[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
ANTIBIOTIC RESISTANCE AND THE THREAT TO PUBLIC HEALTH
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
APRIL 28, 2010
__________
Serial No. 111-115
Printed for the use of the Committee on Energy and Commerce
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COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York PHIL GINGREY, Georgia
JIM MATHESON, Utah STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
Subcommittee on Health
FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan NATHAN DEAL, Georgia,
BART GORDON, Tennessee Ranking Member
ANNA G. ESHOO, California RALPH M. HALL, Texas
ELIOT L. ENGEL, New York BARBARA CUBIN, Wyoming
GENE GREEN, Texas JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado STEVE BUYER, Indiana
LOIS CAPPS, California JOSEPH R. PITTS, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois MARY BONO MACK, California
TAMMY BALDWIN, Wisconsin MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah JOHN SULLIVAN, Oklahoma
JANE HARMAN, California TIM MURPHY, Pennsylvania
CHARLES A. GONZALEZ, Texas MICHAEL C. BURGESS, Texas
JOHN BARROW, Georgia
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
C O N T E N T S
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Page
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 1
Hon. John Shimkus, a Representative in Congress from the State of
Illinois, opening statement.................................... 3
Prepared statement........................................... 5
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 7
Prepared statement........................................... 9
Hon. Ed Whitfield, a Representative in Congress from the
Commonwealth of Kentucky, opening statement.................... 11
Hon. Donna M. Christensen, a Representative in Congress from the
Virgin Islands, opening statement.............................. 11
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 12
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, prepared statement................................ 13
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 16
Prepared statement........................................... 18
Hon. Lois Capps, a Representative in Congress from the State of
California, opening statement.................................. 20
Hon. Jim Matheson, a Representative in Congress from the State of
Utah, opening statement........................................ 20
Prepared statement........................................... 22
Hon. Zachary T. Space, a Representative in Congress from the
State of Ohio, opening statement............................... 25
Hon. Kathy Castor, a Representative in Congress from the State of
Florida, opening statement..................................... 25
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, prepared statement.............................. 96
Hon. Joe Barton, a Representative in Congress from the State of
Texas, prepared statement...................................... 97
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, prepared statement............... 99
Witnesses
Thomas Frieden, M.D., M.P.H., Director, Centers for Disease
Control and Prevention, U.S. Department of Health and Human
Services....................................................... 26
Prepared statement........................................... 29
Answers to submitted questions............................... 109
Anthony S. Fauci, M.D., Director, National Institute of Allergy
and Infectious Diseases, National Institutes of Health, U.S.
Department of Health and Human Services........................ 49
Prepared statement........................................... 51
Answers to submitted questions............................... 125
Submitted material
Statement of Representative Louise M. Slaughter.................. 103
Letter of May 18, 2010, from the STAAR Act Coalition to Mr.
Matheson....................................................... 106
ANTIBIOTIC RESISTANCE AND THE THREAT TO PUBLIC HEALTH
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WEDNESDAY, APRIL 28, 2010
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 3:50 p.m., in
Room 2123, Rayburn House Office Building, Hon. Frank Pallone,
Jr., [chairman of the subcommittee] presiding.
Present: Representatives Pallone, Dingell (ex officio),
Green, Capps, Schakowsky, Matheson, Christensen, Castor, Space,
Waxman (ex officio), Whitfield, Shimkus, Blunt, Pitts, Burgess,
and Blackburn.
Staff Present: Ruth Katz, Chief Public Health Counsel;
Sarah Despres, Counsel; Rachel Sher, Counsel; Elana Stair,
Policy Advisor; Katie Campbell, Professional Staff Member;
Stephen Cha, Professional Staff Member; Virgil Miller,
Professional Staff Member; Anne Morris, Professional Staff
Member; Allison Corr, Special Assistant; Eric Flamm, FDA
Detailee; Andre Bindman, Fellow; Clay Alspach, Minority
Counsel, Health; Ryan Long, Minority Chief Counsel, Health; and
Lyn Walker, Minority Coordinator, Admin/Human Resources.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. The hearing of the subcommittee is called to
order.
Today we are having a hearing on antibiotic resistance and
the threat to public health. And I will first recognize myself
for an opening statement.
This is a very serious public health concern, and I know it
is an issue of great interest to many Members of the House of
Representatives. Antibiotics are among the most impactful
medical innovations of the 20th century. When they were first
discovered in the late 1920s, antibiotics became part of
routine treatment to combat bacterial infections in the 1940s
and were one of the main contributors in the decline of
infectious diseases. Illnesses that had been widespread and
often fatal prior to the development of antibiotics were
suddenly curable with the administration of these new wonder
drugs. In fact, the CDC lists control over infectious disease
as one of their Top 10 Great Public Health Achievements of the
last century and mentions antimicrobials as crucial to that
accomplishment.
But bacteria, as we know, are living organisms, and as
such, they can and will mutate with time to be able to resist
the drugs that have been developed to combat them. And we now
find ourselves in a situation where our triumph over infectious
disease is in jeopardy.
More and more bacteria are proving to be resistant to the
antibiotics currently on the market. Unfortunately, these
resistant diseases are among the most predominant illnesses in
the population, including respiratory diseases, such as
pneumonia; food-related diseases, including E. Coli and
salmonella; and hospital-acquired infections such as
Methicillin-Resistant Staphylococcus Aureus, more commonly
known as MRSA. And I should point out that MRSA in particular
is now migrating out of the health care setting and can also be
found in the community posing a new threat to Americans.
Newspapers across the Nation report on the danger and
prevalence of these bacteria. In my State of New Jersey, we had
a number of schools close a few years ago after children were
diagnosed with MRSA. Some were even hospitalized for weeks. And
I am sure everyone here remembers the scare we had not long ago
in the House of Representatives when MRSA was found in the
House staff gym.
The consequences of these antibiotic-resistant bacteria are
dangerous, expensive, and at times deadly. In 2005, the CDC
estimated that roughly 94,000 Americans contracted MRSA, and
over 18,000 died as a result of that disease, including young
and otherwise healthy patients.
And many in the medical community believe that MRSA might
not be as big of a threat as some of the other antibiotic-
resistant diseases, as fortunately there still are some drugs
that can treat MRSA.
For other diseases, like Acinetobacter, there are very few
options. As articles in the press have highlighted,
Acinetobacter was of particular concern among the wounded
troops in Iraq: 35 percent of those infections responded to
only one antibiotic on the market today, and 4 percent were
resistant to all of our current drugs. It is pretty horrifying
to me to think that our soldiers could survive a war only to
then succumb to a bacterial infection we are powerless to
treat.
In treating these highly resistant infections, physicians
often have to prescribe more expensive, older, and less
commonly used antibiotics that can cause serious side effects,
including nerve and kidney damage. Patients end up hospitalized
for longer periods of time and often suffer recurring
infections that send them back to the doctor time and time
again. And not surprisingly, these illnesses tend to be very
expensive, not to mention the threat that they pose to all who
come in contact with these patients, and that is why this
hearing is important today.
I am very eager to hear from our witnesses about the
problems we experience with antibiotic-resistant bacteria, but
also about the work that they are doing to address these
problems. And I know that both of you are engaged in some very
exciting research that will hopefully help us attack antibiotic
resistance in the most effective way possible.
I want to welcome you both to the committee. I apologize
for the fact that we had to start so late. I know that one or
both of you mentioned catching a plane. I don't know what the
situation is with that.
But for now, I will recognize our ranking member, Mr.
Shimkus, for an opening statement.
OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Mr. Shimkus. Thank you, Mr. Chairman.
Antimicrobial drugs are a life-saving tool when used
correctly. We know that microbes, including bacteria, can
quickly evolve and become resistant to drugs, and resistance is
already a concern in our communities, particularly in the
hospital setting, where numerous deaths occur each year as a
result of a resistance.
I am glad we have a panel before us from the CDC and NIH
here today to discuss the role the Federal Government has
played, particularly with the U.S. Inter-Agency Task Force on
Antibiotic Resistance. I look in order to the hearing more on
the progress made and what we might expect from the task
force's updated action plan expected to be released later this
year.
I have always believed a crucial component in this fight is
providing industry incentives and regulatory framework that
encourages the development of more antimicrobial drugs. Many
manufacturers have turned away from the R&D of new
antimicrobials because of increase incentives to develop drugs
in other therapeutic areas and the uncertainty of the
marketplace.
As members of this committee, we should work hard to break
down the barriers encouraging the marketplace incentives, like
extended patent exclusivity for new antibiotics and new
economic incentives, such as an R&D tax credit.
Unfortunately, I believe that the $27 billion tax on the
drug industry in the health reform law will have a negative
effect and will only serve to stifle, not encourage more,
development of antibiotic drugs. Perhaps that is not the case,
but this is another example of why we must hold hearings on the
new health reform law.
Last week I raised issues we already knew were problems:
pre-existing conditions coverage for children; individuals who
do not qualify for the new high-risk pools; families being
forced into Medicaid; premiums going to rise on average of
$2,100 for those in the individual market; and being able to
drop coverage and avoid penalties after 3 months and 1 day.
And this week we already have new questions. The majority
repeatedly said health care spending will decrease. The
President even pledged to the American people costs would go
down, not up, as a result of health reform.
Yet CMS released a report by actuary Richard Foster last
week saying national health care expenditures will increase by
$311 billion, making health care 21 percent of the GDP.
Should we believe the CMS actuary expert or the majority
and their bill, now law? Are the $575.1 billion in cuts in
Medicare unrealistic and unsustainable as the report claims?
Will the cuts drive 15 percent of hospitals in the red and
force them to close their doors? How would this jeopardize
access to care for seniors? What does the hospital community
say about this?
Are 50 percent of seniors really going to lose their
Medicare Advantage plans? Can 14 million low-wage working
Americans have their employer insurance dropped, forcing them
into Medicaid? How will the State Medicaid plans handle these
new populations and costs?
These are the questions being raised and the real concerns
and fears coming from the public. This committee and this
Congress cannot just bury our heads in the sand and pretend
these problems don't exist in this massive health reform law.
Chairman Pallone, I asked before and I hope we--and
Chairman Waxman is here--I hope we have hearings on the
implementation of this law and address some of these problems
that we should start moving to fix before they actually become
problems. And I have identified quite a few of them.
And with that, Mr. Chairman, I yield back my time.
[The prepared statement of Mr. Shimkus follows:]
[GRAPHIC] [TIFF OMITTED] 76570A.001
[GRAPHIC] [TIFF OMITTED] 76570A.002
Mr. Pallone. Thank you.
Chairman Waxman is recognized for an opening statement.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you very much Mr. Chairman.
We need to debate the health care bill and review its
implementation. But we ought to be able to chew gum and walk at
the same time. Because it is not going to make much difference
if you have health insurance or not if you are going to die
from something that could have been prevented from an
antibiotic.
And we are seeing more and more antibiotic resistance. The
revolution of antibiotics starting with penicillin in 1927 has
been a major accomplishment in the health care world and has
led to many people surviving things that in the past might have
cost them their lives. Before we had antibiotics, common skin
infections could turn fatal; child birth could be a death
sentence for both mother and baby; and superficial wounds could
deteriorate rapidly, often resulting in amputation.
Antibiotics changed all of that, and with the discovery of
these medicines, doctors could regularly treat infections and
literally save lives. The modern age of medicine was launched.
Some 80 years later, this medical miracle is still saving
lives, and without antibiotics, many of today's cancer
protocols would be nearly impossible to use because the immune
system, when it becomes compromised by the treatments, would
quickly leave people to die from opportunistic infections
without antibiotics.
So, in brief, we cannot do 21st century medicine without
antibiotics, whether you like the provisions of the health care
bill or not. We need to have antibiotics available, and
shockingly, experts, which I understand is supposed to be the
reason for this hearing, are telling us that we are on the
precipice of losing the power of many of today's antibiotics.
As a greater number of bacteria become more resistant to them
for reasons that we will explore this afternoon, antibiotics in
turn become less effective, making infections far more
hazardous to health.
This is not an exaggeration or hyperbole or even the stuff
of some hypothetical computer model. This is not propaganda,
which we hear a lot about in these committee sessions when
people are campaigning for the November election and not
looking at the issues that we have to deal with. Too many
Americans have already succumbed to our inability to treat
infections, and the numbers are staggering.
Today we will learn about the impact of antibiotic
resistance on human health from two of the Nation's leading
experts on infectious diseases: Dr. Tom Frieden, director of
the Centers for Disease Control and Prevention; and Dr. Anthony
Fauci, director of the National Institute of Allergy and
Infectious Diseases at NIH.
As we do, I hope we can start to understand and appreciate
the severity of the problem that we face and together work
toward a public-private plan of attack. I don't know what we
need to do. Obviously, research. That is our default and most
important answer to any problem like this. But it is going to
take a strong multifaceted yet coordinated strategy to get the
job done. I think we have to think about things that have not
been on the agenda for a while because of the pressure from
some of the special interests.
What is the impact of using antibiotics without a medical
need when it is applied to large numbers of animals? Is this
resulting in more drug-resistant antibiotics? What will it take
to get the pharmaceutical companies to do more work in this
area? I met with a group yesterday who told me they need this,
they need that, and they need the other thing, but they don't
want to work on the antibiotics because it is not profitable
enough. Well, let's look at that problem.
Let's look at whatever it is going to take and keep our eye
on the objective. We cannot afford to live in a world where
antibiotics don't work anymore. And I think the numbers are
just so staggering: 90,000 Americans die each year of deadly
hospital-acquired infections, which are predominantly caused by
antibiotic resistant bugs. Over 18,000 Americans, including
healthy young people, die annually from Methicillin-Resistant
Staphylococcus Aureus, known as MRSA. We have seen soldiers
defeat deadly enemies in Iraq only to return home with an
epidemic of deadly antibiotic-resistant Acinetobacter.
And we need more hearings so we can say these words
correctly, because these are infections that we want to stop
with antibiotics.
Thank you very much, Mr. Chairman. I look forward to the
testimony.
[The prepared statement of Mr. Waxman follows:]
[GRAPHIC] [TIFF OMITTED] 76570A.003
[GRAPHIC] [TIFF OMITTED] 76570A.004
Mr. Pallone. Thank you, Chairman Waxman.
The gentleman from Kentucky, Mr. Whitfield.
OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF KENTUCKY
Mr. Whitfield. Mr. Chairman, thank you very much.
We look forward to this very important hearing and
certainly appreciate our two witnesses being here today.
I would, however, like to reiterate the importance and
necessity, in my view, of holding hearings regarding the
implementation of this massive and far-reaching change to our
health delivery system.
As Chairman Waxman noted about hospital infections,
according to the Centers for Disease Control and Prevention, 2
million people acquire bacterial infections in hospitals each
year. And of that, around 90,000 people die because of these
infections. And according to the information given to me, 70
percent of the hospital-acquired infections are caused by
bacteria that are resistant to at least one of the drugs most
commonly used to treat them.
I also do believe that we must explore incentives and other
options to encourage pharmaceutical companies to continue their
research and coming up with new medicines to deal with this
problem. I look forward to the testimony of our witnesses
today, and yield back the balance of my time.
Mr. Pallone. Thank you.
The gentlewoman from the Virgin Islands, Mrs. Christensen.
OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A
REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS
Mrs. Christensen. Thank you, Chairman Pallone.
And thank you, Dr. Fauci and Dr. Frieden, for being here,
and it is good to see you again.
The hard facts and data about the prevalence of
antimicrobial resistance are nothing short of astounding.
Because of repeated and widespread improper antibiotic use,
almost every type of bacteria has become stronger and less
responsive to antibiotic treatment. Between 5 and 10 percent of
all hospital patients--that is roughly 2 million people--will
develop an infection, and 90,000 of these patients die. This
trend is related to the fact that more than 70 percent of
bacteria that cause these infections are resistant to at least
one of the antibiotics that is most commonly used to treat
them.
Though the full economic impact is difficult to determine,
the estimated costs are somewhere in the vicinity of $5 billion
a year. What is so disturbing is that because of this
resistance, we are facing the prospect of reverting to times in
health care where we are only able to offer a hand to hold. Not
only may antibiotics be priced out of reach, but we may see
cases where there are none that are effective in a given
infection, and that is unacceptable.
As a physician, I know the pressures that we are always
under to prescribe antibiotics. I made it a point not to use
them unless I thought they were indicated, either for my
patients or my family. And I thank GW and Howard for that.
As I see it, the resistance horse is out of the barn. The
only way to contain it is to fence it in by the National
Institute developing the vaccines, as they did with
Pneumococcus, which had as one of its goals the spurring the
development of new antibiotics, and by the CDC campaigns that
are directed at providers, including hospitals and the public,
especially including the public.
None are easy but have to become a priority because this
country and the world cannot revert to the dark days of
medicine.
Thank you, Chairman Pallone and Ranking Member Shimkus, for
holding this hearing.
Dr. Fauci and Dr. Frieden, I look forward to your
testimony.
I yield back.
Mr. Pallone. The gentleman from Pennsylvania, Mr. Pitts.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Pitts. Thank you, Mr. Chairman.
Antimicrobial drugs have saved countless lives over the
last half century and enhanced the quality of life for many
more people. Unfortunately, we are observing a growing amount
of bacterial resistance to antibiotics, and many infectious
disease are becoming increasingly difficult to treat as a
result.
There are multiple reasons for microbes becoming drug-
resistant, including inappropriate use by physicians,
inadequate diagnostics, hospital use, and agricultural use. I
was pleased to see that in the majority's memo for this hearing
they noted that, ``The National Institute of Allergy and
Infectious Diseases acknowledges there is debate about the
public health impact,'' of antimicrobial use in animal
agriculture, particularly in animal feed.
Because I believe that the legitimate and the judicious use
of antibiotics in animal agriculture has been unfairly attacked
and demonized in recent years. FDA puts these drugs through a
rigorous approval process with many newer antibiotics having
been extensively reviewed specifically to assess any risk to
humans as a result of drug resistance. Treatment, prevention,
control and growth promotion, feed efficiency are all FDA-
approved uses for antibiotics. FDA also conducts post-approval
monitoring, and multiple public and private surveillance
systems monitor for any sign of antibiotic resistance.
While every possible cause of antibiotic resistance should
be studied and explored, I would hope that this series of
hearings would focus more on areas where the science has told
us there is cause for concern, and that is not the antibiotic
use in animals.
I look forward to hearing from our witnesses, and I thank
you, Mr. Chairman, for scheduling this hearing.
Mr. Pallone. Thank you.
Chairman Dingell?
Mr. Dingell. Mr. Chairman, I thank you.
I have a splendid statement. I know that everybody will
benefit by reading it. I ask unanimous consent to insert it
into the record.
Thank you, Mr. Chairman.
[The prepared statement of Mr. Dingell follows:]
[GRAPHIC] [TIFF OMITTED] 76570A.005
[GRAPHIC] [TIFF OMITTED] 76570A.006
[GRAPHIC] [TIFF OMITTED] 76570A.007
Mr. Pallone. Without objection, so ordered.
The gentleman from Texas, Mr. Burgess.
Mr. Burgess. Thank you, Mr. Chairman.
And due to the high-octane witnesses we have, I am going to
waive an opening statement and submit for the record and
reserve time for questions.
[The prepared statement of Mr. Burgess was unavailable at
the time of printing.]
Mr. Pallone. Without objection, so ordered.
Did you have a statement? Oh, submit it for the record.
Let me just say all statements will be submitted for the
record. Thank you.
The gentlewoman from Illinois, Ms. Schakowsky.
Ms. Schakowsky. I will put my full statement in the record,
but I do have a couple of comments.
In my home State, the Illinois Department of Health has
stated that in just 4 years, the incidence of MRSA has
increased 57 percent to over 10,000 cases. As we are going to
hear from the CDC and the National Institutes of Allergy and
Infectious Diseases, antibiotics become less effective as
humans are increasingly and often unnecessarily exposed to
them. This can happen when they are overprescribed.
But it also happens through other types of exposure. It is
for this reason I find the rampant use of antibiotics for
nontherapeutic purposes in livestock populations alarming. Many
factory farms give cows, chickens, and pigs antibiotics in
their daily feed. They are not treating any known diseases.
They are promoting growth and compensating for bad sanitation.
When antibiotics are used in livestock populations, it gets
into our food systems and into our water supply. Using highly
potent medications for this type of use continues to contribute
to the increasing prevalence of antibiotic-resistant
infections.
I applaud by good friend, Representative Louise Slaughter,
for introducing, The Preservation of Antibiotics for Medical
Treatment Act, which would take needed steps to protect the
effectiveness of antibiotics. I am a cosponsor of this
legislation.
And I look forward to Dr. Frieden's and Dr. Fauci's
testimony on this issue.
I hope you will address this as well.
And I yield back. Thank you.
[The prepared statement of Ms. Schakowsky was unavailable
at the time of printing.]
Mr. Pallone. Thank you.
The gentlewoman from Tennessee, Mrs. Blackburn.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mrs. Blackburn. Thank you, Mr. Chairman.
And Dr. Frieden and Dr. Fauci, thank you for being with us
today.
I will have to say that this is a hearing that I have
waited a long time for us to have.
I first wrote you, Mr. Chairman, in October 2007 with my
concerns about MRSA and the fact that we needed to look into
this. I find it astounding, when you look the at 2005 stats,
that there are more people that die from MRSA-caused infections
than those that die from AIDS, Parkinson's, emphysema, or
homicide each year. And I do think that this is something that
has to be addressed.
I was surprised, as I looked at the issue first in 2007, to
find out from our Tennessee Department of Health that there is
not a national standard on a way to report MRSA issues. And
that is of concern to me. It is something that I want to
address with both of you as we move through the hearing.
I do have a full statement that I want to submit for the
record, but I thank you for the hearing and look forward to our
witnesses.
[The prepared statement of Mrs. Blackburn follows:]
[GRAPHIC] [TIFF OMITTED] 76570A.008
[GRAPHIC] [TIFF OMITTED] 76570A.009
Mr. Pallone. And the full statement will be entered into
the record. Thank you.
Our vice chair Ms. Capps, the gentlewoman from California.
OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mrs. Capps. Thank you, Mr. Chairman, I will be very brief.
But I thank you for holding the hearing and thank our
witnesses for coming today and for their testimony.
I have to give a special thanks to Dr. Fauci, who gave a
stirring commencement speech for someone named Amy Fisher, who
is now my medical health specialist on my staff. So you must
have said just the right things when she graduated from Emory.
Thank you very much.
This issue of antibiotic resistance is of extreme
importance to both the health and the economic well-being of
all Americans. Resistant strains of bacteria are harder to
treat, often requiring longer and more difficult courses of
treatment. And the longer an individual must spend fighting an
illness, the greater the loss of valuable time at work and at
home with families.
But there is also an economic consequence to the Nation as
a whole. These infections cost the health care system, through
extended hospital stays, more expensive treatments, nearly $5
billion in annual costs associated with hospital-acquired
infections.
For many years, we have taken for granted that when we are
sick, we can go to our doctor, take a week's worth of medicine,
and be well again. But now we must face the fact that we need a
more comprehensive approach to treating bacterial infection.
Perhaps more concerning is that there are a broad range of
potential causes for the antibiotic resistance that affects us
today: Individual factors, like when and what medicines a
doctor prescribes and how well a patient adheres to treatment,
combined with health-care-associated infections, agricultural
antibiotic use, and a lack of new antibiotic treatments, all of
these have contributed to the current state of antibiotic
resistance.
I look forward to our witnesses' thoughts on how to employ
evidence-based strategies to combat antibiotic resistance and
the multiple factors that contribute to it in a coordinated
approach. Thank you for being here, and I yield back.
Mr. Pallone. Thank you.
Next, the gentleman from Utah, Mr. Matheson.
OPENING STATEMENT OF HON. JIM MATHESON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF UTAH
Mr. Matheson. Thank you, Mr. Chairman.
I have a full statement I will submit for the record, but I
will make just one brief comment.
I just want to point out that on this important issue, I
have once again reintroduced in this Congress H.R. 2400, the
Strategies to Address Antimicrobial Resistance Act, or the
STAAR Act. I believe this is a comprehensive piece of
legislation to strengthen our country's response to pathogens
that are increasingly becoming resistant to antibiotics.
Senators Sherrod Brown and Orrin Hatch will be introducing
a companion bill in the Senate in the coming weeks. I encourage
this hearing and others to move forward to, and I hope that
piece of legislation, the STAAR Act, can contribute to this
debate and offer opportunities for us to make progress.
And with that, I yield back.
[The prepared statement of Mr. Matheson follows:]
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Mr. Pallone. Thank you.
The gentleman from Ohio, Mr. Space.
OPENING STATEMENT OF HON. ZACHARY T. SPACE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OHIO
Mr. Space. Thank you, Mr. Chairman, for holding this
hearing.
I would like to thank the witnesses for their attendance
today.
I think we have all as a Nation kind of taken it for
granted that antibiotics were there. And certainly, as a
parent, I have not thought much about the consequences if they
hadn't been there.
And it is a little unnerving now to see that, in combating
some forms of bacteria, we can now say that antibiotics are
less effective. In the words of Chairman Waxman, that this
would be a very frightening world if it was a world without
antibiotics, ring true.
I am pleased that the CDC and FDA and other agencies have
begun to take some basic steps to combat the problem. I think
public awareness is certainly a big part of it. I think this
Congress and other agencies have an obligation to advance
research into the issue.
My only hope is that if this Congress this term decides to
take legislative action, that we do so with a sense of
moderation, to the extent that that can be done. The concern
always is that we may be overreaching. I certainly don't want
to see that.
So researching and developing a solution to this problem is
very important, but ensuring access to antibiotics for all
Americans is equally important during the process.
With that, Mr. Chairman, I yield back.
Mr. Pallone. Thank you.
The gentlewoman from Florida, Ms. Castor.
OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF FLORIDA
Ms. Castor. Thank you, Mr. Chairman, for holding this
afternoon's hearing on human resistance to antibiotic drugs.
Welcome to our witnesses.
This is a critical and rather frightening issue that we
must work to resolve. Particularly the findings of the recently
released Agency for Health Care Research and Quality Report are
alarming. Post-operative blood infections increased by 8
percent. Catheter-related urinary tract infections increased by
3.6 percent. There are more statistics like that, and the
numbers should be going down, not up.
I thought it was also disturbing that the report found that
Blacks, Hispanics, Asians, and Native American patients were
less likely than whites to receive preventative antibiotics
before surgery in a timely manner. So we still have those
disparities in health care. And all of these infections cause
nearly 100,000 deaths each year and account for up to $26
billion a year in additional costs.
Many of theses infections are resistant to some of the
strongest antibiotics, causing some patients to be in the
hospital for weeks or months. In Florida, drug-resistant MRSA
infections are growing and are infecting healthy adults and
children. The number of cases in Florida from outpatient
facilities increased more than four times in the 3-year period
from 2003 to 2005.
Drug-resistant gram-negative infections, different from
MRSA, are also on the rise. These infections are primarily
acquired in hospitals or long-term care settings. They have a
high death rate and are resistant to antibiotics usually known
as the last line of defense.
According to the CDC, the antimicrobial resistance problem
is a major looming public health crisis. Researchers that I
have heard from have highlighted to me the lack of resources
coming from NIH for this particular issue. They have
highlighted the lack of resources on the State level to detect,
monitor, and control antimicrobial resistance in public health
laboratories. Other States do not have the technical capability
to detect and categorize resistance patterns quickly.
So, gentlemen, you have your work cut out for you. We need
your help in tackling this crisis. I look forward to your
testimony.
Thank you, Mr. Chairman.
Mr. Pallone. Thank you.
I think everyone has had a chance to give an opening
statement, so we will now turn to our panel.
We have our two witnesses today. I want to welcome you. Let
me introduce, on my left, Dr. Thomas R. Frieden, who is
director of the Centers for Disease Control and Prevention; and
to my right is Dr. Anthony S. Fauci, who is director of the
National Institutes of Allergy and Infectious Diseases.
Thank you for being with us today. Sorry, again, you had to
wait. You know that we have 5-minute opening statements that
are made part of the record, and you can submit additional
statements or comments after, and we may also follow up with
some written questions.
STATEMENTS OF THOMAS FRIEDEN, M.D., M.P.H., DIRECTOR, CENTERS
FOR DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH
AND HUMAN SERVICES; AND ANTHONY S. FAUCI, M.D., DIRECTOR,
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL
INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Mr. Pallone. So we will start with Dr. Frieden.
Thank you.
STATEMENT OF THOMAS FRIEDEN, M.D., M.P.H.
Dr. Frieden. Thank you, Chairman Pallone, Chairman Emeritus
Dingell, Ranking Member Shimkus and members of the subcommittee
for your interest in this topic and for holding this hearing.
As an infectious disease physician myself and having worked
as a tuberculosis control officer, health commissioner for more
than 20 years I have seen the growing problem of drug
resistance and also the potential to prevent and reverse drug
resistance with effective public health action.
I appreciate the opportunity to speak with you today about
the public health threat of antibiotic resistance and the role
that CDC plays in preventing, detecting, better understanding,
and responding to the problem.
I would like to share several slides to illustrate the
problem. The first one shows the increase in drug resistance in
two different organisms, Staphylococcus aureus, resistant to
penicillin. Something that emerged almost immediately after
penicillin became available. Early on, tiny doses of penicillin
were able to cure severe infections with Staph aureus. Those
resistant organisms first emerged in the hospital and then,
after a gap of a decade or so, in the community.
That same pattern has existed with MRSA, Methicillin-
Resistant Staph Aureus, which first emerged in hospitals in the
late 1970s, early 1980s, and over the past decade, we have seen
increasingly in the community.
Antibiotic resistance is an increasing public health
problem. Resistance occurs virtually wherever antibiotics are
used. Many bacteria become resistant to more than one class or
type of antibiotics, and doctors and nurses are now all too
often faced with treating infections with antibiotic options
that are limited or in some cases nonexistent. As resistance
increases, both the risk of death and health care costs
increase.
Addressing each antibiotic-resistant pathogen requires a
balanced portfolio, a multifaceted approach that would reduce
inappropriate use of antibiotics, prevent the spread of
resistant organisms, and develop new antibiotics for the
future.
Dr. Fauci will speak about the need to continue and
accelerate our efforts to develop new antibiotics, but unless
we improve our monitoring and use of antibiotics through
effective public health action, we will steadily lose the
ability to use both current and future drugs.
The next slide shows our approach to combating
antimicrobial resistance. It starts with surveillance,
understanding what is happening. Surveillance is key to
assessing and monitoring the scope and magnitude and trends of
antibiotic resistance. Surveillance data can drive and direct
prevention efforts, and determine treatment recommendations,
guide new drug developments, and evaluate whether our
prevention efforts are working.
We need to detect and respond, including through more
effective laboratory facilities in hospitals, in State and
local health departments, and throughout the Federal system.
We need to develop and implement prevention strategies. An
example of this: CDC working with the Veterans Administration
hospital in Pittsburgh documented a 60 percent decline in MRSA
infections. That same approach was rolled out to the VA system
nationally and then to many other health systems nationally.
And although drug resistance is a growing problem, we have
had some good news in that there has been a documented decline
in MRSA nationally by about half and of Methicillin-susceptible
infections in hospitals by about 70 percent, according to the
hospitals that we track over time in the National Healthcare
Safety Network.
And finally, to rigorously evaluate the impact to see what
is working and what is not.
In my written statement, I highlighted several high-
priority antibiotic infection and prevention strategies, and my
next slide outlines some of those. MRSA, gram-negative rods,
gonococcus, gonorrheal infections are becoming increasingly
resistant in the U.S. and around the world; tuberculosis, where
infections increase the risk of death and the cost of
treatment.
Generally, we work to improve antibiotic use; facilitate
rapid and accurate diagnosis; improve treatment of infections,
and we have seen significant progress in reducing inappropriate
antibiotic use among pediatricians; improve infection control;
and wherever possible, create and distribute vaccines, for
example, to prevent pneumococcal infections, a vaccine which
has prevented about 10,000 deaths and saved more than $300
million in direct medical costs each year over the past decade.
We speak of the pre-antibiotic and antibiotic eras. But if
we don't improve our response to the public health problem of
antibiotic resistance, we may enter a post-antibiotic world, in
which we will have few or no clinical interventions for some
infections.
We are working closely with our colleagues across HHS on
this important issue. We very much appreciate the committee's
interest and welcome your questions.
[The prepared statement of Dr. Frieden follows:]
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Mr. Pallone. Thank you, Dr. Frieden.
Dr. Fauci.
STATEMENT OF ANTHONY S. FAUCI, M.D.
Dr. Fauci. Mr. Chairman, Ranking Member Shimkus, Mr.
Dingell, members of the committee, thank you for calling this
hearing, and thank you for giving me the opportunity to discuss
with you for a couple of minutes here the role of the
biomedical research endeavor in the comprehensive strategy to
address antimicrobial resistance.
As shown on the slide on the screen, as pointed out so well
by Dr. Frieden, the strategy to address antimicrobial
resistance includes surveillance, infection control, and the
promotion by various means of the rational use of
antimicrobials.
An important component of that strategy is the biomedical
research endeavor fundamentally to understand the mechanisms of
resistance and to do the basic and clinical research to develop
the countermeasures that are needed against microbial
resistance.
On the next slide is a picture of a journal in which we
have published the research agenda of the National Institute of
Allergy and Infectious Diseases which has three major pillars
to it: basic fundamental research, clinical research, and
transnational research leading to product development.
On the next slide, I want to very briefly address the issue
of basic research. Fundamental to the basic research approach
is the study of the microbe itself. We have been enormously put
at an advantage over the last decade by the striking, if not
stunning, advances in the ability to sequence and annotate the
genomes of microbes.
Just to give you an example, in 1996, when the first
microbe, haemophilus influenzae, was sequenced, it took about
year and about a million dollars. In the year 2000, you could
sequence a bacteria for about $50,000, and it would take about
4 days. Today, you can sequence a bacteria for $1, and it takes
just several hours.
So we have the capability right now to do sequencing, mass
sequencing, of microbes as they evolve into their resistant
form. This gives us the opportunity of what we are pursuing
very aggressively in our research to determine the molecular
mechanisms of resistance and use that to target both diagnostic
vaccines but, importantly, the targets for new pipelines of
antimicrobials.
In addition, we study the host pathogen interaction, namely
how the microbe, be it a virus or bacteria, interacts with the
host and what the body's immune response is in the form of
immunological response.
On the next slide, we also do clinical research activities.
And as Dr. Frieden has pointed out, we focus on some of the
problematic organisms, in this case obviously one that was
mentioned several times already this afternoon, Methicillin-
Resistant Staph Aureus. In addition, the escape organisms,
which are also prone to resistance, are on our top priority.
What do we do with clinical trials? Besides testing new
drugs, we determine under certain circumstances, is treatment
even needed, such as in some of the infections that turn out
actually to be viral infections that for which the use of
antibiotics might not be appropriate?
We also need to know how much antibiotics we should use and
for how long. The appropriate duration of therapy for different
types of infections has still not been fully worked out.
And importantly, we are looking for new uses for older off-
patent drugs. Drugs that have fallen into disuse because of the
more modern antibiotics might actually be brought back if into
the ball game to treat multiple drug-resistant microbes.
On the next slide, it is a scheme that goes from left to
right. I think this is a very important slide that I would like
to just spend a minute on, because it is the scheme of what
happens when you develop products for antimicrobials, in this
case those that are resistant. On the far left is what the NIH,
NIAID in particular, does best and does more intensively, and
that is the fundamental research to develop the concepts to
ultimately, on the far righthand side of the slide, to develop
countermeasures. These could be diagnostics which are critical
in addressing microbial resistance because you want to know if
you are dealing with a resistant microbe. The other is a
vaccine, which some of you have mentioned, to prevent some of
the infections in the first place, and finally the development
of new antimicrobial drugs.
As you go from left to right, industry plays more and more
of a role. As we have seen, the incentive for industry to get
involved in the development of new antimicrobials is not very
great. And I heard several of you mention in your opening
statements, we need to address some of the incentives that we
might partner with them in getting them involved in a very
important public health problem that they don't have as an
economic incentive something that is really a great drive on
their force to get involved. And this is something that we
generally use when we deal with emerging microbes for which
there really are not any countermeasures. I believe this is
something that we should address when we are dealing with
addressing of older microbes that have developed resistance.
Finally, just to go back to my first slide, on the next
slide, to reiterate that there are multiple strategies and
multiple components of strategies to develop the issue of
antimicrobial resistance. And in conclusion, I want to say that
we will continue to pursue the biomedical research approach as
an important part of that comprehensive strategy.
Thank you, Mr. Chairman, I will be happy to answer
questions.
[The prepared statement of Dr. Fauci follows:]
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Mr. Pallone. Thank you, Doctor.
Now we will have questions, 5 minutes, or in some cases 8
for some people who waived their opening statements.
I will start with myself for 5 minutes. I guess I am really
addressing this to both of you, because both of you agree that
resistance occurs wherever antimicrobials are used, whether
they be in the community, on the farm, or in health care. I
don't have time to explore all of these, so I am going to
concentrate on resistance in the community and hope that my
colleagues will talk about farm use or use in other, in health
care settings.
Let me focus on the community. You both describe ways in
which antibiotics are prescribed in the community, and to be
clear, when say use in the community, I mean outside of the
hospital. Dr. Fauci's testimony describes the fact that
physicians often prescribe antibiotics to patients who have
viral infections, not bacterial infections, simply because
patients have come to expect or even demand treatment with
antibiotics, even when they can't help. So my question is, how
concerned should we be about these practices? Or I guess to put
a bluntly, are doctors using antibiotics inappropriately and
too frequently, and if that is true, what can we do about it?
Either one.
Dr. Frieden. Thank you very much. The Centers for Disease
Control has a survey called the National Ambulatory Medical
Care Survey, or NAMCS. This is one of our main instruments for
determining what doctors' practices are and allows us to check
over time what happens in clinical encounters. It is one of the
few systems we have that is nationwide and allows us to monitor
the quality of health care.
In these surveys, we have seen an improvement in that there
has been a smaller proportion of patients who come in with, for
example, upper respiratory infections, who leave with
antibiotics, which they shouldn't leave with.
It still remains too comon a practice. The challenge is
educating physicians and then having a monitoring system in
place to give feedback to clinicians.
One of the things that will greatly facilitate that work is
the expansion of electronic health records where clinical
decisions support systems can remind doctors that this isn't a
good use of antibiotics or can track and give feedback on what
the behavior of individual clinicians are. So we need to both
have the monitoring; we need to intervene by educating better;
and we need to put into the process of health care automatic
ways of telling doctors or helping doctors to make the right
decisions.
I don't know, Dr. Fauci.
Mr. Pallone. I have to say, it is hard for me to relate to
these questions because I never want to go to the doctor, and
when I go, I always try to avoid having them give me anything,
but I know it is a common practice.
Go ahead, Dr. Fauci.
Dr. Fauci. Actually, I would agree completely with Dr.
Frieden.
Also, it is an issue of getting better, sensitive point-of-
care type of diagnostics, where you could really underscore and
confirm, because sometimes, when it physician a talking to a
family member and they say, you have got to put my child or my
husband or whatever on antibiotics because I know they either
have an infection or are going to get one, and if you could in
the office show immediately that that personal doesn't have a
bacterial infection, I think it would go a long way to convince
the person that the decision the physician is making is the
appropriate decision.
Mr. Pallone. Well, what is the Get Smart campaign that the
CDC has been working on, Dr. Frieden? Do you want to talk about
that? And I guess you haven't recommended that it continue in
the budget, so do you want to say why, or what it is and why
you are not recommending that we fund it again?
Dr. Frieden. The Get Smart campaign is an educational
intervention that works with physicians to try to reduce
unnecessary or injudicious use of antibiotics. We are faced
with significant budget constraints. We are not able to
continue or expand all the programs which we would like to
continue or expend, and we are committed to maintaining and
strengthening work to reduce antimicrobial resistance in every
way that we can within our budgetary limitations.
Mr. Pallone. So it is not that, the reason you haven't
recommended continuing it, it is not because it isn't a good
thing. But just it is not that important compared to other
priorities. Is that fair to say?
Dr. Frieden. We believe the program is effective, but we
are not able to include it in the current budget request.
Mr. Pallone. So the answer is yes, right?
I want you to reflect that you said yes, not me.
The gentleman from Illinois, Mr. Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman. I am trying to get my
handles around this, I think, conjecture that is making the
claim that antibiotic use in animals is translated in changing
the resistance in humans, which in one of the testimony
didn't--just kind of said that casually. There are assumptions
made on the other side. Is there any peer-reviewed CDC study
that shows a direct correlation to support that assumption?
Dr. Frieden. It is clear that any antimicrobial use will
result, virtually any antimicrobial use, will result in
emergence, persistence and spread of antimicrobial-resistant
organisms, so the use of antibiotics in farm animals will
generate the development and spread and persistence of
antimicrobial resistance among the farm animals.
Your question relates to whether there is evidence that
that resistance has spread to humans. We do know there are many
interconnections between human and animal health. There is
experience from the several countries in Europe where
prescription of an antibiotic that is related to Vancomycin was
shown to be associated with an increase in Vancomycin
resistance among humans. That was experienced in the European
Union countries. That antibiotic was banned in the European
Union, and the resistance levels then declined.
There is no scientific doubt about the theoretical
possibility of transfer of parts of viruses, transpose onto
other ways that you could spread antibiotic resistance from
animals to people. There also are many outbreaks of----
Mr. Shimkus. I only have a limited amount of time.
But the question is, do you have peer-reviewed scientific
research that shows this connection? Do you, the CDC?
Dr. Frieden. So what I said is there is peer-reviewed
research in Europe.
Mr. Shimkus. I am talking about in----
Dr. Frieden. In the United States, it has not been, to
knowledge, documented as having occurred.
Mr. Shimkus. Thank you.
My point is this, and I use this across the board in this
committee, that running on emotions is running on emotions;
running on science and fact, peer-reviewed replication is
critical if we are going to move public policy. And we don't
seem to want to do that here in Washington.
Do you know the Danish study? Have you followed the Danish
example of banning antibiotic use in livestock?
Dr. Frieden. I am not familiar with the specific study.
Mr. Shimkus. Well, what they did--not study--they actually
did, they actually banned antibiotic use in livestock, and what
they found is a couple of things: Antibiotic resistance, even
though it was banned, increased in humans, issue one. Issue two
was antibiotic use increased in the use of animals because it
was then used therapeutically. So then the other question that
has to be asked is, would we rather have in the livestock
consumption industry antibiotic use for healthy animals, or
would we rather be using antibiotic use treating sick animals
that then eventually go in the food chain?
So these are all part of this debate, and I just want to
caution people to make this jump on this without scientific
research, peer-reviewed study that really makes a direct
correlation, and I think, again, my friends would want to do
this.
One of the issues of this is the industry; how do we get
industry, in one of these charts, to develop that? And we have
done that with different types of drugs. And Chairman Waxman
has been very good PDUFA and stuff. How do you get industry to
market in areas we want to do?
I will tell you one thing you don't do, you don't add an
additional $27 billion tax to an industry you are trying to
incentivize to create life-saving antibiotics, which we just
did in the health reform bill.
And I am concerned that if we go and take antibiotic use
out of livestock, if you believe in economics 101, supply and
demand, you reduce another supply avenue for selling
antibiotics. Then you limit the ability of a return on
investment on those companies that are producing it to begin
with.
So this is an important hearing, and there are a lot of
scientific aspects of this. But I would just plead that we make
sure that any action we do is not based upon emotion, but we do
peer-reviewed science.
With that, Mr. Chairman, I yield back my time.
Mr. Pallone. Thank you, Chairman Waxman.
Mr. Waxman. I am trying to understand the science. It seems
to me, from what I have understood, that when you use an
antibiotic over and over and over again inappropriately--by
inappropriately I mean not to deal with the bacterial infection
but for other reasons--whether it is used on an animal or on
people, it increases the chance of resistance to the
antibiotic. Is that the correct statement of the science,
whichever of you would like to say?
Dr. Fauci. Yes, it is. That is just the nature of how
organisms are involved. You put any pressure on them, they will
select for survival, and survival is resistance. It is just a
natural phenomena of the interaction of a microbe with a
pressure you put on the microbe. That is the scientific
reality.
Mr. Waxman. So to avoid antibacterial-resistant microbes,
we should be sure that we are using the antibiotics where it is
necessary and not using it where it doesn't have a therapeutic
purpose. Does that make sense?
Dr. Fauci. Correct.
Mr. Waxman. You are both answering yes.
Dr. Frieden. There is no disagreement about the use of
antibiotics to treat infections, nor is there disagreement
about the theoretical risk of promotion of drug resistance
through the widespread use of antibiotics.
Mr. Waxman. Now, I don't know of anybody who would argue
that we shouldn't give an antibiotic to an animal that has an
infection, because it is for a legitimate therapeutic purpose.
I haven't heard anybody argue that we shouldn't give an
antibiotic to a person who has a bacterial infection if that
antibiotic could stop that bacterial infection.
But if you give it to large numbers of animals for
nontherapeutic purposes, let's say as a preventative, and if
you give it to kids who may have a virus and not a bacterial
infection, aren't we running a greater risk of resistance?
Dr. Frieden. Yes, our basic principle is to promote
judicious use of antibiotics. The Institute of Medicine has
called for the phasing out----
Mr. Waxman. Is this from science from Europe, or is this
science that is accepted here in the United States?
Dr. Frieden. Public health authorities, including the
Institute of Medicine, have called for phasing out of uses to
promote growth. There is no disagreement, as you note, about
use for treatment or evidence-based prevention of infections.
Mr. Waxman. Now, Dr. Fauci, I think you particularly raised
the question that we don't have companies making new products
where we need new breakthroughs in antimicrobials. And it
appears to be a market failure.
Now I don't accept the idea that if we used it in a more
widespread way, that that would encourage the drug companies to
make more antimicrobials. It sounds to me like we are running a
risk of making more bacterial-resistant diseases. It might make
them more money, but I am not even sure then, because the
product won't work after a while.
We have had market failures in the past, and you and I were
in this room many years ago when we first heard about the AIDS
epidemic, and we are trying to deal with it. And there was a
small patient population. We didn't know what resources we had
to treat them. In this room, we had many hearings on people
with rare diseases, and it didn't offer profit potential for a
lot of the companies to put efforts into drugs for people
with--a small number of people, in effect, for diseases.
We came up with the Orphan Drug Act. We have tried to give
other incentives for research and development. We have a patent
law. We have removal of time that is lost at FDA to help the
producers. Do you have any other ideas on how we can correct
what appears to be a market failure? Is it because it is just
not profitable to produce these antimicrobials, because it is
just too few seldom used and not widespread enough?
Dr. Fauci. Well, certainly, that is, Mr. Waxman, one of the
major reasons why not. Pharmaceutical companies, who do great
things, are driven by the profit margin and what they have to
answer to, to their boards. And if a company has a choice in
making a major investment, to develop a new product, a new
drug, it is several hundreds of millions of dollars, an average
of around $700 million, which includes a risk that they take in
the development of the product. So if they are going to make a
choice of making a product that a lot of people are going to
take every day for the rest of their lives, a lipid-lowering
agent or whatever you have, they are going to lean towards that
rather than to make a new product that a relatively small
proportion of the population will use maybe 10 days to 2 weeks
out of the year and then, because it happens naturally, that
after a period of time, there is going to be resistance against
that antimicrobial.
So from the interactions that I have had with industry, we
need to work with them in partnership to figure out what
incentives that we can do. We at the NIH, I showed that slide,
we fundamentally do basic and clinical research, but what we
are doing now is offering some of our research resources, our
animal model capabilities, our reagent repositories, and even
our clinical trial capabilities to lessen the risk of an
investment on industry to give them more of an incentive to get
involved. And I am sure there are other types of financial
incentives that can be worked out in an appropriate way. But I
really do think we need to push the envelop a bit in getting
rid of some of disincentives for getting them involved.
Mr. Waxman. Just one last question, Mr. Chairman.
I assume this was a problem even before the health
insurance bill was passed last month?
Dr. Fauci. Yes, sir.
Mr. Shimkus. It is probably a bigger problem now though.
I yield back.
Mr. Pallone. Thank you, Chairman Waxman.
The gentleman from Texas, Mr. Burgess.
Mr. Burgess. I am struggling to keep from taking the bait.
Let me depart from what I was going to do for just a
moment, because the whole issue of profitability--penicillin, a
truly wonderful discovery. Sir Alexander Fleming, appropriately
knighted by the king or the queen, appropriately honored with a
statue erected by the bull fighters in Spain, but really it was
an American manufacturing company, I think it was Pfizer, in
the Second World War, that changed penicillin from kind of a
parlor trick that inhibited the bacterial growth on an agar
plate to one of clinical utility for thousands and indeed
hundreds of thousands of people because of the ability to
create a lot of it in the manufacturing process that they
developed in the Second World War.
You argue from purely a profit motive, they would have kept
the numbers of doses of antibiotics low and kept the price
high. But they went with the mass production, and as a
consequence, soldiers during D-Day were spared life and limb
because that they had readily available, abundant, cheap
penicillin, which you alluded to on your slide worked well
until that darn bacteria figured out that they could chew up
that beta-lactam ring and survive quite nicely with their cell
wall intact in spite of the penicillin. So it is not always a
profit motive.
I am telling you stuff that you know better than I. This
was a seminal event in American medicine. It fundamentally
changed the way all of them and subsequently all of us were
trained and practiced in the generations that followed. I mean,
it truly was a life-altering event.
But let's think for just a minute, Dr. Fauci, the new
molecular entities for broad-spectrum antibiotics that have
been introduced by the FDA in the last 10 years, do we have an
idea of how many new drugs have been produced?
Dr. Fauci. Very few.
Mr. Burgess. Broad-spectrum antibiotics.
Dr. Fauci. New antibiotics, very few; I mean, handfuls.
Mr. Burgess. I have a list of 10. Does that sound right?
Dr. Fauci. That sounds about right.
Mr. Burgess. But I have got, my staff has gotten me about
25 pages of antibacterials that have been approved for new
indications, and you referenced that in your slide; new chores
for old drugs that we might find. But these older drugs are not
necessarily helping us fight the war against resistance; they
are just an antibiotic that was found to have an indication for
something else.
So the problem is, if there are only 2--I mean 10 truly new
antibiotics produced in the last decade, and then another
document that tracks $92 million in Federal research at your
institute, Dr. Fauci, in fiscal year 2009 alone on antibiotics
research--does that sound like a fair figure?
Dr. Fauci. No, actually, on antimicrobials research, we do
about $790 million of research; on resistance specifically, we
do about 200-plus.
Mr. Burgess. OK. So my numbers were low.
Dr. Fauci. Right.
Mr. Burgess. So taxpayers are pumping in a lot into the
pipeline, and we are getting out at the other end approximately
the average of one new antibiotic a year? Is that--am I making
a correct----
Dr. Fauci. Now----
Mr. Burgess. Well, I would just ask the question, do we
have a problem with--it sounds like we have a problem with the
pipeline, so where in the pipeline is the problem? Is it the
dollars we are pumping in? Is it the research we are putting
into it? Is it the FDA? Where is the problem in the pipeline?
Dr. Fauci. Well, I think, Mr. Burgess, the problem in the
pipeline is right in the middle of that arrow that I showed in
one of my slides, and that is that the pharmaceutical
companies, as much as we can do research, we can sequence now,
as I mentioned--I mentioned that for a reason. We can sequence
a thousand microbes for a reasonable price really, really
quickly. We can pinpoint all the different targets that could
serve as a target for the development of a drug. There is not
an overwhelming incentive on the part of companies to get
involved in developing a new antimicrobial.
That is why, in answer to the question of Mr. Waxman, I
emphasized that there are a lot of issues that go into why we
don't have a lot more drugs for the amount of fundamental
research money that we put in, but one that is really paramount
is to get the companies involved and incentivized into wanting
to make them. And I don't have the complete answer for that. We
are trying the things that I mentioned in response to Mr.
Waxman's question, but we need to do better than that.
Mr. Burgess. Yes, I do not want to cut you off, because I
know your position in the scientific world and mine, but I need
to ask you this, so market incentives, are those always
dollars? Or are there changes we can make at the regulatory
level that would help the environment?
Dr. Fauci. The FDA right now is putting a considerable
effort in pushing what is referred to now as regulatory
science; in other words, to get them involved in developing
bioassays, biomarkers, new clinical trial designs that would
facilitate the development of any product, including a product
that is geared against a resistant microbe. So there is
something we could do at the regulatory level, and the FDA is
really trying very hard to push that agenda.
Mr. Burgess. Well, I am going to ask Mr. Shimkus this
question, because I can't help myself. We put $27 billion new
tax on to the industry under the health bill, so is that likely
to have a positive or negative effect on the pipeline problem
that we have?
OK, we will go to the next question. Does your institute
track how much of their research invested has translated into
applications and approvals at the FDA? So what kind of data
does the National Institute of Allergy and Infectious Diseases
have that could be shared with this subcommittee?
Dr. Fauci. When you say information, everything we do is
transparent. You can get any information that you want. But I
think you were asking----
Mr. Burgess. The applications and approvals that then go
over--the applications that go over to the Food and Drug
Administration, and the approval of those applications that
come out at the other end.
Dr. Fauci. As a product?
Mr. Burgess. As a product.
Dr. Fauci. See, that is a question that is difficult if not
impossible for me to answer because we don't control the
concept to product. We do fundamental research that might
develop the concept that can be pushed to the pre-clinical, but
if we were solely responsible for soup to nuts, I could give
you an exact answer.
Mr. Burgess. All right.
Dr. Fauci. But we are not. We have to punt it to the
pharmaceutical companies. That is the point.
Mr. Burgess. But on the slide that one of you showed with
the Methicillin-Resistant Staph Aureus and the numbers going up
and now community-acquired. I think it is a huge problem in
jails, and it is a huge problem in dormitories and homeless
shelters. It seems like the market is being created, and none
of the companies are interested in being the first one to cross
the finish line with the silver bullet that wipes out MRSA?
Where is the Paul Ehrlich of our generation?
Dr. Fauci. I would think, personally, that a company would
be very interested in getting in it. They balance the risk for
the benefit. And as I mentioned, there is a considerable risk
for a company to put several hundreds of millions of dollars to
develop a product. And what I would be proposing is that
somehow we in the Federal Government help alleviate that risk
by doing some of the things that I mentioned we can do, but we
are not the only player in this.
Mr. Burgess. Let me just ask you a quick question on
hospital-acquired infection. My epidemiologist that I rely upon
a lot back in Dallas is Bob Haley, and he told me early on that
in order to fix something, you have got to be able to measure
it; in order to measure it, you have to drive out fear. You
can't have people frightened to report data to you, or you will
never have the accurate data to measure. Is that a valid
observation?
Dr. Frieden. Yes. In fact, we have expanding reporting of
hospital-associated infections. Already 28 States report
mandatorily, and about half of all hospitals in the country.
Mr. Burgess. Just briefly, to the point, what is the best
approach here? I have always felt that of the 28 States that
report, you know, find the best practice or set some floor,
perhaps at the Federal level. Let you guys deal with the de-
identified and aggregate data so you are not getting into
patients' privacy issues, so that you have the data to study,
as opposed to what we seem to see here at this committee
sometimes looks very, very punitive. I will just tell you, as
someone who practiced medicine for years, if you make it
punitive on the doctors, we will find a way to obscure things
for you, so you don't pin it on us. I am over-simplifying, but
really, that drive-out-fear concept is one I think we need to
embrace, CMS needs to embrace, and I would encourage you to
continue to work along that line. I think that is where the
ultimate answer for this problem lies.
Thank you, Mr. Chairman, for your indulgence. I will yield
back.
Mr. Pallone. Sure.
Chairman Dingell.
Mr. Dingell. Thank you, Mr. Chairman.
Gentlemen, welcome to the committee.
I am curious, has there ever been a definitive study on the
impact on microbes and other similar creatures to define what
the impact on them might be in terms of resistance to
antibiotics by reason of using these antibiotics in animal feed
and for other similar uses?
Dr. Frieden. There are clear studies that show that use of
antibiotics in animal feed increases resistance among animals.
Mr. Dingell. Among animals or amongst bacteria?
Dr. Frieden. Resistance in the bacteria that resident
within animals.
Mr. Dingell. Would such a study be useful? I mean, a
thorough-going analysis of the matter as opposed to just bits
and pieces.
Dr. Frieden. There is an increasing body of evidence that
looks at where antibiotic resistance emerges and how it
spreads. An additional evaluation of that to understand the
spread from animals to community I think is something that many
groups are working on. There is not right now definitive
evidence. There is a clear understanding that the more
judiciously we use antibiotics, the longer we will be able to
continue to use them effectively.
Mr. Dingell. Now has ever any work been done to define what
is efficient use of antibiotics in animal feed? In other words,
how much is necessary? How much is too much? How much doesn't
work? How much we could do without, and what would be the
benefits of the different steps? Has there been any study of
this kind?
Dr. Frieden. As the director of the Centers for Disease
Control and Prevention, I would have to defer to my colleagues
at the FDA and USDA on those questions.
Mr. Dingell. Who else? I don't see the FDA here in the
room. Who has authority to do this kind of research or to fix
this level of tolerance or content or the time at which these
antibiotics are fed or inserted into animal feed?
Dr. Fauci. Mr. Dingell, I would imagine that the most
appropriate venue to do that would be through the U.S.
Department of Agriculture.
I mean, that is an obvious question of great importance for
people who----
Mr. Dingell. Do they have the authority to fix this or not?
Dr. Fauci. I don't know if I could answer that
definitively. I cannot imagine that they don't have the
authority to do a study if they would want to do it.
Mr. Dingell. I can imagine, A, that they don't have
authority and, B, that they don't use it if they do.
Now let me go into some other questions. CDC's overall
budget would see a 5 percent cut, and the antimicrobial
resistance program would receive a cut of more than 50 percent.
Gentlemen, do you think these cuts would negatively impact
the work you are doing related to antibiotic resistance,
especially support for State and local surveillance, prevention
and control efforts and the Get Smart campaign?
Dr. Frieden. Mr. Dingell, we are committed to doing as much
as we can.
Mr. Dingell. That is not an answer to my question. Is that
level of cut going to hurt what you are doing?
Dr. Frieden. It will be difficult for us to continue
current programs at that level.
Mr. Dingell. Would you tell us, would you submit for the
record the level of your request for financial support for
these programs in the budget? And also submit the amount that
you have been given for the last 3 years and for the coming 3
years.
Dr. Frieden. We will provide that information.
Mr. Dingell. All right.
Now, you have addressed this slightly, but I would like a
little more on it. There appears to be much debate over whether
the practice of adding antibiotics to agricultural feed is
sought to promote drug resistance. What does current science
and surveillance tell us on this point? Is there a direct link,
and what is it?
Dr. Frieden. I think we know that theoretically there is a
risk. The literature that we have reviewed outlines a problem
that clearly emerged in Europe. I am not aware of evidence in
this country that has documented the spread from animals to
humans, feed animals to humans, we have of course seen spread
from animal to humans in a wide variety of infections. But we
know that the more antibiotics that are in the environment,
given to animals and people, the higher the selective----
Mr. Dingell. Let me try, sir, to try to reduce this. I am
getting the impression from what you two gentlemen are telling
us here is that we really don't know what the nexus between the
feed is and the feed with antibiotics is, and when there is a
point of danger, and what is the level of danger, and what
research is going on? What comment do you make on that
statement?
Dr. Fauci. From your questions, Mr. Dingell, and the
questions we have from the other members, there is no doubt in
anyone's mind that if you give antibiotics to anybody, any
animal, and you do it chronically, that resistance to microbes
will evolve.
I think the question that Mr. Shimkus brought up and that
others is that, what is the evidence that if you give it to an
animal for feed and resistance develops in microbes in that
animal, that that resistant microbe will then spread to a
human? And I think----
Mr. Dingell. It might spread to other microbes, or it might
spread to humans.
Dr. Fauci. Right.
Mr. Dingell. Rather than coming to the conclusion, you
don't have much information on that account.
Let me get to this, because time is limited here. The Food
and Drug Administration withdrew its approval for the use of
fluoroquinolone antibiotics, that is FQs, in poultry. Are there
any preliminary, any RMS surveillance reports that would
indicate the impact of FDA's decision? Yes or no.
Well, would you----
Dr. Frieden. We would have to get back to you on that to
give you the most recent information.
Mr. Dingell. Would you submit that for the record?
Dr. Frieden. Absolutely.
Mr. Dingell. Dr. Fauci, in addition to the work that your
agency is currently engaged in with the smaller manufacturers,
what additional steps can or should be taken to incentivize
participation of industry, both large and small manufacturers,
in developing new effective therapies for these drugs-resistant
infections?
Dr. Fauci. There are several things that can be done, Mr.
Dingell. One is to make available to the company some of the
assets and capabilities that we have in the government,
including in my own institute, and that is various assays,
reagent repositories, animal models and clinical trial
capabilities; and then also to reach out and partner with them
on the risk for the advanced development, something that that
they generally do themselves. If we could diminish somewhat the
risk they take, I think there will be much more of an incentive
for them to get involved.
Mr. Dingell. Is this question raised at any point in the
government regulatory structure when you address the questions
of whether or not or how much antibiotics should be used in
animal feed? And if so, who has authority to do that?
Dr. Fauci. Well, we certainly, that is not something that
we as a research institution get involved in.
Mr. Dingell. Here is the purpose of for my question, if
they are putting too much in the animal feed and not using it
wisely and don't have any particular constraints on its use, we
are obviously increasing a risk if a risk there is; is that
right? Clearly, the answer to that is yes.
Dr. Fauci. Well, I am not sure what----
Mr. Dingell. Would you say there is no risk in this?
Dr. Frieden. Certainly----
Dr. Fauci. If----
Mr. Dingell. So we agree. Doctor, my time is limited, and I
am trying to get this through here. So who has the
responsibility for defining the level of risk and defining what
ought to be done to protect the American public and the world
against runaway infections caused by antibiotics that no longer
work on drug-resistant bacteria? Does anybody have this
authority or not?
Dr. Frieden. Both the FDA and the USDA.
Mr. Dingell. They do?
Dr. Fauci. Yes.
Mr. Dingell. The Orphan Drug Act was written in 1983 to
encourage pharmaceutical companies to develop drugs for
diseases that have a small market. This was done through a
series of incentives. FDAAA, the 2007 reauthorization of the
FDA user fee programs included provisions intended to
strengthen the antibiotic pipeline through the orphan drug
program. How effective has the orphan drug program been in your
research and development work related to drug-resistant
bacteria? And what cooperation has it induced on the part of
manufacturers, feed manufacturers, or antibiotic producers or
farm organizations?
Dr. Fauci. Certainly, the Orphan Drug Act has incentivized
the development of drugs of various types.
Mr. Dingell. Now you have said that this is incentivized.
What particular incentive has it produced to do research and
development work related to drug-resistant bacteria?
Dr. Fauci. The basic research that we do feeds into a
company wanting to develop a drug for a, quote, orphan disease,
a disease that is a relatively rare disease.
Mr. Dingell. Do you make it available to them
automatically? Is it made available to them by the FDA, or is
it available by the Department of Agriculture or just sort of
catch as catch can, and we hope they learn about it in some way
so that they can do something about it? And who is in charge of
that?
Mr. Pallone. Mr. Chairman, that has to be the last
question. He can answer this, and we will move on.
Dr. Fauci. When we provide the assets that we have, we
essentially make it available for anyone who needs it or has a
reasonable project.
Mr. Dingell. So if they think they need it, they come by
and see you.
Dr. Fauci. They do.
Mr. Dingell. If they don't think they need it or there is
no incentive for them to come by, they don't come by.
Dr. Fauci. Correct.
Mr. Dingell. Well, Mr. Chairman, this is a very interesting
subject. I commend you for the hearing. I think we have to have
some more, got to learn a little more.
I don't want our two very fine panel members to think that
I have in any way been trying to demean them. I think that we
need a great deal more knowledge on this before I am going to
feel comfortable on the subject.
Mr. Pallone. Thank you.
Gentleman from Missouri, Mr. Blunt.
Mr. Blunt. Thank you, Mr. Chairman.
I agree with the chairman emeritus; this is a good hearing.
I may take a different tact on this same topic.
Several questions came to mind as Chairman Dingell asked
his question, and one would be do, we know that the food chain,
the animal food chain, doesn't get less safe if you don't put
certain antibiotics in the food, in the system; how do we know
that? I mean, there are veterinary guidelines on these
antibiotics, so how do we know that it doesn't have the
opposite effect?
Dr. Fauci. Mr. Blunt, if you don't mind, I would like to
finish the answer to a question that might feed into what you
were saying. The issue is, if you give antibiotics to anybody,
an animal, a human, or whatever, you will unequivocally
ultimately induce the recurrence of a resistant microbe. The
real question----
Mr. Blunt. Isn't it true that antibiotics to animals, you
don't have much of a chain of lifespan here in animals.
I agree with you, if you and I took a antibiotic for 30
years or 3 years, it might make a difference. But we both know
that that is the not the processing system for animal, but
let's not go there, that you are going to induce in the
individual animal itself an antibiotic reaction because they
have had antibiotics for a long time, because the process just
doesn't go that long.
Dr. Fauci. With all due respect you, can--I can have an
upper respiratory tract infection, and I can take an antibiotic
that is suboptimum or not the right antibiotic, and in 10 days
or less, I could have a resistant microbe.
Mr. Blunt. Does that mean you shouldn't take any
antibiotics?
Dr. Fauci. No, I am not saying that.
Mr. Blunt. I think you are answering Mr. Dingell's question
instead of mine. Aren't there American veterinary guidelines on
antibiotics to animals?
Dr. Fauci. That is not my area of expertise of antibiotics
to animals.
Mr. Blunt. Then why wouldn't that be something you would
look at as you look at this Get Smart, know when antibiotics
work on the farm program; why wouldn't you look at the
veterinary medical association's guidelines on judicious use of
antibiotics if it is not your area of expertise?
Dr. Fauci. No, actually, Mr. Blunt, that is actually more
of a CDC issue than--no, it is. I am not trying to pass it off.
Mr. Blunt. Dr. Frieden may answer the question.
Dr. Frieden. Thank you.
The basic question is, we know that there is no
disagreement about certain things, so we should start with
those. First, we know that no one disagrees with the need to
treat infections in humans and animals that are responsive to
those infections. Second, there are evidence-based preventive
antibiotics that are sometimes needed in the situation of
outbreaks or other similar situations. Third, there is a clear
theoretical risk of--well, there is a known fact that the more
antibiotics you give, the more resistance you will have.
The theoretical risk is whether those resistant organisms
that emerge in animals and persistent in animals will cause
human disease. And on that, there is some evidence, as I have
indicated several times, that it occurred in Europe, and there
is less evidence in this country.
Mr. Blunt. But, Doctor, aren't there animal antibiotic
guidelines? Am I wrong? Isn't the relative processing life of
most food animals pretty short? So the more you give in a short
period of time, I would think the veterinary medicine
guidelines would have more impact there than the more you would
give over a longer period of time. I mean, the processing time
or the production time for animal agriculture is relatively
short, and there are guidelines for the safety of animals. I
guess another question would be, are you sure you don't make
the food chain less safe by not giving the proper amounts of
additives, including antibiotics, to animal feed prints is the
question Mr. Dingell asked appropriately several times.
Dr. Frieden. So two questions, two key points to make, the
is that, unfortunately for humans, microbes divide very
rapidly. And as Dr. Fauci indicated, even the course of a 10
days antibiotic course, you can have emergence of resistance by
a variety of molecular mechanisms. So even relatively short
durations of treatment may in fact lead to widespread emergence
of drug resistance.
Second, antibiotics are not an essential nutrient. They may
increase--they do increase growth, but they are not an
essential nutrient. And there are certainly ways to keep the
food supply safe without using antibiotics to promote growth.
Mr. Blunt. I believe Mr. Dingell asked you, does the USDA
have the authority to look at animal antibiotics, and I believe
you said you didn't know, or what was your answer to that?
Dr. Frieden. Yes.
Dr. Fauci. We said yes, I can't imagine they don't have the
authority to do that. There would be no reason why any one
would prohibit them from doing that.
Mr. Blunt. Do you have the authority to look at animal
antibiotics?
Dr. Fauci. I have the authority but not the mandate; that
is not what the mandate of my institute is it to look at animal
antibiotics and the agricultural issues.
Mr. Blunt. Not the mandate, but you think you do have the
authority, but you don't have the mandate?
Dr. Fauci. Well, it depends on what you mean by the
authority. If someone comes in with the grant and wants to do
that, it is likely it would get referred to a different agency.
Mr. Blunt. But you believe the USDA does have the
authority.
Dr. Fauci. I do believe that, but I don't know for sure.
Mr. Blunt. Thank you, Mr. Chairman.
Mr. Pallone. Dr. Fauci, Mr. Shimkus and I are of the
opinion that you wanted to answer a question that you couldn't,
so would you just answer the question.
Mr. Blunt. Is this an extension of my time?
Mr. Pallone. Just answer.
Dr. Fauci. I was almost going to get to the point that, as
Dr. Frieden and I had said several times, that there is no
doubt that if you give antibiotics to an animal, a cow, bull or
whatever, you give them antibiotics in that animal, there is
unquestionably going to be the evolution of antimicrobial
resistance in that animal.
The critical question that Mr. Shimkus was getting at and
that Dr. Frieden answered with regard to a European study is
that the question that people are struggling with is that, if
you develop the antibiotic-resistant microbe in an animal who
is getting antibiotics as part of the feed, is that a danger to
the health of humans by transferring of that microbe to the
humans? And there is some data that says that that is the case;
that is European data. To my knowledge and to Dr. Frieden's
knowledge, I don't think any of those studies have been done in
the United States. So that is still something that people argue
about whether there is any significance to that.
Mr. Pallone. OK. Thank you.
The Gentlewoman from the Virgin Islands, Ms. Christensen.
Mrs. Christensen. Thank you, Mr Chairman.
Dr. Fauci, as you talk about your institute, it supports
basic research, how much of that research is done at
universities, and how many of the universities involved in
basic research are minority-serving institutions? And do you
have any--well, that question to begin with.
Dr. Fauci. About 90 percent, 89 to 90 percent of all of the
research funding that we do goes out to universities on the
outside. We fund by grants and contracts virtually all of the
primarily minority institutions. Whether or not they have
grants in antimicrobial resistance, I would have to get back to
you on that, but we readily fund primarily minority
institutions in our portfolio.
Mrs. Christensen. Another question. Last week at our Spring
Health Braintrust with the Minority Health Forum, where you
received the award last year, we had a discussion on the lack
of adequate minority participation in clinical trials and the
need for diversity. In the translational research that is being
done in this area, is it diverse enough, because given the
different environments, I would assume there are different
exposures, maybe different immunities, and maybe possibly even
different responses to antibiotics? So do you feel that in the
translational research area that we have a good representation
of minorities and women?
Dr. Fauci. It really varies. If you look at the clinical
trials that we do, for example, with HIV/AIDS, because of the
disproportionate disparity of infection among African Americans
and, to a lesser extent, Hispanics, we are over-representative
relative to the population, but equitably represented with
regard to the burden of disease. That is for a specific
disease.
It really varies. There are some clinical trials where, as
hard as we try, because of either of location of where the
trial takes place or, quite frankly, of some of the mistrust
that the minority community has----
Mrs. Christensen. We are going to really make an effort
through those two organizations and others to work on that.
Dr. Frieden, you mention in your testimony that 10 States
make up the network for EIPs, it is a similar question, are
these States that have diverse populations, so the information
that you get is reflective of the country's demographics?
Dr. Frieden. Yes, it is, they are, and it is. However, this
is an area we feel we need to continue to develop to ensure we
have adequate representation.
Mrs. Christensen. Thank you.
And you talked about helping States respond to outbreaks,
and CDC has been very helpful to the Virgin Islands in
assisting and investigating some of our outbreaks. As far as
the NHSN and the NARMs, are the territories included in that?
Dr. Frieden. I would have to get back to you.
Mrs. Christensen. If you find they are not, could you see
what you could do to make sure that we are, if it is
appropriate?
Dr. Frieden. Absolutely.
Mrs. Christensen. Thank you.
Now this question is a little different, because there is a
certain concern that I have had, but in the Patient Protection
and Affordable Care Act, which you have heard a lot about this
afternoon, there are provisions that where hospital-acquired
infections occur, the hospitals will not be reimbursed and the
providers, I assume, would not be reimbursed for the care that
is provided. And there are a lot of antimicrobial products on
the market that are used to clean surfaces in the hospitals,
and some questions have been raised and brought about whether
they are effective.
And I think it is very important if we are going to
penalize hospitals and providers to know that these
antimicrobials that are being used in the facilities are
effective. Do you have any information on whether--that would
suggest that they are not? And do you think that it would be
worthwhile for the oversight subcommittee or this subcommittee
to take a look at that question, given the importance of it
going forward with the new legislation?
Dr. Frieden. This is a complex issue.
Mrs. Christensen. I am asking both of you that question.
Dr. Frieden. One of the things that the new legislation
does is require reporting of hospital-associated infections,
and this we presume will be done through the National
Healthcare Safety Network. This is something that we believe is
an essential first step in recognizing and addressing
infections.
For some infections, like Clostridium difficile, cleaning,
environmental cleaning, may be very important. It may be
challenging because it can be hard on the equipment to do it
regularly. But this is an area where we work with others, with
the hospital systems, to identify effective strategies to
prevent the spread of infection or to stop outbreaks once they
have occurred.
Mrs. Christensen. Dr. Fauci, did you have any?
Thank you, Mr. Chairman.
I yield back the balance of my time.
Mr. Pallone. Thank you, the Gentlewoman from Illinois Ms.
Schakowsky.
Ms. Schakowsky. I want to get back to the use of
antibiotics in animals.
Both of you in your opening statements talked about and the
reason we are here are, public health problems of increasing
magnitude; serious public health challenge posed by
antimicrobial resistance. Both of you have acknowledged this is
a serious problem.
We know that most of the antibiotics that are used in the
United States are used for animals, and most of that is used
for nontherapeutic use, mainly for growth of animals. You know,
we are dancing around this because there is a lot of
opposition. This is a highly-charged political issue. And there
are many forces who think that, you know, stay out of the farm,
leave that alone. And I know that.
But I am trying to understand why we don't have an answer
to that question. If all of this use of antibiotics is going on
right now in what people are eating and we are facing a serious
health threat in this country, explain to me why there has not
been any research done in the United States that you can cite,
why we don't have an answer to this question, and why, even if
we don't have an answer to this question, why nontherapeutic
use of antibiotics is so la-de-da if potentially it has this
kind of negative effect, dangerous effect?
It feels to me like there is this threat out there; there
are so many threats that we can't totally control, but here is
one, if we know about it as a potential threat-- I mean, how
much money are we spending in the Defense Department and
Homeland Security to defend against potential threats? This is
a potential threat. At least don't you think we ought to find
out if this is a real threat? Will both of you please answer.
Dr. Frieden. I think there is no doubt, as I said before,
that there is a potential risk of spread. There is also no
doubt that this is not the only way that resistance gets into
the community. We see widespread abuse----
Ms. Schakowsky. Why don't we try and find out whether or
not this is a source of the problem? And are there any plans to
do that? I am a cosponsor of Congresswoman Slaughter's bill.
What you are saying is not responsive.
Dr. Frieden. There are several ways to study this, what we
can do is look in more detail what is currently happening, what
are the potential additional ways to get more information on
it?
Dr. Fauci.
Dr. Fauci. The simplest way to find out, because
antibiotics are used in feed for the reasons that you
mentioned. We both spoke of the theoretical risk. The real
unanswered question, definitively unanswered, is, what is the
risk----
Ms. Schakowsky. That is correct. That is what I am asking.
Dr. Fauci. So you are asking a very appropriate question,
is that, how do we get the answer to that? It would seem, since
there is widespread use of antibiotics in a nontherapeutic,
nonprophylactic feed for animal growth, that the only way you
can answer the question that you are posing is to stop doing it
and see if antimicrobial resistance goes down.
Ms. Schakowsky. Yes, that is right. And are there no farms
in which they are not using----
Dr. Fauci. Yes.
Ms. Schakowsky. So is there not some sort--are you telling
me that science cannot determine whether or not this is a risk
to human beings? Is that what you are saying?
Dr. Fauci. No, I am saying you can determine it by stopping
the use of it and seeing if the antimicrobial resistance goes
down.
Ms. Schakowsky. Is there is no laboratory way? There is no
possible way to find out? I mean, I just don't believe that.
Dr. Fauci. No, I understand your question, and I understand
your dilemma. If the question is, if an animal is given
antibiotic in the feed, will there be resistance? And I could
tell you, we could do that study, but I can tell you what the
answer is; it is going to be yes.
The question is, does that resistant microbe get out into
the community and spread into the community. That is not a very
easy thing to get the answer to unless you stop it completely
and measure for years what happens.
Ms. Schakowsky. Oh, really?
Dr. Fauci. Yes.
Ms. Schakowsky. No. If we are going to test whether or not
the fact of resistant bacteria in an animal then can transfer
to a human being----
Dr. Fauci. Right.
Ms. Schakowsky. --I mean, you can't possibly do it without
stopping----
Dr. Frieden. There are at least several ways to do that.
Ms. Schakowsky. Thank you.
Dr. Frieden. One of them is to look for the markers of
resistance and see whether the specific way that resistance has
emerged among animals is found in people in the community.
I can just give you a little more information. I mentioned
several times the European experience with the drug called
Avoparcin, which is related to Vancomycin, which is a very
effective drug that has been used to treat severe infections in
animals and people. It is the last line of defense for many
organisms. So it is very important to preserve Vancomycin for
use therapeutically.
It was used for growth promotion in food animals in Europe
in the 1970s and was gradually phased out and banned by the
European Union in 1997. It was found that community carriage of
Vancomycin-resistant strains of one particular microbe,
enterococci, which is a highly-resistant organism, was quite
common before the ban and, after the ban, gradually did
decline. That is why we can say there is strong evidence from
Europe that suggests that there is spread between feed animals
and people in that environment and that restricting the use in
that environment for that antibiotic resulted in a reduction in
the amount of resistant organisms in the community.
That type of study we would have to look more
comprehensively to see what has been done in this country and
what could be done by different means.
Ms. Schakowsky. Well, I certainly think that we ought to do
that, given the amount of antibiotics that we are feeding to
animals and therefore eating ourselves, given that we have this
problem. It is shocking to me that this kind of work doesn't
seem to even be on the table. Thank you.
Mr. Pallone. Thank you.
The vice chair, the gentlewoman from California, Ms. Capps.
Mrs. Capps. Thank you.
This has been an interesting hearing. Thank you very much.
I have a couple of questions for you, Dr. Fauci, and one,
if I have time, for Dr. Frieden.
In today's hearings, we are getting what can be perceived,
I believe, by the public as mixed messages. One hand, there is
overuse of antibiotics, but on the other hand, we do need
greater production of antibiotics as antidotes to antibiotic-
resistant strains of bacteria, new antibiotics. And of course,
underneath it all, provider and consumer education plays a role
in all of this.
How do you reconcile, this is messages for the public, how
do you reconcile these messages? And how are CDC and NIH
working to devise a comprehensive strategy to combat antibiotic
resistance by educating consumers?
Dr. Fauci. It is an excellent question, Mrs. Capps.
There are two fundamental issues. You are asking a
question, if we are concerned about antibiotic resistance, why
are we trying to make more antibiotics? Well, antibiotics are--
--
Mrs. Capps. Well, I understand why, but it is a mixed
message.
Dr. Fauci. I will try to explain. We can get away from the
mixed messages by compartmentalizing it.
You try as best as you can to prevent the emergence of
resistance by the public health measures that Dr. Frieden spoke
about.
Unfortunately, we are in a position where there are
resistant microbes out there that we are up to the last line of
defense with one and at the most two antibiotics that are
useful. So there is a clear need to fill, to feed into the
pipeline for new antimicrobials.
So I look at it as not a mixed message; we need to do two
things simultaneously. We need to put the lid on the evolution
and the development of antimicrobial resistance; and then we
have got to have a pipeline of drugs to take them. So the
message is, we have to get more antibiotics, but we have got to
prevent further evolution of resistance.
Mrs. Capps. Do you have a public message that you are
putting out for the public on ways to not go and keep asking
your doctor for something for a sore throat and so forth, that
kind of thing? Is that being done? The PSAs and so forth? I
will assume that is happening.
Now from the other side, because I want to get at the
concern that has been raised about--you know, I appreciate the
history of the story of the development of penicillin. But
pharmacology, pharmaceutical companies are very much working
from more of a profit motive today than perhaps they were when
some of these initial antibiotics came on to the market, just
because they were out of their way to be developed.
Dr. Fauci, can you elaborate on the pathway that you
illustrated in your sides from basic research to private
development? I would like to know how you are collaborating
with private industry in this area, which you noted isn't
necessarily the first area that private industry would like to
invest in. In other words, you really want some antibiotics to
fight these resistant--to fight the MRSAs and other resistant
diseases. How can you, how can we incentivize them to do this?
Dr. Fauci. I can give you actually a concrete, real-time,
real-life example of how we have done that with one particular
finding. Since we are involved fundamentally in pursuing and
supporting basic research for concept development, we have
funded a group of investigators from several of our centers.
And they have found a small molecule which has the capability
of inhibiting essentially any virus that has a lipid component
to its envelope or its outer coating, potentially a really,
really important advance. They have no----
Mrs. Capps. Where did you do this, at NIH? You have done
this?
Dr. Fauci. We funded them at a university.
Mrs. Capps. OK. Great.
Dr. Fauci. They made the discovery. So how we are
partnering with industry and biotech is that we are providing
the resource reagents, the animal models, the capabilities to
do a phase one clinical trial for those investigators and
hooking them up with biotech companies and then, ultimately,
Pharma in order to take what was just a concept into something
that might actually be a product. And when, I hope, this comes
to fruition of a product, and if and when it does, we are going
to provide the clinical trial capabilities to test it in people
to see if it works.
So we are really forming a partnership that goes right from
the investigator who makes the original observation and
develops the concept, up through and including the translation
of that through biotech and industry.
Mrs. Capps. And you have a commitment from biotech and
industry, because they see the kind of research that you are
incentivizing at the university level, if you will, and so they
are committed already?
Dr. Fauci. We hope they are committed and stay in the game.
If we make--and that was the point I was making in answer to
several questions. If we can facilitate that difficult process
from concept to product by any way we can, by making our assets
available, other things beyond our control, such as financial
incentives, et cetera, it makes that transition from concept to
product much easier. We play an important but not an exclusive
role in that. There are other components that have to come in
to do that.
Mrs. Capps. Thank you very much. That is helpful.
I have a question for you, Dr. Frieden, but I am out of
time so we will wait for the next hearing. Thank you very much.
Mr. Pallone. Thank you.
The gentlewoman from Florida, Ms. Castor.
Ms. Castor. Thank you, Mr. Chairman.
I am interested in whether or not you are able to
accumulate enough data to track what is obviously a major
public health issue, one that has deadly consequences for so
many. When I look at the estimates, we have estimates in the
number of antibiotic-resistant infections, and then we have
estimates in the number of health-care-associated infections.
The CDC's most recent data is that, in the U.S., every year
it is about 2 million hospital-related infections, and about
90,000 Americans die from that. And then the other one included
in our materials, in America, there are annually about 94,000
cases of MRSA every year with 18,000 deaths from MRSA.
Doctors, do these figures sound about right for you? Is it
fair from these figures to conclude that over 100,000 Americans
die each year due to antibiotic resistant?
Dr. Frieden. Large numbers. I think the estimate that you
gave was 90,000, which is an estimate that has been used
before.
As I indicated in my opening statement, there has been
progress in MRSA where we have seen a decrease of about 50
percent in serious infections in the hospitals that participate
in the National Healthcare Safety Network.
Ms. Castor. So how is the data collected for you to compile
these numbers and estimates?
Dr. Frieden. We have two major methods. The one that is
more widespread is the National Healthcare Safety Network. This
builds on really more than a decade of experience working with
hospitals, working with infection-control practitioners,
standardizing definitions, encouraging reporting. And now we
have 28 States which mandate reporting; 21 of them use the NHSN
infrastructure to report. And about half of all hospitals in
the United States currently are on board, including many
hospitals in States that don't require a reporting publicly
yet. And that reporting we expect to see expand nationally over
the next couple of years.
Mrs. Capps. Why would States not mandate that? And why
would hospitals not?
Dr. Frieden. It is a recent phenomenon. So 5, 10 years ago,
no State mandated it. Again, in a few States, it has been
gradually spreading. It is concerning to hospitals. They are
worried about reporting from a reputational risk. And the
approach has been to make clear that reporting is a good thing,
because it helps us to identify problems and then address them.
Ms. Castor. So with the estimates that you have now,
knowing that some is not reported and some States don't mandate
it, do you extrapolate?
Dr. Frieden. Yes. These are extrapolated from both NHSN and
also a network called the ABCs, which allows us to monitor
antibiotic resistance to a series of core infections in a
representative sample across the country.
Ms. Castor. Should it now become a reportable disease?
Dr. Frieden. Certain strains are mandatorily reportable.
There are some that are so common that reporting probably
wouldn't be worth the burden, and sampling may be more
effective. But for many organisms, reporting--mandatory
reporting is something that is recommended by the Council of
State and Territorial Epidemiologists, and is done in most or
all States.
Ms. Castor. It sounds like we can do a lot better. What are
you working on or what recommendations do you have to improve
reporting so that we are able to track with adequate data?
Dr. Frieden. Thank you. All excellent questions.
One of the things that we have done is to try to use
electronic health records to extract information which then is
validated a human being but would allow us to ensure that
infections are reported reliably or assess the completeness of
reporting. One of the things that is essential to make that
happen is electronic reporting. So when a laboratory gets a
result, it ends up in the medical record. If it is a reportable
condition, it ends up with the authorities to which it should
be reported.
We also fundamentally need to make better use of the
information so that we implement the programs that we know
work, and there are some programs that we know can drastically
reduce central-line associated infections and other hospital-
associated infections; and that we continue to generate
knowledge so we can better prevent problems that we don't yet
have good tools to prevent, such as community-associated
Methicillin-resistant Staph aureus.
Ms. Castor. Doctor, do you want to comment on the data
tracking?
Well, I wanted to say, in my district back home, we have a
researcher that is working on the antibiotic resistance, and
he--this is Dr. Turos at the University of South Florida. And
his research is MRSA-based, and he is particularly looking at
the design and development of nanoparticle-based technology for
drug delivery. But in his comments to me in advance of the
hearing, he was right on point with what you all are saying of
what happens from the basic research level, and then turning
that into some kind of new antibiotic. So it is a real issue,
along with the lack of funding at NIH, CDC, and DOD in this
area. He says it is practically nonexistent, and we simply
cannot get the private companies to take any interest.
Thank you very much.
Mr. Pallone. Thank you.
Gentlemen, Mr. Shimkus wanted to ask an additional
question. And then if anybody else does, I will allow it,
because I don't want to have another round, but I know there is
a great deal of interest here.
So I will recognize the gentleman from Illinois.
Mr. Shimkus. Thank you.
And we talked about the CDC, NIH, FDA, USDA. And then,
through this hearing, I remembered that the copper industry had
been working with the Department of Defense to test copper as
an antimicrobial--however you say it--killer, antimicrobial
killer. And so EPA has just certified--the Environmental
Protection Agency approved the registration by the Copper
Development Association for copper and copper alloys to make
public health claims as being antimicrobial. These claims
acknowledge the fact that copper is inherently capable of
killing bacteria.
Have you guys done any look at that? And should you? Is
that something that CDC or NIH--or is this the problem with--I
mean, the Federal Government is huge, and we are doing
different things.
Dr. Fauci. Well, let me try to answer it. It may not be the
direct answer that you are asking for, but there are a lot of
elements that can have antimicrobial activity. The question is
to get it into a drug that would not be toxic. That is the
issue.
Mr. Shimkus. But this is making a claim that copper being
used on surfaces kills microbes. This is what--and I think we
have Federal dollars doing research in DOD through the
Department of Defense. All I would say is, you know----
Mr. Pallone. You want to get back to us?
Mr. Shimkus. That is out there. The EPA has said that they
can make that claim.
Mr. Pallone. Why don't you get back to us?
Dr. Fauci. We will do.
Mr. Pallone. Mrs. Capps, did you want to ask your
additional question?
Mrs. Capps. And I don't want to keep you, because you have
already waited most of the afternoon anyway. But my question,
and it kind of ties in with before and it can come up in
another hearing we might have as well. I was just curious,
because, according to the National Antimicrobial Resistance
Monitoring System Data, and that is a mouthful, at least 80
percent of meat and poultry products are tainted with some kind
of antibiotic-resistant bacteria. At least that is a study that
has been out there. Can I use that as a basis of fact then,
that fact?
Dr. Frieden. I am not familiar with that specific
statistic.
Mrs. Capps. OK, well, maybe we will make the assumption,
since this is a National Antimicrobial Resistance Monitoring
System Data, and they did state that at least 80 percent of
meat and poultry products are tainted with antibiotic-resistant
bacteria. Tainted. I don't know what level.
My question was that, what bacteria are we testing for in
our food? Are we doing any kind of antibiotic-resistant
pathogens, like staph or like MRSA, Methicillin-Resistant Staph
MRSA? Is it possible to test for any markers or any kind of
fact that this might be in food products?
Dr. Frieden. These are all relatively easily tested for in
small quantities. If you want to test a large proportion of the
food supply, there obviously are logistical and financial
implications. This really is the territory of the FDA.
Mrs. Capps. I understand that. But just from the science
point of view, and you don't have to agree with the study.
Dr. Frieden. I am not disagreeing. I just don't know.
Mrs. Capps. We can just take that off the table. But
supposing something like that is true, there is the science to
be able to pick up the markers or tests within food products?
And, again, I am not suggesting that we should, because I
understand--and this belongs to another department. But there
is concern about the spread of MRSA and whether or not it is
there. And there is a possibility that some research in another
department like Food and Drug Administration could do this.
Dr. Frieden. Yes.
Dr. Fauci. It is scientifically possible. It is a
logistical issue. It is very difficult at FDA to test broadly,
and they only have the capability and the logistical capability
of taking a very small fraction.
Mrs. Capps. Exactly. Thank you very much. And that
completes.
Mr. Pallone. Thank you.
Dr. Burgess, do I dare ask if you have another question?
Mr. Burgess. Of course, you can.
I just would like to hear from one or both of you, just
what are some of the things you see over the horizon, just very
quickly, that this committee should be aware of?
Dr. Fauci, you referenced a couple of things with genomics
and being able to sequence things very rapidly. We didn't
really get into the diagnostics part of this. We only talked
about the vaccine part of this. But just very briefly, what is
over the horizon that you guys see on a daily basis that we
wouldn't be aware of?
Dr. Frieden. I think, in terms of practice, the first thing
is to scale up the proven means of reducing hospital-associated
infections and reducing inappropriate antibiotic use. This is
something which we have made progress in, but we could make a
lot more progress in.
And I have to say, because there has been a lot of
discussion of antibiotics in animal feed and use for growth
promotion and feed efficiency, that we do not consider use to
promote growth an example of judicious use of antibiotics.
I think the directions we are going are, first, to apply
the things we know well to reduce infections. And I think we
have a lot farther to go there; and second, to continue to
generate knowledge on how we can reduce infections through
programs, such as hospital-associated programs, electronic
health records, reminder systems, control systems that will
support doctors in restricting use of antibiotics, and, as Dr.
Fauci mentioned, point-of-care diagnostics, which are very
important in helping a doctor know right there, if the kid
doesn't have strep throat, you don't have to treat them for
strep throat.
Mr. Pallone. OK.
You know, we obviously may ask additional written
questions. We will try to get them to you in the next 10 days
or so, which is the normal routine.
But members are free to send more written questions or
comments to you. So I just want you to be aware of that.
But I do thank you. I mean, this was a very good hearing.
And obviously, members are very concerned about the issue, and
the work that you are doing is very crucial.
Thank you very much for your participation. And, without
objection, the meeting of the subcommittee is adjourned.
[Whereupon, at 5:50 p.m., the subcommittee was adjourned.]
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