you were asked a
question about how quickly can you do some of these things, and
I just remember the experience of 2009 and the H1N1, and
probably one of the scariest conference calls I have ever been
on was in the middle of the NBA playoffs, or I guess it was the
NCAA playoffs when these kids were coming back from Mexico with
this novel influenza, and all of the things we had been warned
out with the avian flu, H5N1, seemed to becoming true very
quickly with this new strain. Now, it didn't turn out to be as
devastating as that afternoon painted but when young
populations are predominantly being affected, there seems to be
the facility of transfer from human to human seemed to be well
established, and the overwhelming immune response from a
younger person being very detrimental to their health. I mean,
these were all things we had been warned by Secretary Leavitt
in the previous Administration and now they were coming true
literally before our eyes. And yet you all, CDC, FDA, NIH
worked together, and by August there were preparations for
having this vaccination available for schoolteachers when
school started the next month, and I thought that was an
incredible accomplishment. I am old enough to remember the last
swine flu epidemic when the complications of the vaccination
were worse than the illness, so I was gratified that all parts
seemed to work together. I am sure both of you were there at
that time. Are you as good now as you were 4 years ago or maybe
even a little bit better now? Dr. Frieden, we will take you
first.
Dr. Frieden. I think we have continued to make progress. I
do think a lot of the H1N1 pandemic experience is important to
understand and learn from it as the GAO has summarized. You
know, H1N1 was not a mild pandemic. About 60 million Americans
got sick, more than a quarter of a million were hospitalized,
more than 12,000 died including more than 1,200 children, and
the tragedies that you referred to earlier are heartbreaking.
So we do everything we can to maximize use of existing tools.
There were more than 88 million doses of vaccine administered.
We shipped vaccine to more than 70,000 sites and more than
300,000 shipments generally the day after it was approved for
shipping, and we think that both vaccination and treatment
prevented around a million cases, roughly 15,000
hospitalizations, hundreds of deaths and tens of millions of
dollars of health care costs. So I do think there is a lot that
went well in that but there is always things that we can do
better, and coming up with a vaccine that we can develop
faster, get to market faster, extending our global
surveillance.
So no one expected a pandemic to emerge in North America,
and we had been focusing in places where pandemics generally
emerge, in Asia, but we need to continue to develop our
surveillance. There is so much we don't know about influenza
around the world, what the seasonality is, what the predominant
strains are, what the burden is, so we are working very closely
with global partners around the world, and that is a very
important part of protecting those countries and protecting
ourselves, and then finally of strengthening the vaccine
production systems.
Mr. Burgess. Well, you know, I am about of time, but this
committee so often focuses on what didn't go right. I think
from time to time we need to focus on what has gone right, and
certainly the experience with H1N1, and I only look to
improvement from that, but there were a lot of positives to
take away from that experience.
I will yield back, Mr. Chairman.
Mr. Murphy. I thank the gentleman. Next is Mr. Green of
Texas. You are recognized for 5 minutes.
Mr. Green. I thank our panel and appreciate your patience.
I talked earlier to Dr. Frieden. I think the flu epidemic that
we had--and I watched your map, and being in Texas, at least
for most of the Christmas holidays, I saw it happening there.
I guess some of the questions that I have for the panel,
Dr. Frieden, how can public health providers and hospitals and
hospitals and patients, what can we do to reduce the burden of
the surge of the patients in our health care facilities during
a bad flu season? I know our emergency rooms are stacked up.
You know, typically you can't do a whole lot about it except
the vaccination, which gets into my other question. How can we
actually do more than we are doing now to increase the
percentage of people who are getting their flu shot in
September instead of waiting until the end of December or
January?
Dr. Frieden. Thank you very much. In terms of the surge, we
have worked very closely with the Assistant Secretary for
Preparedness and Response, and we have actually unified two
different federally funded programs. One is the preparedness
program, the Public Health Emergency Preparedness program, and
the second is the Hospital Preparedness program. We now have a
common application, common system, and that makes it much
easier for State and localities to use federal dollars to
improve their ability to address surge capacity. We have also
seen some creative approaches in different States where nurse
call lines have been used through private insurers, through
HMOs, through private doctors to talk to patients and for the
routine patients to address their needs over the phone, perhaps
prescribe medications for them if needed, tell them when they
need to come in and when they don't need to come in.
We also look at what we would do in a surge. It is bad
enough if an emergency department is getting so many patients
in, but if we have a very severe pandemic, some of the things
that would be really problematic is the ability to provide
emergency ventilation, to breathe for patients who can't
breathe for themselves, so through the strategic national
stockpile, we have been increasing the availability of
practical, effective respirators, and in fact, BARDA has come
up with some new designs that should be on the market next
year, which are very encouraging, low cost, high quality, easy
to roll out, because this would be the lowest common
denominator. This would be the bottleneck in an emergency, or
one of them, is being able to help people breathe for a period
of time until they get better.
In terms of increasing vaccination rates, I think what we
have learned is, make as many options as possible so people can
get vaccinated at school, at work, at pharmacies, but within
the health care system make it is automatic as possible so that
all too often people do go to the doctor but they don't get the
vaccination. The strongest risk factor for not being vaccinated
is the doctor didn't offer it or recommend it or provide it, so
we want to have automatic systems to increase vaccination
rates.
Mr. Green. Did the Affordable Care Act help on that in
providing vaccinations more readily available?
Dr. Frieden. One of the components is that for private
insurers, it requires no copayment for a vaccination.
Mr. Green. For either Dr. Frieden or Dr. Goodman, are we
seeing resistance to Tamiflu?
Dr. Frieden. We have seen virtually no Tamiflu resistance
this season in the circulating strains.
Mr. Green. Outstanding. And again, the vaccination rate, I
know making is more available, and I know the controversy over
even medical facilities saying we are going to require all our
staff to have the influenza vaccination. In the private sector,
I have companies that are doing that for their employees just
because it makes good business sense. What we are seeing on
that? Is there a lot of resistance from folks even in the
health care sector saying we don't want to take the vaccine?
Dr. Frieden. I think the biggest lesson is making it easy
and accessible. So 80 to 90 percent of pharmacists, doctors and
nurses are getting vaccinated, but among allied health workers
who may not be able to get vaccinated readily and in nursing
homes which may not be doing as good a job as vaccinating,
rates are 50 percent or lower.
Mr. Green. And in nursing homes, you have immune-challenged
patients. You have the elderly. It is almost like it would be
an incubator for it.
Dr. Frieden. And nursing homes are particularly important
to increase vaccination rates because there is some evidence
that the residents of nursing homes do worse when the staff
don't get vaccinated.
Mr. Green. Thank you, Mr. Chairman.
Mr. Murphy. I thank the gentleman for yielding back. I now
turn to the gentleman from Georgia, Dr. Gingrey.
Dr. Gingrey. Mr. Chairman, thank you, and witnesses, I
apologize for coming in late, and I may end up asking you
questions obviously that have already been asked. Just forgive
me for that, and maybe if you repeat it, it will stick in all
of our brains better anyway.
Dr. Frieden, I thought I would ask you the first question.
According to your Web site, the CDC Web site, and in your
written testimony, manufacturers have produced 145 million
doses of flu vaccine this season and have distributed roughly
135 million, which is almost 2 million more doses than last
year. Why then do you think this season has been more severe
despite the increase in the vaccine compliance? More folks are
getting the flu vaccine, and I am one. I didn't get the flu,
thank goodness, but a lot of folks did.
Dr. Frieden. This year's flu is H3N2, and seasons that are
predominant for H3N2, the particular strain of flu, tend to be
more severe. This year is quite predominant of H3N2. The last
two seasons that happened were 2003-2004 and 2007-2008, and in
both of those years they were severe flu seasons, particularly
for the elderly.
Dr. Gingrey. Were they also H3N2?
Dr. Frieden. They were. And why H3 is more severe, there
are some interesting theories but we do not know for certain.
We do know that our vaccine efficacy, our early season estimate
was about 60 percent overall. We also know that in previous
years, generally the elderly tend to be less protected by the
flu vaccine than the non-elderly and the frail elderly even
less so. We are only at around 40 percent overall vaccination
rates, so being able to knock down influenza by vaccinating
lots of people will probably require more vaccination than we
are seeing but, you know, a reduction of 60 percent in
medically attended flu from vaccination also probably means
significant reduction in the spread of flu from those people
who get vaccinated.
Dr. Gingrey. And also I guess maybe decreased severity of
the infection, that they do better than had they not had the
shot obviously.
Dr. Goodman, I noticed that there was a lot of discussion
about the process of cell-based or egg-based growth factor in
vaccine production. I remember all that discussion several
years ago when we had that avian flu outbreak and the great
concern there. How close are we to developing what you would
call a universal flu vaccine?
Dr. Goodman. I think if you had asked me a couple of years
ago, I would say we really can't be that optimistic. It's sort
of a holy grail. I think there have been some scientific leads
in the last 2 or 3 years that are a little more promising, and
if some of these pan out, I mentioned a couple of possible
technologies--directing the vaccine at conserved parts of the
virus. It is possible that we could at least have some real
leads and progress in this direction in the next 5 to 10 years
but it is not something that is just around the horizon.
The good news is that the science that is out there to
understand the immune system and understand the virus now is
extraordinary, and we are all beginning to work to put that
together, but we have a way to go.
Dr. Gingrey. Dr. Goodman, thank you.
And Dr. Crosse, in your testimony you stated that since
2005 Health and Human Services had awarded over a billion
dollars in contracts to six different manufacturers who are
developing the cell-based technology to enhance our domestic
vaccine production capacity, and I am sure that that is a good
thing. Yet only one of those manufacturers, Novartis, has
received the FDA approval for vaccine production in the 2013-14
season. Is the FDA continuing to work with the five other
manufacturers to continue its progress on switching to a faster
and a more economic production model? I know I could have asked
Dr. Goodman this exact same question but if you will?
Ms. Crosse. We understand that of the six, there are--in
addition to the one vaccine that has just been licensed, there
are two more that are in later stages of clinical trials and
that may be able to complete the process and be licensed in the
next year or two. I can't really predict how quickly they may
come along. The other three, they have ceased activities. I
believe two of those contracts have already been canceled.
Dr. Gingrey. Who are the names, Dr. Crosse or Dr. Goodman,
if you know, that are working on this cell-based----
Mr. Murphy. Is that something you can get back to the
committee?
Dr. Goodman. What I would say is, those who are actively
working on new influenza vaccine technologies, yes, we are
working in a highly interactive way with them and with BARDA
and HHS to help make that happen. The intent--some of these
went through a process where in essence the most promising
technologies and the things that have proceeded the fastest are
the ones that are continuing to be funded, and others have
dropped out of the process.
Dr. Gingrey. Thank you all, and Dr. Crosse. I think the
chairman is gonging me. He has the shepherd's hook out. Mr.
Chairman, thank you for your patience. I know I went over a
bit. I yield back.
Ms. Crosse. There is a table in my statement that has it.
Mr. Murphy. That is part of the record. Thank you, Dr.
Gingrey. The Chair now recognizes the gentleman from New
Mexico, and welcome to the committee, Mr. Lujan.
Mr. Lujan. Mr. Chairman, thank you very much. I really
appreciate that. And to the witnesses, thank you for your
testimony and for being here today.
A different kind of a question. A critical piece of this
infrastructure is the National Infrastructure Simulation and
Analysis Center, or NISAC, which is a project, a program that
exists at both Los Alamos and Sandia National Laboratories.
NISAC has the capability to model global spread of flu strains
and has done so in the past. Have you engaged the national
security laboratories to use their predictive modeling
capabilities such as NISAC to understand both the spread of
influenza as well as to devise strategies for interdiction?
Dr. Frieden. We have had some interactions with them. I
would have to get back to you with the details of those, but
certainly the advanced computing is quite important including
in some of the new diagnostic and genomic experiences. What we
are able to do now is to sequence entire genomes in just a few
hours and to put that together is like putting together a
jigsaw puzzle with more than a million pieces. So the computing
power needed for that is quite important, and that is an area
where we have collaborated with the national labs and where we
see potential for future growth.
Mr. Lujan. Thank you. Anyone else? I would really encourage
that we try to work with our departments, agencies to encourage
them to closely work with the national labs in this endeavor.
There is a huge benefit, and we saw that the last time that we
had a pandemic break out.
My State is also home to a large population of Native
Americans like other communities across the country as well as
a diverse population. What are your agencies doing to ensure
that these communities are being reached out to and included in
your priorities when it comes to pandemic flu preparations, and
is there active consultation?
Dr. Frieden. In fact, just last week, we had our tribal
consultation advisory committee meeting at CDC in Atlanta. We
worked very closely with Native American groups. As you know,
during the 2009 pandemic, we identified Native Americans as one
group that was more severely impacted by influenza for reasons
that we don't fully understand. We have for many years had a
very productive relationship with the tribes on immunization
issues, and vaccine uptake tends to be high in many of the
tribes. In fact, we have collaborated with tribal leaders and
tribal members to do some very important research on things
like pneumococcal disease in the tribes, and that research
benefited not only the tribes but the population throughout the
United States and throughout the world. So there is a good
collaboration, good consultation. We have explored ways to
reach out and increase vaccination rates. We have also worked
closely with the Indian Health Service on detection response
and vaccination not only in influenza but other infectious and
non-infectious diseases. For example, we recently identified
spread in New Mexico of the Rocky Mountain spotted fever from
one reservation to another through the dog tick, and we are
working with private industry and tribal leaders to control
that disease with some efficacy and impact. So we have a real
focus on working effectively with higher-risk groups including
Native Americans and Alaska Natives.
Mr. Lujan. I appreciate that very much and I look forward
to learning more about that.
One of the questions that has been asked over and over is,
why aren't people taking the vaccine. We know that education is
important as well. Are there a lot of efforts being put behind
addressing mistruths or misconceptions associated with getting
the flu shot and what impacts to each of you might
sequestration have associated with scale-backs that we have
seen with disease surveillance activities or some of the work
that takes place from an education perspective?
Dr. Frieden. In terms of your first question, increasing
uptake we think is going to require efforts on many fronts,
making vaccine easier for people to take, making it part of the
work flow of health care professionals. Too many people do see
a doctor during flu season but don't get vaccinated. Increasing
the options for vaccination, and sunlight is the best
disinfectant, so providing information. There are people who
have some reluctance about vaccination and just providing the
information openly we find to be the best way. We are
completely open to all of the adverse events that people report
after vaccination are all reported on our Web. We provide
information openly so if there are any concerns, they can be
addressed.
As I noted earlier, we have made substantial administrative
savings at CDC in recent years through travel conferences,
leases, BlackBerrys, printers, computers, and we have been able
to reduce administrative expenses but at this point further
reductions will unfortunately translate into reductions in
support that we provide for tribes, for States for localities
for disease prevention and control as well as for core
activities.
Mr. Lujan. Thank you, Chairman. I yield back.
Mr. Murphy. I thank the gentleman for yielding back. I now
recognize another new member to the subcommittee, the gentleman
from Mississippi, Mr. Harper.
Mr. Harper. Thank you, Mr. Chairman, and thank each of you
for being here, and I appreciate the work you do. It is
extremely important, and we certainly want to make sure that
you are equipped to do that job in an effective way.
You know, I hadn't planned on touching on this, but since
it has come up and continues to come up about the sequestration
and the potential 5.2 percent cut, I just want to make sure
that--and Dr. Crosse, you gave an answer that was--I will leave
you alone because you said you didn't know, so you can take a
little break on this one. But Dr. Frieden and Dr. Goodman, you
both indicated that it could impact actual programs to go out.
It would seem to me, I want to make sure that you are not
saying how that would be done or how you would operate within
that, but it would seem to me if you got 94.8 percent of your
budget, that you can work it out internally and
administratively where that wouldn't have an impact on patient
care or on the folks that you would be reaching, and I want to
make sure that I am not reading something into your statements
as to what you said because I know built into a budget you have
open positions that may not need to be filled, you have
administrative costs--it may be travel, it may be advertising,
it may things that you built in that you wanted to do that
perhaps you can trim back but won't have a direct impact if
this does indeed kick in. And Dr. Frieden, I will let you go
and then Dr. Goodman next.
Dr. Frieden. We do take very seriously being diligent
stewards of the funds entrusted to us, and over the past few
years as we have seen some reductions in recent years, we have
gotten out of leases, we have reduced conferences, consulting
contracts. We actually at a flat budget level sent more money
out to the field. So we feel that we have done, I can't say
absolutely everything we can do but we have certainly done a
great deal of what we can do.
Mr. Harper. But it is fair to say, Dr. Frieden, I know we
have limited time here but it is fair to say you would make
every effort you could and within the organization to make sure
that it didn't have that impact, if at all possible? That would
be a fair statement, wouldn't it?
Dr. Frieden. We would certainly do everything we could to
mitigate the negative health consequences.
Mr. Harper. Dr. Goodman?
Dr. Goodman. Yes, I think I have a very similar response in
that we have tried to tighten things up and be efficient
stewards of our resources and have our resources really have
the public health benefit that you and the American people want
us to provide so we are doing that. If we were faced with a
cut, it would have some consequences but certainly we are going
to manage that in the most responsible way that we can.
Mr. Harper. Fair enough. Thank you, Dr. Goodman and Dr.
Friedman, for those answers.
You know, we are obviously concerned about the influenza
situation, the virus and obviously supply and distribution are
key, and so this would be each of you if I could get your
response. You know, are you continuing to work with
manufacturers to ensure an adequate domestic supply chain of
medical countermeasures, and secondly, to improve the
distribution of those medical countermeasures during the
pandemic or moderate or severe seasonal flu epidemic like this
year?
Dr. Frieden. Absolutely, and I will let Dr. Goodman discuss
more about the work with the manufacturers. We work with them
by providing seed strains, and what our laboratories have been
able to do is to optimize those seed strains so that there are
strains that grow faster and that may be more effective when
used in vaccines. So we are hoping to see kind of useful and
important tweaks without huge breakthroughs yet in the flu
vaccination. We also work through the strategic national
stockpile in an emergency to provide vaccines, countermeasures
and medications. What we found in the pandemic was that the
vaccinations through the vaccines for children program could be
scaled up enormously, so we were able to provide more than
300,000 shipments, more than 80 million doses very quickly,
very effectively. We have been working to improve our ability
to provide medications. Those are available but there isn't a
system to get them out there, and one of the things that
learned about emergencies is, it is best to have an everyday
system that can be scaled up, so we are looking at some models
of doing that even more effectively in the future.
Mr. Harper. Thank you, Dr. Frieden.
Dr. Goodman?
Dr. Goodman. Yes, absolutely. We work extremely intensively
with the manufacturers, and during flu season it is almost a
daily contact with our staff scientists solving problems,
working on issues, trying to get vaccine out quickly. I would
also say through the Medical Countermeasure Enterprise across
HHS, DOD, we are working together. Now FDA is involved at the
earliest stages when the requirement for countermeasures is
defined, and when requests for information or contracts go out
to industry. The idea there is to avoid surprises, andspend as
much effort as we can to increase the likelihood of success. So
I think we are really helping keep that investment a very
efficient and effective one.
Mr. Harper. Thank you, Dr. Goodman.
Dr. Crosse, I am not meaning to ignore you but I am out of
time, so I yield back.
Mr. Murphy. I thank the gentleman. I now recognize the
gentlelady from Florida, who is returning to the committee, Ms.
Castor. Welcome.
Ms. Castor. Well, thank you very much, Chairman Murphy,
especially for calling this very important hearing, and I want
to thank our panel and experts for doing everything in your
power to help Americans ward off the flu.
Before I get to my flu question, you know, when we are
talking about the sequester, I think it is very important for
everyone to remember, we have already slashed the budget of the
CDC and the FDA. So when you are talking about additional
draconian sequester cuts, you are not just asking the agency to
be efficient because the agencies have been efficient and have
cut. What you are doing is, you are cutting into their core
missions that affect the productivity of Americans, our ability
to ward off foodborne illnesses, SARS outbreaks. Think about
the challenges with the flu. These things don't happen by
magic. We have a responsibility to the American public and
businesses to get them vaccinated, to get them all the tools
they need to ward off disease, and I think it is just wishful
thinking to say well, can you accept more budget cuts, more
budget cuts, more budget cuts and not expect the core missions
of these very important public health agencies to remain
intact.
Back to the flu. In my home State of Florida, the nursing
home population is critical, and the CDC has said that 90
percent of deaths from the flu come from people who are age 65
and older. This year, the flu has hit this population
particularly hard. I am hearing more about how we are faring
this season among that population, how effective our response
has been and what we are doing to protect older Americans. So
Dr. Frieden, can you talk about the impact of this season's flu
on older Americans?
Dr. Frieden. This year is an H3 year, and as in prior H3
years, it is more severe among the elderly. The hospitalization
rate of laboratory-confirmed flu, which is something that
provided in a graphic to the committee, is about twice or more
what it has been in recent years, so overall this is a worse
than average flu season and a particularly severe one for the
elderly. Some of the things that we can do to reduce the
severity is vaccination not only of seniors but if people
around seniors so they are less likely to get infected by
someone else, and then prompt treatment with a medication such
as Tamiflu which particularly if given in the first 48 hours
will reduce the likelihood of progression to severe disease.
Also, in nursing homes, vaccination of health care workers is
particularly important. There is some evidence that nursing
homes that have lower vaccination rates among their staff have
much worse outcomes in flu season.
Ms. Castor. And many of these long-term-care facilities,
they just don't vaccinate their workforce like some hospitals
do or cancer treatment centers. Why is that, and what can we do
to promote greater vaccination rates among long-term-care
employees?
Dr. Frieden. We have seen steady progress in the proportion
of health care workers getting vaccinated. It is currently
slightly over 60 percent. It was in the mid 40s for many years.
So we have seen progress and particularly among doctors, nurses
and pharmacists. We see rates of 80 to 90 percent. But working
with nursing homes to make sure that vaccination is easy,
provided, free on work time for their employees are all
examples of things that are best practice and have been shown
to be associated with higher rates. There are certainly nursing
homes that do an excellent job at this, and so what we would
like to do is see those best practices spread.
Ms. Castor. OK. In addition to increasing vaccination rates
for long-term-care workers and many others, one of the keys to
reducing the severity of seasonal flu is making sure that there
is a good match between the strains in the vaccine and the
strains of flu that are in circulation. Dr. Goodman, how well
matched were the strains in this year's vaccine to what we saw
circulating?
Dr. Goodman. Fortunately, the strains are very well matched
this year, so that isn't an issue. The issue here is the
severity of this virus, the number of unvaccinated people and
then as we have discussed that we would like to have a vaccine
that is even more effective, especially for the elderly.
Ms. Castor. So we had good matches this year. We didn't
have any shortages in vaccines, even regionally?
Dr. Goodman. Well, we had good matches. There are times--
what we always see is--it is sort of like whitewashing the
fence. When there is bad flu around, people want the flu
vaccine, and there is a lot of demand, so we have seen and CDC
has helped manage situations where people might have transient
difficulty locating vaccine but there is still vaccine
available and people can still get vaccinated.
Ms. Castor. Well, I thank you all very much, and it is very
important that we support our public health agencies so we can
continue to minimize life-threatening illnesses and protect the
productivity of American workers and businesses and protect the
health of our families, so thank you very much. I yield back.
Mr. Murphy. I thank the gentlelady for yielding back, and I
will recognize another new member of the committee. The
gentleman from Dr. Texas, Mr. Olson, is recognized for 5
minutes.
Mr. Olson. I thank the chair, and welcome to the witnesses.
Thank you all for your time and your expertise.
Just a little bit of background about myself. The district
I represent is Texas 22. It is a suburban Houston district.
That is ground zero for pandemic flu outbreaks, and we are
about to be the third largest city in America. I want to
apologize to my colleagues from Illinois, but Chicago is going
to be number four pretty quickly. And we have the largest
foreign tonnage port in America. That means traffic is coming
from Asia, from Africa, from Europe, right there, the Port of
Houston. We have got these huge transportation, land
transportation infrastructure from Latin America, all the
trucks, all the traffic coming across from Mexico right down
Highway 59, which goes right to my district, which is now I-69.
And while it is true that my hometown's minor league baseball
team is called the Skeeters after mosquitoes, it is not true
that the mosquito is the national bird of Texas. It is the
mockingbird. But my point is, we have a lot of mosquitoes, we
have a lot of rodents, a lot of birds, all sorts of
transmission paths in addition to human beings, and while I
thought that some of the comments that Dr. Burgess and Gene
Green made about the outbreak we had, the H1N1 outbreak in
2009, that summer we all know we had a big outbreak there
across the country but Houston was number two, I think, of the
national outbreak. And, I mean, 11 schools shut down and
parents were terrified what was happening with their kids. And
as you know, with these pandemic outbreaks, there are basically
four steps we have to take care of. First we have to diagnose
it. The CDC has to come through and say this is the virus, this
is what it is, this is how we fix it. We have to make the
vaccine. We have to get the vaccine manufactured out there and
we have to get it to the people and have it delivered--I mean
get it to the local people to deliver it to the people affected
by disease. And it is pretty clear that outbreak in 2009, CDC
got behind pretty quickly with all the tests being required,
these people getting samples taken and all sent to you guys. I
think you fixed that some, Dr. Frieden, by having some local
regional centers set up to address this sort of explosion of
tests. I also know we had big problems with delivery. I mean,
you know, Texas Children's Hospital had to set up basically a
drive-through in a parking garage because so many people wanted
to come get those vaccines.
So my question is about the big picture, and this one is
for you, Dr. Frieden, and for you, Dr. Goodman. What keeps you
up at night? I mean, what is your base concern? What can we fix
here? What is your biggest concern with our country dealing
with these pandemic flu outbreaks?
Dr. Frieden. So, of all of the naturally occurring
infectious diseases, it is influenza that causes us to lose the
most sleep because of its potential to kill. During the 1918
pandemic, more than 50 million people around the world died,
and influenza can spread rapidly and unpredictably. One of the
most predictable things about influenza is that it is
unpredictable. So in order to do a better job of protecting
Americans, we need to strengthen our global surveillance
systems so that we can detect new strains of influenza soon
after they arise anywhere in the world, and we have worked very
closely with governments around the world as well as the World
Health Organization to strengthen laboratories. In fact, during
the H1N1 pandemic within literally days of the discovery of the
virus, we had already produced a real-time PCR assay that we
distributed ultimately to more than 100 countries around the
world so we could track what was happening with it. But that
virus was probably circulating for a couple of months before it
was identified. So it emphasizes that if any part of the world
doesn't have good monitoring systems, we could miss whether it
is influenza or another health threat emerging and not be able
to respond as quickly because if we can stop it or mitigate it
where it emerges, that is better for that part of the world and
that is better for us as well.
Mr. Olson. There are some other institutions across America
that do that. For example, the University of Texas medical
branch in Galveston has its Bio 4 laboratory. I went and toured
that thing. That is space age technology. They have these suits
they dress you up in because they are dealing with some pretty
serious diseases. They say exactly what you are saying, that
our biggest problem is, we can find something somewhere in the
world here. If we get the virus, we can probably have it done
in 24 to 48 hours, they say. You know, we can figure out what
the vaccine should be and they have obviously got to
manufacture it, but I would encourage you to work with them and
all those different labs out there because they are great
assets for us.
Dr. Goodman, what keeps you up at night, sir?
Dr. Goodman. Well, I think we are all sharing those same
concerns of a new or different infectious agent where we don't
have a great vaccine or great therapies that could occur either
naturally or potentially deliberately. So, I agree totally with
Dr. Frieden. We need to have strong surveillance, and things
really have improved in that area too and the molecular tools.
I think we also need the next piece, which is the ability
to develop and produce medical countermeasures--vaccines,
drugs--much more quickly than we currently can. Normal drug
development and vaccine development is a multiyear process.
Among the things we are working with through our enterprise,
HHS, DOD, etc., are new technologies to have a much more rapid,
flexible response so that we can get vaccines much more quickly
so that we can develop treatments. There also has been
considerable progress as described in our testimony, in
increasing our Nation's capacity and being sure we have the
domestic capacity in the industrial infrastructure to work with
the government and respond to a public health crisis. So again,
we are better off, but we have got to harness new science to
have much faster responses and be able to face a new threat.
This effort isn't just for flu. It protects us from terrorism
too. So for all of these, we are taking a multi-hazard approach
where everything we do, whether it is surveillance or response,
can be used because we can't predict what will emerge. We want
tools that will work for whatever will emerge.
Mr. Olson. Thank you. Dr. Crosse, you can sleep well at
night, ma'am. That is the end of my questions. I do have some
questions for the record, sir, about adjuvant vaccines are
being used in Europe, sort of developing new technologies for
vaccines. But thank you very much.
Mr. Murphy. The gentleman yields back. The gentleman's time
is expired, and we now recognize the gentleman from Virginia,
Mr. Griffith, for 5 minutes.
Mr. Griffith. Thank you, Mr. Chairman.
On these new vaccines that are being worked on, and it
doesn't matter to me who answers the question or if people have
different opinions. I am just curious, we know about the
allergy problems for certain people with the eggs, but with the
new vaccines that are done with cells, have there been any
allergic reactions that we know of? Have there been any tests
to see if folks that have other types of allergies are reacting
to those vaccines?
Dr. Goodman. Well, the good news is that first of all, many
people with egg allergies have safely taken the egg-based
vaccines because they are fairly pure and they don't have tons
of egg protein in them but there also are people who have had
severe allergic reactions to the current vaccines, although it
is extremely rare. For those who have them due to eggs, both
the new recently approved vaccines should provide a potential
advantage. One is produced in cells so there is no exposure to
egg, and the other is produced in cells but using insect cells
through recombinant technology, so these are very pure vaccines
that don't contain egg protein. So I think that will be a help.
I want to get back to you for the record, but I am not aware of
any significant problem with allergic reactions to either of
the new vaccines other than what we would normally expect with
any flu vaccine.
Mr. Griffith. Thank you. With that, Mr. Chairman, if I can
yield the remainder of my time to Dr. Burgess, I would do so.
Mr. Burgess. I thank the gentleman for yielding.
Dr. Goodman and Dr. Frieden, at the end of 2005, an omnibus
appropriations bill was passed that had the defense
appropriations in it. A lot of the pandemic preparedness was
contained therein and, again, going back to my opening
statement, there was discussion about the universal vaccine.
Dr. Frieden, you have talked about the difficulty with the
surface proteins, how they are ever changing. I think, Dr.
Goodman, you even mentioned developing a vaccine to the stalk
or the housekeeping proteins that are contained within the
coat. How close are we? This was one of the promises in 2005.
It is 7 years ago.
Dr. Goodman. Well, I would--nature is very tricky, and as I
said, this is a very crafty virus, so I would really hesitate
to predict, but as I said, I think we see some promising
science. I think the earliest we could begin to see something
where we could maybe examine whether it has clinical benefit
might be within 5 to 10 years. And that is if we see some of
these technologies really take root, and I am excited about
them, but I know my colleagues at NIH who also do this and fund
this for a living, feel the same way. There are some exciting
prospects but it has got a way to go. Certainly, you know, your
support and the investments being made will help us get there
faster, we hope.
You know, these are--we have wonderful vaccines against all
kinds of infectious diseases. We protect children against
pneumonia, against measles, against polio, et cetera. This is
not for lack of trying. This is because this is a hard
scientific problem. As I said, the human immune system does not
respond very well to influenza, and when it does, the influenza
virus is very tricky at getting away from that response.
Mr. Burgess. Well, is a universal vaccine still a
worthwhile goal?
Dr. Goodman. Still a goal?
Mr. Burgess. A universal vaccine, is that still----
Dr. Goodman. Is it a worthwhile goal?
Mr. Burgess. I am asking you, is it a worthwhile goal?
Dr. Goodman. Absolutely, absolutely. I mean, can you
imagine if we could have a world where we didn't have influenza
pandemics?
Mr. Burgess. You can just imagine, though, the frustration
in 2005 we are told we are 3 to 5 years away. You are telling
me now we are 7 to 10 years away, and it----
Dr. Goodman. Well, I don't think I would have said that and
I am not sure who did but I think, you know, we see new
technology and we are always very hopeful, and it is kind of
the way you go in science is to be optimistic and pursue the
best leads, but one of the things we also certainly have seen
is, this is a very challenging scientific problem.
Mr. Burgess. Well, let me ask you this. We got a good match
this year so we are grateful for that. But still, the
prevalence of infections in those over the age of 65 is still
higher, so what is the difficulty there in conferring the
advantage to the individual over 65?
Dr. Frieden. One of the challenges with influenza is that
our own natural immunity isn't particularly good, and vaccines
don't usually do better than we do in nature in defending
against infections. The elderly, particularly the frail
elderly, who are more susceptible to severe flu, don't in the
past respond very well to the flu vaccine. There is a new
product on the market that uses triple does of the antigen. We
are told by the manufacturer that by the end of next flu season
we will be able to get a sense of whether that makes a
different or not. But influenza is one of the things that is
quite challenging. Ninety percent or more of the deaths in most
years tend to be among the elderly, so one of the things that
we can do is vaccinate more people around them to tamp down the
threat of flu. A second is to treat promptly because there is
evidence that if you treat someone within the first 48 hours,
they are less likely to end up in the intensive care unit and
it may have other benefits as well in reducing spread.
Mr. Burgess. Very good. I yield back.
Ms. DeGette. Mr. Chairman, I ask unanimous consent for 30
seconds to follow up on that question.
Mr. Murphy. Without objection.
Ms. DeGette. So the follow-up question, Dr. Goodman, is--
and by the way, it was the CDC apparently in this 2005 hearing
that said it was 3 to 5, and it wasn't Dr. Frieden that said
that.
Dr. Goodman, this universal vaccine 5 to 10 years that you
said, if we wanted to speed that up, is that a resource
question or is it a science question, or both?
Dr. Goodman. I think at this point it is mostly a science
question, to be honest.
Mr. Murphy. Thank you. The Chair recognizes now the
gentleman from Ohio, Mr. Johnson, for 5 minutes.
Mr. Johnson. Well, thank you, Mr. Chairman, and first of
all, let me say what a privilege and an honor it is to now be a
part of the Oversight and Investigations Subcommittee. I look
forward to serving with all of our colleagues as we address the
many important issues that face us.
And with that, let me say I received my flu vaccine this
year and I have not gotten sick yet, so for those involved,
thank you very much. I am very much appreciative.
I represent a district in Ohio that is extremely rural. It
takes me 6\1/2\ hours to drive from one end to the other. There
are many places throughout my district where my constituents
have to drive 30, 40 miles to get to a physician or to get to a
pharmacy or to get to a flu shot if they were to have a
reaction. So this is, and especially given your testimony
already, impacting our seniors, and I have a lot of seniors
down in that area.
So Dr. Goodman, can you explain a little bit more about the
testing process in place to verify the safety, the sterility
and the effectiveness of the vaccine?
Dr. Frieden. So, as part of each manufacturer's approve or
license, they are required to do numerous tests throughout the
vaccine manufacturing. At multiple stages they have to monitor
production. And then when they create these large-scale bulk
amounts of vaccine, those are all tested for their potency,
their sterility to be sure there is no contaminants, toxins,
etc. In addition, they submit samples of that to FDA, which our
laboratories test, and then once all those tests are OK, they
fill the vaccines into the final containers or the syringes or
for the live vaccine, FluMist, the nasal spray, and they also
test where appropriate those final formulations. So there is
very extensive testing and quality control, among the most
intense, I would say, for medical product.
The other thing that we do that is very important is
working closely with CDC. We monitor the safety of all licensed
vaccines very carefully, and this is particularly true of
influenza vaccine. We monitor for major side effects in real
time using, for example, the CMS database, and this is actually
some of the most novel science done in looking for adverse
events, and we are working to stand up a much broader system
that uses health care settings that have electronic medical
records to monitor vaccine safety called Prism, and we plan to
have that up and running next year. So they are very
intensively monitored, and I would say one of the way our
country was able to do a good job with vaccine uptake in the
2009 pandemic is that we were able to track safety in real time
when the public or certain people raised concerns about the
safety of vaccine to be able to share the data which showed it
was safe. Conversely, if there ever were, God forbid, to be a
problem, we think we have support and test systems in place to
detect it rapidly.
Mr. Johnson. Sure. Do you think that the development time
for the vaccine, because it seems to get longer and longer each
year as the virus mutates, is harming our ability to react to a
potentially strong flu season?
Dr. Goodman. You know, the manufacturing of flu vaccine is
complicated, and as Dr. Frieden said, flu is unpredictable. We
also say flu vaccine manufacturing is unpredictable. Sometimes
the viruses grow better than other years. Sometimes they yield
more of the vaccine material than other years, so it can be a
challenge. This year went relatively smoothly. We have had
other years where vaccine is delayed. Typically, it is about a
6-month process beginning to end. We are all working to speed
that up. There are parts the virus controls like how it grows,
and that is what got us in the pandemic. The virus just
wouldn't grow. But there are parts that we can help control
better. We recently approved rapid sterility tests that instead
of taking 2 weeks take 3 to 5 days. We are working with CDC and
others to make better potency tests, which now take weeks to
develop, and we think we can shorten that. So we are working to
shorten the portion of the time that manufacturers and the
regulatory agencies are responsible for but we are at the end
left with the whim of the virus, which is why some of these new
technologies, like cell-based and recombinant, may provide us
with a safety valve if problems occur.
Mr. Johnson. One quick question before my time expires,
which is almost here. Again, given my rural district, I am sure
there must be scientific formulas to determine the distribution
of the vaccine to make sure that you have got them in the right
places so the population can get to them. I am sure there is a
different methodology for a big city like Columbus or Cleveland
or Los Angeles than for rural Appalachia Ohio.
Dr. Frieden. We work closely with public and private
sectors to make sure that vaccine is available. Other than some
spot shortages, it generally was this year, and using community
providers, senior centers, pharmacies and other places, any
opportunity to provide vaccination--many States allow
pharmacists, nurses, nurse practitioners to vaccinate under a
doctor's order or supervision--can increase access in rural and
other areas.
Mr. Johnson. Thank you, Mr. Chairman. I yield back.
Mr. Murphy. I thank the gentleman. I also forgot to mention
welcome to the committee to you, to the gentleman who
represents the east coast of Ohio. I appreciate it.
Mr. Johnson. Yes, the very long east coast.
Mr. Murphy. Now I recognize another new member to our
subcommittee, the gentlelady from North Carolina and a nurse.
Ms. Ellmers is recognized for 5 minutes.
Mrs. Ellmers. Great. Thank you, Mr. Chairman, and again to
our panel, thank you for being here and answering our
questions.
I happen to be the lucky recipient of the district that has
Novartis, the new, beautiful, gorgeous Novartis facility in
Holly Springs, North Carolina, and so my questioning is along
the lines of what they are going to be able to do. My first
question, Dr. Frieden, for you is, you know, considering now
the advancements and how exciting it is that we are taking the
path of new technologies in vaccinations, how is it and how can
you describe to us the demanding or expanding the demand for
facilities like this, manufacturing, can be a help in this
area? Because we are looking for solutions moving forward--how
can this facility be a step in that right direction?
Dr. Frieden. Well, as you know, the cell-based
manufacturing offers advantages, possibly cutting a few weeks
or even a month out of the time frame, not using eggs, and
having one more option, and one of the things that has been
encouraging in recent years is the increased number of
options--intradermal vaccination, intranasal vaccination, high-
does vaccination for seniors. So the more options we have, I
think the more uptake we will have. But we would like to see a
substantial increase in uptake of influenza vaccination, and
that is going to require continued effort.
We do really well with childhood vaccination in this
country through the Vaccines for Children program, where we
provide about half of all the vaccines that are used. Not only
do we have very high rates but we have eliminated racial and
ethnic disparities in childhood vaccination. But we don't do
nearly as well for adolescents and adults, and part of that is
putting in place systems in our health care that make it
routine, that put frankly nurses in charge rather than doctors
to make sure that something gets done regularly and routinely.
Mrs. Ellmers. I am all about that. A little competition
doesn't hurt.
Along that line, and I know Dr. Goodman touched on this as
well, what is the advantage, if you will, speaking to the cell-
based vaccines versus the egg? Of course, we all know about egg
allergies, but I know you had mentioned, you know, the rapid,
you know, rate that we can be manufacturing and growing, so can
you just touch on a couple of those as well?
Dr. Frieden. So not being reliant on eggs is quite
important because you might have a shortage of eggs in the case
of a pandemic, so that is an important advance. As Dr. Goodman
mentioned, the egg allergy issue is less of an issue because we
find that true egg allergy is extremely rare, and we have not
generally seen problems. In fact, we have clarified our
recommendations in the past year to say really it has to have
been a real severe anaphylactic allergy because we found many
people saying well, I don't like eggs so I am not going to have
the flu vaccine.
Mrs. Ellmers. A fear factor?
Dr. Frieden. Right.
Mrs. Ellmers. Dr. Goodman, I did want to ask, in this
particular facility, the Novartis facility, it is licensed now
for the pandemic vaccine but not yet licensed for the seasonal.
Is that correct?
Dr. Goodman. I have to be careful about public information
versus their protected information.
Mrs. Ellmers. I see.
Dr. Goodman. But it is licensed for certain operations with
respect to flu vaccine. It is not finally licensed for
production of seasonal vaccine, and I know Novartis is working
with our staff to get it going and get it onboard, and that is
their plan.
Mrs. Ellmers. In a facility like this, how long would
something like this take? And there again, I will just say
hypothetically for other facilities that may have taken that
plan.
Dr. Goodman. Yes, it sort of depends on the issues
encountered and, you know, I know that there is really highly
interactive engagement and everybody's goal is to get it going
as soon as possible, and you know, things have been going well.
Mrs. Ellmers. Good. And what I will say is, any help that
we can be in that effort, I will be more than----
Dr. Goodman. No. As I said, the relations between FDA and
with manufacturers in this area have been tremendous and very
collaborative.
Mrs. Ellmers. Excellent. Well, thank you so much. I thank
all of you so much for your input, and I yield back.
Mr. Murphy. I thank the gentlelady for yielding back. We
have covered all of the members here. I just want to cover a
couple of----
Ms. DeGette. Will the gentleman yield for 1 second? Mr.
Chairman, I just want to congratulate you on your first
hearing, and I want to congratulate all of the members for the
comity that we have shown. This is an important issue, and I
really appreciate the bipartisan cooperation and I think you
are setting the tone for a really good 113th Congress. I just
wanted to compliment you.
Mr. Murphy. I thank the gentlelady, and the same
compliments go to the ranking member and all the members here.
To those who testified today, we know this is a serious topic,
and I know our hearts go out to all those families across
America who lost loved ones during this flu epidemic, but the
information you are providing, the research you are providing
and recommendations for the future are going to be critically
important to save more lives next year, and so we are looking
forward to that.
A couple housekeeping matters. I do ask unanimous consent
that the written opening statements of members will be
introduced into the record. Without objection, the documents
will be entered into the record.
Again, I thank the witnesses for coming today and for their
testimony and members for their devotion to this hearing. The
committee rules provide that members have 10 days to submit
additional questions for the record to the witnesses.
This was my first hearing as chairman of the subcommittee,
and I appreciate all the constructive and bipartisan dialog
that we have had. When problems or issues arise that impact our
public health, I am committed to finding out how we can
effectively address them, and the FDA is going to continue to
play a critical role in this regard.
Dr. Goodman, I do have a request if you would do this for
us, to take back to the Commissioner, Commissioner Hamburg. As
you know, the committee has investigating the deadly outbreak
of fungal meningitis linked to compound drugs since October.
Almost 2 weeks ago, this committee sent Dr. Hamburg and
notified her that unless all responsive documents are produced
by February 25, the committee will move to compel their
production. We have not received any documents since the day we
sent the letter. Dr. Goodman, could you please on behalf of
this committee tell the Commissioner we expect the FDA's
cooperation, and the only way for HHS to avoid receiving a
subpoena in the meningitis investigation is to produce all the
documents we have requested by the February 25th deadline. I
thank you for taking that message back to the FDA Commissioner.
With that, I thank all the members. This hearing is
adjourned.
[Whereupon, at 11:52 a.m., the subcommittee was adjourned.]