[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

                        energycommerce.house.gov




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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

                              ----------                              
                                                                   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

                              ----------                              


                       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:]
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    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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